title: Analysis of combined data from heterogeneous study designs: an applied example from the patient navigation research program.
abstract: BACKGROUND
  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.
  
  
  OBJECTIVE
  To review possible methodologies for analyzing combined data arising from heterogeneous study designs.
  
  
  METHODS
  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.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  The conclusions reached were based on expert opinion and not derived from actual analyses performed.
  
  
  CONCLUSIONS
  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.
authors.affiliation: University of South Florida Department of Family Medicine, Tampa, FL 33612, USA. rroetzhe@health.usf.edu
authors.forename: Richard G
authors.initials: RG
authors.lastname: Roetzheim
authors.forename: Karen M
authors.initials: KM
authors.lastname: Freund
authors.forename: Don K
authors.initials: DK
authors.lastname: Corle
authors.forename: David M
authors.initials: DM
authors.lastname: Murray
authors.forename: Frederick R
authors.initials: FR
authors.lastname: Snyder
authors.forename: Andrea C
authors.initials: AC
authors.lastname: Kronman
authors.forename: Pascal
authors.initials: P
authors.lastname: Jean-Pierre
authors.forename: Peter C
authors.initials: PC
authors.lastname: Raich
authors.forename: Alan Ec
authors.initials: AE
authors.lastname: Holden
authors.forename: Julie S
authors.initials: JS
authors.lastname: Darnell
authors.forename: Victoria
authors.initials: V
authors.lastname: Warren-Mears
authors.forename: Steven
authors.initials: S
authors.lastname: Patierno
mesh_terms: D002986:Clinical Trials as Topic / Q000706:statistics & numerical data; D003627:Data Interpretation, Statistical; D006801:Humans; D016032:Randomized Controlled Trials as Topic / Q000706:statistics & numerical data; D012107:Research Design; D014481:United States