Informed consent in randomised controlled trials: further development and evaluation of the participatory and informed consent (PIC) measure

Julia Wade*, Elka S Humphrys, Alba Realpe, Daisy M Gaunt, Jenni Burt

*Corresponding author for this work

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

2 Citations (Scopus)
32 Downloads (Pure)

Abstract

Background
Informed consent is an accepted ethical and legal prerequisite for trial participation, yet there is no standardised method of assessing patient understanding for informed consent. The participatory and informed consent (PIC) measure was developed for application to recruitment discussions to evaluate recruiter information provision and evidence of patient understanding. Preliminary evaluation of the PIC indicated the need to improve inter-rater and intra-rater reliability ratings and conduct further psychometric evaluation. This paper describes the assessment, revision and evaluation of the PIC within the context of OPTiMISE, a pragmatic primary care-based trial.

Methods
This study used multiple methods across two phases. In phase one, one researcher applied the existing PIC measure to 18 audio-recorded recruitment discussions from the OPTiMISE study and made detailed observational notes about any uncertainties in application. Appointments were sampled to be maximally diverse for patient gender, study centre, recruiter and before and after an intervention to optimise information provision. Application uncertainties were reviewed by the study team, revisions made and a coding manual developed and agreed. In phase two, the coding manual was used to develop tailored guidelines for applying the PIC to appointments within the OPTiMISE trial. Two researchers then assessed 27 further appointments, purposively sampled as above, to evaluate inter-rater and intra-rater reliability, content validity and feasibility.

Results
Application of the PIC to 18 audio-recorded OPTiMISE recruitment discussions resulted in harmonisation of the scales rating recruiter information provision and evidence of patient understanding, minor amendments to clarify wording and the development of detailed generic coding guidelines for applying the measure within any trial. Application of the revised measure using these guidelines to 27 further recruitment discussions showed good feasibility (time to complete), content validity (completion rate) and reliability (inter- and intra-rater) of the measure.

Conclusion
The PIC provides a means to evaluate the content of information provided by recruiters, patient participation in recruitment discussions and, to some extent, evidence of patient understanding. Future work will use the measure to evaluate recruiter information provision and evidence of patient understanding both across and within trials.
Original languageEnglish
Article number305
Number of pages10
JournalTrials
Volume24
Issue number1
DOIs
Publication statusPublished - 2 May 2023

Bibliographical note

Funding Information:
The authors would like to acknowledge Rebecca Lowe, BSc, Hannah Ashby, BSc, and Hannah Swayze, PhD (University of Oxford); Bethany Diment, PhD (University of Cambridge); and Sarah Oliver, BA (University of Southampton), who worked as research facilitators recruiting and following up participants, including the organisation of the audio recordings analysed here; without them this analysis would not have been possible. The OPTiMISE study group is comprised of: James P. Sheppard, PhD; Mark Lown, MRCGP; Eleanor Temple, BSc; Rebecca Lowe, BSc; Rosalyn Fraser, MSc; Julie Allen, BSc; Gary A Ford, MB, BChir; Carl Heneghan, DPhil; F. D. Richard Hobbs, MBChB; Sue Jowett, PhD; Shahela Kodabuckus, MSc; Paul Little, MD; Jonathan Mant, MD; Jill Mollison, PhD; Rupert A. Payne, MRCGP; Marney Williams, BEd; Ly-Mee Yu, DPhil; and Richard J. McManus, PhD. The QuinteT group is comprised of: Carmel Conefrey, PhD; Jenny Donovan, PhD; Nicola Farrar, PhD; Marcus Jepson, PhD; Ava Lorenc, PhD, Nicola Mills, PhD; Sangeetha Paramasivan, PhD; Leila Rooshenas, PhD;

Funding Information:
The OPTiMISE trial received joint funding from the National Institute for Health Research (NIHR) Oxford Collaboration for Leadership in Applied Health Research and Care (CLAHRC) at Oxford Health NHS Foundation Trust (ref: P2-501) and the NIHR School for Primary Care Research (SPCR; ref 335). Jenni Burt is supported by the Health Foundation’s grant to the University of Cambridge for The Healthcare Improvement Studies (THIS) Institute. THIS Institute is supported by the Health Foundation—an independent charity committed to bringing about better health and health care for people in the UK.

Publisher Copyright:
© 2023, The Author(s).

Keywords

  • informed consent
  • recruitment
  • communication

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