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前瞻性荟萃分析的经验教训。

Lessons learned from a prospective meta-analysis.

作者信息

Margitić S E, Morgan T M, Sager M A, Furberg C D

机构信息

Department of Public Health Sciences, Bowman Gray School of Medicine, Winston-Salem, NC 27157-1063, USA.

出版信息

J Am Geriatr Soc. 1995 Apr;43(4):435-9. doi: 10.1111/j.1532-5415.1995.tb05820.x.

DOI:10.1111/j.1532-5415.1995.tb05820.x
PMID:7706636
Abstract

OBJECTIVE

To describe the unique aspects of and the lessons learned in planning and conducting a pooled analysis of multiple trials evaluating interventions to reduce functional decline in hospitalized older persons. Specific examples from the Hospital Outcomes Project for the Elderly (HOPE) meta-analysis are discussed.

DESIGN

A prospective meta-analysis (PMA) that compiled and pooled data from concurrently conducted clinical trials testing related but distinct interventions.

SETTING

The Data Coordinating Center for the prospective meta-analysis coordinated the collection and analysis of common outcome data from five university-affiliated hospitals and one community hospital conducting the clinical trials.

PARTICIPANTS

Acutely ill hospitalized elderly participants at least 65 to 75 years old.

INTERVENTIONS

Treatments being evaluated included exercise, physical therapy, a multidisciplinary geriatric care unit, a multidisciplinary in-hospital intervention with post-discharge care, a nursing-based geriatric care program, and a program to improve detection and evaluation of delirious patients.

CONCLUSION

The prospective meta-analysis provides selected advantages over independently conducted clinical trials and retrospective meta-analyses. It does, however, pose special design and operational challenges that must be addressed well before initiation of the individual trials. Specific issues of concern include: maintaining scientific integrity of both the individual trials and the PMA; reaching consensus on PMA goals, what data to collect, how and when to collect them and how to maintain uniformly high quality data across all sites; defining the role of the Data Coordinating Center in a multicenter project that utilizes different trials and protocols; and establishing policies concerning analyses of the pooled data, publication of pooled analyses, and ownership of the pooled database.

摘要

目的

描述在规划和开展一项汇总分析时所涉及的独特方面及经验教训,该汇总分析旨在评估多项针对减少住院老年人功能衰退的干预措施。文中讨论了来自老年医院结局项目(HOPE)荟萃分析的具体实例。

设计

一项前瞻性荟萃分析(PMA),它汇总了同时开展的、测试相关但不同干预措施的临床试验数据。

地点

前瞻性荟萃分析的数据协调中心负责协调收集和分析来自五家大学附属医院和一家开展临床试验的社区医院的共同结局数据。

参与者

年龄在65至75岁之间的急性病住院老年参与者。

干预措施

正在评估的治疗方法包括运动、物理治疗、多学科老年护理单元、出院后护理的多学科院内干预、基于护理的老年护理项目,以及一项改善谵妄患者检测和评估的项目。

结论

与独立开展的临床试验和回顾性荟萃分析相比,前瞻性荟萃分析具有某些优势。然而,它确实带来了特殊的设计和操作挑战,必须在开展个别试验之前就妥善解决。值得关注的具体问题包括:保持个别试验和前瞻性荟萃分析的科学完整性;就前瞻性荟萃分析的目标、收集哪些数据、如何及何时收集数据以及如何在所有研究地点保持统一的高质量数据达成共识;在一个利用不同试验和方案的多中心项目中界定数据协调中心的作用;以及制定有关汇总数据分析、汇总分析发表和汇总数据库所有权的政策。

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