Effectiveness of different recruitment strategies in an RCT of a surgical device: experience from the Endobarrier trial
Michael Moore,
Hutan Ashrafian,
Mayank Patel,
Aruchuna Ruban,
Christina Gabriele Prechtl,
Michael Alan Glaysher,
Navpreet Chhina,
Werd Al-Najim,
Alexander Dimitri Miras,
Claire Smith,
Anthony P Goldstone,
James P Byrne,
Julian P Teare
Affiliations
Michael Moore
Primary Care Medical Group, University of Southampton, Southampton, Hampshire, UK
Hutan Ashrafian
1 Department of Surgery and Cancer, Imperial College London, London, UK
Mayank Patel
Department of Diabetes and Endocrinology, University Hospital Southampton, Southampton, Hampshire, UK
Aruchuna Ruban
Department of Gastroenterology, Imperial College Healthcare NHS Trust, London, UK
Christina Gabriele Prechtl
2 Department of Public Health, Imperial College Healthcare NHS Trust, London, London, UK
Michael Alan Glaysher
3 Division of Surgery, Southampton Biomedical Research Centre, University Hospital Southampton, Southampton, UK
Navpreet Chhina
4 PsychoNeuroEndocrinology Research Group, Neuropsychopharmacology Unit, Centre for Psychiatry and Computational, Cognitive and Clinical Neuroimaging Laboratory, Division of Brain Sciences, Imperial College London, London, UK
Werd Al-Najim
5 Dietician, Imperial College London, London, UK
Alexander Dimitri Miras
School of Medicine, Ulster University, Londonderry, UK
Claire Smith
2Health Education and Improvement UK
Anthony P Goldstone
4 PsychoNeuroEndocrinology Research Group, Neuropsychopharmacology Unit, Centre for Psychiatry and Computational, Cognitive and Clinical Neuroimaging Laboratory, Division of Brain Sciences, Imperial College London, London, UK
James P Byrne
Department of Surgery, University of British Columbia, Vancouver, British Columbia, Canada
Julian P Teare
Department of Metabolism, Digestion and Reproduction, Imperial College London, London, UK
Recruiting participants into clinical trials is notoriously difficult and poses the greatest challenge when planning any investigative study. Poor recruitment may not only have financial ramifications owing to increased time and resources being spent but could adversely influence the clinical impact of a study if it becomes underpowered. Herein, we present our own experience of recruiting into a nationally funded, multicentre, randomised controlled trial (RCT) of the Endobarrier versus standard medical therapy in obese patients with type 2diabetes. Despite these both being highly prevalent conditions, there were considerable barriers to the effectiveness of different recruitment strategies across each study site. Although recruitment from primary care proved extremely successful at one study site, this largely failed at another site prompting the implementation of multimodal recruitment strategies including a successful media campaign to ensure sufficient participants were enrolled and the study was adequately powered. From this experience, we propose where appropriate the early engagement and investment in media campaigns to enhance recruitment into clinical trials. Trial Registration: ISRCTN30845205.
