O74 Maintaining recruitment and informed consent in the advanced stages of a trial: The By-Band-Sleeve study

Paul Whybrow, Sangeetha Paramasivan, Jane Blazeby, Chris Rogers, Jenny Donovan, The By-Band-Sleeve Trial Management Group

Research output: Chapter in Book/Report/Conference proceedingConference Contribution (Conference Proceeding)

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Abstract

Background
In 2012 National Institute of Health Research funded the By-Band-Sleeve study (BBS), a multi-centred, pragmatic trial comparing the effectiveness and cost effectiveness of three surgical interventions for weight-loss: the gastric bypass, the adjustable gastric band and the sleeve gastrectomy (Byrne et al. 2015). This was anticipated to be a ‘hard to recruit’ study with the goal of recruiting 1,341 patients. The QuinteT Recruitment Intervention (QRI), a method of understanding recruitment and responding to trial recruitment difficulties (Donovan et al, 2016), was integrated with BBS. Over the last three years the QRI has informed recruitment by identifying issues with the patient pathways, improving patient information leaflets and education sessions and providing regular feedback to surgeons and nurses. With 560 patients randomised, BBS is at an advanced stage of recruitment.
Methods
The QRI methods were employed by a) incorporating key findings from the internal pilot phase into the (pre-recruitment) training provided for the new centres in the main phase and b) concurrently initiating the QRIs in the new centres to identify challenges specific to each centre. This involved thematic analysis of a purposive sample of 198 audio-recorded consultations from 11 centres, observations of education sessions where details of the surgical procedures were explained to patients and analysis of screening log data. Findings were used to deliver group and individual feedback on recruitment across the BBS sites. Centre reviews, similar to those used in previous studies (ProtecT trial), were undertaken for the centres with particularly low recruitment.

Findings
The QRI identified new and unforeseen barriers to recruitment in each centre. Findings show how changes to staff or changes to the organisation of patient care present unexpected obstacles to recruitment. Recruiters reported perceived changes in patient preferences or shifts in opinion within the broader clinical community. These issues undermined recruiters’ confidence and ability to approach patients and obtain informed consent, bringing individual discomforts or conflicts about recruitment to the surface. Centre reviews were helpful in identifying where training and intervention could be most effective.
Conclusion
The By-Band-Sleeve study is a complex, multi-centred and pragmatic trial within a changeable clinical environment. The value of the QRI in the By-Band-Sleeve RCT has been in transforming recruitment in a difficult surgical RCT. More importantly, the flexible, iterative and responsive approach has helped to sustain recruitment and address emergent challenges.
Original languageEnglish
Title of host publicationMeeting abstracts from the 4th International Clinical Trials Methodology Conference (ICTMC) and the 38th Annual Meeting of the Society for Clinical Trials
Subtitle of host publicationLiverpool, UK. 07 – 10 May 2017
PublisherBioMed Central
Pages216
Number of pages1
DOIs
Publication statusPublished - 10 May 2017
Event4th International Clinical Trials Methodology Conference (ICTMC) and the 38th Annual Meeting of the Society for Clinical Trials - Arena and Convention Centre (ACC) Liverpool, Liverpool , United Kingdom
Duration: 7 May 201710 May 2017

Publication series

NameTrials
PublisherBioMed Central
Volume18(Suppl 1)
ISSN (Print)1745-6215
ISSN (Electronic)1745-6215

Conference

Conference4th International Clinical Trials Methodology Conference (ICTMC) and the 38th Annual Meeting of the Society for Clinical Trials
CountryUnited Kingdom
CityLiverpool
Period7/05/1710/05/17

Structured keywords

  • Centre for Surgical Research

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