You are here

Article Text

Article menu
Ethics
Original research
Informed consent and risk communication challenges in antimicrobial clinical trials: a scoping review
  1. Yiyun Shou1,2,3,
  2. Joey Elizabeth Yeo1,
  3. Alexander Shao-Rong Pang4,
  4. David L. Paterson1,
  5. Yin Mo1,4,5,6
  1. 1 Saw Swee Hock School of Public Health, National University of Singapore and National University Health System, Singapore
  2. 2 Lloyd's Register Foundation Institute for the Public Understanding of Risk, National University of Singapore, Singapore
  3. 3 School of Medicine and Psychology, Australian National University, Canberra, ACT, Australia
  4. 4 Yong Loo Lin School of Medicine, National University of Singapore, Singapore
  5. 5 Center for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, UK
  6. 6 Mahidol-Oxford Research Unit, Mahidol University, Bangkok, Thailand
  1. Correspondence to Dr Yiyun Shou; yiyun.shou{at}nus.edu.sg

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.

  • clinical trial
  • medical ethics
  • patient participation
  • systematic review

Data availability statement

Data are available on reasonable request.

https://creativecommons.org/licenses/by/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.

https://doi-org.ezproxy.u-pec.fr/10.1136/bmjopen-2023-082096

Statistics from Altmetric.com

    Request Permissions

    If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.

    Data availability statement

    Data are available on reasonable request.

    View Full Text

    Supplementary materials

    • Supplementary Data

      This web only file has been produced by the BMJ Publishing Group from an electronic file supplied by the author(s) and has not been edited for content.

    • Supplementary Data

      This web only file has been produced by the BMJ Publishing Group from an electronic file supplied by the author(s) and has not been edited for content.

    Footnotes

    • Contributors YS, YM and DLP conceptualised and designed the study. YS, JEY and AS-RP contributed to data collection. YS wrote the original draft and acted as guarantor. All authors contributed to interpretation and reviewed, edited and approved the final version of the manuscript.

    • Funding This research is supported by a National University of Singapore Start-Up Grant (award/grant number is not applicable) and a Wellcome Trust Grant (Ref 227155/Z/23/Z).

    • Competing interests None declared.

    • Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Author note This study was preregistered at https://osf.io/fu49y/. We report OCEBM levels of evidence as quality appraisal ratings in this manuscript instead of JBI/CASP as preregistered due to the significant heterogeneity in the articles included in this review.

    • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.