Crocker Helen, Peters Michele, Foster Charlie, Black Nick, Fitzpatrick Ray
Nuffield Department of Population Health, University of Oxford, Richard Doll Building, Old Road Campus, Headington, Oxford, OX3 7LF, UK.
Quality Safety and Outcomes Policy Research Unit, Kent, UK.
BMC Public Health. 2022 Feb 24;22(1):389. doi: 10.1186/s12889-022-12600-7.
Core outcome sets are standardised sets of outcomes that should be collected and reported for all clinical trials. They have been widely developed and are increasingly influential in clinical research, but despite this, their use in public health has been limited to date. The aim of this study was to develop a core outcome set for public health trials evaluating interventions to promote physical activity in the general adult population.
The core outcome set was developed using a three-stage approach: stage one: a review of literature to identify potential domains for inclusion in the core outcome set; stage two: a Delphi survey was carried out to reach consensus about which outcome domains to include in the core outcome set; and stage three: a second Delphi survey was conducted to determine how best to measure the outcome domains included in the core outcome set.
A classification of 13 outcome domains of physical activity was developed (stage one). Twenty people completed round one of the first Delphi survey (stage two), reaching a consensus to include two domains in the core outcome set, 'device-based level of physical activity' (80.0%, n = 16) and 'health-related quality of life' (70.0%, n = 14). No further consensus on the remaining outcome domains was reached in round two. Nineteen people completed the second Delphi survey (stage three). Participants rated the accelerometer (mean rating = 3.89, on a scale of 1 (do not recommend) to 5 (highly recommend)) as the best device to measure level of physical activity, and the EQ-5D (73.7%, n = 14) as the most appropriate measure of health-related quality of life.
This study has made progress towards the development of a core outcome set for use in physical activity trials, however, there was limited consensus about which domains to include. The development of the core outcome set was challenged by the need for trial-specific outcomes, and the complexities of collecting, processing and reporting device-based data.
核心结局指标集是所有临床试验都应收集和报告的标准化结局指标集。它们已得到广泛开发，并且在临床研究中的影响力日益增强，但尽管如此，其在公共卫生领域的应用至今仍较为有限。本研究的目的是为评估促进一般成年人群身体活动的干预措施的公共卫生试验制定一个核心结局指标集。
核心结局指标集采用三阶段方法制定：第一阶段：对文献进行综述，以确定可能纳入核心结局指标集的领域；第二阶段：开展德尔菲调查，就哪些结局领域应纳入核心结局指标集达成共识；第三阶段：进行第二次德尔菲调查，以确定如何最佳地测量核心结局指标集中包含的结局领域。
制定了身体活动的13个结局领域分类（第一阶段）。20人完成了第一次德尔菲调查的第一轮（第二阶段），达成共识，将两个领域纳入核心结局指标集，即“基于设备的身体活动水平”（80.0%，n = 16）和“健康相关生活质量”（70.0%，n = 14）。在第二轮中，未就其余结局领域达成进一步共识。19人完成了第二次德尔菲调查（第三阶段）。参与者将加速度计（平均评分 = 3.89，评分范围为1（不推荐）至5（强烈推荐））评为测量身体活动水平的最佳设备，将EQ-5D（73.7%，n = 14）评为健康相关生活质量的最合适测量工具。
本研究在制定用于身体活动试验的核心结局指标集方面取得了进展，然而，对于应纳入哪些领域的共识有限。核心结局指标集的制定受到特定试验结局的需求以及收集、处理和报告基于设备的数据的复杂性的挑战。
