Dimethyl fumarate in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial

Dimethyl fumarate (DMF) inhibits inflammasome-mediated inflammation and has been proposed as a treatment for patients hospitalised with COVID-19. This randomised, controlled, open-label platform trial (Randomised Evaluation of COVID-19 Therapy [RECOVERY]), is assessing multiple treatments in patients hospitalised for COVID-19 (NCT04381936, ISRCTN50189673). In this assessment of DMF performed at 27 UK hospitals, adults were randomly allocated (1:1) to either usual standard of care alone or usual standard of care plus DMF. The primary outcome was clinical status on day 5 measured on a seven-point ordinal scale. Secondary outcomes were time to sustained improvement in clinical status, time to discharge, day 5 peripheral blood oxygenation, day 5 C-reactive protein, and improvement in day 10 clinical status. Between 2 March 2021 and 18 November 2021, 713 patients were enroled in the DMF evaluation, of whom 356 were randomly allocated to receive usual care plus DMF, and 357 to usual care alone. 95% of patients received corticosteroids as part of routine care. There was no evidence of a beneficial effect of DMF on clinical status at day 5 (common odds ratio of unfavourable outcome 1.12; 95% CI 0.86-1.47; p = 0.40). There was no significant effect of DMF on any secondary outcome

Convalescent plasma in patients admitted to hospital with COVID-19 (RECOVERY): a randomised controlled, open-label, platform trial

SummaryBackground Azithromycin has been proposed as a treatment for COVID-19 on the basis of its immunomodulatoryactions. We aimed to evaluate the safety and efficacy of azithromycin in patients admitted to hospital with COVID-19.Methods In this randomised, controlled, open-label, adaptive platform trial (Randomised Evaluation of COVID-19Therapy [RECOVERY]), several possible treatments were compared with usual care in patients admitted to hospitalwith COVID-19 in the UK. The trial is underway at 176 hospitals in the UK. Eligible and consenting patients wererandomly allocated to either usual standard of care alone or usual standard of care plus azithromycin 500 mg once perday by mouth or intravenously for 10 days or until discharge (or allocation to one of the other RECOVERY treatmentgroups). Patients were assigned via web-based simple (unstratified) randomisation with allocation concealment andwere twice as likely to be randomly assigned to usual care than to any of the active treatment groups. Participants andlocal study staff were not masked to the allocated treatment, but all others involved in the trial were masked to theoutcome data during the trial. The primary outcome was 28-day all-cause mortality, assessed in the intention-to-treatpopulation. The trial is registered with ISRCTN, 50189673, and ClinicalTrials.gov, NCT04381936.Findings Between April 7 and Nov 27, 2020, of 16 442 patients enrolled in the RECOVERY trial, 9433 (57%) wereeligible and 7763 were included in the assessment of azithromycin. The mean age of these study participants was65·3 years (SD 15·7) and approximately a third were women (2944 [38%] of 7763). 2582 patients were randomlyallocated to receive azithromycin and 5181 patients were randomly allocated to usual care alone. Overall,561 (22%) patients allocated to azithromycin and 1162 (22%) patients allocated to usual care died within 28 days(rate ratio 0·97, 95% CI 0·87–1·07; p=0·50). No significant difference was seen in duration of hospital stay (median10 days [IQR 5 to >28] vs 11 days [5 to >28]) or the proportion of patients discharged from hospital alive within 28 days(rate ratio 1·04, 95% CI 0·98–1·10; p=0·19). Among those not on invasive mechanical ventilation at baseline, nosignificant difference was seen in the proportion meeting the composite endpoint of invasive mechanical ventilationor death (risk ratio 0·95, 95% CI 0·87–1·03; p=0·24).Interpretation In patients admitted to hospital with COVID-19, azithromycin did not improve survival or otherprespecified clinical outcomes. Azithromycin use in patients admitted to hospital with COVID-19 should be restrictedto patients in whom there is a clear antimicrobial indication

Development of a Multi-Domain Assessment Tool for Quality Improvement Projects.

BackgroundImproving the quality of health care and education has become a mandate at all levels within the medical profession. While several published quality improvement (QI) assessment tools exist, all have limitations in addressing the range of QI projects undertaken by learners in undergraduate medical education, graduate medical education, and continuing medical education.ObjectiveWe developed and validated a tool to assess QI projects with learner engagement across the educational continuum.MethodsAfter reviewing existing tools, we interviewed local faculty who taught QI to understand how learners were engaged and what these faculty wanted in an ideal assessment tool. We then developed a list of competencies associated with QI, established items linked to these competencies, revised the items using an iterative process, and collected validity evidence for the tool.ResultsThe resulting Multi-Domain Assessment of Quality Improvement Projects (MAQIP) rating tool contains 9 items, with criteria that may be completely fulfilled, partially fulfilled, or not fulfilled. Interrater reliability was 0.77. Untrained local faculty were able to use the tool with minimal guidance.ConclusionsThe MAQIP is a 9-item, user-friendly tool that can be used to assess QI projects at various stages and to provide formative and summative feedback to learners at all levels

Missing documentation of weight and height at preventive visits for children.

Despite the importance of measuring weight and height at well-child visits, there are limited data on frequency of anthropometric documentation. The authors aimed to identify characteristics associated with missing weight and height documentation at preventive visits for children. Among preventive visits for children from birth to 18 years old, recorded in the National Ambulatory Medical Care and National Hospital Ambulatory Medical Care Surveys for 2005-2009, the authors found that 20.8% had missing weight and/or height (n = 19,033) documentation. Compared with infants younger than 2 years, school-age children (odds ratio [OR] = 1.30; 95% confidence interval [CI] = 1.03-1.64), and adolescents (OR = 1.61; 95% CI = 1.26-2.04) were more likely to lack documentation. Missing documentation was also more likely for visits with nonphysicians (OR = 4.53; 95% CI = 3.17-6.48) and nonpediatricians (OR = 2.63; 95% CI = 2.02-3.41) compared with pediatricians. Efforts to improve weight and height surveillance should be directed to clinics in which midlevel providers and nonpediatric physicians are caring for school-age children and adolescents

The cross-cultural utility of foreign- and locally-derived normative data for three WHO-endorsed neuropsychological tests for South African adolescents

Interpretation of neuropsychological tests may be hampered by confounding sociodemographic factors and by using inappropriate normative data. We investigated these factors in three tests endorsed by the World Health Organization: the Grooved Pegboard Test (GPT), the Children's Color Trails Test (CCTT), and the WHO/UCLA version of the Auditory Verbal Learning Test (AVLT). In a sample of 12-15-year-old, Afrikaans- and English-speaking adolescents from the Cape Town region of South Africa, analyses of covariance (ANCOVAs) demonstrated that quality of education was the sociodemographic factor with the biggest influence on test performance, and that age also significantly influenced GPT and CCTT performance. Based on those findings, we provide appropriately stratified normative data for the age group in question. Comparisons between diagnostic interpretations made using foreign normative data versus those using the current local data demonstrate that it is imperative to use appropriately stratified normative data to guard against misinterpreting performance