George & Fay Yee Centre for Healthcare Innovation, Third Floor, Chown Building, 753 McDermot Avenue, Winnipeg, MB, R3B 0V8, Canada.
Department of Community Health Sciences, Rady Faculty of Health Sciences, Max Rady College of Medicine, University of Manitoba, Winnipeg, MB, Canada.
Trials. 2022 Aug 26;23(1):710. doi: 10.1186/s13063-022-06642-w.
Core outcome sets are advocated as a means to standardize outcome reporting across randomized controlled trials (RCTs) and reduce selective outcome reporting. In 2005, the Prevention of Falls Network Europe (ProFaNE) published a core outcome set identifying five domains that should be measured and reported, at a minimum, in RCTs or meta-analysis on falls in older people. As reporting of all five domains of the ProFaNE core outcome set has been minimal, we set out to investigate factors associated with reporting of the ProFaNE core outcome set domains in a purposeful sample of RCTs on falls in older people.
We conducted a systematic citation analysis to identify all reports of RCTs focused on falls in older people that cited the ProFaNE core outcome set between October 2005 and July 2021. We abstracted author-level, study-level, and manuscript-level data and whether each domain of the ProFaNE core outcome set was reported. We used penalized LASSO regression to identify factors associated with the mean percentage of ProFaNE core outcome set domains reported.
We identified 85 eligible reports of RCTs. Articles were published between 2007 and 2021, described 75 unique RCTs, and were authored by 76 unique corresponding authors. The percentage of ProFaNE core outcome set domains reported ranged from 0 to 100%, with a median of 40% and mean (standard deviation, SD) of 52.2% (25.1). RCTs funded by a non-industry source reported a higher mean percentage of domains than RCTs without a non-industry funding source (estimated mean difference = 17.5%; 95% confidence interval (CI) 1.8-33.2). RCTs examining exercise (15.4%; 95% CI 1.9-28.9) or multi-component/factorial (17.4%; 95% CI 4.7-30.1) interventions each reported a higher mean percentage of domains than RCTs examining other intervention types.
We found that RCTs funded by at least one non-industry source, examining exercise or multi-component/factorial interventions, reported the highest percentages of ProFaNE core outcome set domains. Findings may help inform strategies to increase the impact of the ProFaNE core outcome set. Ultimately, this may lead to enhanced knowledge of the effectiveness and safety of interventions to prevent and/or manage falls in older people.
核心结局集被提倡作为一种标准化随机对照试验（RCT）结局报告并减少选择性报告的手段。2005 年，预防跌倒网络欧洲（ProFaNE）发布了一个核心结局集，确定了五个应至少在老年人跌倒的 RCT 或荟萃分析中测量和报告的领域。由于 ProFaNE 核心结局集的所有五个领域的报告都很少，因此我们着手调查与在老年人跌倒的目的样本 RCT 中报告 ProFaNE 核心结局集领域相关的因素。
我们进行了系统的引文分析，以确定 2005 年 10 月至 2021 年 7 月期间引用 ProFaNE 核心结局集的所有针对老年人跌倒的 RCT 报告。我们提取了作者层面、研究层面和手稿层面的数据，以及 ProFaNE 核心结局集中每个领域的报告情况。我们使用惩罚 LASSO 回归来确定与报告的 ProFaNE 核心结局集领域的平均百分比相关的因素。
我们确定了 85 项符合条件的 RCT 报告。这些文章发表于 2007 年至 2021 年之间，描述了 75 项独特的 RCT，并由 76 位独特的相应作者撰写。ProFaNE 核心结局集领域的报告率从 0 到 100%不等，中位数为 40%，平均值（标准差，SD）为 52.2%（25.1）。由非工业来源资助的 RCT 报告的领域比例平均值高于没有非工业资助来源的 RCT（估计平均差异=17.5%；95%置信区间（CI）1.8-33.2）。检查运动（15.4%；95%CI 1.9-28.9）或多成分/多因素（17.4%；95%CI 4.7-30.1）干预的 RCT 报告的领域比例平均值高于检查其他干预类型的 RCT。
我们发现，至少有一个非工业来源资助、检查运动或多成分/多因素干预的 RCT 报告了 ProFaNE 核心结局集的最高比例。这些发现可能有助于制定提高 ProFaNE 核心结局集影响力的策略。最终，这可能会增加对预防和/或管理老年人跌倒的干预措施的有效性和安全性的了解。
