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DESIGN, ANALYSIS, AND REPORTING OF PILOT STUDIES IN HIV

Pilot studies, a subset of feasibility studies, are essential in determining the feasibility of a larger study. This is especially true when targeting populations that are difficult to recruit, such as people with HIV. Designing high quality pilot studies can help limit waste by informing researchers how to proceed.

We conducted a meta-epidemiological review of pilot studies in the HIV literature published until November 25, 2020 using Medline, Embase and Cochrane Controlled Register of Trials (CENTRAL). We extracted bibliometric information, including the region and income of the country where the study was conducted, study design, using the pilot label, source of funding, nature of intervention, whether feasibility was the primary objective, progression criteria, protocol registration and sample size estimation. We used descriptive analysis to evaluate how pilot studies are designed and conducted, the outcomes assessed and how are they defined.

Our search retrieved 10,597 studies, of which 248 were included in our final review. The number of pilot studies has increased with time, with 25, 55, and 44 HIV studies published in 2018, 2019, and 2020, respectively. We found that 128 studies (70.39%) used the pilot or feasibility labels in their title, however 20.31% used these titles interchangeably. 5 studies in this review included progression criteria, all of which were published in 2020. Sample size estimation was only found in 59 studies (23.9%).

Pilot studies in the HIV literature are mislabeled. Sample size estimations are seldom included, and progression criteria are used. Formal guidance on the design and reporting of pilot studies in the HIV literature is necessary. / Thesis / Master of Science (MSc) / Pilot studies are important in evaluating whether planned larger studies can be conducted. They are particularly useful in the field of HIV where participants may be hard to identify and recruit. However, there are few instructions on how pilot studies in HIV should be designed. We searched the literature to see the current state of HIV pilot studies, including how they are designed, and their findings reported. We found that pilot studies are becoming more popular in the HIV field. However, there were gaps in how these studies are designed and reported. Studies were often mislabeled as pilots when they were not, the pilot study criteria were applied inconsistently and the outcomes that were evaluated were often poorly defined and their information poorly presented. Pilot studies in HIV can be reported better.

Identiferoai:union.ndltd.org:mcmaster.ca/oai:macsphere.mcmaster.ca:11375/26134
Date January 2020
CreatorsEl-Khechen, Hussein
ContributorsMbuagbaw, Lawrence, Health Research Methodology
Source SetsMcMaster University
Languageen_US
Detected LanguageEnglish
TypeThesis

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