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

Abstract

IntroductionPharmaceutical 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).MethodsChecklist 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.ResultsA 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).ConclusionsThe 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.

Proposals for Engaging Patients and Healthcare Professionals in Risk Minimisation from an Analysis of Stakeholder Input to the EU Valproate Assessment Using the Novel Analysing Stakeholder Safety Engagement Tool (ASSET)

“…The quality of RMM effectiveness studies will be supported with EU good pharmacovigilance practices currently under revision by PRAC. A standard to ensure high-quality reporting of such studies, the RIMES statement, has already become available [ 40 ] and its use will be encouraged in the revised EU good pharmacovigilance practices.…”

Adaptation for Regulatory Application: A Content Analysis of FDA Risk Evaluation and Mitigation Strategies Assessment Plans (2014–2018) Using RE-AIM

“…Of note, our study examined the type and quantity of REMS assessment measures from the original approval; however, it did not assess the rigor of proposed study designs nor the quality of their reports. Reporting standards for risk minimization communication and program evaluation have been described by members of the International Society for Pharmacoepidemiology (40). A systematic review of the published literature on pharmaceutical risk minimization evaluation found limited use of conceptual frameworks guiding process and outcome measurement selection and program design and implementation (41).…”

Pre/post effectiveness evaluation of updated additional risk minimisation measures for an orphan disease: Myozyme (alglucosidase alfa) Safety Information Packet

“…A two‐wave online survey study was conducted to evaluate the effectiveness and improvement of the updated SIP, according to PASS GVP module VIII, best practices for the conduct and reporting of survey studies, and research papers in the field . Wave (W) 1 was carried out preimplementation of the updated SIP and W2 after distribution of the updated SIP in the participating countries.…”