Enabling recruitment success in bariatric surgical trials: pilot phase of the By-Band-Sleeve study

S Paramasivan, C A Rogers, R Welbourn, J P Byrne, N Salter, D Mahon, H Noble, J Kelly, G Mazza, P Whybrow, R C Andrews, C Wilson, J M Blazeby, J L Donovan, S Paramasivan, C A Rogers, R Welbourn, J P Byrne, N Salter, D Mahon, H Noble, J Kelly, G Mazza, P Whybrow, R C Andrews, C Wilson, J M Blazeby, J L Donovan

Abstract

Background: Randomized controlled trials (RCTs) involving surgical procedures are challenging for recruitment and infrequent in the specialty of bariatrics. The pilot phase of the By-Band-Sleeve study (gastric bypass versus gastric band versus sleeve gastrectomy) provided the opportunity for an investigation of recruitment using a qualitative research integrated in trials (QuinteT) recruitment intervention (QRI).

Patients/methods: The QRI investigated recruitment in two centers in the pilot phase comparing bypass and banding, through the analysis of 12 in-depth staff interviews, 84 audio recordings of patient consultations, 19 non-participant observations of consultations and patient screening data. QRI findings were developed into a plan of action and fed back to centers to improve information provision and recruitment organization.

Results: Recruitment proved to be extremely difficult with only two patients recruited during the first 2 months. The pivotal issue in Center A was that an effective and established clinical service could not easily adapt to the needs of the RCT. There was little scope to present RCT details or ensure efficient eligibility assessment, and recruiters struggled to convey equipoise. Following presentation of QRI findings, recruitment in Center A increased from 9% in the first 2 months (2/22) to 40% (26/65) in the 4 months thereafter. Center B, commencing recruitment 3 months after Center A, learnt from the emerging issues in Center A and set up a special clinic for trial recruitment. The trial successfully completed pilot recruitment and progressed to the main phase across 11 centers.

Conclusions: The QRI identified key issues that enabled the integration of the trial into the clinical setting. This contributed to successful recruitment in the By-Band-Sleeve trial-currently the largest in bariatric practice-and offers opportunities to optimize recruitment in other trials in bariatrics.

Conflict of interest statement

RW received sponsorship for attending conference/educational workshops from Allergan and Ethicon Endo-Surgery and is a consultant for Novo Nordisk. Taunton and Somerset NHS Foundation Trust, Taunton, UK (where RW is employed), also received grant funding for a bariatric surgery training fellowship from Ethicon Endo-Surgery. The remaining authors declare no conflict of interest.

Figures

Figure 1
Figure 1
Patient pathway across Centers A and B.

References

    1. Baum M. Reflections on randomised controlled trials in surgery. Lancet 1999; 353: S6–S8.
    1. McLeod RS. Issues in surgical randomized controlled trials. World J Surg 1999; 23: 1210–1214.
    1. McCulloch P, Taylor I, Sasako M, Lovett B, Griffin D. Randomised trials in surgery: problems and possible solutions. BMJ 2002; 324: 1448–1451.
    1. Ergina PL, Cook JA, Blazeby JM, Boutron I, Clavien PA, Reeves BC et al. Challenges in evaluating surgical innovation. Lancet 2009; 374: 1097–1104.
    1. Horton R. Surgical research or comic opera: questions, but few answers. Lancet 1996; 347: 984–985.
    1. Solomon MJ, McLeod RS. Clinical studies in surgical journals—have we improved? Dis Colon Rectum 1993; 36: 43–48.
    1. Wente MN, Seiler CM, Uhl W, Büchler MW. Perspectives of evidence-based surgery. Dig Surg 2003; 20: 263–269.
    1. Cook JA. The challenges faced in the design, conduct and analysis of surgical randomised controlled trials. Trials 2009; 10: 1–9.
    1. Howes N, Chagla L, Thorpe M, McCulloch P. Surgical practice is evidence based. Br J Surg 1997; 84: 1220–1223.
    1. Royal College of SurgeonsFrom Theory to Theatre: Overcoming barriers to innovation in surgery. Policy and Communications, RCS Publications Department: London, UK, 2011. Available at .
    1. National Research Collaborative list of Trainee Research Collaborativeshttp:// (accessed 6 December 2016).
    1. The Association of Surgeons in Training (accessed 6 December 2016).
    1. Rogers CA, Welbourn R, Byrne J, Donovan JL, Reeves BC, Wordsworth S et al. The By-Band study: gastric bypass or adjustable gastric band surgery to treat morbid obesity: study protocol for a multi-centre randomised controlled trial with an internal pilot phase. Trials 2014; 15: 53.
    1. Blazeby J, Andrews R, Byrne J, Donovan J, Reeves B, Roderick P et al HTA—09/127/53: Gastric Bypass, adjustable gastric Banding or Sleeve gastrectomy surgery to treat severe and complex obesity: a multi-centre randomised controlled trial (The By-Band-Sleeve study) 2012, (accessed 7 February 2016).
    1. Donovan JL, Rooshenas L, Jepson M, Elliott D, Wade J, Avery K et al. Optimising recruitment and informed consent in randomised controlled trials: the development and implementation of the Quintet Recruitment Intervention (QRI). Trials 2016; 17: 283.
    1. Donovan J, Mills N, Smith M, Brindle L, Jacoby A, Peters T et al. Quality improvement report: improving design and conduct of randomised trials by embedding them in qualitative research: ProtecT (prostate testing for cancer and treatment) study. BMJ 325: 766.
    1. Donovan JL, Lane AJ, Peters TJ, Brindle L, Salter E, Gillatt D et al. Development of a complex intervention improved randomization and informed consent in a randomized controlled trial. J Clin Epidemiol 2009; 62: 29–36.
    1. de Salis I, Tomlin Z, Toerien M, Donovan J. Using qualitative research methods to improve recruitment to randomized controlled trials: the Quartet study. J Health Serv Res Policy 2008; 13 (Suppl 3): 92–96.
    1. Paramasivan S, Huddart R, Hall E, Lewis R, Birtle A, Donovan JL. Key issues in recruitment to randomised controlled trials with very different interventions: a qualitative investigation of recruitment to the SPARE trial (CRUK/07/011). Trials 2011; 12: 78.
    1. Blazeby JM, Strong S, Donovan JL, Wilson C, Hollingworth W, Crosby T et al. Feasibility RCT of definitive chemoradiotherapy or chemotherapy and surgery for oesophageal squamous cell cancer. Br J Cancer 2014; 111: 234–240.
    1. Stein RC, Dunn JA, Bartlett JMS, Campbell AF, Marshall A, Hall P et al. Optima prelim: a randomised feasibility study of personalised care in the treatment of women with early breast cancer. Health Technol Assess 2016; 20: 1–201.
    1. de Salis I, Tomlin Z, Toerien M, Donovan J. Qualitative research to improve RCT recruitment: issues arising in establishing research collaborations. Contemp Clin Trials 2008; 29: 663–670.
    1. Donovan JL, Paramasivan S, de Salis I, Toerien M. Clear obstacles and hidden challenges: understanding recruiter perspectives in six pragmatic randomised controlled trials. Trials 2014; 15: 5.
    1. Glaser BG, Strauss AL. The Discovery of Grounded Theory: Strategies for Qualitative Research. Transaction Publishers: Piscataway, NJ, USA, 2009.
    1. Miles M, Huberman M. Qualitative Data Analysis. Sage: London, UK, 1994.
    1. Fitzpatrick R, Boulton M. Qualitative Methods for assessing healthcare. Qual Health Care 1994; 3: 107–113.
    1. NHS Commissioning Board. Clinical Commissioning Policy: Complex and Specialised Obesity Surgery. Available at 2013.
    1. Donovan JL, de Salis I, Toerien M, Paramasivan S, Hamdy FC, Blazeby JM. The intellectual challenges and emotional consequences of equipoise contributed to the fragility of recruitment in six randomised controlled trials. J Clin Epidemiol 2014; 67: 912–920.
    1. Mills N, Donovan J, Wade J, Hamdy F, Neal D, Lane AJ. 'Exploring treatment preferences facilitated recruitment to randomized controlled trials'. J Clin Epidemiol 2011; 64: 1127–1136.
    1. Rooshenas L, Elliot D, Wade J, Jepson M, Paramasivan S, Wilson C et al. Conveying equipoise during recruitment for clinical trials: qualitative synthesis of clinicians' practices across six randomised controlled trials. PLoS Med 2016; 13: 10.
    1. Campbell MK, Snowdon C, Francis D, Elbourne D, McDonald AM, Knight R et al. Recruitment to randomised trials: strategies for trial enrolment and participation study. The STEPS study. Health Technol Assess 2007; 11: ii, ix–105.
    1. Paramasivan S, Strong S, Wilson C, Campbell B, Blazeby JM, Donovan JL. A simple technique to identify key recruitment issues in randomised controlled trials: Q-QAT – quanti-qualitative appointment timing. Trials 2015; 16: 88.
    1. Strong S, Paramasivan S, Mills N, Wilson C, Donovan JL, Blazeby JM. 'The trial is owned by the team, not by an individual: a qualitative study exploring the role of teamwork in recruitment to randomised controlled trials in surgical oncology'. Trials 2016; 17: 212.
    1. Wade J, Donovan JL, Lane JA, Neal DE, Hamdy FC. It's not just what you say, it's also how you say it: opening the 'black box' of informed consent appointments in randomised controlled trials. Soc Sci Med 2009; 68: 2018–2028.
    1. Mills N, Blazeby JM, Hamdy FC, Neal DE, Campbell B, Wilson CH et al. Training recruiters to randomized trials to facilitate recruitment and informed consent by exploring patients' treatment preferences. Trials 2014; 15: 323.

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