Archives of Physical Medicine and Rehabilitation
Volume 86, Issue 12, Supplement , Pages 8-15, December 2005

Another Look at Observational Studies in Rehabilitation Research: Going Beyond the Holy Grail of the Randomized Controlled Trial

  • Susan D. Horn, PhD

      Affiliations

    • International Severity Information Systems Inc and Institute for Clinical Outcomes Research, Salt Lake City, UT
    • Corresponding Author InformationReprint requests to Susan D. Horn, PhD, Institute for Clinical Outcomes Research, 699 E South Temple, Ste 100, Salt Lake City, UT 84102-1282
  • ,
  • Gerben DeJong, PhD

      Affiliations

    • National Rehabilitation Hospital and Department of Rehabilitation Medicine, Georgetown University, Washington, DC
  • ,
  • David K. Ryser, MD

      Affiliations

    • Division of Physical Medicine and Rehabilitation, Neuro Specialty Rehabilitation Unit, LDS Hospital, Salt Lake City, UT
  • ,
  • Peter J. Veazie, PhD

      Affiliations

    • Division of Health Services Research and Policy, Department of Community and Preventive Medicine, University of Rochester School of Medicine and Dentistry, Rochester, NY
  • ,
  • Jeffrey Teraoka, MD

      Affiliations

    • Division of Physical Medicine and Rehabilitation, Stanford University, Palo Alto, CA

Abstract 

Horn SD, DeJong G, Ryser DK, Veazie PJ, Teraoka J. Another look at observational studies in rehabilitation research: going beyond the holy grail of the randomized controlled trial.

This commentary compares randomized controlled trials (RCTs) and clinical practice improvement (CPI) approaches to study design, evaluates their relative advantages and disadvantages, and discusses their implications for rehabilitation research and evidence-based practice. Many argue that observational cohort studies are not sufficient as scientific evidence for practice change. We challenge this assertion by introducing the concept of a CPI study: a comprehensive observational paradigm structured to decrease biases generally associated with observational research. One strength of CPI studies is their attention to defining and characterizing the “black box” of clinical practice. CPI studies require demanding data collection, but by using bivariate and multivariate associations among patient characteristics, process steps, and outcomes, they can uncover best practices more quickly while achieving many of the presumed advantages of RCTs.

Key Words:  Cerebrovascular accident , Clinical practice variations , Rehabilitation , Treatment outcomes

 

 Supported by the National Institute on Disability & Rehabilitation Research (grant no. H133B990005) and the U.S. Army and Materiel Command (cooperative agreement award no. DAMD17-02-2-0032). The views, opinions, and/or findings contained in this article are those of the author(s) and should not be construed as an official Department of the Army position, policy, or decision unless so designated by other documentation.No commercial party having a direct financial interest in the results of the research supporting this article has or will confer a benefit upon the author(s) or upon any organization with which the author(s) is/are associated.

PII: S0003-9993(05)01183-4

doi:10.1016/j.apmr.2005.08.116

Archives of Physical Medicine and Rehabilitation
Volume 86, Issue 12, Supplement , Pages 8-15, December 2005