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. 2018 Apr;41(4):389-401.
doi: 10.1007/s40264-017-0619-x.

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

Meredith Y Smith  1 , Andrea Russell  2   3 , Priya Bahri  4 , Peter G M Mol  5   6 , Sarah Frise  7   8 , Emily Freeman  9 , Elaine H Morrato  10
Affiliations

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

Meredith Y Smith et al. Drug Saf. 2018 Apr.

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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Conflict of interest statement

Conflict of interest

The following authors are employed by pharmaceutical companies: Meredith Y. Smith (Amgen), Sarah Frise (AstraZeneca), and Emily Freeman (AbbVie). Andrea Russell receives a graduate fellowship stipend from Amgen. Co-authors Priya Bahri, and Peter Mol have no conflicts of interest to declare. Elaine Morrato has received consulting fees and travel reimbursement from the American Academy of Pediatrics, Amgen, and the Merck Foundation. She has received a speaking honorarium, a manuscript preparation honorarium and travel reimbursement from the PhRMA Foundation, and is a Special Government Employee and advises the FDA on issues of drug safety and risk management.

Funding

No sources of funding were used in the preparation of this study and manuscript.

Figures

Fig. 1
Fig. 1
Framework for risk minimization intervention evaluation study reporting criteria
See this image and copyright information in PMC

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