University of South Florida Department of Family Medicine, Tampa, FL 33612, USA.
Clin Trials. 2012 Apr;9(2):176-87. doi: 10.1177/1740774511433284. Epub 2012 Jan 24.
The Patient Navigation Research Program (PNRP) is a cooperative effort of nine research projects, with similar clinical criteria but with different study designs. To evaluate projects such as PNRP, it is desirable to perform a pooled analysis to increase power relative to the individual projects. There is no agreed-upon prospective methodology, however, for analyzing combined data arising from different study designs. Expert opinions were thus solicited from the members of the PNRP Design and Analysis Committee.
To review possible methodologies for analyzing combined data arising from heterogeneous study designs.
The Design and Analysis Committee critically reviewed the pros and cons of five potential methods for analyzing combined PNRP project data. The conclusions were based on simple consensus. The five approaches reviewed included the following: (1) analyzing and reporting each project separately, (2) combining data from all projects and performing an individual-level analysis, (3) pooling data from projects having similar study designs, (4) analyzing pooled data using a prospective meta-analytic technique, and (5) analyzing pooled data utilizing a novel simulated group-randomized design.
Methodologies varied in their ability to incorporate data from all PNRP projects, to appropriately account for differing study designs, and to accommodate differing project sample sizes.
The conclusions reached were based on expert opinion and not derived from actual analyses performed.
The ability to analyze pooled data arising from differing study designs may provide pertinent information to inform programmatic, budgetary, and policy perspectives. Multisite community-based research may not lend itself well to the more stringent explanatory and pragmatic standards of a randomized controlled trial design. Given our growing interest in community-based population research, the challenges inherent in the analysis of heterogeneous study design are likely to become more salient. Discussion of the analytic issues faced by the PNRP and the methodological approaches we considered may be of value to other prospective community-based research programs.
患者导航研究计划（PNRP）是九个研究项目的合作努力，这些项目具有相似的临床标准，但研究设计不同。为了评估 PNRP 等项目，进行汇总分析以提高相对于单个项目的功效是可取的。然而，对于分析来自不同研究设计的组合数据，目前还没有达成一致的前瞻性方法。因此，从 PNRP 设计和分析委员会的成员那里征求了专家意见。
审查分析来自异质研究设计的组合数据的可能方法。
设计和分析委员会批判性地审查了五种潜在方法分析组合 PNRP 项目数据的优缺点。结论基于简单的共识。审查的五种方法包括：（1）分别分析和报告每个项目，（2）合并所有项目的数据并进行个体水平分析，（3）合并具有相似研究设计的项目的数据，（4）使用前瞻性荟萃分析技术分析汇总数据，（5）使用新颖的模拟群组随机设计分析汇总数据。
方法在从所有 PNRP 项目中纳入数据的能力、适当考虑不同研究设计以及适应不同项目样本大小方面存在差异。
得出的结论是基于专家意见，而不是来自实际分析。
分析来自不同研究设计的汇总数据的能力可能为计划、预算和政策视角提供相关信息。基于社区的多地点研究可能不符合随机对照试验设计的更严格解释性和实用性标准。鉴于我们对基于社区的人群研究越来越感兴趣，分析异质研究设计所固有的挑战可能变得更加突出。讨论 PNRP 面临的分析问题以及我们考虑的方法方法可能对其他未来的基于社区的研究计划具有价值。
