| アブストラクト | 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 (kappa = 0.65, AC1 = 0.65) and for three (key information, design and evaluation) of the four subscales (kappa >/= 0.64, AC1 >/= 0.64). The fourth subscale (implementation) showed low reliability based on Cohen's Kappa, but substantial reliability based on the AC1 (kappa = 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. |
|---|
| 投稿者 | Smith, Meredith Y; Russell, Andrea; Bahri, Priya; Mol, Peter G M; Frise, Sarah; Freeman, Emily; Morrato, Elaine H |
|---|
| 組織名 | Global Patient Safety and Labeling, Amgen Inc., One Amgen Center Drive, Thousand;Oaks, CA, 91320, USA. mersmith@amgen.com.;Oaks, CA, 91320, USA.;Health Literacy and Learning Program, Division of General Internal Medicine,;Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.;European Medicines Agency, 30 Churchill Place, London, E14 5EU, UK.;Dutch Medicines Evaluation Board, Utrecht, The Netherlands.;Department of Clinical Pharmacy and Pharmacology, University of Groningen,;University Medical Center Groningen, Groningen, The Netherlands.;Astra Zeneca, Mississauga, ON, Canada.;Dalla Lana School of Public Health (Epidemiology), University of Toronto,;Toronto, ON, Canada.;Pharmacovigilance and Patient Safety, AbbVie, North Chicago, IL, USA.;Department of Health Systems, Management and Policy, Colorado School of Public;Health, University of Colorado Anschutz Medical Campus, Aurora, CO, USA. |
|---|
