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艾滋病病毒(HIV)试点研究的设计、分析与报告:一项系统综述和方法学研究

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

作者信息

El-Khechen Hussein Ali, Khan Mohammed Inam Ullah, Leenus Selvin, Olaiya Oluwatobi, Durrani Zoha, Masood Zaryan, Leenus Alvin, Akhter Shakib, Mbuagbaw Lawrence

机构信息

Department of Health Research Methods, Evidence, and Impact, McMaster University, 1280 Main Street West, Hamilton, Ontario, L8S 4L8, Canada.

Biostatistics Unit, Father Sean O'Sullivan Research Centre, St Joseph's Healthcare, Hamilton, Ontario, Canada.

出版信息

Pilot Feasibility Stud. 2021 Nov 30;7(1):211. doi: 10.1186/s40814-021-00934-9.


DOI:10.1186/s40814-021-00934-9
PMID:34847957
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8630899/
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.

摘要

背景:试点研究对于确定更大规模的研究是否可行至关重要。对于诸如艾滋病毒感染者这类面临污名化且可能难以纳入研究的人群而言,情况尤其如此。我们试图描述试点研究如何被用于为艾滋病毒临床试验提供信息。 方法:我们使用Medline、Embase和Cochrane对照试验注册中心(CENTRAL),对截至2020年11月25日发表的针对艾滋病毒感染者的干预措施试点研究进行了一项方法学研究。我们提取了有关其命名、主要目标、进展标准的使用、样本量、定性方法的使用以及其他背景信息(地区、收入、水平、干预类型、研究设计)的数据。 结果:我们的检索共找到10597项研究,其中248项符合条件。试点研究的数量随时间稳步增加。我们发现,179项研究(72.2%)在其标题中使用了“试点”或“可行性”一词,65.3%将测试可行性作为主要目标,仅2%使用了进展标准,23.9%提供了样本量估计,仅30.2%使用了定性方法。 结论:试点研究越来越多地被用于为艾滋病毒研究提供信息。然而,标题和目标并不总是与试点工作一致。艾滋病毒试点研究的设计和报告有待改进。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fa7c/8630899/e02675104e7a/40814_2021_934_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fa7c/8630899/ae2fd10f3f3c/40814_2021_934_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fa7c/8630899/e02675104e7a/40814_2021_934_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fa7c/8630899/ae2fd10f3f3c/40814_2021_934_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fa7c/8630899/e02675104e7a/40814_2021_934_Fig2_HTML.jpg

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[5]
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引用本文的文献

[1]
Feasibility of a Randomized, Interventional Pilot Clinical Study of Oral Cannabinoids in People with HIV on Antiretroviral Therapy: CTNPT 028.

J Pers Med. 2024-7-13

[2]
Empirical progression criteria thresholds for feasibility outcomes in HIV clinical trials: a methodological study.

Pilot Feasibility Stud. 2023-6-14

本文引用的文献

[1]
More pilot trials could plan to use qualitative data: a meta-epidemiological study.

Pilot Feasibility Stud. 2020-10-29

[2]
Acceptability of a trial of vaginal progesterone for the prevention of preterm birth among HIV-infected women in Lusaka, Zambia: A mixed methods study.

PLoS One. 2020-9-24

[3]
Feasibility of implementing a novel behavioural smoking cessation intervention amongst human immunodeficiency virus-infected smokers in a resource-limited setting: A single-arm pilot trial.

South Afr J HIV Med. 2020-6-24

[4]
Barriers and facilitators to recruitment and enrollment of HIV-infected individuals with opioid use disorder in a clinical trial.

BMC Health Serv Res. 2019-11-21

[5]
The reporting of progression criteria in protocols of pilot trials designed to assess the feasibility of main trials is insufficient: a meta-epidemiological study.

Pilot Feasibility Stud. 2019-11-3

[6]
Optimising recruitment into trials using an internal pilot.

Trials. 2019-4-11

[7]
Building the evidence base to optimize the impact of key population programming across the HIV cascade.

J Int AIDS Soc. 2018-7

[8]
Exploratory studies to decide whether and how to proceed with full-scale evaluations of public health interventions: a systematic review of guidance.

Pilot Feasibility Stud. 2018-5-28

[9]
Do feasibility studies contribute to, or avoid, waste in research?

PLoS One. 2018-4-23

[10]
HIV Research with Men who Have Sex with Men (MSM): Advantages and Challenges of Different Methods for Most Appropriately Targeting a Key Population.

AIMS Public Health. 2017-5-17

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