多病共存且用药复杂的老年患者药物审查临床试验国际核心结局集
International core outcome set for clinical trials of medication review in multi-morbid older patients with polypharmacy.
作者信息
Beuscart Jean-Baptiste, Knol Wilma, Cullinan Shane, Schneider Claudio, Dalleur Olivia, Boland Benoit, Thevelin Stefanie, Jansen Paul A F, O'Mahony Denis, Rodondi Nicolas, Spinewine Anne
机构信息
Louvain Drug Research Institute (LDRI), Clinical pharmacy research group, Université catholique de Louvain, Brussels, Belgium.
Université Lille, EA 2694 - Santé publique: épidémiologie et qualité des soins, F-59000, Lille, France.
出版信息
BMC Med. 2018 Feb 13;16(1):21. doi: 10.1186/s12916-018-1007-9.
BACKGROUND
Comparisons of clinical trial findings in systematic reviews can be hindered by the heterogeneity of the outcomes reported. Moreover, the outcomes that matter most to patients might be underreported. A core outcome set can address these issues, as it defines a minimum set of outcomes that should be reported in all clinical trials in a particular area of research. The objective in this study was to develop a core outcome set for clinical trials of medication review in multi-morbid older patients with polypharmacy.
METHODS
Firstly, eligible outcomes were identified through a systematic review of trials of medication review in older patients (≥65 years) and interviews with 15 older patients. Secondly, an international three-round Delphi survey in four countries involving patients, healthcare professionals, and experts was conducted to validate outcomes to be included in the core outcome set. Consensus meetings were conducted to validate the results.
RESULTS
Of the 164 participants invited to take part in the Delphi survey, 150 completed Round 1, including 55 patients or family caregivers, 55 healthcare professionals, and 40 experts. A total of 129 participants completed all three rounds. Sixty-four eligible outcomes were extracted from 47 articles, 32 clinical trial protocols, and patient interviews. Thirty outcomes were removed and one added after Round 1, 18 outcomes were removed after Round 2, and seven after Round 3. Results were discussed during consensus meetings. Consensus was reached on seven outcomes, which constitute the core outcome set: drug-related hospital admissions; drug overuse; drug underuse; potentially inappropriate medications; clinically significant drug-drug interactions; health-related quality of life; pain relief.
CONCLUSIONS
We developed a core outcome set of seven outcomes which should be used in future trials of medication review in multi-morbid older patients with polypharmacy.
背景
系统评价中临床试验结果的比较可能会受到所报告结果异质性的阻碍。此外，对患者最重要的结果可能报告不足。核心结局集可以解决这些问题，因为它定义了在特定研究领域的所有临床试验中应报告的最小结局集。本研究的目的是为患有多种疾病且用药过多的老年患者的药物审查临床试验制定一个核心结局集。
方法
首先，通过对老年患者（≥65岁）药物审查试验的系统评价以及对15名老年患者的访谈来确定符合条件的结局。其次，在四个国家进行了三轮国际德尔菲调查，涉及患者、医疗保健专业人员和专家，以验证纳入核心结局集的结局。召开了共识会议以验证结果。
结果
在受邀参加德尔菲调查的164名参与者中，150名完成了第一轮，其中包括55名患者或家庭护理人员、55名医疗保健专业人员和40名专家。共有129名参与者完成了所有三轮调查。从47篇文章、32个临床试验方案和患者访谈中提取了64个符合条件的结局。第一轮后删除了30个结局并增加了1个，第二轮后删除了18个结局，第三轮后删除了7个结局。在共识会议期间讨论了结果。就七个结局达成了共识，这些结局构成了核心结局集：与药物相关的住院；药物滥用；药物使用不足；潜在不适当用药；具有临床意义的药物相互作用；健康相关生活质量；疼痛缓解。
结论
我们制定了一个包含七个结局的核心结局集，应在未来对患有多种疾病且用药过多的老年患者进行药物审查的试验中使用。
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