The effectiveness and ineffectiveness of complex behavioral interventions: impact of treatment fidelity

Contemp Clin Trials. 2014 Mar;37(2):234-41. doi: 10.1016/j.cct.2014.01.005. Epub 2014 Jan 24.

Abstract

There is often wide variability in the reported effects of complex behavioral interventions. Effectiveness can vary across studies, sites, and providers. A factor that has been insufficiently considered is the fidelity of the behavioral treatment that was provided. Low quality practice could be likened to partial doses of a vaccine or antibiotic: the right idea but insufficient strength. Using motivational interviewing (MI) as an example, the authors describe three quality conditions that should be present for a study to be regarded as a trial of a complex behavioral intervention: (1) The treatment should clearly contain the components that are theoretically or empirically related to its efficacy; (2) providers should be trained to an adequate and specified criterion of proficiency before treating trial patients; and (3) the fidelity of treatment should be documented by reliable coding of practice throughout the study and reported in a manner that permits comparison with skill levels in other trials. The authors also discuss bona fide intervention failures despite strong clinical trial methodology, offering recommendations for future outcome research.

Keywords: Clinical trials; Fidelity; Motivational interviewing; Quality assurance; Training.

Publication types

  • Clinical Trial

MeSH terms

  • Behavior Therapy / organization & administration*
  • Behavior Therapy / standards
  • Bias
  • Humans
  • Multicenter Studies as Topic / methods
  • Quality Assurance, Health Care / organization & administration*
  • Quality Assurance, Health Care / standards
  • Reproducibility of Results
  • Research Design*