Global Patient Safety and Labeling, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA, 91320, USA.
Health Literacy and Learning Program, Division of General Internal Medicine, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.
Drug Saf. 2018 Apr;41(4):389-401. doi: 10.1007/s40264-017-0619-x.
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).
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.
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).
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.
药品风险最小化计划涉及旨在支持安全和适当使用药物的干预措施。目前，关于这些计划评估的信息没有以标准化和透明的方式公开报告。为了解决这一差距，我们开发并试行 了一个质量报告清单，题为《药品风险最小化评估研究报告建议》（RIMES）。
清单的制定由三个来源指导：（1）源自计划理论和过程评估的理论框架；（2）公共卫生干预设计和评估原则；（3）对现有质量报告清单的审查。两位评分员使用拟议的清单独立审查了最近发表的 10 项（2012-2016 年）风险最小化计划评估研究。使用 Cohen 的 Kappa 和 Gwet 的 AC1 评估清单的评分者间可靠性。
生成了一个 43 项的清单。结果表明，总体上评分者间可靠性很高（κ=0.65，AC1=0.65），四个子量表中的三个（关键信息、设计和评估）的可靠性也很高（κ≥0.64，AC1≥0.64）。第四个子量表（实施）根据 Cohen 的 Kappa 显示出较低的可靠性，但根据 AC1 显示出相当大的可靠性（κ=0.17，AC1=0.61）。
RIMES 声明用针对药品风险最小化计划干预设计、实施和评估方面的项目补充了现有质量报告指南的相关内容。我们的结果表明，RIMES 声明可靠地衡量了报告质量的关键维度。这个定制的清单是提高风险最小化评估研究报告质量的重要第一步，最终可能有助于提高这些干预措施本身的质量。
