User login
Acute STEMI During the COVID-19 Pandemic at a Regional Hospital: Incidence, Clinical Characteristics, and Outcomes
From the Department of Medicine, Medical College of Georgia at the Augusta University-University of Georgia Medical Partnership, Athens, GA (Syed H. Ali, Syed Hyder, and Dr. Murrow), and the Department of Cardiology, Piedmont Heart Institute, Piedmont Athens Regional, Athens, GA (Dr. Murrow and Mrs. Davis).
Abstract
Objectives: The aim of this study was to describe the characteristics and in-hospital outcomes of patients with acute ST-segment elevation myocardial infarction (STEMI) during the early COVID-19 pandemic at Piedmont Athens Regional (PAR), a 330-bed tertiary referral center in Northeast Georgia.
Methods: A retrospective study was conducted at PAR to evaluate patients with acute STEMI admitted over an 8-week period during the initial COVID-19 outbreak. This study group was compared to patients admitted during the corresponding period in 2019. The primary endpoint of this study was defined as a composite of sustained ventricular arrhythmia, congestive heart failure (CHF) with pulmonary congestion, and/or in-hospital mortality.
Results: This study cohort was composed of 64 patients with acute STEMI; 30 patients (46.9%) were hospitalized during the COVID-19 pandemic. Patients with STEMI in both the COVID-19 and control groups had similar comorbidities, Killip classification score, and clinical presentations. The median (interquartile range) time from symptom onset to reperfusion (total ischemic time) increased from 99.5 minutes (84.8-132) in 2019 to 149 minutes (96.3-231.8; P = .032) in 2020. Hospitalization during the COVID-19 period was associated with an increased risk for combined in-hospital outcome (odds ratio, 3.96; P = .046).
Conclusion: Patients with STEMI admitted during the first wave of the COVID-19 outbreak experienced longer total ischemic time and increased risk for combined in-hospital outcomes compared to patients admitted during the corresponding period in 2019.
Keywords: myocardial infarction, acute coronary syndrome, hospitalization, outcomes.
The emergence of the SARS-Cov-2 virus in December 2019 caused a worldwide shift in resource allocation and the restructuring of health care systems within the span of a few months. With the rapid spread of infection, the World Health Organization officially declared a pandemic in March 2020. The pandemic led to the deferral and cancellation of in-person patient visits, routine diagnostic studies, and nonessential surgeries and procedures. This response occurred secondary to a joint effort to reduce transmission via stay-at-home mandates and appropriate social distancing.1
Alongside the reduction in elective procedures and health care visits, significant reductions in hospitalization rates due to decreases in acute ST-segment elevation myocardial infarction (STEMI) and catheterization laboratory utilization have been reported in many studies from around the world.2-7 Comprehensive data demonstrating the impact of the COVID-19 pandemic on acute STEMI patient characteristics, clinical presentation, and in-hospital outcomes are lacking. Although patients with previously diagnosed cardiovascular disease are more likely to encounter worse outcomes in the setting of COVID-19, there may also be an indirect impact of the pandemic on high-risk patients, including those without the infection.8 Several theories have been hypothesized to explain this phenomenon. One theory postulates that the fear of contracting the virus during hospitalization is great enough to prevent patients from seeking care.2 Another theory suggests that the increased utilization of telemedicine prevents exacerbation of chronic conditions and the need for hospitalization.9 Contrary to this trend, previous studies have shown an increased incidence of acute STEMI following stressful events such as natural disasters.10
The aim of this study was to describe trends pertaining to clinical characteristics and in-hospital outcomes of patients with acute STEMI during the early COVID-19 pandemic at Piedmont Athens Regional (PAR), a 330-bed tertiary referral center in Northeast Georgia.
Methods
A retrospective cohort study was conducted at PAR to evaluate patients with STEMI admitted to the cardiovascular intensive care unit over an 8-week period (March 5 to May 5, 2020) during the COVID-19 outbreak. COVID-19 was declared a national emergency on March 13, 2020, in the United States. The institutional review board at PAR approved the study; the need for individual consent was waived under the condition that participant data would undergo de-identification and be strictly safeguarded.
Data Collection
Because there are seasonal variations in cardiovascular admissions, patient data from a control period (March 9 to May 9, 2019) were obtained to compare with data from the 2020 period. The number of patients with the diagnosis of acute STEMI during the COVID-19 period was recorded. Demographic data, clinical characteristics, and primary angiographic findings were gathered for all patients. Time from symptom onset to hospital admission and time from hospital admission to reperfusion (defined as door-to-balloon time) were documented for each patient. Killip classification was used to assess patients’ clinical status on admission. Length of stay was determined as days from hospital admission to discharge or death (if occurring during the same hospitalization).
Adverse in-hospital complications were also recorded. These were selected based on inclusion of the following categories of acute STEMI complications: ischemic, mechanical, arrhythmic, embolic, and inflammatory. The following complications occurred in our patient cohort: sustained ventricular arrhythmia, congestive heart failure (CHF) defined as congestion requiring intravenous diuretics, re-infarction, mechanical complications (free-wall rupture, ventricular septal defect, or mitral regurgitation), second- or third-degree atrioventricular block, atrial fibrillation, stroke, mechanical ventilation, major bleeding, pericarditis, cardiogenic shock, cardiac arrest, and in-hospital mortality. The primary outcome of this study was defined as a composite of sustained ventricular arrhythmia, CHF with congestion requiring intravenous diuretics, and/or in-hospital mortality. Ventricular arrythmia and CHF were included in the composite outcome because they are defined as the 2 most common causes of sudden cardiac death following acute STEMI.11,12
Statistical Analysis
Normally distributed continuous variables and categorical variables were compared using the paired t-test. A 2-sided P value <.05 was considered to be statistically significant. Mean admission rates for acute STEMI hospitalizations were determined by dividing the number of admissions by the number of days in each time period. The daily rate of COVID-19 cases per 100,000 individuals was obtained from the Centers for Disease Control and Prevention COVID-19 database. All data analyses were performed using Microsoft Excel.
Results
The study cohort consisted of 64 patients, of whom 30 (46.9%) were hospitalized between March 5 and May 5, 2020, and 34 (53.1%) who were admitted during the analogous time period in 2019. This reflected a 6% decrease in STEMI admissions at PAR in the COVID-19 cohort.
Acute STEMI Hospitalization Rates and COVID-19 Incidence
The mean daily acute STEMI admission rate was 0.50 during the study period compared to 0.57 during the control period. During the study period in 2020 in the state of Georgia, the daily rate of newly confirmed COVID-19 cases ranged from 0.194 per 100,000 on March 5 to 8.778 per 100,000 on May 5. Results of COVID-19 testing were available for 9 STEMI patients, and of these 0 tests were positive.
Baseline Characteristics
Baseline characteristics of the acute STEMI cohorts are presented in Table 1. Approximately 75% were male; median (interquartile range [IQR]) age was 60 (51-72) years. There were no significant differences in age and gender between the study periods. Three-quarters of patients had a history of hypertension, and 87.5% had a history of dyslipidemia. There was no significant difference in baseline comorbidity profiles between the 2 study periods; therefore, our sample populations shared similar characteristics.
Clinical Presentation
Significant differences were observed regarding the time intervals of STEMI patients in the COVID-19 period and the control period (Table 2). Median time from symptom onset to hospital admission (patient delay) was extended from 57.5 minutes (IQR, 40.3-106) in 2019 to 93 minutes (IQR, 48.8-132) in 2020; however, this difference was not statistically significant (P = .697). Median time from hospital admission to reperfusion (system delay) was prolonged from 45 minutes (IQR, 28-61) in 2019 to 78 minutes (IQR, 50-110) in 2020 (P < .001). Overall time from symptom onset to reperfusion (total ischemic time) increased from 99.5 minutes (IQR, 84.8-132) in 2019 to 149 minutes (IQR, 96.3-231.8) in 2020 (P = .032).
Regarding mode of transportation, 23.5% of patients in 2019 were walk-in admissions to the emergency department. During the COVID-19 period, walk-in admissions decreased to 6.7% (P = .065). There were no significant differences between emergency medical service, transfer, or in-patient admissions for STEMI cases between the 2 study periods.
Killip classification scores were calculated for all patients on admission; 90.6% of patients were classified as Killip Class 1. There was no significant difference between hemodynamic presentations during the COVID-19 period compared to the control period.
Angiographic Data
Overall, 53 (82.8%) patients admitted with acute STEMI underwent coronary angiography during their hospital stay. The proportion of patients who underwent primary reperfusion was greater in the control period than in the COVID-19 period (85.3% vs 80%; P = .582). Angiographic characteristics and findings were similar between the 2 study groups (Table 2).
In-Hospital Outcomes
In-hospital outcome data were available for all patients. As shown in Table 3, hospitalization during the COVID-19 period was independently associated with an increased risk for combined in-hospital outcome (odds ratio, 3.96; P = .046). The rate of in-hospital mortality was greater in the COVID-19 period (P = .013). We found no significant difference when comparing secondary outcomes from admissions during the COVID-19 period and the control period in 2019. For the 5 patients who died during the study period, the primary diagnosis at death was acute STEMI complicated by CHF (3 patients) or cardiogenic shock (2 patients).
Discussion
This single-center retrospective study at PAR looks at the impact of COVID-19 on hospitalizations for acute STEMI during the initial peak of the pandemic. The key findings of this study show a significant increase in ischemic time parameters (symptom onset to reperfusion, hospital admission to reperfusion), in-hospital mortality, and combined in-hospital outcomes.
There was a 49.5-minute increase in total ischemic time noted in this study (P = .032). Though there was a numerical increase in time of symptom onset to hospital admission by 23.5 minutes, this difference was not statistically significant (P = .697). However, this study observed a statistically significant 33-minute increase in ischemic time from hospital admission to reperfusion (P < .001). Multiple studies globally have found a similar increase in total ischemic times, including those conducted in China and Europe.13-15 Every level of potential delay must be considered, including pre-hospital, triage and emergency department, and/or reperfusion team. Pre-hospital sources of delays that have been suggested include “stay-at-home” orders and apprehension to seek medical care due to concern about contracting the virus or overwhelming the health care facilities. There was a clinically significant 4-fold decrease in the number of walk-in acute STEMI cases in the study period. In 2019, there were 8 walk-in cases compared to 2 cases in 2020 (P = .065). However, this change was not statistically significant. In-hospital/systemic sources of delays have been mentioned in other studies; they include increased time taken to rule out COVID-19 (nasopharyngeal swab/chest x-ray) and increased time due to the need for intensive gowning and gloving procedures by staff. It was difficult to objectively determine the sources of system delay by the reperfusion team due to a lack of quantitative data.
In the current study, we found a significant increase in in-hospital mortality during the COVID-19 period compared to a parallel time frame in 2019. This finding is contrary to a multicenter study from Spain that reported no difference in in-hospital outcomes or mortality rates among all acute coronary syndrome cases.16 The worsening outcomes and prognosis may simply be a result of increased ischemic time; however, the virus that causes COVID-19 itself may play a role as well. Studies have found that SARS-Cov-2 infection places patients at greater risk for cardiovascular conditions such as hypercoagulability, myocarditis, and arrhythmias.17 In our study, however, there were no acute STEMI patients who tested positive for COVID-19. Therefore, we cannot discuss the impact of increased thrombus burden in patients with COVID-19. Piedmont Healthcare published a STEMI treatment protocol in May 2020 that advised increased use of tissue plasminogen activator (tPA) in COVID-19-positive cases; during the study period, however, there were no occasions when tPA use was deemed appropriate based on clinical judgment.
Our findings align with previous studies that describe an increase in combined in-hospital adverse outcomes during the COVID-19 era. Previous studies detected a higher rate of complications in the COVID-19 cohort, but in the current study, the adverse in-hospital course is unrelated to underlying infection.18,19 This study reports a higher incidence of major in-hospital outcomes, including a 65% increase in the rate of combined in-hospital outcomes, which is similar to a multicenter study conducted in Israel.19 There was a 2.3-fold numerical increase in sustained ventricular arrhythmias and a 2.5-fold numerical increase in the incidence of cardiac arrest in the study period. This phenomenon was observed despite a similar rate of reperfusion procedures in both groups.
Acute STEMI is a highly fatal condition with an incidence of 8.5 in 10,000 annually in the United States. While studies across the world have shown a 25% to 40% reduction in the rate of hospitalized acute coronary syndrome cases during the COVID-19 pandemic, the decrease from 34 to 30 STEMI admissions at PAR is not statistically significant.20 Possible reasons for the reduction globally include increased out-of-hospital mortality and decreased incidence of acute STEMI across the general population as a result of improved access to telemedicine or decreased levels of life stressors.20
In summary, there was an increase in ischemic time to reperfusion, in-hospital mortality, and combined in-hospital outcomes for acute STEMI patients at PAR during the COVID period.
Limitations
This study has several limitations. This is a single-center study, so the sample size is small and may not be generalizable to a larger population. This is a retrospective observational study, so causation cannot be inferred. This study analyzed ischemic time parameters as average rates over time rather than in an interrupted time series. Post-reperfusion outcomes were limited to hospital stay. Post-hospital follow-up would provide a better picture of the effects of STEMI intervention. There is no account of patients who died out-of-hospital secondary to acute STEMI. COVID-19 testing was not introduced until midway in our study period. Therefore, we cannot rule out the possibility of the SARS-Cov-2 virus inciting acute STEMI and subsequently leading to worse outcomes and poor prognosis.
Conclusions
This study provides an analysis of the incidence, characteristics, and clinical outcomes of patients presenting with acute STEMI during the early period of the COVID-19 pandemic. In-hospital mortality and ischemic time to reperfusion increased while combined in-hospital outcomes worsened.
Acknowledgment: The authors thank Piedmont Athens Regional IRB for approving this project and allowing access to patient data.
Corresponding author: Syed H. Ali; Department of Medicine, Medical College of Georgia at the Augusta University-University of Georgia Medical Partnership, 30606, Athens, GA; [email protected]
Disclosures: None reported.
doi:10.12788/jcom.0085
1. Bhatt AS, Moscone A, McElrath EE, et al. Fewer hospitalizations for acute cardiovascular conditions during the COVID-19 pandemic. J Am Coll Cardiol. 2020;76(3):280-288. doi:10.1016/j.jacc.2020.05.038
2. Metzler B, Siostrzonek P, Binder RK, Bauer A, Reinstadler SJR. Decline of acute coronary syndrome admissions in Austria since the outbreak of Covid-19: the pandemic response causes cardiac collateral damage. Eur Heart J. 2020;41:1852-1853. doi:10.1093/eurheartj/ehaa314
3. De Rosa S, Spaccarotella C, Basso C, et al. Reduction of hospitalizations for myocardial infarction in Italy in the Covid-19 era. Eur Heart J. 2020;41(22):2083-2088.
4. Wilson SJ, Connolly MJ, Elghamry Z, et al. Effect of the COVID-19 pandemic on ST-segment-elevation myocardial infarction presentations and in-hospital outcomes. Circ Cardiovasc Interv. 2020; 13(7):e009438. doi:10.1161/CIRCINTERVENTIONS.120.009438
5. Mafham MM, Spata E, Goldacre R, et al. Covid-19 pandemic and admission rates for and management of acute coronary syndromes in England. Lancet. 2020;396 (10248):381-389. doi:10.1016/S0140-6736(20)31356-8
6. Bhatt AS, Moscone A, McElrath EE, et al. Fewer Hospitalizations for acute cardiovascular conditions during the COVID-19 pandemic. J Am Coll Cardiol. 2020;76(3):280-288. doi:10.1016/j.jacc.2020.05.038
7. Tam CF, Cheung KS, Lam S, et al. Impact of Coronavirus disease 2019 (Covid-19) outbreak on ST-segment elevation myocardial infarction care in Hong Kong, China. Circ Cardiovasc Qual Outcomes. 2020;13(4):e006631. doi:10.1161/CIRCOUTCOMES.120.006631
8. Clerkin KJ, Fried JA, Raikhelkar J, et al. Coronavirus disease 2019 (COVID-19) and cardiovascular disease. Circulation. 2020;141:1648-1655. doi:10.1161/CIRCULATIONAHA.120.046941
9. Ebinger JE, Shah PK. Declining admissions for acute cardiovascular illness: The Covid-19 paradox. J Am Coll Cardiol. 2020;76(3):289-291. doi:10.1016/j.jacc.2020.05.039
10 Leor J, Poole WK, Kloner RA. Sudden cardiac death triggered by an earthquake. N Engl J Med. 1996;334(7):413-419. doi:10.1056/NEJM199602153340701
11. Hiramori K. Major causes of death from acute myocardial infarction in a coronary care unit. Jpn Circ J. 1987;51(9):1041-1047. doi:10.1253/jcj.51.1041
12. Bui AH, Waks JW. Risk stratification of sudden cardiac death after acute myocardial infarction. J Innov Card Rhythm Manag. 2018;9(2):3035-3049. doi:10.19102/icrm.2018.090201
13. Xiang D, Xiang X, Zhang W, et al. Management and outcomes of patients with STEMI during the COVID-19 pandemic in China. J Am Coll Cardiol. 2020;76(11):1318-1324. doi:10.1016/j.jacc.2020.06.039
14. Hakim R, Motreff P, Rangé G. COVID-19 and STEMI. [Article in French]. Ann Cardiol Angeiol (Paris). 2020;69(6):355-359. doi:10.1016/j.ancard.2020.09.034
15. Soylu K, Coksevim M, Yanık A, Bugra Cerik I, Aksan G. Effect of Covid-19 pandemic process on STEMI patients timeline. Int J Clin Pract. 2021;75(5):e14005. doi:10.1111/ijcp.14005
16. Salinas P, Travieso A, Vergara-Uzcategui C, et al. Clinical profile and 30-day mortality of invasively managed patients with suspected acute coronary syndrome during the COVID-19 outbreak. Int Heart J. 2021;62(2):274-281. doi:10.1536/ihj.20-574
17. Hu Y, Sun J, Dai Z, et al. Prevalence and severity of corona virus disease 2019 (Covid-19): a systematic review and meta-analysis. J Clin Virol. 2020;127:104371. doi:10.1016/j.jcv.2020.104371
18. Rodriguez-Leor O, Cid Alvarez AB, Perez de Prado A, et al. In-hospital outcomes of COVID-19 ST-elevation myocardial infarction patients. EuroIntervention. 2021;16(17):1426-1433. doi:10.4244/EIJ-D-20-00935
19. Fardman A, Zahger D, Orvin K, et al. Acute myocardial infarction in the Covid-19 era: incidence, clinical characteristics and in-hospital outcomes—A multicenter registry. PLoS ONE. 2021;16(6): e0253524. doi:10.1371/journal.pone.0253524
20. Pessoa-Amorim G, Camm CF, Gajendragadkar P, et al. Admission of patients with STEMI since the outbreak of the COVID-19 pandemic: a survey by the European Society of Cardiology. Eur Heart J Qual Care Clin Outcomes. 2020;6(3):210-216. doi:10.1093/ehjqcco/qcaa046
From the Department of Medicine, Medical College of Georgia at the Augusta University-University of Georgia Medical Partnership, Athens, GA (Syed H. Ali, Syed Hyder, and Dr. Murrow), and the Department of Cardiology, Piedmont Heart Institute, Piedmont Athens Regional, Athens, GA (Dr. Murrow and Mrs. Davis).
Abstract
Objectives: The aim of this study was to describe the characteristics and in-hospital outcomes of patients with acute ST-segment elevation myocardial infarction (STEMI) during the early COVID-19 pandemic at Piedmont Athens Regional (PAR), a 330-bed tertiary referral center in Northeast Georgia.
Methods: A retrospective study was conducted at PAR to evaluate patients with acute STEMI admitted over an 8-week period during the initial COVID-19 outbreak. This study group was compared to patients admitted during the corresponding period in 2019. The primary endpoint of this study was defined as a composite of sustained ventricular arrhythmia, congestive heart failure (CHF) with pulmonary congestion, and/or in-hospital mortality.
Results: This study cohort was composed of 64 patients with acute STEMI; 30 patients (46.9%) were hospitalized during the COVID-19 pandemic. Patients with STEMI in both the COVID-19 and control groups had similar comorbidities, Killip classification score, and clinical presentations. The median (interquartile range) time from symptom onset to reperfusion (total ischemic time) increased from 99.5 minutes (84.8-132) in 2019 to 149 minutes (96.3-231.8; P = .032) in 2020. Hospitalization during the COVID-19 period was associated with an increased risk for combined in-hospital outcome (odds ratio, 3.96; P = .046).
Conclusion: Patients with STEMI admitted during the first wave of the COVID-19 outbreak experienced longer total ischemic time and increased risk for combined in-hospital outcomes compared to patients admitted during the corresponding period in 2019.
Keywords: myocardial infarction, acute coronary syndrome, hospitalization, outcomes.
The emergence of the SARS-Cov-2 virus in December 2019 caused a worldwide shift in resource allocation and the restructuring of health care systems within the span of a few months. With the rapid spread of infection, the World Health Organization officially declared a pandemic in March 2020. The pandemic led to the deferral and cancellation of in-person patient visits, routine diagnostic studies, and nonessential surgeries and procedures. This response occurred secondary to a joint effort to reduce transmission via stay-at-home mandates and appropriate social distancing.1
Alongside the reduction in elective procedures and health care visits, significant reductions in hospitalization rates due to decreases in acute ST-segment elevation myocardial infarction (STEMI) and catheterization laboratory utilization have been reported in many studies from around the world.2-7 Comprehensive data demonstrating the impact of the COVID-19 pandemic on acute STEMI patient characteristics, clinical presentation, and in-hospital outcomes are lacking. Although patients with previously diagnosed cardiovascular disease are more likely to encounter worse outcomes in the setting of COVID-19, there may also be an indirect impact of the pandemic on high-risk patients, including those without the infection.8 Several theories have been hypothesized to explain this phenomenon. One theory postulates that the fear of contracting the virus during hospitalization is great enough to prevent patients from seeking care.2 Another theory suggests that the increased utilization of telemedicine prevents exacerbation of chronic conditions and the need for hospitalization.9 Contrary to this trend, previous studies have shown an increased incidence of acute STEMI following stressful events such as natural disasters.10
The aim of this study was to describe trends pertaining to clinical characteristics and in-hospital outcomes of patients with acute STEMI during the early COVID-19 pandemic at Piedmont Athens Regional (PAR), a 330-bed tertiary referral center in Northeast Georgia.
Methods
A retrospective cohort study was conducted at PAR to evaluate patients with STEMI admitted to the cardiovascular intensive care unit over an 8-week period (March 5 to May 5, 2020) during the COVID-19 outbreak. COVID-19 was declared a national emergency on March 13, 2020, in the United States. The institutional review board at PAR approved the study; the need for individual consent was waived under the condition that participant data would undergo de-identification and be strictly safeguarded.
Data Collection
Because there are seasonal variations in cardiovascular admissions, patient data from a control period (March 9 to May 9, 2019) were obtained to compare with data from the 2020 period. The number of patients with the diagnosis of acute STEMI during the COVID-19 period was recorded. Demographic data, clinical characteristics, and primary angiographic findings were gathered for all patients. Time from symptom onset to hospital admission and time from hospital admission to reperfusion (defined as door-to-balloon time) were documented for each patient. Killip classification was used to assess patients’ clinical status on admission. Length of stay was determined as days from hospital admission to discharge or death (if occurring during the same hospitalization).
Adverse in-hospital complications were also recorded. These were selected based on inclusion of the following categories of acute STEMI complications: ischemic, mechanical, arrhythmic, embolic, and inflammatory. The following complications occurred in our patient cohort: sustained ventricular arrhythmia, congestive heart failure (CHF) defined as congestion requiring intravenous diuretics, re-infarction, mechanical complications (free-wall rupture, ventricular septal defect, or mitral regurgitation), second- or third-degree atrioventricular block, atrial fibrillation, stroke, mechanical ventilation, major bleeding, pericarditis, cardiogenic shock, cardiac arrest, and in-hospital mortality. The primary outcome of this study was defined as a composite of sustained ventricular arrhythmia, CHF with congestion requiring intravenous diuretics, and/or in-hospital mortality. Ventricular arrythmia and CHF were included in the composite outcome because they are defined as the 2 most common causes of sudden cardiac death following acute STEMI.11,12
Statistical Analysis
Normally distributed continuous variables and categorical variables were compared using the paired t-test. A 2-sided P value <.05 was considered to be statistically significant. Mean admission rates for acute STEMI hospitalizations were determined by dividing the number of admissions by the number of days in each time period. The daily rate of COVID-19 cases per 100,000 individuals was obtained from the Centers for Disease Control and Prevention COVID-19 database. All data analyses were performed using Microsoft Excel.
Results
The study cohort consisted of 64 patients, of whom 30 (46.9%) were hospitalized between March 5 and May 5, 2020, and 34 (53.1%) who were admitted during the analogous time period in 2019. This reflected a 6% decrease in STEMI admissions at PAR in the COVID-19 cohort.
Acute STEMI Hospitalization Rates and COVID-19 Incidence
The mean daily acute STEMI admission rate was 0.50 during the study period compared to 0.57 during the control period. During the study period in 2020 in the state of Georgia, the daily rate of newly confirmed COVID-19 cases ranged from 0.194 per 100,000 on March 5 to 8.778 per 100,000 on May 5. Results of COVID-19 testing were available for 9 STEMI patients, and of these 0 tests were positive.
Baseline Characteristics
Baseline characteristics of the acute STEMI cohorts are presented in Table 1. Approximately 75% were male; median (interquartile range [IQR]) age was 60 (51-72) years. There were no significant differences in age and gender between the study periods. Three-quarters of patients had a history of hypertension, and 87.5% had a history of dyslipidemia. There was no significant difference in baseline comorbidity profiles between the 2 study periods; therefore, our sample populations shared similar characteristics.
Clinical Presentation
Significant differences were observed regarding the time intervals of STEMI patients in the COVID-19 period and the control period (Table 2). Median time from symptom onset to hospital admission (patient delay) was extended from 57.5 minutes (IQR, 40.3-106) in 2019 to 93 minutes (IQR, 48.8-132) in 2020; however, this difference was not statistically significant (P = .697). Median time from hospital admission to reperfusion (system delay) was prolonged from 45 minutes (IQR, 28-61) in 2019 to 78 minutes (IQR, 50-110) in 2020 (P < .001). Overall time from symptom onset to reperfusion (total ischemic time) increased from 99.5 minutes (IQR, 84.8-132) in 2019 to 149 minutes (IQR, 96.3-231.8) in 2020 (P = .032).
Regarding mode of transportation, 23.5% of patients in 2019 were walk-in admissions to the emergency department. During the COVID-19 period, walk-in admissions decreased to 6.7% (P = .065). There were no significant differences between emergency medical service, transfer, or in-patient admissions for STEMI cases between the 2 study periods.
Killip classification scores were calculated for all patients on admission; 90.6% of patients were classified as Killip Class 1. There was no significant difference between hemodynamic presentations during the COVID-19 period compared to the control period.
Angiographic Data
Overall, 53 (82.8%) patients admitted with acute STEMI underwent coronary angiography during their hospital stay. The proportion of patients who underwent primary reperfusion was greater in the control period than in the COVID-19 period (85.3% vs 80%; P = .582). Angiographic characteristics and findings were similar between the 2 study groups (Table 2).
In-Hospital Outcomes
In-hospital outcome data were available for all patients. As shown in Table 3, hospitalization during the COVID-19 period was independently associated with an increased risk for combined in-hospital outcome (odds ratio, 3.96; P = .046). The rate of in-hospital mortality was greater in the COVID-19 period (P = .013). We found no significant difference when comparing secondary outcomes from admissions during the COVID-19 period and the control period in 2019. For the 5 patients who died during the study period, the primary diagnosis at death was acute STEMI complicated by CHF (3 patients) or cardiogenic shock (2 patients).
Discussion
This single-center retrospective study at PAR looks at the impact of COVID-19 on hospitalizations for acute STEMI during the initial peak of the pandemic. The key findings of this study show a significant increase in ischemic time parameters (symptom onset to reperfusion, hospital admission to reperfusion), in-hospital mortality, and combined in-hospital outcomes.
There was a 49.5-minute increase in total ischemic time noted in this study (P = .032). Though there was a numerical increase in time of symptom onset to hospital admission by 23.5 minutes, this difference was not statistically significant (P = .697). However, this study observed a statistically significant 33-minute increase in ischemic time from hospital admission to reperfusion (P < .001). Multiple studies globally have found a similar increase in total ischemic times, including those conducted in China and Europe.13-15 Every level of potential delay must be considered, including pre-hospital, triage and emergency department, and/or reperfusion team. Pre-hospital sources of delays that have been suggested include “stay-at-home” orders and apprehension to seek medical care due to concern about contracting the virus or overwhelming the health care facilities. There was a clinically significant 4-fold decrease in the number of walk-in acute STEMI cases in the study period. In 2019, there were 8 walk-in cases compared to 2 cases in 2020 (P = .065). However, this change was not statistically significant. In-hospital/systemic sources of delays have been mentioned in other studies; they include increased time taken to rule out COVID-19 (nasopharyngeal swab/chest x-ray) and increased time due to the need for intensive gowning and gloving procedures by staff. It was difficult to objectively determine the sources of system delay by the reperfusion team due to a lack of quantitative data.
In the current study, we found a significant increase in in-hospital mortality during the COVID-19 period compared to a parallel time frame in 2019. This finding is contrary to a multicenter study from Spain that reported no difference in in-hospital outcomes or mortality rates among all acute coronary syndrome cases.16 The worsening outcomes and prognosis may simply be a result of increased ischemic time; however, the virus that causes COVID-19 itself may play a role as well. Studies have found that SARS-Cov-2 infection places patients at greater risk for cardiovascular conditions such as hypercoagulability, myocarditis, and arrhythmias.17 In our study, however, there were no acute STEMI patients who tested positive for COVID-19. Therefore, we cannot discuss the impact of increased thrombus burden in patients with COVID-19. Piedmont Healthcare published a STEMI treatment protocol in May 2020 that advised increased use of tissue plasminogen activator (tPA) in COVID-19-positive cases; during the study period, however, there were no occasions when tPA use was deemed appropriate based on clinical judgment.
Our findings align with previous studies that describe an increase in combined in-hospital adverse outcomes during the COVID-19 era. Previous studies detected a higher rate of complications in the COVID-19 cohort, but in the current study, the adverse in-hospital course is unrelated to underlying infection.18,19 This study reports a higher incidence of major in-hospital outcomes, including a 65% increase in the rate of combined in-hospital outcomes, which is similar to a multicenter study conducted in Israel.19 There was a 2.3-fold numerical increase in sustained ventricular arrhythmias and a 2.5-fold numerical increase in the incidence of cardiac arrest in the study period. This phenomenon was observed despite a similar rate of reperfusion procedures in both groups.
Acute STEMI is a highly fatal condition with an incidence of 8.5 in 10,000 annually in the United States. While studies across the world have shown a 25% to 40% reduction in the rate of hospitalized acute coronary syndrome cases during the COVID-19 pandemic, the decrease from 34 to 30 STEMI admissions at PAR is not statistically significant.20 Possible reasons for the reduction globally include increased out-of-hospital mortality and decreased incidence of acute STEMI across the general population as a result of improved access to telemedicine or decreased levels of life stressors.20
In summary, there was an increase in ischemic time to reperfusion, in-hospital mortality, and combined in-hospital outcomes for acute STEMI patients at PAR during the COVID period.
Limitations
This study has several limitations. This is a single-center study, so the sample size is small and may not be generalizable to a larger population. This is a retrospective observational study, so causation cannot be inferred. This study analyzed ischemic time parameters as average rates over time rather than in an interrupted time series. Post-reperfusion outcomes were limited to hospital stay. Post-hospital follow-up would provide a better picture of the effects of STEMI intervention. There is no account of patients who died out-of-hospital secondary to acute STEMI. COVID-19 testing was not introduced until midway in our study period. Therefore, we cannot rule out the possibility of the SARS-Cov-2 virus inciting acute STEMI and subsequently leading to worse outcomes and poor prognosis.
Conclusions
This study provides an analysis of the incidence, characteristics, and clinical outcomes of patients presenting with acute STEMI during the early period of the COVID-19 pandemic. In-hospital mortality and ischemic time to reperfusion increased while combined in-hospital outcomes worsened.
Acknowledgment: The authors thank Piedmont Athens Regional IRB for approving this project and allowing access to patient data.
Corresponding author: Syed H. Ali; Department of Medicine, Medical College of Georgia at the Augusta University-University of Georgia Medical Partnership, 30606, Athens, GA; [email protected]
Disclosures: None reported.
doi:10.12788/jcom.0085
From the Department of Medicine, Medical College of Georgia at the Augusta University-University of Georgia Medical Partnership, Athens, GA (Syed H. Ali, Syed Hyder, and Dr. Murrow), and the Department of Cardiology, Piedmont Heart Institute, Piedmont Athens Regional, Athens, GA (Dr. Murrow and Mrs. Davis).
Abstract
Objectives: The aim of this study was to describe the characteristics and in-hospital outcomes of patients with acute ST-segment elevation myocardial infarction (STEMI) during the early COVID-19 pandemic at Piedmont Athens Regional (PAR), a 330-bed tertiary referral center in Northeast Georgia.
Methods: A retrospective study was conducted at PAR to evaluate patients with acute STEMI admitted over an 8-week period during the initial COVID-19 outbreak. This study group was compared to patients admitted during the corresponding period in 2019. The primary endpoint of this study was defined as a composite of sustained ventricular arrhythmia, congestive heart failure (CHF) with pulmonary congestion, and/or in-hospital mortality.
Results: This study cohort was composed of 64 patients with acute STEMI; 30 patients (46.9%) were hospitalized during the COVID-19 pandemic. Patients with STEMI in both the COVID-19 and control groups had similar comorbidities, Killip classification score, and clinical presentations. The median (interquartile range) time from symptom onset to reperfusion (total ischemic time) increased from 99.5 minutes (84.8-132) in 2019 to 149 minutes (96.3-231.8; P = .032) in 2020. Hospitalization during the COVID-19 period was associated with an increased risk for combined in-hospital outcome (odds ratio, 3.96; P = .046).
Conclusion: Patients with STEMI admitted during the first wave of the COVID-19 outbreak experienced longer total ischemic time and increased risk for combined in-hospital outcomes compared to patients admitted during the corresponding period in 2019.
Keywords: myocardial infarction, acute coronary syndrome, hospitalization, outcomes.
The emergence of the SARS-Cov-2 virus in December 2019 caused a worldwide shift in resource allocation and the restructuring of health care systems within the span of a few months. With the rapid spread of infection, the World Health Organization officially declared a pandemic in March 2020. The pandemic led to the deferral and cancellation of in-person patient visits, routine diagnostic studies, and nonessential surgeries and procedures. This response occurred secondary to a joint effort to reduce transmission via stay-at-home mandates and appropriate social distancing.1
Alongside the reduction in elective procedures and health care visits, significant reductions in hospitalization rates due to decreases in acute ST-segment elevation myocardial infarction (STEMI) and catheterization laboratory utilization have been reported in many studies from around the world.2-7 Comprehensive data demonstrating the impact of the COVID-19 pandemic on acute STEMI patient characteristics, clinical presentation, and in-hospital outcomes are lacking. Although patients with previously diagnosed cardiovascular disease are more likely to encounter worse outcomes in the setting of COVID-19, there may also be an indirect impact of the pandemic on high-risk patients, including those without the infection.8 Several theories have been hypothesized to explain this phenomenon. One theory postulates that the fear of contracting the virus during hospitalization is great enough to prevent patients from seeking care.2 Another theory suggests that the increased utilization of telemedicine prevents exacerbation of chronic conditions and the need for hospitalization.9 Contrary to this trend, previous studies have shown an increased incidence of acute STEMI following stressful events such as natural disasters.10
The aim of this study was to describe trends pertaining to clinical characteristics and in-hospital outcomes of patients with acute STEMI during the early COVID-19 pandemic at Piedmont Athens Regional (PAR), a 330-bed tertiary referral center in Northeast Georgia.
Methods
A retrospective cohort study was conducted at PAR to evaluate patients with STEMI admitted to the cardiovascular intensive care unit over an 8-week period (March 5 to May 5, 2020) during the COVID-19 outbreak. COVID-19 was declared a national emergency on March 13, 2020, in the United States. The institutional review board at PAR approved the study; the need for individual consent was waived under the condition that participant data would undergo de-identification and be strictly safeguarded.
Data Collection
Because there are seasonal variations in cardiovascular admissions, patient data from a control period (March 9 to May 9, 2019) were obtained to compare with data from the 2020 period. The number of patients with the diagnosis of acute STEMI during the COVID-19 period was recorded. Demographic data, clinical characteristics, and primary angiographic findings were gathered for all patients. Time from symptom onset to hospital admission and time from hospital admission to reperfusion (defined as door-to-balloon time) were documented for each patient. Killip classification was used to assess patients’ clinical status on admission. Length of stay was determined as days from hospital admission to discharge or death (if occurring during the same hospitalization).
Adverse in-hospital complications were also recorded. These were selected based on inclusion of the following categories of acute STEMI complications: ischemic, mechanical, arrhythmic, embolic, and inflammatory. The following complications occurred in our patient cohort: sustained ventricular arrhythmia, congestive heart failure (CHF) defined as congestion requiring intravenous diuretics, re-infarction, mechanical complications (free-wall rupture, ventricular septal defect, or mitral regurgitation), second- or third-degree atrioventricular block, atrial fibrillation, stroke, mechanical ventilation, major bleeding, pericarditis, cardiogenic shock, cardiac arrest, and in-hospital mortality. The primary outcome of this study was defined as a composite of sustained ventricular arrhythmia, CHF with congestion requiring intravenous diuretics, and/or in-hospital mortality. Ventricular arrythmia and CHF were included in the composite outcome because they are defined as the 2 most common causes of sudden cardiac death following acute STEMI.11,12
Statistical Analysis
Normally distributed continuous variables and categorical variables were compared using the paired t-test. A 2-sided P value <.05 was considered to be statistically significant. Mean admission rates for acute STEMI hospitalizations were determined by dividing the number of admissions by the number of days in each time period. The daily rate of COVID-19 cases per 100,000 individuals was obtained from the Centers for Disease Control and Prevention COVID-19 database. All data analyses were performed using Microsoft Excel.
Results
The study cohort consisted of 64 patients, of whom 30 (46.9%) were hospitalized between March 5 and May 5, 2020, and 34 (53.1%) who were admitted during the analogous time period in 2019. This reflected a 6% decrease in STEMI admissions at PAR in the COVID-19 cohort.
Acute STEMI Hospitalization Rates and COVID-19 Incidence
The mean daily acute STEMI admission rate was 0.50 during the study period compared to 0.57 during the control period. During the study period in 2020 in the state of Georgia, the daily rate of newly confirmed COVID-19 cases ranged from 0.194 per 100,000 on March 5 to 8.778 per 100,000 on May 5. Results of COVID-19 testing were available for 9 STEMI patients, and of these 0 tests were positive.
Baseline Characteristics
Baseline characteristics of the acute STEMI cohorts are presented in Table 1. Approximately 75% were male; median (interquartile range [IQR]) age was 60 (51-72) years. There were no significant differences in age and gender between the study periods. Three-quarters of patients had a history of hypertension, and 87.5% had a history of dyslipidemia. There was no significant difference in baseline comorbidity profiles between the 2 study periods; therefore, our sample populations shared similar characteristics.
Clinical Presentation
Significant differences were observed regarding the time intervals of STEMI patients in the COVID-19 period and the control period (Table 2). Median time from symptom onset to hospital admission (patient delay) was extended from 57.5 minutes (IQR, 40.3-106) in 2019 to 93 minutes (IQR, 48.8-132) in 2020; however, this difference was not statistically significant (P = .697). Median time from hospital admission to reperfusion (system delay) was prolonged from 45 minutes (IQR, 28-61) in 2019 to 78 minutes (IQR, 50-110) in 2020 (P < .001). Overall time from symptom onset to reperfusion (total ischemic time) increased from 99.5 minutes (IQR, 84.8-132) in 2019 to 149 minutes (IQR, 96.3-231.8) in 2020 (P = .032).
Regarding mode of transportation, 23.5% of patients in 2019 were walk-in admissions to the emergency department. During the COVID-19 period, walk-in admissions decreased to 6.7% (P = .065). There were no significant differences between emergency medical service, transfer, or in-patient admissions for STEMI cases between the 2 study periods.
Killip classification scores were calculated for all patients on admission; 90.6% of patients were classified as Killip Class 1. There was no significant difference between hemodynamic presentations during the COVID-19 period compared to the control period.
Angiographic Data
Overall, 53 (82.8%) patients admitted with acute STEMI underwent coronary angiography during their hospital stay. The proportion of patients who underwent primary reperfusion was greater in the control period than in the COVID-19 period (85.3% vs 80%; P = .582). Angiographic characteristics and findings were similar between the 2 study groups (Table 2).
In-Hospital Outcomes
In-hospital outcome data were available for all patients. As shown in Table 3, hospitalization during the COVID-19 period was independently associated with an increased risk for combined in-hospital outcome (odds ratio, 3.96; P = .046). The rate of in-hospital mortality was greater in the COVID-19 period (P = .013). We found no significant difference when comparing secondary outcomes from admissions during the COVID-19 period and the control period in 2019. For the 5 patients who died during the study period, the primary diagnosis at death was acute STEMI complicated by CHF (3 patients) or cardiogenic shock (2 patients).
Discussion
This single-center retrospective study at PAR looks at the impact of COVID-19 on hospitalizations for acute STEMI during the initial peak of the pandemic. The key findings of this study show a significant increase in ischemic time parameters (symptom onset to reperfusion, hospital admission to reperfusion), in-hospital mortality, and combined in-hospital outcomes.
There was a 49.5-minute increase in total ischemic time noted in this study (P = .032). Though there was a numerical increase in time of symptom onset to hospital admission by 23.5 minutes, this difference was not statistically significant (P = .697). However, this study observed a statistically significant 33-minute increase in ischemic time from hospital admission to reperfusion (P < .001). Multiple studies globally have found a similar increase in total ischemic times, including those conducted in China and Europe.13-15 Every level of potential delay must be considered, including pre-hospital, triage and emergency department, and/or reperfusion team. Pre-hospital sources of delays that have been suggested include “stay-at-home” orders and apprehension to seek medical care due to concern about contracting the virus or overwhelming the health care facilities. There was a clinically significant 4-fold decrease in the number of walk-in acute STEMI cases in the study period. In 2019, there were 8 walk-in cases compared to 2 cases in 2020 (P = .065). However, this change was not statistically significant. In-hospital/systemic sources of delays have been mentioned in other studies; they include increased time taken to rule out COVID-19 (nasopharyngeal swab/chest x-ray) and increased time due to the need for intensive gowning and gloving procedures by staff. It was difficult to objectively determine the sources of system delay by the reperfusion team due to a lack of quantitative data.
In the current study, we found a significant increase in in-hospital mortality during the COVID-19 period compared to a parallel time frame in 2019. This finding is contrary to a multicenter study from Spain that reported no difference in in-hospital outcomes or mortality rates among all acute coronary syndrome cases.16 The worsening outcomes and prognosis may simply be a result of increased ischemic time; however, the virus that causes COVID-19 itself may play a role as well. Studies have found that SARS-Cov-2 infection places patients at greater risk for cardiovascular conditions such as hypercoagulability, myocarditis, and arrhythmias.17 In our study, however, there were no acute STEMI patients who tested positive for COVID-19. Therefore, we cannot discuss the impact of increased thrombus burden in patients with COVID-19. Piedmont Healthcare published a STEMI treatment protocol in May 2020 that advised increased use of tissue plasminogen activator (tPA) in COVID-19-positive cases; during the study period, however, there were no occasions when tPA use was deemed appropriate based on clinical judgment.
Our findings align with previous studies that describe an increase in combined in-hospital adverse outcomes during the COVID-19 era. Previous studies detected a higher rate of complications in the COVID-19 cohort, but in the current study, the adverse in-hospital course is unrelated to underlying infection.18,19 This study reports a higher incidence of major in-hospital outcomes, including a 65% increase in the rate of combined in-hospital outcomes, which is similar to a multicenter study conducted in Israel.19 There was a 2.3-fold numerical increase in sustained ventricular arrhythmias and a 2.5-fold numerical increase in the incidence of cardiac arrest in the study period. This phenomenon was observed despite a similar rate of reperfusion procedures in both groups.
Acute STEMI is a highly fatal condition with an incidence of 8.5 in 10,000 annually in the United States. While studies across the world have shown a 25% to 40% reduction in the rate of hospitalized acute coronary syndrome cases during the COVID-19 pandemic, the decrease from 34 to 30 STEMI admissions at PAR is not statistically significant.20 Possible reasons for the reduction globally include increased out-of-hospital mortality and decreased incidence of acute STEMI across the general population as a result of improved access to telemedicine or decreased levels of life stressors.20
In summary, there was an increase in ischemic time to reperfusion, in-hospital mortality, and combined in-hospital outcomes for acute STEMI patients at PAR during the COVID period.
Limitations
This study has several limitations. This is a single-center study, so the sample size is small and may not be generalizable to a larger population. This is a retrospective observational study, so causation cannot be inferred. This study analyzed ischemic time parameters as average rates over time rather than in an interrupted time series. Post-reperfusion outcomes were limited to hospital stay. Post-hospital follow-up would provide a better picture of the effects of STEMI intervention. There is no account of patients who died out-of-hospital secondary to acute STEMI. COVID-19 testing was not introduced until midway in our study period. Therefore, we cannot rule out the possibility of the SARS-Cov-2 virus inciting acute STEMI and subsequently leading to worse outcomes and poor prognosis.
Conclusions
This study provides an analysis of the incidence, characteristics, and clinical outcomes of patients presenting with acute STEMI during the early period of the COVID-19 pandemic. In-hospital mortality and ischemic time to reperfusion increased while combined in-hospital outcomes worsened.
Acknowledgment: The authors thank Piedmont Athens Regional IRB for approving this project and allowing access to patient data.
Corresponding author: Syed H. Ali; Department of Medicine, Medical College of Georgia at the Augusta University-University of Georgia Medical Partnership, 30606, Athens, GA; [email protected]
Disclosures: None reported.
doi:10.12788/jcom.0085
1. Bhatt AS, Moscone A, McElrath EE, et al. Fewer hospitalizations for acute cardiovascular conditions during the COVID-19 pandemic. J Am Coll Cardiol. 2020;76(3):280-288. doi:10.1016/j.jacc.2020.05.038
2. Metzler B, Siostrzonek P, Binder RK, Bauer A, Reinstadler SJR. Decline of acute coronary syndrome admissions in Austria since the outbreak of Covid-19: the pandemic response causes cardiac collateral damage. Eur Heart J. 2020;41:1852-1853. doi:10.1093/eurheartj/ehaa314
3. De Rosa S, Spaccarotella C, Basso C, et al. Reduction of hospitalizations for myocardial infarction in Italy in the Covid-19 era. Eur Heart J. 2020;41(22):2083-2088.
4. Wilson SJ, Connolly MJ, Elghamry Z, et al. Effect of the COVID-19 pandemic on ST-segment-elevation myocardial infarction presentations and in-hospital outcomes. Circ Cardiovasc Interv. 2020; 13(7):e009438. doi:10.1161/CIRCINTERVENTIONS.120.009438
5. Mafham MM, Spata E, Goldacre R, et al. Covid-19 pandemic and admission rates for and management of acute coronary syndromes in England. Lancet. 2020;396 (10248):381-389. doi:10.1016/S0140-6736(20)31356-8
6. Bhatt AS, Moscone A, McElrath EE, et al. Fewer Hospitalizations for acute cardiovascular conditions during the COVID-19 pandemic. J Am Coll Cardiol. 2020;76(3):280-288. doi:10.1016/j.jacc.2020.05.038
7. Tam CF, Cheung KS, Lam S, et al. Impact of Coronavirus disease 2019 (Covid-19) outbreak on ST-segment elevation myocardial infarction care in Hong Kong, China. Circ Cardiovasc Qual Outcomes. 2020;13(4):e006631. doi:10.1161/CIRCOUTCOMES.120.006631
8. Clerkin KJ, Fried JA, Raikhelkar J, et al. Coronavirus disease 2019 (COVID-19) and cardiovascular disease. Circulation. 2020;141:1648-1655. doi:10.1161/CIRCULATIONAHA.120.046941
9. Ebinger JE, Shah PK. Declining admissions for acute cardiovascular illness: The Covid-19 paradox. J Am Coll Cardiol. 2020;76(3):289-291. doi:10.1016/j.jacc.2020.05.039
10 Leor J, Poole WK, Kloner RA. Sudden cardiac death triggered by an earthquake. N Engl J Med. 1996;334(7):413-419. doi:10.1056/NEJM199602153340701
11. Hiramori K. Major causes of death from acute myocardial infarction in a coronary care unit. Jpn Circ J. 1987;51(9):1041-1047. doi:10.1253/jcj.51.1041
12. Bui AH, Waks JW. Risk stratification of sudden cardiac death after acute myocardial infarction. J Innov Card Rhythm Manag. 2018;9(2):3035-3049. doi:10.19102/icrm.2018.090201
13. Xiang D, Xiang X, Zhang W, et al. Management and outcomes of patients with STEMI during the COVID-19 pandemic in China. J Am Coll Cardiol. 2020;76(11):1318-1324. doi:10.1016/j.jacc.2020.06.039
14. Hakim R, Motreff P, Rangé G. COVID-19 and STEMI. [Article in French]. Ann Cardiol Angeiol (Paris). 2020;69(6):355-359. doi:10.1016/j.ancard.2020.09.034
15. Soylu K, Coksevim M, Yanık A, Bugra Cerik I, Aksan G. Effect of Covid-19 pandemic process on STEMI patients timeline. Int J Clin Pract. 2021;75(5):e14005. doi:10.1111/ijcp.14005
16. Salinas P, Travieso A, Vergara-Uzcategui C, et al. Clinical profile and 30-day mortality of invasively managed patients with suspected acute coronary syndrome during the COVID-19 outbreak. Int Heart J. 2021;62(2):274-281. doi:10.1536/ihj.20-574
17. Hu Y, Sun J, Dai Z, et al. Prevalence and severity of corona virus disease 2019 (Covid-19): a systematic review and meta-analysis. J Clin Virol. 2020;127:104371. doi:10.1016/j.jcv.2020.104371
18. Rodriguez-Leor O, Cid Alvarez AB, Perez de Prado A, et al. In-hospital outcomes of COVID-19 ST-elevation myocardial infarction patients. EuroIntervention. 2021;16(17):1426-1433. doi:10.4244/EIJ-D-20-00935
19. Fardman A, Zahger D, Orvin K, et al. Acute myocardial infarction in the Covid-19 era: incidence, clinical characteristics and in-hospital outcomes—A multicenter registry. PLoS ONE. 2021;16(6): e0253524. doi:10.1371/journal.pone.0253524
20. Pessoa-Amorim G, Camm CF, Gajendragadkar P, et al. Admission of patients with STEMI since the outbreak of the COVID-19 pandemic: a survey by the European Society of Cardiology. Eur Heart J Qual Care Clin Outcomes. 2020;6(3):210-216. doi:10.1093/ehjqcco/qcaa046
1. Bhatt AS, Moscone A, McElrath EE, et al. Fewer hospitalizations for acute cardiovascular conditions during the COVID-19 pandemic. J Am Coll Cardiol. 2020;76(3):280-288. doi:10.1016/j.jacc.2020.05.038
2. Metzler B, Siostrzonek P, Binder RK, Bauer A, Reinstadler SJR. Decline of acute coronary syndrome admissions in Austria since the outbreak of Covid-19: the pandemic response causes cardiac collateral damage. Eur Heart J. 2020;41:1852-1853. doi:10.1093/eurheartj/ehaa314
3. De Rosa S, Spaccarotella C, Basso C, et al. Reduction of hospitalizations for myocardial infarction in Italy in the Covid-19 era. Eur Heart J. 2020;41(22):2083-2088.
4. Wilson SJ, Connolly MJ, Elghamry Z, et al. Effect of the COVID-19 pandemic on ST-segment-elevation myocardial infarction presentations and in-hospital outcomes. Circ Cardiovasc Interv. 2020; 13(7):e009438. doi:10.1161/CIRCINTERVENTIONS.120.009438
5. Mafham MM, Spata E, Goldacre R, et al. Covid-19 pandemic and admission rates for and management of acute coronary syndromes in England. Lancet. 2020;396 (10248):381-389. doi:10.1016/S0140-6736(20)31356-8
6. Bhatt AS, Moscone A, McElrath EE, et al. Fewer Hospitalizations for acute cardiovascular conditions during the COVID-19 pandemic. J Am Coll Cardiol. 2020;76(3):280-288. doi:10.1016/j.jacc.2020.05.038
7. Tam CF, Cheung KS, Lam S, et al. Impact of Coronavirus disease 2019 (Covid-19) outbreak on ST-segment elevation myocardial infarction care in Hong Kong, China. Circ Cardiovasc Qual Outcomes. 2020;13(4):e006631. doi:10.1161/CIRCOUTCOMES.120.006631
8. Clerkin KJ, Fried JA, Raikhelkar J, et al. Coronavirus disease 2019 (COVID-19) and cardiovascular disease. Circulation. 2020;141:1648-1655. doi:10.1161/CIRCULATIONAHA.120.046941
9. Ebinger JE, Shah PK. Declining admissions for acute cardiovascular illness: The Covid-19 paradox. J Am Coll Cardiol. 2020;76(3):289-291. doi:10.1016/j.jacc.2020.05.039
10 Leor J, Poole WK, Kloner RA. Sudden cardiac death triggered by an earthquake. N Engl J Med. 1996;334(7):413-419. doi:10.1056/NEJM199602153340701
11. Hiramori K. Major causes of death from acute myocardial infarction in a coronary care unit. Jpn Circ J. 1987;51(9):1041-1047. doi:10.1253/jcj.51.1041
12. Bui AH, Waks JW. Risk stratification of sudden cardiac death after acute myocardial infarction. J Innov Card Rhythm Manag. 2018;9(2):3035-3049. doi:10.19102/icrm.2018.090201
13. Xiang D, Xiang X, Zhang W, et al. Management and outcomes of patients with STEMI during the COVID-19 pandemic in China. J Am Coll Cardiol. 2020;76(11):1318-1324. doi:10.1016/j.jacc.2020.06.039
14. Hakim R, Motreff P, Rangé G. COVID-19 and STEMI. [Article in French]. Ann Cardiol Angeiol (Paris). 2020;69(6):355-359. doi:10.1016/j.ancard.2020.09.034
15. Soylu K, Coksevim M, Yanık A, Bugra Cerik I, Aksan G. Effect of Covid-19 pandemic process on STEMI patients timeline. Int J Clin Pract. 2021;75(5):e14005. doi:10.1111/ijcp.14005
16. Salinas P, Travieso A, Vergara-Uzcategui C, et al. Clinical profile and 30-day mortality of invasively managed patients with suspected acute coronary syndrome during the COVID-19 outbreak. Int Heart J. 2021;62(2):274-281. doi:10.1536/ihj.20-574
17. Hu Y, Sun J, Dai Z, et al. Prevalence and severity of corona virus disease 2019 (Covid-19): a systematic review and meta-analysis. J Clin Virol. 2020;127:104371. doi:10.1016/j.jcv.2020.104371
18. Rodriguez-Leor O, Cid Alvarez AB, Perez de Prado A, et al. In-hospital outcomes of COVID-19 ST-elevation myocardial infarction patients. EuroIntervention. 2021;16(17):1426-1433. doi:10.4244/EIJ-D-20-00935
19. Fardman A, Zahger D, Orvin K, et al. Acute myocardial infarction in the Covid-19 era: incidence, clinical characteristics and in-hospital outcomes—A multicenter registry. PLoS ONE. 2021;16(6): e0253524. doi:10.1371/journal.pone.0253524
20. Pessoa-Amorim G, Camm CF, Gajendragadkar P, et al. Admission of patients with STEMI since the outbreak of the COVID-19 pandemic: a survey by the European Society of Cardiology. Eur Heart J Qual Care Clin Outcomes. 2020;6(3):210-216. doi:10.1093/ehjqcco/qcaa046
Oxygen Therapies and Clinical Outcomes for Patients Hospitalized With COVID-19: First Surge vs Second Surge
From Lahey Hospital and Medical Center, Burlington, MA (Drs. Liesching and Lei), and Tufts University School of Medicine, Boston, MA (Dr. Liesching)
ABSTRACT
Objective: To compare the utilization of oxygen therapies and clinical outcomes of patients admitted for COVID-19 during the second surge of the pandemic to that of patients admitted during the first surge.
Design: Observational study using a registry database.
Setting: Three hospitals (791 inpatient beds and 76 intensive care unit [ICU] beds) within the Beth Israel Lahey Health system in Massachusetts.
Participants: We included 3183 patients with COVID-19 admitted to hospitals.
Measurements: Baseline data included demographics and comorbidities. Treatments included low-flow supplemental oxygen (2-6 L/min), high-flow oxygen via nasal cannula, and invasive mechanical ventilation. Outcomes included ICU admission, length of stay, ventilator days, and mortality.
Results: A total of 3183 patients were included: 1586 during the first surge and 1597 during the second surge. Compared to the first surge, patients admitted during the second surge had a similar rate of receiving low-flow supplemental oxygen (65.8% vs 64.1%, P = .3), a higher rate of receiving high-flow nasal cannula (15.4% vs 10.8%, P = .0001), and a lower ventilation rate (5.6% vs 9.7%, P < .0001). The outcomes during the second surge were better than those during the first surge: lower ICU admission rate (8.1% vs 12.7%, P < .0001), shorter length of hospital stay (5 vs 6 days, P < .0001), fewer ventilator days (10 vs 16, P = .01), and lower mortality (8.3% vs 19.2%, P < .0001). Among ventilated patients, those who received high-flow nasal cannula had lower mortality.
Conclusion: Compared to the first surge of the COVID-19 pandemic, patients admitted during the second surge had similar likelihood of receiving low-flow supplemental oxygen, were more likely to receive high-flow nasal cannula, were less likely to be ventilated, and had better outcomes.
Keywords: supplemental oxygen, high-flow nasal cannula, ventilator.
The respiratory system receives the major impact of SARS-CoV-2 virus, and hypoxemia has been the predominant diagnosis for patients hospitalized with COVID-19.1,2 During the initial stage of the pandemic, oxygen therapies and mechanical ventilation were the only choices for these patients.3-6 Standard-of-care treatment for patients with COVID-19 during the initial surge included oxygen therapies and mechanical ventilation for hypoxemia and medications for comorbidities and COVID-19–associated sequelae, such as multi-organ dysfunction and failure. A report from New York during the first surge (May 2020) showed that among 5700 hospitalized patients with COVID-19, 27.8% received supplemental oxygen and 12.2% received invasive mechanical ventilation.7 High-flow nasal cannula (HFNC) oxygen delivery has been utilized widely throughout the pandemic due to its superiority over other noninvasive respiratory support techniques.8-12 Mechanical ventilation is always necessary for critically ill patients with acute respiratory distress syndrome. However, ventilator scarcity has become a bottleneck in caring for severely ill patients with COVID-19 during the pandemic.13
The clinical outcomes of hospitalized COVID-19 patients include a high intubation rate, long length of hospital and intensive care unit (ICU) stay, and high mortality.14,15 As the pandemic evolved, new medications, including remdesivir, hydroxychloroquine, lopinavir, or interferon β-1a, were used in addition to the standard of care, but these did not result in significantly different mortality from standard of care.16 Steroids are becoming foundational to the treatment of severe COVID-19 pneumonia, but evidence from high-quality randomized controlled clinical trials is lacking.17
During the first surge from March to May 2020, Massachusetts had the third highest number of COVID-19 cases among states in the United States.18 In early 2021, COVID-19 cases were climbing close to the peak of the second surge in Massachusetts. In this study, we compared utilization of low-flow supplemental oxygen, HFNC, and mechanical ventilation and clinical outcomes of patients admitted to 3 hospitals in Massachusetts during the second surge of the pandemic to that of patients admitted during the first surge.
Methods
Setting
Beth Israel Lahey Health is a system of academic and teaching hospitals with primary care and specialty care providers. We included 3 centers within the Beth Israel Lahey Health system in Massachusetts: Lahey Hospital and Medical Center, with 335 inpatient hospital beds and 52 critical care beds; Beverly Hospital, with 227 beds and 14 critical care beds; and Winchester Hospital, with 229 beds and 10 ICU beds.
Participants
We included patients admitted to the 3 hospitals with COVID-19 as a primary or secondary diagnosis during the first surge of the pandemic (March 1, 2020 to June 15, 2020) and the second surge (November 15, 2020 to January 27, 2021). The timeframe of the first surge was defined as the window between the start date and the end date of data collection. During the time window of the first surge, 1586 patients were included. The start time of the second surge was defined as the date when the data collection was restarted; the end date was set when the number of patients (1597) accumulated was close to the number of patients in the first surge (1586), so that the two groups had similar sample size.
Study Design
A data registry of COVID-19 patients was created by our institution, and the data were prospectively collected starting in March 2020. We retrospectively extracted data on the following from the registry database for this observational study: demographics and baseline comorbidities; the use of low-flow supplemental oxygen, HFNC, and invasive mechanical ventilator; and ICU admission, length of hospital stay, length of ICU stay, and hospital discharge disposition. Start and end times for each oxygen therapy were not entered in the registry. Data about other oxygen therapies, such as noninvasive positive-pressure ventilation, were not collected in the registry database, and therefore were not included in the analysis.
Statistical Analysis
Continuous variables (eg, age) were tested for data distribution normality using the Shapiro-Wilk test. Normally distributed data were tested using unpaired t-tests and displayed as mean (SD). The skewed data were tested using the Wilcoxon rank sum test and displayed as median (interquartile range [IQR]). The categorical variables were compared using chi-square test. Comparisons with P ≤ .05 were considered significantly different. Statistical analysis for this study was generated using Statistical Analysis Software (SAS), version 9.4 for Windows (SAS Institute Inc.).
Results
Baseline Characteristics
We included 3183 patients: 1586 admitted during the first surge and 1597 admitted during the second surge. Baseline characteristics of patients with COVID-19 admitted during the first and second surges are shown in Table 1. Patients admitted during the second surge were older (73 years vs 71 years, P = .01) and had higher rates of hypertension (64.8% vs 59.6%, P = .003) and asthma (12.9% vs 10.7%, P = .049) but a lower rate of interstitial lung disease (3.3% vs 7.7%, P < .001). Sequential organ failure assessment scores at admission and the rates of other comorbidities were not significantly different between the 2 surges.
Oxygen Therapies
The number of patients who were hospitalized and received low-flow supplemental oxygen, and/or HFNC, and/or ventilator in the first surge and the second surge is shown in the Figure. Of all patients included, 2067 (64.9%) received low-flow supplemental oxygen; of these, 374 (18.1%) subsequently received HFNC, and 85 (22.7%) of these subsequently received mechanical ventilation. Of all 3183 patients, 417 (13.1%) received HFNC; 43 of these patients received HFNC without receiving low-flow supplemental oxygen, and 98 (23.5%) subsequently received mechanical ventilation. Out of all 3183 patients, 244 (7.7%) received mechanical ventilation; 98 (40.2%) of these received HFNC while the remaining 146 (59.8%) did not. At the beginning of the first surge, the ratio of patients who received invasive mechanical ventilation to patients who received HFNC was close to 1:1 (10/10); the ratio decreased to 6:10 in May and June 2020. At the beginning of the second surge, the ratio was 8:10 and then decreased to 3:10 in December 2020 and January 2021.
As shown in Table 2, the proportion of patients who received low-flow supplemental oxygen during the second surge was similar to that during the first surge (65.8% vs 64.1%, P = .3). Patients admitted during the second surge were more likely to receive HFNC than patients admitted during the first surge (15.4% vs 10.8%, P = .0001). Patients admitted during the second surge were less likely to be ventilated than the patients admitted during the first surge (5.6% vs 9.7%, P < .0001).
Clinical Outcomes
As shown in Table 3, second surge outcomes were much better than first surge outcomes: the ICU admission rate was lower (8.1% vs 12.7%, P < .0001); patients were more likely to be discharged to home (60.2% vs 47.4%, P < .0001), had a shorter length of hospital stay (5 vs 6 days, P < .0001), and had fewer ventilator days (10 vs 16, P = .01); and mortality was lower (8.3% vs 19.2%, P < .0001). There was a trend that length of ICU stay was shorter during the second surge than during the first surge (7 days vs 9 days, P = .09).
As noted (Figure), the ratio of patients who received invasive mechanical ventilation to patients who received HFNC was decreasing during both the first surge and the second surge. To further analyze the relation between ventilator and HFNC, we performed a subgroup analysis for 244 ventilated patients during both surges to compare outcomes between patients who received HFNC and those who did not receive HFNC (Table 4). Ninety-eight (40%) patients received HFNC. Ventilated patients who received HFNC had lower mortality than those patients who did not receive HFNC (31.6% vs 48%, P = .01), but had a longer length of hospital stay (29 days vs 14 days, P < .0001), longer length of ICU stay (17 days vs 9 days, P < .0001), and a higher number of ventilator days (16 vs 11, P = .001).
Discussion
Our study compared the baseline patient characteristics; utilization of low-flow supplemental oxygen therapy, HFNC, and mechanical ventilation; and clinical outcomes between the first surge (n = 1586) and the second surge (n = 1597) of the COVID-19 pandemic. During both surges, about two-thirds of admitted patients received low-flow supplemental oxygen. A higher proportion of the admitted patients received HFNC during the second surge than during the first surge, while the intubation rate was lower during the second surge than during the first surge.
Reported low-flow supplemental oxygen use ranged from 28% to 63% depending on the cohort characteristics and location during the first surge.6,7,19 A report from New York during the first surge (March 1 to April 4, 2020) showed that among 5700 hospitalized patients with COVID-19, 27.8% received low-flow supplemental oxygen.7 HFNC is recommended in guidelines on management of patients with acute respiratory failure due to COVID-19.20 In our study, HFNC was utilized in a higher proportion of patients admitted for COVID-19 during the second surge (15.5% vs 10.8%, P = .0001). During the early pandemic period in Wuhan, China, 11% to 21% of admitted COVID-19 patients received HFNC.21,22 Utilization of HFNC in New York during the first surge (March to May 2020) varied from 5% to 14.3% of patients admitted with COVID-19.23,24 Our subgroup analysis of the ventilated patients showed that patients who received HFNC had lower mortality than those who did not (31.6% vs 48.0%, P = .011). Comparably, a report from Paris, France, showed that among patients admitted to ICUs for acute hypoxemic respiratory failure, those who received HFNC had lower mortality at day 60 than those who did not (21% vs 31%, P = .052).25 Our recent analysis showed that patients treated with HFNC prior to mechanical ventilation had lower mortality than those treated with only conventional oxygen (30% vs 52%, P = .05).26 In this subgroup analysis, we could not determine if HFNC treatment was administered before or after ventilation because HFNC was entered as dichotomous data (“Yes” or “No”) in the registry database. We merely showed the beneficial effect of HFNC on reducing mortality for ventilated COVID-19 patients, but did not mean to focus on how and when to apply HFNC.
We observed that the patients admitted during the second surge were less likely to be ventilated than the patients admitted during the first surge (5.6% vs 9.7%, P < .0001). During the first surge in New York, among 5700 patients admitted with COVID-19, 12.2% received invasive mechanical ventilation.7 In another report, also from New York during the first surge, 26.1% of 2015 hospitalized COVID-19 patients received mechanical ventilation.27 In our study, the ventilation rate of 9.7% during the first surge was lower.
Outcomes during the second surge were better than during the first surge, including ICU admission rate, hospital and ICU length of stay, ventilator days, and mortality. The mortality was 19.2% during the first surge vs 8.3% during the second surge (P < .0001). The mortality of 19.2% was lower than the 30.6% mortality reported for 2015 hospitalized COVID-19 patients in New York during the first surge.27 A retrospective study showed that early administration of remdesivir was associated with reduced ICU admission, ventilation use, and mortality.28 The RECOVERY clinical trial showed that dexamethasone improved mortality for COVID-19 patients who received respiratory support, but not for patients who did not receive any respiratory support.29 Perhaps some, if not all, of the improvement in ICU admission and mortality during the second surge was attributed to the new medications, such as antivirals and steroids.
The length of hospital stay for patients with moderate to severe COVID-19 varied from 4 to 53 days at different locations of the world, as shown in a meta-analysis by Rees and colleagues.30 Our results showing a length of stay of 6 days during the first surge and 5 days during the second surge fell into the shorter end of this range. In a retrospective analysis of 1643 adults with severe COVID-19 admitted to hospitals in New York City between March 9, 2020 and April 23, 2020, median hospital length of stay was 7 (IQR, 3-14) days.31 For the ventilated patients in our study, the length of stay of 14 days (did not receive HFNC) and 29 days (received HFNC) was much longer. This longer length of stay might be attributed to the patients in our study being older and having more severe comorbidities.
The main purpose of this study was to compare the oxygen therapies and outcomes between 2 surges. It is difficult to associate the clinical outcomes with the oxygen therapies because new therapies and medications were available after the first surge. It was not possible to adjust the outcomes with confounders (other therapies and medications) because the registry data did not include the new therapies and medications.
A strength of this study was that we included a large, balanced number of patients in the first surge and the second surge. We did not plan the sample size in both groups as we could not predict the number of admissions. We set the end date of data collection for analysis as the time when the number of patients admitted during the second surge was similar to the number of patients admitted during the first surge. A limitation was that the registry database was created by the institution and was not designed solely for this study. The data for oxygen therapies were limited to low-flow supplemental oxygen, HFNC, and invasive mechanical ventilation; data for noninvasive ventilation were not included.
Conclusion
At our centers, during the second surge of COVID-19 pandemic, patients hospitalized with COVID-19 infection were more likely to receive HFNC but less likely to be ventilated. Compared to the first surge, the hospitalized patients with COVID-19 infection had a lower ICU admission rate, shorter length of hospital stay, fewer ventilator days, and lower mortality. For ventilated patients, those who received HFNC had lower mortality than those who did not.
Corresponding author: Timothy N. Liesching, MD, 41 Mall Road, Burlington, MA 01805; [email protected]
Disclosures: None reported.
doi:10.12788/jcom.0086
1. Xie J, Covassin N, Fan Z, et al. Association between hypoxemia and mortality in patients with COVID-19. Mayo Clin Proc. 2020;95(6):1138-1147. doi:10.1016/j.mayocp.2020.04.006
2. Asleh R, Asher E, Yagel O, et al. Predictors of hypoxemia and related adverse outcomes in patients hospitalized with COVID-19: a double-center retrospective study. J Clin Med. 2021;10(16):3581. doi:10.3390/jcm10163581
3. Choi KJ, Hong HL, Kim EJ. Association between oxygen saturation/fraction of inhaled oxygen and mortality in patients with COVID-19 associated pneumonia requiring oxygen therapy. Tuberc Respir Dis (Seoul). 2021;84(2):125-133. doi:10.4046/trd.2020.0126
4. Dixit SB. Role of noninvasive oxygen therapy strategies in COVID-19 patients: Where are we going? Indian J Crit Care Med. 2020;24(10):897-898. doi:10.5005/jp-journals-10071-23625
5. Gonzalez-Castro A, Fajardo Campoverde A, Medina A, et al. Non-invasive mechanical ventilation and high-flow oxygen therapy in the COVID-19 pandemic: the value of a draw. Med Intensiva (Engl Ed). 2021;45(5):320-321. doi:10.1016/j.medine.2021.04.001
6. Pan W, Li J, Ou Y, et al. Clinical outcome of standardized oxygen therapy nursing strategy in COVID-19. Ann Palliat Med. 2020;9(4):2171-2177. doi:10.21037/apm-20-1272
7. 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
8. He G, Han Y, Fang Q, et al. Clinical experience of high-flow nasal cannula oxygen therapy in severe COVID-19 patients. Article in Chinese. Zhejiang Da Xue Xue Bao Yi Xue Ban. 2020;49(2):232-239. doi:10.3785/j.issn.1008-9292.2020.03.13
9. Lalla U, Allwood BW, Louw EH, et al. The utility of high-flow nasal cannula oxygen therapy in the management of respiratory failure secondary to COVID-19 pneumonia. S Afr Med J. 2020;110(6):12941.
10. Zhang TT, Dai B, Wang W. Should the high-flow nasal oxygen therapy be used or avoided in COVID-19? J Transl Int Med. 2020;8(2):57-58. doi:10.2478/jtim-2020-0018
11. Agarwal A, Basmaji J, Muttalib F, et al. High-flow nasal cannula for acute hypoxemic respiratory failure in patients with COVID-19: systematic reviews of effectiveness and its risks of aerosolization, dispersion, and infection transmission. Can J Anaesth. 2020;67(9):1217-1248. doi:10.1007/s12630-020-01740-2
12. Geng S, Mei Q, Zhu C, et al. High flow nasal cannula is a good treatment option for COVID-19. Heart Lung. 2020;49(5):444-445. doi:10.1016/j.hrtlng.2020.03.018
13. Feinstein MM, Niforatos JD, Hyun I, et al. Considerations for ventilator triage during the COVID-19 pandemic. Lancet Respir Med. 2020;8(6):e53. doi:10.1016/S2213-2600(20)30192-2
14. Wu Z, McGoogan JM. Characteristics of and important lessons from the coronavirus disease 2019 (COVID-19) outbreak in China: summary of a report of 72314 cases from the Chinese Center for Disease Control and Prevention. JAMA. 2020;323(13):1239-1242. doi:10.1001/jama.2020.2648
15. Rojas-Marte G, Hashmi AT, Khalid M, et al. Outcomes in patients with COVID-19 disease and high oxygen requirements. J Clin Med Res. 2021;13(1):26-37. doi:10.14740/jocmr4405
16. Zhang R, Mylonakis E. In inpatients with COVID-19, none of remdesivir, hydroxychloroquine, lopinavir, or interferon β-1a differed from standard care for in-hospital mortality. Ann Intern Med. 2021;174(2):JC17. doi:10.7326/ACPJ202102160-017
17. Rello J, Waterer GW, Bourdiol A, Roquilly A. COVID-19, steroids and other immunomodulators: The jigsaw is not complete. Anaesth Crit Care Pain Med. 2020;39(6):699-701. doi:10.1016/j.accpm.2020.10.011
18. Dargin J, Stempek S, Lei Y, Gray Jr. A, Liesching T. The effect of a tiered provider staffing model on patient outcomes during the coronavirus disease 2019 pandemic: A single-center observational study. Int J Crit Illn Inj Sci. 2021;11(3). doi:10.4103/ijciis.ijciis_37_21
19. Ni YN, Wang T, Liang BM, Liang ZA. The independent factors associated with oxygen therapy in COVID-19 patients under 65 years old. PLoS One. 2021;16(1):e0245690. doi:10.1371/journal.pone.0245690
20. Alhazzani W, Moller MH, Arabi YM, et al. Surviving Sepsis Campaign: guidelines on the management of critically ill adults with coronavirus disease 2019 (COVID-19). Crit Care Med. 2020;48(6):e440-e469. doi:10.1097/CCM.0000000000004363
21. Wang D, Hu B, Hu C, et al. Clinical characteristics of 138 hospitalized patients with 2019 novel coronavirus-infected pneumonia in Wuhan, China. JAMA. 2020;323(11):1061-1069. doi:10.1001/jama.2020.1585
22. Zhou F, Yu T, Du R, et al. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020;395(10229):1054-1062. doi:10.1016/S0140-6736(20)30566-3
23. Argenziano MG, Bruce SL, Slater CL, et al. Characterization and clinical course of 1000 patients with coronavirus disease 2019 in New York: retrospective case series. BMJ. 2020;369:m1996. doi:10.1136/bmj.m1996
24. Cummings MJ, Baldwin MR, Abrams D, et al. Epidemiology, clinical course, and outcomes of critically ill adults with COVID-19 in New York City: a prospective cohort study. Lancet. 2020;395(10239):1763-1770. doi:10.1016/S0140-6736(20)31189-2
25. Demoule A, Vieillard Baron A, Darmon M, et al. High-flow nasal cannula in critically ill patients with severe COVID-19. Am J Respir Crit Care Med. 2020;202(7):1039-1042. doi:10.1164/rccm.202005-2007LE
26. Hansen CK, Stempek S, Liesching T, Lei Y, Dargin J. Characteristics and outcomes of patients receiving high flow nasal cannula therapy prior to mechanical ventilation in COVID-19 respiratory failure: a prospective observational study. Int J Crit Illn Inj Sci. 2021;11(2):56-60. doi:10.4103/IJCIIS.IJCIIS_181_20
27. van Gerwen M, Alsen M, Little C, et al. Risk factors and outcomes of COVID-19 in New York City; a retrospective cohort study. J Med Virol. 2021;93(2):907-915. doi:10.1002/jmv.26337
28. Hussain Alsayed HA, Saheb Sharif-Askari F, Saheb Sharif-Askari N, Hussain AAS, Hamid Q, Halwani R. Early administration of remdesivir to COVID-19 patients associates with higher recovery rate and lower need for ICU admission: A retrospective cohort study. PLoS One. 2021;16(10):e0258643. doi:10.1371/journal.pone.0258643
29. RECOVERY Collaborative Group, Horby P, Lim WS, et al. Dexamethasone in hospitalized patients with Covid-19. N Engl J Med. 2021;384(8):693-704. doi:10.1056/NEJMoa2021436
30. Rees EM, Nightingale ES, Jafari Y, et al. COVID-19 length of hospital stay: a systematic review and data synthesis. BMC Med. 2020;18(1):270. doi:10.1186/s12916-020-01726-3
31. Anderson M, Bach P, Baldwin MR. Hospital length of stay for severe COVID-19: implications for Remdesivir’s value. medRxiv. 2020;2020.08.10.20171637. doi:10.1101/2020.08.10.20171637
From Lahey Hospital and Medical Center, Burlington, MA (Drs. Liesching and Lei), and Tufts University School of Medicine, Boston, MA (Dr. Liesching)
ABSTRACT
Objective: To compare the utilization of oxygen therapies and clinical outcomes of patients admitted for COVID-19 during the second surge of the pandemic to that of patients admitted during the first surge.
Design: Observational study using a registry database.
Setting: Three hospitals (791 inpatient beds and 76 intensive care unit [ICU] beds) within the Beth Israel Lahey Health system in Massachusetts.
Participants: We included 3183 patients with COVID-19 admitted to hospitals.
Measurements: Baseline data included demographics and comorbidities. Treatments included low-flow supplemental oxygen (2-6 L/min), high-flow oxygen via nasal cannula, and invasive mechanical ventilation. Outcomes included ICU admission, length of stay, ventilator days, and mortality.
Results: A total of 3183 patients were included: 1586 during the first surge and 1597 during the second surge. Compared to the first surge, patients admitted during the second surge had a similar rate of receiving low-flow supplemental oxygen (65.8% vs 64.1%, P = .3), a higher rate of receiving high-flow nasal cannula (15.4% vs 10.8%, P = .0001), and a lower ventilation rate (5.6% vs 9.7%, P < .0001). The outcomes during the second surge were better than those during the first surge: lower ICU admission rate (8.1% vs 12.7%, P < .0001), shorter length of hospital stay (5 vs 6 days, P < .0001), fewer ventilator days (10 vs 16, P = .01), and lower mortality (8.3% vs 19.2%, P < .0001). Among ventilated patients, those who received high-flow nasal cannula had lower mortality.
Conclusion: Compared to the first surge of the COVID-19 pandemic, patients admitted during the second surge had similar likelihood of receiving low-flow supplemental oxygen, were more likely to receive high-flow nasal cannula, were less likely to be ventilated, and had better outcomes.
Keywords: supplemental oxygen, high-flow nasal cannula, ventilator.
The respiratory system receives the major impact of SARS-CoV-2 virus, and hypoxemia has been the predominant diagnosis for patients hospitalized with COVID-19.1,2 During the initial stage of the pandemic, oxygen therapies and mechanical ventilation were the only choices for these patients.3-6 Standard-of-care treatment for patients with COVID-19 during the initial surge included oxygen therapies and mechanical ventilation for hypoxemia and medications for comorbidities and COVID-19–associated sequelae, such as multi-organ dysfunction and failure. A report from New York during the first surge (May 2020) showed that among 5700 hospitalized patients with COVID-19, 27.8% received supplemental oxygen and 12.2% received invasive mechanical ventilation.7 High-flow nasal cannula (HFNC) oxygen delivery has been utilized widely throughout the pandemic due to its superiority over other noninvasive respiratory support techniques.8-12 Mechanical ventilation is always necessary for critically ill patients with acute respiratory distress syndrome. However, ventilator scarcity has become a bottleneck in caring for severely ill patients with COVID-19 during the pandemic.13
The clinical outcomes of hospitalized COVID-19 patients include a high intubation rate, long length of hospital and intensive care unit (ICU) stay, and high mortality.14,15 As the pandemic evolved, new medications, including remdesivir, hydroxychloroquine, lopinavir, or interferon β-1a, were used in addition to the standard of care, but these did not result in significantly different mortality from standard of care.16 Steroids are becoming foundational to the treatment of severe COVID-19 pneumonia, but evidence from high-quality randomized controlled clinical trials is lacking.17
During the first surge from March to May 2020, Massachusetts had the third highest number of COVID-19 cases among states in the United States.18 In early 2021, COVID-19 cases were climbing close to the peak of the second surge in Massachusetts. In this study, we compared utilization of low-flow supplemental oxygen, HFNC, and mechanical ventilation and clinical outcomes of patients admitted to 3 hospitals in Massachusetts during the second surge of the pandemic to that of patients admitted during the first surge.
Methods
Setting
Beth Israel Lahey Health is a system of academic and teaching hospitals with primary care and specialty care providers. We included 3 centers within the Beth Israel Lahey Health system in Massachusetts: Lahey Hospital and Medical Center, with 335 inpatient hospital beds and 52 critical care beds; Beverly Hospital, with 227 beds and 14 critical care beds; and Winchester Hospital, with 229 beds and 10 ICU beds.
Participants
We included patients admitted to the 3 hospitals with COVID-19 as a primary or secondary diagnosis during the first surge of the pandemic (March 1, 2020 to June 15, 2020) and the second surge (November 15, 2020 to January 27, 2021). The timeframe of the first surge was defined as the window between the start date and the end date of data collection. During the time window of the first surge, 1586 patients were included. The start time of the second surge was defined as the date when the data collection was restarted; the end date was set when the number of patients (1597) accumulated was close to the number of patients in the first surge (1586), so that the two groups had similar sample size.
Study Design
A data registry of COVID-19 patients was created by our institution, and the data were prospectively collected starting in March 2020. We retrospectively extracted data on the following from the registry database for this observational study: demographics and baseline comorbidities; the use of low-flow supplemental oxygen, HFNC, and invasive mechanical ventilator; and ICU admission, length of hospital stay, length of ICU stay, and hospital discharge disposition. Start and end times for each oxygen therapy were not entered in the registry. Data about other oxygen therapies, such as noninvasive positive-pressure ventilation, were not collected in the registry database, and therefore were not included in the analysis.
Statistical Analysis
Continuous variables (eg, age) were tested for data distribution normality using the Shapiro-Wilk test. Normally distributed data were tested using unpaired t-tests and displayed as mean (SD). The skewed data were tested using the Wilcoxon rank sum test and displayed as median (interquartile range [IQR]). The categorical variables were compared using chi-square test. Comparisons with P ≤ .05 were considered significantly different. Statistical analysis for this study was generated using Statistical Analysis Software (SAS), version 9.4 for Windows (SAS Institute Inc.).
Results
Baseline Characteristics
We included 3183 patients: 1586 admitted during the first surge and 1597 admitted during the second surge. Baseline characteristics of patients with COVID-19 admitted during the first and second surges are shown in Table 1. Patients admitted during the second surge were older (73 years vs 71 years, P = .01) and had higher rates of hypertension (64.8% vs 59.6%, P = .003) and asthma (12.9% vs 10.7%, P = .049) but a lower rate of interstitial lung disease (3.3% vs 7.7%, P < .001). Sequential organ failure assessment scores at admission and the rates of other comorbidities were not significantly different between the 2 surges.
Oxygen Therapies
The number of patients who were hospitalized and received low-flow supplemental oxygen, and/or HFNC, and/or ventilator in the first surge and the second surge is shown in the Figure. Of all patients included, 2067 (64.9%) received low-flow supplemental oxygen; of these, 374 (18.1%) subsequently received HFNC, and 85 (22.7%) of these subsequently received mechanical ventilation. Of all 3183 patients, 417 (13.1%) received HFNC; 43 of these patients received HFNC without receiving low-flow supplemental oxygen, and 98 (23.5%) subsequently received mechanical ventilation. Out of all 3183 patients, 244 (7.7%) received mechanical ventilation; 98 (40.2%) of these received HFNC while the remaining 146 (59.8%) did not. At the beginning of the first surge, the ratio of patients who received invasive mechanical ventilation to patients who received HFNC was close to 1:1 (10/10); the ratio decreased to 6:10 in May and June 2020. At the beginning of the second surge, the ratio was 8:10 and then decreased to 3:10 in December 2020 and January 2021.
As shown in Table 2, the proportion of patients who received low-flow supplemental oxygen during the second surge was similar to that during the first surge (65.8% vs 64.1%, P = .3). Patients admitted during the second surge were more likely to receive HFNC than patients admitted during the first surge (15.4% vs 10.8%, P = .0001). Patients admitted during the second surge were less likely to be ventilated than the patients admitted during the first surge (5.6% vs 9.7%, P < .0001).
Clinical Outcomes
As shown in Table 3, second surge outcomes were much better than first surge outcomes: the ICU admission rate was lower (8.1% vs 12.7%, P < .0001); patients were more likely to be discharged to home (60.2% vs 47.4%, P < .0001), had a shorter length of hospital stay (5 vs 6 days, P < .0001), and had fewer ventilator days (10 vs 16, P = .01); and mortality was lower (8.3% vs 19.2%, P < .0001). There was a trend that length of ICU stay was shorter during the second surge than during the first surge (7 days vs 9 days, P = .09).
As noted (Figure), the ratio of patients who received invasive mechanical ventilation to patients who received HFNC was decreasing during both the first surge and the second surge. To further analyze the relation between ventilator and HFNC, we performed a subgroup analysis for 244 ventilated patients during both surges to compare outcomes between patients who received HFNC and those who did not receive HFNC (Table 4). Ninety-eight (40%) patients received HFNC. Ventilated patients who received HFNC had lower mortality than those patients who did not receive HFNC (31.6% vs 48%, P = .01), but had a longer length of hospital stay (29 days vs 14 days, P < .0001), longer length of ICU stay (17 days vs 9 days, P < .0001), and a higher number of ventilator days (16 vs 11, P = .001).
Discussion
Our study compared the baseline patient characteristics; utilization of low-flow supplemental oxygen therapy, HFNC, and mechanical ventilation; and clinical outcomes between the first surge (n = 1586) and the second surge (n = 1597) of the COVID-19 pandemic. During both surges, about two-thirds of admitted patients received low-flow supplemental oxygen. A higher proportion of the admitted patients received HFNC during the second surge than during the first surge, while the intubation rate was lower during the second surge than during the first surge.
Reported low-flow supplemental oxygen use ranged from 28% to 63% depending on the cohort characteristics and location during the first surge.6,7,19 A report from New York during the first surge (March 1 to April 4, 2020) showed that among 5700 hospitalized patients with COVID-19, 27.8% received low-flow supplemental oxygen.7 HFNC is recommended in guidelines on management of patients with acute respiratory failure due to COVID-19.20 In our study, HFNC was utilized in a higher proportion of patients admitted for COVID-19 during the second surge (15.5% vs 10.8%, P = .0001). During the early pandemic period in Wuhan, China, 11% to 21% of admitted COVID-19 patients received HFNC.21,22 Utilization of HFNC in New York during the first surge (March to May 2020) varied from 5% to 14.3% of patients admitted with COVID-19.23,24 Our subgroup analysis of the ventilated patients showed that patients who received HFNC had lower mortality than those who did not (31.6% vs 48.0%, P = .011). Comparably, a report from Paris, France, showed that among patients admitted to ICUs for acute hypoxemic respiratory failure, those who received HFNC had lower mortality at day 60 than those who did not (21% vs 31%, P = .052).25 Our recent analysis showed that patients treated with HFNC prior to mechanical ventilation had lower mortality than those treated with only conventional oxygen (30% vs 52%, P = .05).26 In this subgroup analysis, we could not determine if HFNC treatment was administered before or after ventilation because HFNC was entered as dichotomous data (“Yes” or “No”) in the registry database. We merely showed the beneficial effect of HFNC on reducing mortality for ventilated COVID-19 patients, but did not mean to focus on how and when to apply HFNC.
We observed that the patients admitted during the second surge were less likely to be ventilated than the patients admitted during the first surge (5.6% vs 9.7%, P < .0001). During the first surge in New York, among 5700 patients admitted with COVID-19, 12.2% received invasive mechanical ventilation.7 In another report, also from New York during the first surge, 26.1% of 2015 hospitalized COVID-19 patients received mechanical ventilation.27 In our study, the ventilation rate of 9.7% during the first surge was lower.
Outcomes during the second surge were better than during the first surge, including ICU admission rate, hospital and ICU length of stay, ventilator days, and mortality. The mortality was 19.2% during the first surge vs 8.3% during the second surge (P < .0001). The mortality of 19.2% was lower than the 30.6% mortality reported for 2015 hospitalized COVID-19 patients in New York during the first surge.27 A retrospective study showed that early administration of remdesivir was associated with reduced ICU admission, ventilation use, and mortality.28 The RECOVERY clinical trial showed that dexamethasone improved mortality for COVID-19 patients who received respiratory support, but not for patients who did not receive any respiratory support.29 Perhaps some, if not all, of the improvement in ICU admission and mortality during the second surge was attributed to the new medications, such as antivirals and steroids.
The length of hospital stay for patients with moderate to severe COVID-19 varied from 4 to 53 days at different locations of the world, as shown in a meta-analysis by Rees and colleagues.30 Our results showing a length of stay of 6 days during the first surge and 5 days during the second surge fell into the shorter end of this range. In a retrospective analysis of 1643 adults with severe COVID-19 admitted to hospitals in New York City between March 9, 2020 and April 23, 2020, median hospital length of stay was 7 (IQR, 3-14) days.31 For the ventilated patients in our study, the length of stay of 14 days (did not receive HFNC) and 29 days (received HFNC) was much longer. This longer length of stay might be attributed to the patients in our study being older and having more severe comorbidities.
The main purpose of this study was to compare the oxygen therapies and outcomes between 2 surges. It is difficult to associate the clinical outcomes with the oxygen therapies because new therapies and medications were available after the first surge. It was not possible to adjust the outcomes with confounders (other therapies and medications) because the registry data did not include the new therapies and medications.
A strength of this study was that we included a large, balanced number of patients in the first surge and the second surge. We did not plan the sample size in both groups as we could not predict the number of admissions. We set the end date of data collection for analysis as the time when the number of patients admitted during the second surge was similar to the number of patients admitted during the first surge. A limitation was that the registry database was created by the institution and was not designed solely for this study. The data for oxygen therapies were limited to low-flow supplemental oxygen, HFNC, and invasive mechanical ventilation; data for noninvasive ventilation were not included.
Conclusion
At our centers, during the second surge of COVID-19 pandemic, patients hospitalized with COVID-19 infection were more likely to receive HFNC but less likely to be ventilated. Compared to the first surge, the hospitalized patients with COVID-19 infection had a lower ICU admission rate, shorter length of hospital stay, fewer ventilator days, and lower mortality. For ventilated patients, those who received HFNC had lower mortality than those who did not.
Corresponding author: Timothy N. Liesching, MD, 41 Mall Road, Burlington, MA 01805; [email protected]
Disclosures: None reported.
doi:10.12788/jcom.0086
From Lahey Hospital and Medical Center, Burlington, MA (Drs. Liesching and Lei), and Tufts University School of Medicine, Boston, MA (Dr. Liesching)
ABSTRACT
Objective: To compare the utilization of oxygen therapies and clinical outcomes of patients admitted for COVID-19 during the second surge of the pandemic to that of patients admitted during the first surge.
Design: Observational study using a registry database.
Setting: Three hospitals (791 inpatient beds and 76 intensive care unit [ICU] beds) within the Beth Israel Lahey Health system in Massachusetts.
Participants: We included 3183 patients with COVID-19 admitted to hospitals.
Measurements: Baseline data included demographics and comorbidities. Treatments included low-flow supplemental oxygen (2-6 L/min), high-flow oxygen via nasal cannula, and invasive mechanical ventilation. Outcomes included ICU admission, length of stay, ventilator days, and mortality.
Results: A total of 3183 patients were included: 1586 during the first surge and 1597 during the second surge. Compared to the first surge, patients admitted during the second surge had a similar rate of receiving low-flow supplemental oxygen (65.8% vs 64.1%, P = .3), a higher rate of receiving high-flow nasal cannula (15.4% vs 10.8%, P = .0001), and a lower ventilation rate (5.6% vs 9.7%, P < .0001). The outcomes during the second surge were better than those during the first surge: lower ICU admission rate (8.1% vs 12.7%, P < .0001), shorter length of hospital stay (5 vs 6 days, P < .0001), fewer ventilator days (10 vs 16, P = .01), and lower mortality (8.3% vs 19.2%, P < .0001). Among ventilated patients, those who received high-flow nasal cannula had lower mortality.
Conclusion: Compared to the first surge of the COVID-19 pandemic, patients admitted during the second surge had similar likelihood of receiving low-flow supplemental oxygen, were more likely to receive high-flow nasal cannula, were less likely to be ventilated, and had better outcomes.
Keywords: supplemental oxygen, high-flow nasal cannula, ventilator.
The respiratory system receives the major impact of SARS-CoV-2 virus, and hypoxemia has been the predominant diagnosis for patients hospitalized with COVID-19.1,2 During the initial stage of the pandemic, oxygen therapies and mechanical ventilation were the only choices for these patients.3-6 Standard-of-care treatment for patients with COVID-19 during the initial surge included oxygen therapies and mechanical ventilation for hypoxemia and medications for comorbidities and COVID-19–associated sequelae, such as multi-organ dysfunction and failure. A report from New York during the first surge (May 2020) showed that among 5700 hospitalized patients with COVID-19, 27.8% received supplemental oxygen and 12.2% received invasive mechanical ventilation.7 High-flow nasal cannula (HFNC) oxygen delivery has been utilized widely throughout the pandemic due to its superiority over other noninvasive respiratory support techniques.8-12 Mechanical ventilation is always necessary for critically ill patients with acute respiratory distress syndrome. However, ventilator scarcity has become a bottleneck in caring for severely ill patients with COVID-19 during the pandemic.13
The clinical outcomes of hospitalized COVID-19 patients include a high intubation rate, long length of hospital and intensive care unit (ICU) stay, and high mortality.14,15 As the pandemic evolved, new medications, including remdesivir, hydroxychloroquine, lopinavir, or interferon β-1a, were used in addition to the standard of care, but these did not result in significantly different mortality from standard of care.16 Steroids are becoming foundational to the treatment of severe COVID-19 pneumonia, but evidence from high-quality randomized controlled clinical trials is lacking.17
During the first surge from March to May 2020, Massachusetts had the third highest number of COVID-19 cases among states in the United States.18 In early 2021, COVID-19 cases were climbing close to the peak of the second surge in Massachusetts. In this study, we compared utilization of low-flow supplemental oxygen, HFNC, and mechanical ventilation and clinical outcomes of patients admitted to 3 hospitals in Massachusetts during the second surge of the pandemic to that of patients admitted during the first surge.
Methods
Setting
Beth Israel Lahey Health is a system of academic and teaching hospitals with primary care and specialty care providers. We included 3 centers within the Beth Israel Lahey Health system in Massachusetts: Lahey Hospital and Medical Center, with 335 inpatient hospital beds and 52 critical care beds; Beverly Hospital, with 227 beds and 14 critical care beds; and Winchester Hospital, with 229 beds and 10 ICU beds.
Participants
We included patients admitted to the 3 hospitals with COVID-19 as a primary or secondary diagnosis during the first surge of the pandemic (March 1, 2020 to June 15, 2020) and the second surge (November 15, 2020 to January 27, 2021). The timeframe of the first surge was defined as the window between the start date and the end date of data collection. During the time window of the first surge, 1586 patients were included. The start time of the second surge was defined as the date when the data collection was restarted; the end date was set when the number of patients (1597) accumulated was close to the number of patients in the first surge (1586), so that the two groups had similar sample size.
Study Design
A data registry of COVID-19 patients was created by our institution, and the data were prospectively collected starting in March 2020. We retrospectively extracted data on the following from the registry database for this observational study: demographics and baseline comorbidities; the use of low-flow supplemental oxygen, HFNC, and invasive mechanical ventilator; and ICU admission, length of hospital stay, length of ICU stay, and hospital discharge disposition. Start and end times for each oxygen therapy were not entered in the registry. Data about other oxygen therapies, such as noninvasive positive-pressure ventilation, were not collected in the registry database, and therefore were not included in the analysis.
Statistical Analysis
Continuous variables (eg, age) were tested for data distribution normality using the Shapiro-Wilk test. Normally distributed data were tested using unpaired t-tests and displayed as mean (SD). The skewed data were tested using the Wilcoxon rank sum test and displayed as median (interquartile range [IQR]). The categorical variables were compared using chi-square test. Comparisons with P ≤ .05 were considered significantly different. Statistical analysis for this study was generated using Statistical Analysis Software (SAS), version 9.4 for Windows (SAS Institute Inc.).
Results
Baseline Characteristics
We included 3183 patients: 1586 admitted during the first surge and 1597 admitted during the second surge. Baseline characteristics of patients with COVID-19 admitted during the first and second surges are shown in Table 1. Patients admitted during the second surge were older (73 years vs 71 years, P = .01) and had higher rates of hypertension (64.8% vs 59.6%, P = .003) and asthma (12.9% vs 10.7%, P = .049) but a lower rate of interstitial lung disease (3.3% vs 7.7%, P < .001). Sequential organ failure assessment scores at admission and the rates of other comorbidities were not significantly different between the 2 surges.
Oxygen Therapies
The number of patients who were hospitalized and received low-flow supplemental oxygen, and/or HFNC, and/or ventilator in the first surge and the second surge is shown in the Figure. Of all patients included, 2067 (64.9%) received low-flow supplemental oxygen; of these, 374 (18.1%) subsequently received HFNC, and 85 (22.7%) of these subsequently received mechanical ventilation. Of all 3183 patients, 417 (13.1%) received HFNC; 43 of these patients received HFNC without receiving low-flow supplemental oxygen, and 98 (23.5%) subsequently received mechanical ventilation. Out of all 3183 patients, 244 (7.7%) received mechanical ventilation; 98 (40.2%) of these received HFNC while the remaining 146 (59.8%) did not. At the beginning of the first surge, the ratio of patients who received invasive mechanical ventilation to patients who received HFNC was close to 1:1 (10/10); the ratio decreased to 6:10 in May and June 2020. At the beginning of the second surge, the ratio was 8:10 and then decreased to 3:10 in December 2020 and January 2021.
As shown in Table 2, the proportion of patients who received low-flow supplemental oxygen during the second surge was similar to that during the first surge (65.8% vs 64.1%, P = .3). Patients admitted during the second surge were more likely to receive HFNC than patients admitted during the first surge (15.4% vs 10.8%, P = .0001). Patients admitted during the second surge were less likely to be ventilated than the patients admitted during the first surge (5.6% vs 9.7%, P < .0001).
Clinical Outcomes
As shown in Table 3, second surge outcomes were much better than first surge outcomes: the ICU admission rate was lower (8.1% vs 12.7%, P < .0001); patients were more likely to be discharged to home (60.2% vs 47.4%, P < .0001), had a shorter length of hospital stay (5 vs 6 days, P < .0001), and had fewer ventilator days (10 vs 16, P = .01); and mortality was lower (8.3% vs 19.2%, P < .0001). There was a trend that length of ICU stay was shorter during the second surge than during the first surge (7 days vs 9 days, P = .09).
As noted (Figure), the ratio of patients who received invasive mechanical ventilation to patients who received HFNC was decreasing during both the first surge and the second surge. To further analyze the relation between ventilator and HFNC, we performed a subgroup analysis for 244 ventilated patients during both surges to compare outcomes between patients who received HFNC and those who did not receive HFNC (Table 4). Ninety-eight (40%) patients received HFNC. Ventilated patients who received HFNC had lower mortality than those patients who did not receive HFNC (31.6% vs 48%, P = .01), but had a longer length of hospital stay (29 days vs 14 days, P < .0001), longer length of ICU stay (17 days vs 9 days, P < .0001), and a higher number of ventilator days (16 vs 11, P = .001).
Discussion
Our study compared the baseline patient characteristics; utilization of low-flow supplemental oxygen therapy, HFNC, and mechanical ventilation; and clinical outcomes between the first surge (n = 1586) and the second surge (n = 1597) of the COVID-19 pandemic. During both surges, about two-thirds of admitted patients received low-flow supplemental oxygen. A higher proportion of the admitted patients received HFNC during the second surge than during the first surge, while the intubation rate was lower during the second surge than during the first surge.
Reported low-flow supplemental oxygen use ranged from 28% to 63% depending on the cohort characteristics and location during the first surge.6,7,19 A report from New York during the first surge (March 1 to April 4, 2020) showed that among 5700 hospitalized patients with COVID-19, 27.8% received low-flow supplemental oxygen.7 HFNC is recommended in guidelines on management of patients with acute respiratory failure due to COVID-19.20 In our study, HFNC was utilized in a higher proportion of patients admitted for COVID-19 during the second surge (15.5% vs 10.8%, P = .0001). During the early pandemic period in Wuhan, China, 11% to 21% of admitted COVID-19 patients received HFNC.21,22 Utilization of HFNC in New York during the first surge (March to May 2020) varied from 5% to 14.3% of patients admitted with COVID-19.23,24 Our subgroup analysis of the ventilated patients showed that patients who received HFNC had lower mortality than those who did not (31.6% vs 48.0%, P = .011). Comparably, a report from Paris, France, showed that among patients admitted to ICUs for acute hypoxemic respiratory failure, those who received HFNC had lower mortality at day 60 than those who did not (21% vs 31%, P = .052).25 Our recent analysis showed that patients treated with HFNC prior to mechanical ventilation had lower mortality than those treated with only conventional oxygen (30% vs 52%, P = .05).26 In this subgroup analysis, we could not determine if HFNC treatment was administered before or after ventilation because HFNC was entered as dichotomous data (“Yes” or “No”) in the registry database. We merely showed the beneficial effect of HFNC on reducing mortality for ventilated COVID-19 patients, but did not mean to focus on how and when to apply HFNC.
We observed that the patients admitted during the second surge were less likely to be ventilated than the patients admitted during the first surge (5.6% vs 9.7%, P < .0001). During the first surge in New York, among 5700 patients admitted with COVID-19, 12.2% received invasive mechanical ventilation.7 In another report, also from New York during the first surge, 26.1% of 2015 hospitalized COVID-19 patients received mechanical ventilation.27 In our study, the ventilation rate of 9.7% during the first surge was lower.
Outcomes during the second surge were better than during the first surge, including ICU admission rate, hospital and ICU length of stay, ventilator days, and mortality. The mortality was 19.2% during the first surge vs 8.3% during the second surge (P < .0001). The mortality of 19.2% was lower than the 30.6% mortality reported for 2015 hospitalized COVID-19 patients in New York during the first surge.27 A retrospective study showed that early administration of remdesivir was associated with reduced ICU admission, ventilation use, and mortality.28 The RECOVERY clinical trial showed that dexamethasone improved mortality for COVID-19 patients who received respiratory support, but not for patients who did not receive any respiratory support.29 Perhaps some, if not all, of the improvement in ICU admission and mortality during the second surge was attributed to the new medications, such as antivirals and steroids.
The length of hospital stay for patients with moderate to severe COVID-19 varied from 4 to 53 days at different locations of the world, as shown in a meta-analysis by Rees and colleagues.30 Our results showing a length of stay of 6 days during the first surge and 5 days during the second surge fell into the shorter end of this range. In a retrospective analysis of 1643 adults with severe COVID-19 admitted to hospitals in New York City between March 9, 2020 and April 23, 2020, median hospital length of stay was 7 (IQR, 3-14) days.31 For the ventilated patients in our study, the length of stay of 14 days (did not receive HFNC) and 29 days (received HFNC) was much longer. This longer length of stay might be attributed to the patients in our study being older and having more severe comorbidities.
The main purpose of this study was to compare the oxygen therapies and outcomes between 2 surges. It is difficult to associate the clinical outcomes with the oxygen therapies because new therapies and medications were available after the first surge. It was not possible to adjust the outcomes with confounders (other therapies and medications) because the registry data did not include the new therapies and medications.
A strength of this study was that we included a large, balanced number of patients in the first surge and the second surge. We did not plan the sample size in both groups as we could not predict the number of admissions. We set the end date of data collection for analysis as the time when the number of patients admitted during the second surge was similar to the number of patients admitted during the first surge. A limitation was that the registry database was created by the institution and was not designed solely for this study. The data for oxygen therapies were limited to low-flow supplemental oxygen, HFNC, and invasive mechanical ventilation; data for noninvasive ventilation were not included.
Conclusion
At our centers, during the second surge of COVID-19 pandemic, patients hospitalized with COVID-19 infection were more likely to receive HFNC but less likely to be ventilated. Compared to the first surge, the hospitalized patients with COVID-19 infection had a lower ICU admission rate, shorter length of hospital stay, fewer ventilator days, and lower mortality. For ventilated patients, those who received HFNC had lower mortality than those who did not.
Corresponding author: Timothy N. Liesching, MD, 41 Mall Road, Burlington, MA 01805; [email protected]
Disclosures: None reported.
doi:10.12788/jcom.0086
1. Xie J, Covassin N, Fan Z, et al. Association between hypoxemia and mortality in patients with COVID-19. Mayo Clin Proc. 2020;95(6):1138-1147. doi:10.1016/j.mayocp.2020.04.006
2. Asleh R, Asher E, Yagel O, et al. Predictors of hypoxemia and related adverse outcomes in patients hospitalized with COVID-19: a double-center retrospective study. J Clin Med. 2021;10(16):3581. doi:10.3390/jcm10163581
3. Choi KJ, Hong HL, Kim EJ. Association between oxygen saturation/fraction of inhaled oxygen and mortality in patients with COVID-19 associated pneumonia requiring oxygen therapy. Tuberc Respir Dis (Seoul). 2021;84(2):125-133. doi:10.4046/trd.2020.0126
4. Dixit SB. Role of noninvasive oxygen therapy strategies in COVID-19 patients: Where are we going? Indian J Crit Care Med. 2020;24(10):897-898. doi:10.5005/jp-journals-10071-23625
5. Gonzalez-Castro A, Fajardo Campoverde A, Medina A, et al. Non-invasive mechanical ventilation and high-flow oxygen therapy in the COVID-19 pandemic: the value of a draw. Med Intensiva (Engl Ed). 2021;45(5):320-321. doi:10.1016/j.medine.2021.04.001
6. Pan W, Li J, Ou Y, et al. Clinical outcome of standardized oxygen therapy nursing strategy in COVID-19. Ann Palliat Med. 2020;9(4):2171-2177. doi:10.21037/apm-20-1272
7. 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
8. He G, Han Y, Fang Q, et al. Clinical experience of high-flow nasal cannula oxygen therapy in severe COVID-19 patients. Article in Chinese. Zhejiang Da Xue Xue Bao Yi Xue Ban. 2020;49(2):232-239. doi:10.3785/j.issn.1008-9292.2020.03.13
9. Lalla U, Allwood BW, Louw EH, et al. The utility of high-flow nasal cannula oxygen therapy in the management of respiratory failure secondary to COVID-19 pneumonia. S Afr Med J. 2020;110(6):12941.
10. Zhang TT, Dai B, Wang W. Should the high-flow nasal oxygen therapy be used or avoided in COVID-19? J Transl Int Med. 2020;8(2):57-58. doi:10.2478/jtim-2020-0018
11. Agarwal A, Basmaji J, Muttalib F, et al. High-flow nasal cannula for acute hypoxemic respiratory failure in patients with COVID-19: systematic reviews of effectiveness and its risks of aerosolization, dispersion, and infection transmission. Can J Anaesth. 2020;67(9):1217-1248. doi:10.1007/s12630-020-01740-2
12. Geng S, Mei Q, Zhu C, et al. High flow nasal cannula is a good treatment option for COVID-19. Heart Lung. 2020;49(5):444-445. doi:10.1016/j.hrtlng.2020.03.018
13. Feinstein MM, Niforatos JD, Hyun I, et al. Considerations for ventilator triage during the COVID-19 pandemic. Lancet Respir Med. 2020;8(6):e53. doi:10.1016/S2213-2600(20)30192-2
14. Wu Z, McGoogan JM. Characteristics of and important lessons from the coronavirus disease 2019 (COVID-19) outbreak in China: summary of a report of 72314 cases from the Chinese Center for Disease Control and Prevention. JAMA. 2020;323(13):1239-1242. doi:10.1001/jama.2020.2648
15. Rojas-Marte G, Hashmi AT, Khalid M, et al. Outcomes in patients with COVID-19 disease and high oxygen requirements. J Clin Med Res. 2021;13(1):26-37. doi:10.14740/jocmr4405
16. Zhang R, Mylonakis E. In inpatients with COVID-19, none of remdesivir, hydroxychloroquine, lopinavir, or interferon β-1a differed from standard care for in-hospital mortality. Ann Intern Med. 2021;174(2):JC17. doi:10.7326/ACPJ202102160-017
17. Rello J, Waterer GW, Bourdiol A, Roquilly A. COVID-19, steroids and other immunomodulators: The jigsaw is not complete. Anaesth Crit Care Pain Med. 2020;39(6):699-701. doi:10.1016/j.accpm.2020.10.011
18. Dargin J, Stempek S, Lei Y, Gray Jr. A, Liesching T. The effect of a tiered provider staffing model on patient outcomes during the coronavirus disease 2019 pandemic: A single-center observational study. Int J Crit Illn Inj Sci. 2021;11(3). doi:10.4103/ijciis.ijciis_37_21
19. Ni YN, Wang T, Liang BM, Liang ZA. The independent factors associated with oxygen therapy in COVID-19 patients under 65 years old. PLoS One. 2021;16(1):e0245690. doi:10.1371/journal.pone.0245690
20. Alhazzani W, Moller MH, Arabi YM, et al. Surviving Sepsis Campaign: guidelines on the management of critically ill adults with coronavirus disease 2019 (COVID-19). Crit Care Med. 2020;48(6):e440-e469. doi:10.1097/CCM.0000000000004363
21. Wang D, Hu B, Hu C, et al. Clinical characteristics of 138 hospitalized patients with 2019 novel coronavirus-infected pneumonia in Wuhan, China. JAMA. 2020;323(11):1061-1069. doi:10.1001/jama.2020.1585
22. Zhou F, Yu T, Du R, et al. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020;395(10229):1054-1062. doi:10.1016/S0140-6736(20)30566-3
23. Argenziano MG, Bruce SL, Slater CL, et al. Characterization and clinical course of 1000 patients with coronavirus disease 2019 in New York: retrospective case series. BMJ. 2020;369:m1996. doi:10.1136/bmj.m1996
24. Cummings MJ, Baldwin MR, Abrams D, et al. Epidemiology, clinical course, and outcomes of critically ill adults with COVID-19 in New York City: a prospective cohort study. Lancet. 2020;395(10239):1763-1770. doi:10.1016/S0140-6736(20)31189-2
25. Demoule A, Vieillard Baron A, Darmon M, et al. High-flow nasal cannula in critically ill patients with severe COVID-19. Am J Respir Crit Care Med. 2020;202(7):1039-1042. doi:10.1164/rccm.202005-2007LE
26. Hansen CK, Stempek S, Liesching T, Lei Y, Dargin J. Characteristics and outcomes of patients receiving high flow nasal cannula therapy prior to mechanical ventilation in COVID-19 respiratory failure: a prospective observational study. Int J Crit Illn Inj Sci. 2021;11(2):56-60. doi:10.4103/IJCIIS.IJCIIS_181_20
27. van Gerwen M, Alsen M, Little C, et al. Risk factors and outcomes of COVID-19 in New York City; a retrospective cohort study. J Med Virol. 2021;93(2):907-915. doi:10.1002/jmv.26337
28. Hussain Alsayed HA, Saheb Sharif-Askari F, Saheb Sharif-Askari N, Hussain AAS, Hamid Q, Halwani R. Early administration of remdesivir to COVID-19 patients associates with higher recovery rate and lower need for ICU admission: A retrospective cohort study. PLoS One. 2021;16(10):e0258643. doi:10.1371/journal.pone.0258643
29. RECOVERY Collaborative Group, Horby P, Lim WS, et al. Dexamethasone in hospitalized patients with Covid-19. N Engl J Med. 2021;384(8):693-704. doi:10.1056/NEJMoa2021436
30. Rees EM, Nightingale ES, Jafari Y, et al. COVID-19 length of hospital stay: a systematic review and data synthesis. BMC Med. 2020;18(1):270. doi:10.1186/s12916-020-01726-3
31. Anderson M, Bach P, Baldwin MR. Hospital length of stay for severe COVID-19: implications for Remdesivir’s value. medRxiv. 2020;2020.08.10.20171637. doi:10.1101/2020.08.10.20171637
1. Xie J, Covassin N, Fan Z, et al. Association between hypoxemia and mortality in patients with COVID-19. Mayo Clin Proc. 2020;95(6):1138-1147. doi:10.1016/j.mayocp.2020.04.006
2. Asleh R, Asher E, Yagel O, et al. Predictors of hypoxemia and related adverse outcomes in patients hospitalized with COVID-19: a double-center retrospective study. J Clin Med. 2021;10(16):3581. doi:10.3390/jcm10163581
3. Choi KJ, Hong HL, Kim EJ. Association between oxygen saturation/fraction of inhaled oxygen and mortality in patients with COVID-19 associated pneumonia requiring oxygen therapy. Tuberc Respir Dis (Seoul). 2021;84(2):125-133. doi:10.4046/trd.2020.0126
4. Dixit SB. Role of noninvasive oxygen therapy strategies in COVID-19 patients: Where are we going? Indian J Crit Care Med. 2020;24(10):897-898. doi:10.5005/jp-journals-10071-23625
5. Gonzalez-Castro A, Fajardo Campoverde A, Medina A, et al. Non-invasive mechanical ventilation and high-flow oxygen therapy in the COVID-19 pandemic: the value of a draw. Med Intensiva (Engl Ed). 2021;45(5):320-321. doi:10.1016/j.medine.2021.04.001
6. Pan W, Li J, Ou Y, et al. Clinical outcome of standardized oxygen therapy nursing strategy in COVID-19. Ann Palliat Med. 2020;9(4):2171-2177. doi:10.21037/apm-20-1272
7. 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
8. He G, Han Y, Fang Q, et al. Clinical experience of high-flow nasal cannula oxygen therapy in severe COVID-19 patients. Article in Chinese. Zhejiang Da Xue Xue Bao Yi Xue Ban. 2020;49(2):232-239. doi:10.3785/j.issn.1008-9292.2020.03.13
9. Lalla U, Allwood BW, Louw EH, et al. The utility of high-flow nasal cannula oxygen therapy in the management of respiratory failure secondary to COVID-19 pneumonia. S Afr Med J. 2020;110(6):12941.
10. Zhang TT, Dai B, Wang W. Should the high-flow nasal oxygen therapy be used or avoided in COVID-19? J Transl Int Med. 2020;8(2):57-58. doi:10.2478/jtim-2020-0018
11. Agarwal A, Basmaji J, Muttalib F, et al. High-flow nasal cannula for acute hypoxemic respiratory failure in patients with COVID-19: systematic reviews of effectiveness and its risks of aerosolization, dispersion, and infection transmission. Can J Anaesth. 2020;67(9):1217-1248. doi:10.1007/s12630-020-01740-2
12. Geng S, Mei Q, Zhu C, et al. High flow nasal cannula is a good treatment option for COVID-19. Heart Lung. 2020;49(5):444-445. doi:10.1016/j.hrtlng.2020.03.018
13. Feinstein MM, Niforatos JD, Hyun I, et al. Considerations for ventilator triage during the COVID-19 pandemic. Lancet Respir Med. 2020;8(6):e53. doi:10.1016/S2213-2600(20)30192-2
14. Wu Z, McGoogan JM. Characteristics of and important lessons from the coronavirus disease 2019 (COVID-19) outbreak in China: summary of a report of 72314 cases from the Chinese Center for Disease Control and Prevention. JAMA. 2020;323(13):1239-1242. doi:10.1001/jama.2020.2648
15. Rojas-Marte G, Hashmi AT, Khalid M, et al. Outcomes in patients with COVID-19 disease and high oxygen requirements. J Clin Med Res. 2021;13(1):26-37. doi:10.14740/jocmr4405
16. Zhang R, Mylonakis E. In inpatients with COVID-19, none of remdesivir, hydroxychloroquine, lopinavir, or interferon β-1a differed from standard care for in-hospital mortality. Ann Intern Med. 2021;174(2):JC17. doi:10.7326/ACPJ202102160-017
17. Rello J, Waterer GW, Bourdiol A, Roquilly A. COVID-19, steroids and other immunomodulators: The jigsaw is not complete. Anaesth Crit Care Pain Med. 2020;39(6):699-701. doi:10.1016/j.accpm.2020.10.011
18. Dargin J, Stempek S, Lei Y, Gray Jr. A, Liesching T. The effect of a tiered provider staffing model on patient outcomes during the coronavirus disease 2019 pandemic: A single-center observational study. Int J Crit Illn Inj Sci. 2021;11(3). doi:10.4103/ijciis.ijciis_37_21
19. Ni YN, Wang T, Liang BM, Liang ZA. The independent factors associated with oxygen therapy in COVID-19 patients under 65 years old. PLoS One. 2021;16(1):e0245690. doi:10.1371/journal.pone.0245690
20. Alhazzani W, Moller MH, Arabi YM, et al. Surviving Sepsis Campaign: guidelines on the management of critically ill adults with coronavirus disease 2019 (COVID-19). Crit Care Med. 2020;48(6):e440-e469. doi:10.1097/CCM.0000000000004363
21. Wang D, Hu B, Hu C, et al. Clinical characteristics of 138 hospitalized patients with 2019 novel coronavirus-infected pneumonia in Wuhan, China. JAMA. 2020;323(11):1061-1069. doi:10.1001/jama.2020.1585
22. Zhou F, Yu T, Du R, et al. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020;395(10229):1054-1062. doi:10.1016/S0140-6736(20)30566-3
23. Argenziano MG, Bruce SL, Slater CL, et al. Characterization and clinical course of 1000 patients with coronavirus disease 2019 in New York: retrospective case series. BMJ. 2020;369:m1996. doi:10.1136/bmj.m1996
24. Cummings MJ, Baldwin MR, Abrams D, et al. Epidemiology, clinical course, and outcomes of critically ill adults with COVID-19 in New York City: a prospective cohort study. Lancet. 2020;395(10239):1763-1770. doi:10.1016/S0140-6736(20)31189-2
25. Demoule A, Vieillard Baron A, Darmon M, et al. High-flow nasal cannula in critically ill patients with severe COVID-19. Am J Respir Crit Care Med. 2020;202(7):1039-1042. doi:10.1164/rccm.202005-2007LE
26. Hansen CK, Stempek S, Liesching T, Lei Y, Dargin J. Characteristics and outcomes of patients receiving high flow nasal cannula therapy prior to mechanical ventilation in COVID-19 respiratory failure: a prospective observational study. Int J Crit Illn Inj Sci. 2021;11(2):56-60. doi:10.4103/IJCIIS.IJCIIS_181_20
27. van Gerwen M, Alsen M, Little C, et al. Risk factors and outcomes of COVID-19 in New York City; a retrospective cohort study. J Med Virol. 2021;93(2):907-915. doi:10.1002/jmv.26337
28. Hussain Alsayed HA, Saheb Sharif-Askari F, Saheb Sharif-Askari N, Hussain AAS, Hamid Q, Halwani R. Early administration of remdesivir to COVID-19 patients associates with higher recovery rate and lower need for ICU admission: A retrospective cohort study. PLoS One. 2021;16(10):e0258643. doi:10.1371/journal.pone.0258643
29. RECOVERY Collaborative Group, Horby P, Lim WS, et al. Dexamethasone in hospitalized patients with Covid-19. N Engl J Med. 2021;384(8):693-704. doi:10.1056/NEJMoa2021436
30. Rees EM, Nightingale ES, Jafari Y, et al. COVID-19 length of hospital stay: a systematic review and data synthesis. BMC Med. 2020;18(1):270. doi:10.1186/s12916-020-01726-3
31. Anderson M, Bach P, Baldwin MR. Hospital length of stay for severe COVID-19: implications for Remdesivir’s value. medRxiv. 2020;2020.08.10.20171637. doi:10.1101/2020.08.10.20171637
Using a Real-Time Prediction Algorithm to Improve Sleep in the Hospital
Study Overview
Objective: This study evaluated whether a clinical-decision-support (CDS) tool that utilizes a real-time algorithm incorporating patient vital sign data can identify hospitalized patients who can forgo overnight vital sign checks and thus reduce delirium incidence.
Design: This was a parallel randomized clinical trial of adult inpatients admitted to the general medical service of a tertiary care academic medical center in the United States. The trial intervention consisted of a CDS notification in the electronic health record (EHR) that informed the physician if a patient had a high likelihood of nighttime vital signs within the reference ranges based on a logistic regression model of real-time patient data input. This notification provided the physician an opportunity to discontinue nighttime vital sign checks, dismiss the notification for 1 hour, or dismiss the notification until the next day.
Setting and participants: This clinical trial was conducted at the University of California, San Francisco Medical Center from March 11 to November 24, 2019. Participants included physicians who served on the primary team (eg, attending, resident) of 1699 patients on the general medical service who were outside of the intensive care unit (ICU). The hospital encounters were randomized (allocation ratio of 1:1) to sleep promotion vitals CDS (SPV CDS) intervention or usual care.
Main outcome and measures: The primary outcome was delirium as determined by bedside nurse assessment using the Nursing Delirium Screening Scale (Nu-DESC) recorded once per nursing shift. The Nu-DESC is a standardized delirium screening tool that defines delirium with a score ≥2. Secondary outcomes included sleep opportunity (ie, EHR-based sleep metrics that reflected the maximum time between iatrogenic interruptions, such as nighttime vital sign checks) and patient satisfaction (ie, patient satisfaction measured by standardized Hospital Consumer Assessment of Healthcare Providers and Systems [HCAHPS] survey). Potential balancing outcomes were assessed to ensure that reduced vital sign checks were not causing harms; these included ICU transfers, rapid response calls, and code blue alarms. All analyses were conducted on the basis of intention-to-treat.
Main results: A total of 3025 inpatient encounters were screened and 1930 encounters were randomized (966 SPV CDS intervention; 964 usual care). The randomized encounters consisted of 1699 patients; demographic factors between the 2 trial arms were similar. Specifically, the intervention arm included 566 men (59%) and mean (SD) age was 53 (15) years. The incidence of delirium was similar between the intervention and usual care arms: 108 (11%) vs 123 (13%) (P = .32). Compared to the usual care arm, the intervention arm had a higher mean (SD) number of sleep opportunity hours per night (4.95 [1.45] vs 4.57 [1.30], P < .001) and fewer nighttime vital sign checks (0.97 [0.95] vs 1.41 [0.86], P < .001). The post-discharge HCAHPS survey measuring patient satisfaction was completed by only 5% of patients (53 intervention, 49 usual care), and survey results were similar between the 2 arms (P = .86). In addition, safety outcomes including ICU transfers (49 [5%] vs 47 [5%], P = .92), rapid response calls (68 [7%] vs 55 [6%], P = .27), and code blue alarms (2 [0.2%] vs 9 [0.9%], P = .07) were similar between the study arms.
Conclusion: In this randomized clinical trial, a CDS tool utilizing a real-time prediction algorithm embedded in EHR did not reduce the incidence of delirium in hospitalized patients. However, this SPV CDS intervention helped physicians identify clinically stable patients who can forgo routine nighttime vital sign checks and facilitated greater opportunity for patients to sleep. These findings suggest that augmenting physician judgment using a real-time prediction algorithm can help to improve sleep opportunity without an accompanying increased risk of clinical decompensation during acute care.
Commentary
High-quality sleep is fundamental to health and well-being. Sleep deprivation and disorders are associated with many adverse health outcomes, including increased risks for obesity, diabetes, hypertension, myocardial infarction, and depression.1 In hospitalized patients who are acutely ill, restorative sleep is critical to facilitating recovery. However, poor sleep is exceedingly common in hospitalized patients and is associated with deleterious outcomes, such as high blood pressure, hyperglycemia, and delirium.2,3 Moreover, some of these adverse sleep-induced cardiometabolic outcomes, as well as sleep disruption itself, may persist after hospital discharge.4 Factors that precipitate interrupted sleep during hospitalization include iatrogenic causes such as frequent vital sign checks, nighttime procedures or early morning blood draws, and environmental factors such as loud ambient noise.3 Thus, a potential intervention to improve sleep quality in the hospital is to reduce nighttime interruptions such as frequent vital sign checks.
In the current study, Najafi and colleagues conducted a randomized trial to evaluate whether a CDS tool embedded in EHR, powered by a real-time prediction algorithm of patient data, can be utilized to identify patients in whom vital sign checks can be safely discontinued at nighttime. The authors found a modest but statistically significant reduction in the number of nighttime vital sign checks in patients who underwent the SPV CDS intervention, and a corresponding higher sleep opportunity per night in those who received the intervention. Importantly, this reduction in nighttime vital sign checks did not cause a higher risk of clinical decompensation as measured by ICU transfers, rapid response calls, or code blue alarms. Thus, the results demonstrated the feasibility of using a real-time, patient data-driven CDS tool to augment physician judgment in managing sleep disruption, an important hospital-associated stressor and a common hazard of hospitalization in older patients.
Delirium is a common clinical problem in hospitalized older patients that is associated with prolonged hospitalization, functional and cognitive decline, institutionalization, death, and increased health care costs.5 Despite a potential benefit of SPV CDS intervention in reducing vital sign checks and increasing sleep opportunity, this intervention did not reduce the incidence of delirium in hospitalized patients. This finding is not surprising given that delirium has a multifactorial etiology (eg, metabolic derangements, infections, medication side effects and drug toxicity, hospital environment). A small modification in nighttime vital sign checks and sleep opportunity may have limited impact on optimizing sleep quality and does not address other risk factors for delirium. As such, a multicomponent nonpharmacologic approach that includes sleep enhancement, early mobilization, feeding assistance, fluid repletion, infection prevention, and other interventions should guide delirium prevention in the hospital setting. The SPV CDS intervention may play a role in the delivery of a multifaceted, nonpharmacologic delirium prevention intervention in high-risk individuals.
Sleep disruption is one of the multiple hazards of hospitalization frequently experience by hospitalized older patients. Other hazards, or hospital-associated stressors, include mobility restriction (eg, physical restraints such as urinary catheters and intravenous lines, bed elevation and rails), malnourishment and dehydration (eg, frequent use of no-food-by-mouth order, lack of easy access to hydration), and pain (eg, poor pain control). Extended exposures to these stressors may lead to a maladaptive state called allostatic overload that transiently increases vulnerability to post-hospitalization adverse events, including emergency department use, hospital readmission, or death (ie, post-hospital syndrome).6 Thus, the optimization of sleep during hospitalization in vulnerable patients may have benefits that extend beyond delirium prevention. It is perceivable that a CDS tool embedded in EHR, powered by a real-time prediction algorithm of patient data, may be applied to reduce some of these hazards of hospitalization in addition to improving sleep opportunity.
Applications for Clinical Practice
Findings from the current study indicate that a CDS tool embedded in EHR that utilizes a real-time prediction algorithm of patient data may help to safely improve sleep opportunity in hospitalized patients. The participants in the current study were relatively young (53 [15] years). Given that age is a risk factor for delirium, the effects of this intervention on delirium prevention in the most susceptible population (ie, those over the age of 65) remain unknown and further investigation is warranted. Additional studies are needed to determine whether this approach yields similar results in geriatric patients and improves clinical outcomes.
—Fred Ko, MD
1. Institute of Medicine (US) Committee on Sleep Medicine and Research. Sleep Disorders and Sleep Deprivation: An Unmet Public Health Problem. Colten HR, Altevogt BM, editors. National Academies Press (US); 2006.
2. Pilkington S. Causes and consequences of sleep deprivation in hospitalised patients. Nurs Stand. 2013;27(49):350-342. doi:10.7748/ns2013.08.27.49.35.e7649
3. Stewart NH, Arora VM. Sleep in hospitalized older adults. Sleep Med Clin. 2018;13(1):127-135. doi:10.1016/j.jsmc.2017.09.012
4. Altman MT, Knauert MP, Pisani MA. Sleep disturbance after hospitalization and critical illness: a systematic review. Ann Am Thorac Soc. 2017;14(9):1457-1468. doi:10.1513/AnnalsATS.201702-148SR
5. Oh ES, Fong TG, Hshieh TT, Inouye SK. Delirium in older persons: advances in diagnosis and treatment. JAMA. 2017;318(12):1161-1174. doi:10.1001/jama.2017.12067
6. Goldwater DS, Dharmarajan K, McEwan BS, Krumholz HM. Is posthospital syndrome a result of hospitalization-induced allostatic overload? J Hosp Med. 2018;13(5). doi:10.12788/jhm.2986
Study Overview
Objective: This study evaluated whether a clinical-decision-support (CDS) tool that utilizes a real-time algorithm incorporating patient vital sign data can identify hospitalized patients who can forgo overnight vital sign checks and thus reduce delirium incidence.
Design: This was a parallel randomized clinical trial of adult inpatients admitted to the general medical service of a tertiary care academic medical center in the United States. The trial intervention consisted of a CDS notification in the electronic health record (EHR) that informed the physician if a patient had a high likelihood of nighttime vital signs within the reference ranges based on a logistic regression model of real-time patient data input. This notification provided the physician an opportunity to discontinue nighttime vital sign checks, dismiss the notification for 1 hour, or dismiss the notification until the next day.
Setting and participants: This clinical trial was conducted at the University of California, San Francisco Medical Center from March 11 to November 24, 2019. Participants included physicians who served on the primary team (eg, attending, resident) of 1699 patients on the general medical service who were outside of the intensive care unit (ICU). The hospital encounters were randomized (allocation ratio of 1:1) to sleep promotion vitals CDS (SPV CDS) intervention or usual care.
Main outcome and measures: The primary outcome was delirium as determined by bedside nurse assessment using the Nursing Delirium Screening Scale (Nu-DESC) recorded once per nursing shift. The Nu-DESC is a standardized delirium screening tool that defines delirium with a score ≥2. Secondary outcomes included sleep opportunity (ie, EHR-based sleep metrics that reflected the maximum time between iatrogenic interruptions, such as nighttime vital sign checks) and patient satisfaction (ie, patient satisfaction measured by standardized Hospital Consumer Assessment of Healthcare Providers and Systems [HCAHPS] survey). Potential balancing outcomes were assessed to ensure that reduced vital sign checks were not causing harms; these included ICU transfers, rapid response calls, and code blue alarms. All analyses were conducted on the basis of intention-to-treat.
Main results: A total of 3025 inpatient encounters were screened and 1930 encounters were randomized (966 SPV CDS intervention; 964 usual care). The randomized encounters consisted of 1699 patients; demographic factors between the 2 trial arms were similar. Specifically, the intervention arm included 566 men (59%) and mean (SD) age was 53 (15) years. The incidence of delirium was similar between the intervention and usual care arms: 108 (11%) vs 123 (13%) (P = .32). Compared to the usual care arm, the intervention arm had a higher mean (SD) number of sleep opportunity hours per night (4.95 [1.45] vs 4.57 [1.30], P < .001) and fewer nighttime vital sign checks (0.97 [0.95] vs 1.41 [0.86], P < .001). The post-discharge HCAHPS survey measuring patient satisfaction was completed by only 5% of patients (53 intervention, 49 usual care), and survey results were similar between the 2 arms (P = .86). In addition, safety outcomes including ICU transfers (49 [5%] vs 47 [5%], P = .92), rapid response calls (68 [7%] vs 55 [6%], P = .27), and code blue alarms (2 [0.2%] vs 9 [0.9%], P = .07) were similar between the study arms.
Conclusion: In this randomized clinical trial, a CDS tool utilizing a real-time prediction algorithm embedded in EHR did not reduce the incidence of delirium in hospitalized patients. However, this SPV CDS intervention helped physicians identify clinically stable patients who can forgo routine nighttime vital sign checks and facilitated greater opportunity for patients to sleep. These findings suggest that augmenting physician judgment using a real-time prediction algorithm can help to improve sleep opportunity without an accompanying increased risk of clinical decompensation during acute care.
Commentary
High-quality sleep is fundamental to health and well-being. Sleep deprivation and disorders are associated with many adverse health outcomes, including increased risks for obesity, diabetes, hypertension, myocardial infarction, and depression.1 In hospitalized patients who are acutely ill, restorative sleep is critical to facilitating recovery. However, poor sleep is exceedingly common in hospitalized patients and is associated with deleterious outcomes, such as high blood pressure, hyperglycemia, and delirium.2,3 Moreover, some of these adverse sleep-induced cardiometabolic outcomes, as well as sleep disruption itself, may persist after hospital discharge.4 Factors that precipitate interrupted sleep during hospitalization include iatrogenic causes such as frequent vital sign checks, nighttime procedures or early morning blood draws, and environmental factors such as loud ambient noise.3 Thus, a potential intervention to improve sleep quality in the hospital is to reduce nighttime interruptions such as frequent vital sign checks.
In the current study, Najafi and colleagues conducted a randomized trial to evaluate whether a CDS tool embedded in EHR, powered by a real-time prediction algorithm of patient data, can be utilized to identify patients in whom vital sign checks can be safely discontinued at nighttime. The authors found a modest but statistically significant reduction in the number of nighttime vital sign checks in patients who underwent the SPV CDS intervention, and a corresponding higher sleep opportunity per night in those who received the intervention. Importantly, this reduction in nighttime vital sign checks did not cause a higher risk of clinical decompensation as measured by ICU transfers, rapid response calls, or code blue alarms. Thus, the results demonstrated the feasibility of using a real-time, patient data-driven CDS tool to augment physician judgment in managing sleep disruption, an important hospital-associated stressor and a common hazard of hospitalization in older patients.
Delirium is a common clinical problem in hospitalized older patients that is associated with prolonged hospitalization, functional and cognitive decline, institutionalization, death, and increased health care costs.5 Despite a potential benefit of SPV CDS intervention in reducing vital sign checks and increasing sleep opportunity, this intervention did not reduce the incidence of delirium in hospitalized patients. This finding is not surprising given that delirium has a multifactorial etiology (eg, metabolic derangements, infections, medication side effects and drug toxicity, hospital environment). A small modification in nighttime vital sign checks and sleep opportunity may have limited impact on optimizing sleep quality and does not address other risk factors for delirium. As such, a multicomponent nonpharmacologic approach that includes sleep enhancement, early mobilization, feeding assistance, fluid repletion, infection prevention, and other interventions should guide delirium prevention in the hospital setting. The SPV CDS intervention may play a role in the delivery of a multifaceted, nonpharmacologic delirium prevention intervention in high-risk individuals.
Sleep disruption is one of the multiple hazards of hospitalization frequently experience by hospitalized older patients. Other hazards, or hospital-associated stressors, include mobility restriction (eg, physical restraints such as urinary catheters and intravenous lines, bed elevation and rails), malnourishment and dehydration (eg, frequent use of no-food-by-mouth order, lack of easy access to hydration), and pain (eg, poor pain control). Extended exposures to these stressors may lead to a maladaptive state called allostatic overload that transiently increases vulnerability to post-hospitalization adverse events, including emergency department use, hospital readmission, or death (ie, post-hospital syndrome).6 Thus, the optimization of sleep during hospitalization in vulnerable patients may have benefits that extend beyond delirium prevention. It is perceivable that a CDS tool embedded in EHR, powered by a real-time prediction algorithm of patient data, may be applied to reduce some of these hazards of hospitalization in addition to improving sleep opportunity.
Applications for Clinical Practice
Findings from the current study indicate that a CDS tool embedded in EHR that utilizes a real-time prediction algorithm of patient data may help to safely improve sleep opportunity in hospitalized patients. The participants in the current study were relatively young (53 [15] years). Given that age is a risk factor for delirium, the effects of this intervention on delirium prevention in the most susceptible population (ie, those over the age of 65) remain unknown and further investigation is warranted. Additional studies are needed to determine whether this approach yields similar results in geriatric patients and improves clinical outcomes.
—Fred Ko, MD
Study Overview
Objective: This study evaluated whether a clinical-decision-support (CDS) tool that utilizes a real-time algorithm incorporating patient vital sign data can identify hospitalized patients who can forgo overnight vital sign checks and thus reduce delirium incidence.
Design: This was a parallel randomized clinical trial of adult inpatients admitted to the general medical service of a tertiary care academic medical center in the United States. The trial intervention consisted of a CDS notification in the electronic health record (EHR) that informed the physician if a patient had a high likelihood of nighttime vital signs within the reference ranges based on a logistic regression model of real-time patient data input. This notification provided the physician an opportunity to discontinue nighttime vital sign checks, dismiss the notification for 1 hour, or dismiss the notification until the next day.
Setting and participants: This clinical trial was conducted at the University of California, San Francisco Medical Center from March 11 to November 24, 2019. Participants included physicians who served on the primary team (eg, attending, resident) of 1699 patients on the general medical service who were outside of the intensive care unit (ICU). The hospital encounters were randomized (allocation ratio of 1:1) to sleep promotion vitals CDS (SPV CDS) intervention or usual care.
Main outcome and measures: The primary outcome was delirium as determined by bedside nurse assessment using the Nursing Delirium Screening Scale (Nu-DESC) recorded once per nursing shift. The Nu-DESC is a standardized delirium screening tool that defines delirium with a score ≥2. Secondary outcomes included sleep opportunity (ie, EHR-based sleep metrics that reflected the maximum time between iatrogenic interruptions, such as nighttime vital sign checks) and patient satisfaction (ie, patient satisfaction measured by standardized Hospital Consumer Assessment of Healthcare Providers and Systems [HCAHPS] survey). Potential balancing outcomes were assessed to ensure that reduced vital sign checks were not causing harms; these included ICU transfers, rapid response calls, and code blue alarms. All analyses were conducted on the basis of intention-to-treat.
Main results: A total of 3025 inpatient encounters were screened and 1930 encounters were randomized (966 SPV CDS intervention; 964 usual care). The randomized encounters consisted of 1699 patients; demographic factors between the 2 trial arms were similar. Specifically, the intervention arm included 566 men (59%) and mean (SD) age was 53 (15) years. The incidence of delirium was similar between the intervention and usual care arms: 108 (11%) vs 123 (13%) (P = .32). Compared to the usual care arm, the intervention arm had a higher mean (SD) number of sleep opportunity hours per night (4.95 [1.45] vs 4.57 [1.30], P < .001) and fewer nighttime vital sign checks (0.97 [0.95] vs 1.41 [0.86], P < .001). The post-discharge HCAHPS survey measuring patient satisfaction was completed by only 5% of patients (53 intervention, 49 usual care), and survey results were similar between the 2 arms (P = .86). In addition, safety outcomes including ICU transfers (49 [5%] vs 47 [5%], P = .92), rapid response calls (68 [7%] vs 55 [6%], P = .27), and code blue alarms (2 [0.2%] vs 9 [0.9%], P = .07) were similar between the study arms.
Conclusion: In this randomized clinical trial, a CDS tool utilizing a real-time prediction algorithm embedded in EHR did not reduce the incidence of delirium in hospitalized patients. However, this SPV CDS intervention helped physicians identify clinically stable patients who can forgo routine nighttime vital sign checks and facilitated greater opportunity for patients to sleep. These findings suggest that augmenting physician judgment using a real-time prediction algorithm can help to improve sleep opportunity without an accompanying increased risk of clinical decompensation during acute care.
Commentary
High-quality sleep is fundamental to health and well-being. Sleep deprivation and disorders are associated with many adverse health outcomes, including increased risks for obesity, diabetes, hypertension, myocardial infarction, and depression.1 In hospitalized patients who are acutely ill, restorative sleep is critical to facilitating recovery. However, poor sleep is exceedingly common in hospitalized patients and is associated with deleterious outcomes, such as high blood pressure, hyperglycemia, and delirium.2,3 Moreover, some of these adverse sleep-induced cardiometabolic outcomes, as well as sleep disruption itself, may persist after hospital discharge.4 Factors that precipitate interrupted sleep during hospitalization include iatrogenic causes such as frequent vital sign checks, nighttime procedures or early morning blood draws, and environmental factors such as loud ambient noise.3 Thus, a potential intervention to improve sleep quality in the hospital is to reduce nighttime interruptions such as frequent vital sign checks.
In the current study, Najafi and colleagues conducted a randomized trial to evaluate whether a CDS tool embedded in EHR, powered by a real-time prediction algorithm of patient data, can be utilized to identify patients in whom vital sign checks can be safely discontinued at nighttime. The authors found a modest but statistically significant reduction in the number of nighttime vital sign checks in patients who underwent the SPV CDS intervention, and a corresponding higher sleep opportunity per night in those who received the intervention. Importantly, this reduction in nighttime vital sign checks did not cause a higher risk of clinical decompensation as measured by ICU transfers, rapid response calls, or code blue alarms. Thus, the results demonstrated the feasibility of using a real-time, patient data-driven CDS tool to augment physician judgment in managing sleep disruption, an important hospital-associated stressor and a common hazard of hospitalization in older patients.
Delirium is a common clinical problem in hospitalized older patients that is associated with prolonged hospitalization, functional and cognitive decline, institutionalization, death, and increased health care costs.5 Despite a potential benefit of SPV CDS intervention in reducing vital sign checks and increasing sleep opportunity, this intervention did not reduce the incidence of delirium in hospitalized patients. This finding is not surprising given that delirium has a multifactorial etiology (eg, metabolic derangements, infections, medication side effects and drug toxicity, hospital environment). A small modification in nighttime vital sign checks and sleep opportunity may have limited impact on optimizing sleep quality and does not address other risk factors for delirium. As such, a multicomponent nonpharmacologic approach that includes sleep enhancement, early mobilization, feeding assistance, fluid repletion, infection prevention, and other interventions should guide delirium prevention in the hospital setting. The SPV CDS intervention may play a role in the delivery of a multifaceted, nonpharmacologic delirium prevention intervention in high-risk individuals.
Sleep disruption is one of the multiple hazards of hospitalization frequently experience by hospitalized older patients. Other hazards, or hospital-associated stressors, include mobility restriction (eg, physical restraints such as urinary catheters and intravenous lines, bed elevation and rails), malnourishment and dehydration (eg, frequent use of no-food-by-mouth order, lack of easy access to hydration), and pain (eg, poor pain control). Extended exposures to these stressors may lead to a maladaptive state called allostatic overload that transiently increases vulnerability to post-hospitalization adverse events, including emergency department use, hospital readmission, or death (ie, post-hospital syndrome).6 Thus, the optimization of sleep during hospitalization in vulnerable patients may have benefits that extend beyond delirium prevention. It is perceivable that a CDS tool embedded in EHR, powered by a real-time prediction algorithm of patient data, may be applied to reduce some of these hazards of hospitalization in addition to improving sleep opportunity.
Applications for Clinical Practice
Findings from the current study indicate that a CDS tool embedded in EHR that utilizes a real-time prediction algorithm of patient data may help to safely improve sleep opportunity in hospitalized patients. The participants in the current study were relatively young (53 [15] years). Given that age is a risk factor for delirium, the effects of this intervention on delirium prevention in the most susceptible population (ie, those over the age of 65) remain unknown and further investigation is warranted. Additional studies are needed to determine whether this approach yields similar results in geriatric patients and improves clinical outcomes.
—Fred Ko, MD
1. Institute of Medicine (US) Committee on Sleep Medicine and Research. Sleep Disorders and Sleep Deprivation: An Unmet Public Health Problem. Colten HR, Altevogt BM, editors. National Academies Press (US); 2006.
2. Pilkington S. Causes and consequences of sleep deprivation in hospitalised patients. Nurs Stand. 2013;27(49):350-342. doi:10.7748/ns2013.08.27.49.35.e7649
3. Stewart NH, Arora VM. Sleep in hospitalized older adults. Sleep Med Clin. 2018;13(1):127-135. doi:10.1016/j.jsmc.2017.09.012
4. Altman MT, Knauert MP, Pisani MA. Sleep disturbance after hospitalization and critical illness: a systematic review. Ann Am Thorac Soc. 2017;14(9):1457-1468. doi:10.1513/AnnalsATS.201702-148SR
5. Oh ES, Fong TG, Hshieh TT, Inouye SK. Delirium in older persons: advances in diagnosis and treatment. JAMA. 2017;318(12):1161-1174. doi:10.1001/jama.2017.12067
6. Goldwater DS, Dharmarajan K, McEwan BS, Krumholz HM. Is posthospital syndrome a result of hospitalization-induced allostatic overload? J Hosp Med. 2018;13(5). doi:10.12788/jhm.2986
1. Institute of Medicine (US) Committee on Sleep Medicine and Research. Sleep Disorders and Sleep Deprivation: An Unmet Public Health Problem. Colten HR, Altevogt BM, editors. National Academies Press (US); 2006.
2. Pilkington S. Causes and consequences of sleep deprivation in hospitalised patients. Nurs Stand. 2013;27(49):350-342. doi:10.7748/ns2013.08.27.49.35.e7649
3. Stewart NH, Arora VM. Sleep in hospitalized older adults. Sleep Med Clin. 2018;13(1):127-135. doi:10.1016/j.jsmc.2017.09.012
4. Altman MT, Knauert MP, Pisani MA. Sleep disturbance after hospitalization and critical illness: a systematic review. Ann Am Thorac Soc. 2017;14(9):1457-1468. doi:10.1513/AnnalsATS.201702-148SR
5. Oh ES, Fong TG, Hshieh TT, Inouye SK. Delirium in older persons: advances in diagnosis and treatment. JAMA. 2017;318(12):1161-1174. doi:10.1001/jama.2017.12067
6. Goldwater DS, Dharmarajan K, McEwan BS, Krumholz HM. Is posthospital syndrome a result of hospitalization-induced allostatic overload? J Hosp Med. 2018;13(5). doi:10.12788/jhm.2986
Early Hospital Discharge Following PCI for Patients With STEMI
Study Overview
Objective: To assess the safety and efficacy of early hospital discharge (EHD) for selected low-risk patients with ST-segment elevation myocardial infarction (STEMI) after primary percutaneous coronary intervention (PCI).
Design: Single-center retrospective analysis of prospectively collected data.
Setting and participants: An EHD group comprised of 600 patients who were discharged at <48 hours between April 2020 and June 2021 was compared to a control group of 700 patients who met EHD criteria but were discharged at >48 hour between October 2018 and June 2021. Patients were selected into the EHD group based on the following criteria, in accordance with recommendations from the European Society of Cardiology, and all patients had close follow-up with a combination of structured telephone follow-up at 48 hours post discharge and virtual visits at 2, 6, and 8 weeks and at 3 months:
- Left ventricular ejection fraction ≥40%
- Successful primary PCI (that achieved thrombolysis in myocardial infarction flow grade 3)
- Absence of severe nonculprit disease requiring further inpatient revascularization
- Absence of ischemic symptoms post PCI
- Absence of heart failure or hemodynamic instability
- Absence of significant arrhythmia (ventricular fibrillation, ventricular tachycardia, or atrial fibrillation or atrial flutter requiring prolonged stay)
- Mobility with suitable social circumstances for discharge
Main outcome measures: The outcomes measured were length of hospitalization and a composite primary endpoint of cardiovascular mortality and major adverse cardiovascular event (MACE) rates, defined as a composite of all-cause mortality, recurrent MI, and target lesion revascularization.
Main results: The median length of stay of hospitalization in the EHD group was 24.6 hours compared to 56.1 hours in the >48-hour historical control group. On median follow-up of 271 days, the EHD group demonstrated 0% cardiovascular mortality and a MACE rate of 1.2%. This was shown to be noninferior compared to the >48-hour historical control group, which had mortality of 0.7% and a MACE rate of 1.9%.
Conclusion: Selected low-risk STEMI patients can be safely discharged early with appropriate follow-up after primary PCI.
Commentary
Patients with STEMI have a higher risk of postprocedural adverse events such as MI, arrhythmia, or acute heart failure compared to patients with stable ischemic heart disease, and thus are monitored after primary PCI. Although patients were traditionally monitored for 5 to 7 days a few decades ago,1 with improvements in PCI techniques, devices, and pharmacotherapy as well as in door-to-balloon time, the in-hospital complication rates for patients with STEMI have been decreasing, leading to earlier discharge. Currently in the United States, patients are most commonly monitored for 48 to 72 hours post PCI.2 The current guidelines support this practice, recommending early discharge within 48 to 72 hours in selected low-risk patients if adequate follow-up and rehabilitation are arranged.3
Given the COVID-19 pandemic and decreased hospital bed availability, Rathod et al took one step further on the question of whether low-risk STEMI patients with primary PCI can be discharged safely within 48 hours with adequate follow-up. They found that at a median follow-up of 271 days, EHD patients had 2 COVID-related deaths, with 0% cardiovascular mortality and a MACE rate of 1.2%, including deaths, MI, and ischemic revascularization. The median time to discharge was 25 hours. This was noninferior to the >48-hour historical control group, which had mortality of 0.7% (P = 0.349) and a MACE rate of 1.9% (P = .674). The results remained similar after propensity matching for mortality (0.34% vs 0.69%, P = .410) or MACE (1.2% vs 1.9%, P = .342).
This is the first prospective study to systematically assess the safety and feasibility of discharge of low-risk STEMI patients with primary PCI within 48 hours. This study is unique in that it involved the use of telemedicine, including a virtual platform to collect data such as heart rate, blood pressure, and blood glucose, and virtual visits to facilitate follow-up and reduce clinic travel, cost, and potential COVID-19 exposure. The investigators’ protocol included virtual follow-up by cardiology advanced practitioners at 2, 6, and 8 weeks and by an interventional cardiologist at 12 weeks. This protocol led to an increase in patient satisfaction. The study’s main limitation is that it is a single-center trial with a smaller sample size. Further studies are necessary to confirm the safety and feasibility of this approach. In addition, further refinement of the patient selection criteria for EHD should be considered.
Applications for Clinical Practice
In low-risk STEMI patients after primary PCI, discharge within 48 hours may be considered if close follow-up is arranged. However, further studies are necessary to confirm this finding.
—Thai Nguyen, MD, Albert Chan, MD, and Taishi Hirai MD
1. Grines CL, Marsalese DL, Brodie B, et al. Safety and cost-effectiveness of early discharge after primary angioplasty in low risk patients with acute myocardial infarction. PAMI-II Investigators. Primary Angioplasty in Myocardial Infarction. J Am Coll Cardiol. 1998;31:967-72. doi:10.1016/s0735-1097(98)00031-x
2. Seto AH, Shroff A, Abu-Fadel M, et al. Length of stay following percutaneous coronary intervention: An expert consensus document update from the society for cardiovascular angiography and interventions. Catheter Cardiovasc Interv. 2018;92:717-731. doi:10.1002/ccd.27637
3. Ibanez B, James S, Agewall S, et al. 2017 ESC Guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation. Eur Heart J. 2018;39:119-177. doi:10.1093/eurheartj/ehx393
Study Overview
Objective: To assess the safety and efficacy of early hospital discharge (EHD) for selected low-risk patients with ST-segment elevation myocardial infarction (STEMI) after primary percutaneous coronary intervention (PCI).
Design: Single-center retrospective analysis of prospectively collected data.
Setting and participants: An EHD group comprised of 600 patients who were discharged at <48 hours between April 2020 and June 2021 was compared to a control group of 700 patients who met EHD criteria but were discharged at >48 hour between October 2018 and June 2021. Patients were selected into the EHD group based on the following criteria, in accordance with recommendations from the European Society of Cardiology, and all patients had close follow-up with a combination of structured telephone follow-up at 48 hours post discharge and virtual visits at 2, 6, and 8 weeks and at 3 months:
- Left ventricular ejection fraction ≥40%
- Successful primary PCI (that achieved thrombolysis in myocardial infarction flow grade 3)
- Absence of severe nonculprit disease requiring further inpatient revascularization
- Absence of ischemic symptoms post PCI
- Absence of heart failure or hemodynamic instability
- Absence of significant arrhythmia (ventricular fibrillation, ventricular tachycardia, or atrial fibrillation or atrial flutter requiring prolonged stay)
- Mobility with suitable social circumstances for discharge
Main outcome measures: The outcomes measured were length of hospitalization and a composite primary endpoint of cardiovascular mortality and major adverse cardiovascular event (MACE) rates, defined as a composite of all-cause mortality, recurrent MI, and target lesion revascularization.
Main results: The median length of stay of hospitalization in the EHD group was 24.6 hours compared to 56.1 hours in the >48-hour historical control group. On median follow-up of 271 days, the EHD group demonstrated 0% cardiovascular mortality and a MACE rate of 1.2%. This was shown to be noninferior compared to the >48-hour historical control group, which had mortality of 0.7% and a MACE rate of 1.9%.
Conclusion: Selected low-risk STEMI patients can be safely discharged early with appropriate follow-up after primary PCI.
Commentary
Patients with STEMI have a higher risk of postprocedural adverse events such as MI, arrhythmia, or acute heart failure compared to patients with stable ischemic heart disease, and thus are monitored after primary PCI. Although patients were traditionally monitored for 5 to 7 days a few decades ago,1 with improvements in PCI techniques, devices, and pharmacotherapy as well as in door-to-balloon time, the in-hospital complication rates for patients with STEMI have been decreasing, leading to earlier discharge. Currently in the United States, patients are most commonly monitored for 48 to 72 hours post PCI.2 The current guidelines support this practice, recommending early discharge within 48 to 72 hours in selected low-risk patients if adequate follow-up and rehabilitation are arranged.3
Given the COVID-19 pandemic and decreased hospital bed availability, Rathod et al took one step further on the question of whether low-risk STEMI patients with primary PCI can be discharged safely within 48 hours with adequate follow-up. They found that at a median follow-up of 271 days, EHD patients had 2 COVID-related deaths, with 0% cardiovascular mortality and a MACE rate of 1.2%, including deaths, MI, and ischemic revascularization. The median time to discharge was 25 hours. This was noninferior to the >48-hour historical control group, which had mortality of 0.7% (P = 0.349) and a MACE rate of 1.9% (P = .674). The results remained similar after propensity matching for mortality (0.34% vs 0.69%, P = .410) or MACE (1.2% vs 1.9%, P = .342).
This is the first prospective study to systematically assess the safety and feasibility of discharge of low-risk STEMI patients with primary PCI within 48 hours. This study is unique in that it involved the use of telemedicine, including a virtual platform to collect data such as heart rate, blood pressure, and blood glucose, and virtual visits to facilitate follow-up and reduce clinic travel, cost, and potential COVID-19 exposure. The investigators’ protocol included virtual follow-up by cardiology advanced practitioners at 2, 6, and 8 weeks and by an interventional cardiologist at 12 weeks. This protocol led to an increase in patient satisfaction. The study’s main limitation is that it is a single-center trial with a smaller sample size. Further studies are necessary to confirm the safety and feasibility of this approach. In addition, further refinement of the patient selection criteria for EHD should be considered.
Applications for Clinical Practice
In low-risk STEMI patients after primary PCI, discharge within 48 hours may be considered if close follow-up is arranged. However, further studies are necessary to confirm this finding.
—Thai Nguyen, MD, Albert Chan, MD, and Taishi Hirai MD
Study Overview
Objective: To assess the safety and efficacy of early hospital discharge (EHD) for selected low-risk patients with ST-segment elevation myocardial infarction (STEMI) after primary percutaneous coronary intervention (PCI).
Design: Single-center retrospective analysis of prospectively collected data.
Setting and participants: An EHD group comprised of 600 patients who were discharged at <48 hours between April 2020 and June 2021 was compared to a control group of 700 patients who met EHD criteria but were discharged at >48 hour between October 2018 and June 2021. Patients were selected into the EHD group based on the following criteria, in accordance with recommendations from the European Society of Cardiology, and all patients had close follow-up with a combination of structured telephone follow-up at 48 hours post discharge and virtual visits at 2, 6, and 8 weeks and at 3 months:
- Left ventricular ejection fraction ≥40%
- Successful primary PCI (that achieved thrombolysis in myocardial infarction flow grade 3)
- Absence of severe nonculprit disease requiring further inpatient revascularization
- Absence of ischemic symptoms post PCI
- Absence of heart failure or hemodynamic instability
- Absence of significant arrhythmia (ventricular fibrillation, ventricular tachycardia, or atrial fibrillation or atrial flutter requiring prolonged stay)
- Mobility with suitable social circumstances for discharge
Main outcome measures: The outcomes measured were length of hospitalization and a composite primary endpoint of cardiovascular mortality and major adverse cardiovascular event (MACE) rates, defined as a composite of all-cause mortality, recurrent MI, and target lesion revascularization.
Main results: The median length of stay of hospitalization in the EHD group was 24.6 hours compared to 56.1 hours in the >48-hour historical control group. On median follow-up of 271 days, the EHD group demonstrated 0% cardiovascular mortality and a MACE rate of 1.2%. This was shown to be noninferior compared to the >48-hour historical control group, which had mortality of 0.7% and a MACE rate of 1.9%.
Conclusion: Selected low-risk STEMI patients can be safely discharged early with appropriate follow-up after primary PCI.
Commentary
Patients with STEMI have a higher risk of postprocedural adverse events such as MI, arrhythmia, or acute heart failure compared to patients with stable ischemic heart disease, and thus are monitored after primary PCI. Although patients were traditionally monitored for 5 to 7 days a few decades ago,1 with improvements in PCI techniques, devices, and pharmacotherapy as well as in door-to-balloon time, the in-hospital complication rates for patients with STEMI have been decreasing, leading to earlier discharge. Currently in the United States, patients are most commonly monitored for 48 to 72 hours post PCI.2 The current guidelines support this practice, recommending early discharge within 48 to 72 hours in selected low-risk patients if adequate follow-up and rehabilitation are arranged.3
Given the COVID-19 pandemic and decreased hospital bed availability, Rathod et al took one step further on the question of whether low-risk STEMI patients with primary PCI can be discharged safely within 48 hours with adequate follow-up. They found that at a median follow-up of 271 days, EHD patients had 2 COVID-related deaths, with 0% cardiovascular mortality and a MACE rate of 1.2%, including deaths, MI, and ischemic revascularization. The median time to discharge was 25 hours. This was noninferior to the >48-hour historical control group, which had mortality of 0.7% (P = 0.349) and a MACE rate of 1.9% (P = .674). The results remained similar after propensity matching for mortality (0.34% vs 0.69%, P = .410) or MACE (1.2% vs 1.9%, P = .342).
This is the first prospective study to systematically assess the safety and feasibility of discharge of low-risk STEMI patients with primary PCI within 48 hours. This study is unique in that it involved the use of telemedicine, including a virtual platform to collect data such as heart rate, blood pressure, and blood glucose, and virtual visits to facilitate follow-up and reduce clinic travel, cost, and potential COVID-19 exposure. The investigators’ protocol included virtual follow-up by cardiology advanced practitioners at 2, 6, and 8 weeks and by an interventional cardiologist at 12 weeks. This protocol led to an increase in patient satisfaction. The study’s main limitation is that it is a single-center trial with a smaller sample size. Further studies are necessary to confirm the safety and feasibility of this approach. In addition, further refinement of the patient selection criteria for EHD should be considered.
Applications for Clinical Practice
In low-risk STEMI patients after primary PCI, discharge within 48 hours may be considered if close follow-up is arranged. However, further studies are necessary to confirm this finding.
—Thai Nguyen, MD, Albert Chan, MD, and Taishi Hirai MD
1. Grines CL, Marsalese DL, Brodie B, et al. Safety and cost-effectiveness of early discharge after primary angioplasty in low risk patients with acute myocardial infarction. PAMI-II Investigators. Primary Angioplasty in Myocardial Infarction. J Am Coll Cardiol. 1998;31:967-72. doi:10.1016/s0735-1097(98)00031-x
2. Seto AH, Shroff A, Abu-Fadel M, et al. Length of stay following percutaneous coronary intervention: An expert consensus document update from the society for cardiovascular angiography and interventions. Catheter Cardiovasc Interv. 2018;92:717-731. doi:10.1002/ccd.27637
3. Ibanez B, James S, Agewall S, et al. 2017 ESC Guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation. Eur Heart J. 2018;39:119-177. doi:10.1093/eurheartj/ehx393
1. Grines CL, Marsalese DL, Brodie B, et al. Safety and cost-effectiveness of early discharge after primary angioplasty in low risk patients with acute myocardial infarction. PAMI-II Investigators. Primary Angioplasty in Myocardial Infarction. J Am Coll Cardiol. 1998;31:967-72. doi:10.1016/s0735-1097(98)00031-x
2. Seto AH, Shroff A, Abu-Fadel M, et al. Length of stay following percutaneous coronary intervention: An expert consensus document update from the society for cardiovascular angiography and interventions. Catheter Cardiovasc Interv. 2018;92:717-731. doi:10.1002/ccd.27637
3. Ibanez B, James S, Agewall S, et al. 2017 ESC Guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation. Eur Heart J. 2018;39:119-177. doi:10.1093/eurheartj/ehx393
Cancer patients vulnerable to COVID misinformation
For the past 2 years, oncology practitioners around the world have struggled with the same dilemma: how to maintain their patients’ cancer care without exposing them to COVID-19. Regardless of the country, language, or even which wave of the pandemic, the conversations have likely been very similar: weighing risks versuss benefits, and individualizing each patient’s pandemic cancer plan.
But one question most oncologists have probably overlooked in these discussions is about where their patients get their COVID information – or misinformation.
Surprisingly, this seemingly small detail could make a big difference in a patient’s prognosis.
A recent study found that building on an earlier finding of similar vulnerabilities among parents of children with cancer, compared with parents of healthy children.
“It doesn’t matter what you search for, there is an overwhelming level of information online,” the lead author on both studies, Jeanine Guidry, PhD, from Virginia Commonwealth University’s Massey Cancer Center in Richmond, said in an interview. “If misinformation is the first thing you encounter about a topic, you’re much more likely to believe it and it’s going to be very hard to convince you otherwise.”
Before the pandemic, Dr. Guidry, who is director of the Media+Health Lab at VCU, had already been studying vaccine misinformation on Pinterest and Instagram.
So when data coming out at the start of the pandemic suggested that an increase in pediatric cancer mortality might be partially because of COVID-19 misinformation, she jumped on it.
Dr. Guidry and associates designed a questionnaire involving COVID misinformation statements available online and found that parents of children with cancer were significantly more likely to endorse them, compared with parents of healthy children.
“Our advice to clinicians is you may have an issue here,” Dr. Guidry said in an interview. “You may want to check where they get their news, and if there’s any pieces of misinformation that could be harmful.”
Some beliefs, such as eating more garlic protects against COVID, are not particularly harmful, she acknowledged, but others – such as drinking bleach being protective – are quite harmful, and they often stem from the same misinformation sources.
Both of Dr. Guidry’s studies involved surveys of either adult patients with cancer or parents of children with cancer.
The adult patient survey was conducted June 1-15, 2020, and included 897 respondents, of whom 287 were patients in active treatment for cancer, 301 were survivors not currently in treatment, and 309 had no cancer history.
The parents’ survey, conducted in May 2020, included 735 parents of children aged 2-17 years, 315 of whom had children currently undergoing cancer treatment, and 420 of whom had children with no history of cancer.
Among the misinformation they were asked to agree or disagree with were statements such as “it is unsafe to receive mail from China,” “antibiotics can prevent and treat COVID-19,” and “COVID is less deadly than the ‘flu,’ ” among others.
The surveys revealed that the patients in current treatment for cancer and the parents of patients in current treatment were most likely to endorse COVID misinformation. Results from the parents’ survey showed that “believing misinformation was also more likely for fathers, younger parents, and parents with higher perceived stress from COVID-19,” the authors wrote. Among adult patients and controls, patients in active treatment were most likely to believe misinformation, with cancer survivors no longer in treatment being the least likely to believe it, compared with healthy controls who were in between.
Why the difference? The authors suggested that patients in active treatment “may seek out more information on the internet or via social media where they are more exposed to misinformation,” whereas survivors no longer undergoing treatment may be more “media savvy and have learned to be wary of questionable health information.”
In their articles, Dr. Guidry and associates advised oncologists to be aware of their patients’ potential to endorse COVID misinformation and to “proactively address this in routine visits as well as tailored written materials.” This is easier said than done, she commented, acknowledging that keeping up with the latest misinformation is a challenge.
The misinformation statements her group used in their surveys were popular early in the pandemic, but “some of them have shown fairly remarkable staying power and some have been replaced,” she said. She invited interested clinicians to contact her team for guidance on newer misinformation.
Ultimately, she believes most patients with cancer who endorse misinformation are simply afraid, and looking for help. “They’re already dealing with a level of stress from their illness and then they’re thrown into a pandemic,” Dr. Guidry said. “At some point you just want a solution. Hydroxychloroquine? Great! Horse dewormer? Fantastic! Just wanting to control the situation and not having something else to deal with.”
Both studies were funded by the National Cancer Institute at the National Institutes of Health. The authors disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
For the past 2 years, oncology practitioners around the world have struggled with the same dilemma: how to maintain their patients’ cancer care without exposing them to COVID-19. Regardless of the country, language, or even which wave of the pandemic, the conversations have likely been very similar: weighing risks versuss benefits, and individualizing each patient’s pandemic cancer plan.
But one question most oncologists have probably overlooked in these discussions is about where their patients get their COVID information – or misinformation.
Surprisingly, this seemingly small detail could make a big difference in a patient’s prognosis.
A recent study found that building on an earlier finding of similar vulnerabilities among parents of children with cancer, compared with parents of healthy children.
“It doesn’t matter what you search for, there is an overwhelming level of information online,” the lead author on both studies, Jeanine Guidry, PhD, from Virginia Commonwealth University’s Massey Cancer Center in Richmond, said in an interview. “If misinformation is the first thing you encounter about a topic, you’re much more likely to believe it and it’s going to be very hard to convince you otherwise.”
Before the pandemic, Dr. Guidry, who is director of the Media+Health Lab at VCU, had already been studying vaccine misinformation on Pinterest and Instagram.
So when data coming out at the start of the pandemic suggested that an increase in pediatric cancer mortality might be partially because of COVID-19 misinformation, she jumped on it.
Dr. Guidry and associates designed a questionnaire involving COVID misinformation statements available online and found that parents of children with cancer were significantly more likely to endorse them, compared with parents of healthy children.
“Our advice to clinicians is you may have an issue here,” Dr. Guidry said in an interview. “You may want to check where they get their news, and if there’s any pieces of misinformation that could be harmful.”
Some beliefs, such as eating more garlic protects against COVID, are not particularly harmful, she acknowledged, but others – such as drinking bleach being protective – are quite harmful, and they often stem from the same misinformation sources.
Both of Dr. Guidry’s studies involved surveys of either adult patients with cancer or parents of children with cancer.
The adult patient survey was conducted June 1-15, 2020, and included 897 respondents, of whom 287 were patients in active treatment for cancer, 301 were survivors not currently in treatment, and 309 had no cancer history.
The parents’ survey, conducted in May 2020, included 735 parents of children aged 2-17 years, 315 of whom had children currently undergoing cancer treatment, and 420 of whom had children with no history of cancer.
Among the misinformation they were asked to agree or disagree with were statements such as “it is unsafe to receive mail from China,” “antibiotics can prevent and treat COVID-19,” and “COVID is less deadly than the ‘flu,’ ” among others.
The surveys revealed that the patients in current treatment for cancer and the parents of patients in current treatment were most likely to endorse COVID misinformation. Results from the parents’ survey showed that “believing misinformation was also more likely for fathers, younger parents, and parents with higher perceived stress from COVID-19,” the authors wrote. Among adult patients and controls, patients in active treatment were most likely to believe misinformation, with cancer survivors no longer in treatment being the least likely to believe it, compared with healthy controls who were in between.
Why the difference? The authors suggested that patients in active treatment “may seek out more information on the internet or via social media where they are more exposed to misinformation,” whereas survivors no longer undergoing treatment may be more “media savvy and have learned to be wary of questionable health information.”
In their articles, Dr. Guidry and associates advised oncologists to be aware of their patients’ potential to endorse COVID misinformation and to “proactively address this in routine visits as well as tailored written materials.” This is easier said than done, she commented, acknowledging that keeping up with the latest misinformation is a challenge.
The misinformation statements her group used in their surveys were popular early in the pandemic, but “some of them have shown fairly remarkable staying power and some have been replaced,” she said. She invited interested clinicians to contact her team for guidance on newer misinformation.
Ultimately, she believes most patients with cancer who endorse misinformation are simply afraid, and looking for help. “They’re already dealing with a level of stress from their illness and then they’re thrown into a pandemic,” Dr. Guidry said. “At some point you just want a solution. Hydroxychloroquine? Great! Horse dewormer? Fantastic! Just wanting to control the situation and not having something else to deal with.”
Both studies were funded by the National Cancer Institute at the National Institutes of Health. The authors disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
For the past 2 years, oncology practitioners around the world have struggled with the same dilemma: how to maintain their patients’ cancer care without exposing them to COVID-19. Regardless of the country, language, or even which wave of the pandemic, the conversations have likely been very similar: weighing risks versuss benefits, and individualizing each patient’s pandemic cancer plan.
But one question most oncologists have probably overlooked in these discussions is about where their patients get their COVID information – or misinformation.
Surprisingly, this seemingly small detail could make a big difference in a patient’s prognosis.
A recent study found that building on an earlier finding of similar vulnerabilities among parents of children with cancer, compared with parents of healthy children.
“It doesn’t matter what you search for, there is an overwhelming level of information online,” the lead author on both studies, Jeanine Guidry, PhD, from Virginia Commonwealth University’s Massey Cancer Center in Richmond, said in an interview. “If misinformation is the first thing you encounter about a topic, you’re much more likely to believe it and it’s going to be very hard to convince you otherwise.”
Before the pandemic, Dr. Guidry, who is director of the Media+Health Lab at VCU, had already been studying vaccine misinformation on Pinterest and Instagram.
So when data coming out at the start of the pandemic suggested that an increase in pediatric cancer mortality might be partially because of COVID-19 misinformation, she jumped on it.
Dr. Guidry and associates designed a questionnaire involving COVID misinformation statements available online and found that parents of children with cancer were significantly more likely to endorse them, compared with parents of healthy children.
“Our advice to clinicians is you may have an issue here,” Dr. Guidry said in an interview. “You may want to check where they get their news, and if there’s any pieces of misinformation that could be harmful.”
Some beliefs, such as eating more garlic protects against COVID, are not particularly harmful, she acknowledged, but others – such as drinking bleach being protective – are quite harmful, and they often stem from the same misinformation sources.
Both of Dr. Guidry’s studies involved surveys of either adult patients with cancer or parents of children with cancer.
The adult patient survey was conducted June 1-15, 2020, and included 897 respondents, of whom 287 were patients in active treatment for cancer, 301 were survivors not currently in treatment, and 309 had no cancer history.
The parents’ survey, conducted in May 2020, included 735 parents of children aged 2-17 years, 315 of whom had children currently undergoing cancer treatment, and 420 of whom had children with no history of cancer.
Among the misinformation they were asked to agree or disagree with were statements such as “it is unsafe to receive mail from China,” “antibiotics can prevent and treat COVID-19,” and “COVID is less deadly than the ‘flu,’ ” among others.
The surveys revealed that the patients in current treatment for cancer and the parents of patients in current treatment were most likely to endorse COVID misinformation. Results from the parents’ survey showed that “believing misinformation was also more likely for fathers, younger parents, and parents with higher perceived stress from COVID-19,” the authors wrote. Among adult patients and controls, patients in active treatment were most likely to believe misinformation, with cancer survivors no longer in treatment being the least likely to believe it, compared with healthy controls who were in between.
Why the difference? The authors suggested that patients in active treatment “may seek out more information on the internet or via social media where they are more exposed to misinformation,” whereas survivors no longer undergoing treatment may be more “media savvy and have learned to be wary of questionable health information.”
In their articles, Dr. Guidry and associates advised oncologists to be aware of their patients’ potential to endorse COVID misinformation and to “proactively address this in routine visits as well as tailored written materials.” This is easier said than done, she commented, acknowledging that keeping up with the latest misinformation is a challenge.
The misinformation statements her group used in their surveys were popular early in the pandemic, but “some of them have shown fairly remarkable staying power and some have been replaced,” she said. She invited interested clinicians to contact her team for guidance on newer misinformation.
Ultimately, she believes most patients with cancer who endorse misinformation are simply afraid, and looking for help. “They’re already dealing with a level of stress from their illness and then they’re thrown into a pandemic,” Dr. Guidry said. “At some point you just want a solution. Hydroxychloroquine? Great! Horse dewormer? Fantastic! Just wanting to control the situation and not having something else to deal with.”
Both studies were funded by the National Cancer Institute at the National Institutes of Health. The authors disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM PATIENT EDUCATION AND COUNSELING
Telehealth apps in ObGyn practice
The COVID-19 pandemic has presented increasing demands on health care systems internationally. In addition to redistribution of inpatient health care resources, outpatient care practices evolved, with health care providers offering streamlined access to care to patients via telehealth.
Due to updated insurance practices, physicians now can receive reimbursement via private insurers, Medicare, and Medicaid (as determined by states) for telehealth visits both related and unrelated to COVID-19 care. Increased telehealth use has advantages, including increased health care access, reduced in-clinic wait times, and reduced patient and physician travel time. Within the field of obstetrics and gynecology, clinicians have used telehealth to maintain access to prenatal maternity care while redirecting resources and minimizing the risk of COVID-19 transmission. Additional advantages include provision of care during expanded hours, including evenings and weekends, to increase patient access without increasing the demand on office support staff and the ability to bill for 5- to 10-minute phone counseling encounters.1 Research shows that patients express satisfaction regarding the quality of telehealth care in the setting of prenatal care.2
In February 2020, the American College of Obstetricians and Gynecologists (ACOG) released a Committee Opinion regarding telehealth use in ObGyn, a sign of telehealth’s likely long-standing role within the field.3 Within the statement, ACOG commented on the increasing application of telemedicine in all aspects of obstetrics and gynecology and recommended that physicians become acquainted with new technologies and consider using them in their practice.
There is a large opportunity for development of mobile applications (apps) to further streamline telehealth-based medical care. During the pandemic, the Centers for Medicare and Medicaid Services instituted waivers for telemedicine use on non-HIPAA (Health Insurance Portability and Accountability Act) compliant video communications products, such as Google+ Hangout and Skype. However, HIPAA-compliant video services are preferred, and many virtual apps have released methods for patient communication that meet HIPAA guidelines.1,4 These apps offer services such as phone- and video-based patient visits, appointment scheduling, secure physician-patient messaging, and electronic health record (EHR) documentation.
App recommendations
To identify current mobile apps with clinical use for the ObGyn, we conducted a search of the Apple App Store using the term “telehealth” between December 1, 2021 and January 1, 2022. We limited search results to apps that had at least 1,000 user ratings and to HIPAA-compliant user communication apps. Based on our review, we selected 4 apps to highlight here: Doximity, OhMD, Spruce, and Telehealth by SimplePractice (TABLE). We excluded apps that were advertised as having internal medical clinicians with first patient encounter on-demand through the app or that were associated with a singular insurance company or hospital system.
These apps are largely enabled for iOS and Android mobile devices and are offered at a range of price points for individual physician and practice-scale clinical implementation. Most apps offer secure messaging services between health care practitioners in addition to HIPAA-compliant patient messaging. Some apps offer additional features with the aim to increase patient attendance; these include push notifications, appointment reminders, and an option for automated replies with clinic information. For an additional fee, several apps offer integration to established EHR systems.
An additional tool
The COVID-19 pandemic caused health care systems and individual clinicians to rapidly evolve their practices to maintain patient access to essential health care. Notably, the pandemic led to accelerated implementation of virtual health care services. Telehealth apps likely will become another tool that ObGyns can use to improve the efficiency of their clinical practice and expand patient access to care. ●
- Karram M, Baum N. Telemedicine: a primer for today’s ObGyn. OBG Manag. 2020;32:28-32.
- Marko KI, Ganju N, Krapf JM, et al. A mobile prenatal care app to reduce in-person visits: prospective controlled trial. JMIR Mhealth Uhealth. 2019;7:e10520.
- American College of Obstetricians and Gynecologists. Implementing telehealth in practice: committee opinion no. 798. Obstet Gynecol. 2020;135:e73-e79.
- Karram M, Dooley A, de la Houssaye N, et al. Telemedicine: navigating legal issues. OBG Manag. 2020;32:18-24.
Dr. Warren is a second-year resident in the Department of Obstetrics, Gynecology, and Reproductive Science, Icahn School of Medicine at Mount Sinai, New York, New York.
Dr. Chen is Professor of Obstetrics, Gynecology, and Reproductive Science and Medical Education, Vice-Chair of Ob-Gyn Education for the Mount Sinai Health System, Icahn School of Medicine at Mount Sinai, New York. She is an OBG Management Contributing Editor.
Dr. Chen reports being an advisory board member and receiving royalties from UpToDate, Inc. and acting as a speaker for Sanofi Pasteur. Dr. Warren reports no financial relationships relevant to this article.
Dr. Warren is a second-year resident in the Department of Obstetrics, Gynecology, and Reproductive Science, Icahn School of Medicine at Mount Sinai, New York, New York.
Dr. Chen is Professor of Obstetrics, Gynecology, and Reproductive Science and Medical Education, Vice-Chair of Ob-Gyn Education for the Mount Sinai Health System, Icahn School of Medicine at Mount Sinai, New York. She is an OBG Management Contributing Editor.
Dr. Chen reports being an advisory board member and receiving royalties from UpToDate, Inc. and acting as a speaker for Sanofi Pasteur. Dr. Warren reports no financial relationships relevant to this article.
Dr. Warren is a second-year resident in the Department of Obstetrics, Gynecology, and Reproductive Science, Icahn School of Medicine at Mount Sinai, New York, New York.
Dr. Chen is Professor of Obstetrics, Gynecology, and Reproductive Science and Medical Education, Vice-Chair of Ob-Gyn Education for the Mount Sinai Health System, Icahn School of Medicine at Mount Sinai, New York. She is an OBG Management Contributing Editor.
Dr. Chen reports being an advisory board member and receiving royalties from UpToDate, Inc. and acting as a speaker for Sanofi Pasteur. Dr. Warren reports no financial relationships relevant to this article.
The COVID-19 pandemic has presented increasing demands on health care systems internationally. In addition to redistribution of inpatient health care resources, outpatient care practices evolved, with health care providers offering streamlined access to care to patients via telehealth.
Due to updated insurance practices, physicians now can receive reimbursement via private insurers, Medicare, and Medicaid (as determined by states) for telehealth visits both related and unrelated to COVID-19 care. Increased telehealth use has advantages, including increased health care access, reduced in-clinic wait times, and reduced patient and physician travel time. Within the field of obstetrics and gynecology, clinicians have used telehealth to maintain access to prenatal maternity care while redirecting resources and minimizing the risk of COVID-19 transmission. Additional advantages include provision of care during expanded hours, including evenings and weekends, to increase patient access without increasing the demand on office support staff and the ability to bill for 5- to 10-minute phone counseling encounters.1 Research shows that patients express satisfaction regarding the quality of telehealth care in the setting of prenatal care.2
In February 2020, the American College of Obstetricians and Gynecologists (ACOG) released a Committee Opinion regarding telehealth use in ObGyn, a sign of telehealth’s likely long-standing role within the field.3 Within the statement, ACOG commented on the increasing application of telemedicine in all aspects of obstetrics and gynecology and recommended that physicians become acquainted with new technologies and consider using them in their practice.
There is a large opportunity for development of mobile applications (apps) to further streamline telehealth-based medical care. During the pandemic, the Centers for Medicare and Medicaid Services instituted waivers for telemedicine use on non-HIPAA (Health Insurance Portability and Accountability Act) compliant video communications products, such as Google+ Hangout and Skype. However, HIPAA-compliant video services are preferred, and many virtual apps have released methods for patient communication that meet HIPAA guidelines.1,4 These apps offer services such as phone- and video-based patient visits, appointment scheduling, secure physician-patient messaging, and electronic health record (EHR) documentation.
App recommendations
To identify current mobile apps with clinical use for the ObGyn, we conducted a search of the Apple App Store using the term “telehealth” between December 1, 2021 and January 1, 2022. We limited search results to apps that had at least 1,000 user ratings and to HIPAA-compliant user communication apps. Based on our review, we selected 4 apps to highlight here: Doximity, OhMD, Spruce, and Telehealth by SimplePractice (TABLE). We excluded apps that were advertised as having internal medical clinicians with first patient encounter on-demand through the app or that were associated with a singular insurance company or hospital system.
These apps are largely enabled for iOS and Android mobile devices and are offered at a range of price points for individual physician and practice-scale clinical implementation. Most apps offer secure messaging services between health care practitioners in addition to HIPAA-compliant patient messaging. Some apps offer additional features with the aim to increase patient attendance; these include push notifications, appointment reminders, and an option for automated replies with clinic information. For an additional fee, several apps offer integration to established EHR systems.
An additional tool
The COVID-19 pandemic caused health care systems and individual clinicians to rapidly evolve their practices to maintain patient access to essential health care. Notably, the pandemic led to accelerated implementation of virtual health care services. Telehealth apps likely will become another tool that ObGyns can use to improve the efficiency of their clinical practice and expand patient access to care. ●
The COVID-19 pandemic has presented increasing demands on health care systems internationally. In addition to redistribution of inpatient health care resources, outpatient care practices evolved, with health care providers offering streamlined access to care to patients via telehealth.
Due to updated insurance practices, physicians now can receive reimbursement via private insurers, Medicare, and Medicaid (as determined by states) for telehealth visits both related and unrelated to COVID-19 care. Increased telehealth use has advantages, including increased health care access, reduced in-clinic wait times, and reduced patient and physician travel time. Within the field of obstetrics and gynecology, clinicians have used telehealth to maintain access to prenatal maternity care while redirecting resources and minimizing the risk of COVID-19 transmission. Additional advantages include provision of care during expanded hours, including evenings and weekends, to increase patient access without increasing the demand on office support staff and the ability to bill for 5- to 10-minute phone counseling encounters.1 Research shows that patients express satisfaction regarding the quality of telehealth care in the setting of prenatal care.2
In February 2020, the American College of Obstetricians and Gynecologists (ACOG) released a Committee Opinion regarding telehealth use in ObGyn, a sign of telehealth’s likely long-standing role within the field.3 Within the statement, ACOG commented on the increasing application of telemedicine in all aspects of obstetrics and gynecology and recommended that physicians become acquainted with new technologies and consider using them in their practice.
There is a large opportunity for development of mobile applications (apps) to further streamline telehealth-based medical care. During the pandemic, the Centers for Medicare and Medicaid Services instituted waivers for telemedicine use on non-HIPAA (Health Insurance Portability and Accountability Act) compliant video communications products, such as Google+ Hangout and Skype. However, HIPAA-compliant video services are preferred, and many virtual apps have released methods for patient communication that meet HIPAA guidelines.1,4 These apps offer services such as phone- and video-based patient visits, appointment scheduling, secure physician-patient messaging, and electronic health record (EHR) documentation.
App recommendations
To identify current mobile apps with clinical use for the ObGyn, we conducted a search of the Apple App Store using the term “telehealth” between December 1, 2021 and January 1, 2022. We limited search results to apps that had at least 1,000 user ratings and to HIPAA-compliant user communication apps. Based on our review, we selected 4 apps to highlight here: Doximity, OhMD, Spruce, and Telehealth by SimplePractice (TABLE). We excluded apps that were advertised as having internal medical clinicians with first patient encounter on-demand through the app or that were associated with a singular insurance company or hospital system.
These apps are largely enabled for iOS and Android mobile devices and are offered at a range of price points for individual physician and practice-scale clinical implementation. Most apps offer secure messaging services between health care practitioners in addition to HIPAA-compliant patient messaging. Some apps offer additional features with the aim to increase patient attendance; these include push notifications, appointment reminders, and an option for automated replies with clinic information. For an additional fee, several apps offer integration to established EHR systems.
An additional tool
The COVID-19 pandemic caused health care systems and individual clinicians to rapidly evolve their practices to maintain patient access to essential health care. Notably, the pandemic led to accelerated implementation of virtual health care services. Telehealth apps likely will become another tool that ObGyns can use to improve the efficiency of their clinical practice and expand patient access to care. ●
- Karram M, Baum N. Telemedicine: a primer for today’s ObGyn. OBG Manag. 2020;32:28-32.
- Marko KI, Ganju N, Krapf JM, et al. A mobile prenatal care app to reduce in-person visits: prospective controlled trial. JMIR Mhealth Uhealth. 2019;7:e10520.
- American College of Obstetricians and Gynecologists. Implementing telehealth in practice: committee opinion no. 798. Obstet Gynecol. 2020;135:e73-e79.
- Karram M, Dooley A, de la Houssaye N, et al. Telemedicine: navigating legal issues. OBG Manag. 2020;32:18-24.
- Karram M, Baum N. Telemedicine: a primer for today’s ObGyn. OBG Manag. 2020;32:28-32.
- Marko KI, Ganju N, Krapf JM, et al. A mobile prenatal care app to reduce in-person visits: prospective controlled trial. JMIR Mhealth Uhealth. 2019;7:e10520.
- American College of Obstetricians and Gynecologists. Implementing telehealth in practice: committee opinion no. 798. Obstet Gynecol. 2020;135:e73-e79.
- Karram M, Dooley A, de la Houssaye N, et al. Telemedicine: navigating legal issues. OBG Manag. 2020;32:18-24.
Free now to speak, nine oncologists spill the beans over firing
Last year, nine oncologists filed a lawsuit against the Anne Arundel Medical Center (AAMC), in Annapolis, Md., alleging that the hospital had fired them and had refused to allow them privileges to see their patients.
The oncologists said that the hospital chose profit over the needs of cancer patients, as it slashed oncology care services to cut costs.
The hospital denied any wrongdoing and alleged that the oncologists were not fired but that they had quit because they had been offered a more profitable opportunity.
At that time, the oncologists were not free to respond because of the ongoing litigation. But now that the lawsuit is over and the dust has settled, they are free to speak, and they contacted this news organization to tell their side of the story.
AAMC is a private, not-for-profit corporation that operates a large acute care hospital in Annapolis. It is affiliated with Luminis Health, the parent company of the medical center. Until October 23, 2020, the nine oncologists were employed by the AA Physician Group.
The doctors are Jason Taksey, MD, Benjamin Bridges, MD, Ravin Garg, MD, Adam Goldrich, MD, Carol Tweed, MD, Peter Graze, MD, Stuart Selonick, MD, David Weng, MD, and Jeanine Werner, MD.
They are all “highly respected, board certified oncologists and hematologists, with regional and, for some, national reputations in their medical specialty. The oncologists have had privileges at AAMC for many years and their capability as physicians is unquestioned,” according to the court filing made on behalf of the oncologists.
“Most of us have been in this town for decades,” said Dr. Tweed, who served as the unofficial spokesperson for the group. “Some of us are faculty members at Johns Hopkins, and this hospital’s oncology service was historically defined by our group.”
AAMC has a good reputation for providing high-quality medicine, “which is what brought many of us there in the first place,” Dr. Tweed said in an interview.
Triggered by cost cutting
The situation began when the hospital began cutting services to curtail costs, which directly affected the delivery of oncology care, Dr. Tweed explained. “They were also creating a very toxic and difficult interpersonal work environment, and that made it difficult to do patient care,” she said. “We would go to them and let them know that we were having difficulty delivering optimal patient care because we didn’t have enough staff or the resources we needed for safety — and it got to the point where we were being ignored and our input was no longer welcome.”
Dr. Tweed explained that the administrators announced which patient-care services would be cut without asking for their input as to the safety of those decisions. “Perhaps the most notorious was when they shut down the oncology lab,” she said. “That lab to an oncologist/hematologist is like a scalpel to a surgeon. I need lab results immediately — I need to know if I can give chemotherapy right now, or do I need to hold a dose. The lab is intrinsic to oncology care anywhere.”
There was a continuing cascade of events, and the oncology group mulled over some ideas as to how to provide optimal patient care in this increasingly difficult environment. The decision they reached was to discuss running their own practice with the hospital administrators as a means of making up for the gaps that they were now having to contend with. “As physicians, we do a lot of non-billable work, such as patient education, nighttime rounds for our cancer patients, and so on, and we told them that we would continue doing that,” said Dr. Tweed. “They said that they would talk to us, but they didn’t.”
Within a week of sending their proposal for setting up their own practice, all nine physicians were fired. “Instead of arranging a discussion, we received termination letters,” she explained. “We were terminated without cause.”
As physicians, Dr. Tweed explained that they were by contract obligated to arbitrate. It dragged on for weeks and months, to the tune of hundreds of thousands of dollars in legal fees.
“The only thing we wanted was to be able to practice in this town,” said Dr. Tweed. “And what is important to know is that it was never for money, and that was never our motivation for wanting to form our own practice.”
Dr. Tweed was referring to the hospital’s allegations that the oncologists had left their employment for monetary gain. A statement given to this news organization by the Luminis Health Anne Arundel Medical Center at the time stated that “this dispute started after nine oncologists left their employment to join a for-profit organization. We tried repeatedly to remain aligned with them.”
The oncologists had resigned during the height of the coronavirus pandemic to “pursue lucrative contracts” with a “major pharmaceutical distribution,” according to Todd M. Reinecker, attorney for Luminis Health, as reported by the Capital Gazette (this news organization reached out to Mr. Reinecker at that time but did not receive a response).
This was not the case, Dr. Tweed emphasized. “We took a great financial risk in doing this for patient care. It was pretty disgusting that was in print from the hospital’s lawyer.”
“The doctors anticipated Luminis Health would be unable to recruit new physicians and be forced to continue to use their services,” Mr. Reinecker maintained.
In fact, the medical center hired seven new oncologists to replace them.
Noncompete covenant
In filing their lawsuit, the nine oncologists put before the arbitrator the issue of the enforceability of the noncompete provision in their employment agreement, which prohibited the oncologists from working in the geographic area that includes the hospital. Their position was that the agreement was overly broad and thus unenforceable.
“We sign noncompete restrictive covenant contracts and we’re told that they are nonenforceable, and that’s the general discourse,” said Dr. Tweed. “Some states don’t even allow them. Well, we found out that they are very enforceable.”
The arbitrator eventually determined that three of the oncologists, including Dr. Tweed, had enforceable noncompete contracts.
“During the year or so while this was all going on, I would say that 90% of my patients wanted to stay with me,” said Dr. Tweed. “Patients were looking all over the place for us because, in many cases, the hospital did not tell them where to find us. In fact, they told us that we couldn’t contact the patients — they said it was ‘solicitation of a patient.’ “
In addition, the hospital continued to put more restrictions on the doctors. Six of the nine oncologists were able to continue practicing in Annapolis, and the remaining three will be able to join them in October 2022 when their noncompete contracts expire.
Now that the hospital has seen that there was a new oncology practice in town, Dr. Tweed noted, they changed their bylaws, and they now forbid hospital privileges to every physician in that group.
“The new bylaws do not restrict all private oncologists, just specifically our group, which prevents us from being able to do rounds in the hospital,” said Dr. Tweed. “If I want to see any of my patients, I have to get a visitor badge.”
Dr. Tweed contends that this move was purely for financial and business reasons to keep the oncologists from their patients. This is the primary hospital where their patients would be admitted if they need hospital care. AAMC is the only hospital within a 15-mile radius, and it serves as the regional hospital for the greater Annapolis area and for many Eastern Shore communities, whose hospitals do not offer various specialty services, such as oncology care.
“This was done purely because they were finance focused and not patient care focused,” Dr. Tweed emphasized. “We basically had to bargain with the hospital to let us even transfuse our patients.”
Telemedicine added to the mix
Yet another restriction that surfaced during the arbitration involved telemedicine. Dr. Tweed explained that as soon as the hospital realized that the three oncologists planned to stay in town and that their patients wanted to continue receiving care with them, they put telemedicine on the chopping block.
As if the restrictions and removal of hospital privileges wasn’t enough, the hospital decided to go after telemedicine during arbitration, Dr. Tweed said. If patients lived in any of the restricted ZIP codes, they were forbidden to conduct virtual visits with them.
“This isn’t ethical, but they tried to do everything to keep us from seeing our patients,” she said. “This is patient choice, but they were telling patients that if you live in any of these ZIP codes, you cannot do telemedicine if you choose Carol Tweed as your doctor,” Dr. Tweed said.
Of course, a patient isn’t bound by the arbitration and can see any doctor, but Dr. Tweed explained that the hospital threatened to come after her with a lawsuit.
One of the other physicians, Stuart Selonick, MD, said in an interview that he wasn’t quite sure how the idea of prohibiting telemedicine even came up. “There is little precedence for telemedicine in the U.S.,” he said. “They’ve extended the restrictions to telemedicine, and this is a new legal boundary, and it was new to the judge. But they made it part of the definition of the restrictive covenant. But to fight it would mean another lawsuit,” he added.
A separate lawsuit had previously been filed in an effort to regain hospital privileges, but the decision was made not to continue, owing to the amount of litigation it would involve.
“We can’t spend a lifetime and millions on another legal battle,” said Dr. Tweed. “We don’t have the corporate legal pool that the hospital has, and they know it.”
Patients have written endless letters supporting the doctors, Dr. Tweed said, but to no avail, as the hospital did not change course.
Litigation is now completed, and in about 9 months, the remaining three physicians will be able to rejoin their colleagues and put this behind them as best they can.
“The hospital knows that they harmed patient care for financial gain -- that’s the tagline,” said Tweed.
Approached for a response, Justin McLeod, spokesperson for Luminis Health, said that they are “pleased with the outcome of the case and the resolution agreed to by both sides. This agreement ensures patient access and continuity of care for patients with cancer. These providers have access to their patients’ electronic medical records, can order outpatient services, and attend quarterly cancer committee meetings with other providers.
“Our focus is the future of cancer care for our community. Luminis Health Anne Arundel Medical Center is committed to providing patients with high quality, comprehensive cancer care that is accessible to all,” he added.
A version of this article first appeared on Medscape.com.
Last year, nine oncologists filed a lawsuit against the Anne Arundel Medical Center (AAMC), in Annapolis, Md., alleging that the hospital had fired them and had refused to allow them privileges to see their patients.
The oncologists said that the hospital chose profit over the needs of cancer patients, as it slashed oncology care services to cut costs.
The hospital denied any wrongdoing and alleged that the oncologists were not fired but that they had quit because they had been offered a more profitable opportunity.
At that time, the oncologists were not free to respond because of the ongoing litigation. But now that the lawsuit is over and the dust has settled, they are free to speak, and they contacted this news organization to tell their side of the story.
AAMC is a private, not-for-profit corporation that operates a large acute care hospital in Annapolis. It is affiliated with Luminis Health, the parent company of the medical center. Until October 23, 2020, the nine oncologists were employed by the AA Physician Group.
The doctors are Jason Taksey, MD, Benjamin Bridges, MD, Ravin Garg, MD, Adam Goldrich, MD, Carol Tweed, MD, Peter Graze, MD, Stuart Selonick, MD, David Weng, MD, and Jeanine Werner, MD.
They are all “highly respected, board certified oncologists and hematologists, with regional and, for some, national reputations in their medical specialty. The oncologists have had privileges at AAMC for many years and their capability as physicians is unquestioned,” according to the court filing made on behalf of the oncologists.
“Most of us have been in this town for decades,” said Dr. Tweed, who served as the unofficial spokesperson for the group. “Some of us are faculty members at Johns Hopkins, and this hospital’s oncology service was historically defined by our group.”
AAMC has a good reputation for providing high-quality medicine, “which is what brought many of us there in the first place,” Dr. Tweed said in an interview.
Triggered by cost cutting
The situation began when the hospital began cutting services to curtail costs, which directly affected the delivery of oncology care, Dr. Tweed explained. “They were also creating a very toxic and difficult interpersonal work environment, and that made it difficult to do patient care,” she said. “We would go to them and let them know that we were having difficulty delivering optimal patient care because we didn’t have enough staff or the resources we needed for safety — and it got to the point where we were being ignored and our input was no longer welcome.”
Dr. Tweed explained that the administrators announced which patient-care services would be cut without asking for their input as to the safety of those decisions. “Perhaps the most notorious was when they shut down the oncology lab,” she said. “That lab to an oncologist/hematologist is like a scalpel to a surgeon. I need lab results immediately — I need to know if I can give chemotherapy right now, or do I need to hold a dose. The lab is intrinsic to oncology care anywhere.”
There was a continuing cascade of events, and the oncology group mulled over some ideas as to how to provide optimal patient care in this increasingly difficult environment. The decision they reached was to discuss running their own practice with the hospital administrators as a means of making up for the gaps that they were now having to contend with. “As physicians, we do a lot of non-billable work, such as patient education, nighttime rounds for our cancer patients, and so on, and we told them that we would continue doing that,” said Dr. Tweed. “They said that they would talk to us, but they didn’t.”
Within a week of sending their proposal for setting up their own practice, all nine physicians were fired. “Instead of arranging a discussion, we received termination letters,” she explained. “We were terminated without cause.”
As physicians, Dr. Tweed explained that they were by contract obligated to arbitrate. It dragged on for weeks and months, to the tune of hundreds of thousands of dollars in legal fees.
“The only thing we wanted was to be able to practice in this town,” said Dr. Tweed. “And what is important to know is that it was never for money, and that was never our motivation for wanting to form our own practice.”
Dr. Tweed was referring to the hospital’s allegations that the oncologists had left their employment for monetary gain. A statement given to this news organization by the Luminis Health Anne Arundel Medical Center at the time stated that “this dispute started after nine oncologists left their employment to join a for-profit organization. We tried repeatedly to remain aligned with them.”
The oncologists had resigned during the height of the coronavirus pandemic to “pursue lucrative contracts” with a “major pharmaceutical distribution,” according to Todd M. Reinecker, attorney for Luminis Health, as reported by the Capital Gazette (this news organization reached out to Mr. Reinecker at that time but did not receive a response).
This was not the case, Dr. Tweed emphasized. “We took a great financial risk in doing this for patient care. It was pretty disgusting that was in print from the hospital’s lawyer.”
“The doctors anticipated Luminis Health would be unable to recruit new physicians and be forced to continue to use their services,” Mr. Reinecker maintained.
In fact, the medical center hired seven new oncologists to replace them.
Noncompete covenant
In filing their lawsuit, the nine oncologists put before the arbitrator the issue of the enforceability of the noncompete provision in their employment agreement, which prohibited the oncologists from working in the geographic area that includes the hospital. Their position was that the agreement was overly broad and thus unenforceable.
“We sign noncompete restrictive covenant contracts and we’re told that they are nonenforceable, and that’s the general discourse,” said Dr. Tweed. “Some states don’t even allow them. Well, we found out that they are very enforceable.”
The arbitrator eventually determined that three of the oncologists, including Dr. Tweed, had enforceable noncompete contracts.
“During the year or so while this was all going on, I would say that 90% of my patients wanted to stay with me,” said Dr. Tweed. “Patients were looking all over the place for us because, in many cases, the hospital did not tell them where to find us. In fact, they told us that we couldn’t contact the patients — they said it was ‘solicitation of a patient.’ “
In addition, the hospital continued to put more restrictions on the doctors. Six of the nine oncologists were able to continue practicing in Annapolis, and the remaining three will be able to join them in October 2022 when their noncompete contracts expire.
Now that the hospital has seen that there was a new oncology practice in town, Dr. Tweed noted, they changed their bylaws, and they now forbid hospital privileges to every physician in that group.
“The new bylaws do not restrict all private oncologists, just specifically our group, which prevents us from being able to do rounds in the hospital,” said Dr. Tweed. “If I want to see any of my patients, I have to get a visitor badge.”
Dr. Tweed contends that this move was purely for financial and business reasons to keep the oncologists from their patients. This is the primary hospital where their patients would be admitted if they need hospital care. AAMC is the only hospital within a 15-mile radius, and it serves as the regional hospital for the greater Annapolis area and for many Eastern Shore communities, whose hospitals do not offer various specialty services, such as oncology care.
“This was done purely because they were finance focused and not patient care focused,” Dr. Tweed emphasized. “We basically had to bargain with the hospital to let us even transfuse our patients.”
Telemedicine added to the mix
Yet another restriction that surfaced during the arbitration involved telemedicine. Dr. Tweed explained that as soon as the hospital realized that the three oncologists planned to stay in town and that their patients wanted to continue receiving care with them, they put telemedicine on the chopping block.
As if the restrictions and removal of hospital privileges wasn’t enough, the hospital decided to go after telemedicine during arbitration, Dr. Tweed said. If patients lived in any of the restricted ZIP codes, they were forbidden to conduct virtual visits with them.
“This isn’t ethical, but they tried to do everything to keep us from seeing our patients,” she said. “This is patient choice, but they were telling patients that if you live in any of these ZIP codes, you cannot do telemedicine if you choose Carol Tweed as your doctor,” Dr. Tweed said.
Of course, a patient isn’t bound by the arbitration and can see any doctor, but Dr. Tweed explained that the hospital threatened to come after her with a lawsuit.
One of the other physicians, Stuart Selonick, MD, said in an interview that he wasn’t quite sure how the idea of prohibiting telemedicine even came up. “There is little precedence for telemedicine in the U.S.,” he said. “They’ve extended the restrictions to telemedicine, and this is a new legal boundary, and it was new to the judge. But they made it part of the definition of the restrictive covenant. But to fight it would mean another lawsuit,” he added.
A separate lawsuit had previously been filed in an effort to regain hospital privileges, but the decision was made not to continue, owing to the amount of litigation it would involve.
“We can’t spend a lifetime and millions on another legal battle,” said Dr. Tweed. “We don’t have the corporate legal pool that the hospital has, and they know it.”
Patients have written endless letters supporting the doctors, Dr. Tweed said, but to no avail, as the hospital did not change course.
Litigation is now completed, and in about 9 months, the remaining three physicians will be able to rejoin their colleagues and put this behind them as best they can.
“The hospital knows that they harmed patient care for financial gain -- that’s the tagline,” said Tweed.
Approached for a response, Justin McLeod, spokesperson for Luminis Health, said that they are “pleased with the outcome of the case and the resolution agreed to by both sides. This agreement ensures patient access and continuity of care for patients with cancer. These providers have access to their patients’ electronic medical records, can order outpatient services, and attend quarterly cancer committee meetings with other providers.
“Our focus is the future of cancer care for our community. Luminis Health Anne Arundel Medical Center is committed to providing patients with high quality, comprehensive cancer care that is accessible to all,” he added.
A version of this article first appeared on Medscape.com.
Last year, nine oncologists filed a lawsuit against the Anne Arundel Medical Center (AAMC), in Annapolis, Md., alleging that the hospital had fired them and had refused to allow them privileges to see their patients.
The oncologists said that the hospital chose profit over the needs of cancer patients, as it slashed oncology care services to cut costs.
The hospital denied any wrongdoing and alleged that the oncologists were not fired but that they had quit because they had been offered a more profitable opportunity.
At that time, the oncologists were not free to respond because of the ongoing litigation. But now that the lawsuit is over and the dust has settled, they are free to speak, and they contacted this news organization to tell their side of the story.
AAMC is a private, not-for-profit corporation that operates a large acute care hospital in Annapolis. It is affiliated with Luminis Health, the parent company of the medical center. Until October 23, 2020, the nine oncologists were employed by the AA Physician Group.
The doctors are Jason Taksey, MD, Benjamin Bridges, MD, Ravin Garg, MD, Adam Goldrich, MD, Carol Tweed, MD, Peter Graze, MD, Stuart Selonick, MD, David Weng, MD, and Jeanine Werner, MD.
They are all “highly respected, board certified oncologists and hematologists, with regional and, for some, national reputations in their medical specialty. The oncologists have had privileges at AAMC for many years and their capability as physicians is unquestioned,” according to the court filing made on behalf of the oncologists.
“Most of us have been in this town for decades,” said Dr. Tweed, who served as the unofficial spokesperson for the group. “Some of us are faculty members at Johns Hopkins, and this hospital’s oncology service was historically defined by our group.”
AAMC has a good reputation for providing high-quality medicine, “which is what brought many of us there in the first place,” Dr. Tweed said in an interview.
Triggered by cost cutting
The situation began when the hospital began cutting services to curtail costs, which directly affected the delivery of oncology care, Dr. Tweed explained. “They were also creating a very toxic and difficult interpersonal work environment, and that made it difficult to do patient care,” she said. “We would go to them and let them know that we were having difficulty delivering optimal patient care because we didn’t have enough staff or the resources we needed for safety — and it got to the point where we were being ignored and our input was no longer welcome.”
Dr. Tweed explained that the administrators announced which patient-care services would be cut without asking for their input as to the safety of those decisions. “Perhaps the most notorious was when they shut down the oncology lab,” she said. “That lab to an oncologist/hematologist is like a scalpel to a surgeon. I need lab results immediately — I need to know if I can give chemotherapy right now, or do I need to hold a dose. The lab is intrinsic to oncology care anywhere.”
There was a continuing cascade of events, and the oncology group mulled over some ideas as to how to provide optimal patient care in this increasingly difficult environment. The decision they reached was to discuss running their own practice with the hospital administrators as a means of making up for the gaps that they were now having to contend with. “As physicians, we do a lot of non-billable work, such as patient education, nighttime rounds for our cancer patients, and so on, and we told them that we would continue doing that,” said Dr. Tweed. “They said that they would talk to us, but they didn’t.”
Within a week of sending their proposal for setting up their own practice, all nine physicians were fired. “Instead of arranging a discussion, we received termination letters,” she explained. “We were terminated without cause.”
As physicians, Dr. Tweed explained that they were by contract obligated to arbitrate. It dragged on for weeks and months, to the tune of hundreds of thousands of dollars in legal fees.
“The only thing we wanted was to be able to practice in this town,” said Dr. Tweed. “And what is important to know is that it was never for money, and that was never our motivation for wanting to form our own practice.”
Dr. Tweed was referring to the hospital’s allegations that the oncologists had left their employment for monetary gain. A statement given to this news organization by the Luminis Health Anne Arundel Medical Center at the time stated that “this dispute started after nine oncologists left their employment to join a for-profit organization. We tried repeatedly to remain aligned with them.”
The oncologists had resigned during the height of the coronavirus pandemic to “pursue lucrative contracts” with a “major pharmaceutical distribution,” according to Todd M. Reinecker, attorney for Luminis Health, as reported by the Capital Gazette (this news organization reached out to Mr. Reinecker at that time but did not receive a response).
This was not the case, Dr. Tweed emphasized. “We took a great financial risk in doing this for patient care. It was pretty disgusting that was in print from the hospital’s lawyer.”
“The doctors anticipated Luminis Health would be unable to recruit new physicians and be forced to continue to use their services,” Mr. Reinecker maintained.
In fact, the medical center hired seven new oncologists to replace them.
Noncompete covenant
In filing their lawsuit, the nine oncologists put before the arbitrator the issue of the enforceability of the noncompete provision in their employment agreement, which prohibited the oncologists from working in the geographic area that includes the hospital. Their position was that the agreement was overly broad and thus unenforceable.
“We sign noncompete restrictive covenant contracts and we’re told that they are nonenforceable, and that’s the general discourse,” said Dr. Tweed. “Some states don’t even allow them. Well, we found out that they are very enforceable.”
The arbitrator eventually determined that three of the oncologists, including Dr. Tweed, had enforceable noncompete contracts.
“During the year or so while this was all going on, I would say that 90% of my patients wanted to stay with me,” said Dr. Tweed. “Patients were looking all over the place for us because, in many cases, the hospital did not tell them where to find us. In fact, they told us that we couldn’t contact the patients — they said it was ‘solicitation of a patient.’ “
In addition, the hospital continued to put more restrictions on the doctors. Six of the nine oncologists were able to continue practicing in Annapolis, and the remaining three will be able to join them in October 2022 when their noncompete contracts expire.
Now that the hospital has seen that there was a new oncology practice in town, Dr. Tweed noted, they changed their bylaws, and they now forbid hospital privileges to every physician in that group.
“The new bylaws do not restrict all private oncologists, just specifically our group, which prevents us from being able to do rounds in the hospital,” said Dr. Tweed. “If I want to see any of my patients, I have to get a visitor badge.”
Dr. Tweed contends that this move was purely for financial and business reasons to keep the oncologists from their patients. This is the primary hospital where their patients would be admitted if they need hospital care. AAMC is the only hospital within a 15-mile radius, and it serves as the regional hospital for the greater Annapolis area and for many Eastern Shore communities, whose hospitals do not offer various specialty services, such as oncology care.
“This was done purely because they were finance focused and not patient care focused,” Dr. Tweed emphasized. “We basically had to bargain with the hospital to let us even transfuse our patients.”
Telemedicine added to the mix
Yet another restriction that surfaced during the arbitration involved telemedicine. Dr. Tweed explained that as soon as the hospital realized that the three oncologists planned to stay in town and that their patients wanted to continue receiving care with them, they put telemedicine on the chopping block.
As if the restrictions and removal of hospital privileges wasn’t enough, the hospital decided to go after telemedicine during arbitration, Dr. Tweed said. If patients lived in any of the restricted ZIP codes, they were forbidden to conduct virtual visits with them.
“This isn’t ethical, but they tried to do everything to keep us from seeing our patients,” she said. “This is patient choice, but they were telling patients that if you live in any of these ZIP codes, you cannot do telemedicine if you choose Carol Tweed as your doctor,” Dr. Tweed said.
Of course, a patient isn’t bound by the arbitration and can see any doctor, but Dr. Tweed explained that the hospital threatened to come after her with a lawsuit.
One of the other physicians, Stuart Selonick, MD, said in an interview that he wasn’t quite sure how the idea of prohibiting telemedicine even came up. “There is little precedence for telemedicine in the U.S.,” he said. “They’ve extended the restrictions to telemedicine, and this is a new legal boundary, and it was new to the judge. But they made it part of the definition of the restrictive covenant. But to fight it would mean another lawsuit,” he added.
A separate lawsuit had previously been filed in an effort to regain hospital privileges, but the decision was made not to continue, owing to the amount of litigation it would involve.
“We can’t spend a lifetime and millions on another legal battle,” said Dr. Tweed. “We don’t have the corporate legal pool that the hospital has, and they know it.”
Patients have written endless letters supporting the doctors, Dr. Tweed said, but to no avail, as the hospital did not change course.
Litigation is now completed, and in about 9 months, the remaining three physicians will be able to rejoin their colleagues and put this behind them as best they can.
“The hospital knows that they harmed patient care for financial gain -- that’s the tagline,” said Tweed.
Approached for a response, Justin McLeod, spokesperson for Luminis Health, said that they are “pleased with the outcome of the case and the resolution agreed to by both sides. This agreement ensures patient access and continuity of care for patients with cancer. These providers have access to their patients’ electronic medical records, can order outpatient services, and attend quarterly cancer committee meetings with other providers.
“Our focus is the future of cancer care for our community. Luminis Health Anne Arundel Medical Center is committed to providing patients with high quality, comprehensive cancer care that is accessible to all,” he added.
A version of this article first appeared on Medscape.com.
Which companies aren’t exiting Russia? Big pharma
Even as the war in Ukraine has prompted an exodus of international companies — from fast-food chains and oil producers to luxury retailers — from Russia,
Airlines, automakers, banks, and technology giants — at least 320 companies by one count — are among the businesses curtailing operations or making high-profile exits from Russia as its invasion of Ukraine intensifies. McDonald’s, Starbucks, and Coca-Cola announced a pause in sales recently.
But drugmakers, medical device manufacturers, and health care companies, which are exempted from U.S. and European sanctions, said Russians need access to medicines and medical equipment and contend that international humanitarian law requires they keep supply chains open.
“As a health care company, we have an important purpose, which is why at this time we continue to serve people in all countries in which we operate who depend on us for essential products, some life-sustaining,” said Scott Stoffel, divisional vice president for Illinois-based Abbott Laboratories, which manufactures and sells medicines in Russia for oncology, women’s health, pancreatic insufficiency, and liver health.
Johnson & Johnson — which has corporate offices in Moscow, Novosibirsk, St. Petersburg, and Yekaterinburg — said in a statement, “We remain committed to providing essential health products to those in need in Ukraine, Russia, and the region, in compliance with current sanctions and while adapting to the rapidly changing situation on the ground.”
The reluctance of drugmakers to pause operations in Russia is being met with a growing chorus of criticism.
Pharmaceutical companies that say they must continue to manufacture drugs in Russia for humanitarian reasons are “being misguided at best, cynical in the medium case, and outright deplorably misleading and deceptive,” said Jeffrey Sonnenfeld, DBA, a professor at the Yale School of Management who is tracking which companies have curtailed operations in Russia. He noted that banks and technology companies also provide essential services.
“Russians are put in a tragic position of unearned suffering. If we continue to make life palatable for them, then we are continuing to support the regime,” Dr. Sonnenfeld said. “These drug companies will be seen as complicit with the most vicious operation on the planet. Instead of protecting life, they are going to be seen as destroying life. The goal here is to show that Putin is not in control of all sectors of the economy.”
U.S. pharmaceutical and medical companies have operated in Russia for decades, and many ramped up operations after Russia invaded and annexed Crimea in 2014, navigating the fraught relationship between the United States and Russia amid sanctions. In 2010, Vladimir Putin, then Russian prime minister, announced an ambitious national plan for the Russian pharmaceutical industry that would be a pillar in his efforts to reestablish his country as an influential superpower and wean the country off Western pharmaceutical imports. Under the plan, called “Pharma-2020” and “Pharma-2030,” the government required Western pharmaceutical companies eager to sell to Russia’s growing middle class to locate production inside the country.
Pfizer, Johnson & Johnson, Novartis, and Abbott are among the drugmakers that manufacture pharmaceutical drugs at facilities in St. Petersburg and elsewhere in the country and typically sell those drugs as branded generics or under Russian brands.
Pfizer’s CEO, Albert Bourla, said on CBS that the giant drugmaker is not going to make further investments in Russia, but that it will not cut ties with Russia, as multinational companies in other industries are doing.
Pharmaceutical manufacturing plants in Kaluga, a major manufacturing center for Volkswagen and Volvo southwest of Moscow, have been funded through a partnership between Rusnano, a state-owned venture that promotes the development of high-tech enterprises, and U.S. venture capital firms.
Russia also has sought to position itself as an attractive research market, offering an inexpensive and lax regulatory environment for clinical drug trials. Last year, Pfizer conducted in Russia clinical trials of Paxlovid, its experimental antiviral pill to treat covid-19. Before the invasion began in late February, 3,072 trials were underway in Russia and 503 were underway in Ukraine, according to BioWorld, a reporting hub focused on drug development that features data from Cortellis.
AstraZeneca is the top sponsor of clinical trials in Russia, with 49 trials, followed by a subsidiary of Merck, with 48 trials.
So far, drugmakers’ response to the Ukraine invasion has largely centered on public pledges to donate essential medicines and vaccines to Ukrainian patients and refugees. They’ve also made general comments about the need to keep open the supply of medicines flowing within Russia.
Abbott has pledged $2 million to support humanitarian efforts in Ukraine, and Pfizer, based in New York, said it has supplied $1 million in humanitarian grants. Swiss drug maker Novartis said it was expanding humanitarian efforts in Ukraine and working to “ensure the continued supply of our medicines in Ukraine.”
But no major pharmaceutical or medical device maker has announced plans to shutter manufacturing plants or halt sales inside Russia.
In an open letter, hundreds of leaders of mainly smaller biotechnology companies have called on industry members to cease business activities in Russia, including “investment in Russian companies and new investment within the borders of Russia,” and to halt trade and collaboration with Russian companies, except for supplying food and medicines. How many of the signatories have business operations in Russia was unclear.
Ulrich Neumann, director for market access at Janssen, a Johnson & Johnson company, was among those who signed the letter, but whether he was speaking for the company was unclear. In its own statement posted on social media, the company said it’s “committed to providing access to our essential medical products in the countries where we operate, in compliance with current international sanctions.”
GlaxoSmithKline, headquartered in the United Kingdom, said in a statement that it’s stopping all advertising in Russia and will not enter into contracts that “directly support the Russian administration or military.” But the company said that as a “supplier of needed medicines, vaccines and everyday health products, we have a responsibility to do all we can to make them available. For this reason, we will continue to supply our products to the people of Russia, while we can.”
Nell Minow, vice chair of ValueEdge Advisors, an investment consulting firm, noted that drug companies have been treated differently than other industries during previous global conflicts. For example, some corporate ethicists advised against pharmaceutical companies’ total divestment from South Africa’s apartheid regime to ensure essential medicines flowed to the country.
“There is a difference between a hamburger and a pill,” Mr. Minow said. Companies should strongly condemn Russia’s actions, she said, but unless the United States enters directly into a war with Russia, companies that make essential medicines and health care products should continue to operate. Before U.S. involvement in World War II, she added, there were “some American companies that did business with Germany until the last minute.”
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation. KHN senior correspondent Arthur Allen contributed to this article.
Even as the war in Ukraine has prompted an exodus of international companies — from fast-food chains and oil producers to luxury retailers — from Russia,
Airlines, automakers, banks, and technology giants — at least 320 companies by one count — are among the businesses curtailing operations or making high-profile exits from Russia as its invasion of Ukraine intensifies. McDonald’s, Starbucks, and Coca-Cola announced a pause in sales recently.
But drugmakers, medical device manufacturers, and health care companies, which are exempted from U.S. and European sanctions, said Russians need access to medicines and medical equipment and contend that international humanitarian law requires they keep supply chains open.
“As a health care company, we have an important purpose, which is why at this time we continue to serve people in all countries in which we operate who depend on us for essential products, some life-sustaining,” said Scott Stoffel, divisional vice president for Illinois-based Abbott Laboratories, which manufactures and sells medicines in Russia for oncology, women’s health, pancreatic insufficiency, and liver health.
Johnson & Johnson — which has corporate offices in Moscow, Novosibirsk, St. Petersburg, and Yekaterinburg — said in a statement, “We remain committed to providing essential health products to those in need in Ukraine, Russia, and the region, in compliance with current sanctions and while adapting to the rapidly changing situation on the ground.”
The reluctance of drugmakers to pause operations in Russia is being met with a growing chorus of criticism.
Pharmaceutical companies that say they must continue to manufacture drugs in Russia for humanitarian reasons are “being misguided at best, cynical in the medium case, and outright deplorably misleading and deceptive,” said Jeffrey Sonnenfeld, DBA, a professor at the Yale School of Management who is tracking which companies have curtailed operations in Russia. He noted that banks and technology companies also provide essential services.
“Russians are put in a tragic position of unearned suffering. If we continue to make life palatable for them, then we are continuing to support the regime,” Dr. Sonnenfeld said. “These drug companies will be seen as complicit with the most vicious operation on the planet. Instead of protecting life, they are going to be seen as destroying life. The goal here is to show that Putin is not in control of all sectors of the economy.”
U.S. pharmaceutical and medical companies have operated in Russia for decades, and many ramped up operations after Russia invaded and annexed Crimea in 2014, navigating the fraught relationship between the United States and Russia amid sanctions. In 2010, Vladimir Putin, then Russian prime minister, announced an ambitious national plan for the Russian pharmaceutical industry that would be a pillar in his efforts to reestablish his country as an influential superpower and wean the country off Western pharmaceutical imports. Under the plan, called “Pharma-2020” and “Pharma-2030,” the government required Western pharmaceutical companies eager to sell to Russia’s growing middle class to locate production inside the country.
Pfizer, Johnson & Johnson, Novartis, and Abbott are among the drugmakers that manufacture pharmaceutical drugs at facilities in St. Petersburg and elsewhere in the country and typically sell those drugs as branded generics or under Russian brands.
Pfizer’s CEO, Albert Bourla, said on CBS that the giant drugmaker is not going to make further investments in Russia, but that it will not cut ties with Russia, as multinational companies in other industries are doing.
Pharmaceutical manufacturing plants in Kaluga, a major manufacturing center for Volkswagen and Volvo southwest of Moscow, have been funded through a partnership between Rusnano, a state-owned venture that promotes the development of high-tech enterprises, and U.S. venture capital firms.
Russia also has sought to position itself as an attractive research market, offering an inexpensive and lax regulatory environment for clinical drug trials. Last year, Pfizer conducted in Russia clinical trials of Paxlovid, its experimental antiviral pill to treat covid-19. Before the invasion began in late February, 3,072 trials were underway in Russia and 503 were underway in Ukraine, according to BioWorld, a reporting hub focused on drug development that features data from Cortellis.
AstraZeneca is the top sponsor of clinical trials in Russia, with 49 trials, followed by a subsidiary of Merck, with 48 trials.
So far, drugmakers’ response to the Ukraine invasion has largely centered on public pledges to donate essential medicines and vaccines to Ukrainian patients and refugees. They’ve also made general comments about the need to keep open the supply of medicines flowing within Russia.
Abbott has pledged $2 million to support humanitarian efforts in Ukraine, and Pfizer, based in New York, said it has supplied $1 million in humanitarian grants. Swiss drug maker Novartis said it was expanding humanitarian efforts in Ukraine and working to “ensure the continued supply of our medicines in Ukraine.”
But no major pharmaceutical or medical device maker has announced plans to shutter manufacturing plants or halt sales inside Russia.
In an open letter, hundreds of leaders of mainly smaller biotechnology companies have called on industry members to cease business activities in Russia, including “investment in Russian companies and new investment within the borders of Russia,” and to halt trade and collaboration with Russian companies, except for supplying food and medicines. How many of the signatories have business operations in Russia was unclear.
Ulrich Neumann, director for market access at Janssen, a Johnson & Johnson company, was among those who signed the letter, but whether he was speaking for the company was unclear. In its own statement posted on social media, the company said it’s “committed to providing access to our essential medical products in the countries where we operate, in compliance with current international sanctions.”
GlaxoSmithKline, headquartered in the United Kingdom, said in a statement that it’s stopping all advertising in Russia and will not enter into contracts that “directly support the Russian administration or military.” But the company said that as a “supplier of needed medicines, vaccines and everyday health products, we have a responsibility to do all we can to make them available. For this reason, we will continue to supply our products to the people of Russia, while we can.”
Nell Minow, vice chair of ValueEdge Advisors, an investment consulting firm, noted that drug companies have been treated differently than other industries during previous global conflicts. For example, some corporate ethicists advised against pharmaceutical companies’ total divestment from South Africa’s apartheid regime to ensure essential medicines flowed to the country.
“There is a difference between a hamburger and a pill,” Mr. Minow said. Companies should strongly condemn Russia’s actions, she said, but unless the United States enters directly into a war with Russia, companies that make essential medicines and health care products should continue to operate. Before U.S. involvement in World War II, she added, there were “some American companies that did business with Germany until the last minute.”
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation. KHN senior correspondent Arthur Allen contributed to this article.
Even as the war in Ukraine has prompted an exodus of international companies — from fast-food chains and oil producers to luxury retailers — from Russia,
Airlines, automakers, banks, and technology giants — at least 320 companies by one count — are among the businesses curtailing operations or making high-profile exits from Russia as its invasion of Ukraine intensifies. McDonald’s, Starbucks, and Coca-Cola announced a pause in sales recently.
But drugmakers, medical device manufacturers, and health care companies, which are exempted from U.S. and European sanctions, said Russians need access to medicines and medical equipment and contend that international humanitarian law requires they keep supply chains open.
“As a health care company, we have an important purpose, which is why at this time we continue to serve people in all countries in which we operate who depend on us for essential products, some life-sustaining,” said Scott Stoffel, divisional vice president for Illinois-based Abbott Laboratories, which manufactures and sells medicines in Russia for oncology, women’s health, pancreatic insufficiency, and liver health.
Johnson & Johnson — which has corporate offices in Moscow, Novosibirsk, St. Petersburg, and Yekaterinburg — said in a statement, “We remain committed to providing essential health products to those in need in Ukraine, Russia, and the region, in compliance with current sanctions and while adapting to the rapidly changing situation on the ground.”
The reluctance of drugmakers to pause operations in Russia is being met with a growing chorus of criticism.
Pharmaceutical companies that say they must continue to manufacture drugs in Russia for humanitarian reasons are “being misguided at best, cynical in the medium case, and outright deplorably misleading and deceptive,” said Jeffrey Sonnenfeld, DBA, a professor at the Yale School of Management who is tracking which companies have curtailed operations in Russia. He noted that banks and technology companies also provide essential services.
“Russians are put in a tragic position of unearned suffering. If we continue to make life palatable for them, then we are continuing to support the regime,” Dr. Sonnenfeld said. “These drug companies will be seen as complicit with the most vicious operation on the planet. Instead of protecting life, they are going to be seen as destroying life. The goal here is to show that Putin is not in control of all sectors of the economy.”
U.S. pharmaceutical and medical companies have operated in Russia for decades, and many ramped up operations after Russia invaded and annexed Crimea in 2014, navigating the fraught relationship between the United States and Russia amid sanctions. In 2010, Vladimir Putin, then Russian prime minister, announced an ambitious national plan for the Russian pharmaceutical industry that would be a pillar in his efforts to reestablish his country as an influential superpower and wean the country off Western pharmaceutical imports. Under the plan, called “Pharma-2020” and “Pharma-2030,” the government required Western pharmaceutical companies eager to sell to Russia’s growing middle class to locate production inside the country.
Pfizer, Johnson & Johnson, Novartis, and Abbott are among the drugmakers that manufacture pharmaceutical drugs at facilities in St. Petersburg and elsewhere in the country and typically sell those drugs as branded generics or under Russian brands.
Pfizer’s CEO, Albert Bourla, said on CBS that the giant drugmaker is not going to make further investments in Russia, but that it will not cut ties with Russia, as multinational companies in other industries are doing.
Pharmaceutical manufacturing plants in Kaluga, a major manufacturing center for Volkswagen and Volvo southwest of Moscow, have been funded through a partnership between Rusnano, a state-owned venture that promotes the development of high-tech enterprises, and U.S. venture capital firms.
Russia also has sought to position itself as an attractive research market, offering an inexpensive and lax regulatory environment for clinical drug trials. Last year, Pfizer conducted in Russia clinical trials of Paxlovid, its experimental antiviral pill to treat covid-19. Before the invasion began in late February, 3,072 trials were underway in Russia and 503 were underway in Ukraine, according to BioWorld, a reporting hub focused on drug development that features data from Cortellis.
AstraZeneca is the top sponsor of clinical trials in Russia, with 49 trials, followed by a subsidiary of Merck, with 48 trials.
So far, drugmakers’ response to the Ukraine invasion has largely centered on public pledges to donate essential medicines and vaccines to Ukrainian patients and refugees. They’ve also made general comments about the need to keep open the supply of medicines flowing within Russia.
Abbott has pledged $2 million to support humanitarian efforts in Ukraine, and Pfizer, based in New York, said it has supplied $1 million in humanitarian grants. Swiss drug maker Novartis said it was expanding humanitarian efforts in Ukraine and working to “ensure the continued supply of our medicines in Ukraine.”
But no major pharmaceutical or medical device maker has announced plans to shutter manufacturing plants or halt sales inside Russia.
In an open letter, hundreds of leaders of mainly smaller biotechnology companies have called on industry members to cease business activities in Russia, including “investment in Russian companies and new investment within the borders of Russia,” and to halt trade and collaboration with Russian companies, except for supplying food and medicines. How many of the signatories have business operations in Russia was unclear.
Ulrich Neumann, director for market access at Janssen, a Johnson & Johnson company, was among those who signed the letter, but whether he was speaking for the company was unclear. In its own statement posted on social media, the company said it’s “committed to providing access to our essential medical products in the countries where we operate, in compliance with current international sanctions.”
GlaxoSmithKline, headquartered in the United Kingdom, said in a statement that it’s stopping all advertising in Russia and will not enter into contracts that “directly support the Russian administration or military.” But the company said that as a “supplier of needed medicines, vaccines and everyday health products, we have a responsibility to do all we can to make them available. For this reason, we will continue to supply our products to the people of Russia, while we can.”
Nell Minow, vice chair of ValueEdge Advisors, an investment consulting firm, noted that drug companies have been treated differently than other industries during previous global conflicts. For example, some corporate ethicists advised against pharmaceutical companies’ total divestment from South Africa’s apartheid regime to ensure essential medicines flowed to the country.
“There is a difference between a hamburger and a pill,” Mr. Minow said. Companies should strongly condemn Russia’s actions, she said, but unless the United States enters directly into a war with Russia, companies that make essential medicines and health care products should continue to operate. Before U.S. involvement in World War II, she added, there were “some American companies that did business with Germany until the last minute.”
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation. KHN senior correspondent Arthur Allen contributed to this article.
Wake Forest Cancer Center director fired, advisory board resigns
and withdrew their endorsement for renewal of the center’s National Cancer Institute comprehensive cancer center support grant.
The move was prompted by the abrupt firing of center director Boris Pasche, MD, PhD, on February 10, one day after NCI renewed a multimillion dollar grant.
The Cancer Letter broke the story and published the resignation letter from the EAB. It was signed by board chair Gerold Bepler, MD, PhD, CEO and director of the Karmanos Cancer Institute, Detroit, on behalf of the board.
The mass resignation of an EAB, a panel of outside experts that help shepherd cancer centers through the NCI grant process, is “highly unusual,” according to The Cancer Letter. It also raises concerns about the “immediate future” of Wake Forest’s cancer center, the publication added.
Numerous people involved with the situation did not respond or declined to comment when this news organization requested additional information and updates, including questions about the reason for Dr. Pasche’s termination; whether or not withdrawal of the endorsement puts Wake’s NCI designation in jeopardy; and if the EAB is being reconstituted.
A written statement from Wake Forest simply said that “the situation involving Dr. Pasche is an administrative decision. Various administrative changes occur regularly in organizations across the country. Dr. Pasche remains employed by Atrium Health Wake Forest Baptist. We are very grateful to Dr. Pasche for his years of service and many contributions to the mission and vision of our NCI-designated Comprehensive Cancer Center in Winston-Salem.”
Wake’s cancer center is in the process of combining with the Atrium Health Levine Cancer Center, which is not NCI-designated, following Atrium Health system’s recent acquisition of the Wake Forest Baptist Medical Center.
The NCI renewal notice, dated February 9, states that Dr. Pasche “and his leadership team have built a robust, transdisciplinary center that includes 140 scientists.”
Dr. Pasche was fired a day later.
The EAB resignation letter states that during Wake Forest’s recent NCI review process, “leadership gave their glowing endorsement of Dr. Pasche...This endorsement included unequivocal statements of support for Dr. Pasche’s oversight of the combined Atrium-Wake Forest cancer program.”
“What followed was his rapid dismissal after the...notice of award was issued, following a period during which the approach to integration was apparently being revisited,” Dr. Bepler said on behalf of the board.
“It is with sadness and dismay that we witnessed the change in approach by the institutional leadership towards” the merger, he wrote.
The Cancer Letter quotes an unnamed board member as saying, “EABs for cancer centers can only provide value to the center when there is openness and transparency in the process. In the absence of such, I believe the members felt that there was no further utility in providing guidance to the organization.”
The resignation letter was sent to the interim director of Wake’s cancer center, radiation oncologist William Blackstock, Jr, MD, and also copied to Atrium-Wake and NCI leadership.
The resignation letter endorsed Dr. Blackstock’s qualifications to run the center, and noted that as the board is reconstituted, “some of us would be honored to discuss participation...if there is unequivocal evidence from the health system’s senior management for support of a single, academically driven, comprehensive, and integrated cancer center.”
A version of this article first appeared on Medscape.com.
and withdrew their endorsement for renewal of the center’s National Cancer Institute comprehensive cancer center support grant.
The move was prompted by the abrupt firing of center director Boris Pasche, MD, PhD, on February 10, one day after NCI renewed a multimillion dollar grant.
The Cancer Letter broke the story and published the resignation letter from the EAB. It was signed by board chair Gerold Bepler, MD, PhD, CEO and director of the Karmanos Cancer Institute, Detroit, on behalf of the board.
The mass resignation of an EAB, a panel of outside experts that help shepherd cancer centers through the NCI grant process, is “highly unusual,” according to The Cancer Letter. It also raises concerns about the “immediate future” of Wake Forest’s cancer center, the publication added.
Numerous people involved with the situation did not respond or declined to comment when this news organization requested additional information and updates, including questions about the reason for Dr. Pasche’s termination; whether or not withdrawal of the endorsement puts Wake’s NCI designation in jeopardy; and if the EAB is being reconstituted.
A written statement from Wake Forest simply said that “the situation involving Dr. Pasche is an administrative decision. Various administrative changes occur regularly in organizations across the country. Dr. Pasche remains employed by Atrium Health Wake Forest Baptist. We are very grateful to Dr. Pasche for his years of service and many contributions to the mission and vision of our NCI-designated Comprehensive Cancer Center in Winston-Salem.”
Wake’s cancer center is in the process of combining with the Atrium Health Levine Cancer Center, which is not NCI-designated, following Atrium Health system’s recent acquisition of the Wake Forest Baptist Medical Center.
The NCI renewal notice, dated February 9, states that Dr. Pasche “and his leadership team have built a robust, transdisciplinary center that includes 140 scientists.”
Dr. Pasche was fired a day later.
The EAB resignation letter states that during Wake Forest’s recent NCI review process, “leadership gave their glowing endorsement of Dr. Pasche...This endorsement included unequivocal statements of support for Dr. Pasche’s oversight of the combined Atrium-Wake Forest cancer program.”
“What followed was his rapid dismissal after the...notice of award was issued, following a period during which the approach to integration was apparently being revisited,” Dr. Bepler said on behalf of the board.
“It is with sadness and dismay that we witnessed the change in approach by the institutional leadership towards” the merger, he wrote.
The Cancer Letter quotes an unnamed board member as saying, “EABs for cancer centers can only provide value to the center when there is openness and transparency in the process. In the absence of such, I believe the members felt that there was no further utility in providing guidance to the organization.”
The resignation letter was sent to the interim director of Wake’s cancer center, radiation oncologist William Blackstock, Jr, MD, and also copied to Atrium-Wake and NCI leadership.
The resignation letter endorsed Dr. Blackstock’s qualifications to run the center, and noted that as the board is reconstituted, “some of us would be honored to discuss participation...if there is unequivocal evidence from the health system’s senior management for support of a single, academically driven, comprehensive, and integrated cancer center.”
A version of this article first appeared on Medscape.com.
and withdrew their endorsement for renewal of the center’s National Cancer Institute comprehensive cancer center support grant.
The move was prompted by the abrupt firing of center director Boris Pasche, MD, PhD, on February 10, one day after NCI renewed a multimillion dollar grant.
The Cancer Letter broke the story and published the resignation letter from the EAB. It was signed by board chair Gerold Bepler, MD, PhD, CEO and director of the Karmanos Cancer Institute, Detroit, on behalf of the board.
The mass resignation of an EAB, a panel of outside experts that help shepherd cancer centers through the NCI grant process, is “highly unusual,” according to The Cancer Letter. It also raises concerns about the “immediate future” of Wake Forest’s cancer center, the publication added.
Numerous people involved with the situation did not respond or declined to comment when this news organization requested additional information and updates, including questions about the reason for Dr. Pasche’s termination; whether or not withdrawal of the endorsement puts Wake’s NCI designation in jeopardy; and if the EAB is being reconstituted.
A written statement from Wake Forest simply said that “the situation involving Dr. Pasche is an administrative decision. Various administrative changes occur regularly in organizations across the country. Dr. Pasche remains employed by Atrium Health Wake Forest Baptist. We are very grateful to Dr. Pasche for his years of service and many contributions to the mission and vision of our NCI-designated Comprehensive Cancer Center in Winston-Salem.”
Wake’s cancer center is in the process of combining with the Atrium Health Levine Cancer Center, which is not NCI-designated, following Atrium Health system’s recent acquisition of the Wake Forest Baptist Medical Center.
The NCI renewal notice, dated February 9, states that Dr. Pasche “and his leadership team have built a robust, transdisciplinary center that includes 140 scientists.”
Dr. Pasche was fired a day later.
The EAB resignation letter states that during Wake Forest’s recent NCI review process, “leadership gave their glowing endorsement of Dr. Pasche...This endorsement included unequivocal statements of support for Dr. Pasche’s oversight of the combined Atrium-Wake Forest cancer program.”
“What followed was his rapid dismissal after the...notice of award was issued, following a period during which the approach to integration was apparently being revisited,” Dr. Bepler said on behalf of the board.
“It is with sadness and dismay that we witnessed the change in approach by the institutional leadership towards” the merger, he wrote.
The Cancer Letter quotes an unnamed board member as saying, “EABs for cancer centers can only provide value to the center when there is openness and transparency in the process. In the absence of such, I believe the members felt that there was no further utility in providing guidance to the organization.”
The resignation letter was sent to the interim director of Wake’s cancer center, radiation oncologist William Blackstock, Jr, MD, and also copied to Atrium-Wake and NCI leadership.
The resignation letter endorsed Dr. Blackstock’s qualifications to run the center, and noted that as the board is reconstituted, “some of us would be honored to discuss participation...if there is unequivocal evidence from the health system’s senior management for support of a single, academically driven, comprehensive, and integrated cancer center.”
A version of this article first appeared on Medscape.com.
Physicians beware: Feds start tracking information-blocking claims
The federal government’s efforts to thwart information blocking are underway. As such,
Recently, the Office of the National Coordinator revealed that the Department of Health & Humans Services has received 299 reports of information blocking since inviting anyone who suspected that health care providers, IT developers, or health information networks/exchanges might have interfered with access, exchange, or use of EHI through the Report Information Blocking Portal on April 5, 2021.
The vast majority of these claims – 211 – were filed against providers, while 46 alleged incidents of information blocking were by health IT developers, and two claims point to health information networks/ exchanges. The other 25 claims did not appear to present a claim of information blocking.
Of the 274 possible claims of information blocking recently released by ONC, 176 were made by patients.
The ONC has sent all possible claims to the HHS’s Office of the Inspector General. The claims have not yet been investigated and substantiated.
Do the stats tell the story?
The numbers in the recent ONC report do not shed much light on how much impact the regulations are having on information sharing. Health care providers, including physicians, might not yet be complying with the rules because monetary penalties are not in place.
Indeed, HHS has yet to spell out exactly what the disincentives on providers will be, though the 21st Century Cures Act stipulates that regulators could fine up to $1 million per information-blocking incident.
“Some providers might be saying, ‘I’m not going to be penalized at this point … so I can take a little bit longer to think about how I come into compliance.’ That could be just one factor of a host of many that are affecting compliance. We also are still in the middle of a public health emergency. So it’s hard to say at this point” exactly how the regulations will affect information blocking, Lauren Riplinger, vice president of policy and public affairs at the American Health Information Management Association, Chicago, said in an interview.
A long time coming
The government first zeroed in on ensuring that patients have access to their information in 2016 when President Obama signed the Cures Act into law. The legislation directed ONC to implement a standardized process for the public to report claims of possible information blocking.
The initiative appears to be picking up steam. The ONC is expected to release monthly reports on the cumulative number of information-blocking claims. The announcement of associated penalties is expected sometime in the future.
Industry leaders are advising health care providers to brush up on compliance. Physicians can look to professional groups such as the American Medical Association, the Medical Group Management Association, and other specialty associations for guidance. In addition, the ONC is educating providers on the rule.
“The ONC has provided a lot of great content for the past couple months, not only in terms of putting out FAQs to help clarify some of the gray areas in the rule, but they also have produced a series of provider-specific webinars where they walk through a potential scenario and address the extent to the rules apply,” Ms. Riplinger said.
With education, more is better
These efforts, however, could be expanded, according to MGMA.
“There is a general awareness of the rules, but we encourage ONC to continue educating the provider community: More FAQs and educational webinars would be helpful,” Claire Ernst, director of government affairs for MGMA, said in an interview. “A June 2021 MGMA poll found that 51% of medical groups said they needed more government guidance on complying with the new information-blocking rules.”
Although ONC already has provided some “scenario-based” education, more of this type of guidance could prove valuable.
“This rule is that it is very circumstance based. … and so it’s those more nuanced cases that I think are more challenging for providers to know whether or not they are engaging in information blocking,” Ms. Riplinger noted.
For example, a physician might choose to not upload lab test results to a patient portal and prefer to wait to discuss the results directly with the patient, which could potentially be construed as information blocking under the regulations.
The MGMA is requesting that ONC take a second look at these situations – and possibly adjust the regulations.
“MGMA has heard concerns about the impact of providing immediate results to patients before medical groups have the time to thoroughly review test results and discuss them compassionately with their patients,” Ms. Ernst said. “To address this, ONC could expand the current definition of harm to account for other unintended consequences, such as emotional distress, or provide more flexibility in terms of the time frame.”
A version of this article first appeared on Medscape.com.
The federal government’s efforts to thwart information blocking are underway. As such,
Recently, the Office of the National Coordinator revealed that the Department of Health & Humans Services has received 299 reports of information blocking since inviting anyone who suspected that health care providers, IT developers, or health information networks/exchanges might have interfered with access, exchange, or use of EHI through the Report Information Blocking Portal on April 5, 2021.
The vast majority of these claims – 211 – were filed against providers, while 46 alleged incidents of information blocking were by health IT developers, and two claims point to health information networks/ exchanges. The other 25 claims did not appear to present a claim of information blocking.
Of the 274 possible claims of information blocking recently released by ONC, 176 were made by patients.
The ONC has sent all possible claims to the HHS’s Office of the Inspector General. The claims have not yet been investigated and substantiated.
Do the stats tell the story?
The numbers in the recent ONC report do not shed much light on how much impact the regulations are having on information sharing. Health care providers, including physicians, might not yet be complying with the rules because monetary penalties are not in place.
Indeed, HHS has yet to spell out exactly what the disincentives on providers will be, though the 21st Century Cures Act stipulates that regulators could fine up to $1 million per information-blocking incident.
“Some providers might be saying, ‘I’m not going to be penalized at this point … so I can take a little bit longer to think about how I come into compliance.’ That could be just one factor of a host of many that are affecting compliance. We also are still in the middle of a public health emergency. So it’s hard to say at this point” exactly how the regulations will affect information blocking, Lauren Riplinger, vice president of policy and public affairs at the American Health Information Management Association, Chicago, said in an interview.
A long time coming
The government first zeroed in on ensuring that patients have access to their information in 2016 when President Obama signed the Cures Act into law. The legislation directed ONC to implement a standardized process for the public to report claims of possible information blocking.
The initiative appears to be picking up steam. The ONC is expected to release monthly reports on the cumulative number of information-blocking claims. The announcement of associated penalties is expected sometime in the future.
Industry leaders are advising health care providers to brush up on compliance. Physicians can look to professional groups such as the American Medical Association, the Medical Group Management Association, and other specialty associations for guidance. In addition, the ONC is educating providers on the rule.
“The ONC has provided a lot of great content for the past couple months, not only in terms of putting out FAQs to help clarify some of the gray areas in the rule, but they also have produced a series of provider-specific webinars where they walk through a potential scenario and address the extent to the rules apply,” Ms. Riplinger said.
With education, more is better
These efforts, however, could be expanded, according to MGMA.
“There is a general awareness of the rules, but we encourage ONC to continue educating the provider community: More FAQs and educational webinars would be helpful,” Claire Ernst, director of government affairs for MGMA, said in an interview. “A June 2021 MGMA poll found that 51% of medical groups said they needed more government guidance on complying with the new information-blocking rules.”
Although ONC already has provided some “scenario-based” education, more of this type of guidance could prove valuable.
“This rule is that it is very circumstance based. … and so it’s those more nuanced cases that I think are more challenging for providers to know whether or not they are engaging in information blocking,” Ms. Riplinger noted.
For example, a physician might choose to not upload lab test results to a patient portal and prefer to wait to discuss the results directly with the patient, which could potentially be construed as information blocking under the regulations.
The MGMA is requesting that ONC take a second look at these situations – and possibly adjust the regulations.
“MGMA has heard concerns about the impact of providing immediate results to patients before medical groups have the time to thoroughly review test results and discuss them compassionately with their patients,” Ms. Ernst said. “To address this, ONC could expand the current definition of harm to account for other unintended consequences, such as emotional distress, or provide more flexibility in terms of the time frame.”
A version of this article first appeared on Medscape.com.
The federal government’s efforts to thwart information blocking are underway. As such,
Recently, the Office of the National Coordinator revealed that the Department of Health & Humans Services has received 299 reports of information blocking since inviting anyone who suspected that health care providers, IT developers, or health information networks/exchanges might have interfered with access, exchange, or use of EHI through the Report Information Blocking Portal on April 5, 2021.
The vast majority of these claims – 211 – were filed against providers, while 46 alleged incidents of information blocking were by health IT developers, and two claims point to health information networks/ exchanges. The other 25 claims did not appear to present a claim of information blocking.
Of the 274 possible claims of information blocking recently released by ONC, 176 were made by patients.
The ONC has sent all possible claims to the HHS’s Office of the Inspector General. The claims have not yet been investigated and substantiated.
Do the stats tell the story?
The numbers in the recent ONC report do not shed much light on how much impact the regulations are having on information sharing. Health care providers, including physicians, might not yet be complying with the rules because monetary penalties are not in place.
Indeed, HHS has yet to spell out exactly what the disincentives on providers will be, though the 21st Century Cures Act stipulates that regulators could fine up to $1 million per information-blocking incident.
“Some providers might be saying, ‘I’m not going to be penalized at this point … so I can take a little bit longer to think about how I come into compliance.’ That could be just one factor of a host of many that are affecting compliance. We also are still in the middle of a public health emergency. So it’s hard to say at this point” exactly how the regulations will affect information blocking, Lauren Riplinger, vice president of policy and public affairs at the American Health Information Management Association, Chicago, said in an interview.
A long time coming
The government first zeroed in on ensuring that patients have access to their information in 2016 when President Obama signed the Cures Act into law. The legislation directed ONC to implement a standardized process for the public to report claims of possible information blocking.
The initiative appears to be picking up steam. The ONC is expected to release monthly reports on the cumulative number of information-blocking claims. The announcement of associated penalties is expected sometime in the future.
Industry leaders are advising health care providers to brush up on compliance. Physicians can look to professional groups such as the American Medical Association, the Medical Group Management Association, and other specialty associations for guidance. In addition, the ONC is educating providers on the rule.
“The ONC has provided a lot of great content for the past couple months, not only in terms of putting out FAQs to help clarify some of the gray areas in the rule, but they also have produced a series of provider-specific webinars where they walk through a potential scenario and address the extent to the rules apply,” Ms. Riplinger said.
With education, more is better
These efforts, however, could be expanded, according to MGMA.
“There is a general awareness of the rules, but we encourage ONC to continue educating the provider community: More FAQs and educational webinars would be helpful,” Claire Ernst, director of government affairs for MGMA, said in an interview. “A June 2021 MGMA poll found that 51% of medical groups said they needed more government guidance on complying with the new information-blocking rules.”
Although ONC already has provided some “scenario-based” education, more of this type of guidance could prove valuable.
“This rule is that it is very circumstance based. … and so it’s those more nuanced cases that I think are more challenging for providers to know whether or not they are engaging in information blocking,” Ms. Riplinger noted.
For example, a physician might choose to not upload lab test results to a patient portal and prefer to wait to discuss the results directly with the patient, which could potentially be construed as information blocking under the regulations.
The MGMA is requesting that ONC take a second look at these situations – and possibly adjust the regulations.
“MGMA has heard concerns about the impact of providing immediate results to patients before medical groups have the time to thoroughly review test results and discuss them compassionately with their patients,” Ms. Ernst said. “To address this, ONC could expand the current definition of harm to account for other unintended consequences, such as emotional distress, or provide more flexibility in terms of the time frame.”
A version of this article first appeared on Medscape.com.