Effect of angiotensin-converting enzyme inhibitor and angiotensin receptor blocker initiation on organ support-free days in patients hospitalized with COVID-19

IMPORTANCE Overactivation of the renin-angiotensin system (RAS) may contribute to poor clinical outcomes in patients with COVID-19. Objective To determine whether angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) initiation improves outcomes in patients hospitalized for COVID-19. DESIGN, SETTING, AND PARTICIPANTS In an ongoing, adaptive platform randomized clinical trial, 721 critically ill and 58 non–critically ill hospitalized adults were randomized to receive an RAS inhibitor or control between March 16, 2021, and February 25, 2022, at 69 sites in 7 countries (final follow-up on June 1, 2022). INTERVENTIONS Patients were randomized to receive open-label initiation of an ACE inhibitor (n = 257), ARB (n = 248), ARB in combination with DMX-200 (a chemokine receptor-2 inhibitor; n = 10), or no RAS inhibitor (control; n = 264) for up to 10 days. MAIN OUTCOMES AND MEASURES The primary outcome was organ support–free days, a composite of hospital survival and days alive without cardiovascular or respiratory organ support through 21 days. The primary analysis was a bayesian cumulative logistic model. Odds ratios (ORs) greater than 1 represent improved outcomes. RESULTS On February 25, 2022, enrollment was discontinued due to safety concerns. Among 679 critically ill patients with available primary outcome data, the median age was 56 years and 239 participants (35.2%) were women. Median (IQR) organ support–free days among critically ill patients was 10 (–1 to 16) in the ACE inhibitor group (n = 231), 8 (–1 to 17) in the ARB group (n = 217), and 12 (0 to 17) in the control group (n = 231) (median adjusted odds ratios of 0.77 [95% bayesian credible interval, 0.58-1.06] for improvement for ACE inhibitor and 0.76 [95% credible interval, 0.56-1.05] for ARB compared with control). The posterior probabilities that ACE inhibitors and ARBs worsened organ support–free days compared with control were 94.9% and 95.4%, respectively. Hospital survival occurred in 166 of 231 critically ill participants (71.9%) in the ACE inhibitor group, 152 of 217 (70.0%) in the ARB group, and 182 of 231 (78.8%) in the control group (posterior probabilities that ACE inhibitor and ARB worsened hospital survival compared with control were 95.3% and 98.1%, respectively). CONCLUSIONS AND RELEVANCE In this trial, among critically ill adults with COVID-19, initiation of an ACE inhibitor or ARB did not improve, and likely worsened, clinical outcomes. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT0273570

The MOS 36-Item Short-Form Health Survey (SF-36): II. Psychometric and clinical tests of validity in measuring physical and mental health constructs

Cross-sectional data from the Medical Outcomes Study (MOS) were analyzed to test the validity of the MOS 36-Item Short-Form Health Survey (SF-36) scales as measures of physical and mental health constructs. Results from traditional psychometric and clinical tests of validity were compared. Principal components analysis was used to test for hypothesized physical and mental health dimensions. For purposes of clinical tests of validity, clinical criteria defined mutually exclusive adult patient groups differing in severity of medical and psychiatric conditions. Scales shown in the components analysis to primarily measure physical health (physical functioning and role limitations-physical) best distinguished groups differing in severity of chronic medical condition and had the most pure physical health interpretation. Scales shown to primarily measure mental health (mental health and role limitations-emotional) best distinguished groups differing in the presence and severity of psychiatric disorders and had the most pure mental health interpretation. The social functioning, vitality, and general health perceptions scales measured both physical and mental health components and, thus, had the most complex interpretation. These results are useful in establishing guidelines for the interpretation of each scale and in documenting the size of differences between clinical groups that should be considered very large

An online evidence based medicine exercise prompts reflection in third year medical students

BACKGROUND: Reflective practice is a desirable trait in physicians, yet there is little information about how it is taught to or learned by medical students. The purpose of this study was to determine whether an online Evidence Based Medicine (EBM) exercise with a face-to-face debriefing session would prompt third year medical students to reflect on their current skills and lead them to further reflection on clinical decision making in the future. METHODS: All third year medical students at the University Of Maryland School Of Medicine who completed their pediatrics clerkship between 7/1/09 and 2/11/11 were required to complete the EBM exercise. Following completion each student received a personal report (Learning Profile) of their responses and attended a one hour large group debriefing session. Student responses to a survey following the debriefing sessions were analyzed using a post-test survey design with a single experimental cohort. RESULTS: Ninety-five percent of students completing the debriefing survey indicated that the debriefing session helped them better understand their learning profiles; 68% stated that their profiles allowed them to evaluate themselves and their decisions. Sixty-three percent noted that participating in the exercise and the debrief would lead them to either learn more about EBM and use EBM more in the future or reflect more on their own decision making. CONCLUSIONS: The EBM exercise was a successful way to introduce the concept of reflective practice to third year medical students, and the graphic Learning Profiles were effective instigators of discussion and reflection

Cognitive Simulation in Virtual Patients

We present an overview of the Virtual Patient project at the University of Maryland, which is developing a cognitive model of humans experiencing various states of health and disease to be used in interactive simulations for physician training. Overview This Virtual Patient 1 project is devoted to creating a cognitive, knowledge-based model of a virtual patient (VP) that undergoes both normal and pathological physiological processes. VPs are ontological objects, specifically, subclasses of VIRTUAL-HUMAN that have various diseases and disorders. Like all VIRTUAL-HUMANs, their large inventory of property-value pairs changes in response to ontological events, includin

The validity and relative precision of MOS short- and long-form health status scales and Dartmouth COOP charts. Results from the Medical Outcomes Study

This study estimated the validity and relative precision (RP) of four methods (MOS long- and short-form scales, global items, and COOP Poster Charts) in measuring six general health concepts. The authors also tested whether and how precisely each method discriminated relatively well adult patients (N = 638) from those with only severe chronic medical (N = 168) and only psychiatric conditions (N = 163), as clinically defined. For comparisons between the well group and both medical and psychiatric groups, RP estimates favored long-form over short-form, multi-item scales, and favored multi-item scales over single-item global measures and poster charts. In relation to long forms, short-form multi-item scales achieved a median RP of .93; RP estimates for global items and poster charts were .81 and .67, respectively. Variations in RP across methods and concepts were linked to differences in the coarseness of measurement scales, reliability, and content (including the effects of chart illustrations). These variations in RP have implications for the interpretation of scores, the statistical power of comparisons between clinical groups, and the size of confidence intervals around individual patient scores

The Long-Term Impact of Systemic Student Support in Elementary School: Reducing High School Dropout

Dropping out of high school has adverse consequences, including negative effects on employment, lifetime earnings, and physical health. Students often fail to complete high school for complex reasons that often manifest long before they reach high school. This study examines the link between participation in a comprehensive elementary school student support intervention and high school dropout. In this study, students who attended intervention elementary schools in a large, urban, high-poverty district during 2001–2014 ( N =894) were compared to students who did not attend intervention schools ( N =10,200). Likelihood of dropping out in grades 9–12 was estimated using propensity score-weighted Discrete Event History Analysis. Intervention students had approximately half the odds of dropout ( p <.001); the probability of dropout for intervention was 9.2%, compared to 16.6% for non-intervention students. Individually tailored student support interventions during elementary school can lead to lasting and meaningful effects

Comparison of Rasch and summated rating scales constructed from SF-36 physical functioning items in seven countries: results from the IQOLA Project. International Quality of Life Assessment

Rasch models for polytomous items were used to assess the scaling assumptions and compare item response patterns in the 10-item SF-36 physical functioning scale (PF-10) for general population respondents in Denmark, Germany, Italy, the Netherlands, Sweden, the United Kingdom, and the United States. The Rasch model of physical functioning developed in the United States was compared to models for other countries, and each country was compared to a multinational composite. Strong scale congruence across the seven countries was demonstrated; items that varied between countries and from the composite may reflect unique cultural response patterns or differences in translation. Scoring algorithms based on the Rasch model for each country were superior to the current Likert scoring in tests of relative validity (RV) in discriminating among age groups in all countries. In relation to the Likert PF-10 scoring (RV = 1.00), scores estimated using the Rasch rating scale model achieve a median RV of 1.31 (range: 1.01-1.59), while the Rasch partial credit model attained a median RV of 1.44 (range: 1.01-2.23). Rasch models hold good potential for improving health status measures, estimating individual scores when responses to scale items are missing, and equating scores across countries