University of Southampton, Southampton, UK.
University of Bristol, Bristol, UK.
Lancet. 2015 Feb 26;385 Suppl 1:S43. doi: 10.1016/S0140-6736(15)60358-0.
Outcome reporting in bariatric surgery needs uniformity. A core outcome set is an agreed minimum set of outcomes reported in all studies of a particular condition, but members of the bariatric multidisciplinary team might value outcomes differently. The aim of this study was to summarise existing outcome reporting in bariatric surgery, to inform the development of a core outcome set, and to compare outcomes selected as important by type of health professional.
Outcomes reported in randomised controlled trials (RCTs) and large non-randomised studies, identified by a systematic review, were listed verbatim. Frequency of outcome reporting and uniformity of definition were assessed. A questionnaire to rate the importance of each outcome was completed by members of the bariatric multidisciplinary team. Responses to each item were scored as 1 (not essential) to 9 (absolutely essential). We ranked outcomes according to percentage deemed important (7-9) and according to respondents by type of health professional.
We identified 1088 individual outcomes from 90 studies (39 RCTs), grouped them into health domains, and presented them as a questionnaire with 131 items to 489 multidisciplinary team members. Most outcomes (n=920, 85%) were reported only once. The largest outcome domain was surgical complications, and 432 outcomes (42%) corresponded to an adverse event. Only a quarter of outcomes (n=461) were defined, and were often contradictory. For questionnaire responders (n=164, response rate 33·5%), most were surgeons (n=80, 48·8%), followed by dietitians (n=31, 18·9%), nurses (n=24, 14·6%), physicians (n=12, 7·3%), and others (n=16, 9·9%). Improvement in diabetes was the top outcome for all health professionals. Seven of the surgeon's top ten outcomes were adverse events, compared with three for other health professionals. Groups valued a measure of weight differently (third vs 15th for other health professionals and surgeons, respectively).
This study shows that the assessment of bariatric surgery focuses largely on adverse events and resolution of comorbidity, but that reporting is inconsistent and ill-defined. Substantial variation between the views of surgeons and those of other health professionals was evident. The next step is to provide feedback to participants and to survey their views again before a final consensus meeting to produce a core outcome set for the Benefits and Adverse events in BARIAtric surgery Clinical Trials (BARIACT) as a solution to this problem.
National Institute for Health Research (NIHR), and the NIHR Health Technology Assessment programme. This work was also undertaken with the support of the MRC ConDuCT-II Hub (Collaboration and innovation for Difficult and Complex randomised controlled Trials In Invasive procedures, MR/K025643/1).
减重手术的结果报告需要统一。核心结果集是指在特定疾病的所有研究中都报告的一套商定的最低限度的结果，但减重多学科团队的成员可能对结果有不同的重视。本研究旨在总结减重手术的现有结果报告，为核心结果集的制定提供信息，并比较不同类型的卫生专业人员选择的重要结果。
通过系统评价确定随机对照试验（RCT）和大型非随机研究中报告的结果，并逐字列出。评估结果报告的频率和定义的一致性。减重多学科团队的成员填写了一份评估每个结果重要性的问卷。对每个项目的回答得分为 1（不重要）到 9（绝对重要）。我们根据被认为重要的百分比（7-9）和按卫生专业人员类型对结果进行了排名。
我们从 90 项研究（39 项 RCT）中确定了 1088 个单独的结果，将它们归入健康领域，并将它们作为一个包含 131 个项目的问卷呈现给 489 名多学科团队成员。大多数结果（n=920，85%）仅报告过一次。最大的结果领域是手术并发症，432 个结果（42%）对应不良事件。只有四分之一的结果（n=461）被定义，而且往往相互矛盾。对于问卷回答者（n=164，响应率 33.5%），大多数是外科医生（n=80，48.8%），其次是营养师（n=31，18.9%），护士（n=24，14.6%），医生（n=12，7.3%）和其他（n=16，9.9%）。所有卫生专业人员的糖尿病改善都是最重要的结果。对于所有卫生专业人员来说，医生的前十个结果中有七个是不良事件，而其他卫生专业人员只有三个。各组对体重的衡量标准重视程度不同（对于其他卫生专业人员和外科医生来说，分别是第三和第十五）。
本研究表明，减重手术的评估主要集中在不良事件和并发症的解决上，但报告不一致且定义不明确。外科医生和其他卫生专业人员的观点之间存在明显差异。下一步是向参与者提供反馈，并在最终共识会议前再次调查他们的意见，以制定 BARIACT 作为解决这一问题的利益和不良事件在减肥手术临床试验中的核心结果集。
国家卫生研究院（NIHR）和国家卫生研究院健康技术评估计划。这项工作还得到了 MRC ConDuCT-II 中心（协作和创新，用于困难和复杂的随机对照试验在侵入性手术中，MR/K025643/1）的支持。
