Patient Information Leaflets for placebo-controlled surgical trials: A review of current practice and recommendations for developers

Sian E Cousins, Marc M Huttman, Natalie S Blencowe, Carmen Tsang, Daisy Elliott, Jane Blazeby, David J Beard, Marion K Campbell, Katie Gillies*

*Corresponding author for this work

Research output: Contribution to journalArticle (Academic Journal)peer-review

Abstract

Introduction
Informed consent for participation in an RCT is an important ethical and legal requirement. In placebo surgical trials further issues are raised and to date this has not been explored. Patient information leaflets (PILs) are a core component of the informed consent process. This study aimed to investigate the key content of PILs for recently completed placebo-controlled trials of invasive procedures, including surgery, to highlight areas of good practice, identify gaps in information provision for trials of this type, and provide recommendations for practice.

Methods
PILs were sought from trials included in a recent systematic review of placebo controlled trials of invasive procedures, including surgery. Trial characteristics and data on surgical and placebo interventions under evaluation was extracted. Directed content analysis was applied, informed by published regulatory and good practice guidance on PIL content and existing research on placebo controlled surgical trials. Results were analysed using descriptive statistics and presented as a narrative summary.

Results
Of the 62 eligible RCTs, authors of 59 trials were contactable and 14 PILs were received for analysis. At least 50% of all PILs included content on general trial design. Explanations of how the placebo differs or is similar to the surgical intervention (i.e. fidelity) was reported in 6 (43%) of the included PILs. Over half (57%) of the PILs included information on the potential therapeutic benefits of the surgical intervention. One (7%) included information on potential indirect therapeutic benefits from invasive components of the placebo. Five (36%) presented the known risks of the placebo intervention, whilst 8 (57%) presented information on the known risk of the surgical intervention. A range of terms was used across the PILs to describe the placebo component, including ‘control’, ‘mock’, and ‘sham’.

Conclusion
Developers of PILs for placebo-controlled surgical trials should carefully consider the use of language (e.g. sham, mock), be explicit about how the placebo differs (or is similar to) the surgical intervention, and provide balanced presentations of potential benefits and risks of the surgical intervention separately from the placebo. Further research is required to determine optimal approaches to design and deliver this information for these trials.
Original languageEnglish
Article number339
Number of pages10
JournalTrials
Volume25
Issue number1
DOIs
Publication statusPublished - 22 May 2024

Bibliographical note

Publisher Copyright:
© The Author(s) 2024.

Fingerprint

Dive into the research topics of 'Patient Information Leaflets for placebo-controlled surgical trials: A review of current practice and recommendations for developers'. Together they form a unique fingerprint.

Cite this