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目的 运用描述干预措施的清单和报告规范（TIDie R）来评估已发表的Cochrane系统综述及中国知网收录的药学服务随机对照试验（RCT）报告的充分性，以识别需要改进的领域，协助临床药师更有效地设计药学服务RCT，提升干预报告的质量。方法对Cochrane系统综述中评价药学服务措施对住院患者影响的RCT进行了2次分析，并检索了中国知网近5年内发表的临床药师药学服务RCT研究报告。2名研究人员依据改良的TIDie R检查表中的15个条目进行独立评估。结果 共纳入91项RCT研究，样本量介于47至330例患者之间。研究涉及多种干预方式，其中用药教育（46项研究，占50.55%）、以患者为对象的研究（58项研究，占63.74%），以及心血管疾病领域的研究（25项，占27.47%）为多见。然而，没有一篇研究报告包含了TIDie R清单中的所有条目。在15个条目中，没有任何一条的报告率达到100%。条目2a和条目5b的报告率超过80%，而报告率低于20%的条目包括条目5a（报告率18.68%）、条目5c（报告率13.19%）、条目9（报告率4.40%）和条目10（报告率5.49%）。主成分分析（PCA）显示，干预实施方式（条目3、条目4、条目6、条目7和条目8）及干预实施者的背景和培训（条目5a和条目5c）的描述对报告质量有显著影响。结论 已发表的药学服务RCT研究报告的整体质量有待提高，尤其在干预措施的充分性、完整性和详细性方面。未来研究者在设计临床药学干预RCT及撰写报告时，应参考TIDie R清单的要求，以确保干预设计的规范性和报告的详尽性，从而提高研究的可信度和可复制性，促进临床药学服务的规范化发展。
Abstract：AIM To assess the adequacy of published Cochrane systematic reviews and clinical pharmacist intervention randomized controlled trial(RCT) reports included in China National Knowledge Infrastructure using the Template for Intervention Description and Replication(TIDieR) checklist, so as to identify areas for improvement, assist clinical pharmacists to design RCTs of pharmaceutical care more effectively, and improve the quality of intervention reports. METHODS A secondary analysis was conducted on the studies included in Cochrane systematic reviews that evaluated the impact of drug intervention measures on the outcomes of hospitalized patients, and RCTs of clinical pharmacist intervention reports published in CNKI over the past 5 years were searched. The completeness of reporting was independently assessed by 2 researchers using the 15 items from the TIDieR checklist. RESULTS A total of 91studies were included in the analysis. The study sample sizes ranged from 47 patients to 330 patients. The included studies involved diverse intervention methods, among which medication education(46 studies, 50.55%), patient-oriented studies(58 studies, 63.74%), and cardiovascular disease-related studies(25 studies, 27.47%) were the most common. None of the studies reported on all checklist items. Among the 15 items, none reached a reporting rate of 100%, while only items 2a and 5b had detailed reporting rates exceeding 80%. The items with reporting rates below 20% were item 5a(18.68%),item 5c(13.19%), item 9(4.40%), and item 10(5.49%). Principal component analysis showed that the description of intervention implementation methods(items 3, 4, 6, 7, and 8) and the background and training of intervention implementers(items 5a and 5c) had a greater impact on report quality. CONCLUSION The overall quality of reporting in published RCTs on pharmaceutical care requires enhancement, particularly focusing on the adequacy, completeness,and detail of the intervention measures. In the future, researchers can refer to the TIDieR checklist requirements when designing and writing clinical pharmacy intervention reports to ensure a thorough and detailed account of the complete intervention details. Thus, the credibility and replicability of research can be improved, and the standardized development of clinical pharmacy services can be promoted.
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基本信息:
DOI：10.19577/j.1007-4406.2024.10.004
中图分类号:R95
引用信息:
[1]张春娟,洪煜璐,周昔程,等.基于TIDieR检查表评估住院患者临床药学服务随机对照试验的报告质量[J].中国临床药学杂志,2024,33(10):739-745.DOI:10.19577/j.1007-4406.2024.10.004.
基金信息:
海盐县卫健局卫生科技计划项目（编号2021wsyb008）