Andrew C. Persch, Stephen J. Page; Protocol Development, Treatment Fidelity, Adherence to Treatment, and Quality Control. Am J Occup Ther 2013;67(2):146-153. doi: 10.5014/ajot.2013.006213.
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© 2019 American Occupational Therapy Association
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.
A description of the organization of the study
Information on the personnel and their training
A detailed version of the study protocol
Details on specific methods for recruiting
Copies of screening and enrollment logs
Information on how study personnel will be trained and retrained
Training and signature logs for personnel
Randomization and blinding procedures
Procedures for administration of outcome measures
Events that occur at each study visit
Data management practices
Procedures for handling adverse events.
Early collaboration with content experts and a statistician allows for precise identification of the target population and facilitates rigor in the development of the research design.
Researchers can minimize collaborator burden by carefully considering the requirements of participation in terms of time, effort, and resources.
Precision is essential when developing the intervention and includes specification of the content, dosage, duration, and methods of administration.
Outcome measures should target primary study objectives.
Randomization, blinding, and statistical procedures should be planned well before the study begins.
Both fidelity (i.e., extent to which the study team complies with the study protocol) and adherence (i.e., extent to which the participant complies with the intervention or outcome measure to be administered) are important to reduce the incidence of Type I and II errors and to diminish variability in the ways in which the protocol is carried out.
Practices to increase fidelity include ensuring a priori that the study design in place will satisfactorily answer the study hypotheses (design fidelity) and having regular checks of outcome assessors and treatment therapists to ensure consistency (training fidelity).
Strategies to increase adherence center around ensuring that the study design is straightforward, minimizes participant burden, and reduces features of the study that may be superfluous and ensuring that eligibility criteria are well elucidated and specific to the target population.
Quality control (i.e., methods of ensuring that the study adheres to the highest quality standards possible) includes development and use of a MOP, the involvement of a trained PI and study coordinator, and regular team meetings.
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