澳大利亚围手术期临床试验中的消费者参与和患者报告结局：一项系统评价
Consumer engagement and patient reported outcomes in perioperative clinical trials in Australia: a systematic review.
作者信息
Wallace Sophie K A, Goulding Karen R, Myles Paul S
机构信息
Department of Anaesthesiology and Perioperative Medicine, Alfred Hospital, Melbourne, Victoria, Australia.
Central Clinical School, Monash University, Melbourne, Victoria, Australia.
出版信息
ANZ J Surg. 2022 Oct;92(10):2464-2473. doi: 10.1111/ans.17897. Epub 2022 Jul 23.
BACKGROUND
Consumer engagement in clinical research is increasingly being prioritized by major funders such as the Australian National Health and Medical Research Council.
METHODS
We performed a systematic literature search of the Cochrane library, Embase, CINAHL PubMed and Medline to identify randomized clinical trials in surgery with perioperative outcomes conducted in Australia. All publications underwent review and thematic analysis to identify levels of consumer engagement and the inclusion of patient-reported outcome measures (PROMS).
RESULTS
From 5373 records, the full texts of 809 articles were retrieved, of which 41 clinical trials met the inclusion criteria. PROMS were identified in 63% of the trials as a primary or secondary outcome. Despite multiple available checklists and analysis tools, less than 2% of studies documented any consumer engagement apart from PROMS.
CONCLUSION
There was very little consumer engagement in formulation, management, conduct and dissemination of the trial findings.
背景
澳大利亚国家卫生与医学研究理事会等主要资助机构越来越重视消费者参与临床研究。
方法
我们对考克兰图书馆、Embase、护理学与健康领域数据库、PubMed和Medline进行了系统的文献检索，以确定在澳大利亚进行的、具有围手术期结果的外科随机临床试验。所有出版物都经过审查和主题分析，以确定消费者参与的程度以及患者报告结局指标（PROMs）的纳入情况。
结果
从5373条记录中，检索到809篇文章的全文，其中41项临床试验符合纳入标准。在63%的试验中，PROMs被确定为主要或次要结局。尽管有多种可用的清单和分析工具，但除了PROMs之外，记录有任何消费者参与情况的研究不到2%。
结论
在试验的制定、管理、实施和研究结果传播方面，消费者参与度极低。
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