Rhodes Sarah, Dodd Susanna, Deckert Stefanie, Vasanthan Lenny, Qiu Ruijin, Rohde Jeanett Friis, Florez Ivan D, Schmitt Jochen, Nieuwlaat Robby, Kirkham Jamie, Williamson Paula R
Centre for Biostatistics, The University of Manchester, Manchester Academic Health Science Centre, Manchester, UK.
MRC-NIHR Trials Methodology Research Partnership, Department of Health Data Science, University of Liverpool, Liverpool, L63 3GL, UK.
J Clin Epidemiol. 2024 May;169:111311. doi: 10.1016/j.jclinepi.2024.111311. Epub 2024 Feb 27.
A core outcome set (COS) is an agreed standardized set of outcomes that should be measured and reported, as a minimum, in specific areas of health or health care. A COS is developed through a consensus process to ensure health care outcomes to be measured are relevant to decision-makers, including patients and health-care professionals. Use of COS in guideline development is likely to increase the relevance of the guideline to those decision-makers. Previous work has looked at the uptake of COS in trials, systematic reviews, health technology assessments and regulatory guidance but to date there has been no evaluation of the use of COS in practice guideline development. The objective of this study was to investigate the representation of core outcomes in a set of international practice guidelines.
We searched for clinical guidelines relevant to ten high-quality COS (with focus on the United Kingdom, Germany, China, India, Canada, Denmark, United States and World Health Organisation). We matched scope between COS and guideline in terms of condition, population and outcome. We calculated the proportion of guidelines mentioning or referencing COS and the proportion of COS domains specifically, or generally, matching to outcomes specified in each guideline populations, interventions, comparators and outcome (PICO) statement.
We found 38 guidelines that contained 170 PICO statements matching the scope of the ten COS and of sufficient quality to allow data extraction. None of the guidelines reviewed explicitly mentioned or referenced the relevant COS. The median (range) of the proportion of core outcomes covered either specifically or generally by the guideline PICO was 30% (0%-100%).
There is no evidence that COS are being used routinely to inform the guideline development process, and concordance between outcomes in published guidelines and those in COS is limited. Further work is warranted to explore barriers and facilitators in the use of COS when developing clinical guidelines.
核心结局集（COS）是一组商定的标准化结局，在健康或医疗保健的特定领域中，至少应予以测量和报告。COS是通过共识过程制定的，以确保所测量的医疗保健结局与包括患者和医疗保健专业人员在内的决策者相关。在指南制定中使用COS可能会提高指南与这些决策者的相关性。以往的工作关注了COS在试验、系统评价、卫生技术评估和监管指南中的应用，但迄今为止，尚未对COS在实践指南制定中的应用进行评估。本研究的目的是调查一组国际实践指南中核心结局的呈现情况。
我们搜索了与十项高质量COS相关的临床指南（重点关注英国、德国、中国、印度、加拿大、丹麦、美国和世界卫生组织）。我们在疾病、人群和结局方面匹配了COS与指南之间的范围。我们计算了提及或引用COS的指南比例，以及COS领域与每个指南的人群、干预措施、对照和结局（PICO）声明中指定的结局具体或总体匹配的比例。
我们发现38项指南包含170条与十项COS范围匹配且质量足以进行数据提取的PICO声明。所审查的指南均未明确提及或引用相关COS。指南PICO具体或总体涵盖的核心结局比例的中位数（范围）为30%（0%-100%）。
没有证据表明COS被常规用于指导指南制定过程，并且已发表指南中的结局与COS中的结局之间的一致性有限。有必要进一步开展工作，以探索在制定临床指南时使用COS的障碍和促进因素。
