Protocol Development, Treatment Fidelity, Adherence to Treatment, and Quality Control

Headnote

MeSH TERMS

* clinical protocols

* patient adherence

* quality control

* research design

* treatment outcome

Occupational therapy leaders have emphasized the importance of intervention effectiveness research. The CONSORT and TREND checklists have been suggested as useful tools for reporting the results of randomized and nonrandomized studies, respectively. Despite such recommendations, research protocols and reports continue to underutilize the available tools, a situation reflecting limited resources for and experience with the conduct of effectiveness research. To address this issue, and using the CONSORT statement to structure the analysis, this article discusses strategies for optimization of protocol development, treatment fidelity, adherence to treatment, and quality control. We recommend several approaches to increase the quality of research throughout these various processes. Examples of implementation from our laboratory provide evidence of the utility of these strategies.

In the past decade, occupational therapy leaders and scholars have emphasized the importance of intervention effectiveness trials in occupational therapy. For example, the occupational therapy research agenda emphasizes that "the efficacy and effectiveness of occupational therapy interventions be ascertained; that the optimal dose, frequency, duration, and location of occupational therapy interventions be determined; and that the salient elements... be identified" (American Occupational Therapy Association [AOTA]/American Occupational Therapy Foundation [AOTF] Advisory Panel, 2011, p. 52). These priorities are consistent with national guidelines and help define the research activities that are essential to achievement of the Centennial Vision (AOTA, 2007; Case-Smith, 2011). Moving forward, occupational therapists must be prepared to provide robust interventions to populations in need. Toward this end, effectiveness research is identified as a critical element of the research agenda.

Guidelines for reporting effectiveness studies have been developed as a resource for investigators. The most prominent example of such guidelines was developed by the Consolidated Standards of Reporting Trials (CONSORT) group, which provided standards for the systematic reporting of randomized controlled trials (RCTs). The CONSORT 2010 statement includes a 25-item checklist and a flow diagram that aids in the preparation and reporting of findings in randomized trials of intervention effectiveness (Schulz, Altman, & Moher, 2010). Similarly, nonrandomized research designs can use the TREND (Transparent Reporting of Evaluations with Nonrandomized Designs) statement, which includes a 22-item checklist developed to address the unique requirements of nonrandomized studies (Des Jarlais, Lyles, & Crepaz,...