Assessing the impact of a research funder’s recommendation to consider core outcome sets

BackgroundCore outcome sets (COS) have the potential to reduce waste in research by improving the consistency of outcomes measured in trials of the same health condition. However, this reduction in waste will only be realised through the uptake of COS by clinical trialists. Without uptake, the continued development of COS that are not implemented may add to waste in research. Funders of clinical trials have the potential to have an impact on COS uptake by recommending their use to those applying for funding. The aim of our study was to assess the extent to which applicants followed the National Institute for Health Research Health Technology Assessment (NIHR HTA) programme’s recommendation to search for a COS to include in their clinical trial.Methods and findingsWe examined the outcomes section and detailed project descriptions of all 95 researcher-led primary research applications submitted to the NIHR HTA between January 2012, when the recommendation to search for a COS was included in the guidance for applicants, and December 2015 for evidence that a search for a COS had taken place and rationale for outcome choice in the absence of COS. A survey of applicants was conducted to further explore their use of COS and choice of outcomes with a response rate of 49%. Nine out of 95 applicants (10%) stated in their application that they had searched the COMET (Core Outcome Measures for Effectiveness Trials) Initiative database for a COS and another nine referred to searching for a COS using another method, e.g. a review of the literature. Of the 77 (81%) applicants that did not mention COMET or COS in their application, eight stated in the survey that they had searched the COMET database and ten carried out a search using another method. Some applicants who did not search for a COS gave reasons for their choice of outcomes including taking advice from patients and the public and choosing outcomes used in previous trials.ConclusionA funding body can have an impact on COS uptake by encouraging trialists to search for a COS. Funders could take further steps by putting processes in place to prompt applicants to be explicit about searching for COS in their application and notifying the funding board if a search has not taken place. The sources of information used by trialists to make decisions about outcomes in the absence of COS may suggest methods of dissemination for COS.背景 核心结局指标集（Core Outcome Sets, COS）可通过提升同一健康状况临床试验中结局测量的一致性，减少研究资源浪费。但唯有临床试验研究者采纳COS，方能实现这一减废目标；若缺乏采纳行为，未得到应用的COS的持续开发反而可能加剧研究浪费。临床试验资助方可通过向资助申请者推荐使用COS，对COS的采纳情况施加影响。本研究旨在评估：在2012年1月（将检索COS的要求纳入申请者指南之日）至2015年12月期间，提交给英国国家卫生与保健研究卫生技术评估（National Institute for Health Research Health Technology Assessment, NIHR HTA）项目的全部95项研究者主导的基础研究申请中，申请者遵循该推荐、检索并纳入COS至临床试验的程度。 方法与结果 我们审查了上述时段内提交给NIHR HTA的全部95项研究者主导的基础研究申请的结局章节与详细项目描述，以检索是否存在开展COS检索的证据，以及未检索COS时的结局选择依据。同时针对申请者开展了一项调查，以进一步探究其COS使用与结局选择情况，最终有效回收率为49%。95名申请者中有9名（10%）在申请材料中提及已检索疗效试验核心结局指标集（Core Outcome Measures for Effectiveness Trials, COMET）数据库以获取COS，另有9名申请者提及通过其他方式检索COS，例如开展文献综述。在77名（81%）未在申请中提及COMET或COS的申请者中，有8名在调查中表示已检索COMET数据库，另有10名通过其他方式完成了检索。部分未检索COS的申请者给出了其结局选择的理由，包括参考患者与公众的建议，以及选用既往临床试验中已使用的结局指标。 结论 资助机构可通过鼓励临床试验研究者检索COS，对其采纳情况产生积极影响。资助方可进一步完善相关流程，例如要求申请者在申请材料中明确说明是否开展了COS检索，并对未开展检索的情况通报资助委员会，以此推动COS的采纳。未检索COS的研究者用于决策结局选择的信息来源，或可为COS的推广传播提供可行路径。