Smith James A, DeVito Nicholas, Lee Hopin, Tiplady Catherine, Abhari Roxanna E, Kartsonaki Christiana
Botnar Research Centre and Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford OX1 2JD, UK.
National Institute for Health Research Oxford Biomedical Research Centre, John Radcliffe Hospital, Oxford OX3 9DU, UK.
R Soc Open Sci. 2023 Jan 11;10(1):201543. doi: 10.1098/rsos.201543. eCollection 2023 Jan.
There have been reports of poor-quality research during the COVID-19 pandemic. This registered report assessed design characteristics of registered clinical trials for COVID-19 compared to non-COVID-19 trials to empirically explore the design of clinical research during a pandemic and how it compares to research conducted in non-pandemic times. We did a retrospective cohort study with a 1 : 1 ratio of interventional COVID-19 registrations to non-COVID-19 registrations, with four trial design outcomes: use of control arm, randomization, blinding and prospective registration. Logistic regression was used to estimate the odds ratio of investigating COVID-19 versus not COVID-19 and estimate direct and total effects of investigating COVID-19 for each outcome. The primary analysis showed a positive direct and total effect of COVID-19 on the use of control arms and randomization. It showed a negative direct effect of COVID-19 on blinding but no evidence of a total effect. There was no evidence of an effect on prospective registration. Taken together with secondary and sensitivity analyses, our findings are inconclusive but point towards a higher prevalence of key design characteristics in COVID-19 trials versus controls. The findings do not support much existing COVID-19 research quality literature, which generally suggests that COVID-19 led to a reduction in quality. Limitations included some data quality issues, minor deviations from the pre-registered plan and the fact that trial registrations were analysed which may not accurately reflect study design and conduct. Following in-principle acceptance, the approved stage 1 version of this manuscript was pre-registered on the Open Science Framework at https://doi.org/10.17605/OSF.IO/5YAEB. This pre-registration was performed prior to data analysis.
有报告称在新冠疫情期间存在研究质量不佳的情况。本预注册报告评估了新冠疫情相关注册临床试验与非新冠疫情相关试验的设计特征，以实证探索疫情期间临床研究的设计情况以及与非疫情时期研究的对比。我们进行了一项回顾性队列研究，将新冠疫情相关干预性注册与非新冠疫情相关注册按1:1的比例进行对比，有四个试验设计结果：对照组的使用、随机化、盲法和前瞻性注册。采用逻辑回归来估计研究新冠疫情与不研究新冠疫情的比值比，并估计研究新冠疫情对每个结果的直接和总体影响。初步分析显示，新冠疫情对对照组的使用和随机化有积极的直接和总体影响。它显示新冠疫情对盲法有负面直接影响，但没有总体影响的证据。没有证据表明对前瞻性注册有影响。结合二次分析和敏感性分析，我们的研究结果尚无定论，但表明新冠疫情相关试验与对照组相比，关键设计特征的发生率更高。这些发现不支持现有的许多新冠疫情研究质量文献，这些文献普遍认为新冠疫情导致了质量下降。局限性包括一些数据质量问题、与预注册计划的轻微偏差以及所分析的试验注册可能无法准确反映研究设计和实施情况这一事实。原则上接受后，本稿件经批准的第一阶段版本在开放科学框架（https://doi.org/10.17605/OSF.IO/5YAEB）上进行了预注册。此预注册在数据分析之前进行。
