Clark Alexander M, Savard Lori A, Thompson David R
University of Alberta, Level 3, Clinical Sciences Building, Edmonton, Alberta T6G 2G3, Canada.
J Am Coll Cardiol. 2009 Jul 28;54(5):397-401. doi: 10.1016/j.jacc.2009.04.051.
Heart failure (HF) disease-management programs are increasingly common. However, some large and recent trials of programs have not reported positive findings. There have also been parallel recent advances in reporting standards and theory around complex nonpharmacological interventions. These developments compel reconsideration in this Viewpoint of how research into HF-management programs should be evaluated, the quality, specificity, and usefulness of this evidence, and the recommendations for future research. Addressing the main determinants of intervention effectiveness by using the PICO (Patient, Intervention, Comparison, and Outcome) approach and the recent CONSORT (Consolidated Standards of Reporting Trials) statement on nonpharmacological trials, we will argue that in both current trials and meta-analyses, interventions and comparisons are not sufficiently well described; that complex programs have been excessively oversimplified; and that potentially salient differences in programs, populations, and settings are not incorporated into analyses. In preference to more general meta-analyses of programs, adequate descriptions are first needed of populations, interventions, comparisons, and outcomes in past and future trials. This could be achieved via a systematic survey of study authors based on the CONSORT statement. These more detailed data on studies should be incorporated into future meta-analyses of comparable trials and used with other techniques such as patient-based outcomes data and meta-regression. Although trials and meta-analyses continue to have potential to generate useful evidence, a more specific evidence base is needed to support the development of effective programs for different populations and settings.
心力衰竭（HF）疾病管理项目越来越普遍。然而，近期一些关于此类项目的大型试验并未报告出积极的结果。同时，围绕复杂非药物干预的报告标准和理论也在近期取得了相应进展。这些进展促使我们在本观点中重新思考如何评估心力衰竭管理项目的研究、此类证据的质量、特异性和实用性，以及对未来研究的建议。通过采用PICO（患者、干预措施、对照和结局）方法以及近期关于非药物试验的CONSORT（试验报告统一标准）声明来解决干预效果的主要决定因素，我们将论证，在当前的试验和荟萃分析中，干预措施和对照的描述都不够充分；复杂的项目被过度简化；并且项目、人群和环境中潜在的显著差异未纳入分析。相较于对项目进行更一般的荟萃分析，首先需要对过去和未来试验中的人群、干预措施、对照和结局进行充分描述。这可以通过基于CONSORT声明对研究作者进行系统调查来实现。这些关于研究的更详细数据应纳入未来可比试验的荟萃分析，并与其他技术（如基于患者的结局数据和荟萃回归）一起使用。尽管试验和荟萃分析仍有潜力产生有用的证据，但需要一个更具体的证据基础来支持针对不同人群和环境开发有效的项目。
