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

Abstract Background Pilot 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 info...

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Autores principales: Hussein Ali El-Khechen, Mohammed Inam Ullah Khan, Selvin Leenus, Oluwatobi Olaiya, Zoha Durrani, Zaryan Masood, Alvin Leenus, Shakib Akhter, Lawrence Mbuagbaw
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Lenguaje:EN
Publicado: BMC 2021
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HIV
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spelling oai:doaj.org-article:4f3742647e244e7291bf3caeb40843dd2021-12-05T12:08:30ZDesign, analysis, and reporting of pilot studies in HIV: a systematic review and methodological study10.1186/s40814-021-00934-92055-5784https://doaj.org/article/4f3742647e244e7291bf3caeb40843dd2021-11-01T00:00:00Zhttps://doi.org/10.1186/s40814-021-00934-9https://doaj.org/toc/2055-5784Abstract Background Pilot 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. Methods We 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). Results Our 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. Conclusions Pilot 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.Hussein Ali El-KhechenMohammed Inam Ullah KhanSelvin LeenusOluwatobi OlaiyaZoha DurraniZaryan MasoodAlvin LeenusShakib AkhterLawrence MbuagbawBMCarticlePilot studyFeasibility studyFeasibility outcomeProgression criteriaKey populationHIVMedicine (General)R5-920ENPilot and Feasibility Studies, Vol 7, Iss 1, Pp 1-8 (2021)
institution DOAJ
collection DOAJ
language EN
topic Pilot study
Feasibility study
Feasibility outcome
Progression criteria
Key population
HIV
Medicine (General)
R5-920
spellingShingle Pilot study
Feasibility study
Feasibility outcome
Progression criteria
Key population
HIV
Medicine (General)
R5-920
Hussein Ali El-Khechen
Mohammed Inam Ullah Khan
Selvin Leenus
Oluwatobi Olaiya
Zoha Durrani
Zaryan Masood
Alvin Leenus
Shakib Akhter
Lawrence Mbuagbaw
Design, analysis, and reporting of pilot studies in HIV: a systematic review and methodological study
description Abstract Background Pilot 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. Methods We 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). Results Our 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. Conclusions Pilot 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.
format article
author Hussein Ali El-Khechen
Mohammed Inam Ullah Khan
Selvin Leenus
Oluwatobi Olaiya
Zoha Durrani
Zaryan Masood
Alvin Leenus
Shakib Akhter
Lawrence Mbuagbaw
author_facet Hussein Ali El-Khechen
Mohammed Inam Ullah Khan
Selvin Leenus
Oluwatobi Olaiya
Zoha Durrani
Zaryan Masood
Alvin Leenus
Shakib Akhter
Lawrence Mbuagbaw
author_sort Hussein Ali El-Khechen
title Design, analysis, and reporting of pilot studies in HIV: a systematic review and methodological study
title_short Design, analysis, and reporting of pilot studies in HIV: a systematic review and methodological study
title_full Design, analysis, and reporting of pilot studies in HIV: a systematic review and methodological study
title_fullStr Design, analysis, and reporting of pilot studies in HIV: a systematic review and methodological study
title_full_unstemmed Design, analysis, and reporting of pilot studies in HIV: a systematic review and methodological study
title_sort design, analysis, and reporting of pilot studies in hiv: a systematic review and methodological study
publisher BMC
publishDate 2021
url https://doaj.org/article/4f3742647e244e7291bf3caeb40843dd
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