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Keywords:

  • intervention effectiveness;
  • research design;
  • methods

Abstract

Effectiveness research is undertaken to evaluate the effects of interventions in achieving desired outcomes when tested in the real-world conditions of everyday practice. Although the randomized clinical trial (RCT) is considered the gold standard for effectiveness research, its feasibility, generalizability, and the clinical utility of its results are being questioned. This state of the science prompted the call for a paradigm shift, characterized by alternative methods for clinical research. The alternative methods attempt to account for clinical realities when conducting research, with the goal of minimizing discrepancies in the perspective and assumptions underlying practice and research. In this article a theory-driven approach to intervention evaluation is presented as a viable alternative paradigm for clinical research. The application of this approach demands changes in four aspects of research: participant selection criteria, assignment to treatment options, delivery of the intervention, and selection of outcome measures. The changes are discussed at the conceptual level and illustrated with examples from an ongoing multisite study aimed at determining the usefulness of this theory-driven approach to intervention evaluation. © 2003 Wiley Periodicals, Inc. Res Nurs Health 26: 244–255, 2003