Background: The novel coronavirus disease (COVID-19) was declared a pandemic in March 2020. This rapid systematic review synthesised published reports of medical educational developments in response to the pandemic, considering descriptions of interventions, evaluation data and lessons learned. Methods: The authors systematically searched four online databases and hand searched MedEdPublish up to 24 May 2020. Two authors independently screened titles, abstracts and full texts, performed data extraction and assessed risk of bias for included articles. Discrepancies were resolved by a third author. A descriptive synthesis and outcomes were reported. Results: Forty-nine articles were included. The majority were from North America, Asia and Europe. Sixteen studies described Kirkpatrick's outcomes, with one study describing levels 1-3. A few papers were of exceptional quality, though the risk of bias framework generally revealed capricious reporting of underpinning theory, resources, setting, educational methods, and content. Key developments were pivoting educational delivery from classroom-based learning to virtual spaces, replacing clinical placement based learning with alternate approaches, and supporting direct patient contact with mitigated risk. Training for treating patients with COVID-19, service reconfiguration, assessment, well-being, faculty development, and admissions were all addressed, with the latter categories receiving the least attention. Conclusions: This review highlights several areas of educational response in the immediate aftermath of the COVID-19 pandemic and identifies a few articles of exceptional quality that can serve as models for future developments and educational reporting. There was often a lack of practical detail to support the educational community in enactment of novel interventions, as well as limited evaluation data. However, the range of options deployed offers much guidance for the medical education community moving forward and there was an indication that outcome data and greater detail will be reported in the future.
Background Hyperkalemia rates in renin–angiotensin–aldosterone system (RAAS) inhibitor users, and factors associated with treatment interruptions and cessations, have not been explored in a large, population-wide database. Methods RAAS inhibitor users were identified in the linked UK Clinical Practice Research Datalink-Hospital Episodes Statistics data set, 2009–15. Treatment interruptions (no active prescription followed by reappearance) and cessations were determined. Hyperkalemia (serum K+>5.5 mmol/L) rates were calculated and factors associated with interruptions and cessations modeled using time-varying Cox regression, including hyperkalemia (as a time-dependent variable). Results Among 434 027 RAAS inhibitor users, the hyperkalemia rate was 1.30 (95% confidence interval 1.28–1.32) per 100 patient-years. Of 73.7% of patients who experienced off-treatment periods, 57.6% experienced interruption only, 7.5% cessation only and 8.6% both. Within 1 year of initiating RAAS inhibitor treatment, approximately one-third of the patients experienced interruption or cessation. Hazard ratios for patients with severe hyperkalemia were 1.10 (10.5–1.16) for interruptions and 3.37 (3.25–3.50) for cessation. Compared with no chronic kidney disease (CKD), risk of interruption was 1.20 (1.16–1.25) and 1.57 (1.44–1.72) for Stages 4 and 5, respectively, and of cessation was 2.20 (2.07–2.33) and 2.87 (2.56–3.22). Risk of interruption increased for patients with heart failure or diabetes [1.04 (1.02–1.05); 1.13 (1.12–1.14), respectively] but the risk of cessation decreased [0.85 (0.82–0.87); 0.92 (0.90–0.94)]. Conclusions Risk of RAAS inhibitor interruption and cessation increased as CKD stage progressed. Efforts targeting reasons for interruptions and, especially, cessations, such as hyperkalemia prevention, could decrease off-treatment periods for patients who would otherwise benefit, such as those with CKD, heart failure or diabetes.
Background Anti-tumour necrosis factor (TNF) and anti-interleukin (IL)-12/23 biologics revolutionized plaque psoriasis treatment by enabling ≥75% improvement in the Psoriasis Area and Severity Index (PASI 75) in clinical trials. Modern biologics are now reported to achieve PASI 100 (complete skin clearance) in clinical trials. However, real-world evidence of skin clearance rates with biologics is limited. PSO-BIO-REAL was conducted to understand the real-world burden of plaque psoriasis. Objective The primary objective of this observational study was to estimate the proportion of patients who achieved complete skin clearance at 6 months. Secondary objectives included maintenance of response and evaluation of complete skin clearance at 12 months. Methods PSO-BIO-REAL was a multinational, prospective, real-world, non-interventional study of skin clearance and patient-reported outcomes (PROs) with biologics. A total of 846 patients from the United States (32%), France (28%), Italy (22%), the United Kingdom (11%) and Germany (8%) were enrolled and followed for one year. Eligible patients were aged ≥18 years with moderate-to-severe plaque psoriasis who had initiated a biologic for plaque psoriasis. Patients could be biologic-na€ ıve or switching biologics (biologic-experienced). Assessments were made at baseline and at months 6 and 12. Results At 6 and 12 months, 23% and 26% of patients achieved complete skin clearance, respectively. Prior to study entry, 60% were biologic-na€ ıve. The proportion of patients achieving complete skin clearance was lower among biologic-experienced patients (20% at both months 6 and 12) compared with biologic-na€ ıve patients (25% at month 6, 30% at month 12). The rate of complete skin clearance decreased as the number of prior biologics and baseline comorbidities increased. Conclusion Only one in four patients achieved complete skin clearance after 6 months of treatment with biologics. The study indicates there still is an unmet need for more efficacious biologics for patients with psoriasis.
ObjectivePatients with rheumatoid arthritis (RA) have an increased risk of serious infections. Comparing infection rates across RA populations is complicated by differences in background infection risk, population composition and study methodology. We measured infection rates from five RA registries globally, with the aim to contextualise infection rates from an RA clinical trials population.MethodsWe used data from Consortium of Rheumatology Research of North America (CORRONA) (USA), Swedish Rheumatology Quality of Care Register (Sweden), Norfolk Arthritis Register (UK), CORRONA International (multiple countries) and Institute of Rheumatology Rheumatoid Arthritis (Japan) and an RA clinical trial programme (fostamatinib). Within each registry, we analysed a main cohort of all patients with RA from January 2000 to last available data. Infection definitions were harmonised across registries. Sensitivity analyses to address potential confounding explored subcohorts defined by disease activity, treatment change and/or prior comorbidities and restriction by calendar time or follow-up. Rates of infections were estimated and standardised to the trial population for age/sex and, in one sensitivity analysis also, for Health Assessment Questionnaire (HAQ) score.ResultsOverall, age/sex-standardised rates of hospitalised infection were quite consistent across registries (range 1.14–1.62 per 100 patient-years). Higher and more consistent rates across registries and with the trial programme overall were seen when adding standardisation for HAQ score (registry range 1.86–2.18, trials rate 2.92) or restricting to a treatment initiation subcohort followed for 18 months (registry range 0.99–2.84, trials rate 2.74).ConclusionThis prospective, coordinated analysis of RA registries provided incidence rate estimates for infection events to contextualise infection rates from an RA clinical trial programme and demonstrated relative comparability of hospitalised infection rates across registries.
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