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Complete Atrioventricular Nodal Block Due to Malignancy-Related Hypercalcemia
Complete atrioventricular (AV) block can occur due to structural or functional causes. Common structural etiologies include sclerodegenerative disease of the conduction system, ischemic heart disease in the acute or chronic setting, infiltrative myocardial disease, congenital heart disease, and cardiac surgery. Reversible etiologies of complete AV block include drug overdose and electrolyte abnormalities. In the following case study, the authors present a rare case of complete AV block caused by severe hypercalcemia related to malignancy that completely normalized after treatment of the hypercalcemia.
Case Report
A 63-year-old African-American man with metastatic carcinoma of the lungs (Figure 1) with unknown primary cancer was found to have a serum calcium level of 17.5 mg/dL (reference range:8.4-10.2 mg/dL) on routine preoperative laboratory testing prior to placement of a surgical port for chemotherapy. The patient also was noted to have a slow heart rate, and his electrocardiogram revealed a third-degree AV block with an escape rhythm at 29 bpm with a prolonged corrected QT (QTc) of 556 ms (Figure 2).
Although the patient reported nonspecific symptoms of fatigue, anorexia, dysphagia, and weight loss for 3 months, there were no new symptoms of dizziness, chest discomfort, or syncope. His past medical history included hypertension, hyperlipidemia, chronic kidney disease, obstructive sleep apnea, and the recently discovered bilateral lung metastasis. The patient reported no prior history of cardiac arrhythmias, coronary artery disease, or structural heart defects. His outpatient medications included aspirin, amlodipine, bupropion, hydralazine, and simvastatin.
At the physical examination the patient was cachectic but in no apparent distress. His heart rate escape rhythm was 29 bpm, with no murmurs and mildly reduced breath sounds. The patient’s blood pressure was 110/70. After correction for albumin, the serum calcium level was 17.8 mg/dL; ionized calcium level was 8.6 mg/dL; parathyroid hormone was 7.6 pg/mL (normal range, 12-88 pg/mL); parathyroid hormone-related protein was 6.4 pmol/L (normal range, < 2.0 pmol/L); potassium was 3.4 mmol/L (normal range, 3.5 – 5.1 mmol/L); and magnesium was 2.01 mg/dL. The patient’s thyroid stimulating hormone level was normal, and serial cardiac enzymes stayed within the reference range.
The patient was admitted to a cardiac care unit. A temporary transvenous pacemaker was placed, and the hypercalcemia was treated with aggressive fluid hydration, calcitonin, and zoledronic acid. Serum calcium gradually decreased to 14.6 mg/dL the following day and 9.6 mg/dL the subsequent day. The normalization of calcium resulted in resolution of complete heart block (Figure 3). The patient did not experience recurrence of AV nodal dysfunction and eventually died 3 months later due to his advanced metastatic disease.
Discussion
The reported cardiovascular effects of hypercalcemia include hypertension, arrhythmias, increased myocardial contractility at serum calcium level below 15 mg/dL, and myocardial depression above that level. Electrocardiographic manifestations of hypercalcemia include a shortened ST segment leading to a short corrected QT interval (QTc), slight increase in T wave duration, and rarely, Osborn waves or J waves.1-3 However, its influence on the AV node is less clear.
One small study assessed the prevalence of cardiac arrhythmias and conduction disturbances in 20 patients with hyperparathyroidism and moderate hypercalcemia and found no increase in the frequency of arrhythmias or high grade AV block.4
There are reports of conduction abnormality secondary to experimentally induced hypercalcemia in the literature. Hoff and colleagues described findings of AV block generated by the injection of IV calcium in dogs.5 In 2 human subjects, sinus bradycardia was precipitated after they received IV infusion of calcium gluconate.6 Shah and colleagues described 2 patients with sinus node dysfunction attributed to hypercalcemia secondary to hyperparathyroidism.7
Case reports of AV nodal dysfunction provoked by hypercalcemia have primarily occurred in the setting of primary hyperparathyroidism.8,9 Milk-alkali syndrome and vitamin D related hypercalcemia also have been reported to cause complete heart block.10,11 Reports of malignancy-related hypercalcemia causing conduction abnormalities are rare. The authors also found one case report of marked sinus bradycardia due to hypercalcemia related to breast cancer.12The case study presented in this report is rare because the patient developed complete AV block due to malignancy-related hypercalcemia that resolved completely with resolution of hypercalcemia. The prolongation of the QTc interval was another unique electrocardiographic change observed in this case. Calcium levels are inversely proportional to the QTc interval, and hypercalcemia is typically associated with a shortened QTc interval. However, this patient had a prolonged QTc without any other clear-cut cause. His hypokalemia was of a mild degree and not severe enough to produce such a long QTc interval. A possible explanation of QTc prolongation may be an increase in the T wave width associated with a serum calcium level above 16 mg/dL.
The pathophysiology of hypercalcemia-induced AV nodal conduction system disease is unknown. Calcium deposition in AV nodes of elderly patients has been associated with paroxysmal 2:1 AV block.8 It could be postulated that elevated serum calcium levels predispose to calcium deposition in cardiac conduction tissue, leading to progressive dysfunction. Although this theory may be applicable in a chronic setting, the mechanism in an acute setting likely relates to elevated serum levels of calcium that causes an alteration in electrochemical gradients. These elevated serum levels also increase intracellular calcium. This rise may result in increased calmodulin activation on the intracellular portion of the myocyte cell membrane and consequent enhanced sodium channel activation, which may then inhibit AV nodal conduction.13
Conclusion
Physicians should be aware that severe hypercalcemia can cause significant conduction system alterations, including complete AV block. A short QTc interval is typical, but a prolonged QTc interval also may be seen. While temporary support with a transvenous pacemaker may be needed, the conduction system abnormality is expected to resolve by treatment of the underlying hypercalcemia.
1. Nierenberg DW, Ransil BJ. Q-aTc interval as a clinical indicator of hypercalcemia. Am J Cardiol. 1979;44(2):243-248.
2. Bronsky D, Dubin A, Waldstein SS, Kushner DS. Calcium and the electrocardiogram II. The electrocardiographic manifestations of hyperparathyroidism and of marked hypercalcemia from various other etiologies. Am J Cardiol. 1961;7(6):833-839.
3. Otero J, Lenihan DJ. The "normothermic" Osborn wave induced by severe hypercalcemia. Tex Heart Inst J. 2000;27(3):316-317.
4. Rosenqvist M, Nordenström J, Andersson M, Edhag OK. Cardiac conduction inpatients with hypercalcaemia due to primary hyperparathyroidism. Clin Endocrinol (Oxf). 1992;37(1):29-33.
5. Hoff H, Smith P, Winkler A. Electrocardiographic changes and concentration of calcium in serum following injection of calcium chloride. Am J Physiol. 1939;125:162-171.
6. Howard JE, Hopkins TR, Connor TB. The use of intravenous calcium as a measure of activity of the parathyroid glands. Trans Assoc Am Physicians. 1952;65:351-358.
7. Shah AP, Lopez A, Wachsner RY, Meymandi SK, El-Bialy AK, Ichiuji AM. Sinus node dysfunction secondary to hyperparathyroidism. J Cardiovasc Pharmacol Ther. 2004;9(2):145-147.
8. Vosnakidis A, Polymeropoulos K, Zaragoulidis P, Zarifis I. Atrioventricular nodal dysfunction secondary to hyperparathyroidism. J Thoracic Dis. 2013;5(3):E90-E92.
9. Crum WB, Till HJ. Hyperparathyroidism with Wenckebach's phenomenon. Am J Cardiol. 1960;6:838-840.
10. Ginsberg H, Schwarz KV. Letter: hypercalcemia and complete heart block. Ann Intern Med. 1973;79(6):903.
11. Garg G, Khadgwat R, Khandelwal D, Gupta N. Vitamin D toxicity presenting as hypercalcemia and complete heart block: an interesting case report. Indian J Endocrinol Metab. 2012;16 (suppl 2):S423-S425.
12. Badertscher E, Warnica JW, Ernst DS. Acute hypercalcemia and severe bradycardia in a patient with breast cancer. CMAJ. 1993;148(9):1506-1508.
13. Potet F, Chagot B, Anghelescu M, et al. Functional interactions between distinct sodium channel cytoplasmic domains through the action of calmodulin. J Biol Chem. 2009;284(13):8846-8854.
Complete atrioventricular (AV) block can occur due to structural or functional causes. Common structural etiologies include sclerodegenerative disease of the conduction system, ischemic heart disease in the acute or chronic setting, infiltrative myocardial disease, congenital heart disease, and cardiac surgery. Reversible etiologies of complete AV block include drug overdose and electrolyte abnormalities. In the following case study, the authors present a rare case of complete AV block caused by severe hypercalcemia related to malignancy that completely normalized after treatment of the hypercalcemia.
Case Report
A 63-year-old African-American man with metastatic carcinoma of the lungs (Figure 1) with unknown primary cancer was found to have a serum calcium level of 17.5 mg/dL (reference range:8.4-10.2 mg/dL) on routine preoperative laboratory testing prior to placement of a surgical port for chemotherapy. The patient also was noted to have a slow heart rate, and his electrocardiogram revealed a third-degree AV block with an escape rhythm at 29 bpm with a prolonged corrected QT (QTc) of 556 ms (Figure 2).
Although the patient reported nonspecific symptoms of fatigue, anorexia, dysphagia, and weight loss for 3 months, there were no new symptoms of dizziness, chest discomfort, or syncope. His past medical history included hypertension, hyperlipidemia, chronic kidney disease, obstructive sleep apnea, and the recently discovered bilateral lung metastasis. The patient reported no prior history of cardiac arrhythmias, coronary artery disease, or structural heart defects. His outpatient medications included aspirin, amlodipine, bupropion, hydralazine, and simvastatin.
At the physical examination the patient was cachectic but in no apparent distress. His heart rate escape rhythm was 29 bpm, with no murmurs and mildly reduced breath sounds. The patient’s blood pressure was 110/70. After correction for albumin, the serum calcium level was 17.8 mg/dL; ionized calcium level was 8.6 mg/dL; parathyroid hormone was 7.6 pg/mL (normal range, 12-88 pg/mL); parathyroid hormone-related protein was 6.4 pmol/L (normal range, < 2.0 pmol/L); potassium was 3.4 mmol/L (normal range, 3.5 – 5.1 mmol/L); and magnesium was 2.01 mg/dL. The patient’s thyroid stimulating hormone level was normal, and serial cardiac enzymes stayed within the reference range.
The patient was admitted to a cardiac care unit. A temporary transvenous pacemaker was placed, and the hypercalcemia was treated with aggressive fluid hydration, calcitonin, and zoledronic acid. Serum calcium gradually decreased to 14.6 mg/dL the following day and 9.6 mg/dL the subsequent day. The normalization of calcium resulted in resolution of complete heart block (Figure 3). The patient did not experience recurrence of AV nodal dysfunction and eventually died 3 months later due to his advanced metastatic disease.
Discussion
The reported cardiovascular effects of hypercalcemia include hypertension, arrhythmias, increased myocardial contractility at serum calcium level below 15 mg/dL, and myocardial depression above that level. Electrocardiographic manifestations of hypercalcemia include a shortened ST segment leading to a short corrected QT interval (QTc), slight increase in T wave duration, and rarely, Osborn waves or J waves.1-3 However, its influence on the AV node is less clear.
One small study assessed the prevalence of cardiac arrhythmias and conduction disturbances in 20 patients with hyperparathyroidism and moderate hypercalcemia and found no increase in the frequency of arrhythmias or high grade AV block.4
There are reports of conduction abnormality secondary to experimentally induced hypercalcemia in the literature. Hoff and colleagues described findings of AV block generated by the injection of IV calcium in dogs.5 In 2 human subjects, sinus bradycardia was precipitated after they received IV infusion of calcium gluconate.6 Shah and colleagues described 2 patients with sinus node dysfunction attributed to hypercalcemia secondary to hyperparathyroidism.7
Case reports of AV nodal dysfunction provoked by hypercalcemia have primarily occurred in the setting of primary hyperparathyroidism.8,9 Milk-alkali syndrome and vitamin D related hypercalcemia also have been reported to cause complete heart block.10,11 Reports of malignancy-related hypercalcemia causing conduction abnormalities are rare. The authors also found one case report of marked sinus bradycardia due to hypercalcemia related to breast cancer.12The case study presented in this report is rare because the patient developed complete AV block due to malignancy-related hypercalcemia that resolved completely with resolution of hypercalcemia. The prolongation of the QTc interval was another unique electrocardiographic change observed in this case. Calcium levels are inversely proportional to the QTc interval, and hypercalcemia is typically associated with a shortened QTc interval. However, this patient had a prolonged QTc without any other clear-cut cause. His hypokalemia was of a mild degree and not severe enough to produce such a long QTc interval. A possible explanation of QTc prolongation may be an increase in the T wave width associated with a serum calcium level above 16 mg/dL.
The pathophysiology of hypercalcemia-induced AV nodal conduction system disease is unknown. Calcium deposition in AV nodes of elderly patients has been associated with paroxysmal 2:1 AV block.8 It could be postulated that elevated serum calcium levels predispose to calcium deposition in cardiac conduction tissue, leading to progressive dysfunction. Although this theory may be applicable in a chronic setting, the mechanism in an acute setting likely relates to elevated serum levels of calcium that causes an alteration in electrochemical gradients. These elevated serum levels also increase intracellular calcium. This rise may result in increased calmodulin activation on the intracellular portion of the myocyte cell membrane and consequent enhanced sodium channel activation, which may then inhibit AV nodal conduction.13
Conclusion
Physicians should be aware that severe hypercalcemia can cause significant conduction system alterations, including complete AV block. A short QTc interval is typical, but a prolonged QTc interval also may be seen. While temporary support with a transvenous pacemaker may be needed, the conduction system abnormality is expected to resolve by treatment of the underlying hypercalcemia.
Complete atrioventricular (AV) block can occur due to structural or functional causes. Common structural etiologies include sclerodegenerative disease of the conduction system, ischemic heart disease in the acute or chronic setting, infiltrative myocardial disease, congenital heart disease, and cardiac surgery. Reversible etiologies of complete AV block include drug overdose and electrolyte abnormalities. In the following case study, the authors present a rare case of complete AV block caused by severe hypercalcemia related to malignancy that completely normalized after treatment of the hypercalcemia.
Case Report
A 63-year-old African-American man with metastatic carcinoma of the lungs (Figure 1) with unknown primary cancer was found to have a serum calcium level of 17.5 mg/dL (reference range:8.4-10.2 mg/dL) on routine preoperative laboratory testing prior to placement of a surgical port for chemotherapy. The patient also was noted to have a slow heart rate, and his electrocardiogram revealed a third-degree AV block with an escape rhythm at 29 bpm with a prolonged corrected QT (QTc) of 556 ms (Figure 2).
Although the patient reported nonspecific symptoms of fatigue, anorexia, dysphagia, and weight loss for 3 months, there were no new symptoms of dizziness, chest discomfort, or syncope. His past medical history included hypertension, hyperlipidemia, chronic kidney disease, obstructive sleep apnea, and the recently discovered bilateral lung metastasis. The patient reported no prior history of cardiac arrhythmias, coronary artery disease, or structural heart defects. His outpatient medications included aspirin, amlodipine, bupropion, hydralazine, and simvastatin.
At the physical examination the patient was cachectic but in no apparent distress. His heart rate escape rhythm was 29 bpm, with no murmurs and mildly reduced breath sounds. The patient’s blood pressure was 110/70. After correction for albumin, the serum calcium level was 17.8 mg/dL; ionized calcium level was 8.6 mg/dL; parathyroid hormone was 7.6 pg/mL (normal range, 12-88 pg/mL); parathyroid hormone-related protein was 6.4 pmol/L (normal range, < 2.0 pmol/L); potassium was 3.4 mmol/L (normal range, 3.5 – 5.1 mmol/L); and magnesium was 2.01 mg/dL. The patient’s thyroid stimulating hormone level was normal, and serial cardiac enzymes stayed within the reference range.
The patient was admitted to a cardiac care unit. A temporary transvenous pacemaker was placed, and the hypercalcemia was treated with aggressive fluid hydration, calcitonin, and zoledronic acid. Serum calcium gradually decreased to 14.6 mg/dL the following day and 9.6 mg/dL the subsequent day. The normalization of calcium resulted in resolution of complete heart block (Figure 3). The patient did not experience recurrence of AV nodal dysfunction and eventually died 3 months later due to his advanced metastatic disease.
Discussion
The reported cardiovascular effects of hypercalcemia include hypertension, arrhythmias, increased myocardial contractility at serum calcium level below 15 mg/dL, and myocardial depression above that level. Electrocardiographic manifestations of hypercalcemia include a shortened ST segment leading to a short corrected QT interval (QTc), slight increase in T wave duration, and rarely, Osborn waves or J waves.1-3 However, its influence on the AV node is less clear.
One small study assessed the prevalence of cardiac arrhythmias and conduction disturbances in 20 patients with hyperparathyroidism and moderate hypercalcemia and found no increase in the frequency of arrhythmias or high grade AV block.4
There are reports of conduction abnormality secondary to experimentally induced hypercalcemia in the literature. Hoff and colleagues described findings of AV block generated by the injection of IV calcium in dogs.5 In 2 human subjects, sinus bradycardia was precipitated after they received IV infusion of calcium gluconate.6 Shah and colleagues described 2 patients with sinus node dysfunction attributed to hypercalcemia secondary to hyperparathyroidism.7
Case reports of AV nodal dysfunction provoked by hypercalcemia have primarily occurred in the setting of primary hyperparathyroidism.8,9 Milk-alkali syndrome and vitamin D related hypercalcemia also have been reported to cause complete heart block.10,11 Reports of malignancy-related hypercalcemia causing conduction abnormalities are rare. The authors also found one case report of marked sinus bradycardia due to hypercalcemia related to breast cancer.12The case study presented in this report is rare because the patient developed complete AV block due to malignancy-related hypercalcemia that resolved completely with resolution of hypercalcemia. The prolongation of the QTc interval was another unique electrocardiographic change observed in this case. Calcium levels are inversely proportional to the QTc interval, and hypercalcemia is typically associated with a shortened QTc interval. However, this patient had a prolonged QTc without any other clear-cut cause. His hypokalemia was of a mild degree and not severe enough to produce such a long QTc interval. A possible explanation of QTc prolongation may be an increase in the T wave width associated with a serum calcium level above 16 mg/dL.
The pathophysiology of hypercalcemia-induced AV nodal conduction system disease is unknown. Calcium deposition in AV nodes of elderly patients has been associated with paroxysmal 2:1 AV block.8 It could be postulated that elevated serum calcium levels predispose to calcium deposition in cardiac conduction tissue, leading to progressive dysfunction. Although this theory may be applicable in a chronic setting, the mechanism in an acute setting likely relates to elevated serum levels of calcium that causes an alteration in electrochemical gradients. These elevated serum levels also increase intracellular calcium. This rise may result in increased calmodulin activation on the intracellular portion of the myocyte cell membrane and consequent enhanced sodium channel activation, which may then inhibit AV nodal conduction.13
Conclusion
Physicians should be aware that severe hypercalcemia can cause significant conduction system alterations, including complete AV block. A short QTc interval is typical, but a prolonged QTc interval also may be seen. While temporary support with a transvenous pacemaker may be needed, the conduction system abnormality is expected to resolve by treatment of the underlying hypercalcemia.
1. Nierenberg DW, Ransil BJ. Q-aTc interval as a clinical indicator of hypercalcemia. Am J Cardiol. 1979;44(2):243-248.
2. Bronsky D, Dubin A, Waldstein SS, Kushner DS. Calcium and the electrocardiogram II. The electrocardiographic manifestations of hyperparathyroidism and of marked hypercalcemia from various other etiologies. Am J Cardiol. 1961;7(6):833-839.
3. Otero J, Lenihan DJ. The "normothermic" Osborn wave induced by severe hypercalcemia. Tex Heart Inst J. 2000;27(3):316-317.
4. Rosenqvist M, Nordenström J, Andersson M, Edhag OK. Cardiac conduction inpatients with hypercalcaemia due to primary hyperparathyroidism. Clin Endocrinol (Oxf). 1992;37(1):29-33.
5. Hoff H, Smith P, Winkler A. Electrocardiographic changes and concentration of calcium in serum following injection of calcium chloride. Am J Physiol. 1939;125:162-171.
6. Howard JE, Hopkins TR, Connor TB. The use of intravenous calcium as a measure of activity of the parathyroid glands. Trans Assoc Am Physicians. 1952;65:351-358.
7. Shah AP, Lopez A, Wachsner RY, Meymandi SK, El-Bialy AK, Ichiuji AM. Sinus node dysfunction secondary to hyperparathyroidism. J Cardiovasc Pharmacol Ther. 2004;9(2):145-147.
8. Vosnakidis A, Polymeropoulos K, Zaragoulidis P, Zarifis I. Atrioventricular nodal dysfunction secondary to hyperparathyroidism. J Thoracic Dis. 2013;5(3):E90-E92.
9. Crum WB, Till HJ. Hyperparathyroidism with Wenckebach's phenomenon. Am J Cardiol. 1960;6:838-840.
10. Ginsberg H, Schwarz KV. Letter: hypercalcemia and complete heart block. Ann Intern Med. 1973;79(6):903.
11. Garg G, Khadgwat R, Khandelwal D, Gupta N. Vitamin D toxicity presenting as hypercalcemia and complete heart block: an interesting case report. Indian J Endocrinol Metab. 2012;16 (suppl 2):S423-S425.
12. Badertscher E, Warnica JW, Ernst DS. Acute hypercalcemia and severe bradycardia in a patient with breast cancer. CMAJ. 1993;148(9):1506-1508.
13. Potet F, Chagot B, Anghelescu M, et al. Functional interactions between distinct sodium channel cytoplasmic domains through the action of calmodulin. J Biol Chem. 2009;284(13):8846-8854.
1. Nierenberg DW, Ransil BJ. Q-aTc interval as a clinical indicator of hypercalcemia. Am J Cardiol. 1979;44(2):243-248.
2. Bronsky D, Dubin A, Waldstein SS, Kushner DS. Calcium and the electrocardiogram II. The electrocardiographic manifestations of hyperparathyroidism and of marked hypercalcemia from various other etiologies. Am J Cardiol. 1961;7(6):833-839.
3. Otero J, Lenihan DJ. The "normothermic" Osborn wave induced by severe hypercalcemia. Tex Heart Inst J. 2000;27(3):316-317.
4. Rosenqvist M, Nordenström J, Andersson M, Edhag OK. Cardiac conduction inpatients with hypercalcaemia due to primary hyperparathyroidism. Clin Endocrinol (Oxf). 1992;37(1):29-33.
5. Hoff H, Smith P, Winkler A. Electrocardiographic changes and concentration of calcium in serum following injection of calcium chloride. Am J Physiol. 1939;125:162-171.
6. Howard JE, Hopkins TR, Connor TB. The use of intravenous calcium as a measure of activity of the parathyroid glands. Trans Assoc Am Physicians. 1952;65:351-358.
7. Shah AP, Lopez A, Wachsner RY, Meymandi SK, El-Bialy AK, Ichiuji AM. Sinus node dysfunction secondary to hyperparathyroidism. J Cardiovasc Pharmacol Ther. 2004;9(2):145-147.
8. Vosnakidis A, Polymeropoulos K, Zaragoulidis P, Zarifis I. Atrioventricular nodal dysfunction secondary to hyperparathyroidism. J Thoracic Dis. 2013;5(3):E90-E92.
9. Crum WB, Till HJ. Hyperparathyroidism with Wenckebach's phenomenon. Am J Cardiol. 1960;6:838-840.
10. Ginsberg H, Schwarz KV. Letter: hypercalcemia and complete heart block. Ann Intern Med. 1973;79(6):903.
11. Garg G, Khadgwat R, Khandelwal D, Gupta N. Vitamin D toxicity presenting as hypercalcemia and complete heart block: an interesting case report. Indian J Endocrinol Metab. 2012;16 (suppl 2):S423-S425.
12. Badertscher E, Warnica JW, Ernst DS. Acute hypercalcemia and severe bradycardia in a patient with breast cancer. CMAJ. 1993;148(9):1506-1508.
13. Potet F, Chagot B, Anghelescu M, et al. Functional interactions between distinct sodium channel cytoplasmic domains through the action of calmodulin. J Biol Chem. 2009;284(13):8846-8854.
Peer Technical Consultant: Veteran-Centric Technical Support Model for VA Home-Based Telehealth Programs
With an increasing demand for mental health services for veterans in rural clinics, telehealth can deliver services to veterans at home or in other nonclinic settings. Telehealth can reduce demands on VA clinic space and staff required for traditional videoconferencing.
Clinic-based telemental health started at the VA in 2003 and has provided access to more than 1 million appointments.1 Despite the great strides in accessibility, logistic barriers limit expansion of clinic-based telehealth appointments. A VA staff member at the patient site must be available to “greet and seat” the veteran; scheduling requires 2 separate appointments (on patient and provider sites); and limited telehealth equipment and clinic space need to be reserved ahead of time.
The first known use of telehealth technologies to deliver mental health services within the VA network information technology system to at-home veterans occurred in 2009 at the VA Portland Health Care System (VAPORHCS) in Oregon. Between 2010 and 2013, the VAPORHCS Home-Based Telemental Health (HBTMH) pilot served about 82 veterans through about 740 appointments. The HBTMH pilot transitioned from a single facility to a regional implementation model under an Office of Innovation Grant Innovation #669: Home-Based Telemental Health (Innovation), which served about 84 veterans from 2013 to 2014.
In 2014, about 4,200 veterans accessed some health care via the national Clinical Video Telehealth–Into the Home (CVT-IH) program, with all 21 VISNs participating (John Peters, e-mail communication, February 2014). In all 3 implementation models (HBTMH pilot, Innovation, and CVT-IH), the veteran can receive health services via videoconferencing in real time, on personal or loaned computers, at home or in another nonclinic setting.
As the VA’s use of telehealth services grows in non-VA settings, technical support remains a significant challenge.2 Increased use of CVT-IH through veterans’ personal computers and devices has generated a corresponding need for technical support. The National Telehealth Technical Help Desk (NTTHD), which supports the national CVT-IH program, does not provide technical support directly to veterans. Instead, recommendations are given to the providers who are expected to transmit and implement the technical solutions with the veterans. Similarly, HBTMH pilot providers were initially responsible for all technical issues for home-based telehealth work, including helping patients with software installation and subsequent troubleshooting.
Providers participating in the HBTMH pilot project encountered veterans with all levels of comfort and skill with the required technology. Some veterans have never used a personal computer, e-mail, and/or webcam. Addressing technical issues often required up to 15 to 20 minutes during an HBTMH pilot session; some cases took hours spread over several days. In VISN 20, providers in Oregon and Washington have reported discontinuation of treatment of veterans enrolled in CVT-IH for technical reasons, including poor connections, lack of timely technical support, and incompatibility of veteran-owned computers with VA-approved third-party software (Anders Goranson, Sara Smucker Barnwell, Kathleen Woodside, e-mail communication, December 2013).
A peer technical consultant (PTC) who directly serves patients and providers may be better positioned to meet the technical needs of everyone involved in a home-based telehealth program. The PTC role was developed for the HBTMH Pilot and expanded during the Innovation program. The authors describe the role of the PTC, outline key responsibilities, and highlight how the PTC can provide effective technical support and improve provider and patient access and engagement with nonclinic-based telehealth services.
Methods
Lessons from the initial phases of the HBTMH pilot strongly suggested that technical barriers had to be reduced. In 2010, a former patient in the HBTMH pilot who had a background in information technology and computer systems and interest in helping other veterans contacted Dr. Peter Shore. They developed the novel role of a PTC, focused on delivering technical support with compassion (Table 1). A functional statement and position description were submitted to volunteer services at the VAPORHCS (Appendix). With the regionwide expansion of the HBTMH pilot into the Innovation program, the PTC was hired as a full-time contract employee to increase the availability of technical support.
The PTC assumed responsibility for installations and troubleshooting for both providers and veterans enrolled in the HBTMH pilot. The PTC, who was based at the VAPORHCS, received referrals, contacted veterans by telephone, addressed technical problems, and reported the result to the provider. No face-to-face contact occurred between the PTC and the veterans. The PTC received regular supervision from the project director. Starting in mid-2012, local providers who were using the national CVT-IH program also requested PTC services. The PTC was able to add technical support for veterans beyond the NTTHD model, allowing for immediate in-session attention in some cases.
For the Innovation program, which loaned devices (netbooks or iPads) and connectivity (mobile broadband Internet access) to veterans who needed them, the role of PTC expanded to become a technology concierge, helping to set up and manage all mobile telecommunication devices. The PTC phoned veterans when they received their device and provided a virtual tour, helped familiarize them with the technology by using test calls, and guided them in the use of relevant mobile applications installed on the device. During treatment, the PTC called enrolled veterans to follow up and to answer additional questions. The PTC also provided assistance to veterans interested in enrolling in the patient online portal My HealtheVet to access health information, communicate with providers, and request medication refills.
The VAPORHCS received institutional review board approval to present HBTMH pilot research data and program evaluation data for Innovation (as a quality improvement project). An initial evaluation of the position was completed through review of PTC workload and productivity, informal feedback from telehealth providers, and veteran and provider surveys during and after treatment.
Results
From March 2010 through April 2012, the PTC logged more than 2,500 hours of volunteer service on behalf of the HBTMH pilot (before the Innovation expansion). The dropout rate due to nonclinical reasons for veterans enrolled in the HBTMH pilot was 11%.3 During the HBTMH pilot, 78% of veterans reported that they had enough technical support (ie, from the volunteer PTC), whereas among veterans receiving clinic-based videoconferencing sessions, 61% reported having adequate technical support (ie, from telehealth clinical technicians employed by the VA).3
During 2013 to 2014, veterans and providers were surveyed during and after Innovation program treatment. Eighty percent of participants stated that the PTC was prompt in resolving any issues (20% reported “neutral”). One hundred percent of providers indicated that the PTC was able to resolve the technical issues and that they were “very likely” to continue participating in HBTMH if the PTC was involved. Eighty-nine percent of veterans reported they felt there was enough technical support, and 11% responded “neutral” to this question. Table 2 describes typical PTC services provided during the Innovation program.
Informal summary observations from the PTC confirmed that the most frequent interventions were device and software orientation, assessment of audio and/or video disruptions during sessions, and software log-in configuration and support. Common technical issues included audio and video bandwidth limitations and the need to clean up veterans’ personal computers to restore functionality or improve performance (eg, problems due to malware and viruses; e-mail communication, various dates, William Cannon).
Troubleshooting was performed immediately during a session about half the time (vs between sessions) and initiated by veterans about half the time (vs by providers on their behalf) according to informal observations. The average length of a technical support appointment was about 30 minutes for veterans who were comfortable with technology; in contrast, appointments with veterans who were unfamiliar with technology averaged about 90 minutes.
The task logs recorded instances where flexibility and availability were needed for optimal task completion. Although many tasks seemed to be routine, others showed considerable use of the PTC’s time or direct participation during a session.
One PTC noted, “Client called around 9:30 and had me put [provider’s name] info into Jabber. Also Jabber had an issue of being stuck but forced a call and issue cleared up. 15 min. Stayed online with client to ensure appointment connection went well. 5 min.”
Malware, although not the most common issue, seemed to be time consuming. A task that required 4 hours for resolution of multiple issues was described as “requested outside assist due to drivers. Troubleshooting discovered 240 plus malware and numerous Trojan [horses].”
Another time-consuming issue involved software or updates to existing software interfering with the videoconferencing program, with the following example logged for 90 minutes: “Jabber will not store contacts. Updated IOS. Deleted games. Deleted and reinstalled Jabber. Re-updated Jabber. Problem finally resolved” (December 19, 2014). Other patients simply needed more time to familiarize themselves with the technology, as in this example: “2.5 hours of training and using the iPad” (November 25, 2014).
Informal feedback from providers as well as formal feedback from a program audit indicated appreciation for the PTC’s ability to facilitate engagement and surmount technical hurdles. One provider reflected on a particular instance in which the PTC worked with both the veteran and the provider over the phone and webchat to teach them to use the equipment. “[Veteran] and the peer technician developed a friendly rapport and [veteran] expressed gratitude for the team’s efforts to deliver treatment that he would not have had otherwise.” Another provider commented, “The [National] Help Desk is almost too general. You have to explain who you are each time, and never get to explain who [the] veteran is. … They are aware of national problems. Otherwise, they can’t help out much.”
In 2012, the Office of Telehealth Services completed its Conditions of Participation review of all VISN 20 Telehealth programs and in their final report commended the practices of the HBTMH program, highlighting the associated peer-to-peer volunteer program.4
Discussion
The number of technical issues addressed by the PTC demonstrates the versatility and potential impact of this role. In each case, the PTC accommodates the specific needs of the veteran and any factors that might impact their technology use (eg, low cognitive functioning, hyperarousal, slowed processing speed, low frustration tolerance, or paranoia). This model could be expanded within or outside the VA, although due to the limited scope of the evaluation and the unique qualifications of the individual who filled the PTC role, generalizability remains to be established.
By providing direct support, the PTC attempts to meet veterans where they are and helps them become comfortable with the technology so they are not preoccupied with technical problems while receiving health care. In doing so, engagement in telehealth care is enhanced for patients and providers, and dropouts due to technologic problems may be prevented. Initial program evaluation of this role also suggests considerable provider and veteran satisfaction.
The PTC’s interactions help minimize potential frustrations related to technology use for the delivery of mental health care. Frequently, veterans using in-home telehealth have little experience with technology. Moreover, technology use has been found to be lower for rural dwelling adults.5 Other populations (eg, geriatric) may have greater technology challenges and need additional support.6 When patients start CVT services, there is a potential for dropout if there are initial connection problems, particularly among patients who may have low stress tolerance. The PTC can develop an ongoing relationship with veterans who have a history of technologic difficulties and help monitor them.
Technology barriers and limited support are also a documented barrier to provider engagement.7 Given the inherent limitations and reported provider discouragement with the NTTHD model, more directed technical support may enhance provider engagement and efficiency. With the immediate and one-on-one support given by the PTC, this concern has been assertively addressed. In VISN 20 some mental health care providers elected not to use the CVT-IH program technical support system of the and chose instead to work with the Innovation PTC.
Programmatically, the PTC role is consistent with the VA Office of Mental Health Services and the VA Central Office initiative to increase involvement of peer support programs. From a recovery model perspective, the role of the PTC goes beyond technical support in connecting veterans to other veterans who are encouraged to take control of their health care by making self-directed choices. They can experience empowerment through interactions with another veteran who may share some of their experiences. Further investigation into the effects of using a peer technical support system on veterans, providers, and PTCs compared with the existing national VA technical support help desk system might be useful, particularly with regard to rates of initiation of care or dropouts.
Integration of this role should be done in a purposeful and direct manner, defining peer roles and establishing clear policies and practices. Logistically, the transition of the PTC from a volunteer to a contract employee afforded increased credentialing to allow for improved integration with the other HBTMH team members. The PTC was able to effectively coordinate with clinical, support and administrative staff to share information, resolve issues collaboratively, and bridge gaps in technology knowledge.
Conclusion
Between the HBTMH pilot and the Innovation program, the authors have demonstrated the growing need for personalized and attentive technical support for patients enrolled in home-based telehealth services. Under a current call center help desk model, satisfaction and services may be inadequate for some veterans’ needs. The authors contend that the PTC is an effective way to deliver the necessary specialized technical assistance to veterans and providers and encourage further implementation and evaluation of this approach.
There is preliminary evidence suggesting that this support can have a beneficial impact on provider and veteran engagement in telehealth services. The PTC offers much needed support to providers who frequently do not have the time or knowledge to address all the technical issues that arise during telehealth care. Veterans helping veterans is a powerful alternative deserving of national resources and policy change. Although this case developed in a very VA-specific context, peer technical support may be applicable to other organizations as well.
Acknowledgements
Being the first to do anything in the VA takes courage, tenacity, and luck. The following individuals greatly assisted with the HBTMH pilot and the subsequent Innovation: William “Bear” Cannon, David Greaves, Tracy Dekelboum, William Minium, Sean O’Connor, Joe Ronzio, Kit Teague, and Mark Ward. For assistance with data entry and analysis, the authors thank Athalia White. For help with administrative approvals, the authors thank Bradford Felker and Carol Simons.
This article is dedicated to William “Bear” Cannon, who reinvented himself while serving as the PTC and saved his life along the way. His unwavering commitment to serve his fellow veterans is unheralded. May he be the shining light to those who follow him.
1. Darkins A. The growth of telehealth services in the Veterans Health Administration between 1994 and 2014: a study in the diffusion of innovation. Telemed J E Health. 2014;20(9):761-768.
2. Ronzio JL, Tuerk PW, Shore P. Technology and clinical videoconferencing infrastructures: a guide to selecting appropriate system. In: Tuerk PW, Shore P, eds. Clinical Video Teleconferencing: Program Development and Practice. New York, NY: Springer;2015:3-22.
3. Shore P, Goranson A, Ward MF, Lu MW. Meeting veterans where they're @: a VA home-based telemental health (HBTMH) pilot program. Int J Psychiatry Med. 2014;48(1):5-17.
4. U.S. Department of Veterans Affairs, Veterans Health Administration. Telehealth Conditions of Participation: Final Core and Modality-Specific Standards. Washington, DC: Veterans Health Administration; 2014.
5. Calvert JF Jr, Kaye J, Leahy M, Hexem K, Carlson N. Technology use by rural and urban oldest old. Technol Health Care. 2009;17(1):1-11.
6. Kang HG, Mahoney DF, Hoenig H, et al; Center for Integration of Medicine and Innovative Technology Working Group on Advanced Approaches to Physiologic Monitoring for the Aged. In situ monitoring of health in older adults: technologies and issues. J Am Geriatr Soc. 2010;58(8):1579-1586.
7. Brooks E, Turvey C, Augusterfer EF. Provider barriers to telemental health: obstacles overcome, obstacles remain. Telemed J E Health. 2013;19(6):433-437.
With an increasing demand for mental health services for veterans in rural clinics, telehealth can deliver services to veterans at home or in other nonclinic settings. Telehealth can reduce demands on VA clinic space and staff required for traditional videoconferencing.
Clinic-based telemental health started at the VA in 2003 and has provided access to more than 1 million appointments.1 Despite the great strides in accessibility, logistic barriers limit expansion of clinic-based telehealth appointments. A VA staff member at the patient site must be available to “greet and seat” the veteran; scheduling requires 2 separate appointments (on patient and provider sites); and limited telehealth equipment and clinic space need to be reserved ahead of time.
The first known use of telehealth technologies to deliver mental health services within the VA network information technology system to at-home veterans occurred in 2009 at the VA Portland Health Care System (VAPORHCS) in Oregon. Between 2010 and 2013, the VAPORHCS Home-Based Telemental Health (HBTMH) pilot served about 82 veterans through about 740 appointments. The HBTMH pilot transitioned from a single facility to a regional implementation model under an Office of Innovation Grant Innovation #669: Home-Based Telemental Health (Innovation), which served about 84 veterans from 2013 to 2014.
In 2014, about 4,200 veterans accessed some health care via the national Clinical Video Telehealth–Into the Home (CVT-IH) program, with all 21 VISNs participating (John Peters, e-mail communication, February 2014). In all 3 implementation models (HBTMH pilot, Innovation, and CVT-IH), the veteran can receive health services via videoconferencing in real time, on personal or loaned computers, at home or in another nonclinic setting.
As the VA’s use of telehealth services grows in non-VA settings, technical support remains a significant challenge.2 Increased use of CVT-IH through veterans’ personal computers and devices has generated a corresponding need for technical support. The National Telehealth Technical Help Desk (NTTHD), which supports the national CVT-IH program, does not provide technical support directly to veterans. Instead, recommendations are given to the providers who are expected to transmit and implement the technical solutions with the veterans. Similarly, HBTMH pilot providers were initially responsible for all technical issues for home-based telehealth work, including helping patients with software installation and subsequent troubleshooting.
Providers participating in the HBTMH pilot project encountered veterans with all levels of comfort and skill with the required technology. Some veterans have never used a personal computer, e-mail, and/or webcam. Addressing technical issues often required up to 15 to 20 minutes during an HBTMH pilot session; some cases took hours spread over several days. In VISN 20, providers in Oregon and Washington have reported discontinuation of treatment of veterans enrolled in CVT-IH for technical reasons, including poor connections, lack of timely technical support, and incompatibility of veteran-owned computers with VA-approved third-party software (Anders Goranson, Sara Smucker Barnwell, Kathleen Woodside, e-mail communication, December 2013).
A peer technical consultant (PTC) who directly serves patients and providers may be better positioned to meet the technical needs of everyone involved in a home-based telehealth program. The PTC role was developed for the HBTMH Pilot and expanded during the Innovation program. The authors describe the role of the PTC, outline key responsibilities, and highlight how the PTC can provide effective technical support and improve provider and patient access and engagement with nonclinic-based telehealth services.
Methods
Lessons from the initial phases of the HBTMH pilot strongly suggested that technical barriers had to be reduced. In 2010, a former patient in the HBTMH pilot who had a background in information technology and computer systems and interest in helping other veterans contacted Dr. Peter Shore. They developed the novel role of a PTC, focused on delivering technical support with compassion (Table 1). A functional statement and position description were submitted to volunteer services at the VAPORHCS (Appendix). With the regionwide expansion of the HBTMH pilot into the Innovation program, the PTC was hired as a full-time contract employee to increase the availability of technical support.
The PTC assumed responsibility for installations and troubleshooting for both providers and veterans enrolled in the HBTMH pilot. The PTC, who was based at the VAPORHCS, received referrals, contacted veterans by telephone, addressed technical problems, and reported the result to the provider. No face-to-face contact occurred between the PTC and the veterans. The PTC received regular supervision from the project director. Starting in mid-2012, local providers who were using the national CVT-IH program also requested PTC services. The PTC was able to add technical support for veterans beyond the NTTHD model, allowing for immediate in-session attention in some cases.
For the Innovation program, which loaned devices (netbooks or iPads) and connectivity (mobile broadband Internet access) to veterans who needed them, the role of PTC expanded to become a technology concierge, helping to set up and manage all mobile telecommunication devices. The PTC phoned veterans when they received their device and provided a virtual tour, helped familiarize them with the technology by using test calls, and guided them in the use of relevant mobile applications installed on the device. During treatment, the PTC called enrolled veterans to follow up and to answer additional questions. The PTC also provided assistance to veterans interested in enrolling in the patient online portal My HealtheVet to access health information, communicate with providers, and request medication refills.
The VAPORHCS received institutional review board approval to present HBTMH pilot research data and program evaluation data for Innovation (as a quality improvement project). An initial evaluation of the position was completed through review of PTC workload and productivity, informal feedback from telehealth providers, and veteran and provider surveys during and after treatment.
Results
From March 2010 through April 2012, the PTC logged more than 2,500 hours of volunteer service on behalf of the HBTMH pilot (before the Innovation expansion). The dropout rate due to nonclinical reasons for veterans enrolled in the HBTMH pilot was 11%.3 During the HBTMH pilot, 78% of veterans reported that they had enough technical support (ie, from the volunteer PTC), whereas among veterans receiving clinic-based videoconferencing sessions, 61% reported having adequate technical support (ie, from telehealth clinical technicians employed by the VA).3
During 2013 to 2014, veterans and providers were surveyed during and after Innovation program treatment. Eighty percent of participants stated that the PTC was prompt in resolving any issues (20% reported “neutral”). One hundred percent of providers indicated that the PTC was able to resolve the technical issues and that they were “very likely” to continue participating in HBTMH if the PTC was involved. Eighty-nine percent of veterans reported they felt there was enough technical support, and 11% responded “neutral” to this question. Table 2 describes typical PTC services provided during the Innovation program.
Informal summary observations from the PTC confirmed that the most frequent interventions were device and software orientation, assessment of audio and/or video disruptions during sessions, and software log-in configuration and support. Common technical issues included audio and video bandwidth limitations and the need to clean up veterans’ personal computers to restore functionality or improve performance (eg, problems due to malware and viruses; e-mail communication, various dates, William Cannon).
Troubleshooting was performed immediately during a session about half the time (vs between sessions) and initiated by veterans about half the time (vs by providers on their behalf) according to informal observations. The average length of a technical support appointment was about 30 minutes for veterans who were comfortable with technology; in contrast, appointments with veterans who were unfamiliar with technology averaged about 90 minutes.
The task logs recorded instances where flexibility and availability were needed for optimal task completion. Although many tasks seemed to be routine, others showed considerable use of the PTC’s time or direct participation during a session.
One PTC noted, “Client called around 9:30 and had me put [provider’s name] info into Jabber. Also Jabber had an issue of being stuck but forced a call and issue cleared up. 15 min. Stayed online with client to ensure appointment connection went well. 5 min.”
Malware, although not the most common issue, seemed to be time consuming. A task that required 4 hours for resolution of multiple issues was described as “requested outside assist due to drivers. Troubleshooting discovered 240 plus malware and numerous Trojan [horses].”
Another time-consuming issue involved software or updates to existing software interfering with the videoconferencing program, with the following example logged for 90 minutes: “Jabber will not store contacts. Updated IOS. Deleted games. Deleted and reinstalled Jabber. Re-updated Jabber. Problem finally resolved” (December 19, 2014). Other patients simply needed more time to familiarize themselves with the technology, as in this example: “2.5 hours of training and using the iPad” (November 25, 2014).
Informal feedback from providers as well as formal feedback from a program audit indicated appreciation for the PTC’s ability to facilitate engagement and surmount technical hurdles. One provider reflected on a particular instance in which the PTC worked with both the veteran and the provider over the phone and webchat to teach them to use the equipment. “[Veteran] and the peer technician developed a friendly rapport and [veteran] expressed gratitude for the team’s efforts to deliver treatment that he would not have had otherwise.” Another provider commented, “The [National] Help Desk is almost too general. You have to explain who you are each time, and never get to explain who [the] veteran is. … They are aware of national problems. Otherwise, they can’t help out much.”
In 2012, the Office of Telehealth Services completed its Conditions of Participation review of all VISN 20 Telehealth programs and in their final report commended the practices of the HBTMH program, highlighting the associated peer-to-peer volunteer program.4
Discussion
The number of technical issues addressed by the PTC demonstrates the versatility and potential impact of this role. In each case, the PTC accommodates the specific needs of the veteran and any factors that might impact their technology use (eg, low cognitive functioning, hyperarousal, slowed processing speed, low frustration tolerance, or paranoia). This model could be expanded within or outside the VA, although due to the limited scope of the evaluation and the unique qualifications of the individual who filled the PTC role, generalizability remains to be established.
By providing direct support, the PTC attempts to meet veterans where they are and helps them become comfortable with the technology so they are not preoccupied with technical problems while receiving health care. In doing so, engagement in telehealth care is enhanced for patients and providers, and dropouts due to technologic problems may be prevented. Initial program evaluation of this role also suggests considerable provider and veteran satisfaction.
The PTC’s interactions help minimize potential frustrations related to technology use for the delivery of mental health care. Frequently, veterans using in-home telehealth have little experience with technology. Moreover, technology use has been found to be lower for rural dwelling adults.5 Other populations (eg, geriatric) may have greater technology challenges and need additional support.6 When patients start CVT services, there is a potential for dropout if there are initial connection problems, particularly among patients who may have low stress tolerance. The PTC can develop an ongoing relationship with veterans who have a history of technologic difficulties and help monitor them.
Technology barriers and limited support are also a documented barrier to provider engagement.7 Given the inherent limitations and reported provider discouragement with the NTTHD model, more directed technical support may enhance provider engagement and efficiency. With the immediate and one-on-one support given by the PTC, this concern has been assertively addressed. In VISN 20 some mental health care providers elected not to use the CVT-IH program technical support system of the and chose instead to work with the Innovation PTC.
Programmatically, the PTC role is consistent with the VA Office of Mental Health Services and the VA Central Office initiative to increase involvement of peer support programs. From a recovery model perspective, the role of the PTC goes beyond technical support in connecting veterans to other veterans who are encouraged to take control of their health care by making self-directed choices. They can experience empowerment through interactions with another veteran who may share some of their experiences. Further investigation into the effects of using a peer technical support system on veterans, providers, and PTCs compared with the existing national VA technical support help desk system might be useful, particularly with regard to rates of initiation of care or dropouts.
Integration of this role should be done in a purposeful and direct manner, defining peer roles and establishing clear policies and practices. Logistically, the transition of the PTC from a volunteer to a contract employee afforded increased credentialing to allow for improved integration with the other HBTMH team members. The PTC was able to effectively coordinate with clinical, support and administrative staff to share information, resolve issues collaboratively, and bridge gaps in technology knowledge.
Conclusion
Between the HBTMH pilot and the Innovation program, the authors have demonstrated the growing need for personalized and attentive technical support for patients enrolled in home-based telehealth services. Under a current call center help desk model, satisfaction and services may be inadequate for some veterans’ needs. The authors contend that the PTC is an effective way to deliver the necessary specialized technical assistance to veterans and providers and encourage further implementation and evaluation of this approach.
There is preliminary evidence suggesting that this support can have a beneficial impact on provider and veteran engagement in telehealth services. The PTC offers much needed support to providers who frequently do not have the time or knowledge to address all the technical issues that arise during telehealth care. Veterans helping veterans is a powerful alternative deserving of national resources and policy change. Although this case developed in a very VA-specific context, peer technical support may be applicable to other organizations as well.
Acknowledgements
Being the first to do anything in the VA takes courage, tenacity, and luck. The following individuals greatly assisted with the HBTMH pilot and the subsequent Innovation: William “Bear” Cannon, David Greaves, Tracy Dekelboum, William Minium, Sean O’Connor, Joe Ronzio, Kit Teague, and Mark Ward. For assistance with data entry and analysis, the authors thank Athalia White. For help with administrative approvals, the authors thank Bradford Felker and Carol Simons.
This article is dedicated to William “Bear” Cannon, who reinvented himself while serving as the PTC and saved his life along the way. His unwavering commitment to serve his fellow veterans is unheralded. May he be the shining light to those who follow him.
With an increasing demand for mental health services for veterans in rural clinics, telehealth can deliver services to veterans at home or in other nonclinic settings. Telehealth can reduce demands on VA clinic space and staff required for traditional videoconferencing.
Clinic-based telemental health started at the VA in 2003 and has provided access to more than 1 million appointments.1 Despite the great strides in accessibility, logistic barriers limit expansion of clinic-based telehealth appointments. A VA staff member at the patient site must be available to “greet and seat” the veteran; scheduling requires 2 separate appointments (on patient and provider sites); and limited telehealth equipment and clinic space need to be reserved ahead of time.
The first known use of telehealth technologies to deliver mental health services within the VA network information technology system to at-home veterans occurred in 2009 at the VA Portland Health Care System (VAPORHCS) in Oregon. Between 2010 and 2013, the VAPORHCS Home-Based Telemental Health (HBTMH) pilot served about 82 veterans through about 740 appointments. The HBTMH pilot transitioned from a single facility to a regional implementation model under an Office of Innovation Grant Innovation #669: Home-Based Telemental Health (Innovation), which served about 84 veterans from 2013 to 2014.
In 2014, about 4,200 veterans accessed some health care via the national Clinical Video Telehealth–Into the Home (CVT-IH) program, with all 21 VISNs participating (John Peters, e-mail communication, February 2014). In all 3 implementation models (HBTMH pilot, Innovation, and CVT-IH), the veteran can receive health services via videoconferencing in real time, on personal or loaned computers, at home or in another nonclinic setting.
As the VA’s use of telehealth services grows in non-VA settings, technical support remains a significant challenge.2 Increased use of CVT-IH through veterans’ personal computers and devices has generated a corresponding need for technical support. The National Telehealth Technical Help Desk (NTTHD), which supports the national CVT-IH program, does not provide technical support directly to veterans. Instead, recommendations are given to the providers who are expected to transmit and implement the technical solutions with the veterans. Similarly, HBTMH pilot providers were initially responsible for all technical issues for home-based telehealth work, including helping patients with software installation and subsequent troubleshooting.
Providers participating in the HBTMH pilot project encountered veterans with all levels of comfort and skill with the required technology. Some veterans have never used a personal computer, e-mail, and/or webcam. Addressing technical issues often required up to 15 to 20 minutes during an HBTMH pilot session; some cases took hours spread over several days. In VISN 20, providers in Oregon and Washington have reported discontinuation of treatment of veterans enrolled in CVT-IH for technical reasons, including poor connections, lack of timely technical support, and incompatibility of veteran-owned computers with VA-approved third-party software (Anders Goranson, Sara Smucker Barnwell, Kathleen Woodside, e-mail communication, December 2013).
A peer technical consultant (PTC) who directly serves patients and providers may be better positioned to meet the technical needs of everyone involved in a home-based telehealth program. The PTC role was developed for the HBTMH Pilot and expanded during the Innovation program. The authors describe the role of the PTC, outline key responsibilities, and highlight how the PTC can provide effective technical support and improve provider and patient access and engagement with nonclinic-based telehealth services.
Methods
Lessons from the initial phases of the HBTMH pilot strongly suggested that technical barriers had to be reduced. In 2010, a former patient in the HBTMH pilot who had a background in information technology and computer systems and interest in helping other veterans contacted Dr. Peter Shore. They developed the novel role of a PTC, focused on delivering technical support with compassion (Table 1). A functional statement and position description were submitted to volunteer services at the VAPORHCS (Appendix). With the regionwide expansion of the HBTMH pilot into the Innovation program, the PTC was hired as a full-time contract employee to increase the availability of technical support.
The PTC assumed responsibility for installations and troubleshooting for both providers and veterans enrolled in the HBTMH pilot. The PTC, who was based at the VAPORHCS, received referrals, contacted veterans by telephone, addressed technical problems, and reported the result to the provider. No face-to-face contact occurred between the PTC and the veterans. The PTC received regular supervision from the project director. Starting in mid-2012, local providers who were using the national CVT-IH program also requested PTC services. The PTC was able to add technical support for veterans beyond the NTTHD model, allowing for immediate in-session attention in some cases.
For the Innovation program, which loaned devices (netbooks or iPads) and connectivity (mobile broadband Internet access) to veterans who needed them, the role of PTC expanded to become a technology concierge, helping to set up and manage all mobile telecommunication devices. The PTC phoned veterans when they received their device and provided a virtual tour, helped familiarize them with the technology by using test calls, and guided them in the use of relevant mobile applications installed on the device. During treatment, the PTC called enrolled veterans to follow up and to answer additional questions. The PTC also provided assistance to veterans interested in enrolling in the patient online portal My HealtheVet to access health information, communicate with providers, and request medication refills.
The VAPORHCS received institutional review board approval to present HBTMH pilot research data and program evaluation data for Innovation (as a quality improvement project). An initial evaluation of the position was completed through review of PTC workload and productivity, informal feedback from telehealth providers, and veteran and provider surveys during and after treatment.
Results
From March 2010 through April 2012, the PTC logged more than 2,500 hours of volunteer service on behalf of the HBTMH pilot (before the Innovation expansion). The dropout rate due to nonclinical reasons for veterans enrolled in the HBTMH pilot was 11%.3 During the HBTMH pilot, 78% of veterans reported that they had enough technical support (ie, from the volunteer PTC), whereas among veterans receiving clinic-based videoconferencing sessions, 61% reported having adequate technical support (ie, from telehealth clinical technicians employed by the VA).3
During 2013 to 2014, veterans and providers were surveyed during and after Innovation program treatment. Eighty percent of participants stated that the PTC was prompt in resolving any issues (20% reported “neutral”). One hundred percent of providers indicated that the PTC was able to resolve the technical issues and that they were “very likely” to continue participating in HBTMH if the PTC was involved. Eighty-nine percent of veterans reported they felt there was enough technical support, and 11% responded “neutral” to this question. Table 2 describes typical PTC services provided during the Innovation program.
Informal summary observations from the PTC confirmed that the most frequent interventions were device and software orientation, assessment of audio and/or video disruptions during sessions, and software log-in configuration and support. Common technical issues included audio and video bandwidth limitations and the need to clean up veterans’ personal computers to restore functionality or improve performance (eg, problems due to malware and viruses; e-mail communication, various dates, William Cannon).
Troubleshooting was performed immediately during a session about half the time (vs between sessions) and initiated by veterans about half the time (vs by providers on their behalf) according to informal observations. The average length of a technical support appointment was about 30 minutes for veterans who were comfortable with technology; in contrast, appointments with veterans who were unfamiliar with technology averaged about 90 minutes.
The task logs recorded instances where flexibility and availability were needed for optimal task completion. Although many tasks seemed to be routine, others showed considerable use of the PTC’s time or direct participation during a session.
One PTC noted, “Client called around 9:30 and had me put [provider’s name] info into Jabber. Also Jabber had an issue of being stuck but forced a call and issue cleared up. 15 min. Stayed online with client to ensure appointment connection went well. 5 min.”
Malware, although not the most common issue, seemed to be time consuming. A task that required 4 hours for resolution of multiple issues was described as “requested outside assist due to drivers. Troubleshooting discovered 240 plus malware and numerous Trojan [horses].”
Another time-consuming issue involved software or updates to existing software interfering with the videoconferencing program, with the following example logged for 90 minutes: “Jabber will not store contacts. Updated IOS. Deleted games. Deleted and reinstalled Jabber. Re-updated Jabber. Problem finally resolved” (December 19, 2014). Other patients simply needed more time to familiarize themselves with the technology, as in this example: “2.5 hours of training and using the iPad” (November 25, 2014).
Informal feedback from providers as well as formal feedback from a program audit indicated appreciation for the PTC’s ability to facilitate engagement and surmount technical hurdles. One provider reflected on a particular instance in which the PTC worked with both the veteran and the provider over the phone and webchat to teach them to use the equipment. “[Veteran] and the peer technician developed a friendly rapport and [veteran] expressed gratitude for the team’s efforts to deliver treatment that he would not have had otherwise.” Another provider commented, “The [National] Help Desk is almost too general. You have to explain who you are each time, and never get to explain who [the] veteran is. … They are aware of national problems. Otherwise, they can’t help out much.”
In 2012, the Office of Telehealth Services completed its Conditions of Participation review of all VISN 20 Telehealth programs and in their final report commended the practices of the HBTMH program, highlighting the associated peer-to-peer volunteer program.4
Discussion
The number of technical issues addressed by the PTC demonstrates the versatility and potential impact of this role. In each case, the PTC accommodates the specific needs of the veteran and any factors that might impact their technology use (eg, low cognitive functioning, hyperarousal, slowed processing speed, low frustration tolerance, or paranoia). This model could be expanded within or outside the VA, although due to the limited scope of the evaluation and the unique qualifications of the individual who filled the PTC role, generalizability remains to be established.
By providing direct support, the PTC attempts to meet veterans where they are and helps them become comfortable with the technology so they are not preoccupied with technical problems while receiving health care. In doing so, engagement in telehealth care is enhanced for patients and providers, and dropouts due to technologic problems may be prevented. Initial program evaluation of this role also suggests considerable provider and veteran satisfaction.
The PTC’s interactions help minimize potential frustrations related to technology use for the delivery of mental health care. Frequently, veterans using in-home telehealth have little experience with technology. Moreover, technology use has been found to be lower for rural dwelling adults.5 Other populations (eg, geriatric) may have greater technology challenges and need additional support.6 When patients start CVT services, there is a potential for dropout if there are initial connection problems, particularly among patients who may have low stress tolerance. The PTC can develop an ongoing relationship with veterans who have a history of technologic difficulties and help monitor them.
Technology barriers and limited support are also a documented barrier to provider engagement.7 Given the inherent limitations and reported provider discouragement with the NTTHD model, more directed technical support may enhance provider engagement and efficiency. With the immediate and one-on-one support given by the PTC, this concern has been assertively addressed. In VISN 20 some mental health care providers elected not to use the CVT-IH program technical support system of the and chose instead to work with the Innovation PTC.
Programmatically, the PTC role is consistent with the VA Office of Mental Health Services and the VA Central Office initiative to increase involvement of peer support programs. From a recovery model perspective, the role of the PTC goes beyond technical support in connecting veterans to other veterans who are encouraged to take control of their health care by making self-directed choices. They can experience empowerment through interactions with another veteran who may share some of their experiences. Further investigation into the effects of using a peer technical support system on veterans, providers, and PTCs compared with the existing national VA technical support help desk system might be useful, particularly with regard to rates of initiation of care or dropouts.
Integration of this role should be done in a purposeful and direct manner, defining peer roles and establishing clear policies and practices. Logistically, the transition of the PTC from a volunteer to a contract employee afforded increased credentialing to allow for improved integration with the other HBTMH team members. The PTC was able to effectively coordinate with clinical, support and administrative staff to share information, resolve issues collaboratively, and bridge gaps in technology knowledge.
Conclusion
Between the HBTMH pilot and the Innovation program, the authors have demonstrated the growing need for personalized and attentive technical support for patients enrolled in home-based telehealth services. Under a current call center help desk model, satisfaction and services may be inadequate for some veterans’ needs. The authors contend that the PTC is an effective way to deliver the necessary specialized technical assistance to veterans and providers and encourage further implementation and evaluation of this approach.
There is preliminary evidence suggesting that this support can have a beneficial impact on provider and veteran engagement in telehealth services. The PTC offers much needed support to providers who frequently do not have the time or knowledge to address all the technical issues that arise during telehealth care. Veterans helping veterans is a powerful alternative deserving of national resources and policy change. Although this case developed in a very VA-specific context, peer technical support may be applicable to other organizations as well.
Acknowledgements
Being the first to do anything in the VA takes courage, tenacity, and luck. The following individuals greatly assisted with the HBTMH pilot and the subsequent Innovation: William “Bear” Cannon, David Greaves, Tracy Dekelboum, William Minium, Sean O’Connor, Joe Ronzio, Kit Teague, and Mark Ward. For assistance with data entry and analysis, the authors thank Athalia White. For help with administrative approvals, the authors thank Bradford Felker and Carol Simons.
This article is dedicated to William “Bear” Cannon, who reinvented himself while serving as the PTC and saved his life along the way. His unwavering commitment to serve his fellow veterans is unheralded. May he be the shining light to those who follow him.
1. Darkins A. The growth of telehealth services in the Veterans Health Administration between 1994 and 2014: a study in the diffusion of innovation. Telemed J E Health. 2014;20(9):761-768.
2. Ronzio JL, Tuerk PW, Shore P. Technology and clinical videoconferencing infrastructures: a guide to selecting appropriate system. In: Tuerk PW, Shore P, eds. Clinical Video Teleconferencing: Program Development and Practice. New York, NY: Springer;2015:3-22.
3. Shore P, Goranson A, Ward MF, Lu MW. Meeting veterans where they're @: a VA home-based telemental health (HBTMH) pilot program. Int J Psychiatry Med. 2014;48(1):5-17.
4. U.S. Department of Veterans Affairs, Veterans Health Administration. Telehealth Conditions of Participation: Final Core and Modality-Specific Standards. Washington, DC: Veterans Health Administration; 2014.
5. Calvert JF Jr, Kaye J, Leahy M, Hexem K, Carlson N. Technology use by rural and urban oldest old. Technol Health Care. 2009;17(1):1-11.
6. Kang HG, Mahoney DF, Hoenig H, et al; Center for Integration of Medicine and Innovative Technology Working Group on Advanced Approaches to Physiologic Monitoring for the Aged. In situ monitoring of health in older adults: technologies and issues. J Am Geriatr Soc. 2010;58(8):1579-1586.
7. Brooks E, Turvey C, Augusterfer EF. Provider barriers to telemental health: obstacles overcome, obstacles remain. Telemed J E Health. 2013;19(6):433-437.
1. Darkins A. The growth of telehealth services in the Veterans Health Administration between 1994 and 2014: a study in the diffusion of innovation. Telemed J E Health. 2014;20(9):761-768.
2. Ronzio JL, Tuerk PW, Shore P. Technology and clinical videoconferencing infrastructures: a guide to selecting appropriate system. In: Tuerk PW, Shore P, eds. Clinical Video Teleconferencing: Program Development and Practice. New York, NY: Springer;2015:3-22.
3. Shore P, Goranson A, Ward MF, Lu MW. Meeting veterans where they're @: a VA home-based telemental health (HBTMH) pilot program. Int J Psychiatry Med. 2014;48(1):5-17.
4. U.S. Department of Veterans Affairs, Veterans Health Administration. Telehealth Conditions of Participation: Final Core and Modality-Specific Standards. Washington, DC: Veterans Health Administration; 2014.
5. Calvert JF Jr, Kaye J, Leahy M, Hexem K, Carlson N. Technology use by rural and urban oldest old. Technol Health Care. 2009;17(1):1-11.
6. Kang HG, Mahoney DF, Hoenig H, et al; Center for Integration of Medicine and Innovative Technology Working Group on Advanced Approaches to Physiologic Monitoring for the Aged. In situ monitoring of health in older adults: technologies and issues. J Am Geriatr Soc. 2010;58(8):1579-1586.
7. Brooks E, Turvey C, Augusterfer EF. Provider barriers to telemental health: obstacles overcome, obstacles remain. Telemed J E Health. 2013;19(6):433-437.
Predictors of VA and Non-VA Health Care Service Use by Homeless Veterans Residing in a Low-Demand Emergency Shelter
In 2009, the VA announced a goal of ending veteran homelessness by 2015.1 The primary focus of this new policy has been housing veterans experiencing chronic homelessness, many of whom languish outside the VA housing system. Since that time, progress has been made with point-in-time enumerations indicating that veteran homelessness has decreased nationally. Despite this progress, however, more than 55,000 veterans are still estimated to experience homelessness each night.2
Historically, the VA has offered an array of services specifically meant to alleviate veteran homelessness (grant, per diem, and other transitional housing programs; vocational rehabilitation, etc).3 The majority of these programs require some period of veteran abstinence as a condition for providing housing services. The recent move toward permanent “housing first” programs with few conditions for enrollment and participation provides new opportunities for housing veterans experiencing chronic homelessness, who are the specific target of the goal of ending veteran homelessness.4
Because veterans experiencing chronic homelessness have additional, substantial need for medical, psychiatric, and substance-abuse services, the VA also offers these services to this population.5-7 Veterans experiencing homelessness also may access parallel non-VA services.8 Information about veterans outside of traditional VA housing services, specifically those housed in low-demand shelters, is needed to develop services for this population and will be critical to success in ending veteran homelessness.
The Behavioral Model of Health Services Use9-11 and its later refinement, the Behavioral Model for Vulnerable Persons,12 have been used to conceptualize health care service use (Figure). In these models, health service use is predicted by 3 types of factors: predisposing factors (eg, age, race, gender, residential history), enabling factors (eg, availability, accessibility, affordability, acceptability), and service need factors (eg, substance-use disorders, mental health problems, physical health problems).
Studies applying these models of health care service use to both general homeless populations and, specifically to populations of veterans experiencing homelessness have found that service use is most influenced by need-based factors (eg, drug abuse, poor health, mental health problems).6,12-20 These same studies indicate that predisposing factors (eg, age, race, and gender) and enabling factors (eg, insurance, use of other services, and usual place of care) are also associated with service use, though less consistently.
Studies focused on veterans experiencing homelessness, however, included only treatment-seeking populations, which are not necessarily representative of the broader population of veterans experiencing homelessness. Additionally, none of these prior studies focused on the unique subset of veterans residing in low-demand shelters (characterized by unlimited duration of stay, no government ID or fee required for entry, and no requirement for service participation). This is a population that seems to be less engaged in services but nevertheless is challenged.21 This study, therefore, is focused on nontreatment seeking veterans residing in a low-demand shelter. The study applied the Behavioral Model of Health Services Use and the Behavioral Model for Vulnerable Persons to examine use of VA and non-VA services.
Study Parameters
This study was conducted in Fort Worth, Texas, the 17th largest city in the U.S. with more than 810,000 residents.22 In 2013, a biennial point-in-time count identified about 2,300 individuals who were homeless in Fort Worth. Most were found in emergency shelters (n = 1,126, 50%) or transitional housing (n = 965, 40%). Slightly more than 10% (n = 281) were found to be unsheltered: sleeping on the streets or in encampments, automobiles, or abandoned buildings.23 Although national estimates identify 12% of all adults who are homeless as veterans,2 only 8% (n = 189) of people experiencing homelessness in Fort Worth reported military service.23
Access to the full array of VA emergency department (ED), inpatient, and outpatient medical, psychiatric, and substance-abuse services are available to veterans experiencing homelessness at the Dallas VA Medical Center (DVAMC), located 35 miles away. Only VA outpatient medical, psychiatric, and substance-related services are available in Fort Worth through the VA Outpatient Clinic and Health Care for the Homeless Veterans (HCHV) program. If veterans experiencing homelessness seek care outside of the VA system, a comprehensive network of emergency, inpatient and outpatient medical, psychiatric, and substance-related services is available in Fort Worth.
Sample
The study sample included 110 adult male veterans randomly recruited as they awaited admission to a private, low-demand emergency shelter. The study excluded veterans with a dishonorable discharge to ensure participants were eligible for VA services. Institutional review board approvals were obtained prior to the study from the University of Texas at Arlington and DVAMC. All participants provided informed consent and were given a $5 gift for their involvement.
Instruments
Through structured interviews, experienced research staff collected demographics, history of homelessness, military service, and substance abuse in the previous 30 days. Data on alcohol and drug problems in the past 12 months were obtained using the Short Michigan Alcohol Screening Test (SMAST) and the Drug Abuse Screening Test. The Veterans RAND 12-Item Health Survey (VR-12) was used to measure physical and mental health functioning in the previous 4 weeks. Finally, participants reported their use of VA or non-VA medical (ED, inpatient, and outpatient), psychiatric (ED, inpatient, and outpatient), and substance abuse-related (inpatient and outpatient) services in the 12 months prior to the interview. These measures have been shown to be valid and reliable with acceptable psychometrics.24-26
Data Analysis
Statistical analysis was completed using IBM SPSS Statistics version 19. Descriptive data were summarized using counts, percentages, means, and standard deviations. A dichotomous variable for alcohol abuse was defined as SMAST score ≥ 3. A variable representing participant’s VR-12 mental component summary scores was used as an indicator of mental health functioning.
McNemar’s test was used to compare the use of VA and non-VA medical, psychiatric, and substance-related services using dichotomous variables for each overall sector as well as respective sector subcomponent services (emergency, inpatient, and outpatient for medical and psychiatric sectors and inpatient and outpatient for the substance-related sector). Statistical significance level was set at α = .05.
Logistic regression was used to predict psychiatric and substance abuse-related service use with separate dependent variables for VA, non-VA, and both VA and non-VA services. Need-based factors included in all models as independent variables were mental health functioning, alcohol abuse, and a dichotomous variable representing cocaine use in the previous 30 days. Independent variables for the other service sectors were included as enabling factors (eg, medical and substance-related problems predicting psychiatric service use), aligning all service use variables in the model to the same provider system (eg, VA service sector independent variables with VA service sector dependent variables).
Results
The sample mean age was 49.2 years (SD = 9.2), and fewer than half (n = 45, 41%) were white. Three-fourths (n = 82, 75%) had ever been married, and few participants (n = 5, 5%) were currently married. Total mean lifetime experience of homelessness was 3.9 years (SD = 4.3). One-third of the samples participants (n = 36, 33%) reported that their current episode of homelessness had lasted 1 year or longer. Most had an adult felony conviction (n = 78, 71%) and a history of incarceration as an adult (n = 104, 95%). All military branches were represented, with 49% serving in the Army, 23% in the Marine Corps, 17% in the Navy, 10% in the Air Force, and 1% in the Coast Guard.
Most of the sample’s veterans served during the Vietnam era (n = 43, 43%) or the post-Vietnam era (n = 49, 45%), but 12 (11%) served during the Persian Gulf era (including Operation Iraqi Freedom and Operation Enduring Freedom). Few received a nonservice connected VA pension (n = 21, 19%) or service-connected disability benefits (n = 20, 18%). The mean income earned in the previous 30 days was $466 (SD = $431). None of these predisposing factors were associated with any service variables.
The sample’s mean VR-12 physical functioning score was 43.8 (SD = 9.1), which was significantly higher (t = 6.2, df = 109, P < .001) than the 38.4 (SD = 12.2) population norm used with the instrument. The sample’s mean mental health functioning score of 39.4 (SD = 14.3) was significantly lower (t = -8.6, df = 109, P < .001) than the population norm (51.1, SD = 11.4).27 Substance-related problems were prevalent, with an identified alcohol problem in 62% (n = 68) and a drug problem in 79% (n = 87) of participants. More than half reported illicit drug use in the past 30 days (n = 61, 56%), especially cocaine (n = 42, 38%) and marijuana (n = 37, 33%).
The majority of veterans (n = 96, 87%) reported using some type of service in the past 12 months (Table 1). Most survey respondents used medical services. About half used psychiatric services, and almost one-third used substance-related services. More veterans used non-VA ED services than used VA ED services. More veterans used VA outpatient medical services than used non-VA outpatient medical services. Examining service sectors indicated that more veterans used VA psychiatric services than used non-VA psychiatric services, especially VA outpatient psychiatric services. More veterans used non-VA substance abuse-related services, especially outpatient services, rather than similar services offered by the VA.
Separate logistic regression models predicted use of psychiatric and substance-abuse services with 3 models (VA, non-VA, or any service use) for each dependent variable from independent variables that reflected need and enabling factors (Tables 2 and 3). Demographic predisposing factors, which were not associated with service use, were not included as covariates in these models. For the model predicting the use of non-VA substance-abuse services, collinearity between the alcohol-abuse and cocaine-abuse variables required separate models for each of the 2 variables.
Medical sector service use predicted psychiatric sector service use in all models. In fact, VA medical service use was the only predictor of use of VA psychiatric services. Lower mental health functioning predicted the use of any (VA or non-VA) psychiatric service use. In addition to the use of medical services, 30-day cocaine use predicted non-VA psychiatric service use.
Any substance-related sector service use was predicted by lower mental health functioning, self-reported alcohol problem, and any medical services utilization. No independent variables included in the model predicted any VA substance-related service use. Non-VA substance abuse service use was predicted by non-VA psychiatric service use and alcohol abuse. In the separate analysis that replaced alcohol problems with 30-day cocaine use variable, only 30-day cocaine use predicted non-VA substance-related service utilization.
Discussion
This study examined the use of medical, psychiatric, and substance-abuse services by randomly sampled veterans from a low-demand emergency shelter. Random selection of the sample and its high (98%) participation rate virtually eliminated potential for bias within this sample. Another strength of this study is its focus on low-demand shelter users—a population that has not been well studied. This low-demand shelter-dwelling population of veterans experiencing homelessness is of interest because more substance-abuse problems and histories of incarceration seem to make them especially disadvantaged and challenged.
The limitation of the sample to users of a low-demand shelter at only 1 location may reduce generalizability to other veteran homeless populations and settings. The study also may not generalize to populations of female veterans experiencing homelessness. Another limitation of the study is that it did not use diagnostic assessments for psychiatric and substance use disorders and objective collateral information such as agency record data. Finally, although the limited size of the sample may have been insufficient to adequately test certain hypotheses, it was a relatively large sample of this population and was large enough to yield significant findings.
This study found that need-based factors predicted the use of some service sectors intended for those needs. For example, mental health functioning appropriately predicted any psychiatric service use, and presence of an alcohol problem appropriately predicted any substance abuse service use. Specifically for non-VA services, both cocaine use and presence of an alcohol problem in separate models predicted substance-abuse service use. However for VA substance-abuse services, neither cocaine use nor presence of an alcohol problem predicted service use. Despite the high need, very few veterans used substance-abuse services, and they rarely used VA substance-abuse services.
For 2 service sectors, need-based factors predicted the use of services intended for other needs. Cocaine use predicted non-VA psychiatric service use, and low mental health functioning predicted substance-abuse service use. One potential explanation for this finding could be that providers or patients incorrectly classified cocaine-related substance use problems as psychiatric. The VR-12 mental health functioning measure also may have incorrectly classified cocaine-related problems as psychiatric.
Three enabling factors predicted service use by sector and type. The first 2 are preference for VA-provided services and the geographic availability of services, which competed for veterans’ selection of service providers. When both VA and non-VA services were present in Fort Worth, a preference for VA-provided services was observed, with the exception of outpatient substance abuse services which were highly underutilized in general. No preference was observed for any non-VA services when both were present. When VA services were not present in Fort Worth, veterans used geographically available non-VA providers for some services, but for other services they used Dallas-based VA and Fort Worth-based non-VA providers equally (Table 3 and Table 4).
The third enabling factor influencing service use was through other service use as an enabling pathway. Those veterans who opted out of locally available services in favor of VA services in Dallas may have been prompted to do so by provider referrals, which were further facilitated by VA and public transportation between Fort Worth and Dallas. The most consistent enabling pathway was medical service use, which predicted all types of psychiatric service use (VA and non-VA combined, VA only, and non-VA only), and any substance-related service use. Psychiatric service use predicted substance abuse service use but only in non-VA settings; no pathways led from VA medical or psychiatric services to VA substance abuse services.
Conclusions
These findings suggest, in large part, the validity of the Andersen and Gelberg models of health care service use. Consistent with prior studies, need-based factors predicted the use of any psychiatric and substance-related sector services as well as the use of non-VA subcomponent services for both sectors. Also consistent with prior studies, enabling factors (medical sector service use) predicted service use, with the exception of VA or non-VA substance-abuse services. Unlike prior studies, however, predisposing factors (eg, age, race, marital status, and income) were not associated with service use.
This study could not determine why veterans underutilized substance-abuse services, even those available locally to them in Fort Worth. One possible barrier to care is that the services are designed or delivered in a manner that does not engage these veterans (eg, expectations regarding abstinence or service involvement). Another barrier could be that referral pathways between VA outpatient medical and psychiatric service providers and VA substance-related services are not sufficiently facilitative. Future investigations could build upon the findings of this study by collecting data that could help assess these potential barriers.
The data from this study suggest 3 opportunities to improve the utilization of services most needed by this population. The first opportunity would be to accurately differentiate between substance abuse and psychiatric problems in clinical assessment and identify the most appropriate type of care. Another opportunity, linked closely to the first, would be to facilitate more effective and efficient referral pathways among VA service sectors, especially from medical and psychiatric services to substance-abuse services. Another strategy to improve referral pathways would be for VA service networks to systematically examine local service systems for factors or processes that may disrupt integrated care and implement program improvements.28 For homeless veterans navigating an inherently complex VA health care system, peer-to-peer and patient navigator programs have helped improve service efficiency and service outcomes.29 The third opportunity to improve utilization of services would be to ensure geographic availability and accessibility by strategic placement of these services.
The results from this study, while informative, point directly to needed areas for further inquiry to inform public health response. Although the low-demand shelter users are a particularly challenging subgroup of veterans experiencing chronic homelessness, other equally challenging populations warrant additional study. For example, veterans outside of both VA and community services (eg, unsheltered populations) are likely to require different approaches to engage in appropriate services. Additionally, changes to the homeless policy implemented in the period after this sample was recruited suggest the need to revisit the service-using behaviors of this population. Finally, interventions developed as part of the national response need to be assessed for their ability to engage these difficult-to-reach veterans.
Acknowledgements
This study was funded by a U.S. Department of Veterans Affairs Office of Academic Affiliations Pre-Doctoral Social Work Research Fellowship award.
1. U.S. Department of Veterans Affairs. Homeless veterans: VA is working to end homelessness among veterans. U.S. Department of Veterans Affairs Website. www.va.gov/homeless/about_the_initiative.asp#one. Updated January 26, 2016. Accessed February 16, 2016.
2. Henry M, Cortes A, Morris S, Abt Associates; U. S. Department of Housing and Urban Development Office of Community Planning and Development. The 2013 Annual Homeless Assessment Report (AHAR) to Congress: Part 1 Point-in-Time Estimates of Homelessness. HUD Exchange Website. https://www.hudexchange.info/resources/documents/ahar-2013-part1.pdf. Published October 2014. Accessed February 16, 2016.
3. U.S. Department of Veterans Affairs. Homeless Veterans: Housing Assistance. U.S. Department of Veterans Affairs Web site. http://www.va.gov/homeless/housing.asp. Updated November 5, 2015. Accessed February 16, 2016.
4. Austin EL, Pollio DE, Holmes S, et al. VA's expansion of supportive housing: successes and challenges on the path to Housing First. Psychiatr Serv. 2014;65(5):641-647.
5. Tsai J, Kasprow WJ, Rosenheck RA. Alcohol and drug use disorders among homeless veterans: prevalence and association with supported housing outcomes. Addict Behav. 2014;39(2):455-460.
6. Wenzel SL, Bakhtiar L, Caskey NH, et al. Homeless veterans utilization of medical, psychiatric, and substance abuse services. Med Care. 1995;33(11):1132-1144.
7. McQuire J, Gelberg L, Blue-Howells J, Rosenheck RA. Access to primary care for homeless veterans with serious mental health illness or substance abuse: a follow-up evaluation of co-located primary care and homeless social services. Adm Policy Ment Health. 2009;36(4):255-264.
8. Tsai J, Mares AS, Rosenheck RA. Do homeless veterans have the same needs and outcomes as non-veterans? Mil Med. 2012;177(1):27-31.
9. Andersen RM. A behavioral model of families use of health services: Research Series No. 25. Chicago, IL: University of Chicago Center for Health Administrative Studies; 1968.
10. Andersen RM. Revisiting the behavioral model and access to medical care: does it matter? J Health Soc Behav. 1995;36(1):1-10.
11. Pollio DE, North CS, Eyrich KM, Foster DA, Spitznagel E. Modeling service access in a homeless population. J Psychoactive Drugs. 2003;35(4):487-495.
12. Gelberg L, Andersen RM, Leake BD. The Behavioral Model for Vulnerable Populations: application to medical care use and outcomes for homeless people. Health Serv Res. 2000;34(6):1273-1302.
13. Padgett D, Struening EL, Andrews H. Factors affecting the use of medical, mental health, alcohol, and drug treatment services by homeless adults. Med Care. 1990;28(9):805-821.
14. Stein JA, Andersen RM, Koegel P, Gelberg L. Predicting health services utilization among homeless adults: a prospective analysis. J Health Care Poor Underserved. 2000;11(2):212-230.
15. Gamache G, Rosenheck RA, Tessler R. Factors predicting choice of provider among homeless veterans with mental illness. Psychiatr Serv. 2000;51(8):1024-1028.
16. Wenzel SL, Audrey Burnam, M, Koegel P, et al. Access to inpatient or residential substance abuse treatment among homeless adults with alcohol or other drug use disorders. Med Care. 2001;39(11):1158-1169.
17. Pollio DE, North CS, Eyrich KM, Foster DA, Spitznagel E. Modeling service access in a homeless population. J Psychoactive Drugs. 2003;35(4):487-495.
18. Solorio MR, Milburn NG, Andersen RM, Trifskin S, Rodríguez MA. Emotional distress and mental health service use among urban homeless adolescents. J Behav Health Serv Res. 2006;33(4):381-393.
19. Stein JA, Andersen RM, Robertson M, Gelberg L. Impact of hepatitis B and C infection on health services utilization in homeless adults: a test of the Gelberg-Anderson Behavioral Model for Vulnerable Populations. Health Psychol. 2012;31(1):20-30.
20. Linton KF, Shafer MS. Factors associated with the health service use of unsheltered, chronically homeless adults. Soc Work Public Health. 2013;29(1):73-80.
21. Petrovich JC, Pollio DE, North CS. Characteristics and service use of homeless veterans and nonveterans residing in a low-demand emergency shelter. Psych Serv. 2014;65(6):751-757.
22. U.S. Census Bureau. State & County Quick Facts: Fort Worth (city), Texas. U.S. Census Bureau Website. http://quickfacts.census.gov/qfd/states/48/4827000.html. Revised December 2, 2015. Accessed February 17, 2016.
23. Tarrant County Homeless Coalition. 2014 point in time count results. Tarrant County Homeless Coalition Website. http://www.ahomewithhope.org/staff/local-data-research/2014-homeless-count/. Accessed February 16, 2016.
24. North CS, Eyrich KM, Pollio DE, Foster DA, Cottler LB, Spitznagel EL. The Homeless Supplement to the Diagnostic Interview Schedule: test-retest analyses. Int J Method Psychiatr Res. 2004;13(3):184-191.
25. Iqbal SU, Rogers W, Selim A, et al. The Veterans RAND 12 Item Health Survey (VR-12): What it is and how it is Used. Washington, DC: Veterans Health Administration; 2009.
26. Fischer J, Corcoran K, eds. Measures for Clinical Practice and Research: A Sourcebook. 4th ed. New York, NY: Oxford University Press; 2013.
27. Selim AJ, Rogers W, Fleishman JA, Qian SX, Finke BG, Rothendler JA, Kazis LE. Updated U.S. population standard for the Veterans RAND 12-Item Health Survey (VR-12). Qual Life Res. 2009;18(1):43-52.
28. Blue-Howells J, McQuire J, Nakashima J. Co-location of health care services for homeless veterans: a case study of innovation in program implementation. Soc Work Health Care. 2008;47(3):219-231.
29. Piette JD, Holtz B, Beard AJ, et al; Ann Arbor PACT Steering Committee. Improving chronic illness care for veterans within the framework of the Patient-Centered Medical Home: experiences from the Ann Arbor Patient-Aligned Care Team Laboratory. Transl Behav Med. 2011;1(4):615-623.
In 2009, the VA announced a goal of ending veteran homelessness by 2015.1 The primary focus of this new policy has been housing veterans experiencing chronic homelessness, many of whom languish outside the VA housing system. Since that time, progress has been made with point-in-time enumerations indicating that veteran homelessness has decreased nationally. Despite this progress, however, more than 55,000 veterans are still estimated to experience homelessness each night.2
Historically, the VA has offered an array of services specifically meant to alleviate veteran homelessness (grant, per diem, and other transitional housing programs; vocational rehabilitation, etc).3 The majority of these programs require some period of veteran abstinence as a condition for providing housing services. The recent move toward permanent “housing first” programs with few conditions for enrollment and participation provides new opportunities for housing veterans experiencing chronic homelessness, who are the specific target of the goal of ending veteran homelessness.4
Because veterans experiencing chronic homelessness have additional, substantial need for medical, psychiatric, and substance-abuse services, the VA also offers these services to this population.5-7 Veterans experiencing homelessness also may access parallel non-VA services.8 Information about veterans outside of traditional VA housing services, specifically those housed in low-demand shelters, is needed to develop services for this population and will be critical to success in ending veteran homelessness.
The Behavioral Model of Health Services Use9-11 and its later refinement, the Behavioral Model for Vulnerable Persons,12 have been used to conceptualize health care service use (Figure). In these models, health service use is predicted by 3 types of factors: predisposing factors (eg, age, race, gender, residential history), enabling factors (eg, availability, accessibility, affordability, acceptability), and service need factors (eg, substance-use disorders, mental health problems, physical health problems).
Studies applying these models of health care service use to both general homeless populations and, specifically to populations of veterans experiencing homelessness have found that service use is most influenced by need-based factors (eg, drug abuse, poor health, mental health problems).6,12-20 These same studies indicate that predisposing factors (eg, age, race, and gender) and enabling factors (eg, insurance, use of other services, and usual place of care) are also associated with service use, though less consistently.
Studies focused on veterans experiencing homelessness, however, included only treatment-seeking populations, which are not necessarily representative of the broader population of veterans experiencing homelessness. Additionally, none of these prior studies focused on the unique subset of veterans residing in low-demand shelters (characterized by unlimited duration of stay, no government ID or fee required for entry, and no requirement for service participation). This is a population that seems to be less engaged in services but nevertheless is challenged.21 This study, therefore, is focused on nontreatment seeking veterans residing in a low-demand shelter. The study applied the Behavioral Model of Health Services Use and the Behavioral Model for Vulnerable Persons to examine use of VA and non-VA services.
Study Parameters
This study was conducted in Fort Worth, Texas, the 17th largest city in the U.S. with more than 810,000 residents.22 In 2013, a biennial point-in-time count identified about 2,300 individuals who were homeless in Fort Worth. Most were found in emergency shelters (n = 1,126, 50%) or transitional housing (n = 965, 40%). Slightly more than 10% (n = 281) were found to be unsheltered: sleeping on the streets or in encampments, automobiles, or abandoned buildings.23 Although national estimates identify 12% of all adults who are homeless as veterans,2 only 8% (n = 189) of people experiencing homelessness in Fort Worth reported military service.23
Access to the full array of VA emergency department (ED), inpatient, and outpatient medical, psychiatric, and substance-abuse services are available to veterans experiencing homelessness at the Dallas VA Medical Center (DVAMC), located 35 miles away. Only VA outpatient medical, psychiatric, and substance-related services are available in Fort Worth through the VA Outpatient Clinic and Health Care for the Homeless Veterans (HCHV) program. If veterans experiencing homelessness seek care outside of the VA system, a comprehensive network of emergency, inpatient and outpatient medical, psychiatric, and substance-related services is available in Fort Worth.
Sample
The study sample included 110 adult male veterans randomly recruited as they awaited admission to a private, low-demand emergency shelter. The study excluded veterans with a dishonorable discharge to ensure participants were eligible for VA services. Institutional review board approvals were obtained prior to the study from the University of Texas at Arlington and DVAMC. All participants provided informed consent and were given a $5 gift for their involvement.
Instruments
Through structured interviews, experienced research staff collected demographics, history of homelessness, military service, and substance abuse in the previous 30 days. Data on alcohol and drug problems in the past 12 months were obtained using the Short Michigan Alcohol Screening Test (SMAST) and the Drug Abuse Screening Test. The Veterans RAND 12-Item Health Survey (VR-12) was used to measure physical and mental health functioning in the previous 4 weeks. Finally, participants reported their use of VA or non-VA medical (ED, inpatient, and outpatient), psychiatric (ED, inpatient, and outpatient), and substance abuse-related (inpatient and outpatient) services in the 12 months prior to the interview. These measures have been shown to be valid and reliable with acceptable psychometrics.24-26
Data Analysis
Statistical analysis was completed using IBM SPSS Statistics version 19. Descriptive data were summarized using counts, percentages, means, and standard deviations. A dichotomous variable for alcohol abuse was defined as SMAST score ≥ 3. A variable representing participant’s VR-12 mental component summary scores was used as an indicator of mental health functioning.
McNemar’s test was used to compare the use of VA and non-VA medical, psychiatric, and substance-related services using dichotomous variables for each overall sector as well as respective sector subcomponent services (emergency, inpatient, and outpatient for medical and psychiatric sectors and inpatient and outpatient for the substance-related sector). Statistical significance level was set at α = .05.
Logistic regression was used to predict psychiatric and substance abuse-related service use with separate dependent variables for VA, non-VA, and both VA and non-VA services. Need-based factors included in all models as independent variables were mental health functioning, alcohol abuse, and a dichotomous variable representing cocaine use in the previous 30 days. Independent variables for the other service sectors were included as enabling factors (eg, medical and substance-related problems predicting psychiatric service use), aligning all service use variables in the model to the same provider system (eg, VA service sector independent variables with VA service sector dependent variables).
Results
The sample mean age was 49.2 years (SD = 9.2), and fewer than half (n = 45, 41%) were white. Three-fourths (n = 82, 75%) had ever been married, and few participants (n = 5, 5%) were currently married. Total mean lifetime experience of homelessness was 3.9 years (SD = 4.3). One-third of the samples participants (n = 36, 33%) reported that their current episode of homelessness had lasted 1 year or longer. Most had an adult felony conviction (n = 78, 71%) and a history of incarceration as an adult (n = 104, 95%). All military branches were represented, with 49% serving in the Army, 23% in the Marine Corps, 17% in the Navy, 10% in the Air Force, and 1% in the Coast Guard.
Most of the sample’s veterans served during the Vietnam era (n = 43, 43%) or the post-Vietnam era (n = 49, 45%), but 12 (11%) served during the Persian Gulf era (including Operation Iraqi Freedom and Operation Enduring Freedom). Few received a nonservice connected VA pension (n = 21, 19%) or service-connected disability benefits (n = 20, 18%). The mean income earned in the previous 30 days was $466 (SD = $431). None of these predisposing factors were associated with any service variables.
The sample’s mean VR-12 physical functioning score was 43.8 (SD = 9.1), which was significantly higher (t = 6.2, df = 109, P < .001) than the 38.4 (SD = 12.2) population norm used with the instrument. The sample’s mean mental health functioning score of 39.4 (SD = 14.3) was significantly lower (t = -8.6, df = 109, P < .001) than the population norm (51.1, SD = 11.4).27 Substance-related problems were prevalent, with an identified alcohol problem in 62% (n = 68) and a drug problem in 79% (n = 87) of participants. More than half reported illicit drug use in the past 30 days (n = 61, 56%), especially cocaine (n = 42, 38%) and marijuana (n = 37, 33%).
The majority of veterans (n = 96, 87%) reported using some type of service in the past 12 months (Table 1). Most survey respondents used medical services. About half used psychiatric services, and almost one-third used substance-related services. More veterans used non-VA ED services than used VA ED services. More veterans used VA outpatient medical services than used non-VA outpatient medical services. Examining service sectors indicated that more veterans used VA psychiatric services than used non-VA psychiatric services, especially VA outpatient psychiatric services. More veterans used non-VA substance abuse-related services, especially outpatient services, rather than similar services offered by the VA.
Separate logistic regression models predicted use of psychiatric and substance-abuse services with 3 models (VA, non-VA, or any service use) for each dependent variable from independent variables that reflected need and enabling factors (Tables 2 and 3). Demographic predisposing factors, which were not associated with service use, were not included as covariates in these models. For the model predicting the use of non-VA substance-abuse services, collinearity between the alcohol-abuse and cocaine-abuse variables required separate models for each of the 2 variables.
Medical sector service use predicted psychiatric sector service use in all models. In fact, VA medical service use was the only predictor of use of VA psychiatric services. Lower mental health functioning predicted the use of any (VA or non-VA) psychiatric service use. In addition to the use of medical services, 30-day cocaine use predicted non-VA psychiatric service use.
Any substance-related sector service use was predicted by lower mental health functioning, self-reported alcohol problem, and any medical services utilization. No independent variables included in the model predicted any VA substance-related service use. Non-VA substance abuse service use was predicted by non-VA psychiatric service use and alcohol abuse. In the separate analysis that replaced alcohol problems with 30-day cocaine use variable, only 30-day cocaine use predicted non-VA substance-related service utilization.
Discussion
This study examined the use of medical, psychiatric, and substance-abuse services by randomly sampled veterans from a low-demand emergency shelter. Random selection of the sample and its high (98%) participation rate virtually eliminated potential for bias within this sample. Another strength of this study is its focus on low-demand shelter users—a population that has not been well studied. This low-demand shelter-dwelling population of veterans experiencing homelessness is of interest because more substance-abuse problems and histories of incarceration seem to make them especially disadvantaged and challenged.
The limitation of the sample to users of a low-demand shelter at only 1 location may reduce generalizability to other veteran homeless populations and settings. The study also may not generalize to populations of female veterans experiencing homelessness. Another limitation of the study is that it did not use diagnostic assessments for psychiatric and substance use disorders and objective collateral information such as agency record data. Finally, although the limited size of the sample may have been insufficient to adequately test certain hypotheses, it was a relatively large sample of this population and was large enough to yield significant findings.
This study found that need-based factors predicted the use of some service sectors intended for those needs. For example, mental health functioning appropriately predicted any psychiatric service use, and presence of an alcohol problem appropriately predicted any substance abuse service use. Specifically for non-VA services, both cocaine use and presence of an alcohol problem in separate models predicted substance-abuse service use. However for VA substance-abuse services, neither cocaine use nor presence of an alcohol problem predicted service use. Despite the high need, very few veterans used substance-abuse services, and they rarely used VA substance-abuse services.
For 2 service sectors, need-based factors predicted the use of services intended for other needs. Cocaine use predicted non-VA psychiatric service use, and low mental health functioning predicted substance-abuse service use. One potential explanation for this finding could be that providers or patients incorrectly classified cocaine-related substance use problems as psychiatric. The VR-12 mental health functioning measure also may have incorrectly classified cocaine-related problems as psychiatric.
Three enabling factors predicted service use by sector and type. The first 2 are preference for VA-provided services and the geographic availability of services, which competed for veterans’ selection of service providers. When both VA and non-VA services were present in Fort Worth, a preference for VA-provided services was observed, with the exception of outpatient substance abuse services which were highly underutilized in general. No preference was observed for any non-VA services when both were present. When VA services were not present in Fort Worth, veterans used geographically available non-VA providers for some services, but for other services they used Dallas-based VA and Fort Worth-based non-VA providers equally (Table 3 and Table 4).
The third enabling factor influencing service use was through other service use as an enabling pathway. Those veterans who opted out of locally available services in favor of VA services in Dallas may have been prompted to do so by provider referrals, which were further facilitated by VA and public transportation between Fort Worth and Dallas. The most consistent enabling pathway was medical service use, which predicted all types of psychiatric service use (VA and non-VA combined, VA only, and non-VA only), and any substance-related service use. Psychiatric service use predicted substance abuse service use but only in non-VA settings; no pathways led from VA medical or psychiatric services to VA substance abuse services.
Conclusions
These findings suggest, in large part, the validity of the Andersen and Gelberg models of health care service use. Consistent with prior studies, need-based factors predicted the use of any psychiatric and substance-related sector services as well as the use of non-VA subcomponent services for both sectors. Also consistent with prior studies, enabling factors (medical sector service use) predicted service use, with the exception of VA or non-VA substance-abuse services. Unlike prior studies, however, predisposing factors (eg, age, race, marital status, and income) were not associated with service use.
This study could not determine why veterans underutilized substance-abuse services, even those available locally to them in Fort Worth. One possible barrier to care is that the services are designed or delivered in a manner that does not engage these veterans (eg, expectations regarding abstinence or service involvement). Another barrier could be that referral pathways between VA outpatient medical and psychiatric service providers and VA substance-related services are not sufficiently facilitative. Future investigations could build upon the findings of this study by collecting data that could help assess these potential barriers.
The data from this study suggest 3 opportunities to improve the utilization of services most needed by this population. The first opportunity would be to accurately differentiate between substance abuse and psychiatric problems in clinical assessment and identify the most appropriate type of care. Another opportunity, linked closely to the first, would be to facilitate more effective and efficient referral pathways among VA service sectors, especially from medical and psychiatric services to substance-abuse services. Another strategy to improve referral pathways would be for VA service networks to systematically examine local service systems for factors or processes that may disrupt integrated care and implement program improvements.28 For homeless veterans navigating an inherently complex VA health care system, peer-to-peer and patient navigator programs have helped improve service efficiency and service outcomes.29 The third opportunity to improve utilization of services would be to ensure geographic availability and accessibility by strategic placement of these services.
The results from this study, while informative, point directly to needed areas for further inquiry to inform public health response. Although the low-demand shelter users are a particularly challenging subgroup of veterans experiencing chronic homelessness, other equally challenging populations warrant additional study. For example, veterans outside of both VA and community services (eg, unsheltered populations) are likely to require different approaches to engage in appropriate services. Additionally, changes to the homeless policy implemented in the period after this sample was recruited suggest the need to revisit the service-using behaviors of this population. Finally, interventions developed as part of the national response need to be assessed for their ability to engage these difficult-to-reach veterans.
Acknowledgements
This study was funded by a U.S. Department of Veterans Affairs Office of Academic Affiliations Pre-Doctoral Social Work Research Fellowship award.
In 2009, the VA announced a goal of ending veteran homelessness by 2015.1 The primary focus of this new policy has been housing veterans experiencing chronic homelessness, many of whom languish outside the VA housing system. Since that time, progress has been made with point-in-time enumerations indicating that veteran homelessness has decreased nationally. Despite this progress, however, more than 55,000 veterans are still estimated to experience homelessness each night.2
Historically, the VA has offered an array of services specifically meant to alleviate veteran homelessness (grant, per diem, and other transitional housing programs; vocational rehabilitation, etc).3 The majority of these programs require some period of veteran abstinence as a condition for providing housing services. The recent move toward permanent “housing first” programs with few conditions for enrollment and participation provides new opportunities for housing veterans experiencing chronic homelessness, who are the specific target of the goal of ending veteran homelessness.4
Because veterans experiencing chronic homelessness have additional, substantial need for medical, psychiatric, and substance-abuse services, the VA also offers these services to this population.5-7 Veterans experiencing homelessness also may access parallel non-VA services.8 Information about veterans outside of traditional VA housing services, specifically those housed in low-demand shelters, is needed to develop services for this population and will be critical to success in ending veteran homelessness.
The Behavioral Model of Health Services Use9-11 and its later refinement, the Behavioral Model for Vulnerable Persons,12 have been used to conceptualize health care service use (Figure). In these models, health service use is predicted by 3 types of factors: predisposing factors (eg, age, race, gender, residential history), enabling factors (eg, availability, accessibility, affordability, acceptability), and service need factors (eg, substance-use disorders, mental health problems, physical health problems).
Studies applying these models of health care service use to both general homeless populations and, specifically to populations of veterans experiencing homelessness have found that service use is most influenced by need-based factors (eg, drug abuse, poor health, mental health problems).6,12-20 These same studies indicate that predisposing factors (eg, age, race, and gender) and enabling factors (eg, insurance, use of other services, and usual place of care) are also associated with service use, though less consistently.
Studies focused on veterans experiencing homelessness, however, included only treatment-seeking populations, which are not necessarily representative of the broader population of veterans experiencing homelessness. Additionally, none of these prior studies focused on the unique subset of veterans residing in low-demand shelters (characterized by unlimited duration of stay, no government ID or fee required for entry, and no requirement for service participation). This is a population that seems to be less engaged in services but nevertheless is challenged.21 This study, therefore, is focused on nontreatment seeking veterans residing in a low-demand shelter. The study applied the Behavioral Model of Health Services Use and the Behavioral Model for Vulnerable Persons to examine use of VA and non-VA services.
Study Parameters
This study was conducted in Fort Worth, Texas, the 17th largest city in the U.S. with more than 810,000 residents.22 In 2013, a biennial point-in-time count identified about 2,300 individuals who were homeless in Fort Worth. Most were found in emergency shelters (n = 1,126, 50%) or transitional housing (n = 965, 40%). Slightly more than 10% (n = 281) were found to be unsheltered: sleeping on the streets or in encampments, automobiles, or abandoned buildings.23 Although national estimates identify 12% of all adults who are homeless as veterans,2 only 8% (n = 189) of people experiencing homelessness in Fort Worth reported military service.23
Access to the full array of VA emergency department (ED), inpatient, and outpatient medical, psychiatric, and substance-abuse services are available to veterans experiencing homelessness at the Dallas VA Medical Center (DVAMC), located 35 miles away. Only VA outpatient medical, psychiatric, and substance-related services are available in Fort Worth through the VA Outpatient Clinic and Health Care for the Homeless Veterans (HCHV) program. If veterans experiencing homelessness seek care outside of the VA system, a comprehensive network of emergency, inpatient and outpatient medical, psychiatric, and substance-related services is available in Fort Worth.
Sample
The study sample included 110 adult male veterans randomly recruited as they awaited admission to a private, low-demand emergency shelter. The study excluded veterans with a dishonorable discharge to ensure participants were eligible for VA services. Institutional review board approvals were obtained prior to the study from the University of Texas at Arlington and DVAMC. All participants provided informed consent and were given a $5 gift for their involvement.
Instruments
Through structured interviews, experienced research staff collected demographics, history of homelessness, military service, and substance abuse in the previous 30 days. Data on alcohol and drug problems in the past 12 months were obtained using the Short Michigan Alcohol Screening Test (SMAST) and the Drug Abuse Screening Test. The Veterans RAND 12-Item Health Survey (VR-12) was used to measure physical and mental health functioning in the previous 4 weeks. Finally, participants reported their use of VA or non-VA medical (ED, inpatient, and outpatient), psychiatric (ED, inpatient, and outpatient), and substance abuse-related (inpatient and outpatient) services in the 12 months prior to the interview. These measures have been shown to be valid and reliable with acceptable psychometrics.24-26
Data Analysis
Statistical analysis was completed using IBM SPSS Statistics version 19. Descriptive data were summarized using counts, percentages, means, and standard deviations. A dichotomous variable for alcohol abuse was defined as SMAST score ≥ 3. A variable representing participant’s VR-12 mental component summary scores was used as an indicator of mental health functioning.
McNemar’s test was used to compare the use of VA and non-VA medical, psychiatric, and substance-related services using dichotomous variables for each overall sector as well as respective sector subcomponent services (emergency, inpatient, and outpatient for medical and psychiatric sectors and inpatient and outpatient for the substance-related sector). Statistical significance level was set at α = .05.
Logistic regression was used to predict psychiatric and substance abuse-related service use with separate dependent variables for VA, non-VA, and both VA and non-VA services. Need-based factors included in all models as independent variables were mental health functioning, alcohol abuse, and a dichotomous variable representing cocaine use in the previous 30 days. Independent variables for the other service sectors were included as enabling factors (eg, medical and substance-related problems predicting psychiatric service use), aligning all service use variables in the model to the same provider system (eg, VA service sector independent variables with VA service sector dependent variables).
Results
The sample mean age was 49.2 years (SD = 9.2), and fewer than half (n = 45, 41%) were white. Three-fourths (n = 82, 75%) had ever been married, and few participants (n = 5, 5%) were currently married. Total mean lifetime experience of homelessness was 3.9 years (SD = 4.3). One-third of the samples participants (n = 36, 33%) reported that their current episode of homelessness had lasted 1 year or longer. Most had an adult felony conviction (n = 78, 71%) and a history of incarceration as an adult (n = 104, 95%). All military branches were represented, with 49% serving in the Army, 23% in the Marine Corps, 17% in the Navy, 10% in the Air Force, and 1% in the Coast Guard.
Most of the sample’s veterans served during the Vietnam era (n = 43, 43%) or the post-Vietnam era (n = 49, 45%), but 12 (11%) served during the Persian Gulf era (including Operation Iraqi Freedom and Operation Enduring Freedom). Few received a nonservice connected VA pension (n = 21, 19%) or service-connected disability benefits (n = 20, 18%). The mean income earned in the previous 30 days was $466 (SD = $431). None of these predisposing factors were associated with any service variables.
The sample’s mean VR-12 physical functioning score was 43.8 (SD = 9.1), which was significantly higher (t = 6.2, df = 109, P < .001) than the 38.4 (SD = 12.2) population norm used with the instrument. The sample’s mean mental health functioning score of 39.4 (SD = 14.3) was significantly lower (t = -8.6, df = 109, P < .001) than the population norm (51.1, SD = 11.4).27 Substance-related problems were prevalent, with an identified alcohol problem in 62% (n = 68) and a drug problem in 79% (n = 87) of participants. More than half reported illicit drug use in the past 30 days (n = 61, 56%), especially cocaine (n = 42, 38%) and marijuana (n = 37, 33%).
The majority of veterans (n = 96, 87%) reported using some type of service in the past 12 months (Table 1). Most survey respondents used medical services. About half used psychiatric services, and almost one-third used substance-related services. More veterans used non-VA ED services than used VA ED services. More veterans used VA outpatient medical services than used non-VA outpatient medical services. Examining service sectors indicated that more veterans used VA psychiatric services than used non-VA psychiatric services, especially VA outpatient psychiatric services. More veterans used non-VA substance abuse-related services, especially outpatient services, rather than similar services offered by the VA.
Separate logistic regression models predicted use of psychiatric and substance-abuse services with 3 models (VA, non-VA, or any service use) for each dependent variable from independent variables that reflected need and enabling factors (Tables 2 and 3). Demographic predisposing factors, which were not associated with service use, were not included as covariates in these models. For the model predicting the use of non-VA substance-abuse services, collinearity between the alcohol-abuse and cocaine-abuse variables required separate models for each of the 2 variables.
Medical sector service use predicted psychiatric sector service use in all models. In fact, VA medical service use was the only predictor of use of VA psychiatric services. Lower mental health functioning predicted the use of any (VA or non-VA) psychiatric service use. In addition to the use of medical services, 30-day cocaine use predicted non-VA psychiatric service use.
Any substance-related sector service use was predicted by lower mental health functioning, self-reported alcohol problem, and any medical services utilization. No independent variables included in the model predicted any VA substance-related service use. Non-VA substance abuse service use was predicted by non-VA psychiatric service use and alcohol abuse. In the separate analysis that replaced alcohol problems with 30-day cocaine use variable, only 30-day cocaine use predicted non-VA substance-related service utilization.
Discussion
This study examined the use of medical, psychiatric, and substance-abuse services by randomly sampled veterans from a low-demand emergency shelter. Random selection of the sample and its high (98%) participation rate virtually eliminated potential for bias within this sample. Another strength of this study is its focus on low-demand shelter users—a population that has not been well studied. This low-demand shelter-dwelling population of veterans experiencing homelessness is of interest because more substance-abuse problems and histories of incarceration seem to make them especially disadvantaged and challenged.
The limitation of the sample to users of a low-demand shelter at only 1 location may reduce generalizability to other veteran homeless populations and settings. The study also may not generalize to populations of female veterans experiencing homelessness. Another limitation of the study is that it did not use diagnostic assessments for psychiatric and substance use disorders and objective collateral information such as agency record data. Finally, although the limited size of the sample may have been insufficient to adequately test certain hypotheses, it was a relatively large sample of this population and was large enough to yield significant findings.
This study found that need-based factors predicted the use of some service sectors intended for those needs. For example, mental health functioning appropriately predicted any psychiatric service use, and presence of an alcohol problem appropriately predicted any substance abuse service use. Specifically for non-VA services, both cocaine use and presence of an alcohol problem in separate models predicted substance-abuse service use. However for VA substance-abuse services, neither cocaine use nor presence of an alcohol problem predicted service use. Despite the high need, very few veterans used substance-abuse services, and they rarely used VA substance-abuse services.
For 2 service sectors, need-based factors predicted the use of services intended for other needs. Cocaine use predicted non-VA psychiatric service use, and low mental health functioning predicted substance-abuse service use. One potential explanation for this finding could be that providers or patients incorrectly classified cocaine-related substance use problems as psychiatric. The VR-12 mental health functioning measure also may have incorrectly classified cocaine-related problems as psychiatric.
Three enabling factors predicted service use by sector and type. The first 2 are preference for VA-provided services and the geographic availability of services, which competed for veterans’ selection of service providers. When both VA and non-VA services were present in Fort Worth, a preference for VA-provided services was observed, with the exception of outpatient substance abuse services which were highly underutilized in general. No preference was observed for any non-VA services when both were present. When VA services were not present in Fort Worth, veterans used geographically available non-VA providers for some services, but for other services they used Dallas-based VA and Fort Worth-based non-VA providers equally (Table 3 and Table 4).
The third enabling factor influencing service use was through other service use as an enabling pathway. Those veterans who opted out of locally available services in favor of VA services in Dallas may have been prompted to do so by provider referrals, which were further facilitated by VA and public transportation between Fort Worth and Dallas. The most consistent enabling pathway was medical service use, which predicted all types of psychiatric service use (VA and non-VA combined, VA only, and non-VA only), and any substance-related service use. Psychiatric service use predicted substance abuse service use but only in non-VA settings; no pathways led from VA medical or psychiatric services to VA substance abuse services.
Conclusions
These findings suggest, in large part, the validity of the Andersen and Gelberg models of health care service use. Consistent with prior studies, need-based factors predicted the use of any psychiatric and substance-related sector services as well as the use of non-VA subcomponent services for both sectors. Also consistent with prior studies, enabling factors (medical sector service use) predicted service use, with the exception of VA or non-VA substance-abuse services. Unlike prior studies, however, predisposing factors (eg, age, race, marital status, and income) were not associated with service use.
This study could not determine why veterans underutilized substance-abuse services, even those available locally to them in Fort Worth. One possible barrier to care is that the services are designed or delivered in a manner that does not engage these veterans (eg, expectations regarding abstinence or service involvement). Another barrier could be that referral pathways between VA outpatient medical and psychiatric service providers and VA substance-related services are not sufficiently facilitative. Future investigations could build upon the findings of this study by collecting data that could help assess these potential barriers.
The data from this study suggest 3 opportunities to improve the utilization of services most needed by this population. The first opportunity would be to accurately differentiate between substance abuse and psychiatric problems in clinical assessment and identify the most appropriate type of care. Another opportunity, linked closely to the first, would be to facilitate more effective and efficient referral pathways among VA service sectors, especially from medical and psychiatric services to substance-abuse services. Another strategy to improve referral pathways would be for VA service networks to systematically examine local service systems for factors or processes that may disrupt integrated care and implement program improvements.28 For homeless veterans navigating an inherently complex VA health care system, peer-to-peer and patient navigator programs have helped improve service efficiency and service outcomes.29 The third opportunity to improve utilization of services would be to ensure geographic availability and accessibility by strategic placement of these services.
The results from this study, while informative, point directly to needed areas for further inquiry to inform public health response. Although the low-demand shelter users are a particularly challenging subgroup of veterans experiencing chronic homelessness, other equally challenging populations warrant additional study. For example, veterans outside of both VA and community services (eg, unsheltered populations) are likely to require different approaches to engage in appropriate services. Additionally, changes to the homeless policy implemented in the period after this sample was recruited suggest the need to revisit the service-using behaviors of this population. Finally, interventions developed as part of the national response need to be assessed for their ability to engage these difficult-to-reach veterans.
Acknowledgements
This study was funded by a U.S. Department of Veterans Affairs Office of Academic Affiliations Pre-Doctoral Social Work Research Fellowship award.
1. U.S. Department of Veterans Affairs. Homeless veterans: VA is working to end homelessness among veterans. U.S. Department of Veterans Affairs Website. www.va.gov/homeless/about_the_initiative.asp#one. Updated January 26, 2016. Accessed February 16, 2016.
2. Henry M, Cortes A, Morris S, Abt Associates; U. S. Department of Housing and Urban Development Office of Community Planning and Development. The 2013 Annual Homeless Assessment Report (AHAR) to Congress: Part 1 Point-in-Time Estimates of Homelessness. HUD Exchange Website. https://www.hudexchange.info/resources/documents/ahar-2013-part1.pdf. Published October 2014. Accessed February 16, 2016.
3. U.S. Department of Veterans Affairs. Homeless Veterans: Housing Assistance. U.S. Department of Veterans Affairs Web site. http://www.va.gov/homeless/housing.asp. Updated November 5, 2015. Accessed February 16, 2016.
4. Austin EL, Pollio DE, Holmes S, et al. VA's expansion of supportive housing: successes and challenges on the path to Housing First. Psychiatr Serv. 2014;65(5):641-647.
5. Tsai J, Kasprow WJ, Rosenheck RA. Alcohol and drug use disorders among homeless veterans: prevalence and association with supported housing outcomes. Addict Behav. 2014;39(2):455-460.
6. Wenzel SL, Bakhtiar L, Caskey NH, et al. Homeless veterans utilization of medical, psychiatric, and substance abuse services. Med Care. 1995;33(11):1132-1144.
7. McQuire J, Gelberg L, Blue-Howells J, Rosenheck RA. Access to primary care for homeless veterans with serious mental health illness or substance abuse: a follow-up evaluation of co-located primary care and homeless social services. Adm Policy Ment Health. 2009;36(4):255-264.
8. Tsai J, Mares AS, Rosenheck RA. Do homeless veterans have the same needs and outcomes as non-veterans? Mil Med. 2012;177(1):27-31.
9. Andersen RM. A behavioral model of families use of health services: Research Series No. 25. Chicago, IL: University of Chicago Center for Health Administrative Studies; 1968.
10. Andersen RM. Revisiting the behavioral model and access to medical care: does it matter? J Health Soc Behav. 1995;36(1):1-10.
11. Pollio DE, North CS, Eyrich KM, Foster DA, Spitznagel E. Modeling service access in a homeless population. J Psychoactive Drugs. 2003;35(4):487-495.
12. Gelberg L, Andersen RM, Leake BD. The Behavioral Model for Vulnerable Populations: application to medical care use and outcomes for homeless people. Health Serv Res. 2000;34(6):1273-1302.
13. Padgett D, Struening EL, Andrews H. Factors affecting the use of medical, mental health, alcohol, and drug treatment services by homeless adults. Med Care. 1990;28(9):805-821.
14. Stein JA, Andersen RM, Koegel P, Gelberg L. Predicting health services utilization among homeless adults: a prospective analysis. J Health Care Poor Underserved. 2000;11(2):212-230.
15. Gamache G, Rosenheck RA, Tessler R. Factors predicting choice of provider among homeless veterans with mental illness. Psychiatr Serv. 2000;51(8):1024-1028.
16. Wenzel SL, Audrey Burnam, M, Koegel P, et al. Access to inpatient or residential substance abuse treatment among homeless adults with alcohol or other drug use disorders. Med Care. 2001;39(11):1158-1169.
17. Pollio DE, North CS, Eyrich KM, Foster DA, Spitznagel E. Modeling service access in a homeless population. J Psychoactive Drugs. 2003;35(4):487-495.
18. Solorio MR, Milburn NG, Andersen RM, Trifskin S, Rodríguez MA. Emotional distress and mental health service use among urban homeless adolescents. J Behav Health Serv Res. 2006;33(4):381-393.
19. Stein JA, Andersen RM, Robertson M, Gelberg L. Impact of hepatitis B and C infection on health services utilization in homeless adults: a test of the Gelberg-Anderson Behavioral Model for Vulnerable Populations. Health Psychol. 2012;31(1):20-30.
20. Linton KF, Shafer MS. Factors associated with the health service use of unsheltered, chronically homeless adults. Soc Work Public Health. 2013;29(1):73-80.
21. Petrovich JC, Pollio DE, North CS. Characteristics and service use of homeless veterans and nonveterans residing in a low-demand emergency shelter. Psych Serv. 2014;65(6):751-757.
22. U.S. Census Bureau. State & County Quick Facts: Fort Worth (city), Texas. U.S. Census Bureau Website. http://quickfacts.census.gov/qfd/states/48/4827000.html. Revised December 2, 2015. Accessed February 17, 2016.
23. Tarrant County Homeless Coalition. 2014 point in time count results. Tarrant County Homeless Coalition Website. http://www.ahomewithhope.org/staff/local-data-research/2014-homeless-count/. Accessed February 16, 2016.
24. North CS, Eyrich KM, Pollio DE, Foster DA, Cottler LB, Spitznagel EL. The Homeless Supplement to the Diagnostic Interview Schedule: test-retest analyses. Int J Method Psychiatr Res. 2004;13(3):184-191.
25. Iqbal SU, Rogers W, Selim A, et al. The Veterans RAND 12 Item Health Survey (VR-12): What it is and how it is Used. Washington, DC: Veterans Health Administration; 2009.
26. Fischer J, Corcoran K, eds. Measures for Clinical Practice and Research: A Sourcebook. 4th ed. New York, NY: Oxford University Press; 2013.
27. Selim AJ, Rogers W, Fleishman JA, Qian SX, Finke BG, Rothendler JA, Kazis LE. Updated U.S. population standard for the Veterans RAND 12-Item Health Survey (VR-12). Qual Life Res. 2009;18(1):43-52.
28. Blue-Howells J, McQuire J, Nakashima J. Co-location of health care services for homeless veterans: a case study of innovation in program implementation. Soc Work Health Care. 2008;47(3):219-231.
29. Piette JD, Holtz B, Beard AJ, et al; Ann Arbor PACT Steering Committee. Improving chronic illness care for veterans within the framework of the Patient-Centered Medical Home: experiences from the Ann Arbor Patient-Aligned Care Team Laboratory. Transl Behav Med. 2011;1(4):615-623.
1. U.S. Department of Veterans Affairs. Homeless veterans: VA is working to end homelessness among veterans. U.S. Department of Veterans Affairs Website. www.va.gov/homeless/about_the_initiative.asp#one. Updated January 26, 2016. Accessed February 16, 2016.
2. Henry M, Cortes A, Morris S, Abt Associates; U. S. Department of Housing and Urban Development Office of Community Planning and Development. The 2013 Annual Homeless Assessment Report (AHAR) to Congress: Part 1 Point-in-Time Estimates of Homelessness. HUD Exchange Website. https://www.hudexchange.info/resources/documents/ahar-2013-part1.pdf. Published October 2014. Accessed February 16, 2016.
3. U.S. Department of Veterans Affairs. Homeless Veterans: Housing Assistance. U.S. Department of Veterans Affairs Web site. http://www.va.gov/homeless/housing.asp. Updated November 5, 2015. Accessed February 16, 2016.
4. Austin EL, Pollio DE, Holmes S, et al. VA's expansion of supportive housing: successes and challenges on the path to Housing First. Psychiatr Serv. 2014;65(5):641-647.
5. Tsai J, Kasprow WJ, Rosenheck RA. Alcohol and drug use disorders among homeless veterans: prevalence and association with supported housing outcomes. Addict Behav. 2014;39(2):455-460.
6. Wenzel SL, Bakhtiar L, Caskey NH, et al. Homeless veterans utilization of medical, psychiatric, and substance abuse services. Med Care. 1995;33(11):1132-1144.
7. McQuire J, Gelberg L, Blue-Howells J, Rosenheck RA. Access to primary care for homeless veterans with serious mental health illness or substance abuse: a follow-up evaluation of co-located primary care and homeless social services. Adm Policy Ment Health. 2009;36(4):255-264.
8. Tsai J, Mares AS, Rosenheck RA. Do homeless veterans have the same needs and outcomes as non-veterans? Mil Med. 2012;177(1):27-31.
9. Andersen RM. A behavioral model of families use of health services: Research Series No. 25. Chicago, IL: University of Chicago Center for Health Administrative Studies; 1968.
10. Andersen RM. Revisiting the behavioral model and access to medical care: does it matter? J Health Soc Behav. 1995;36(1):1-10.
11. Pollio DE, North CS, Eyrich KM, Foster DA, Spitznagel E. Modeling service access in a homeless population. J Psychoactive Drugs. 2003;35(4):487-495.
12. Gelberg L, Andersen RM, Leake BD. The Behavioral Model for Vulnerable Populations: application to medical care use and outcomes for homeless people. Health Serv Res. 2000;34(6):1273-1302.
13. Padgett D, Struening EL, Andrews H. Factors affecting the use of medical, mental health, alcohol, and drug treatment services by homeless adults. Med Care. 1990;28(9):805-821.
14. Stein JA, Andersen RM, Koegel P, Gelberg L. Predicting health services utilization among homeless adults: a prospective analysis. J Health Care Poor Underserved. 2000;11(2):212-230.
15. Gamache G, Rosenheck RA, Tessler R. Factors predicting choice of provider among homeless veterans with mental illness. Psychiatr Serv. 2000;51(8):1024-1028.
16. Wenzel SL, Audrey Burnam, M, Koegel P, et al. Access to inpatient or residential substance abuse treatment among homeless adults with alcohol or other drug use disorders. Med Care. 2001;39(11):1158-1169.
17. Pollio DE, North CS, Eyrich KM, Foster DA, Spitznagel E. Modeling service access in a homeless population. J Psychoactive Drugs. 2003;35(4):487-495.
18. Solorio MR, Milburn NG, Andersen RM, Trifskin S, Rodríguez MA. Emotional distress and mental health service use among urban homeless adolescents. J Behav Health Serv Res. 2006;33(4):381-393.
19. Stein JA, Andersen RM, Robertson M, Gelberg L. Impact of hepatitis B and C infection on health services utilization in homeless adults: a test of the Gelberg-Anderson Behavioral Model for Vulnerable Populations. Health Psychol. 2012;31(1):20-30.
20. Linton KF, Shafer MS. Factors associated with the health service use of unsheltered, chronically homeless adults. Soc Work Public Health. 2013;29(1):73-80.
21. Petrovich JC, Pollio DE, North CS. Characteristics and service use of homeless veterans and nonveterans residing in a low-demand emergency shelter. Psych Serv. 2014;65(6):751-757.
22. U.S. Census Bureau. State & County Quick Facts: Fort Worth (city), Texas. U.S. Census Bureau Website. http://quickfacts.census.gov/qfd/states/48/4827000.html. Revised December 2, 2015. Accessed February 17, 2016.
23. Tarrant County Homeless Coalition. 2014 point in time count results. Tarrant County Homeless Coalition Website. http://www.ahomewithhope.org/staff/local-data-research/2014-homeless-count/. Accessed February 16, 2016.
24. North CS, Eyrich KM, Pollio DE, Foster DA, Cottler LB, Spitznagel EL. The Homeless Supplement to the Diagnostic Interview Schedule: test-retest analyses. Int J Method Psychiatr Res. 2004;13(3):184-191.
25. Iqbal SU, Rogers W, Selim A, et al. The Veterans RAND 12 Item Health Survey (VR-12): What it is and how it is Used. Washington, DC: Veterans Health Administration; 2009.
26. Fischer J, Corcoran K, eds. Measures for Clinical Practice and Research: A Sourcebook. 4th ed. New York, NY: Oxford University Press; 2013.
27. Selim AJ, Rogers W, Fleishman JA, Qian SX, Finke BG, Rothendler JA, Kazis LE. Updated U.S. population standard for the Veterans RAND 12-Item Health Survey (VR-12). Qual Life Res. 2009;18(1):43-52.
28. Blue-Howells J, McQuire J, Nakashima J. Co-location of health care services for homeless veterans: a case study of innovation in program implementation. Soc Work Health Care. 2008;47(3):219-231.
29. Piette JD, Holtz B, Beard AJ, et al; Ann Arbor PACT Steering Committee. Improving chronic illness care for veterans within the framework of the Patient-Centered Medical Home: experiences from the Ann Arbor Patient-Aligned Care Team Laboratory. Transl Behav Med. 2011;1(4):615-623.
Partial Flexor Tendon Laceration Assessment: Interobserver and Intraobserver Reliability
How to manage complete flexor tendon lacerations in the hand is well documented and a subject of relative agreement among authors. However, treatment of partial flexor tendon lacerations is controversial and lacking clear consensus in the literature. Managing these injuries can be challenging, as clinicians must weigh the diminished tensile strength in the injured tendon and the potential for later complications (eg, entrapment, triggering, rupture) against the negative effects of tenorrhaphy.1 Several studies have found impaired tendon gliding on the basis of bulk and inflammatory reaction secondary to suture material within the flexor sheath as well as decreased tendon strength after tenorrhaphy.2-6 This finding led the investigators to recommend nonsurgical management for partial lacerations up to as much as 95% of the cross-sectional area (CSA) of the tendon. According to a survey by McCarthy and colleagues,7 45% of 591 members of the American Society for Surgery of the Hand (ASSH) indicated they would perform tenorrhaphy for a laceration that involved more than 50% of the tendon.
However, accurate assessment of partial-thickness flexor tendon lacerations is difficult owing to the subjectivity of evaluation. In the survey just mentioned,7 the majority of surgeons used the naked eye to make assessments, and only 14% used other means, such as a ruler, a pair of calipers, or loupe magnification. In addition, flexor tendon injuries are often evaluated under less than ideal circumstances—a dirty or bloody field, poor lighting, an uncomfortable patient.
We conducted a study to determine the interobserver and intraobserver reliability of surgeons assessing the percentage of CSA injured in partially lacerated digital flexor tendons. We hypothesized that participants’ accuracy and agreement would be poor.
Materials and Methods
Eight 1-cm transverse, volar skin incisions were made over the midportions of the middle and proximal phalanges of the index, middle, ring, and small fingers of a fresh-frozen human cadaver hand (Figure 1). The tendon sheaths were incised, and the flexor digitorum profundus tendons to each digit were delivered through the wound. With use of a method described previously by Manning and colleagues,8 the tendon was then placed over a flat metal post to be used as a cutting board, and the proposed laceration site was marked with ink. Under loupe magnification, a No. 15 blade was used to create a partial transverse, volar-to-dorsal laceration in each tendon.8 The goal was to create lacerations of about 30%, 50%, and 70% of the total CSA of the tendon. The tendons were then returned to the wound, and visibility of the marked laceration within the wound was ensured. A similar exercise was performed at the level of the proximal palmar crease. Four flexor digitorum superficialis tendons were exposed through 1-cm transverse incisions, and partial lacerations were made in the volar substance of the tendons. The tendons were then returned to the wound, resulting in 12 partially lacerated tendons (8 flexor digitorum profundus, 4 flexor digitorum superficialis).
Six orthopedic surgery residents (2 postgraduate year 1 [PGY-1], 2 PGY-3, 2 PGY-5) and 4 fellowship-trained hand surgeons participated in our study. Each was asked to evaluate the tendons and determine the percentage of total CSA lacerated. Loupe magnification and measuring tools were not permitted, but participants were allowed to handle the tendons. In addition, they were asked if they would perform tenorrhaphy on the injured tendons, given only the amount of injury. The participants repeated this exercise 4 weeks later.
After all measurements were made, a longitudinal incision was made down each of the digits, and the flexor tendons were exposed within the flexor sheath. The transverse incisions in the palm were connected to expose the flexor digitorum superficialis tendons. Under an operating microscope, a pair of digital microcalipers (Kobalt 0.5-ft Metric and SAE Caliper; Figure 2) accurate to 0.01 mm was used to measure the external width (a) and height (b + bˈ) of the tendons just proximal to the lacerations. Measurements were made with the caliper blades just touching the edges of the lacerated tendon, thus minimizing deformation of the tendon. Other measurements made at the laceration site were width of the remaining tendon (c) and height of the remaining tendon (bˈ). CSA of the tendon was calculated assuming a regular ellipsoid shape and using the equation:
Area = 1/2π(b+b')
The area of the tendon injured was determined by calculating the area under a parabola and using the equation:
Area = 2/3c[(b+b')-b']
Last, the percentage of total CSA lacerated was calculated using the equation:
Area (total area)
Statistical analysis was performed to determine accuracy and interobserver and intraobserver reliability. Paired t tests were used in the assessment of accuracy to determine if there were differences between estimated and calibrated measurements.
Results
The 10 participants’ estimates differed significantly (P < .0006) from the calibrated measurements, as did residents’ estimates (P < .0025) and fellowship-trained hand surgeons’ estimates (P < .0002). Estimates were scored 1 to 5 on the basis of proximity to calibrated measurements (Table 1). Thus, more accurate estimates received lower scores. Individual estimates were then scored and stratified into groups for comparison. Third-year residents were the most accurate residents, and there was no difference in accuracy between residents and fellowship-trained hand surgeons. These results are listed in Table 2. Once overall and grouped accuracy was analyzed, κ statistics were calculated to compare interobserver and intraobserver reliability. Overall interobserver agreement was poor for both initial readings (κ = 0.16) and secondary readings (κ = 0.16), indicating poor strength of agreement between individuals both initially and secondarily. Table 3 presents the κ interpretations. There was moderate overall intraobserver agreement (45.83%), indicating participants’ secondary estimates agreed with their primary estimates 46% of the time. Fellowship-trained hand surgeons and first-year residents had the highest intraobserver agreement (50.0%). These results are listed in Table 4.
Discussion
Accurate assessment of partial flexor tendon lacerations is difficult and subjective. There is no standardized method for determining the extent of injury, regardless of whether the evaluation is performed in an emergency department or in the operating room. As McCarthy and colleagues7 noted in their survey of ASSH members, naked eye assessment was by far the most popular means of estimating percentage injured in partial lacerations, and only 10% of the survey respondents used intraoperative measuring devices. Our study showed that participants agreed with one another less than 50% of the time when evaluating injuries without the aid of measuring devices. In addition, interobserver agreement in this study was about 50%, highlighting the difficulty in making an accurate and reproducible assessment.
In a study of canine flexor tendons, McCarthy and colleagues9 found calipers are inaccurate as well and do not provide a reliable means of assessing partial flexor tendon lacerations. They compared caliper measurements with laser micrometer measurements, and the differences averaged 29.3%. They suggested that methods for calculating loss of CSA and for creating precise lacerations must be developed in order to evaluate treatments. One such method is the “tenotome,” devised by Hitchcock and colleagues10: A device with standard scalpel blades is used to make uniform lacerations in tendons by leaving a constant area of the tendon intact, regardless of the size or shape of the original tendon. Measurements made with calipers or rulers assume the tendon has a regular ellipsoid shape, but in reality the shape is a double-ellipse, particularly within the flexor sheath.
Dobyns and colleagues11 observed that changes in CSA size can be related to changes in the size of the bundle pattern of the tendon. They found that, on average, the radial bundle comprised about 60% of the total CSA of the tendon. This finding was clarified by Grewal and colleagues.12 Using histologic sections of tendons plus photomicrographs, they determined that, in zone II of the index and small fingers, the ulnar bundle had an area consistently larger than 50% and the radial bundle less than 50% of the total tendon area. In the ring and middle fingers, the areas of both bundles were almost 50% of the total tendon area. The authors suggested that, using this bundle pattern theory of injury, surgeons could more accurately evaluate the extent of injury with the naked eye.
One of the questions that prompted our study is how reliable is the information a surgeon receives regarding a partial flexor tendon injury evaluated by someone else in another setting. What is done with this information is another question. The scenario can be considered in 2 settings: emergency department and operating room.
Given the poor accuracy and interobserver agreement found in our study, along with the inaccuracy of caliper and ruler measurements, it seems decisions to perform tenorrhaphy based on reported percentages lacerated are unreliable. Our results showed that the ability to accurately assess partial tendon injuries does not improve with surgeon experience, as fellowship-trained hand surgeons were not statistically more accurate or consistent than residents. To this effect, one institution treats all its partial flexor tendon lacerations with wound inspection and irrigation in the emergency department, under digital block and after neurovascular injury has been excluded.8 If the patient is able to actively flex and extend the digit without triggering, then the wound is closed without closing the tendon sheath, a dorsal blocking splint is applied, and motion is begun early, 48 hours later, regardless of laceration severity.
Once the decision has been made to go to the operating room and the injury is being evaluated, what should be done with the information from the measurement, whether made with loupe magnification, calipers, rulers, or the naked eye? Surgeons must weigh the risks for triggering, entrapment, and rupture of untreated partial tendon lacerations1 with the added bulk and potential for adhesions, along with the tensile strength reduction that accompanies tendon repair. Both Reynolds and colleagues13 and Ollinger and colleagues14 found tensile strength significantly diminished in sutured tendons. Ollinger and colleagues14 showed a decrease in tendon gliding after surgical exposure and tenorrhaphy for partial tendon lacerations. Reynolds and colleagues13 concluded that surgical repair leads to poorer results than nonsurgical treatment.
Clinical studies have demonstrated excellent results with nonintervention, and in vivo and in vitro studies have indicated that early motion can be initiated in partial lacerations of up to 95% of total CSA. Wray and Weeks6 treated 26 patients with partial lacerations varying from 25% to 95% of total CSA and noted 1 incidence of trigger finger (which resolved) and no late ruptures. They advocated treatment with early motion and excision or repair of beveled partial lacerations with simple sutures. Stahl and colleagues2 reported comparable outcomes in children with partial lacerations up to 75% of total CSA treated with and without surgery and noted no complications in either group. In a biomechanical study, Hariharan and colleagues4 found lacerations up to 75% can withstand forces associated with active unresisted mobilization.
Conversely, how many patients or surgeons want to return to the operating room to fix a late rupture when it could have been repaired in the primary setting? Schlenker and colleagues,1 reporting on a late flexor pollicus tendon rupture that required tendon grafting, recommended exploration and primary repair of all partial flexor tendon lacerations. Often, it is difficult to determine whether surgical repair is necessary to ensure the best outcome for the patient.
Our study results showed that, in the evaluation of flexor tendon lacerations, both accuracy and interobserver agreement were poor among residents and fellowship-trained hand surgeons, and intraobserver agreement was moderate. Third-year residents were the most accurate residents, and there was no difference in accuracy between residents and fellowship-trained hand surgeons. Our results highlight the difficulty in making accurate assessments of flexor tendon lacerations owing to the subjectivity of evaluation, which appear not to improve with surgeon experience.
1. Schlenker JD, Lister GD, Kleinert HE. Three complications of untreated partial laceration of flexor tendon—entrapment, rupture, and triggering. J Hand Surg Am. 1981;6(4):392-398.
2. Stahl S, Kaufman T, Bialik V. Partial lacerations of flexor tendons in children. Primary repair versus conservative treatment. J Hand Surg Br. 1997;22(3):377-380.
3. Al-Qattan MM. Conservative management of zone II partial flexor tendon lacerations greater than half the width of the tendon. J Hand Surg Am. 2000;25(6):1118-1121.
4. Hariharan JS, Diao E, Soejima O, Lotz JC. Partial lacerations of human digital flexor tendons: a biomechanical analysis. J Hand Surg Am. 1997;22(6):1011-1015.
5. Bishop AT, Cooney WP 3rd, Wood MB. Treatment of partial flexor tendon lacerations: the effect of tenorrhaphy and early protected mobilization. J Trauma. 1986;26(4):301-312.
6. Wray RC Jr, Weeks PM. Treatment of partial tendon lacerations. Hand. 1980;12(2):163-166.
7. McCarthy DM, Boardman ND 3rd, Tramaglini DM, Sotereanos DG, Herndon JH. Clinical management of partially lacerated digital flexor tendons: a survey of hand surgeons. J Hand Surg Am. 1995;20(2):273-275.
8. Manning DW, Spiguel AR, Mass DP. Biomechanical analysis of partial flexor tendon lacerations in zone II of human cadavers. J Hand Surg Am. 2010;35(1):11-18.
9. McCarthy DM, Tramaglini DM, Chan SS, Schmidt CC, Sotereanos DG, Herndon JH. Effect of partial laceration on the structural properties of the canine FDP tendon: an in vitro study. J Hand Surg Am. 1995;20(5):795-800.
10. Hitchcock TF, Candel AG, Light TR, Blevens AD. New technique for producing uniform partial lacerations of tendons. J Orthop Res. 1989;7(3):451-455.
11. Dobyns RC, Cooney WC, Wood MB. Effect of partial lacerations on canine flexor tendons. Minn Med. 1982;65(1):27-32.
12. Grewal R, Sotereanos DG, Rao U, Herndon JH, Woo SL. Bundle pattern of the flexor digitorum profundus tendon in zone II of the hand: a quantitative assessment of the size of a laceration. J Hand Surg Am. 1996;21(6):978-983.
13. Reynolds B, Wray RC Jr, Weeks PM. Should an incompletely severed tendon be sutured? Plast Reconstr Surg. 1976;57(1):36-38.
14. Ollinger H, Wray RC Jr, Weeks PM. Effects of suture on tensile strength gain of partially and completely severed tendons. Surg Forum. 1975;26:63-64.
How to manage complete flexor tendon lacerations in the hand is well documented and a subject of relative agreement among authors. However, treatment of partial flexor tendon lacerations is controversial and lacking clear consensus in the literature. Managing these injuries can be challenging, as clinicians must weigh the diminished tensile strength in the injured tendon and the potential for later complications (eg, entrapment, triggering, rupture) against the negative effects of tenorrhaphy.1 Several studies have found impaired tendon gliding on the basis of bulk and inflammatory reaction secondary to suture material within the flexor sheath as well as decreased tendon strength after tenorrhaphy.2-6 This finding led the investigators to recommend nonsurgical management for partial lacerations up to as much as 95% of the cross-sectional area (CSA) of the tendon. According to a survey by McCarthy and colleagues,7 45% of 591 members of the American Society for Surgery of the Hand (ASSH) indicated they would perform tenorrhaphy for a laceration that involved more than 50% of the tendon.
However, accurate assessment of partial-thickness flexor tendon lacerations is difficult owing to the subjectivity of evaluation. In the survey just mentioned,7 the majority of surgeons used the naked eye to make assessments, and only 14% used other means, such as a ruler, a pair of calipers, or loupe magnification. In addition, flexor tendon injuries are often evaluated under less than ideal circumstances—a dirty or bloody field, poor lighting, an uncomfortable patient.
We conducted a study to determine the interobserver and intraobserver reliability of surgeons assessing the percentage of CSA injured in partially lacerated digital flexor tendons. We hypothesized that participants’ accuracy and agreement would be poor.
Materials and Methods
Eight 1-cm transverse, volar skin incisions were made over the midportions of the middle and proximal phalanges of the index, middle, ring, and small fingers of a fresh-frozen human cadaver hand (Figure 1). The tendon sheaths were incised, and the flexor digitorum profundus tendons to each digit were delivered through the wound. With use of a method described previously by Manning and colleagues,8 the tendon was then placed over a flat metal post to be used as a cutting board, and the proposed laceration site was marked with ink. Under loupe magnification, a No. 15 blade was used to create a partial transverse, volar-to-dorsal laceration in each tendon.8 The goal was to create lacerations of about 30%, 50%, and 70% of the total CSA of the tendon. The tendons were then returned to the wound, and visibility of the marked laceration within the wound was ensured. A similar exercise was performed at the level of the proximal palmar crease. Four flexor digitorum superficialis tendons were exposed through 1-cm transverse incisions, and partial lacerations were made in the volar substance of the tendons. The tendons were then returned to the wound, resulting in 12 partially lacerated tendons (8 flexor digitorum profundus, 4 flexor digitorum superficialis).
Six orthopedic surgery residents (2 postgraduate year 1 [PGY-1], 2 PGY-3, 2 PGY-5) and 4 fellowship-trained hand surgeons participated in our study. Each was asked to evaluate the tendons and determine the percentage of total CSA lacerated. Loupe magnification and measuring tools were not permitted, but participants were allowed to handle the tendons. In addition, they were asked if they would perform tenorrhaphy on the injured tendons, given only the amount of injury. The participants repeated this exercise 4 weeks later.
After all measurements were made, a longitudinal incision was made down each of the digits, and the flexor tendons were exposed within the flexor sheath. The transverse incisions in the palm were connected to expose the flexor digitorum superficialis tendons. Under an operating microscope, a pair of digital microcalipers (Kobalt 0.5-ft Metric and SAE Caliper; Figure 2) accurate to 0.01 mm was used to measure the external width (a) and height (b + bˈ) of the tendons just proximal to the lacerations. Measurements were made with the caliper blades just touching the edges of the lacerated tendon, thus minimizing deformation of the tendon. Other measurements made at the laceration site were width of the remaining tendon (c) and height of the remaining tendon (bˈ). CSA of the tendon was calculated assuming a regular ellipsoid shape and using the equation:
Area = 1/2π(b+b')
The area of the tendon injured was determined by calculating the area under a parabola and using the equation:
Area = 2/3c[(b+b')-b']
Last, the percentage of total CSA lacerated was calculated using the equation:
Area (total area)
Statistical analysis was performed to determine accuracy and interobserver and intraobserver reliability. Paired t tests were used in the assessment of accuracy to determine if there were differences between estimated and calibrated measurements.
Results
The 10 participants’ estimates differed significantly (P < .0006) from the calibrated measurements, as did residents’ estimates (P < .0025) and fellowship-trained hand surgeons’ estimates (P < .0002). Estimates were scored 1 to 5 on the basis of proximity to calibrated measurements (Table 1). Thus, more accurate estimates received lower scores. Individual estimates were then scored and stratified into groups for comparison. Third-year residents were the most accurate residents, and there was no difference in accuracy between residents and fellowship-trained hand surgeons. These results are listed in Table 2. Once overall and grouped accuracy was analyzed, κ statistics were calculated to compare interobserver and intraobserver reliability. Overall interobserver agreement was poor for both initial readings (κ = 0.16) and secondary readings (κ = 0.16), indicating poor strength of agreement between individuals both initially and secondarily. Table 3 presents the κ interpretations. There was moderate overall intraobserver agreement (45.83%), indicating participants’ secondary estimates agreed with their primary estimates 46% of the time. Fellowship-trained hand surgeons and first-year residents had the highest intraobserver agreement (50.0%). These results are listed in Table 4.
Discussion
Accurate assessment of partial flexor tendon lacerations is difficult and subjective. There is no standardized method for determining the extent of injury, regardless of whether the evaluation is performed in an emergency department or in the operating room. As McCarthy and colleagues7 noted in their survey of ASSH members, naked eye assessment was by far the most popular means of estimating percentage injured in partial lacerations, and only 10% of the survey respondents used intraoperative measuring devices. Our study showed that participants agreed with one another less than 50% of the time when evaluating injuries without the aid of measuring devices. In addition, interobserver agreement in this study was about 50%, highlighting the difficulty in making an accurate and reproducible assessment.
In a study of canine flexor tendons, McCarthy and colleagues9 found calipers are inaccurate as well and do not provide a reliable means of assessing partial flexor tendon lacerations. They compared caliper measurements with laser micrometer measurements, and the differences averaged 29.3%. They suggested that methods for calculating loss of CSA and for creating precise lacerations must be developed in order to evaluate treatments. One such method is the “tenotome,” devised by Hitchcock and colleagues10: A device with standard scalpel blades is used to make uniform lacerations in tendons by leaving a constant area of the tendon intact, regardless of the size or shape of the original tendon. Measurements made with calipers or rulers assume the tendon has a regular ellipsoid shape, but in reality the shape is a double-ellipse, particularly within the flexor sheath.
Dobyns and colleagues11 observed that changes in CSA size can be related to changes in the size of the bundle pattern of the tendon. They found that, on average, the radial bundle comprised about 60% of the total CSA of the tendon. This finding was clarified by Grewal and colleagues.12 Using histologic sections of tendons plus photomicrographs, they determined that, in zone II of the index and small fingers, the ulnar bundle had an area consistently larger than 50% and the radial bundle less than 50% of the total tendon area. In the ring and middle fingers, the areas of both bundles were almost 50% of the total tendon area. The authors suggested that, using this bundle pattern theory of injury, surgeons could more accurately evaluate the extent of injury with the naked eye.
One of the questions that prompted our study is how reliable is the information a surgeon receives regarding a partial flexor tendon injury evaluated by someone else in another setting. What is done with this information is another question. The scenario can be considered in 2 settings: emergency department and operating room.
Given the poor accuracy and interobserver agreement found in our study, along with the inaccuracy of caliper and ruler measurements, it seems decisions to perform tenorrhaphy based on reported percentages lacerated are unreliable. Our results showed that the ability to accurately assess partial tendon injuries does not improve with surgeon experience, as fellowship-trained hand surgeons were not statistically more accurate or consistent than residents. To this effect, one institution treats all its partial flexor tendon lacerations with wound inspection and irrigation in the emergency department, under digital block and after neurovascular injury has been excluded.8 If the patient is able to actively flex and extend the digit without triggering, then the wound is closed without closing the tendon sheath, a dorsal blocking splint is applied, and motion is begun early, 48 hours later, regardless of laceration severity.
Once the decision has been made to go to the operating room and the injury is being evaluated, what should be done with the information from the measurement, whether made with loupe magnification, calipers, rulers, or the naked eye? Surgeons must weigh the risks for triggering, entrapment, and rupture of untreated partial tendon lacerations1 with the added bulk and potential for adhesions, along with the tensile strength reduction that accompanies tendon repair. Both Reynolds and colleagues13 and Ollinger and colleagues14 found tensile strength significantly diminished in sutured tendons. Ollinger and colleagues14 showed a decrease in tendon gliding after surgical exposure and tenorrhaphy for partial tendon lacerations. Reynolds and colleagues13 concluded that surgical repair leads to poorer results than nonsurgical treatment.
Clinical studies have demonstrated excellent results with nonintervention, and in vivo and in vitro studies have indicated that early motion can be initiated in partial lacerations of up to 95% of total CSA. Wray and Weeks6 treated 26 patients with partial lacerations varying from 25% to 95% of total CSA and noted 1 incidence of trigger finger (which resolved) and no late ruptures. They advocated treatment with early motion and excision or repair of beveled partial lacerations with simple sutures. Stahl and colleagues2 reported comparable outcomes in children with partial lacerations up to 75% of total CSA treated with and without surgery and noted no complications in either group. In a biomechanical study, Hariharan and colleagues4 found lacerations up to 75% can withstand forces associated with active unresisted mobilization.
Conversely, how many patients or surgeons want to return to the operating room to fix a late rupture when it could have been repaired in the primary setting? Schlenker and colleagues,1 reporting on a late flexor pollicus tendon rupture that required tendon grafting, recommended exploration and primary repair of all partial flexor tendon lacerations. Often, it is difficult to determine whether surgical repair is necessary to ensure the best outcome for the patient.
Our study results showed that, in the evaluation of flexor tendon lacerations, both accuracy and interobserver agreement were poor among residents and fellowship-trained hand surgeons, and intraobserver agreement was moderate. Third-year residents were the most accurate residents, and there was no difference in accuracy between residents and fellowship-trained hand surgeons. Our results highlight the difficulty in making accurate assessments of flexor tendon lacerations owing to the subjectivity of evaluation, which appear not to improve with surgeon experience.
How to manage complete flexor tendon lacerations in the hand is well documented and a subject of relative agreement among authors. However, treatment of partial flexor tendon lacerations is controversial and lacking clear consensus in the literature. Managing these injuries can be challenging, as clinicians must weigh the diminished tensile strength in the injured tendon and the potential for later complications (eg, entrapment, triggering, rupture) against the negative effects of tenorrhaphy.1 Several studies have found impaired tendon gliding on the basis of bulk and inflammatory reaction secondary to suture material within the flexor sheath as well as decreased tendon strength after tenorrhaphy.2-6 This finding led the investigators to recommend nonsurgical management for partial lacerations up to as much as 95% of the cross-sectional area (CSA) of the tendon. According to a survey by McCarthy and colleagues,7 45% of 591 members of the American Society for Surgery of the Hand (ASSH) indicated they would perform tenorrhaphy for a laceration that involved more than 50% of the tendon.
However, accurate assessment of partial-thickness flexor tendon lacerations is difficult owing to the subjectivity of evaluation. In the survey just mentioned,7 the majority of surgeons used the naked eye to make assessments, and only 14% used other means, such as a ruler, a pair of calipers, or loupe magnification. In addition, flexor tendon injuries are often evaluated under less than ideal circumstances—a dirty or bloody field, poor lighting, an uncomfortable patient.
We conducted a study to determine the interobserver and intraobserver reliability of surgeons assessing the percentage of CSA injured in partially lacerated digital flexor tendons. We hypothesized that participants’ accuracy and agreement would be poor.
Materials and Methods
Eight 1-cm transverse, volar skin incisions were made over the midportions of the middle and proximal phalanges of the index, middle, ring, and small fingers of a fresh-frozen human cadaver hand (Figure 1). The tendon sheaths were incised, and the flexor digitorum profundus tendons to each digit were delivered through the wound. With use of a method described previously by Manning and colleagues,8 the tendon was then placed over a flat metal post to be used as a cutting board, and the proposed laceration site was marked with ink. Under loupe magnification, a No. 15 blade was used to create a partial transverse, volar-to-dorsal laceration in each tendon.8 The goal was to create lacerations of about 30%, 50%, and 70% of the total CSA of the tendon. The tendons were then returned to the wound, and visibility of the marked laceration within the wound was ensured. A similar exercise was performed at the level of the proximal palmar crease. Four flexor digitorum superficialis tendons were exposed through 1-cm transverse incisions, and partial lacerations were made in the volar substance of the tendons. The tendons were then returned to the wound, resulting in 12 partially lacerated tendons (8 flexor digitorum profundus, 4 flexor digitorum superficialis).
Six orthopedic surgery residents (2 postgraduate year 1 [PGY-1], 2 PGY-3, 2 PGY-5) and 4 fellowship-trained hand surgeons participated in our study. Each was asked to evaluate the tendons and determine the percentage of total CSA lacerated. Loupe magnification and measuring tools were not permitted, but participants were allowed to handle the tendons. In addition, they were asked if they would perform tenorrhaphy on the injured tendons, given only the amount of injury. The participants repeated this exercise 4 weeks later.
After all measurements were made, a longitudinal incision was made down each of the digits, and the flexor tendons were exposed within the flexor sheath. The transverse incisions in the palm were connected to expose the flexor digitorum superficialis tendons. Under an operating microscope, a pair of digital microcalipers (Kobalt 0.5-ft Metric and SAE Caliper; Figure 2) accurate to 0.01 mm was used to measure the external width (a) and height (b + bˈ) of the tendons just proximal to the lacerations. Measurements were made with the caliper blades just touching the edges of the lacerated tendon, thus minimizing deformation of the tendon. Other measurements made at the laceration site were width of the remaining tendon (c) and height of the remaining tendon (bˈ). CSA of the tendon was calculated assuming a regular ellipsoid shape and using the equation:
Area = 1/2π(b+b')
The area of the tendon injured was determined by calculating the area under a parabola and using the equation:
Area = 2/3c[(b+b')-b']
Last, the percentage of total CSA lacerated was calculated using the equation:
Area (total area)
Statistical analysis was performed to determine accuracy and interobserver and intraobserver reliability. Paired t tests were used in the assessment of accuracy to determine if there were differences between estimated and calibrated measurements.
Results
The 10 participants’ estimates differed significantly (P < .0006) from the calibrated measurements, as did residents’ estimates (P < .0025) and fellowship-trained hand surgeons’ estimates (P < .0002). Estimates were scored 1 to 5 on the basis of proximity to calibrated measurements (Table 1). Thus, more accurate estimates received lower scores. Individual estimates were then scored and stratified into groups for comparison. Third-year residents were the most accurate residents, and there was no difference in accuracy between residents and fellowship-trained hand surgeons. These results are listed in Table 2. Once overall and grouped accuracy was analyzed, κ statistics were calculated to compare interobserver and intraobserver reliability. Overall interobserver agreement was poor for both initial readings (κ = 0.16) and secondary readings (κ = 0.16), indicating poor strength of agreement between individuals both initially and secondarily. Table 3 presents the κ interpretations. There was moderate overall intraobserver agreement (45.83%), indicating participants’ secondary estimates agreed with their primary estimates 46% of the time. Fellowship-trained hand surgeons and first-year residents had the highest intraobserver agreement (50.0%). These results are listed in Table 4.
Discussion
Accurate assessment of partial flexor tendon lacerations is difficult and subjective. There is no standardized method for determining the extent of injury, regardless of whether the evaluation is performed in an emergency department or in the operating room. As McCarthy and colleagues7 noted in their survey of ASSH members, naked eye assessment was by far the most popular means of estimating percentage injured in partial lacerations, and only 10% of the survey respondents used intraoperative measuring devices. Our study showed that participants agreed with one another less than 50% of the time when evaluating injuries without the aid of measuring devices. In addition, interobserver agreement in this study was about 50%, highlighting the difficulty in making an accurate and reproducible assessment.
In a study of canine flexor tendons, McCarthy and colleagues9 found calipers are inaccurate as well and do not provide a reliable means of assessing partial flexor tendon lacerations. They compared caliper measurements with laser micrometer measurements, and the differences averaged 29.3%. They suggested that methods for calculating loss of CSA and for creating precise lacerations must be developed in order to evaluate treatments. One such method is the “tenotome,” devised by Hitchcock and colleagues10: A device with standard scalpel blades is used to make uniform lacerations in tendons by leaving a constant area of the tendon intact, regardless of the size or shape of the original tendon. Measurements made with calipers or rulers assume the tendon has a regular ellipsoid shape, but in reality the shape is a double-ellipse, particularly within the flexor sheath.
Dobyns and colleagues11 observed that changes in CSA size can be related to changes in the size of the bundle pattern of the tendon. They found that, on average, the radial bundle comprised about 60% of the total CSA of the tendon. This finding was clarified by Grewal and colleagues.12 Using histologic sections of tendons plus photomicrographs, they determined that, in zone II of the index and small fingers, the ulnar bundle had an area consistently larger than 50% and the radial bundle less than 50% of the total tendon area. In the ring and middle fingers, the areas of both bundles were almost 50% of the total tendon area. The authors suggested that, using this bundle pattern theory of injury, surgeons could more accurately evaluate the extent of injury with the naked eye.
One of the questions that prompted our study is how reliable is the information a surgeon receives regarding a partial flexor tendon injury evaluated by someone else in another setting. What is done with this information is another question. The scenario can be considered in 2 settings: emergency department and operating room.
Given the poor accuracy and interobserver agreement found in our study, along with the inaccuracy of caliper and ruler measurements, it seems decisions to perform tenorrhaphy based on reported percentages lacerated are unreliable. Our results showed that the ability to accurately assess partial tendon injuries does not improve with surgeon experience, as fellowship-trained hand surgeons were not statistically more accurate or consistent than residents. To this effect, one institution treats all its partial flexor tendon lacerations with wound inspection and irrigation in the emergency department, under digital block and after neurovascular injury has been excluded.8 If the patient is able to actively flex and extend the digit without triggering, then the wound is closed without closing the tendon sheath, a dorsal blocking splint is applied, and motion is begun early, 48 hours later, regardless of laceration severity.
Once the decision has been made to go to the operating room and the injury is being evaluated, what should be done with the information from the measurement, whether made with loupe magnification, calipers, rulers, or the naked eye? Surgeons must weigh the risks for triggering, entrapment, and rupture of untreated partial tendon lacerations1 with the added bulk and potential for adhesions, along with the tensile strength reduction that accompanies tendon repair. Both Reynolds and colleagues13 and Ollinger and colleagues14 found tensile strength significantly diminished in sutured tendons. Ollinger and colleagues14 showed a decrease in tendon gliding after surgical exposure and tenorrhaphy for partial tendon lacerations. Reynolds and colleagues13 concluded that surgical repair leads to poorer results than nonsurgical treatment.
Clinical studies have demonstrated excellent results with nonintervention, and in vivo and in vitro studies have indicated that early motion can be initiated in partial lacerations of up to 95% of total CSA. Wray and Weeks6 treated 26 patients with partial lacerations varying from 25% to 95% of total CSA and noted 1 incidence of trigger finger (which resolved) and no late ruptures. They advocated treatment with early motion and excision or repair of beveled partial lacerations with simple sutures. Stahl and colleagues2 reported comparable outcomes in children with partial lacerations up to 75% of total CSA treated with and without surgery and noted no complications in either group. In a biomechanical study, Hariharan and colleagues4 found lacerations up to 75% can withstand forces associated with active unresisted mobilization.
Conversely, how many patients or surgeons want to return to the operating room to fix a late rupture when it could have been repaired in the primary setting? Schlenker and colleagues,1 reporting on a late flexor pollicus tendon rupture that required tendon grafting, recommended exploration and primary repair of all partial flexor tendon lacerations. Often, it is difficult to determine whether surgical repair is necessary to ensure the best outcome for the patient.
Our study results showed that, in the evaluation of flexor tendon lacerations, both accuracy and interobserver agreement were poor among residents and fellowship-trained hand surgeons, and intraobserver agreement was moderate. Third-year residents were the most accurate residents, and there was no difference in accuracy between residents and fellowship-trained hand surgeons. Our results highlight the difficulty in making accurate assessments of flexor tendon lacerations owing to the subjectivity of evaluation, which appear not to improve with surgeon experience.
1. Schlenker JD, Lister GD, Kleinert HE. Three complications of untreated partial laceration of flexor tendon—entrapment, rupture, and triggering. J Hand Surg Am. 1981;6(4):392-398.
2. Stahl S, Kaufman T, Bialik V. Partial lacerations of flexor tendons in children. Primary repair versus conservative treatment. J Hand Surg Br. 1997;22(3):377-380.
3. Al-Qattan MM. Conservative management of zone II partial flexor tendon lacerations greater than half the width of the tendon. J Hand Surg Am. 2000;25(6):1118-1121.
4. Hariharan JS, Diao E, Soejima O, Lotz JC. Partial lacerations of human digital flexor tendons: a biomechanical analysis. J Hand Surg Am. 1997;22(6):1011-1015.
5. Bishop AT, Cooney WP 3rd, Wood MB. Treatment of partial flexor tendon lacerations: the effect of tenorrhaphy and early protected mobilization. J Trauma. 1986;26(4):301-312.
6. Wray RC Jr, Weeks PM. Treatment of partial tendon lacerations. Hand. 1980;12(2):163-166.
7. McCarthy DM, Boardman ND 3rd, Tramaglini DM, Sotereanos DG, Herndon JH. Clinical management of partially lacerated digital flexor tendons: a survey of hand surgeons. J Hand Surg Am. 1995;20(2):273-275.
8. Manning DW, Spiguel AR, Mass DP. Biomechanical analysis of partial flexor tendon lacerations in zone II of human cadavers. J Hand Surg Am. 2010;35(1):11-18.
9. McCarthy DM, Tramaglini DM, Chan SS, Schmidt CC, Sotereanos DG, Herndon JH. Effect of partial laceration on the structural properties of the canine FDP tendon: an in vitro study. J Hand Surg Am. 1995;20(5):795-800.
10. Hitchcock TF, Candel AG, Light TR, Blevens AD. New technique for producing uniform partial lacerations of tendons. J Orthop Res. 1989;7(3):451-455.
11. Dobyns RC, Cooney WC, Wood MB. Effect of partial lacerations on canine flexor tendons. Minn Med. 1982;65(1):27-32.
12. Grewal R, Sotereanos DG, Rao U, Herndon JH, Woo SL. Bundle pattern of the flexor digitorum profundus tendon in zone II of the hand: a quantitative assessment of the size of a laceration. J Hand Surg Am. 1996;21(6):978-983.
13. Reynolds B, Wray RC Jr, Weeks PM. Should an incompletely severed tendon be sutured? Plast Reconstr Surg. 1976;57(1):36-38.
14. Ollinger H, Wray RC Jr, Weeks PM. Effects of suture on tensile strength gain of partially and completely severed tendons. Surg Forum. 1975;26:63-64.
1. Schlenker JD, Lister GD, Kleinert HE. Three complications of untreated partial laceration of flexor tendon—entrapment, rupture, and triggering. J Hand Surg Am. 1981;6(4):392-398.
2. Stahl S, Kaufman T, Bialik V. Partial lacerations of flexor tendons in children. Primary repair versus conservative treatment. J Hand Surg Br. 1997;22(3):377-380.
3. Al-Qattan MM. Conservative management of zone II partial flexor tendon lacerations greater than half the width of the tendon. J Hand Surg Am. 2000;25(6):1118-1121.
4. Hariharan JS, Diao E, Soejima O, Lotz JC. Partial lacerations of human digital flexor tendons: a biomechanical analysis. J Hand Surg Am. 1997;22(6):1011-1015.
5. Bishop AT, Cooney WP 3rd, Wood MB. Treatment of partial flexor tendon lacerations: the effect of tenorrhaphy and early protected mobilization. J Trauma. 1986;26(4):301-312.
6. Wray RC Jr, Weeks PM. Treatment of partial tendon lacerations. Hand. 1980;12(2):163-166.
7. McCarthy DM, Boardman ND 3rd, Tramaglini DM, Sotereanos DG, Herndon JH. Clinical management of partially lacerated digital flexor tendons: a survey of hand surgeons. J Hand Surg Am. 1995;20(2):273-275.
8. Manning DW, Spiguel AR, Mass DP. Biomechanical analysis of partial flexor tendon lacerations in zone II of human cadavers. J Hand Surg Am. 2010;35(1):11-18.
9. McCarthy DM, Tramaglini DM, Chan SS, Schmidt CC, Sotereanos DG, Herndon JH. Effect of partial laceration on the structural properties of the canine FDP tendon: an in vitro study. J Hand Surg Am. 1995;20(5):795-800.
10. Hitchcock TF, Candel AG, Light TR, Blevens AD. New technique for producing uniform partial lacerations of tendons. J Orthop Res. 1989;7(3):451-455.
11. Dobyns RC, Cooney WC, Wood MB. Effect of partial lacerations on canine flexor tendons. Minn Med. 1982;65(1):27-32.
12. Grewal R, Sotereanos DG, Rao U, Herndon JH, Woo SL. Bundle pattern of the flexor digitorum profundus tendon in zone II of the hand: a quantitative assessment of the size of a laceration. J Hand Surg Am. 1996;21(6):978-983.
13. Reynolds B, Wray RC Jr, Weeks PM. Should an incompletely severed tendon be sutured? Plast Reconstr Surg. 1976;57(1):36-38.
14. Ollinger H, Wray RC Jr, Weeks PM. Effects of suture on tensile strength gain of partially and completely severed tendons. Surg Forum. 1975;26:63-64.
Technical Errors May Affect Accuracy of Torque Limiter in Locking Plate Osteosynthesis
Proper surgical technique must be used to ensure that surgical fracture management is long-lasting. Plate implantation and screw implantation are among the most common orthopedic procedures performed. Plate and screw osteosynthesis can be done with nonlocking or locking plate and screw constructs or with hybrid fixation that incorporates both methods.
Nonlocking plate and screw osteosynthesis uses friction-fit for fixation. In osteoporotic bone, less torque is generated because of poor bone quality, and thus less friction force between plate and bone.1,2 Locked plating has dramatically changed fracture management, especially in frail and comminuted osteoporotic bone, with significant advantages over conventional plating.3-7
Development of locked plating systems, including the Less Invasive Stabilization System (LISS; DePuy Synthes) with its soft-tissue and fracture-fragment preservation, has changed treatment of distal femur and proximal tibia fractures. Cole and colleagues8 reported stable fixation and union in 97% of their patients. The LISS system proved to be stable, but there were cases of implant removal difficulty with this titanium construct. In 1 of the 10 cases in which the LISS plate was removed, 4 of the 11 locking screws were welded to the plate.8
Cold welding, in which similar metals are chemically bonded together under extreme pressure, is a complication associated with use of titanium-only plates and screws.9 This process, which is more likely to happen if cross-threading occurs within the screw–plate interface, can make screw removal extremely difficult. Screw removal difficulty strips screw heads, and often the surgeon must use either metal cutting instruments or trephines to remove screw remnants, which often results in retained implant or debris and damage or necrosis to surrounding bone.9,10
Locking screws are often inserted under power with a torque-limiting device attached to the drill mechanism to reduce the risk of lock screw overtightening and to try to prevent difficult implant removal. Although standard practice is to insert the screw and stop just before screw head engagement, with final tightening with a torque limiter and hand power, final tightening is often inadvertently done under power.3 Most technique guides instruct surgeons how to insert screws under power while using a torque limiter, but the exact technique is not emphasized.
We conducted a study to determine if rotational speed of screw insertion affects maximum torque on screw with use of a torque limiter. We describe proper use of a torque limiter as well as possible pitfalls. We hypothesized that improper use would result in substantially higher than expected insertion torque.
Materials and Methods
Torque-Limiting Attachments, Torque Wrench, and Drill
The Small Fragment Locking Compression Plate System (Synthes) includes a 1.5-Nm torque-limiting attachment and quick-coupling wooden handles and Star Drive attachments. All devices in this study were in active use at 6 urban institutions (3 level I trauma centers, 2 level II trauma centers, 1 level III hospital). Permission to obtain and test each device was granted by each institution.
A 0.25-inch dial torque wrench (751LDIN; CDI Torque Products) was purchased through an established distributor. The manufacturer includes a traceable certificate of accuracy to verify correct calibration. The torque wrench has a torque range of 0 to 9 Nm with visual increment demarcations of 0.2 Nm and a memory needle to retain maximum torque measurement. The same torque wrench was used in each experiment in order to maintain consistent measurements between devices. It was reset to zero after each use.
This study used a 0.5-inch, 19.2-V lithium drill (Craftsman C3) with 2 speed options: 0 to 440 rpm high torque and 0 to 1600 rpm high speed. This device provides variable torque output with a maximum output of 38.4 Nm. For this study, all measurements were done with the device on its high torque setting.
Maximum Torque Determination for Different Scenarios
Each torque limiter was evaluated for variations in maximum torque under 4 different scenarios. In each scenario, the torque limiter was coupled to the Star Drive attachment and then to that scenario’s rotating force. The completed system was then inserted into the torque wrench, which was secured to a flat working surface and rotated in accordance with each scenario; maximum torque was measured and recorded (Figures 1, 2). A torque-limiting event was defined as a single audible click on the torque limiter.
In scenario 1, each torque-limiting attachment system was attached to a quick-coupling wooden handle. The completed system was then rotated at controlled low velocity under hand power until 1 torque-limiting event occurred. This scenario was also used as an internal control to verify that the torque limiters were calibrated correctly.
In Scenario 2, the device was again attached to a quick-coupling wooden handle. The completed system was rotated at high velocity under hand power until multiple torque-limiting events occurred in a row. High velocity was defined as the operator freely rotating the wooden handle in a single action with full power resulting in multiple torque-limiting events.
In Scenario 3, the device was attached to a power drill braced to the flat working surface and rotated at low velocity under power until 1 torque-limiting event occurred.
In Scenario 4, the device was again attached to a power drill braced to the flat working surface. The completed system was rotated at high velocity under power until multiple torque-limiting events occurred.
After each trial, we recorded maximum torque achieved before each device’s torque-limiting event. Either an orthopedic surgery resident or a qualified medical student tested each torque-limiting device in each standardized testing scenario.
Statistical Analysis
Experiments for each torque limiter were repeated for 3 trials of each of the 4 different scenarios. For comparative statistics between experiments, maximum torque measurements were expressed as means and SDs; 95% confidence interval (95% CI) was calculated and reported to determine extent of variation within a single group. One-way analysis of variance (ANOVA) and Tukey post hoc tests were performed between groups for comparison of the normally distributed data. Significance was set at P ≤ .05.
Results
During simulation, we successfully measured maximum torque achieved with each torque limiter under the 4 different scenarios. All testing was done by 2 operators. ANOVA demonstrated significant (P ≤ .001) differences in torque among the scenarios.
In scenario 1, mean (SD) maximum torque under hand power at low velocity was 1.49 (0.15) Nm (95% CI, 1.43-1.55), near the advertised maximum torque of 1.5 Nm, with relatively minimal variation between devices. This scenario confirmed proper calibration of properly used torque limiters. Mean maximum torque ranged from 1.25 to 1.93 Nm.
In scenario 2, mean (SD) maximum torque under hand power at high velocity was 3.73 (0.79) Nm (95% CI, 3.33-4.13), a 2.5-fold increase compared with scenario 1 (P < .0001) (Figure 3). There also was an increase in variation of maximum torque between trials of individual devices and between different devices. Mean maximum torque ranged from 2.27 to 5.53 Nm.
In scenario 3, mean (SD) maximum torque under drill power at controlled low velocity was 1.47 (0.14) Nm (95% CI, 1.37-1.56), again near the advertised maximum torque of 1.5 Nm, with relatively minimal variation. Mean maximum torque ranged from 1.10 to 1.73 Nm.
In scenario 4, mean (SD) maximum torque under drill power at full power/high velocity was 5.37 (0.90) Nm (95% CI, 4.92-5.83), a 3.65-fold increase compared with scenario 3 (P < .0001) (Figure 3). Mean maximum torque measured in 3 tests ranged from 3.40 to 6.92 Nm.
There was no significant difference in mean maximum torque between the scenarios of hand power at low velocity and drill power at low velocities (P = .999) (Figure 4). Highest maximum torque from any device was 9.0 Nm (drill at full power). Results are summarized in the Table. There was no statistical significance in the test between the 2 test operators.
Discussion
Maximum torque was measured using a torque-limiting attachment under 4 different simulated scenarios. Our goals were to determine if varying practice and rotational velocity would affect maximum insertional torque and to measure consistency among torque limiters. We designed the scenarios to mimic practice patterns, including hand insertion and power insertion of locking screws. Results demonstrated that misuse of a torque-limiting device may inadvertently produce insertional torque substantially higher than recommended. Highest maximum torque was 9.0 Nm, which is 6.0-fold higher than expected for a locking screw using a 1.5-Nm torque limiter.
Our study results showed that insertion under controlled hand power (and low-velocity drill power) until 1 torque-limiting event occurred produced the most consistent and predictable results. Insertion under drill power or high-velocity hand power produced multiple sequential torque-limiting events, yielding inaccurate insertion torque. Low-velocity insertion under hand power, or carefully controlled drill power, consistently produced torque similar to advertised values.
Manufacturers’ technique guides are available for proximal humerus locking compression plate (LCP) systems, small-fragment LCP systems, the Proximal Humeral Interlocking System (PHILOS; DePuy Synthes), and the LISS. These technique guides clearly state that insertion can be performed under power. Only the PHILOS and LISS guides state that insertion should be performed under power until a single click is heard or that final tightening should be completed under hand power. The proximal humerus LCP guide states that surgeons should insert the locking screw under power until the torque-limiting device clicks. The small-fragment LCP guide states that insertion under power should always be completed with the torque-limiting attachment; there is no mention of reducing power or a single click (this may give the surgeon a false sense of security).
Screw overtightening and head/thread stripping can make screw removal challenging.10 Removal rates for LISS plates range from 8% to 26%, and removal is often reported as taking longer than the index procedure, with complication rates as high as 47%.11-13 Bae and colleagues3 reported significant difficulty in removing 24 of 279 self-tapping locking screws (3.5 mm).
It is important to note that these complications, most notably cold welding, are mostly associated with titanium locking plate and screw constructs. Although stainless steel constructs have gained favor, titanium constructs are still widely used around the world.14,15
In 10% of cases in a laboratory setting, insertion of a 3.5-mm locking screw at 4 to 6 Nm damaged the screw.9 Removal of 3.5-mm locking screws had a stripping rate of 8.6%, and use of the torque limiter did not make removal easy all the time.3 Torque limiters are set specific to each screw diameter to reduce the risk of damage/stripping or even overtightening. Even when a surgeon intends to stop a drill before locking, final tightening often inadvertently occurs under power.3
Cold welding is often described as a cause of difficult implant removal.3,12 According to a newer definition, this process is independent of temperature and can occur when 2 metallic surfaces are in direct contact.16 High contact pressures between 2 similar metals can lead to this solid state welding.17 Theoretically, improper use of torque limiters can increase the risk of welding; however, it appears to be associated only with titanium locking plate and screw constructs.
Locked plating osteosynthesis is a valuable tool for fracture management, but improper use can have significant consequences, including morbid implant removal procedures, which are more difficult and time-consuming than the index surgery. We determined that proper use of torque limiters involves insertion under hand or power control at slow velocity until 1 torque-limiting event occurs. Many orthopedic surgeons may assume that torque limiters are accurate no matter how screws are inserted into locking plates. In addition, they may be unaware guidelines exist, as these are often deeply embedded within text. Therefore, we must emphasize that torque limiters can be inaccurate when used improperly.
One limitation of this study is that it tested only the Synthes 1.5-Nm torque-limiting attachment, though we can speculate that torque limiters designed for larger screws and limiters manufactured by different companies will behave similarly. Another limitation is that we did not obtain the hospitals’ service records for the tested equipment and assumed the equipment was properly checked for accuracy by the providing company. However, we hypothesized that, if maintenance were an issue, then our results would not be similar across all sites tested.
These tests involved a torque limiter linked to a torque-measuring device and may not perfectly represent actual torque measured at the locked screw–thread interface. However, we think our construct accurately determines the torque produced at the level of the driver tip. Also, we can speculate that the torque produced with improper use will lead to the complications mentioned and demonstrated in previous studies. Welding of the screw–plate interface may simply be a result of improper trajectory and cross-threading. However, if we assume that torque limiters prevent excessive torque no matter how they are used, high insertion speeds may compound the effect of welding. Additional biomechanical studies with full locked plate osteosynthesis constructs on bone specimens are planned to further characterize the potential complications of this issue.
1. Sommer C, Babst R, Müller M, Hanson B. Locking compression plate loosening and plate breakage: a report of four cases. J Orthop Trauma. 2004;18(8):571-577.
2. Schütz M, Südkamp NP. Revolution in plate osteosynthesis: new internal fixator systems. J Orthop Sci. 2003;8(2):252-258.
3. Bae JH, Oh JK, Oh CW, Hur CR. Technical difficulties of removal of locking screw after locking compression plating. Arch Orthop Trauma Surg. 2009;129(1):91-95.
4. Frigg R. Locking compression plate (LCP). An osteosynthesis plate based on the dynamic compression plate and the point contact fixator (PC-Fix). Injury. 2001;32(suppl 2):63-66.
5. Frigg R. Development of the locking compression plate. Injury. 2003;34(suppl 2):B6-B10.
6. Korner J, Lill H, Müller LP, Rommens PM, Schneider E, Linke B. The LCP-concept in the operative treatment of distal humerus fractures—biological, biomechanical and surgical aspects. Injury. 2003;34(suppl 2):B20-B30.
7. Egol KA, Kubiak EN, Fulkerson E, Kummer FJ, Koval KJ. Biomechanics of locked plates and screws. J Orthop Trauma. 2004;18(8):488-493.
8. Cole PA, Zlowodzki M, Kregor PJ. Treatment of proximal tibia fractures using the Less Invasive Stabilization System: surgical experience and early clinical results in 77 fractures. J Orthop Trauma. 2004;18(8):528-535.
9. Ehlinger M, Adam P, Simon P, Bonnomet F. Technical difficulties in hardware removal in titanium compression plates with locking screws. Orthop Traumatol Surg Res. 2009;95(5):373-376.
10. Gopinathan NR, Dhillon MS, Kumar R. Surgical technique: simple technique for removing a locking recon plate with damaged screw heads. Clin Orthop Relat Res. 2013;471(5):1572-1575.
11. Pattison G, Reynolds J, Hardy J. Salvaging a stripped drive connection when removing screws. Injury. 1999;30(1):74-75.
12. Raja S, Imbuldeniya AM, Garg S, Groom G. Difficulties encountered removing locked plates. Ann R Coll Surg Engl. 2012;94(7):502-505.
13. Kumar G, Dunlop C. Case report: a technique to remove a jammed locking screw from a locking plate. Clin Orthop Relat Res. 2011;469(2):613-616.
14. Disegi JA. Titanium alloys for fracture fixation implants. Injury. 2000;31(suppl 4):14-17.
15. El-Zayat BF, Ruchholtz S, Efe T, Paletta J, Kreslo D, Zettl R. Results of titanium locking plate and stainless steel cerclage wire combination in femoral fractures. Indian J Orthop. 2013;47(5):454-458.
16. Van Nortwick SS, Yao J, Ladd AL. Titanium integration with bone, welding, and screw head destruction complicating hardware removal of the distal radius: report of 2 cases. J Hand Surg. 2012;37(7):1388-1392.
17. Ferguson GS, Chaudhury MK, Sigal GB, Whitesides GM. Contact adhesion of thin gold films on elastomeric supports: cold welding under ambient conditions. Science. 1991;253(5021):776-778.
Proper surgical technique must be used to ensure that surgical fracture management is long-lasting. Plate implantation and screw implantation are among the most common orthopedic procedures performed. Plate and screw osteosynthesis can be done with nonlocking or locking plate and screw constructs or with hybrid fixation that incorporates both methods.
Nonlocking plate and screw osteosynthesis uses friction-fit for fixation. In osteoporotic bone, less torque is generated because of poor bone quality, and thus less friction force between plate and bone.1,2 Locked plating has dramatically changed fracture management, especially in frail and comminuted osteoporotic bone, with significant advantages over conventional plating.3-7
Development of locked plating systems, including the Less Invasive Stabilization System (LISS; DePuy Synthes) with its soft-tissue and fracture-fragment preservation, has changed treatment of distal femur and proximal tibia fractures. Cole and colleagues8 reported stable fixation and union in 97% of their patients. The LISS system proved to be stable, but there were cases of implant removal difficulty with this titanium construct. In 1 of the 10 cases in which the LISS plate was removed, 4 of the 11 locking screws were welded to the plate.8
Cold welding, in which similar metals are chemically bonded together under extreme pressure, is a complication associated with use of titanium-only plates and screws.9 This process, which is more likely to happen if cross-threading occurs within the screw–plate interface, can make screw removal extremely difficult. Screw removal difficulty strips screw heads, and often the surgeon must use either metal cutting instruments or trephines to remove screw remnants, which often results in retained implant or debris and damage or necrosis to surrounding bone.9,10
Locking screws are often inserted under power with a torque-limiting device attached to the drill mechanism to reduce the risk of lock screw overtightening and to try to prevent difficult implant removal. Although standard practice is to insert the screw and stop just before screw head engagement, with final tightening with a torque limiter and hand power, final tightening is often inadvertently done under power.3 Most technique guides instruct surgeons how to insert screws under power while using a torque limiter, but the exact technique is not emphasized.
We conducted a study to determine if rotational speed of screw insertion affects maximum torque on screw with use of a torque limiter. We describe proper use of a torque limiter as well as possible pitfalls. We hypothesized that improper use would result in substantially higher than expected insertion torque.
Materials and Methods
Torque-Limiting Attachments, Torque Wrench, and Drill
The Small Fragment Locking Compression Plate System (Synthes) includes a 1.5-Nm torque-limiting attachment and quick-coupling wooden handles and Star Drive attachments. All devices in this study were in active use at 6 urban institutions (3 level I trauma centers, 2 level II trauma centers, 1 level III hospital). Permission to obtain and test each device was granted by each institution.
A 0.25-inch dial torque wrench (751LDIN; CDI Torque Products) was purchased through an established distributor. The manufacturer includes a traceable certificate of accuracy to verify correct calibration. The torque wrench has a torque range of 0 to 9 Nm with visual increment demarcations of 0.2 Nm and a memory needle to retain maximum torque measurement. The same torque wrench was used in each experiment in order to maintain consistent measurements between devices. It was reset to zero after each use.
This study used a 0.5-inch, 19.2-V lithium drill (Craftsman C3) with 2 speed options: 0 to 440 rpm high torque and 0 to 1600 rpm high speed. This device provides variable torque output with a maximum output of 38.4 Nm. For this study, all measurements were done with the device on its high torque setting.
Maximum Torque Determination for Different Scenarios
Each torque limiter was evaluated for variations in maximum torque under 4 different scenarios. In each scenario, the torque limiter was coupled to the Star Drive attachment and then to that scenario’s rotating force. The completed system was then inserted into the torque wrench, which was secured to a flat working surface and rotated in accordance with each scenario; maximum torque was measured and recorded (Figures 1, 2). A torque-limiting event was defined as a single audible click on the torque limiter.
In scenario 1, each torque-limiting attachment system was attached to a quick-coupling wooden handle. The completed system was then rotated at controlled low velocity under hand power until 1 torque-limiting event occurred. This scenario was also used as an internal control to verify that the torque limiters were calibrated correctly.
In Scenario 2, the device was again attached to a quick-coupling wooden handle. The completed system was rotated at high velocity under hand power until multiple torque-limiting events occurred in a row. High velocity was defined as the operator freely rotating the wooden handle in a single action with full power resulting in multiple torque-limiting events.
In Scenario 3, the device was attached to a power drill braced to the flat working surface and rotated at low velocity under power until 1 torque-limiting event occurred.
In Scenario 4, the device was again attached to a power drill braced to the flat working surface. The completed system was rotated at high velocity under power until multiple torque-limiting events occurred.
After each trial, we recorded maximum torque achieved before each device’s torque-limiting event. Either an orthopedic surgery resident or a qualified medical student tested each torque-limiting device in each standardized testing scenario.
Statistical Analysis
Experiments for each torque limiter were repeated for 3 trials of each of the 4 different scenarios. For comparative statistics between experiments, maximum torque measurements were expressed as means and SDs; 95% confidence interval (95% CI) was calculated and reported to determine extent of variation within a single group. One-way analysis of variance (ANOVA) and Tukey post hoc tests were performed between groups for comparison of the normally distributed data. Significance was set at P ≤ .05.
Results
During simulation, we successfully measured maximum torque achieved with each torque limiter under the 4 different scenarios. All testing was done by 2 operators. ANOVA demonstrated significant (P ≤ .001) differences in torque among the scenarios.
In scenario 1, mean (SD) maximum torque under hand power at low velocity was 1.49 (0.15) Nm (95% CI, 1.43-1.55), near the advertised maximum torque of 1.5 Nm, with relatively minimal variation between devices. This scenario confirmed proper calibration of properly used torque limiters. Mean maximum torque ranged from 1.25 to 1.93 Nm.
In scenario 2, mean (SD) maximum torque under hand power at high velocity was 3.73 (0.79) Nm (95% CI, 3.33-4.13), a 2.5-fold increase compared with scenario 1 (P < .0001) (Figure 3). There also was an increase in variation of maximum torque between trials of individual devices and between different devices. Mean maximum torque ranged from 2.27 to 5.53 Nm.
In scenario 3, mean (SD) maximum torque under drill power at controlled low velocity was 1.47 (0.14) Nm (95% CI, 1.37-1.56), again near the advertised maximum torque of 1.5 Nm, with relatively minimal variation. Mean maximum torque ranged from 1.10 to 1.73 Nm.
In scenario 4, mean (SD) maximum torque under drill power at full power/high velocity was 5.37 (0.90) Nm (95% CI, 4.92-5.83), a 3.65-fold increase compared with scenario 3 (P < .0001) (Figure 3). Mean maximum torque measured in 3 tests ranged from 3.40 to 6.92 Nm.
There was no significant difference in mean maximum torque between the scenarios of hand power at low velocity and drill power at low velocities (P = .999) (Figure 4). Highest maximum torque from any device was 9.0 Nm (drill at full power). Results are summarized in the Table. There was no statistical significance in the test between the 2 test operators.
Discussion
Maximum torque was measured using a torque-limiting attachment under 4 different simulated scenarios. Our goals were to determine if varying practice and rotational velocity would affect maximum insertional torque and to measure consistency among torque limiters. We designed the scenarios to mimic practice patterns, including hand insertion and power insertion of locking screws. Results demonstrated that misuse of a torque-limiting device may inadvertently produce insertional torque substantially higher than recommended. Highest maximum torque was 9.0 Nm, which is 6.0-fold higher than expected for a locking screw using a 1.5-Nm torque limiter.
Our study results showed that insertion under controlled hand power (and low-velocity drill power) until 1 torque-limiting event occurred produced the most consistent and predictable results. Insertion under drill power or high-velocity hand power produced multiple sequential torque-limiting events, yielding inaccurate insertion torque. Low-velocity insertion under hand power, or carefully controlled drill power, consistently produced torque similar to advertised values.
Manufacturers’ technique guides are available for proximal humerus locking compression plate (LCP) systems, small-fragment LCP systems, the Proximal Humeral Interlocking System (PHILOS; DePuy Synthes), and the LISS. These technique guides clearly state that insertion can be performed under power. Only the PHILOS and LISS guides state that insertion should be performed under power until a single click is heard or that final tightening should be completed under hand power. The proximal humerus LCP guide states that surgeons should insert the locking screw under power until the torque-limiting device clicks. The small-fragment LCP guide states that insertion under power should always be completed with the torque-limiting attachment; there is no mention of reducing power or a single click (this may give the surgeon a false sense of security).
Screw overtightening and head/thread stripping can make screw removal challenging.10 Removal rates for LISS plates range from 8% to 26%, and removal is often reported as taking longer than the index procedure, with complication rates as high as 47%.11-13 Bae and colleagues3 reported significant difficulty in removing 24 of 279 self-tapping locking screws (3.5 mm).
It is important to note that these complications, most notably cold welding, are mostly associated with titanium locking plate and screw constructs. Although stainless steel constructs have gained favor, titanium constructs are still widely used around the world.14,15
In 10% of cases in a laboratory setting, insertion of a 3.5-mm locking screw at 4 to 6 Nm damaged the screw.9 Removal of 3.5-mm locking screws had a stripping rate of 8.6%, and use of the torque limiter did not make removal easy all the time.3 Torque limiters are set specific to each screw diameter to reduce the risk of damage/stripping or even overtightening. Even when a surgeon intends to stop a drill before locking, final tightening often inadvertently occurs under power.3
Cold welding is often described as a cause of difficult implant removal.3,12 According to a newer definition, this process is independent of temperature and can occur when 2 metallic surfaces are in direct contact.16 High contact pressures between 2 similar metals can lead to this solid state welding.17 Theoretically, improper use of torque limiters can increase the risk of welding; however, it appears to be associated only with titanium locking plate and screw constructs.
Locked plating osteosynthesis is a valuable tool for fracture management, but improper use can have significant consequences, including morbid implant removal procedures, which are more difficult and time-consuming than the index surgery. We determined that proper use of torque limiters involves insertion under hand or power control at slow velocity until 1 torque-limiting event occurs. Many orthopedic surgeons may assume that torque limiters are accurate no matter how screws are inserted into locking plates. In addition, they may be unaware guidelines exist, as these are often deeply embedded within text. Therefore, we must emphasize that torque limiters can be inaccurate when used improperly.
One limitation of this study is that it tested only the Synthes 1.5-Nm torque-limiting attachment, though we can speculate that torque limiters designed for larger screws and limiters manufactured by different companies will behave similarly. Another limitation is that we did not obtain the hospitals’ service records for the tested equipment and assumed the equipment was properly checked for accuracy by the providing company. However, we hypothesized that, if maintenance were an issue, then our results would not be similar across all sites tested.
These tests involved a torque limiter linked to a torque-measuring device and may not perfectly represent actual torque measured at the locked screw–thread interface. However, we think our construct accurately determines the torque produced at the level of the driver tip. Also, we can speculate that the torque produced with improper use will lead to the complications mentioned and demonstrated in previous studies. Welding of the screw–plate interface may simply be a result of improper trajectory and cross-threading. However, if we assume that torque limiters prevent excessive torque no matter how they are used, high insertion speeds may compound the effect of welding. Additional biomechanical studies with full locked plate osteosynthesis constructs on bone specimens are planned to further characterize the potential complications of this issue.
Proper surgical technique must be used to ensure that surgical fracture management is long-lasting. Plate implantation and screw implantation are among the most common orthopedic procedures performed. Plate and screw osteosynthesis can be done with nonlocking or locking plate and screw constructs or with hybrid fixation that incorporates both methods.
Nonlocking plate and screw osteosynthesis uses friction-fit for fixation. In osteoporotic bone, less torque is generated because of poor bone quality, and thus less friction force between plate and bone.1,2 Locked plating has dramatically changed fracture management, especially in frail and comminuted osteoporotic bone, with significant advantages over conventional plating.3-7
Development of locked plating systems, including the Less Invasive Stabilization System (LISS; DePuy Synthes) with its soft-tissue and fracture-fragment preservation, has changed treatment of distal femur and proximal tibia fractures. Cole and colleagues8 reported stable fixation and union in 97% of their patients. The LISS system proved to be stable, but there were cases of implant removal difficulty with this titanium construct. In 1 of the 10 cases in which the LISS plate was removed, 4 of the 11 locking screws were welded to the plate.8
Cold welding, in which similar metals are chemically bonded together under extreme pressure, is a complication associated with use of titanium-only plates and screws.9 This process, which is more likely to happen if cross-threading occurs within the screw–plate interface, can make screw removal extremely difficult. Screw removal difficulty strips screw heads, and often the surgeon must use either metal cutting instruments or trephines to remove screw remnants, which often results in retained implant or debris and damage or necrosis to surrounding bone.9,10
Locking screws are often inserted under power with a torque-limiting device attached to the drill mechanism to reduce the risk of lock screw overtightening and to try to prevent difficult implant removal. Although standard practice is to insert the screw and stop just before screw head engagement, with final tightening with a torque limiter and hand power, final tightening is often inadvertently done under power.3 Most technique guides instruct surgeons how to insert screws under power while using a torque limiter, but the exact technique is not emphasized.
We conducted a study to determine if rotational speed of screw insertion affects maximum torque on screw with use of a torque limiter. We describe proper use of a torque limiter as well as possible pitfalls. We hypothesized that improper use would result in substantially higher than expected insertion torque.
Materials and Methods
Torque-Limiting Attachments, Torque Wrench, and Drill
The Small Fragment Locking Compression Plate System (Synthes) includes a 1.5-Nm torque-limiting attachment and quick-coupling wooden handles and Star Drive attachments. All devices in this study were in active use at 6 urban institutions (3 level I trauma centers, 2 level II trauma centers, 1 level III hospital). Permission to obtain and test each device was granted by each institution.
A 0.25-inch dial torque wrench (751LDIN; CDI Torque Products) was purchased through an established distributor. The manufacturer includes a traceable certificate of accuracy to verify correct calibration. The torque wrench has a torque range of 0 to 9 Nm with visual increment demarcations of 0.2 Nm and a memory needle to retain maximum torque measurement. The same torque wrench was used in each experiment in order to maintain consistent measurements between devices. It was reset to zero after each use.
This study used a 0.5-inch, 19.2-V lithium drill (Craftsman C3) with 2 speed options: 0 to 440 rpm high torque and 0 to 1600 rpm high speed. This device provides variable torque output with a maximum output of 38.4 Nm. For this study, all measurements were done with the device on its high torque setting.
Maximum Torque Determination for Different Scenarios
Each torque limiter was evaluated for variations in maximum torque under 4 different scenarios. In each scenario, the torque limiter was coupled to the Star Drive attachment and then to that scenario’s rotating force. The completed system was then inserted into the torque wrench, which was secured to a flat working surface and rotated in accordance with each scenario; maximum torque was measured and recorded (Figures 1, 2). A torque-limiting event was defined as a single audible click on the torque limiter.
In scenario 1, each torque-limiting attachment system was attached to a quick-coupling wooden handle. The completed system was then rotated at controlled low velocity under hand power until 1 torque-limiting event occurred. This scenario was also used as an internal control to verify that the torque limiters were calibrated correctly.
In Scenario 2, the device was again attached to a quick-coupling wooden handle. The completed system was rotated at high velocity under hand power until multiple torque-limiting events occurred in a row. High velocity was defined as the operator freely rotating the wooden handle in a single action with full power resulting in multiple torque-limiting events.
In Scenario 3, the device was attached to a power drill braced to the flat working surface and rotated at low velocity under power until 1 torque-limiting event occurred.
In Scenario 4, the device was again attached to a power drill braced to the flat working surface. The completed system was rotated at high velocity under power until multiple torque-limiting events occurred.
After each trial, we recorded maximum torque achieved before each device’s torque-limiting event. Either an orthopedic surgery resident or a qualified medical student tested each torque-limiting device in each standardized testing scenario.
Statistical Analysis
Experiments for each torque limiter were repeated for 3 trials of each of the 4 different scenarios. For comparative statistics between experiments, maximum torque measurements were expressed as means and SDs; 95% confidence interval (95% CI) was calculated and reported to determine extent of variation within a single group. One-way analysis of variance (ANOVA) and Tukey post hoc tests were performed between groups for comparison of the normally distributed data. Significance was set at P ≤ .05.
Results
During simulation, we successfully measured maximum torque achieved with each torque limiter under the 4 different scenarios. All testing was done by 2 operators. ANOVA demonstrated significant (P ≤ .001) differences in torque among the scenarios.
In scenario 1, mean (SD) maximum torque under hand power at low velocity was 1.49 (0.15) Nm (95% CI, 1.43-1.55), near the advertised maximum torque of 1.5 Nm, with relatively minimal variation between devices. This scenario confirmed proper calibration of properly used torque limiters. Mean maximum torque ranged from 1.25 to 1.93 Nm.
In scenario 2, mean (SD) maximum torque under hand power at high velocity was 3.73 (0.79) Nm (95% CI, 3.33-4.13), a 2.5-fold increase compared with scenario 1 (P < .0001) (Figure 3). There also was an increase in variation of maximum torque between trials of individual devices and between different devices. Mean maximum torque ranged from 2.27 to 5.53 Nm.
In scenario 3, mean (SD) maximum torque under drill power at controlled low velocity was 1.47 (0.14) Nm (95% CI, 1.37-1.56), again near the advertised maximum torque of 1.5 Nm, with relatively minimal variation. Mean maximum torque ranged from 1.10 to 1.73 Nm.
In scenario 4, mean (SD) maximum torque under drill power at full power/high velocity was 5.37 (0.90) Nm (95% CI, 4.92-5.83), a 3.65-fold increase compared with scenario 3 (P < .0001) (Figure 3). Mean maximum torque measured in 3 tests ranged from 3.40 to 6.92 Nm.
There was no significant difference in mean maximum torque between the scenarios of hand power at low velocity and drill power at low velocities (P = .999) (Figure 4). Highest maximum torque from any device was 9.0 Nm (drill at full power). Results are summarized in the Table. There was no statistical significance in the test between the 2 test operators.
Discussion
Maximum torque was measured using a torque-limiting attachment under 4 different simulated scenarios. Our goals were to determine if varying practice and rotational velocity would affect maximum insertional torque and to measure consistency among torque limiters. We designed the scenarios to mimic practice patterns, including hand insertion and power insertion of locking screws. Results demonstrated that misuse of a torque-limiting device may inadvertently produce insertional torque substantially higher than recommended. Highest maximum torque was 9.0 Nm, which is 6.0-fold higher than expected for a locking screw using a 1.5-Nm torque limiter.
Our study results showed that insertion under controlled hand power (and low-velocity drill power) until 1 torque-limiting event occurred produced the most consistent and predictable results. Insertion under drill power or high-velocity hand power produced multiple sequential torque-limiting events, yielding inaccurate insertion torque. Low-velocity insertion under hand power, or carefully controlled drill power, consistently produced torque similar to advertised values.
Manufacturers’ technique guides are available for proximal humerus locking compression plate (LCP) systems, small-fragment LCP systems, the Proximal Humeral Interlocking System (PHILOS; DePuy Synthes), and the LISS. These technique guides clearly state that insertion can be performed under power. Only the PHILOS and LISS guides state that insertion should be performed under power until a single click is heard or that final tightening should be completed under hand power. The proximal humerus LCP guide states that surgeons should insert the locking screw under power until the torque-limiting device clicks. The small-fragment LCP guide states that insertion under power should always be completed with the torque-limiting attachment; there is no mention of reducing power or a single click (this may give the surgeon a false sense of security).
Screw overtightening and head/thread stripping can make screw removal challenging.10 Removal rates for LISS plates range from 8% to 26%, and removal is often reported as taking longer than the index procedure, with complication rates as high as 47%.11-13 Bae and colleagues3 reported significant difficulty in removing 24 of 279 self-tapping locking screws (3.5 mm).
It is important to note that these complications, most notably cold welding, are mostly associated with titanium locking plate and screw constructs. Although stainless steel constructs have gained favor, titanium constructs are still widely used around the world.14,15
In 10% of cases in a laboratory setting, insertion of a 3.5-mm locking screw at 4 to 6 Nm damaged the screw.9 Removal of 3.5-mm locking screws had a stripping rate of 8.6%, and use of the torque limiter did not make removal easy all the time.3 Torque limiters are set specific to each screw diameter to reduce the risk of damage/stripping or even overtightening. Even when a surgeon intends to stop a drill before locking, final tightening often inadvertently occurs under power.3
Cold welding is often described as a cause of difficult implant removal.3,12 According to a newer definition, this process is independent of temperature and can occur when 2 metallic surfaces are in direct contact.16 High contact pressures between 2 similar metals can lead to this solid state welding.17 Theoretically, improper use of torque limiters can increase the risk of welding; however, it appears to be associated only with titanium locking plate and screw constructs.
Locked plating osteosynthesis is a valuable tool for fracture management, but improper use can have significant consequences, including morbid implant removal procedures, which are more difficult and time-consuming than the index surgery. We determined that proper use of torque limiters involves insertion under hand or power control at slow velocity until 1 torque-limiting event occurs. Many orthopedic surgeons may assume that torque limiters are accurate no matter how screws are inserted into locking plates. In addition, they may be unaware guidelines exist, as these are often deeply embedded within text. Therefore, we must emphasize that torque limiters can be inaccurate when used improperly.
One limitation of this study is that it tested only the Synthes 1.5-Nm torque-limiting attachment, though we can speculate that torque limiters designed for larger screws and limiters manufactured by different companies will behave similarly. Another limitation is that we did not obtain the hospitals’ service records for the tested equipment and assumed the equipment was properly checked for accuracy by the providing company. However, we hypothesized that, if maintenance were an issue, then our results would not be similar across all sites tested.
These tests involved a torque limiter linked to a torque-measuring device and may not perfectly represent actual torque measured at the locked screw–thread interface. However, we think our construct accurately determines the torque produced at the level of the driver tip. Also, we can speculate that the torque produced with improper use will lead to the complications mentioned and demonstrated in previous studies. Welding of the screw–plate interface may simply be a result of improper trajectory and cross-threading. However, if we assume that torque limiters prevent excessive torque no matter how they are used, high insertion speeds may compound the effect of welding. Additional biomechanical studies with full locked plate osteosynthesis constructs on bone specimens are planned to further characterize the potential complications of this issue.
1. Sommer C, Babst R, Müller M, Hanson B. Locking compression plate loosening and plate breakage: a report of four cases. J Orthop Trauma. 2004;18(8):571-577.
2. Schütz M, Südkamp NP. Revolution in plate osteosynthesis: new internal fixator systems. J Orthop Sci. 2003;8(2):252-258.
3. Bae JH, Oh JK, Oh CW, Hur CR. Technical difficulties of removal of locking screw after locking compression plating. Arch Orthop Trauma Surg. 2009;129(1):91-95.
4. Frigg R. Locking compression plate (LCP). An osteosynthesis plate based on the dynamic compression plate and the point contact fixator (PC-Fix). Injury. 2001;32(suppl 2):63-66.
5. Frigg R. Development of the locking compression plate. Injury. 2003;34(suppl 2):B6-B10.
6. Korner J, Lill H, Müller LP, Rommens PM, Schneider E, Linke B. The LCP-concept in the operative treatment of distal humerus fractures—biological, biomechanical and surgical aspects. Injury. 2003;34(suppl 2):B20-B30.
7. Egol KA, Kubiak EN, Fulkerson E, Kummer FJ, Koval KJ. Biomechanics of locked plates and screws. J Orthop Trauma. 2004;18(8):488-493.
8. Cole PA, Zlowodzki M, Kregor PJ. Treatment of proximal tibia fractures using the Less Invasive Stabilization System: surgical experience and early clinical results in 77 fractures. J Orthop Trauma. 2004;18(8):528-535.
9. Ehlinger M, Adam P, Simon P, Bonnomet F. Technical difficulties in hardware removal in titanium compression plates with locking screws. Orthop Traumatol Surg Res. 2009;95(5):373-376.
10. Gopinathan NR, Dhillon MS, Kumar R. Surgical technique: simple technique for removing a locking recon plate with damaged screw heads. Clin Orthop Relat Res. 2013;471(5):1572-1575.
11. Pattison G, Reynolds J, Hardy J. Salvaging a stripped drive connection when removing screws. Injury. 1999;30(1):74-75.
12. Raja S, Imbuldeniya AM, Garg S, Groom G. Difficulties encountered removing locked plates. Ann R Coll Surg Engl. 2012;94(7):502-505.
13. Kumar G, Dunlop C. Case report: a technique to remove a jammed locking screw from a locking plate. Clin Orthop Relat Res. 2011;469(2):613-616.
14. Disegi JA. Titanium alloys for fracture fixation implants. Injury. 2000;31(suppl 4):14-17.
15. El-Zayat BF, Ruchholtz S, Efe T, Paletta J, Kreslo D, Zettl R. Results of titanium locking plate and stainless steel cerclage wire combination in femoral fractures. Indian J Orthop. 2013;47(5):454-458.
16. Van Nortwick SS, Yao J, Ladd AL. Titanium integration with bone, welding, and screw head destruction complicating hardware removal of the distal radius: report of 2 cases. J Hand Surg. 2012;37(7):1388-1392.
17. Ferguson GS, Chaudhury MK, Sigal GB, Whitesides GM. Contact adhesion of thin gold films on elastomeric supports: cold welding under ambient conditions. Science. 1991;253(5021):776-778.
1. Sommer C, Babst R, Müller M, Hanson B. Locking compression plate loosening and plate breakage: a report of four cases. J Orthop Trauma. 2004;18(8):571-577.
2. Schütz M, Südkamp NP. Revolution in plate osteosynthesis: new internal fixator systems. J Orthop Sci. 2003;8(2):252-258.
3. Bae JH, Oh JK, Oh CW, Hur CR. Technical difficulties of removal of locking screw after locking compression plating. Arch Orthop Trauma Surg. 2009;129(1):91-95.
4. Frigg R. Locking compression plate (LCP). An osteosynthesis plate based on the dynamic compression plate and the point contact fixator (PC-Fix). Injury. 2001;32(suppl 2):63-66.
5. Frigg R. Development of the locking compression plate. Injury. 2003;34(suppl 2):B6-B10.
6. Korner J, Lill H, Müller LP, Rommens PM, Schneider E, Linke B. The LCP-concept in the operative treatment of distal humerus fractures—biological, biomechanical and surgical aspects. Injury. 2003;34(suppl 2):B20-B30.
7. Egol KA, Kubiak EN, Fulkerson E, Kummer FJ, Koval KJ. Biomechanics of locked plates and screws. J Orthop Trauma. 2004;18(8):488-493.
8. Cole PA, Zlowodzki M, Kregor PJ. Treatment of proximal tibia fractures using the Less Invasive Stabilization System: surgical experience and early clinical results in 77 fractures. J Orthop Trauma. 2004;18(8):528-535.
9. Ehlinger M, Adam P, Simon P, Bonnomet F. Technical difficulties in hardware removal in titanium compression plates with locking screws. Orthop Traumatol Surg Res. 2009;95(5):373-376.
10. Gopinathan NR, Dhillon MS, Kumar R. Surgical technique: simple technique for removing a locking recon plate with damaged screw heads. Clin Orthop Relat Res. 2013;471(5):1572-1575.
11. Pattison G, Reynolds J, Hardy J. Salvaging a stripped drive connection when removing screws. Injury. 1999;30(1):74-75.
12. Raja S, Imbuldeniya AM, Garg S, Groom G. Difficulties encountered removing locked plates. Ann R Coll Surg Engl. 2012;94(7):502-505.
13. Kumar G, Dunlop C. Case report: a technique to remove a jammed locking screw from a locking plate. Clin Orthop Relat Res. 2011;469(2):613-616.
14. Disegi JA. Titanium alloys for fracture fixation implants. Injury. 2000;31(suppl 4):14-17.
15. El-Zayat BF, Ruchholtz S, Efe T, Paletta J, Kreslo D, Zettl R. Results of titanium locking plate and stainless steel cerclage wire combination in femoral fractures. Indian J Orthop. 2013;47(5):454-458.
16. Van Nortwick SS, Yao J, Ladd AL. Titanium integration with bone, welding, and screw head destruction complicating hardware removal of the distal radius: report of 2 cases. J Hand Surg. 2012;37(7):1388-1392.
17. Ferguson GS, Chaudhury MK, Sigal GB, Whitesides GM. Contact adhesion of thin gold films on elastomeric supports: cold welding under ambient conditions. Science. 1991;253(5021):776-778.
Treating Tibia Fractures With Far Cortical Locking Implants
Fracture healing can be categorized as primary or secondary. Primary healing requires precise reapproximation of bone fragments and compression of cortices. Osteons are formed across the fracture line, allowing blood supply and endothelial cells to gain access, leading to osteoblast infiltration and subsequent bone formation.1 This type of bone healing can be accomplished only with absolute stability—specifically, only with less than 2% strain at the fracture site, necessitating operative intervention with compression plating (Figure 1).2 This type of construct generates friction between the bone fragments against a metal plate, created by tightening screws that purchase both far and near cortices of bone.3 Although this type of fixation works well with many fractures, there are several instances in which compression plating is not ideal.4 Osteoporotic bone, for example, limits the amount of compression that can be developed, as screws strip the bone more readily, leading to weakened constructs prone to failure. Metaphyseal fractures in which there is minimal cortex for screw thread purchase are a similar challenge.5 Highly comminuted fractures do not allow for sufficient fragment compression and stability. In addition, compression plating requires periosteal stripping at the fracture, and often substantial soft-tissue disruption, which is especially a problem in areas of tenuous blood supply (eg, the tibia).
Locked plating therefore has become a valuable technique in managing osteoporotic fractures.2 Locking plates may be used to achieve secondary bone healing through a small amount of interfragmentary motion, 0.2 to 10 mm, as seen with bridge plating for example, whereby the locking plates act as internal fixators. Much as with external fixators, as the distance from the fixator bar (or plate) to bone decreases, construct stiffness increases. Thus, locking plates function as extremely stiff fixators when the plate is very near bone. It has therefore been speculated that such stiffness is insufficient to provide optimal secondary healing conditions.6,7 Titanium (vs stainless steel) plates have been used, and screws have been omitted just adjacent to either side of the fracture site, in attempts to increase plate flexibility and thus interfragmentary motion.8,9 In addition, biomechanical and animal model studies have demonstrated that, with use of locking plates, motion at the fracture site is asymmetric and leads to unequal callus formation at the near and far cortices, thus weakening the fracture site.10,11
The locking plate design was recently modified to address these concerns. Far cortical locking (FCL) uses locking screws threaded only distally (Figure 2), which allows for purchase into the far cortex but not the near cortex, which increases pin length from plate to bone. The near cortex is no longer anchored to the plate and thus increases construct flexibility. Pilot holes in the near cortex allow for movement of the nonthreaded screw shaft in a controlled, biphasic manner.12 This design decreases stiffness while sacrificing very little construct strength.10 In addition, motion at the far and near cortices is nearly parallel. It has been shown in an ovine tibial osteotomy model that, compared with the traditional locking plate design, FCL generates symmetric callus formation and improved fracture healing.11 Although these results are promising, there are only limited clinical data on use of the FCL technique in fracture repair. Our null hypothesis was that, despite the theoretical advantages of FCL constructs over conventional locking plates, there would be no clinically observed differences between the constructs.
Patients and Methods
After obtaining Institutional Review Board approval from the 2 level I trauma centers and 1 level II trauma center involved in this study, we retrospectively reviewed the cases of all adults who presented with a tibia fracture and were treated with FCL technology (MotionLoc, Zimmer) by a fellowship-trained trauma surgeon at these hospitals (Figures 3A–3C). Any primary tibia fracture treated with FCL was considered. Only patients with follow-up of at least 20 weeks were included in the analysis. Exclusion criteria were tibial malunions or nonunions treated with FCL and fractures treated with a combination of intramedullary fixation and plating.
We reviewed the patient charts for demographic data, mechanism of injury, fracture type, and comorbidities. Risk factors for poor healing—such as diabetes and tobacco use, either current or prior—were recorded. We also reviewed the radiographs of the initial injuries for analysis of the tibia fracture types (Table 1) as well as the follow-up radiographs for evaluation of fracture healing. Using the Orthopaedic Trauma Association classification system, we identified a variety of fracture patterns. Fracture healing rates were recorded and used to calculate the overall healing rates for each group. Union was defined as either radiographic evidence of a completely healed fracture (≥3 cortices) or radiographic evidence of osseous bridging at the fracture site in addition to full weight-bearing without pain. Infection was defined as positive intraoperative cultures or grossly infected wounds with purulence and erythema.
For statistical analysis, we used Welch 2-sample t test to compare categorical data, including rates of fracture union, infection, and revision surgery. We chose this test because it was unclear whether variance in the groups would be similar. FCL and control data were compared for significant differences by calculating P values. Similarly, for continuous data, Fisher exact test was used to calculate P values for mean time to union and mean time to full weight-bearing in order to compare FCL and control outcomes.
Results
Twelve patients treated at 2 level I and 1 level II trauma centers between November 2010 and May 2012 met the inclusion and exclusion criteria for this study. Another 10 patients were treated with standard plating techniques (control group). Mean age was 52 years (range, 25-72 years) for the FCL group and 46 years (range, 28-67 years) for the control group. The FCL group included 2 open fractures (control, 0) and 2 patients with diabetes (control, 1) (Table 1).
Eleven of the 12 FCL patients and all 10 control patients achieved fracture union by most recent follow-up (Table 2). The difference was not statistically significant (P = .363). The FCL-treated fracture that did not heal received an interfragmentary screw in addition to the standard FCL technology construct. The interfragmentary screw inhibited motion at the fracture site and could potentially have led to nonunion. For this patient, revision surgery to an intramedullary nail was required. Removal of the interfragmentary screw was uneventful. Each of the 2 open fractures in the FCL group required bone grafting because of large segmental bone loss. One of these fractures, a type 3B, became infected after bone grafting, and complete healing required plate removal. The patient was eventually treated with a brace. An infection that occurred after union in a closed tibia fracture in the FCL group required hardware removal. No patient in either group experienced loss or failure of fixation.
Discussion
Far cortical locking is a relatively new technology designed to increase fracture fixation flexibility by functionally lengthening the distance between the locking plate and the screw cortical purchase, which occurs at the far cortex rather than the near cortex. This construct thereby functions as an internal fixator and is functionally similar to an external fixator. Rather than there being bars external to the skin, a plate is placed internally, adjacent to but without compressing fracture fragments or the plate to the bone. This theoretically leads to a desirable amount of interfragmentary motion, promoting callus formation and secondary healing. However, too much motion at the fracture site disrupts healing by shearing proliferating cells attempting to bridge the fracture gap. Therefore, there is a narrow target zone of desirable motion between fracture fragments required to promote secondary bone healing—defined as 2% to 10% gap strain.2 FCL constructs are thought to fall in this range of gap strain and thus better promote secondary healing over standard locked plates. Although biomechanical studies have been used as proof of concept, there are no published clinical data on the effectiveness of FCL implants. The present article describes early data on clinical outcomes of this new type of implant.
The main limitation of this study is its small cohort size, which is largely a result of the short time these implants have been available and our attempt to compare only similar fractures in this analysis. In addition, follow-up was on average less than 1 year. We consider such follow-up acceptable, though, as all fractures essentially reached final healing status within that period. Another limitation is that we combined compression plating and locked plating in the control group. Considering the mechanism of the theoretical advantage of FCL implants, with larger cohorts it would be useful to perform a subanalysis in which compression and standard locking plates are separately compared with FCL implants.
This study found no statistically significant difference between FCL and standard plating, suggesting FCL likely is not inferior to standard plating. Although the FCL group included a nonunion, it is important to note that, in this case, there was a technical discrepancy in the ideal technique whereby another interfragmentary screw was placed, eliminating the interfragmentary motion that establishes the premise of FCL technology. This case thereby demonstrated that a breach in the FCL technique, as with standard locking techniques, may lead to fracture-healing complications. In the FCL group, 2 open fractures with significant segmental bone loss requiring bone graft subsequently healed. In addition, compared with the control group, the FCL group included more patients with diabetes and more tobacco users (both diabetes and tobacco use are associated with poor bone and wound healing). The FCL group was also, on average, 6 years older than the control group. None of these group differences, however, reached statistical significance. Indeed, part of the impetus to use FCL implants in this population was that these patients likely were at higher risk for poor healing and nonunion. This factor therefore represents a selection bias—the FCL group was more predisposed to nonunion—and a study limitation.
Together, our data show neither superiority nor inferiority of the FCL technique. This study is an important step in furthering investigations into FCL constructs. The finding of similar efficacy with FCL and conventional plating may assuage safety concerns and pave the way for more definitive studies of FCL technology and fuller evaluations of its effectiveness. These studies will be essential in determining whether the theoretical advantage of FCL translates into better clinical outcomes. Larger, prospective randomized studies with longer follow-ups will be needed to better compare FCL technology with current implants and techniques. At this early stage, however, FCL technology appears to be a viable option for complex fractures of the tibia.
1. Bernstein J, ed. Musculoskeletal Medicine. Rosemont, IL: American Academy of Orthopaedic Surgeons; 2003.
2. Egol KA, Kubiak EN, Fulkerson E, Kummer FJ, Koval KJ. Biomechanics of locked plates and screws. J Orthop Trauma. 2004;18(8):488-493.
3. Bagby GW. Compression bone-plating: historical considerations. J Bone Joint Surg Am. 1977;59(5):625-631.
4. Kubiak EN, Fulkerson E, Strauss E, Egol KA. The evolution of locked plates. J Bone Joint Surg Am. 2006;88(suppl 4):189-200.
5. Fitzpatrick DC, Doornink J, Madey SM, Bottlang M. Relative stability of conventional and locked plating fixation in a model of the osteoporotic femoral diaphysis. Clin Biomech. 2009;24(2):203-209.
6. Henderson CE, Bottlang M, Marsh JL, Fitzpatrick DC, Madey SM. Does locked plating of periprosthetic supracondylar femur fractures promote bone healing by callus formation? Two cases with opposite outcomes. Iowa Orthop J. 2008;28:73-76.
7. Lujan TJ, Henderson CE, Madey SM, Fitzpatrick DC, Marsh JL, Bottlang M. Locked plating of distal femur fractures leads to inconsistent and asymmetric callus formation. J Orthop Trauma. 2010;24(3):156-162.
8. Stoffel K, Dieter U, Stachowiak G, Gächter A, Kuster MS. Biomechanical testing of the LCP—how can stability in locked internal fixators be controlled? Injury. 2003;34(suppl 2):B11-B19.
9. Schmal H, Strohm PC, Jaeger M, Südkamp NP. Flexible fixation and fracture healing: do locked plating ‘internal fixators’ resemble external fixators? J Orthop Trauma. 2011;25(suppl 1):S15-S20.
10. Bottlang M, Doornink J, Fitzpatrick DC, Madey SM. Far cortical locking can reduce stiffness of locked plating constructs while retaining construct strength. J Bone Joint Surg Am. 2009;91(8):1985-1994.
11. Bottlang M, Lesser M, Koerber J, et al. Far cortical locking can improve healing of fractures stabilized with locking plates. J Bone Joint Surg Am. 2010;92(7):1652-1660.
12. Bottlang M, Feist F. Biomechanics of far cortical locking. J Orthop Trauma. 2011;25(suppl 1):S21-S28.
Fracture healing can be categorized as primary or secondary. Primary healing requires precise reapproximation of bone fragments and compression of cortices. Osteons are formed across the fracture line, allowing blood supply and endothelial cells to gain access, leading to osteoblast infiltration and subsequent bone formation.1 This type of bone healing can be accomplished only with absolute stability—specifically, only with less than 2% strain at the fracture site, necessitating operative intervention with compression plating (Figure 1).2 This type of construct generates friction between the bone fragments against a metal plate, created by tightening screws that purchase both far and near cortices of bone.3 Although this type of fixation works well with many fractures, there are several instances in which compression plating is not ideal.4 Osteoporotic bone, for example, limits the amount of compression that can be developed, as screws strip the bone more readily, leading to weakened constructs prone to failure. Metaphyseal fractures in which there is minimal cortex for screw thread purchase are a similar challenge.5 Highly comminuted fractures do not allow for sufficient fragment compression and stability. In addition, compression plating requires periosteal stripping at the fracture, and often substantial soft-tissue disruption, which is especially a problem in areas of tenuous blood supply (eg, the tibia).
Locked plating therefore has become a valuable technique in managing osteoporotic fractures.2 Locking plates may be used to achieve secondary bone healing through a small amount of interfragmentary motion, 0.2 to 10 mm, as seen with bridge plating for example, whereby the locking plates act as internal fixators. Much as with external fixators, as the distance from the fixator bar (or plate) to bone decreases, construct stiffness increases. Thus, locking plates function as extremely stiff fixators when the plate is very near bone. It has therefore been speculated that such stiffness is insufficient to provide optimal secondary healing conditions.6,7 Titanium (vs stainless steel) plates have been used, and screws have been omitted just adjacent to either side of the fracture site, in attempts to increase plate flexibility and thus interfragmentary motion.8,9 In addition, biomechanical and animal model studies have demonstrated that, with use of locking plates, motion at the fracture site is asymmetric and leads to unequal callus formation at the near and far cortices, thus weakening the fracture site.10,11
The locking plate design was recently modified to address these concerns. Far cortical locking (FCL) uses locking screws threaded only distally (Figure 2), which allows for purchase into the far cortex but not the near cortex, which increases pin length from plate to bone. The near cortex is no longer anchored to the plate and thus increases construct flexibility. Pilot holes in the near cortex allow for movement of the nonthreaded screw shaft in a controlled, biphasic manner.12 This design decreases stiffness while sacrificing very little construct strength.10 In addition, motion at the far and near cortices is nearly parallel. It has been shown in an ovine tibial osteotomy model that, compared with the traditional locking plate design, FCL generates symmetric callus formation and improved fracture healing.11 Although these results are promising, there are only limited clinical data on use of the FCL technique in fracture repair. Our null hypothesis was that, despite the theoretical advantages of FCL constructs over conventional locking plates, there would be no clinically observed differences between the constructs.
Patients and Methods
After obtaining Institutional Review Board approval from the 2 level I trauma centers and 1 level II trauma center involved in this study, we retrospectively reviewed the cases of all adults who presented with a tibia fracture and were treated with FCL technology (MotionLoc, Zimmer) by a fellowship-trained trauma surgeon at these hospitals (Figures 3A–3C). Any primary tibia fracture treated with FCL was considered. Only patients with follow-up of at least 20 weeks were included in the analysis. Exclusion criteria were tibial malunions or nonunions treated with FCL and fractures treated with a combination of intramedullary fixation and plating.
We reviewed the patient charts for demographic data, mechanism of injury, fracture type, and comorbidities. Risk factors for poor healing—such as diabetes and tobacco use, either current or prior—were recorded. We also reviewed the radiographs of the initial injuries for analysis of the tibia fracture types (Table 1) as well as the follow-up radiographs for evaluation of fracture healing. Using the Orthopaedic Trauma Association classification system, we identified a variety of fracture patterns. Fracture healing rates were recorded and used to calculate the overall healing rates for each group. Union was defined as either radiographic evidence of a completely healed fracture (≥3 cortices) or radiographic evidence of osseous bridging at the fracture site in addition to full weight-bearing without pain. Infection was defined as positive intraoperative cultures or grossly infected wounds with purulence and erythema.
For statistical analysis, we used Welch 2-sample t test to compare categorical data, including rates of fracture union, infection, and revision surgery. We chose this test because it was unclear whether variance in the groups would be similar. FCL and control data were compared for significant differences by calculating P values. Similarly, for continuous data, Fisher exact test was used to calculate P values for mean time to union and mean time to full weight-bearing in order to compare FCL and control outcomes.
Results
Twelve patients treated at 2 level I and 1 level II trauma centers between November 2010 and May 2012 met the inclusion and exclusion criteria for this study. Another 10 patients were treated with standard plating techniques (control group). Mean age was 52 years (range, 25-72 years) for the FCL group and 46 years (range, 28-67 years) for the control group. The FCL group included 2 open fractures (control, 0) and 2 patients with diabetes (control, 1) (Table 1).
Eleven of the 12 FCL patients and all 10 control patients achieved fracture union by most recent follow-up (Table 2). The difference was not statistically significant (P = .363). The FCL-treated fracture that did not heal received an interfragmentary screw in addition to the standard FCL technology construct. The interfragmentary screw inhibited motion at the fracture site and could potentially have led to nonunion. For this patient, revision surgery to an intramedullary nail was required. Removal of the interfragmentary screw was uneventful. Each of the 2 open fractures in the FCL group required bone grafting because of large segmental bone loss. One of these fractures, a type 3B, became infected after bone grafting, and complete healing required plate removal. The patient was eventually treated with a brace. An infection that occurred after union in a closed tibia fracture in the FCL group required hardware removal. No patient in either group experienced loss or failure of fixation.
Discussion
Far cortical locking is a relatively new technology designed to increase fracture fixation flexibility by functionally lengthening the distance between the locking plate and the screw cortical purchase, which occurs at the far cortex rather than the near cortex. This construct thereby functions as an internal fixator and is functionally similar to an external fixator. Rather than there being bars external to the skin, a plate is placed internally, adjacent to but without compressing fracture fragments or the plate to the bone. This theoretically leads to a desirable amount of interfragmentary motion, promoting callus formation and secondary healing. However, too much motion at the fracture site disrupts healing by shearing proliferating cells attempting to bridge the fracture gap. Therefore, there is a narrow target zone of desirable motion between fracture fragments required to promote secondary bone healing—defined as 2% to 10% gap strain.2 FCL constructs are thought to fall in this range of gap strain and thus better promote secondary healing over standard locked plates. Although biomechanical studies have been used as proof of concept, there are no published clinical data on the effectiveness of FCL implants. The present article describes early data on clinical outcomes of this new type of implant.
The main limitation of this study is its small cohort size, which is largely a result of the short time these implants have been available and our attempt to compare only similar fractures in this analysis. In addition, follow-up was on average less than 1 year. We consider such follow-up acceptable, though, as all fractures essentially reached final healing status within that period. Another limitation is that we combined compression plating and locked plating in the control group. Considering the mechanism of the theoretical advantage of FCL implants, with larger cohorts it would be useful to perform a subanalysis in which compression and standard locking plates are separately compared with FCL implants.
This study found no statistically significant difference between FCL and standard plating, suggesting FCL likely is not inferior to standard plating. Although the FCL group included a nonunion, it is important to note that, in this case, there was a technical discrepancy in the ideal technique whereby another interfragmentary screw was placed, eliminating the interfragmentary motion that establishes the premise of FCL technology. This case thereby demonstrated that a breach in the FCL technique, as with standard locking techniques, may lead to fracture-healing complications. In the FCL group, 2 open fractures with significant segmental bone loss requiring bone graft subsequently healed. In addition, compared with the control group, the FCL group included more patients with diabetes and more tobacco users (both diabetes and tobacco use are associated with poor bone and wound healing). The FCL group was also, on average, 6 years older than the control group. None of these group differences, however, reached statistical significance. Indeed, part of the impetus to use FCL implants in this population was that these patients likely were at higher risk for poor healing and nonunion. This factor therefore represents a selection bias—the FCL group was more predisposed to nonunion—and a study limitation.
Together, our data show neither superiority nor inferiority of the FCL technique. This study is an important step in furthering investigations into FCL constructs. The finding of similar efficacy with FCL and conventional plating may assuage safety concerns and pave the way for more definitive studies of FCL technology and fuller evaluations of its effectiveness. These studies will be essential in determining whether the theoretical advantage of FCL translates into better clinical outcomes. Larger, prospective randomized studies with longer follow-ups will be needed to better compare FCL technology with current implants and techniques. At this early stage, however, FCL technology appears to be a viable option for complex fractures of the tibia.
Fracture healing can be categorized as primary or secondary. Primary healing requires precise reapproximation of bone fragments and compression of cortices. Osteons are formed across the fracture line, allowing blood supply and endothelial cells to gain access, leading to osteoblast infiltration and subsequent bone formation.1 This type of bone healing can be accomplished only with absolute stability—specifically, only with less than 2% strain at the fracture site, necessitating operative intervention with compression plating (Figure 1).2 This type of construct generates friction between the bone fragments against a metal plate, created by tightening screws that purchase both far and near cortices of bone.3 Although this type of fixation works well with many fractures, there are several instances in which compression plating is not ideal.4 Osteoporotic bone, for example, limits the amount of compression that can be developed, as screws strip the bone more readily, leading to weakened constructs prone to failure. Metaphyseal fractures in which there is minimal cortex for screw thread purchase are a similar challenge.5 Highly comminuted fractures do not allow for sufficient fragment compression and stability. In addition, compression plating requires periosteal stripping at the fracture, and often substantial soft-tissue disruption, which is especially a problem in areas of tenuous blood supply (eg, the tibia).
Locked plating therefore has become a valuable technique in managing osteoporotic fractures.2 Locking plates may be used to achieve secondary bone healing through a small amount of interfragmentary motion, 0.2 to 10 mm, as seen with bridge plating for example, whereby the locking plates act as internal fixators. Much as with external fixators, as the distance from the fixator bar (or plate) to bone decreases, construct stiffness increases. Thus, locking plates function as extremely stiff fixators when the plate is very near bone. It has therefore been speculated that such stiffness is insufficient to provide optimal secondary healing conditions.6,7 Titanium (vs stainless steel) plates have been used, and screws have been omitted just adjacent to either side of the fracture site, in attempts to increase plate flexibility and thus interfragmentary motion.8,9 In addition, biomechanical and animal model studies have demonstrated that, with use of locking plates, motion at the fracture site is asymmetric and leads to unequal callus formation at the near and far cortices, thus weakening the fracture site.10,11
The locking plate design was recently modified to address these concerns. Far cortical locking (FCL) uses locking screws threaded only distally (Figure 2), which allows for purchase into the far cortex but not the near cortex, which increases pin length from plate to bone. The near cortex is no longer anchored to the plate and thus increases construct flexibility. Pilot holes in the near cortex allow for movement of the nonthreaded screw shaft in a controlled, biphasic manner.12 This design decreases stiffness while sacrificing very little construct strength.10 In addition, motion at the far and near cortices is nearly parallel. It has been shown in an ovine tibial osteotomy model that, compared with the traditional locking plate design, FCL generates symmetric callus formation and improved fracture healing.11 Although these results are promising, there are only limited clinical data on use of the FCL technique in fracture repair. Our null hypothesis was that, despite the theoretical advantages of FCL constructs over conventional locking plates, there would be no clinically observed differences between the constructs.
Patients and Methods
After obtaining Institutional Review Board approval from the 2 level I trauma centers and 1 level II trauma center involved in this study, we retrospectively reviewed the cases of all adults who presented with a tibia fracture and were treated with FCL technology (MotionLoc, Zimmer) by a fellowship-trained trauma surgeon at these hospitals (Figures 3A–3C). Any primary tibia fracture treated with FCL was considered. Only patients with follow-up of at least 20 weeks were included in the analysis. Exclusion criteria were tibial malunions or nonunions treated with FCL and fractures treated with a combination of intramedullary fixation and plating.
We reviewed the patient charts for demographic data, mechanism of injury, fracture type, and comorbidities. Risk factors for poor healing—such as diabetes and tobacco use, either current or prior—were recorded. We also reviewed the radiographs of the initial injuries for analysis of the tibia fracture types (Table 1) as well as the follow-up radiographs for evaluation of fracture healing. Using the Orthopaedic Trauma Association classification system, we identified a variety of fracture patterns. Fracture healing rates were recorded and used to calculate the overall healing rates for each group. Union was defined as either radiographic evidence of a completely healed fracture (≥3 cortices) or radiographic evidence of osseous bridging at the fracture site in addition to full weight-bearing without pain. Infection was defined as positive intraoperative cultures or grossly infected wounds with purulence and erythema.
For statistical analysis, we used Welch 2-sample t test to compare categorical data, including rates of fracture union, infection, and revision surgery. We chose this test because it was unclear whether variance in the groups would be similar. FCL and control data were compared for significant differences by calculating P values. Similarly, for continuous data, Fisher exact test was used to calculate P values for mean time to union and mean time to full weight-bearing in order to compare FCL and control outcomes.
Results
Twelve patients treated at 2 level I and 1 level II trauma centers between November 2010 and May 2012 met the inclusion and exclusion criteria for this study. Another 10 patients were treated with standard plating techniques (control group). Mean age was 52 years (range, 25-72 years) for the FCL group and 46 years (range, 28-67 years) for the control group. The FCL group included 2 open fractures (control, 0) and 2 patients with diabetes (control, 1) (Table 1).
Eleven of the 12 FCL patients and all 10 control patients achieved fracture union by most recent follow-up (Table 2). The difference was not statistically significant (P = .363). The FCL-treated fracture that did not heal received an interfragmentary screw in addition to the standard FCL technology construct. The interfragmentary screw inhibited motion at the fracture site and could potentially have led to nonunion. For this patient, revision surgery to an intramedullary nail was required. Removal of the interfragmentary screw was uneventful. Each of the 2 open fractures in the FCL group required bone grafting because of large segmental bone loss. One of these fractures, a type 3B, became infected after bone grafting, and complete healing required plate removal. The patient was eventually treated with a brace. An infection that occurred after union in a closed tibia fracture in the FCL group required hardware removal. No patient in either group experienced loss or failure of fixation.
Discussion
Far cortical locking is a relatively new technology designed to increase fracture fixation flexibility by functionally lengthening the distance between the locking plate and the screw cortical purchase, which occurs at the far cortex rather than the near cortex. This construct thereby functions as an internal fixator and is functionally similar to an external fixator. Rather than there being bars external to the skin, a plate is placed internally, adjacent to but without compressing fracture fragments or the plate to the bone. This theoretically leads to a desirable amount of interfragmentary motion, promoting callus formation and secondary healing. However, too much motion at the fracture site disrupts healing by shearing proliferating cells attempting to bridge the fracture gap. Therefore, there is a narrow target zone of desirable motion between fracture fragments required to promote secondary bone healing—defined as 2% to 10% gap strain.2 FCL constructs are thought to fall in this range of gap strain and thus better promote secondary healing over standard locked plates. Although biomechanical studies have been used as proof of concept, there are no published clinical data on the effectiveness of FCL implants. The present article describes early data on clinical outcomes of this new type of implant.
The main limitation of this study is its small cohort size, which is largely a result of the short time these implants have been available and our attempt to compare only similar fractures in this analysis. In addition, follow-up was on average less than 1 year. We consider such follow-up acceptable, though, as all fractures essentially reached final healing status within that period. Another limitation is that we combined compression plating and locked plating in the control group. Considering the mechanism of the theoretical advantage of FCL implants, with larger cohorts it would be useful to perform a subanalysis in which compression and standard locking plates are separately compared with FCL implants.
This study found no statistically significant difference between FCL and standard plating, suggesting FCL likely is not inferior to standard plating. Although the FCL group included a nonunion, it is important to note that, in this case, there was a technical discrepancy in the ideal technique whereby another interfragmentary screw was placed, eliminating the interfragmentary motion that establishes the premise of FCL technology. This case thereby demonstrated that a breach in the FCL technique, as with standard locking techniques, may lead to fracture-healing complications. In the FCL group, 2 open fractures with significant segmental bone loss requiring bone graft subsequently healed. In addition, compared with the control group, the FCL group included more patients with diabetes and more tobacco users (both diabetes and tobacco use are associated with poor bone and wound healing). The FCL group was also, on average, 6 years older than the control group. None of these group differences, however, reached statistical significance. Indeed, part of the impetus to use FCL implants in this population was that these patients likely were at higher risk for poor healing and nonunion. This factor therefore represents a selection bias—the FCL group was more predisposed to nonunion—and a study limitation.
Together, our data show neither superiority nor inferiority of the FCL technique. This study is an important step in furthering investigations into FCL constructs. The finding of similar efficacy with FCL and conventional plating may assuage safety concerns and pave the way for more definitive studies of FCL technology and fuller evaluations of its effectiveness. These studies will be essential in determining whether the theoretical advantage of FCL translates into better clinical outcomes. Larger, prospective randomized studies with longer follow-ups will be needed to better compare FCL technology with current implants and techniques. At this early stage, however, FCL technology appears to be a viable option for complex fractures of the tibia.
1. Bernstein J, ed. Musculoskeletal Medicine. Rosemont, IL: American Academy of Orthopaedic Surgeons; 2003.
2. Egol KA, Kubiak EN, Fulkerson E, Kummer FJ, Koval KJ. Biomechanics of locked plates and screws. J Orthop Trauma. 2004;18(8):488-493.
3. Bagby GW. Compression bone-plating: historical considerations. J Bone Joint Surg Am. 1977;59(5):625-631.
4. Kubiak EN, Fulkerson E, Strauss E, Egol KA. The evolution of locked plates. J Bone Joint Surg Am. 2006;88(suppl 4):189-200.
5. Fitzpatrick DC, Doornink J, Madey SM, Bottlang M. Relative stability of conventional and locked plating fixation in a model of the osteoporotic femoral diaphysis. Clin Biomech. 2009;24(2):203-209.
6. Henderson CE, Bottlang M, Marsh JL, Fitzpatrick DC, Madey SM. Does locked plating of periprosthetic supracondylar femur fractures promote bone healing by callus formation? Two cases with opposite outcomes. Iowa Orthop J. 2008;28:73-76.
7. Lujan TJ, Henderson CE, Madey SM, Fitzpatrick DC, Marsh JL, Bottlang M. Locked plating of distal femur fractures leads to inconsistent and asymmetric callus formation. J Orthop Trauma. 2010;24(3):156-162.
8. Stoffel K, Dieter U, Stachowiak G, Gächter A, Kuster MS. Biomechanical testing of the LCP—how can stability in locked internal fixators be controlled? Injury. 2003;34(suppl 2):B11-B19.
9. Schmal H, Strohm PC, Jaeger M, Südkamp NP. Flexible fixation and fracture healing: do locked plating ‘internal fixators’ resemble external fixators? J Orthop Trauma. 2011;25(suppl 1):S15-S20.
10. Bottlang M, Doornink J, Fitzpatrick DC, Madey SM. Far cortical locking can reduce stiffness of locked plating constructs while retaining construct strength. J Bone Joint Surg Am. 2009;91(8):1985-1994.
11. Bottlang M, Lesser M, Koerber J, et al. Far cortical locking can improve healing of fractures stabilized with locking plates. J Bone Joint Surg Am. 2010;92(7):1652-1660.
12. Bottlang M, Feist F. Biomechanics of far cortical locking. J Orthop Trauma. 2011;25(suppl 1):S21-S28.
1. Bernstein J, ed. Musculoskeletal Medicine. Rosemont, IL: American Academy of Orthopaedic Surgeons; 2003.
2. Egol KA, Kubiak EN, Fulkerson E, Kummer FJ, Koval KJ. Biomechanics of locked plates and screws. J Orthop Trauma. 2004;18(8):488-493.
3. Bagby GW. Compression bone-plating: historical considerations. J Bone Joint Surg Am. 1977;59(5):625-631.
4. Kubiak EN, Fulkerson E, Strauss E, Egol KA. The evolution of locked plates. J Bone Joint Surg Am. 2006;88(suppl 4):189-200.
5. Fitzpatrick DC, Doornink J, Madey SM, Bottlang M. Relative stability of conventional and locked plating fixation in a model of the osteoporotic femoral diaphysis. Clin Biomech. 2009;24(2):203-209.
6. Henderson CE, Bottlang M, Marsh JL, Fitzpatrick DC, Madey SM. Does locked plating of periprosthetic supracondylar femur fractures promote bone healing by callus formation? Two cases with opposite outcomes. Iowa Orthop J. 2008;28:73-76.
7. Lujan TJ, Henderson CE, Madey SM, Fitzpatrick DC, Marsh JL, Bottlang M. Locked plating of distal femur fractures leads to inconsistent and asymmetric callus formation. J Orthop Trauma. 2010;24(3):156-162.
8. Stoffel K, Dieter U, Stachowiak G, Gächter A, Kuster MS. Biomechanical testing of the LCP—how can stability in locked internal fixators be controlled? Injury. 2003;34(suppl 2):B11-B19.
9. Schmal H, Strohm PC, Jaeger M, Südkamp NP. Flexible fixation and fracture healing: do locked plating ‘internal fixators’ resemble external fixators? J Orthop Trauma. 2011;25(suppl 1):S15-S20.
10. Bottlang M, Doornink J, Fitzpatrick DC, Madey SM. Far cortical locking can reduce stiffness of locked plating constructs while retaining construct strength. J Bone Joint Surg Am. 2009;91(8):1985-1994.
11. Bottlang M, Lesser M, Koerber J, et al. Far cortical locking can improve healing of fractures stabilized with locking plates. J Bone Joint Surg Am. 2010;92(7):1652-1660.
12. Bottlang M, Feist F. Biomechanics of far cortical locking. J Orthop Trauma. 2011;25(suppl 1):S21-S28.
Patients' Sleep Quality and Duration
Approximately 70 million adults within the United States have sleep disorders,[1] and up to 30% of adults report sleeping less than 6 hours per night.[2] Poor sleep has been associated with undesirable health outcomes.[1] Suboptimal sleep duration and sleep quality has been associated with a higher prevalence of chronic health conditions including hypertension, type 2 diabetes, coronary artery disease, stroke, and obesity, as well as increased overall mortality.[3, 4, 5, 6, 7]
Sleep plays an important role in restoration of wellness. Poor sleep is associated with physiological disturbances that may result in poor healing.[8, 9, 10] In the literature, prevalence of insomnia among elderly hospitalized patients was 36.7%,[11] whereas in younger hospitalized patients it was 50%.[12] Hospitalized patients frequently cite their acute illness, hospital‐related environmental factors, and disruptions that are part of routine care as causes for poor sleep during hospitalization.[13, 14, 15] Although the pervasiveness of poor sleep among hospitalized patients is high, interventions that prioritize sleep optimization as routine care, are uncommon. Few studies have reviewed the effect of sleep‐promoting measures on both sleep quality and sleep duration among patients hospitalized on general medicine units.
In this study, we aimed to assess the feasibility of incorporating sleep‐promoting interventions on a general medicine unit. We sought to identify differences in sleep measures between intervention and control groups. The primary outcome that we hoped to influence and lengthen in the intervention group was sleep duration. This outcome was measured both by sleep diary and with actigraphy. Secondary outcomes that we hypothesized should improve in the intervention group included feeling more refreshed in the mornings, sleep efficiency, and fewer sleep disruptions. As a feasibility pilot, we also wanted to explore the ease or difficulty with which sleep‐promoting interventions could be incorporated to the team's workflow.
METHODS
Study Design
A quasi‐experimental prospective pilot study was conducted at a single academic center, the Johns Hopkins Bayview Medical Center. Participants included adult patients admitted to the general medicine ward from July 2013 through January 2014. Patients with dementia; inability to complete survey questionnaires due to delirium, disability, or a language barrier; active withdrawal from alcohol or controlled substances; or acute psychiatric illness were excluded in this study.
The medicine ward at our medical center is comprised of 2 structurally identical units that admit patients with similar diagnoses, disease severity, and case‐mix disease groups. Nursing and support staff are unit specific. Pertaining to the sleep environment, the units both have semiprivate and private rooms. Visitors are encouraged to leave by 10 pm. Patients admitted from the emergency room to the medicine ward are assigned haphazardly to either unit based on bed availability. For the purpose of this study, we selected 1 unit to be a control unit and identified the other as the sleep‐promoting intervention unit.
Study Procedure
Upon arrival to the medicine unit, the research team approached all patients who met study eligibility criteria for study participation. Patients were provided full disclosure of the study using institutional research guidelines, and those interested in participating were consented. Participants were not explicitly told about their group assignment. This study was approved by the Johns Hopkins Institutional Review Board for human subject research.
In this study, the control group participants received standard of care as it pertains to sleep promotion. No additional sleep‐promoting measures were implemented to routine medical care, medication administration, nursing care, and overnight monitoring. Patients who used sleep medications at home, prior to admission, had those medicines continued only if they requested them and they were not contraindicated given their acute illness. Participants on the intervention unit were exposed to a nurse‐delivered sleep‐promoting protocol aimed at transforming the culture of care such that helping patients to sleep soundly was made a top priority. Environmental changes included unit‐wide efforts to minimize light and noise disturbances by dimming hallway lights, turning off room lights, and encouraging care teams to be as quiet as possible. Other strategies focused largely on minimizing care‐related disruptions. These included, when appropriate, administering nighttime medications in the early evening, minimizing fluids overnight, and closing patient room doors where appropriate. Further, patients were offered the following sleep‐promoting items to choose from: ear plugs, eye masks, warm blankets, and relaxation music. The final component of our intervention was 30‐minute sleep hygiene education taught by a physician. It highlighted basic sleep physiology and healthy sleep behavior adapted from Buysse.[16] Patients learned the role of behaviors such as reducing time lying awake in bed, setting standard wake‐up time and sleep time, and going to bed only when sleepy. This behavioral education was supplemented by a handout with sleep‐promoting suggestions.
The care team on the intervention unit received comprehensive study‐focused training in which night nursing teams were familiarized with the sleep‐promoting protocol through in‐service sessions facilitated by 1 of the authors (E.W.G.). To further promote study implementation, sleep‐promoting procedures were supported and encouraged by supervising nurses who made daily reminders to the intervention unit night care team of the goals of the sleep‐promoting study during evening huddles performed at the beginning of each shift. To assess the adherence of the sleep protocol, the nursing staff completed a daily checklist of elements within the protocol that were employed .
Data Collection and Measures
Baseline Measures
At the time of enrollment, study patients' demographic information, including use of chronic sleep medication prior to admission, was collected. Participants were assessed for baseline sleep disturbance prior to admission using standardized, validated sleep assessment tools: Pittsburgh Sleep Quality Index (PSQI), the Insomnia Severity Index (ISI), and the Epworth Sleepiness Scale (ESS). PSQI, a 19‐item tool, assessed self‐rated sleep quality measured over the prior month; a score of 5 or greater indicated poor sleep.[17] ISI, a 7‐item tool, identified the presence, rated the severity, and described the impact of insomnia; a score of 10 or greater indicated insomnia.[18] ESS, an 8‐item self‐rated tool, evaluated the impact of perceived sleepiness on daily functioning in 8 different environments; a score of 9 or greater was linked to burden of sleepiness. Participants were also screened for both obstructive sleep apnea (using the Berlin Sleep Apnea Index) and clinical depression (using Center for Epidemiologic Studies‐Depression 10‐point scale), as these conditions affect sleep patterns. These data are shown in Table 1.
| Intervention, n = 48 | Control, n = 64 | P Value | |
|---|---|---|---|
| |||
| Age, y, mean (SD) | 58.2 (16) | 56.9 (17) | 0.69 |
| Female, n (%) | 26 (54.2) | 36 (56.3) | 0.83 |
| Race, n (%) | |||
| Caucasian | 33 (68.8) | 46 (71.9) | 0.92 |
| African American | 13 (27.1) | 16 (25.0) | |
| Other | 2 (4.2) | 2 (3.1) | |
| BMI, mean (SD) | 32.1 (9.2) | 31.8 (9.3) | 0.85 |
| Admitting service, n (%) | |||
| Teaching | 21 (43.8) | 18 (28.1) | 0.09 |
| Nonteaching | 27 (56.3) | 46 (71.9) | |
| Sleep medication prior to admission, n (%) | 7 (14.9) | 21 (32.8) | 0.03 |
| Length of stay, d, mean (SD) | 4.9 (3) | 5.8 (3.9) | 0.19 |
| Number of sleep diaries per participant, mean (SD) | 2.2 (0.8) | 2.6 (0.9) | 0.02 |
| Proportion of hospital days with sleep diaries per participant, (SD) | 0.6 (0.2) | 0.5 (0.2) | 0.71 |
| Number of nights with actigraphy per participant, mean (SD) | 1.2 (0.7) | 1.4 (0.8) | 0.16 |
| Proportion of hospital nights with actigraphy per participant (SD) | 0.3 (0.2) | 0.3 (0.1) | 0.91 |
| Baseline sleep measures | |||
| PSQI, mean (SD) | 9.9 (4.6) | 9.1 (4.5) | 0.39 |
| ESS, mean (SD) | 7.4 (4.2) | 7.7 (4.8) | 0.79 |
| ISI, mean (SD) | 11.9 (7.6) | 10.8 (7.4) | 0.44 |
| CESD‐10, mean (SD) | 12.2 (7.2) | 12.8 (7.6) | 0.69 |
| Berlin Sleep Apnea, mean (SD) | 0.63 (0.5) | 0.61 (0.5) | 0.87 |
Sleep Diary Measures
A sleep diary completed each morning assessed the outcome measures, perceived sleep quality, how refreshing sleep was, and sleep durations. The diary employed a 5‐point Likert rating scale ranging from poor (1) to excellent (5). Perceived sleep duration was calculated from patients' reported time in bed, time to fall asleep, wake time, and number and duration of awakenings after sleep onset on their sleep diary. These data were used to compute total sleep time (TST) and sleep efficiency (SE). The sleep diary also included other pertinent sleep‐related measures including use of sleep medication the night prior and specific sleep disruptions from the prior night. To measure the impact of disruptions due to disturbances the prior night, we created a summed scale score of 4 items that negatively interfered with sleep (light, temperature, noise, and interruptions; 5 point scales from 1 = not at all to 5 = significant). Analysis of principal axis factors with varimax rotation yielded 1 disruption factor accounting for 55% of the variance, and Cronbach's was 0.73.
Actigraphy Measures
Actigraphy outcomes of sleep were recorded using the actigraphy wrist watch (ActiSleep Plus (GT3X+); ActiGraph, Pensacola, FL). Participants wore the monitor from the day of enrollment throughout the hospital stay or until transfer out of the unit. Objective data were analyzed and scored using ActiLife 6 data analysis software (version 6.10.1; Actigraph). Time in bed, given the unique inpatient setting, was calculated using sleep diary responses as the interval between sleep time and reported wake up time. These were entered into the Actilife 6 software for the sleep scoring analysis using a validated algorithm, Cole‐Kripke, to calculate actigraphy TST and SE.
Statistical Analysis
Descriptive and inferential statistics were computed using Statistical Package for the Social Sciences version 22 (IBM, Armonk, NY). We computed means, proportions, and measures of dispersion for all study variables. To test differences in sleep diary and actigraphy outcomes between the intervention and control arms, we used linear mixed models with full maximum likelihood estimation to model each of the 7 continuous sleep outcomes. These statistical methods are appropriate to account for the nonindependence of continuous repeated observations within hospital patients.[19] For all outcomes, the unit of analysis was nightly observations nested within patient‐ level characteristics. The use of full maximum likelihood estimation is a robust and preferred method for handling values missing at random in longitudinal datasets.[20]
To model repeated observations, mixed models included a term representing time in days. For each outcome, we specified unconditional growth models to examine the variability between and within patients by computing intraclass correlations and inspecting variance components. We used model fit indices (‐2LL deviance, Akaike's information criterion, and Schwartz's Bayesian criterion) as appropriate to determine best fitting model specifications in terms of random effects and covariance structure.[21, 22]
We tested the main effect of the intervention on sleep outcomes and the interactive effect of group (intervention vs control) by hospital day, to test whether there were group differences in slopes representing average change in sleep outcomes over hospital days. All models adjusted for age, body mass index, depression, and baseline sleep quality (PSQI) as time‐invariant covariates, and whether participants had taken a sleep medication the day before, as a time‐varying covariate. Adjustment for prehospitalization sleep quality was a matter of particular importance. We used the PSQI to control for sleep quality because it is both a well‐validated, multidimensional measure, and it includes prehospital use of sleep medications. In a series of sensitivity analyses, we also explored whether the dichotomous self‐reported measure of whether or not participants regularly took sleep medications prior to hospitalization, rather than the PSQI, would change our substantive findings. All covariates were centered at the grand‐mean following guidelines for appropriate interpretation of regression coefficients.[23]
RESULTS
Of the 112 study patients, 48 were in the intervention unit and 64 in the control unit. Eighty‐five percent of study participants endorsed poor sleep prior to hospital admission on the PSQI sleep quality measure, which was similar in both groups (Table 1).
Participants completed 1 to 8 sleep diary entries (mean = 2.5, standard deviation = 1.1). Because only 6 participants completed 5 or more diaries, we constrained the number of diaries included in the inferential analysis to 4 to avoid influential outliers identified by scatterplots. Fifty‐seven percent of participants had 1 night of valid actigraphy data (n = 64); 29%, 2 nights (n = 32), 8% had 3 or 4 nights, and 9 participants did not have any usable actigraphy data. The extent to which the intervention was accepted by patients in the intervention group was highly variable. Unit‐wide patient adherence with the 10 pm lights off, telephone off, and TV off policy was 87%, 67%, and 64% of intervention patients, respectively. Uptake of sleep menu items was also highly variable, and not a single element was used by more than half of patients (acceptance rates ranged from 11% to 44%). Eye masks (44%) and ear plugs (32%) were the most commonly utilized items.
A greater proportion of patients in the control arm (33%) had been taking sleep medications prior to hospitalization compared to the intervention arm (15%; 2 = 4.6, P 0.05). However, hypnotic medication use in the hospital was similar across the both groups (intervention unit patients: 25% and controls: 21%, P = 0.49).
Intraclass correlations for the 7 sleep outcomes ranged from 0.59 to 0.76 on sleep diary outcomes, and from 0.61 to 0.85 on actigraphy. Dependency of sleep measures within patients accounted for 59% to 85% of variance in sleep outcomes. The best‐fit mixed models included random intercepts only. The results of mixed models testing the main effect of intervention versus comparison arm on sleep outcome measures, adjusted for covariates, are presented in Table 2. Total sleep time was the only outcome that was significantly different between groups; the average total sleep time, calculated from sleep diary data, was longer in the intervention group by 49 minutes.
| Intervention, n = 48 | Control, n = 64 | P Value | |
|---|---|---|---|
| |||
| Sleep diary outcomes | |||
| Sleep quality, mean (SE) | 3.14 (0.16) | 3.08 (0.13) | 0.79 |
| Refreshed sleep, mean (SE) | 2.94 (0.17) | 2.74 (0.14) | 0.38 |
| Negative impact of sleep disruptions, mean (SE) | 4.39 (0.58) | 4.81 (0.48) | 0.58 |
| Total sleep time, min, mean (SE) | 422 (16.2) | 373 (13.2) | 0.02 |
| Sleep efficiency, %, mean (SE) | 83.5 (2.3) | 82.1 (1.9) | 0.65 |
| Actigraphy outcomes | |||
| Total sleep time, min, mean (SE) | 377 (16.8) | 356 (13.2) | 0.32 |
| Sleep efficiency, %, mean (SE) | 72.7 (2.2) | 74.8 (1.8) | 0.45 |
Table 3 lists slopes representing average change in sleep measures over hospital days in both groups. The P values represent z tests of interaction terms in mixed models, after adjustment for covariates, testing whether slopes significantly differed between groups. Of the 7 outcomes, 3 sleep diary measures had significant interaction terms. For ratings of sleep quality, refreshing sleep, and sleep disruptions, slopes in the control group were flat, whereas slopes in the intervention group demonstrated improvements in ratings of sleep quality and refreshed sleep, and a decrease in the impact of sleep disruptions over the course of subsequent nights in the hospital. Figure 1 illustrates a plot of the adjusted average slopes for the refreshed sleep score across hospital days in intervention and control groups.
| Intervention, Slope (SE), n = 48 | Control, Slope (SE), n = 64 | P Value | |
|---|---|---|---|
| |||
| Refreshed sleep rating | 0.55 (0.18) | 0.03 (0.13) | 0.006 |
| Sleep quality rating | 0.52 (0.16) | 0.02 (0.11) | 0.012 |
| Negative impact of sleep interruptions | 1.65 (0.48) | 0.05 (0.32) | 0.006 |
| Total sleep time, diary | 11.2 (18.1) | 6.3 (13.0) | 0.44 |
| Total sleep time, actigraphy | 7.3 (25.5) | 1.0 (15.3) | 0.83 |
| Sleep efficiency, diary | 1.1 (2.3) | 1.5 (1.6) | 0.89 |
| Sleep efficiency, actigraphy | 0.9 (4.0) | 0.7 (2.4) | 0.74 |
DISCUSSION
Poor sleep is common among hospitalized adults, both at home prior to the admission and especially when in the hospital. This pilot study demonstrated the feasibility of rolling out a sleep‐promoting intervention on a hospital's general medicine unit. Although participants on the intervention unit reported improved sleep quality and feeling more refreshed, this was not supported by actigraphy data (such as sleep time or sleep efficiency). Although care team engagement and implementation of unit‐wide interventions were high, patient use of individual components was imperfect. Of particular interest, however, the intervention group actually began to have improved sleep quality and fewer disruptions with subsequent nights sleeping in the hospital.
Our findings of the high prevalence of poor sleep among hospitalized patients is congruent with prior studies and supports the great need to screen for and address poor sleep within the hospital setting.[24, 25, 26] Attempts to promote sleep among hospitalized patients may be effective. Prior literature on sleep‐promoting intervention studies demonstrated relaxation techniques improved sleep quality by almost 38%,[27] and ear plugs and eye masks showed some benefit in promoting sleep within the hospital.[28] Our study's multicomponent intervention that attempted to minimize disruptions led to improvement in sleep quality, more restorative sleep, and decreased report of sleep disruptions, especially among patients who had a longer length of stay. As suggested by Thomas et al.[29] and seen in our data, this temporal relationship with improvement across subsequent nights suggests there may be an adaptation to the new environment and that it may take time for the sleep intervention to work.
Hospitalized patients often fail to reclaim the much‐needed restorative sleep at the time when they are most vulnerable. Patients cite routine care as the primary cause of sleep disruption, and often recognize the way that the hospital environment interferes with their ability to sleep.[30, 31, 32] The sleep‐promoting interventions used in our study would be characterized by most as low effort[33] and a potential for high yield, even though our patients only appreciated modest improvements in sleep outcomes.
Several limitations of this study should be considered. First, although we had hoped to collect substantial amounts of objective data, the average time of actigraphy observation was less than 48 hours. This may have constrained the group by time interaction analysis with actigraphy data, as studies have shown increased accuracy in actigraphy measures with longer wear.[34] By contrast, the sleep diary survey collected throughout hospitalization yielded significant improvements in consecutive daily measurements. Second, the proximity of the study units raised concern for study contamination, which could have reduced the differences in the outcome measures that may have been observed. Although the physicians work on both units, the nursing and support care teams are distinct and unit dependent. Finally, this was not a randomized trial. Patient assignment to the treatment arms was haphazard and occurred within the hospital's admitting strategy. Allocation of patients to either the intervention or the control group was based on bed availability at the time of admission. Although both groups were similar in most characteristics, more of the control participants reported taking more sleep medications prior to admission as compared to the intervention participants. Fortunately, hypnotic use was not different between groups during the admission, the time when sleep data were being captured.
Overall, this pilot study suggests that patients admitted to general medical ward fail to realize sufficient restorative sleep when they are in the hospital. Sleep disruption is rather frequent. This study demonstrates the opportunity for and feasibility of sleep‐promoting interventions where facilitating sleep is considered to be a top priority and vital component of the healthcare delivery. When trying to improve patients' sleep in the hospital, it may take several consecutive nights to realize a return on investment.
Acknowledgements
The authors acknowledge the Department of Nursing, Johns Hopkins Bayview Medical Center, and care teams of the Zieve Medicine Units, and the Center for Child and Community Health Research Biostatistics, Epidemiology and Data Management (BEAD) Core group.
Disclosures: Dr. Wright is a Miller‐Coulson Family Scholar and is supported through the Johns Hopkins Center for Innovative Medicine. Dr. Howell is the chief of the Division of Hospital Medicine at Johns Hopkins Bayview Medical Center and associate professor at Johns Hopkins School of Medicine. He served as the president of the Society of Hospital Medicine (SHM) in 2013 and currently serves as a board member. He is also a senior physician advisor for SHM. He is a coinvestigator grant recipient on an Agency for Healthcare Research and Quality grant on medication reconciliation funded through Baylor University. He was previously a coinvestigator grant recipient of Center for Medicare and Medicaid Innovations grant that ended in June 2015.
- Institute of Medicine (US) Committee on Sleep Medicine and Research. Sleep disorders and sleep deprivation: an unmet public health problem. Washington, DC: National Academies Press; 2006. Available at: http://www.ncbi.nlm.nih.gov/books/NBK19960. Accessed September 16, 2014.
- , . Health behaviors of adults: United States, 2005–2007. Vital Health Stat 10. 2010;245:1–132.
- , , . High incidence of diabetes in men with sleep complaints or short sleep duration: a 12‐year follow‐up study of a middle‐aged population. Diabetes Care. 2005;28:2762–2767.
- , , , et al. Linking sleep duration and obesity among black and white US adults. Clin Pract (Lond). 2013;10(5):661–667.
- , , , et al. Gender‐specific associations of short sleep duration with prevalent and incident hypertension: the Whitehall II Study. Hypertension. 2007;50:693–700.
- , , , , , . The joint effect of sleep duration and disturbed sleep on cause‐specific mortality: results from the Whitehall II cohort study. PLoS One. 2014;9(4):e91965.
- , , , , , . Poor self‐reported sleep quality predicts mortality within one year of inpatient post‐acute rehabilitation among older adults. Sleep. 2011;34(12):1715–1721.
- , , , , . The effects of sleep deprivation on symptoms of psychopathology in healthy adults. Sleep Med. 2007;8(3):215–221.
- , , , , . Sleep deprivation and activation of morning levels of cellular and genomic markers of inflammation. Arch Intern Med. 2006;166:1756–1762.
- , , , . The metabolic consequences of sleep deprivation. Sleep Med Rev. 2007;11(3):163–178.
- , , , et al. Insomnia among hospitalized elderly patients: prevalence, clinical characteristics and risk factors. Arch Gerontol Geriatr. 2011;52:133–137.
- , , , et al. Is insomnia a marker for psychiatric disorders in general hospitals? Sleep Med. 2005;6:549–553.
- , , , , , . Perceived control and sleep in hospitalized older adults: a sound hypothesis? J Hosp Med. 2013;8:184–190.
- , , , et al. Sleep disruption due to hospital noises: a prospective evaluation. Ann Intern Med. 2012;157:170–179.
- . Sleep in acute care settings: an integrative review. J Nurs Scholarsh. 2000;32(1):31–38.
- . Physical health as it relates to insomnia. Talk presented at: Center for Behavior and Health, Lecture Series in Johns Hopkins Bayview Medical Center; July 17, 2012; Baltimore, MD.
- , , , , . The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989;28:193–213.
- , . Measures of sleep: The Insomnia Severity Index, Medical Outcomes Study (MOS) Sleep Scale, Pittsburgh Sleep Diary (PSD), and Pittsburgh Sleep Quality Index (PSQI). Arthritis Rheumatol. 2003;49:S184–S196.
- , . Applied Mixed Models in Medicine. 3rd ed. Somerset, NJ: Wiley; 2014:539.
- , , , Applying mixed regression models to the analysis of repeated‐measures data in psychosomatic medicine. Psychosom Med. 2006;68(6):870–878.
- , . Using the SPSS mixed procedure to fit cross‐sectional and longitudinal multilevel models. Educ Psychol Meas. 2005;65(5):717–741.
- , . Introduction to estimation issues in multilevel modeling. New Dir Inst Res. 2012;2012(154):23–39.
- , . Centering predictor variables in cross‐sectional multilevel models: a new look at an old issue. Psychol Methods. 2007;12(2):121–138.
- , . Sleep quality in adult hospitalized patients with infection: an observational study. Am J Med Sci. 2015;349(1):56–60.
- , , , et al. Risk of sleep apnea in hospitalized older patients. J Clin Sleep Med. 2014;10:1061–1066.
- , , . Hospital ward policy and patients' sleep patterns: a multiple baseline study. Rehabil Psychol. 1989;34(1):43–50.
- , , . Non‐pharmacologic interventions to improve the sleep of hospitalized patients: a systematic review. J Gen Intern Med. 2014;29:788–795.
- , , , , , Earplugs and eye masks vs routine care prevent sleep impairment in post‐anaesthesia care unit: a randomized study. Br J Anaesth. 2014;112(1):89–95.
- , , , et al. Sleep rounds: a multidisciplinary approach to optimize sleep quality and satisfaction in hospitalized patients. J Hosp Med. 2012;7:508–512.
- , , , , . Factors affecting sleep quality of patients in intensive care unit. J Clin Sleep Med. 2012;8(3):301–307.
- . Insomnia among hospitalized older persons. Clin Geriatr Med. 2008;24(1):51–67.
- , , , . A nonpharmacological sleep protocol for hospitalized older patients. J Am Geriatr Soc. 1998;46(6):700–705.
- The Action Priority Matrix: making the most of your opportunities. TimeAnalyzer website. Available at: http://www.timeanalyzer.com/lib/priority.htm. Published 2006. Accessed July 10, 2015.
- , , , et al. Measuring sleep: accuracy, sensitivity, and specificity of wrist actigraphy compared to polysomnography. Sleep. 2013;36(11):1747–1755.
Approximately 70 million adults within the United States have sleep disorders,[1] and up to 30% of adults report sleeping less than 6 hours per night.[2] Poor sleep has been associated with undesirable health outcomes.[1] Suboptimal sleep duration and sleep quality has been associated with a higher prevalence of chronic health conditions including hypertension, type 2 diabetes, coronary artery disease, stroke, and obesity, as well as increased overall mortality.[3, 4, 5, 6, 7]
Sleep plays an important role in restoration of wellness. Poor sleep is associated with physiological disturbances that may result in poor healing.[8, 9, 10] In the literature, prevalence of insomnia among elderly hospitalized patients was 36.7%,[11] whereas in younger hospitalized patients it was 50%.[12] Hospitalized patients frequently cite their acute illness, hospital‐related environmental factors, and disruptions that are part of routine care as causes for poor sleep during hospitalization.[13, 14, 15] Although the pervasiveness of poor sleep among hospitalized patients is high, interventions that prioritize sleep optimization as routine care, are uncommon. Few studies have reviewed the effect of sleep‐promoting measures on both sleep quality and sleep duration among patients hospitalized on general medicine units.
In this study, we aimed to assess the feasibility of incorporating sleep‐promoting interventions on a general medicine unit. We sought to identify differences in sleep measures between intervention and control groups. The primary outcome that we hoped to influence and lengthen in the intervention group was sleep duration. This outcome was measured both by sleep diary and with actigraphy. Secondary outcomes that we hypothesized should improve in the intervention group included feeling more refreshed in the mornings, sleep efficiency, and fewer sleep disruptions. As a feasibility pilot, we also wanted to explore the ease or difficulty with which sleep‐promoting interventions could be incorporated to the team's workflow.
METHODS
Study Design
A quasi‐experimental prospective pilot study was conducted at a single academic center, the Johns Hopkins Bayview Medical Center. Participants included adult patients admitted to the general medicine ward from July 2013 through January 2014. Patients with dementia; inability to complete survey questionnaires due to delirium, disability, or a language barrier; active withdrawal from alcohol or controlled substances; or acute psychiatric illness were excluded in this study.
The medicine ward at our medical center is comprised of 2 structurally identical units that admit patients with similar diagnoses, disease severity, and case‐mix disease groups. Nursing and support staff are unit specific. Pertaining to the sleep environment, the units both have semiprivate and private rooms. Visitors are encouraged to leave by 10 pm. Patients admitted from the emergency room to the medicine ward are assigned haphazardly to either unit based on bed availability. For the purpose of this study, we selected 1 unit to be a control unit and identified the other as the sleep‐promoting intervention unit.
Study Procedure
Upon arrival to the medicine unit, the research team approached all patients who met study eligibility criteria for study participation. Patients were provided full disclosure of the study using institutional research guidelines, and those interested in participating were consented. Participants were not explicitly told about their group assignment. This study was approved by the Johns Hopkins Institutional Review Board for human subject research.
In this study, the control group participants received standard of care as it pertains to sleep promotion. No additional sleep‐promoting measures were implemented to routine medical care, medication administration, nursing care, and overnight monitoring. Patients who used sleep medications at home, prior to admission, had those medicines continued only if they requested them and they were not contraindicated given their acute illness. Participants on the intervention unit were exposed to a nurse‐delivered sleep‐promoting protocol aimed at transforming the culture of care such that helping patients to sleep soundly was made a top priority. Environmental changes included unit‐wide efforts to minimize light and noise disturbances by dimming hallway lights, turning off room lights, and encouraging care teams to be as quiet as possible. Other strategies focused largely on minimizing care‐related disruptions. These included, when appropriate, administering nighttime medications in the early evening, minimizing fluids overnight, and closing patient room doors where appropriate. Further, patients were offered the following sleep‐promoting items to choose from: ear plugs, eye masks, warm blankets, and relaxation music. The final component of our intervention was 30‐minute sleep hygiene education taught by a physician. It highlighted basic sleep physiology and healthy sleep behavior adapted from Buysse.[16] Patients learned the role of behaviors such as reducing time lying awake in bed, setting standard wake‐up time and sleep time, and going to bed only when sleepy. This behavioral education was supplemented by a handout with sleep‐promoting suggestions.
The care team on the intervention unit received comprehensive study‐focused training in which night nursing teams were familiarized with the sleep‐promoting protocol through in‐service sessions facilitated by 1 of the authors (E.W.G.). To further promote study implementation, sleep‐promoting procedures were supported and encouraged by supervising nurses who made daily reminders to the intervention unit night care team of the goals of the sleep‐promoting study during evening huddles performed at the beginning of each shift. To assess the adherence of the sleep protocol, the nursing staff completed a daily checklist of elements within the protocol that were employed .
Data Collection and Measures
Baseline Measures
At the time of enrollment, study patients' demographic information, including use of chronic sleep medication prior to admission, was collected. Participants were assessed for baseline sleep disturbance prior to admission using standardized, validated sleep assessment tools: Pittsburgh Sleep Quality Index (PSQI), the Insomnia Severity Index (ISI), and the Epworth Sleepiness Scale (ESS). PSQI, a 19‐item tool, assessed self‐rated sleep quality measured over the prior month; a score of 5 or greater indicated poor sleep.[17] ISI, a 7‐item tool, identified the presence, rated the severity, and described the impact of insomnia; a score of 10 or greater indicated insomnia.[18] ESS, an 8‐item self‐rated tool, evaluated the impact of perceived sleepiness on daily functioning in 8 different environments; a score of 9 or greater was linked to burden of sleepiness. Participants were also screened for both obstructive sleep apnea (using the Berlin Sleep Apnea Index) and clinical depression (using Center for Epidemiologic Studies‐Depression 10‐point scale), as these conditions affect sleep patterns. These data are shown in Table 1.
| Intervention, n = 48 | Control, n = 64 | P Value | |
|---|---|---|---|
| |||
| Age, y, mean (SD) | 58.2 (16) | 56.9 (17) | 0.69 |
| Female, n (%) | 26 (54.2) | 36 (56.3) | 0.83 |
| Race, n (%) | |||
| Caucasian | 33 (68.8) | 46 (71.9) | 0.92 |
| African American | 13 (27.1) | 16 (25.0) | |
| Other | 2 (4.2) | 2 (3.1) | |
| BMI, mean (SD) | 32.1 (9.2) | 31.8 (9.3) | 0.85 |
| Admitting service, n (%) | |||
| Teaching | 21 (43.8) | 18 (28.1) | 0.09 |
| Nonteaching | 27 (56.3) | 46 (71.9) | |
| Sleep medication prior to admission, n (%) | 7 (14.9) | 21 (32.8) | 0.03 |
| Length of stay, d, mean (SD) | 4.9 (3) | 5.8 (3.9) | 0.19 |
| Number of sleep diaries per participant, mean (SD) | 2.2 (0.8) | 2.6 (0.9) | 0.02 |
| Proportion of hospital days with sleep diaries per participant, (SD) | 0.6 (0.2) | 0.5 (0.2) | 0.71 |
| Number of nights with actigraphy per participant, mean (SD) | 1.2 (0.7) | 1.4 (0.8) | 0.16 |
| Proportion of hospital nights with actigraphy per participant (SD) | 0.3 (0.2) | 0.3 (0.1) | 0.91 |
| Baseline sleep measures | |||
| PSQI, mean (SD) | 9.9 (4.6) | 9.1 (4.5) | 0.39 |
| ESS, mean (SD) | 7.4 (4.2) | 7.7 (4.8) | 0.79 |
| ISI, mean (SD) | 11.9 (7.6) | 10.8 (7.4) | 0.44 |
| CESD‐10, mean (SD) | 12.2 (7.2) | 12.8 (7.6) | 0.69 |
| Berlin Sleep Apnea, mean (SD) | 0.63 (0.5) | 0.61 (0.5) | 0.87 |
Sleep Diary Measures
A sleep diary completed each morning assessed the outcome measures, perceived sleep quality, how refreshing sleep was, and sleep durations. The diary employed a 5‐point Likert rating scale ranging from poor (1) to excellent (5). Perceived sleep duration was calculated from patients' reported time in bed, time to fall asleep, wake time, and number and duration of awakenings after sleep onset on their sleep diary. These data were used to compute total sleep time (TST) and sleep efficiency (SE). The sleep diary also included other pertinent sleep‐related measures including use of sleep medication the night prior and specific sleep disruptions from the prior night. To measure the impact of disruptions due to disturbances the prior night, we created a summed scale score of 4 items that negatively interfered with sleep (light, temperature, noise, and interruptions; 5 point scales from 1 = not at all to 5 = significant). Analysis of principal axis factors with varimax rotation yielded 1 disruption factor accounting for 55% of the variance, and Cronbach's was 0.73.
Actigraphy Measures
Actigraphy outcomes of sleep were recorded using the actigraphy wrist watch (ActiSleep Plus (GT3X+); ActiGraph, Pensacola, FL). Participants wore the monitor from the day of enrollment throughout the hospital stay or until transfer out of the unit. Objective data were analyzed and scored using ActiLife 6 data analysis software (version 6.10.1; Actigraph). Time in bed, given the unique inpatient setting, was calculated using sleep diary responses as the interval between sleep time and reported wake up time. These were entered into the Actilife 6 software for the sleep scoring analysis using a validated algorithm, Cole‐Kripke, to calculate actigraphy TST and SE.
Statistical Analysis
Descriptive and inferential statistics were computed using Statistical Package for the Social Sciences version 22 (IBM, Armonk, NY). We computed means, proportions, and measures of dispersion for all study variables. To test differences in sleep diary and actigraphy outcomes between the intervention and control arms, we used linear mixed models with full maximum likelihood estimation to model each of the 7 continuous sleep outcomes. These statistical methods are appropriate to account for the nonindependence of continuous repeated observations within hospital patients.[19] For all outcomes, the unit of analysis was nightly observations nested within patient‐ level characteristics. The use of full maximum likelihood estimation is a robust and preferred method for handling values missing at random in longitudinal datasets.[20]
To model repeated observations, mixed models included a term representing time in days. For each outcome, we specified unconditional growth models to examine the variability between and within patients by computing intraclass correlations and inspecting variance components. We used model fit indices (‐2LL deviance, Akaike's information criterion, and Schwartz's Bayesian criterion) as appropriate to determine best fitting model specifications in terms of random effects and covariance structure.[21, 22]
We tested the main effect of the intervention on sleep outcomes and the interactive effect of group (intervention vs control) by hospital day, to test whether there were group differences in slopes representing average change in sleep outcomes over hospital days. All models adjusted for age, body mass index, depression, and baseline sleep quality (PSQI) as time‐invariant covariates, and whether participants had taken a sleep medication the day before, as a time‐varying covariate. Adjustment for prehospitalization sleep quality was a matter of particular importance. We used the PSQI to control for sleep quality because it is both a well‐validated, multidimensional measure, and it includes prehospital use of sleep medications. In a series of sensitivity analyses, we also explored whether the dichotomous self‐reported measure of whether or not participants regularly took sleep medications prior to hospitalization, rather than the PSQI, would change our substantive findings. All covariates were centered at the grand‐mean following guidelines for appropriate interpretation of regression coefficients.[23]
RESULTS
Of the 112 study patients, 48 were in the intervention unit and 64 in the control unit. Eighty‐five percent of study participants endorsed poor sleep prior to hospital admission on the PSQI sleep quality measure, which was similar in both groups (Table 1).
Participants completed 1 to 8 sleep diary entries (mean = 2.5, standard deviation = 1.1). Because only 6 participants completed 5 or more diaries, we constrained the number of diaries included in the inferential analysis to 4 to avoid influential outliers identified by scatterplots. Fifty‐seven percent of participants had 1 night of valid actigraphy data (n = 64); 29%, 2 nights (n = 32), 8% had 3 or 4 nights, and 9 participants did not have any usable actigraphy data. The extent to which the intervention was accepted by patients in the intervention group was highly variable. Unit‐wide patient adherence with the 10 pm lights off, telephone off, and TV off policy was 87%, 67%, and 64% of intervention patients, respectively. Uptake of sleep menu items was also highly variable, and not a single element was used by more than half of patients (acceptance rates ranged from 11% to 44%). Eye masks (44%) and ear plugs (32%) were the most commonly utilized items.
A greater proportion of patients in the control arm (33%) had been taking sleep medications prior to hospitalization compared to the intervention arm (15%; 2 = 4.6, P 0.05). However, hypnotic medication use in the hospital was similar across the both groups (intervention unit patients: 25% and controls: 21%, P = 0.49).
Intraclass correlations for the 7 sleep outcomes ranged from 0.59 to 0.76 on sleep diary outcomes, and from 0.61 to 0.85 on actigraphy. Dependency of sleep measures within patients accounted for 59% to 85% of variance in sleep outcomes. The best‐fit mixed models included random intercepts only. The results of mixed models testing the main effect of intervention versus comparison arm on sleep outcome measures, adjusted for covariates, are presented in Table 2. Total sleep time was the only outcome that was significantly different between groups; the average total sleep time, calculated from sleep diary data, was longer in the intervention group by 49 minutes.
| Intervention, n = 48 | Control, n = 64 | P Value | |
|---|---|---|---|
| |||
| Sleep diary outcomes | |||
| Sleep quality, mean (SE) | 3.14 (0.16) | 3.08 (0.13) | 0.79 |
| Refreshed sleep, mean (SE) | 2.94 (0.17) | 2.74 (0.14) | 0.38 |
| Negative impact of sleep disruptions, mean (SE) | 4.39 (0.58) | 4.81 (0.48) | 0.58 |
| Total sleep time, min, mean (SE) | 422 (16.2) | 373 (13.2) | 0.02 |
| Sleep efficiency, %, mean (SE) | 83.5 (2.3) | 82.1 (1.9) | 0.65 |
| Actigraphy outcomes | |||
| Total sleep time, min, mean (SE) | 377 (16.8) | 356 (13.2) | 0.32 |
| Sleep efficiency, %, mean (SE) | 72.7 (2.2) | 74.8 (1.8) | 0.45 |
Table 3 lists slopes representing average change in sleep measures over hospital days in both groups. The P values represent z tests of interaction terms in mixed models, after adjustment for covariates, testing whether slopes significantly differed between groups. Of the 7 outcomes, 3 sleep diary measures had significant interaction terms. For ratings of sleep quality, refreshing sleep, and sleep disruptions, slopes in the control group were flat, whereas slopes in the intervention group demonstrated improvements in ratings of sleep quality and refreshed sleep, and a decrease in the impact of sleep disruptions over the course of subsequent nights in the hospital. Figure 1 illustrates a plot of the adjusted average slopes for the refreshed sleep score across hospital days in intervention and control groups.
| Intervention, Slope (SE), n = 48 | Control, Slope (SE), n = 64 | P Value | |
|---|---|---|---|
| |||
| Refreshed sleep rating | 0.55 (0.18) | 0.03 (0.13) | 0.006 |
| Sleep quality rating | 0.52 (0.16) | 0.02 (0.11) | 0.012 |
| Negative impact of sleep interruptions | 1.65 (0.48) | 0.05 (0.32) | 0.006 |
| Total sleep time, diary | 11.2 (18.1) | 6.3 (13.0) | 0.44 |
| Total sleep time, actigraphy | 7.3 (25.5) | 1.0 (15.3) | 0.83 |
| Sleep efficiency, diary | 1.1 (2.3) | 1.5 (1.6) | 0.89 |
| Sleep efficiency, actigraphy | 0.9 (4.0) | 0.7 (2.4) | 0.74 |
DISCUSSION
Poor sleep is common among hospitalized adults, both at home prior to the admission and especially when in the hospital. This pilot study demonstrated the feasibility of rolling out a sleep‐promoting intervention on a hospital's general medicine unit. Although participants on the intervention unit reported improved sleep quality and feeling more refreshed, this was not supported by actigraphy data (such as sleep time or sleep efficiency). Although care team engagement and implementation of unit‐wide interventions were high, patient use of individual components was imperfect. Of particular interest, however, the intervention group actually began to have improved sleep quality and fewer disruptions with subsequent nights sleeping in the hospital.
Our findings of the high prevalence of poor sleep among hospitalized patients is congruent with prior studies and supports the great need to screen for and address poor sleep within the hospital setting.[24, 25, 26] Attempts to promote sleep among hospitalized patients may be effective. Prior literature on sleep‐promoting intervention studies demonstrated relaxation techniques improved sleep quality by almost 38%,[27] and ear plugs and eye masks showed some benefit in promoting sleep within the hospital.[28] Our study's multicomponent intervention that attempted to minimize disruptions led to improvement in sleep quality, more restorative sleep, and decreased report of sleep disruptions, especially among patients who had a longer length of stay. As suggested by Thomas et al.[29] and seen in our data, this temporal relationship with improvement across subsequent nights suggests there may be an adaptation to the new environment and that it may take time for the sleep intervention to work.
Hospitalized patients often fail to reclaim the much‐needed restorative sleep at the time when they are most vulnerable. Patients cite routine care as the primary cause of sleep disruption, and often recognize the way that the hospital environment interferes with their ability to sleep.[30, 31, 32] The sleep‐promoting interventions used in our study would be characterized by most as low effort[33] and a potential for high yield, even though our patients only appreciated modest improvements in sleep outcomes.
Several limitations of this study should be considered. First, although we had hoped to collect substantial amounts of objective data, the average time of actigraphy observation was less than 48 hours. This may have constrained the group by time interaction analysis with actigraphy data, as studies have shown increased accuracy in actigraphy measures with longer wear.[34] By contrast, the sleep diary survey collected throughout hospitalization yielded significant improvements in consecutive daily measurements. Second, the proximity of the study units raised concern for study contamination, which could have reduced the differences in the outcome measures that may have been observed. Although the physicians work on both units, the nursing and support care teams are distinct and unit dependent. Finally, this was not a randomized trial. Patient assignment to the treatment arms was haphazard and occurred within the hospital's admitting strategy. Allocation of patients to either the intervention or the control group was based on bed availability at the time of admission. Although both groups were similar in most characteristics, more of the control participants reported taking more sleep medications prior to admission as compared to the intervention participants. Fortunately, hypnotic use was not different between groups during the admission, the time when sleep data were being captured.
Overall, this pilot study suggests that patients admitted to general medical ward fail to realize sufficient restorative sleep when they are in the hospital. Sleep disruption is rather frequent. This study demonstrates the opportunity for and feasibility of sleep‐promoting interventions where facilitating sleep is considered to be a top priority and vital component of the healthcare delivery. When trying to improve patients' sleep in the hospital, it may take several consecutive nights to realize a return on investment.
Acknowledgements
The authors acknowledge the Department of Nursing, Johns Hopkins Bayview Medical Center, and care teams of the Zieve Medicine Units, and the Center for Child and Community Health Research Biostatistics, Epidemiology and Data Management (BEAD) Core group.
Disclosures: Dr. Wright is a Miller‐Coulson Family Scholar and is supported through the Johns Hopkins Center for Innovative Medicine. Dr. Howell is the chief of the Division of Hospital Medicine at Johns Hopkins Bayview Medical Center and associate professor at Johns Hopkins School of Medicine. He served as the president of the Society of Hospital Medicine (SHM) in 2013 and currently serves as a board member. He is also a senior physician advisor for SHM. He is a coinvestigator grant recipient on an Agency for Healthcare Research and Quality grant on medication reconciliation funded through Baylor University. He was previously a coinvestigator grant recipient of Center for Medicare and Medicaid Innovations grant that ended in June 2015.
Approximately 70 million adults within the United States have sleep disorders,[1] and up to 30% of adults report sleeping less than 6 hours per night.[2] Poor sleep has been associated with undesirable health outcomes.[1] Suboptimal sleep duration and sleep quality has been associated with a higher prevalence of chronic health conditions including hypertension, type 2 diabetes, coronary artery disease, stroke, and obesity, as well as increased overall mortality.[3, 4, 5, 6, 7]
Sleep plays an important role in restoration of wellness. Poor sleep is associated with physiological disturbances that may result in poor healing.[8, 9, 10] In the literature, prevalence of insomnia among elderly hospitalized patients was 36.7%,[11] whereas in younger hospitalized patients it was 50%.[12] Hospitalized patients frequently cite their acute illness, hospital‐related environmental factors, and disruptions that are part of routine care as causes for poor sleep during hospitalization.[13, 14, 15] Although the pervasiveness of poor sleep among hospitalized patients is high, interventions that prioritize sleep optimization as routine care, are uncommon. Few studies have reviewed the effect of sleep‐promoting measures on both sleep quality and sleep duration among patients hospitalized on general medicine units.
In this study, we aimed to assess the feasibility of incorporating sleep‐promoting interventions on a general medicine unit. We sought to identify differences in sleep measures between intervention and control groups. The primary outcome that we hoped to influence and lengthen in the intervention group was sleep duration. This outcome was measured both by sleep diary and with actigraphy. Secondary outcomes that we hypothesized should improve in the intervention group included feeling more refreshed in the mornings, sleep efficiency, and fewer sleep disruptions. As a feasibility pilot, we also wanted to explore the ease or difficulty with which sleep‐promoting interventions could be incorporated to the team's workflow.
METHODS
Study Design
A quasi‐experimental prospective pilot study was conducted at a single academic center, the Johns Hopkins Bayview Medical Center. Participants included adult patients admitted to the general medicine ward from July 2013 through January 2014. Patients with dementia; inability to complete survey questionnaires due to delirium, disability, or a language barrier; active withdrawal from alcohol or controlled substances; or acute psychiatric illness were excluded in this study.
The medicine ward at our medical center is comprised of 2 structurally identical units that admit patients with similar diagnoses, disease severity, and case‐mix disease groups. Nursing and support staff are unit specific. Pertaining to the sleep environment, the units both have semiprivate and private rooms. Visitors are encouraged to leave by 10 pm. Patients admitted from the emergency room to the medicine ward are assigned haphazardly to either unit based on bed availability. For the purpose of this study, we selected 1 unit to be a control unit and identified the other as the sleep‐promoting intervention unit.
Study Procedure
Upon arrival to the medicine unit, the research team approached all patients who met study eligibility criteria for study participation. Patients were provided full disclosure of the study using institutional research guidelines, and those interested in participating were consented. Participants were not explicitly told about their group assignment. This study was approved by the Johns Hopkins Institutional Review Board for human subject research.
In this study, the control group participants received standard of care as it pertains to sleep promotion. No additional sleep‐promoting measures were implemented to routine medical care, medication administration, nursing care, and overnight monitoring. Patients who used sleep medications at home, prior to admission, had those medicines continued only if they requested them and they were not contraindicated given their acute illness. Participants on the intervention unit were exposed to a nurse‐delivered sleep‐promoting protocol aimed at transforming the culture of care such that helping patients to sleep soundly was made a top priority. Environmental changes included unit‐wide efforts to minimize light and noise disturbances by dimming hallway lights, turning off room lights, and encouraging care teams to be as quiet as possible. Other strategies focused largely on minimizing care‐related disruptions. These included, when appropriate, administering nighttime medications in the early evening, minimizing fluids overnight, and closing patient room doors where appropriate. Further, patients were offered the following sleep‐promoting items to choose from: ear plugs, eye masks, warm blankets, and relaxation music. The final component of our intervention was 30‐minute sleep hygiene education taught by a physician. It highlighted basic sleep physiology and healthy sleep behavior adapted from Buysse.[16] Patients learned the role of behaviors such as reducing time lying awake in bed, setting standard wake‐up time and sleep time, and going to bed only when sleepy. This behavioral education was supplemented by a handout with sleep‐promoting suggestions.
The care team on the intervention unit received comprehensive study‐focused training in which night nursing teams were familiarized with the sleep‐promoting protocol through in‐service sessions facilitated by 1 of the authors (E.W.G.). To further promote study implementation, sleep‐promoting procedures were supported and encouraged by supervising nurses who made daily reminders to the intervention unit night care team of the goals of the sleep‐promoting study during evening huddles performed at the beginning of each shift. To assess the adherence of the sleep protocol, the nursing staff completed a daily checklist of elements within the protocol that were employed .
Data Collection and Measures
Baseline Measures
At the time of enrollment, study patients' demographic information, including use of chronic sleep medication prior to admission, was collected. Participants were assessed for baseline sleep disturbance prior to admission using standardized, validated sleep assessment tools: Pittsburgh Sleep Quality Index (PSQI), the Insomnia Severity Index (ISI), and the Epworth Sleepiness Scale (ESS). PSQI, a 19‐item tool, assessed self‐rated sleep quality measured over the prior month; a score of 5 or greater indicated poor sleep.[17] ISI, a 7‐item tool, identified the presence, rated the severity, and described the impact of insomnia; a score of 10 or greater indicated insomnia.[18] ESS, an 8‐item self‐rated tool, evaluated the impact of perceived sleepiness on daily functioning in 8 different environments; a score of 9 or greater was linked to burden of sleepiness. Participants were also screened for both obstructive sleep apnea (using the Berlin Sleep Apnea Index) and clinical depression (using Center for Epidemiologic Studies‐Depression 10‐point scale), as these conditions affect sleep patterns. These data are shown in Table 1.
| Intervention, n = 48 | Control, n = 64 | P Value | |
|---|---|---|---|
| |||
| Age, y, mean (SD) | 58.2 (16) | 56.9 (17) | 0.69 |
| Female, n (%) | 26 (54.2) | 36 (56.3) | 0.83 |
| Race, n (%) | |||
| Caucasian | 33 (68.8) | 46 (71.9) | 0.92 |
| African American | 13 (27.1) | 16 (25.0) | |
| Other | 2 (4.2) | 2 (3.1) | |
| BMI, mean (SD) | 32.1 (9.2) | 31.8 (9.3) | 0.85 |
| Admitting service, n (%) | |||
| Teaching | 21 (43.8) | 18 (28.1) | 0.09 |
| Nonteaching | 27 (56.3) | 46 (71.9) | |
| Sleep medication prior to admission, n (%) | 7 (14.9) | 21 (32.8) | 0.03 |
| Length of stay, d, mean (SD) | 4.9 (3) | 5.8 (3.9) | 0.19 |
| Number of sleep diaries per participant, mean (SD) | 2.2 (0.8) | 2.6 (0.9) | 0.02 |
| Proportion of hospital days with sleep diaries per participant, (SD) | 0.6 (0.2) | 0.5 (0.2) | 0.71 |
| Number of nights with actigraphy per participant, mean (SD) | 1.2 (0.7) | 1.4 (0.8) | 0.16 |
| Proportion of hospital nights with actigraphy per participant (SD) | 0.3 (0.2) | 0.3 (0.1) | 0.91 |
| Baseline sleep measures | |||
| PSQI, mean (SD) | 9.9 (4.6) | 9.1 (4.5) | 0.39 |
| ESS, mean (SD) | 7.4 (4.2) | 7.7 (4.8) | 0.79 |
| ISI, mean (SD) | 11.9 (7.6) | 10.8 (7.4) | 0.44 |
| CESD‐10, mean (SD) | 12.2 (7.2) | 12.8 (7.6) | 0.69 |
| Berlin Sleep Apnea, mean (SD) | 0.63 (0.5) | 0.61 (0.5) | 0.87 |
Sleep Diary Measures
A sleep diary completed each morning assessed the outcome measures, perceived sleep quality, how refreshing sleep was, and sleep durations. The diary employed a 5‐point Likert rating scale ranging from poor (1) to excellent (5). Perceived sleep duration was calculated from patients' reported time in bed, time to fall asleep, wake time, and number and duration of awakenings after sleep onset on their sleep diary. These data were used to compute total sleep time (TST) and sleep efficiency (SE). The sleep diary also included other pertinent sleep‐related measures including use of sleep medication the night prior and specific sleep disruptions from the prior night. To measure the impact of disruptions due to disturbances the prior night, we created a summed scale score of 4 items that negatively interfered with sleep (light, temperature, noise, and interruptions; 5 point scales from 1 = not at all to 5 = significant). Analysis of principal axis factors with varimax rotation yielded 1 disruption factor accounting for 55% of the variance, and Cronbach's was 0.73.
Actigraphy Measures
Actigraphy outcomes of sleep were recorded using the actigraphy wrist watch (ActiSleep Plus (GT3X+); ActiGraph, Pensacola, FL). Participants wore the monitor from the day of enrollment throughout the hospital stay or until transfer out of the unit. Objective data were analyzed and scored using ActiLife 6 data analysis software (version 6.10.1; Actigraph). Time in bed, given the unique inpatient setting, was calculated using sleep diary responses as the interval between sleep time and reported wake up time. These were entered into the Actilife 6 software for the sleep scoring analysis using a validated algorithm, Cole‐Kripke, to calculate actigraphy TST and SE.
Statistical Analysis
Descriptive and inferential statistics were computed using Statistical Package for the Social Sciences version 22 (IBM, Armonk, NY). We computed means, proportions, and measures of dispersion for all study variables. To test differences in sleep diary and actigraphy outcomes between the intervention and control arms, we used linear mixed models with full maximum likelihood estimation to model each of the 7 continuous sleep outcomes. These statistical methods are appropriate to account for the nonindependence of continuous repeated observations within hospital patients.[19] For all outcomes, the unit of analysis was nightly observations nested within patient‐ level characteristics. The use of full maximum likelihood estimation is a robust and preferred method for handling values missing at random in longitudinal datasets.[20]
To model repeated observations, mixed models included a term representing time in days. For each outcome, we specified unconditional growth models to examine the variability between and within patients by computing intraclass correlations and inspecting variance components. We used model fit indices (‐2LL deviance, Akaike's information criterion, and Schwartz's Bayesian criterion) as appropriate to determine best fitting model specifications in terms of random effects and covariance structure.[21, 22]
We tested the main effect of the intervention on sleep outcomes and the interactive effect of group (intervention vs control) by hospital day, to test whether there were group differences in slopes representing average change in sleep outcomes over hospital days. All models adjusted for age, body mass index, depression, and baseline sleep quality (PSQI) as time‐invariant covariates, and whether participants had taken a sleep medication the day before, as a time‐varying covariate. Adjustment for prehospitalization sleep quality was a matter of particular importance. We used the PSQI to control for sleep quality because it is both a well‐validated, multidimensional measure, and it includes prehospital use of sleep medications. In a series of sensitivity analyses, we also explored whether the dichotomous self‐reported measure of whether or not participants regularly took sleep medications prior to hospitalization, rather than the PSQI, would change our substantive findings. All covariates were centered at the grand‐mean following guidelines for appropriate interpretation of regression coefficients.[23]
RESULTS
Of the 112 study patients, 48 were in the intervention unit and 64 in the control unit. Eighty‐five percent of study participants endorsed poor sleep prior to hospital admission on the PSQI sleep quality measure, which was similar in both groups (Table 1).
Participants completed 1 to 8 sleep diary entries (mean = 2.5, standard deviation = 1.1). Because only 6 participants completed 5 or more diaries, we constrained the number of diaries included in the inferential analysis to 4 to avoid influential outliers identified by scatterplots. Fifty‐seven percent of participants had 1 night of valid actigraphy data (n = 64); 29%, 2 nights (n = 32), 8% had 3 or 4 nights, and 9 participants did not have any usable actigraphy data. The extent to which the intervention was accepted by patients in the intervention group was highly variable. Unit‐wide patient adherence with the 10 pm lights off, telephone off, and TV off policy was 87%, 67%, and 64% of intervention patients, respectively. Uptake of sleep menu items was also highly variable, and not a single element was used by more than half of patients (acceptance rates ranged from 11% to 44%). Eye masks (44%) and ear plugs (32%) were the most commonly utilized items.
A greater proportion of patients in the control arm (33%) had been taking sleep medications prior to hospitalization compared to the intervention arm (15%; 2 = 4.6, P 0.05). However, hypnotic medication use in the hospital was similar across the both groups (intervention unit patients: 25% and controls: 21%, P = 0.49).
Intraclass correlations for the 7 sleep outcomes ranged from 0.59 to 0.76 on sleep diary outcomes, and from 0.61 to 0.85 on actigraphy. Dependency of sleep measures within patients accounted for 59% to 85% of variance in sleep outcomes. The best‐fit mixed models included random intercepts only. The results of mixed models testing the main effect of intervention versus comparison arm on sleep outcome measures, adjusted for covariates, are presented in Table 2. Total sleep time was the only outcome that was significantly different between groups; the average total sleep time, calculated from sleep diary data, was longer in the intervention group by 49 minutes.
| Intervention, n = 48 | Control, n = 64 | P Value | |
|---|---|---|---|
| |||
| Sleep diary outcomes | |||
| Sleep quality, mean (SE) | 3.14 (0.16) | 3.08 (0.13) | 0.79 |
| Refreshed sleep, mean (SE) | 2.94 (0.17) | 2.74 (0.14) | 0.38 |
| Negative impact of sleep disruptions, mean (SE) | 4.39 (0.58) | 4.81 (0.48) | 0.58 |
| Total sleep time, min, mean (SE) | 422 (16.2) | 373 (13.2) | 0.02 |
| Sleep efficiency, %, mean (SE) | 83.5 (2.3) | 82.1 (1.9) | 0.65 |
| Actigraphy outcomes | |||
| Total sleep time, min, mean (SE) | 377 (16.8) | 356 (13.2) | 0.32 |
| Sleep efficiency, %, mean (SE) | 72.7 (2.2) | 74.8 (1.8) | 0.45 |
Table 3 lists slopes representing average change in sleep measures over hospital days in both groups. The P values represent z tests of interaction terms in mixed models, after adjustment for covariates, testing whether slopes significantly differed between groups. Of the 7 outcomes, 3 sleep diary measures had significant interaction terms. For ratings of sleep quality, refreshing sleep, and sleep disruptions, slopes in the control group were flat, whereas slopes in the intervention group demonstrated improvements in ratings of sleep quality and refreshed sleep, and a decrease in the impact of sleep disruptions over the course of subsequent nights in the hospital. Figure 1 illustrates a plot of the adjusted average slopes for the refreshed sleep score across hospital days in intervention and control groups.
| Intervention, Slope (SE), n = 48 | Control, Slope (SE), n = 64 | P Value | |
|---|---|---|---|
| |||
| Refreshed sleep rating | 0.55 (0.18) | 0.03 (0.13) | 0.006 |
| Sleep quality rating | 0.52 (0.16) | 0.02 (0.11) | 0.012 |
| Negative impact of sleep interruptions | 1.65 (0.48) | 0.05 (0.32) | 0.006 |
| Total sleep time, diary | 11.2 (18.1) | 6.3 (13.0) | 0.44 |
| Total sleep time, actigraphy | 7.3 (25.5) | 1.0 (15.3) | 0.83 |
| Sleep efficiency, diary | 1.1 (2.3) | 1.5 (1.6) | 0.89 |
| Sleep efficiency, actigraphy | 0.9 (4.0) | 0.7 (2.4) | 0.74 |
DISCUSSION
Poor sleep is common among hospitalized adults, both at home prior to the admission and especially when in the hospital. This pilot study demonstrated the feasibility of rolling out a sleep‐promoting intervention on a hospital's general medicine unit. Although participants on the intervention unit reported improved sleep quality and feeling more refreshed, this was not supported by actigraphy data (such as sleep time or sleep efficiency). Although care team engagement and implementation of unit‐wide interventions were high, patient use of individual components was imperfect. Of particular interest, however, the intervention group actually began to have improved sleep quality and fewer disruptions with subsequent nights sleeping in the hospital.
Our findings of the high prevalence of poor sleep among hospitalized patients is congruent with prior studies and supports the great need to screen for and address poor sleep within the hospital setting.[24, 25, 26] Attempts to promote sleep among hospitalized patients may be effective. Prior literature on sleep‐promoting intervention studies demonstrated relaxation techniques improved sleep quality by almost 38%,[27] and ear plugs and eye masks showed some benefit in promoting sleep within the hospital.[28] Our study's multicomponent intervention that attempted to minimize disruptions led to improvement in sleep quality, more restorative sleep, and decreased report of sleep disruptions, especially among patients who had a longer length of stay. As suggested by Thomas et al.[29] and seen in our data, this temporal relationship with improvement across subsequent nights suggests there may be an adaptation to the new environment and that it may take time for the sleep intervention to work.
Hospitalized patients often fail to reclaim the much‐needed restorative sleep at the time when they are most vulnerable. Patients cite routine care as the primary cause of sleep disruption, and often recognize the way that the hospital environment interferes with their ability to sleep.[30, 31, 32] The sleep‐promoting interventions used in our study would be characterized by most as low effort[33] and a potential for high yield, even though our patients only appreciated modest improvements in sleep outcomes.
Several limitations of this study should be considered. First, although we had hoped to collect substantial amounts of objective data, the average time of actigraphy observation was less than 48 hours. This may have constrained the group by time interaction analysis with actigraphy data, as studies have shown increased accuracy in actigraphy measures with longer wear.[34] By contrast, the sleep diary survey collected throughout hospitalization yielded significant improvements in consecutive daily measurements. Second, the proximity of the study units raised concern for study contamination, which could have reduced the differences in the outcome measures that may have been observed. Although the physicians work on both units, the nursing and support care teams are distinct and unit dependent. Finally, this was not a randomized trial. Patient assignment to the treatment arms was haphazard and occurred within the hospital's admitting strategy. Allocation of patients to either the intervention or the control group was based on bed availability at the time of admission. Although both groups were similar in most characteristics, more of the control participants reported taking more sleep medications prior to admission as compared to the intervention participants. Fortunately, hypnotic use was not different between groups during the admission, the time when sleep data were being captured.
Overall, this pilot study suggests that patients admitted to general medical ward fail to realize sufficient restorative sleep when they are in the hospital. Sleep disruption is rather frequent. This study demonstrates the opportunity for and feasibility of sleep‐promoting interventions where facilitating sleep is considered to be a top priority and vital component of the healthcare delivery. When trying to improve patients' sleep in the hospital, it may take several consecutive nights to realize a return on investment.
Acknowledgements
The authors acknowledge the Department of Nursing, Johns Hopkins Bayview Medical Center, and care teams of the Zieve Medicine Units, and the Center for Child and Community Health Research Biostatistics, Epidemiology and Data Management (BEAD) Core group.
Disclosures: Dr. Wright is a Miller‐Coulson Family Scholar and is supported through the Johns Hopkins Center for Innovative Medicine. Dr. Howell is the chief of the Division of Hospital Medicine at Johns Hopkins Bayview Medical Center and associate professor at Johns Hopkins School of Medicine. He served as the president of the Society of Hospital Medicine (SHM) in 2013 and currently serves as a board member. He is also a senior physician advisor for SHM. He is a coinvestigator grant recipient on an Agency for Healthcare Research and Quality grant on medication reconciliation funded through Baylor University. He was previously a coinvestigator grant recipient of Center for Medicare and Medicaid Innovations grant that ended in June 2015.
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- , , . High incidence of diabetes in men with sleep complaints or short sleep duration: a 12‐year follow‐up study of a middle‐aged population. Diabetes Care. 2005;28:2762–2767.
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- , , , , , . The joint effect of sleep duration and disturbed sleep on cause‐specific mortality: results from the Whitehall II cohort study. PLoS One. 2014;9(4):e91965.
- , , , , , . Poor self‐reported sleep quality predicts mortality within one year of inpatient post‐acute rehabilitation among older adults. Sleep. 2011;34(12):1715–1721.
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- , , , , , . Perceived control and sleep in hospitalized older adults: a sound hypothesis? J Hosp Med. 2013;8:184–190.
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- , . Sleep quality in adult hospitalized patients with infection: an observational study. Am J Med Sci. 2015;349(1):56–60.
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Introducing the Hospitalist Morale Index
Explosive growth in hospital medicine has led to hospitalists having the option to change jobs easily. Annual turnover for all physicians is 6.8%, whereas that of hospitalists exceeds 14.8%.[1] Losing a single physician has significant financial and operational implications, with estimates of $20,000 to $120,000 in recruiting costs, and up to $500,000 in lost revenue that may take years to recoup due to the time required for new physician assimilation.[2, 3] In 2006, the Society of Hospital Medicine (SHM) appointed a career task force to develop retention recommendations, 1 of which includes monitoring hospitalists' job satisfaction.[4]
Studies examining physician satisfaction have demonstrated that high physician job satisfaction is associated with lower physician turnover.[5] However, surveys of hospitalists, including SHM's Hospital Medicine Physician Worklife Survey (HMPWS), have reported high job satisfaction among hospitalists,[6, 7, 8, 9, 10] suggesting that high job satisfaction may not be enough to overcome forces that pull hospitalists toward other opportunities.
Morale, a more complex construct related to an individual's contentment and happiness, might provide insight into reducing hospitalist turnover. Morale has been defined as the emotional or mental condition with respect to cheerfulness, confidence, or zeal and is especially relevant in the face of opposition or hardship.[11] Job satisfaction is 1 element that contributes to morale, but alone does not equate morale.[12] Morale, more than satisfaction, relates to how people see themselves within the group and may be closely tied to the concept of esprit de corps. To illustrate, workers may feel satisfied with the content of their job, but frustration with the organization may result in low morale.[13] Efforts focused on assessing provider morale may provide deeper understanding of hospitalists' professional needs and garner insight for retention strategies.
The construct of hospitalist morale and its underlying drivers has not been explored in the literature. Using literature within and outside of healthcare,[1, 12, 14, 15, 16, 17, 18, 19, 20, 21, 22] and our own prior work,[23] we sought to characterize elements that contribute to hospitalist morale and develop a metric to measure it. The HMPWS found that job satisfaction factors vary across hospitalist groups.[9] We suspected that the same would hold true for factors important to morale at the individual level. This study describes the development and validation of the Hospitalist Morale Index (HMI), and explores the relationship between morale and intent to leave due to unhappiness.
METHODS
2009 Pilot Survey
To establish content validity, after reviewing employee morale literature, and examining qualitative comments from our 2007 and 2008 morale surveys, our expert panel, consisting of practicing hospitalists, hospitalist leaders, and administrative staff, identified 46 potential drivers of hospitalist morale. In May 2009, all hospitalists, including physicians, nurse practitioners (NPs), and physician assistants (PAs) from a single hospitalist group received invitations to complete the pilot survey. We asked hospitalists to assess on 5‐point Likert scales the importance of (not at all to tremendously) and contentment with (extremely discontent to extremely content) each of the 46 items as it relates to their work morale. Also included were demographic questions and general morale questions (including rating participants' own morale), investment, long‐term career plans, and intent to leave due to unhappiness.
Data Collection
To maintain anonymity and limit social desirability bias, a database manager, working outside the Division of Hospital Medicine and otherwise not associated with the research team, used Survey Monkey to coordinate survey distribution and data collection. Each respondent had a unique identifier code that was unrelated to the respondent's name and email address. Personal identifiers were maintained in a secure database accessible only to the database manager.
Establishing Internal Structure Validity Evidence
Response frequency to each question was examined for irregularities in distribution. For continuous variables, descriptive statistics were examined for evidence of skewness, outliers, and non‐normality to ensure appropriate use of parametric statistical tests. Upon ranking importance ratings by mode, 15 of 46 items were judged to be of low importance by almost all participants and removed from further consideration.
Stata 13.1 (StataCorp, College Station, TX) was used for exploratory factor analysis (EFA) of the importance responses for all 31 remaining items by principal components factoring. Eigenvalues >1 were designated as a cutoff point for inclusion in varimax rotation. Factor loading of 0.50 was the threshold for inclusion in a factor.
The 31 items loaded across 10 factors; however, 3 factors included 1 item each. After reviewing the scree plot and considering their face value, these items/factors were omitted. Repeating the factor analysis resulted in a 28‐item, 7‐factor solution that accounted for 75% variance. All items were considered informative as demonstrated by low uniqueness scores (0.050.38). Using standard validation procedures, all 7 factors were found to have acceptable factor loadings (0.460.98) and face validity. Cronbach's quantified internal reliability of the 7 factors with scores ranging from 0.68 to 0.92. We named the resultant solution the Hospitalist Morale Index (HMI).
Establishing Response Process Validity Evidence
In developing the HMI, we asked respondents to rate the importance of and their contentment with each variable as related to their work morale. From pilot testing, which included discussions with respondents immediately after completing the survey, we learned that the 2‐part consideration of each variable resulted in thoughtful reflection about their morale. Further, by multiplying the contentment score for each item (scaled from 15) by the corresponding importance score (scaled 01), we quantified the relative contribution and contentment of each item for each hospitalist. Scaling importance scores from 0 to 1 insured that items that were not considered important to the respondent did not affect the respondent's personal morale score. Averaging resultant item scores that were greater than 0 resulted in a personal morale score for each hospitalist. Averaging item scores >0 that constituted each factor resulted in factor scores.
May 2011 Survey
The refined survey was distributed in May 2011 to a convenience sample of 5 hospitalist programs at separate hospitals (3 community hospitals, 2 academic hospitals) encompassing 108 hospitalists in 3 different states. Responses to the 2011 survey were used to complete confirmatory factor analyses (CFA) and establish further validity and reliability evidence.
Based on the 28‐item, 7‐factor solution developed from the pilot study, we developed the theoretical model of factors constituting hospitalist morale. We used the structural equation modeling command in Stata 13 to perform CFA. Factor loading of 0.50 was the threshold for inclusion of an item in a factor. To measure internal consistency, we considered Cronbach's score of 0.60 acceptable. Iterative models were reviewed to find the optimal solution for the data. Four items did not fit into any of the 5 resulting factors and were evaluated in terms of mean importance score and face value. Three items were considered important enough to warrant being stand‐alone items, whereas 1 was omitted. Two additional items had borderline factor loadings (0.48, 0.49) and were included in the model as stand‐alone items due to their overall relevance. The resultant solution was a 5‐factor model with 5 additional stand‐alone items (Table 1).
| Factor | Cronbach's | |||||
|---|---|---|---|---|---|---|
| Clinical | Workload | Leadership | Appreciation and Acknowledgement | Material Rewards | ||
| How much does the following item contribute to your morale? | ||||||
| Paperwork | 0.72 | 0.89 | ||||
| Relationship with patients | 0.69 | 0.90 | ||||
| Electronic medical system | 0.60 | 0.90 | ||||
| Intellectual stimulation | 0.59 | 0.90 | ||||
| Variety of cases | 0.58 | 0.90 | ||||
| Relationship with consultants | 0.51 | 0.89 | ||||
| No. of night shifts | 0.74 | 0.89 | ||||
| Patient census | 0.61 | 0.90 | ||||
| No. of shifts | 0.52 | 0.90 | ||||
| Fairness of leadership | 0.82 | 0.89 | ||||
| Effectiveness of leadership | 0.82 | 0.89 | ||||
| Leadership's receptiveness to my thoughts and suggestions | 0.78 | 0.89 | ||||
| Leadership as advocate for my needs | 0.77 | 0.89 | ||||
| Approachability of leadership | 0.77 | 0.89 | ||||
| Accessibility of leadership | 0.69 | 0.89 | ||||
| Alignment of the group's goals with my goals | 0.50 | 0.89 | ||||
| Recognition within the group | 0.82 | 0.89 | ||||
| Feeling valued within the institution | 0.73 | 0.89 | ||||
| Feeling valued within the group | 0.73 | 0.89 | ||||
| Feedback | 0.52 | 0.89 | ||||
| Pay | 0.99 | 0.90 | ||||
| Benefits | 0.56 | 0.89 | ||||
| Cronbach's | 0.78 | 0.65 | 0.89 | 0.78 | 0.71 | |
| How much does the following item contribute to your morale? | Single item indicators | |||||
| Family time | 0.90 | |||||
| Job security | 0.90 | |||||
| Institutional climate | 0.89 | |||||
| Opportunities for professional growth | 0.90 | |||||
| Autonomy | 0.89 | |||||
| Cronbach's | 0.90 | |||||
Establishing Convergent, Concurrent, and Discriminant Validity Evidence
To establish convergent, concurrent, and discriminant validity, linear and logistic regression models were examined for continuous and categorical data accordingly.
Self‐perceived overall work morale and perceived group morale, as assessed by 6‐point Likert questions with response options from terrible to excellent, were modeled as predictors for personal morale as calculated by the HMI.
Personal morale scores were modeled as predictors of professional growth, stress, investment in the group, and intent to leave due to unhappiness. While completing the HMI, hospitalists simultaneously completed a validated professional growth scale[24] and Cohen stress scale.[25] We hypothesized that those with higher morale would have more professional growth. Stress, although an important issue in the workplace, is a distinct construct from morale, and we did not expect a significant relationship between personal morale and stress. We used Pearson's r to assess the strength of association between the HMI and these scales. Participants' level of investment in their group was assessed on a 5‐point Likert scale. To simplify presentation, highly invested represents those claiming to be very or tremendously invested in the success of their current hospitalist group. Intent to leave due to unhappiness was assessed on a 5‐point Likert scale, I have had serious thoughts about leaving my current hospitalist group because I am unhappy, with responses from strongly disagree (1) to strongly agree (5). To simplify presentation, responses higher than 2 are considered to be consistent with intending to leave due to unhappiness.
Our institutional review board approved the study.
RESULTS
Respondents
In May 2009, 30 of the 33 (91%) invited hospitalists completed the original pilot morale survey; 19 (63%) were women. Eleven hospitalists (37%) had been part of the group 1 year or less, whereas 4 (13%) had been with the group for more than 5 years.
In May 2011, 93 of the 108 (86%) hospitalists from 5 hospitals completed the demographic and global parts of the survey. Fifty (53%) were from community hospitals; 47 (51%) were women. Thirty‐seven (40%) physicians and 6 (60%) NPs/PAs were from academic hospitals. Thirty‐nine hospitalists (42%) had been with their current group 1 year or less. Ten hospitalists (11%) had been with their current group over 5 years. Sixty‐three respondents (68%) considered themselves career hospitalists, whereas 5 (5%) did not; the rest were undecided.
Internal Structure Validity Evidence
The final CFA from the 2011 survey resulted in a 5‐factor plus 5stand‐alone‐items HMI. The solution with item‐level and factor‐level Cronbach's scores (range, 0.890.90 and range, 0.650.89, respectively) are shown in Table 1.
Personal Morale Scores and Factor Scores
Personal morale scores were normally distributed (mean = 2.79; standard deviation [SD] = 0.58), ranging from 1.23 to 4.22, with a theoretical low of 0 and high of 5 (Figure 1). Mean personal morale scores across hospitalist groups ranged from 2.70 to 2.99 (P > 0.05). Personal morale scores, factor sores and item scores for NPs and PAs did not significantly differ from those of physicians (P > 0.05 for all analyses). Personal morale scores were lower for those in their first 3 years with their current group, compared to those with greater institutional longevity. For every categorical increase in a participant's response to seeing oneself as a career hospitalist, the personal morale score rose 0.23 points (P < 0.001).
Factor scores for material reward and mean item scores for professional growth were significantly different across the 5 hospitalist groups (P = 0.03 and P < 0.001, respectively). Community hospitalists had significantly higher factor scores, despite having similar importance scores, for material rewards than academic hospitalists (diff. = 0.44, P = 0.02). Academic hospitalists had significantly higher scores for professional growth (diff. = 0.94, P < 0.001) (Table 2). Professional growth had the highest importance score for academic hospitalists (mean = 0.87, SD = 0.18) and the lowest importance score for community hospitalists (mean = 0.65, SD = 0.24, P < 0.001).
| Personal Morale Score | Factor 1 | Factor 2 | Factor 3 | Factor 4 | Factor 5 | Item 1 | Item 2 | Item 3 | Item 4 | Item 5 | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical | Workload | Leadership | Appreciation and Acknowledgement | Material Rewards | Family Time | Institutional Climate | Job Security | Autonomy | Professional Growth | |||
| ||||||||||||
| All participants | Mean | 2.79 | 2.54 | 2.78 | 3.18 | 2.58 | 2.48 | 3.05 | 2.67 | 2.92 | 3.00 | 2.76 |
| SD | 0.58 | 0.63 | 0.70 | 0.95 | 0.86 | 0.85 | 1.15 | 0.97 | 1.11 | 1.10 | 1.21 | |
| Academic A | Mean | 2.77 | 2.43 | 2.92 | 3.10 | 2.54 | 2.28 | 3.16 | 2.70 | 3.06 | 3.20 | 3.08 |
| SD | 0.57 | 0.62 | 0.64 | 0.92 | 0.84 | 0.77 | 1.19 | 0.95 | 1.08 | 1.12 | 1.24 | |
| Academic B | Mean | 2.99 | 2.58 | 2.99 | 3.88 | 2.69 | 2.00 | 2.58 | 2.13 | 1.65 | 3.29 | 4.33 |
| SD | 0.36 | 0.70 | 0.80 | 0.29 | 0.80 | 0.35 | 0.92 | 0.88 | 0.78 | 1.01 | 0.82 | |
| Community A | Mean | 2.86 | 2.61 | 2.51 | 3.23 | 2.73 | 3.03 | 2.88 | 2.84 | 2.95 | 3.23 | 2.66 |
| SD | 0.75 | 0.79 | 0.68 | 1.21 | 1.11 | 1.14 | 1.37 | 1.17 | 0.98 | 1.24 | 1.15 | |
| Community B | Mean | 2.86 | 2.74 | 2.97 | 3.37 | 2.67 | 2.44 | 3.28 | 2.35 | 2.70 | 2.50 | 2.25 |
| SD | 0.67 | 0.55 | 0.86 | 1.04 | 0.94 | 0.87 | 1.00 | 1.15 | 1.40 | 0.72 | 1.26 | |
| Community C | Mean | 2.70 | 2.56 | 2.64 | 2.99 | 2.47 | 2.53 | 3.03 | 2.79 | 3.07 | 2.68 | 2.15 |
| SD | 0.49 | 0.53 | 0.67 | 0.85 | 0.73 | 0.64 | 1.08 | 0.76 | 1.05 | 1.07 | 0.71 | |
| Academic combined | Mean | 2.80 | 2.45 | 2.93 | 3.22 | 2.56 | 2.24 | 3.07 | 2.62 | 2.88 | 3.21 | 3.28 |
| SD | 0.54 | 0.63 | 0.66 | 0.89 | 0.82 | 0.72 | 1.16 | 0.95 | 1.14 | 1.10 | 1.26 | |
| Community combined | Mean | 2.79 | 2.61 | 2.66 | 3.14 | 2.60 | 2.68 | 3.03 | 2.72 | 2.95 | 2.82 | 2.34 |
| SD | 0.62 | 0.62 | 0.72 | 1.01 | 0.90 | 0.90 | 1.15 | 0.99 | 1.09 | 1.09 | 1.00 | |
| P value | >0.05 | >0.05 | >0.05 | >0.05 | >0.05 | 0.02 | >0.05 | >0.05 | >0.05 | >0.05 | <0.001 | |
Convergent, Concurrent, and Discriminant Validity Evidence
For every categorical increase on the question assessing overall morale, the personal morale score was 0.23 points higher (P < 0.001). For every categorical increase in a participant's perception of the group's morale, the personal morale score was 0.29 points higher (P < 0.001).
For every 1‐point increase in personal morale score, the odds of being highly invested in the group increased by 5 times (odds ratio [OR]: 5.23, 95% confidence interval [CI]: 1.91‐14.35, P = 0.001). The mean personal morale score for highly invested hospitalists was 2.92, whereas that of those less invested was 2.43 (diff. = 0.49, P < 0.001) (Table 3). Highly invested hospitalists had significantly higher importance factor scores for leadership (diff. = 0.08, P = 0.03) as well as appreciation and acknowledgement (diff. = 0.08, P = 0.02).
| Personal Morale Score | Factor 1 | Factor 2 | Factor 3 | Factor 4 | Factor 5 | Item 1 | Item 2 | Item 3 | Item 4 | Item 5 | |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical | Workload | Leadership | Appreciation and Acknowledgement | Material Rewards | Family Time | Institutional Climate | Job Security | Autonomy | Professional Growth | ||
| |||||||||||
| Highly invested in success of current hospitalist group | |||||||||||
| Mean | 2.92 | 2.61 | 2.89 | 3.38 | 2.78 | 2.45 | 3.21 | 2.78 | 2.86 | 3.10 | 2.95 |
| SD | 0.55 | 0.59 | 0.68 | 0.92 | 0.88 | 0.77 | 1.11 | 1.00 | 1.09 | 1.06 | 1.25 |
| Less invested in success of current hospitalist group | |||||||||||
| Mean | 2.43 | 2.34 | 2.48 | 2.60 | 2.02 | 2.57 | 2.60 | 2.38 | 3.08 | 2.69 | 2.24 |
| SD | 0.52 | 0.69 | 0.69 | 0.81 | 0.49 | 1.04 | 1.17 | 0.83 | 1.18 | 1.19 | 0.94 |
| P value | <0.001 | >0.05 | 0.02 | 0.001 | <0.001 | >0.05 | 0.03 | >0.05 | >0.05 | >0.05 | 0.02 |
| Not intending to leave because unhappy | |||||||||||
| Mean | 2.97 | 2.67 | 2.89 | 3.48 | 2.77 | 2.52 | 3.24 | 2.85 | 3.05 | 3.06 | 3.01 |
| SD | 0.51 | 0.54 | 0.61 | 0.91 | 0.89 | 0.78 | 1.03 | 0.99 | 1.10 | 1.07 | 1.25 |
| Intending to leave current group because unhappy | |||||||||||
| Mean | 2.45 | 2.30 | 2.59 | 2.59 | 2.21 | 2.40 | 2.68 | 2.33 | 2.67 | 2.88 | 2.28 |
| SD | 0.56 | 0.72 | 0.82 | 0.74 | 0.68 | 0.97 | 1.29 | 0.83 | 1.11 | 1.17 | 0.97 |
| P value | <0.001 | 0.01 | >0.05 | <0.001 | 0.003 | >0.05 | 0.03 | 0.01 | >0.05 | >0.05 | 0.01 |
Every 1‐point increase in personal morale was associated with a rise of 2.27 on the professional growth scale (P = 0.01). The correlation between these 2 scales was 0.26 (P = 0.01). Every 1‐point increase in personal morale was associated with a 2.21 point decrease on the Cohen stress scale (P > 0.05). The correlation between these 2 scales was 0.21 (P > 0.05).
Morale and Intent to Leave Due to Unhappiness
Sixteen (37%) academic and 18 (36%) community hospitalists reported having thoughts of leaving their current hospitalist program due to unhappiness. The mean personal morale score for hospitalists with no intent to leave their current group was 2.97, whereas that of those with intent to leave was 2.45 (diff. = 0.53, P < 0.001). Each 1‐point increase in the personal morale score was associated with an 85% decrease (OR: 0.15, 95% CI: 0.05‐0.41, P < 0.001) in the odds of leaving because of unhappiness. Holding self‐perception of being a career hospitalist constant, each 1‐point increase in the personal morale score was associated with an 83% decrease (OR: 0.17, 95% CI: 0.05‐0.51, P = 0.002) in the odds of leaving because of unhappiness. Hospitalists who reported intent to leave had significantly lower factor scores for all factors and items except workload, material reward, and autonomy than those who did not report intent to leave (Table 3). Within the academic groups, those who reported intent to leave had significantly lower scores for professional growth (diff. = 1.08, P = 0.01). For community groups, those who reported intent to leave had significantly lower scores for clinical work (diff. = 0.54, P = 0.003), workload (diff. = 0.50, P = 0.02), leadership (diff. = 1.19, P < 0.001), feeling appreciated and acknowledged (diff. = 0.68, P = 0.01), job security (diff. = 0.70, P = 0.03), and institutional climate (diff. = 0.67, P = 0.02) than those who did not report intent to leave.
DISCUSSION
The HMI is a validated tool that objectively measures and quantifies hospitalist morale. The HMI's capacity to comprehensively assess morale comes from its breadth and depth in uncovering work‐related areas that may be sources of contentment or displeasure. Furthermore, the fact that HMI scores varied among groups of individuals, including those who are thinking about leaving their hospitalist group because they are unhappy and those who are highly invested in their hospitalist group, speaks to its ability to highlight and account for what is most important to hospitalist providers.
Low employee morale has been associated with decreased productivity, increased absenteeism, increased turnover, and decreased patient satisfaction.[2, 26, 27, 28] A few frustrated workers can breed group discontentment and lower the entire group's morale.[28] In addition to its financial impact, departures due to low morale can be sudden and devastating, leading to loss of team cohesiveness, increased work burden on the remaining workforce, burnout, and cascades of more turnover.[2] In contrast, when morale is high, workers more commonly go the extra mile, are more committed to the organization's mission, and are more supportive of their coworkers.[28]
While we asked the informants about plans to leave their job, there are many factors that drive an individual's intent and ultimate decision to make changes in his or her employment. Some factors are outside the control of the employer or practice leaders, such as change in an individual's family life or desire and opportunity to pursue fellowship training. Others variables, however, are more directly tied to the job or practice environment. In a specialty where providers are relatively mobile and turnover is high, it is important for hospitalist practices to cultivate a climate in which the sacrifices associated with leaving outweigh the promised benefits.[29]
Results from the HMPWS suggested the need to address climate and fairness issues in hospitalist programs to improve satisfaction and retention.[9] Two large healthcare systems achieved success by investing in multipronged physician retention strategies including recruiting advisors, sign‐on bonuses, extensive onboarding, family support, and the promotion of ongoing effective communication.[3, 30]
Our findings suggest that morale for hospitalists is a complex amalgam of contentment and importance, and that there may not be a one size fits all solution to improving morale for all. While we did not find a difference in personal morale scores across individual hospitalist groups, or even between academic and community groups, each group had a unique profile with variability in the dynamics between importance and contentment of different factors. If practice group leaders review HMI data for their providers and use the information to facilitate meaningful dialogue with them about the factors influencing their morale, such leaders will have great insight into allocating resources for the best return on investment.
While we believe that the HMI is providing unique perspective compared to other commonly used metrics, it may be best to employ HMI data as complementary measures alongside that of some of the benchmarked scales that explore job satisfaction, job fit, and burnout among hospitalists.[6, 9, 10, 31, 32, 33, 34, 35] Aggregate HMI data at the group level may allow for the identification of factors that are highly important to morale but scored low in contentment. Such factors deserve priority and attention such that the subgroups within a practice can collaborate to come to consensus on strategies for amelioration. Because the HMI generates a score and profile for each provider, we can imagine effective leaders using the HMI with individuals as part of an annual review to facilitate discussion about maximizing contentment at work. Being fully transparent and sharing an honest nonanonymous version of the HMI with a superior would require a special relationship founded on trust and mutual respect.
Several limitations of this study should be considered. First, the initial item reduction and EFA were based on a single‐site survey, and our overall sample size was relatively small. We plan on expanding our sample size in the future for further validation of our exploratory findings. Second, the data were collected at 2 specific times several years ago. In continuing to analyze the data from subsequent years, validity and reliability results remain stable, thereby minimizing the likelihood of significant historical bias. Third, there may have been some recall bias, in that respondents may have overlooked the good and perseverated over variables that disappointed them. Fourth, although intention to leave does not necessarily equate actual employee turnover, intention has been found to be a strong predictor of quitting a job.[36, 37] Finally, while we had high response rates, response bias may have existed wherein those with lower morale may have elected not to complete the survey or became apathetic in their responses.
The HMI is a validated instrument that evaluates hospitalist morale by incorporating each provider's characterization of the importance of and contentment with 27 variables. By accounting for the multidimensional and dynamic nature of morale, the HMI may help program leaders tailor retention and engagement strategies specific to their own group. Future studies may explore trends in contributors to morale and examine whether interventions to augment low morale can result in improved morale and hospitalist retention.
Acknowledgements
The authors are indebted to the hospitalists who were willing to share their perspectives about their work, and grateful to Ms. Lisa Roberts, Ms. Barbara Brigade, and Ms. Regina Landis for insuring confidentiality in managing the survey database.
Disclosures: Dr. Chandra had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Dr. Wright is a Miller‐Coulson Family Scholar through the Johns Hopkins Center for Innovative Medicine. Ethical approval has been granted for studies involving human subjects by a Johns Hopkins University School of Medicine institutional review board. The authors report no conflicts of interest.
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Explosive growth in hospital medicine has led to hospitalists having the option to change jobs easily. Annual turnover for all physicians is 6.8%, whereas that of hospitalists exceeds 14.8%.[1] Losing a single physician has significant financial and operational implications, with estimates of $20,000 to $120,000 in recruiting costs, and up to $500,000 in lost revenue that may take years to recoup due to the time required for new physician assimilation.[2, 3] In 2006, the Society of Hospital Medicine (SHM) appointed a career task force to develop retention recommendations, 1 of which includes monitoring hospitalists' job satisfaction.[4]
Studies examining physician satisfaction have demonstrated that high physician job satisfaction is associated with lower physician turnover.[5] However, surveys of hospitalists, including SHM's Hospital Medicine Physician Worklife Survey (HMPWS), have reported high job satisfaction among hospitalists,[6, 7, 8, 9, 10] suggesting that high job satisfaction may not be enough to overcome forces that pull hospitalists toward other opportunities.
Morale, a more complex construct related to an individual's contentment and happiness, might provide insight into reducing hospitalist turnover. Morale has been defined as the emotional or mental condition with respect to cheerfulness, confidence, or zeal and is especially relevant in the face of opposition or hardship.[11] Job satisfaction is 1 element that contributes to morale, but alone does not equate morale.[12] Morale, more than satisfaction, relates to how people see themselves within the group and may be closely tied to the concept of esprit de corps. To illustrate, workers may feel satisfied with the content of their job, but frustration with the organization may result in low morale.[13] Efforts focused on assessing provider morale may provide deeper understanding of hospitalists' professional needs and garner insight for retention strategies.
The construct of hospitalist morale and its underlying drivers has not been explored in the literature. Using literature within and outside of healthcare,[1, 12, 14, 15, 16, 17, 18, 19, 20, 21, 22] and our own prior work,[23] we sought to characterize elements that contribute to hospitalist morale and develop a metric to measure it. The HMPWS found that job satisfaction factors vary across hospitalist groups.[9] We suspected that the same would hold true for factors important to morale at the individual level. This study describes the development and validation of the Hospitalist Morale Index (HMI), and explores the relationship between morale and intent to leave due to unhappiness.
METHODS
2009 Pilot Survey
To establish content validity, after reviewing employee morale literature, and examining qualitative comments from our 2007 and 2008 morale surveys, our expert panel, consisting of practicing hospitalists, hospitalist leaders, and administrative staff, identified 46 potential drivers of hospitalist morale. In May 2009, all hospitalists, including physicians, nurse practitioners (NPs), and physician assistants (PAs) from a single hospitalist group received invitations to complete the pilot survey. We asked hospitalists to assess on 5‐point Likert scales the importance of (not at all to tremendously) and contentment with (extremely discontent to extremely content) each of the 46 items as it relates to their work morale. Also included were demographic questions and general morale questions (including rating participants' own morale), investment, long‐term career plans, and intent to leave due to unhappiness.
Data Collection
To maintain anonymity and limit social desirability bias, a database manager, working outside the Division of Hospital Medicine and otherwise not associated with the research team, used Survey Monkey to coordinate survey distribution and data collection. Each respondent had a unique identifier code that was unrelated to the respondent's name and email address. Personal identifiers were maintained in a secure database accessible only to the database manager.
Establishing Internal Structure Validity Evidence
Response frequency to each question was examined for irregularities in distribution. For continuous variables, descriptive statistics were examined for evidence of skewness, outliers, and non‐normality to ensure appropriate use of parametric statistical tests. Upon ranking importance ratings by mode, 15 of 46 items were judged to be of low importance by almost all participants and removed from further consideration.
Stata 13.1 (StataCorp, College Station, TX) was used for exploratory factor analysis (EFA) of the importance responses for all 31 remaining items by principal components factoring. Eigenvalues >1 were designated as a cutoff point for inclusion in varimax rotation. Factor loading of 0.50 was the threshold for inclusion in a factor.
The 31 items loaded across 10 factors; however, 3 factors included 1 item each. After reviewing the scree plot and considering their face value, these items/factors were omitted. Repeating the factor analysis resulted in a 28‐item, 7‐factor solution that accounted for 75% variance. All items were considered informative as demonstrated by low uniqueness scores (0.050.38). Using standard validation procedures, all 7 factors were found to have acceptable factor loadings (0.460.98) and face validity. Cronbach's quantified internal reliability of the 7 factors with scores ranging from 0.68 to 0.92. We named the resultant solution the Hospitalist Morale Index (HMI).
Establishing Response Process Validity Evidence
In developing the HMI, we asked respondents to rate the importance of and their contentment with each variable as related to their work morale. From pilot testing, which included discussions with respondents immediately after completing the survey, we learned that the 2‐part consideration of each variable resulted in thoughtful reflection about their morale. Further, by multiplying the contentment score for each item (scaled from 15) by the corresponding importance score (scaled 01), we quantified the relative contribution and contentment of each item for each hospitalist. Scaling importance scores from 0 to 1 insured that items that were not considered important to the respondent did not affect the respondent's personal morale score. Averaging resultant item scores that were greater than 0 resulted in a personal morale score for each hospitalist. Averaging item scores >0 that constituted each factor resulted in factor scores.
May 2011 Survey
The refined survey was distributed in May 2011 to a convenience sample of 5 hospitalist programs at separate hospitals (3 community hospitals, 2 academic hospitals) encompassing 108 hospitalists in 3 different states. Responses to the 2011 survey were used to complete confirmatory factor analyses (CFA) and establish further validity and reliability evidence.
Based on the 28‐item, 7‐factor solution developed from the pilot study, we developed the theoretical model of factors constituting hospitalist morale. We used the structural equation modeling command in Stata 13 to perform CFA. Factor loading of 0.50 was the threshold for inclusion of an item in a factor. To measure internal consistency, we considered Cronbach's score of 0.60 acceptable. Iterative models were reviewed to find the optimal solution for the data. Four items did not fit into any of the 5 resulting factors and were evaluated in terms of mean importance score and face value. Three items were considered important enough to warrant being stand‐alone items, whereas 1 was omitted. Two additional items had borderline factor loadings (0.48, 0.49) and were included in the model as stand‐alone items due to their overall relevance. The resultant solution was a 5‐factor model with 5 additional stand‐alone items (Table 1).
| Factor | Cronbach's | |||||
|---|---|---|---|---|---|---|
| Clinical | Workload | Leadership | Appreciation and Acknowledgement | Material Rewards | ||
| How much does the following item contribute to your morale? | ||||||
| Paperwork | 0.72 | 0.89 | ||||
| Relationship with patients | 0.69 | 0.90 | ||||
| Electronic medical system | 0.60 | 0.90 | ||||
| Intellectual stimulation | 0.59 | 0.90 | ||||
| Variety of cases | 0.58 | 0.90 | ||||
| Relationship with consultants | 0.51 | 0.89 | ||||
| No. of night shifts | 0.74 | 0.89 | ||||
| Patient census | 0.61 | 0.90 | ||||
| No. of shifts | 0.52 | 0.90 | ||||
| Fairness of leadership | 0.82 | 0.89 | ||||
| Effectiveness of leadership | 0.82 | 0.89 | ||||
| Leadership's receptiveness to my thoughts and suggestions | 0.78 | 0.89 | ||||
| Leadership as advocate for my needs | 0.77 | 0.89 | ||||
| Approachability of leadership | 0.77 | 0.89 | ||||
| Accessibility of leadership | 0.69 | 0.89 | ||||
| Alignment of the group's goals with my goals | 0.50 | 0.89 | ||||
| Recognition within the group | 0.82 | 0.89 | ||||
| Feeling valued within the institution | 0.73 | 0.89 | ||||
| Feeling valued within the group | 0.73 | 0.89 | ||||
| Feedback | 0.52 | 0.89 | ||||
| Pay | 0.99 | 0.90 | ||||
| Benefits | 0.56 | 0.89 | ||||
| Cronbach's | 0.78 | 0.65 | 0.89 | 0.78 | 0.71 | |
| How much does the following item contribute to your morale? | Single item indicators | |||||
| Family time | 0.90 | |||||
| Job security | 0.90 | |||||
| Institutional climate | 0.89 | |||||
| Opportunities for professional growth | 0.90 | |||||
| Autonomy | 0.89 | |||||
| Cronbach's | 0.90 | |||||
Establishing Convergent, Concurrent, and Discriminant Validity Evidence
To establish convergent, concurrent, and discriminant validity, linear and logistic regression models were examined for continuous and categorical data accordingly.
Self‐perceived overall work morale and perceived group morale, as assessed by 6‐point Likert questions with response options from terrible to excellent, were modeled as predictors for personal morale as calculated by the HMI.
Personal morale scores were modeled as predictors of professional growth, stress, investment in the group, and intent to leave due to unhappiness. While completing the HMI, hospitalists simultaneously completed a validated professional growth scale[24] and Cohen stress scale.[25] We hypothesized that those with higher morale would have more professional growth. Stress, although an important issue in the workplace, is a distinct construct from morale, and we did not expect a significant relationship between personal morale and stress. We used Pearson's r to assess the strength of association between the HMI and these scales. Participants' level of investment in their group was assessed on a 5‐point Likert scale. To simplify presentation, highly invested represents those claiming to be very or tremendously invested in the success of their current hospitalist group. Intent to leave due to unhappiness was assessed on a 5‐point Likert scale, I have had serious thoughts about leaving my current hospitalist group because I am unhappy, with responses from strongly disagree (1) to strongly agree (5). To simplify presentation, responses higher than 2 are considered to be consistent with intending to leave due to unhappiness.
Our institutional review board approved the study.
RESULTS
Respondents
In May 2009, 30 of the 33 (91%) invited hospitalists completed the original pilot morale survey; 19 (63%) were women. Eleven hospitalists (37%) had been part of the group 1 year or less, whereas 4 (13%) had been with the group for more than 5 years.
In May 2011, 93 of the 108 (86%) hospitalists from 5 hospitals completed the demographic and global parts of the survey. Fifty (53%) were from community hospitals; 47 (51%) were women. Thirty‐seven (40%) physicians and 6 (60%) NPs/PAs were from academic hospitals. Thirty‐nine hospitalists (42%) had been with their current group 1 year or less. Ten hospitalists (11%) had been with their current group over 5 years. Sixty‐three respondents (68%) considered themselves career hospitalists, whereas 5 (5%) did not; the rest were undecided.
Internal Structure Validity Evidence
The final CFA from the 2011 survey resulted in a 5‐factor plus 5stand‐alone‐items HMI. The solution with item‐level and factor‐level Cronbach's scores (range, 0.890.90 and range, 0.650.89, respectively) are shown in Table 1.
Personal Morale Scores and Factor Scores
Personal morale scores were normally distributed (mean = 2.79; standard deviation [SD] = 0.58), ranging from 1.23 to 4.22, with a theoretical low of 0 and high of 5 (Figure 1). Mean personal morale scores across hospitalist groups ranged from 2.70 to 2.99 (P > 0.05). Personal morale scores, factor sores and item scores for NPs and PAs did not significantly differ from those of physicians (P > 0.05 for all analyses). Personal morale scores were lower for those in their first 3 years with their current group, compared to those with greater institutional longevity. For every categorical increase in a participant's response to seeing oneself as a career hospitalist, the personal morale score rose 0.23 points (P < 0.001).
Factor scores for material reward and mean item scores for professional growth were significantly different across the 5 hospitalist groups (P = 0.03 and P < 0.001, respectively). Community hospitalists had significantly higher factor scores, despite having similar importance scores, for material rewards than academic hospitalists (diff. = 0.44, P = 0.02). Academic hospitalists had significantly higher scores for professional growth (diff. = 0.94, P < 0.001) (Table 2). Professional growth had the highest importance score for academic hospitalists (mean = 0.87, SD = 0.18) and the lowest importance score for community hospitalists (mean = 0.65, SD = 0.24, P < 0.001).
| Personal Morale Score | Factor 1 | Factor 2 | Factor 3 | Factor 4 | Factor 5 | Item 1 | Item 2 | Item 3 | Item 4 | Item 5 | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical | Workload | Leadership | Appreciation and Acknowledgement | Material Rewards | Family Time | Institutional Climate | Job Security | Autonomy | Professional Growth | |||
| ||||||||||||
| All participants | Mean | 2.79 | 2.54 | 2.78 | 3.18 | 2.58 | 2.48 | 3.05 | 2.67 | 2.92 | 3.00 | 2.76 |
| SD | 0.58 | 0.63 | 0.70 | 0.95 | 0.86 | 0.85 | 1.15 | 0.97 | 1.11 | 1.10 | 1.21 | |
| Academic A | Mean | 2.77 | 2.43 | 2.92 | 3.10 | 2.54 | 2.28 | 3.16 | 2.70 | 3.06 | 3.20 | 3.08 |
| SD | 0.57 | 0.62 | 0.64 | 0.92 | 0.84 | 0.77 | 1.19 | 0.95 | 1.08 | 1.12 | 1.24 | |
| Academic B | Mean | 2.99 | 2.58 | 2.99 | 3.88 | 2.69 | 2.00 | 2.58 | 2.13 | 1.65 | 3.29 | 4.33 |
| SD | 0.36 | 0.70 | 0.80 | 0.29 | 0.80 | 0.35 | 0.92 | 0.88 | 0.78 | 1.01 | 0.82 | |
| Community A | Mean | 2.86 | 2.61 | 2.51 | 3.23 | 2.73 | 3.03 | 2.88 | 2.84 | 2.95 | 3.23 | 2.66 |
| SD | 0.75 | 0.79 | 0.68 | 1.21 | 1.11 | 1.14 | 1.37 | 1.17 | 0.98 | 1.24 | 1.15 | |
| Community B | Mean | 2.86 | 2.74 | 2.97 | 3.37 | 2.67 | 2.44 | 3.28 | 2.35 | 2.70 | 2.50 | 2.25 |
| SD | 0.67 | 0.55 | 0.86 | 1.04 | 0.94 | 0.87 | 1.00 | 1.15 | 1.40 | 0.72 | 1.26 | |
| Community C | Mean | 2.70 | 2.56 | 2.64 | 2.99 | 2.47 | 2.53 | 3.03 | 2.79 | 3.07 | 2.68 | 2.15 |
| SD | 0.49 | 0.53 | 0.67 | 0.85 | 0.73 | 0.64 | 1.08 | 0.76 | 1.05 | 1.07 | 0.71 | |
| Academic combined | Mean | 2.80 | 2.45 | 2.93 | 3.22 | 2.56 | 2.24 | 3.07 | 2.62 | 2.88 | 3.21 | 3.28 |
| SD | 0.54 | 0.63 | 0.66 | 0.89 | 0.82 | 0.72 | 1.16 | 0.95 | 1.14 | 1.10 | 1.26 | |
| Community combined | Mean | 2.79 | 2.61 | 2.66 | 3.14 | 2.60 | 2.68 | 3.03 | 2.72 | 2.95 | 2.82 | 2.34 |
| SD | 0.62 | 0.62 | 0.72 | 1.01 | 0.90 | 0.90 | 1.15 | 0.99 | 1.09 | 1.09 | 1.00 | |
| P value | >0.05 | >0.05 | >0.05 | >0.05 | >0.05 | 0.02 | >0.05 | >0.05 | >0.05 | >0.05 | <0.001 | |
Convergent, Concurrent, and Discriminant Validity Evidence
For every categorical increase on the question assessing overall morale, the personal morale score was 0.23 points higher (P < 0.001). For every categorical increase in a participant's perception of the group's morale, the personal morale score was 0.29 points higher (P < 0.001).
For every 1‐point increase in personal morale score, the odds of being highly invested in the group increased by 5 times (odds ratio [OR]: 5.23, 95% confidence interval [CI]: 1.91‐14.35, P = 0.001). The mean personal morale score for highly invested hospitalists was 2.92, whereas that of those less invested was 2.43 (diff. = 0.49, P < 0.001) (Table 3). Highly invested hospitalists had significantly higher importance factor scores for leadership (diff. = 0.08, P = 0.03) as well as appreciation and acknowledgement (diff. = 0.08, P = 0.02).
| Personal Morale Score | Factor 1 | Factor 2 | Factor 3 | Factor 4 | Factor 5 | Item 1 | Item 2 | Item 3 | Item 4 | Item 5 | |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical | Workload | Leadership | Appreciation and Acknowledgement | Material Rewards | Family Time | Institutional Climate | Job Security | Autonomy | Professional Growth | ||
| |||||||||||
| Highly invested in success of current hospitalist group | |||||||||||
| Mean | 2.92 | 2.61 | 2.89 | 3.38 | 2.78 | 2.45 | 3.21 | 2.78 | 2.86 | 3.10 | 2.95 |
| SD | 0.55 | 0.59 | 0.68 | 0.92 | 0.88 | 0.77 | 1.11 | 1.00 | 1.09 | 1.06 | 1.25 |
| Less invested in success of current hospitalist group | |||||||||||
| Mean | 2.43 | 2.34 | 2.48 | 2.60 | 2.02 | 2.57 | 2.60 | 2.38 | 3.08 | 2.69 | 2.24 |
| SD | 0.52 | 0.69 | 0.69 | 0.81 | 0.49 | 1.04 | 1.17 | 0.83 | 1.18 | 1.19 | 0.94 |
| P value | <0.001 | >0.05 | 0.02 | 0.001 | <0.001 | >0.05 | 0.03 | >0.05 | >0.05 | >0.05 | 0.02 |
| Not intending to leave because unhappy | |||||||||||
| Mean | 2.97 | 2.67 | 2.89 | 3.48 | 2.77 | 2.52 | 3.24 | 2.85 | 3.05 | 3.06 | 3.01 |
| SD | 0.51 | 0.54 | 0.61 | 0.91 | 0.89 | 0.78 | 1.03 | 0.99 | 1.10 | 1.07 | 1.25 |
| Intending to leave current group because unhappy | |||||||||||
| Mean | 2.45 | 2.30 | 2.59 | 2.59 | 2.21 | 2.40 | 2.68 | 2.33 | 2.67 | 2.88 | 2.28 |
| SD | 0.56 | 0.72 | 0.82 | 0.74 | 0.68 | 0.97 | 1.29 | 0.83 | 1.11 | 1.17 | 0.97 |
| P value | <0.001 | 0.01 | >0.05 | <0.001 | 0.003 | >0.05 | 0.03 | 0.01 | >0.05 | >0.05 | 0.01 |
Every 1‐point increase in personal morale was associated with a rise of 2.27 on the professional growth scale (P = 0.01). The correlation between these 2 scales was 0.26 (P = 0.01). Every 1‐point increase in personal morale was associated with a 2.21 point decrease on the Cohen stress scale (P > 0.05). The correlation between these 2 scales was 0.21 (P > 0.05).
Morale and Intent to Leave Due to Unhappiness
Sixteen (37%) academic and 18 (36%) community hospitalists reported having thoughts of leaving their current hospitalist program due to unhappiness. The mean personal morale score for hospitalists with no intent to leave their current group was 2.97, whereas that of those with intent to leave was 2.45 (diff. = 0.53, P < 0.001). Each 1‐point increase in the personal morale score was associated with an 85% decrease (OR: 0.15, 95% CI: 0.05‐0.41, P < 0.001) in the odds of leaving because of unhappiness. Holding self‐perception of being a career hospitalist constant, each 1‐point increase in the personal morale score was associated with an 83% decrease (OR: 0.17, 95% CI: 0.05‐0.51, P = 0.002) in the odds of leaving because of unhappiness. Hospitalists who reported intent to leave had significantly lower factor scores for all factors and items except workload, material reward, and autonomy than those who did not report intent to leave (Table 3). Within the academic groups, those who reported intent to leave had significantly lower scores for professional growth (diff. = 1.08, P = 0.01). For community groups, those who reported intent to leave had significantly lower scores for clinical work (diff. = 0.54, P = 0.003), workload (diff. = 0.50, P = 0.02), leadership (diff. = 1.19, P < 0.001), feeling appreciated and acknowledged (diff. = 0.68, P = 0.01), job security (diff. = 0.70, P = 0.03), and institutional climate (diff. = 0.67, P = 0.02) than those who did not report intent to leave.
DISCUSSION
The HMI is a validated tool that objectively measures and quantifies hospitalist morale. The HMI's capacity to comprehensively assess morale comes from its breadth and depth in uncovering work‐related areas that may be sources of contentment or displeasure. Furthermore, the fact that HMI scores varied among groups of individuals, including those who are thinking about leaving their hospitalist group because they are unhappy and those who are highly invested in their hospitalist group, speaks to its ability to highlight and account for what is most important to hospitalist providers.
Low employee morale has been associated with decreased productivity, increased absenteeism, increased turnover, and decreased patient satisfaction.[2, 26, 27, 28] A few frustrated workers can breed group discontentment and lower the entire group's morale.[28] In addition to its financial impact, departures due to low morale can be sudden and devastating, leading to loss of team cohesiveness, increased work burden on the remaining workforce, burnout, and cascades of more turnover.[2] In contrast, when morale is high, workers more commonly go the extra mile, are more committed to the organization's mission, and are more supportive of their coworkers.[28]
While we asked the informants about plans to leave their job, there are many factors that drive an individual's intent and ultimate decision to make changes in his or her employment. Some factors are outside the control of the employer or practice leaders, such as change in an individual's family life or desire and opportunity to pursue fellowship training. Others variables, however, are more directly tied to the job or practice environment. In a specialty where providers are relatively mobile and turnover is high, it is important for hospitalist practices to cultivate a climate in which the sacrifices associated with leaving outweigh the promised benefits.[29]
Results from the HMPWS suggested the need to address climate and fairness issues in hospitalist programs to improve satisfaction and retention.[9] Two large healthcare systems achieved success by investing in multipronged physician retention strategies including recruiting advisors, sign‐on bonuses, extensive onboarding, family support, and the promotion of ongoing effective communication.[3, 30]
Our findings suggest that morale for hospitalists is a complex amalgam of contentment and importance, and that there may not be a one size fits all solution to improving morale for all. While we did not find a difference in personal morale scores across individual hospitalist groups, or even between academic and community groups, each group had a unique profile with variability in the dynamics between importance and contentment of different factors. If practice group leaders review HMI data for their providers and use the information to facilitate meaningful dialogue with them about the factors influencing their morale, such leaders will have great insight into allocating resources for the best return on investment.
While we believe that the HMI is providing unique perspective compared to other commonly used metrics, it may be best to employ HMI data as complementary measures alongside that of some of the benchmarked scales that explore job satisfaction, job fit, and burnout among hospitalists.[6, 9, 10, 31, 32, 33, 34, 35] Aggregate HMI data at the group level may allow for the identification of factors that are highly important to morale but scored low in contentment. Such factors deserve priority and attention such that the subgroups within a practice can collaborate to come to consensus on strategies for amelioration. Because the HMI generates a score and profile for each provider, we can imagine effective leaders using the HMI with individuals as part of an annual review to facilitate discussion about maximizing contentment at work. Being fully transparent and sharing an honest nonanonymous version of the HMI with a superior would require a special relationship founded on trust and mutual respect.
Several limitations of this study should be considered. First, the initial item reduction and EFA were based on a single‐site survey, and our overall sample size was relatively small. We plan on expanding our sample size in the future for further validation of our exploratory findings. Second, the data were collected at 2 specific times several years ago. In continuing to analyze the data from subsequent years, validity and reliability results remain stable, thereby minimizing the likelihood of significant historical bias. Third, there may have been some recall bias, in that respondents may have overlooked the good and perseverated over variables that disappointed them. Fourth, although intention to leave does not necessarily equate actual employee turnover, intention has been found to be a strong predictor of quitting a job.[36, 37] Finally, while we had high response rates, response bias may have existed wherein those with lower morale may have elected not to complete the survey or became apathetic in their responses.
The HMI is a validated instrument that evaluates hospitalist morale by incorporating each provider's characterization of the importance of and contentment with 27 variables. By accounting for the multidimensional and dynamic nature of morale, the HMI may help program leaders tailor retention and engagement strategies specific to their own group. Future studies may explore trends in contributors to morale and examine whether interventions to augment low morale can result in improved morale and hospitalist retention.
Acknowledgements
The authors are indebted to the hospitalists who were willing to share their perspectives about their work, and grateful to Ms. Lisa Roberts, Ms. Barbara Brigade, and Ms. Regina Landis for insuring confidentiality in managing the survey database.
Disclosures: Dr. Chandra had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Dr. Wright is a Miller‐Coulson Family Scholar through the Johns Hopkins Center for Innovative Medicine. Ethical approval has been granted for studies involving human subjects by a Johns Hopkins University School of Medicine institutional review board. The authors report no conflicts of interest.
Explosive growth in hospital medicine has led to hospitalists having the option to change jobs easily. Annual turnover for all physicians is 6.8%, whereas that of hospitalists exceeds 14.8%.[1] Losing a single physician has significant financial and operational implications, with estimates of $20,000 to $120,000 in recruiting costs, and up to $500,000 in lost revenue that may take years to recoup due to the time required for new physician assimilation.[2, 3] In 2006, the Society of Hospital Medicine (SHM) appointed a career task force to develop retention recommendations, 1 of which includes monitoring hospitalists' job satisfaction.[4]
Studies examining physician satisfaction have demonstrated that high physician job satisfaction is associated with lower physician turnover.[5] However, surveys of hospitalists, including SHM's Hospital Medicine Physician Worklife Survey (HMPWS), have reported high job satisfaction among hospitalists,[6, 7, 8, 9, 10] suggesting that high job satisfaction may not be enough to overcome forces that pull hospitalists toward other opportunities.
Morale, a more complex construct related to an individual's contentment and happiness, might provide insight into reducing hospitalist turnover. Morale has been defined as the emotional or mental condition with respect to cheerfulness, confidence, or zeal and is especially relevant in the face of opposition or hardship.[11] Job satisfaction is 1 element that contributes to morale, but alone does not equate morale.[12] Morale, more than satisfaction, relates to how people see themselves within the group and may be closely tied to the concept of esprit de corps. To illustrate, workers may feel satisfied with the content of their job, but frustration with the organization may result in low morale.[13] Efforts focused on assessing provider morale may provide deeper understanding of hospitalists' professional needs and garner insight for retention strategies.
The construct of hospitalist morale and its underlying drivers has not been explored in the literature. Using literature within and outside of healthcare,[1, 12, 14, 15, 16, 17, 18, 19, 20, 21, 22] and our own prior work,[23] we sought to characterize elements that contribute to hospitalist morale and develop a metric to measure it. The HMPWS found that job satisfaction factors vary across hospitalist groups.[9] We suspected that the same would hold true for factors important to morale at the individual level. This study describes the development and validation of the Hospitalist Morale Index (HMI), and explores the relationship between morale and intent to leave due to unhappiness.
METHODS
2009 Pilot Survey
To establish content validity, after reviewing employee morale literature, and examining qualitative comments from our 2007 and 2008 morale surveys, our expert panel, consisting of practicing hospitalists, hospitalist leaders, and administrative staff, identified 46 potential drivers of hospitalist morale. In May 2009, all hospitalists, including physicians, nurse practitioners (NPs), and physician assistants (PAs) from a single hospitalist group received invitations to complete the pilot survey. We asked hospitalists to assess on 5‐point Likert scales the importance of (not at all to tremendously) and contentment with (extremely discontent to extremely content) each of the 46 items as it relates to their work morale. Also included were demographic questions and general morale questions (including rating participants' own morale), investment, long‐term career plans, and intent to leave due to unhappiness.
Data Collection
To maintain anonymity and limit social desirability bias, a database manager, working outside the Division of Hospital Medicine and otherwise not associated with the research team, used Survey Monkey to coordinate survey distribution and data collection. Each respondent had a unique identifier code that was unrelated to the respondent's name and email address. Personal identifiers were maintained in a secure database accessible only to the database manager.
Establishing Internal Structure Validity Evidence
Response frequency to each question was examined for irregularities in distribution. For continuous variables, descriptive statistics were examined for evidence of skewness, outliers, and non‐normality to ensure appropriate use of parametric statistical tests. Upon ranking importance ratings by mode, 15 of 46 items were judged to be of low importance by almost all participants and removed from further consideration.
Stata 13.1 (StataCorp, College Station, TX) was used for exploratory factor analysis (EFA) of the importance responses for all 31 remaining items by principal components factoring. Eigenvalues >1 were designated as a cutoff point for inclusion in varimax rotation. Factor loading of 0.50 was the threshold for inclusion in a factor.
The 31 items loaded across 10 factors; however, 3 factors included 1 item each. After reviewing the scree plot and considering their face value, these items/factors were omitted. Repeating the factor analysis resulted in a 28‐item, 7‐factor solution that accounted for 75% variance. All items were considered informative as demonstrated by low uniqueness scores (0.050.38). Using standard validation procedures, all 7 factors were found to have acceptable factor loadings (0.460.98) and face validity. Cronbach's quantified internal reliability of the 7 factors with scores ranging from 0.68 to 0.92. We named the resultant solution the Hospitalist Morale Index (HMI).
Establishing Response Process Validity Evidence
In developing the HMI, we asked respondents to rate the importance of and their contentment with each variable as related to their work morale. From pilot testing, which included discussions with respondents immediately after completing the survey, we learned that the 2‐part consideration of each variable resulted in thoughtful reflection about their morale. Further, by multiplying the contentment score for each item (scaled from 15) by the corresponding importance score (scaled 01), we quantified the relative contribution and contentment of each item for each hospitalist. Scaling importance scores from 0 to 1 insured that items that were not considered important to the respondent did not affect the respondent's personal morale score. Averaging resultant item scores that were greater than 0 resulted in a personal morale score for each hospitalist. Averaging item scores >0 that constituted each factor resulted in factor scores.
May 2011 Survey
The refined survey was distributed in May 2011 to a convenience sample of 5 hospitalist programs at separate hospitals (3 community hospitals, 2 academic hospitals) encompassing 108 hospitalists in 3 different states. Responses to the 2011 survey were used to complete confirmatory factor analyses (CFA) and establish further validity and reliability evidence.
Based on the 28‐item, 7‐factor solution developed from the pilot study, we developed the theoretical model of factors constituting hospitalist morale. We used the structural equation modeling command in Stata 13 to perform CFA. Factor loading of 0.50 was the threshold for inclusion of an item in a factor. To measure internal consistency, we considered Cronbach's score of 0.60 acceptable. Iterative models were reviewed to find the optimal solution for the data. Four items did not fit into any of the 5 resulting factors and were evaluated in terms of mean importance score and face value. Three items were considered important enough to warrant being stand‐alone items, whereas 1 was omitted. Two additional items had borderline factor loadings (0.48, 0.49) and were included in the model as stand‐alone items due to their overall relevance. The resultant solution was a 5‐factor model with 5 additional stand‐alone items (Table 1).
| Factor | Cronbach's | |||||
|---|---|---|---|---|---|---|
| Clinical | Workload | Leadership | Appreciation and Acknowledgement | Material Rewards | ||
| How much does the following item contribute to your morale? | ||||||
| Paperwork | 0.72 | 0.89 | ||||
| Relationship with patients | 0.69 | 0.90 | ||||
| Electronic medical system | 0.60 | 0.90 | ||||
| Intellectual stimulation | 0.59 | 0.90 | ||||
| Variety of cases | 0.58 | 0.90 | ||||
| Relationship with consultants | 0.51 | 0.89 | ||||
| No. of night shifts | 0.74 | 0.89 | ||||
| Patient census | 0.61 | 0.90 | ||||
| No. of shifts | 0.52 | 0.90 | ||||
| Fairness of leadership | 0.82 | 0.89 | ||||
| Effectiveness of leadership | 0.82 | 0.89 | ||||
| Leadership's receptiveness to my thoughts and suggestions | 0.78 | 0.89 | ||||
| Leadership as advocate for my needs | 0.77 | 0.89 | ||||
| Approachability of leadership | 0.77 | 0.89 | ||||
| Accessibility of leadership | 0.69 | 0.89 | ||||
| Alignment of the group's goals with my goals | 0.50 | 0.89 | ||||
| Recognition within the group | 0.82 | 0.89 | ||||
| Feeling valued within the institution | 0.73 | 0.89 | ||||
| Feeling valued within the group | 0.73 | 0.89 | ||||
| Feedback | 0.52 | 0.89 | ||||
| Pay | 0.99 | 0.90 | ||||
| Benefits | 0.56 | 0.89 | ||||
| Cronbach's | 0.78 | 0.65 | 0.89 | 0.78 | 0.71 | |
| How much does the following item contribute to your morale? | Single item indicators | |||||
| Family time | 0.90 | |||||
| Job security | 0.90 | |||||
| Institutional climate | 0.89 | |||||
| Opportunities for professional growth | 0.90 | |||||
| Autonomy | 0.89 | |||||
| Cronbach's | 0.90 | |||||
Establishing Convergent, Concurrent, and Discriminant Validity Evidence
To establish convergent, concurrent, and discriminant validity, linear and logistic regression models were examined for continuous and categorical data accordingly.
Self‐perceived overall work morale and perceived group morale, as assessed by 6‐point Likert questions with response options from terrible to excellent, were modeled as predictors for personal morale as calculated by the HMI.
Personal morale scores were modeled as predictors of professional growth, stress, investment in the group, and intent to leave due to unhappiness. While completing the HMI, hospitalists simultaneously completed a validated professional growth scale[24] and Cohen stress scale.[25] We hypothesized that those with higher morale would have more professional growth. Stress, although an important issue in the workplace, is a distinct construct from morale, and we did not expect a significant relationship between personal morale and stress. We used Pearson's r to assess the strength of association between the HMI and these scales. Participants' level of investment in their group was assessed on a 5‐point Likert scale. To simplify presentation, highly invested represents those claiming to be very or tremendously invested in the success of their current hospitalist group. Intent to leave due to unhappiness was assessed on a 5‐point Likert scale, I have had serious thoughts about leaving my current hospitalist group because I am unhappy, with responses from strongly disagree (1) to strongly agree (5). To simplify presentation, responses higher than 2 are considered to be consistent with intending to leave due to unhappiness.
Our institutional review board approved the study.
RESULTS
Respondents
In May 2009, 30 of the 33 (91%) invited hospitalists completed the original pilot morale survey; 19 (63%) were women. Eleven hospitalists (37%) had been part of the group 1 year or less, whereas 4 (13%) had been with the group for more than 5 years.
In May 2011, 93 of the 108 (86%) hospitalists from 5 hospitals completed the demographic and global parts of the survey. Fifty (53%) were from community hospitals; 47 (51%) were women. Thirty‐seven (40%) physicians and 6 (60%) NPs/PAs were from academic hospitals. Thirty‐nine hospitalists (42%) had been with their current group 1 year or less. Ten hospitalists (11%) had been with their current group over 5 years. Sixty‐three respondents (68%) considered themselves career hospitalists, whereas 5 (5%) did not; the rest were undecided.
Internal Structure Validity Evidence
The final CFA from the 2011 survey resulted in a 5‐factor plus 5stand‐alone‐items HMI. The solution with item‐level and factor‐level Cronbach's scores (range, 0.890.90 and range, 0.650.89, respectively) are shown in Table 1.
Personal Morale Scores and Factor Scores
Personal morale scores were normally distributed (mean = 2.79; standard deviation [SD] = 0.58), ranging from 1.23 to 4.22, with a theoretical low of 0 and high of 5 (Figure 1). Mean personal morale scores across hospitalist groups ranged from 2.70 to 2.99 (P > 0.05). Personal morale scores, factor sores and item scores for NPs and PAs did not significantly differ from those of physicians (P > 0.05 for all analyses). Personal morale scores were lower for those in their first 3 years with their current group, compared to those with greater institutional longevity. For every categorical increase in a participant's response to seeing oneself as a career hospitalist, the personal morale score rose 0.23 points (P < 0.001).
Factor scores for material reward and mean item scores for professional growth were significantly different across the 5 hospitalist groups (P = 0.03 and P < 0.001, respectively). Community hospitalists had significantly higher factor scores, despite having similar importance scores, for material rewards than academic hospitalists (diff. = 0.44, P = 0.02). Academic hospitalists had significantly higher scores for professional growth (diff. = 0.94, P < 0.001) (Table 2). Professional growth had the highest importance score for academic hospitalists (mean = 0.87, SD = 0.18) and the lowest importance score for community hospitalists (mean = 0.65, SD = 0.24, P < 0.001).
| Personal Morale Score | Factor 1 | Factor 2 | Factor 3 | Factor 4 | Factor 5 | Item 1 | Item 2 | Item 3 | Item 4 | Item 5 | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical | Workload | Leadership | Appreciation and Acknowledgement | Material Rewards | Family Time | Institutional Climate | Job Security | Autonomy | Professional Growth | |||
| ||||||||||||
| All participants | Mean | 2.79 | 2.54 | 2.78 | 3.18 | 2.58 | 2.48 | 3.05 | 2.67 | 2.92 | 3.00 | 2.76 |
| SD | 0.58 | 0.63 | 0.70 | 0.95 | 0.86 | 0.85 | 1.15 | 0.97 | 1.11 | 1.10 | 1.21 | |
| Academic A | Mean | 2.77 | 2.43 | 2.92 | 3.10 | 2.54 | 2.28 | 3.16 | 2.70 | 3.06 | 3.20 | 3.08 |
| SD | 0.57 | 0.62 | 0.64 | 0.92 | 0.84 | 0.77 | 1.19 | 0.95 | 1.08 | 1.12 | 1.24 | |
| Academic B | Mean | 2.99 | 2.58 | 2.99 | 3.88 | 2.69 | 2.00 | 2.58 | 2.13 | 1.65 | 3.29 | 4.33 |
| SD | 0.36 | 0.70 | 0.80 | 0.29 | 0.80 | 0.35 | 0.92 | 0.88 | 0.78 | 1.01 | 0.82 | |
| Community A | Mean | 2.86 | 2.61 | 2.51 | 3.23 | 2.73 | 3.03 | 2.88 | 2.84 | 2.95 | 3.23 | 2.66 |
| SD | 0.75 | 0.79 | 0.68 | 1.21 | 1.11 | 1.14 | 1.37 | 1.17 | 0.98 | 1.24 | 1.15 | |
| Community B | Mean | 2.86 | 2.74 | 2.97 | 3.37 | 2.67 | 2.44 | 3.28 | 2.35 | 2.70 | 2.50 | 2.25 |
| SD | 0.67 | 0.55 | 0.86 | 1.04 | 0.94 | 0.87 | 1.00 | 1.15 | 1.40 | 0.72 | 1.26 | |
| Community C | Mean | 2.70 | 2.56 | 2.64 | 2.99 | 2.47 | 2.53 | 3.03 | 2.79 | 3.07 | 2.68 | 2.15 |
| SD | 0.49 | 0.53 | 0.67 | 0.85 | 0.73 | 0.64 | 1.08 | 0.76 | 1.05 | 1.07 | 0.71 | |
| Academic combined | Mean | 2.80 | 2.45 | 2.93 | 3.22 | 2.56 | 2.24 | 3.07 | 2.62 | 2.88 | 3.21 | 3.28 |
| SD | 0.54 | 0.63 | 0.66 | 0.89 | 0.82 | 0.72 | 1.16 | 0.95 | 1.14 | 1.10 | 1.26 | |
| Community combined | Mean | 2.79 | 2.61 | 2.66 | 3.14 | 2.60 | 2.68 | 3.03 | 2.72 | 2.95 | 2.82 | 2.34 |
| SD | 0.62 | 0.62 | 0.72 | 1.01 | 0.90 | 0.90 | 1.15 | 0.99 | 1.09 | 1.09 | 1.00 | |
| P value | >0.05 | >0.05 | >0.05 | >0.05 | >0.05 | 0.02 | >0.05 | >0.05 | >0.05 | >0.05 | <0.001 | |
Convergent, Concurrent, and Discriminant Validity Evidence
For every categorical increase on the question assessing overall morale, the personal morale score was 0.23 points higher (P < 0.001). For every categorical increase in a participant's perception of the group's morale, the personal morale score was 0.29 points higher (P < 0.001).
For every 1‐point increase in personal morale score, the odds of being highly invested in the group increased by 5 times (odds ratio [OR]: 5.23, 95% confidence interval [CI]: 1.91‐14.35, P = 0.001). The mean personal morale score for highly invested hospitalists was 2.92, whereas that of those less invested was 2.43 (diff. = 0.49, P < 0.001) (Table 3). Highly invested hospitalists had significantly higher importance factor scores for leadership (diff. = 0.08, P = 0.03) as well as appreciation and acknowledgement (diff. = 0.08, P = 0.02).
| Personal Morale Score | Factor 1 | Factor 2 | Factor 3 | Factor 4 | Factor 5 | Item 1 | Item 2 | Item 3 | Item 4 | Item 5 | |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical | Workload | Leadership | Appreciation and Acknowledgement | Material Rewards | Family Time | Institutional Climate | Job Security | Autonomy | Professional Growth | ||
| |||||||||||
| Highly invested in success of current hospitalist group | |||||||||||
| Mean | 2.92 | 2.61 | 2.89 | 3.38 | 2.78 | 2.45 | 3.21 | 2.78 | 2.86 | 3.10 | 2.95 |
| SD | 0.55 | 0.59 | 0.68 | 0.92 | 0.88 | 0.77 | 1.11 | 1.00 | 1.09 | 1.06 | 1.25 |
| Less invested in success of current hospitalist group | |||||||||||
| Mean | 2.43 | 2.34 | 2.48 | 2.60 | 2.02 | 2.57 | 2.60 | 2.38 | 3.08 | 2.69 | 2.24 |
| SD | 0.52 | 0.69 | 0.69 | 0.81 | 0.49 | 1.04 | 1.17 | 0.83 | 1.18 | 1.19 | 0.94 |
| P value | <0.001 | >0.05 | 0.02 | 0.001 | <0.001 | >0.05 | 0.03 | >0.05 | >0.05 | >0.05 | 0.02 |
| Not intending to leave because unhappy | |||||||||||
| Mean | 2.97 | 2.67 | 2.89 | 3.48 | 2.77 | 2.52 | 3.24 | 2.85 | 3.05 | 3.06 | 3.01 |
| SD | 0.51 | 0.54 | 0.61 | 0.91 | 0.89 | 0.78 | 1.03 | 0.99 | 1.10 | 1.07 | 1.25 |
| Intending to leave current group because unhappy | |||||||||||
| Mean | 2.45 | 2.30 | 2.59 | 2.59 | 2.21 | 2.40 | 2.68 | 2.33 | 2.67 | 2.88 | 2.28 |
| SD | 0.56 | 0.72 | 0.82 | 0.74 | 0.68 | 0.97 | 1.29 | 0.83 | 1.11 | 1.17 | 0.97 |
| P value | <0.001 | 0.01 | >0.05 | <0.001 | 0.003 | >0.05 | 0.03 | 0.01 | >0.05 | >0.05 | 0.01 |
Every 1‐point increase in personal morale was associated with a rise of 2.27 on the professional growth scale (P = 0.01). The correlation between these 2 scales was 0.26 (P = 0.01). Every 1‐point increase in personal morale was associated with a 2.21 point decrease on the Cohen stress scale (P > 0.05). The correlation between these 2 scales was 0.21 (P > 0.05).
Morale and Intent to Leave Due to Unhappiness
Sixteen (37%) academic and 18 (36%) community hospitalists reported having thoughts of leaving their current hospitalist program due to unhappiness. The mean personal morale score for hospitalists with no intent to leave their current group was 2.97, whereas that of those with intent to leave was 2.45 (diff. = 0.53, P < 0.001). Each 1‐point increase in the personal morale score was associated with an 85% decrease (OR: 0.15, 95% CI: 0.05‐0.41, P < 0.001) in the odds of leaving because of unhappiness. Holding self‐perception of being a career hospitalist constant, each 1‐point increase in the personal morale score was associated with an 83% decrease (OR: 0.17, 95% CI: 0.05‐0.51, P = 0.002) in the odds of leaving because of unhappiness. Hospitalists who reported intent to leave had significantly lower factor scores for all factors and items except workload, material reward, and autonomy than those who did not report intent to leave (Table 3). Within the academic groups, those who reported intent to leave had significantly lower scores for professional growth (diff. = 1.08, P = 0.01). For community groups, those who reported intent to leave had significantly lower scores for clinical work (diff. = 0.54, P = 0.003), workload (diff. = 0.50, P = 0.02), leadership (diff. = 1.19, P < 0.001), feeling appreciated and acknowledged (diff. = 0.68, P = 0.01), job security (diff. = 0.70, P = 0.03), and institutional climate (diff. = 0.67, P = 0.02) than those who did not report intent to leave.
DISCUSSION
The HMI is a validated tool that objectively measures and quantifies hospitalist morale. The HMI's capacity to comprehensively assess morale comes from its breadth and depth in uncovering work‐related areas that may be sources of contentment or displeasure. Furthermore, the fact that HMI scores varied among groups of individuals, including those who are thinking about leaving their hospitalist group because they are unhappy and those who are highly invested in their hospitalist group, speaks to its ability to highlight and account for what is most important to hospitalist providers.
Low employee morale has been associated with decreased productivity, increased absenteeism, increased turnover, and decreased patient satisfaction.[2, 26, 27, 28] A few frustrated workers can breed group discontentment and lower the entire group's morale.[28] In addition to its financial impact, departures due to low morale can be sudden and devastating, leading to loss of team cohesiveness, increased work burden on the remaining workforce, burnout, and cascades of more turnover.[2] In contrast, when morale is high, workers more commonly go the extra mile, are more committed to the organization's mission, and are more supportive of their coworkers.[28]
While we asked the informants about plans to leave their job, there are many factors that drive an individual's intent and ultimate decision to make changes in his or her employment. Some factors are outside the control of the employer or practice leaders, such as change in an individual's family life or desire and opportunity to pursue fellowship training. Others variables, however, are more directly tied to the job or practice environment. In a specialty where providers are relatively mobile and turnover is high, it is important for hospitalist practices to cultivate a climate in which the sacrifices associated with leaving outweigh the promised benefits.[29]
Results from the HMPWS suggested the need to address climate and fairness issues in hospitalist programs to improve satisfaction and retention.[9] Two large healthcare systems achieved success by investing in multipronged physician retention strategies including recruiting advisors, sign‐on bonuses, extensive onboarding, family support, and the promotion of ongoing effective communication.[3, 30]
Our findings suggest that morale for hospitalists is a complex amalgam of contentment and importance, and that there may not be a one size fits all solution to improving morale for all. While we did not find a difference in personal morale scores across individual hospitalist groups, or even between academic and community groups, each group had a unique profile with variability in the dynamics between importance and contentment of different factors. If practice group leaders review HMI data for their providers and use the information to facilitate meaningful dialogue with them about the factors influencing their morale, such leaders will have great insight into allocating resources for the best return on investment.
While we believe that the HMI is providing unique perspective compared to other commonly used metrics, it may be best to employ HMI data as complementary measures alongside that of some of the benchmarked scales that explore job satisfaction, job fit, and burnout among hospitalists.[6, 9, 10, 31, 32, 33, 34, 35] Aggregate HMI data at the group level may allow for the identification of factors that are highly important to morale but scored low in contentment. Such factors deserve priority and attention such that the subgroups within a practice can collaborate to come to consensus on strategies for amelioration. Because the HMI generates a score and profile for each provider, we can imagine effective leaders using the HMI with individuals as part of an annual review to facilitate discussion about maximizing contentment at work. Being fully transparent and sharing an honest nonanonymous version of the HMI with a superior would require a special relationship founded on trust and mutual respect.
Several limitations of this study should be considered. First, the initial item reduction and EFA were based on a single‐site survey, and our overall sample size was relatively small. We plan on expanding our sample size in the future for further validation of our exploratory findings. Second, the data were collected at 2 specific times several years ago. In continuing to analyze the data from subsequent years, validity and reliability results remain stable, thereby minimizing the likelihood of significant historical bias. Third, there may have been some recall bias, in that respondents may have overlooked the good and perseverated over variables that disappointed them. Fourth, although intention to leave does not necessarily equate actual employee turnover, intention has been found to be a strong predictor of quitting a job.[36, 37] Finally, while we had high response rates, response bias may have existed wherein those with lower morale may have elected not to complete the survey or became apathetic in their responses.
The HMI is a validated instrument that evaluates hospitalist morale by incorporating each provider's characterization of the importance of and contentment with 27 variables. By accounting for the multidimensional and dynamic nature of morale, the HMI may help program leaders tailor retention and engagement strategies specific to their own group. Future studies may explore trends in contributors to morale and examine whether interventions to augment low morale can result in improved morale and hospitalist retention.
Acknowledgements
The authors are indebted to the hospitalists who were willing to share their perspectives about their work, and grateful to Ms. Lisa Roberts, Ms. Barbara Brigade, and Ms. Regina Landis for insuring confidentiality in managing the survey database.
Disclosures: Dr. Chandra had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Dr. Wright is a Miller‐Coulson Family Scholar through the Johns Hopkins Center for Innovative Medicine. Ethical approval has been granted for studies involving human subjects by a Johns Hopkins University School of Medicine institutional review board. The authors report no conflicts of interest.
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- SHM Career Satisfaction Task Force. A Challenge for a New Specialty: A White Paper on Hospitalist Career Satisfaction.; 2006. Available at: www.hospitalmedicine.org. Accessed February 28, 2009.
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- , , . A review of physician turnover: rates, causes, and consequences. Am J Med Qual. 2004;19(2):56–66.
- . Physician retention plans help reduce costs and optimize revenues. Healthc Financ Manage. 1998;52(1):75–77.
- SHM Career Satisfaction Task Force. A Challenge for a New Specialty: A White Paper on Hospitalist Career Satisfaction.; 2006. Available at: www.hospitalmedicine.org. Accessed February 28, 2009.
- , . Outcomes of physician job satisfaction: a narrative review, implications, and directions for future research. Health Care Manage Rev. 2003;28(2):119–139.
- , , , , . Characteristics and work experiences of hospitalists in the United States. Arch Intern Med. 2001;161(6):851–858.
- . Doing the same and earning less: male and female physicians in a new medical specialty. Inquiry. 2004;41(3):301–315.
- . Physician satisfaction and communication. National findings and best practices. Available at: http://www.pressganey.com/files/clark_cox_acpe_apr06.pdf. Accessed October 10, 2010.
- , , , , . Worklife and satisfaction of hospitalists: toward flourishing careers. J Gen Intern Med. 2012;27(1):28–36.
- , , , , ; Society of Hospital Medicine Career Satisfaction Task Force. Job characteristics, satisfaction, and burnout across hospitalist practice models. J Hosp Med. 2012;7(5):402–410.
- Morale | Define Morale at Dictionary.com. Morale | Define Morale at Dictionary.com. Morale | Define Morale at Dictionary.com. Available at: http://dictionary.reference.com/browse/morale. Accessed June 5, 2014.
- . Morale and satisfaction: a study in past‐future time perspective. Adm Sci Q. 1958:195–209.
- . Men and Women of the Corporation. 2nd ed. New York, NY: Basic Books; 1993.
- . The relation of morale to turnover among teachers. Am Educ Res J. 1965:163–173.
- . Structural and individual determinants of organization morale and satisfaction. Soc Forces. 1982;61:1088.
- , , . Morale matters: midlevel administrators and their intent to leave. J Higher Educ. 2000:34–59.
- . Factors influencing employee morale. Harv Bus Rev. 1950;28(1):61–73.
- . Dimensions of teacher morale. Am Educ Res J. 1970;7(2):221.
- , . The definition and measurement of employee morale. Adm Sci Q. 1958:157–184.
- , , , et al. Measuring physician job satisfaction in a changing workplace and a challenging environment. SGIM Career Satisfaction Study Group. Society of General Internal Medicine. Med Care. 1999;37(11):1174–1182.
- . Structural and individual determinants of organization morale and satisfaction. Soc Forces. 1983;61(4):1088–1108.
- . Morale and its measurement. Am J Sociol. 1941;47(3):406–414.
- , , , . Following morale over time within an academic hospitalist division. J Clin Outcomes Manag. 2011;18(1):21–26.
- , , , et al. Personal growth and its correlates during residency training. Med Educ. 2006;40(8):737–745.
- , , . A global measure of perceived stress. J Health Soc Behav. 1983:385–396.
- , , . Morale matters: midlevel administrators and their intent to leave. J Higher Educ. 2000;71(1):34–59.
- , . Faculty members' morale and their intention to leave: a multilevel explanation. J Higher Educ. 2002;73(4):518–542.
- , . Employee Morale. New York, NY: Palgrave Macmillan; 2009.
- , , , , . Silence Kills. Silence Kills: The Seven Crucial Conversations® for Healthcare. VitalSmarts™ in association with the American Association of Critical Care Nurses, USA. 2005. Accessed October 10, 2014.
- , , . The lifelong iterative process of physician retention. J Healthc Manag. 2009;54(4):220–226.
- . Physicians' burnout. Rev Prat. 2004;54(7):753–754.
- , , , , , . Work stress and health in primary health care physicians and hospital physicians. Occup Environ Med. 2008;65(5):364–366.
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- , , , , , . Physician satisfaction and burnout at different career stages. Mayo Clin Proc. 2013;88(12):1358–1367.
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- , , , et al. Nurse turnover: a literature review. Int J Nurs Stud. 2006;43(2):237–263.
© 2016 Society of Hospital Medicine
On Track to Professorship? A Bibliometric Analysis of Early Scholarly Output
Professors of orthopedic surgery, by dint of their elevation to the highest academic rank, are men and women of achievement. Some of these surgeons have made their professional contribution primarily as clinicians; some have excelled as teachers. The common attribute of all medical school professors, though, is academic productivity, manifest in the form of scholarly publications.
The question of how much scholarly productivity is enough is of practical concern to junior faculty members contemplating their own chances for being promoted to the rank of professor. Specifically, a junior faculty member may wonder if his or her current performance augurs well for promotion. For these young faculty members (and the mentors advising them), there are not much objective data to offer guidance.
Research within other surgical subspecialties has revealed that the Hirsch index (h-index) is correlated with promotion to full professorship status.1,2 (An author earns an h-index of h if h of his or her papers has at least h citations.3 For example, an author of 10 papers each cited once and an author of 1 paper cited 10 times both have an h-index of 1, whereas an author of 5 papers each cited 5 times has an h-index of 5, as does an author of 10 papers, 5 of which were cited 5 times or more, and 5 of which were cited 4 or fewer times.) To our knowledge, within orthopedic surgery there has been only 1 study of the relationship between early-career academic output and ultimate academic rank—a single-institution study of 130 residents showing that those pursuing academic careers published more articles during residency.4
To help address the relationship between early-career academic output and the attainment of professorship, we performed a bibliometric benchmarking analysis of current orthopedic surgery professors’ productivity at a point likely before they were promoted to that rank. In measuring the early scholarly output of these now senior surgeons, we aim to give younger faculty members a basis of comparison for their own output and thus a sense of where they stand. Although a purely bibliometric analysis must be understood as a crude measure—one that fails to capture any of a professor’s attributes in a domain other than scholarly output—it may nevertheless serve as a basis for meaningful advice.
Therefore, we performed a bibliometric analysis to determine the number of scholarly papers published by current professors of orthopedic surgery within 5 years after their having acquired American Board of Orthopaedic Surgery (ABOS) certification (termed early scholarly output). We tried to determine not only quantity (how many papers were published) but quality (how often papers were cited). Last, by comparing professors across periods, we tried to address the relevant question of whether professor-worthy early output is increasing over time.
Methods
A cohort of orthopedic surgery professors at nominally elite medical schools was constructed as follows. The U.S. News & World Report ranking list was consulted to identify the top 10 US medical schools, and in February 2014 the website of each school was accessed to identify the orthopedic surgery faculty. Names of orthopedic surgery professors were noted. The website for Duke University did not list academic ranks, so data for this school were obtained by personal communication. Whether a professor’s title included the clinical descriptor was documented.
The ABOS website was then consulted to determine which of the faculty members were board-certified. Only certified faculty members were retained.
The Web of Science research platform (wokinfo.com) was used to identify each faculty member’s early scholarly output in the field of orthopedics. After limiting the period under consideration to 5 years after the author was ABOS-certified, we performed an author search using all combinations of first and middle initials. Results were then refined by category orthopedics and document type article. To reinforce the search specificity, we manually reviewed the generated bibliography and retained only correctly identified papers.
A Web of Science citation report was then generated for the author. All bibliometric data were recorded. The quantity of early output was logged as number of papers in 1 of 3 bins: first author, last author, and middle author (any author except first or last). Quality was approximated by total number of times the author was cited across total output. In addition, number of publications in Clinical Orthopaedics and Related Research (CORR) and Journal of Bone and Joint Surgery (JBJS) was recorded.
To further make an inference about the importance of papers published in this early career window, we calculated an h-index for this “5 years post ABOS certification” bibliography. As noted, an author earns an h-index of h if h of his or her papers has at least h citations.
The faculty member was assessed for publication of any “blockbuster” research, defined as a paper that had been cited at least 50 times between publication date and present day.
Last, to assess trends, we compared our output metrics for nonclinical professors ABOS-certified before 1990 versus after 1995. Significance was set at P < .006 using a conservative Bonferroni correction. Scatter plots were generated for total publications, citations, and h-index versus time since ABOS certification. Stata Statistical Software Release 11 (StataCorp) was used to analyze the data.
Results
Of the 108 professors identified, 88 did not have a clinical designation. Within this nonclinical group, median number of total publications and total citations 5 years after ABOS certification were 11.5 (mean, 15.4; SD, 12.3) and 33.5 (mean, 87.5; SD, 130.4), respectively. This group had a median h-index of 3 (mean, 3.9; SD, 3.1). Median number of papers published in CORR and JBJS was 4 (mean, 6.2; SD, 6.2). Median number of papers cited at least 50 times was 2 (mean, 3.2; SD, 4.0). A complete bibliometric summary is detailed in Tables 1 and 2.
Mean certification year was 1989 (range, 1968-2005; SD, 9.1 years). T tests revealed that total publications, first-author publications, last-author publications, middle-author publications, total citations, and h-indexes were higher (Ps < .001-.004) for those certified after 1995 (n = 30) than for those certified before 1990 (n = 39) (Table 3). Scatter plots suggested that early total publications, citations, and h-indexes were increasing over time (Figure).
Discussion
Publication in the medical literature is an indication of academic productivity. However, there are no data establishing early-career productivity milestones. These data would interest young faculty members aspiring to attain professor status. We conducted the present study to describe the early academic productivity of current professors of orthopedic surgery at elite medical schools.
This study had several limitations. First, using bibliometric analysis to measure merit is admittedly crude, as it fails to capture contributions in nonacademic domains. For some faculty members, achievement in nonclinical areas may be substantial, and indeed the reason for their promotion. Second, the method used here tends to emphasize quantity over quality. Although we attempted to compensate for this bias—by reporting total citations, h-indexes, and numbers of CORR, JBJS, and blockbuster publications—we could not remove it completely. Third, choice of schools was arbitrary. Fourth, the sample included only those who attained professor rank; no data are available for orthopedic surgeons who were once assistant or associate professors and were not promoted further. Thus, even if number of publications was the sole criterion for promotion, no statement can be made about the likelihood of promotion given a certain number. Meaningful inferences about a candidate’s chance for promotion (assuming that the standards have not changed) can be made only with complete data, including “failures.”
Despite its limitations, this study provided novel information that can be useful to junior faculty members. Our cohort of orthopedic surgery professors at a select group of schools published 11 papers by year 5 after ABOS certification. A faculty member was the first or last author of 7 of these papers, and 3 papers were published in CORR or JBJS. Each of the 11 papers was cited almost 30 times, and 2 of the 11 eventually received at least 50 citations each. Faculty members had an h-index of about 3 at the 5-year mark. As expected, those who were clinical professors were less academically productive (nevertheless, some had formidable achievements). As schools may have different criteria for various academic titles, it is not possible to generalize across all schools. Of particular importance is the wide range for all data categories, particularly at the low end—buttressing the idea that, at some schools, clinical or teaching work may be sufficient for promotion.
Younger professors demonstrated higher early output than their senior counterparts did, as evidenced by increases in publications of any authorship, citations, and h-indexes. However, number of publications in CORR and JBJS was stagnant, as was number of publications cited more than 50 times. These findings may parallel the proliferation of journals, publications, and citations since the digitization of scientific media. For example, number of orthopedic Medline articles nearly doubled over the period 2000–2010, from 29,471 to 55,074 per year; in addition, number of authors per JBJS article increased from 1.6 in 1949 to 5.1 in 2009.5 This inflationary landscape may impose higher expectations on young faculty members, and, though this report suggests that professor-worthy output is increasing, it makes no effort to predict future milestones.To be sure, the information presented here does not represent a complete assessment of a faculty member’s contribution. In addition, standards for promotion will be different in the future than they were in the past. Nevertheless, our study results provide the best available (though imperfect) benchmarks for professor-worthy early productivity.
1. Tomei KL, Nahass MM, Husain Q, et al. A gender-based comparison of academic rank and scholarly productivity in academic neurological surgery. J Clin Neurosci. 2014;21(7):1102-1105.
2. Svider PF, Choudhry ZA, Choudhry OJ, Baredes S, Liu JK, Eloy JA. The use of the h-index in academic otolaryngology. Laryngoscope. 2013;123(1):103-106.
3. Sharma B, Boet S, Grantcharov T, Shin E, Barrowman NJ, Bould MD. The h-index outperforms other bibliometrics in the assessment of research performance in general surgery: a province-wide study. Surgery. 2013;153(4):493-501.
4. Namdari S, Jani S, Baldwin K, Mehta S. What is the relationship between number of publications during orthopaedic residency and selection of an academic career? J Bone Joint Surg Am. 2013;95(7):e45.
5. Camp M, Escott BG. Authorship proliferation in the orthopaedic literature. J Bone Joint Surg Am. 2013;95(7):e44.
Professors of orthopedic surgery, by dint of their elevation to the highest academic rank, are men and women of achievement. Some of these surgeons have made their professional contribution primarily as clinicians; some have excelled as teachers. The common attribute of all medical school professors, though, is academic productivity, manifest in the form of scholarly publications.
The question of how much scholarly productivity is enough is of practical concern to junior faculty members contemplating their own chances for being promoted to the rank of professor. Specifically, a junior faculty member may wonder if his or her current performance augurs well for promotion. For these young faculty members (and the mentors advising them), there are not much objective data to offer guidance.
Research within other surgical subspecialties has revealed that the Hirsch index (h-index) is correlated with promotion to full professorship status.1,2 (An author earns an h-index of h if h of his or her papers has at least h citations.3 For example, an author of 10 papers each cited once and an author of 1 paper cited 10 times both have an h-index of 1, whereas an author of 5 papers each cited 5 times has an h-index of 5, as does an author of 10 papers, 5 of which were cited 5 times or more, and 5 of which were cited 4 or fewer times.) To our knowledge, within orthopedic surgery there has been only 1 study of the relationship between early-career academic output and ultimate academic rank—a single-institution study of 130 residents showing that those pursuing academic careers published more articles during residency.4
To help address the relationship between early-career academic output and the attainment of professorship, we performed a bibliometric benchmarking analysis of current orthopedic surgery professors’ productivity at a point likely before they were promoted to that rank. In measuring the early scholarly output of these now senior surgeons, we aim to give younger faculty members a basis of comparison for their own output and thus a sense of where they stand. Although a purely bibliometric analysis must be understood as a crude measure—one that fails to capture any of a professor’s attributes in a domain other than scholarly output—it may nevertheless serve as a basis for meaningful advice.
Therefore, we performed a bibliometric analysis to determine the number of scholarly papers published by current professors of orthopedic surgery within 5 years after their having acquired American Board of Orthopaedic Surgery (ABOS) certification (termed early scholarly output). We tried to determine not only quantity (how many papers were published) but quality (how often papers were cited). Last, by comparing professors across periods, we tried to address the relevant question of whether professor-worthy early output is increasing over time.
Methods
A cohort of orthopedic surgery professors at nominally elite medical schools was constructed as follows. The U.S. News & World Report ranking list was consulted to identify the top 10 US medical schools, and in February 2014 the website of each school was accessed to identify the orthopedic surgery faculty. Names of orthopedic surgery professors were noted. The website for Duke University did not list academic ranks, so data for this school were obtained by personal communication. Whether a professor’s title included the clinical descriptor was documented.
The ABOS website was then consulted to determine which of the faculty members were board-certified. Only certified faculty members were retained.
The Web of Science research platform (wokinfo.com) was used to identify each faculty member’s early scholarly output in the field of orthopedics. After limiting the period under consideration to 5 years after the author was ABOS-certified, we performed an author search using all combinations of first and middle initials. Results were then refined by category orthopedics and document type article. To reinforce the search specificity, we manually reviewed the generated bibliography and retained only correctly identified papers.
A Web of Science citation report was then generated for the author. All bibliometric data were recorded. The quantity of early output was logged as number of papers in 1 of 3 bins: first author, last author, and middle author (any author except first or last). Quality was approximated by total number of times the author was cited across total output. In addition, number of publications in Clinical Orthopaedics and Related Research (CORR) and Journal of Bone and Joint Surgery (JBJS) was recorded.
To further make an inference about the importance of papers published in this early career window, we calculated an h-index for this “5 years post ABOS certification” bibliography. As noted, an author earns an h-index of h if h of his or her papers has at least h citations.
The faculty member was assessed for publication of any “blockbuster” research, defined as a paper that had been cited at least 50 times between publication date and present day.
Last, to assess trends, we compared our output metrics for nonclinical professors ABOS-certified before 1990 versus after 1995. Significance was set at P < .006 using a conservative Bonferroni correction. Scatter plots were generated for total publications, citations, and h-index versus time since ABOS certification. Stata Statistical Software Release 11 (StataCorp) was used to analyze the data.
Results
Of the 108 professors identified, 88 did not have a clinical designation. Within this nonclinical group, median number of total publications and total citations 5 years after ABOS certification were 11.5 (mean, 15.4; SD, 12.3) and 33.5 (mean, 87.5; SD, 130.4), respectively. This group had a median h-index of 3 (mean, 3.9; SD, 3.1). Median number of papers published in CORR and JBJS was 4 (mean, 6.2; SD, 6.2). Median number of papers cited at least 50 times was 2 (mean, 3.2; SD, 4.0). A complete bibliometric summary is detailed in Tables 1 and 2.
Mean certification year was 1989 (range, 1968-2005; SD, 9.1 years). T tests revealed that total publications, first-author publications, last-author publications, middle-author publications, total citations, and h-indexes were higher (Ps < .001-.004) for those certified after 1995 (n = 30) than for those certified before 1990 (n = 39) (Table 3). Scatter plots suggested that early total publications, citations, and h-indexes were increasing over time (Figure).
Discussion
Publication in the medical literature is an indication of academic productivity. However, there are no data establishing early-career productivity milestones. These data would interest young faculty members aspiring to attain professor status. We conducted the present study to describe the early academic productivity of current professors of orthopedic surgery at elite medical schools.
This study had several limitations. First, using bibliometric analysis to measure merit is admittedly crude, as it fails to capture contributions in nonacademic domains. For some faculty members, achievement in nonclinical areas may be substantial, and indeed the reason for their promotion. Second, the method used here tends to emphasize quantity over quality. Although we attempted to compensate for this bias—by reporting total citations, h-indexes, and numbers of CORR, JBJS, and blockbuster publications—we could not remove it completely. Third, choice of schools was arbitrary. Fourth, the sample included only those who attained professor rank; no data are available for orthopedic surgeons who were once assistant or associate professors and were not promoted further. Thus, even if number of publications was the sole criterion for promotion, no statement can be made about the likelihood of promotion given a certain number. Meaningful inferences about a candidate’s chance for promotion (assuming that the standards have not changed) can be made only with complete data, including “failures.”
Despite its limitations, this study provided novel information that can be useful to junior faculty members. Our cohort of orthopedic surgery professors at a select group of schools published 11 papers by year 5 after ABOS certification. A faculty member was the first or last author of 7 of these papers, and 3 papers were published in CORR or JBJS. Each of the 11 papers was cited almost 30 times, and 2 of the 11 eventually received at least 50 citations each. Faculty members had an h-index of about 3 at the 5-year mark. As expected, those who were clinical professors were less academically productive (nevertheless, some had formidable achievements). As schools may have different criteria for various academic titles, it is not possible to generalize across all schools. Of particular importance is the wide range for all data categories, particularly at the low end—buttressing the idea that, at some schools, clinical or teaching work may be sufficient for promotion.
Younger professors demonstrated higher early output than their senior counterparts did, as evidenced by increases in publications of any authorship, citations, and h-indexes. However, number of publications in CORR and JBJS was stagnant, as was number of publications cited more than 50 times. These findings may parallel the proliferation of journals, publications, and citations since the digitization of scientific media. For example, number of orthopedic Medline articles nearly doubled over the period 2000–2010, from 29,471 to 55,074 per year; in addition, number of authors per JBJS article increased from 1.6 in 1949 to 5.1 in 2009.5 This inflationary landscape may impose higher expectations on young faculty members, and, though this report suggests that professor-worthy output is increasing, it makes no effort to predict future milestones.To be sure, the information presented here does not represent a complete assessment of a faculty member’s contribution. In addition, standards for promotion will be different in the future than they were in the past. Nevertheless, our study results provide the best available (though imperfect) benchmarks for professor-worthy early productivity.
Professors of orthopedic surgery, by dint of their elevation to the highest academic rank, are men and women of achievement. Some of these surgeons have made their professional contribution primarily as clinicians; some have excelled as teachers. The common attribute of all medical school professors, though, is academic productivity, manifest in the form of scholarly publications.
The question of how much scholarly productivity is enough is of practical concern to junior faculty members contemplating their own chances for being promoted to the rank of professor. Specifically, a junior faculty member may wonder if his or her current performance augurs well for promotion. For these young faculty members (and the mentors advising them), there are not much objective data to offer guidance.
Research within other surgical subspecialties has revealed that the Hirsch index (h-index) is correlated with promotion to full professorship status.1,2 (An author earns an h-index of h if h of his or her papers has at least h citations.3 For example, an author of 10 papers each cited once and an author of 1 paper cited 10 times both have an h-index of 1, whereas an author of 5 papers each cited 5 times has an h-index of 5, as does an author of 10 papers, 5 of which were cited 5 times or more, and 5 of which were cited 4 or fewer times.) To our knowledge, within orthopedic surgery there has been only 1 study of the relationship between early-career academic output and ultimate academic rank—a single-institution study of 130 residents showing that those pursuing academic careers published more articles during residency.4
To help address the relationship between early-career academic output and the attainment of professorship, we performed a bibliometric benchmarking analysis of current orthopedic surgery professors’ productivity at a point likely before they were promoted to that rank. In measuring the early scholarly output of these now senior surgeons, we aim to give younger faculty members a basis of comparison for their own output and thus a sense of where they stand. Although a purely bibliometric analysis must be understood as a crude measure—one that fails to capture any of a professor’s attributes in a domain other than scholarly output—it may nevertheless serve as a basis for meaningful advice.
Therefore, we performed a bibliometric analysis to determine the number of scholarly papers published by current professors of orthopedic surgery within 5 years after their having acquired American Board of Orthopaedic Surgery (ABOS) certification (termed early scholarly output). We tried to determine not only quantity (how many papers were published) but quality (how often papers were cited). Last, by comparing professors across periods, we tried to address the relevant question of whether professor-worthy early output is increasing over time.
Methods
A cohort of orthopedic surgery professors at nominally elite medical schools was constructed as follows. The U.S. News & World Report ranking list was consulted to identify the top 10 US medical schools, and in February 2014 the website of each school was accessed to identify the orthopedic surgery faculty. Names of orthopedic surgery professors were noted. The website for Duke University did not list academic ranks, so data for this school were obtained by personal communication. Whether a professor’s title included the clinical descriptor was documented.
The ABOS website was then consulted to determine which of the faculty members were board-certified. Only certified faculty members were retained.
The Web of Science research platform (wokinfo.com) was used to identify each faculty member’s early scholarly output in the field of orthopedics. After limiting the period under consideration to 5 years after the author was ABOS-certified, we performed an author search using all combinations of first and middle initials. Results were then refined by category orthopedics and document type article. To reinforce the search specificity, we manually reviewed the generated bibliography and retained only correctly identified papers.
A Web of Science citation report was then generated for the author. All bibliometric data were recorded. The quantity of early output was logged as number of papers in 1 of 3 bins: first author, last author, and middle author (any author except first or last). Quality was approximated by total number of times the author was cited across total output. In addition, number of publications in Clinical Orthopaedics and Related Research (CORR) and Journal of Bone and Joint Surgery (JBJS) was recorded.
To further make an inference about the importance of papers published in this early career window, we calculated an h-index for this “5 years post ABOS certification” bibliography. As noted, an author earns an h-index of h if h of his or her papers has at least h citations.
The faculty member was assessed for publication of any “blockbuster” research, defined as a paper that had been cited at least 50 times between publication date and present day.
Last, to assess trends, we compared our output metrics for nonclinical professors ABOS-certified before 1990 versus after 1995. Significance was set at P < .006 using a conservative Bonferroni correction. Scatter plots were generated for total publications, citations, and h-index versus time since ABOS certification. Stata Statistical Software Release 11 (StataCorp) was used to analyze the data.
Results
Of the 108 professors identified, 88 did not have a clinical designation. Within this nonclinical group, median number of total publications and total citations 5 years after ABOS certification were 11.5 (mean, 15.4; SD, 12.3) and 33.5 (mean, 87.5; SD, 130.4), respectively. This group had a median h-index of 3 (mean, 3.9; SD, 3.1). Median number of papers published in CORR and JBJS was 4 (mean, 6.2; SD, 6.2). Median number of papers cited at least 50 times was 2 (mean, 3.2; SD, 4.0). A complete bibliometric summary is detailed in Tables 1 and 2.
Mean certification year was 1989 (range, 1968-2005; SD, 9.1 years). T tests revealed that total publications, first-author publications, last-author publications, middle-author publications, total citations, and h-indexes were higher (Ps < .001-.004) for those certified after 1995 (n = 30) than for those certified before 1990 (n = 39) (Table 3). Scatter plots suggested that early total publications, citations, and h-indexes were increasing over time (Figure).
Discussion
Publication in the medical literature is an indication of academic productivity. However, there are no data establishing early-career productivity milestones. These data would interest young faculty members aspiring to attain professor status. We conducted the present study to describe the early academic productivity of current professors of orthopedic surgery at elite medical schools.
This study had several limitations. First, using bibliometric analysis to measure merit is admittedly crude, as it fails to capture contributions in nonacademic domains. For some faculty members, achievement in nonclinical areas may be substantial, and indeed the reason for their promotion. Second, the method used here tends to emphasize quantity over quality. Although we attempted to compensate for this bias—by reporting total citations, h-indexes, and numbers of CORR, JBJS, and blockbuster publications—we could not remove it completely. Third, choice of schools was arbitrary. Fourth, the sample included only those who attained professor rank; no data are available for orthopedic surgeons who were once assistant or associate professors and were not promoted further. Thus, even if number of publications was the sole criterion for promotion, no statement can be made about the likelihood of promotion given a certain number. Meaningful inferences about a candidate’s chance for promotion (assuming that the standards have not changed) can be made only with complete data, including “failures.”
Despite its limitations, this study provided novel information that can be useful to junior faculty members. Our cohort of orthopedic surgery professors at a select group of schools published 11 papers by year 5 after ABOS certification. A faculty member was the first or last author of 7 of these papers, and 3 papers were published in CORR or JBJS. Each of the 11 papers was cited almost 30 times, and 2 of the 11 eventually received at least 50 citations each. Faculty members had an h-index of about 3 at the 5-year mark. As expected, those who were clinical professors were less academically productive (nevertheless, some had formidable achievements). As schools may have different criteria for various academic titles, it is not possible to generalize across all schools. Of particular importance is the wide range for all data categories, particularly at the low end—buttressing the idea that, at some schools, clinical or teaching work may be sufficient for promotion.
Younger professors demonstrated higher early output than their senior counterparts did, as evidenced by increases in publications of any authorship, citations, and h-indexes. However, number of publications in CORR and JBJS was stagnant, as was number of publications cited more than 50 times. These findings may parallel the proliferation of journals, publications, and citations since the digitization of scientific media. For example, number of orthopedic Medline articles nearly doubled over the period 2000–2010, from 29,471 to 55,074 per year; in addition, number of authors per JBJS article increased from 1.6 in 1949 to 5.1 in 2009.5 This inflationary landscape may impose higher expectations on young faculty members, and, though this report suggests that professor-worthy output is increasing, it makes no effort to predict future milestones.To be sure, the information presented here does not represent a complete assessment of a faculty member’s contribution. In addition, standards for promotion will be different in the future than they were in the past. Nevertheless, our study results provide the best available (though imperfect) benchmarks for professor-worthy early productivity.
1. Tomei KL, Nahass MM, Husain Q, et al. A gender-based comparison of academic rank and scholarly productivity in academic neurological surgery. J Clin Neurosci. 2014;21(7):1102-1105.
2. Svider PF, Choudhry ZA, Choudhry OJ, Baredes S, Liu JK, Eloy JA. The use of the h-index in academic otolaryngology. Laryngoscope. 2013;123(1):103-106.
3. Sharma B, Boet S, Grantcharov T, Shin E, Barrowman NJ, Bould MD. The h-index outperforms other bibliometrics in the assessment of research performance in general surgery: a province-wide study. Surgery. 2013;153(4):493-501.
4. Namdari S, Jani S, Baldwin K, Mehta S. What is the relationship between number of publications during orthopaedic residency and selection of an academic career? J Bone Joint Surg Am. 2013;95(7):e45.
5. Camp M, Escott BG. Authorship proliferation in the orthopaedic literature. J Bone Joint Surg Am. 2013;95(7):e44.
1. Tomei KL, Nahass MM, Husain Q, et al. A gender-based comparison of academic rank and scholarly productivity in academic neurological surgery. J Clin Neurosci. 2014;21(7):1102-1105.
2. Svider PF, Choudhry ZA, Choudhry OJ, Baredes S, Liu JK, Eloy JA. The use of the h-index in academic otolaryngology. Laryngoscope. 2013;123(1):103-106.
3. Sharma B, Boet S, Grantcharov T, Shin E, Barrowman NJ, Bould MD. The h-index outperforms other bibliometrics in the assessment of research performance in general surgery: a province-wide study. Surgery. 2013;153(4):493-501.
4. Namdari S, Jani S, Baldwin K, Mehta S. What is the relationship between number of publications during orthopaedic residency and selection of an academic career? J Bone Joint Surg Am. 2013;95(7):e45.
5. Camp M, Escott BG. Authorship proliferation in the orthopaedic literature. J Bone Joint Surg Am. 2013;95(7):e44.
Effects of Tumor Necrosis Factor α Inhibitors Extend Beyond Psoriasis: Insulin Sensitivity in Psoriasis Patients With Type 2 Diabetes Mellitus
Psoriasis is a chronic inflammatory disorder associated with increased expression of proinflammatory mediators such as tumor necrosis factor (TNF) α.1 Anti-TNF drugs (eg, etanercept, adalimumab, infliximab) were proven to be highly effective for the treatment of psoriasis over the last 2 decades.2 Interestingly, TNF inhibitors have been thought to be effective in improving insulin resistance in patients with type 2 diabetes mellitus (DM) by blocking TNF, which is involved in the inflammatory condition in DM.
Type 2 DM is a common chronic condition characterized by hyperglycemia resulting from a combination of peripheral and hepatic insulin resistance and impaired insulin secretion.3 It is characterized by defects in both insulin secretion and insulin sensitivity.4,5 Type 2 DM has been linked with a marked increase in cardiovascular disease, morbidity, and mortality.6 Evidence-based literature regarding the role of chronic inflammation as an important pathogenetic factor in type 2 DM has been growing.7-9 It also has been suggested that pharmacological strategies to reduce this underlying associated silent inflammation are useful in treating DM, which also is true for other conditions such as obesity, metabolic syndrome, and cardiovascular diseases.10
Psoriasis predisposes patients to insulin resistance and may put them at risk for developing DM.11,12 The association between psoriasis and DM suggests that systemic immunosuppression also may diminish the risk for developing DM. Several longitudinal studies have found that TNF inhibitors improve insulin resistance.13,14 Dandona et al15 reported a considerable decrease of TNF-α levels with the concurrent restoration of insulin sensitivity during weight loss.
Pereira et al16 found a notable connection between psoriasis, DM, and insulin resistance with an odds ratio of 2.63 of abnormal glucose homeostasis in patients with psoriasis compared to controls. Yazdani-Biuki et al17 proved that extended administration of anti–TNF-α antibody was able to improve insulin sensitivity in insulin-resistant patients. The same finding was established by Kiortsis et al.14
In this prospective controlled study, we evaluated the effects of anti-TNF agents on insulin resistance and sensitivity in psoriasis patients with type 2 DM treated with anti-TNF agents.
Methods
A total of 70 patients attending the dermatological outpatient clinics at Farwaniya Hospital (Kuwait City, Kuwait) between January 2012 and September 2014 were enrolled in the study and were randomly distributed into 2 equal groups (n=35 each). The study was approved by the hospital ethics committee. Patients were included in the study if they had moderate to severe psoriasis (ie, psoriasis area severity index score ≥10) with documented type 2 DM and high fasting plasma glucose (FPG) levels (ie, >10 mmol/L). Patients who were currently being treated with oral hypoglycemic agents but not insulin therapy were included in the study. Patients were excluded if they had phototherapy within the last 4 weeks, prior biologic therapy, current and prior insulin therapy, a change in oral hypoglycemic drug dosage in the last 2 months, other serious systemic illness (eg, malignancy, hepatitis B or C virus, metabolic or endocrine disease), and/or abnormal laboratory investigations (eg, liver/kidney profile, chest radiograph abnormality, positive Mantoux test). All of the patients enrolled in the study provided informed consent and underwent routine baseline investigations including complete blood cell counts, general health profile, chest radiograph, antinuclear antibody test, Mantoux test, FPG and insulin levels, glycated hemoglobin (HbA1C), homeostasis model assessment (HOMA), routine urine examination, and enzyme-linked immunosorbent assay for tuberculosis. The study group was treated with anti-TNF agents, and the control group received conventional antipsoriatic medications.
All the patients included in the study had high FPG levels (ie, >10 mmol/L) at the time of enrollment and were currently being treated with oral hypoglycemic agents. The dose of oral hypoglycemic agents was unchanged for at least 2 months before entry into the run-in period and throughout the 24-week study period. Demographic details including sex, age, medical history (eg, type of psoriasis, prior and concomitant treatments) were collected from the participants’ clinical histories. Participants from both groups were appropriately matched in terms of age, sex, body weight, body mass index, and duration of type 2 DM (Table 1). The primary end point of the study was to analyze and compare clinical and serum data collected at baseline and after 24 weeks of therapy.
A complete biochemical profile was repeated in both groups after 24 weeks of treatment. Each participant underwent a baseline short insulin sensitivity test immediately before treatment and at 4 and 24 weeks of treatment. We assessed insulin resistance via HOMA, calculated as follows: FPG [mmol/L] × fasting serum insulin [pmol/L] / 22.5.18 Oral glucose tolerance tests were performed to calculate the HOMA of insulin resistance. Serum insulin concentration was determined via enzyme-linked immunosorbent assay.
Statistical analysis was performed using SPSS software (version 12.0). Continuous patient characteristics were analyzed using mean and SD as well as discrete data as counts and proportions. Association was examined using χ2 tests for categorical variables and 2-sided t test/Wilcoxon rank sum test for continuous variables. Analysis of variance was used to compare the results in 3 different anti-TNF agents used in the study group.
Results
Of the 35 participants enrolled in the study group, 34 (97.1%) completed the study and were evaluated. The study group included 16 men and 18 women aged 19 to 63 years (mean age [SD], 43.7 [21.6] years) who were treated with TNF-α inhibitors—8 participants with etanercept, 14 with adalimumab, and 12 with infliximab—according to the standard dosage schedule for 24 weeks.
Of the 35 participants enrolled in the control group, 29 (82.9%) completed the study and were evaluated. Six patients did not follow up for the complete duration of the 24-week study period and were not evaluated. The control group included 14 men and 15 women aged 18 to 65 years (mean age [SD], 47.7 [14.2] years) who were treated with other systemic therapies—8 participants with topical corticosteroids or calcipotriol only, 7 with cyclosporine A, and 14 with methotrexate. The dose of the drug was kept stable throughout the 24-week study period.
Demographic and baseline characteristics for all participants are shown in Table 1. There were no significant differences in demographic or baseline characteristics among the study group versus the control group, and all participants were similar in age; body mass index; as well as FPG, fasting insulin, and HbA1C levels.
At baseline, both study and control participants had elevated mean (SD) FPG levels (10 [25] mmol/L and 11 [0.4] mmol/L, respectively), fasting insulin levels (2.79 [0.17] pmol/L and 2.82 [0.13] pmol/L, respectively), and HbA1C levels (8.4% [0.38%] and 8.1% [0.21%], respectively)(Table 1).
The study group showed significant improvements in glycemic control at the end of the study (Table 2). At week 24, study group participants had a mean (SD) decrease in FPG levels of 2.74 (0.34) mmol/L versus 0.02 (0.16) mmol/L in the control group. This difference between the 2 groups after 24 weeks was found to be statistically significant (P<.01). On further analysis of the study group, no statistically significant difference (P>.01) was noted in the 3 anti-TNF agents used. Compared to the control group, the study group showed a significant decrease from baseline values of FPG and HbA1C (P<.01). Fasting insulin levels decreased significantly for study group participants as compared with control (–1.91 pmol/L vs 0.04 pmol/L)(P<.001)(Table 2). However, on analysis of the 3 anti-TNF agents, no statistically significant difference was found (P>.05). Participants in the control group showed no significant change in fasting insulin and FPG levels.
To confirm that there was a change in insulin sensitivity in response to TNF-α inhibitors, we analyzed FPG and fasting insulin values using the HOMA method. There was no change in mean relative insulin resistance in the control group in response to therapy (mean [SD], 5.4 [0.31] vs 5.6 [0.15], before vs after therapy), while there was mild improvement in relative insulin resistance in the study group (5.9 [0.52] vs 4.8 [0.34], before vs after therapy). There also was a significant difference in the change in relative insulin resistance in response to treatment between the study and control groups (1.2 [0.40] vs –0.3 [0.12]; P<.01)(Table 2).
Comment
There has been an unprecedented rise in the rate of obesity and associated metabolic diseases such as type 2 DM. Following the current trend, it is estimated that the world will have approximately 592 million cases of type 2 DM by the year 2035.19 Almost two-thirds of these patients are estimated to die of cardiovascular diseases.
Although the pathophysiology of type 2 DM is not known, insulin resistance in the muscles and liver as well as failure of pancreatic β cells represent the core of the complex pathophysiology. The associated underlying silent inflammation was thought to have a key role in both insulin resistance and insulin secretory defects seen in type 2 DM. Furthermore, recent data suggest the central role of TNF-α, IL-1, and IL-6 pathways in this inflammation.10 Tumor necrosis factor α has been shown to have a dual effect on insulin resistance as well as pancreatic β cell function. It blocks the function of insulin at the receptor level and has been implicated as a causative factor in obesity-associated insulin resistance and also in the pathogenesis of type 2 DM.20,21 Furthermore, cytokines that activate nuclear factor κβ (a nuclear transcription factor closely involved in the regulation of cellular inflammatory response), such as TNF-α, are thought to be a common denominator for β-cell apoptosis in types 1 and 2 DM.22 Additionally, it has been suggested that TNF-α is a powerful regulator of adipose tissue.23 Neutralizing TNF-α in obese Zucker rats has shown increased insulin sensitivity.3 Tumor necrosis factor α and IL-6 as well as C-reactive protein and plasminogen activator inhibitor 1 are negatively associated with insulin sensitivity.24-27 These findings have led researchers to investigate the role of anti-TNF agents for the management of type 2 DM.28
Psoriasis has now come to be known as a systemic inflammatory disorder and is associated with increased expression of TNF-α. It predisposes patients to insulin resistance and places them at higher risk for developing DM.11,12 Systematic reports recommend that there is a link between psoriasis and DM featured by helper T cell (TH1) cytokines.29 This link can stimulate insulin resistance and metabolic syndrome as well as inflammatory cytokines identified to motivate psoriasis.29,30 The association between psoriasis and type 2 DM proposes a possible pathophysiologic connection between the 2 diseases. Patients with psoriasis have altered T-cell subtype 1 pathways and dysregulated oxidative and angiogenic mechanisms.31,32 Many of these immune pathways may similarly predispose psoriasis patients to impaired glucose tolerance and DM. Inflammation may cause insulin resistance and DM through numerous mechanisms. Systemic inflammation linked with psoriasis may lead to high levels of circulating IL-1, IL-6, and TNF-α that predispose patients to impaired glucose tolerance and type 2 DM.33
Several longitudinal investigations have found that TNF inhibitors improve insulin resistance.13,14,34-38 Gonzalez-Gay et al13 confirmed a rapid beneficial effect of infliximab on insulin resistance and insulin sensitivity in rheumatoid arthritis (RA) patients, which might support the long-term use of drugs that act by blocking TNF-α to diminish the mechanisms implicated in the development of atherosclerosis in patients with RA. Kiortsis et al14 performed a complete biochemical profile before and after 6 months of treatment with infliximab in 17 patients with ankylosing spondylitis and 28 patients with RA. The researchers found a significant decrease of the HOMA index in the percentile of their patients with the highest insulin resistance (P<.01).14
Stagakis et al34 found that 12 weeks of treatment with anti-TNF agents may improve insulin resistance in patients with active RA and high insulin resistance. Treatment with anti-TNF agents was shown to restore the phosphorylation status of serine phosphorylation of insulin receptor substrate 1 (Ser312-IRS-1) and AKT (protein kinase B), which are important mediators in the insulin signaling cascade. The investigators concluded that treatment with anti-TNF agents may improve insulin resistance and sensitivity in RA patients with active disease and high insulin resistance.34
Solomon et al35 studied the link between disease-modifying antirheumatic drugs and DM risk in patients with RA and psoriasis. The authors proposed that initiation of treatment with TNF inhibitors in psoriasis patients was associated with a reduced incidence of DM. The results showed a lower risk for developing DM in patients with psoriasis who were treated with a TNF inhibitor compared with numerous other drugs.35
Marra et al36 studied the effects of etanercept on insulin sensitivity in 9 patients with psoriasis. They reported a decrease in insulin resistance evaluated by HOMA after 24 weeks of etanercept treatment.36 Wambier et al37 reported severe hypoglycemia after initiation of anti-TNF therapy with etanercept in a patient with generalized pustular psoriasis and type 2 DM.
Yazdani-Biuki et al38 reported the case of a patient who demonstrated a relapse of type 2 DM after an interruption of prolonged treatment with infliximab, an anti–TNF-α antibody for psoriatic arthritis. The improvement in insulin sensitivity of this patient has been reported along with post hoc evidence that chronic administration of infliximab improves insulin resistance in a small sample of patients with inflammatory joint diseases.17
Other studies on the effects of TNF inhibitors on insulin resistance and sensitivity have yielded conflicting results. Martínez-Abundis et al39 studied the effects of etanercept on insulin resistance and sensitivity in a randomized trial of psoriatic patients at risk for developing type 2 DM. Results indicated that anti-TNF therapy had no significant influence on insulin sensitivity measured using a hyperinsulinemic clamp during 2 weeks of etanercept treatment in psoriatic patients with risk factors for type 2 DM. The explanation of this discrepancy may be due to the short duration of the study period.
It is still unknown if psoriasis treatment affects a patient’s risk for developing DM. However, Solomon et al35 evaluated the association of incidental DM among patients with prescribed TNF inhibitors or methotrexate and proposed that initiation of treatment with TNF inhibitors was associated with a diminished incidence of DM.
Our study supports and confirms that psoriasis patients treated with TNF-α inhibitors showed improved glycemic indices and insulin resistance compared with control patients treated with other common systemic drugs for psoriasis. We did not take into consideration other conventional risk factors such as hypertension and coronary artery disease. The number of participants included in the current study was not large enough to evaluate each of the anti-TNF agents in a separate group, and participants were not followed up long enough to see the impact of the biochemical changes noted in the results on long-term morbidity or mortality.
Conclusion
Our study confirms a beneficial effect of TNF-α inhibitors on insulin resistance and insulin sensitivity in psoriasis patients with type 2 DM. Treatment with TNF-α inhibitors may have beneficial effects on insulin sensitivity in even the most insulin-resistant patients with psoriasis. The study results may support the hypothesis that long-term use of TNF inhibitors may reduce the mechanisms involved in the development of DM in patients with psoriasis. The improvement in insulin sensitivity may in turn decrease the coronary artery disease risk in these patients. Additional large, prospective, multicenter studies are required to further analyze the effects of anti–TNF-α antibodies on insulin sensitivity and β cell function in insulin-resistant or diabetic psoriasis patients.
- Lowes MA, Bowcock AM, Krueger JG. Pathogenesis and therapy of psoriasis. Nature. 2007;445:866-873.
- Boehncke WH, Prinz J, Gottlieb AB. Biologic therapies for psoriasis. a systematic review. J Rheumatol. 2006;33:1447-1451.
- DeFronzo RA, Bonadonna RC, Ferrannini E. Pathogenesis of NIDDM. a balanced overview. Diabetes Care. 1992;15:318-368.
- DeFronzo RA. Pathogenesis of type 2 diabetes: metabolic and molecular implications for identifying diabetes genes. Diabetes Rev. 1997;4:177-269.
- Reaven GM. Banting Lecture 1988. role of insulin resistance in human disease. Diabetes. 1988;37:1595-1607.
- Erkelens DW. Insulin resistance syndrome and type 2 diabetes mellitus. Am J Cardiol. 2001;88(7B):38J-42J.
- Hotamisligil GS, Shargill NS, Spiegelman BM. Adipose expression of tumor necrosis factor alpha: direct role in obesity-linked insulin resistance. Science. 1993;259:87-91.
- Hotamisligil GS, Spiegelman BM. Tumor necrosis factor alpha: a key component of the obesity-diabetes link. Diabetes. 1994;43:1271-1278.
- Van der Poll T, Romijn JA, Endert E, et al. Tumor necrosis factor mimics the metabolic response to acute infection in healthy humans. Am J Physiol. 1991;261:457-465.
- Tabas I, Glass CK. Anti-inflammatory therapy in chronic disease: challenges and opportunities. Science. 2013;339:166-172.
- Qureshi AA, Choi HK, Setty AR, et al. Psoriasis and the risk of diabetes and hypertension: a prospective study of US female nurses. Arch Dermatol. 2009;145:379-382.
- Solomon DH, Love TJ, Canning C, et al. Risk of diabetes among patients with rheumatoid arthritis, psoriatic arthritis and psoriasis. Ann Rheum Dis. 2010;69:2114-2117.
- Gonzalez-Gay MA, De Matias JM, Gonzalez-Juanatey C, et al. Anti-tumor necrosis factor-alpha blockade improves insulin resistance in patients with rheumatoid arthritis. Clin Exp Rheumatol. 2006;24:83-86.
- Kiortsis DN, Mavridis AK, Vasakos S, et al. Effects of infliximab treatment on insulin resistance in patients with rheumatoid arthritis and ankylosing spondylitis. Ann Rheum Dis. 2005;64:765-766.
- Dandona P, Weinstock R, Thusu K, et al. Tumor necrosis factor-α in sera of obese patients: fall with weight loss. J Clin Endocrinol Metabol. 1998;83:2907-2910.
- Pereira RR, Amladi ST, Varthakavi PK. A study of the prevalence of diabetes, insulin resistance, lipid abnormalities, and cardiovascular risk factors in patients with chronic plaque psoriasis. Ind J Dermatol. 2011;56:520-526.
- Yazdani-Biuki B, Stelzl H, Brezinschek HP, et al. Improvement of insulin sensitivity in insulin resistant subjects during prolonged treatment with the anti-TNF-α antibody infliximab. Eur J Clin Invest. 2004;34:641-642.
- Bonora E, Kiechl S, Willeit J, et al. Prevalence of insulin resistance in metabolic disorders. The Bruneck Study. Diabetes. 1998;47:1643-1649.
- Ryden L, Grant PJ, Anker SD, et al. ESC Guidelines on diabetes, prediabetes, and cardiovascular diseases developed in collaboration with the EASD: the Task Force on diabetes, prediabetes, and cardiovascular diseases of the European Society of Cardiology (ESC) and developed in collaboration with the European Association for the Study of Diabetes (EASD). Eur Heart J. 2013;34:3035-3087.
- Peraldi P, Spiegelman B. TNF-alpha and insulin resistance: summary and future prospects. Mol Cell Biochem. 1998;182:169-175.
- Moller DE. Potential role of TNF-alpha in the pathogenesis of insulin resistance and type 2 diabetes. Trends Endocrinol Metab. 2000;11:212-217.
- Mandrup-Poulsen T. Apoptotic signal transduction pathways in diabetes. Biochem Pharmacol. 2003;66:1433-1440.
- Coppack SW. Pro-inflammatory cytokines and adipose tissue. Proc Nutr Soc. 2001;60:349-356.
- Pradhan AD, Manson JE, Rifai N, et al. C-reactive protein, interleukin 6, and risk of developing type 2 diabetes mellitus. JAMA. 2001;286:327-334.
- Festa A, D’Agostino R Jr, Tracy RP, et al. Insulin Resistance Atherosclerosis Study. elevated levels of acute-phase proteins and plasminogen activator inhibitor-1 predict the development of type 2 diabetes: the insulin resistance atherosclerosis study. Diabetes. 2002;51:1131-1137.
- Meigs JB, O’Donnell CJ, Tofler GH, et al. Hemostatic markers of endothelial dysfunction and risk of incident type 2 diabetes: the Framingham Offspring Study. Diabetes. 2006;55:530-537.
- Liu S, Tinker L, Song Y, et al. A prospective study of inflammatory cytokines and diabetes mellitus in a multiethnic cohort of postmenopausal women. Arch Intern Med. 2007;167:1676-1685.
- Esser N, Paquot N, Scheen AJ. Anti-inflammatory agents to treat or prevent type 2 diabetes, metabolic syndrome and cardiovascular disease. Exp Opin Invest Drugs. 2014;24:1-25.
- Wellen KE, Hotamisligil GS. Inflammation, stress, and diabetes. J Clin Invest. 2005;115:1111-1119.
- Karadag AS, Yavuz B, Ertugrul DT, et al. Is psoriasis a pre-atherosclerotic disease? increased insulin resistance and impaired endothelial function in patients with psoriasis. Int J Dermatol. 2010;49:642-646.
- Armstrong AW, Voyles SV, Armstrong EJ, et al. A tale of two plaques: convergent mechanisms of T-cell–mediated inflammation in psoriasis and atherosclerosis. Exp Dermatol. 2011;20:544-549.
- Armstrong AW, Voyles SV, Armstrong EJ, et al. Angiogenesis and oxidative stress: common mechanisms linking psoriasis with atherosclerosis. J Dermatol Sci. 2011;63:1-9.
- Boehncke S, Thaci D, Beschmann H, et al. Psoriasis patients show signs of insulin resistance. Br J Dermatol. 2007;157:1249-1251.
- Stagakis I, Bertsias G, Karvounaris S, et al. Anti-tumor necrosis factor therapy improves insulin resistance, beta cell function and insulin signaling in active rheumatoid arthritis patients with high insulin resistance. Arthritis Res Ther. 2012;14:R141.
- Solomon DH, Massarotti E, Garg R, et al. Association between disease-modifying antirheumatic drugs and diabetes risk in patients with rheumatoid arthritis and psoriasis. JAMA. 2011;305:2525-2531.
- Marra M, Campanati A, Testa R, et al. Effect of etanercept on insulin sensitivity in nine patients with psoriasis. Int J Immunopathol Pharmacol. 2007;20:731-736.
- Wambier CG, Foss-Freitas MC, Paschoal RS, et al. Severe hypoglycemia after initiation of anti-tumor necrosis factor therapy with etanercept in a patient with generalized pustular psoriasis and type 2 diabetes mellitus. J Am Acad Dermatol. 2009;60:883-885.
- Yazdani-Biuki B, Mueller T, Brezinschek HP, et al. Relapse of diabetes after interruption of chronic administration of anti-tumor necrosis factor-alpha antibody infliximab: a case observation. Diabetes Care. 2006;29:1712.
- Martínez-Abundis E, Reynoso-von Drateln C, Hernández-Salazar E, et al. Effect of etanercept on insulin secretion and insulin sensitivity in a randomized trial with psoriatic patients at risk for developing type 2 diabetes mellitus. Arch Dermatol Res. 2007;299:461-465.
Psoriasis is a chronic inflammatory disorder associated with increased expression of proinflammatory mediators such as tumor necrosis factor (TNF) α.1 Anti-TNF drugs (eg, etanercept, adalimumab, infliximab) were proven to be highly effective for the treatment of psoriasis over the last 2 decades.2 Interestingly, TNF inhibitors have been thought to be effective in improving insulin resistance in patients with type 2 diabetes mellitus (DM) by blocking TNF, which is involved in the inflammatory condition in DM.
Type 2 DM is a common chronic condition characterized by hyperglycemia resulting from a combination of peripheral and hepatic insulin resistance and impaired insulin secretion.3 It is characterized by defects in both insulin secretion and insulin sensitivity.4,5 Type 2 DM has been linked with a marked increase in cardiovascular disease, morbidity, and mortality.6 Evidence-based literature regarding the role of chronic inflammation as an important pathogenetic factor in type 2 DM has been growing.7-9 It also has been suggested that pharmacological strategies to reduce this underlying associated silent inflammation are useful in treating DM, which also is true for other conditions such as obesity, metabolic syndrome, and cardiovascular diseases.10
Psoriasis predisposes patients to insulin resistance and may put them at risk for developing DM.11,12 The association between psoriasis and DM suggests that systemic immunosuppression also may diminish the risk for developing DM. Several longitudinal studies have found that TNF inhibitors improve insulin resistance.13,14 Dandona et al15 reported a considerable decrease of TNF-α levels with the concurrent restoration of insulin sensitivity during weight loss.
Pereira et al16 found a notable connection between psoriasis, DM, and insulin resistance with an odds ratio of 2.63 of abnormal glucose homeostasis in patients with psoriasis compared to controls. Yazdani-Biuki et al17 proved that extended administration of anti–TNF-α antibody was able to improve insulin sensitivity in insulin-resistant patients. The same finding was established by Kiortsis et al.14
In this prospective controlled study, we evaluated the effects of anti-TNF agents on insulin resistance and sensitivity in psoriasis patients with type 2 DM treated with anti-TNF agents.
Methods
A total of 70 patients attending the dermatological outpatient clinics at Farwaniya Hospital (Kuwait City, Kuwait) between January 2012 and September 2014 were enrolled in the study and were randomly distributed into 2 equal groups (n=35 each). The study was approved by the hospital ethics committee. Patients were included in the study if they had moderate to severe psoriasis (ie, psoriasis area severity index score ≥10) with documented type 2 DM and high fasting plasma glucose (FPG) levels (ie, >10 mmol/L). Patients who were currently being treated with oral hypoglycemic agents but not insulin therapy were included in the study. Patients were excluded if they had phototherapy within the last 4 weeks, prior biologic therapy, current and prior insulin therapy, a change in oral hypoglycemic drug dosage in the last 2 months, other serious systemic illness (eg, malignancy, hepatitis B or C virus, metabolic or endocrine disease), and/or abnormal laboratory investigations (eg, liver/kidney profile, chest radiograph abnormality, positive Mantoux test). All of the patients enrolled in the study provided informed consent and underwent routine baseline investigations including complete blood cell counts, general health profile, chest radiograph, antinuclear antibody test, Mantoux test, FPG and insulin levels, glycated hemoglobin (HbA1C), homeostasis model assessment (HOMA), routine urine examination, and enzyme-linked immunosorbent assay for tuberculosis. The study group was treated with anti-TNF agents, and the control group received conventional antipsoriatic medications.
All the patients included in the study had high FPG levels (ie, >10 mmol/L) at the time of enrollment and were currently being treated with oral hypoglycemic agents. The dose of oral hypoglycemic agents was unchanged for at least 2 months before entry into the run-in period and throughout the 24-week study period. Demographic details including sex, age, medical history (eg, type of psoriasis, prior and concomitant treatments) were collected from the participants’ clinical histories. Participants from both groups were appropriately matched in terms of age, sex, body weight, body mass index, and duration of type 2 DM (Table 1). The primary end point of the study was to analyze and compare clinical and serum data collected at baseline and after 24 weeks of therapy.
A complete biochemical profile was repeated in both groups after 24 weeks of treatment. Each participant underwent a baseline short insulin sensitivity test immediately before treatment and at 4 and 24 weeks of treatment. We assessed insulin resistance via HOMA, calculated as follows: FPG [mmol/L] × fasting serum insulin [pmol/L] / 22.5.18 Oral glucose tolerance tests were performed to calculate the HOMA of insulin resistance. Serum insulin concentration was determined via enzyme-linked immunosorbent assay.
Statistical analysis was performed using SPSS software (version 12.0). Continuous patient characteristics were analyzed using mean and SD as well as discrete data as counts and proportions. Association was examined using χ2 tests for categorical variables and 2-sided t test/Wilcoxon rank sum test for continuous variables. Analysis of variance was used to compare the results in 3 different anti-TNF agents used in the study group.
Results
Of the 35 participants enrolled in the study group, 34 (97.1%) completed the study and were evaluated. The study group included 16 men and 18 women aged 19 to 63 years (mean age [SD], 43.7 [21.6] years) who were treated with TNF-α inhibitors—8 participants with etanercept, 14 with adalimumab, and 12 with infliximab—according to the standard dosage schedule for 24 weeks.
Of the 35 participants enrolled in the control group, 29 (82.9%) completed the study and were evaluated. Six patients did not follow up for the complete duration of the 24-week study period and were not evaluated. The control group included 14 men and 15 women aged 18 to 65 years (mean age [SD], 47.7 [14.2] years) who were treated with other systemic therapies—8 participants with topical corticosteroids or calcipotriol only, 7 with cyclosporine A, and 14 with methotrexate. The dose of the drug was kept stable throughout the 24-week study period.
Demographic and baseline characteristics for all participants are shown in Table 1. There were no significant differences in demographic or baseline characteristics among the study group versus the control group, and all participants were similar in age; body mass index; as well as FPG, fasting insulin, and HbA1C levels.
At baseline, both study and control participants had elevated mean (SD) FPG levels (10 [25] mmol/L and 11 [0.4] mmol/L, respectively), fasting insulin levels (2.79 [0.17] pmol/L and 2.82 [0.13] pmol/L, respectively), and HbA1C levels (8.4% [0.38%] and 8.1% [0.21%], respectively)(Table 1).
The study group showed significant improvements in glycemic control at the end of the study (Table 2). At week 24, study group participants had a mean (SD) decrease in FPG levels of 2.74 (0.34) mmol/L versus 0.02 (0.16) mmol/L in the control group. This difference between the 2 groups after 24 weeks was found to be statistically significant (P<.01). On further analysis of the study group, no statistically significant difference (P>.01) was noted in the 3 anti-TNF agents used. Compared to the control group, the study group showed a significant decrease from baseline values of FPG and HbA1C (P<.01). Fasting insulin levels decreased significantly for study group participants as compared with control (–1.91 pmol/L vs 0.04 pmol/L)(P<.001)(Table 2). However, on analysis of the 3 anti-TNF agents, no statistically significant difference was found (P>.05). Participants in the control group showed no significant change in fasting insulin and FPG levels.
To confirm that there was a change in insulin sensitivity in response to TNF-α inhibitors, we analyzed FPG and fasting insulin values using the HOMA method. There was no change in mean relative insulin resistance in the control group in response to therapy (mean [SD], 5.4 [0.31] vs 5.6 [0.15], before vs after therapy), while there was mild improvement in relative insulin resistance in the study group (5.9 [0.52] vs 4.8 [0.34], before vs after therapy). There also was a significant difference in the change in relative insulin resistance in response to treatment between the study and control groups (1.2 [0.40] vs –0.3 [0.12]; P<.01)(Table 2).
Comment
There has been an unprecedented rise in the rate of obesity and associated metabolic diseases such as type 2 DM. Following the current trend, it is estimated that the world will have approximately 592 million cases of type 2 DM by the year 2035.19 Almost two-thirds of these patients are estimated to die of cardiovascular diseases.
Although the pathophysiology of type 2 DM is not known, insulin resistance in the muscles and liver as well as failure of pancreatic β cells represent the core of the complex pathophysiology. The associated underlying silent inflammation was thought to have a key role in both insulin resistance and insulin secretory defects seen in type 2 DM. Furthermore, recent data suggest the central role of TNF-α, IL-1, and IL-6 pathways in this inflammation.10 Tumor necrosis factor α has been shown to have a dual effect on insulin resistance as well as pancreatic β cell function. It blocks the function of insulin at the receptor level and has been implicated as a causative factor in obesity-associated insulin resistance and also in the pathogenesis of type 2 DM.20,21 Furthermore, cytokines that activate nuclear factor κβ (a nuclear transcription factor closely involved in the regulation of cellular inflammatory response), such as TNF-α, are thought to be a common denominator for β-cell apoptosis in types 1 and 2 DM.22 Additionally, it has been suggested that TNF-α is a powerful regulator of adipose tissue.23 Neutralizing TNF-α in obese Zucker rats has shown increased insulin sensitivity.3 Tumor necrosis factor α and IL-6 as well as C-reactive protein and plasminogen activator inhibitor 1 are negatively associated with insulin sensitivity.24-27 These findings have led researchers to investigate the role of anti-TNF agents for the management of type 2 DM.28
Psoriasis has now come to be known as a systemic inflammatory disorder and is associated with increased expression of TNF-α. It predisposes patients to insulin resistance and places them at higher risk for developing DM.11,12 Systematic reports recommend that there is a link between psoriasis and DM featured by helper T cell (TH1) cytokines.29 This link can stimulate insulin resistance and metabolic syndrome as well as inflammatory cytokines identified to motivate psoriasis.29,30 The association between psoriasis and type 2 DM proposes a possible pathophysiologic connection between the 2 diseases. Patients with psoriasis have altered T-cell subtype 1 pathways and dysregulated oxidative and angiogenic mechanisms.31,32 Many of these immune pathways may similarly predispose psoriasis patients to impaired glucose tolerance and DM. Inflammation may cause insulin resistance and DM through numerous mechanisms. Systemic inflammation linked with psoriasis may lead to high levels of circulating IL-1, IL-6, and TNF-α that predispose patients to impaired glucose tolerance and type 2 DM.33
Several longitudinal investigations have found that TNF inhibitors improve insulin resistance.13,14,34-38 Gonzalez-Gay et al13 confirmed a rapid beneficial effect of infliximab on insulin resistance and insulin sensitivity in rheumatoid arthritis (RA) patients, which might support the long-term use of drugs that act by blocking TNF-α to diminish the mechanisms implicated in the development of atherosclerosis in patients with RA. Kiortsis et al14 performed a complete biochemical profile before and after 6 months of treatment with infliximab in 17 patients with ankylosing spondylitis and 28 patients with RA. The researchers found a significant decrease of the HOMA index in the percentile of their patients with the highest insulin resistance (P<.01).14
Stagakis et al34 found that 12 weeks of treatment with anti-TNF agents may improve insulin resistance in patients with active RA and high insulin resistance. Treatment with anti-TNF agents was shown to restore the phosphorylation status of serine phosphorylation of insulin receptor substrate 1 (Ser312-IRS-1) and AKT (protein kinase B), which are important mediators in the insulin signaling cascade. The investigators concluded that treatment with anti-TNF agents may improve insulin resistance and sensitivity in RA patients with active disease and high insulin resistance.34
Solomon et al35 studied the link between disease-modifying antirheumatic drugs and DM risk in patients with RA and psoriasis. The authors proposed that initiation of treatment with TNF inhibitors in psoriasis patients was associated with a reduced incidence of DM. The results showed a lower risk for developing DM in patients with psoriasis who were treated with a TNF inhibitor compared with numerous other drugs.35
Marra et al36 studied the effects of etanercept on insulin sensitivity in 9 patients with psoriasis. They reported a decrease in insulin resistance evaluated by HOMA after 24 weeks of etanercept treatment.36 Wambier et al37 reported severe hypoglycemia after initiation of anti-TNF therapy with etanercept in a patient with generalized pustular psoriasis and type 2 DM.
Yazdani-Biuki et al38 reported the case of a patient who demonstrated a relapse of type 2 DM after an interruption of prolonged treatment with infliximab, an anti–TNF-α antibody for psoriatic arthritis. The improvement in insulin sensitivity of this patient has been reported along with post hoc evidence that chronic administration of infliximab improves insulin resistance in a small sample of patients with inflammatory joint diseases.17
Other studies on the effects of TNF inhibitors on insulin resistance and sensitivity have yielded conflicting results. Martínez-Abundis et al39 studied the effects of etanercept on insulin resistance and sensitivity in a randomized trial of psoriatic patients at risk for developing type 2 DM. Results indicated that anti-TNF therapy had no significant influence on insulin sensitivity measured using a hyperinsulinemic clamp during 2 weeks of etanercept treatment in psoriatic patients with risk factors for type 2 DM. The explanation of this discrepancy may be due to the short duration of the study period.
It is still unknown if psoriasis treatment affects a patient’s risk for developing DM. However, Solomon et al35 evaluated the association of incidental DM among patients with prescribed TNF inhibitors or methotrexate and proposed that initiation of treatment with TNF inhibitors was associated with a diminished incidence of DM.
Our study supports and confirms that psoriasis patients treated with TNF-α inhibitors showed improved glycemic indices and insulin resistance compared with control patients treated with other common systemic drugs for psoriasis. We did not take into consideration other conventional risk factors such as hypertension and coronary artery disease. The number of participants included in the current study was not large enough to evaluate each of the anti-TNF agents in a separate group, and participants were not followed up long enough to see the impact of the biochemical changes noted in the results on long-term morbidity or mortality.
Conclusion
Our study confirms a beneficial effect of TNF-α inhibitors on insulin resistance and insulin sensitivity in psoriasis patients with type 2 DM. Treatment with TNF-α inhibitors may have beneficial effects on insulin sensitivity in even the most insulin-resistant patients with psoriasis. The study results may support the hypothesis that long-term use of TNF inhibitors may reduce the mechanisms involved in the development of DM in patients with psoriasis. The improvement in insulin sensitivity may in turn decrease the coronary artery disease risk in these patients. Additional large, prospective, multicenter studies are required to further analyze the effects of anti–TNF-α antibodies on insulin sensitivity and β cell function in insulin-resistant or diabetic psoriasis patients.
Psoriasis is a chronic inflammatory disorder associated with increased expression of proinflammatory mediators such as tumor necrosis factor (TNF) α.1 Anti-TNF drugs (eg, etanercept, adalimumab, infliximab) were proven to be highly effective for the treatment of psoriasis over the last 2 decades.2 Interestingly, TNF inhibitors have been thought to be effective in improving insulin resistance in patients with type 2 diabetes mellitus (DM) by blocking TNF, which is involved in the inflammatory condition in DM.
Type 2 DM is a common chronic condition characterized by hyperglycemia resulting from a combination of peripheral and hepatic insulin resistance and impaired insulin secretion.3 It is characterized by defects in both insulin secretion and insulin sensitivity.4,5 Type 2 DM has been linked with a marked increase in cardiovascular disease, morbidity, and mortality.6 Evidence-based literature regarding the role of chronic inflammation as an important pathogenetic factor in type 2 DM has been growing.7-9 It also has been suggested that pharmacological strategies to reduce this underlying associated silent inflammation are useful in treating DM, which also is true for other conditions such as obesity, metabolic syndrome, and cardiovascular diseases.10
Psoriasis predisposes patients to insulin resistance and may put them at risk for developing DM.11,12 The association between psoriasis and DM suggests that systemic immunosuppression also may diminish the risk for developing DM. Several longitudinal studies have found that TNF inhibitors improve insulin resistance.13,14 Dandona et al15 reported a considerable decrease of TNF-α levels with the concurrent restoration of insulin sensitivity during weight loss.
Pereira et al16 found a notable connection between psoriasis, DM, and insulin resistance with an odds ratio of 2.63 of abnormal glucose homeostasis in patients with psoriasis compared to controls. Yazdani-Biuki et al17 proved that extended administration of anti–TNF-α antibody was able to improve insulin sensitivity in insulin-resistant patients. The same finding was established by Kiortsis et al.14
In this prospective controlled study, we evaluated the effects of anti-TNF agents on insulin resistance and sensitivity in psoriasis patients with type 2 DM treated with anti-TNF agents.
Methods
A total of 70 patients attending the dermatological outpatient clinics at Farwaniya Hospital (Kuwait City, Kuwait) between January 2012 and September 2014 were enrolled in the study and were randomly distributed into 2 equal groups (n=35 each). The study was approved by the hospital ethics committee. Patients were included in the study if they had moderate to severe psoriasis (ie, psoriasis area severity index score ≥10) with documented type 2 DM and high fasting plasma glucose (FPG) levels (ie, >10 mmol/L). Patients who were currently being treated with oral hypoglycemic agents but not insulin therapy were included in the study. Patients were excluded if they had phototherapy within the last 4 weeks, prior biologic therapy, current and prior insulin therapy, a change in oral hypoglycemic drug dosage in the last 2 months, other serious systemic illness (eg, malignancy, hepatitis B or C virus, metabolic or endocrine disease), and/or abnormal laboratory investigations (eg, liver/kidney profile, chest radiograph abnormality, positive Mantoux test). All of the patients enrolled in the study provided informed consent and underwent routine baseline investigations including complete blood cell counts, general health profile, chest radiograph, antinuclear antibody test, Mantoux test, FPG and insulin levels, glycated hemoglobin (HbA1C), homeostasis model assessment (HOMA), routine urine examination, and enzyme-linked immunosorbent assay for tuberculosis. The study group was treated with anti-TNF agents, and the control group received conventional antipsoriatic medications.
All the patients included in the study had high FPG levels (ie, >10 mmol/L) at the time of enrollment and were currently being treated with oral hypoglycemic agents. The dose of oral hypoglycemic agents was unchanged for at least 2 months before entry into the run-in period and throughout the 24-week study period. Demographic details including sex, age, medical history (eg, type of psoriasis, prior and concomitant treatments) were collected from the participants’ clinical histories. Participants from both groups were appropriately matched in terms of age, sex, body weight, body mass index, and duration of type 2 DM (Table 1). The primary end point of the study was to analyze and compare clinical and serum data collected at baseline and after 24 weeks of therapy.
A complete biochemical profile was repeated in both groups after 24 weeks of treatment. Each participant underwent a baseline short insulin sensitivity test immediately before treatment and at 4 and 24 weeks of treatment. We assessed insulin resistance via HOMA, calculated as follows: FPG [mmol/L] × fasting serum insulin [pmol/L] / 22.5.18 Oral glucose tolerance tests were performed to calculate the HOMA of insulin resistance. Serum insulin concentration was determined via enzyme-linked immunosorbent assay.
Statistical analysis was performed using SPSS software (version 12.0). Continuous patient characteristics were analyzed using mean and SD as well as discrete data as counts and proportions. Association was examined using χ2 tests for categorical variables and 2-sided t test/Wilcoxon rank sum test for continuous variables. Analysis of variance was used to compare the results in 3 different anti-TNF agents used in the study group.
Results
Of the 35 participants enrolled in the study group, 34 (97.1%) completed the study and were evaluated. The study group included 16 men and 18 women aged 19 to 63 years (mean age [SD], 43.7 [21.6] years) who were treated with TNF-α inhibitors—8 participants with etanercept, 14 with adalimumab, and 12 with infliximab—according to the standard dosage schedule for 24 weeks.
Of the 35 participants enrolled in the control group, 29 (82.9%) completed the study and were evaluated. Six patients did not follow up for the complete duration of the 24-week study period and were not evaluated. The control group included 14 men and 15 women aged 18 to 65 years (mean age [SD], 47.7 [14.2] years) who were treated with other systemic therapies—8 participants with topical corticosteroids or calcipotriol only, 7 with cyclosporine A, and 14 with methotrexate. The dose of the drug was kept stable throughout the 24-week study period.
Demographic and baseline characteristics for all participants are shown in Table 1. There were no significant differences in demographic or baseline characteristics among the study group versus the control group, and all participants were similar in age; body mass index; as well as FPG, fasting insulin, and HbA1C levels.
At baseline, both study and control participants had elevated mean (SD) FPG levels (10 [25] mmol/L and 11 [0.4] mmol/L, respectively), fasting insulin levels (2.79 [0.17] pmol/L and 2.82 [0.13] pmol/L, respectively), and HbA1C levels (8.4% [0.38%] and 8.1% [0.21%], respectively)(Table 1).
The study group showed significant improvements in glycemic control at the end of the study (Table 2). At week 24, study group participants had a mean (SD) decrease in FPG levels of 2.74 (0.34) mmol/L versus 0.02 (0.16) mmol/L in the control group. This difference between the 2 groups after 24 weeks was found to be statistically significant (P<.01). On further analysis of the study group, no statistically significant difference (P>.01) was noted in the 3 anti-TNF agents used. Compared to the control group, the study group showed a significant decrease from baseline values of FPG and HbA1C (P<.01). Fasting insulin levels decreased significantly for study group participants as compared with control (–1.91 pmol/L vs 0.04 pmol/L)(P<.001)(Table 2). However, on analysis of the 3 anti-TNF agents, no statistically significant difference was found (P>.05). Participants in the control group showed no significant change in fasting insulin and FPG levels.
To confirm that there was a change in insulin sensitivity in response to TNF-α inhibitors, we analyzed FPG and fasting insulin values using the HOMA method. There was no change in mean relative insulin resistance in the control group in response to therapy (mean [SD], 5.4 [0.31] vs 5.6 [0.15], before vs after therapy), while there was mild improvement in relative insulin resistance in the study group (5.9 [0.52] vs 4.8 [0.34], before vs after therapy). There also was a significant difference in the change in relative insulin resistance in response to treatment between the study and control groups (1.2 [0.40] vs –0.3 [0.12]; P<.01)(Table 2).
Comment
There has been an unprecedented rise in the rate of obesity and associated metabolic diseases such as type 2 DM. Following the current trend, it is estimated that the world will have approximately 592 million cases of type 2 DM by the year 2035.19 Almost two-thirds of these patients are estimated to die of cardiovascular diseases.
Although the pathophysiology of type 2 DM is not known, insulin resistance in the muscles and liver as well as failure of pancreatic β cells represent the core of the complex pathophysiology. The associated underlying silent inflammation was thought to have a key role in both insulin resistance and insulin secretory defects seen in type 2 DM. Furthermore, recent data suggest the central role of TNF-α, IL-1, and IL-6 pathways in this inflammation.10 Tumor necrosis factor α has been shown to have a dual effect on insulin resistance as well as pancreatic β cell function. It blocks the function of insulin at the receptor level and has been implicated as a causative factor in obesity-associated insulin resistance and also in the pathogenesis of type 2 DM.20,21 Furthermore, cytokines that activate nuclear factor κβ (a nuclear transcription factor closely involved in the regulation of cellular inflammatory response), such as TNF-α, are thought to be a common denominator for β-cell apoptosis in types 1 and 2 DM.22 Additionally, it has been suggested that TNF-α is a powerful regulator of adipose tissue.23 Neutralizing TNF-α in obese Zucker rats has shown increased insulin sensitivity.3 Tumor necrosis factor α and IL-6 as well as C-reactive protein and plasminogen activator inhibitor 1 are negatively associated with insulin sensitivity.24-27 These findings have led researchers to investigate the role of anti-TNF agents for the management of type 2 DM.28
Psoriasis has now come to be known as a systemic inflammatory disorder and is associated with increased expression of TNF-α. It predisposes patients to insulin resistance and places them at higher risk for developing DM.11,12 Systematic reports recommend that there is a link between psoriasis and DM featured by helper T cell (TH1) cytokines.29 This link can stimulate insulin resistance and metabolic syndrome as well as inflammatory cytokines identified to motivate psoriasis.29,30 The association between psoriasis and type 2 DM proposes a possible pathophysiologic connection between the 2 diseases. Patients with psoriasis have altered T-cell subtype 1 pathways and dysregulated oxidative and angiogenic mechanisms.31,32 Many of these immune pathways may similarly predispose psoriasis patients to impaired glucose tolerance and DM. Inflammation may cause insulin resistance and DM through numerous mechanisms. Systemic inflammation linked with psoriasis may lead to high levels of circulating IL-1, IL-6, and TNF-α that predispose patients to impaired glucose tolerance and type 2 DM.33
Several longitudinal investigations have found that TNF inhibitors improve insulin resistance.13,14,34-38 Gonzalez-Gay et al13 confirmed a rapid beneficial effect of infliximab on insulin resistance and insulin sensitivity in rheumatoid arthritis (RA) patients, which might support the long-term use of drugs that act by blocking TNF-α to diminish the mechanisms implicated in the development of atherosclerosis in patients with RA. Kiortsis et al14 performed a complete biochemical profile before and after 6 months of treatment with infliximab in 17 patients with ankylosing spondylitis and 28 patients with RA. The researchers found a significant decrease of the HOMA index in the percentile of their patients with the highest insulin resistance (P<.01).14
Stagakis et al34 found that 12 weeks of treatment with anti-TNF agents may improve insulin resistance in patients with active RA and high insulin resistance. Treatment with anti-TNF agents was shown to restore the phosphorylation status of serine phosphorylation of insulin receptor substrate 1 (Ser312-IRS-1) and AKT (protein kinase B), which are important mediators in the insulin signaling cascade. The investigators concluded that treatment with anti-TNF agents may improve insulin resistance and sensitivity in RA patients with active disease and high insulin resistance.34
Solomon et al35 studied the link between disease-modifying antirheumatic drugs and DM risk in patients with RA and psoriasis. The authors proposed that initiation of treatment with TNF inhibitors in psoriasis patients was associated with a reduced incidence of DM. The results showed a lower risk for developing DM in patients with psoriasis who were treated with a TNF inhibitor compared with numerous other drugs.35
Marra et al36 studied the effects of etanercept on insulin sensitivity in 9 patients with psoriasis. They reported a decrease in insulin resistance evaluated by HOMA after 24 weeks of etanercept treatment.36 Wambier et al37 reported severe hypoglycemia after initiation of anti-TNF therapy with etanercept in a patient with generalized pustular psoriasis and type 2 DM.
Yazdani-Biuki et al38 reported the case of a patient who demonstrated a relapse of type 2 DM after an interruption of prolonged treatment with infliximab, an anti–TNF-α antibody for psoriatic arthritis. The improvement in insulin sensitivity of this patient has been reported along with post hoc evidence that chronic administration of infliximab improves insulin resistance in a small sample of patients with inflammatory joint diseases.17
Other studies on the effects of TNF inhibitors on insulin resistance and sensitivity have yielded conflicting results. Martínez-Abundis et al39 studied the effects of etanercept on insulin resistance and sensitivity in a randomized trial of psoriatic patients at risk for developing type 2 DM. Results indicated that anti-TNF therapy had no significant influence on insulin sensitivity measured using a hyperinsulinemic clamp during 2 weeks of etanercept treatment in psoriatic patients with risk factors for type 2 DM. The explanation of this discrepancy may be due to the short duration of the study period.
It is still unknown if psoriasis treatment affects a patient’s risk for developing DM. However, Solomon et al35 evaluated the association of incidental DM among patients with prescribed TNF inhibitors or methotrexate and proposed that initiation of treatment with TNF inhibitors was associated with a diminished incidence of DM.
Our study supports and confirms that psoriasis patients treated with TNF-α inhibitors showed improved glycemic indices and insulin resistance compared with control patients treated with other common systemic drugs for psoriasis. We did not take into consideration other conventional risk factors such as hypertension and coronary artery disease. The number of participants included in the current study was not large enough to evaluate each of the anti-TNF agents in a separate group, and participants were not followed up long enough to see the impact of the biochemical changes noted in the results on long-term morbidity or mortality.
Conclusion
Our study confirms a beneficial effect of TNF-α inhibitors on insulin resistance and insulin sensitivity in psoriasis patients with type 2 DM. Treatment with TNF-α inhibitors may have beneficial effects on insulin sensitivity in even the most insulin-resistant patients with psoriasis. The study results may support the hypothesis that long-term use of TNF inhibitors may reduce the mechanisms involved in the development of DM in patients with psoriasis. The improvement in insulin sensitivity may in turn decrease the coronary artery disease risk in these patients. Additional large, prospective, multicenter studies are required to further analyze the effects of anti–TNF-α antibodies on insulin sensitivity and β cell function in insulin-resistant or diabetic psoriasis patients.
- Lowes MA, Bowcock AM, Krueger JG. Pathogenesis and therapy of psoriasis. Nature. 2007;445:866-873.
- Boehncke WH, Prinz J, Gottlieb AB. Biologic therapies for psoriasis. a systematic review. J Rheumatol. 2006;33:1447-1451.
- DeFronzo RA, Bonadonna RC, Ferrannini E. Pathogenesis of NIDDM. a balanced overview. Diabetes Care. 1992;15:318-368.
- DeFronzo RA. Pathogenesis of type 2 diabetes: metabolic and molecular implications for identifying diabetes genes. Diabetes Rev. 1997;4:177-269.
- Reaven GM. Banting Lecture 1988. role of insulin resistance in human disease. Diabetes. 1988;37:1595-1607.
- Erkelens DW. Insulin resistance syndrome and type 2 diabetes mellitus. Am J Cardiol. 2001;88(7B):38J-42J.
- Hotamisligil GS, Shargill NS, Spiegelman BM. Adipose expression of tumor necrosis factor alpha: direct role in obesity-linked insulin resistance. Science. 1993;259:87-91.
- Hotamisligil GS, Spiegelman BM. Tumor necrosis factor alpha: a key component of the obesity-diabetes link. Diabetes. 1994;43:1271-1278.
- Van der Poll T, Romijn JA, Endert E, et al. Tumor necrosis factor mimics the metabolic response to acute infection in healthy humans. Am J Physiol. 1991;261:457-465.
- Tabas I, Glass CK. Anti-inflammatory therapy in chronic disease: challenges and opportunities. Science. 2013;339:166-172.
- Qureshi AA, Choi HK, Setty AR, et al. Psoriasis and the risk of diabetes and hypertension: a prospective study of US female nurses. Arch Dermatol. 2009;145:379-382.
- Solomon DH, Love TJ, Canning C, et al. Risk of diabetes among patients with rheumatoid arthritis, psoriatic arthritis and psoriasis. Ann Rheum Dis. 2010;69:2114-2117.
- Gonzalez-Gay MA, De Matias JM, Gonzalez-Juanatey C, et al. Anti-tumor necrosis factor-alpha blockade improves insulin resistance in patients with rheumatoid arthritis. Clin Exp Rheumatol. 2006;24:83-86.
- Kiortsis DN, Mavridis AK, Vasakos S, et al. Effects of infliximab treatment on insulin resistance in patients with rheumatoid arthritis and ankylosing spondylitis. Ann Rheum Dis. 2005;64:765-766.
- Dandona P, Weinstock R, Thusu K, et al. Tumor necrosis factor-α in sera of obese patients: fall with weight loss. J Clin Endocrinol Metabol. 1998;83:2907-2910.
- Pereira RR, Amladi ST, Varthakavi PK. A study of the prevalence of diabetes, insulin resistance, lipid abnormalities, and cardiovascular risk factors in patients with chronic plaque psoriasis. Ind J Dermatol. 2011;56:520-526.
- Yazdani-Biuki B, Stelzl H, Brezinschek HP, et al. Improvement of insulin sensitivity in insulin resistant subjects during prolonged treatment with the anti-TNF-α antibody infliximab. Eur J Clin Invest. 2004;34:641-642.
- Bonora E, Kiechl S, Willeit J, et al. Prevalence of insulin resistance in metabolic disorders. The Bruneck Study. Diabetes. 1998;47:1643-1649.
- Ryden L, Grant PJ, Anker SD, et al. ESC Guidelines on diabetes, prediabetes, and cardiovascular diseases developed in collaboration with the EASD: the Task Force on diabetes, prediabetes, and cardiovascular diseases of the European Society of Cardiology (ESC) and developed in collaboration with the European Association for the Study of Diabetes (EASD). Eur Heart J. 2013;34:3035-3087.
- Peraldi P, Spiegelman B. TNF-alpha and insulin resistance: summary and future prospects. Mol Cell Biochem. 1998;182:169-175.
- Moller DE. Potential role of TNF-alpha in the pathogenesis of insulin resistance and type 2 diabetes. Trends Endocrinol Metab. 2000;11:212-217.
- Mandrup-Poulsen T. Apoptotic signal transduction pathways in diabetes. Biochem Pharmacol. 2003;66:1433-1440.
- Coppack SW. Pro-inflammatory cytokines and adipose tissue. Proc Nutr Soc. 2001;60:349-356.
- Pradhan AD, Manson JE, Rifai N, et al. C-reactive protein, interleukin 6, and risk of developing type 2 diabetes mellitus. JAMA. 2001;286:327-334.
- Festa A, D’Agostino R Jr, Tracy RP, et al. Insulin Resistance Atherosclerosis Study. elevated levels of acute-phase proteins and plasminogen activator inhibitor-1 predict the development of type 2 diabetes: the insulin resistance atherosclerosis study. Diabetes. 2002;51:1131-1137.
- Meigs JB, O’Donnell CJ, Tofler GH, et al. Hemostatic markers of endothelial dysfunction and risk of incident type 2 diabetes: the Framingham Offspring Study. Diabetes. 2006;55:530-537.
- Liu S, Tinker L, Song Y, et al. A prospective study of inflammatory cytokines and diabetes mellitus in a multiethnic cohort of postmenopausal women. Arch Intern Med. 2007;167:1676-1685.
- Esser N, Paquot N, Scheen AJ. Anti-inflammatory agents to treat or prevent type 2 diabetes, metabolic syndrome and cardiovascular disease. Exp Opin Invest Drugs. 2014;24:1-25.
- Wellen KE, Hotamisligil GS. Inflammation, stress, and diabetes. J Clin Invest. 2005;115:1111-1119.
- Karadag AS, Yavuz B, Ertugrul DT, et al. Is psoriasis a pre-atherosclerotic disease? increased insulin resistance and impaired endothelial function in patients with psoriasis. Int J Dermatol. 2010;49:642-646.
- Armstrong AW, Voyles SV, Armstrong EJ, et al. A tale of two plaques: convergent mechanisms of T-cell–mediated inflammation in psoriasis and atherosclerosis. Exp Dermatol. 2011;20:544-549.
- Armstrong AW, Voyles SV, Armstrong EJ, et al. Angiogenesis and oxidative stress: common mechanisms linking psoriasis with atherosclerosis. J Dermatol Sci. 2011;63:1-9.
- Boehncke S, Thaci D, Beschmann H, et al. Psoriasis patients show signs of insulin resistance. Br J Dermatol. 2007;157:1249-1251.
- Stagakis I, Bertsias G, Karvounaris S, et al. Anti-tumor necrosis factor therapy improves insulin resistance, beta cell function and insulin signaling in active rheumatoid arthritis patients with high insulin resistance. Arthritis Res Ther. 2012;14:R141.
- Solomon DH, Massarotti E, Garg R, et al. Association between disease-modifying antirheumatic drugs and diabetes risk in patients with rheumatoid arthritis and psoriasis. JAMA. 2011;305:2525-2531.
- Marra M, Campanati A, Testa R, et al. Effect of etanercept on insulin sensitivity in nine patients with psoriasis. Int J Immunopathol Pharmacol. 2007;20:731-736.
- Wambier CG, Foss-Freitas MC, Paschoal RS, et al. Severe hypoglycemia after initiation of anti-tumor necrosis factor therapy with etanercept in a patient with generalized pustular psoriasis and type 2 diabetes mellitus. J Am Acad Dermatol. 2009;60:883-885.
- Yazdani-Biuki B, Mueller T, Brezinschek HP, et al. Relapse of diabetes after interruption of chronic administration of anti-tumor necrosis factor-alpha antibody infliximab: a case observation. Diabetes Care. 2006;29:1712.
- Martínez-Abundis E, Reynoso-von Drateln C, Hernández-Salazar E, et al. Effect of etanercept on insulin secretion and insulin sensitivity in a randomized trial with psoriatic patients at risk for developing type 2 diabetes mellitus. Arch Dermatol Res. 2007;299:461-465.
- Lowes MA, Bowcock AM, Krueger JG. Pathogenesis and therapy of psoriasis. Nature. 2007;445:866-873.
- Boehncke WH, Prinz J, Gottlieb AB. Biologic therapies for psoriasis. a systematic review. J Rheumatol. 2006;33:1447-1451.
- DeFronzo RA, Bonadonna RC, Ferrannini E. Pathogenesis of NIDDM. a balanced overview. Diabetes Care. 1992;15:318-368.
- DeFronzo RA. Pathogenesis of type 2 diabetes: metabolic and molecular implications for identifying diabetes genes. Diabetes Rev. 1997;4:177-269.
- Reaven GM. Banting Lecture 1988. role of insulin resistance in human disease. Diabetes. 1988;37:1595-1607.
- Erkelens DW. Insulin resistance syndrome and type 2 diabetes mellitus. Am J Cardiol. 2001;88(7B):38J-42J.
- Hotamisligil GS, Shargill NS, Spiegelman BM. Adipose expression of tumor necrosis factor alpha: direct role in obesity-linked insulin resistance. Science. 1993;259:87-91.
- Hotamisligil GS, Spiegelman BM. Tumor necrosis factor alpha: a key component of the obesity-diabetes link. Diabetes. 1994;43:1271-1278.
- Van der Poll T, Romijn JA, Endert E, et al. Tumor necrosis factor mimics the metabolic response to acute infection in healthy humans. Am J Physiol. 1991;261:457-465.
- Tabas I, Glass CK. Anti-inflammatory therapy in chronic disease: challenges and opportunities. Science. 2013;339:166-172.
- Qureshi AA, Choi HK, Setty AR, et al. Psoriasis and the risk of diabetes and hypertension: a prospective study of US female nurses. Arch Dermatol. 2009;145:379-382.
- Solomon DH, Love TJ, Canning C, et al. Risk of diabetes among patients with rheumatoid arthritis, psoriatic arthritis and psoriasis. Ann Rheum Dis. 2010;69:2114-2117.
- Gonzalez-Gay MA, De Matias JM, Gonzalez-Juanatey C, et al. Anti-tumor necrosis factor-alpha blockade improves insulin resistance in patients with rheumatoid arthritis. Clin Exp Rheumatol. 2006;24:83-86.
- Kiortsis DN, Mavridis AK, Vasakos S, et al. Effects of infliximab treatment on insulin resistance in patients with rheumatoid arthritis and ankylosing spondylitis. Ann Rheum Dis. 2005;64:765-766.
- Dandona P, Weinstock R, Thusu K, et al. Tumor necrosis factor-α in sera of obese patients: fall with weight loss. J Clin Endocrinol Metabol. 1998;83:2907-2910.
- Pereira RR, Amladi ST, Varthakavi PK. A study of the prevalence of diabetes, insulin resistance, lipid abnormalities, and cardiovascular risk factors in patients with chronic plaque psoriasis. Ind J Dermatol. 2011;56:520-526.
- Yazdani-Biuki B, Stelzl H, Brezinschek HP, et al. Improvement of insulin sensitivity in insulin resistant subjects during prolonged treatment with the anti-TNF-α antibody infliximab. Eur J Clin Invest. 2004;34:641-642.
- Bonora E, Kiechl S, Willeit J, et al. Prevalence of insulin resistance in metabolic disorders. The Bruneck Study. Diabetes. 1998;47:1643-1649.
- Ryden L, Grant PJ, Anker SD, et al. ESC Guidelines on diabetes, prediabetes, and cardiovascular diseases developed in collaboration with the EASD: the Task Force on diabetes, prediabetes, and cardiovascular diseases of the European Society of Cardiology (ESC) and developed in collaboration with the European Association for the Study of Diabetes (EASD). Eur Heart J. 2013;34:3035-3087.
- Peraldi P, Spiegelman B. TNF-alpha and insulin resistance: summary and future prospects. Mol Cell Biochem. 1998;182:169-175.
- Moller DE. Potential role of TNF-alpha in the pathogenesis of insulin resistance and type 2 diabetes. Trends Endocrinol Metab. 2000;11:212-217.
- Mandrup-Poulsen T. Apoptotic signal transduction pathways in diabetes. Biochem Pharmacol. 2003;66:1433-1440.
- Coppack SW. Pro-inflammatory cytokines and adipose tissue. Proc Nutr Soc. 2001;60:349-356.
- Pradhan AD, Manson JE, Rifai N, et al. C-reactive protein, interleukin 6, and risk of developing type 2 diabetes mellitus. JAMA. 2001;286:327-334.
- Festa A, D’Agostino R Jr, Tracy RP, et al. Insulin Resistance Atherosclerosis Study. elevated levels of acute-phase proteins and plasminogen activator inhibitor-1 predict the development of type 2 diabetes: the insulin resistance atherosclerosis study. Diabetes. 2002;51:1131-1137.
- Meigs JB, O’Donnell CJ, Tofler GH, et al. Hemostatic markers of endothelial dysfunction and risk of incident type 2 diabetes: the Framingham Offspring Study. Diabetes. 2006;55:530-537.
- Liu S, Tinker L, Song Y, et al. A prospective study of inflammatory cytokines and diabetes mellitus in a multiethnic cohort of postmenopausal women. Arch Intern Med. 2007;167:1676-1685.
- Esser N, Paquot N, Scheen AJ. Anti-inflammatory agents to treat or prevent type 2 diabetes, metabolic syndrome and cardiovascular disease. Exp Opin Invest Drugs. 2014;24:1-25.
- Wellen KE, Hotamisligil GS. Inflammation, stress, and diabetes. J Clin Invest. 2005;115:1111-1119.
- Karadag AS, Yavuz B, Ertugrul DT, et al. Is psoriasis a pre-atherosclerotic disease? increased insulin resistance and impaired endothelial function in patients with psoriasis. Int J Dermatol. 2010;49:642-646.
- Armstrong AW, Voyles SV, Armstrong EJ, et al. A tale of two plaques: convergent mechanisms of T-cell–mediated inflammation in psoriasis and atherosclerosis. Exp Dermatol. 2011;20:544-549.
- Armstrong AW, Voyles SV, Armstrong EJ, et al. Angiogenesis and oxidative stress: common mechanisms linking psoriasis with atherosclerosis. J Dermatol Sci. 2011;63:1-9.
- Boehncke S, Thaci D, Beschmann H, et al. Psoriasis patients show signs of insulin resistance. Br J Dermatol. 2007;157:1249-1251.
- Stagakis I, Bertsias G, Karvounaris S, et al. Anti-tumor necrosis factor therapy improves insulin resistance, beta cell function and insulin signaling in active rheumatoid arthritis patients with high insulin resistance. Arthritis Res Ther. 2012;14:R141.
- Solomon DH, Massarotti E, Garg R, et al. Association between disease-modifying antirheumatic drugs and diabetes risk in patients with rheumatoid arthritis and psoriasis. JAMA. 2011;305:2525-2531.
- Marra M, Campanati A, Testa R, et al. Effect of etanercept on insulin sensitivity in nine patients with psoriasis. Int J Immunopathol Pharmacol. 2007;20:731-736.
- Wambier CG, Foss-Freitas MC, Paschoal RS, et al. Severe hypoglycemia after initiation of anti-tumor necrosis factor therapy with etanercept in a patient with generalized pustular psoriasis and type 2 diabetes mellitus. J Am Acad Dermatol. 2009;60:883-885.
- Yazdani-Biuki B, Mueller T, Brezinschek HP, et al. Relapse of diabetes after interruption of chronic administration of anti-tumor necrosis factor-alpha antibody infliximab: a case observation. Diabetes Care. 2006;29:1712.
- Martínez-Abundis E, Reynoso-von Drateln C, Hernández-Salazar E, et al. Effect of etanercept on insulin secretion and insulin sensitivity in a randomized trial with psoriatic patients at risk for developing type 2 diabetes mellitus. Arch Dermatol Res. 2007;299:461-465.
Practice Points
- Psoriasis is associated with an increased incidence of insulin resistance and type 2 diabetes mellitus (DM).
- Anti–tumor necrosis factor drugs, which are effective for the treatment of psoriasis, were found to improve insulin resistance in psoriasis patients with type 2 DM.