Health Policy

Studies have shown that a majority of patients remain confused about their health care plans after being discharged from the hospital.^1,2 Furthermore, most patients do not recognize their lack of comprehension.² A substantial proportion of medical information is forgotten immediately after discharge. Kessels found that when larger amounts of information were presented, less was recalled, and almost half of the recalled information was incorrect.³ Researchers also have found that health information that was focused on individual needs not only increased patients’ understanding of their health needs and improved their health literacy, but supported self-management and promoted health outcomes for adults with chronic illness.^4,5

Health literacy is the “capacity to obtain, process, and understand basic health information and services needed to make appropriate health decisions.”⁶ To read instructions on a prescription bottle, patients need an intermediate level of health literacy. Even for patients with such a level of health literacy, comprehending and managing a health care plan for a chronic disease can be challenging. About 35% of Americans had lower than an intermediate level of health literacy.⁷ Insufficient health literacy is associated with increased health system use and costs, health disparities, and poor health outcomes.⁸ As a result, it is crucial to gear oral instructions to patients’ health literacy levels to ensure that patients understand health information and instructions and perform self-care at home. The teach-back method, a technique for verifying patients’ understanding of their health information, has been recommended by the Agency for Healthcare Research and Quality (AHRQ) and the Institute for Healthcare Improvement (IHI) as a strategy for taking universal precautions for health literacy. Patients are asked to repeat the instructions they receive from their health care professionals (HCPs). HCPs should use caring and plain language in a shame-free environment during patient education. By using the teach-back method, HCPs can assess patients’ understanding, and reteach or modify teaching if comprehension is not demonstrated. Patients have an important role in their health and their ability to understand health information has a significant impact on their health behavior and outcomes.

In our systematic research, we examined the effectiveness of using the teach-back method to understand health education as well as the impact of this method on patients’ disease self-management and health outcomes.

Methods

In the teach-back method, patients explain health information in their own words.⁹ To gauge the use and effectiveness of this method, investigators have studied patient perceptions and acknowledgments of the method as well as the effects of the method on health interventions. According to Dorothea Orem’s self-care deficit nursing theory, disease self-management is an “executive ability” to “control, handle, direct or govern” self-care activities.¹⁰ We define disease self-management as disease knowledge and disease management changes that promote self-care activities. In addition, we define health outcomes as health changes that result from the teach-back method, such as changes in postdischarge readmission rates, patient satisfaction, and health behavior.

Inclusion Criteria

We systematically reviewed evidence regarding the teach-back method as an educational intervention for patients aged ≥ 18 years. We included articles if they reported the process and outcomes of using the method alone or in combination with other educational strategies. The literature search focused on English-language articles published in peer-reviewed journals. Included in the review were qualitative, randomized controlled trials (RCTs); quasi-experimental studies; cohort studies; and pretest–posttest studies on the effects of the teach-back method. As the method can be applied in any health care setting, we used studies conducted in a variety of settings, including primary care, inpatient, outpatient, emergency department (ED), and community, in any time frame. Study participants had heart failure, diabetes mellitus (DM), hypertension, asthma, or other chronic diseases.

Exclusion Criteria

Studies that used the teach-back method as an outcome measurement but not an intervention were excluded. For example, those that used the method to measure patients’ postintervention understanding were excluded. Also excluded were those that used the method to examine HCP training or to measure HCP outcomes (ie, studies that did not use the method for patient education or outcomes).

Literature Search

In September 2017, we searched 4 databases: Ovid Medline, PubMed, EBSCO (Elton B. Stephens Co), CINAHL (Cumulative Index to Nursing and Allied Health Literature), and ProQuest. Also included were relevant studies from cited reference searching (Figure).

This systematic review followed the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guideline for searches and formatting results. The literature search was performed with the term teach-back and terms from the structured PICO (population, intervention, comparison, outcomes) statement. The study population consisted of patients who received the teach-back intervention as part of the patient education process in a medical care setting, and the comparator population consisted of patients who did not receive the intervention in their patient education. Target outcomes were disease self-management, self-care, patient satisfaction, patient perception and acknowledgment of the teach-back method, and other health outcomes.

Data Collection

Data collected included authors, publication date, and journal; purpose; study design; setting, sample, and population; intervention; and outcomes.

The methodologic quality of papers retrieved for review was determined with Critical Appraisals Skills Programme (CASP) guidelines (casp-uk.net/casp-tools-checklists). CASP randomised controlled trial, cohort study, case control study, and qualitative checklists were used. The authors assessed the full texts for eligibility. Disagreements were resolved through discussion.

The initial literature search found 112, 135, and 161 articles from EBSCO CINAHL, Ovid Medline, and PubMed, respectively. Five articles from ProQuest were identified through the EBSCO CINAHL search. After inclusion and exclusion criteria were applied, duplicate articles removed, a cited reference added, and CASP criteria assessed, 26 articles remained in the review. The 26 studies consisted of 15 cohort studies, 5 case–control studies, 5 RCTs, and 1 qualitative interview. Twenty-two of the articles were published in the US, the other 4 in Australia and Iran (2 each).^11-14 All 26 studies used the teach-back method with other educational interventions to reinforce learning (eg, the method was used after heart failure or DM education). Of the 26 studies, 10 used a pretest–posttest intervention design,^15-24 and 10 used a quasi-experimental or experimental design.^{11,13,14,25-31}

Results

The common outcome measures used in the 26 studies fall into 5 categories: patient satisfaction; postdischarge readmission; patient perception of teach-back method effectiveness; disease knowledge and disease management improvements; and intervention effects on health-related quality of life (HR-QOL). A summary of included articles, study setting, design, outcomes, and details is available from the author.

Patient Satisfaction

Ten studies examined the impact of the teach-back method on patient satisfaction.^{15,17,19,21,23,26,27,29,31,32} Of these 10 studies, 6 explored the influence of the method on Hospital Consumer Assessment of Healthcare Providers and Systems survey scores.^{15,17,19,21,22,26} All included studies indicated improved satisfaction with medication education, discharge information, and health management—except for the Silva study, who found an upward trend but not a statistically significant improvement in patient understanding of the purpose of a medication.²³

Grice and colleagues also found that community-dwelling seniors expressed satisfaction with using the teach-back method while being evaluated and assessed for health services at home.³² Improvement or a positive trend in teach-back groups was reported in a majority of the studies except for those by Hyrkas and Wiggins, and Griffey and colleagues.^27,29 Hyrkas and Wiggins found the method slightly improved patients’ medication confidence after hospital discharge, though patient satisfaction scores were associated with patient–nurse relationships, not with use of the teach-back method and a motivational interview.²⁷ Similarly, Griffey and colleagues found that patients who had limited health literacy and received a standard discharge with teach-back scored higher on medication comprehension, compared with patients who received only a standard discharge, but there was no difference in patient satisfaction after an ED visit.²⁹

Postdischarge Readmission

Results emphasized the importance of teach-back in reinforcing discharge instructions and improving postdischarge readmission rates. Of the 6 studies on the effect that teach-back with discharge summary had on readmission rates, 2 found statistically significant improvement for patients with heart failure at 12 months (teach-back, 59%; non-teach-back, 44%; P = .005) and patients with coronary artery bypass grafting (CABG) at 30 days (preintervention, 25%; postintervention, 12%; P = .02).^11,16 In addition, 3 of the 6 studies reported improvement but did not provide P values.^18,20,22 One study indicated improvement in other measured outcomes but found no significant difference for patients who received teach-back with their discharge summaries.²⁷ In all studies, teach-back was added to an intervention and used to confirm and promote knowledge and self-care management.

Patient Perception of Teach-Back Effectiveness

In 2 qualitative studies, patients indicated teach-back was an effective educational method.^16,33 For patients with CABG, Bates and colleagues added a scheduled cardiology follow-up appointment and teach-back patient education to their State Action on Avoidable Rehospitalizations interventions; 96% of participants rated teach-back effective or highly effective.¹⁶ In the other study, Samuels-Kalow and colleagues interviewed 51 patients and parents who received teach-back as part of the discharge process in 2 EDs; participants indicated teach-back helped them remember what they learned from their HCPs, and gave them the opportunity to connect with their HCPs, though some with lower health literacy expressed concerns about perceived judgment by HCPs.³³

Disease Knowledge and Management

Thirteen studies examined knowledge improvement after interventions that included teach-back. Study participants answered most questions correctly after receiving teach-back.^20,32,34,35 Slater and colleagues found ED patients who received discharge instructions with teach-back had significantly higher scores measuring knowledge of diagnosis (P < .001), signs and symptoms indicating a need to return to the ED (P < .001), and follow-up instructions (P = .03); scores measuring knowledge of medication were higher as well, but were not statistically different (P = .14).²⁴ In multiple studies, improvement was not always statistically significant in terms of knowledge retention.^{12,25,29-31,36} Studies that compared medication adherence found teach-back was more effective than motivational interviews (P = .56).²⁷

Teach-back has been widely used in primary care, inpatient, and ED settings. Two studies on the effect of teach-back in primary care sampled patients with DM.^28,36 Kandula and colleagues found that participants who answered questions incorrectly after watching a multimedia DM education program could significantly improve their DM knowledge by engaging in teach-back immediately after the intervention; however, knowledge retention was not improved at 2-week follow-up (phone call).²⁸ In contrast, Swavely and colleagues compared patients who completed a 13-hour DM education program with or without teach-back and found that teach-back patients demonstrated significantly improved DM knowledge and self-care activities at 3 months.³⁶

Effects of Interventions on HR-QOL

The teach-back method had been used with QOL improvement programs and other interventions. Ahmadidarrehsima and colleagues incorporated teach-back into their medical self-management program (8 to 11 sessions, each lasting 1.5 to 2 hours) for women with breast cancer and found that the mean happiness score increased to 62.9 from 37.2 (P < .001) in the intervention group, whereas the score for the usual-care group decreased from 41.4 to 29.8.¹³ Ghiasvand and colleagues compared QOL of postpartum mothers who received routine care with QOL of those who received routine care plus 2 sessions of postpartum self-care with teach-back; mean QOL scores were significantly (P < .001) higher for the teach-back group (124.73) than for the no teach-back group (115.03).¹⁴

Discussion

This review examined the use and effectiveness of the teach-back method in health education and its influence in patients’ disease self-management and health outcomes. Results showed positive effects of teach-back on patient satisfaction, patient perceptions and acknowledgments, postdischarge readmissions, disease self-management and knowledge, and HR-QOL.

The teach-back method has been widely used in inpatient, outpatient, ED, and community settings as part of health education programs and interventions. It has been paired with educational interventions ranging from short instructions to 20-hour programs. These differences reflect the broad application of the method in patient education. Many studies have found that teach-back improves disease knowledge and self-management, though their results are not always statistically significant. In an RCT of patients with low health literacy, Griffey and colleagues studied the effect of ED discharge education with and without teach-back and found teach-back did not increase post-ED comprehension of diagnoses, medical examinations, and treatments or perceived comprehension of treatment and care; however, compared with the no teach-back group, the teach-back group had significantly higher scores on comprehension of post-ED self-care (P < .02), follow-up (P < .0001), and medication (P = .054).²⁹ This finding indicates teach-back is an effective method for helping patients understand self-care and disease self-management at home.

Comprehending medical diagnoses, examinations, and treatments involves acquiring, analyzing, and comparing multiple pieces of health information. Because comprehension requires a level of abstract thinking usually present in patients with intermediate and proficient health literacy,improvements might be more difficult to see in patients with low health literacy.⁸ Press and colleagues found that asthma patients who repeated respiratory inhaler instructions with teach-back during discharge education had less misuse of (P = .01) metered-dose and Diskus (P = .05) inhalers and lower 30-day readmission rates (P = .02) compared with the misuse of patients who received only 1 set of oral and written instructions.³¹ Even though the Diskus result was not statistically significant, it demonstrated teach-back can be used to improve patient self-care and education.³¹

Most participants in the reviewed studies improved their disease knowledge with teach-back, though the evidence regarding improved health care knowledge retention was limited. For example, the 2 studies on use of teach-back in primary care clinics had contradictory knowledge retention results.^28,36 As both studies incorporated teach-back into existing interventions, these results could be associated with those interventions and not with the teach-back method.

Health literacy is achieved through a complicated process of obtaining, analyzing, choosing, and communicating health information. Even though its knowledge retention results are inconsistent, the teach-back method is recommended by the American Academy of Family Physicians at strength of recommendation taxonomy level C.⁸ Such a designation indicates that the recommendation is based on expert opinion, bench research, consensus guideline, usual practice, clinical experience, or a case series and is appropriate for assessment of patient comprehension.³⁷ Teach-back is also suggested by AHRQ and IHI for university precautions regarding health literacy and as such should remain a standard of practice. More study is needed to understand the inconsistent results of knowledge retention and the long-term effects of the teach-back method.

Limitations

Although this review did not limit the publication years of its articles, no pre-2011 articles were found. The teach-back method has been used to measure patients’ postintervention understanding and to educate HCPs on ways to improve patient communication. As this review did not include studies of teach-back as an outcome measurement or studies of training and adaptation of teach-back in HCP or nurse education, other study results may have a bearing on the current findings. Teach-back has been used to close communication gaps between patients and HCPs.

All articles included in this review used the teach-back method with other educational or organizational interventions. The outcomes found in this review may be associated with those interventions and not with teach-back itself. Data reported here have not demonstrated a definite association between teach-back and the measured outcomes; therefore, caution should be exercised when drawing conclusions based on these data. In addition, most of the studies considered in this review were cohort or case–control studies; only 5 RCTs were included. Other confounding factors, including patient health literacy levels, HCP types, HCP competencies in use of teach-back, and type and duration of interventions used before teach-back, may have contributed to this review’s findings.

Conclusion

Findings of this systematic review support use of the teach-back method as effective in reinforcing or confirming patient education. As none of the included studies reported harmful outcomes, the teach-back method poses little risk with respect to increasing patients’ understanding of their education. The findings emphasize the importance of conducting more studies to try to understand the inconsistent results of knowledge retention and determine ways to preserve the long-term effects of teach-back.

Studies have shown that a majority of patients remain confused about their health care plans after being discharged from the hospital.^1,2 Furthermore, most patients do not recognize their lack of comprehension.² A substantial proportion of medical information is forgotten immediately after discharge. Kessels found that when larger amounts of information were presented, less was recalled, and almost half of the recalled information was incorrect.³ Researchers also have found that health information that was focused on individual needs not only increased patients’ understanding of their health needs and improved their health literacy, but supported self-management and promoted health outcomes for adults with chronic illness.^4,5

Health literacy is the “capacity to obtain, process, and understand basic health information and services needed to make appropriate health decisions.”⁶ To read instructions on a prescription bottle, patients need an intermediate level of health literacy. Even for patients with such a level of health literacy, comprehending and managing a health care plan for a chronic disease can be challenging. About 35% of Americans had lower than an intermediate level of health literacy.⁷ Insufficient health literacy is associated with increased health system use and costs, health disparities, and poor health outcomes.⁸ As a result, it is crucial to gear oral instructions to patients’ health literacy levels to ensure that patients understand health information and instructions and perform self-care at home. The teach-back method, a technique for verifying patients’ understanding of their health information, has been recommended by the Agency for Healthcare Research and Quality (AHRQ) and the Institute for Healthcare Improvement (IHI) as a strategy for taking universal precautions for health literacy. Patients are asked to repeat the instructions they receive from their health care professionals (HCPs). HCPs should use caring and plain language in a shame-free environment during patient education. By using the teach-back method, HCPs can assess patients’ understanding, and reteach or modify teaching if comprehension is not demonstrated. Patients have an important role in their health and their ability to understand health information has a significant impact on their health behavior and outcomes.

In our systematic research, we examined the effectiveness of using the teach-back method to understand health education as well as the impact of this method on patients’ disease self-management and health outcomes.

Methods

In the teach-back method, patients explain health information in their own words.⁹ To gauge the use and effectiveness of this method, investigators have studied patient perceptions and acknowledgments of the method as well as the effects of the method on health interventions. According to Dorothea Orem’s self-care deficit nursing theory, disease self-management is an “executive ability” to “control, handle, direct or govern” self-care activities.¹⁰ We define disease self-management as disease knowledge and disease management changes that promote self-care activities. In addition, we define health outcomes as health changes that result from the teach-back method, such as changes in postdischarge readmission rates, patient satisfaction, and health behavior.

Inclusion Criteria

We systematically reviewed evidence regarding the teach-back method as an educational intervention for patients aged ≥ 18 years. We included articles if they reported the process and outcomes of using the method alone or in combination with other educational strategies. The literature search focused on English-language articles published in peer-reviewed journals. Included in the review were qualitative, randomized controlled trials (RCTs); quasi-experimental studies; cohort studies; and pretest–posttest studies on the effects of the teach-back method. As the method can be applied in any health care setting, we used studies conducted in a variety of settings, including primary care, inpatient, outpatient, emergency department (ED), and community, in any time frame. Study participants had heart failure, diabetes mellitus (DM), hypertension, asthma, or other chronic diseases.

Exclusion Criteria

Studies that used the teach-back method as an outcome measurement but not an intervention were excluded. For example, those that used the method to measure patients’ postintervention understanding were excluded. Also excluded were those that used the method to examine HCP training or to measure HCP outcomes (ie, studies that did not use the method for patient education or outcomes).

Literature Search

In September 2017, we searched 4 databases: Ovid Medline, PubMed, EBSCO (Elton B. Stephens Co), CINAHL (Cumulative Index to Nursing and Allied Health Literature), and ProQuest. Also included were relevant studies from cited reference searching (Figure).

This systematic review followed the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guideline for searches and formatting results. The literature search was performed with the term teach-back and terms from the structured PICO (population, intervention, comparison, outcomes) statement. The study population consisted of patients who received the teach-back intervention as part of the patient education process in a medical care setting, and the comparator population consisted of patients who did not receive the intervention in their patient education. Target outcomes were disease self-management, self-care, patient satisfaction, patient perception and acknowledgment of the teach-back method, and other health outcomes.

Data Collection

Data collected included authors, publication date, and journal; purpose; study design; setting, sample, and population; intervention; and outcomes.

The methodologic quality of papers retrieved for review was determined with Critical Appraisals Skills Programme (CASP) guidelines (casp-uk.net/casp-tools-checklists). CASP randomised controlled trial, cohort study, case control study, and qualitative checklists were used. The authors assessed the full texts for eligibility. Disagreements were resolved through discussion.

The initial literature search found 112, 135, and 161 articles from EBSCO CINAHL, Ovid Medline, and PubMed, respectively. Five articles from ProQuest were identified through the EBSCO CINAHL search. After inclusion and exclusion criteria were applied, duplicate articles removed, a cited reference added, and CASP criteria assessed, 26 articles remained in the review. The 26 studies consisted of 15 cohort studies, 5 case–control studies, 5 RCTs, and 1 qualitative interview. Twenty-two of the articles were published in the US, the other 4 in Australia and Iran (2 each).^11-14 All 26 studies used the teach-back method with other educational interventions to reinforce learning (eg, the method was used after heart failure or DM education). Of the 26 studies, 10 used a pretest–posttest intervention design,^15-24 and 10 used a quasi-experimental or experimental design.^{11,13,14,25-31}

Results

The common outcome measures used in the 26 studies fall into 5 categories: patient satisfaction; postdischarge readmission; patient perception of teach-back method effectiveness; disease knowledge and disease management improvements; and intervention effects on health-related quality of life (HR-QOL). A summary of included articles, study setting, design, outcomes, and details is available from the author.

Patient Satisfaction

Ten studies examined the impact of the teach-back method on patient satisfaction.^{15,17,19,21,23,26,27,29,31,32} Of these 10 studies, 6 explored the influence of the method on Hospital Consumer Assessment of Healthcare Providers and Systems survey scores.^{15,17,19,21,22,26} All included studies indicated improved satisfaction with medication education, discharge information, and health management—except for the Silva study, who found an upward trend but not a statistically significant improvement in patient understanding of the purpose of a medication.²³

Grice and colleagues also found that community-dwelling seniors expressed satisfaction with using the teach-back method while being evaluated and assessed for health services at home.³² Improvement or a positive trend in teach-back groups was reported in a majority of the studies except for those by Hyrkas and Wiggins, and Griffey and colleagues.^27,29 Hyrkas and Wiggins found the method slightly improved patients’ medication confidence after hospital discharge, though patient satisfaction scores were associated with patient–nurse relationships, not with use of the teach-back method and a motivational interview.²⁷ Similarly, Griffey and colleagues found that patients who had limited health literacy and received a standard discharge with teach-back scored higher on medication comprehension, compared with patients who received only a standard discharge, but there was no difference in patient satisfaction after an ED visit.²⁹

Postdischarge Readmission

Results emphasized the importance of teach-back in reinforcing discharge instructions and improving postdischarge readmission rates. Of the 6 studies on the effect that teach-back with discharge summary had on readmission rates, 2 found statistically significant improvement for patients with heart failure at 12 months (teach-back, 59%; non-teach-back, 44%; P = .005) and patients with coronary artery bypass grafting (CABG) at 30 days (preintervention, 25%; postintervention, 12%; P = .02).^11,16 In addition, 3 of the 6 studies reported improvement but did not provide P values.^18,20,22 One study indicated improvement in other measured outcomes but found no significant difference for patients who received teach-back with their discharge summaries.²⁷ In all studies, teach-back was added to an intervention and used to confirm and promote knowledge and self-care management.

Patient Perception of Teach-Back Effectiveness

In 2 qualitative studies, patients indicated teach-back was an effective educational method.^16,33 For patients with CABG, Bates and colleagues added a scheduled cardiology follow-up appointment and teach-back patient education to their State Action on Avoidable Rehospitalizations interventions; 96% of participants rated teach-back effective or highly effective.¹⁶ In the other study, Samuels-Kalow and colleagues interviewed 51 patients and parents who received teach-back as part of the discharge process in 2 EDs; participants indicated teach-back helped them remember what they learned from their HCPs, and gave them the opportunity to connect with their HCPs, though some with lower health literacy expressed concerns about perceived judgment by HCPs.³³

Disease Knowledge and Management

Thirteen studies examined knowledge improvement after interventions that included teach-back. Study participants answered most questions correctly after receiving teach-back.^20,32,34,35 Slater and colleagues found ED patients who received discharge instructions with teach-back had significantly higher scores measuring knowledge of diagnosis (P < .001), signs and symptoms indicating a need to return to the ED (P < .001), and follow-up instructions (P = .03); scores measuring knowledge of medication were higher as well, but were not statistically different (P = .14).²⁴ In multiple studies, improvement was not always statistically significant in terms of knowledge retention.^{12,25,29-31,36} Studies that compared medication adherence found teach-back was more effective than motivational interviews (P = .56).²⁷

Teach-back has been widely used in primary care, inpatient, and ED settings. Two studies on the effect of teach-back in primary care sampled patients with DM.^28,36 Kandula and colleagues found that participants who answered questions incorrectly after watching a multimedia DM education program could significantly improve their DM knowledge by engaging in teach-back immediately after the intervention; however, knowledge retention was not improved at 2-week follow-up (phone call).²⁸ In contrast, Swavely and colleagues compared patients who completed a 13-hour DM education program with or without teach-back and found that teach-back patients demonstrated significantly improved DM knowledge and self-care activities at 3 months.³⁶

Effects of Interventions on HR-QOL

The teach-back method had been used with QOL improvement programs and other interventions. Ahmadidarrehsima and colleagues incorporated teach-back into their medical self-management program (8 to 11 sessions, each lasting 1.5 to 2 hours) for women with breast cancer and found that the mean happiness score increased to 62.9 from 37.2 (P < .001) in the intervention group, whereas the score for the usual-care group decreased from 41.4 to 29.8.¹³ Ghiasvand and colleagues compared QOL of postpartum mothers who received routine care with QOL of those who received routine care plus 2 sessions of postpartum self-care with teach-back; mean QOL scores were significantly (P < .001) higher for the teach-back group (124.73) than for the no teach-back group (115.03).¹⁴

Discussion

This review examined the use and effectiveness of the teach-back method in health education and its influence in patients’ disease self-management and health outcomes. Results showed positive effects of teach-back on patient satisfaction, patient perceptions and acknowledgments, postdischarge readmissions, disease self-management and knowledge, and HR-QOL.

The teach-back method has been widely used in inpatient, outpatient, ED, and community settings as part of health education programs and interventions. It has been paired with educational interventions ranging from short instructions to 20-hour programs. These differences reflect the broad application of the method in patient education. Many studies have found that teach-back improves disease knowledge and self-management, though their results are not always statistically significant. In an RCT of patients with low health literacy, Griffey and colleagues studied the effect of ED discharge education with and without teach-back and found teach-back did not increase post-ED comprehension of diagnoses, medical examinations, and treatments or perceived comprehension of treatment and care; however, compared with the no teach-back group, the teach-back group had significantly higher scores on comprehension of post-ED self-care (P < .02), follow-up (P < .0001), and medication (P = .054).²⁹ This finding indicates teach-back is an effective method for helping patients understand self-care and disease self-management at home.

Comprehending medical diagnoses, examinations, and treatments involves acquiring, analyzing, and comparing multiple pieces of health information. Because comprehension requires a level of abstract thinking usually present in patients with intermediate and proficient health literacy,improvements might be more difficult to see in patients with low health literacy.⁸ Press and colleagues found that asthma patients who repeated respiratory inhaler instructions with teach-back during discharge education had less misuse of (P = .01) metered-dose and Diskus (P = .05) inhalers and lower 30-day readmission rates (P = .02) compared with the misuse of patients who received only 1 set of oral and written instructions.³¹ Even though the Diskus result was not statistically significant, it demonstrated teach-back can be used to improve patient self-care and education.³¹

Most participants in the reviewed studies improved their disease knowledge with teach-back, though the evidence regarding improved health care knowledge retention was limited. For example, the 2 studies on use of teach-back in primary care clinics had contradictory knowledge retention results.^28,36 As both studies incorporated teach-back into existing interventions, these results could be associated with those interventions and not with the teach-back method.

Health literacy is achieved through a complicated process of obtaining, analyzing, choosing, and communicating health information. Even though its knowledge retention results are inconsistent, the teach-back method is recommended by the American Academy of Family Physicians at strength of recommendation taxonomy level C.⁸ Such a designation indicates that the recommendation is based on expert opinion, bench research, consensus guideline, usual practice, clinical experience, or a case series and is appropriate for assessment of patient comprehension.³⁷ Teach-back is also suggested by AHRQ and IHI for university precautions regarding health literacy and as such should remain a standard of practice. More study is needed to understand the inconsistent results of knowledge retention and the long-term effects of the teach-back method.

Limitations

Although this review did not limit the publication years of its articles, no pre-2011 articles were found. The teach-back method has been used to measure patients’ postintervention understanding and to educate HCPs on ways to improve patient communication. As this review did not include studies of teach-back as an outcome measurement or studies of training and adaptation of teach-back in HCP or nurse education, other study results may have a bearing on the current findings. Teach-back has been used to close communication gaps between patients and HCPs.

All articles included in this review used the teach-back method with other educational or organizational interventions. The outcomes found in this review may be associated with those interventions and not with teach-back itself. Data reported here have not demonstrated a definite association between teach-back and the measured outcomes; therefore, caution should be exercised when drawing conclusions based on these data. In addition, most of the studies considered in this review were cohort or case–control studies; only 5 RCTs were included. Other confounding factors, including patient health literacy levels, HCP types, HCP competencies in use of teach-back, and type and duration of interventions used before teach-back, may have contributed to this review’s findings.

Conclusion

Findings of this systematic review support use of the teach-back method as effective in reinforcing or confirming patient education. As none of the included studies reported harmful outcomes, the teach-back method poses little risk with respect to increasing patients’ understanding of their education. The findings emphasize the importance of conducting more studies to try to understand the inconsistent results of knowledge retention and determine ways to preserve the long-term effects of teach-back.

Studies have shown that a majority of patients remain confused about their health care plans after being discharged from the hospital.^1,2 Furthermore, most patients do not recognize their lack of comprehension.² A substantial proportion of medical information is forgotten immediately after discharge. Kessels found that when larger amounts of information were presented, less was recalled, and almost half of the recalled information was incorrect.³ Researchers also have found that health information that was focused on individual needs not only increased patients’ understanding of their health needs and improved their health literacy, but supported self-management and promoted health outcomes for adults with chronic illness.^4,5

Health literacy is the “capacity to obtain, process, and understand basic health information and services needed to make appropriate health decisions.”⁶ To read instructions on a prescription bottle, patients need an intermediate level of health literacy. Even for patients with such a level of health literacy, comprehending and managing a health care plan for a chronic disease can be challenging. About 35% of Americans had lower than an intermediate level of health literacy.⁷ Insufficient health literacy is associated with increased health system use and costs, health disparities, and poor health outcomes.⁸ As a result, it is crucial to gear oral instructions to patients’ health literacy levels to ensure that patients understand health information and instructions and perform self-care at home. The teach-back method, a technique for verifying patients’ understanding of their health information, has been recommended by the Agency for Healthcare Research and Quality (AHRQ) and the Institute for Healthcare Improvement (IHI) as a strategy for taking universal precautions for health literacy. Patients are asked to repeat the instructions they receive from their health care professionals (HCPs). HCPs should use caring and plain language in a shame-free environment during patient education. By using the teach-back method, HCPs can assess patients’ understanding, and reteach or modify teaching if comprehension is not demonstrated. Patients have an important role in their health and their ability to understand health information has a significant impact on their health behavior and outcomes.

In our systematic research, we examined the effectiveness of using the teach-back method to understand health education as well as the impact of this method on patients’ disease self-management and health outcomes.

Methods

In the teach-back method, patients explain health information in their own words.⁹ To gauge the use and effectiveness of this method, investigators have studied patient perceptions and acknowledgments of the method as well as the effects of the method on health interventions. According to Dorothea Orem’s self-care deficit nursing theory, disease self-management is an “executive ability” to “control, handle, direct or govern” self-care activities.¹⁰ We define disease self-management as disease knowledge and disease management changes that promote self-care activities. In addition, we define health outcomes as health changes that result from the teach-back method, such as changes in postdischarge readmission rates, patient satisfaction, and health behavior.

Inclusion Criteria

We systematically reviewed evidence regarding the teach-back method as an educational intervention for patients aged ≥ 18 years. We included articles if they reported the process and outcomes of using the method alone or in combination with other educational strategies. The literature search focused on English-language articles published in peer-reviewed journals. Included in the review were qualitative, randomized controlled trials (RCTs); quasi-experimental studies; cohort studies; and pretest–posttest studies on the effects of the teach-back method. As the method can be applied in any health care setting, we used studies conducted in a variety of settings, including primary care, inpatient, outpatient, emergency department (ED), and community, in any time frame. Study participants had heart failure, diabetes mellitus (DM), hypertension, asthma, or other chronic diseases.

Exclusion Criteria

Studies that used the teach-back method as an outcome measurement but not an intervention were excluded. For example, those that used the method to measure patients’ postintervention understanding were excluded. Also excluded were those that used the method to examine HCP training or to measure HCP outcomes (ie, studies that did not use the method for patient education or outcomes).

Literature Search

In September 2017, we searched 4 databases: Ovid Medline, PubMed, EBSCO (Elton B. Stephens Co), CINAHL (Cumulative Index to Nursing and Allied Health Literature), and ProQuest. Also included were relevant studies from cited reference searching (Figure).

This systematic review followed the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guideline for searches and formatting results. The literature search was performed with the term teach-back and terms from the structured PICO (population, intervention, comparison, outcomes) statement. The study population consisted of patients who received the teach-back intervention as part of the patient education process in a medical care setting, and the comparator population consisted of patients who did not receive the intervention in their patient education. Target outcomes were disease self-management, self-care, patient satisfaction, patient perception and acknowledgment of the teach-back method, and other health outcomes.

Data Collection

Data collected included authors, publication date, and journal; purpose; study design; setting, sample, and population; intervention; and outcomes.

The methodologic quality of papers retrieved for review was determined with Critical Appraisals Skills Programme (CASP) guidelines (casp-uk.net/casp-tools-checklists). CASP randomised controlled trial, cohort study, case control study, and qualitative checklists were used. The authors assessed the full texts for eligibility. Disagreements were resolved through discussion.

The initial literature search found 112, 135, and 161 articles from EBSCO CINAHL, Ovid Medline, and PubMed, respectively. Five articles from ProQuest were identified through the EBSCO CINAHL search. After inclusion and exclusion criteria were applied, duplicate articles removed, a cited reference added, and CASP criteria assessed, 26 articles remained in the review. The 26 studies consisted of 15 cohort studies, 5 case–control studies, 5 RCTs, and 1 qualitative interview. Twenty-two of the articles were published in the US, the other 4 in Australia and Iran (2 each).^11-14 All 26 studies used the teach-back method with other educational interventions to reinforce learning (eg, the method was used after heart failure or DM education). Of the 26 studies, 10 used a pretest–posttest intervention design,^15-24 and 10 used a quasi-experimental or experimental design.^{11,13,14,25-31}

Results

The common outcome measures used in the 26 studies fall into 5 categories: patient satisfaction; postdischarge readmission; patient perception of teach-back method effectiveness; disease knowledge and disease management improvements; and intervention effects on health-related quality of life (HR-QOL). A summary of included articles, study setting, design, outcomes, and details is available from the author.

Patient Satisfaction

Ten studies examined the impact of the teach-back method on patient satisfaction.^{15,17,19,21,23,26,27,29,31,32} Of these 10 studies, 6 explored the influence of the method on Hospital Consumer Assessment of Healthcare Providers and Systems survey scores.^{15,17,19,21,22,26} All included studies indicated improved satisfaction with medication education, discharge information, and health management—except for the Silva study, who found an upward trend but not a statistically significant improvement in patient understanding of the purpose of a medication.²³

Grice and colleagues also found that community-dwelling seniors expressed satisfaction with using the teach-back method while being evaluated and assessed for health services at home.³² Improvement or a positive trend in teach-back groups was reported in a majority of the studies except for those by Hyrkas and Wiggins, and Griffey and colleagues.^27,29 Hyrkas and Wiggins found the method slightly improved patients’ medication confidence after hospital discharge, though patient satisfaction scores were associated with patient–nurse relationships, not with use of the teach-back method and a motivational interview.²⁷ Similarly, Griffey and colleagues found that patients who had limited health literacy and received a standard discharge with teach-back scored higher on medication comprehension, compared with patients who received only a standard discharge, but there was no difference in patient satisfaction after an ED visit.²⁹

Postdischarge Readmission

Results emphasized the importance of teach-back in reinforcing discharge instructions and improving postdischarge readmission rates. Of the 6 studies on the effect that teach-back with discharge summary had on readmission rates, 2 found statistically significant improvement for patients with heart failure at 12 months (teach-back, 59%; non-teach-back, 44%; P = .005) and patients with coronary artery bypass grafting (CABG) at 30 days (preintervention, 25%; postintervention, 12%; P = .02).^11,16 In addition, 3 of the 6 studies reported improvement but did not provide P values.^18,20,22 One study indicated improvement in other measured outcomes but found no significant difference for patients who received teach-back with their discharge summaries.²⁷ In all studies, teach-back was added to an intervention and used to confirm and promote knowledge and self-care management.

Patient Perception of Teach-Back Effectiveness

In 2 qualitative studies, patients indicated teach-back was an effective educational method.^16,33 For patients with CABG, Bates and colleagues added a scheduled cardiology follow-up appointment and teach-back patient education to their State Action on Avoidable Rehospitalizations interventions; 96% of participants rated teach-back effective or highly effective.¹⁶ In the other study, Samuels-Kalow and colleagues interviewed 51 patients and parents who received teach-back as part of the discharge process in 2 EDs; participants indicated teach-back helped them remember what they learned from their HCPs, and gave them the opportunity to connect with their HCPs, though some with lower health literacy expressed concerns about perceived judgment by HCPs.³³

Disease Knowledge and Management

Thirteen studies examined knowledge improvement after interventions that included teach-back. Study participants answered most questions correctly after receiving teach-back.^20,32,34,35 Slater and colleagues found ED patients who received discharge instructions with teach-back had significantly higher scores measuring knowledge of diagnosis (P < .001), signs and symptoms indicating a need to return to the ED (P < .001), and follow-up instructions (P = .03); scores measuring knowledge of medication were higher as well, but were not statistically different (P = .14).²⁴ In multiple studies, improvement was not always statistically significant in terms of knowledge retention.^{12,25,29-31,36} Studies that compared medication adherence found teach-back was more effective than motivational interviews (P = .56).²⁷

Teach-back has been widely used in primary care, inpatient, and ED settings. Two studies on the effect of teach-back in primary care sampled patients with DM.^28,36 Kandula and colleagues found that participants who answered questions incorrectly after watching a multimedia DM education program could significantly improve their DM knowledge by engaging in teach-back immediately after the intervention; however, knowledge retention was not improved at 2-week follow-up (phone call).²⁸ In contrast, Swavely and colleagues compared patients who completed a 13-hour DM education program with or without teach-back and found that teach-back patients demonstrated significantly improved DM knowledge and self-care activities at 3 months.³⁶

Effects of Interventions on HR-QOL

The teach-back method had been used with QOL improvement programs and other interventions. Ahmadidarrehsima and colleagues incorporated teach-back into their medical self-management program (8 to 11 sessions, each lasting 1.5 to 2 hours) for women with breast cancer and found that the mean happiness score increased to 62.9 from 37.2 (P < .001) in the intervention group, whereas the score for the usual-care group decreased from 41.4 to 29.8.¹³ Ghiasvand and colleagues compared QOL of postpartum mothers who received routine care with QOL of those who received routine care plus 2 sessions of postpartum self-care with teach-back; mean QOL scores were significantly (P < .001) higher for the teach-back group (124.73) than for the no teach-back group (115.03).¹⁴

Discussion

This review examined the use and effectiveness of the teach-back method in health education and its influence in patients’ disease self-management and health outcomes. Results showed positive effects of teach-back on patient satisfaction, patient perceptions and acknowledgments, postdischarge readmissions, disease self-management and knowledge, and HR-QOL.

The teach-back method has been widely used in inpatient, outpatient, ED, and community settings as part of health education programs and interventions. It has been paired with educational interventions ranging from short instructions to 20-hour programs. These differences reflect the broad application of the method in patient education. Many studies have found that teach-back improves disease knowledge and self-management, though their results are not always statistically significant. In an RCT of patients with low health literacy, Griffey and colleagues studied the effect of ED discharge education with and without teach-back and found teach-back did not increase post-ED comprehension of diagnoses, medical examinations, and treatments or perceived comprehension of treatment and care; however, compared with the no teach-back group, the teach-back group had significantly higher scores on comprehension of post-ED self-care (P < .02), follow-up (P < .0001), and medication (P = .054).²⁹ This finding indicates teach-back is an effective method for helping patients understand self-care and disease self-management at home.

Comprehending medical diagnoses, examinations, and treatments involves acquiring, analyzing, and comparing multiple pieces of health information. Because comprehension requires a level of abstract thinking usually present in patients with intermediate and proficient health literacy,improvements might be more difficult to see in patients with low health literacy.⁸ Press and colleagues found that asthma patients who repeated respiratory inhaler instructions with teach-back during discharge education had less misuse of (P = .01) metered-dose and Diskus (P = .05) inhalers and lower 30-day readmission rates (P = .02) compared with the misuse of patients who received only 1 set of oral and written instructions.³¹ Even though the Diskus result was not statistically significant, it demonstrated teach-back can be used to improve patient self-care and education.³¹

Most participants in the reviewed studies improved their disease knowledge with teach-back, though the evidence regarding improved health care knowledge retention was limited. For example, the 2 studies on use of teach-back in primary care clinics had contradictory knowledge retention results.^28,36 As both studies incorporated teach-back into existing interventions, these results could be associated with those interventions and not with the teach-back method.

Health literacy is achieved through a complicated process of obtaining, analyzing, choosing, and communicating health information. Even though its knowledge retention results are inconsistent, the teach-back method is recommended by the American Academy of Family Physicians at strength of recommendation taxonomy level C.⁸ Such a designation indicates that the recommendation is based on expert opinion, bench research, consensus guideline, usual practice, clinical experience, or a case series and is appropriate for assessment of patient comprehension.³⁷ Teach-back is also suggested by AHRQ and IHI for university precautions regarding health literacy and as such should remain a standard of practice. More study is needed to understand the inconsistent results of knowledge retention and the long-term effects of the teach-back method.

Limitations

Although this review did not limit the publication years of its articles, no pre-2011 articles were found. The teach-back method has been used to measure patients’ postintervention understanding and to educate HCPs on ways to improve patient communication. As this review did not include studies of teach-back as an outcome measurement or studies of training and adaptation of teach-back in HCP or nurse education, other study results may have a bearing on the current findings. Teach-back has been used to close communication gaps between patients and HCPs.

All articles included in this review used the teach-back method with other educational or organizational interventions. The outcomes found in this review may be associated with those interventions and not with teach-back itself. Data reported here have not demonstrated a definite association between teach-back and the measured outcomes; therefore, caution should be exercised when drawing conclusions based on these data. In addition, most of the studies considered in this review were cohort or case–control studies; only 5 RCTs were included. Other confounding factors, including patient health literacy levels, HCP types, HCP competencies in use of teach-back, and type and duration of interventions used before teach-back, may have contributed to this review’s findings.

Conclusion

Findings of this systematic review support use of the teach-back method as effective in reinforcing or confirming patient education. As none of the included studies reported harmful outcomes, the teach-back method poses little risk with respect to increasing patients’ understanding of their education. The findings emphasize the importance of conducting more studies to try to understand the inconsistent results of knowledge retention and determine ways to preserve the long-term effects of teach-back.

Clostridium difficile (C difficile) is a gram-positive, toxin-producing bacterium that is of increasing concern among health care providers and patients. Infection with C difficile can have manifestations ranging from mild diarrhea to severe toxic megacolon and can result in prolonged hospitalization with severe cases requiring admission to an intensive care unit.¹ In 2014, the US was estimated to have more than 600,000 cases of C difficile infection (CDI), previously known as C difficile–associated diarrhea, and more than 44,000 associated deaths. The annual economic cost of CDI is thought to exceed $5 billion.¹ According to studies of health care–associated illness, CDI rates are comparable to or have surpassed rates of methicillin-resistant Staphylococcus aureus infection within the US, including at US Department of Veterans Affairs (VA) acute care centers nationwide.^2,3

C difficile has been shown to be the causative agent in 10% to 20% of antibiotic-associated diarrhea episodes.⁴ Colonization of C difficile is uncommon in healthy adults, but colonization rates are as high as 21% in hospitalized patients, with increasing rates proportional to increasing hospital length of stay.^5,6 Although not all colonized patients develop clinically significant CDI, those who do may require multiple treatment courses, over months to years, because of the high risk of disease recurrence. An estimated 25% of patients have a single recurrent episode of CDI within 30 days after treatment completion, and 45% of those patients have additional recurrent infections.^7,8 Although probiotics do not have an approved US Food and Drug Administration (FDA) indication, these supplements are often used to try to prevent CDI from developing during concomitant antibiotic use. Probiotics are microorganisms with potential health benefits, but the mechanisms of these benefits are not fully understood. Proposed mechanisms include reduced growth of pathogenic bacteria, modulation of the immune system, and support of the intestinal wall barrier.⁹ The many probiotic formulations currently marketed include Lactobacillus acidophilus (L acidophilus) capsules and various combinations of L acidophilus, Lactobacillus casei, Bifidobacterium lactis, Bifidobacterium longum, Streptococcus thermophilus, and other bacterial strains.

Dosing and Guidelines

Manufacturers’ suggested dosing for their Lactobacillus capsules, tablets, and packets varies from 1 unit daily to 4 units 4 times daily for dietary supplementation; the products’ labeling does not include any information regarding treatment duration.^10-13 In addition, there are no published recommendations or product labeling guiding the dosing of probiotics or their duration of use in the primary prevention of CDI.

In 2017, the Infectious Diseases Society of America (IDSA) and the Society for Healthcare Epidemiology of America (SHEA) updated their CDI treatment guidelines.¹⁴ As these guidelines indicate that the data on probiotic use in CDI are inadequate, IDSA and SHEA make no recommendation for or against probiotic use in primary prevention of the disease. The guidelines point to several limitations in the literature, including variability in probiotic formulations studied, duration of probiotic administration, definitions of CDI, and duration of study follow-up.

Given the lack of consensus guidelines that clinicians can use when deciding which probiotic dosing and duration are appropriate for a patient for primary prevention of CDI, we evaluated the literature on the topic and summarize their findings here.

Review of Probiotoc Literature

Conflicting data exist about probiotics and their effect on CDI prevention. The literature reviewed was selected based on our assessment of its contribution to the topic and its potential utility to clinicians in determining appropriate probiotic therapies and recommendations. Included in our discussion is a large Cochrane Review of probiotic efficacy, 2 trials of probiotic dosing, the PLACIDE trial, and a systematic review of timely probiotic initiation. All of these studies attempted to determine the effect of probiotics on CDI incidence (Table).

In their 2017 Cochrane Review, Goldenberg and colleagues reviewed 39 trials that investigated the efficacy of probiotics in CDI prevention in 9,955 immunocompetent patients receiving antibiotics.¹⁵ The incidence of CDI was significantly lower in patients who received a probiotic than in patients who received placebo or no treatment (1.5% vs 4.0%; relative risk [RR], 0.40; 95% CI, 0.30-0.52; I² = 0%). It is important to note that trials with a control-group CDI incidence of 0% to 2% (baseline CDI risk) found no statistically significant difference in CDI risk between patients using and not using probiotics (RR, 0.77; 95% CI, 0.45-1.32; I² = 0%) and that the preceding statistically significant result may have been driven by the inclusion of trials with high baseline CDI risk (> 5%). Trials that enrolled patients who were at this risk level found a statistically significant 70% reduction in CDI risk in those using probiotics (vs no probiotics) while on concomitant antibiotic therapy (RR, 0.30; 95% CI, 0.21-0.42; I² = 0%).

Probiotic therapy seems to be effective in reducing CDI risk in immunocompetent patients and may be particularly beneficial in patients at higher CDI risk, though Goldenberg and colleagues did not elaborate on what constitutes higher risk and based their conclusion on their control group’s high CDI incidence (> 5%). The most common adverse events (AEs) attributable to probiotics included abdominal cramping, nausea, fever, soft stools, flatulence, and taste disturbance. The review’s findings are limited in that the inclusion of many small trials with high baseline CDI risk likely contributed to a statistically significant result, and 17 of the review’s 39 trials were industry-sponsored or were conducted by investigators with industry associations; another 12 lacked statements about funding or sponsorship.

Two of the trials in the Cochrane Review investigated whether probiotics have a dose effect on CDI prevention. Gao and colleagues randomly assigned 255 hospitalized Asian patients to 3 groups: those receiving placebo, 1 probiotic capsule daily, and 2 probiotic capsules daily.¹⁶ Each probiotic capsule contained 50 billion colony-forming units (CFUs) of Lactobacillus. Incidence of CDI was lower in patients taking 2 probiotic capsules daily than in those taking 1 probiotic capsule daily (1.2% vs 9.4%; P = .04) or placebo (1.2% vs 23.8%; P = .002). In the other trial, Ouwehand and colleagues randomly assigned 503 hospitalized Asian patients to 3 groups as well: those receiving placebo, low-dose probiotic (4.17 billion CFUs of Lactobacillus and Bifidobacterium), and high-dose probiotic (17 billion CFUs).¹⁷ The incidence of CDI in each probiotic group (low-dose, high-dose) was 1.8%, which was significantly lower than the 4.8% in the placebo group (P = .04).

The Cochrane Review’s largest and most rigorous trial was PLACIDE, a 2013 randomized controlled study of the effect of probiotics on CDI.¹⁸ Allen and colleagues randomly assigned 2,981 inpatients (aged ≥ 65 years; exposed to antibiotics within preceding 7 days) to 2 groups: those receiving either 1 probiotic capsule daily, or 1 placebo capsule daily, for 21 days. Results showed no difference in CDI incidence between the probiotic and placebo groups (0.8% vs 1.2%; RR, 0.71; 95% CI, 0.34-1.47; P = .35). Of note, this trial is free of industry sponsorship, is the largest probiotic trial to date, has a control-group baseline CDI rate consistent with the rate in hospital and ambulatory settings in the US, and found a negative result regarding probiotic use in CDI prevention. Findings are limited in that the study allowed for initiating probiotic therapy up to 7 days after the start of antibiotics, and patients were given 1 relatively low-dose capsule daily, which may have contributed to lack of an effect on CDI prevention. No serious AEs were attributed to probiotic use.

In a 2017 systematic meta-analysis of 19 studies, Shen and colleagues investigated whether timely use of probiotics prevented CDI in 6,261 hospitalized patients receiving antibiotics.¹⁹ The incidence of CDI was significantly lower in patients receiving vs not receiving probiotics (1.6% vs 3.9%; RR, 0.42; 95% CI, 0.30-0.57; I² = 0%; P < .001).¹⁹ A subgroup analysis was performed to compare studies initiating probiotics within 2 days after the start of antibiotics with studies initiating probiotics more than 2 days after the start. CDI risk was reduced by 68% when probiotics were started within 2 days, vs 30% when started after 2 days (RR, 0.32; 95% CI, 0.22-0.48; I² = 0% vs RR, 0.70; 95% CI, 0.40-1.23; I² = 0%; P = .02). Of note, no difference was found in efficacy among the various probiotic formulations, and no significant AEs were noted in any study group.

Trials included in the Cochrane Review used many different probiotic regimens over various durations.¹⁵ All these trials continued probiotics for at least the duration of antibiotic therapy. The 2 trials that evaluated the effect of probiotic therapy over an extended period required probiotics be started within 48 hours after initiation of antibiotic therapy; one trial continued probiotics for 5 days after completion of antibiotics, and the other for 7 days after completion.^16,20 In both trials, CDI was statistically significantly reduced among adults using probiotics compared with adults receiving placebo.

Probiotic Safety

The FDA has not approved probiotics for the prevention or treatment of any health problems. Most probiotics are FDA-regulated as dietary supplements and do not have to meet stringent drug-approval requirements. The FDA has given many strains of common probiotics the Generally Recognized as Safe designation for use in commercially available products and foods.^21-23 Probiotic use has not been associated with significant AEs in clinical trials and generally has been considered safe in immunocompetent and otherwise healthy persons.^15-19 However, clinical trials have been inadequate in reporting or investigating AEs; the alternative for evaluating the risks of probiotic therapy is case reports.^24,25 Theoretical risks associated with probiotics include sepsis, deleterious effects on normal gut digestion, excessive immune stimulation, and possible transfer of antimicrobial resistance genes among microorganisms.²⁶ Boyle and colleagues further described a handful of case reports of sepsis caused by probiotics in immunocompromised individuals; the other theoretical risks have not been reported outside animal studies.²⁶

CDI Risk Factors

Many factors can increase a patient’s CDI risk. Specific antibiotics (eg, ampicillin, amoxicillin, cephalosporins, clindamycin, fluoroquinolones) confer higher risk.^27,28 Other factors include inflammatory bowel disease, organ transplantation, chemotherapy, chronic kidney disease, and immunodeficiency. Advanced age increases CDI risk and can increase the severity of infection. The evidence regarding acid suppression and CDI risk is conflicting, though a recent meta-analysis found that use of proton pump inhibitors is associated with a 2-fold higher risk of developing CDI.²⁹ Patient-specific risk factors should be evaluated when the risk–benefit ratio for probiotic use is being considered.

Conclusion

CDIs are becoming increasingly burdensome to the health care system. More research is needed on the role of probiotics in CDI prevention in patients taking antibiotics. Given the limited risk for AEs when probiotics are used in immunocompetent patients and the relatively low cost of these supplements, the risks likely are outweighed by the postulated benefits, and probiotics may be recommended in select patient populations.

The PLACIDE trial found no benefit of probiotics in preventing CDI in a population similar to that of a typical US hospital or ambulatory setting, but its intervention allowed late initiation of relatively low doses of probiotics. Therefore, probiotics may be recommended for CDI prevention in patients taking antibiotics, especially patients at high risk for developing CDI. When clinicians recommend probiotic use in this setting, the probiotic should be initiated within 2 days after the start of antibiotics and should be continued for the duration of antibiotic therapy and for up to 7 days after that therapy is completed. Optimal probiotic dosing, likely dependent on the product used, remains unclear. PLACIDE trial results suggest that a dosage of at least 1 probiotic capsule 2 times daily may confer additional efficacy.

Clostridium difficile (C difficile) is a gram-positive, toxin-producing bacterium that is of increasing concern among health care providers and patients. Infection with C difficile can have manifestations ranging from mild diarrhea to severe toxic megacolon and can result in prolonged hospitalization with severe cases requiring admission to an intensive care unit.¹ In 2014, the US was estimated to have more than 600,000 cases of C difficile infection (CDI), previously known as C difficile–associated diarrhea, and more than 44,000 associated deaths. The annual economic cost of CDI is thought to exceed $5 billion.¹ According to studies of health care–associated illness, CDI rates are comparable to or have surpassed rates of methicillin-resistant Staphylococcus aureus infection within the US, including at US Department of Veterans Affairs (VA) acute care centers nationwide.^2,3

C difficile has been shown to be the causative agent in 10% to 20% of antibiotic-associated diarrhea episodes.⁴ Colonization of C difficile is uncommon in healthy adults, but colonization rates are as high as 21% in hospitalized patients, with increasing rates proportional to increasing hospital length of stay.^5,6 Although not all colonized patients develop clinically significant CDI, those who do may require multiple treatment courses, over months to years, because of the high risk of disease recurrence. An estimated 25% of patients have a single recurrent episode of CDI within 30 days after treatment completion, and 45% of those patients have additional recurrent infections.^7,8 Although probiotics do not have an approved US Food and Drug Administration (FDA) indication, these supplements are often used to try to prevent CDI from developing during concomitant antibiotic use. Probiotics are microorganisms with potential health benefits, but the mechanisms of these benefits are not fully understood. Proposed mechanisms include reduced growth of pathogenic bacteria, modulation of the immune system, and support of the intestinal wall barrier.⁹ The many probiotic formulations currently marketed include Lactobacillus acidophilus (L acidophilus) capsules and various combinations of L acidophilus, Lactobacillus casei, Bifidobacterium lactis, Bifidobacterium longum, Streptococcus thermophilus, and other bacterial strains.

Dosing and Guidelines

Manufacturers’ suggested dosing for their Lactobacillus capsules, tablets, and packets varies from 1 unit daily to 4 units 4 times daily for dietary supplementation; the products’ labeling does not include any information regarding treatment duration.^10-13 In addition, there are no published recommendations or product labeling guiding the dosing of probiotics or their duration of use in the primary prevention of CDI.

In 2017, the Infectious Diseases Society of America (IDSA) and the Society for Healthcare Epidemiology of America (SHEA) updated their CDI treatment guidelines.¹⁴ As these guidelines indicate that the data on probiotic use in CDI are inadequate, IDSA and SHEA make no recommendation for or against probiotic use in primary prevention of the disease. The guidelines point to several limitations in the literature, including variability in probiotic formulations studied, duration of probiotic administration, definitions of CDI, and duration of study follow-up.

Given the lack of consensus guidelines that clinicians can use when deciding which probiotic dosing and duration are appropriate for a patient for primary prevention of CDI, we evaluated the literature on the topic and summarize their findings here.

Review of Probiotoc Literature

Conflicting data exist about probiotics and their effect on CDI prevention. The literature reviewed was selected based on our assessment of its contribution to the topic and its potential utility to clinicians in determining appropriate probiotic therapies and recommendations. Included in our discussion is a large Cochrane Review of probiotic efficacy, 2 trials of probiotic dosing, the PLACIDE trial, and a systematic review of timely probiotic initiation. All of these studies attempted to determine the effect of probiotics on CDI incidence (Table).

In their 2017 Cochrane Review, Goldenberg and colleagues reviewed 39 trials that investigated the efficacy of probiotics in CDI prevention in 9,955 immunocompetent patients receiving antibiotics.¹⁵ The incidence of CDI was significantly lower in patients who received a probiotic than in patients who received placebo or no treatment (1.5% vs 4.0%; relative risk [RR], 0.40; 95% CI, 0.30-0.52; I² = 0%). It is important to note that trials with a control-group CDI incidence of 0% to 2% (baseline CDI risk) found no statistically significant difference in CDI risk between patients using and not using probiotics (RR, 0.77; 95% CI, 0.45-1.32; I² = 0%) and that the preceding statistically significant result may have been driven by the inclusion of trials with high baseline CDI risk (> 5%). Trials that enrolled patients who were at this risk level found a statistically significant 70% reduction in CDI risk in those using probiotics (vs no probiotics) while on concomitant antibiotic therapy (RR, 0.30; 95% CI, 0.21-0.42; I² = 0%).

Probiotic therapy seems to be effective in reducing CDI risk in immunocompetent patients and may be particularly beneficial in patients at higher CDI risk, though Goldenberg and colleagues did not elaborate on what constitutes higher risk and based their conclusion on their control group’s high CDI incidence (> 5%). The most common adverse events (AEs) attributable to probiotics included abdominal cramping, nausea, fever, soft stools, flatulence, and taste disturbance. The review’s findings are limited in that the inclusion of many small trials with high baseline CDI risk likely contributed to a statistically significant result, and 17 of the review’s 39 trials were industry-sponsored or were conducted by investigators with industry associations; another 12 lacked statements about funding or sponsorship.

Two of the trials in the Cochrane Review investigated whether probiotics have a dose effect on CDI prevention. Gao and colleagues randomly assigned 255 hospitalized Asian patients to 3 groups: those receiving placebo, 1 probiotic capsule daily, and 2 probiotic capsules daily.¹⁶ Each probiotic capsule contained 50 billion colony-forming units (CFUs) of Lactobacillus. Incidence of CDI was lower in patients taking 2 probiotic capsules daily than in those taking 1 probiotic capsule daily (1.2% vs 9.4%; P = .04) or placebo (1.2% vs 23.8%; P = .002). In the other trial, Ouwehand and colleagues randomly assigned 503 hospitalized Asian patients to 3 groups as well: those receiving placebo, low-dose probiotic (4.17 billion CFUs of Lactobacillus and Bifidobacterium), and high-dose probiotic (17 billion CFUs).¹⁷ The incidence of CDI in each probiotic group (low-dose, high-dose) was 1.8%, which was significantly lower than the 4.8% in the placebo group (P = .04).

The Cochrane Review’s largest and most rigorous trial was PLACIDE, a 2013 randomized controlled study of the effect of probiotics on CDI.¹⁸ Allen and colleagues randomly assigned 2,981 inpatients (aged ≥ 65 years; exposed to antibiotics within preceding 7 days) to 2 groups: those receiving either 1 probiotic capsule daily, or 1 placebo capsule daily, for 21 days. Results showed no difference in CDI incidence between the probiotic and placebo groups (0.8% vs 1.2%; RR, 0.71; 95% CI, 0.34-1.47; P = .35). Of note, this trial is free of industry sponsorship, is the largest probiotic trial to date, has a control-group baseline CDI rate consistent with the rate in hospital and ambulatory settings in the US, and found a negative result regarding probiotic use in CDI prevention. Findings are limited in that the study allowed for initiating probiotic therapy up to 7 days after the start of antibiotics, and patients were given 1 relatively low-dose capsule daily, which may have contributed to lack of an effect on CDI prevention. No serious AEs were attributed to probiotic use.

In a 2017 systematic meta-analysis of 19 studies, Shen and colleagues investigated whether timely use of probiotics prevented CDI in 6,261 hospitalized patients receiving antibiotics.¹⁹ The incidence of CDI was significantly lower in patients receiving vs not receiving probiotics (1.6% vs 3.9%; RR, 0.42; 95% CI, 0.30-0.57; I² = 0%; P < .001).¹⁹ A subgroup analysis was performed to compare studies initiating probiotics within 2 days after the start of antibiotics with studies initiating probiotics more than 2 days after the start. CDI risk was reduced by 68% when probiotics were started within 2 days, vs 30% when started after 2 days (RR, 0.32; 95% CI, 0.22-0.48; I² = 0% vs RR, 0.70; 95% CI, 0.40-1.23; I² = 0%; P = .02). Of note, no difference was found in efficacy among the various probiotic formulations, and no significant AEs were noted in any study group.

Trials included in the Cochrane Review used many different probiotic regimens over various durations.¹⁵ All these trials continued probiotics for at least the duration of antibiotic therapy. The 2 trials that evaluated the effect of probiotic therapy over an extended period required probiotics be started within 48 hours after initiation of antibiotic therapy; one trial continued probiotics for 5 days after completion of antibiotics, and the other for 7 days after completion.^16,20 In both trials, CDI was statistically significantly reduced among adults using probiotics compared with adults receiving placebo.

Probiotic Safety

The FDA has not approved probiotics for the prevention or treatment of any health problems. Most probiotics are FDA-regulated as dietary supplements and do not have to meet stringent drug-approval requirements. The FDA has given many strains of common probiotics the Generally Recognized as Safe designation for use in commercially available products and foods.^21-23 Probiotic use has not been associated with significant AEs in clinical trials and generally has been considered safe in immunocompetent and otherwise healthy persons.^15-19 However, clinical trials have been inadequate in reporting or investigating AEs; the alternative for evaluating the risks of probiotic therapy is case reports.^24,25 Theoretical risks associated with probiotics include sepsis, deleterious effects on normal gut digestion, excessive immune stimulation, and possible transfer of antimicrobial resistance genes among microorganisms.²⁶ Boyle and colleagues further described a handful of case reports of sepsis caused by probiotics in immunocompromised individuals; the other theoretical risks have not been reported outside animal studies.²⁶

CDI Risk Factors

Many factors can increase a patient’s CDI risk. Specific antibiotics (eg, ampicillin, amoxicillin, cephalosporins, clindamycin, fluoroquinolones) confer higher risk.^27,28 Other factors include inflammatory bowel disease, organ transplantation, chemotherapy, chronic kidney disease, and immunodeficiency. Advanced age increases CDI risk and can increase the severity of infection. The evidence regarding acid suppression and CDI risk is conflicting, though a recent meta-analysis found that use of proton pump inhibitors is associated with a 2-fold higher risk of developing CDI.²⁹ Patient-specific risk factors should be evaluated when the risk–benefit ratio for probiotic use is being considered.

Conclusion

CDIs are becoming increasingly burdensome to the health care system. More research is needed on the role of probiotics in CDI prevention in patients taking antibiotics. Given the limited risk for AEs when probiotics are used in immunocompetent patients and the relatively low cost of these supplements, the risks likely are outweighed by the postulated benefits, and probiotics may be recommended in select patient populations.

The PLACIDE trial found no benefit of probiotics in preventing CDI in a population similar to that of a typical US hospital or ambulatory setting, but its intervention allowed late initiation of relatively low doses of probiotics. Therefore, probiotics may be recommended for CDI prevention in patients taking antibiotics, especially patients at high risk for developing CDI. When clinicians recommend probiotic use in this setting, the probiotic should be initiated within 2 days after the start of antibiotics and should be continued for the duration of antibiotic therapy and for up to 7 days after that therapy is completed. Optimal probiotic dosing, likely dependent on the product used, remains unclear. PLACIDE trial results suggest that a dosage of at least 1 probiotic capsule 2 times daily may confer additional efficacy.

Clostridium difficile (C difficile) is a gram-positive, toxin-producing bacterium that is of increasing concern among health care providers and patients. Infection with C difficile can have manifestations ranging from mild diarrhea to severe toxic megacolon and can result in prolonged hospitalization with severe cases requiring admission to an intensive care unit.¹ In 2014, the US was estimated to have more than 600,000 cases of C difficile infection (CDI), previously known as C difficile–associated diarrhea, and more than 44,000 associated deaths. The annual economic cost of CDI is thought to exceed $5 billion.¹ According to studies of health care–associated illness, CDI rates are comparable to or have surpassed rates of methicillin-resistant Staphylococcus aureus infection within the US, including at US Department of Veterans Affairs (VA) acute care centers nationwide.^2,3

C difficile has been shown to be the causative agent in 10% to 20% of antibiotic-associated diarrhea episodes.⁴ Colonization of C difficile is uncommon in healthy adults, but colonization rates are as high as 21% in hospitalized patients, with increasing rates proportional to increasing hospital length of stay.^5,6 Although not all colonized patients develop clinically significant CDI, those who do may require multiple treatment courses, over months to years, because of the high risk of disease recurrence. An estimated 25% of patients have a single recurrent episode of CDI within 30 days after treatment completion, and 45% of those patients have additional recurrent infections.^7,8 Although probiotics do not have an approved US Food and Drug Administration (FDA) indication, these supplements are often used to try to prevent CDI from developing during concomitant antibiotic use. Probiotics are microorganisms with potential health benefits, but the mechanisms of these benefits are not fully understood. Proposed mechanisms include reduced growth of pathogenic bacteria, modulation of the immune system, and support of the intestinal wall barrier.⁹ The many probiotic formulations currently marketed include Lactobacillus acidophilus (L acidophilus) capsules and various combinations of L acidophilus, Lactobacillus casei, Bifidobacterium lactis, Bifidobacterium longum, Streptococcus thermophilus, and other bacterial strains.

Dosing and Guidelines

Manufacturers’ suggested dosing for their Lactobacillus capsules, tablets, and packets varies from 1 unit daily to 4 units 4 times daily for dietary supplementation; the products’ labeling does not include any information regarding treatment duration.^10-13 In addition, there are no published recommendations or product labeling guiding the dosing of probiotics or their duration of use in the primary prevention of CDI.

In 2017, the Infectious Diseases Society of America (IDSA) and the Society for Healthcare Epidemiology of America (SHEA) updated their CDI treatment guidelines.¹⁴ As these guidelines indicate that the data on probiotic use in CDI are inadequate, IDSA and SHEA make no recommendation for or against probiotic use in primary prevention of the disease. The guidelines point to several limitations in the literature, including variability in probiotic formulations studied, duration of probiotic administration, definitions of CDI, and duration of study follow-up.

Given the lack of consensus guidelines that clinicians can use when deciding which probiotic dosing and duration are appropriate for a patient for primary prevention of CDI, we evaluated the literature on the topic and summarize their findings here.

Review of Probiotoc Literature

Conflicting data exist about probiotics and their effect on CDI prevention. The literature reviewed was selected based on our assessment of its contribution to the topic and its potential utility to clinicians in determining appropriate probiotic therapies and recommendations. Included in our discussion is a large Cochrane Review of probiotic efficacy, 2 trials of probiotic dosing, the PLACIDE trial, and a systematic review of timely probiotic initiation. All of these studies attempted to determine the effect of probiotics on CDI incidence (Table).

In their 2017 Cochrane Review, Goldenberg and colleagues reviewed 39 trials that investigated the efficacy of probiotics in CDI prevention in 9,955 immunocompetent patients receiving antibiotics.¹⁵ The incidence of CDI was significantly lower in patients who received a probiotic than in patients who received placebo or no treatment (1.5% vs 4.0%; relative risk [RR], 0.40; 95% CI, 0.30-0.52; I² = 0%). It is important to note that trials with a control-group CDI incidence of 0% to 2% (baseline CDI risk) found no statistically significant difference in CDI risk between patients using and not using probiotics (RR, 0.77; 95% CI, 0.45-1.32; I² = 0%) and that the preceding statistically significant result may have been driven by the inclusion of trials with high baseline CDI risk (> 5%). Trials that enrolled patients who were at this risk level found a statistically significant 70% reduction in CDI risk in those using probiotics (vs no probiotics) while on concomitant antibiotic therapy (RR, 0.30; 95% CI, 0.21-0.42; I² = 0%).

Probiotic therapy seems to be effective in reducing CDI risk in immunocompetent patients and may be particularly beneficial in patients at higher CDI risk, though Goldenberg and colleagues did not elaborate on what constitutes higher risk and based their conclusion on their control group’s high CDI incidence (> 5%). The most common adverse events (AEs) attributable to probiotics included abdominal cramping, nausea, fever, soft stools, flatulence, and taste disturbance. The review’s findings are limited in that the inclusion of many small trials with high baseline CDI risk likely contributed to a statistically significant result, and 17 of the review’s 39 trials were industry-sponsored or were conducted by investigators with industry associations; another 12 lacked statements about funding or sponsorship.

Two of the trials in the Cochrane Review investigated whether probiotics have a dose effect on CDI prevention. Gao and colleagues randomly assigned 255 hospitalized Asian patients to 3 groups: those receiving placebo, 1 probiotic capsule daily, and 2 probiotic capsules daily.¹⁶ Each probiotic capsule contained 50 billion colony-forming units (CFUs) of Lactobacillus. Incidence of CDI was lower in patients taking 2 probiotic capsules daily than in those taking 1 probiotic capsule daily (1.2% vs 9.4%; P = .04) or placebo (1.2% vs 23.8%; P = .002). In the other trial, Ouwehand and colleagues randomly assigned 503 hospitalized Asian patients to 3 groups as well: those receiving placebo, low-dose probiotic (4.17 billion CFUs of Lactobacillus and Bifidobacterium), and high-dose probiotic (17 billion CFUs).¹⁷ The incidence of CDI in each probiotic group (low-dose, high-dose) was 1.8%, which was significantly lower than the 4.8% in the placebo group (P = .04).

The Cochrane Review’s largest and most rigorous trial was PLACIDE, a 2013 randomized controlled study of the effect of probiotics on CDI.¹⁸ Allen and colleagues randomly assigned 2,981 inpatients (aged ≥ 65 years; exposed to antibiotics within preceding 7 days) to 2 groups: those receiving either 1 probiotic capsule daily, or 1 placebo capsule daily, for 21 days. Results showed no difference in CDI incidence between the probiotic and placebo groups (0.8% vs 1.2%; RR, 0.71; 95% CI, 0.34-1.47; P = .35). Of note, this trial is free of industry sponsorship, is the largest probiotic trial to date, has a control-group baseline CDI rate consistent with the rate in hospital and ambulatory settings in the US, and found a negative result regarding probiotic use in CDI prevention. Findings are limited in that the study allowed for initiating probiotic therapy up to 7 days after the start of antibiotics, and patients were given 1 relatively low-dose capsule daily, which may have contributed to lack of an effect on CDI prevention. No serious AEs were attributed to probiotic use.

In a 2017 systematic meta-analysis of 19 studies, Shen and colleagues investigated whether timely use of probiotics prevented CDI in 6,261 hospitalized patients receiving antibiotics.¹⁹ The incidence of CDI was significantly lower in patients receiving vs not receiving probiotics (1.6% vs 3.9%; RR, 0.42; 95% CI, 0.30-0.57; I² = 0%; P < .001).¹⁹ A subgroup analysis was performed to compare studies initiating probiotics within 2 days after the start of antibiotics with studies initiating probiotics more than 2 days after the start. CDI risk was reduced by 68% when probiotics were started within 2 days, vs 30% when started after 2 days (RR, 0.32; 95% CI, 0.22-0.48; I² = 0% vs RR, 0.70; 95% CI, 0.40-1.23; I² = 0%; P = .02). Of note, no difference was found in efficacy among the various probiotic formulations, and no significant AEs were noted in any study group.

Trials included in the Cochrane Review used many different probiotic regimens over various durations.¹⁵ All these trials continued probiotics for at least the duration of antibiotic therapy. The 2 trials that evaluated the effect of probiotic therapy over an extended period required probiotics be started within 48 hours after initiation of antibiotic therapy; one trial continued probiotics for 5 days after completion of antibiotics, and the other for 7 days after completion.^16,20 In both trials, CDI was statistically significantly reduced among adults using probiotics compared with adults receiving placebo.

Probiotic Safety

The FDA has not approved probiotics for the prevention or treatment of any health problems. Most probiotics are FDA-regulated as dietary supplements and do not have to meet stringent drug-approval requirements. The FDA has given many strains of common probiotics the Generally Recognized as Safe designation for use in commercially available products and foods.^21-23 Probiotic use has not been associated with significant AEs in clinical trials and generally has been considered safe in immunocompetent and otherwise healthy persons.^15-19 However, clinical trials have been inadequate in reporting or investigating AEs; the alternative for evaluating the risks of probiotic therapy is case reports.^24,25 Theoretical risks associated with probiotics include sepsis, deleterious effects on normal gut digestion, excessive immune stimulation, and possible transfer of antimicrobial resistance genes among microorganisms.²⁶ Boyle and colleagues further described a handful of case reports of sepsis caused by probiotics in immunocompromised individuals; the other theoretical risks have not been reported outside animal studies.²⁶

CDI Risk Factors

Many factors can increase a patient’s CDI risk. Specific antibiotics (eg, ampicillin, amoxicillin, cephalosporins, clindamycin, fluoroquinolones) confer higher risk.^27,28 Other factors include inflammatory bowel disease, organ transplantation, chemotherapy, chronic kidney disease, and immunodeficiency. Advanced age increases CDI risk and can increase the severity of infection. The evidence regarding acid suppression and CDI risk is conflicting, though a recent meta-analysis found that use of proton pump inhibitors is associated with a 2-fold higher risk of developing CDI.²⁹ Patient-specific risk factors should be evaluated when the risk–benefit ratio for probiotic use is being considered.

Conclusion

CDIs are becoming increasingly burdensome to the health care system. More research is needed on the role of probiotics in CDI prevention in patients taking antibiotics. Given the limited risk for AEs when probiotics are used in immunocompetent patients and the relatively low cost of these supplements, the risks likely are outweighed by the postulated benefits, and probiotics may be recommended in select patient populations.

The PLACIDE trial found no benefit of probiotics in preventing CDI in a population similar to that of a typical US hospital or ambulatory setting, but its intervention allowed late initiation of relatively low doses of probiotics. Therefore, probiotics may be recommended for CDI prevention in patients taking antibiotics, especially patients at high risk for developing CDI. When clinicians recommend probiotic use in this setting, the probiotic should be initiated within 2 days after the start of antibiotics and should be continued for the duration of antibiotic therapy and for up to 7 days after that therapy is completed. Optimal probiotic dosing, likely dependent on the product used, remains unclear. PLACIDE trial results suggest that a dosage of at least 1 probiotic capsule 2 times daily may confer additional efficacy.

As the rest of the industrialized world has seen a decline in maternal mortality, the United States has seen a substantial rise over the last 30 years (FIGURE).¹ It is estimated that more than 60% of these pregnancy-related deaths are preventable. Additionally, substantial disparities exist, with African-American women 3 to 4 times more likely to die of pregnancy-related complications than white women.¹

A good first step

The Preventing Maternal Deaths Act was passed by the 115th Congress and signed into law December 2018 in an effort to support and expand maternal mortality review committees (MMRCs) on a state level while allowing the Centers for Disease Control and Prevention (CDC) to further study disparities within maternal mortality. Although these efforts are a good first step to help reduce maternal mortality, more needs to be done to quell this growing epidemic.

We must now improve care access

One strategy to aid in decreasing maternal morbidity and mortality is to improve affordable access to medical care. Medicaid is the largest single payer of maternity care in the United States, covering 42.6% of births. Currently, in many states, Medicaid coverage only lasts until a woman is 60 days postpartum.² Although 31 states, including the District of Columbia, have adopted Medicaid expansion programs to allow women to extend coverage beyond those 60 days, offering these programs is not a federal law. In the 19 remaining states with no extension options, the vast majority of women will lose their Medicaid coverage just after they are 2 months postpartum and will have no alternative health insurance coverage.²

Why does this coverage cutoff matter? Pregnancy-related deaths are defined as up to 12 months postpartum. A report reviewing 9 MMRCs found that 38% of pregnancy-related deaths occurred while a woman was pregnant, 45% of deaths occurred within 42 days of delivery, and 18% from 43 days to 1 year after delivery.³ Additionally, nearly half of women with Medicaid do not come to their 6-week postpartum visit (for a variety of reasons), missing a critical opportunity to address health concerns.² Of the deaths that occurred in this later postpartum period, leading causes were cardiomyopathy (32%), mental health conditions (16%), and embolism (11%).³ Prevention and management of these conditions require regular follow-up with an ObGyn, as well as potentially from subspecialists in cardiology, psychiatry, hematology, and other subspecialties. Women not having access to affordable health care during the critical postpartum period greatly increases their risk of death or severe morbidity.

An important next step beyond the Preventing Maternal Deaths Act is to extend Medicaid coverage to 12 months postpartum for all women everywhere. MMRCs have concluded that extending coverage would ensure that “medical and behavioral health conditions [could be] managed and treated before becoming progressively severe.”³ This would presumably help decrease the risk of pregnancy-related death and address worsening morbidity. Additionally, the postpartum period is a well-established time of increased stress and can be an overwhelming and emotional time for many new mothers, especially for those with limited resources for childcare, transportation, stable housing, etc.⁶ Providing and ensuring ongoing medical care would substantially improve the lives and health of women and the health of their families.

We, as a country, need to make changes

Every step of the way, a woman faces challenges to safely and affordably access health care. Providing access to insurance coverage for 12 months postpartum can help to decrease our country’s rising maternal mortality and morbidity rates.

Take action

Congresswoman Robin Kelly (D-IL) and Senator Dick Durbin (D-IL) have introduced the MOMMA Act (H.R. 1897/S. 916) to help address the rising maternal mortality rate.

This Act would:

• Expand Medicaid coverage to 1 year postpartum.
• Work with the CDC to uniformly collect data to accurately assess maternal mortality and morbidity.
• Ensure the sharing of best practices of care across hospital systems.
• Focus on culturally-competent care to address implicit bias among health care workers.
• Support and expand the Alliance for Innovation on Maternal Health (AIM)—a data-driven initiative to implement safety protocols in hospitals across the country.

To call or contact your representative to co-sponsor this bill, click here. To review if your Congressperson is a co-sponsor, click here. To review if your Senator is a co-sponsor, click here.
 

As the rest of the industrialized world has seen a decline in maternal mortality, the United States has seen a substantial rise over the last 30 years (FIGURE).¹ It is estimated that more than 60% of these pregnancy-related deaths are preventable. Additionally, substantial disparities exist, with African-American women 3 to 4 times more likely to die of pregnancy-related complications than white women.¹

A good first step

The Preventing Maternal Deaths Act was passed by the 115th Congress and signed into law December 2018 in an effort to support and expand maternal mortality review committees (MMRCs) on a state level while allowing the Centers for Disease Control and Prevention (CDC) to further study disparities within maternal mortality. Although these efforts are a good first step to help reduce maternal mortality, more needs to be done to quell this growing epidemic.

We must now improve care access

One strategy to aid in decreasing maternal morbidity and mortality is to improve affordable access to medical care. Medicaid is the largest single payer of maternity care in the United States, covering 42.6% of births. Currently, in many states, Medicaid coverage only lasts until a woman is 60 days postpartum.² Although 31 states, including the District of Columbia, have adopted Medicaid expansion programs to allow women to extend coverage beyond those 60 days, offering these programs is not a federal law. In the 19 remaining states with no extension options, the vast majority of women will lose their Medicaid coverage just after they are 2 months postpartum and will have no alternative health insurance coverage.²

Why does this coverage cutoff matter? Pregnancy-related deaths are defined as up to 12 months postpartum. A report reviewing 9 MMRCs found that 38% of pregnancy-related deaths occurred while a woman was pregnant, 45% of deaths occurred within 42 days of delivery, and 18% from 43 days to 1 year after delivery.³ Additionally, nearly half of women with Medicaid do not come to their 6-week postpartum visit (for a variety of reasons), missing a critical opportunity to address health concerns.² Of the deaths that occurred in this later postpartum period, leading causes were cardiomyopathy (32%), mental health conditions (16%), and embolism (11%).³ Prevention and management of these conditions require regular follow-up with an ObGyn, as well as potentially from subspecialists in cardiology, psychiatry, hematology, and other subspecialties. Women not having access to affordable health care during the critical postpartum period greatly increases their risk of death or severe morbidity.

An important next step beyond the Preventing Maternal Deaths Act is to extend Medicaid coverage to 12 months postpartum for all women everywhere. MMRCs have concluded that extending coverage would ensure that “medical and behavioral health conditions [could be] managed and treated before becoming progressively severe.”³ This would presumably help decrease the risk of pregnancy-related death and address worsening morbidity. Additionally, the postpartum period is a well-established time of increased stress and can be an overwhelming and emotional time for many new mothers, especially for those with limited resources for childcare, transportation, stable housing, etc.⁶ Providing and ensuring ongoing medical care would substantially improve the lives and health of women and the health of their families.

We, as a country, need to make changes

Every step of the way, a woman faces challenges to safely and affordably access health care. Providing access to insurance coverage for 12 months postpartum can help to decrease our country’s rising maternal mortality and morbidity rates.

Take action

Congresswoman Robin Kelly (D-IL) and Senator Dick Durbin (D-IL) have introduced the MOMMA Act (H.R. 1897/S. 916) to help address the rising maternal mortality rate.

This Act would:

• Expand Medicaid coverage to 1 year postpartum.
• Work with the CDC to uniformly collect data to accurately assess maternal mortality and morbidity.
• Ensure the sharing of best practices of care across hospital systems.
• Focus on culturally-competent care to address implicit bias among health care workers.
• Support and expand the Alliance for Innovation on Maternal Health (AIM)—a data-driven initiative to implement safety protocols in hospitals across the country.

To call or contact your representative to co-sponsor this bill, click here. To review if your Congressperson is a co-sponsor, click here. To review if your Senator is a co-sponsor, click here.
 

As the rest of the industrialized world has seen a decline in maternal mortality, the United States has seen a substantial rise over the last 30 years (FIGURE).¹ It is estimated that more than 60% of these pregnancy-related deaths are preventable. Additionally, substantial disparities exist, with African-American women 3 to 4 times more likely to die of pregnancy-related complications than white women.¹

A good first step

The Preventing Maternal Deaths Act was passed by the 115th Congress and signed into law December 2018 in an effort to support and expand maternal mortality review committees (MMRCs) on a state level while allowing the Centers for Disease Control and Prevention (CDC) to further study disparities within maternal mortality. Although these efforts are a good first step to help reduce maternal mortality, more needs to be done to quell this growing epidemic.

We must now improve care access

One strategy to aid in decreasing maternal morbidity and mortality is to improve affordable access to medical care. Medicaid is the largest single payer of maternity care in the United States, covering 42.6% of births. Currently, in many states, Medicaid coverage only lasts until a woman is 60 days postpartum.² Although 31 states, including the District of Columbia, have adopted Medicaid expansion programs to allow women to extend coverage beyond those 60 days, offering these programs is not a federal law. In the 19 remaining states with no extension options, the vast majority of women will lose their Medicaid coverage just after they are 2 months postpartum and will have no alternative health insurance coverage.²

Why does this coverage cutoff matter? Pregnancy-related deaths are defined as up to 12 months postpartum. A report reviewing 9 MMRCs found that 38% of pregnancy-related deaths occurred while a woman was pregnant, 45% of deaths occurred within 42 days of delivery, and 18% from 43 days to 1 year after delivery.³ Additionally, nearly half of women with Medicaid do not come to their 6-week postpartum visit (for a variety of reasons), missing a critical opportunity to address health concerns.² Of the deaths that occurred in this later postpartum period, leading causes were cardiomyopathy (32%), mental health conditions (16%), and embolism (11%).³ Prevention and management of these conditions require regular follow-up with an ObGyn, as well as potentially from subspecialists in cardiology, psychiatry, hematology, and other subspecialties. Women not having access to affordable health care during the critical postpartum period greatly increases their risk of death or severe morbidity.

An important next step beyond the Preventing Maternal Deaths Act is to extend Medicaid coverage to 12 months postpartum for all women everywhere. MMRCs have concluded that extending coverage would ensure that “medical and behavioral health conditions [could be] managed and treated before becoming progressively severe.”³ This would presumably help decrease the risk of pregnancy-related death and address worsening morbidity. Additionally, the postpartum period is a well-established time of increased stress and can be an overwhelming and emotional time for many new mothers, especially for those with limited resources for childcare, transportation, stable housing, etc.⁶ Providing and ensuring ongoing medical care would substantially improve the lives and health of women and the health of their families.

We, as a country, need to make changes

Every step of the way, a woman faces challenges to safely and affordably access health care. Providing access to insurance coverage for 12 months postpartum can help to decrease our country’s rising maternal mortality and morbidity rates.

Take action

Congresswoman Robin Kelly (D-IL) and Senator Dick Durbin (D-IL) have introduced the MOMMA Act (H.R. 1897/S. 916) to help address the rising maternal mortality rate.

This Act would:

• Expand Medicaid coverage to 1 year postpartum.
• Work with the CDC to uniformly collect data to accurately assess maternal mortality and morbidity.
• Ensure the sharing of best practices of care across hospital systems.
• Focus on culturally-competent care to address implicit bias among health care workers.
• Support and expand the Alliance for Innovation on Maternal Health (AIM)—a data-driven initiative to implement safety protocols in hospitals across the country.

To call or contact your representative to co-sponsor this bill, click here. To review if your Congressperson is a co-sponsor, click here. To review if your Senator is a co-sponsor, click here.
 

Liver transplantation (LT) is “one of the most resource-intense procedures despite significant improvements in procedures and protocols,” say researchers from Seoul National University Hospital in South Korea. But little is known about the “practical aspects of life after liver transplantation,” such as unplanned visits to the emergency department (ED) or readmission for complications. So the researchers conducted a study to find out what health care resources are used after discharge.

Of 430 patients, half visited the ED at least once, and 57% were readmitted at least once. The rate of ED visits rose from 15% at 30 days after discharge to 44% at 1 year. Readmission rates more than tripled, from 16% at 30 days to 49% at 1 year.

Contrary to other research, living donor liver transplantation was not a risk factor of readmission. Emergency LT was a risk factor for ED visits and readmission within 30 days of discharge. And although LT using the left liver lobe and pre-existing hepatitis C are known risk factors for long-term graft failure, at the researchers’ hospital hepatitis B is the most common indication for living donor LT. Most of their patients undergo LT using the right liver lobe.

Some of the identified risk factors were unexpected, the researchers say. One was donor age of < 60 years. Warm ischemic time of 15 minutes or longer was another. The researchers note that prolonged warm ischemic time increases hepatic ischemia and reperfusion injury and is related to postoperative complications, which can be a cause of frequent readmission.

Length of stay (LOS)  > 2 weeks also was a risk factor for readmission. In their institution, the average LOS for patients with a warm ischemic time of < 15 minutes was 15.6 days, shorter than the overall average LOS. Shorter LOS, the researchers add, may reflect fewer immediate postoperative complications.

Although they identified no specific complication as a risk factor for readmission, the researchers found specific conditions that accounted for a relatively high proportion of readmissions and repeated readmission, including abnormal liver function test  (32% of readmissions) and fever (17% of readmissions and 39% of repeated readmissions). The researchers suggest those are conditions to monitor and manage.

Notably, patients who did not require readmission or ED visits in the first 20 months almost never required unplanned health care resources thereafter.

Liver transplantation (LT) is “one of the most resource-intense procedures despite significant improvements in procedures and protocols,” say researchers from Seoul National University Hospital in South Korea. But little is known about the “practical aspects of life after liver transplantation,” such as unplanned visits to the emergency department (ED) or readmission for complications. So the researchers conducted a study to find out what health care resources are used after discharge.

Of 430 patients, half visited the ED at least once, and 57% were readmitted at least once. The rate of ED visits rose from 15% at 30 days after discharge to 44% at 1 year. Readmission rates more than tripled, from 16% at 30 days to 49% at 1 year.

Contrary to other research, living donor liver transplantation was not a risk factor of readmission. Emergency LT was a risk factor for ED visits and readmission within 30 days of discharge. And although LT using the left liver lobe and pre-existing hepatitis C are known risk factors for long-term graft failure, at the researchers’ hospital hepatitis B is the most common indication for living donor LT. Most of their patients undergo LT using the right liver lobe.

Some of the identified risk factors were unexpected, the researchers say. One was donor age of < 60 years. Warm ischemic time of 15 minutes or longer was another. The researchers note that prolonged warm ischemic time increases hepatic ischemia and reperfusion injury and is related to postoperative complications, which can be a cause of frequent readmission.

Length of stay (LOS)  > 2 weeks also was a risk factor for readmission. In their institution, the average LOS for patients with a warm ischemic time of < 15 minutes was 15.6 days, shorter than the overall average LOS. Shorter LOS, the researchers add, may reflect fewer immediate postoperative complications.

Although they identified no specific complication as a risk factor for readmission, the researchers found specific conditions that accounted for a relatively high proportion of readmissions and repeated readmission, including abnormal liver function test  (32% of readmissions) and fever (17% of readmissions and 39% of repeated readmissions). The researchers suggest those are conditions to monitor and manage.

Notably, patients who did not require readmission or ED visits in the first 20 months almost never required unplanned health care resources thereafter.

Liver transplantation (LT) is “one of the most resource-intense procedures despite significant improvements in procedures and protocols,” say researchers from Seoul National University Hospital in South Korea. But little is known about the “practical aspects of life after liver transplantation,” such as unplanned visits to the emergency department (ED) or readmission for complications. So the researchers conducted a study to find out what health care resources are used after discharge.

Of 430 patients, half visited the ED at least once, and 57% were readmitted at least once. The rate of ED visits rose from 15% at 30 days after discharge to 44% at 1 year. Readmission rates more than tripled, from 16% at 30 days to 49% at 1 year.

Contrary to other research, living donor liver transplantation was not a risk factor of readmission. Emergency LT was a risk factor for ED visits and readmission within 30 days of discharge. And although LT using the left liver lobe and pre-existing hepatitis C are known risk factors for long-term graft failure, at the researchers’ hospital hepatitis B is the most common indication for living donor LT. Most of their patients undergo LT using the right liver lobe.

Some of the identified risk factors were unexpected, the researchers say. One was donor age of < 60 years. Warm ischemic time of 15 minutes or longer was another. The researchers note that prolonged warm ischemic time increases hepatic ischemia and reperfusion injury and is related to postoperative complications, which can be a cause of frequent readmission.

Length of stay (LOS)  > 2 weeks also was a risk factor for readmission. In their institution, the average LOS for patients with a warm ischemic time of < 15 minutes was 15.6 days, shorter than the overall average LOS. Shorter LOS, the researchers add, may reflect fewer immediate postoperative complications.

Although they identified no specific complication as a risk factor for readmission, the researchers found specific conditions that accounted for a relatively high proportion of readmissions and repeated readmission, including abnormal liver function test  (32% of readmissions) and fever (17% of readmissions and 39% of repeated readmissions). The researchers suggest those are conditions to monitor and manage.

Notably, patients who did not require readmission or ED visits in the first 20 months almost never required unplanned health care resources thereafter.

US Department of Veterans Affairs (VA) Community Living Centers (CLCs) provide a dynamic array of long- and short-term health and rehabilitative services in a person-centered environment designed to meet the individual needs of veteran residents. The VA Office of Geriatrics and Extended Care (GEC) manages CLCs as part of its commitment to “optimizing the health and well-being of veterans with multiple chronic conditions, life-limiting illness, frailty or disability associated with chronic disease, aging or injury.”¹

CLCs are home to veterans who require short stays before going home, as well as those who require longer or permanent domicile. CLCs also are home to several special populations of veterans, including those with spinal cord injury and those who choose palliative or hospice care. CLCs have embraced cultural transformation, creating therapeutic environments that function as real homes, with the kitchen at the center, and daily activities scheduled around the veterans’ preferences. Data about CLC quality are now available to the public, highlighting the important role of support for and continual refinement to quality improvement (QI) processes in the CLC system. ^2,3

CONCERT Program

High-functioning teams are critical to achieving improvement in such processes.⁴ In fiscal year (FY) 2017, GEC launched a national center to engage and support CLC staff in creating high-functioning, relationship-based teams through specific QI practices, thereby aiming to improve veteran experience and quality of care. The center, known as the CLCs’ Ongoing National Center for Enhancing Resources and Training (CONCERT), is based on extensive VA-funded research in CLCs^5-7 and builds on existing, evidence-based literature emphasizing the importance of strengths-based learning, collaborative problem solving, and structured observation.^8-13 The CONCERT mission is to support CLCs in ongoing QI efforts, providing guidance, training, and resources. This article summarizes the previous research on which CONCERT is based and describes its current activities, which focus on implementing a national team-based quality improvement initiative.

Earlier VA-funded CLC research included a VA Office of Patient Centered Care and Cultural Transformation local innovation project and 2 VA Office of Research and Development-funded research studies. The local innovation project focused on strengthening staff leadership and relational skills in 1 CLC by engaging leaders and staff in collaborative work to reduce stress. The goal was to build high-functioning team skills through shared projects that created positive work experiences and reduced job-related stress while also improving veteran experience and quality of care.^14,15 Over the course of a year, 2 national consultants in nursing home quality improvement worked with CLC leadership and staff, including conducting nine 4-day site visits. Using an approach designed to foster development of high-functioning teams, individual CLC neighborhoods (ie, units) developed and implemented neighborhood-initiated, neighborhood-based pilot projects, such as an individualized finger foods dining option for residents with dementia who became distressed when sitting at a table during a meal. Outcomes of these projects included improved staff communication and staff satisfaction, particularly psychological safety.

In the concurrently conducted pilot research study, a research team comprehensively assessed the person-centered care efforts of 3 CLCs prior to their construction of Green House-type (small house) homes. This mixed-methods study included more than 50 qualitative interviews conducted with VA medical center leadership and CLC staff and residents. Researchers also administered online employee surveys and conducted site visits, including more than 60 hours of direct observation of CLC life and team functioning. The local institutional review boards approved all study procedures, and researchers notified local unions.

Analyses highlighted 2 important aspects of person-centered care not captured by then-existing measurement instruments: the type, quality, and number of staff/resident interactions and the type, quality, and level of resident engagement. The team therefore developed a structured, systematic, observation-based instrument to measure these concepts.⁵ But while researchers found this instrument useful, it was too complex to be used by CLC staff for QI.

LOCK Quality Improvement

A later and larger research study addressed this issue. In the study, researchers worked with CLC staff to convert the complex observation-based research instrument into several structured tools that were easier for CLC staff to use.⁶ The researchers then incorporated their experience with the prior local innovation project and designed and implemented a QI program, which operationalized an evidence-based bundle of practices to implement the new tools in 6 CLCs. Researchers called the bundle of practices “LOCK”: (1) Learn from the bright spots; (2) Observe; (3) Collaborate in huddles; and (4) Keep it bite-sized.

Learn from the bright spots. Studies on strengths-based learning indicate that recognizing and sharing positive instances of ideal practice helps provide clear direction regarding what needs to be done differently to achieve success. Identifying and learning from outlying instances of successful practice encourages staff to continue those behaviors and gives staff tangible examples of how they may improve.^16-19 That is, concentrating on instances where a negative outcome was at risk of occurring but did not occur (ie, a positive outlier or “bright spot”) enables staff to analyze what facilitated the success and design and pilot strategies to replicate it.

Observe. Human factors engineering is built on the principle that integrated approaches for studying work systems can identify areas for improvement.⁸ Observation is a key tool in this approach. A recent review of 69 studies that used observation to assess clinical performance found it useful in identifying factors affecting quality and safety.⁹

Collaborate in huddles. A necessary component to overcoming barriers to successful QI is having high-functioning teams effectively coordinate work. In the theory of relational coordination, this is operationalized as high-quality interactions (frequent, timely, and accurate communication) and high-quality relationships (share knowledge, shared goals, and mutual respect).^10,11 Improved relational coordination can lead to higher quality of care outcomes and job satisfaction by enabling individuals to manage their tasks with less delay, more rapid and effective responses, fewer errors, and less wasted effort.¹²

Keep it bite-sized. Regular practice of a new behavior is one of the keys to making that new behavior part of an automatic routine (ie, a habit). To be successfully integrated into staff work routines, QI initiatives must be perceived as congruent with and easily integrated into care goals and workplace practices. Quick, focused, team-building and solution-oriented QI initiatives, therefore, have the greatest chance of success, particularly if staff feel they have little time for participating in new initiatives.¹³

Researchers designed the 4 LOCK practices to be interrelated and build on one another, creating a bundle to be used together to help facilitate positive change in resident/staff interactions and resident engagement.⁷ For 6 months, researchers studied the 6 CLCs’ use of the new structured observation tools as part of the LOCK-based QI program. The participating CLCs had such success in improving staff interactions with residents and residents’ engagement in CLC life that GEC, under the CONCERT umbrella, rolled out the LOCK bundle of practices to CLCs nationwide.²⁰

CONCERT’s current activities focus on helping CLCs implement the LOCK bundle nationwide as a relational coordination-based national QI initiative designed to improve quality of care and staff satisfaction. The CONCERT team began this implementation in FY 2017 using a train-the-trainer approach through a staggered veterans integrated service network (VISN) rollout. Each CLC sent 2 leaders to a VISN-wide training program at a host CLC site (the host site was able to have more participants attend). Afterward, the CONCERT team provided individualized phone support to help CLCs implement the program. A VA Pulse (intranet-based social media portal) site hosts all training materials, program videos, an active blog, community discussions, etc.

In FY 2018, the program shifted to a VISN-based support system, with a CONCERT team member assigned to each VISN and VISN-based webinars to facilitate information exchange, collaboration, and group learning. In FY 2018, the CONCERT team also conducted site visits to selected CLCs with strong implementation success records to learn about program facilitators and to disseminate the lessons learned. Spanning FYs 2018 and 2019, the CONCERT team also supports historically low-performing CLCs through a series of rapid-cycle learning intensives based on the Institute for Healthcare Improvement breakthrough collaborative series model for accelerated and sustained QI.²¹ These incorporate in-person or virtual learning sessions, in which participants learn about and share effective practices, and between-session learning assignments, to facilitate the piloting, implementation, and sustainment of system changes. As part of the CONCERT continuous QI process, the CONCERT team closely monitors the impact of the program and continues to pilot, adapt, and change practices as it learns more about how best to help CLCs improve.

Conclusion

A key CONCERT principle is that health care systems create health care outcomes. The CONCERT team uses the theory of relational coordination to support implementation of the LOCK bundle of practices to help CLCs change their systems to achieve high performance. Through implementation of the LOCK bundle of practices, CLC staff develop, pilot, and spread new systems for communication, teamwork, and collaborative problem solving, as well as developing skills to participate effectively in these systems. CONCERT represents just 1 way VA supports CLCs in their continual journeys toward ever-improved quality of veteran care.

Acknowledgments
The authors thank Barbara Frank and Cathie Brady for their contributions to the development of the CONCERT program.

US Department of Veterans Affairs (VA) Community Living Centers (CLCs) provide a dynamic array of long- and short-term health and rehabilitative services in a person-centered environment designed to meet the individual needs of veteran residents. The VA Office of Geriatrics and Extended Care (GEC) manages CLCs as part of its commitment to “optimizing the health and well-being of veterans with multiple chronic conditions, life-limiting illness, frailty or disability associated with chronic disease, aging or injury.”¹

CLCs are home to veterans who require short stays before going home, as well as those who require longer or permanent domicile. CLCs also are home to several special populations of veterans, including those with spinal cord injury and those who choose palliative or hospice care. CLCs have embraced cultural transformation, creating therapeutic environments that function as real homes, with the kitchen at the center, and daily activities scheduled around the veterans’ preferences. Data about CLC quality are now available to the public, highlighting the important role of support for and continual refinement to quality improvement (QI) processes in the CLC system. ^2,3

CONCERT Program

High-functioning teams are critical to achieving improvement in such processes.⁴ In fiscal year (FY) 2017, GEC launched a national center to engage and support CLC staff in creating high-functioning, relationship-based teams through specific QI practices, thereby aiming to improve veteran experience and quality of care. The center, known as the CLCs’ Ongoing National Center for Enhancing Resources and Training (CONCERT), is based on extensive VA-funded research in CLCs^5-7 and builds on existing, evidence-based literature emphasizing the importance of strengths-based learning, collaborative problem solving, and structured observation.^8-13 The CONCERT mission is to support CLCs in ongoing QI efforts, providing guidance, training, and resources. This article summarizes the previous research on which CONCERT is based and describes its current activities, which focus on implementing a national team-based quality improvement initiative.

Earlier VA-funded CLC research included a VA Office of Patient Centered Care and Cultural Transformation local innovation project and 2 VA Office of Research and Development-funded research studies. The local innovation project focused on strengthening staff leadership and relational skills in 1 CLC by engaging leaders and staff in collaborative work to reduce stress. The goal was to build high-functioning team skills through shared projects that created positive work experiences and reduced job-related stress while also improving veteran experience and quality of care.^14,15 Over the course of a year, 2 national consultants in nursing home quality improvement worked with CLC leadership and staff, including conducting nine 4-day site visits. Using an approach designed to foster development of high-functioning teams, individual CLC neighborhoods (ie, units) developed and implemented neighborhood-initiated, neighborhood-based pilot projects, such as an individualized finger foods dining option for residents with dementia who became distressed when sitting at a table during a meal. Outcomes of these projects included improved staff communication and staff satisfaction, particularly psychological safety.

In the concurrently conducted pilot research study, a research team comprehensively assessed the person-centered care efforts of 3 CLCs prior to their construction of Green House-type (small house) homes. This mixed-methods study included more than 50 qualitative interviews conducted with VA medical center leadership and CLC staff and residents. Researchers also administered online employee surveys and conducted site visits, including more than 60 hours of direct observation of CLC life and team functioning. The local institutional review boards approved all study procedures, and researchers notified local unions.

Analyses highlighted 2 important aspects of person-centered care not captured by then-existing measurement instruments: the type, quality, and number of staff/resident interactions and the type, quality, and level of resident engagement. The team therefore developed a structured, systematic, observation-based instrument to measure these concepts.⁵ But while researchers found this instrument useful, it was too complex to be used by CLC staff for QI.

LOCK Quality Improvement

A later and larger research study addressed this issue. In the study, researchers worked with CLC staff to convert the complex observation-based research instrument into several structured tools that were easier for CLC staff to use.⁶ The researchers then incorporated their experience with the prior local innovation project and designed and implemented a QI program, which operationalized an evidence-based bundle of practices to implement the new tools in 6 CLCs. Researchers called the bundle of practices “LOCK”: (1) Learn from the bright spots; (2) Observe; (3) Collaborate in huddles; and (4) Keep it bite-sized.

Learn from the bright spots. Studies on strengths-based learning indicate that recognizing and sharing positive instances of ideal practice helps provide clear direction regarding what needs to be done differently to achieve success. Identifying and learning from outlying instances of successful practice encourages staff to continue those behaviors and gives staff tangible examples of how they may improve.^16-19 That is, concentrating on instances where a negative outcome was at risk of occurring but did not occur (ie, a positive outlier or “bright spot”) enables staff to analyze what facilitated the success and design and pilot strategies to replicate it.

Observe. Human factors engineering is built on the principle that integrated approaches for studying work systems can identify areas for improvement.⁸ Observation is a key tool in this approach. A recent review of 69 studies that used observation to assess clinical performance found it useful in identifying factors affecting quality and safety.⁹

Collaborate in huddles. A necessary component to overcoming barriers to successful QI is having high-functioning teams effectively coordinate work. In the theory of relational coordination, this is operationalized as high-quality interactions (frequent, timely, and accurate communication) and high-quality relationships (share knowledge, shared goals, and mutual respect).^10,11 Improved relational coordination can lead to higher quality of care outcomes and job satisfaction by enabling individuals to manage their tasks with less delay, more rapid and effective responses, fewer errors, and less wasted effort.¹²

Keep it bite-sized. Regular practice of a new behavior is one of the keys to making that new behavior part of an automatic routine (ie, a habit). To be successfully integrated into staff work routines, QI initiatives must be perceived as congruent with and easily integrated into care goals and workplace practices. Quick, focused, team-building and solution-oriented QI initiatives, therefore, have the greatest chance of success, particularly if staff feel they have little time for participating in new initiatives.¹³

Researchers designed the 4 LOCK practices to be interrelated and build on one another, creating a bundle to be used together to help facilitate positive change in resident/staff interactions and resident engagement.⁷ For 6 months, researchers studied the 6 CLCs’ use of the new structured observation tools as part of the LOCK-based QI program. The participating CLCs had such success in improving staff interactions with residents and residents’ engagement in CLC life that GEC, under the CONCERT umbrella, rolled out the LOCK bundle of practices to CLCs nationwide.²⁰

CONCERT’s current activities focus on helping CLCs implement the LOCK bundle nationwide as a relational coordination-based national QI initiative designed to improve quality of care and staff satisfaction. The CONCERT team began this implementation in FY 2017 using a train-the-trainer approach through a staggered veterans integrated service network (VISN) rollout. Each CLC sent 2 leaders to a VISN-wide training program at a host CLC site (the host site was able to have more participants attend). Afterward, the CONCERT team provided individualized phone support to help CLCs implement the program. A VA Pulse (intranet-based social media portal) site hosts all training materials, program videos, an active blog, community discussions, etc.

In FY 2018, the program shifted to a VISN-based support system, with a CONCERT team member assigned to each VISN and VISN-based webinars to facilitate information exchange, collaboration, and group learning. In FY 2018, the CONCERT team also conducted site visits to selected CLCs with strong implementation success records to learn about program facilitators and to disseminate the lessons learned. Spanning FYs 2018 and 2019, the CONCERT team also supports historically low-performing CLCs through a series of rapid-cycle learning intensives based on the Institute for Healthcare Improvement breakthrough collaborative series model for accelerated and sustained QI.²¹ These incorporate in-person or virtual learning sessions, in which participants learn about and share effective practices, and between-session learning assignments, to facilitate the piloting, implementation, and sustainment of system changes. As part of the CONCERT continuous QI process, the CONCERT team closely monitors the impact of the program and continues to pilot, adapt, and change practices as it learns more about how best to help CLCs improve.

Conclusion

A key CONCERT principle is that health care systems create health care outcomes. The CONCERT team uses the theory of relational coordination to support implementation of the LOCK bundle of practices to help CLCs change their systems to achieve high performance. Through implementation of the LOCK bundle of practices, CLC staff develop, pilot, and spread new systems for communication, teamwork, and collaborative problem solving, as well as developing skills to participate effectively in these systems. CONCERT represents just 1 way VA supports CLCs in their continual journeys toward ever-improved quality of veteran care.

Acknowledgments
The authors thank Barbara Frank and Cathie Brady for their contributions to the development of the CONCERT program.

US Department of Veterans Affairs (VA) Community Living Centers (CLCs) provide a dynamic array of long- and short-term health and rehabilitative services in a person-centered environment designed to meet the individual needs of veteran residents. The VA Office of Geriatrics and Extended Care (GEC) manages CLCs as part of its commitment to “optimizing the health and well-being of veterans with multiple chronic conditions, life-limiting illness, frailty or disability associated with chronic disease, aging or injury.”¹

CLCs are home to veterans who require short stays before going home, as well as those who require longer or permanent domicile. CLCs also are home to several special populations of veterans, including those with spinal cord injury and those who choose palliative or hospice care. CLCs have embraced cultural transformation, creating therapeutic environments that function as real homes, with the kitchen at the center, and daily activities scheduled around the veterans’ preferences. Data about CLC quality are now available to the public, highlighting the important role of support for and continual refinement to quality improvement (QI) processes in the CLC system. ^2,3

CONCERT Program

High-functioning teams are critical to achieving improvement in such processes.⁴ In fiscal year (FY) 2017, GEC launched a national center to engage and support CLC staff in creating high-functioning, relationship-based teams through specific QI practices, thereby aiming to improve veteran experience and quality of care. The center, known as the CLCs’ Ongoing National Center for Enhancing Resources and Training (CONCERT), is based on extensive VA-funded research in CLCs^5-7 and builds on existing, evidence-based literature emphasizing the importance of strengths-based learning, collaborative problem solving, and structured observation.^8-13 The CONCERT mission is to support CLCs in ongoing QI efforts, providing guidance, training, and resources. This article summarizes the previous research on which CONCERT is based and describes its current activities, which focus on implementing a national team-based quality improvement initiative.

Earlier VA-funded CLC research included a VA Office of Patient Centered Care and Cultural Transformation local innovation project and 2 VA Office of Research and Development-funded research studies. The local innovation project focused on strengthening staff leadership and relational skills in 1 CLC by engaging leaders and staff in collaborative work to reduce stress. The goal was to build high-functioning team skills through shared projects that created positive work experiences and reduced job-related stress while also improving veteran experience and quality of care.^14,15 Over the course of a year, 2 national consultants in nursing home quality improvement worked with CLC leadership and staff, including conducting nine 4-day site visits. Using an approach designed to foster development of high-functioning teams, individual CLC neighborhoods (ie, units) developed and implemented neighborhood-initiated, neighborhood-based pilot projects, such as an individualized finger foods dining option for residents with dementia who became distressed when sitting at a table during a meal. Outcomes of these projects included improved staff communication and staff satisfaction, particularly psychological safety.

In the concurrently conducted pilot research study, a research team comprehensively assessed the person-centered care efforts of 3 CLCs prior to their construction of Green House-type (small house) homes. This mixed-methods study included more than 50 qualitative interviews conducted with VA medical center leadership and CLC staff and residents. Researchers also administered online employee surveys and conducted site visits, including more than 60 hours of direct observation of CLC life and team functioning. The local institutional review boards approved all study procedures, and researchers notified local unions.

Analyses highlighted 2 important aspects of person-centered care not captured by then-existing measurement instruments: the type, quality, and number of staff/resident interactions and the type, quality, and level of resident engagement. The team therefore developed a structured, systematic, observation-based instrument to measure these concepts.⁵ But while researchers found this instrument useful, it was too complex to be used by CLC staff for QI.

LOCK Quality Improvement

A later and larger research study addressed this issue. In the study, researchers worked with CLC staff to convert the complex observation-based research instrument into several structured tools that were easier for CLC staff to use.⁶ The researchers then incorporated their experience with the prior local innovation project and designed and implemented a QI program, which operationalized an evidence-based bundle of practices to implement the new tools in 6 CLCs. Researchers called the bundle of practices “LOCK”: (1) Learn from the bright spots; (2) Observe; (3) Collaborate in huddles; and (4) Keep it bite-sized.

Learn from the bright spots. Studies on strengths-based learning indicate that recognizing and sharing positive instances of ideal practice helps provide clear direction regarding what needs to be done differently to achieve success. Identifying and learning from outlying instances of successful practice encourages staff to continue those behaviors and gives staff tangible examples of how they may improve.^16-19 That is, concentrating on instances where a negative outcome was at risk of occurring but did not occur (ie, a positive outlier or “bright spot”) enables staff to analyze what facilitated the success and design and pilot strategies to replicate it.

Observe. Human factors engineering is built on the principle that integrated approaches for studying work systems can identify areas for improvement.⁸ Observation is a key tool in this approach. A recent review of 69 studies that used observation to assess clinical performance found it useful in identifying factors affecting quality and safety.⁹

Collaborate in huddles. A necessary component to overcoming barriers to successful QI is having high-functioning teams effectively coordinate work. In the theory of relational coordination, this is operationalized as high-quality interactions (frequent, timely, and accurate communication) and high-quality relationships (share knowledge, shared goals, and mutual respect).^10,11 Improved relational coordination can lead to higher quality of care outcomes and job satisfaction by enabling individuals to manage their tasks with less delay, more rapid and effective responses, fewer errors, and less wasted effort.¹²

Keep it bite-sized. Regular practice of a new behavior is one of the keys to making that new behavior part of an automatic routine (ie, a habit). To be successfully integrated into staff work routines, QI initiatives must be perceived as congruent with and easily integrated into care goals and workplace practices. Quick, focused, team-building and solution-oriented QI initiatives, therefore, have the greatest chance of success, particularly if staff feel they have little time for participating in new initiatives.¹³

Researchers designed the 4 LOCK practices to be interrelated and build on one another, creating a bundle to be used together to help facilitate positive change in resident/staff interactions and resident engagement.⁷ For 6 months, researchers studied the 6 CLCs’ use of the new structured observation tools as part of the LOCK-based QI program. The participating CLCs had such success in improving staff interactions with residents and residents’ engagement in CLC life that GEC, under the CONCERT umbrella, rolled out the LOCK bundle of practices to CLCs nationwide.²⁰

CONCERT’s current activities focus on helping CLCs implement the LOCK bundle nationwide as a relational coordination-based national QI initiative designed to improve quality of care and staff satisfaction. The CONCERT team began this implementation in FY 2017 using a train-the-trainer approach through a staggered veterans integrated service network (VISN) rollout. Each CLC sent 2 leaders to a VISN-wide training program at a host CLC site (the host site was able to have more participants attend). Afterward, the CONCERT team provided individualized phone support to help CLCs implement the program. A VA Pulse (intranet-based social media portal) site hosts all training materials, program videos, an active blog, community discussions, etc.

In FY 2018, the program shifted to a VISN-based support system, with a CONCERT team member assigned to each VISN and VISN-based webinars to facilitate information exchange, collaboration, and group learning. In FY 2018, the CONCERT team also conducted site visits to selected CLCs with strong implementation success records to learn about program facilitators and to disseminate the lessons learned. Spanning FYs 2018 and 2019, the CONCERT team also supports historically low-performing CLCs through a series of rapid-cycle learning intensives based on the Institute for Healthcare Improvement breakthrough collaborative series model for accelerated and sustained QI.²¹ These incorporate in-person or virtual learning sessions, in which participants learn about and share effective practices, and between-session learning assignments, to facilitate the piloting, implementation, and sustainment of system changes. As part of the CONCERT continuous QI process, the CONCERT team closely monitors the impact of the program and continues to pilot, adapt, and change practices as it learns more about how best to help CLCs improve.

Conclusion

A key CONCERT principle is that health care systems create health care outcomes. The CONCERT team uses the theory of relational coordination to support implementation of the LOCK bundle of practices to help CLCs change their systems to achieve high performance. Through implementation of the LOCK bundle of practices, CLC staff develop, pilot, and spread new systems for communication, teamwork, and collaborative problem solving, as well as developing skills to participate effectively in these systems. CONCERT represents just 1 way VA supports CLCs in their continual journeys toward ever-improved quality of veteran care.

Acknowledgments
The authors thank Barbara Frank and Cathie Brady for their contributions to the development of the CONCERT program.

Many veterans of the Gulf War are experiencing deployment-related chronic illness, known as Gulf War illness (GWI). Symptoms of GWI include cognitive impairments (mood and memory), chronic fatigue, musculoskeletal pain, gastrointestinal (GI) disorders, respiratory problems, and skin rashes.^1-4 Three survey studies of the physical and mental health of a large cohort of Gulf War and Gulf era veterans, conducted by the US Department of Veterans Affairs (VA) Office of Public Health, established the increased prevalence of GWI in the decades that followed the end of the conflict.^5-7 Thus, GWI has become the signature adverse health-related outcome of the Gulf War. Quality improvement (QI) within the Veterans Health Administration (VHA) is needed in the diagnosis and treatment of GWI.

Background

GWI was first termed chronic multisymptom illness (CMI) by the Centers for Disease Control and Prevention (CDC). According to the CDC-10 case definition, CMI in veterans of the 1990-1991 Gulf War is defined as having ≥ 1 symptoms lasting ≥ 6 months in at least 2 of 3 categories: fatigue, depressed mood and altered cognition, and musculoskeletal pain.³ The Kansas case definition of GWI is more specific and is defined as having moderate-to-severe symptoms that are unexplained by any other diagnosis, in at least 3 of 6 categories: fatigue/sleep, somatic pain, neurologic/cognition/mood, GI, respiratory, and skin.⁴ Although chronic unexplained symptoms have occurred after other modern conflicts, the prevalence of GWI among Gulf War veterans has proven higher than those of prior conflicts.⁸

The Persian Gulf War Veterans Act of 1998 and the Veterans Programs Enhancement Act of 1998 mandated studies by the Institute of Medicine (IOM) on the biologic and chemical exposures that may have contributed to illness in the Kuwaiti theater of operations.⁹ However, elucidating the etiology and underlying pathophysiology of GWI has been a major research challenge. In the absence of objective diagnostic measures, an understanding of the fundamental pathophysiology, evidence-based treatments, a single case definition, and definitive guidelines for health care providers (HCPs) for the diagnosis and management of GWI has not been produced. As a result, veterans with GWI have struggled for nearly 3 decades to find a consistent diagnosis of and an effective treatment for their condition.

According to a report by the Government Accountability Office (GAO), the VA approved only 17% of claims for compensation for veterans with GWI from 2011 to 2015, about one-third the level of approval for all other claimed disabilities.¹⁰ Although the VA applied GAO recommendations to improve the compensation process, many veterans consider that their illness is treated as psychosomatic in clinical practice, despite emerging evidence of GWI-associated biomarkers.¹¹ Others think they have been forgotten due to their short 1-year period of service in the Gulf War.¹² To realign research, guidelines, clinical care, and the health care experience of veterans with GWI, focused QI within VHA is urgently needed.

Veterans of Operations Enduring Freedom, Iraqi Freedom, and New Dawn (OEF/OIF/OND) are experiencing similar CMI symptoms. A study of US Army Reserve OEF/OIF veterans found that > 60% met the CDC-10 case definition for GWI 1-year postdeployment.¹³ Thus, CMI is emerging as a serious health problem for post-9/11 veterans. The evidence of postdeployment CMI among veterans of recent conflicts underscores the need to increase efforts at a national level, beginning with the VHA. This report includes a summary of Gulf War veterans’ experiences at the Minneapolis VA Health Care System (MVAHCS) and a proposal for QI of MVAHCS processes focused on HCP education and clinical care.

Methods

To determine areas of GWI health care that needed QI at the MVAHCS, veterans with GWI were contacted for a telephone survey. These veterans had participated in the Gulf War Illness Inflammation Reduction Trial (ClinicalTrials.gov. Identifier: NCT02506192). Therefore, all met the Kansas case definition for GWI.⁴ The aim of the survey was to characterize veterans’ experiences seeking health care for chronic postdeployment symptoms.

Sixty Gulf War veterans were contacted by telephone and invited to participate in a 15-minute survey about their experience seeking diagnosis and treatment for GWI. They were informed that the survey was voluntary and confidential, that it was not part of the research trial in which they had been enrolled, and that their participation would not affect compensation received from VA. Verbal consent was requested, and 30 veterans agreed to participate in the survey.

The survey included questions about the course of illness, disability and service connection status, HCPs seen, and suggestions for improvement in their care (Table 1). 

Results

Of the 30 veterans who participated in the survey, most were male with only 2 female veterans. This proportion of female veterans (7%) is similar to the overall percentage of female veterans (6.7%) of the first Gulf War.² Ages ranged from 46 to 66 years with a mean age of 53. Mean duration of illness, defined as time elapsed since perceived onset of chronic systemic symptoms during or after deployment, was 22.8 years, with a range of 4 to 27 years. Most respondents reported symptom onset within a few years after the end of the conflict, while a few reported the onset within weeks of arriving in the Kuwaiti theater of operations. A little more than half the respondents considered themselves disabled due to their symptoms, while one-third reported losing the ability to work due to symptoms. Respondents described needing to reduce hours, retire early, or stop working altogether because of their symptoms.

Respondents attributed several common chronic symptoms to deployment in the Gulf Wars (Table 2). 

Most veterans surveyed were service connected for individual chronic symptoms. Some were service connected for systemic conditions such as fibromyalgia (FM), chronic fatigue syndrome (CFS), and irritable bowel syndrome (IBS) (5 veterans were connected for each condition). Three of the 30 veterans had been diagnosed with GWI—2 by past VA physicians and 1 by a physician at a GWI research center in another state. Of those 3, only 1 was service connected for the condition. Three respondents were not service connected at all.

The most common VA HCPs seen were in primary care and neurology followed by psychiatry and psychology. Of non-VA HCPs, most respondents saw primary care providers (PCPs) followed by chiropractors (Table 4).

Before taking the Gulf War survey, a broad subjective question was posed. Respondents were asked whether VA HCPs were “supportive as you sought care for chronic postdeployment symptoms.” A majority of veterans reported that their VA HCPs were supportive. Reasons veterans gave for VA HCPs lack of support included feeling that HCPs did not believe them or trust their reported symptoms; did not care about their symptoms; refused to attribute their symptoms to Gulf War deployment; attributed symptoms to mental health issues; focused on doing things a certain way; or did not have the tools or information necessary to help.

Most non-VA HCPs were supportive. Reasons community HCPs were not supportive included “not looking at the whole picture,” not knowing veteran issues, not feeling comfortable with GWI, or not having much they could do.

Veterans were then asked whether they felt their HCPs were knowledgeable about GWI, and 13 respondents reported that their HCP was knowledgeable. Reasons respondents felt VA HCPs were not knowledgeable included denying that GWI exists, attributing symptoms to other conditions, not being aware of or familiar with GWI, needing education from the veteran, avoiding discussion about GWI or not caring to learn, or not knowing the latest research evidence to talk about GWI with authority. Compared with VA HCPs, veterans found community HCPs about half as likely to be knowledgeable about GWI. Many reported that community HCPs had not heard of GWI or had no knowledge about it.

Respondents also were asked what types of treatments they tried in order to typify the care received. The most common responses were pain medications, symptom-specific treatments, or “just putting up with it” (no treatment). Many patients were also self-medicating, trying lifestyle changes, or seeking alternative therapies.

Finally, respondents were asked on a scale of 0 (very unsatisfied) to 5 (very satisfied), how satisfied they were with their overall care at the VA. The majority were satisfied with their overall care, with two-thirds very satisfied (5 of 5) or pretty satisfied (4 of 5). Only 3 (10%) were unsatisfied or very unsatisfied. Respondents had the following comments about their care: “They treat me like I am important;” “I am very thankful even though they cannot figure it out;” “They are doing the best they can with no answers and not enough help;” “[I know] it is still a work in progress.” A number of respondents were satisfied with some HCPs or care for some but not all of their symptoms. Reasons respondents were less satisfied included desiring answers, feeling they were not respected, or feeling that their concerns were not addressed.

When asked for suggestions for improvement of GWI care, the most common response was providing up-to-date HCP education (Table 5).

Discussion

The veterans participating in this QI survey had similar demographics, symptomology, and exposures as did those in other studies.^1-7 Therefore, improvements based on their responses are likely applicable to the health care of veterans experiencing GWI-associated symptoms at other VA health care systems as well.

Veterans with GWI can lose significant functional capacity and productivity due to their symptoms. The symptoms are chronic and have afflicted many Gulf War veterans for nearly 3 decades. Furthermore, the prevalence of GWI in Gulf War veterans continues to increase.^5-7 These facts testify to the enormous health-related quality-of-life impact of GWI.

Veterans who meet the Kansas case definition for GWI were not diagnosed or service connected in a uniform manner. Only 3 of the 30 veterans in this study were given a unifying diagnosis that connected their chronic illness to Gulf War deployment. Under current guidelines, Gulf War veterans are able to receive compensation for chronic symptoms in 3 ways: (1) compensation for chronic unexplained symptoms existing for ≥ 6 months that appeared during active duty in the Southwest Asia theater or by December 31, 2021, and are ≥ 10% disabling; (2) the 1995 Persian Gulf War Veterans’ Act recognizes 3 multisymptom illnesses for which veterans can be service connected: FM, CFS, and functional GI disorders, including IBS; and (3) expansion to include any CMI of unknown etiology is underway. A uniform diagnostic protocol based on biomarkers and updated understanding of disease pathology would be helpful.

Respondents shared experiences that demonstrated perceived gaps in HCP support or knowledge. Overall, more respondents found their HCPs supportive. Many of the reasons respondents found HCPs unsupportive related to acknowledgment of symptoms. Also, more respondents found that both VA and non-VA HCPs lacked knowledge about GWI symptoms. These findings further highlight the need for HCP education within the VA and in community-based care.

The treatments tried by respondents also highlight potential areas for improvement. Most of the treatments were for pain; therefore, more involvement with pain clinics and specialists could be helpful. Symptom-specific medications also are appropriate, although only one-third of patients reported use. While medications are not necessarily markers of quality care, the fact that many patients self-medicate or go without treatment suggests that access to care could be improved. In 2014, the VA and the US Department of Defense (DoD) released the “VA/DoD Clinical Practice Guideline for the Management of Chronic Multisymptom Illness,” which recommended treatments for the global disease and specific symptoms.¹⁵

Since then, GWI research points to inflammatory and metabolic disease mechanisms.^11-14,16 As the underlying pathophysiology is further elucidated, practice guidelines will need to be updated to include anti-inflammatory and antioxidant treatments used in practice for GWI and similar chronic systemic illnesses (eg, CFS, FM, and IBS).^17-19

Randomized control trials are needed to determine the efficacy of such medications for the treatment of GWI. As new results emerge, disseminating and updating evidence-based guidelines in a coordinated manner will be required for veterans to receive appropriate treatment. Veterans also seek alternative or nonpharmaceutical interventions, such as physical therapy and diet changes. Improving access to integrative medicine, physical therapy, nutritionists, and other practitioners also could optimize veterans’ health and function.

HCP Education

The Gulf War veteran respondents who participated in the survey noted HCP education, research progress, and veteran inclusion as areas for improvement. Respondents requested dissemination of information on diagnosis and treatment of GWI for HCPs and updates on research and other actions. They suggested ways research could be more effective (such as subgrouping by exposure, which researchers have been doing) and could extend to veterans experiencing CMI from other conflicts as well.²⁰ Respondents also recommended team approaches or centers of excellence in order to receive more comprehensive care.

An asset of VHA is the culture of QI and education. The VA Employee Education System previously produced “Caring for Gulf War I Veterans,” a systemwide training module.²¹ In 2014, updated clinical practice guidelines for GWI were provided by the VA and the DoD, including evidence for each recommendation. In 2016, the VA in collaboration with the IOM produced a report summarizing conclusions and recommendations regarding associations between health concerns and Gulf War deployment.²² A concise guide for HCPs caring for veterans with GWI, updated in 2018, is available.²³ Updated treatment guidelines, based on evolving understanding of GWI pathophysiology, and continuing efforts to disseminate information will be essential.

Respondents most often presented to primary care, both within and outside of MVAHCS. Therefore, VA and community PCPs who see veterans should be equipped to recognize and diagnose GWI as well as be familiar with basic disease management and specialists whom they could refer their patients. Neurology was the second most common specialty seen by respondents. The most prominent symptoms of GWI are related to nervous system function in addition to evidence of underlying neuroinflammation.²⁰ Veterans may present to a neurologist with a variety of concerns, such as cognitive issues, sleep problems, migraines and headaches, and pain. Neurologists could best manage treatments targeting common neurologic GWI symptoms and neuroinflammation, especially as new treatments are discovered.

The next 2 most common specialty services seen were psychiatry and psychology (7 responses for each). Five respondents reported mental health issues as part of their chronic postdeployment symptoms. Population-based studies have indicated that rates of PTSD in Gulf War veterans is 3% to 6%, much lower than the prevalence of GWI.^8,20 The 2010 IOM study concluded that GWI symptoms cannot be ascribed to any known psychiatric disorder. Unfortunately, several surveyed veterans made it clear that they had been denied care due to HCPs attributing their symptoms solely to mental health issues. Therefore, psychiatrists and psychologists must be educated about GWI, mental health issues occurring in Gulf War veterans, and physiologic symptoms of GWI that may mimic or coincide with mental health issues. These HCPs also would be important to include in an interdisciplinary clinic for veterans with GWI.

Finally, respondents sought care from numerous other specialties, including gastroenterology, physical therapy, pulmonology, dermatology, and surgical subspecialties, such as orthopedics and otolaryngology. This wide range of specialists seen emphasizes the need for medical education, beginning in medical school. If provided education on GWI, these specialists would be able to treat veterans with GWI, know to look for updates on GWI management, or know to look for other common symptoms, such as chronic sinusitis in otolaryngology or recurring rashes in dermatology. We also recommend identifying HCPs in these specialties who could be part of an interdisciplinary clinic or be referrals for symptom management.

Protocol Implementation

HCP education and clinical care protocol implementation should be the initial focus of improving GWI management. A team of stakeholders within the different areas of MVAHCS, including education, HCPs, and administrative staff, will need to be developed. Reaching out to VA HCPs who have seen veterans with GWI will be an essential first step to equip them with updated education about the diagnosis and management of CMI. Providing integrated widespread education to current HCPs who are likely to encounter veterans with deployment-related CMI from the Gulf War, OND/OEF/OIF, or other deployments also will be necessary. Finally, educating medical trainees, including residents and medical students, will ensure continuous care for future veterans, post-9/11 veterans.

GWI presentations at medical grand rounds or at other medical community educational events could provide educational outlets. These events create face-to-face opportunities to discuss GWI/CMI education with HCPs, giving them the opportunity to offer feedback about their experiences and create relationships with other HCPs who have seen patients with GWI/CMI. At an educational event, a short postevent feedback form that indicates whether HCPs would like more information or get involved in a clinic for veterans with CMI could be included. This information would help identify key HCPs and areas within the local VA needing further improvements, such as creating a clinic for veterans with GWI.

Since 1946, the VA has worked with academic institutions to provide state-of-the-art health care to US veterans and train new HCPs to meet the health care needs of the nation. Every year, > 40,000 residents and 20,000 medical students receive medical training at VA facilities, making VA the largest single provider of medical education in the country. Therefore, providing detailed GWI/CMI education to medical students and residents as a standard part of the VA Talent Management System would be of value for all VA professionals.

GWI Clinics

Access to comprehensive care can be accomplished by organizing a clinic for veterans with GWI. The most likely effective location would be in primary care. PCPs who have seen veterans with GWI and/or expressed interest in learning more about GWI will be the initial point of contact. As the primary care service has connections to ancillary services, such as pharmacists, dieticians, psychologists, and social workers, organizing 1 day each week to see patients with GWI would improve care.

As the need for specialty care arises, the team also would need to identify specialists willing to receive referrals from HCPs of veterans with GWI. These specialists could be identified via feedback forms from educational events, surveys after an online educational training, or through relationships among VA physicians. As the clinic becomes established, it may be effective to have certain commonly seen specialists available in person, most likely neurology, psychiatry, gastroenterology, pulmonology, and dermatology. Also, relationships with a pain clinic, sleep medicine, and integrative medicine services should be established.

Measures of improvement in the veteran health care experience could include veterans’ perceptions of the supportiveness and knowledge of physicians about GWI as well as overall satisfaction. A follow-up survey on these measures of veterans involved in a GWI clinic and those not involved would be a way to determine whether these clinics better meet veterans’ needs and what additional QI is needed.

Conclusion

A significant number of Gulf War veterans experience chronic postdeployment symptoms that need to be better addressed. Physicians need to be equipped to recognize and manage GWI and similar postdeployment CMI among veterans of OEF/OIF/OND. We recommend creating an educational initiative about GWI among VA physicians and trainees, connecting physicians who see veterans with GWI, and establishing an interdisciplinary clinic with a referral system as the next steps to improve care for veterans. An additional goal would be to reach out to veteran networks to update them on GWI research, education, and available health care, as veterans are the essential stakeholders in the QI process.

Many veterans of the Gulf War are experiencing deployment-related chronic illness, known as Gulf War illness (GWI). Symptoms of GWI include cognitive impairments (mood and memory), chronic fatigue, musculoskeletal pain, gastrointestinal (GI) disorders, respiratory problems, and skin rashes.^1-4 Three survey studies of the physical and mental health of a large cohort of Gulf War and Gulf era veterans, conducted by the US Department of Veterans Affairs (VA) Office of Public Health, established the increased prevalence of GWI in the decades that followed the end of the conflict.^5-7 Thus, GWI has become the signature adverse health-related outcome of the Gulf War. Quality improvement (QI) within the Veterans Health Administration (VHA) is needed in the diagnosis and treatment of GWI.

Background

GWI was first termed chronic multisymptom illness (CMI) by the Centers for Disease Control and Prevention (CDC). According to the CDC-10 case definition, CMI in veterans of the 1990-1991 Gulf War is defined as having ≥ 1 symptoms lasting ≥ 6 months in at least 2 of 3 categories: fatigue, depressed mood and altered cognition, and musculoskeletal pain.³ The Kansas case definition of GWI is more specific and is defined as having moderate-to-severe symptoms that are unexplained by any other diagnosis, in at least 3 of 6 categories: fatigue/sleep, somatic pain, neurologic/cognition/mood, GI, respiratory, and skin.⁴ Although chronic unexplained symptoms have occurred after other modern conflicts, the prevalence of GWI among Gulf War veterans has proven higher than those of prior conflicts.⁸

The Persian Gulf War Veterans Act of 1998 and the Veterans Programs Enhancement Act of 1998 mandated studies by the Institute of Medicine (IOM) on the biologic and chemical exposures that may have contributed to illness in the Kuwaiti theater of operations.⁹ However, elucidating the etiology and underlying pathophysiology of GWI has been a major research challenge. In the absence of objective diagnostic measures, an understanding of the fundamental pathophysiology, evidence-based treatments, a single case definition, and definitive guidelines for health care providers (HCPs) for the diagnosis and management of GWI has not been produced. As a result, veterans with GWI have struggled for nearly 3 decades to find a consistent diagnosis of and an effective treatment for their condition.

According to a report by the Government Accountability Office (GAO), the VA approved only 17% of claims for compensation for veterans with GWI from 2011 to 2015, about one-third the level of approval for all other claimed disabilities.¹⁰ Although the VA applied GAO recommendations to improve the compensation process, many veterans consider that their illness is treated as psychosomatic in clinical practice, despite emerging evidence of GWI-associated biomarkers.¹¹ Others think they have been forgotten due to their short 1-year period of service in the Gulf War.¹² To realign research, guidelines, clinical care, and the health care experience of veterans with GWI, focused QI within VHA is urgently needed.

Veterans of Operations Enduring Freedom, Iraqi Freedom, and New Dawn (OEF/OIF/OND) are experiencing similar CMI symptoms. A study of US Army Reserve OEF/OIF veterans found that > 60% met the CDC-10 case definition for GWI 1-year postdeployment.¹³ Thus, CMI is emerging as a serious health problem for post-9/11 veterans. The evidence of postdeployment CMI among veterans of recent conflicts underscores the need to increase efforts at a national level, beginning with the VHA. This report includes a summary of Gulf War veterans’ experiences at the Minneapolis VA Health Care System (MVAHCS) and a proposal for QI of MVAHCS processes focused on HCP education and clinical care.

Methods

To determine areas of GWI health care that needed QI at the MVAHCS, veterans with GWI were contacted for a telephone survey. These veterans had participated in the Gulf War Illness Inflammation Reduction Trial (ClinicalTrials.gov. Identifier: NCT02506192). Therefore, all met the Kansas case definition for GWI.⁴ The aim of the survey was to characterize veterans’ experiences seeking health care for chronic postdeployment symptoms.

Sixty Gulf War veterans were contacted by telephone and invited to participate in a 15-minute survey about their experience seeking diagnosis and treatment for GWI. They were informed that the survey was voluntary and confidential, that it was not part of the research trial in which they had been enrolled, and that their participation would not affect compensation received from VA. Verbal consent was requested, and 30 veterans agreed to participate in the survey.

The survey included questions about the course of illness, disability and service connection status, HCPs seen, and suggestions for improvement in their care (Table 1). 

Results

Of the 30 veterans who participated in the survey, most were male with only 2 female veterans. This proportion of female veterans (7%) is similar to the overall percentage of female veterans (6.7%) of the first Gulf War.² Ages ranged from 46 to 66 years with a mean age of 53. Mean duration of illness, defined as time elapsed since perceived onset of chronic systemic symptoms during or after deployment, was 22.8 years, with a range of 4 to 27 years. Most respondents reported symptom onset within a few years after the end of the conflict, while a few reported the onset within weeks of arriving in the Kuwaiti theater of operations. A little more than half the respondents considered themselves disabled due to their symptoms, while one-third reported losing the ability to work due to symptoms. Respondents described needing to reduce hours, retire early, or stop working altogether because of their symptoms.

Respondents attributed several common chronic symptoms to deployment in the Gulf Wars (Table 2). 

Most veterans surveyed were service connected for individual chronic symptoms. Some were service connected for systemic conditions such as fibromyalgia (FM), chronic fatigue syndrome (CFS), and irritable bowel syndrome (IBS) (5 veterans were connected for each condition). Three of the 30 veterans had been diagnosed with GWI—2 by past VA physicians and 1 by a physician at a GWI research center in another state. Of those 3, only 1 was service connected for the condition. Three respondents were not service connected at all.

The most common VA HCPs seen were in primary care and neurology followed by psychiatry and psychology. Of non-VA HCPs, most respondents saw primary care providers (PCPs) followed by chiropractors (Table 4).

Before taking the Gulf War survey, a broad subjective question was posed. Respondents were asked whether VA HCPs were “supportive as you sought care for chronic postdeployment symptoms.” A majority of veterans reported that their VA HCPs were supportive. Reasons veterans gave for VA HCPs lack of support included feeling that HCPs did not believe them or trust their reported symptoms; did not care about their symptoms; refused to attribute their symptoms to Gulf War deployment; attributed symptoms to mental health issues; focused on doing things a certain way; or did not have the tools or information necessary to help.

Most non-VA HCPs were supportive. Reasons community HCPs were not supportive included “not looking at the whole picture,” not knowing veteran issues, not feeling comfortable with GWI, or not having much they could do.

Veterans were then asked whether they felt their HCPs were knowledgeable about GWI, and 13 respondents reported that their HCP was knowledgeable. Reasons respondents felt VA HCPs were not knowledgeable included denying that GWI exists, attributing symptoms to other conditions, not being aware of or familiar with GWI, needing education from the veteran, avoiding discussion about GWI or not caring to learn, or not knowing the latest research evidence to talk about GWI with authority. Compared with VA HCPs, veterans found community HCPs about half as likely to be knowledgeable about GWI. Many reported that community HCPs had not heard of GWI or had no knowledge about it.

Respondents also were asked what types of treatments they tried in order to typify the care received. The most common responses were pain medications, symptom-specific treatments, or “just putting up with it” (no treatment). Many patients were also self-medicating, trying lifestyle changes, or seeking alternative therapies.

Finally, respondents were asked on a scale of 0 (very unsatisfied) to 5 (very satisfied), how satisfied they were with their overall care at the VA. The majority were satisfied with their overall care, with two-thirds very satisfied (5 of 5) or pretty satisfied (4 of 5). Only 3 (10%) were unsatisfied or very unsatisfied. Respondents had the following comments about their care: “They treat me like I am important;” “I am very thankful even though they cannot figure it out;” “They are doing the best they can with no answers and not enough help;” “[I know] it is still a work in progress.” A number of respondents were satisfied with some HCPs or care for some but not all of their symptoms. Reasons respondents were less satisfied included desiring answers, feeling they were not respected, or feeling that their concerns were not addressed.

When asked for suggestions for improvement of GWI care, the most common response was providing up-to-date HCP education (Table 5).

Discussion

The veterans participating in this QI survey had similar demographics, symptomology, and exposures as did those in other studies.^1-7 Therefore, improvements based on their responses are likely applicable to the health care of veterans experiencing GWI-associated symptoms at other VA health care systems as well.

Veterans with GWI can lose significant functional capacity and productivity due to their symptoms. The symptoms are chronic and have afflicted many Gulf War veterans for nearly 3 decades. Furthermore, the prevalence of GWI in Gulf War veterans continues to increase.^5-7 These facts testify to the enormous health-related quality-of-life impact of GWI.

Veterans who meet the Kansas case definition for GWI were not diagnosed or service connected in a uniform manner. Only 3 of the 30 veterans in this study were given a unifying diagnosis that connected their chronic illness to Gulf War deployment. Under current guidelines, Gulf War veterans are able to receive compensation for chronic symptoms in 3 ways: (1) compensation for chronic unexplained symptoms existing for ≥ 6 months that appeared during active duty in the Southwest Asia theater or by December 31, 2021, and are ≥ 10% disabling; (2) the 1995 Persian Gulf War Veterans’ Act recognizes 3 multisymptom illnesses for which veterans can be service connected: FM, CFS, and functional GI disorders, including IBS; and (3) expansion to include any CMI of unknown etiology is underway. A uniform diagnostic protocol based on biomarkers and updated understanding of disease pathology would be helpful.

Respondents shared experiences that demonstrated perceived gaps in HCP support or knowledge. Overall, more respondents found their HCPs supportive. Many of the reasons respondents found HCPs unsupportive related to acknowledgment of symptoms. Also, more respondents found that both VA and non-VA HCPs lacked knowledge about GWI symptoms. These findings further highlight the need for HCP education within the VA and in community-based care.

The treatments tried by respondents also highlight potential areas for improvement. Most of the treatments were for pain; therefore, more involvement with pain clinics and specialists could be helpful. Symptom-specific medications also are appropriate, although only one-third of patients reported use. While medications are not necessarily markers of quality care, the fact that many patients self-medicate or go without treatment suggests that access to care could be improved. In 2014, the VA and the US Department of Defense (DoD) released the “VA/DoD Clinical Practice Guideline for the Management of Chronic Multisymptom Illness,” which recommended treatments for the global disease and specific symptoms.¹⁵

Since then, GWI research points to inflammatory and metabolic disease mechanisms.^11-14,16 As the underlying pathophysiology is further elucidated, practice guidelines will need to be updated to include anti-inflammatory and antioxidant treatments used in practice for GWI and similar chronic systemic illnesses (eg, CFS, FM, and IBS).^17-19

Randomized control trials are needed to determine the efficacy of such medications for the treatment of GWI. As new results emerge, disseminating and updating evidence-based guidelines in a coordinated manner will be required for veterans to receive appropriate treatment. Veterans also seek alternative or nonpharmaceutical interventions, such as physical therapy and diet changes. Improving access to integrative medicine, physical therapy, nutritionists, and other practitioners also could optimize veterans’ health and function.

HCP Education

The Gulf War veteran respondents who participated in the survey noted HCP education, research progress, and veteran inclusion as areas for improvement. Respondents requested dissemination of information on diagnosis and treatment of GWI for HCPs and updates on research and other actions. They suggested ways research could be more effective (such as subgrouping by exposure, which researchers have been doing) and could extend to veterans experiencing CMI from other conflicts as well.²⁰ Respondents also recommended team approaches or centers of excellence in order to receive more comprehensive care.

An asset of VHA is the culture of QI and education. The VA Employee Education System previously produced “Caring for Gulf War I Veterans,” a systemwide training module.²¹ In 2014, updated clinical practice guidelines for GWI were provided by the VA and the DoD, including evidence for each recommendation. In 2016, the VA in collaboration with the IOM produced a report summarizing conclusions and recommendations regarding associations between health concerns and Gulf War deployment.²² A concise guide for HCPs caring for veterans with GWI, updated in 2018, is available.²³ Updated treatment guidelines, based on evolving understanding of GWI pathophysiology, and continuing efforts to disseminate information will be essential.

Respondents most often presented to primary care, both within and outside of MVAHCS. Therefore, VA and community PCPs who see veterans should be equipped to recognize and diagnose GWI as well as be familiar with basic disease management and specialists whom they could refer their patients. Neurology was the second most common specialty seen by respondents. The most prominent symptoms of GWI are related to nervous system function in addition to evidence of underlying neuroinflammation.²⁰ Veterans may present to a neurologist with a variety of concerns, such as cognitive issues, sleep problems, migraines and headaches, and pain. Neurologists could best manage treatments targeting common neurologic GWI symptoms and neuroinflammation, especially as new treatments are discovered.

The next 2 most common specialty services seen were psychiatry and psychology (7 responses for each). Five respondents reported mental health issues as part of their chronic postdeployment symptoms. Population-based studies have indicated that rates of PTSD in Gulf War veterans is 3% to 6%, much lower than the prevalence of GWI.^8,20 The 2010 IOM study concluded that GWI symptoms cannot be ascribed to any known psychiatric disorder. Unfortunately, several surveyed veterans made it clear that they had been denied care due to HCPs attributing their symptoms solely to mental health issues. Therefore, psychiatrists and psychologists must be educated about GWI, mental health issues occurring in Gulf War veterans, and physiologic symptoms of GWI that may mimic or coincide with mental health issues. These HCPs also would be important to include in an interdisciplinary clinic for veterans with GWI.

Finally, respondents sought care from numerous other specialties, including gastroenterology, physical therapy, pulmonology, dermatology, and surgical subspecialties, such as orthopedics and otolaryngology. This wide range of specialists seen emphasizes the need for medical education, beginning in medical school. If provided education on GWI, these specialists would be able to treat veterans with GWI, know to look for updates on GWI management, or know to look for other common symptoms, such as chronic sinusitis in otolaryngology or recurring rashes in dermatology. We also recommend identifying HCPs in these specialties who could be part of an interdisciplinary clinic or be referrals for symptom management.

Protocol Implementation

HCP education and clinical care protocol implementation should be the initial focus of improving GWI management. A team of stakeholders within the different areas of MVAHCS, including education, HCPs, and administrative staff, will need to be developed. Reaching out to VA HCPs who have seen veterans with GWI will be an essential first step to equip them with updated education about the diagnosis and management of CMI. Providing integrated widespread education to current HCPs who are likely to encounter veterans with deployment-related CMI from the Gulf War, OND/OEF/OIF, or other deployments also will be necessary. Finally, educating medical trainees, including residents and medical students, will ensure continuous care for future veterans, post-9/11 veterans.

GWI presentations at medical grand rounds or at other medical community educational events could provide educational outlets. These events create face-to-face opportunities to discuss GWI/CMI education with HCPs, giving them the opportunity to offer feedback about their experiences and create relationships with other HCPs who have seen patients with GWI/CMI. At an educational event, a short postevent feedback form that indicates whether HCPs would like more information or get involved in a clinic for veterans with CMI could be included. This information would help identify key HCPs and areas within the local VA needing further improvements, such as creating a clinic for veterans with GWI.

Since 1946, the VA has worked with academic institutions to provide state-of-the-art health care to US veterans and train new HCPs to meet the health care needs of the nation. Every year, > 40,000 residents and 20,000 medical students receive medical training at VA facilities, making VA the largest single provider of medical education in the country. Therefore, providing detailed GWI/CMI education to medical students and residents as a standard part of the VA Talent Management System would be of value for all VA professionals.

GWI Clinics

Access to comprehensive care can be accomplished by organizing a clinic for veterans with GWI. The most likely effective location would be in primary care. PCPs who have seen veterans with GWI and/or expressed interest in learning more about GWI will be the initial point of contact. As the primary care service has connections to ancillary services, such as pharmacists, dieticians, psychologists, and social workers, organizing 1 day each week to see patients with GWI would improve care.

As the need for specialty care arises, the team also would need to identify specialists willing to receive referrals from HCPs of veterans with GWI. These specialists could be identified via feedback forms from educational events, surveys after an online educational training, or through relationships among VA physicians. As the clinic becomes established, it may be effective to have certain commonly seen specialists available in person, most likely neurology, psychiatry, gastroenterology, pulmonology, and dermatology. Also, relationships with a pain clinic, sleep medicine, and integrative medicine services should be established.

Measures of improvement in the veteran health care experience could include veterans’ perceptions of the supportiveness and knowledge of physicians about GWI as well as overall satisfaction. A follow-up survey on these measures of veterans involved in a GWI clinic and those not involved would be a way to determine whether these clinics better meet veterans’ needs and what additional QI is needed.

Conclusion

A significant number of Gulf War veterans experience chronic postdeployment symptoms that need to be better addressed. Physicians need to be equipped to recognize and manage GWI and similar postdeployment CMI among veterans of OEF/OIF/OND. We recommend creating an educational initiative about GWI among VA physicians and trainees, connecting physicians who see veterans with GWI, and establishing an interdisciplinary clinic with a referral system as the next steps to improve care for veterans. An additional goal would be to reach out to veteran networks to update them on GWI research, education, and available health care, as veterans are the essential stakeholders in the QI process.

Many veterans of the Gulf War are experiencing deployment-related chronic illness, known as Gulf War illness (GWI). Symptoms of GWI include cognitive impairments (mood and memory), chronic fatigue, musculoskeletal pain, gastrointestinal (GI) disorders, respiratory problems, and skin rashes.^1-4 Three survey studies of the physical and mental health of a large cohort of Gulf War and Gulf era veterans, conducted by the US Department of Veterans Affairs (VA) Office of Public Health, established the increased prevalence of GWI in the decades that followed the end of the conflict.^5-7 Thus, GWI has become the signature adverse health-related outcome of the Gulf War. Quality improvement (QI) within the Veterans Health Administration (VHA) is needed in the diagnosis and treatment of GWI.

Background

GWI was first termed chronic multisymptom illness (CMI) by the Centers for Disease Control and Prevention (CDC). According to the CDC-10 case definition, CMI in veterans of the 1990-1991 Gulf War is defined as having ≥ 1 symptoms lasting ≥ 6 months in at least 2 of 3 categories: fatigue, depressed mood and altered cognition, and musculoskeletal pain.³ The Kansas case definition of GWI is more specific and is defined as having moderate-to-severe symptoms that are unexplained by any other diagnosis, in at least 3 of 6 categories: fatigue/sleep, somatic pain, neurologic/cognition/mood, GI, respiratory, and skin.⁴ Although chronic unexplained symptoms have occurred after other modern conflicts, the prevalence of GWI among Gulf War veterans has proven higher than those of prior conflicts.⁸

The Persian Gulf War Veterans Act of 1998 and the Veterans Programs Enhancement Act of 1998 mandated studies by the Institute of Medicine (IOM) on the biologic and chemical exposures that may have contributed to illness in the Kuwaiti theater of operations.⁹ However, elucidating the etiology and underlying pathophysiology of GWI has been a major research challenge. In the absence of objective diagnostic measures, an understanding of the fundamental pathophysiology, evidence-based treatments, a single case definition, and definitive guidelines for health care providers (HCPs) for the diagnosis and management of GWI has not been produced. As a result, veterans with GWI have struggled for nearly 3 decades to find a consistent diagnosis of and an effective treatment for their condition.

According to a report by the Government Accountability Office (GAO), the VA approved only 17% of claims for compensation for veterans with GWI from 2011 to 2015, about one-third the level of approval for all other claimed disabilities.¹⁰ Although the VA applied GAO recommendations to improve the compensation process, many veterans consider that their illness is treated as psychosomatic in clinical practice, despite emerging evidence of GWI-associated biomarkers.¹¹ Others think they have been forgotten due to their short 1-year period of service in the Gulf War.¹² To realign research, guidelines, clinical care, and the health care experience of veterans with GWI, focused QI within VHA is urgently needed.

Veterans of Operations Enduring Freedom, Iraqi Freedom, and New Dawn (OEF/OIF/OND) are experiencing similar CMI symptoms. A study of US Army Reserve OEF/OIF veterans found that > 60% met the CDC-10 case definition for GWI 1-year postdeployment.¹³ Thus, CMI is emerging as a serious health problem for post-9/11 veterans. The evidence of postdeployment CMI among veterans of recent conflicts underscores the need to increase efforts at a national level, beginning with the VHA. This report includes a summary of Gulf War veterans’ experiences at the Minneapolis VA Health Care System (MVAHCS) and a proposal for QI of MVAHCS processes focused on HCP education and clinical care.

Methods

To determine areas of GWI health care that needed QI at the MVAHCS, veterans with GWI were contacted for a telephone survey. These veterans had participated in the Gulf War Illness Inflammation Reduction Trial (ClinicalTrials.gov. Identifier: NCT02506192). Therefore, all met the Kansas case definition for GWI.⁴ The aim of the survey was to characterize veterans’ experiences seeking health care for chronic postdeployment symptoms.

Sixty Gulf War veterans were contacted by telephone and invited to participate in a 15-minute survey about their experience seeking diagnosis and treatment for GWI. They were informed that the survey was voluntary and confidential, that it was not part of the research trial in which they had been enrolled, and that their participation would not affect compensation received from VA. Verbal consent was requested, and 30 veterans agreed to participate in the survey.

The survey included questions about the course of illness, disability and service connection status, HCPs seen, and suggestions for improvement in their care (Table 1). 

Results

Of the 30 veterans who participated in the survey, most were male with only 2 female veterans. This proportion of female veterans (7%) is similar to the overall percentage of female veterans (6.7%) of the first Gulf War.² Ages ranged from 46 to 66 years with a mean age of 53. Mean duration of illness, defined as time elapsed since perceived onset of chronic systemic symptoms during or after deployment, was 22.8 years, with a range of 4 to 27 years. Most respondents reported symptom onset within a few years after the end of the conflict, while a few reported the onset within weeks of arriving in the Kuwaiti theater of operations. A little more than half the respondents considered themselves disabled due to their symptoms, while one-third reported losing the ability to work due to symptoms. Respondents described needing to reduce hours, retire early, or stop working altogether because of their symptoms.

Respondents attributed several common chronic symptoms to deployment in the Gulf Wars (Table 2). 

Most veterans surveyed were service connected for individual chronic symptoms. Some were service connected for systemic conditions such as fibromyalgia (FM), chronic fatigue syndrome (CFS), and irritable bowel syndrome (IBS) (5 veterans were connected for each condition). Three of the 30 veterans had been diagnosed with GWI—2 by past VA physicians and 1 by a physician at a GWI research center in another state. Of those 3, only 1 was service connected for the condition. Three respondents were not service connected at all.

The most common VA HCPs seen were in primary care and neurology followed by psychiatry and psychology. Of non-VA HCPs, most respondents saw primary care providers (PCPs) followed by chiropractors (Table 4).

Before taking the Gulf War survey, a broad subjective question was posed. Respondents were asked whether VA HCPs were “supportive as you sought care for chronic postdeployment symptoms.” A majority of veterans reported that their VA HCPs were supportive. Reasons veterans gave for VA HCPs lack of support included feeling that HCPs did not believe them or trust their reported symptoms; did not care about their symptoms; refused to attribute their symptoms to Gulf War deployment; attributed symptoms to mental health issues; focused on doing things a certain way; or did not have the tools or information necessary to help.

Most non-VA HCPs were supportive. Reasons community HCPs were not supportive included “not looking at the whole picture,” not knowing veteran issues, not feeling comfortable with GWI, or not having much they could do.

Veterans were then asked whether they felt their HCPs were knowledgeable about GWI, and 13 respondents reported that their HCP was knowledgeable. Reasons respondents felt VA HCPs were not knowledgeable included denying that GWI exists, attributing symptoms to other conditions, not being aware of or familiar with GWI, needing education from the veteran, avoiding discussion about GWI or not caring to learn, or not knowing the latest research evidence to talk about GWI with authority. Compared with VA HCPs, veterans found community HCPs about half as likely to be knowledgeable about GWI. Many reported that community HCPs had not heard of GWI or had no knowledge about it.

Respondents also were asked what types of treatments they tried in order to typify the care received. The most common responses were pain medications, symptom-specific treatments, or “just putting up with it” (no treatment). Many patients were also self-medicating, trying lifestyle changes, or seeking alternative therapies.

Finally, respondents were asked on a scale of 0 (very unsatisfied) to 5 (very satisfied), how satisfied they were with their overall care at the VA. The majority were satisfied with their overall care, with two-thirds very satisfied (5 of 5) or pretty satisfied (4 of 5). Only 3 (10%) were unsatisfied or very unsatisfied. Respondents had the following comments about their care: “They treat me like I am important;” “I am very thankful even though they cannot figure it out;” “They are doing the best they can with no answers and not enough help;” “[I know] it is still a work in progress.” A number of respondents were satisfied with some HCPs or care for some but not all of their symptoms. Reasons respondents were less satisfied included desiring answers, feeling they were not respected, or feeling that their concerns were not addressed.

When asked for suggestions for improvement of GWI care, the most common response was providing up-to-date HCP education (Table 5).

Discussion

The veterans participating in this QI survey had similar demographics, symptomology, and exposures as did those in other studies.^1-7 Therefore, improvements based on their responses are likely applicable to the health care of veterans experiencing GWI-associated symptoms at other VA health care systems as well.

Veterans with GWI can lose significant functional capacity and productivity due to their symptoms. The symptoms are chronic and have afflicted many Gulf War veterans for nearly 3 decades. Furthermore, the prevalence of GWI in Gulf War veterans continues to increase.^5-7 These facts testify to the enormous health-related quality-of-life impact of GWI.

Veterans who meet the Kansas case definition for GWI were not diagnosed or service connected in a uniform manner. Only 3 of the 30 veterans in this study were given a unifying diagnosis that connected their chronic illness to Gulf War deployment. Under current guidelines, Gulf War veterans are able to receive compensation for chronic symptoms in 3 ways: (1) compensation for chronic unexplained symptoms existing for ≥ 6 months that appeared during active duty in the Southwest Asia theater or by December 31, 2021, and are ≥ 10% disabling; (2) the 1995 Persian Gulf War Veterans’ Act recognizes 3 multisymptom illnesses for which veterans can be service connected: FM, CFS, and functional GI disorders, including IBS; and (3) expansion to include any CMI of unknown etiology is underway. A uniform diagnostic protocol based on biomarkers and updated understanding of disease pathology would be helpful.

Respondents shared experiences that demonstrated perceived gaps in HCP support or knowledge. Overall, more respondents found their HCPs supportive. Many of the reasons respondents found HCPs unsupportive related to acknowledgment of symptoms. Also, more respondents found that both VA and non-VA HCPs lacked knowledge about GWI symptoms. These findings further highlight the need for HCP education within the VA and in community-based care.

The treatments tried by respondents also highlight potential areas for improvement. Most of the treatments were for pain; therefore, more involvement with pain clinics and specialists could be helpful. Symptom-specific medications also are appropriate, although only one-third of patients reported use. While medications are not necessarily markers of quality care, the fact that many patients self-medicate or go without treatment suggests that access to care could be improved. In 2014, the VA and the US Department of Defense (DoD) released the “VA/DoD Clinical Practice Guideline for the Management of Chronic Multisymptom Illness,” which recommended treatments for the global disease and specific symptoms.¹⁵

Since then, GWI research points to inflammatory and metabolic disease mechanisms.^11-14,16 As the underlying pathophysiology is further elucidated, practice guidelines will need to be updated to include anti-inflammatory and antioxidant treatments used in practice for GWI and similar chronic systemic illnesses (eg, CFS, FM, and IBS).^17-19

Randomized control trials are needed to determine the efficacy of such medications for the treatment of GWI. As new results emerge, disseminating and updating evidence-based guidelines in a coordinated manner will be required for veterans to receive appropriate treatment. Veterans also seek alternative or nonpharmaceutical interventions, such as physical therapy and diet changes. Improving access to integrative medicine, physical therapy, nutritionists, and other practitioners also could optimize veterans’ health and function.

HCP Education

The Gulf War veteran respondents who participated in the survey noted HCP education, research progress, and veteran inclusion as areas for improvement. Respondents requested dissemination of information on diagnosis and treatment of GWI for HCPs and updates on research and other actions. They suggested ways research could be more effective (such as subgrouping by exposure, which researchers have been doing) and could extend to veterans experiencing CMI from other conflicts as well.²⁰ Respondents also recommended team approaches or centers of excellence in order to receive more comprehensive care.

An asset of VHA is the culture of QI and education. The VA Employee Education System previously produced “Caring for Gulf War I Veterans,” a systemwide training module.²¹ In 2014, updated clinical practice guidelines for GWI were provided by the VA and the DoD, including evidence for each recommendation. In 2016, the VA in collaboration with the IOM produced a report summarizing conclusions and recommendations regarding associations between health concerns and Gulf War deployment.²² A concise guide for HCPs caring for veterans with GWI, updated in 2018, is available.²³ Updated treatment guidelines, based on evolving understanding of GWI pathophysiology, and continuing efforts to disseminate information will be essential.

Respondents most often presented to primary care, both within and outside of MVAHCS. Therefore, VA and community PCPs who see veterans should be equipped to recognize and diagnose GWI as well as be familiar with basic disease management and specialists whom they could refer their patients. Neurology was the second most common specialty seen by respondents. The most prominent symptoms of GWI are related to nervous system function in addition to evidence of underlying neuroinflammation.²⁰ Veterans may present to a neurologist with a variety of concerns, such as cognitive issues, sleep problems, migraines and headaches, and pain. Neurologists could best manage treatments targeting common neurologic GWI symptoms and neuroinflammation, especially as new treatments are discovered.

The next 2 most common specialty services seen were psychiatry and psychology (7 responses for each). Five respondents reported mental health issues as part of their chronic postdeployment symptoms. Population-based studies have indicated that rates of PTSD in Gulf War veterans is 3% to 6%, much lower than the prevalence of GWI.^8,20 The 2010 IOM study concluded that GWI symptoms cannot be ascribed to any known psychiatric disorder. Unfortunately, several surveyed veterans made it clear that they had been denied care due to HCPs attributing their symptoms solely to mental health issues. Therefore, psychiatrists and psychologists must be educated about GWI, mental health issues occurring in Gulf War veterans, and physiologic symptoms of GWI that may mimic or coincide with mental health issues. These HCPs also would be important to include in an interdisciplinary clinic for veterans with GWI.

Finally, respondents sought care from numerous other specialties, including gastroenterology, physical therapy, pulmonology, dermatology, and surgical subspecialties, such as orthopedics and otolaryngology. This wide range of specialists seen emphasizes the need for medical education, beginning in medical school. If provided education on GWI, these specialists would be able to treat veterans with GWI, know to look for updates on GWI management, or know to look for other common symptoms, such as chronic sinusitis in otolaryngology or recurring rashes in dermatology. We also recommend identifying HCPs in these specialties who could be part of an interdisciplinary clinic or be referrals for symptom management.

Protocol Implementation

HCP education and clinical care protocol implementation should be the initial focus of improving GWI management. A team of stakeholders within the different areas of MVAHCS, including education, HCPs, and administrative staff, will need to be developed. Reaching out to VA HCPs who have seen veterans with GWI will be an essential first step to equip them with updated education about the diagnosis and management of CMI. Providing integrated widespread education to current HCPs who are likely to encounter veterans with deployment-related CMI from the Gulf War, OND/OEF/OIF, or other deployments also will be necessary. Finally, educating medical trainees, including residents and medical students, will ensure continuous care for future veterans, post-9/11 veterans.

GWI presentations at medical grand rounds or at other medical community educational events could provide educational outlets. These events create face-to-face opportunities to discuss GWI/CMI education with HCPs, giving them the opportunity to offer feedback about their experiences and create relationships with other HCPs who have seen patients with GWI/CMI. At an educational event, a short postevent feedback form that indicates whether HCPs would like more information or get involved in a clinic for veterans with CMI could be included. This information would help identify key HCPs and areas within the local VA needing further improvements, such as creating a clinic for veterans with GWI.

Since 1946, the VA has worked with academic institutions to provide state-of-the-art health care to US veterans and train new HCPs to meet the health care needs of the nation. Every year, > 40,000 residents and 20,000 medical students receive medical training at VA facilities, making VA the largest single provider of medical education in the country. Therefore, providing detailed GWI/CMI education to medical students and residents as a standard part of the VA Talent Management System would be of value for all VA professionals.

GWI Clinics

Access to comprehensive care can be accomplished by organizing a clinic for veterans with GWI. The most likely effective location would be in primary care. PCPs who have seen veterans with GWI and/or expressed interest in learning more about GWI will be the initial point of contact. As the primary care service has connections to ancillary services, such as pharmacists, dieticians, psychologists, and social workers, organizing 1 day each week to see patients with GWI would improve care.

As the need for specialty care arises, the team also would need to identify specialists willing to receive referrals from HCPs of veterans with GWI. These specialists could be identified via feedback forms from educational events, surveys after an online educational training, or through relationships among VA physicians. As the clinic becomes established, it may be effective to have certain commonly seen specialists available in person, most likely neurology, psychiatry, gastroenterology, pulmonology, and dermatology. Also, relationships with a pain clinic, sleep medicine, and integrative medicine services should be established.

Measures of improvement in the veteran health care experience could include veterans’ perceptions of the supportiveness and knowledge of physicians about GWI as well as overall satisfaction. A follow-up survey on these measures of veterans involved in a GWI clinic and those not involved would be a way to determine whether these clinics better meet veterans’ needs and what additional QI is needed.

Conclusion

A significant number of Gulf War veterans experience chronic postdeployment symptoms that need to be better addressed. Physicians need to be equipped to recognize and manage GWI and similar postdeployment CMI among veterans of OEF/OIF/OND. We recommend creating an educational initiative about GWI among VA physicians and trainees, connecting physicians who see veterans with GWI, and establishing an interdisciplinary clinic with a referral system as the next steps to improve care for veterans. An additional goal would be to reach out to veteran networks to update them on GWI research, education, and available health care, as veterans are the essential stakeholders in the QI process.

Higher reliance on electronic health records (EHRs) in ambulatory oncology practice was significantly associated with reduced safety actions among oncology nurses and prescribers, according to results of a statewide survey.

“The purpose of this study was to investigate the degree to which EHRs, satisfaction with technology, and clinician communication enable a safety culture in ambulatory oncology treatment settings,” wrote Minal R. Patel, PhD, MPH, of the University of Michigan, Ann Arbor, and colleagues. The report is published in the Journal of Oncology Practice.

The researchers conducted a statewide survey of 297 oncology nurses and prescribers in 29 ambulatory oncology practices in Michigan. They obtained quantitative data for May to October 2017 from clinician surveys and practice logs at these clinical sites.

The study methodology was built by use of the sociotechnical framework, which examined how EHR technologies influenced the safe administration of chemotherapy.

Eligible survey participants included physicians, nurses, physician assistants, and nurse practitioners who cared for adult patients receiving infusion treatments for cancer.

A total of 438 clinicians were recruited and confirmed to be eligible, and 297 (68%) completed a survey.

After analysis, the researchers found that higher reliance on electronic health records in practice was associated with reduced safety scores (P less than .001). The mean safety score was reported to be 5.3 (standard deviation, 1.1; practice-level range, 4.9-5.4).

In an opposite manner, increased satisfaction with technology and better-quality communication were associated with higher safety actions.

The researchers acknowledged a key limitation of the study was cross-sectional design. As a result, confounding factors could influence the findings.

“Careful attention to technology adoption and updates coupled with high-quality communication skills across clinicians are promising strategies to administer high-risk treatments safely in ambulatory oncology settings,” they concluded.

The study was supported by grant funding from the Agency for Healthcare Research and Quality and the National Cancer Institute. No conflicts of interest were reported.

SOURCE: Patel MR et al. J Oncol Pract. 2019 Apr 22. doi: 10.1200/JOP.18.00507.

Higher reliance on electronic health records (EHRs) in ambulatory oncology practice was significantly associated with reduced safety actions among oncology nurses and prescribers, according to results of a statewide survey.

“The purpose of this study was to investigate the degree to which EHRs, satisfaction with technology, and clinician communication enable a safety culture in ambulatory oncology treatment settings,” wrote Minal R. Patel, PhD, MPH, of the University of Michigan, Ann Arbor, and colleagues. The report is published in the Journal of Oncology Practice.

The researchers conducted a statewide survey of 297 oncology nurses and prescribers in 29 ambulatory oncology practices in Michigan. They obtained quantitative data for May to October 2017 from clinician surveys and practice logs at these clinical sites.

The study methodology was built by use of the sociotechnical framework, which examined how EHR technologies influenced the safe administration of chemotherapy.

Eligible survey participants included physicians, nurses, physician assistants, and nurse practitioners who cared for adult patients receiving infusion treatments for cancer.

A total of 438 clinicians were recruited and confirmed to be eligible, and 297 (68%) completed a survey.

After analysis, the researchers found that higher reliance on electronic health records in practice was associated with reduced safety scores (P less than .001). The mean safety score was reported to be 5.3 (standard deviation, 1.1; practice-level range, 4.9-5.4).

In an opposite manner, increased satisfaction with technology and better-quality communication were associated with higher safety actions.

The researchers acknowledged a key limitation of the study was cross-sectional design. As a result, confounding factors could influence the findings.

“Careful attention to technology adoption and updates coupled with high-quality communication skills across clinicians are promising strategies to administer high-risk treatments safely in ambulatory oncology settings,” they concluded.

The study was supported by grant funding from the Agency for Healthcare Research and Quality and the National Cancer Institute. No conflicts of interest were reported.

SOURCE: Patel MR et al. J Oncol Pract. 2019 Apr 22. doi: 10.1200/JOP.18.00507.

Higher reliance on electronic health records (EHRs) in ambulatory oncology practice was significantly associated with reduced safety actions among oncology nurses and prescribers, according to results of a statewide survey.

“The purpose of this study was to investigate the degree to which EHRs, satisfaction with technology, and clinician communication enable a safety culture in ambulatory oncology treatment settings,” wrote Minal R. Patel, PhD, MPH, of the University of Michigan, Ann Arbor, and colleagues. The report is published in the Journal of Oncology Practice.

The researchers conducted a statewide survey of 297 oncology nurses and prescribers in 29 ambulatory oncology practices in Michigan. They obtained quantitative data for May to October 2017 from clinician surveys and practice logs at these clinical sites.

The study methodology was built by use of the sociotechnical framework, which examined how EHR technologies influenced the safe administration of chemotherapy.

Eligible survey participants included physicians, nurses, physician assistants, and nurse practitioners who cared for adult patients receiving infusion treatments for cancer.

A total of 438 clinicians were recruited and confirmed to be eligible, and 297 (68%) completed a survey.

After analysis, the researchers found that higher reliance on electronic health records in practice was associated with reduced safety scores (P less than .001). The mean safety score was reported to be 5.3 (standard deviation, 1.1; practice-level range, 4.9-5.4).

In an opposite manner, increased satisfaction with technology and better-quality communication were associated with higher safety actions.

The researchers acknowledged a key limitation of the study was cross-sectional design. As a result, confounding factors could influence the findings.

“Careful attention to technology adoption and updates coupled with high-quality communication skills across clinicians are promising strategies to administer high-risk treatments safely in ambulatory oncology settings,” they concluded.

The study was supported by grant funding from the Agency for Healthcare Research and Quality and the National Cancer Institute. No conflicts of interest were reported.

SOURCE: Patel MR et al. J Oncol Pract. 2019 Apr 22. doi: 10.1200/JOP.18.00507.

Food and Drug Administration Commissioner Scott Gottlieb, MD, announced in a tweet Wednesday that the agency plans to release hundreds of thousands, if not millions, of previously unpublished injury and malfunction reports tied to about 100 medical devices.

“We’re now prioritizing making ALL of this data available,” Dr. Gottlieb tweeted.

A recent Kaiser Health News investigation revealed the scope of a hidden reporting pathway for device makers, with the agency accepting more than 1.1 million such reports since the start of 2016.

Device makers for nearly 20 years were able to quietly seek an “exemption” from standard, public harm-reporting rules. Devices with such exemptions have included surgical staplers and balloon pumps used in the vessels of heart-surgery patients.

Dr. Gottlieb’s tweet also referenced the challenge in opening the database, saying it “wasn’t easily accessible electronically owing to the system’s age. But it’s imperative that all safety information be available to the public.”

The agency made changes to the “alternative summary reporting” program in mid-2017 to require a public report summarizing data filed within the FDA. But nearly two decades of data remained cordoned off from doctors, patients, and device-safety researchers who say they could use it to detect problems.

Dr. Gottlieb’s announcement was welcomed by Madris Tomes, who has testified to FDA device-review panels about the importance of making summary data on patient harm open to the public.

“That’s the best news I’ve heard in years,” said Ms. Tomes, president of Device Events, which makes the FDA device-harm data more user-friendly. “I’m really happy that they’re taking notice and realizing that physicians who couldn’t see this data before were using devices that they wouldn’t have used if they had this data in front of them.”

Since September, KHN has filed Freedom of Information Act requests for parts or all of the “alternative summary reporting” database and for other special “exemption” reports, to little effect. A request to expedite delivery of those records was denied, and the FDA cited the lack of “compelling need” for the public to have the information. Officials noted that it might take up to 2 years to get such records through the FOIA process.

As recently as March 22, though, the agency began publishing previously undisclosed reports of harm, suddenly updating the numbers of breast implant malfunctions or injuries submitted over the years. The new data was presented to an FDA advisory panel, which is reviewing the safety of such devices. The panel, which met March 25 and 26, saw a chart showing hundreds of thousands more accounts of harm or malfunctions than had previously been acknowledged.

Michael Carome, MD, director of Public Citizen’s health research group, said his initial reaction to the news is “better late than never.”

“If [Dr. Gottlieb] follows through with his pledge to make all this data public, then that’s certainly a positive development,” he said. “But this is safety information that should have been made available years ago.”
 

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of the Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

Food and Drug Administration Commissioner Scott Gottlieb, MD, announced in a tweet Wednesday that the agency plans to release hundreds of thousands, if not millions, of previously unpublished injury and malfunction reports tied to about 100 medical devices.

“We’re now prioritizing making ALL of this data available,” Dr. Gottlieb tweeted.

A recent Kaiser Health News investigation revealed the scope of a hidden reporting pathway for device makers, with the agency accepting more than 1.1 million such reports since the start of 2016.

Device makers for nearly 20 years were able to quietly seek an “exemption” from standard, public harm-reporting rules. Devices with such exemptions have included surgical staplers and balloon pumps used in the vessels of heart-surgery patients.

Dr. Gottlieb’s tweet also referenced the challenge in opening the database, saying it “wasn’t easily accessible electronically owing to the system’s age. But it’s imperative that all safety information be available to the public.”

The agency made changes to the “alternative summary reporting” program in mid-2017 to require a public report summarizing data filed within the FDA. But nearly two decades of data remained cordoned off from doctors, patients, and device-safety researchers who say they could use it to detect problems.

Dr. Gottlieb’s announcement was welcomed by Madris Tomes, who has testified to FDA device-review panels about the importance of making summary data on patient harm open to the public.

“That’s the best news I’ve heard in years,” said Ms. Tomes, president of Device Events, which makes the FDA device-harm data more user-friendly. “I’m really happy that they’re taking notice and realizing that physicians who couldn’t see this data before were using devices that they wouldn’t have used if they had this data in front of them.”

Since September, KHN has filed Freedom of Information Act requests for parts or all of the “alternative summary reporting” database and for other special “exemption” reports, to little effect. A request to expedite delivery of those records was denied, and the FDA cited the lack of “compelling need” for the public to have the information. Officials noted that it might take up to 2 years to get such records through the FOIA process.

As recently as March 22, though, the agency began publishing previously undisclosed reports of harm, suddenly updating the numbers of breast implant malfunctions or injuries submitted over the years. The new data was presented to an FDA advisory panel, which is reviewing the safety of such devices. The panel, which met March 25 and 26, saw a chart showing hundreds of thousands more accounts of harm or malfunctions than had previously been acknowledged.

Michael Carome, MD, director of Public Citizen’s health research group, said his initial reaction to the news is “better late than never.”

“If [Dr. Gottlieb] follows through with his pledge to make all this data public, then that’s certainly a positive development,” he said. “But this is safety information that should have been made available years ago.”
 

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of the Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

Food and Drug Administration Commissioner Scott Gottlieb, MD, announced in a tweet Wednesday that the agency plans to release hundreds of thousands, if not millions, of previously unpublished injury and malfunction reports tied to about 100 medical devices.

“We’re now prioritizing making ALL of this data available,” Dr. Gottlieb tweeted.

A recent Kaiser Health News investigation revealed the scope of a hidden reporting pathway for device makers, with the agency accepting more than 1.1 million such reports since the start of 2016.

Device makers for nearly 20 years were able to quietly seek an “exemption” from standard, public harm-reporting rules. Devices with such exemptions have included surgical staplers and balloon pumps used in the vessels of heart-surgery patients.

Dr. Gottlieb’s tweet also referenced the challenge in opening the database, saying it “wasn’t easily accessible electronically owing to the system’s age. But it’s imperative that all safety information be available to the public.”

The agency made changes to the “alternative summary reporting” program in mid-2017 to require a public report summarizing data filed within the FDA. But nearly two decades of data remained cordoned off from doctors, patients, and device-safety researchers who say they could use it to detect problems.

Dr. Gottlieb’s announcement was welcomed by Madris Tomes, who has testified to FDA device-review panels about the importance of making summary data on patient harm open to the public.

“That’s the best news I’ve heard in years,” said Ms. Tomes, president of Device Events, which makes the FDA device-harm data more user-friendly. “I’m really happy that they’re taking notice and realizing that physicians who couldn’t see this data before were using devices that they wouldn’t have used if they had this data in front of them.”

Since September, KHN has filed Freedom of Information Act requests for parts or all of the “alternative summary reporting” database and for other special “exemption” reports, to little effect. A request to expedite delivery of those records was denied, and the FDA cited the lack of “compelling need” for the public to have the information. Officials noted that it might take up to 2 years to get such records through the FOIA process.

As recently as March 22, though, the agency began publishing previously undisclosed reports of harm, suddenly updating the numbers of breast implant malfunctions or injuries submitted over the years. The new data was presented to an FDA advisory panel, which is reviewing the safety of such devices. The panel, which met March 25 and 26, saw a chart showing hundreds of thousands more accounts of harm or malfunctions than had previously been acknowledged.

Michael Carome, MD, director of Public Citizen’s health research group, said his initial reaction to the news is “better late than never.”

“If [Dr. Gottlieb] follows through with his pledge to make all this data public, then that’s certainly a positive development,” he said. “But this is safety information that should have been made available years ago.”
 

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of the Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

Although VA nursing homes, on the whole, have sicker patients than do those in private sector nursing homes, they compare closely in terms of quality of care—and in some cases, VA health care gets higher marks. VA has more higher performing facilities (17% vs 11%) and fewer low-performing facilities (17% vs 20%).

Those figures come from the health care inspection reports and staffing data for its 134 community living centers (CLCs) that the VA is, for the first time, posting publicly. So far, VA has posted 101 health inspection reports; the remainder are scheduled for later this year. The reports cover April 2018 to the present.

The VA reports are based on yearly, unannounced inspections conducted by an outside contracted agency. The survey teams assess a variety of aspects of life at VA nursing homes, such as the care of residents and the processes used to give that care, how the staff and residents interact, and the nursing home environment. The surveyors also review residents’ clinical records and interview residents, family members, caregivers, and staff.

VA nursing homes also had a significantly lower percentage (6%) of 1-star (lowest rated) nursing homes compared with 15,487 private sector nursing homes rated by the Centers for Medicare and Medicaid Services. Both Medicare-certified skilled nursing facilities and VA CLCs must meet federal standards, such as having enough staff to provide adequate care. “There is significant evidence of a relationship between resident outcomes and staffing levels in nursing homes,” the VA says in its description of survey criteria.

Many VA nursing home residents are being treated for conditions rarely seen in private sector nursing homes, the VA says, including veteran-specific conditions, such as posttraumatic stress disorder (12% vs 0.5%) and traumatic brain injury (2% vs 0.8%). In 2018, 42% of 41,076 VA CLC residents had a service-connected disability rating of ≥ 50%. CLCs also provide more hospice care and care for conditions related to homelessness.

However, the VA notes that “quality measures are not the same as quality standards.” According to Medicare Nursing Home Compare, the quality of resident care measures are not benchmarks, thresholds, guidelines, or standards of care—they are a “snapshot at a point in time” of the average condition of residents. For instance, individual CLCs may serve special populations and have a higher rate of certain conditions. A CLC that specializes in complex skin and wound care may admit veterans with severe pressure ulcers that occurred at home or another hospital.

Detailed information on individual quality measures and how VA facilities compare with others in their areas are available at www.accesstocare.va.gov/healthcare/qualityofcare. That site also has an interactive searchable map that can be used to locate CLCs by zip code or distance. The health inspection reports are available at www.va.gov/qualityofcare/apps/aspire/clcsurvey.aspx.

Although VA nursing homes, on the whole, have sicker patients than do those in private sector nursing homes, they compare closely in terms of quality of care—and in some cases, VA health care gets higher marks. VA has more higher performing facilities (17% vs 11%) and fewer low-performing facilities (17% vs 20%).

Those figures come from the health care inspection reports and staffing data for its 134 community living centers (CLCs) that the VA is, for the first time, posting publicly. So far, VA has posted 101 health inspection reports; the remainder are scheduled for later this year. The reports cover April 2018 to the present.

The VA reports are based on yearly, unannounced inspections conducted by an outside contracted agency. The survey teams assess a variety of aspects of life at VA nursing homes, such as the care of residents and the processes used to give that care, how the staff and residents interact, and the nursing home environment. The surveyors also review residents’ clinical records and interview residents, family members, caregivers, and staff.

VA nursing homes also had a significantly lower percentage (6%) of 1-star (lowest rated) nursing homes compared with 15,487 private sector nursing homes rated by the Centers for Medicare and Medicaid Services. Both Medicare-certified skilled nursing facilities and VA CLCs must meet federal standards, such as having enough staff to provide adequate care. “There is significant evidence of a relationship between resident outcomes and staffing levels in nursing homes,” the VA says in its description of survey criteria.

Many VA nursing home residents are being treated for conditions rarely seen in private sector nursing homes, the VA says, including veteran-specific conditions, such as posttraumatic stress disorder (12% vs 0.5%) and traumatic brain injury (2% vs 0.8%). In 2018, 42% of 41,076 VA CLC residents had a service-connected disability rating of ≥ 50%. CLCs also provide more hospice care and care for conditions related to homelessness.

However, the VA notes that “quality measures are not the same as quality standards.” According to Medicare Nursing Home Compare, the quality of resident care measures are not benchmarks, thresholds, guidelines, or standards of care—they are a “snapshot at a point in time” of the average condition of residents. For instance, individual CLCs may serve special populations and have a higher rate of certain conditions. A CLC that specializes in complex skin and wound care may admit veterans with severe pressure ulcers that occurred at home or another hospital.

Detailed information on individual quality measures and how VA facilities compare with others in their areas are available at www.accesstocare.va.gov/healthcare/qualityofcare. That site also has an interactive searchable map that can be used to locate CLCs by zip code or distance. The health inspection reports are available at www.va.gov/qualityofcare/apps/aspire/clcsurvey.aspx.

Although VA nursing homes, on the whole, have sicker patients than do those in private sector nursing homes, they compare closely in terms of quality of care—and in some cases, VA health care gets higher marks. VA has more higher performing facilities (17% vs 11%) and fewer low-performing facilities (17% vs 20%).

Those figures come from the health care inspection reports and staffing data for its 134 community living centers (CLCs) that the VA is, for the first time, posting publicly. So far, VA has posted 101 health inspection reports; the remainder are scheduled for later this year. The reports cover April 2018 to the present.

The VA reports are based on yearly, unannounced inspections conducted by an outside contracted agency. The survey teams assess a variety of aspects of life at VA nursing homes, such as the care of residents and the processes used to give that care, how the staff and residents interact, and the nursing home environment. The surveyors also review residents’ clinical records and interview residents, family members, caregivers, and staff.

VA nursing homes also had a significantly lower percentage (6%) of 1-star (lowest rated) nursing homes compared with 15,487 private sector nursing homes rated by the Centers for Medicare and Medicaid Services. Both Medicare-certified skilled nursing facilities and VA CLCs must meet federal standards, such as having enough staff to provide adequate care. “There is significant evidence of a relationship between resident outcomes and staffing levels in nursing homes,” the VA says in its description of survey criteria.

Many VA nursing home residents are being treated for conditions rarely seen in private sector nursing homes, the VA says, including veteran-specific conditions, such as posttraumatic stress disorder (12% vs 0.5%) and traumatic brain injury (2% vs 0.8%). In 2018, 42% of 41,076 VA CLC residents had a service-connected disability rating of ≥ 50%. CLCs also provide more hospice care and care for conditions related to homelessness.

However, the VA notes that “quality measures are not the same as quality standards.” According to Medicare Nursing Home Compare, the quality of resident care measures are not benchmarks, thresholds, guidelines, or standards of care—they are a “snapshot at a point in time” of the average condition of residents. For instance, individual CLCs may serve special populations and have a higher rate of certain conditions. A CLC that specializes in complex skin and wound care may admit veterans with severe pressure ulcers that occurred at home or another hospital.

Detailed information on individual quality measures and how VA facilities compare with others in their areas are available at www.accesstocare.va.gov/healthcare/qualityofcare. That site also has an interactive searchable map that can be used to locate CLCs by zip code or distance. The health inspection reports are available at www.va.gov/qualityofcare/apps/aspire/clcsurvey.aspx.

Physicians should actively advocate for policies that will reduce children’s consumption of sugar-sweetened beverages and subsequently reduce their risk of obesity, type 2 diabetes and other chronic diseases, urges a new policy statement from the American Academy of Pediatrics and the American Heart Association.

American Heart Association

As “the leading source of added sugars in the U.S. diet,” sugary drinks “provide little to no nutritional value, are high in energy density, and do little to increase feelings of satiety,” wrote Natalie D. Muth, MD, MPH, of the University of California, Los Angeles, and the Children’s Primary Care Medical Group in Carlsbad, Calif., and her associates from the AAP’s Section on Obesity, the AAP’s Committee on Nutrition, and the American Heart Association.

Added sugars include sucrose, glucose, high-fructose corn syrup and processed fruit juice (but not naturally occurring fructose or lactose) that are added as sweeteners to food and drink products. In addition to contributing to childhood obesity, consuming drinks with added sugars increases children’s risk for “dental decay, cardiovascular disease, hypertension, dyslipidemia, insulin resistance, type 2 diabetes mellitus, fatty liver disease and all-cause mortality,” the statement noted.

Although less than 10% of individuals’ total calories should come from added sugars, according to the 2015–2020 Dietary Guidelines for Americans, added sugars make up an estimated 17% of U.S. children’s and teens’ average total caloric intake, and sugary drinks comprise almost half of this excess sugar, the statement noted. Consumption is higher and therefore more harmful in several subgroups, particularly those from minority and economically disadvantaged communities.

Previous AAP policy statements have urged doctors to encourage children and teens to drink water instead of high-calorie drinks, such as fruit juice, energy drinks and high-carbohydrate “sports drinks.” But this statement takes a page from success with tobacco control measures and focuses on the need for policy changes at local, state, and federal levels to help to reduce children’s intake of sugary drinks.

The statement makes six major recommendations:

• Excise tax: The AAP and AHA support the use of excise taxes or other means of increasing the cost of sugar-sweetened beverages – alongside an educational campaign to explain the rationale – and apportioning some of the subsequent revenue to addressing health and socioeconomic disparities.

Evidence shows how tobacco and alcohol consumption declined as their prices rose from taxes, and several places that have already implemented a sugary beverage tax have seen similar declines in consumption. Research models suggest an excise tax would potentially prevent 575,000 cases of childhood obesity.

• Reducing advertising/marketing: Research shows that teens, especially low-income and minority teens, are exposed to high amounts of advertising for soft drinks, fruit drinks, energy drinks, and sports drinks. Though such advertising cannot be outright banned without violating free speech, policies can disincentivize such marketing, such as “eliminating the advertising subsidy for nutritionally poor foods and beverages marketed to children” and not allowing in-school marketing.

• Improve existing nutritional assistance programs: WIC, the Child and Adult Care Food Program, school breakfast and lunch programs, and the Supplemental Nutrition Assistance Program (SNAP) vary in how well they discourage sugary drink consumption and can be improved through legislative changes.

• Consumer risk information: The AAP and AHA promote use of clear nutrition labels and menu labeling that explain the sugar content and risks of products, “including warning labels of the health harms of consumption of added sugars” not unlike those on cigarette packages.

• Changing the default: Physicians should advocate for policies that reduce access to sugary drinks and prioritize access to water and similarly healthier options.

• Norm-changing medical industry: Hospitals should implement policies that reduce consumption and/or access to sugary beverages, such as higher prices, less availability and risk-related labeling.

Pediatricians should continue to advise families about the risks of consuming added sugars, the substantial contribution that sugary drinks make to excess sugars in one’s diet, and the need to replace sugar-sweetened beverages with drinking water. Yet pediatricians can go beyond individual recommendations by advocating “for policy change through school boards, school health councils, hospital and medical group boards and committees, outreach to elected representatives and public comment opportunities.”

The statement used no external funding, and the authors had no disclosures or conflicts of interest.

SOURCE: Muth ND et al. Pediatrics. 2019;143(4):e20190282. doi: 10.1542/peds.2019-0282

Physicians should actively advocate for policies that will reduce children’s consumption of sugar-sweetened beverages and subsequently reduce their risk of obesity, type 2 diabetes and other chronic diseases, urges a new policy statement from the American Academy of Pediatrics and the American Heart Association.

American Heart Association

As “the leading source of added sugars in the U.S. diet,” sugary drinks “provide little to no nutritional value, are high in energy density, and do little to increase feelings of satiety,” wrote Natalie D. Muth, MD, MPH, of the University of California, Los Angeles, and the Children’s Primary Care Medical Group in Carlsbad, Calif., and her associates from the AAP’s Section on Obesity, the AAP’s Committee on Nutrition, and the American Heart Association.

Added sugars include sucrose, glucose, high-fructose corn syrup and processed fruit juice (but not naturally occurring fructose or lactose) that are added as sweeteners to food and drink products. In addition to contributing to childhood obesity, consuming drinks with added sugars increases children’s risk for “dental decay, cardiovascular disease, hypertension, dyslipidemia, insulin resistance, type 2 diabetes mellitus, fatty liver disease and all-cause mortality,” the statement noted.

Although less than 10% of individuals’ total calories should come from added sugars, according to the 2015–2020 Dietary Guidelines for Americans, added sugars make up an estimated 17% of U.S. children’s and teens’ average total caloric intake, and sugary drinks comprise almost half of this excess sugar, the statement noted. Consumption is higher and therefore more harmful in several subgroups, particularly those from minority and economically disadvantaged communities.

Previous AAP policy statements have urged doctors to encourage children and teens to drink water instead of high-calorie drinks, such as fruit juice, energy drinks and high-carbohydrate “sports drinks.” But this statement takes a page from success with tobacco control measures and focuses on the need for policy changes at local, state, and federal levels to help to reduce children’s intake of sugary drinks.

The statement makes six major recommendations:

• Excise tax: The AAP and AHA support the use of excise taxes or other means of increasing the cost of sugar-sweetened beverages – alongside an educational campaign to explain the rationale – and apportioning some of the subsequent revenue to addressing health and socioeconomic disparities.

Evidence shows how tobacco and alcohol consumption declined as their prices rose from taxes, and several places that have already implemented a sugary beverage tax have seen similar declines in consumption. Research models suggest an excise tax would potentially prevent 575,000 cases of childhood obesity.

• Reducing advertising/marketing: Research shows that teens, especially low-income and minority teens, are exposed to high amounts of advertising for soft drinks, fruit drinks, energy drinks, and sports drinks. Though such advertising cannot be outright banned without violating free speech, policies can disincentivize such marketing, such as “eliminating the advertising subsidy for nutritionally poor foods and beverages marketed to children” and not allowing in-school marketing.

• Improve existing nutritional assistance programs: WIC, the Child and Adult Care Food Program, school breakfast and lunch programs, and the Supplemental Nutrition Assistance Program (SNAP) vary in how well they discourage sugary drink consumption and can be improved through legislative changes.

• Consumer risk information: The AAP and AHA promote use of clear nutrition labels and menu labeling that explain the sugar content and risks of products, “including warning labels of the health harms of consumption of added sugars” not unlike those on cigarette packages.

• Changing the default: Physicians should advocate for policies that reduce access to sugary drinks and prioritize access to water and similarly healthier options.

• Norm-changing medical industry: Hospitals should implement policies that reduce consumption and/or access to sugary beverages, such as higher prices, less availability and risk-related labeling.

Pediatricians should continue to advise families about the risks of consuming added sugars, the substantial contribution that sugary drinks make to excess sugars in one’s diet, and the need to replace sugar-sweetened beverages with drinking water. Yet pediatricians can go beyond individual recommendations by advocating “for policy change through school boards, school health councils, hospital and medical group boards and committees, outreach to elected representatives and public comment opportunities.”

The statement used no external funding, and the authors had no disclosures or conflicts of interest.

SOURCE: Muth ND et al. Pediatrics. 2019;143(4):e20190282. doi: 10.1542/peds.2019-0282

Physicians should actively advocate for policies that will reduce children’s consumption of sugar-sweetened beverages and subsequently reduce their risk of obesity, type 2 diabetes and other chronic diseases, urges a new policy statement from the American Academy of Pediatrics and the American Heart Association.

American Heart Association

As “the leading source of added sugars in the U.S. diet,” sugary drinks “provide little to no nutritional value, are high in energy density, and do little to increase feelings of satiety,” wrote Natalie D. Muth, MD, MPH, of the University of California, Los Angeles, and the Children’s Primary Care Medical Group in Carlsbad, Calif., and her associates from the AAP’s Section on Obesity, the AAP’s Committee on Nutrition, and the American Heart Association.

Added sugars include sucrose, glucose, high-fructose corn syrup and processed fruit juice (but not naturally occurring fructose or lactose) that are added as sweeteners to food and drink products. In addition to contributing to childhood obesity, consuming drinks with added sugars increases children’s risk for “dental decay, cardiovascular disease, hypertension, dyslipidemia, insulin resistance, type 2 diabetes mellitus, fatty liver disease and all-cause mortality,” the statement noted.

Although less than 10% of individuals’ total calories should come from added sugars, according to the 2015–2020 Dietary Guidelines for Americans, added sugars make up an estimated 17% of U.S. children’s and teens’ average total caloric intake, and sugary drinks comprise almost half of this excess sugar, the statement noted. Consumption is higher and therefore more harmful in several subgroups, particularly those from minority and economically disadvantaged communities.

Previous AAP policy statements have urged doctors to encourage children and teens to drink water instead of high-calorie drinks, such as fruit juice, energy drinks and high-carbohydrate “sports drinks.” But this statement takes a page from success with tobacco control measures and focuses on the need for policy changes at local, state, and federal levels to help to reduce children’s intake of sugary drinks.

The statement makes six major recommendations:

• Excise tax: The AAP and AHA support the use of excise taxes or other means of increasing the cost of sugar-sweetened beverages – alongside an educational campaign to explain the rationale – and apportioning some of the subsequent revenue to addressing health and socioeconomic disparities.

Evidence shows how tobacco and alcohol consumption declined as their prices rose from taxes, and several places that have already implemented a sugary beverage tax have seen similar declines in consumption. Research models suggest an excise tax would potentially prevent 575,000 cases of childhood obesity.

• Reducing advertising/marketing: Research shows that teens, especially low-income and minority teens, are exposed to high amounts of advertising for soft drinks, fruit drinks, energy drinks, and sports drinks. Though such advertising cannot be outright banned without violating free speech, policies can disincentivize such marketing, such as “eliminating the advertising subsidy for nutritionally poor foods and beverages marketed to children” and not allowing in-school marketing.

• Improve existing nutritional assistance programs: WIC, the Child and Adult Care Food Program, school breakfast and lunch programs, and the Supplemental Nutrition Assistance Program (SNAP) vary in how well they discourage sugary drink consumption and can be improved through legislative changes.

• Consumer risk information: The AAP and AHA promote use of clear nutrition labels and menu labeling that explain the sugar content and risks of products, “including warning labels of the health harms of consumption of added sugars” not unlike those on cigarette packages.

• Changing the default: Physicians should advocate for policies that reduce access to sugary drinks and prioritize access to water and similarly healthier options.

• Norm-changing medical industry: Hospitals should implement policies that reduce consumption and/or access to sugary beverages, such as higher prices, less availability and risk-related labeling.

Pediatricians should continue to advise families about the risks of consuming added sugars, the substantial contribution that sugary drinks make to excess sugars in one’s diet, and the need to replace sugar-sweetened beverages with drinking water. Yet pediatricians can go beyond individual recommendations by advocating “for policy change through school boards, school health councils, hospital and medical group boards and committees, outreach to elected representatives and public comment opportunities.”

The statement used no external funding, and the authors had no disclosures or conflicts of interest.

SOURCE: Muth ND et al. Pediatrics. 2019;143(4):e20190282. doi: 10.1542/peds.2019-0282