Role and Experience of a Subintensive Care Unit in Caring for Patients With COVID-19 in Italy: The CO-RESP Study

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Role and Experience of a Subintensive Care Unit in Caring for Patients With COVID-19 in Italy: The CO-RESP Study

From the Department of Emergency Medicine, Santa Croce e Carle Hospital, Cuneo, Italy (Drs. Abram, Tosello, Emanuele Bernardi, Allione, Cavalot, Dutto, Corsini, Martini, Sciolla, Sara Bernardi, and Lauria). From the School of Emergency Medicine, University of Turin, Turin, Italy (Drs. Paglietta and Giamello).

Objective: This retrospective and prospective cohort study was designed to describe the characteristics, treatments, and outcomes of patients with SARS-CoV-2 infection (COVID-19) admitted to subintensive care units (SICU) and to identify the variables associated with outcomes. SICUs have been extremely stressed during the pandemic, but most data regarding critically ill COVID-19 patients come from intensive care units (ICUs). Studies about COVID-19 patients in SICUs are lacking.

Setting and participants: The study included 88 COVID-19 patients admitted to our SICU in Cuneo, Italy, between March and May 2020.

Measurements: Clinical and ventilatory data were collected, and patients were divided by outcome. Multivariable logistic regression analysis examined the variables associated with negative outcomes (transfer to the ICU, palliation, or death in a SICU).

Results: A total of 60 patients (68%) had a positive outcome, and 28 patients (32%) had a negative outcome; 69 patients (78%) underwent continuous positive airway pressure (CPAP). Pronation (n = 37 [42%]) had been more frequently adopted in patients who had a positive outcome vs a negative outcome (n = 30 [50%] vs n = 7 [25%]; P = .048), and the median (interquartile range) Pao2/Fio2 ratio after 6 hours of prone positioning was lower in patients who had a negative outcome vs a positive outcome (144 [140-168] vs 249 [195-268], P = .006). Independent predictors of a negative outcome were diabetes (odds ratio [OR], 8.22; 95% CI, 1.50-44.70; P = .015), higher D-dimer (OR, 1.28; 95% CI, 1.04-1.57; P = .019), higher lactate dehydrogenase level (OR, 1.003; 95% CI, 1.000-1.006; P = .039), and lower lymphocytes count (OR, 0.996; 95% CI, 0.993-0.999; P = .004).

Conclusion: SICUs have a fundamental role in the treatment of critically ill patients with COVID-19, who require long-term CPAP and pronation cycles. Diabetes, lymphopenia, and high D-dimer and LDH levels are associated with negative outcomes.

Keywords: emergency medicine, noninvasive ventilation, prone position, continuous positive airway pressure.

The COVID-19 pandemic has led to large increases in hospital admissions. Subintensive care units (SICUs) are among the wards most under pressure worldwide,1 dealing with the increased number of critically ill patients who need noninvasive ventilation, as well as serving as the best alternative to overfilled intensive care units (ICUs). In Italy, SICUs are playing a fundamental role in the management of COVID-19 patients, providing early treatment of respiratory failure by continuous noninvasive ventilation in order to reduce the need for intubation.2-5 Nevertheless, the great majority of available data about critically ill COVID-19 patients comes from ICUs. Full studies about outcomes of patients in SICUs are lacking and need to be conducted.

We sought to evaluate the characteristics and outcomes of patients admitted to our SICU for COVID-19 to describe the treatments they needed and their impact on prognosis, and to identify the variables associated with patient outcomes.

Methods

Study Design

This cohort study used data from patients who were admitted in the very first weeks of the pandemic. Data were collected retrospectively as well as prospectively, since the ethical committee approved our project. The quality and quantity of data in the 2 groups were comparable.

Data were collected from electronic and written medical records gathered during the patient’s entire stay in our SICU. Data were entered in a database with limited and controlled access. This study complied with the Declaration of Helsinki and was approved by the local ethics committees (ID: MEDURG10).

Study Population

We studied 88 consecutive patients admitted to the SICU of the Santa Croce e Carle Teaching Hospital, Cuneo, Italy, for COVID-19, from March 8 to May 1, 2020. The diagnosis was based on acute respiratory failure associated with SARS-CoV-2 RNA detection on nasopharyngeal swab or tracheal aspirate and/or typical COVID-19 features on a pulmonary computed tomography (CT) scan.6 Exclusion criteria were age younger than 18 years and patient denial of permission to use their data for research purposes (the great majority of patients could actively give consent; for patients who were too sick to do so, family members were asked whether they were aware of any reason why the patient would deny consent).

 

 

Clinical Data

The past medical history and recent symptoms description were obtained by manually reviewing medical records. Epidemiological exposure was defined as contact with SARS-CoV-2–positive people or staying in an epidemic outbreak area. Initial vital parameters, venous blood tests, arterial blood gas analysis, chest x-ray, as well as the result of the nasopharyngeal swab were gathered from the emergency department (ED) examination. (Additional swabs could be requested when the first one was negative but clinical suspicion for COVID-19 was high.) Upon admission to the SICU, a standardized panel of blood tests was performed, which was repeated the next day and then every 48 hours. Arterial blood gas analysis was performed when clinically indicated, at least twice a day, or following a scheduled time in patients undergoing pronation. Charlson Comorbidity Index7 and MuLBSTA score8 were calculated based on the collected data.

Imaging

Chest ultrasonography was performed in the ED at the time of hospitalization and once a day in the SICU. Pulmonary high-resolution computed tomography (HRCT) was performed when clinically indicated or when the results of nasopharyngeal swabs and/or x-ray results were discordant with COVID-19 clinical suspicion. Contrast CT was performed when pulmonary embolism was suspected.

Medical Therapy

Hydroxychloroquine, antiviral agents, tocilizumab, and ruxolitinib were used in the early phase of the pandemic, then were dismissed after evidence of no efficacy.9-11 Steroids and low-molecular-weight heparin were used afterward. Enoxaparin was used at the standard prophylactic dosage, and 70% of the anticoagulant dosage was also adopted in patients with moderate-to-severe COVID-19 and D-dimer values >3 times the normal value.12-14 Antibiotics were given when a bacterial superinfection was suspected.

Oxygen and Ventilatory Therapy

Oxygen support or noninvasive ventilation were started based on patients’ respiratory efficacy, estimated by respiratory rate and the ratio of partial pressure of arterial oxygen and fraction of inspired oxygen (P/F ratio).15,16 Oxygen support was delivered through nasal cannula, Venturi mask, or reservoir mask. Noninvasive ventilation was performed by continuous positive airway pressure (CPAP) when the P/F ratio was <250 or the respiratory rate was >25 breaths per minute, using the helmet interface.5,17 Prone positioning during CPAP18-20 was adopted in patients meeting the acute respiratory distress syndrome (ARDS) criteria21 and having persistence of respiratory distress and P/F <300 after a 1-hour trial of CPAP.

The prone position was maintained based on patient tolerance. P/F ratio was measured before pronation (T0), after 1 hour of prone position (T1), before resupination (T2), and 6 hours after resupination (T3). With the same timing, the patient was asked to rate their comfort in each position, from 0 (lack of comfort) to 10 (optimal comfort). Delta P/F was defined as the difference between P/F at T3 and basal P/F at T0.

Outcomes

Positive outcomes were defined as patient discharge from the SICU or transfer to a lower-intensity care ward for treatment continuation. Negative outcomes were defined as need for transfer to the ICU, transfer to another ward for palliation, or death in the SICU.

Statistical Analysis

Continuous data are reported as median and interquartile range (IQR); normal distribution of variables was tested using the Shapiro-Wilk test. Categorical variables were reported as absolute number and percentage. The Mann-Whitney test was used to compare continuous variables between groups, and chi-square test with continuity correction was used for categorical variables. The variables that were most significantly associated with a negative outcome on the univariate analysis were included in a stepwise logistic regression analysis, in order to identify independent predictors of patient outcome. Statistical analysis was performed using JASP (JASP Team) software.

 

 

Results

Study Population

Of the 88 patients included in the study, 70% were male; the median age was 66 years (IQR, 60-77). In most patients, the diagnosis of COVID-19 was derived from a positive SARS-CoV-2 nasopharyngeal swab. Six patients, however, maintained a negative swab at all determinations but had clinical and imaging features strongly suggesting COVID-19. No patients met the exclusion criteria. Most patients came from the ED (n = 58 [66%]) or general wards (n = 22 [25%]), while few were transferred from the ICU (n = 8 [9%]). The median length of stay in the SICU was 4 days (IQR, 2-7). An epidemiological link to affected persons or a known virus exposure was identifiable in 37 patients (42%).

Clinical, Laboratory, and Imaging Data

The clinical and anthropometric characteristics of patients are shown in Table 1. Hypertension and smoking habits were prevalent in our population, and the median Charlson Comorbidity Index was 3. Most patients experienced fever, dyspnea, and cough during the days before hospitalization.

Laboratory data showed a marked inflammatory milieu in all studied patients, both at baseline and after 24 and 72 hours. Lymphopenia was observed, along with a significant increase of lactate dehydrogenase (LDH), C-reactive protein (CPR), and D-dimer, and a mild increase of procalcitonin. N-terminal pro-brain natriuretic peptide (NT-proBNP) values were also increased, with normal troponin I values (Table 2).



Chest x-rays were obtained in almost all patients, while HRCT was performed in nearly half of patients. Complete bedside pulmonary ultrasonography data were available for 64 patients. Heterogeneous pulmonary alterations were found, regardless of the radiological technique, and multilobe infiltrates were the prevalent radiological pattern (73%) (Table 3). Seven patients (8%) were diagnosed with associated pulmonary embolism.

 

 

Medical Therapy

Most patients (89%) received hydroxychloroquine, whereas steroids were used in one-third of the population (36%). Immunomodulators (tocilizumab and ruxolitinib) were restricted to 12 patients (14%). Empirical antiviral therapy was introduced in the first 41 patients (47%). Enoxaparin was the default agent for thromboembolism prophylaxis, and 6 patients (7%) received 70% of the anticoagulating dose.

Oxygen and Ventilatory Therapy

Basal median P/F ratio was 253 (IQR, 218-291), and respiratory rate at triage was 20 breaths/min (IQR, 16-28), underlining a moderate-to-severe respiratory insufficiency at presentation. A total of 69 patients (78%) underwent CPAP, with a median positive end-expiratory pressure (PEEP) of 10.0 cm H2O (IQR, 7.5-10.0) and fraction of inspired oxygen (Fio2) of 0.40 (IQR, 0.40-0.50). In 37 patients (42%) who received ongoing CPAP, prone positioning was adopted. In this subgroup, respiratory rate was not significantly different from baseline to resupination (24 vs 25 breaths/min). The median P/F improved from 197 (IQR, 154-236) at baseline to 217 (IQR, 180-262) after pronation (the duration of the prone position was variable, depending on patients’ tolerance: 1 to 6 hours or every pronation cycle). The median delta P/F ratio was 39.4 (IQR, –17.0 to 78.0).

Outcomes

A total of 28 patients (32%) had a negative outcome in the SICU: 8 patients (9%) died, having no clinical indication for higher-intensity care; 6 patients (7%) were transferred to general wards for palliation; and 14 patients (16%) needed an upgrade of cure intensity and were transferred to the ICU. Of these 14 patients, 9 died in the ICU. The total in-hospital mortality of COVID-19 patients, including patients transferred from the SICU to general wards in fair condition, was 27% (n = 24). Clinical, laboratory, and therapeutic characteristics between the 2 groups are shown in Table 4.

Patients who had a negative outcome were significantly older and had more comorbidities, as suggested by a significantly higher prevalence of diabetes and higher Charlson Comorbidity scores (reflecting the mortality risk based on age and comorbidities). The median MuLBSTA score, which estimates the 90-day mortality risk from viral pneumonia, was also higher in patients who had a negative outcome (9.33%). Symptom occurrence was not different in patients with a negative outcome (apart from cough, which was less frequent), but these patients underwent hospitalization earlier—since the appearance of their first COVID-19 symptoms—compared to patients who had a positive outcome. No difference was found in antihypertensive therapy with angiotensin-converting enzyme inhibitors or angiotensin-receptor blockers among outcome groups.

More pronounced laboratory abnormalities were found in patients who had a negative outcome, compared to patients who had a positive outcome: lower lymphocytes and higher C-reactive protein (CRP), procalcitonin, D-dimer, LDH, and NT-proBNP. We found no differences in the radiological distribution of pulmonary involvement in patients who had negative or positive outcomes, nor in the adopted medical treatment.

Data showed no difference in CPAP implementation in the 2 groups. However, prone positioning had been more frequently adopted in the group of patients who had a positive outcome, compared with patients who had a negative outcome. No differences of basal P/F were found in patients who had a negative or positive outcome, but the median P/F after 6 hours of prone position was significantly lower in patients who had a negative outcome. The delta P/F ratio did not differ in the 2 groups of patients.

Multivariate Analysis

A logistic regression model was created, including the variables significantly associated with outcomes in the univariate analysis (age, sex, history of diabetes, lymphocytes, CRP, procalcitonin, LDH, NT-proBNP, and D-dimer). In the multivariate analysis, independent predictors of a negative outcome were history of diabetes (odds ratio [OR], 8.22; 95% CI, 1.50-44.70; P =.015), high D-dimer values (OR, 1.28; CI, 1.04-1.57; P = .019), high LDH values (OR, 1.003; CI, 1.000-1.006; P = .039), and low lymphocytes count (OR, 0.996; CI, 0.993-0.999; P = .004).

 

 

Discussion

Role of Subintensive Units and Mortality

The novelty of our report is its attempt to investigate the specific group of COVID-19 patients admitted to a SICU. In Italy, SICUs receive acutely ill, spontaneously breathing patients who need (invasive) hemodynamic monitoring, vasoactive medication, renal replacement therapy, chest- tube placement, thrombolysis, and respiratory noninvasive support. The nurse-to-patient ratio is higher than for general wards (usually 1 nurse to every 4 or 5 patients), though lower than for ICUs. In northern Italy, a great number of COVID-19 patients have required this kind of high-intensity care during the pandemic: Noninvasive ventilation support had to be maintained for several days, pronation maneuvers required a high number of people 2 or 3 times a day, and strict monitoring had to be assured. The SICU setting allows patients to buy time as a bridge to progressive reduction of pulmonary involvement, sometimes preventing the need for intubation.

The high prevalence of negative outcomes in the SICU underlines the complexity of COVID-19 patients in this setting. In fact, published data about mortality for patients with severe COVID-19 pneumonia are similar to ours.22,23

Clinical, Laboratory, and Imaging Data

Our analysis confirmed a high rate of comorbidities in COVID-19 patients24 and their prognostic role with age.25,26 A marked inflammatory milieu was a negative prognostic indicator, and associated concomitant bacterial superinfection could have led to a worse prognosis (procalcitonin was associated with negative outcomes).27 The cardiovascular system was nevertheless stressed, as suggested by higher values of NT-proBNP in patients with negative outcomes, which could reflect sepsis-related systemic involvement.28

It is known that the pulmonary damage caused by SARS-CoV-2 has a dynamic radiological and clinical course, with early areas of subsegmental consolidation, and bilateral ground-glass opacities predominating later in the course of the disease.29 This could explain why in our population we found no specific radiological pattern leading to a worse outcome.

Medical Therapy

No specific pharmacological therapy was found to be associated with a positive outcome in our study, just like antiviral and immunomodulator therapies failed to demonstrate effectiveness in subsequent pandemic surges. The low statistical power of our study did not allow us to give insight into the effectiveness of steroids and heparin at any dosage.

PEEP Support and Prone Positioning

Continuous positive airway pressure was initiated in the majority of patients and maintained for several days. This was an absolute novelty, because we rarely had to keep patients in helmets for long. This was feasible thanks to the SICU’s high nurse-to-patient ratio and the possibility of providing monitored sedation. Patients who could no longer tolerate CPAP helmets or did not improve with CPAP support were evaluated with anesthetists for programming further management. No initial data on respiratory rate, level of hypoxemia, or oxygen support need (level of PEEP and Fio2) could discriminate between outcomes.

Prone positioning during CPAP was implemented in 42% of our study population: P/F ratio amelioration after prone positioning was highly variable, ranging from very good P/F ratio improvements to few responses or no response. No significantly greater delta P/F ratio was seen after the first prone positioning cycle in patients who had a positive outcome, probably due to the small size of our population, but we observed a clear positive trend. Interestingly, patients showing a negative outcome had a lower percentage of long-term responses to prone positioning: 6 hours after resupination, they lost the benefit of prone positioning in terms of P/F ratio amelioration. Similarly, a greater number of patients tolerating prone positioning had a positive outcome. These data give insight on the possible benefits of prone positioning in a noninvasively supported cohort of patients, which has been mentioned in previous studies.30,31

 

 

Outcomes and Variables Associated With Negative Outcomes

After correction for age and sex, we found in multiple regression analysis that higher D-dimer and LDH values, lymphopenia, and history of diabetes were independently associated with a worse outcome. Although our results had low statistical significance, we consider the trend of the obtained odds ratios important from a clinical point of view. These results could lead to greater attention being placed on COVID-19 patients who present with these characteristics upon their arrival to the ED because they have increased risk of death or intensive care need. Clinicians should consider SICU admission for these patients in order to guarantee closer monitoring and possibly more aggressive ventilatory treatments, earlier pronation, or earlier transfer to the ICU.

Limitations

The major limitation to our study is undoubtedly its statistical power, due to its relatively low patient population. Particularly, the small number of patients who underwent pronation did not allow speculation about the efficacy of this technique, although preliminary data seem promising. However, ours is among the first studies regarding patients with COVID-19 admitted to a SICU, and these preliminary data truthfully describe the Italian, and perhaps international, experience with the first surge of the pandemic.

Conclusions

Our data highlight the primary role of the SICU in COVID-19 in adequately treating critically ill patients who have high care needs different from intubation, and who require noninvasive ventilation for prolonged times as well as frequent pronation cycles. This setting of care may represent a valid, reliable, and effective option for critically ill respiratory patients. History of diabetes, lymphopenia, and high D-dimer and LDH values are independently associated with negative outcomes, and patients presenting with these characteristics should be strictly monitored.

Acknowledgments: The authors thank the Informatica System S.R.L., as well as Allessando Mendolia for the pro bono creation of the ISCovidCollect data collecting app.

Corresponding author: Sara Abram, MD, via Coppino, 12100 Cuneo, Italy; [email protected].

Disclosures: None.

References

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8. Guo L, Wei D, Zhang X, et al. Clinical features predicting mortality risk in patients with viral pneumonia: the MuLBSTA score. Front Microbiol. 2019;10:2752. doi:10.3389/fmicb.2019.02752

9. Lombardy Section Italian Society Infectious and Tropical Disease. Vademecum for the treatment of people with COVID-19. Edition 2.0, 13 March 2020. Infez Med. 2020;28(2):143-152.

10. Wang M, Cao R, Zhang L, et al. Remdesivir and chloroquine effectively inhibit the recently emerged novel coronavirus (2019-nCoV) in vitro. Cell Res. 2020;30(3):269-271. doi:10.1038/s41422-020-0282-0

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12. Stone JH, Frigault MJ, Serling-Boyd NJ, et al; BACC Bay Tocilizumab Trial Investigators. Efficacy of tocilizumab in patients hospitalized with Covid-19. N Engl J Med. 2020;383(24):2333-2344. doi:10.1056/NEJMoa2028836

13. Shastri MD, Stewart N, Horne J, et al. In-vitro suppression of IL-6 and IL-8 release from human pulmonary epithelial cells by non-anticoagulant fraction of enoxaparin. PLoS One. 2015;10(5):e0126763. doi:10.1371/journal.pone.0126763

14. Milewska A, Zarebski M, Nowak P, Stozek K, Potempa J, Pyrc K. Human coronavirus NL63 utilizes heparin sulfate proteoglycans for attachment to target cells. J Virol. 2014;88(22):13221-13230. doi:10.1128/JVI.02078-14

15. Marietta M, Vandelli P, Mighali P, Vicini R, Coluccio V, D’Amico R; COVID-19 HD Study Group. Randomised controlled trial comparing efficacy and safety of high versus low low-molecular weight heparin dosages in hospitalized patients with severe COVID-19 pneumonia and coagulopathy not requiring invasive mechanical ventilation (COVID-19 HD): a structured summary of a study protocol. Trials. 2020;21(1):574. doi:10.1186/s13063-020-04475-z

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19. Ding L, Wang L, Ma W, He H. Efficacy and safety of early prone positioning combined with HFNC or NIV in moderate to severe ARDS: a multi-center prospective cohort study. Crit Care. 2020;24(1):28. doi:10.1186/s13054-020-2738-5

20. Scaravilli V, Grasselli G, Castagna L, et al. Prone positioning improves oxygenation in spontaneously breathing nonintubated patients with hypoxemic acute respiratory failure: a retrospective study. J Crit Care. 2015;30(6):1390-1394. doi:10.1016/j.jcrc.2015.07.008

21. Caputo ND, Strayer RJ, Levitan R. Early self-proning in awake, non-intubated patients in the emergency department: a single ED’s experience during the COVID-19 pandemic. Acad Emerg Med. 2020;27(5):375-378. doi:10.1111/acem.13994

22. ARDS Definition Task Force; Ranieri VM, Rubenfeld GD, Thompson BT, et al. Acute respiratory distress syndrome: the Berlin Definition. JAMA. 2012;307(23):2526-2533. doi:10.1001/jama.2012.5669

23. Petrilli CM, Jones SA, Yang J, et al. Factors associated with hospital admission and critical illness among 5279 people with coronavirus disease 2019 in New York City: prospective cohort study. BMJ. 2020;369:m1966. doi:10.1136/bmj.m1966

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25. Richardson S, Hirsch JS, Narasimhan M, et al. Presenting characteristics, comorbidities, and outcomes among 5700 patients hospitalized with COVID-19 in the New York City area. JAMA. 2020;323(20):2052-2059. doi:10.1001/jama.2020.6775

26. Muniyappa R, Gubbi S. COVID-19 pandemic, coronaviruses, and diabetes mellitus. Am J Physiol Endocrinol Metab. 2020;318(5):E736-E741. doi:10.1152/ajpendo.00124.2020

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From the Department of Emergency Medicine, Santa Croce e Carle Hospital, Cuneo, Italy (Drs. Abram, Tosello, Emanuele Bernardi, Allione, Cavalot, Dutto, Corsini, Martini, Sciolla, Sara Bernardi, and Lauria). From the School of Emergency Medicine, University of Turin, Turin, Italy (Drs. Paglietta and Giamello).

Objective: This retrospective and prospective cohort study was designed to describe the characteristics, treatments, and outcomes of patients with SARS-CoV-2 infection (COVID-19) admitted to subintensive care units (SICU) and to identify the variables associated with outcomes. SICUs have been extremely stressed during the pandemic, but most data regarding critically ill COVID-19 patients come from intensive care units (ICUs). Studies about COVID-19 patients in SICUs are lacking.

Setting and participants: The study included 88 COVID-19 patients admitted to our SICU in Cuneo, Italy, between March and May 2020.

Measurements: Clinical and ventilatory data were collected, and patients were divided by outcome. Multivariable logistic regression analysis examined the variables associated with negative outcomes (transfer to the ICU, palliation, or death in a SICU).

Results: A total of 60 patients (68%) had a positive outcome, and 28 patients (32%) had a negative outcome; 69 patients (78%) underwent continuous positive airway pressure (CPAP). Pronation (n = 37 [42%]) had been more frequently adopted in patients who had a positive outcome vs a negative outcome (n = 30 [50%] vs n = 7 [25%]; P = .048), and the median (interquartile range) Pao2/Fio2 ratio after 6 hours of prone positioning was lower in patients who had a negative outcome vs a positive outcome (144 [140-168] vs 249 [195-268], P = .006). Independent predictors of a negative outcome were diabetes (odds ratio [OR], 8.22; 95% CI, 1.50-44.70; P = .015), higher D-dimer (OR, 1.28; 95% CI, 1.04-1.57; P = .019), higher lactate dehydrogenase level (OR, 1.003; 95% CI, 1.000-1.006; P = .039), and lower lymphocytes count (OR, 0.996; 95% CI, 0.993-0.999; P = .004).

Conclusion: SICUs have a fundamental role in the treatment of critically ill patients with COVID-19, who require long-term CPAP and pronation cycles. Diabetes, lymphopenia, and high D-dimer and LDH levels are associated with negative outcomes.

Keywords: emergency medicine, noninvasive ventilation, prone position, continuous positive airway pressure.

The COVID-19 pandemic has led to large increases in hospital admissions. Subintensive care units (SICUs) are among the wards most under pressure worldwide,1 dealing with the increased number of critically ill patients who need noninvasive ventilation, as well as serving as the best alternative to overfilled intensive care units (ICUs). In Italy, SICUs are playing a fundamental role in the management of COVID-19 patients, providing early treatment of respiratory failure by continuous noninvasive ventilation in order to reduce the need for intubation.2-5 Nevertheless, the great majority of available data about critically ill COVID-19 patients comes from ICUs. Full studies about outcomes of patients in SICUs are lacking and need to be conducted.

We sought to evaluate the characteristics and outcomes of patients admitted to our SICU for COVID-19 to describe the treatments they needed and their impact on prognosis, and to identify the variables associated with patient outcomes.

Methods

Study Design

This cohort study used data from patients who were admitted in the very first weeks of the pandemic. Data were collected retrospectively as well as prospectively, since the ethical committee approved our project. The quality and quantity of data in the 2 groups were comparable.

Data were collected from electronic and written medical records gathered during the patient’s entire stay in our SICU. Data were entered in a database with limited and controlled access. This study complied with the Declaration of Helsinki and was approved by the local ethics committees (ID: MEDURG10).

Study Population

We studied 88 consecutive patients admitted to the SICU of the Santa Croce e Carle Teaching Hospital, Cuneo, Italy, for COVID-19, from March 8 to May 1, 2020. The diagnosis was based on acute respiratory failure associated with SARS-CoV-2 RNA detection on nasopharyngeal swab or tracheal aspirate and/or typical COVID-19 features on a pulmonary computed tomography (CT) scan.6 Exclusion criteria were age younger than 18 years and patient denial of permission to use their data for research purposes (the great majority of patients could actively give consent; for patients who were too sick to do so, family members were asked whether they were aware of any reason why the patient would deny consent).

 

 

Clinical Data

The past medical history and recent symptoms description were obtained by manually reviewing medical records. Epidemiological exposure was defined as contact with SARS-CoV-2–positive people or staying in an epidemic outbreak area. Initial vital parameters, venous blood tests, arterial blood gas analysis, chest x-ray, as well as the result of the nasopharyngeal swab were gathered from the emergency department (ED) examination. (Additional swabs could be requested when the first one was negative but clinical suspicion for COVID-19 was high.) Upon admission to the SICU, a standardized panel of blood tests was performed, which was repeated the next day and then every 48 hours. Arterial blood gas analysis was performed when clinically indicated, at least twice a day, or following a scheduled time in patients undergoing pronation. Charlson Comorbidity Index7 and MuLBSTA score8 were calculated based on the collected data.

Imaging

Chest ultrasonography was performed in the ED at the time of hospitalization and once a day in the SICU. Pulmonary high-resolution computed tomography (HRCT) was performed when clinically indicated or when the results of nasopharyngeal swabs and/or x-ray results were discordant with COVID-19 clinical suspicion. Contrast CT was performed when pulmonary embolism was suspected.

Medical Therapy

Hydroxychloroquine, antiviral agents, tocilizumab, and ruxolitinib were used in the early phase of the pandemic, then were dismissed after evidence of no efficacy.9-11 Steroids and low-molecular-weight heparin were used afterward. Enoxaparin was used at the standard prophylactic dosage, and 70% of the anticoagulant dosage was also adopted in patients with moderate-to-severe COVID-19 and D-dimer values >3 times the normal value.12-14 Antibiotics were given when a bacterial superinfection was suspected.

Oxygen and Ventilatory Therapy

Oxygen support or noninvasive ventilation were started based on patients’ respiratory efficacy, estimated by respiratory rate and the ratio of partial pressure of arterial oxygen and fraction of inspired oxygen (P/F ratio).15,16 Oxygen support was delivered through nasal cannula, Venturi mask, or reservoir mask. Noninvasive ventilation was performed by continuous positive airway pressure (CPAP) when the P/F ratio was <250 or the respiratory rate was >25 breaths per minute, using the helmet interface.5,17 Prone positioning during CPAP18-20 was adopted in patients meeting the acute respiratory distress syndrome (ARDS) criteria21 and having persistence of respiratory distress and P/F <300 after a 1-hour trial of CPAP.

The prone position was maintained based on patient tolerance. P/F ratio was measured before pronation (T0), after 1 hour of prone position (T1), before resupination (T2), and 6 hours after resupination (T3). With the same timing, the patient was asked to rate their comfort in each position, from 0 (lack of comfort) to 10 (optimal comfort). Delta P/F was defined as the difference between P/F at T3 and basal P/F at T0.

Outcomes

Positive outcomes were defined as patient discharge from the SICU or transfer to a lower-intensity care ward for treatment continuation. Negative outcomes were defined as need for transfer to the ICU, transfer to another ward for palliation, or death in the SICU.

Statistical Analysis

Continuous data are reported as median and interquartile range (IQR); normal distribution of variables was tested using the Shapiro-Wilk test. Categorical variables were reported as absolute number and percentage. The Mann-Whitney test was used to compare continuous variables between groups, and chi-square test with continuity correction was used for categorical variables. The variables that were most significantly associated with a negative outcome on the univariate analysis were included in a stepwise logistic regression analysis, in order to identify independent predictors of patient outcome. Statistical analysis was performed using JASP (JASP Team) software.

 

 

Results

Study Population

Of the 88 patients included in the study, 70% were male; the median age was 66 years (IQR, 60-77). In most patients, the diagnosis of COVID-19 was derived from a positive SARS-CoV-2 nasopharyngeal swab. Six patients, however, maintained a negative swab at all determinations but had clinical and imaging features strongly suggesting COVID-19. No patients met the exclusion criteria. Most patients came from the ED (n = 58 [66%]) or general wards (n = 22 [25%]), while few were transferred from the ICU (n = 8 [9%]). The median length of stay in the SICU was 4 days (IQR, 2-7). An epidemiological link to affected persons or a known virus exposure was identifiable in 37 patients (42%).

Clinical, Laboratory, and Imaging Data

The clinical and anthropometric characteristics of patients are shown in Table 1. Hypertension and smoking habits were prevalent in our population, and the median Charlson Comorbidity Index was 3. Most patients experienced fever, dyspnea, and cough during the days before hospitalization.

Laboratory data showed a marked inflammatory milieu in all studied patients, both at baseline and after 24 and 72 hours. Lymphopenia was observed, along with a significant increase of lactate dehydrogenase (LDH), C-reactive protein (CPR), and D-dimer, and a mild increase of procalcitonin. N-terminal pro-brain natriuretic peptide (NT-proBNP) values were also increased, with normal troponin I values (Table 2).



Chest x-rays were obtained in almost all patients, while HRCT was performed in nearly half of patients. Complete bedside pulmonary ultrasonography data were available for 64 patients. Heterogeneous pulmonary alterations were found, regardless of the radiological technique, and multilobe infiltrates were the prevalent radiological pattern (73%) (Table 3). Seven patients (8%) were diagnosed with associated pulmonary embolism.

 

 

Medical Therapy

Most patients (89%) received hydroxychloroquine, whereas steroids were used in one-third of the population (36%). Immunomodulators (tocilizumab and ruxolitinib) were restricted to 12 patients (14%). Empirical antiviral therapy was introduced in the first 41 patients (47%). Enoxaparin was the default agent for thromboembolism prophylaxis, and 6 patients (7%) received 70% of the anticoagulating dose.

Oxygen and Ventilatory Therapy

Basal median P/F ratio was 253 (IQR, 218-291), and respiratory rate at triage was 20 breaths/min (IQR, 16-28), underlining a moderate-to-severe respiratory insufficiency at presentation. A total of 69 patients (78%) underwent CPAP, with a median positive end-expiratory pressure (PEEP) of 10.0 cm H2O (IQR, 7.5-10.0) and fraction of inspired oxygen (Fio2) of 0.40 (IQR, 0.40-0.50). In 37 patients (42%) who received ongoing CPAP, prone positioning was adopted. In this subgroup, respiratory rate was not significantly different from baseline to resupination (24 vs 25 breaths/min). The median P/F improved from 197 (IQR, 154-236) at baseline to 217 (IQR, 180-262) after pronation (the duration of the prone position was variable, depending on patients’ tolerance: 1 to 6 hours or every pronation cycle). The median delta P/F ratio was 39.4 (IQR, –17.0 to 78.0).

Outcomes

A total of 28 patients (32%) had a negative outcome in the SICU: 8 patients (9%) died, having no clinical indication for higher-intensity care; 6 patients (7%) were transferred to general wards for palliation; and 14 patients (16%) needed an upgrade of cure intensity and were transferred to the ICU. Of these 14 patients, 9 died in the ICU. The total in-hospital mortality of COVID-19 patients, including patients transferred from the SICU to general wards in fair condition, was 27% (n = 24). Clinical, laboratory, and therapeutic characteristics between the 2 groups are shown in Table 4.

Patients who had a negative outcome were significantly older and had more comorbidities, as suggested by a significantly higher prevalence of diabetes and higher Charlson Comorbidity scores (reflecting the mortality risk based on age and comorbidities). The median MuLBSTA score, which estimates the 90-day mortality risk from viral pneumonia, was also higher in patients who had a negative outcome (9.33%). Symptom occurrence was not different in patients with a negative outcome (apart from cough, which was less frequent), but these patients underwent hospitalization earlier—since the appearance of their first COVID-19 symptoms—compared to patients who had a positive outcome. No difference was found in antihypertensive therapy with angiotensin-converting enzyme inhibitors or angiotensin-receptor blockers among outcome groups.

More pronounced laboratory abnormalities were found in patients who had a negative outcome, compared to patients who had a positive outcome: lower lymphocytes and higher C-reactive protein (CRP), procalcitonin, D-dimer, LDH, and NT-proBNP. We found no differences in the radiological distribution of pulmonary involvement in patients who had negative or positive outcomes, nor in the adopted medical treatment.

Data showed no difference in CPAP implementation in the 2 groups. However, prone positioning had been more frequently adopted in the group of patients who had a positive outcome, compared with patients who had a negative outcome. No differences of basal P/F were found in patients who had a negative or positive outcome, but the median P/F after 6 hours of prone position was significantly lower in patients who had a negative outcome. The delta P/F ratio did not differ in the 2 groups of patients.

Multivariate Analysis

A logistic regression model was created, including the variables significantly associated with outcomes in the univariate analysis (age, sex, history of diabetes, lymphocytes, CRP, procalcitonin, LDH, NT-proBNP, and D-dimer). In the multivariate analysis, independent predictors of a negative outcome were history of diabetes (odds ratio [OR], 8.22; 95% CI, 1.50-44.70; P =.015), high D-dimer values (OR, 1.28; CI, 1.04-1.57; P = .019), high LDH values (OR, 1.003; CI, 1.000-1.006; P = .039), and low lymphocytes count (OR, 0.996; CI, 0.993-0.999; P = .004).

 

 

Discussion

Role of Subintensive Units and Mortality

The novelty of our report is its attempt to investigate the specific group of COVID-19 patients admitted to a SICU. In Italy, SICUs receive acutely ill, spontaneously breathing patients who need (invasive) hemodynamic monitoring, vasoactive medication, renal replacement therapy, chest- tube placement, thrombolysis, and respiratory noninvasive support. The nurse-to-patient ratio is higher than for general wards (usually 1 nurse to every 4 or 5 patients), though lower than for ICUs. In northern Italy, a great number of COVID-19 patients have required this kind of high-intensity care during the pandemic: Noninvasive ventilation support had to be maintained for several days, pronation maneuvers required a high number of people 2 or 3 times a day, and strict monitoring had to be assured. The SICU setting allows patients to buy time as a bridge to progressive reduction of pulmonary involvement, sometimes preventing the need for intubation.

The high prevalence of negative outcomes in the SICU underlines the complexity of COVID-19 patients in this setting. In fact, published data about mortality for patients with severe COVID-19 pneumonia are similar to ours.22,23

Clinical, Laboratory, and Imaging Data

Our analysis confirmed a high rate of comorbidities in COVID-19 patients24 and their prognostic role with age.25,26 A marked inflammatory milieu was a negative prognostic indicator, and associated concomitant bacterial superinfection could have led to a worse prognosis (procalcitonin was associated with negative outcomes).27 The cardiovascular system was nevertheless stressed, as suggested by higher values of NT-proBNP in patients with negative outcomes, which could reflect sepsis-related systemic involvement.28

It is known that the pulmonary damage caused by SARS-CoV-2 has a dynamic radiological and clinical course, with early areas of subsegmental consolidation, and bilateral ground-glass opacities predominating later in the course of the disease.29 This could explain why in our population we found no specific radiological pattern leading to a worse outcome.

Medical Therapy

No specific pharmacological therapy was found to be associated with a positive outcome in our study, just like antiviral and immunomodulator therapies failed to demonstrate effectiveness in subsequent pandemic surges. The low statistical power of our study did not allow us to give insight into the effectiveness of steroids and heparin at any dosage.

PEEP Support and Prone Positioning

Continuous positive airway pressure was initiated in the majority of patients and maintained for several days. This was an absolute novelty, because we rarely had to keep patients in helmets for long. This was feasible thanks to the SICU’s high nurse-to-patient ratio and the possibility of providing monitored sedation. Patients who could no longer tolerate CPAP helmets or did not improve with CPAP support were evaluated with anesthetists for programming further management. No initial data on respiratory rate, level of hypoxemia, or oxygen support need (level of PEEP and Fio2) could discriminate between outcomes.

Prone positioning during CPAP was implemented in 42% of our study population: P/F ratio amelioration after prone positioning was highly variable, ranging from very good P/F ratio improvements to few responses or no response. No significantly greater delta P/F ratio was seen after the first prone positioning cycle in patients who had a positive outcome, probably due to the small size of our population, but we observed a clear positive trend. Interestingly, patients showing a negative outcome had a lower percentage of long-term responses to prone positioning: 6 hours after resupination, they lost the benefit of prone positioning in terms of P/F ratio amelioration. Similarly, a greater number of patients tolerating prone positioning had a positive outcome. These data give insight on the possible benefits of prone positioning in a noninvasively supported cohort of patients, which has been mentioned in previous studies.30,31

 

 

Outcomes and Variables Associated With Negative Outcomes

After correction for age and sex, we found in multiple regression analysis that higher D-dimer and LDH values, lymphopenia, and history of diabetes were independently associated with a worse outcome. Although our results had low statistical significance, we consider the trend of the obtained odds ratios important from a clinical point of view. These results could lead to greater attention being placed on COVID-19 patients who present with these characteristics upon their arrival to the ED because they have increased risk of death or intensive care need. Clinicians should consider SICU admission for these patients in order to guarantee closer monitoring and possibly more aggressive ventilatory treatments, earlier pronation, or earlier transfer to the ICU.

Limitations

The major limitation to our study is undoubtedly its statistical power, due to its relatively low patient population. Particularly, the small number of patients who underwent pronation did not allow speculation about the efficacy of this technique, although preliminary data seem promising. However, ours is among the first studies regarding patients with COVID-19 admitted to a SICU, and these preliminary data truthfully describe the Italian, and perhaps international, experience with the first surge of the pandemic.

Conclusions

Our data highlight the primary role of the SICU in COVID-19 in adequately treating critically ill patients who have high care needs different from intubation, and who require noninvasive ventilation for prolonged times as well as frequent pronation cycles. This setting of care may represent a valid, reliable, and effective option for critically ill respiratory patients. History of diabetes, lymphopenia, and high D-dimer and LDH values are independently associated with negative outcomes, and patients presenting with these characteristics should be strictly monitored.

Acknowledgments: The authors thank the Informatica System S.R.L., as well as Allessando Mendolia for the pro bono creation of the ISCovidCollect data collecting app.

Corresponding author: Sara Abram, MD, via Coppino, 12100 Cuneo, Italy; [email protected].

Disclosures: None.

From the Department of Emergency Medicine, Santa Croce e Carle Hospital, Cuneo, Italy (Drs. Abram, Tosello, Emanuele Bernardi, Allione, Cavalot, Dutto, Corsini, Martini, Sciolla, Sara Bernardi, and Lauria). From the School of Emergency Medicine, University of Turin, Turin, Italy (Drs. Paglietta and Giamello).

Objective: This retrospective and prospective cohort study was designed to describe the characteristics, treatments, and outcomes of patients with SARS-CoV-2 infection (COVID-19) admitted to subintensive care units (SICU) and to identify the variables associated with outcomes. SICUs have been extremely stressed during the pandemic, but most data regarding critically ill COVID-19 patients come from intensive care units (ICUs). Studies about COVID-19 patients in SICUs are lacking.

Setting and participants: The study included 88 COVID-19 patients admitted to our SICU in Cuneo, Italy, between March and May 2020.

Measurements: Clinical and ventilatory data were collected, and patients were divided by outcome. Multivariable logistic regression analysis examined the variables associated with negative outcomes (transfer to the ICU, palliation, or death in a SICU).

Results: A total of 60 patients (68%) had a positive outcome, and 28 patients (32%) had a negative outcome; 69 patients (78%) underwent continuous positive airway pressure (CPAP). Pronation (n = 37 [42%]) had been more frequently adopted in patients who had a positive outcome vs a negative outcome (n = 30 [50%] vs n = 7 [25%]; P = .048), and the median (interquartile range) Pao2/Fio2 ratio after 6 hours of prone positioning was lower in patients who had a negative outcome vs a positive outcome (144 [140-168] vs 249 [195-268], P = .006). Independent predictors of a negative outcome were diabetes (odds ratio [OR], 8.22; 95% CI, 1.50-44.70; P = .015), higher D-dimer (OR, 1.28; 95% CI, 1.04-1.57; P = .019), higher lactate dehydrogenase level (OR, 1.003; 95% CI, 1.000-1.006; P = .039), and lower lymphocytes count (OR, 0.996; 95% CI, 0.993-0.999; P = .004).

Conclusion: SICUs have a fundamental role in the treatment of critically ill patients with COVID-19, who require long-term CPAP and pronation cycles. Diabetes, lymphopenia, and high D-dimer and LDH levels are associated with negative outcomes.

Keywords: emergency medicine, noninvasive ventilation, prone position, continuous positive airway pressure.

The COVID-19 pandemic has led to large increases in hospital admissions. Subintensive care units (SICUs) are among the wards most under pressure worldwide,1 dealing with the increased number of critically ill patients who need noninvasive ventilation, as well as serving as the best alternative to overfilled intensive care units (ICUs). In Italy, SICUs are playing a fundamental role in the management of COVID-19 patients, providing early treatment of respiratory failure by continuous noninvasive ventilation in order to reduce the need for intubation.2-5 Nevertheless, the great majority of available data about critically ill COVID-19 patients comes from ICUs. Full studies about outcomes of patients in SICUs are lacking and need to be conducted.

We sought to evaluate the characteristics and outcomes of patients admitted to our SICU for COVID-19 to describe the treatments they needed and their impact on prognosis, and to identify the variables associated with patient outcomes.

Methods

Study Design

This cohort study used data from patients who were admitted in the very first weeks of the pandemic. Data were collected retrospectively as well as prospectively, since the ethical committee approved our project. The quality and quantity of data in the 2 groups were comparable.

Data were collected from electronic and written medical records gathered during the patient’s entire stay in our SICU. Data were entered in a database with limited and controlled access. This study complied with the Declaration of Helsinki and was approved by the local ethics committees (ID: MEDURG10).

Study Population

We studied 88 consecutive patients admitted to the SICU of the Santa Croce e Carle Teaching Hospital, Cuneo, Italy, for COVID-19, from March 8 to May 1, 2020. The diagnosis was based on acute respiratory failure associated with SARS-CoV-2 RNA detection on nasopharyngeal swab or tracheal aspirate and/or typical COVID-19 features on a pulmonary computed tomography (CT) scan.6 Exclusion criteria were age younger than 18 years and patient denial of permission to use their data for research purposes (the great majority of patients could actively give consent; for patients who were too sick to do so, family members were asked whether they were aware of any reason why the patient would deny consent).

 

 

Clinical Data

The past medical history and recent symptoms description were obtained by manually reviewing medical records. Epidemiological exposure was defined as contact with SARS-CoV-2–positive people or staying in an epidemic outbreak area. Initial vital parameters, venous blood tests, arterial blood gas analysis, chest x-ray, as well as the result of the nasopharyngeal swab were gathered from the emergency department (ED) examination. (Additional swabs could be requested when the first one was negative but clinical suspicion for COVID-19 was high.) Upon admission to the SICU, a standardized panel of blood tests was performed, which was repeated the next day and then every 48 hours. Arterial blood gas analysis was performed when clinically indicated, at least twice a day, or following a scheduled time in patients undergoing pronation. Charlson Comorbidity Index7 and MuLBSTA score8 were calculated based on the collected data.

Imaging

Chest ultrasonography was performed in the ED at the time of hospitalization and once a day in the SICU. Pulmonary high-resolution computed tomography (HRCT) was performed when clinically indicated or when the results of nasopharyngeal swabs and/or x-ray results were discordant with COVID-19 clinical suspicion. Contrast CT was performed when pulmonary embolism was suspected.

Medical Therapy

Hydroxychloroquine, antiviral agents, tocilizumab, and ruxolitinib were used in the early phase of the pandemic, then were dismissed after evidence of no efficacy.9-11 Steroids and low-molecular-weight heparin were used afterward. Enoxaparin was used at the standard prophylactic dosage, and 70% of the anticoagulant dosage was also adopted in patients with moderate-to-severe COVID-19 and D-dimer values >3 times the normal value.12-14 Antibiotics were given when a bacterial superinfection was suspected.

Oxygen and Ventilatory Therapy

Oxygen support or noninvasive ventilation were started based on patients’ respiratory efficacy, estimated by respiratory rate and the ratio of partial pressure of arterial oxygen and fraction of inspired oxygen (P/F ratio).15,16 Oxygen support was delivered through nasal cannula, Venturi mask, or reservoir mask. Noninvasive ventilation was performed by continuous positive airway pressure (CPAP) when the P/F ratio was <250 or the respiratory rate was >25 breaths per minute, using the helmet interface.5,17 Prone positioning during CPAP18-20 was adopted in patients meeting the acute respiratory distress syndrome (ARDS) criteria21 and having persistence of respiratory distress and P/F <300 after a 1-hour trial of CPAP.

The prone position was maintained based on patient tolerance. P/F ratio was measured before pronation (T0), after 1 hour of prone position (T1), before resupination (T2), and 6 hours after resupination (T3). With the same timing, the patient was asked to rate their comfort in each position, from 0 (lack of comfort) to 10 (optimal comfort). Delta P/F was defined as the difference between P/F at T3 and basal P/F at T0.

Outcomes

Positive outcomes were defined as patient discharge from the SICU or transfer to a lower-intensity care ward for treatment continuation. Negative outcomes were defined as need for transfer to the ICU, transfer to another ward for palliation, or death in the SICU.

Statistical Analysis

Continuous data are reported as median and interquartile range (IQR); normal distribution of variables was tested using the Shapiro-Wilk test. Categorical variables were reported as absolute number and percentage. The Mann-Whitney test was used to compare continuous variables between groups, and chi-square test with continuity correction was used for categorical variables. The variables that were most significantly associated with a negative outcome on the univariate analysis were included in a stepwise logistic regression analysis, in order to identify independent predictors of patient outcome. Statistical analysis was performed using JASP (JASP Team) software.

 

 

Results

Study Population

Of the 88 patients included in the study, 70% were male; the median age was 66 years (IQR, 60-77). In most patients, the diagnosis of COVID-19 was derived from a positive SARS-CoV-2 nasopharyngeal swab. Six patients, however, maintained a negative swab at all determinations but had clinical and imaging features strongly suggesting COVID-19. No patients met the exclusion criteria. Most patients came from the ED (n = 58 [66%]) or general wards (n = 22 [25%]), while few were transferred from the ICU (n = 8 [9%]). The median length of stay in the SICU was 4 days (IQR, 2-7). An epidemiological link to affected persons or a known virus exposure was identifiable in 37 patients (42%).

Clinical, Laboratory, and Imaging Data

The clinical and anthropometric characteristics of patients are shown in Table 1. Hypertension and smoking habits were prevalent in our population, and the median Charlson Comorbidity Index was 3. Most patients experienced fever, dyspnea, and cough during the days before hospitalization.

Laboratory data showed a marked inflammatory milieu in all studied patients, both at baseline and after 24 and 72 hours. Lymphopenia was observed, along with a significant increase of lactate dehydrogenase (LDH), C-reactive protein (CPR), and D-dimer, and a mild increase of procalcitonin. N-terminal pro-brain natriuretic peptide (NT-proBNP) values were also increased, with normal troponin I values (Table 2).



Chest x-rays were obtained in almost all patients, while HRCT was performed in nearly half of patients. Complete bedside pulmonary ultrasonography data were available for 64 patients. Heterogeneous pulmonary alterations were found, regardless of the radiological technique, and multilobe infiltrates were the prevalent radiological pattern (73%) (Table 3). Seven patients (8%) were diagnosed with associated pulmonary embolism.

 

 

Medical Therapy

Most patients (89%) received hydroxychloroquine, whereas steroids were used in one-third of the population (36%). Immunomodulators (tocilizumab and ruxolitinib) were restricted to 12 patients (14%). Empirical antiviral therapy was introduced in the first 41 patients (47%). Enoxaparin was the default agent for thromboembolism prophylaxis, and 6 patients (7%) received 70% of the anticoagulating dose.

Oxygen and Ventilatory Therapy

Basal median P/F ratio was 253 (IQR, 218-291), and respiratory rate at triage was 20 breaths/min (IQR, 16-28), underlining a moderate-to-severe respiratory insufficiency at presentation. A total of 69 patients (78%) underwent CPAP, with a median positive end-expiratory pressure (PEEP) of 10.0 cm H2O (IQR, 7.5-10.0) and fraction of inspired oxygen (Fio2) of 0.40 (IQR, 0.40-0.50). In 37 patients (42%) who received ongoing CPAP, prone positioning was adopted. In this subgroup, respiratory rate was not significantly different from baseline to resupination (24 vs 25 breaths/min). The median P/F improved from 197 (IQR, 154-236) at baseline to 217 (IQR, 180-262) after pronation (the duration of the prone position was variable, depending on patients’ tolerance: 1 to 6 hours or every pronation cycle). The median delta P/F ratio was 39.4 (IQR, –17.0 to 78.0).

Outcomes

A total of 28 patients (32%) had a negative outcome in the SICU: 8 patients (9%) died, having no clinical indication for higher-intensity care; 6 patients (7%) were transferred to general wards for palliation; and 14 patients (16%) needed an upgrade of cure intensity and were transferred to the ICU. Of these 14 patients, 9 died in the ICU. The total in-hospital mortality of COVID-19 patients, including patients transferred from the SICU to general wards in fair condition, was 27% (n = 24). Clinical, laboratory, and therapeutic characteristics between the 2 groups are shown in Table 4.

Patients who had a negative outcome were significantly older and had more comorbidities, as suggested by a significantly higher prevalence of diabetes and higher Charlson Comorbidity scores (reflecting the mortality risk based on age and comorbidities). The median MuLBSTA score, which estimates the 90-day mortality risk from viral pneumonia, was also higher in patients who had a negative outcome (9.33%). Symptom occurrence was not different in patients with a negative outcome (apart from cough, which was less frequent), but these patients underwent hospitalization earlier—since the appearance of their first COVID-19 symptoms—compared to patients who had a positive outcome. No difference was found in antihypertensive therapy with angiotensin-converting enzyme inhibitors or angiotensin-receptor blockers among outcome groups.

More pronounced laboratory abnormalities were found in patients who had a negative outcome, compared to patients who had a positive outcome: lower lymphocytes and higher C-reactive protein (CRP), procalcitonin, D-dimer, LDH, and NT-proBNP. We found no differences in the radiological distribution of pulmonary involvement in patients who had negative or positive outcomes, nor in the adopted medical treatment.

Data showed no difference in CPAP implementation in the 2 groups. However, prone positioning had been more frequently adopted in the group of patients who had a positive outcome, compared with patients who had a negative outcome. No differences of basal P/F were found in patients who had a negative or positive outcome, but the median P/F after 6 hours of prone position was significantly lower in patients who had a negative outcome. The delta P/F ratio did not differ in the 2 groups of patients.

Multivariate Analysis

A logistic regression model was created, including the variables significantly associated with outcomes in the univariate analysis (age, sex, history of diabetes, lymphocytes, CRP, procalcitonin, LDH, NT-proBNP, and D-dimer). In the multivariate analysis, independent predictors of a negative outcome were history of diabetes (odds ratio [OR], 8.22; 95% CI, 1.50-44.70; P =.015), high D-dimer values (OR, 1.28; CI, 1.04-1.57; P = .019), high LDH values (OR, 1.003; CI, 1.000-1.006; P = .039), and low lymphocytes count (OR, 0.996; CI, 0.993-0.999; P = .004).

 

 

Discussion

Role of Subintensive Units and Mortality

The novelty of our report is its attempt to investigate the specific group of COVID-19 patients admitted to a SICU. In Italy, SICUs receive acutely ill, spontaneously breathing patients who need (invasive) hemodynamic monitoring, vasoactive medication, renal replacement therapy, chest- tube placement, thrombolysis, and respiratory noninvasive support. The nurse-to-patient ratio is higher than for general wards (usually 1 nurse to every 4 or 5 patients), though lower than for ICUs. In northern Italy, a great number of COVID-19 patients have required this kind of high-intensity care during the pandemic: Noninvasive ventilation support had to be maintained for several days, pronation maneuvers required a high number of people 2 or 3 times a day, and strict monitoring had to be assured. The SICU setting allows patients to buy time as a bridge to progressive reduction of pulmonary involvement, sometimes preventing the need for intubation.

The high prevalence of negative outcomes in the SICU underlines the complexity of COVID-19 patients in this setting. In fact, published data about mortality for patients with severe COVID-19 pneumonia are similar to ours.22,23

Clinical, Laboratory, and Imaging Data

Our analysis confirmed a high rate of comorbidities in COVID-19 patients24 and their prognostic role with age.25,26 A marked inflammatory milieu was a negative prognostic indicator, and associated concomitant bacterial superinfection could have led to a worse prognosis (procalcitonin was associated with negative outcomes).27 The cardiovascular system was nevertheless stressed, as suggested by higher values of NT-proBNP in patients with negative outcomes, which could reflect sepsis-related systemic involvement.28

It is known that the pulmonary damage caused by SARS-CoV-2 has a dynamic radiological and clinical course, with early areas of subsegmental consolidation, and bilateral ground-glass opacities predominating later in the course of the disease.29 This could explain why in our population we found no specific radiological pattern leading to a worse outcome.

Medical Therapy

No specific pharmacological therapy was found to be associated with a positive outcome in our study, just like antiviral and immunomodulator therapies failed to demonstrate effectiveness in subsequent pandemic surges. The low statistical power of our study did not allow us to give insight into the effectiveness of steroids and heparin at any dosage.

PEEP Support and Prone Positioning

Continuous positive airway pressure was initiated in the majority of patients and maintained for several days. This was an absolute novelty, because we rarely had to keep patients in helmets for long. This was feasible thanks to the SICU’s high nurse-to-patient ratio and the possibility of providing monitored sedation. Patients who could no longer tolerate CPAP helmets or did not improve with CPAP support were evaluated with anesthetists for programming further management. No initial data on respiratory rate, level of hypoxemia, or oxygen support need (level of PEEP and Fio2) could discriminate between outcomes.

Prone positioning during CPAP was implemented in 42% of our study population: P/F ratio amelioration after prone positioning was highly variable, ranging from very good P/F ratio improvements to few responses or no response. No significantly greater delta P/F ratio was seen after the first prone positioning cycle in patients who had a positive outcome, probably due to the small size of our population, but we observed a clear positive trend. Interestingly, patients showing a negative outcome had a lower percentage of long-term responses to prone positioning: 6 hours after resupination, they lost the benefit of prone positioning in terms of P/F ratio amelioration. Similarly, a greater number of patients tolerating prone positioning had a positive outcome. These data give insight on the possible benefits of prone positioning in a noninvasively supported cohort of patients, which has been mentioned in previous studies.30,31

 

 

Outcomes and Variables Associated With Negative Outcomes

After correction for age and sex, we found in multiple regression analysis that higher D-dimer and LDH values, lymphopenia, and history of diabetes were independently associated with a worse outcome. Although our results had low statistical significance, we consider the trend of the obtained odds ratios important from a clinical point of view. These results could lead to greater attention being placed on COVID-19 patients who present with these characteristics upon their arrival to the ED because they have increased risk of death or intensive care need. Clinicians should consider SICU admission for these patients in order to guarantee closer monitoring and possibly more aggressive ventilatory treatments, earlier pronation, or earlier transfer to the ICU.

Limitations

The major limitation to our study is undoubtedly its statistical power, due to its relatively low patient population. Particularly, the small number of patients who underwent pronation did not allow speculation about the efficacy of this technique, although preliminary data seem promising. However, ours is among the first studies regarding patients with COVID-19 admitted to a SICU, and these preliminary data truthfully describe the Italian, and perhaps international, experience with the first surge of the pandemic.

Conclusions

Our data highlight the primary role of the SICU in COVID-19 in adequately treating critically ill patients who have high care needs different from intubation, and who require noninvasive ventilation for prolonged times as well as frequent pronation cycles. This setting of care may represent a valid, reliable, and effective option for critically ill respiratory patients. History of diabetes, lymphopenia, and high D-dimer and LDH values are independently associated with negative outcomes, and patients presenting with these characteristics should be strictly monitored.

Acknowledgments: The authors thank the Informatica System S.R.L., as well as Allessando Mendolia for the pro bono creation of the ISCovidCollect data collecting app.

Corresponding author: Sara Abram, MD, via Coppino, 12100 Cuneo, Italy; [email protected].

Disclosures: None.

References

1. Plate JDJ, Leenen LPH, Houwert M, Hietbrink F. Utilisation of intermediate care units: a systematic review. Crit Care Res Pract. 2017;2017:8038460. doi:10.1155/2017/8038460

2. Antonelli M, Conti G, Esquinas A, et al. A multiple-center survey on the use in clinical practice of noninvasive ventilation as a first-line intervention for acute respiratory distress syndrome. Crit Care Med. 2007;35(1):18-25. doi:10.1097/01.CCM.0000251821.44259.F3

3. Patel BK, Wolfe KS, Pohlman AS, Hall JB, Kress JP. Effect of noninvasive ventilation delivered by helmet vs face mask on the rate of endotracheal intubation in patients with acute respiratory distress syndrome: a randomized clinical trial. JAMA. 2016;315(22):2435-2441. doi:10.1001/jama.2016.6338

4. Mas A, Masip J. Noninvasive ventilation in acute respiratory failure. Int J Chron Obstruct Pulmon Dis. 2014;9:837-852. doi:10.2147/COPD.S42664

5. Bellani G, Patroniti N, Greco M, Foti G, Pesenti A. The use of helmets to deliver non-invasive continuous positive airway pressure in hypoxemic acute respiratory failure. Minerva Anestesiol. 2008;74(11):651-656.

6. Lomoro P, Verde F, Zerboni F, et al. COVID-19 pneumonia manifestations at the admission on chest ultrasound, radiographs, and CT: single-center study and comprehensive radiologic literature review. Eur J Radiol Open. 2020;7:100231. doi:10.1016/j.ejro.2020.100231

7. Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987;40:373-383. doi:10.1016/0021-9681(87)90171-8

8. Guo L, Wei D, Zhang X, et al. Clinical features predicting mortality risk in patients with viral pneumonia: the MuLBSTA score. Front Microbiol. 2019;10:2752. doi:10.3389/fmicb.2019.02752

9. Lombardy Section Italian Society Infectious and Tropical Disease. Vademecum for the treatment of people with COVID-19. Edition 2.0, 13 March 2020. Infez Med. 2020;28(2):143-152.

10. Wang M, Cao R, Zhang L, et al. Remdesivir and chloroquine effectively inhibit the recently emerged novel coronavirus (2019-nCoV) in vitro. Cell Res. 2020;30(3):269-271. doi:10.1038/s41422-020-0282-0

11. Cao B, Wang Y, Wen D, et al. A trial of lopinavir-ritonavir in adults hospitalized with severe Covid-19. N Engl J Med. 2020;382(19):1787-1799. doi:10.1056/NEJMoa2001282

12. Stone JH, Frigault MJ, Serling-Boyd NJ, et al; BACC Bay Tocilizumab Trial Investigators. Efficacy of tocilizumab in patients hospitalized with Covid-19. N Engl J Med. 2020;383(24):2333-2344. doi:10.1056/NEJMoa2028836

13. Shastri MD, Stewart N, Horne J, et al. In-vitro suppression of IL-6 and IL-8 release from human pulmonary epithelial cells by non-anticoagulant fraction of enoxaparin. PLoS One. 2015;10(5):e0126763. doi:10.1371/journal.pone.0126763

14. Milewska A, Zarebski M, Nowak P, Stozek K, Potempa J, Pyrc K. Human coronavirus NL63 utilizes heparin sulfate proteoglycans for attachment to target cells. J Virol. 2014;88(22):13221-13230. doi:10.1128/JVI.02078-14

15. Marietta M, Vandelli P, Mighali P, Vicini R, Coluccio V, D’Amico R; COVID-19 HD Study Group. Randomised controlled trial comparing efficacy and safety of high versus low low-molecular weight heparin dosages in hospitalized patients with severe COVID-19 pneumonia and coagulopathy not requiring invasive mechanical ventilation (COVID-19 HD): a structured summary of a study protocol. Trials. 2020;21(1):574. doi:10.1186/s13063-020-04475-z

16. Marshall JC, Cook DJ, Christou NV, Bernard GR, Sprung CL, Sibbald WJ. Multiple organ dysfunction score: a reliable descriptor of a complex clinical outcome. Crit Care Med. 1995;23(10):1638-1652. doi:10.1097/00003246-199510000-00007

17. Sinha P, Calfee CS. Phenotypes in acute respiratory distress syndrome: moving towards precision medicine. Curr Opin Crit Care. 2019;25(1):12-20. doi:10.1097/MCC.0000000000000571

18. Lucchini A, Giani M, Isgrò S, Rona R, Foti G. The “helmet bundle” in COVID-19 patients undergoing non-invasive ventilation. Intensive Crit Care Nurs. 2020;58:102859. doi:10.1016/j.iccn.2020.102859

19. Ding L, Wang L, Ma W, He H. Efficacy and safety of early prone positioning combined with HFNC or NIV in moderate to severe ARDS: a multi-center prospective cohort study. Crit Care. 2020;24(1):28. doi:10.1186/s13054-020-2738-5

20. Scaravilli V, Grasselli G, Castagna L, et al. Prone positioning improves oxygenation in spontaneously breathing nonintubated patients with hypoxemic acute respiratory failure: a retrospective study. J Crit Care. 2015;30(6):1390-1394. doi:10.1016/j.jcrc.2015.07.008

21. Caputo ND, Strayer RJ, Levitan R. Early self-proning in awake, non-intubated patients in the emergency department: a single ED’s experience during the COVID-19 pandemic. Acad Emerg Med. 2020;27(5):375-378. doi:10.1111/acem.13994

22. ARDS Definition Task Force; Ranieri VM, Rubenfeld GD, Thompson BT, et al. Acute respiratory distress syndrome: the Berlin Definition. JAMA. 2012;307(23):2526-2533. doi:10.1001/jama.2012.5669

23. Petrilli CM, Jones SA, Yang J, et al. Factors associated with hospital admission and critical illness among 5279 people with coronavirus disease 2019 in New York City: prospective cohort study. BMJ. 2020;369:m1966. doi:10.1136/bmj.m1966

24. Docherty AB, Harrison EM, Green CA, et al; ISARIC4C investigators. Features of 20 133 UK patients in hospital with Covid-19 using the ISARIC WHO Clinical Characterisation Protocol: prospective observational cohort study. BMJ. 2020;369:m1985. doi:10.1136/bmj.m1985

25. Richardson S, Hirsch JS, Narasimhan M, et al. Presenting characteristics, comorbidities, and outcomes among 5700 patients hospitalized with COVID-19 in the New York City area. JAMA. 2020;323(20):2052-2059. doi:10.1001/jama.2020.6775

26. Muniyappa R, Gubbi S. COVID-19 pandemic, coronaviruses, and diabetes mellitus. Am J Physiol Endocrinol Metab. 2020;318(5):E736-E741. doi:10.1152/ajpendo.00124.2020

27. Guo W, Li M, Dong Y, et al. Diabetes is a risk factor for the progression and prognosis of COVID-19. Diabetes Metab Res Rev. 2020:e3319. doi:10.1002/dmrr.3319

28. Chen N, Zhou M, Dong X, et al. Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: a descriptive study. Lancet. 2020;395(10223):507-513. doi:10.1016/S0140-6736(20)30211-7

29. Kooraki S, Hosseiny M, Myers L, Gholamrezanezhad A. Coronavirus (COVID-19) outbreak: what the Department of Radiology should know. J Am Coll Radiol. 2020;17(4):447-451. doi:10.1016/j.jacr.2020.02.008

30. Coppo A, Bellani G, Winterton D, et al. Feasibility and physiological effects of prone positioning in non-intubated patients with acute respiratory failure due to COVID-19 (PRON-COVID): a prospective cohort study. Lancet Respir Med. 2020;8(8):765-774. doi:10.1016/S2213-2600(20)30268-X

31. Weatherald J, Solverson K, Zuege DJ, Loroff N, Fiest KM, Parhar KKS. Awake prone positioning for COVID-19 hypoxemic respiratory failure: a rapid review. J Crit Care. 2021;61:63-70. doi:10.1016/j.jcrc.2020.08.018

References

1. Plate JDJ, Leenen LPH, Houwert M, Hietbrink F. Utilisation of intermediate care units: a systematic review. Crit Care Res Pract. 2017;2017:8038460. doi:10.1155/2017/8038460

2. Antonelli M, Conti G, Esquinas A, et al. A multiple-center survey on the use in clinical practice of noninvasive ventilation as a first-line intervention for acute respiratory distress syndrome. Crit Care Med. 2007;35(1):18-25. doi:10.1097/01.CCM.0000251821.44259.F3

3. Patel BK, Wolfe KS, Pohlman AS, Hall JB, Kress JP. Effect of noninvasive ventilation delivered by helmet vs face mask on the rate of endotracheal intubation in patients with acute respiratory distress syndrome: a randomized clinical trial. JAMA. 2016;315(22):2435-2441. doi:10.1001/jama.2016.6338

4. Mas A, Masip J. Noninvasive ventilation in acute respiratory failure. Int J Chron Obstruct Pulmon Dis. 2014;9:837-852. doi:10.2147/COPD.S42664

5. Bellani G, Patroniti N, Greco M, Foti G, Pesenti A. The use of helmets to deliver non-invasive continuous positive airway pressure in hypoxemic acute respiratory failure. Minerva Anestesiol. 2008;74(11):651-656.

6. Lomoro P, Verde F, Zerboni F, et al. COVID-19 pneumonia manifestations at the admission on chest ultrasound, radiographs, and CT: single-center study and comprehensive radiologic literature review. Eur J Radiol Open. 2020;7:100231. doi:10.1016/j.ejro.2020.100231

7. Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987;40:373-383. doi:10.1016/0021-9681(87)90171-8

8. Guo L, Wei D, Zhang X, et al. Clinical features predicting mortality risk in patients with viral pneumonia: the MuLBSTA score. Front Microbiol. 2019;10:2752. doi:10.3389/fmicb.2019.02752

9. Lombardy Section Italian Society Infectious and Tropical Disease. Vademecum for the treatment of people with COVID-19. Edition 2.0, 13 March 2020. Infez Med. 2020;28(2):143-152.

10. Wang M, Cao R, Zhang L, et al. Remdesivir and chloroquine effectively inhibit the recently emerged novel coronavirus (2019-nCoV) in vitro. Cell Res. 2020;30(3):269-271. doi:10.1038/s41422-020-0282-0

11. Cao B, Wang Y, Wen D, et al. A trial of lopinavir-ritonavir in adults hospitalized with severe Covid-19. N Engl J Med. 2020;382(19):1787-1799. doi:10.1056/NEJMoa2001282

12. Stone JH, Frigault MJ, Serling-Boyd NJ, et al; BACC Bay Tocilizumab Trial Investigators. Efficacy of tocilizumab in patients hospitalized with Covid-19. N Engl J Med. 2020;383(24):2333-2344. doi:10.1056/NEJMoa2028836

13. Shastri MD, Stewart N, Horne J, et al. In-vitro suppression of IL-6 and IL-8 release from human pulmonary epithelial cells by non-anticoagulant fraction of enoxaparin. PLoS One. 2015;10(5):e0126763. doi:10.1371/journal.pone.0126763

14. Milewska A, Zarebski M, Nowak P, Stozek K, Potempa J, Pyrc K. Human coronavirus NL63 utilizes heparin sulfate proteoglycans for attachment to target cells. J Virol. 2014;88(22):13221-13230. doi:10.1128/JVI.02078-14

15. Marietta M, Vandelli P, Mighali P, Vicini R, Coluccio V, D’Amico R; COVID-19 HD Study Group. Randomised controlled trial comparing efficacy and safety of high versus low low-molecular weight heparin dosages in hospitalized patients with severe COVID-19 pneumonia and coagulopathy not requiring invasive mechanical ventilation (COVID-19 HD): a structured summary of a study protocol. Trials. 2020;21(1):574. doi:10.1186/s13063-020-04475-z

16. Marshall JC, Cook DJ, Christou NV, Bernard GR, Sprung CL, Sibbald WJ. Multiple organ dysfunction score: a reliable descriptor of a complex clinical outcome. Crit Care Med. 1995;23(10):1638-1652. doi:10.1097/00003246-199510000-00007

17. Sinha P, Calfee CS. Phenotypes in acute respiratory distress syndrome: moving towards precision medicine. Curr Opin Crit Care. 2019;25(1):12-20. doi:10.1097/MCC.0000000000000571

18. Lucchini A, Giani M, Isgrò S, Rona R, Foti G. The “helmet bundle” in COVID-19 patients undergoing non-invasive ventilation. Intensive Crit Care Nurs. 2020;58:102859. doi:10.1016/j.iccn.2020.102859

19. Ding L, Wang L, Ma W, He H. Efficacy and safety of early prone positioning combined with HFNC or NIV in moderate to severe ARDS: a multi-center prospective cohort study. Crit Care. 2020;24(1):28. doi:10.1186/s13054-020-2738-5

20. Scaravilli V, Grasselli G, Castagna L, et al. Prone positioning improves oxygenation in spontaneously breathing nonintubated patients with hypoxemic acute respiratory failure: a retrospective study. J Crit Care. 2015;30(6):1390-1394. doi:10.1016/j.jcrc.2015.07.008

21. Caputo ND, Strayer RJ, Levitan R. Early self-proning in awake, non-intubated patients in the emergency department: a single ED’s experience during the COVID-19 pandemic. Acad Emerg Med. 2020;27(5):375-378. doi:10.1111/acem.13994

22. ARDS Definition Task Force; Ranieri VM, Rubenfeld GD, Thompson BT, et al. Acute respiratory distress syndrome: the Berlin Definition. JAMA. 2012;307(23):2526-2533. doi:10.1001/jama.2012.5669

23. Petrilli CM, Jones SA, Yang J, et al. Factors associated with hospital admission and critical illness among 5279 people with coronavirus disease 2019 in New York City: prospective cohort study. BMJ. 2020;369:m1966. doi:10.1136/bmj.m1966

24. Docherty AB, Harrison EM, Green CA, et al; ISARIC4C investigators. Features of 20 133 UK patients in hospital with Covid-19 using the ISARIC WHO Clinical Characterisation Protocol: prospective observational cohort study. BMJ. 2020;369:m1985. doi:10.1136/bmj.m1985

25. Richardson S, Hirsch JS, Narasimhan M, et al. Presenting characteristics, comorbidities, and outcomes among 5700 patients hospitalized with COVID-19 in the New York City area. JAMA. 2020;323(20):2052-2059. doi:10.1001/jama.2020.6775

26. Muniyappa R, Gubbi S. COVID-19 pandemic, coronaviruses, and diabetes mellitus. Am J Physiol Endocrinol Metab. 2020;318(5):E736-E741. doi:10.1152/ajpendo.00124.2020

27. Guo W, Li M, Dong Y, et al. Diabetes is a risk factor for the progression and prognosis of COVID-19. Diabetes Metab Res Rev. 2020:e3319. doi:10.1002/dmrr.3319

28. Chen N, Zhou M, Dong X, et al. Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: a descriptive study. Lancet. 2020;395(10223):507-513. doi:10.1016/S0140-6736(20)30211-7

29. Kooraki S, Hosseiny M, Myers L, Gholamrezanezhad A. Coronavirus (COVID-19) outbreak: what the Department of Radiology should know. J Am Coll Radiol. 2020;17(4):447-451. doi:10.1016/j.jacr.2020.02.008

30. Coppo A, Bellani G, Winterton D, et al. Feasibility and physiological effects of prone positioning in non-intubated patients with acute respiratory failure due to COVID-19 (PRON-COVID): a prospective cohort study. Lancet Respir Med. 2020;8(8):765-774. doi:10.1016/S2213-2600(20)30268-X

31. Weatherald J, Solverson K, Zuege DJ, Loroff N, Fiest KM, Parhar KKS. Awake prone positioning for COVID-19 hypoxemic respiratory failure: a rapid review. J Crit Care. 2021;61:63-70. doi:10.1016/j.jcrc.2020.08.018

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Intervention in Acute Hospital Unit Reduces Delirium Incidence for Older Adults, Has No Effect on Length of Stay, Other Complications

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Intervention in Acute Hospital Unit Reduces Delirium Incidence for Older Adults, Has No Effect on Length of Stay, Other Complications

Study Overview

Objective: To examine the effect of the intervention “Eat Walk Engage,” a program that is designed to more consistently deliver age-friendly principles of care to older individuals in acute medical and surgical wards.

Design: This cluster randomized trial to examine the effect of an intervention in acute medical and surgical wards on older adults was conducted in 8 acute medical and surgical wards in 4 public hospitals in Australia from 2016 to 2017. To be eligible to participate in this trial, wards had to have the following: a patient population with 50% of patients aged 65 years and older; perceived alignment with hospital priorities; and nurse manager agreement to participation. Randomization was stratified by hospital, resulting in 4 wards with the intervention (a general medicine ward, an orthopedic ward, a general surgery ward, and a respiratory medicine ward) and 4 control wards (2 general medicine wards, a respiratory medicine ward, and a general surgery ward). Participants were consecutive inpatients aged 65 years or older who were admitted to the ward for at least 3 consecutive days during the study time period. Exclusion criteria included terminal or critical illness, severe cognitive impairment without a surrogate decision-maker, non-English speaking, or previously enrolled in the trial. Of a total of 453 patients who were eligible from the intervention wards, 188 were excluded and 6 died, yielding 259 participants in the intervention group. There were 413 patients eligible from the control wards, with 139 excluded and 3 deaths, yielding 271 participants in the control group.

Intervention: The intervention, called “Eat Walk Engage,” was developed to target older adults at risk for hospital-associated complications of delirium, functional decline, pressure injuries, falls, and incontinence, and aimed to improve care practices, environment, and culture to support age-friendly principles. This ward-based program delivered a structured improvement intervention through a site facilitator who is a nurse or allied health professional. The site facilitator identified opportunities for improvement using structured assessments of context, patient-experience interviews, and audits of care processes, and engaged an interdisciplinary working group from the intervention wards to participate in an hour-per-month meeting to develop plans for iterative improvements. Each site developed their own intervention plan; examples of interventions include shifting priorities to enable staff to increase the proportion of patients sitting in a chair for meals; designating the patient lounge as a walking destination to increase the proportion of time patients spend mobile; and using orientation boards and small groups to engage older patients in meaningful activities.

Main outcome measures: Study outcome measures included hospital-associated complications for older people, which is a composite of hospital-associated delirium, hospital-associated disability, hospital-associated incontinence, and fall or pressure injury during hospitalization. Delirium was assessed using the 3-minute diagnostic interview for Confusion Assessment Method (3D-CAM); hospital-associated disability was defined as new disability at discharge compared to 2 weeks prior to hospitalization. The primary outcome was defined as incidence of any complications and hospital length of stay. Secondary outcomes included incidence of individual complications, hospital discharge to facility, mortality at 6 months, and readmission for any cause at 6 months.

Main results: Patient characteristics for the intervention and control groups, respectively, were: 47% women with a mean age of 75.9 years (SD, 7.3), and 53% women with a mean age of 78.0 years (SD, 8.2). For the primary outcome, 46.4% of participants in the intervention group experienced any hospital complications compared with 51.8% in the control group (odds ratio [OR], 1.07; 95% CI, 0.71-1.61). The incidence of delirium was lower in the intervention group as compared with the control group (15.9% vs 31.4%; OR, 0.53; 95% CI, 0.31-0.90), while there were no other differences in the incidence rates of other complications. There was also no difference in hospital length of stay; median length of stay in the intervention group was 6 days (interquartile range [IQR], 4-9 days) compared with 7 days in the control group (IQR, 5-10), with an estimated mean difference in length of stay of 0.16 days (95% CI, –0.43 to 0.78 days). There was also no significant difference in mortality or all-cause readmission at 6 months.

Conclusion: The intervention “Eat Walk Engage” did not reduce hospital-associated complications overall or hospital length of stay, but it did reduce the incidence of hospital-associated delirium.

 

 

Commentary

Older adults, often with reduced physiologic reserve, when admitted to the hospital with an acute illness may be vulnerable to potential hazards of hospitalization, such as complications from prolonged periods of immobility, pressure injury, and delirium.1 Models of care in the inpatient setting to reduce these hazards, including the Acute Care for the Elderly model and the Mobile Acute Care for the Elderly Team model, have been examined in clinical trials.2,3 Specifically, models of care to prevent and treat delirium have been developed and tested over the past decade.4 The effect of these models in improving function, reducing complications, and reducing delirium incidence has been well documented. The present study adds to the literature by testing a model that utilizes implementation science methods to take into account real-world settings. In contrast with prior models-of-care studies, the implementation of the intervention at each ward was not prescriptive, but rather was developed in each ward in an iterative manner with stakeholder input. The advantage of this approach is that engagement of stakeholders at each intervention ward obtains buy-in from staff, mobilizing staff in a way that a prescriptive model of care may not; this ultimately may lead to longer-lasting change. The iterative approach also allows for the intervention to be adapted to conditions and settings over time. Other studies have taken this approach of using implementation science to drive change.5 Although the intervention in the present study failed to improve the primary outcome, it did reduce the incidence of delirium, which is a significant outcome and one that may confer considerable benefits to older adults under the model’s care.

A limitation of the intervention’s nonprescriptive approach is that, because of the variation of the interventions across sites, it is difficult to discern what elements drove the clinical outcomes. In addition, it would be challenging to consider what aspects of the intervention did not work should refinement or changes be needed. How one may measure fidelity to the intervention or how well a site implements the intervention and its relationship with clinical outcomes will need to be examined further.

Application for Clinical Practice

Clinicians look to effective models of care to improve clinical outcomes for older adults in the hospital. The intervention described in this study offers a real-world approach that may need less upfront investment than other recently studied models, such as the Acute Care for the Elderly model, which requires structural and staffing enhancements. Clinicians and health system leaders may consider implementing this model to improve the care delivered to older adults in the hospital as it may help reduce the incidence of delirium among the older adults they serve.

–William W. Hung, MD, MPH

Disclosures: None.

 

References

1. Creditor MC. Hazards of hospitalization of the elderly. Ann Intern Med. 1993;118(3):219-223. doi:10.7326/0003-4819-118-3-199302010-00011

2. Fox MT, Persaud M, Maimets I, et al. Effectiveness of acute geriatric unit care using acute care for elders components: a systematic review and meta-analysis. J Am Geriatr Soc. 2012;60(12):2237-2245. doi:10.1111/jgs.12028

3. Hung WW, Ross JS, Farber J, Siu AL. Evaluation of the Mobile Acute Care of the Elderly (MACE) service. JAMA Intern Med. 2013;173(11):990-996. doi:10.1001/jamainternmed.2013.478

4. Hshieh TT, Yang T, Gartaganis SL, Yue J, Inouye SK. Hospital Elder Life Program: systematic review and meta-analysis of effectiveness. Am J Geriatr Psychiatry. 2018;26(10):1015-1033. doi:10.1016/j.jagp.2018.06.007

5. Naughton C, Cummins H, de Foubert M, et al. Implementation of the Frailty Care Bundle (FCB) to promote mobilisation, nutrition and cognitive engagement in older people in acute care settings: protocol for an implementation science study. [version 1; peer review: 1 approved]. HRB Open Res. 2022;5:3. doi:10.12688/hrbopenres.134731

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Study Overview

Objective: To examine the effect of the intervention “Eat Walk Engage,” a program that is designed to more consistently deliver age-friendly principles of care to older individuals in acute medical and surgical wards.

Design: This cluster randomized trial to examine the effect of an intervention in acute medical and surgical wards on older adults was conducted in 8 acute medical and surgical wards in 4 public hospitals in Australia from 2016 to 2017. To be eligible to participate in this trial, wards had to have the following: a patient population with 50% of patients aged 65 years and older; perceived alignment with hospital priorities; and nurse manager agreement to participation. Randomization was stratified by hospital, resulting in 4 wards with the intervention (a general medicine ward, an orthopedic ward, a general surgery ward, and a respiratory medicine ward) and 4 control wards (2 general medicine wards, a respiratory medicine ward, and a general surgery ward). Participants were consecutive inpatients aged 65 years or older who were admitted to the ward for at least 3 consecutive days during the study time period. Exclusion criteria included terminal or critical illness, severe cognitive impairment without a surrogate decision-maker, non-English speaking, or previously enrolled in the trial. Of a total of 453 patients who were eligible from the intervention wards, 188 were excluded and 6 died, yielding 259 participants in the intervention group. There were 413 patients eligible from the control wards, with 139 excluded and 3 deaths, yielding 271 participants in the control group.

Intervention: The intervention, called “Eat Walk Engage,” was developed to target older adults at risk for hospital-associated complications of delirium, functional decline, pressure injuries, falls, and incontinence, and aimed to improve care practices, environment, and culture to support age-friendly principles. This ward-based program delivered a structured improvement intervention through a site facilitator who is a nurse or allied health professional. The site facilitator identified opportunities for improvement using structured assessments of context, patient-experience interviews, and audits of care processes, and engaged an interdisciplinary working group from the intervention wards to participate in an hour-per-month meeting to develop plans for iterative improvements. Each site developed their own intervention plan; examples of interventions include shifting priorities to enable staff to increase the proportion of patients sitting in a chair for meals; designating the patient lounge as a walking destination to increase the proportion of time patients spend mobile; and using orientation boards and small groups to engage older patients in meaningful activities.

Main outcome measures: Study outcome measures included hospital-associated complications for older people, which is a composite of hospital-associated delirium, hospital-associated disability, hospital-associated incontinence, and fall or pressure injury during hospitalization. Delirium was assessed using the 3-minute diagnostic interview for Confusion Assessment Method (3D-CAM); hospital-associated disability was defined as new disability at discharge compared to 2 weeks prior to hospitalization. The primary outcome was defined as incidence of any complications and hospital length of stay. Secondary outcomes included incidence of individual complications, hospital discharge to facility, mortality at 6 months, and readmission for any cause at 6 months.

Main results: Patient characteristics for the intervention and control groups, respectively, were: 47% women with a mean age of 75.9 years (SD, 7.3), and 53% women with a mean age of 78.0 years (SD, 8.2). For the primary outcome, 46.4% of participants in the intervention group experienced any hospital complications compared with 51.8% in the control group (odds ratio [OR], 1.07; 95% CI, 0.71-1.61). The incidence of delirium was lower in the intervention group as compared with the control group (15.9% vs 31.4%; OR, 0.53; 95% CI, 0.31-0.90), while there were no other differences in the incidence rates of other complications. There was also no difference in hospital length of stay; median length of stay in the intervention group was 6 days (interquartile range [IQR], 4-9 days) compared with 7 days in the control group (IQR, 5-10), with an estimated mean difference in length of stay of 0.16 days (95% CI, –0.43 to 0.78 days). There was also no significant difference in mortality or all-cause readmission at 6 months.

Conclusion: The intervention “Eat Walk Engage” did not reduce hospital-associated complications overall or hospital length of stay, but it did reduce the incidence of hospital-associated delirium.

 

 

Commentary

Older adults, often with reduced physiologic reserve, when admitted to the hospital with an acute illness may be vulnerable to potential hazards of hospitalization, such as complications from prolonged periods of immobility, pressure injury, and delirium.1 Models of care in the inpatient setting to reduce these hazards, including the Acute Care for the Elderly model and the Mobile Acute Care for the Elderly Team model, have been examined in clinical trials.2,3 Specifically, models of care to prevent and treat delirium have been developed and tested over the past decade.4 The effect of these models in improving function, reducing complications, and reducing delirium incidence has been well documented. The present study adds to the literature by testing a model that utilizes implementation science methods to take into account real-world settings. In contrast with prior models-of-care studies, the implementation of the intervention at each ward was not prescriptive, but rather was developed in each ward in an iterative manner with stakeholder input. The advantage of this approach is that engagement of stakeholders at each intervention ward obtains buy-in from staff, mobilizing staff in a way that a prescriptive model of care may not; this ultimately may lead to longer-lasting change. The iterative approach also allows for the intervention to be adapted to conditions and settings over time. Other studies have taken this approach of using implementation science to drive change.5 Although the intervention in the present study failed to improve the primary outcome, it did reduce the incidence of delirium, which is a significant outcome and one that may confer considerable benefits to older adults under the model’s care.

A limitation of the intervention’s nonprescriptive approach is that, because of the variation of the interventions across sites, it is difficult to discern what elements drove the clinical outcomes. In addition, it would be challenging to consider what aspects of the intervention did not work should refinement or changes be needed. How one may measure fidelity to the intervention or how well a site implements the intervention and its relationship with clinical outcomes will need to be examined further.

Application for Clinical Practice

Clinicians look to effective models of care to improve clinical outcomes for older adults in the hospital. The intervention described in this study offers a real-world approach that may need less upfront investment than other recently studied models, such as the Acute Care for the Elderly model, which requires structural and staffing enhancements. Clinicians and health system leaders may consider implementing this model to improve the care delivered to older adults in the hospital as it may help reduce the incidence of delirium among the older adults they serve.

–William W. Hung, MD, MPH

Disclosures: None.

 

Study Overview

Objective: To examine the effect of the intervention “Eat Walk Engage,” a program that is designed to more consistently deliver age-friendly principles of care to older individuals in acute medical and surgical wards.

Design: This cluster randomized trial to examine the effect of an intervention in acute medical and surgical wards on older adults was conducted in 8 acute medical and surgical wards in 4 public hospitals in Australia from 2016 to 2017. To be eligible to participate in this trial, wards had to have the following: a patient population with 50% of patients aged 65 years and older; perceived alignment with hospital priorities; and nurse manager agreement to participation. Randomization was stratified by hospital, resulting in 4 wards with the intervention (a general medicine ward, an orthopedic ward, a general surgery ward, and a respiratory medicine ward) and 4 control wards (2 general medicine wards, a respiratory medicine ward, and a general surgery ward). Participants were consecutive inpatients aged 65 years or older who were admitted to the ward for at least 3 consecutive days during the study time period. Exclusion criteria included terminal or critical illness, severe cognitive impairment without a surrogate decision-maker, non-English speaking, or previously enrolled in the trial. Of a total of 453 patients who were eligible from the intervention wards, 188 were excluded and 6 died, yielding 259 participants in the intervention group. There were 413 patients eligible from the control wards, with 139 excluded and 3 deaths, yielding 271 participants in the control group.

Intervention: The intervention, called “Eat Walk Engage,” was developed to target older adults at risk for hospital-associated complications of delirium, functional decline, pressure injuries, falls, and incontinence, and aimed to improve care practices, environment, and culture to support age-friendly principles. This ward-based program delivered a structured improvement intervention through a site facilitator who is a nurse or allied health professional. The site facilitator identified opportunities for improvement using structured assessments of context, patient-experience interviews, and audits of care processes, and engaged an interdisciplinary working group from the intervention wards to participate in an hour-per-month meeting to develop plans for iterative improvements. Each site developed their own intervention plan; examples of interventions include shifting priorities to enable staff to increase the proportion of patients sitting in a chair for meals; designating the patient lounge as a walking destination to increase the proportion of time patients spend mobile; and using orientation boards and small groups to engage older patients in meaningful activities.

Main outcome measures: Study outcome measures included hospital-associated complications for older people, which is a composite of hospital-associated delirium, hospital-associated disability, hospital-associated incontinence, and fall or pressure injury during hospitalization. Delirium was assessed using the 3-minute diagnostic interview for Confusion Assessment Method (3D-CAM); hospital-associated disability was defined as new disability at discharge compared to 2 weeks prior to hospitalization. The primary outcome was defined as incidence of any complications and hospital length of stay. Secondary outcomes included incidence of individual complications, hospital discharge to facility, mortality at 6 months, and readmission for any cause at 6 months.

Main results: Patient characteristics for the intervention and control groups, respectively, were: 47% women with a mean age of 75.9 years (SD, 7.3), and 53% women with a mean age of 78.0 years (SD, 8.2). For the primary outcome, 46.4% of participants in the intervention group experienced any hospital complications compared with 51.8% in the control group (odds ratio [OR], 1.07; 95% CI, 0.71-1.61). The incidence of delirium was lower in the intervention group as compared with the control group (15.9% vs 31.4%; OR, 0.53; 95% CI, 0.31-0.90), while there were no other differences in the incidence rates of other complications. There was also no difference in hospital length of stay; median length of stay in the intervention group was 6 days (interquartile range [IQR], 4-9 days) compared with 7 days in the control group (IQR, 5-10), with an estimated mean difference in length of stay of 0.16 days (95% CI, –0.43 to 0.78 days). There was also no significant difference in mortality or all-cause readmission at 6 months.

Conclusion: The intervention “Eat Walk Engage” did not reduce hospital-associated complications overall or hospital length of stay, but it did reduce the incidence of hospital-associated delirium.

 

 

Commentary

Older adults, often with reduced physiologic reserve, when admitted to the hospital with an acute illness may be vulnerable to potential hazards of hospitalization, such as complications from prolonged periods of immobility, pressure injury, and delirium.1 Models of care in the inpatient setting to reduce these hazards, including the Acute Care for the Elderly model and the Mobile Acute Care for the Elderly Team model, have been examined in clinical trials.2,3 Specifically, models of care to prevent and treat delirium have been developed and tested over the past decade.4 The effect of these models in improving function, reducing complications, and reducing delirium incidence has been well documented. The present study adds to the literature by testing a model that utilizes implementation science methods to take into account real-world settings. In contrast with prior models-of-care studies, the implementation of the intervention at each ward was not prescriptive, but rather was developed in each ward in an iterative manner with stakeholder input. The advantage of this approach is that engagement of stakeholders at each intervention ward obtains buy-in from staff, mobilizing staff in a way that a prescriptive model of care may not; this ultimately may lead to longer-lasting change. The iterative approach also allows for the intervention to be adapted to conditions and settings over time. Other studies have taken this approach of using implementation science to drive change.5 Although the intervention in the present study failed to improve the primary outcome, it did reduce the incidence of delirium, which is a significant outcome and one that may confer considerable benefits to older adults under the model’s care.

A limitation of the intervention’s nonprescriptive approach is that, because of the variation of the interventions across sites, it is difficult to discern what elements drove the clinical outcomes. In addition, it would be challenging to consider what aspects of the intervention did not work should refinement or changes be needed. How one may measure fidelity to the intervention or how well a site implements the intervention and its relationship with clinical outcomes will need to be examined further.

Application for Clinical Practice

Clinicians look to effective models of care to improve clinical outcomes for older adults in the hospital. The intervention described in this study offers a real-world approach that may need less upfront investment than other recently studied models, such as the Acute Care for the Elderly model, which requires structural and staffing enhancements. Clinicians and health system leaders may consider implementing this model to improve the care delivered to older adults in the hospital as it may help reduce the incidence of delirium among the older adults they serve.

–William W. Hung, MD, MPH

Disclosures: None.

 

References

1. Creditor MC. Hazards of hospitalization of the elderly. Ann Intern Med. 1993;118(3):219-223. doi:10.7326/0003-4819-118-3-199302010-00011

2. Fox MT, Persaud M, Maimets I, et al. Effectiveness of acute geriatric unit care using acute care for elders components: a systematic review and meta-analysis. J Am Geriatr Soc. 2012;60(12):2237-2245. doi:10.1111/jgs.12028

3. Hung WW, Ross JS, Farber J, Siu AL. Evaluation of the Mobile Acute Care of the Elderly (MACE) service. JAMA Intern Med. 2013;173(11):990-996. doi:10.1001/jamainternmed.2013.478

4. Hshieh TT, Yang T, Gartaganis SL, Yue J, Inouye SK. Hospital Elder Life Program: systematic review and meta-analysis of effectiveness. Am J Geriatr Psychiatry. 2018;26(10):1015-1033. doi:10.1016/j.jagp.2018.06.007

5. Naughton C, Cummins H, de Foubert M, et al. Implementation of the Frailty Care Bundle (FCB) to promote mobilisation, nutrition and cognitive engagement in older people in acute care settings: protocol for an implementation science study. [version 1; peer review: 1 approved]. HRB Open Res. 2022;5:3. doi:10.12688/hrbopenres.134731

References

1. Creditor MC. Hazards of hospitalization of the elderly. Ann Intern Med. 1993;118(3):219-223. doi:10.7326/0003-4819-118-3-199302010-00011

2. Fox MT, Persaud M, Maimets I, et al. Effectiveness of acute geriatric unit care using acute care for elders components: a systematic review and meta-analysis. J Am Geriatr Soc. 2012;60(12):2237-2245. doi:10.1111/jgs.12028

3. Hung WW, Ross JS, Farber J, Siu AL. Evaluation of the Mobile Acute Care of the Elderly (MACE) service. JAMA Intern Med. 2013;173(11):990-996. doi:10.1001/jamainternmed.2013.478

4. Hshieh TT, Yang T, Gartaganis SL, Yue J, Inouye SK. Hospital Elder Life Program: systematic review and meta-analysis of effectiveness. Am J Geriatr Psychiatry. 2018;26(10):1015-1033. doi:10.1016/j.jagp.2018.06.007

5. Naughton C, Cummins H, de Foubert M, et al. Implementation of the Frailty Care Bundle (FCB) to promote mobilisation, nutrition and cognitive engagement in older people in acute care settings: protocol for an implementation science study. [version 1; peer review: 1 approved]. HRB Open Res. 2022;5:3. doi:10.12688/hrbopenres.134731

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Motherhood and mortality: Navigating miscarriages as a physician

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One clinic morning in an office visit, I stood next to the door talking, hand on the doorknob ready to exit. My elderly patient was sitting in the chair next to the door, family member in another, as I attempted my exit. Suddenly, as if looking for something, my patient locked her gaze to my abdomen and began to slowly advance herself forward, eyes squinting for a better view. She had found something. Poke, poke, poke. Three pokes in quick succession into my apparently protruding abdomen stoked an internal horror that I dared not release onto my face. How in the hell could she know? My heart sank – the signs were still there. 

“There’s something in there,” she said with a seasoned certainty.

“No there’s not,” I said trying hard to hide any emotion. 

“Yes, there is,” she said flatly. 

“Grannie, no there isn’t,” her family member interrupted, unknowingly saving me. I thanked them again and quickly left the room. 

My patient had the ongoings of slowly progressing dementia. Little did she know she was right. Maybe she had known something in another time and space. Either way, I wasn’t prepared to tell the story. She wasn’t prepared to fully understand. 

I tried to forge on to see the next patient. Tears began welling in both eyes. I tilted my head back slightly to prevent the water from falling. I wanted to feel offended, but she couldn’t have known the war my body was fighting at the time. I had not yet shared the pregnancy news with this particular patient, and yet her knowing was telling in a sense. I’m learning that the old folks always know. 

I was at work, actively having yet another miscarriage. This was the second of two. This most recent time, we found out at 9 weeks that our baby had stopped growing about a week or so earlier. Cue the denial. Cue the rage. Cue the devastation. 

Thinking back, with each pregnancy discovery, we did not wait the customary 3 months before telling anyone. Just about everyone knew. We were immediately excited to start sharing with friends, family, coworkers, and even patients early on. We knew the risks in my 40-something age group but were quintessentially optimistic. 

I am a family medicine physician with expert-level knowledge and clinical experiences in women’s health counseling, contraception, conception, and pregnancy. In my training, I’ve delivered babies, been elbow-deep searching for wayward tissue from bleeding uteri, and sutured gaping vaginal lacerations. I’ve cried with new mothers at the end of long labors. I’ve been bear-hugged by doting new fathers. I have an abundance of medical knowledge, and yet the pain and struggle of miscarriage over the past 2.5 years has twice reduced me to absolute pieces. There was no course to teach me how to navigate loss within my own body, no textbook to study so that I could test out of the experience. Life hit us dead-on, and I was broken.

I can say that the experience of a miscarriage does not get easier with each subsequent loss. At least for me, the emotions were always raw and tender. Each one was a new gash to my emotional and physical health. My sanity bled out. I was physically exhausted. The struggles of being a health care worker in the midst of a global pandemic I’m sure did not help the situation. My first miscarriage was just before the start of the pandemic. I was in New York visiting family and after dinner at Tavern on the Green, of all places, when I began showing signs. Two days later, I was at the coffee station in our clinic cafeteria adding my cream and sugar when my ob.gyn.’s office called. The hCG levels were probably too low; a miscarriage was likely. I kept my composure, walked out of the cafeteria, got my car keys, went to my car, and proceeded to scream at the top of my lungs for a few minutes. Afterward, I went back to finish up my work and canceled my clinic for the rest of the day. 

For my second miscarriage, I was laying in my doctor’s office getting an ultrasound. I had started bleeding the previous day but thought that the subchorionic hemorrhage noted on the last ultrasound might be the culprit. The bleeding was light. That’s the thing about being a pregnant physician: We know too much. The image on the screen looked abnormal, the remnants a ghost of its former self. I knew something was wrong but held out some hope. She searched and turned and pressed the transducer into my belly for a seemingly better view. She apologized for not finding the heartbeat. How is this happening again?

So how does one get through the loss of multiple pregnancies? I know my husband and I worked hard to get through each loss. We did all the right things a good therapist would recommend: Be present in the moment, go with your feelings, allow yourself to feel everything. There were no wrong emotions. Little by little we grieved and healed, grieved and healed. Having a successful pregnancy did help. Miracles are not promised but I believe we were sent one, and her name is Giavonna Barbara. Bookended by miscarriages, she has made me realize just how precious and delicate life really is. She is our absolute world and joy. 

I’ve learned twice now that men mourn differently than women. Not any less, just in a different way. There is a pain in the silence that often goes unvocalized, but it is of no less value. My husband and I allowed each other to heal in our own unique ways, and that has made all of the difference. I think I knew I was doing okay when one day I found something funny and I let out the heartiest laugh my belly could muster. A different purpose was renewed. Tears were harder to come by. Hope for the future again sprung eternal. Life went on and so did we. 

Looking back, I realize that having a miscarriage and working as a physician in the middle of a global pandemic pushed me to my emotional and physical limits. There is a second-guessing of sorts that occurs. Did the miscarriage happen because I was under so much stress at work? It had happened in the past, was this going to continue to happen? 

I can say that I was great at compartmentalizing emotions. I’d try and box them away until I got off of work and then turn them on like a switch once I hit the driver’s seat. It’s easy as a busy physician with so many patients to see, messages to return, notes to write, students and residents to teach, and programs to run to completely tune out the thought of mourning. Temporarily anyway. Work was actually a welcome distraction at times. A purpose. The journey to healing is individualized and can’t be rushed. I like to think that I heal a little bit more every day thinking about the losses and gains that I’ve had. I’m grateful for the experience and growth. 

In 2022, I’m looking forward to continuing my healing journey among the twists and turns of the pandemic. I now bring a different level of understanding and empathy to my patients who are undergoing or who have undergone a miscarriage. There will always be a piece of me that viscerally mourns with them. We have a hidden shared experience. I believe I am a better physician because of those lessons learned from my own personal tragedy. Now, I look forward to sharing big belly laughs with my family and friends and savoring the small, quiet moments with my husband and daughter. 

A version of this article first appeared on Medscape.com.

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One clinic morning in an office visit, I stood next to the door talking, hand on the doorknob ready to exit. My elderly patient was sitting in the chair next to the door, family member in another, as I attempted my exit. Suddenly, as if looking for something, my patient locked her gaze to my abdomen and began to slowly advance herself forward, eyes squinting for a better view. She had found something. Poke, poke, poke. Three pokes in quick succession into my apparently protruding abdomen stoked an internal horror that I dared not release onto my face. How in the hell could she know? My heart sank – the signs were still there. 

“There’s something in there,” she said with a seasoned certainty.

“No there’s not,” I said trying hard to hide any emotion. 

“Yes, there is,” she said flatly. 

“Grannie, no there isn’t,” her family member interrupted, unknowingly saving me. I thanked them again and quickly left the room. 

My patient had the ongoings of slowly progressing dementia. Little did she know she was right. Maybe she had known something in another time and space. Either way, I wasn’t prepared to tell the story. She wasn’t prepared to fully understand. 

I tried to forge on to see the next patient. Tears began welling in both eyes. I tilted my head back slightly to prevent the water from falling. I wanted to feel offended, but she couldn’t have known the war my body was fighting at the time. I had not yet shared the pregnancy news with this particular patient, and yet her knowing was telling in a sense. I’m learning that the old folks always know. 

I was at work, actively having yet another miscarriage. This was the second of two. This most recent time, we found out at 9 weeks that our baby had stopped growing about a week or so earlier. Cue the denial. Cue the rage. Cue the devastation. 

Thinking back, with each pregnancy discovery, we did not wait the customary 3 months before telling anyone. Just about everyone knew. We were immediately excited to start sharing with friends, family, coworkers, and even patients early on. We knew the risks in my 40-something age group but were quintessentially optimistic. 

I am a family medicine physician with expert-level knowledge and clinical experiences in women’s health counseling, contraception, conception, and pregnancy. In my training, I’ve delivered babies, been elbow-deep searching for wayward tissue from bleeding uteri, and sutured gaping vaginal lacerations. I’ve cried with new mothers at the end of long labors. I’ve been bear-hugged by doting new fathers. I have an abundance of medical knowledge, and yet the pain and struggle of miscarriage over the past 2.5 years has twice reduced me to absolute pieces. There was no course to teach me how to navigate loss within my own body, no textbook to study so that I could test out of the experience. Life hit us dead-on, and I was broken.

I can say that the experience of a miscarriage does not get easier with each subsequent loss. At least for me, the emotions were always raw and tender. Each one was a new gash to my emotional and physical health. My sanity bled out. I was physically exhausted. The struggles of being a health care worker in the midst of a global pandemic I’m sure did not help the situation. My first miscarriage was just before the start of the pandemic. I was in New York visiting family and after dinner at Tavern on the Green, of all places, when I began showing signs. Two days later, I was at the coffee station in our clinic cafeteria adding my cream and sugar when my ob.gyn.’s office called. The hCG levels were probably too low; a miscarriage was likely. I kept my composure, walked out of the cafeteria, got my car keys, went to my car, and proceeded to scream at the top of my lungs for a few minutes. Afterward, I went back to finish up my work and canceled my clinic for the rest of the day. 

For my second miscarriage, I was laying in my doctor’s office getting an ultrasound. I had started bleeding the previous day but thought that the subchorionic hemorrhage noted on the last ultrasound might be the culprit. The bleeding was light. That’s the thing about being a pregnant physician: We know too much. The image on the screen looked abnormal, the remnants a ghost of its former self. I knew something was wrong but held out some hope. She searched and turned and pressed the transducer into my belly for a seemingly better view. She apologized for not finding the heartbeat. How is this happening again?

So how does one get through the loss of multiple pregnancies? I know my husband and I worked hard to get through each loss. We did all the right things a good therapist would recommend: Be present in the moment, go with your feelings, allow yourself to feel everything. There were no wrong emotions. Little by little we grieved and healed, grieved and healed. Having a successful pregnancy did help. Miracles are not promised but I believe we were sent one, and her name is Giavonna Barbara. Bookended by miscarriages, she has made me realize just how precious and delicate life really is. She is our absolute world and joy. 

I’ve learned twice now that men mourn differently than women. Not any less, just in a different way. There is a pain in the silence that often goes unvocalized, but it is of no less value. My husband and I allowed each other to heal in our own unique ways, and that has made all of the difference. I think I knew I was doing okay when one day I found something funny and I let out the heartiest laugh my belly could muster. A different purpose was renewed. Tears were harder to come by. Hope for the future again sprung eternal. Life went on and so did we. 

Looking back, I realize that having a miscarriage and working as a physician in the middle of a global pandemic pushed me to my emotional and physical limits. There is a second-guessing of sorts that occurs. Did the miscarriage happen because I was under so much stress at work? It had happened in the past, was this going to continue to happen? 

I can say that I was great at compartmentalizing emotions. I’d try and box them away until I got off of work and then turn them on like a switch once I hit the driver’s seat. It’s easy as a busy physician with so many patients to see, messages to return, notes to write, students and residents to teach, and programs to run to completely tune out the thought of mourning. Temporarily anyway. Work was actually a welcome distraction at times. A purpose. The journey to healing is individualized and can’t be rushed. I like to think that I heal a little bit more every day thinking about the losses and gains that I’ve had. I’m grateful for the experience and growth. 

In 2022, I’m looking forward to continuing my healing journey among the twists and turns of the pandemic. I now bring a different level of understanding and empathy to my patients who are undergoing or who have undergone a miscarriage. There will always be a piece of me that viscerally mourns with them. We have a hidden shared experience. I believe I am a better physician because of those lessons learned from my own personal tragedy. Now, I look forward to sharing big belly laughs with my family and friends and savoring the small, quiet moments with my husband and daughter. 

A version of this article first appeared on Medscape.com.

One clinic morning in an office visit, I stood next to the door talking, hand on the doorknob ready to exit. My elderly patient was sitting in the chair next to the door, family member in another, as I attempted my exit. Suddenly, as if looking for something, my patient locked her gaze to my abdomen and began to slowly advance herself forward, eyes squinting for a better view. She had found something. Poke, poke, poke. Three pokes in quick succession into my apparently protruding abdomen stoked an internal horror that I dared not release onto my face. How in the hell could she know? My heart sank – the signs were still there. 

“There’s something in there,” she said with a seasoned certainty.

“No there’s not,” I said trying hard to hide any emotion. 

“Yes, there is,” she said flatly. 

“Grannie, no there isn’t,” her family member interrupted, unknowingly saving me. I thanked them again and quickly left the room. 

My patient had the ongoings of slowly progressing dementia. Little did she know she was right. Maybe she had known something in another time and space. Either way, I wasn’t prepared to tell the story. She wasn’t prepared to fully understand. 

I tried to forge on to see the next patient. Tears began welling in both eyes. I tilted my head back slightly to prevent the water from falling. I wanted to feel offended, but she couldn’t have known the war my body was fighting at the time. I had not yet shared the pregnancy news with this particular patient, and yet her knowing was telling in a sense. I’m learning that the old folks always know. 

I was at work, actively having yet another miscarriage. This was the second of two. This most recent time, we found out at 9 weeks that our baby had stopped growing about a week or so earlier. Cue the denial. Cue the rage. Cue the devastation. 

Thinking back, with each pregnancy discovery, we did not wait the customary 3 months before telling anyone. Just about everyone knew. We were immediately excited to start sharing with friends, family, coworkers, and even patients early on. We knew the risks in my 40-something age group but were quintessentially optimistic. 

I am a family medicine physician with expert-level knowledge and clinical experiences in women’s health counseling, contraception, conception, and pregnancy. In my training, I’ve delivered babies, been elbow-deep searching for wayward tissue from bleeding uteri, and sutured gaping vaginal lacerations. I’ve cried with new mothers at the end of long labors. I’ve been bear-hugged by doting new fathers. I have an abundance of medical knowledge, and yet the pain and struggle of miscarriage over the past 2.5 years has twice reduced me to absolute pieces. There was no course to teach me how to navigate loss within my own body, no textbook to study so that I could test out of the experience. Life hit us dead-on, and I was broken.

I can say that the experience of a miscarriage does not get easier with each subsequent loss. At least for me, the emotions were always raw and tender. Each one was a new gash to my emotional and physical health. My sanity bled out. I was physically exhausted. The struggles of being a health care worker in the midst of a global pandemic I’m sure did not help the situation. My first miscarriage was just before the start of the pandemic. I was in New York visiting family and after dinner at Tavern on the Green, of all places, when I began showing signs. Two days later, I was at the coffee station in our clinic cafeteria adding my cream and sugar when my ob.gyn.’s office called. The hCG levels were probably too low; a miscarriage was likely. I kept my composure, walked out of the cafeteria, got my car keys, went to my car, and proceeded to scream at the top of my lungs for a few minutes. Afterward, I went back to finish up my work and canceled my clinic for the rest of the day. 

For my second miscarriage, I was laying in my doctor’s office getting an ultrasound. I had started bleeding the previous day but thought that the subchorionic hemorrhage noted on the last ultrasound might be the culprit. The bleeding was light. That’s the thing about being a pregnant physician: We know too much. The image on the screen looked abnormal, the remnants a ghost of its former self. I knew something was wrong but held out some hope. She searched and turned and pressed the transducer into my belly for a seemingly better view. She apologized for not finding the heartbeat. How is this happening again?

So how does one get through the loss of multiple pregnancies? I know my husband and I worked hard to get through each loss. We did all the right things a good therapist would recommend: Be present in the moment, go with your feelings, allow yourself to feel everything. There were no wrong emotions. Little by little we grieved and healed, grieved and healed. Having a successful pregnancy did help. Miracles are not promised but I believe we were sent one, and her name is Giavonna Barbara. Bookended by miscarriages, she has made me realize just how precious and delicate life really is. She is our absolute world and joy. 

I’ve learned twice now that men mourn differently than women. Not any less, just in a different way. There is a pain in the silence that often goes unvocalized, but it is of no less value. My husband and I allowed each other to heal in our own unique ways, and that has made all of the difference. I think I knew I was doing okay when one day I found something funny and I let out the heartiest laugh my belly could muster. A different purpose was renewed. Tears were harder to come by. Hope for the future again sprung eternal. Life went on and so did we. 

Looking back, I realize that having a miscarriage and working as a physician in the middle of a global pandemic pushed me to my emotional and physical limits. There is a second-guessing of sorts that occurs. Did the miscarriage happen because I was under so much stress at work? It had happened in the past, was this going to continue to happen? 

I can say that I was great at compartmentalizing emotions. I’d try and box them away until I got off of work and then turn them on like a switch once I hit the driver’s seat. It’s easy as a busy physician with so many patients to see, messages to return, notes to write, students and residents to teach, and programs to run to completely tune out the thought of mourning. Temporarily anyway. Work was actually a welcome distraction at times. A purpose. The journey to healing is individualized and can’t be rushed. I like to think that I heal a little bit more every day thinking about the losses and gains that I’ve had. I’m grateful for the experience and growth. 

In 2022, I’m looking forward to continuing my healing journey among the twists and turns of the pandemic. I now bring a different level of understanding and empathy to my patients who are undergoing or who have undergone a miscarriage. There will always be a piece of me that viscerally mourns with them. We have a hidden shared experience. I believe I am a better physician because of those lessons learned from my own personal tragedy. Now, I look forward to sharing big belly laughs with my family and friends and savoring the small, quiet moments with my husband and daughter. 

A version of this article first appeared on Medscape.com.

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Dr. Jeremiah Stamler, pioneer of preventive cardiology, dies at 102

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Thu, 02/03/2022 - 15:30

On the occasion of his 100th birthday, The Washington Post wrote of the trailblazing cardiologist and scientist Jeremiah Dr. Stamler, MD: “You may not know him, but he may have saved your life.”

Hyperbole, it was not.

Over a career spanning more than 70 years, Dr. Stamler transformed medicine and the public’s understanding of diet and lifestyle in cardiovascular health and helped introduce the concept of readily measured ‘risk factors’ such as cholesterol, hypertension, smoking, and diabetes.

Dr. Stamler, the founding chair and a professor emeritus of preventive medicine at Northwestern University’s Feinberg School of Medicine, Chicago, died Wednesday at his home in Sag Harbor, New York, at age 102.

“It is no exaggeration to say that few people in history have had as great an impact on human health,” Donald Lloyd-Jones, MD, chair of the department of preventive medicine at Feinberg and president of the American Heart Association, said in a statement.

“Jerry was a giant intellect who founded the fields of cardiovascular epidemiology and preventive cardiology and led [the way] in defining new prevention concepts right up until his last days,” Dr. Lloyd-Jones added in a statement issued by the university.

Tom Frieden, MD, former director of the Centers for Disease Control and Prevention, tweeted, “Jerry and my father did research on sodium together in the early 1950s. He was a giant in the field of public health, and we’re still benefiting from his brilliance and dedication.”

Roger Blumenthal, MD, director of the Johns Hopkins Ciccarone Center for Prevention of Cardiovascular Disease, tweeted, “R.I.P., Dr. Jeremiah Stamler, ‘the father of preventive cardiology,’ dies at 102 – a true legendary force for health.”

The son of Russian immigrants, Dr. Stamler was born in Brooklyn in 1919 and received a bachelor’s degree from Columbia University and a medical degree from State University of New York.

Discharged from the U.S. Army with the rank of captain, Dr. Stamler and his first wife, Rose, herself a distinguished cardiology researcher, moved to Chicago in 1947 and began researching nutrition and atherosclerosis under pioneering cardiology researcher Louis N. Katz, MD, ultimately showing that atherosclerosis could be introduced by changing the diet of chickens. She died in 1998.

Dr. Stamler also worked for Chicago’s Public Health Department in the 1950s, starting a rheumatic fever prevention program for children and the Chicago Coronary Prevention Evaluation Program, working with higher-risk middle-aged men.

Dr. Stamler’s international INTERSALT study established an independent relationship between blood pressure and increased sodium intake, as well as body mass index and heavy alcohol intake. First published in 1988, the research faced opposition from fellow scientists and the food industry alike.

In a 2006 interview, Dr. Stamler said he and fellow researchers began pressing the American Heart Association in the late 1950s to adopt a public policy of support to improve lifestyles, including smoking cessation and better nutrition. “It took some doing. The AHA was initially reluctant and was under pressure from industry.”

Their efforts were rewarded with the AHA’s first statement on smoking in 1959 and first statement on diet in 1960, whereas, Dr. Stamler noted, “the first World Health Organization statement did not come out until the 1980s.”

Philip Greenland, MD, professor of cardiology and former chair of preventive medicine at Northwestern, described Dr. Stamler as a “force for truth that never backed down when confronted by others who did not share his passion for truth and the best science.”

“I loved working with him since I always knew he would make our research better, clearer, more relevant, and more impactful,” he said in the AHA statement.

A lifelong activist and opponent of the Vietnam War, Dr. Stamler was subpoenaed in May 1965 by the House Un-American Activities Committee (HUAC) along with his nutritionist-assistant Yolanda Hall. Rather than pleading the Fifth Amendment against self-incrimination, Dr. Stamler and Ms. Hall refused to testify before the committee and were charged with contempt of Congress.

With the help of local attorneys, Dr. Stamler filed a civil suit against the HUAC, charging that its mandate was unconstitutional. After 8½ years of litigation that went all the way to the Supreme Court, the government agreed to drop its indictment against Dr. Stamler and he dropped his civil suit against the committee.

A year after the Stamler v. Willis case ended, the House voted to terminate the HUAC. In an essay detailing the high-profile case, Henry Blackburn quipped, “They simply did not know who they were taking on when they tagged ol’ Jerry Stamler.”

“Dr. Stamler’s exceptional science was paralleled by his remarkable humanity. He was a champion of our best American ideals, he was fearless when facing the status quo, and he was tireless in the pursuit of what was right and just. He remains a beacon for all that is noble in medicine,” said Clyde Yancy, MD, MSc, Northwestern’s chair of cardiology.

Over the course of his career, Dr. Stamler published more than 670 peer-reviewed papers, 22 books and monographs, and his work has been cited more than 56,000 times. A committed mentor, Dr. Stamler was the 2014 recipient of the AHA’s Eugene Braunwald Academic Mentorship Award.

A lifelong proponent of the Mediterranean diet, Dr. Stamler divided his time between New York, a home in Italy, and Chicago, with his wife Gloria Beckerman Stamler, whom he married in 2004 and who preceded him in death.

A version of this article first appeared on Medscape.com.

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On the occasion of his 100th birthday, The Washington Post wrote of the trailblazing cardiologist and scientist Jeremiah Dr. Stamler, MD: “You may not know him, but he may have saved your life.”

Hyperbole, it was not.

Over a career spanning more than 70 years, Dr. Stamler transformed medicine and the public’s understanding of diet and lifestyle in cardiovascular health and helped introduce the concept of readily measured ‘risk factors’ such as cholesterol, hypertension, smoking, and diabetes.

Dr. Stamler, the founding chair and a professor emeritus of preventive medicine at Northwestern University’s Feinberg School of Medicine, Chicago, died Wednesday at his home in Sag Harbor, New York, at age 102.

“It is no exaggeration to say that few people in history have had as great an impact on human health,” Donald Lloyd-Jones, MD, chair of the department of preventive medicine at Feinberg and president of the American Heart Association, said in a statement.

“Jerry was a giant intellect who founded the fields of cardiovascular epidemiology and preventive cardiology and led [the way] in defining new prevention concepts right up until his last days,” Dr. Lloyd-Jones added in a statement issued by the university.

Tom Frieden, MD, former director of the Centers for Disease Control and Prevention, tweeted, “Jerry and my father did research on sodium together in the early 1950s. He was a giant in the field of public health, and we’re still benefiting from his brilliance and dedication.”

Roger Blumenthal, MD, director of the Johns Hopkins Ciccarone Center for Prevention of Cardiovascular Disease, tweeted, “R.I.P., Dr. Jeremiah Stamler, ‘the father of preventive cardiology,’ dies at 102 – a true legendary force for health.”

The son of Russian immigrants, Dr. Stamler was born in Brooklyn in 1919 and received a bachelor’s degree from Columbia University and a medical degree from State University of New York.

Discharged from the U.S. Army with the rank of captain, Dr. Stamler and his first wife, Rose, herself a distinguished cardiology researcher, moved to Chicago in 1947 and began researching nutrition and atherosclerosis under pioneering cardiology researcher Louis N. Katz, MD, ultimately showing that atherosclerosis could be introduced by changing the diet of chickens. She died in 1998.

Dr. Stamler also worked for Chicago’s Public Health Department in the 1950s, starting a rheumatic fever prevention program for children and the Chicago Coronary Prevention Evaluation Program, working with higher-risk middle-aged men.

Dr. Stamler’s international INTERSALT study established an independent relationship between blood pressure and increased sodium intake, as well as body mass index and heavy alcohol intake. First published in 1988, the research faced opposition from fellow scientists and the food industry alike.

In a 2006 interview, Dr. Stamler said he and fellow researchers began pressing the American Heart Association in the late 1950s to adopt a public policy of support to improve lifestyles, including smoking cessation and better nutrition. “It took some doing. The AHA was initially reluctant and was under pressure from industry.”

Their efforts were rewarded with the AHA’s first statement on smoking in 1959 and first statement on diet in 1960, whereas, Dr. Stamler noted, “the first World Health Organization statement did not come out until the 1980s.”

Philip Greenland, MD, professor of cardiology and former chair of preventive medicine at Northwestern, described Dr. Stamler as a “force for truth that never backed down when confronted by others who did not share his passion for truth and the best science.”

“I loved working with him since I always knew he would make our research better, clearer, more relevant, and more impactful,” he said in the AHA statement.

A lifelong activist and opponent of the Vietnam War, Dr. Stamler was subpoenaed in May 1965 by the House Un-American Activities Committee (HUAC) along with his nutritionist-assistant Yolanda Hall. Rather than pleading the Fifth Amendment against self-incrimination, Dr. Stamler and Ms. Hall refused to testify before the committee and were charged with contempt of Congress.

With the help of local attorneys, Dr. Stamler filed a civil suit against the HUAC, charging that its mandate was unconstitutional. After 8½ years of litigation that went all the way to the Supreme Court, the government agreed to drop its indictment against Dr. Stamler and he dropped his civil suit against the committee.

A year after the Stamler v. Willis case ended, the House voted to terminate the HUAC. In an essay detailing the high-profile case, Henry Blackburn quipped, “They simply did not know who they were taking on when they tagged ol’ Jerry Stamler.”

“Dr. Stamler’s exceptional science was paralleled by his remarkable humanity. He was a champion of our best American ideals, he was fearless when facing the status quo, and he was tireless in the pursuit of what was right and just. He remains a beacon for all that is noble in medicine,” said Clyde Yancy, MD, MSc, Northwestern’s chair of cardiology.

Over the course of his career, Dr. Stamler published more than 670 peer-reviewed papers, 22 books and monographs, and his work has been cited more than 56,000 times. A committed mentor, Dr. Stamler was the 2014 recipient of the AHA’s Eugene Braunwald Academic Mentorship Award.

A lifelong proponent of the Mediterranean diet, Dr. Stamler divided his time between New York, a home in Italy, and Chicago, with his wife Gloria Beckerman Stamler, whom he married in 2004 and who preceded him in death.

A version of this article first appeared on Medscape.com.

On the occasion of his 100th birthday, The Washington Post wrote of the trailblazing cardiologist and scientist Jeremiah Dr. Stamler, MD: “You may not know him, but he may have saved your life.”

Hyperbole, it was not.

Over a career spanning more than 70 years, Dr. Stamler transformed medicine and the public’s understanding of diet and lifestyle in cardiovascular health and helped introduce the concept of readily measured ‘risk factors’ such as cholesterol, hypertension, smoking, and diabetes.

Dr. Stamler, the founding chair and a professor emeritus of preventive medicine at Northwestern University’s Feinberg School of Medicine, Chicago, died Wednesday at his home in Sag Harbor, New York, at age 102.

“It is no exaggeration to say that few people in history have had as great an impact on human health,” Donald Lloyd-Jones, MD, chair of the department of preventive medicine at Feinberg and president of the American Heart Association, said in a statement.

“Jerry was a giant intellect who founded the fields of cardiovascular epidemiology and preventive cardiology and led [the way] in defining new prevention concepts right up until his last days,” Dr. Lloyd-Jones added in a statement issued by the university.

Tom Frieden, MD, former director of the Centers for Disease Control and Prevention, tweeted, “Jerry and my father did research on sodium together in the early 1950s. He was a giant in the field of public health, and we’re still benefiting from his brilliance and dedication.”

Roger Blumenthal, MD, director of the Johns Hopkins Ciccarone Center for Prevention of Cardiovascular Disease, tweeted, “R.I.P., Dr. Jeremiah Stamler, ‘the father of preventive cardiology,’ dies at 102 – a true legendary force for health.”

The son of Russian immigrants, Dr. Stamler was born in Brooklyn in 1919 and received a bachelor’s degree from Columbia University and a medical degree from State University of New York.

Discharged from the U.S. Army with the rank of captain, Dr. Stamler and his first wife, Rose, herself a distinguished cardiology researcher, moved to Chicago in 1947 and began researching nutrition and atherosclerosis under pioneering cardiology researcher Louis N. Katz, MD, ultimately showing that atherosclerosis could be introduced by changing the diet of chickens. She died in 1998.

Dr. Stamler also worked for Chicago’s Public Health Department in the 1950s, starting a rheumatic fever prevention program for children and the Chicago Coronary Prevention Evaluation Program, working with higher-risk middle-aged men.

Dr. Stamler’s international INTERSALT study established an independent relationship between blood pressure and increased sodium intake, as well as body mass index and heavy alcohol intake. First published in 1988, the research faced opposition from fellow scientists and the food industry alike.

In a 2006 interview, Dr. Stamler said he and fellow researchers began pressing the American Heart Association in the late 1950s to adopt a public policy of support to improve lifestyles, including smoking cessation and better nutrition. “It took some doing. The AHA was initially reluctant and was under pressure from industry.”

Their efforts were rewarded with the AHA’s first statement on smoking in 1959 and first statement on diet in 1960, whereas, Dr. Stamler noted, “the first World Health Organization statement did not come out until the 1980s.”

Philip Greenland, MD, professor of cardiology and former chair of preventive medicine at Northwestern, described Dr. Stamler as a “force for truth that never backed down when confronted by others who did not share his passion for truth and the best science.”

“I loved working with him since I always knew he would make our research better, clearer, more relevant, and more impactful,” he said in the AHA statement.

A lifelong activist and opponent of the Vietnam War, Dr. Stamler was subpoenaed in May 1965 by the House Un-American Activities Committee (HUAC) along with his nutritionist-assistant Yolanda Hall. Rather than pleading the Fifth Amendment against self-incrimination, Dr. Stamler and Ms. Hall refused to testify before the committee and were charged with contempt of Congress.

With the help of local attorneys, Dr. Stamler filed a civil suit against the HUAC, charging that its mandate was unconstitutional. After 8½ years of litigation that went all the way to the Supreme Court, the government agreed to drop its indictment against Dr. Stamler and he dropped his civil suit against the committee.

A year after the Stamler v. Willis case ended, the House voted to terminate the HUAC. In an essay detailing the high-profile case, Henry Blackburn quipped, “They simply did not know who they were taking on when they tagged ol’ Jerry Stamler.”

“Dr. Stamler’s exceptional science was paralleled by his remarkable humanity. He was a champion of our best American ideals, he was fearless when facing the status quo, and he was tireless in the pursuit of what was right and just. He remains a beacon for all that is noble in medicine,” said Clyde Yancy, MD, MSc, Northwestern’s chair of cardiology.

Over the course of his career, Dr. Stamler published more than 670 peer-reviewed papers, 22 books and monographs, and his work has been cited more than 56,000 times. A committed mentor, Dr. Stamler was the 2014 recipient of the AHA’s Eugene Braunwald Academic Mentorship Award.

A lifelong proponent of the Mediterranean diet, Dr. Stamler divided his time between New York, a home in Italy, and Chicago, with his wife Gloria Beckerman Stamler, whom he married in 2004 and who preceded him in death.

A version of this article first appeared on Medscape.com.

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What docs don’t know about the Disabilities Act can hurt them and patients

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Changed
Wed, 02/02/2022 - 09:57

Lisa Iezzoni, MD, a professor of medicine at Harvard Medical School and a disability researcher at Massachusetts General Hospital, both in Boston, has used a wheelchair for more than 30 years because of multiple sclerosis. When she visits her primary care doctor, she doesn’t get weighed because the scales are not wheelchair accessible.

This failure to weigh her and other patients in wheelchairs could lead to serious medical problems. Weight is used to monitor a person’s overall health and prenatal health and to determine accurate doses for medications such as some chemotherapies, said Dr. Iezzoni.

In another situation, a man who used a wheelchair said that his primary care doctor never got him out of it for a complete physical exam. The patient later developed lymphoma, which first appeared in his groin. The doctor should have accommodated his disability and used a height-adjustable exam table or a portable lift to transfer him onto the table.

When physicians don’t provide access to medical care that patients with disabilities need, they put themselves at greater risk of lawsuits, fines, and settlements.

Yet, a new study in Health Affairs suggests that a large percentage of doctors are not fully aware of what they are legally required to do.

Under federal nondiscrimination laws (Americans With Disabilities Act, American Rehabilitation Act, and ADA Amendments Act), medical practices must provide equal access to people with disabilities, accommodate their disability-related needs, and not refuse them medical services because of their disabilities, say disability experts.
 

Where doctors go wrong with disability laws

What doctors don’t know about providing reasonable accommodations makes them vulnerable to lawsuits, which worries more than two-thirds of the 714 outpatient doctors surveyed.

Not only are they required to provide reasonable accommodations, but they also have to pay for them, the researchers said. One-fifth of the surveyed doctors said they didn’t know that practice owners have to pay.

More than one practice has made patients pay for services needed for their disability, such as sign language interpreters – the patients later complained this violated the ADA to enforcement agencies.

Doctors also don’t know that they have to collaborate with patients to determine what reasonable accommodations they need – over two-thirds of those surveyed said they didn’t know it was a joint responsibility, the study found.

When doctors fail to accommodate patients’ disability needs, they engage in discrimination and violate the ADA, says Elizabeth Pendo, JD, a coauthor of the study and the Joseph J. Simeone Professor of Law at Saint Louis University.

The Department of Justice has investigated several patient complaints of alleged disability discrimination recently and resolved the disputes with agreements and small fines in some cases. “The goal is not to get large financial settlements but to work with practices to get the correct procedures in place to be compliant,” said Ms. Pendo.

Physicians would be wise to check out whether their practices are as accessible as they think. Even if there’s a ramp to the office building, the parking lot may not have a van-accessible space or enough handicapped parking signs, or the exam room may be too narrow for a wheelchair to navigate.

These practices violated the ADA and agreed to make changes:

  • Hamden, Conn., has two buildings that patients with physical disabilities couldn’t easily enter. The physician owners agreed to change the buildings’ entrances and access routes and add features to make it easier to use examination rooms and restrooms and the check-in and check-out areas.
  • Seven medical offices in Riverside, Calif., failed to communicate effectively with deaf and hard-of-hearing patients. They should have had a qualified sign language interpreter, an assistive listening device, or another appropriate aid or service available to a deaf patient and her family. Instead, the office relied on a video remote interpretation system that often failed to work. The agreement requires the clinic to provide those aids and services to patients and their companions who are deaf or hard of hearing, advertise their availability, assess each patient who is deaf or hard of hearing to determine the best aids and services for their needs, and pay $5,000 in compensation to the complainant and a $1,000 civil penalty to the United States.
  • Springfield, Mass., refused to provide full joint replacements to two patients being treated with buprenorphine, a medication used to treat opioid use disorder. Rather than accommodate the patients, the surgeons referred them elsewhere because they were uncomfortable with the postoperative pain management protocol for patients prescribed buprenorphine. “The Americans With Disabilities Act protects health care access for people under medical treatment for opioid use disorder,” said Acting U.S. Attorney Nathaniel R. Mendell. “Health care providers must comply with the ADA, even when doing so is inconvenient or makes them uncomfortable.” The agreement requires the practice to adopt a nondiscrimination policy, provide training on the ADA and opioid use disorder, and pay two complainants $15,000 each for pain and suffering.

The DOJ has filed civil lawsuits against medical practices when they failed to resolve the allegations. Recent cases include an ophthalmology practice with 24 facilities in Arizona that refused to help transfer patients in wheelchairs to surgery tables for eye surgery and required them to pay for transfer support services and two obstetricians-gynecologists in Bakersfield, Calif., who refused to provide routine medical care to a patient because of her HIV status.
 

What doctors should know

Many people tend to think of a person with a disability as being in a wheelchair. But the ADA has a very broad definition of disability, which includes any physical or mental impairment that substantially limits any major life activity, said Ms. Pendo.

“It was amended in 2008 to clarify that the definition includes people with chronic diseases such as diabetes and cancer, cognitive and neurological disorders, substance abuse disorders, vision and hearing loss, and learning and other disabilities,” she said.

That means that doctors have to accommodate many types of disabilities, which can be challenging. The ADA only specifies that fixed structures need to be accessible, such as parking lots, driveways, and buildings, said Dr. Iezzoni.

When it comes to “reasonable accommodations,” doctors should decide that on a case-by-case basis, she said.

“We can say based on our study that 71% of doctors don’t know the right way to think about the accommodations – they don’t know they need to talk to patients so they can explain to them exactly what they need to accommodate their disability,” said Dr. Iezzoni.

Doctors are also required to provide effective communication for patients with sensory or cognitive disabilities, which can depend on the severity, said Ms. Pendo. Is the person deaf or hard of hearing, blind or partially sighted – is the dementia mild or severe?

“The requirement is there, but what that looks like will vary by patient. That’s what’s challenging,” said Ms. Pendo.

Dr. Iezzoni recommends that doctor’s offices ask patients whether they need special help or individual assistance when they make appointments and enter their responses in their records. She also suggests that patients be asked at follow-up appointments whether they still need the same help or not.

“Disabilities can change over time – a person with bad arthritis may need help getting onto an exam table, but later get a knee or hip replacement that is effective and no longer need that help,” said Dr. Iezzoni.

 

 

Benefits outweigh costs

Physicians have made progress in meeting the ADA’s physical accessibility requirements, said Dr. Iezzoni. “The literature suggests that doctors have done a good job at fixing the structural barriers people with mobility issues face, such as ramps and bathrooms.”

However, there are exceptions in rural older buildings which can be harder to retrofit for wheelchair accessibility, she said. “I recall interviewing a rural doctor several years ago who said that he knew his patients well and when a patient visits with mobility problems, he goes down and carries the patient up the steps to his office. My response was that is not respectful of the patient or safe for the patient or you. That doctor has since changed the location of his practice,” said Dr. Iezzoni.

Some doctors may resist paying for accessible medical equipment because of cost, but she said the benefits are worth it. These include preventing staff injuries when they transfer patients and being used by patients with temporary disabilities and aging people with bad knees, backs, hearing and sight. In addition, businesses may be eligible for federal and state tax credits.

Dr. Iezzoni recently visited her doctor where they finally got height-adjustable exam tables. “I asked the assistant, who really likes these tables? She said it’s the elderly ladies of short stature – the table is lowered and they sit down and get on it.”

But, Dr. Iezonni’s main message to doctors is that patients with disabilities deserve equal quality of care. “Just because we have a disability doesn’t mean we should get worse care than other people. It’s a matter of professionalism that doctors should want to give the same quality care to all their patients.”

A version of this article first appeared on Medscape.com.

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Lisa Iezzoni, MD, a professor of medicine at Harvard Medical School and a disability researcher at Massachusetts General Hospital, both in Boston, has used a wheelchair for more than 30 years because of multiple sclerosis. When she visits her primary care doctor, she doesn’t get weighed because the scales are not wheelchair accessible.

This failure to weigh her and other patients in wheelchairs could lead to serious medical problems. Weight is used to monitor a person’s overall health and prenatal health and to determine accurate doses for medications such as some chemotherapies, said Dr. Iezzoni.

In another situation, a man who used a wheelchair said that his primary care doctor never got him out of it for a complete physical exam. The patient later developed lymphoma, which first appeared in his groin. The doctor should have accommodated his disability and used a height-adjustable exam table or a portable lift to transfer him onto the table.

When physicians don’t provide access to medical care that patients with disabilities need, they put themselves at greater risk of lawsuits, fines, and settlements.

Yet, a new study in Health Affairs suggests that a large percentage of doctors are not fully aware of what they are legally required to do.

Under federal nondiscrimination laws (Americans With Disabilities Act, American Rehabilitation Act, and ADA Amendments Act), medical practices must provide equal access to people with disabilities, accommodate their disability-related needs, and not refuse them medical services because of their disabilities, say disability experts.
 

Where doctors go wrong with disability laws

What doctors don’t know about providing reasonable accommodations makes them vulnerable to lawsuits, which worries more than two-thirds of the 714 outpatient doctors surveyed.

Not only are they required to provide reasonable accommodations, but they also have to pay for them, the researchers said. One-fifth of the surveyed doctors said they didn’t know that practice owners have to pay.

More than one practice has made patients pay for services needed for their disability, such as sign language interpreters – the patients later complained this violated the ADA to enforcement agencies.

Doctors also don’t know that they have to collaborate with patients to determine what reasonable accommodations they need – over two-thirds of those surveyed said they didn’t know it was a joint responsibility, the study found.

When doctors fail to accommodate patients’ disability needs, they engage in discrimination and violate the ADA, says Elizabeth Pendo, JD, a coauthor of the study and the Joseph J. Simeone Professor of Law at Saint Louis University.

The Department of Justice has investigated several patient complaints of alleged disability discrimination recently and resolved the disputes with agreements and small fines in some cases. “The goal is not to get large financial settlements but to work with practices to get the correct procedures in place to be compliant,” said Ms. Pendo.

Physicians would be wise to check out whether their practices are as accessible as they think. Even if there’s a ramp to the office building, the parking lot may not have a van-accessible space or enough handicapped parking signs, or the exam room may be too narrow for a wheelchair to navigate.

These practices violated the ADA and agreed to make changes:

  • Hamden, Conn., has two buildings that patients with physical disabilities couldn’t easily enter. The physician owners agreed to change the buildings’ entrances and access routes and add features to make it easier to use examination rooms and restrooms and the check-in and check-out areas.
  • Seven medical offices in Riverside, Calif., failed to communicate effectively with deaf and hard-of-hearing patients. They should have had a qualified sign language interpreter, an assistive listening device, or another appropriate aid or service available to a deaf patient and her family. Instead, the office relied on a video remote interpretation system that often failed to work. The agreement requires the clinic to provide those aids and services to patients and their companions who are deaf or hard of hearing, advertise their availability, assess each patient who is deaf or hard of hearing to determine the best aids and services for their needs, and pay $5,000 in compensation to the complainant and a $1,000 civil penalty to the United States.
  • Springfield, Mass., refused to provide full joint replacements to two patients being treated with buprenorphine, a medication used to treat opioid use disorder. Rather than accommodate the patients, the surgeons referred them elsewhere because they were uncomfortable with the postoperative pain management protocol for patients prescribed buprenorphine. “The Americans With Disabilities Act protects health care access for people under medical treatment for opioid use disorder,” said Acting U.S. Attorney Nathaniel R. Mendell. “Health care providers must comply with the ADA, even when doing so is inconvenient or makes them uncomfortable.” The agreement requires the practice to adopt a nondiscrimination policy, provide training on the ADA and opioid use disorder, and pay two complainants $15,000 each for pain and suffering.

The DOJ has filed civil lawsuits against medical practices when they failed to resolve the allegations. Recent cases include an ophthalmology practice with 24 facilities in Arizona that refused to help transfer patients in wheelchairs to surgery tables for eye surgery and required them to pay for transfer support services and two obstetricians-gynecologists in Bakersfield, Calif., who refused to provide routine medical care to a patient because of her HIV status.
 

What doctors should know

Many people tend to think of a person with a disability as being in a wheelchair. But the ADA has a very broad definition of disability, which includes any physical or mental impairment that substantially limits any major life activity, said Ms. Pendo.

“It was amended in 2008 to clarify that the definition includes people with chronic diseases such as diabetes and cancer, cognitive and neurological disorders, substance abuse disorders, vision and hearing loss, and learning and other disabilities,” she said.

That means that doctors have to accommodate many types of disabilities, which can be challenging. The ADA only specifies that fixed structures need to be accessible, such as parking lots, driveways, and buildings, said Dr. Iezzoni.

When it comes to “reasonable accommodations,” doctors should decide that on a case-by-case basis, she said.

“We can say based on our study that 71% of doctors don’t know the right way to think about the accommodations – they don’t know they need to talk to patients so they can explain to them exactly what they need to accommodate their disability,” said Dr. Iezzoni.

Doctors are also required to provide effective communication for patients with sensory or cognitive disabilities, which can depend on the severity, said Ms. Pendo. Is the person deaf or hard of hearing, blind or partially sighted – is the dementia mild or severe?

“The requirement is there, but what that looks like will vary by patient. That’s what’s challenging,” said Ms. Pendo.

Dr. Iezzoni recommends that doctor’s offices ask patients whether they need special help or individual assistance when they make appointments and enter their responses in their records. She also suggests that patients be asked at follow-up appointments whether they still need the same help or not.

“Disabilities can change over time – a person with bad arthritis may need help getting onto an exam table, but later get a knee or hip replacement that is effective and no longer need that help,” said Dr. Iezzoni.

 

 

Benefits outweigh costs

Physicians have made progress in meeting the ADA’s physical accessibility requirements, said Dr. Iezzoni. “The literature suggests that doctors have done a good job at fixing the structural barriers people with mobility issues face, such as ramps and bathrooms.”

However, there are exceptions in rural older buildings which can be harder to retrofit for wheelchair accessibility, she said. “I recall interviewing a rural doctor several years ago who said that he knew his patients well and when a patient visits with mobility problems, he goes down and carries the patient up the steps to his office. My response was that is not respectful of the patient or safe for the patient or you. That doctor has since changed the location of his practice,” said Dr. Iezzoni.

Some doctors may resist paying for accessible medical equipment because of cost, but she said the benefits are worth it. These include preventing staff injuries when they transfer patients and being used by patients with temporary disabilities and aging people with bad knees, backs, hearing and sight. In addition, businesses may be eligible for federal and state tax credits.

Dr. Iezzoni recently visited her doctor where they finally got height-adjustable exam tables. “I asked the assistant, who really likes these tables? She said it’s the elderly ladies of short stature – the table is lowered and they sit down and get on it.”

But, Dr. Iezonni’s main message to doctors is that patients with disabilities deserve equal quality of care. “Just because we have a disability doesn’t mean we should get worse care than other people. It’s a matter of professionalism that doctors should want to give the same quality care to all their patients.”

A version of this article first appeared on Medscape.com.

Lisa Iezzoni, MD, a professor of medicine at Harvard Medical School and a disability researcher at Massachusetts General Hospital, both in Boston, has used a wheelchair for more than 30 years because of multiple sclerosis. When she visits her primary care doctor, she doesn’t get weighed because the scales are not wheelchair accessible.

This failure to weigh her and other patients in wheelchairs could lead to serious medical problems. Weight is used to monitor a person’s overall health and prenatal health and to determine accurate doses for medications such as some chemotherapies, said Dr. Iezzoni.

In another situation, a man who used a wheelchair said that his primary care doctor never got him out of it for a complete physical exam. The patient later developed lymphoma, which first appeared in his groin. The doctor should have accommodated his disability and used a height-adjustable exam table or a portable lift to transfer him onto the table.

When physicians don’t provide access to medical care that patients with disabilities need, they put themselves at greater risk of lawsuits, fines, and settlements.

Yet, a new study in Health Affairs suggests that a large percentage of doctors are not fully aware of what they are legally required to do.

Under federal nondiscrimination laws (Americans With Disabilities Act, American Rehabilitation Act, and ADA Amendments Act), medical practices must provide equal access to people with disabilities, accommodate their disability-related needs, and not refuse them medical services because of their disabilities, say disability experts.
 

Where doctors go wrong with disability laws

What doctors don’t know about providing reasonable accommodations makes them vulnerable to lawsuits, which worries more than two-thirds of the 714 outpatient doctors surveyed.

Not only are they required to provide reasonable accommodations, but they also have to pay for them, the researchers said. One-fifth of the surveyed doctors said they didn’t know that practice owners have to pay.

More than one practice has made patients pay for services needed for their disability, such as sign language interpreters – the patients later complained this violated the ADA to enforcement agencies.

Doctors also don’t know that they have to collaborate with patients to determine what reasonable accommodations they need – over two-thirds of those surveyed said they didn’t know it was a joint responsibility, the study found.

When doctors fail to accommodate patients’ disability needs, they engage in discrimination and violate the ADA, says Elizabeth Pendo, JD, a coauthor of the study and the Joseph J. Simeone Professor of Law at Saint Louis University.

The Department of Justice has investigated several patient complaints of alleged disability discrimination recently and resolved the disputes with agreements and small fines in some cases. “The goal is not to get large financial settlements but to work with practices to get the correct procedures in place to be compliant,” said Ms. Pendo.

Physicians would be wise to check out whether their practices are as accessible as they think. Even if there’s a ramp to the office building, the parking lot may not have a van-accessible space or enough handicapped parking signs, or the exam room may be too narrow for a wheelchair to navigate.

These practices violated the ADA and agreed to make changes:

  • Hamden, Conn., has two buildings that patients with physical disabilities couldn’t easily enter. The physician owners agreed to change the buildings’ entrances and access routes and add features to make it easier to use examination rooms and restrooms and the check-in and check-out areas.
  • Seven medical offices in Riverside, Calif., failed to communicate effectively with deaf and hard-of-hearing patients. They should have had a qualified sign language interpreter, an assistive listening device, or another appropriate aid or service available to a deaf patient and her family. Instead, the office relied on a video remote interpretation system that often failed to work. The agreement requires the clinic to provide those aids and services to patients and their companions who are deaf or hard of hearing, advertise their availability, assess each patient who is deaf or hard of hearing to determine the best aids and services for their needs, and pay $5,000 in compensation to the complainant and a $1,000 civil penalty to the United States.
  • Springfield, Mass., refused to provide full joint replacements to two patients being treated with buprenorphine, a medication used to treat opioid use disorder. Rather than accommodate the patients, the surgeons referred them elsewhere because they were uncomfortable with the postoperative pain management protocol for patients prescribed buprenorphine. “The Americans With Disabilities Act protects health care access for people under medical treatment for opioid use disorder,” said Acting U.S. Attorney Nathaniel R. Mendell. “Health care providers must comply with the ADA, even when doing so is inconvenient or makes them uncomfortable.” The agreement requires the practice to adopt a nondiscrimination policy, provide training on the ADA and opioid use disorder, and pay two complainants $15,000 each for pain and suffering.

The DOJ has filed civil lawsuits against medical practices when they failed to resolve the allegations. Recent cases include an ophthalmology practice with 24 facilities in Arizona that refused to help transfer patients in wheelchairs to surgery tables for eye surgery and required them to pay for transfer support services and two obstetricians-gynecologists in Bakersfield, Calif., who refused to provide routine medical care to a patient because of her HIV status.
 

What doctors should know

Many people tend to think of a person with a disability as being in a wheelchair. But the ADA has a very broad definition of disability, which includes any physical or mental impairment that substantially limits any major life activity, said Ms. Pendo.

“It was amended in 2008 to clarify that the definition includes people with chronic diseases such as diabetes and cancer, cognitive and neurological disorders, substance abuse disorders, vision and hearing loss, and learning and other disabilities,” she said.

That means that doctors have to accommodate many types of disabilities, which can be challenging. The ADA only specifies that fixed structures need to be accessible, such as parking lots, driveways, and buildings, said Dr. Iezzoni.

When it comes to “reasonable accommodations,” doctors should decide that on a case-by-case basis, she said.

“We can say based on our study that 71% of doctors don’t know the right way to think about the accommodations – they don’t know they need to talk to patients so they can explain to them exactly what they need to accommodate their disability,” said Dr. Iezzoni.

Doctors are also required to provide effective communication for patients with sensory or cognitive disabilities, which can depend on the severity, said Ms. Pendo. Is the person deaf or hard of hearing, blind or partially sighted – is the dementia mild or severe?

“The requirement is there, but what that looks like will vary by patient. That’s what’s challenging,” said Ms. Pendo.

Dr. Iezzoni recommends that doctor’s offices ask patients whether they need special help or individual assistance when they make appointments and enter their responses in their records. She also suggests that patients be asked at follow-up appointments whether they still need the same help or not.

“Disabilities can change over time – a person with bad arthritis may need help getting onto an exam table, but later get a knee or hip replacement that is effective and no longer need that help,” said Dr. Iezzoni.

 

 

Benefits outweigh costs

Physicians have made progress in meeting the ADA’s physical accessibility requirements, said Dr. Iezzoni. “The literature suggests that doctors have done a good job at fixing the structural barriers people with mobility issues face, such as ramps and bathrooms.”

However, there are exceptions in rural older buildings which can be harder to retrofit for wheelchair accessibility, she said. “I recall interviewing a rural doctor several years ago who said that he knew his patients well and when a patient visits with mobility problems, he goes down and carries the patient up the steps to his office. My response was that is not respectful of the patient or safe for the patient or you. That doctor has since changed the location of his practice,” said Dr. Iezzoni.

Some doctors may resist paying for accessible medical equipment because of cost, but she said the benefits are worth it. These include preventing staff injuries when they transfer patients and being used by patients with temporary disabilities and aging people with bad knees, backs, hearing and sight. In addition, businesses may be eligible for federal and state tax credits.

Dr. Iezzoni recently visited her doctor where they finally got height-adjustable exam tables. “I asked the assistant, who really likes these tables? She said it’s the elderly ladies of short stature – the table is lowered and they sit down and get on it.”

But, Dr. Iezonni’s main message to doctors is that patients with disabilities deserve equal quality of care. “Just because we have a disability doesn’t mean we should get worse care than other people. It’s a matter of professionalism that doctors should want to give the same quality care to all their patients.”

A version of this article first appeared on Medscape.com.

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When the wrong history repeats itself

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Mon, 01/31/2022 - 15:15

Fifteen years ago, Mrs. Smith was hospitalized for a dural sinus thrombosis.

This is a scary enough diagnosis as it is, but with the miracle of modern medicine she did great. She still checks in with me every year or so, but hasn’t had any recurrence.

Three years ago she tripped over her dog (amazing how often that seems to happen) and broke her arm. She landed in the hospital and needed orthopedic surgery, so they consulted me about the safety of getting her off the antiplatelet agent she was taking since stopping Coumadin.

Dr. Allan M. Block, a neurologist in Scottsdale, Arizona.
Dr. Allan M. Block

When I arrived someone had already written an admitting note, which included a past history of “subdural hematoma, maintained on daily aspirin.”

Where this error came from, I don’t know. When I asked Mrs. Smith, she was quite clear on her correct diagnosis, and said she’d given it to the person who admitted her. So I dictated a consult, and typed it into my progress note each day. My notes made it clear that she’d had a dural sinus thrombosis and not a subdural hematoma.

This isn’t just nitpicking, obviously. They’re entirely different disorders. While the point may not be critical to her needing wrist surgery, these are medical records, and medical records need to be as accurate as possible for this, and future hospital stays and for physicians to be aware of.

I signed off after a few days and didn’t think much of it until I was faxed a copy of her discharge summary. Which listed “subdural hematoma, maintained on daily aspirin.”

Apparently no one read my notes. Not that I’m really surprised.

We’re now 3 years later. As do many patients of her age, Mrs. Smith has landed in the hospital a few times since then. COVID, syncope, another fall. In each one of them the “subdural hematoma, maintained on daily aspirin” shows up.

At the most recent incident, the hospital’s neurologist called and asked me why I was treating a subdural hematoma with aspirin, then said Mrs. Smith had told him it was a dural sinus thrombosis. I said she was right, and he said “that makes more sense” and that he’d put it in his note.

He did, but it didn’t change anything. The discharge summary still listed “subdural hematoma, maintained on daily aspirin.”

At some point resistance is futile.

The stupidity of the whole thing is frustrating, as is knowing that it’s not just Mrs. Smith. The same scenario of incorrect history and medications is propagated from visit to visit. Taking a history is too time consuming for some. It’s easier to just read off, or cut and paste, a previous note. In cases where the patient can’t give a history I understand this. But when they can it’s just being too rushed – or lazy – to care.

It’s easy to blame EMRs as the culprits. Bashing them is fashionable. But in this case I can’t. They make it easier, but it’s nothing new. I remember a night almost 30 years ago when I was doing an admission at the Phoenix VA. When I picked up the most recent volume of the patient’s old chart to look at labs, the previous H&P said “see old chart.”

The problem is human nature. Not the computer.

But in this field the fallout can be serious – the wrong precautions taken, or medication given, based on a nonexistent contraindication. In medicine the stakes are high. Our decisions are only as good as the information we base them on, and if that information is wrong ...

Shortcuts have consequences.

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

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Fifteen years ago, Mrs. Smith was hospitalized for a dural sinus thrombosis.

This is a scary enough diagnosis as it is, but with the miracle of modern medicine she did great. She still checks in with me every year or so, but hasn’t had any recurrence.

Three years ago she tripped over her dog (amazing how often that seems to happen) and broke her arm. She landed in the hospital and needed orthopedic surgery, so they consulted me about the safety of getting her off the antiplatelet agent she was taking since stopping Coumadin.

Dr. Allan M. Block, a neurologist in Scottsdale, Arizona.
Dr. Allan M. Block

When I arrived someone had already written an admitting note, which included a past history of “subdural hematoma, maintained on daily aspirin.”

Where this error came from, I don’t know. When I asked Mrs. Smith, she was quite clear on her correct diagnosis, and said she’d given it to the person who admitted her. So I dictated a consult, and typed it into my progress note each day. My notes made it clear that she’d had a dural sinus thrombosis and not a subdural hematoma.

This isn’t just nitpicking, obviously. They’re entirely different disorders. While the point may not be critical to her needing wrist surgery, these are medical records, and medical records need to be as accurate as possible for this, and future hospital stays and for physicians to be aware of.

I signed off after a few days and didn’t think much of it until I was faxed a copy of her discharge summary. Which listed “subdural hematoma, maintained on daily aspirin.”

Apparently no one read my notes. Not that I’m really surprised.

We’re now 3 years later. As do many patients of her age, Mrs. Smith has landed in the hospital a few times since then. COVID, syncope, another fall. In each one of them the “subdural hematoma, maintained on daily aspirin” shows up.

At the most recent incident, the hospital’s neurologist called and asked me why I was treating a subdural hematoma with aspirin, then said Mrs. Smith had told him it was a dural sinus thrombosis. I said she was right, and he said “that makes more sense” and that he’d put it in his note.

He did, but it didn’t change anything. The discharge summary still listed “subdural hematoma, maintained on daily aspirin.”

At some point resistance is futile.

The stupidity of the whole thing is frustrating, as is knowing that it’s not just Mrs. Smith. The same scenario of incorrect history and medications is propagated from visit to visit. Taking a history is too time consuming for some. It’s easier to just read off, or cut and paste, a previous note. In cases where the patient can’t give a history I understand this. But when they can it’s just being too rushed – or lazy – to care.

It’s easy to blame EMRs as the culprits. Bashing them is fashionable. But in this case I can’t. They make it easier, but it’s nothing new. I remember a night almost 30 years ago when I was doing an admission at the Phoenix VA. When I picked up the most recent volume of the patient’s old chart to look at labs, the previous H&P said “see old chart.”

The problem is human nature. Not the computer.

But in this field the fallout can be serious – the wrong precautions taken, or medication given, based on a nonexistent contraindication. In medicine the stakes are high. Our decisions are only as good as the information we base them on, and if that information is wrong ...

Shortcuts have consequences.

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

Fifteen years ago, Mrs. Smith was hospitalized for a dural sinus thrombosis.

This is a scary enough diagnosis as it is, but with the miracle of modern medicine she did great. She still checks in with me every year or so, but hasn’t had any recurrence.

Three years ago she tripped over her dog (amazing how often that seems to happen) and broke her arm. She landed in the hospital and needed orthopedic surgery, so they consulted me about the safety of getting her off the antiplatelet agent she was taking since stopping Coumadin.

Dr. Allan M. Block, a neurologist in Scottsdale, Arizona.
Dr. Allan M. Block

When I arrived someone had already written an admitting note, which included a past history of “subdural hematoma, maintained on daily aspirin.”

Where this error came from, I don’t know. When I asked Mrs. Smith, she was quite clear on her correct diagnosis, and said she’d given it to the person who admitted her. So I dictated a consult, and typed it into my progress note each day. My notes made it clear that she’d had a dural sinus thrombosis and not a subdural hematoma.

This isn’t just nitpicking, obviously. They’re entirely different disorders. While the point may not be critical to her needing wrist surgery, these are medical records, and medical records need to be as accurate as possible for this, and future hospital stays and for physicians to be aware of.

I signed off after a few days and didn’t think much of it until I was faxed a copy of her discharge summary. Which listed “subdural hematoma, maintained on daily aspirin.”

Apparently no one read my notes. Not that I’m really surprised.

We’re now 3 years later. As do many patients of her age, Mrs. Smith has landed in the hospital a few times since then. COVID, syncope, another fall. In each one of them the “subdural hematoma, maintained on daily aspirin” shows up.

At the most recent incident, the hospital’s neurologist called and asked me why I was treating a subdural hematoma with aspirin, then said Mrs. Smith had told him it was a dural sinus thrombosis. I said she was right, and he said “that makes more sense” and that he’d put it in his note.

He did, but it didn’t change anything. The discharge summary still listed “subdural hematoma, maintained on daily aspirin.”

At some point resistance is futile.

The stupidity of the whole thing is frustrating, as is knowing that it’s not just Mrs. Smith. The same scenario of incorrect history and medications is propagated from visit to visit. Taking a history is too time consuming for some. It’s easier to just read off, or cut and paste, a previous note. In cases where the patient can’t give a history I understand this. But when they can it’s just being too rushed – or lazy – to care.

It’s easy to blame EMRs as the culprits. Bashing them is fashionable. But in this case I can’t. They make it easier, but it’s nothing new. I remember a night almost 30 years ago when I was doing an admission at the Phoenix VA. When I picked up the most recent volume of the patient’s old chart to look at labs, the previous H&P said “see old chart.”

The problem is human nature. Not the computer.

But in this field the fallout can be serious – the wrong precautions taken, or medication given, based on a nonexistent contraindication. In medicine the stakes are high. Our decisions are only as good as the information we base them on, and if that information is wrong ...

Shortcuts have consequences.

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

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Billionaire Mark Cuban launches online pharmacy for generics

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Fri, 02/04/2022 - 11:04

 

Mark Cuban, the owner of the Dallas Mavericks basketball team and star of TV’s Shark Tank, is backing a new online pharmacy that aims to reduce the prices people pay for 100 generic medications.

The Mark Cuban Cost Plus Drugs Company (MCCPDC) plans to offer the leukemia therapy imatinib for $47 per month, for example, compared with $120 or more with a common voucher and a retail price of $9,657 per month.

Other examples of lower-priced generics include the ulcerative colitis treatment mesalamine, which goes for $32.40 per month on the new online pharmacy versus $940 per month retail. In addition, the MCCPDC will offer the gout treatment colchicine at a lower price, charging $8.70, compared with $182 per month retail.

Likely in part because of claims of significant cost savings and in part because of Mr. Cuban’s celebrity status, the new venture is getting widespread media attention. Forbes, NPR, and TMZ have shared the news since the new digital pharmacy was announced earlier this month.

The new venture plans to charge consumers 15% above the manufacturing cost for the generic medications, plus a $3 fee for pharmacists and $5 for shipping. People will still require a prescription from their doctor to get the medications.
 

Generic pricing and social benefit

The top 100 generic products account for about half of generic sales, and there is enough competition for these high-demand medications that “the prices have come down close to zero,” said William Comanor, PhD, a health economist and professor of health policy and management at the University of California, Los Angeles. The remaining generic agents have lower-volume demand.

One prominent example is Daraprim, a decades-old treatment for the life-threatening parasitic infection toxoplasmosis. The drug jumped into the spotlight in 2015 when Martin Shkreli and his company Vyera Pharmaceuticals bought the rights to make the generic drug and raised the price overnight from $13.50 to $750. In January 2022, a U.S. judge banned Mr. Shkreli from the pharmaceutical industry and ordered him to pay an almost $65 million fine.

Dr. Comanor agreed the price should have been raised – $13.50 “was not economically viable” – but not as steep as $750.

“Say Mark Cuban says he will cut the price from $750 to $300. He will still make money. There is a market for these low-volume products,” he said. “There would also be a social benefit.”
 

A direct-to-consumer digital pharmacy

MCCPDC is “cutting out the middleman” in two ways. The business model calls for charging consumers out of pocket, so insurance companies are not involved. Also, the company created its own pharmacy business manager firm in October 2021, allowing it to negotiate prices with drugmakers in house.

The company also announced plans to complete construction of a 22,000-square-foot pharmaceutical factory in Dallas by the end of 2022.

Reactions on social media ranged from celebratory to people disappointed their generic medication would not cost significantly less or is not provided by the digital pharmacy.

When weighted by the number of prescriptions, prices for generics have declined in the United States.

“Overall, U.S. generic prices are the lowest in the world,” Dr. Comanor said. “People say U.S. drug prices are the highest in the world. That’s true for branded, but it’s not true for generics.

“So if someone asks if U.S. drug prices are the highest or lowest in the world, the answer is both,” he said.

“Maybe there is a role to play for this new pharmacy,” Dr. Comanor said when asked if the initiative seems like a positive development.

The state of California also announced plans to provide its own generic drugs, he said.

“But you won’t see a lot of entrepreneurs getting into this because the volumes are so low. If Cuban called me, I would tell him to provide Daraprim and similar, low-volume products,” Dr. Comanor said of the billionaire. “He’s a rich guy; maybe he can do it.”

A version of this article first appeared on WebMD.com.

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Mark Cuban, the owner of the Dallas Mavericks basketball team and star of TV’s Shark Tank, is backing a new online pharmacy that aims to reduce the prices people pay for 100 generic medications.

The Mark Cuban Cost Plus Drugs Company (MCCPDC) plans to offer the leukemia therapy imatinib for $47 per month, for example, compared with $120 or more with a common voucher and a retail price of $9,657 per month.

Other examples of lower-priced generics include the ulcerative colitis treatment mesalamine, which goes for $32.40 per month on the new online pharmacy versus $940 per month retail. In addition, the MCCPDC will offer the gout treatment colchicine at a lower price, charging $8.70, compared with $182 per month retail.

Likely in part because of claims of significant cost savings and in part because of Mr. Cuban’s celebrity status, the new venture is getting widespread media attention. Forbes, NPR, and TMZ have shared the news since the new digital pharmacy was announced earlier this month.

The new venture plans to charge consumers 15% above the manufacturing cost for the generic medications, plus a $3 fee for pharmacists and $5 for shipping. People will still require a prescription from their doctor to get the medications.
 

Generic pricing and social benefit

The top 100 generic products account for about half of generic sales, and there is enough competition for these high-demand medications that “the prices have come down close to zero,” said William Comanor, PhD, a health economist and professor of health policy and management at the University of California, Los Angeles. The remaining generic agents have lower-volume demand.

One prominent example is Daraprim, a decades-old treatment for the life-threatening parasitic infection toxoplasmosis. The drug jumped into the spotlight in 2015 when Martin Shkreli and his company Vyera Pharmaceuticals bought the rights to make the generic drug and raised the price overnight from $13.50 to $750. In January 2022, a U.S. judge banned Mr. Shkreli from the pharmaceutical industry and ordered him to pay an almost $65 million fine.

Dr. Comanor agreed the price should have been raised – $13.50 “was not economically viable” – but not as steep as $750.

“Say Mark Cuban says he will cut the price from $750 to $300. He will still make money. There is a market for these low-volume products,” he said. “There would also be a social benefit.”
 

A direct-to-consumer digital pharmacy

MCCPDC is “cutting out the middleman” in two ways. The business model calls for charging consumers out of pocket, so insurance companies are not involved. Also, the company created its own pharmacy business manager firm in October 2021, allowing it to negotiate prices with drugmakers in house.

The company also announced plans to complete construction of a 22,000-square-foot pharmaceutical factory in Dallas by the end of 2022.

Reactions on social media ranged from celebratory to people disappointed their generic medication would not cost significantly less or is not provided by the digital pharmacy.

When weighted by the number of prescriptions, prices for generics have declined in the United States.

“Overall, U.S. generic prices are the lowest in the world,” Dr. Comanor said. “People say U.S. drug prices are the highest in the world. That’s true for branded, but it’s not true for generics.

“So if someone asks if U.S. drug prices are the highest or lowest in the world, the answer is both,” he said.

“Maybe there is a role to play for this new pharmacy,” Dr. Comanor said when asked if the initiative seems like a positive development.

The state of California also announced plans to provide its own generic drugs, he said.

“But you won’t see a lot of entrepreneurs getting into this because the volumes are so low. If Cuban called me, I would tell him to provide Daraprim and similar, low-volume products,” Dr. Comanor said of the billionaire. “He’s a rich guy; maybe he can do it.”

A version of this article first appeared on WebMD.com.

 

Mark Cuban, the owner of the Dallas Mavericks basketball team and star of TV’s Shark Tank, is backing a new online pharmacy that aims to reduce the prices people pay for 100 generic medications.

The Mark Cuban Cost Plus Drugs Company (MCCPDC) plans to offer the leukemia therapy imatinib for $47 per month, for example, compared with $120 or more with a common voucher and a retail price of $9,657 per month.

Other examples of lower-priced generics include the ulcerative colitis treatment mesalamine, which goes for $32.40 per month on the new online pharmacy versus $940 per month retail. In addition, the MCCPDC will offer the gout treatment colchicine at a lower price, charging $8.70, compared with $182 per month retail.

Likely in part because of claims of significant cost savings and in part because of Mr. Cuban’s celebrity status, the new venture is getting widespread media attention. Forbes, NPR, and TMZ have shared the news since the new digital pharmacy was announced earlier this month.

The new venture plans to charge consumers 15% above the manufacturing cost for the generic medications, plus a $3 fee for pharmacists and $5 for shipping. People will still require a prescription from their doctor to get the medications.
 

Generic pricing and social benefit

The top 100 generic products account for about half of generic sales, and there is enough competition for these high-demand medications that “the prices have come down close to zero,” said William Comanor, PhD, a health economist and professor of health policy and management at the University of California, Los Angeles. The remaining generic agents have lower-volume demand.

One prominent example is Daraprim, a decades-old treatment for the life-threatening parasitic infection toxoplasmosis. The drug jumped into the spotlight in 2015 when Martin Shkreli and his company Vyera Pharmaceuticals bought the rights to make the generic drug and raised the price overnight from $13.50 to $750. In January 2022, a U.S. judge banned Mr. Shkreli from the pharmaceutical industry and ordered him to pay an almost $65 million fine.

Dr. Comanor agreed the price should have been raised – $13.50 “was not economically viable” – but not as steep as $750.

“Say Mark Cuban says he will cut the price from $750 to $300. He will still make money. There is a market for these low-volume products,” he said. “There would also be a social benefit.”
 

A direct-to-consumer digital pharmacy

MCCPDC is “cutting out the middleman” in two ways. The business model calls for charging consumers out of pocket, so insurance companies are not involved. Also, the company created its own pharmacy business manager firm in October 2021, allowing it to negotiate prices with drugmakers in house.

The company also announced plans to complete construction of a 22,000-square-foot pharmaceutical factory in Dallas by the end of 2022.

Reactions on social media ranged from celebratory to people disappointed their generic medication would not cost significantly less or is not provided by the digital pharmacy.

When weighted by the number of prescriptions, prices for generics have declined in the United States.

“Overall, U.S. generic prices are the lowest in the world,” Dr. Comanor said. “People say U.S. drug prices are the highest in the world. That’s true for branded, but it’s not true for generics.

“So if someone asks if U.S. drug prices are the highest or lowest in the world, the answer is both,” he said.

“Maybe there is a role to play for this new pharmacy,” Dr. Comanor said when asked if the initiative seems like a positive development.

The state of California also announced plans to provide its own generic drugs, he said.

“But you won’t see a lot of entrepreneurs getting into this because the volumes are so low. If Cuban called me, I would tell him to provide Daraprim and similar, low-volume products,” Dr. Comanor said of the billionaire. “He’s a rich guy; maybe he can do it.”

A version of this article first appeared on WebMD.com.

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Doc accused of killing 14 patients in the ICU: Upcoming trial notes patient safety lapses

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Changed
Wed, 02/02/2022 - 09:56

On Dec. 5, 2017, Danny Mollette, age 74, was brought to the emergency department of Mount Carmel West Medical Center in Columbus, Ohio, in critical condition. Staff inserted a breathing tube and sent him to the intensive care unit.

Mr. Mollette, who had diabetes, previously had been hospitalized for treatment of a gangrenous foot. When he arrived in the ICU, he was suffering from acute renal failure and low blood pressure, and had had two heart stoppages, according to a 2020 Ohio Board of Pharmacy report. He was placed under the care of William Husel, DO, the sole physician on duty in the ICU during the overnight shift.

Around 9:00 p.m., Dr. Husel discussed Mr. Mollette’s “grim prognosis” with family members at the patient’s bedside. He advised them that Mr. Mollette had “minutes to live” and asked, “How would you want him to take his last breath: on the ventilator or without these machines?”

In less than an hour, Mr. Mollette was dead. Some said that what happened in his case was similar to what happened with 34 other ICU patients at Mount Carmel West and Mount Carmel St. Ann’s in Westerville, Ohio, from 2014 through 2018 – all under Dr. Husel’s care.

Like Mr. Mollette, most of these gravely ill patients died minutes after receiving a single, unusually large intravenous dose of the powerful opioid fentanyl – often combined with a dose of one or more other painkillers or sedatives like hydromorphone – and being withdrawn from the ventilator. These deaths all occurred following a procedure called palliative extubation, the removal of the endotracheal tube in patients who are expected to die.

Mount Carmel fired Dr. Husel in December 2018 following an investigation that concluded that the opioid dosages he used were “significantly excessive and potentially fatal,” and “went beyond providing comfort.” His Ohio medical license was suspended. In February 2022, he is scheduled to go on trial in Columbus on 14 counts of murder.*

Hanging over the murder case against Dr. Husel is the question of how Mount Carmel, a 136-year-old Catholic hospital owned by the giant Trinity Health system, allowed this pattern of care to continue for so many patients over 4 years, and why numerous registered nurses and hospital pharmacists went along with Dr. Husel’s actions. Nearly two dozen RNs and two pharmacists involved in these cases have faced disciplinary action, mostly license suspension.  

“The first time a patient died on a very high dose, someone should have flagged this,” said Lewis Nelson, MD, chair of emergency medicine at Rutgers New Jersey Medical School, Newark. “As soon as I see it the second time or 27th time, it doesn’t seem okay. There was a breakdown in oversight to allow this to continue. The hospital didn’t have guardrails in place.”

The Franklin County (Ohio) Prosecuting Attorney’s Office faces two big challenges in trying Dr. Husel for murder. The prosecutors must prove that the drugs Dr. Husel ordered are what directly caused these critically ill patients to die, and that he intended to kill them.

Federal and state agencies have cited the hospital system for faults in its patient safety systems and culture that were exposed by the Husel cases. An outside medical expert, Robert Powers, MD, a professor of emergency medicine at the University of Virginia, Charlottesville, testified in one of the dozens of wrongful death lawsuits against Mount Carmel and Dr. Husel that there was no record of anyone supervising Dr. Husel or monitoring his care.

There also are questions about why Mount Carmel administrators and physician leaders did not find out about Dr. Husel’s criminal record as a young man before hiring and credentialing him, even though the Ohio Medical Board had obtained that record. As a college freshman in West Virginia in 1994, Dr. Husel and a friend allegedly stole car stereos, and after a classmate reported their behavior, they built a pipe bomb they planned to plant under the classmate’s car, according to court records.

Dr. Husel pleaded guilty in 1996 to a federal misdemeanor for improperly storing explosive materials, and he received a 6-month sentence followed by supervision. He did not disclose that criminal conviction on his application for medical liability insurance as part of his Mount Carmel employment application, attorneys representing the families of his deceased patients say.

A Mount Carmel spokeswoman said the hospital only checks a physician applicant’s background record for the previous 10 years.

“I think [the credentialing process] should have been more careful and more comprehensive than it was,” Robert Powers testified in a September 2020 deposition. “This guy was a bomber and a thief. You don’t hire bombers and thieves to take care of patients.”

Mount Carmel and Trinity leaders say they knew nothing about Dr. Husel’s palliative extubation practices until a staffer reported Dr. Husel’s high-dose fentanyl orders in October 2018. However, three more Husel patients died under similar circumstances before he was removed from patient care in November 2018.

Mount Carmel and Trinity already have settled a number of wrongful death lawsuits filed by the families of Dr. Husel’s patients for nearly $20 million, with many more suits pending. The Mount Carmel CEO, the chief clinical officer, other physician, nursing, and pharmacy leaders, as well as dozens of nurses and pharmacists have been terminated or entered into retirement.

“What happened is tragic and unacceptable,” the Mount Carmel spokeswoman said in a written statement. “We have made a number of changes designed to prevent this from ever happening again. … Our new hospital leadership team is committed to patient safety and will take immediate action whenever patient safety is at issue.”

In January 2019, Mount Carmel’s then-CEO Ed Lamb acknowledged that “processes in place were not sufficient to prevent these actions from happening.” Mr. Lamb later said Mount Carmel was investigating whether five of the ICU patients who died under Dr. Husel’s care could have been treated and survived. Mr. Lamb stepped down in June 2019.

Before performing a palliative extubation, physicians commonly administer opioids and/or sedatives to ease pain and discomfort, and spare family members from witnessing their loved one gasping for breath. But most medical experts say the fentanyl doses Dr. Husel ordered – 500-2,000 mcg – were five to 20 times larger than doses normally used in palliative extubation. Such doses, they say, would quickly kill most patients – except those with high opioid tolerance – by stopping their breathing.

Physicians say they typically give much smaller doses of fentanyl or morphine, then administer more as needed if they observe the patient experiencing pain or distress. Mount Carmel’s 2016 guidelines for IV administration of fentanyl specified a dosage range of 50-100 mcg for relieving pain, and its 2018 guidelines reduced that to 25-50 mcg.

“If I perform a painful procedure, I might give 100 or 150 micrograms of fentanyl, or 500 or 600 for open heart surgery,” said Dr. Nelson of Rutgers, who also practices medical toxicology and addiction medicine. “But you’ll be intubated and monitored carefully. Without having a tube in your airway to help you breathe, those doses will kill you.”**

Mount Carmel West hired Dr. Husel in 2013 to work the late-night shift in its ICU. It was his first job as a full-fledged physician, after completing a residency and fellowship in critical care medicine at Cleveland Clinic. A good-looking and charismatic former high school basketball star, he was a hard worker and was popular with the ICU nurses and staff, who looked to him as a teacher and mentor, according to depositions of nurses and Ohio Board of Nursing reports.

In 2014, Dr. Husel was chosen by his hospital colleagues as physician of the year. He was again nominated in 2018. Before October 2018, there were no complaints about his care, according to the deposition of Larry Swanner, MD, Mount Carmel’s former vice president of medical affairs, who was fired in 2019.

“Dr. Husel is so knowledgeable that we would try to soak up as much knowledge as we could,” said Jason Schulze, RN, in a July 2020 deposition. Mr. Schulze’s license was suspended, however, that suspension was stayed for a minimum period of two years. This was in connection with his care of one of Dr. Husel’s ICU patients, 44-year-old Troy Allison, who died 3 minutes after Mr. Schulze administered a 1,000-microgram dose of fentanyl ordered by Dr. Husel in July 2018.

Dr. Husel’s winning personality and seeming expertise in the use of pain drugs, combined with his training at the prestigious Cleveland Clinic, may have lulled other hospital staff into going along with his decisions.

“They’re thinking, the guy’s likable and he must know what he’s doing,” said Michael Cohen, RPh, founder and president emeritus of the Institute for Safe Medication Practices. “But you can’t get fooled by that. You need a policy in place for what to do if pharmacists or nurses disagree with an order, and you need to have practice simulations so people know how to handle these situations.”

Dr. Husel’s criminal defense attorney, Jose Baez, said Dr. Husel’s treatment of all these palliative extubation patients, including his prescribed dosages of fentanyl and other drugs, was completely appropriate. “Dr. Husel practiced medicine with compassion, and never wanted to see any of his patients suffer, nor their family,” Mr. Baez said.

Most medical and pharmacy experts sharply disagree. “I’m a pharmacist, and I’ve never seen anything like those kinds of doses,” Mr. Cohen said. “Something strange was going on there.”

Complicating these issues, eight nurses and a pharmacist have sued Mount Carmel and Trinity for wrongful termination and defamation in connection with the Husel allegations. They strongly defend Dr. Husel’s and their care as compassionate and appropriate. Beyond that, they argue that the changes Mount Carmel and Trinity made to ICU procedures to prevent such situations from happening again are potentially harmful to patient care.

“None of the nurses ever thought that Dr. Husel did anything to harm his patients or do anything other than provide comfort care during a very difficult time,” said Robert Landy, a New York attorney who’s representing the plaintiffs in the federal wrongful termination suit. “The real harm came in January 2019, when there were substantial policy changes that were detrimental to patient care and safety.”

Many of these patient deaths occurred during a period when the Mount Carmel system and Trinity were in the process of closing the old Mount Carmel West hospital, located in the low-income, inner-city neighborhood of Columbus, and opening a new hospital in the affluent suburb of Grove City, Ohio.

“They were done with this old, worn-out, inner-city hospital and its patient base and wanted a brand-new sparkling object in the suburbs,” said Gerry Leeseberg, a Columbus attorney who is representing 17 families of patients who died under Dr. Husel’s care. “They may have directed less energy, attention, and resources to the inner-city hospital.”

The case of Danny Mollette illustrates the multiple issues with Mount Carmel’s patient safety system.

 

 

First, there was no evidence in the record that Mr. Mollette was in pain or lacked the ability to breathe on his own prior to Dr. Husel’s palliative extubation. He had received no pain medications in the hospital that day, according to the report of an Ohio Board of Nursing examiner in a licensure discipline action brought against nurse Jacob Deemer for his care of Mr. Mollette and two other ICU patients who died. Mr. Deemer said Dr. Husel told him that the patient had to be in pain given his condition.

After consulting with Mr. Mollette’s family at the bedside, Dr. Husel ordered Mr. Deemer to administer 1,000 mcg of fentanyl, followed by 2 mg of hydromorphone, and 4 mg of midzolam, a sedative. Mr. Deemer withdrew the drugs from the Pyxis dispensing cabinet, overriding the pharmacist preapproval system. He said Dr. Husel told him the pharmacist had said, “It is okay.”

Actually, according to the pharmacy board report, the pharmacist, Gregory White, wrote in the medical record system that he did not agree to the fentanyl order. But his dissent came as the drugs were being administered, the breathing tube was being removed, and the patient was about to die. Mr. White was later disciplined by the Ohio Board of Pharmacy for failing to inform his supervisors about the incident and preventing the use of those high drug dosages in the cases of Mr. Mollette and two subsequent Husel patients.

Then there are questions about whether the families of Mr. Mollette and other Husel patients were fully and accurately informed about their loved ones’ conditions before agreeing to the palliative extubation. Mr. Mollette’s son, Brian, told reporters in July 2019 that Dr. Husel “said my father’s organs were shutting down and he was brain damaged. In hindsight, we felt kind of rushed to make that decision.”

Plaintiff attorneys bringing civil wrongful death cases against Mount Carmel and Dr. Husel must overcome hurdles similar to those faced by prosecutors in the murder case against Dr. Husel. Even if the patients were likely to die from their underlying conditions, did the drugs hasten their deaths, and by how much? In the civil cases, there’s the additional question of how much a few more hours or days or weeks of life are worth in terms of monetary damages.

Another challenge in bringing both the criminal and civil cases is that physicians and other medical providers have certain legal protections for administering drugs to patients for the purpose of relieving pain and suffering, even if the drugs hasten the patients’ deaths – as long the intent was not to cause death and the drugs were properly used. This is known as the double-effect principle. In contrast, intentional killing to relieve pain and suffering is called euthanasia, and that’s illegal in the United States.

“There is no evidence that medication played any part in the death of any of these patients,” said Mr. Landy, who’s representing the nurses and pharmacists in the wrongful termination suit. “The only evidence we have is that higher dosages of opioids following extubation extend life, not shorten it.”

Dr. Husel, as well as the nurses and pharmacists who have faced licensure actions, claim their actions were legally shielded by the double-effect principle. But the Centers for Medicare & Medicaid Services, the Ohio Board of Nursing, and Ohio Board of Pharmacy haven’t accepted that defense. Instead, they have cited Mount Carmel, Dr. Husel, and the nurses and pharmacists for numerous patient safety violations, including administering excessive dosages of fentanyl and other drugs.

Among those violations is that many of Dr. Husel’s drug orders were given verbally instead of through the standard process of entering the orders into the electronic health record. He and the nurses on duty skipped the standard nonemergency process of getting preapproval from the pharmacist on duty. Instead, they used the override function on Mount Carmel’s automated Pyxis system to withdraw the drugs from the cabinet and avoid pharmacist review. In many cases, there was no retrospective review of the appropriateness of the orders by a pharmacist after the drugs were administered, which is required.

After threatening to cut off Medicare and Medicaid payments to Mount Carmel, CMS in June 2019 accepted the hospital’s correction plan, which restricted use of verbal drug orders and prohibited Pyxis system overrides for opioids except in life-threatening emergencies. The Ohio Board of Pharmacy hit Mount Carmel with $477,000 in fines and costs for pharmacy rules violations.

Under the agreement with CMS, Mount Carmel physicians must receive permission from a physician executive to order painkilling drugs that exceed hospital-set dosage parameters for palliative ventilator withdrawal. In addition, pharmacists must immediately report concerns about drug-prescribing safety up the hospital pharmacy chain of command.

“We have trained staff to ensure they feel empowered to speak up when appropriate,” the Mount Carmel spokeswoman said. “Staff members have multiple avenues for elevating a complaint or concern.”

Dr. Husel’s high dosages of fentanyl and other painkillers were well-known among the ICU nurses and pharmacists, who rarely – if ever – questioned those dosages, and went along with his standard use of verbal orders and overrides of the Pyxis system, according to depositions of nurses and pharmacists in the wrongful death lawsuits.

But the Mount Carmel nurses and pharmacists had a professional responsibility to question such dosages and demand evidence from the medical literature to support their use, according to hearing examiners at the nursing and pharmacy boards, who meted out licensure actions to providers working with Dr. Husel. Under the Zero Harm patient safety program Mount Carmel West launched in 2017, medical staffers were supposed to report safety concerns up the chain of command. That apparently did not happen.

Nursing board hearing examiner Jack Decker emphasized those responsibilities in his November 30, 2020, report on nurse Deemer’s actions regarding three patients who died under Dr. Husel’s care in 2017 and 2018. Mr. Deemer’s license was suspended, however, that suspension was stayed for a minimum period of three years. Mr. Decker wrote that the ICU nurses had a professional responsibility to question Dr. Husel and, if necessary, refuse to carry out the doctor’s order and report their concerns to managers.

“Challenging a physician’s order is a difficult step even under ideal circumstances,” wrote Mr. Decker, who called Mount Carmel West’s ICU a “dysfunctional” environment. “But,” he noted, “when Mr. Deemer signed on to become a nurse, he enlisted to use his own critical thinking skills to serve as a patient protector and advocate. … Clearly, Mr. Deemer trusted Dr. Husel. But Dr. Husel was not to be trusted.”

While patient safety experts say these cases reveal that Mount Carmel had a flawed system and culture that did not train and empower staff to report safety concerns up the chain of command, they acknowledged that this could have happened at many U.S. hospitals.

“Sadly, I’m not sure it’s all that uncommon,” said Dr. Nelson of Rutgers. “Nurses and pharmacists have historically been afraid to raise concerns about physicians. We’ve been trying to break down barriers, but it’s a natural human instinct to play your role in the hierarchy.”

A version of this article first appeared on Medscape.com.

Corrections 2/1/22: An earlier version of this article misstated (*) the number of murder counts and (**) Dr. Nelson's area of practice. 

This article was updated 2/2/22 to reflect the fact that the license suspensions of Mr. Deemer and Mr. Schulze were stayed.

 

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On Dec. 5, 2017, Danny Mollette, age 74, was brought to the emergency department of Mount Carmel West Medical Center in Columbus, Ohio, in critical condition. Staff inserted a breathing tube and sent him to the intensive care unit.

Mr. Mollette, who had diabetes, previously had been hospitalized for treatment of a gangrenous foot. When he arrived in the ICU, he was suffering from acute renal failure and low blood pressure, and had had two heart stoppages, according to a 2020 Ohio Board of Pharmacy report. He was placed under the care of William Husel, DO, the sole physician on duty in the ICU during the overnight shift.

Around 9:00 p.m., Dr. Husel discussed Mr. Mollette’s “grim prognosis” with family members at the patient’s bedside. He advised them that Mr. Mollette had “minutes to live” and asked, “How would you want him to take his last breath: on the ventilator or without these machines?”

In less than an hour, Mr. Mollette was dead. Some said that what happened in his case was similar to what happened with 34 other ICU patients at Mount Carmel West and Mount Carmel St. Ann’s in Westerville, Ohio, from 2014 through 2018 – all under Dr. Husel’s care.

Like Mr. Mollette, most of these gravely ill patients died minutes after receiving a single, unusually large intravenous dose of the powerful opioid fentanyl – often combined with a dose of one or more other painkillers or sedatives like hydromorphone – and being withdrawn from the ventilator. These deaths all occurred following a procedure called palliative extubation, the removal of the endotracheal tube in patients who are expected to die.

Mount Carmel fired Dr. Husel in December 2018 following an investigation that concluded that the opioid dosages he used were “significantly excessive and potentially fatal,” and “went beyond providing comfort.” His Ohio medical license was suspended. In February 2022, he is scheduled to go on trial in Columbus on 14 counts of murder.*

Hanging over the murder case against Dr. Husel is the question of how Mount Carmel, a 136-year-old Catholic hospital owned by the giant Trinity Health system, allowed this pattern of care to continue for so many patients over 4 years, and why numerous registered nurses and hospital pharmacists went along with Dr. Husel’s actions. Nearly two dozen RNs and two pharmacists involved in these cases have faced disciplinary action, mostly license suspension.  

“The first time a patient died on a very high dose, someone should have flagged this,” said Lewis Nelson, MD, chair of emergency medicine at Rutgers New Jersey Medical School, Newark. “As soon as I see it the second time or 27th time, it doesn’t seem okay. There was a breakdown in oversight to allow this to continue. The hospital didn’t have guardrails in place.”

The Franklin County (Ohio) Prosecuting Attorney’s Office faces two big challenges in trying Dr. Husel for murder. The prosecutors must prove that the drugs Dr. Husel ordered are what directly caused these critically ill patients to die, and that he intended to kill them.

Federal and state agencies have cited the hospital system for faults in its patient safety systems and culture that were exposed by the Husel cases. An outside medical expert, Robert Powers, MD, a professor of emergency medicine at the University of Virginia, Charlottesville, testified in one of the dozens of wrongful death lawsuits against Mount Carmel and Dr. Husel that there was no record of anyone supervising Dr. Husel or monitoring his care.

There also are questions about why Mount Carmel administrators and physician leaders did not find out about Dr. Husel’s criminal record as a young man before hiring and credentialing him, even though the Ohio Medical Board had obtained that record. As a college freshman in West Virginia in 1994, Dr. Husel and a friend allegedly stole car stereos, and after a classmate reported their behavior, they built a pipe bomb they planned to plant under the classmate’s car, according to court records.

Dr. Husel pleaded guilty in 1996 to a federal misdemeanor for improperly storing explosive materials, and he received a 6-month sentence followed by supervision. He did not disclose that criminal conviction on his application for medical liability insurance as part of his Mount Carmel employment application, attorneys representing the families of his deceased patients say.

A Mount Carmel spokeswoman said the hospital only checks a physician applicant’s background record for the previous 10 years.

“I think [the credentialing process] should have been more careful and more comprehensive than it was,” Robert Powers testified in a September 2020 deposition. “This guy was a bomber and a thief. You don’t hire bombers and thieves to take care of patients.”

Mount Carmel and Trinity leaders say they knew nothing about Dr. Husel’s palliative extubation practices until a staffer reported Dr. Husel’s high-dose fentanyl orders in October 2018. However, three more Husel patients died under similar circumstances before he was removed from patient care in November 2018.

Mount Carmel and Trinity already have settled a number of wrongful death lawsuits filed by the families of Dr. Husel’s patients for nearly $20 million, with many more suits pending. The Mount Carmel CEO, the chief clinical officer, other physician, nursing, and pharmacy leaders, as well as dozens of nurses and pharmacists have been terminated or entered into retirement.

“What happened is tragic and unacceptable,” the Mount Carmel spokeswoman said in a written statement. “We have made a number of changes designed to prevent this from ever happening again. … Our new hospital leadership team is committed to patient safety and will take immediate action whenever patient safety is at issue.”

In January 2019, Mount Carmel’s then-CEO Ed Lamb acknowledged that “processes in place were not sufficient to prevent these actions from happening.” Mr. Lamb later said Mount Carmel was investigating whether five of the ICU patients who died under Dr. Husel’s care could have been treated and survived. Mr. Lamb stepped down in June 2019.

Before performing a palliative extubation, physicians commonly administer opioids and/or sedatives to ease pain and discomfort, and spare family members from witnessing their loved one gasping for breath. But most medical experts say the fentanyl doses Dr. Husel ordered – 500-2,000 mcg – were five to 20 times larger than doses normally used in palliative extubation. Such doses, they say, would quickly kill most patients – except those with high opioid tolerance – by stopping their breathing.

Physicians say they typically give much smaller doses of fentanyl or morphine, then administer more as needed if they observe the patient experiencing pain or distress. Mount Carmel’s 2016 guidelines for IV administration of fentanyl specified a dosage range of 50-100 mcg for relieving pain, and its 2018 guidelines reduced that to 25-50 mcg.

“If I perform a painful procedure, I might give 100 or 150 micrograms of fentanyl, or 500 or 600 for open heart surgery,” said Dr. Nelson of Rutgers, who also practices medical toxicology and addiction medicine. “But you’ll be intubated and monitored carefully. Without having a tube in your airway to help you breathe, those doses will kill you.”**

Mount Carmel West hired Dr. Husel in 2013 to work the late-night shift in its ICU. It was his first job as a full-fledged physician, after completing a residency and fellowship in critical care medicine at Cleveland Clinic. A good-looking and charismatic former high school basketball star, he was a hard worker and was popular with the ICU nurses and staff, who looked to him as a teacher and mentor, according to depositions of nurses and Ohio Board of Nursing reports.

In 2014, Dr. Husel was chosen by his hospital colleagues as physician of the year. He was again nominated in 2018. Before October 2018, there were no complaints about his care, according to the deposition of Larry Swanner, MD, Mount Carmel’s former vice president of medical affairs, who was fired in 2019.

“Dr. Husel is so knowledgeable that we would try to soak up as much knowledge as we could,” said Jason Schulze, RN, in a July 2020 deposition. Mr. Schulze’s license was suspended, however, that suspension was stayed for a minimum period of two years. This was in connection with his care of one of Dr. Husel’s ICU patients, 44-year-old Troy Allison, who died 3 minutes after Mr. Schulze administered a 1,000-microgram dose of fentanyl ordered by Dr. Husel in July 2018.

Dr. Husel’s winning personality and seeming expertise in the use of pain drugs, combined with his training at the prestigious Cleveland Clinic, may have lulled other hospital staff into going along with his decisions.

“They’re thinking, the guy’s likable and he must know what he’s doing,” said Michael Cohen, RPh, founder and president emeritus of the Institute for Safe Medication Practices. “But you can’t get fooled by that. You need a policy in place for what to do if pharmacists or nurses disagree with an order, and you need to have practice simulations so people know how to handle these situations.”

Dr. Husel’s criminal defense attorney, Jose Baez, said Dr. Husel’s treatment of all these palliative extubation patients, including his prescribed dosages of fentanyl and other drugs, was completely appropriate. “Dr. Husel practiced medicine with compassion, and never wanted to see any of his patients suffer, nor their family,” Mr. Baez said.

Most medical and pharmacy experts sharply disagree. “I’m a pharmacist, and I’ve never seen anything like those kinds of doses,” Mr. Cohen said. “Something strange was going on there.”

Complicating these issues, eight nurses and a pharmacist have sued Mount Carmel and Trinity for wrongful termination and defamation in connection with the Husel allegations. They strongly defend Dr. Husel’s and their care as compassionate and appropriate. Beyond that, they argue that the changes Mount Carmel and Trinity made to ICU procedures to prevent such situations from happening again are potentially harmful to patient care.

“None of the nurses ever thought that Dr. Husel did anything to harm his patients or do anything other than provide comfort care during a very difficult time,” said Robert Landy, a New York attorney who’s representing the plaintiffs in the federal wrongful termination suit. “The real harm came in January 2019, when there were substantial policy changes that were detrimental to patient care and safety.”

Many of these patient deaths occurred during a period when the Mount Carmel system and Trinity were in the process of closing the old Mount Carmel West hospital, located in the low-income, inner-city neighborhood of Columbus, and opening a new hospital in the affluent suburb of Grove City, Ohio.

“They were done with this old, worn-out, inner-city hospital and its patient base and wanted a brand-new sparkling object in the suburbs,” said Gerry Leeseberg, a Columbus attorney who is representing 17 families of patients who died under Dr. Husel’s care. “They may have directed less energy, attention, and resources to the inner-city hospital.”

The case of Danny Mollette illustrates the multiple issues with Mount Carmel’s patient safety system.

 

 

First, there was no evidence in the record that Mr. Mollette was in pain or lacked the ability to breathe on his own prior to Dr. Husel’s palliative extubation. He had received no pain medications in the hospital that day, according to the report of an Ohio Board of Nursing examiner in a licensure discipline action brought against nurse Jacob Deemer for his care of Mr. Mollette and two other ICU patients who died. Mr. Deemer said Dr. Husel told him that the patient had to be in pain given his condition.

After consulting with Mr. Mollette’s family at the bedside, Dr. Husel ordered Mr. Deemer to administer 1,000 mcg of fentanyl, followed by 2 mg of hydromorphone, and 4 mg of midzolam, a sedative. Mr. Deemer withdrew the drugs from the Pyxis dispensing cabinet, overriding the pharmacist preapproval system. He said Dr. Husel told him the pharmacist had said, “It is okay.”

Actually, according to the pharmacy board report, the pharmacist, Gregory White, wrote in the medical record system that he did not agree to the fentanyl order. But his dissent came as the drugs were being administered, the breathing tube was being removed, and the patient was about to die. Mr. White was later disciplined by the Ohio Board of Pharmacy for failing to inform his supervisors about the incident and preventing the use of those high drug dosages in the cases of Mr. Mollette and two subsequent Husel patients.

Then there are questions about whether the families of Mr. Mollette and other Husel patients were fully and accurately informed about their loved ones’ conditions before agreeing to the palliative extubation. Mr. Mollette’s son, Brian, told reporters in July 2019 that Dr. Husel “said my father’s organs were shutting down and he was brain damaged. In hindsight, we felt kind of rushed to make that decision.”

Plaintiff attorneys bringing civil wrongful death cases against Mount Carmel and Dr. Husel must overcome hurdles similar to those faced by prosecutors in the murder case against Dr. Husel. Even if the patients were likely to die from their underlying conditions, did the drugs hasten their deaths, and by how much? In the civil cases, there’s the additional question of how much a few more hours or days or weeks of life are worth in terms of monetary damages.

Another challenge in bringing both the criminal and civil cases is that physicians and other medical providers have certain legal protections for administering drugs to patients for the purpose of relieving pain and suffering, even if the drugs hasten the patients’ deaths – as long the intent was not to cause death and the drugs were properly used. This is known as the double-effect principle. In contrast, intentional killing to relieve pain and suffering is called euthanasia, and that’s illegal in the United States.

“There is no evidence that medication played any part in the death of any of these patients,” said Mr. Landy, who’s representing the nurses and pharmacists in the wrongful termination suit. “The only evidence we have is that higher dosages of opioids following extubation extend life, not shorten it.”

Dr. Husel, as well as the nurses and pharmacists who have faced licensure actions, claim their actions were legally shielded by the double-effect principle. But the Centers for Medicare & Medicaid Services, the Ohio Board of Nursing, and Ohio Board of Pharmacy haven’t accepted that defense. Instead, they have cited Mount Carmel, Dr. Husel, and the nurses and pharmacists for numerous patient safety violations, including administering excessive dosages of fentanyl and other drugs.

Among those violations is that many of Dr. Husel’s drug orders were given verbally instead of through the standard process of entering the orders into the electronic health record. He and the nurses on duty skipped the standard nonemergency process of getting preapproval from the pharmacist on duty. Instead, they used the override function on Mount Carmel’s automated Pyxis system to withdraw the drugs from the cabinet and avoid pharmacist review. In many cases, there was no retrospective review of the appropriateness of the orders by a pharmacist after the drugs were administered, which is required.

After threatening to cut off Medicare and Medicaid payments to Mount Carmel, CMS in June 2019 accepted the hospital’s correction plan, which restricted use of verbal drug orders and prohibited Pyxis system overrides for opioids except in life-threatening emergencies. The Ohio Board of Pharmacy hit Mount Carmel with $477,000 in fines and costs for pharmacy rules violations.

Under the agreement with CMS, Mount Carmel physicians must receive permission from a physician executive to order painkilling drugs that exceed hospital-set dosage parameters for palliative ventilator withdrawal. In addition, pharmacists must immediately report concerns about drug-prescribing safety up the hospital pharmacy chain of command.

“We have trained staff to ensure they feel empowered to speak up when appropriate,” the Mount Carmel spokeswoman said. “Staff members have multiple avenues for elevating a complaint or concern.”

Dr. Husel’s high dosages of fentanyl and other painkillers were well-known among the ICU nurses and pharmacists, who rarely – if ever – questioned those dosages, and went along with his standard use of verbal orders and overrides of the Pyxis system, according to depositions of nurses and pharmacists in the wrongful death lawsuits.

But the Mount Carmel nurses and pharmacists had a professional responsibility to question such dosages and demand evidence from the medical literature to support their use, according to hearing examiners at the nursing and pharmacy boards, who meted out licensure actions to providers working with Dr. Husel. Under the Zero Harm patient safety program Mount Carmel West launched in 2017, medical staffers were supposed to report safety concerns up the chain of command. That apparently did not happen.

Nursing board hearing examiner Jack Decker emphasized those responsibilities in his November 30, 2020, report on nurse Deemer’s actions regarding three patients who died under Dr. Husel’s care in 2017 and 2018. Mr. Deemer’s license was suspended, however, that suspension was stayed for a minimum period of three years. Mr. Decker wrote that the ICU nurses had a professional responsibility to question Dr. Husel and, if necessary, refuse to carry out the doctor’s order and report their concerns to managers.

“Challenging a physician’s order is a difficult step even under ideal circumstances,” wrote Mr. Decker, who called Mount Carmel West’s ICU a “dysfunctional” environment. “But,” he noted, “when Mr. Deemer signed on to become a nurse, he enlisted to use his own critical thinking skills to serve as a patient protector and advocate. … Clearly, Mr. Deemer trusted Dr. Husel. But Dr. Husel was not to be trusted.”

While patient safety experts say these cases reveal that Mount Carmel had a flawed system and culture that did not train and empower staff to report safety concerns up the chain of command, they acknowledged that this could have happened at many U.S. hospitals.

“Sadly, I’m not sure it’s all that uncommon,” said Dr. Nelson of Rutgers. “Nurses and pharmacists have historically been afraid to raise concerns about physicians. We’ve been trying to break down barriers, but it’s a natural human instinct to play your role in the hierarchy.”

A version of this article first appeared on Medscape.com.

Corrections 2/1/22: An earlier version of this article misstated (*) the number of murder counts and (**) Dr. Nelson's area of practice. 

This article was updated 2/2/22 to reflect the fact that the license suspensions of Mr. Deemer and Mr. Schulze were stayed.

 

On Dec. 5, 2017, Danny Mollette, age 74, was brought to the emergency department of Mount Carmel West Medical Center in Columbus, Ohio, in critical condition. Staff inserted a breathing tube and sent him to the intensive care unit.

Mr. Mollette, who had diabetes, previously had been hospitalized for treatment of a gangrenous foot. When he arrived in the ICU, he was suffering from acute renal failure and low blood pressure, and had had two heart stoppages, according to a 2020 Ohio Board of Pharmacy report. He was placed under the care of William Husel, DO, the sole physician on duty in the ICU during the overnight shift.

Around 9:00 p.m., Dr. Husel discussed Mr. Mollette’s “grim prognosis” with family members at the patient’s bedside. He advised them that Mr. Mollette had “minutes to live” and asked, “How would you want him to take his last breath: on the ventilator or without these machines?”

In less than an hour, Mr. Mollette was dead. Some said that what happened in his case was similar to what happened with 34 other ICU patients at Mount Carmel West and Mount Carmel St. Ann’s in Westerville, Ohio, from 2014 through 2018 – all under Dr. Husel’s care.

Like Mr. Mollette, most of these gravely ill patients died minutes after receiving a single, unusually large intravenous dose of the powerful opioid fentanyl – often combined with a dose of one or more other painkillers or sedatives like hydromorphone – and being withdrawn from the ventilator. These deaths all occurred following a procedure called palliative extubation, the removal of the endotracheal tube in patients who are expected to die.

Mount Carmel fired Dr. Husel in December 2018 following an investigation that concluded that the opioid dosages he used were “significantly excessive and potentially fatal,” and “went beyond providing comfort.” His Ohio medical license was suspended. In February 2022, he is scheduled to go on trial in Columbus on 14 counts of murder.*

Hanging over the murder case against Dr. Husel is the question of how Mount Carmel, a 136-year-old Catholic hospital owned by the giant Trinity Health system, allowed this pattern of care to continue for so many patients over 4 years, and why numerous registered nurses and hospital pharmacists went along with Dr. Husel’s actions. Nearly two dozen RNs and two pharmacists involved in these cases have faced disciplinary action, mostly license suspension.  

“The first time a patient died on a very high dose, someone should have flagged this,” said Lewis Nelson, MD, chair of emergency medicine at Rutgers New Jersey Medical School, Newark. “As soon as I see it the second time or 27th time, it doesn’t seem okay. There was a breakdown in oversight to allow this to continue. The hospital didn’t have guardrails in place.”

The Franklin County (Ohio) Prosecuting Attorney’s Office faces two big challenges in trying Dr. Husel for murder. The prosecutors must prove that the drugs Dr. Husel ordered are what directly caused these critically ill patients to die, and that he intended to kill them.

Federal and state agencies have cited the hospital system for faults in its patient safety systems and culture that were exposed by the Husel cases. An outside medical expert, Robert Powers, MD, a professor of emergency medicine at the University of Virginia, Charlottesville, testified in one of the dozens of wrongful death lawsuits against Mount Carmel and Dr. Husel that there was no record of anyone supervising Dr. Husel or monitoring his care.

There also are questions about why Mount Carmel administrators and physician leaders did not find out about Dr. Husel’s criminal record as a young man before hiring and credentialing him, even though the Ohio Medical Board had obtained that record. As a college freshman in West Virginia in 1994, Dr. Husel and a friend allegedly stole car stereos, and after a classmate reported their behavior, they built a pipe bomb they planned to plant under the classmate’s car, according to court records.

Dr. Husel pleaded guilty in 1996 to a federal misdemeanor for improperly storing explosive materials, and he received a 6-month sentence followed by supervision. He did not disclose that criminal conviction on his application for medical liability insurance as part of his Mount Carmel employment application, attorneys representing the families of his deceased patients say.

A Mount Carmel spokeswoman said the hospital only checks a physician applicant’s background record for the previous 10 years.

“I think [the credentialing process] should have been more careful and more comprehensive than it was,” Robert Powers testified in a September 2020 deposition. “This guy was a bomber and a thief. You don’t hire bombers and thieves to take care of patients.”

Mount Carmel and Trinity leaders say they knew nothing about Dr. Husel’s palliative extubation practices until a staffer reported Dr. Husel’s high-dose fentanyl orders in October 2018. However, three more Husel patients died under similar circumstances before he was removed from patient care in November 2018.

Mount Carmel and Trinity already have settled a number of wrongful death lawsuits filed by the families of Dr. Husel’s patients for nearly $20 million, with many more suits pending. The Mount Carmel CEO, the chief clinical officer, other physician, nursing, and pharmacy leaders, as well as dozens of nurses and pharmacists have been terminated or entered into retirement.

“What happened is tragic and unacceptable,” the Mount Carmel spokeswoman said in a written statement. “We have made a number of changes designed to prevent this from ever happening again. … Our new hospital leadership team is committed to patient safety and will take immediate action whenever patient safety is at issue.”

In January 2019, Mount Carmel’s then-CEO Ed Lamb acknowledged that “processes in place were not sufficient to prevent these actions from happening.” Mr. Lamb later said Mount Carmel was investigating whether five of the ICU patients who died under Dr. Husel’s care could have been treated and survived. Mr. Lamb stepped down in June 2019.

Before performing a palliative extubation, physicians commonly administer opioids and/or sedatives to ease pain and discomfort, and spare family members from witnessing their loved one gasping for breath. But most medical experts say the fentanyl doses Dr. Husel ordered – 500-2,000 mcg – were five to 20 times larger than doses normally used in palliative extubation. Such doses, they say, would quickly kill most patients – except those with high opioid tolerance – by stopping their breathing.

Physicians say they typically give much smaller doses of fentanyl or morphine, then administer more as needed if they observe the patient experiencing pain or distress. Mount Carmel’s 2016 guidelines for IV administration of fentanyl specified a dosage range of 50-100 mcg for relieving pain, and its 2018 guidelines reduced that to 25-50 mcg.

“If I perform a painful procedure, I might give 100 or 150 micrograms of fentanyl, or 500 or 600 for open heart surgery,” said Dr. Nelson of Rutgers, who also practices medical toxicology and addiction medicine. “But you’ll be intubated and monitored carefully. Without having a tube in your airway to help you breathe, those doses will kill you.”**

Mount Carmel West hired Dr. Husel in 2013 to work the late-night shift in its ICU. It was his first job as a full-fledged physician, after completing a residency and fellowship in critical care medicine at Cleveland Clinic. A good-looking and charismatic former high school basketball star, he was a hard worker and was popular with the ICU nurses and staff, who looked to him as a teacher and mentor, according to depositions of nurses and Ohio Board of Nursing reports.

In 2014, Dr. Husel was chosen by his hospital colleagues as physician of the year. He was again nominated in 2018. Before October 2018, there were no complaints about his care, according to the deposition of Larry Swanner, MD, Mount Carmel’s former vice president of medical affairs, who was fired in 2019.

“Dr. Husel is so knowledgeable that we would try to soak up as much knowledge as we could,” said Jason Schulze, RN, in a July 2020 deposition. Mr. Schulze’s license was suspended, however, that suspension was stayed for a minimum period of two years. This was in connection with his care of one of Dr. Husel’s ICU patients, 44-year-old Troy Allison, who died 3 minutes after Mr. Schulze administered a 1,000-microgram dose of fentanyl ordered by Dr. Husel in July 2018.

Dr. Husel’s winning personality and seeming expertise in the use of pain drugs, combined with his training at the prestigious Cleveland Clinic, may have lulled other hospital staff into going along with his decisions.

“They’re thinking, the guy’s likable and he must know what he’s doing,” said Michael Cohen, RPh, founder and president emeritus of the Institute for Safe Medication Practices. “But you can’t get fooled by that. You need a policy in place for what to do if pharmacists or nurses disagree with an order, and you need to have practice simulations so people know how to handle these situations.”

Dr. Husel’s criminal defense attorney, Jose Baez, said Dr. Husel’s treatment of all these palliative extubation patients, including his prescribed dosages of fentanyl and other drugs, was completely appropriate. “Dr. Husel practiced medicine with compassion, and never wanted to see any of his patients suffer, nor their family,” Mr. Baez said.

Most medical and pharmacy experts sharply disagree. “I’m a pharmacist, and I’ve never seen anything like those kinds of doses,” Mr. Cohen said. “Something strange was going on there.”

Complicating these issues, eight nurses and a pharmacist have sued Mount Carmel and Trinity for wrongful termination and defamation in connection with the Husel allegations. They strongly defend Dr. Husel’s and their care as compassionate and appropriate. Beyond that, they argue that the changes Mount Carmel and Trinity made to ICU procedures to prevent such situations from happening again are potentially harmful to patient care.

“None of the nurses ever thought that Dr. Husel did anything to harm his patients or do anything other than provide comfort care during a very difficult time,” said Robert Landy, a New York attorney who’s representing the plaintiffs in the federal wrongful termination suit. “The real harm came in January 2019, when there were substantial policy changes that were detrimental to patient care and safety.”

Many of these patient deaths occurred during a period when the Mount Carmel system and Trinity were in the process of closing the old Mount Carmel West hospital, located in the low-income, inner-city neighborhood of Columbus, and opening a new hospital in the affluent suburb of Grove City, Ohio.

“They were done with this old, worn-out, inner-city hospital and its patient base and wanted a brand-new sparkling object in the suburbs,” said Gerry Leeseberg, a Columbus attorney who is representing 17 families of patients who died under Dr. Husel’s care. “They may have directed less energy, attention, and resources to the inner-city hospital.”

The case of Danny Mollette illustrates the multiple issues with Mount Carmel’s patient safety system.

 

 

First, there was no evidence in the record that Mr. Mollette was in pain or lacked the ability to breathe on his own prior to Dr. Husel’s palliative extubation. He had received no pain medications in the hospital that day, according to the report of an Ohio Board of Nursing examiner in a licensure discipline action brought against nurse Jacob Deemer for his care of Mr. Mollette and two other ICU patients who died. Mr. Deemer said Dr. Husel told him that the patient had to be in pain given his condition.

After consulting with Mr. Mollette’s family at the bedside, Dr. Husel ordered Mr. Deemer to administer 1,000 mcg of fentanyl, followed by 2 mg of hydromorphone, and 4 mg of midzolam, a sedative. Mr. Deemer withdrew the drugs from the Pyxis dispensing cabinet, overriding the pharmacist preapproval system. He said Dr. Husel told him the pharmacist had said, “It is okay.”

Actually, according to the pharmacy board report, the pharmacist, Gregory White, wrote in the medical record system that he did not agree to the fentanyl order. But his dissent came as the drugs were being administered, the breathing tube was being removed, and the patient was about to die. Mr. White was later disciplined by the Ohio Board of Pharmacy for failing to inform his supervisors about the incident and preventing the use of those high drug dosages in the cases of Mr. Mollette and two subsequent Husel patients.

Then there are questions about whether the families of Mr. Mollette and other Husel patients were fully and accurately informed about their loved ones’ conditions before agreeing to the palliative extubation. Mr. Mollette’s son, Brian, told reporters in July 2019 that Dr. Husel “said my father’s organs were shutting down and he was brain damaged. In hindsight, we felt kind of rushed to make that decision.”

Plaintiff attorneys bringing civil wrongful death cases against Mount Carmel and Dr. Husel must overcome hurdles similar to those faced by prosecutors in the murder case against Dr. Husel. Even if the patients were likely to die from their underlying conditions, did the drugs hasten their deaths, and by how much? In the civil cases, there’s the additional question of how much a few more hours or days or weeks of life are worth in terms of monetary damages.

Another challenge in bringing both the criminal and civil cases is that physicians and other medical providers have certain legal protections for administering drugs to patients for the purpose of relieving pain and suffering, even if the drugs hasten the patients’ deaths – as long the intent was not to cause death and the drugs were properly used. This is known as the double-effect principle. In contrast, intentional killing to relieve pain and suffering is called euthanasia, and that’s illegal in the United States.

“There is no evidence that medication played any part in the death of any of these patients,” said Mr. Landy, who’s representing the nurses and pharmacists in the wrongful termination suit. “The only evidence we have is that higher dosages of opioids following extubation extend life, not shorten it.”

Dr. Husel, as well as the nurses and pharmacists who have faced licensure actions, claim their actions were legally shielded by the double-effect principle. But the Centers for Medicare & Medicaid Services, the Ohio Board of Nursing, and Ohio Board of Pharmacy haven’t accepted that defense. Instead, they have cited Mount Carmel, Dr. Husel, and the nurses and pharmacists for numerous patient safety violations, including administering excessive dosages of fentanyl and other drugs.

Among those violations is that many of Dr. Husel’s drug orders were given verbally instead of through the standard process of entering the orders into the electronic health record. He and the nurses on duty skipped the standard nonemergency process of getting preapproval from the pharmacist on duty. Instead, they used the override function on Mount Carmel’s automated Pyxis system to withdraw the drugs from the cabinet and avoid pharmacist review. In many cases, there was no retrospective review of the appropriateness of the orders by a pharmacist after the drugs were administered, which is required.

After threatening to cut off Medicare and Medicaid payments to Mount Carmel, CMS in June 2019 accepted the hospital’s correction plan, which restricted use of verbal drug orders and prohibited Pyxis system overrides for opioids except in life-threatening emergencies. The Ohio Board of Pharmacy hit Mount Carmel with $477,000 in fines and costs for pharmacy rules violations.

Under the agreement with CMS, Mount Carmel physicians must receive permission from a physician executive to order painkilling drugs that exceed hospital-set dosage parameters for palliative ventilator withdrawal. In addition, pharmacists must immediately report concerns about drug-prescribing safety up the hospital pharmacy chain of command.

“We have trained staff to ensure they feel empowered to speak up when appropriate,” the Mount Carmel spokeswoman said. “Staff members have multiple avenues for elevating a complaint or concern.”

Dr. Husel’s high dosages of fentanyl and other painkillers were well-known among the ICU nurses and pharmacists, who rarely – if ever – questioned those dosages, and went along with his standard use of verbal orders and overrides of the Pyxis system, according to depositions of nurses and pharmacists in the wrongful death lawsuits.

But the Mount Carmel nurses and pharmacists had a professional responsibility to question such dosages and demand evidence from the medical literature to support their use, according to hearing examiners at the nursing and pharmacy boards, who meted out licensure actions to providers working with Dr. Husel. Under the Zero Harm patient safety program Mount Carmel West launched in 2017, medical staffers were supposed to report safety concerns up the chain of command. That apparently did not happen.

Nursing board hearing examiner Jack Decker emphasized those responsibilities in his November 30, 2020, report on nurse Deemer’s actions regarding three patients who died under Dr. Husel’s care in 2017 and 2018. Mr. Deemer’s license was suspended, however, that suspension was stayed for a minimum period of three years. Mr. Decker wrote that the ICU nurses had a professional responsibility to question Dr. Husel and, if necessary, refuse to carry out the doctor’s order and report their concerns to managers.

“Challenging a physician’s order is a difficult step even under ideal circumstances,” wrote Mr. Decker, who called Mount Carmel West’s ICU a “dysfunctional” environment. “But,” he noted, “when Mr. Deemer signed on to become a nurse, he enlisted to use his own critical thinking skills to serve as a patient protector and advocate. … Clearly, Mr. Deemer trusted Dr. Husel. But Dr. Husel was not to be trusted.”

While patient safety experts say these cases reveal that Mount Carmel had a flawed system and culture that did not train and empower staff to report safety concerns up the chain of command, they acknowledged that this could have happened at many U.S. hospitals.

“Sadly, I’m not sure it’s all that uncommon,” said Dr. Nelson of Rutgers. “Nurses and pharmacists have historically been afraid to raise concerns about physicians. We’ve been trying to break down barriers, but it’s a natural human instinct to play your role in the hierarchy.”

A version of this article first appeared on Medscape.com.

Corrections 2/1/22: An earlier version of this article misstated (*) the number of murder counts and (**) Dr. Nelson's area of practice. 

This article was updated 2/2/22 to reflect the fact that the license suspensions of Mr. Deemer and Mr. Schulze were stayed.

 

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Jeopardy! champion’s parents sue doctors, hospital when patient dies after colectomy

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Fri, 01/28/2022 - 11:09

The parents of Jeopardy! winner Brayden Smith are suing a Las Vegas surgeon and a hospitalist for negligence after their son died following a colectomy.

Mr. Smith, who suffered from ulcerative colitis, underwent a colectomy on Jan. 15, 2021, at St. Rose Dominican Hospital–San Martin Campus in Las Vegas. At the time, the 24-year-old man was malnourished, extremely weak, and was having more than 10 bloody bowel movements a day, according to a Jan. 11, 2022, lawsuit filed by Smith’s parents.

The allegations state that, after the procedure, hospital staff did not provide Mr. Smith with anticoagulants and did not administer or suggest that Mr. Smith take anticoagulants upon his discharge on Jan. 19. On Jan. 29, 2021, Mr. Smith collapsed at home and his family called an ambulance. He was taken back to St. Rose where he died from bilateral pulmonary emboli.

Mr. Smith’s legal complaint claims that treatment by Smith’s surgeon, hospitalist, and nursing staff fell below the standard of care because they failed to administer anticoagulants following the surgery. After the surgery, Mr. Smith’s surgeon referenced “DVT/VTE prophylaxis/anticoagulation” in the record and another note read “already ordered,” according to Keith Beiermeister, MD, a colon and rectal surgeon retained by the Smiths’ attorney, Robert E. Murdock. However, the order section of the notes included no specific order for heparin or Lovenox (enoxaparin). A hospitalist who cared for Mr. Smith after the surgery also mentioned “DVT prophylaxis” in the progress notes, but the hospitalist did not order it nor ensure that anticoagulants were given, the lawsuit claims.

“In a surgery such as this, the standard of care requires both mechanical and chemical anticoagulation,” Dr. Beiermeister wrote in the complaint. “This is especially true after colectomy and with Brayden’s history. Anticoagulants and mechanical anticoagulation are needed to prevent emboli. The medical literature is clear that patients undergoing colorectal surgery as compared to general surgery have a significant increase in the risk of emboli. This is especially true with preexisting inflammation as is present in inflammatory bowel disease.”

A spokesman for St. Rose said the hospital does not comment on pending litigation.

Mr. Smith was a five-time Jeopardy! winner and gained national fame during his championship run. In a statement, Jeopardy! officials said the Jeopardy! family was “heartbroken by the tragic loss of Brayden Smith” and that he “will be missed.”
 

Surgeon must face second trial in stroke suit

A cardiovascular surgeon must face a second trial over claims that he performed an unnecessary surgery that caused a patient’s stroke, the Iowa Supreme Court has ruled.

William McGrew visited a Waterloo, Iowa, cardiovascular surgeon in 2014 after experiencing transient foggy vision in one eye. An ophthalmologist initially diagnosed Mr. McGrew with cataract, but he was referred to the surgeon to rule out other possibilities.

Because of Mr. McGrew’s age (69) and history of hypertension, the cardiovascular surgeon suspected carotid disease and recommended a CT angiogram to further investigate, according to a summary in the Iowa Supreme Court’s opinion.

The CT angiogram was performed at a local imaging center and read by a radiologist who interpreted it as showing 65% stenosis, or narrowing, of the right carotid artery. The surgeon did his own review and interpreted the results as showing 70% stenosis, according to court documents. The surgeon believed that McGrew was at significant risk for stroke and he recommended surgery, specifically a right carotid endarterectomy to remove the plaque from the right carotid artery. He advised McGrew of the surgery’s possible risks, the most common being a stroke.

The endarterectomy initially appeared successful, but the next morning, Mr. McGrew experienced facial droop and weakness on his left side. An MRI and CT scan showed that Mr. McGrew experienced a stroke on the right side of his brain. A CT angiogram showed that his right carotid artery was blocked. The surgeon performed another surgery to remove the carotid artery blockage, but the second surgery did not alleviate Mr. McGrew’s symptoms, according to court documents. Mr. McGrew remains wheelchair-bound, unable to move his left side, and requires nursing home care.

Mr. McGrew and his family later went to a neurologist who analyzed Mr. McGrew’s prior CT angiogram. He interpreted the angiogram as showing only 40% stenosis. The neurologist also asked a neuroradiologist to analyze the CT angiogram, and he assessed the stenosis at 32%. In his opinion, 40% stenosis was not significant to justify an endarterectomy, the neurologist told Mr. McGrew.

Mr. McGrew sued the surgeon and the radiologist in 2016, and later settled with the radiologist. The McGrews claimed that the surgeon negligently misinterpreted the CT angiogram and performed an ill-advised surgery that resulted in a stroke. The McGrews sought damages for pain and suffering, permanent loss of function, loss of income, past and future medical expenses, and loss of consortium.

At trial, attorneys for the surgeon asked the court to limit his and the radiologist’s testimonies, arguing that their opinions were not properly disclosed in expert reports. The trial court granted the motion, and jurors heard only a limited version of the testimony. In addition, some medical records were redacted. A jury found in the surgeon’s favor, deeming him not negligent.

The McGrews appealed. In a Jan. 21, 2022, opinion, the Iowa Supreme Court ruled that the trial court abused its discretion by not allowing the earlier testimonies. Justices said both the neurologist and the neuroradiologist should have been allowed to testify on the applicable standard of care. The district court also abused its discretion in preventing Mr. McGrew from introducing complete versions of the contemporaneous medical records, the court ruled.

Justices reversed the district court’s decision and remanded the case for a new trial.
 

 

 

Court: Patient must pay doc’s legal expenses

A patient must pay a physician about $20,000 in legal expenses after the patient’s malpractice suit was thrown out, an Arizona appeals court has ruled.

Scottsdale plastic surgeon Corwin Martin, MD, performed dental implant surgery on Penny Preszler in February 2012. Following the surgery, Ms. Preszler claimed numbness in her face and mouth, according to the appellate decision. She sued Dr. Martin and his practice for malpractice in 2015.

As the case continued, Ms. Preszler withdrew her first expert and disclosed a new expert. When Ms. Preszler’s second standard of care expert withdrew, she was given 30 days to disclose a new expert. When she failed to do so, Dr. Martin asked the court to dismiss the suit based on Ms. Preszler’s failure to disclose a proper standard of care expert.

She eventually presented a third expert, but Martin’s attorneys argued that the doctor was not a qualified expert under state law because he was board certified in periodontia, while Dr. Martin is board certified in oral and maxillofacial surgery. By this time, the case had gone on for 4 years.

When Ms. Preszler couldn’t come up with a fourth expert who was qualified, the court dismissed the case. The judge also awarded Dr. Martin $19,279.05 for expenses incurred in discovery related to Ms. Preszler’s first expert, attorneys’ fees, and expenses.

Ms. Preszler appealed, arguing that the periodontist was qualified to testify against Martin because he performed dental implant surgeries in the past without the board certification Dr. Martin obtained. In its Jan. 20, 2022, decision, a panel of the Arizona Court of Appeals upheld the decision, ruling that the expert was not qualified to opine. The patient must also pay the physician’s legal expenses as ordered by the lower court.

“[Ms.] Preszler has not shown the superior court abused its discretion in the award issued,” appellate judges wrote. “Three years after [Ms.] Preszler disclosed her first expert witness, that expert withdrew. [Dr.] Martin claimed substantial expenses relating to discovery addressing [Ms.] Preszler’s first expert, which were no longer beneficial given his withdrawal. ... [Ms.] Preszler has not shown that the expenses awarded to [Dr.] Martin were unreasonable or disproportionate to the time and costs expended regarding the withdrawn expert.”

A version of this article first appeared on Medscape.com.

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The parents of Jeopardy! winner Brayden Smith are suing a Las Vegas surgeon and a hospitalist for negligence after their son died following a colectomy.

Mr. Smith, who suffered from ulcerative colitis, underwent a colectomy on Jan. 15, 2021, at St. Rose Dominican Hospital–San Martin Campus in Las Vegas. At the time, the 24-year-old man was malnourished, extremely weak, and was having more than 10 bloody bowel movements a day, according to a Jan. 11, 2022, lawsuit filed by Smith’s parents.

The allegations state that, after the procedure, hospital staff did not provide Mr. Smith with anticoagulants and did not administer or suggest that Mr. Smith take anticoagulants upon his discharge on Jan. 19. On Jan. 29, 2021, Mr. Smith collapsed at home and his family called an ambulance. He was taken back to St. Rose where he died from bilateral pulmonary emboli.

Mr. Smith’s legal complaint claims that treatment by Smith’s surgeon, hospitalist, and nursing staff fell below the standard of care because they failed to administer anticoagulants following the surgery. After the surgery, Mr. Smith’s surgeon referenced “DVT/VTE prophylaxis/anticoagulation” in the record and another note read “already ordered,” according to Keith Beiermeister, MD, a colon and rectal surgeon retained by the Smiths’ attorney, Robert E. Murdock. However, the order section of the notes included no specific order for heparin or Lovenox (enoxaparin). A hospitalist who cared for Mr. Smith after the surgery also mentioned “DVT prophylaxis” in the progress notes, but the hospitalist did not order it nor ensure that anticoagulants were given, the lawsuit claims.

“In a surgery such as this, the standard of care requires both mechanical and chemical anticoagulation,” Dr. Beiermeister wrote in the complaint. “This is especially true after colectomy and with Brayden’s history. Anticoagulants and mechanical anticoagulation are needed to prevent emboli. The medical literature is clear that patients undergoing colorectal surgery as compared to general surgery have a significant increase in the risk of emboli. This is especially true with preexisting inflammation as is present in inflammatory bowel disease.”

A spokesman for St. Rose said the hospital does not comment on pending litigation.

Mr. Smith was a five-time Jeopardy! winner and gained national fame during his championship run. In a statement, Jeopardy! officials said the Jeopardy! family was “heartbroken by the tragic loss of Brayden Smith” and that he “will be missed.”
 

Surgeon must face second trial in stroke suit

A cardiovascular surgeon must face a second trial over claims that he performed an unnecessary surgery that caused a patient’s stroke, the Iowa Supreme Court has ruled.

William McGrew visited a Waterloo, Iowa, cardiovascular surgeon in 2014 after experiencing transient foggy vision in one eye. An ophthalmologist initially diagnosed Mr. McGrew with cataract, but he was referred to the surgeon to rule out other possibilities.

Because of Mr. McGrew’s age (69) and history of hypertension, the cardiovascular surgeon suspected carotid disease and recommended a CT angiogram to further investigate, according to a summary in the Iowa Supreme Court’s opinion.

The CT angiogram was performed at a local imaging center and read by a radiologist who interpreted it as showing 65% stenosis, or narrowing, of the right carotid artery. The surgeon did his own review and interpreted the results as showing 70% stenosis, according to court documents. The surgeon believed that McGrew was at significant risk for stroke and he recommended surgery, specifically a right carotid endarterectomy to remove the plaque from the right carotid artery. He advised McGrew of the surgery’s possible risks, the most common being a stroke.

The endarterectomy initially appeared successful, but the next morning, Mr. McGrew experienced facial droop and weakness on his left side. An MRI and CT scan showed that Mr. McGrew experienced a stroke on the right side of his brain. A CT angiogram showed that his right carotid artery was blocked. The surgeon performed another surgery to remove the carotid artery blockage, but the second surgery did not alleviate Mr. McGrew’s symptoms, according to court documents. Mr. McGrew remains wheelchair-bound, unable to move his left side, and requires nursing home care.

Mr. McGrew and his family later went to a neurologist who analyzed Mr. McGrew’s prior CT angiogram. He interpreted the angiogram as showing only 40% stenosis. The neurologist also asked a neuroradiologist to analyze the CT angiogram, and he assessed the stenosis at 32%. In his opinion, 40% stenosis was not significant to justify an endarterectomy, the neurologist told Mr. McGrew.

Mr. McGrew sued the surgeon and the radiologist in 2016, and later settled with the radiologist. The McGrews claimed that the surgeon negligently misinterpreted the CT angiogram and performed an ill-advised surgery that resulted in a stroke. The McGrews sought damages for pain and suffering, permanent loss of function, loss of income, past and future medical expenses, and loss of consortium.

At trial, attorneys for the surgeon asked the court to limit his and the radiologist’s testimonies, arguing that their opinions were not properly disclosed in expert reports. The trial court granted the motion, and jurors heard only a limited version of the testimony. In addition, some medical records were redacted. A jury found in the surgeon’s favor, deeming him not negligent.

The McGrews appealed. In a Jan. 21, 2022, opinion, the Iowa Supreme Court ruled that the trial court abused its discretion by not allowing the earlier testimonies. Justices said both the neurologist and the neuroradiologist should have been allowed to testify on the applicable standard of care. The district court also abused its discretion in preventing Mr. McGrew from introducing complete versions of the contemporaneous medical records, the court ruled.

Justices reversed the district court’s decision and remanded the case for a new trial.
 

 

 

Court: Patient must pay doc’s legal expenses

A patient must pay a physician about $20,000 in legal expenses after the patient’s malpractice suit was thrown out, an Arizona appeals court has ruled.

Scottsdale plastic surgeon Corwin Martin, MD, performed dental implant surgery on Penny Preszler in February 2012. Following the surgery, Ms. Preszler claimed numbness in her face and mouth, according to the appellate decision. She sued Dr. Martin and his practice for malpractice in 2015.

As the case continued, Ms. Preszler withdrew her first expert and disclosed a new expert. When Ms. Preszler’s second standard of care expert withdrew, she was given 30 days to disclose a new expert. When she failed to do so, Dr. Martin asked the court to dismiss the suit based on Ms. Preszler’s failure to disclose a proper standard of care expert.

She eventually presented a third expert, but Martin’s attorneys argued that the doctor was not a qualified expert under state law because he was board certified in periodontia, while Dr. Martin is board certified in oral and maxillofacial surgery. By this time, the case had gone on for 4 years.

When Ms. Preszler couldn’t come up with a fourth expert who was qualified, the court dismissed the case. The judge also awarded Dr. Martin $19,279.05 for expenses incurred in discovery related to Ms. Preszler’s first expert, attorneys’ fees, and expenses.

Ms. Preszler appealed, arguing that the periodontist was qualified to testify against Martin because he performed dental implant surgeries in the past without the board certification Dr. Martin obtained. In its Jan. 20, 2022, decision, a panel of the Arizona Court of Appeals upheld the decision, ruling that the expert was not qualified to opine. The patient must also pay the physician’s legal expenses as ordered by the lower court.

“[Ms.] Preszler has not shown the superior court abused its discretion in the award issued,” appellate judges wrote. “Three years after [Ms.] Preszler disclosed her first expert witness, that expert withdrew. [Dr.] Martin claimed substantial expenses relating to discovery addressing [Ms.] Preszler’s first expert, which were no longer beneficial given his withdrawal. ... [Ms.] Preszler has not shown that the expenses awarded to [Dr.] Martin were unreasonable or disproportionate to the time and costs expended regarding the withdrawn expert.”

A version of this article first appeared on Medscape.com.

The parents of Jeopardy! winner Brayden Smith are suing a Las Vegas surgeon and a hospitalist for negligence after their son died following a colectomy.

Mr. Smith, who suffered from ulcerative colitis, underwent a colectomy on Jan. 15, 2021, at St. Rose Dominican Hospital–San Martin Campus in Las Vegas. At the time, the 24-year-old man was malnourished, extremely weak, and was having more than 10 bloody bowel movements a day, according to a Jan. 11, 2022, lawsuit filed by Smith’s parents.

The allegations state that, after the procedure, hospital staff did not provide Mr. Smith with anticoagulants and did not administer or suggest that Mr. Smith take anticoagulants upon his discharge on Jan. 19. On Jan. 29, 2021, Mr. Smith collapsed at home and his family called an ambulance. He was taken back to St. Rose where he died from bilateral pulmonary emboli.

Mr. Smith’s legal complaint claims that treatment by Smith’s surgeon, hospitalist, and nursing staff fell below the standard of care because they failed to administer anticoagulants following the surgery. After the surgery, Mr. Smith’s surgeon referenced “DVT/VTE prophylaxis/anticoagulation” in the record and another note read “already ordered,” according to Keith Beiermeister, MD, a colon and rectal surgeon retained by the Smiths’ attorney, Robert E. Murdock. However, the order section of the notes included no specific order for heparin or Lovenox (enoxaparin). A hospitalist who cared for Mr. Smith after the surgery also mentioned “DVT prophylaxis” in the progress notes, but the hospitalist did not order it nor ensure that anticoagulants were given, the lawsuit claims.

“In a surgery such as this, the standard of care requires both mechanical and chemical anticoagulation,” Dr. Beiermeister wrote in the complaint. “This is especially true after colectomy and with Brayden’s history. Anticoagulants and mechanical anticoagulation are needed to prevent emboli. The medical literature is clear that patients undergoing colorectal surgery as compared to general surgery have a significant increase in the risk of emboli. This is especially true with preexisting inflammation as is present in inflammatory bowel disease.”

A spokesman for St. Rose said the hospital does not comment on pending litigation.

Mr. Smith was a five-time Jeopardy! winner and gained national fame during his championship run. In a statement, Jeopardy! officials said the Jeopardy! family was “heartbroken by the tragic loss of Brayden Smith” and that he “will be missed.”
 

Surgeon must face second trial in stroke suit

A cardiovascular surgeon must face a second trial over claims that he performed an unnecessary surgery that caused a patient’s stroke, the Iowa Supreme Court has ruled.

William McGrew visited a Waterloo, Iowa, cardiovascular surgeon in 2014 after experiencing transient foggy vision in one eye. An ophthalmologist initially diagnosed Mr. McGrew with cataract, but he was referred to the surgeon to rule out other possibilities.

Because of Mr. McGrew’s age (69) and history of hypertension, the cardiovascular surgeon suspected carotid disease and recommended a CT angiogram to further investigate, according to a summary in the Iowa Supreme Court’s opinion.

The CT angiogram was performed at a local imaging center and read by a radiologist who interpreted it as showing 65% stenosis, or narrowing, of the right carotid artery. The surgeon did his own review and interpreted the results as showing 70% stenosis, according to court documents. The surgeon believed that McGrew was at significant risk for stroke and he recommended surgery, specifically a right carotid endarterectomy to remove the plaque from the right carotid artery. He advised McGrew of the surgery’s possible risks, the most common being a stroke.

The endarterectomy initially appeared successful, but the next morning, Mr. McGrew experienced facial droop and weakness on his left side. An MRI and CT scan showed that Mr. McGrew experienced a stroke on the right side of his brain. A CT angiogram showed that his right carotid artery was blocked. The surgeon performed another surgery to remove the carotid artery blockage, but the second surgery did not alleviate Mr. McGrew’s symptoms, according to court documents. Mr. McGrew remains wheelchair-bound, unable to move his left side, and requires nursing home care.

Mr. McGrew and his family later went to a neurologist who analyzed Mr. McGrew’s prior CT angiogram. He interpreted the angiogram as showing only 40% stenosis. The neurologist also asked a neuroradiologist to analyze the CT angiogram, and he assessed the stenosis at 32%. In his opinion, 40% stenosis was not significant to justify an endarterectomy, the neurologist told Mr. McGrew.

Mr. McGrew sued the surgeon and the radiologist in 2016, and later settled with the radiologist. The McGrews claimed that the surgeon negligently misinterpreted the CT angiogram and performed an ill-advised surgery that resulted in a stroke. The McGrews sought damages for pain and suffering, permanent loss of function, loss of income, past and future medical expenses, and loss of consortium.

At trial, attorneys for the surgeon asked the court to limit his and the radiologist’s testimonies, arguing that their opinions were not properly disclosed in expert reports. The trial court granted the motion, and jurors heard only a limited version of the testimony. In addition, some medical records were redacted. A jury found in the surgeon’s favor, deeming him not negligent.

The McGrews appealed. In a Jan. 21, 2022, opinion, the Iowa Supreme Court ruled that the trial court abused its discretion by not allowing the earlier testimonies. Justices said both the neurologist and the neuroradiologist should have been allowed to testify on the applicable standard of care. The district court also abused its discretion in preventing Mr. McGrew from introducing complete versions of the contemporaneous medical records, the court ruled.

Justices reversed the district court’s decision and remanded the case for a new trial.
 

 

 

Court: Patient must pay doc’s legal expenses

A patient must pay a physician about $20,000 in legal expenses after the patient’s malpractice suit was thrown out, an Arizona appeals court has ruled.

Scottsdale plastic surgeon Corwin Martin, MD, performed dental implant surgery on Penny Preszler in February 2012. Following the surgery, Ms. Preszler claimed numbness in her face and mouth, according to the appellate decision. She sued Dr. Martin and his practice for malpractice in 2015.

As the case continued, Ms. Preszler withdrew her first expert and disclosed a new expert. When Ms. Preszler’s second standard of care expert withdrew, she was given 30 days to disclose a new expert. When she failed to do so, Dr. Martin asked the court to dismiss the suit based on Ms. Preszler’s failure to disclose a proper standard of care expert.

She eventually presented a third expert, but Martin’s attorneys argued that the doctor was not a qualified expert under state law because he was board certified in periodontia, while Dr. Martin is board certified in oral and maxillofacial surgery. By this time, the case had gone on for 4 years.

When Ms. Preszler couldn’t come up with a fourth expert who was qualified, the court dismissed the case. The judge also awarded Dr. Martin $19,279.05 for expenses incurred in discovery related to Ms. Preszler’s first expert, attorneys’ fees, and expenses.

Ms. Preszler appealed, arguing that the periodontist was qualified to testify against Martin because he performed dental implant surgeries in the past without the board certification Dr. Martin obtained. In its Jan. 20, 2022, decision, a panel of the Arizona Court of Appeals upheld the decision, ruling that the expert was not qualified to opine. The patient must also pay the physician’s legal expenses as ordered by the lower court.

“[Ms.] Preszler has not shown the superior court abused its discretion in the award issued,” appellate judges wrote. “Three years after [Ms.] Preszler disclosed her first expert witness, that expert withdrew. [Dr.] Martin claimed substantial expenses relating to discovery addressing [Ms.] Preszler’s first expert, which were no longer beneficial given his withdrawal. ... [Ms.] Preszler has not shown that the expenses awarded to [Dr.] Martin were unreasonable or disproportionate to the time and costs expended regarding the withdrawn expert.”

A version of this article first appeared on Medscape.com.

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'The whitest specialty,' revisited

Article Type
Changed
Tue, 02/01/2022 - 13:41

A recent STAT article by Usha Lee McFarling identified orthopedic surgery as “the whitest specialty.” That’s a problem many, perhaps most, orthopedic surgeons are aware of. But seeing it stated so bluntly is jolting. It’s disconcerting to think that the orthopedic community is making so little progress toward achieving the principal ideal articulated in our country’s fundamental declaration of moral values: that all people are created equal and that they have inalienable rights – in our case, that everyone, Black, brown, as well as White, has the right to the same high level of medical care.

Unfortunately, as study after study has shown, minorities do not enjoy the right to equitable care. Instead, they are subject to disparities in treatment and outcomes that speak to the prejudices that are built into the health care system and are present – sometimes consciously, but most often subconsciously – in the minds of physicians. One important contributing element to these disparities is the paucity of minority practitioners. Studies have also shown that Black patients, for example, respond better to Black physicians, who so often share a psychological and cultural sympathy unavailable to most White physicians. It’s for that reason that being identified as “the whitest specialty” is so immensely troubling.

In researching her STAT article, Ms. McFarling spoke with American Academy of Orthopaedic Surgeons leaders, practicing surgeons, residents, and med students about the dearth of minority and female orthopedic surgeons. What she heard was perplexity and frustration about why better progress hasn’t been made toward correcting the gross underrepresentation of everyone other than White men. The AAOS, she noted, was one of the first specialties to recognize the lack of diversity and over the years has put in great effort to address the problem, creating task forces, committees, and diversity awards and sponsoring conferences and discussions. Yet progress has been glacial, at best.

From her respondents, Ms. McFarling heard an array of reasons for this. Black, Hispanic, and Native American persons are underrepresented in medical schools, so the pool of potential applicants for orthopedic residencies is shallow to begin with. STEM studies are notoriously inadequate in poorer primary and secondary schools, in which so many minority students are educated. The MCAT and USMLE Step 1 test, which play a role in acceptance to residencies, have been shown to be biased. The specialty has few Black or brown role models and, consequently, few advocates and a lack of mentorship. Overt bias may be fairly rare (though microaggressions are still a common and ongoing problem), but most minority and female orthopedic surgeons feel strongly that implicit or subconscious bias is entrenched and works against acceptance to residencies, success in residencies, and advancement in the field.

One of this article’s authors (AW) saw all these factors at work as a resident, then as an admissions committee member at both Yale and Harvard. But the fact is that other medical specialties face exactly these problems and barriers, and yet have been substantially more successful in overcoming them.

What seems to be distinctive about orthopedics is that the mindset which perpetuated (and still perpetuates) the old, lily-white, male predominance in medicine seems stronger, more ingrained, and more resistant to change than it is among physicians in other specialties. In this regard, Kristy Weber, MD, the first female president of the AAOS, told Ms. McFarling that the critical first step to bringing in more women or people of color is changing the culture. There seems to be a consensus about that.

So, what does that mean, given that the AAOS has made serious efforts in that regard that have clearly been less than effective?

The answer, as we see it, is first – to not give in to frustration. The time frames involved in changing customary states of mind are typically elongated, and the deeper the habituation, the longer transformation takes. Deep changes always mean a long, hard slog. For transformations of this sort to take place, the requirements are a general agreement on the value of the transformation, exposure to the destructive consequences of the customary modus operandi, and persuasion for why change needs to happen.

In orthopedics, the first requirement has been met. The AAOS espouses diversity and inclusion as a high-level value. In terms of the second two requirements – exposure and persuasion – orthopedic surgeons have been witness to events, campaigns, conferences, et cetera. But these have not been enough, which means that efforts need to be focused, enlarged, sustained, determined, and innovative.

Does the orthopedic surgery community have the ability to do that?

The answer is: Yes, it does.

Currently the orthopedic surgeon community boasts a number of organizations, groups, and individuals pushing for change, in addition to the AAOS’s Diversity Advisory Board. The predominantly African American J. Robert Gladden Orthopaedic Society, the Ruth Jackson Orthopaedic Society of female orthopedic physicians, and the Association of Latino Orthopaedic Surgeons are all energetic advocates, as is Nth Dimensions, the Perry Initiative, and various ad hoc and individual endeavors.

These are all strong proponents for their own groups in their own way. But history has shown in so many cases that concerted rather than individual action empowers advocacy, and what orthopedic surgery needs in its current situation of gross underrepresentation of minorities and women is an enhanced campaign to raise awareness and redouble persuasion.

One of many examples of the power of collective action is the Association of Minority Health Professions Schools founded by Dr. Louis Sullivan in 1977.* Dr. Sullivan (later secretary of the Department of Health & Human Services) was at that time the founding dean of Morehouse School of Medicine. Morehouse had been launched on a shoestring and needed funding urgently. Other Black health schools, such as Meharry Medical College and Tuskegee College of Veterinary Medicine, were in even more pressing financial need. The coalition of schools that Dr. Sullivan organized became a powerful force in Congress and the National Institutes of Health, magnitudes more effective in raising funds from government and other sources than the best individual efforts of the separate institutions.

Dr. Sullivan’s association is only one of a multitude of historical examples of the effectiveness of unified action. AAOS currently has no single officer charged with bringing together the efforts of the change assets that already exist. It could, perhaps should, have someone in that position. AAOS could invest that same office with a mandate to survey the other medical specialties and bring to bear the most effective diversity, equity, and inclusion (DEI) practices in their arsenals.

Finally, despite the attention AAOS has brought to DEI needs, a look at the organization’s strategic goals, its core values, and its “key enablers” finds not a single mention of diversity or inclusion. Given the country’s current focus on the need for equality, given the poor performance of the orthopedic surgery specialty in terms of inclusion, the obvious question is: Should there not be an official declaration positing diversity as a primary AAOS desideratum?

There is recent precedent for this in the American College of Physicians/American Board of Internal Medicine’s Physician Charter on Professionalism, which includes “social justice” as a primary goal of medical practice. This highlights and reinforces the humanitarian strivings of the profession. In light of the paralysis illuminated by Ms. McFarling’s STAT article, a clear, concise declaration by the AAOS of the value and need for DEI as a central component of the organization’s values should be high on the AAOS order of business. A commitment in that form would serve as a powerful catalyst for bringing orthopedic surgery into step with its sister specialties, as well as affirming the core egalitarian principle that underlies all of medical care.

Dr. White is the Ellen and Melvin Gordon Distinguished Professor of Medical Education and Professor of Orthopedic Surgery at Harvard Medical School, Boston. Dr. Chanoff is a founding board member of the Augustus A. White III Institute for Healthcare Equity. Neither Dr. White nor Dr. Chanoff reported any conflicts of interest. A version of this article first appeared on Medscape.com.

Correction, 2/1/22: An earlier version of this article omitted the title of "Dr." before Dr. Louis Sullivan's name.

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A recent STAT article by Usha Lee McFarling identified orthopedic surgery as “the whitest specialty.” That’s a problem many, perhaps most, orthopedic surgeons are aware of. But seeing it stated so bluntly is jolting. It’s disconcerting to think that the orthopedic community is making so little progress toward achieving the principal ideal articulated in our country’s fundamental declaration of moral values: that all people are created equal and that they have inalienable rights – in our case, that everyone, Black, brown, as well as White, has the right to the same high level of medical care.

Unfortunately, as study after study has shown, minorities do not enjoy the right to equitable care. Instead, they are subject to disparities in treatment and outcomes that speak to the prejudices that are built into the health care system and are present – sometimes consciously, but most often subconsciously – in the minds of physicians. One important contributing element to these disparities is the paucity of minority practitioners. Studies have also shown that Black patients, for example, respond better to Black physicians, who so often share a psychological and cultural sympathy unavailable to most White physicians. It’s for that reason that being identified as “the whitest specialty” is so immensely troubling.

In researching her STAT article, Ms. McFarling spoke with American Academy of Orthopaedic Surgeons leaders, practicing surgeons, residents, and med students about the dearth of minority and female orthopedic surgeons. What she heard was perplexity and frustration about why better progress hasn’t been made toward correcting the gross underrepresentation of everyone other than White men. The AAOS, she noted, was one of the first specialties to recognize the lack of diversity and over the years has put in great effort to address the problem, creating task forces, committees, and diversity awards and sponsoring conferences and discussions. Yet progress has been glacial, at best.

From her respondents, Ms. McFarling heard an array of reasons for this. Black, Hispanic, and Native American persons are underrepresented in medical schools, so the pool of potential applicants for orthopedic residencies is shallow to begin with. STEM studies are notoriously inadequate in poorer primary and secondary schools, in which so many minority students are educated. The MCAT and USMLE Step 1 test, which play a role in acceptance to residencies, have been shown to be biased. The specialty has few Black or brown role models and, consequently, few advocates and a lack of mentorship. Overt bias may be fairly rare (though microaggressions are still a common and ongoing problem), but most minority and female orthopedic surgeons feel strongly that implicit or subconscious bias is entrenched and works against acceptance to residencies, success in residencies, and advancement in the field.

One of this article’s authors (AW) saw all these factors at work as a resident, then as an admissions committee member at both Yale and Harvard. But the fact is that other medical specialties face exactly these problems and barriers, and yet have been substantially more successful in overcoming them.

What seems to be distinctive about orthopedics is that the mindset which perpetuated (and still perpetuates) the old, lily-white, male predominance in medicine seems stronger, more ingrained, and more resistant to change than it is among physicians in other specialties. In this regard, Kristy Weber, MD, the first female president of the AAOS, told Ms. McFarling that the critical first step to bringing in more women or people of color is changing the culture. There seems to be a consensus about that.

So, what does that mean, given that the AAOS has made serious efforts in that regard that have clearly been less than effective?

The answer, as we see it, is first – to not give in to frustration. The time frames involved in changing customary states of mind are typically elongated, and the deeper the habituation, the longer transformation takes. Deep changes always mean a long, hard slog. For transformations of this sort to take place, the requirements are a general agreement on the value of the transformation, exposure to the destructive consequences of the customary modus operandi, and persuasion for why change needs to happen.

In orthopedics, the first requirement has been met. The AAOS espouses diversity and inclusion as a high-level value. In terms of the second two requirements – exposure and persuasion – orthopedic surgeons have been witness to events, campaigns, conferences, et cetera. But these have not been enough, which means that efforts need to be focused, enlarged, sustained, determined, and innovative.

Does the orthopedic surgery community have the ability to do that?

The answer is: Yes, it does.

Currently the orthopedic surgeon community boasts a number of organizations, groups, and individuals pushing for change, in addition to the AAOS’s Diversity Advisory Board. The predominantly African American J. Robert Gladden Orthopaedic Society, the Ruth Jackson Orthopaedic Society of female orthopedic physicians, and the Association of Latino Orthopaedic Surgeons are all energetic advocates, as is Nth Dimensions, the Perry Initiative, and various ad hoc and individual endeavors.

These are all strong proponents for their own groups in their own way. But history has shown in so many cases that concerted rather than individual action empowers advocacy, and what orthopedic surgery needs in its current situation of gross underrepresentation of minorities and women is an enhanced campaign to raise awareness and redouble persuasion.

One of many examples of the power of collective action is the Association of Minority Health Professions Schools founded by Dr. Louis Sullivan in 1977.* Dr. Sullivan (later secretary of the Department of Health & Human Services) was at that time the founding dean of Morehouse School of Medicine. Morehouse had been launched on a shoestring and needed funding urgently. Other Black health schools, such as Meharry Medical College and Tuskegee College of Veterinary Medicine, were in even more pressing financial need. The coalition of schools that Dr. Sullivan organized became a powerful force in Congress and the National Institutes of Health, magnitudes more effective in raising funds from government and other sources than the best individual efforts of the separate institutions.

Dr. Sullivan’s association is only one of a multitude of historical examples of the effectiveness of unified action. AAOS currently has no single officer charged with bringing together the efforts of the change assets that already exist. It could, perhaps should, have someone in that position. AAOS could invest that same office with a mandate to survey the other medical specialties and bring to bear the most effective diversity, equity, and inclusion (DEI) practices in their arsenals.

Finally, despite the attention AAOS has brought to DEI needs, a look at the organization’s strategic goals, its core values, and its “key enablers” finds not a single mention of diversity or inclusion. Given the country’s current focus on the need for equality, given the poor performance of the orthopedic surgery specialty in terms of inclusion, the obvious question is: Should there not be an official declaration positing diversity as a primary AAOS desideratum?

There is recent precedent for this in the American College of Physicians/American Board of Internal Medicine’s Physician Charter on Professionalism, which includes “social justice” as a primary goal of medical practice. This highlights and reinforces the humanitarian strivings of the profession. In light of the paralysis illuminated by Ms. McFarling’s STAT article, a clear, concise declaration by the AAOS of the value and need for DEI as a central component of the organization’s values should be high on the AAOS order of business. A commitment in that form would serve as a powerful catalyst for bringing orthopedic surgery into step with its sister specialties, as well as affirming the core egalitarian principle that underlies all of medical care.

Dr. White is the Ellen and Melvin Gordon Distinguished Professor of Medical Education and Professor of Orthopedic Surgery at Harvard Medical School, Boston. Dr. Chanoff is a founding board member of the Augustus A. White III Institute for Healthcare Equity. Neither Dr. White nor Dr. Chanoff reported any conflicts of interest. A version of this article first appeared on Medscape.com.

Correction, 2/1/22: An earlier version of this article omitted the title of "Dr." before Dr. Louis Sullivan's name.

A recent STAT article by Usha Lee McFarling identified orthopedic surgery as “the whitest specialty.” That’s a problem many, perhaps most, orthopedic surgeons are aware of. But seeing it stated so bluntly is jolting. It’s disconcerting to think that the orthopedic community is making so little progress toward achieving the principal ideal articulated in our country’s fundamental declaration of moral values: that all people are created equal and that they have inalienable rights – in our case, that everyone, Black, brown, as well as White, has the right to the same high level of medical care.

Unfortunately, as study after study has shown, minorities do not enjoy the right to equitable care. Instead, they are subject to disparities in treatment and outcomes that speak to the prejudices that are built into the health care system and are present – sometimes consciously, but most often subconsciously – in the minds of physicians. One important contributing element to these disparities is the paucity of minority practitioners. Studies have also shown that Black patients, for example, respond better to Black physicians, who so often share a psychological and cultural sympathy unavailable to most White physicians. It’s for that reason that being identified as “the whitest specialty” is so immensely troubling.

In researching her STAT article, Ms. McFarling spoke with American Academy of Orthopaedic Surgeons leaders, practicing surgeons, residents, and med students about the dearth of minority and female orthopedic surgeons. What she heard was perplexity and frustration about why better progress hasn’t been made toward correcting the gross underrepresentation of everyone other than White men. The AAOS, she noted, was one of the first specialties to recognize the lack of diversity and over the years has put in great effort to address the problem, creating task forces, committees, and diversity awards and sponsoring conferences and discussions. Yet progress has been glacial, at best.

From her respondents, Ms. McFarling heard an array of reasons for this. Black, Hispanic, and Native American persons are underrepresented in medical schools, so the pool of potential applicants for orthopedic residencies is shallow to begin with. STEM studies are notoriously inadequate in poorer primary and secondary schools, in which so many minority students are educated. The MCAT and USMLE Step 1 test, which play a role in acceptance to residencies, have been shown to be biased. The specialty has few Black or brown role models and, consequently, few advocates and a lack of mentorship. Overt bias may be fairly rare (though microaggressions are still a common and ongoing problem), but most minority and female orthopedic surgeons feel strongly that implicit or subconscious bias is entrenched and works against acceptance to residencies, success in residencies, and advancement in the field.

One of this article’s authors (AW) saw all these factors at work as a resident, then as an admissions committee member at both Yale and Harvard. But the fact is that other medical specialties face exactly these problems and barriers, and yet have been substantially more successful in overcoming them.

What seems to be distinctive about orthopedics is that the mindset which perpetuated (and still perpetuates) the old, lily-white, male predominance in medicine seems stronger, more ingrained, and more resistant to change than it is among physicians in other specialties. In this regard, Kristy Weber, MD, the first female president of the AAOS, told Ms. McFarling that the critical first step to bringing in more women or people of color is changing the culture. There seems to be a consensus about that.

So, what does that mean, given that the AAOS has made serious efforts in that regard that have clearly been less than effective?

The answer, as we see it, is first – to not give in to frustration. The time frames involved in changing customary states of mind are typically elongated, and the deeper the habituation, the longer transformation takes. Deep changes always mean a long, hard slog. For transformations of this sort to take place, the requirements are a general agreement on the value of the transformation, exposure to the destructive consequences of the customary modus operandi, and persuasion for why change needs to happen.

In orthopedics, the first requirement has been met. The AAOS espouses diversity and inclusion as a high-level value. In terms of the second two requirements – exposure and persuasion – orthopedic surgeons have been witness to events, campaigns, conferences, et cetera. But these have not been enough, which means that efforts need to be focused, enlarged, sustained, determined, and innovative.

Does the orthopedic surgery community have the ability to do that?

The answer is: Yes, it does.

Currently the orthopedic surgeon community boasts a number of organizations, groups, and individuals pushing for change, in addition to the AAOS’s Diversity Advisory Board. The predominantly African American J. Robert Gladden Orthopaedic Society, the Ruth Jackson Orthopaedic Society of female orthopedic physicians, and the Association of Latino Orthopaedic Surgeons are all energetic advocates, as is Nth Dimensions, the Perry Initiative, and various ad hoc and individual endeavors.

These are all strong proponents for their own groups in their own way. But history has shown in so many cases that concerted rather than individual action empowers advocacy, and what orthopedic surgery needs in its current situation of gross underrepresentation of minorities and women is an enhanced campaign to raise awareness and redouble persuasion.

One of many examples of the power of collective action is the Association of Minority Health Professions Schools founded by Dr. Louis Sullivan in 1977.* Dr. Sullivan (later secretary of the Department of Health & Human Services) was at that time the founding dean of Morehouse School of Medicine. Morehouse had been launched on a shoestring and needed funding urgently. Other Black health schools, such as Meharry Medical College and Tuskegee College of Veterinary Medicine, were in even more pressing financial need. The coalition of schools that Dr. Sullivan organized became a powerful force in Congress and the National Institutes of Health, magnitudes more effective in raising funds from government and other sources than the best individual efforts of the separate institutions.

Dr. Sullivan’s association is only one of a multitude of historical examples of the effectiveness of unified action. AAOS currently has no single officer charged with bringing together the efforts of the change assets that already exist. It could, perhaps should, have someone in that position. AAOS could invest that same office with a mandate to survey the other medical specialties and bring to bear the most effective diversity, equity, and inclusion (DEI) practices in their arsenals.

Finally, despite the attention AAOS has brought to DEI needs, a look at the organization’s strategic goals, its core values, and its “key enablers” finds not a single mention of diversity or inclusion. Given the country’s current focus on the need for equality, given the poor performance of the orthopedic surgery specialty in terms of inclusion, the obvious question is: Should there not be an official declaration positing diversity as a primary AAOS desideratum?

There is recent precedent for this in the American College of Physicians/American Board of Internal Medicine’s Physician Charter on Professionalism, which includes “social justice” as a primary goal of medical practice. This highlights and reinforces the humanitarian strivings of the profession. In light of the paralysis illuminated by Ms. McFarling’s STAT article, a clear, concise declaration by the AAOS of the value and need for DEI as a central component of the organization’s values should be high on the AAOS order of business. A commitment in that form would serve as a powerful catalyst for bringing orthopedic surgery into step with its sister specialties, as well as affirming the core egalitarian principle that underlies all of medical care.

Dr. White is the Ellen and Melvin Gordon Distinguished Professor of Medical Education and Professor of Orthopedic Surgery at Harvard Medical School, Boston. Dr. Chanoff is a founding board member of the Augustus A. White III Institute for Healthcare Equity. Neither Dr. White nor Dr. Chanoff reported any conflicts of interest. A version of this article first appeared on Medscape.com.

Correction, 2/1/22: An earlier version of this article omitted the title of "Dr." before Dr. Louis Sullivan's name.

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