Maintaining Recruitment and Informed Consent in the Later Stages of a Trial: the By-Band-Sleeve Study Paul Whybrow, Sangeetha Paramasivan, Jane Blazeby, Chris Rogers and Jenny Donovan on behalf of the By-Band-Sleeve Trial Management Group

SCHOOL OF SOCIAL AND COMMUNITY MEDICINE 07/02/14 Outline QuinteT Recruitment Intervention (QRI) Three phases The By-Band-Sleeve study Aims and progress Three examples of emergent issues SCHOOL OF SOCIAL AND COMMUNITY MEDICINE 07/02/14

The QuinteT Recruitment Intervention Phase 1 Understanding recruitment Screening log Interviews Audio recordings… Phase 2 Designing & delivering interventions Group meetings Individual feedback Amend documentation… Phase 3 Evaluating interventions and monitoring recruitment Identifying and responding to (re) emergent recruitment issues Continued support to sites

“By-Band-Sleeve will establish the effectiveness and cost effectiveness of gastric bypass, adjustable gastric band and sleeve gastrectomy for severe and complex obesity” Gastric Bypass Gastric Sleeve Gastric Band N=447 N=447 N=447 Target sample size: 1,341

Paramasivan et al. (forthcoming) Phase 1 findings: Study not explained Uneven description of procedures Not addressing patient preferences Phase 2 interventions: Patient information leaflet Group and individual feedback Patient education sessions Research nurse training… Paramasivan et al. (forthcoming) Phase 3 evaluation & monitoring: Clear obstacles & hidden challenges New and re-emerging

New obstacles “I mean we’re very much into doing the trial… but our numbers have gone down as referrals have just crashed.” BBS staff interview 2016 “We’re facing a whole bunch of organisational issues. We haven’t had the patients coming through from our weight management clinic. There’s a bottleneck of more than 100 patients due to […] staffing issues in the psychology department.” BBS staff interview 2016

Challenges re-emerge S: If you decided to take part - and you don’t have to, it doesn’t affect your care - you have to give up the ability to choose what operation you want. BBS Consultation 2016, patient declined

Challenges re-emerge S: If you decided to take part - and you don’t have to, it doesn’t affect your care - you have to give up the ability to choose what operation you want. BBS Consultation 2016, patient declined P: Yeah, I’d be happy to do to take part and fill in forms but as far as choice goes, I would like to maintain some choice. Site had received two feedback sessions and other interventions A new surgeon: keen to recruit but had not received training

New challenges “I don’t know how you feel about the study, if you maybe have any strong views? The study is for people who haven’t quite made their minds up.” BBS Consultation 2016 , patient declined

New challenges “I don’t know how you feel about the study, if you maybe have any strong views? The study is for people who haven’t quite made their minds up.” BBS Consultation 2016 , patient declined Suggests discomfort in offering study participation and that recruiters may lack of equipoise How come..?

New challenges “Things go in and out of popularity in bariatric surgery…” BBS staff interview 2016 “Well I think there is some waning in popularity of one of the arms...” BBS staff interview 2016 “Some of my colleagues are convinced by this new operation…” BBS staff interview 2016 Recent interviews revealed new discomforts related to changes within the bariatric community

SCHOOL OF SOCIAL AND COMMUNITY MEDICINE 07/02/14 Conclusion The By-Band-Sleeve QRI is embedded throughout recruitment Challenges can emerge later in recruitment Maintaining recruitment requires: Evaluating interventions Monitoring recruitment Providing continued support to sites The QRI is a reiterative process SCHOOL OF SOCIAL AND COMMUNITY MEDICINE 07/02/14

paul.whybrow@bristol.ac.uk by-band-sleeve@bristol.ac.uk With thanks to: ConDuCT-II Hub for Trials Methodology Research (www.bristol.ac.uk/social-community-medicine/centres/conduct2) The By-Band-Sleeve study is funded by the National Institute for Health Research Health Technology Assessment Programme

Acknowledgements MRC Network of Hubs for Trials Methodology Research (www.methodologyhubs.mrc.ac.uk) ConDuCT-II Hub for Trials Methodology Research (www.Bristol.ac.uk/social-community-medicine/ centres/conduct2) The By-Band-Sleeve Trial Management group (www.Bristol.ac.uk/social-community-medicine/ centres/conduct2) The By-Band-Sleeve study is funded by the National Institute for Health Research Health Technology Assessment Programme