More pilot trials could plan to use qualitative data: a meta-epidemiological study.
More pilot trials could plan to use qualitative data: a meta-epidemiological study.
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DOI：
10.1186/s40814-020-00712-z
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发表时间：
2020-10-29
影响因子：
1.7
通讯作者：
Mbuagbaw L
中科院分区：
文献类型：
--
作者：
Baldeh T;MacDonald T;Kosa SD;Lawson DO;Stalteri R;Olaiya OR;Alotaibi A;Thabane L;Mbuagbaw L
试点试验通常使用招募率和留存率等定量数据来为更大规模试验的设计和可行性提供信息。然而，患者、医疗服务提供者以及研究人员对干预措施的看法等定性数据也可能为更大规模的试验提供见解。
作为一项更大规模研究的一部分，该研究旨在调查试点研究中进展标准的报告情况，我们试图确定试点研究计划使用定性数据来为更大规模试验的设计和可行性提供信息的频率，以及与使用定性数据的计划相关的因素。我们在2013年至2017年期间在PubMed中搜索了随机试验的试点研究方案。
我们纳入了227篇文章。只有92篇（40.5%；95%置信区间[CI]为34.1% - 47.2%）报告了收集定性数据的计划。与收集定性数据相关的因素包括大规模研究（定义为样本量≥60；调整后的优势比[aOR]为2.77；95% CI为1.47 - 5.23；p = 0.002）以及来自欧洲的研究（aOR为3.86；95% CI为1.68 - 8.88；p = 0.001），与北美和世界其他地区相比。采用药物干预的试点试验不太可能计划收集定性数据（aOR为0.20；95% CI为0.07 - 0.58；p = 0.003）。
定性数据在试点试验中未得到充分利用。大规模试点试验、来自欧洲的试点试验以及非药物干预的试点试验更有可能计划使用定性数据。
Pilot trials often use quantitative data such as recruitment rate and retention rate to inform the design and feasibility of a larger trial. However, qualitative data such as patient, healthcare provider, and research staff perceptions of an intervention may also provide insights for a larger trial. As part of a larger study investigating the reporting of progression criteria in pilot studies, we sought to determine how often pilot studies planned to use qualitative data to inform the design and feasibility of a larger trial and the factors associated with plans to use qualitative data. We searched for protocols of pilot studies of randomized trials in PubMed between 2013 and 2017. We included 227 articles. Only 92 (40.5%; 95% confidence interval [CI] 34.1–47.2) reported plans to collect qualitative data. The factors associated with collecting qualitative data were large studies (defined as sample size ≥ 60; adjusted odds ratio [aOR] 2.77; 95% CI 1.47–5.23; p = 0.002) and studies from Europe (aOR 3.86; 95% CI 1.68–8.88; p = 0.001) compared to North America and the rest of the world. Pilot trials with pharmacological interventions were less likely to plan to collect qualitative data (aOR 0.20; 95% CI 0.07–0.58; p = 0.003). Qualitative data is not used enough in pilot trials. Large pilot trials, pilot trials from Europe, and pilot trials of non-pharmacological interventions are more likely to plan for qualitative data.
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影响因子：
1.1
作者：
Khankeh H;Ranjbar M;Khorasani-Zavareh D;Zargham-Boroujeni A;Johansson E
通讯作者：
Johansson E
影响因子：
1.7
作者：
Murphy, Patrick J;Noone, Chris;Byrne, Molly
通讯作者：
Byrne, Molly
影响因子：
1.7
作者：
Winder, Rachel;Richards, Suzanne H;Turner, Katrina
通讯作者：
Turner, Katrina
影响因子：
3.3
作者：
Samaan Z;Mbuagbaw L;Kosa D;Borg Debono V;Dillenburg R;Zhang S;Fruci V;Dennis B;Bawor M;Thabane L
通讯作者：
Thabane L
影响因子：
4.5
作者：
Harris PA;Taylor R;Thielke R;Payne J;Gonzalez N;Conde JG
通讯作者：
Conde JG