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Over the past year, the SARS-CoV-2 pandemic has swept the globe, resulting in an enormous worldwide burden of infection and mortality. However, the additional toll resulting from long-term consequences of the pandemic has yet to be tallied. Heterogeneous disease manifestations and syndromes are now recognized among some persons after their initial recovery from SARS-CoV-2 infection, representing in the broadest sense a failure to return to a baseline state of health after acute SARS-CoV-2 infection. On 3 to 4 December 2020, the National Institute of Allergy and Infectious Diseases, in collaboration with other Institutes and Centers of the National Institutes of Health, convened a virtual workshop to summarize existing knowledge on postacute COVID-19 and to identify key knowledge gaps regarding this condition.

A New Triple Threat

Effect of Bedside Compared With Outside the Room Patient Case Presentation on Patients' Knowledge About Their Medical Care: A Randomized, Controlled, Multicenter Trial: Annals of Internal Medicine: Vol 174, No 9

Background: Although bedside case presentation contributes to patient-centered care through active patient participation in medical discussions, the complexity of medical information and jargon-induced confusion may cause misunderstandings and patient discomfort. Objective: To compare bedside versus outside the room patient case presentation regarding patients' knowledge about their medical care. Design: Randomized, controlled, parallel-group trial. (ClinicalTrials.gov: NCT03210987) Setting: 3 Swiss teaching hospitals. Patients: Adult medical patients who were hospitalized. Intervention: Patients were randomly assigned to bedside or outside the room case presentation. Measurements: The primary endpoint was patients' average knowledge of 3 dimensions of their medical care (each rated on a visual analogue scale from 0 to 100): understanding their disease, the therapeutic approach being used, and further plans for care. Results: Compared with patients in the outside the room group (n = 443), those in the bedside presentation group (n = 476) reported similar knowledge about their medical care (mean, 79.5 points [SD, 21.6] vs. 79.4 points [SD, 19.8]; adjusted difference, 0.09 points [95% CI, −2.58 to 2.76 points]; P = 0.95). Also, an objective rating of patient knowledge by the study team was similar for the 2 groups, but the bedside presentation group had higher ratings of confusion about medical jargon and uncertainty caused by team discussions. Bedside ward rounds were more efficient (mean, 11.89 minutes per patient [SD, 4.92] vs. 14.14 minutes per patient [SD, 5.65]; adjusted difference, −2.31 minutes [CI, −2.98 to −1.63 minutes]; P < 0.001). Limitation: Only Swiss hospitals and medical patients were included. Conclusion: Compared with outside the room case presentation, bedside case presentation was shorter and resulted in similar patient knowledge, but sensitive topics were more often avoided and patient confusion was higher. Physicians presenting at the bedside need to be skilled in the use of medical language to avoid confusion and misunderstandings. Primary Funding Source: Swiss National Foundation (10531C_ 182422).

Residual Confounding in Health Plan Performance Assessments: Evidence From Randomization in Medicaid

Background: Risk adjustment is used widely in payment systems and performance assessments, but the extent to which it distinguishes plan or provider effects from confounding due to patient differences is typically unknown. Objective: To assess the degree to which risk-adjusted measures of health plan performance adequately adjust for the variation across plans that arises because of differences in patient characteristics (residual confounding). Design: Comparison between plan performance estimates based on enrollees who made plan choices (observational population) and estimates based on enrollees assigned to plans (randomized population). Setting: Natural experiment in which more than two thirds of a state's Medicaid population in 1 region was randomly assigned to 1 of 5 plans. Participants: 137 933 enrollees in 2013 to 2014, of whom 31.1% selected a plan and 68.9% were randomly assigned to 1 of the same 5 plans. Measurements: Annual total spending (that is, payments to providers), primary care use, dental care use, and avoidable emergency department visits, all scored as plan-specific deviations from the “average” plan performance within each population. Results: Enrollee characteristics were appreciably imbalanced across plans in the observational population, as expected, but were not in the randomized population. Annual total spending varied across plans more in the observational population (SD, $147 per enrollee) than in the randomized population (SD, $70 per enrollee) after accounting for baseline differences in the observational and randomized populations and for differences across plans. On average, a plan's spending score (its deviation from the “average” performance) in the observational population differed from its score in the randomized population by $67 per enrollee in absolute value (95% CI, $38 to $123), or 4.2% of mean spending per enrollee (P = 0.009, rejecting the null hypothesis that this difference would be expected from sampling error). The difference was reduced modestly by risk adjustment to $62 per enrollee (P = 0.012). Residual confounding was similarly substantial for most other performance measures. Further adjustment for social factors did not materially change estimates. Limitation: Potential heterogeneity in plan effects between the 2 populations. Conclusion: Residual confounding in risk-adjusted performance assessments can be substantial and should caution policymakers against assuming that risk adjustment isolates real differences in plan performance. Primary Funding Source: Arnold Ventures.

Prevalence of Symptoms More Than Seven Months After Diagnosis of Symptomatic COVID-19 in an Outpatient Setting

Background: With millions of SARS-CoV-2 infections worldwide, increasing numbers of patients are coming forward with long-term clinical effects of the disease lasting several weeks to months. Objective: To characterize symptoms 7 to 9 months after diagnosis of COVID-19. Design: Self-reported surveys and semistructured telephone interviews at enrollment and 30 to 45 days and 7 to 9 months from diagnosis. Setting: From 18 March to 15 May 2020, symptomatic persons who tested positive for SARS-CoV-2 at the Geneva University Hospitals were followed by CoviCare, a virtual, clinical, outpatient follow-up program. Persons were contacted again at 30 to 45 days and 7 to 9 months from diagnosis. Participants: Persons who were a part of the CoviCare program from 18 March to 15 May 2020. Measurements: A standardized interview of symptoms consistent with COVID-19, with grading of intensity. Results: Of the 629 participants in the study who completed the baseline interviews, 410 completed follow-up at 7 to 9 months after COVID-19 diagnosis; 39.0% reported residual symptoms. Fatigue (20.7%) was the most common symptom reported, followed by loss of taste or smell (16.8%), dyspnea (11.7%), and headache (10.0%). Limitation: Limitations include generalizability and missing data for 34.8% of participants. Conclusion: Residual symptoms after SARS-CoV-2 infection are common among otherwise young and healthy persons followed in an outpatient setting. These findings contribute to the recognition of long-term effects in a disease mostly counted by its death toll to date by promoting communication on postacute sequelae of SARS-CoV-2 and encouraging physicians to continue long-term monitoring of their patients. Primary Funding Source: None.

Use of Hydroxychloroquine, Remdesivir, and Dexamethasone Among Adults Hospitalized With COVID-19 in the United States: A Retrospective Cohort Study: Annals of Internal Medicine: Vol 174, No 10

Background: Relatively little is known about the use patterns of potential pharmacologic treatments of COVID-19 in the United States. Objective: To use the National COVID Cohort Collaborative (N3C), a large, multicenter, longitudinal cohort, to characterize the use of hydroxychloroquine, remdesivir, and dexamethasone, overall as well as across individuals, health systems, and time. Design: Retrospective cohort study. Setting: 43 health systems in the United States. Participants: 137 870 adults hospitalized with COVID-19 between 1 February 2020 and 28 February 2021. Measurements: Inpatient use of hydroxychloroquine, remdesivir, or dexamethasone. Results: Among 137 870 persons hospitalized with confirmed or suspected COVID-19, 8754 (6.3%) received hydroxychloroquine, 29 272 (21.2%) remdesivir, and 53 909 (39.1%) dexamethasone during the study period. Since the release of results from the RECOVERY (Randomised Evaluation of COVID-19 Therapy) trial in mid-June, approximately 78% to 84% of people who have had invasive mechanical ventilation have received dexamethasone or other glucocorticoids. The use of hydroxychloroquine increased during March 2020, peaking at 42%, and started declining by April 2020. By contrast, remdesivir and dexamethasone use gradually increased over the study period. Dexamethasone and remdesivir use varied substantially across health centers (intraclass correlation coefficient, 14.2% for dexamethasone and 84.6% for remdesivir). Limitation: Because most N3C data contributors are academic medical centers, findings may not reflect the experience of community hospitals. Conclusion: Dexamethasone, an evidence-based treatment of COVID-19, may be underused among persons who are mechanically ventilated. The use of remdesivir and dexamethasone varied across health systems, suggesting variation in patient case mix, drug access, treatment protocols, and quality of care. Primary Funding Source: National Center for Advancing Translational Sciences; National Heart, Lung, and Blood Institute; and National Institute on Aging.

Effect of Sotagliflozin on Total Hospitalizations in Patients With Type 2 Diabetes and Worsening Heart Failure: A Randomized Trial: Annals of Internal Medicine: Vol 174, No 8

Background: In the SOLOIST-WHF (Effect of Sotagliflozin on Cardiovascular Events in Patients With Type 2 Diabetes Post Worsening Heart Failure) trial, sotagliflozin, a sodium–glucose cotransporter-1 and sodium–glucose cotransporter-2 inhibitor, reduced total occurrences of cardiovascular deaths, hospitalizations for heart failure, and urgent visits for heart failure relative to placebo by 33%. Objective: To determine whether sotagliflozin increased the prespecified efficacy outcome of days alive and out of the hospital (DAOH) in the SOLOIST-WHF trial. Design: Randomized, double-blind, placebo-controlled trial. (ClinicalTrials.gov: NCT03521934) Setting: 306 sites in 32 countries. Participants: 1222 patients with type 2 diabetes and reduced or preserved ejection fraction who were recently hospitalized for worsening heart failure. Intervention: 200 mg of sotagliflozin once daily (with a possible dose increase to 400 mg) or matching placebo. Measurements: The primary analysis included hospitalizations for any reason on the basis of investigator-reported incidence and duration of admissions after randomization. Days alive and out of the hospital and its converse (days dead and days in the hospital) were analyzed using prespecified Poisson regression models. Results: Although similar proportions of patients in the sotagliflozin and placebo groups were hospitalized at least once (38.5% vs. 41.4%), fewer patients in the sotagliflozin group were hospitalized more than once (16.3% vs. 22.1%). There were 64 and 76 deaths in the sotagliflozin and placebo groups, respectively. The DAOH rate in the sotagliflozin group was 3% higher than in the placebo group (rate ratio [RR], 1.03 [95% CI, 1.00 to 1.06]; P = 0.027). This difference was primarily driven by a reduction in the rate of days dead (RR, 0.71 [CI, 0.52 to 0.99]; P = 0.041) rather than by a reduction in the rate of days hospitalized for any cause. For every 100 days of follow-up, patients in the sotagliflozin group were alive and out of the hospital for 3% or 2.9 more days than those in the placebo group (91.8 vs. 88.9 days); this difference reflected a 2.6-day difference in days dead (6.3 vs. 8.9 days) and a 0.3-day difference in days in the hospital (1.9 vs. 2.2 days). Limitation: Other than heart failure, the primary reason for each hospitalization was unspecified. Conclusion: Sotagliflozin increased DAOH, a metric that may provide an additional patient-centered outcome to capture the totality of disease burden. Future studies are needed to quantify the consequences of increasing DAOH in terms of health economics and patient quality of life. Primary Funding Source: Sanofi at initiation and Lexicon Pharmaceuticals at completion.

Déjà Vu: Coronaviruses and Transmission in Health Care Settings

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