Informed consent and risk communication challenges in antimicrobial clinical trials: a scoping review

Abstract

OBJECTIVES: 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.

DESIGN: Scoping review.

DATA SOURCES: 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.

ELIGIBILITY CRITERIA: 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.

DATA EXTRACTION AND SYNTHESIS: 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.

RESULTS: 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.

CONCLUSION: 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.