Institute of Systems, Molecular and Integrative Biology, University of Liverpool, Liverpool, UK.
Department of Health Data Science, University of Liverpool (a member of Liverpool Health Partners), Liverpool, UK.
F1000Res. 2021 Oct 25;10:1084. doi: 10.12688/f1000research.73647.2. eCollection 2021.
Core outcome sets (COS) are an agreed standardised collection of outcomes created with representation from all key stakeholders (such as patients, clinicians, researchers), which should be reported as a minimum for all trials in that corresponding clinical area. There has been little research investigating the use of core outcomes in Health technology assessments (HTAs) and none in non-oncology HTAs. This study aimed to assess the similarity between COS and HTA outcomes. Ten COS published between 2015 and 2019 were selected, with patient participation taken as a proxy measure for a high quality COS. The INAHTA database was used as a source to identify relevant HTAs, which were accessed through the hyperlinks provided. Outcomes selected for these assessments were categorised as either a specific, partial or no match compared to the COS. An additional cohort of non-oncology HTAs published between 2019 and 2021 were identified from the NICE website and compared against a relevant COS. Six hundred and fifty-one HTAs were matched to the ten COS areas, of which 119 were reviewed. Of a possible 1318 core outcome matches, there were 562 (43%) matches, 413 (31%) specific and 149 (11%) partial. NICE HTA matches against corresponding COS ranged from 44% to 100%, with a total of 78% (73/94) matches, 57 (61%) specific and 16 (17%) partial. Further work is required to promote the awareness and implementation of COS within HTAs. The degree of matching between COS and NICE HTA outcomes is encouraging, demonstrating acceptance of COS by HTA producers.
核心结局集(COS)是一种经过所有主要利益相关者(如患者、临床医生、研究人员)代表共同制定的标准化结局集合,应作为相应临床领域内所有试验的最低报告标准。目前,关于核心结局在健康技术评估(HTA)中的应用研究较少,非肿瘤学 HTA 中则没有。本研究旨在评估 COS 和 HTA 结局之间的相似性。 选择了 2015 年至 2019 年发表的 10 个 COS,以患者参与作为高质量 COS 的代理指标。INAHTA 数据库被用作识别相关 HTA 的来源,并通过提供的超链接访问这些 HTA。这些评估中选择的结局被归类为与 COS 完全匹配、部分匹配或不匹配。还从 NICE 网站确定了一个 2019 年至 2021 年发表的非肿瘤学 HTA 队列,并与相关 COS 进行了比较。 将 651 项 HTA 与十个 COS 领域进行匹配,其中 119 项进行了审查。在可能的 1318 个核心结局匹配中,有 562 个(43%)匹配,413 个(31%)完全匹配,149 个(11%)部分匹配。NICE HTA 与相应 COS 的匹配率从 44%到 100%不等,总共有 78%(73/94)匹配,57 个(61%)完全匹配,16 个(17%)部分匹配。 需要进一步努力提高 HTA 领域对 COS 的认识和实施。COS 与 NICE HTA 结局之间的匹配程度令人鼓舞,表明 HTA 制作者对 COS 的接受程度。