You Can’t Assess Treatment Efficacy if You Can’t Define the Treatment: Challenges and Solutions in Specifying Non-Pharmacologic Treatments


John Whyte


Evidence related to treatment efficacy is underdeveloped in many areas of rehabilitation, including TBI rehabilitation. One of the obstacles in developing the evidence is the difficulty in defining or specifying many rehabilitation treatments. Unlike pharmacologic treatments, where the active ingredients are defined by their molecular structure, the hypothesized active ingredients are ill-defined in many experience-based rehabilitation treatments. Lacking a means of specification related to their active ingredients, rehabilitation treatments have generally been defined in one of two ways: contact over specified days/sessions/hours with particular facilities or treatment disciplines (e.g., hours of OT; days of inpatient rehabilitation); or engagement in “”goal-defined”” treatments such as “”gait training”” or “”memory remediation””, where the actual “”ingredients”” of the treatment are unknown. These approaches do not support efficacy research, or training and supervision of clinicians to ensure the delivery of the ingredients necessary for optimal outcomes. Indeed, the recent IOM study of cognitive rehabilitation after TBI found treatment specification to be one of the key obstacles in synthesizing the evidence.

This symposium discusses progress in a multi-year effort to develop a system for rehabilitation treatment specification that is based on the known or hypothesized active ingredients of treatment. The evolving system is argued to facilitate clinical problem solving, clinician training and supervision, interdisciplinary communication about treatment, and treatment research. In the first phase of the project, funded by NIDILRR, the broad concepts underlying the approach were developed and published in a supplement to the Archives of Physical Medicine and Rehabilitation, along with companion pieces in several other professional journals. Key concepts included: the distinction between treatment theory (which specifies the mechanisms by which specific ingredients alter treatment targets, and forms the basis of treatment specification) and enablement theory (which predicts the impact of treatment-induced changes on other aspects of functioning); the initial taxonomy groupings of treatment targets related to organ function, skill development, and cognitive and affective representations. More recent efforts have highlighted the key differences in specifying passive treatments (which can be done to a patient/client) versus volitional treatments (which require the patient to enact behavior for the mechanism of action to become active), as well as the special problems of specifying devices and compensatory strategies used in rehabilitation. In the current, PCORI-funded phase, these concepts are being operationalized into the Manual for Rehabilitation Treatment Specification, which will be tested on a cohort of clinicians, in terms of its impact on the clarity and operationalization of their independent treatment specifications.


  • Participants will be able to describe the deficiencies associated with current methods of rehabilitation treatment specification with respect to efficacy research, treatment documentation, and clinical education and supervision.
  • Participants will be able to identify the 3 essential components of all treatment theories, and describe the 3 major treatment groupings.
  • Participants will be able to describe the 2-component structure of all treatments that require the client’s voluntary effort.


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