Thursday, July 22, 2004
This presentation is part of : Enhancing Methodological Rigor in Intervention Research
Standardizing Intervention Protocols: Maintaining Treatment Integrity
Victoria Mock, DNSc, FAAN, School of Nursing, School of Nursing, Johns Hopkins University, Baltimore, MD, USA

Problem: One of the most important methodological challenges in any experimental research study is that of maintaining consistently uniform treatment for subjects throughout the study as the intervention is being tested. The challenge of maintaining treatment integrity is particularly difficult and essential to address successfully in multi-institutional research studies where several research sites are involved. Purpose: This presentation will discuss approaches to maintaining treatment integrity from the researcher’s experiences in intervention research from several multisite studies. Approach: The treatment or intervention being tested must be the same treatment, administered in the same fashion, to all subjects across all sites. Inconsistent treatment or variations in the treatments across sites or even within one site can reduce the effect size and make it more difficult to determine the power or efficacy of the intervention. If there is a dose-response relationship, subjects who receive less than the optimal amount or quality of the treatment will have a reduced response. This will increase the variance in the posttest measures within the experimental group. Increased variability within the groups can decrease the effect size of the intervention. Standardizing the intervention involves three fundamental concepts. One, a careful detailed protocol for administering the treatment; two, a rigorous training process for all the research team members who are applying the treatment; and three, a vigilant plan for monitoring the entire process. When we use a rapidly changing clinical setting for research, and vulnerable patients– rather than mice or microorganisms or DNA –as our subjects, whatever can go wrong often does. Implications: Therefore, it is essential to specify the protocol in detail, carefully train the team members, and vigilantly monitor all aspects of the intervention in order to maintain treatment integrity and accurately determine the true effects of the intervention.

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Sigma Theta Tau International
July 22-24, 2004