目标:核心结果集(COS)是一套商定的标准化结果集,应进行衡量和报告,至少,在特定的健康或保健领域。COS是通过共识过程制定的,以确保要衡量的医疗保健结果与决策者相关,包括患者和医疗保健专业人员。在准则制定中使用COS可能会增加准则与这些决策者的相关性。以前的工作已经研究了COS在试验中的吸收,系统评价,健康技术评估和监管指导,但迄今为止,尚未对COS在实践指南开发中的使用进行评估。这项研究的目的是调查一套国际惯例指南中核心结果的代表性。
方法:我们搜索了与十种高质量COS相关的临床指南(重点是英国,德国,中国,印度,加拿大,丹麦,美国和世界卫生组织)。我们在条件方面匹配了COS和指南之间的范围,人口和结果。我们特别计算了提及或引用COS的指南的比例以及COS域的比例,或者一般来说,与每个指南PICO声明中指定的结果匹配。
结果:我们发现了38条指南,其中包含170条PICO语句,与10条COS的范围相匹配,并且质量足够,可以进行数据提取。审查的指南均未明确提及或引用相关COS。PICO指南具体或总体涵盖的核心结果比例的中位数(范围)为30%(0%至100%)。
结论:没有证据表明COS被常规用于指导指南制定过程,并且已发布指南中的结果与COS中的结果之间的一致性有限。在制定临床指南时,需要进一步的工作来探索使用COS的障碍和促进因素。
OBJECTIVE: 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.
METHODS: 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.
RESULTS: 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%).
CONCLUSIONS: 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.