Lessons learned from a prospective meta-analysis

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.