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影响患者和公众不良药物反应报告的因素:使用理论领域框架进行的系统评价。

Factors that influence patient and public adverse drug reaction reporting: a systematic review using the theoretical domains framework.

机构信息

College of Pharmacy, QU Health, Qatar University, Doha, Qatar.

出版信息

Int J Clin Pharm. 2023 Aug;45(4):801-813. doi: 10.1007/s11096-023-01591-z. Epub 2023 May 29.

Abstract

BACKGROUND

Only 5-10% of all adverse drug reactions (ADRs) are reported. Mechanisms to support patient and public reporting offer numerous advantages to health care systems including increasing reporting rate. Theory-informed insights into the factors implicated in patient and public underreporting are likely to offer valuable opportunity for the development of effective reporting-interventions and optimization of existing systems.

AIM

To collate, summarize and synthesize the reported behavioral determinants using the theoretical domains framework (TDF), that influence patient and public reporting of ADRs.

METHOD

Cochrane, CINAHL, Web of science, EMBASE and PubMed were systematically searched on October 25th, 2021. Studies assessing the factors influencing public or patients reporting of ADRs were included. Full-text screening, data extraction and quality appraisal were performed independently by two authors. Extracted factors were mapped to TDF.

RESULTS

26 studies were included conducted in 14 countries across five continents. Knowledge, social/professional role and identity, beliefs about consequences, and environmental context and resources, appeared to be the most significant TDF domains that influenced patient and public behaviors regarding ADR reporting.

CONCLUSION

Studies included in this review were deemed of low risk of bias and allowed for identification of key behavioural determinants, which may be mapped to evidence-based behavioral change strategies that facilitate intervention development to enhance rates of ADR reporting. Aligning strategies should focus on education, training and further involvement from regulatory bodies and government support to establish mechanisms, which facilitate feedback and follow-ups on submitted reports.

摘要

背景

仅有 5-10%的药物不良反应(ADR)被报告。支持患者和公众报告的机制为医疗保健系统提供了诸多优势,包括提高报告率。从理论上深入了解影响患者和公众报告不足的因素,可能为开发有效的报告干预措施和优化现有系统提供宝贵机会。

目的

使用理论领域框架(TDF)整理、总结和综合报告的行为决定因素,这些因素影响患者和公众对 ADR 的报告。

方法

于 2021 年 10 月 25 日系统地在 Cochrane、CINAHL、Web of Science、EMBASE 和 PubMed 上进行了搜索。纳入评估影响公众或患者报告 ADR 因素的研究。两名作者独立进行了全文筛选、数据提取和质量评估。提取的因素被映射到 TDF。

结果

共纳入 26 项在五个洲的 14 个国家进行的研究。知识、社会/专业角色和身份、对后果的信念以及环境背景和资源,似乎是影响患者和公众对 ADR 报告行为的最重要的 TDF 领域。

结论

本综述中纳入的研究被认为具有低偏倚风险,并确定了关键的行为决定因素,这些因素可以映射到基于证据的行为改变策略,以促进干预措施的开发,从而提高 ADR 报告率。策略的调整应侧重于教育、培训以及监管机构和政府的进一步参与,以建立促进提交报告的反馈和跟进的机制。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b825/10366238/1a05526c96b9/11096_2023_1591_Fig1_HTML.jpg

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