Supported Intervention Versus Intervention Alone for Management of Fecal Incontinence in Patients With Inflammatory Bowel Disease: A Multicenter Mixed-Methods Randomized Controlled Trial

Lesley Dibley, PhD, Florence Nightingale Faculty of Nursing, Midwifery and Palliative, King's College London, London, United Kingdom; University of Greenwich, London, United Kingdom.

Ailsa Hart, PhD, St Mark's Hospital (IBD Unit), Northwick Park Hospital, Harrow, Middlesex, United Kingdom.

Julie Duncan, MSc, Department of Gastroenterology, St Thomas' NHS Foundation Trust, London, London, United Kingdom; Takeda UK, London, United Kingdom.

Charles H. Knowles, PhD, Blizard Institute, Barts and The London School of Medicine and Dentistry, London, United Kingdom.

Sally Kerry, MSc, Pragmatic Clinical Trials Unit (PCTU), Institute for Population Health Sciences, Queen Mary University of London, London, United Kingdom.

Doris Lanz, MA, Pragmatic Clinical Trials Unit (PCTU), Institute for Population Health Sciences, Queen Mary University of London, London, United Kingdom.

Vladislav Berdunov, PhD, Pragmatic Clinical Trials Unit (PCTU), Institute for Population Health Sciences, Queen Mary University of London, London, United Kingdom.

Vichithranie W. Madurasinghe, MSc, Pragmatic Clinical Trials Unit (PCTU), Institute for Population Health Sciences, Queen Mary University of London, London, United Kingdom; University of Oxford, Oxford, United Kingdom.

Tiffany Wade, MSc, Florence Nightingale Faculty of Nursing, Midwifery and Palliative, King's College London, London, United Kingdom.

Helen Terry, BA(Hons), Crohn's and Colitis UK, Hatfield Business Park, Hatfield, United Kingdom.

Azmina Verjee, PGDip, Patient and Public Involvement Team Lead. Crohn's and Colitis UK, Hatfield Business Park, Hatfield, United Kingdom.

Mandy Fader, PhD, School of Health Sciences, University of Southampton, Southampton, United Kingdom.

Christine Norton, PhD, Florence Nightingale Faculty of Nursing, Midwifery and Palliative, King's College London, London, United Kingdom.

Correspondence: Lesley Dibley, PhD, The Institute for Lifecourse Development, Faculty of Education, Health, and Human Sciences, University of Greenwich (Southwood site), Health Sciences Bldg, Avery Hill Rd, Eltham, London SE9 2 UG, United Kingdom ([email protected]).

Conflicts of Interest:

L.D. has received speaker fees from AbbVie, Dr Falk Pharma, Eli-Lilly (WebMD), Janssen; consultancy fees from GL Assessments and Crohn's & Colitis UK; research funding from Takeda and Janssen.

A.H. has served as consultant, advisory board member, or speaker for AbbVie, Atlantic, Bristol-Myers Squibb, Celltrion, Falk, Ferring, Janssen, MSD, Napp Pharmaceuticals, Pfizer, Pharmacosmos, Shire, and Takeda. She also serves on the Global Steering Committee for Genentech.

J.D. has received speaker fees from Warner Chilcott, Dr Falk Pharma, AbbVie, Janssen, Takeda, and MSD, while an IBD Nurse Manager at Guy's & St Thomas's Hospitals Trust. Since July 2018, she has been in full-time employment with Takeda UK Ltd.

C.K. has received speaker fees from, and acted as a consultant for, Medtronic.

C.N. has received speaker fees from Ferring, Takeda, and Tillotts Pharma.

M.F., S.K., D.L., V.B., V.M., T.W., H.T., and AV: none to declare.

*L.D. is now at the University of Greenwich, London. J.D. is now with Takeda UK; Takeda has no connection, financial or otherwise, with this study. V.B. is now at Putnam PHMR. D.L. is now at the Institute for Cancer Research, Surry, UK. V.W.M. is now at Oxford University.

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