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Drug Safety
Published in: Drug Safety 4/2018

Open Access 01-04-2018 | Original Research Article

The RIMES Statement: A Checklist to Assess the Quality of Studies Evaluating Risk Minimization Programs for Medicinal Products

Authors: Meredith Y. Smith, Andrea Russell, Priya Bahri, Peter G. M. Mol, Sarah Frise, Emily Freeman, Elaine H. Morrato

Published in: Drug Safety | Issue 4/2018

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Abstract

Introduction

Pharmaceutical risk minimization programs involve interventions designed to support safe and appropriate use of medicines. Currently, information regarding the evaluation of these programs is not publicly reported in a standardized and transparent manner. To address this gap, we developed and piloted a quality reporting checklist entitled the Reporting recommendations Intended for pharmaceutical risk Minimization Evaluation Studies (RIMES).

Methods

Checklist development was guided by three sources: (1) a theoretical framework derived from program theory and process evaluation; (2) public health intervention design and evaluation principles; and (3) a review of existing quality reporting checklists. Two raters independently reviewed 10 recently published (2012–2016) risk minimization program evaluation studies using the proposed checklist. Inter-rater reliability of the checklist was assessed using Cohen’s Kappa and Gwet’s AC1.

Results

A 43-item checklist was generated. Results indicated substantial inter-rater reliability overall (κ = 0.65, AC1 = 0.65) and for three (key information, design and evaluation) of the four subscales (κ ≥ 0.64, AC1 ≥ 0.64). The fourth subscale (implementation) showed low reliability based on Cohen’s Kappa, but substantial reliability based on the AC1 (κ = 0.17, AC1 = 0.61).

Conclusions

The RIMES statement augments relevant elements from existing quality reporting guidelines with items that address aspects of intervention design, implementation and evaluation specific to pharmaceutical risk minimization programs. Our results show that the RIMES statement reliably measures key dimensions of reporting quality. This tailored checklist is an important first step in improving the reporting quality of risk minimization evaluation studies and may ultimately help to improve the quality of these interventions themselves.
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Metadata
Title
The RIMES Statement: A Checklist to Assess the Quality of Studies Evaluating Risk Minimization Programs for Medicinal Products
Authors
Meredith Y. Smith
Andrea Russell
Priya Bahri
Peter G. M. Mol
Sarah Frise
Emily Freeman
Elaine H. Morrato
Publication date
01-04-2018
Publisher
Springer International Publishing
Published in
Drug Safety / Issue 4/2018
Print ISSN: 0114-5916
Electronic ISSN: 1179-1942
DOI
https://doi.org/10.1007/s40264-017-0619-x

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