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Experimental Approaches and Generating the Evidence

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Encyclopedia of Evidence in Pharmaceutical Public Health and Health Services Research in Pharmacy

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Abstract

Improving the safety of medicine use is a global priority and the pharmacy profession has a major role to play in reducing harm from medicines. High-quality randomized controlled trials offer the opportunity to generate the evidence to demonstrate the contribution of pharmacists to improving health care and reducing medicine-related harm. There are many challenges in implementing rigorous trials in the pharmacy practice setting. In this entry we describe the method and practices to maximize the likelihood of success of randomized controlled trials, and provide examples from published pharmacy practice trials. We describe the need to develop interventions that are underpinned by behavioral theories and the need for comprehensive preliminary research including engagement with stakeholders, feasibility testing, and pilot studies using participatory methods to ensure the intervention fits within workflows. We highlight important issues for trial implementation including the need to ensure the research design is fit for purpose and the importance of adhering to ethical criteria and best practice. We describe the mechanisms by which researchers can limit participant or investigator bias. We also describe the importance of outcome selection including the need to choose clinical and surrogate endpoints that are sensitive to changes in medicine use or pharmacist services. We provide examples of outcome measures suitable for use in pharmacy trials and explain the importance of evaluating process, impact, and outcome to ensure the trial was implemented as intended and provides rigorous results, such that evidence is generated that demonstrates the value of the interventions.

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Authors and Affiliations

  1. Clinical and Health Sciences, University of South Australia, Adelaide, SA, Australia

    Elizabeth E. Roughead, Gereltuya Dorj & Renly Lim

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  1. Elizabeth E. Roughead
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  2. Gereltuya Dorj
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  3. Renly Lim
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Correspondence to Elizabeth E. Roughead .

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  1. College of Pharmacy, Qatar University, Doha, Qatar

    Derek Charles Stewart

  2. Department of Pharmacy, University of Huddersfield, Huddersfield, United Kingdom

    Zaheer-Ud-Din Babar

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Roughead, E.E., Dorj, G., Lim, R. (2023). Experimental Approaches and Generating the Evidence. In: Encyclopedia of Evidence in Pharmaceutical Public Health and Health Services Research in Pharmacy. Springer, Cham. https://doi.org/10.1007/978-3-030-50247-8_63-1

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