Objectives Little is known about how innovative surgical procedures are introduced and discussed with patients. This qualitative study aimed to explore perspectives on information provision and consent prior to innovative surgical procedures.
Design Qualitative study involving semi-structured interviews. Interviews were audio recorded, transcribed and analysed thematically.
Participants 42 interviews were conducted (26 surgeons and 16 governance representatives).
Setting Surgeons and governance representatives recruited from various surgical specialties and National Health Service (NHS) Trusts across England, UK.
Results Participants stated that if a procedure was innovative, patients should be provided with additional information extending beyond that given during routine surgical consultations. However, difficulty defining innovation had implications for whether patients were informed about novel components of surgery and how the procedure was introduced (ie, as part of a research study, trust approval or in routine clinical practice). Furthermore, data suggest surgeons found it difficult to establish what information is essential and how much detail is sufficient, and governance surrounding written and verbal information provision differed between NHS Trusts. Generally, surgeons believed patients held a view that ‘new’ was best and reported that managing these expectations could be difficult, particularly if patient views aligned with their own.
Conclusions This study highlights the challenges of information provision and obtaining informed consent in the context of innovative surgery, including establishing if and how a procedure is truly innovative, determining the key information to discuss with patients, ensuring information provision is objective and balanced, and managing patient expectations and preferences. This suggests that surgeons may require support and training to discuss novel procedures with patients. Further work should capture consultations where new procedures are discussed with patients and patients’ views of these information exchanges.
- health policy
- qualitative research
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/.
Statistics from Altmetric.com
Twitter @NatalieBlencowe, @KnlAvery, @angusgkmcnair
Contributors JMB conceptualised the idea to study informed consent and information provision in the context of surgical innovation. DE developed the idea for the current study with support from JMB, JZ, SP, SC, NSB, BGM, AGKM, JM and KA. NSB, JM, AGKM and BGM identified potential participants. JZ and DE conducted the interviews and analysed the data, with regular discussion of data interpretation with SP and JMB. The NIHR Bristol Biomedical Research Centre Surgical Innovation theme is directed by JMB (theme lead) and RH (deputy theme lead). The manuscript was written by JZ, and DE critically reviewed the manuscript and responded to reviewers’ comments. All authors commented on the article.
Funding This study was funded by the NIHR Biomedical Research Centre at University Hospitals Bristol and Weston NHS Foundation Trust and the University of Bristol, with support from the MRC ConDuCT-II (Collaboration and innovation for Difficult and Complex randomised controlled Trials In Invasive procedures) Hub for Trials Methodology Research (MR/K025643/1). BM is an NIHR clinical lecturer, AM is funded by a Clinician Scientist Fellowship (NIHR-CS-2017-17-010) from the National Institute for Health Research, and NB is funded by an MRC Clinician Scientist Award.
Disclaimer The views expressed are those of the author(s) and not necessarily those of the NIHR or the MRC.
Competing interests None declared.
Patient consent for publication Not required.
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement No data are available. All data relevant to the study are included in the article or uploaded as supplemental information.
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.
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.