Abstract
BackgroundTraditional randomized controlled trials are considered the gold standard for evaluating the efficacy of a treatment. However, in adherence research, limitations to this study design exist, especially when evaluating real-world applicability of an intervention. Although adherence interventions by community pharmacists have been tested, problems with internal and external validity have limited the usefulness of these studies, and further well-designed and well-conducted research is needed. We aimed to determine the real-world effectiveness of a community pharmacy adherence intervention using a robust study design. This novel design integrates cluster randomization and an outcome evaluation of medication adherence using a population-based administrative data source in the province of Saskatchewan, Canada.Methods/DesignCommunity pharmacies from across the province of Saskatchewan, Canada were randomized to deliver an adherence intervention to their patients or usual care. Intervention pharmacies were trained to employ a practical adherence strategy targeted at new users of statin medications. While randomization and implementation of the intervention occurred at the community pharmacy level, the outcome analysis will occur at the level of the individual subjects. The primary outcome is the mean statin adherence among all eligible new users of statin medications. Secondary outcomes include the proportion of new statin users who exhibit adherence ≥80%, and persistence with statin use.DiscussionThis novel study design was developed to combine the rigor of a randomized trial with a pragmatic approach to implementing and capturing the results in a real-world fashion. We believe this approach can serve as an example for future study designs evaluating practice-based adherence interventions.Trial RegistrationClinicalTrials.gov no. NCT00971412.
Highlights
Randomized controlled trials (RCT) are considered the gold standard design for the evaluation of treatment efficacy [1], and are increasingly being used for evaluating interventions aimed at improving medication adherence [2]
This novel study design was developed to combine the rigor of a randomized trial with a pragmatic approach to implementing and capturing the results in a real-world fashion
We believe this approach can serve as an example for future study designs evaluating practice-based adherence interventions
Summary
Randomized controlled trials (RCT) are considered the gold standard design for the evaluation of treatment efficacy [1], and are increasingly being used for evaluating interventions aimed at improving medication adherence [2]. In adherence research, limitations to this contamination is unavoidable when the same health practitioner is providing the control and experimental conditions simultaneously [3] Because of their accessibility and frequent interactions with patients, community pharmacists are considered ideally situated to deliver interventions aimed at improving medication adherence [3]. We aimed to determine the real-world effectiveness of a community pharmacy adherence intervention using a robust study design This novel design integrates cluster randomization and an outcome evaluation of medication adherence using a population-based administrative data source in the province of Saskatchewan, Canada
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