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Protocol refinement for a diabetes pragmatic trial using the PRECIS-2 framework.

Russell E Glasgow1,2, Dennis Gurfinkel3, Jeanette Waxmonsky3

  • 1University of Colorado Anschutz Medical Campus, 13199 E Montview Blvd Ste 210, Aurora, CO, 80045, USA. Russell.Glasgow@CUAnschutz.edu.

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Summary

This study refined a diabetes intervention protocol using the PRECIS-2 tool for pragmatic comparative effectiveness research. Results showed high pragmatism, with targeted adjustments for real-world application and COVID-19.

Keywords:
DesignImplementation sciencePRECIS-2PlanningPragmatic researchShared medical appointmentsTransparencyType 2 diabetes

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Area of Science:

  • Health Services Research
  • Comparative Effectiveness Research
  • Diabetes Management

Background:

  • Protocol refinement for a pragmatic comparative effectiveness study of two evidence-based diabetes shared medical appointment interventions.
  • Utilized the PRECIS-2 rating system to evaluate protocol adaptations for pragmatism.

Purpose of the Study:

  • To describe the refinement of a study protocol for pragmatic comparative effectiveness research.
  • To evaluate the adaptations using the PRECIS-2 rating system.

Main Methods:

  • Conducted primary data collection from June to August 2019 and protocol refinements from 2018 to 2020.
  • Twenty-two study team members collaboratively refined the protocol and rated study pragmatism using the PRECIS-2 system.
  • Analyzed ratings using descriptive statistics to assess agreement and identify areas for design refinement.

Main Results:

  • PRECIS-2 ratings indicated high overall study pragmatism.
  • Lower pragmatism scores were observed in Delivery and Organization (costs, resources), which was a purposeful design choice.
  • General agreement on PRECIS-2 ratings was found among diverse study team members and stakeholders.

Conclusions:

  • Lessons learned from applying PRECIS-2 in refining study pragmatism were discussed.
  • The study demonstrated strategies for achieving targeted pragmatism levels and adapting protocols to changing contexts, including COVID-19.
  • Recommendations are provided for future use of PRECIS-2 in pragmatic and comparative effectiveness research planning and reporting.