Treatment definition in complex rehabilitation interventions

Abstract

Rehabilitation research is challenged to improve its evidence base, which requires more precise and more consistent conceptualisation and measurement of treatment ingredients. This paper presents the steps in defining and specifying treatments towards the construction of a therapy manual for experimental interventions, or a coding system for observational treatment research. Specifying the active ingredients, identifying the behavioural operations that are aligned with each, and developing procedural details and materials are discussed and illustrated using two on-going trials for treatment of traumatic brain injury. The process of assessing treatment fidelity, that is, the extent to which interventions are delivered, received and used as intended, is also discussed.

Keywords:

• Rehabilitation
• Clinical trials
• Treatment fidelity
• Complex intervention
• Traumatic brain injury

This work was supported by the Neuro-Cognitive Rehabilitation Research Network, Grant No. R24 HD050836, sponsored by the National Institutes of Health (National Institute of Child Health and Human Development), and by Grant No. H133G070143 from the National Institute on Disability and Rehabilitation Research. The projects described in this article are collaborative multi-center studies with many contributors. Kathleen Bell, MD, is Principal Investigator of the Scheduled Telephone Intervention project. She, Jo Ann Brockway, PhD, and John Whyte, MD, PhD, are gratefully acknowledged for their collaboration on the Treatment Components and Active Ingredients study. Keith Cicerone, PhD, and Jonathan Evans, PhD, also served as consultants to the latter project. Roland Maiuro, PhD, and Jo Ann Brockway, PhD, contributed substantially to the development of the Anger Self-Management Training manual and associated materials.