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

Meredith Y. Smith (), Andrea Russell, Priya Bahri, Peter G. M. Mol, Sarah Frise, Emily Freeman and Elaine H. Morrato
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Meredith Y. Smith: Amgen Inc.
Andrea Russell: Amgen Inc.
Priya Bahri: European Medicines Agency
Peter G. M. Mol: Dutch Medicines Evaluation Board
Sarah Frise: Astra Zeneca
Emily Freeman: AbbVie
Elaine H. Morrato: University of Colorado Anschutz Medical Campus

Drug Safety, 2018, vol. 41, issue 4, No 7, 389-401

Abstract: 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.

Date: 2018
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DOI: 10.1007/s40264-017-0619-x

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