Design, analysis, and reporting of pilot studies in HIV: a systematic review and methodological study

Pilot and Feasibility Studies

Mohammed Inam Ullah Khan¹  Hussein Ali El-Khechen²  Shakib Akhter²  Lawrence Mbuagbaw³  Zaryan Masood⁴  Selvin Leenus⁵  Alvin Leenus⁵  Zoha Durrani⁶  Oluwatobi Olaiya⁷ 

[1] Biostatistics Unit, Father Sean O’Sullivan Research Centre, St Joseph’s Healthcare, Hamilton, Ontario, Canada;Department of Health Research Methods, Evidence, and Impact, McMaster University, 1280 Main Street West, L8S 4L8, Hamilton, Ontario, Canada;Department of Health Research Methods, Evidence, and Impact, McMaster University, 1280 Main Street West, L8S 4L8, Hamilton, Ontario, Canada;Biostatistics Unit, Father Sean O’Sullivan Research Centre, St Joseph’s Healthcare, Hamilton, Ontario, Canada;Center for the Development of Best Practices in Health, Yaoundé, Cameroon;Department of Kinesiology, Faculty of Science, McMaster University, Hamilton, Ontario, Canada;Faculty of Health Sciences, McMaster University, Hamilton, Ontario, Canada;Joan C. Edwards School of Medicine, Marshall University, Huntington, WV, USA;Michael G. DeGroote School of Medicine, McMaster University, Hamilton, Ontario, Canada;

关键词: Pilot study;    Feasibility study;    Feasibility outcome;    Progression criteria;    Key population;    HIV;   

DOI  :  10.1186/s40814-021-00934-9

来源: Springer

【 摘 要 】

BackgroundPilot studies are essential in determining if a larger study is feasible. This is especially true when targeting populations that experience stigma and may be difficult to include in research, such as people with HIV. We sought to describe how pilot studies have been used to inform HIV clinical trials.MethodsWe conducted a methodological study of pilot studies of interventions in people living with HIV published until November 25, 2020, using Medline, Embase, and Cochrane Controlled Register of Trials (CENTRAL). We extracted data on their nomenclature, primary objective, use of progression criteria, sample size, use of qualitative methods, and other contextual information (region, income, level, type of intervention, study design).ResultsOur search retrieved 10,597 studies, of which 248 were eligible. The number of pilot studies increased steadily over time. We found that 179 studies (72.2%) used the terms “pilot” or “feasibility” in their title, 65.3% tested feasibility as a primary objective, only 2% used progression criteria, 23.9% provided a sample size estimation and only 30.2% used qualitative methods.ConclusionsPilot studies are increasingly being used to inform HIV research. However, the titles and objectives are not always consistent with piloting. The design and reporting of pilot studies in HIV could be improved.

【 授权许可】

CC BY