Identification and categorisation of relevant outcomes for symptomatic uncomplicated gallstone disease: in-depth analysis to inform the development of a core outcome set.
Identification and categorisation of relevant outcomes for symptomatic uncomplicated gallstone disease: in-depth analysis to inform the development of a core outcome set.
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DOI：
10.1136/bmjopen-2020-045568
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发表时间：
2021-06-24
期刊：
影响因子：
2.9
通讯作者：
Gillies K
中科院分区：
文献类型：
--
作者：
Cruickshank M;Newlands R;Blazeby J;Ahmed I;Bekheit M;Brazzelli M;Croal B;Innes K;Ramsay C;Gillies K
由于研究、结果定义、收集和报告缺乏标准化，许多已完成的针对非复杂性胆结石疾病的干预试验并没有发挥应有的作用。研究结果的异质性阻碍了对初步研究的有效综合，并最终对所有利益相关者的决策产生负面影响。核心结果集提供了一种潜在的解决方案，以解决异质性问题，并关注是否测量了“正确”的结果。核心结果集生成的第一步是确定被认为重要的（文献中或直接由患者）报告的结果范围。制定一个系统的地图，检查无并发症症状性胆结石疾病干预措施结果报告的差异，并确定对胆结石患者重要的其他结果，这些结果以前没有在干预研究中测量或报告过。文献检索确定了794个可能相关的标题和摘要，其中137个被认为符合纳入条件。共纳入129项随机对照试验、4项胆结石疾病特异性患者报告结局测量（PROMs）和8项定性研究。该研究还补充了来自6个个人访谈、1个焦点小组（n=5名参与者）和20个咨询分析的数据。在综合证据中确定了386个单独记录的结果：330个结果（报告了1147次）来自评估干预措施的试验，22个结果来自PROMs， 17个结果来自现有定性研究，17个结果来自初步定性研究。证据来源之间存在重叠区域，但主要研究也贡献了新的，未在此背景下报告的结果。本研究采用严格的方法对胆囊结石疾病的重要结果进行分类和绘制，以促进COS“长”清单的发展。需要一个考虑所有相关利益相关者意见的简单胆石病COS。
Many completed trials of interventions for uncomplicated gallstone disease are not as helpful as they could be due to lack of standardisation across studies, outcome definition, collection and reporting. This heterogeneity of outcomes across studies hampers useful synthesis of primary studies and ultimately negatively impacts on decision making by all stakeholders. Core outcome sets offer a potential solution to this problem of heterogeneity and concerns over whether the ‘right’ outcomes are being measured. One of the first steps in core outcome set generation is to identify the range of outcomes reported (in the literature or by patients directly) that are considered important. To develop a systematic map that examines the variation in outcome reporting of interventions for uncomplicated symptomatic gallstone disease, and to identify other outcomes of importance to patients with gallstones not previously measured or reported in interventional studies. The literature search identified 794 potentially relevant titles and abstracts of which 137 were deemed eligible for inclusion. A total of 129 randomised controlled trials, 4 gallstone disease specific patient-reported outcome measures (PROMs) and 8 qualitative studies were included. This was supplemented with data from 6 individual interviews, 1 focus group (n=5 participants) and analysis of 20 consultations. A total of 386 individual recorded outcomes were identified across the combined evidence: 330 outcomes (which were reported 1147 times) from trials evaluating interventions, 22 outcomes from PROMs, 17 outcomes from existing qualitative studies and 17 outcomes from primary qualitative research. Areas of overlap between the evidence sources existed but also the primary research contributed new, unreported in this context, outcomes. This study took a rigorous approach to catalogue and map the outcomes of importance in gallstone disease to enhance the development of the COS ‘long’ list. A COS for uncomplicated gallstone disease that considers the views of all relevant stakeholders is needed.
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