Ghods Mary P, Schmid Ian T, Pamer Carol A, Lappin Brian M, Slavin Dale C
U. S. Food and Drug Administration, Center for Drug Evaluation and Research, Safe Use Initiative, Silver Spring, MD, 20993, USA,
Patient. 2015 Aug;8(4):349-58. doi: 10.1007/s40271-014-0094-8.
Opioid treatment agreements generally are used in pain treatment to delineate the terms and consequences of opioid use and abuse.
The US Food and Drug Administration (FDA) Safe Use Initiative convened a multi-disciplinary working group with outside experts to draft a patient-centered, model opioid treatment agreement named the Model Patient-Prescriber Agreement (model PPA). The model PPA was evaluated for readability and usability in two tests that sampled both healthcare professional and non-healthcare professional FDA employees. In a survey sent to FDA employees in the Center for Drug Evaluation and Research (CDER), 209 respondents assessed the quality of the content and the level of difficulty in reading and understanding the model PPA. Ten other FDA employees participated in usability testing to assess the effectiveness of the model PPA as an educational and decision-making tool.
The majority of the 209 CDER employee survey respondents indicated the model PPA was neutral in tone (67.5%) and easy or somewhat easy to understand (90.4%). Usability study participants generally thought the model PPA would facilitate discussion between patient and prescriber and that the content was informative, thorough, and clear.
These studies suggest that the working group was able to develop an opioid PPA that may be acceptable and usable among a diverse population of stakeholders. A follow-up pilot study using the model PPA in medical facilities in the USA with patients is underway and will facilitate this determination.
阿片类药物治疗协议通常用于疼痛治疗，以明确阿片类药物使用及滥用的条款和后果。
美国食品药品监督管理局（FDA）安全使用倡议召集了一个多学科工作组及外部专家，起草一份以患者为中心的阿片类药物治疗协议范本，即范本患者-开方者协议（范本PPA）。在两项对FDA医疗保健专业人员和非医疗保健专业人员员工进行抽样的测试中，对范本PPA的可读性和可用性进行了评估。在一项发给药物评价和研究中心（CDER）的FDA员工的调查中，209名受访者评估了范本PPA的内容质量以及阅读和理解的难易程度。另外10名FDA员工参与了可用性测试，以评估范本PPA作为教育和决策工具的有效性。
209名CDER员工调查受访者中的大多数表示，范本PPA语气中立（67.5%），易于理解或 somewhat easy to understand（90.4%）。可用性研究参与者普遍认为，范本PPA将促进患者与开方者之间的讨论，且内容信息丰富、全面且清晰。
这些研究表明，该工作组能够制定出一份在不同利益相关者群体中可能被接受且可用的阿片类药物PPA。一项在美国医疗机构对患者使用范本PPA的后续试点研究正在进行中，这将有助于做出这一判定。
