Saw Swee Hock School of Public Health, National University of Singapore and National University Health System, Singapore
Lloyd's Register Foundation Institute for the Public Understanding of Risk, National University of Singapore, Singapore.
BMJ Open. 2024 Nov 24;14(11):e082096. doi: 10.1136/bmjopen-2023-082096.
Randomised trials for the management of drug-resistant infections are challenging to conduct as target patient populations often lack decision-making capacity, and enrolment windows are typically short. Improving informed consent and risk communication in these trials is especially crucial for protecting patient interests and maximising trial efficiency. This study aimed to understand challenges in risk communication and informed consent in antimicrobial clinical trials.
Scoping review.
Searches were conducted in Embase, Medline, CINAHL and Web of Science Core for peer-reviewed English articles that were published from January 2000 to April 2023.
Included articles were empirical studies or expert opinions that sought experts', patients' or representatives' opinions on informed consent in the context of clinical trials involving antibiotic/anti-infective agents.
Abstract screening, full-text review, data extraction and evidence rating were performed by two independent reviewers. Extracted data were summarised and reported qualitatively based on common themes. A total of 2330 records were retrieved, and 29 articles were included in the review.
Half of the articles involving medical experts and one-third involving patients and representatives reported that full comprehension by patients and representatives was challenging or not achievable. Healthcare providers and consent takers were crucial for the quality of informed consent. The level of trust consent givers placed on healthcare providers had a critical influence on the consent rate. Emotional distress was pervasive among patients/representatives.
The findings indicate that strengthening consent takers' communication skills in providing emotional support to patients and their representatives may improve informed consent. More research is needed to understand informed consent in low-income and middle-income and non-English-speaking countries.
耐药感染管理的随机试验具有挑战性，因为目标患者群体通常缺乏决策能力，且入组窗口期通常很短。在这些试验中改进知情同意和风险沟通对于保护患者利益和最大限度提高试验效率尤为重要。本研究旨在了解抗菌药物临床试验中风险沟通和知情同意的挑战。
范围综述。
在 Embase、Medline、CINAHL 和 Web of Science Core 中进行了检索，以获取 2000 年 1 月至 2023 年 4 月发表的关于临床试验中抗生素/抗感染药物知情同意的同行评议英文文章。
纳入的文章为经验研究或专家意见，旨在征求专家、患者或代表在涉及抗生素/抗感染药物的临床试验中知情同意的意见。
由两名独立审查员进行摘要筛选、全文审查、数据提取和证据评级。提取的数据根据共同主题进行总结和定性报告。共检索到 2330 条记录，29 篇文章纳入综述。
一半涉及医学专家的文章和三分之一涉及患者和代表的文章报告称，患者和代表的充分理解具有挑战性或无法实现。医疗保健提供者和同意者对于知情同意的质量至关重要。同意者对医疗保健提供者的信任程度对同意率有重大影响。患者/代表普遍存在情绪困扰。
研究结果表明，加强同意者在向患者及其代表提供情感支持方面的沟通技巧，可能会改善知情同意。需要进一步研究了解低收入和中等收入国家和非英语国家的知情同意情况。
