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The Reporting Recommendations Intended for Pharmaceutical Risk Minimization Evaluation Studies: Standards for

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The updated Reporting recommendations Intended for pharmaceutical risk Minimization Evaluation Studies (RIMES-SE) checklist improves reporting quality for drug safety studies. It incorporates implementation science concepts to enhance transparency and advance drug safety.

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Area of Science:

  • Pharmacovigilance
  • Implementation Science
  • Drug Safety Research

Background:

  • The Reporting recommendations Intended for pharmaceutical risk Minimization Evaluation Studies (RIMES) aimed to enhance reporting quality for risk minimization program evaluations.
  • Persistent reporting inadequacies and program failures necessitated an update to the RIMES Checklist.
  • The update incorporated concepts from the Standards for Reporting of Implementation studies (StaRI) to address these issues.

Purpose of the Study:

  • To update the RIMES Checklist by integrating implementation science principles.
  • To develop a comprehensive reporting guideline for pharmaceutical risk minimization evaluation studies.

Main Methods:

  • A study protocol was developed for the updated checklist, named RIMES-StaRI Extension (RIMES-SE).
  • Items were drafted by mapping RIMES against the StaRI checklist.
  • A modified e-Delphi exercise, expert workshop, and online commentary were used to refine checklist items.

Main Results:

  • The RIMES-SE comprises 27 items.
  • It features a dual-column structure detailing the risk minimization intervention and its implementation strategy.
  • The checklist is adaptable to various research methodologies.

Conclusions:

  • The RIMES-SE Statement and Checklist enhance original RIMES guidelines with implementation science concepts.
  • It aims to improve the quality and transparency of reporting for risk minimization evaluation studies.
  • The ultimate goal is to advance drug safety science through better reporting.