We are especially grateful to the patients with DPNP who participated in this trial. We would like to thank the members of the TSC and DMEC for their support and guidance. We are grateful to the PIs and their teams for their hard work delivering this complex trial.
The OPTION-DM group
Solomon Tesfaye was the chief investigator.
Dinesh Selvarajah was the co-chief investigator.
The following were co-applicants on the grant, contributed to the study design, were members of the TMG and contributed to data interpretation: David Bennett, Oscar Bortolami, Didier Bouhassira, Cindy Cooper, Rajiv Gandhi, Ravikanth Gouni, Michelle Horspool, Martin Johnson, Edward Jude, Steven A Julious, Satyan Rajbhandari, Gerry Rayman, Prashanth Vas and David White.
The following were site PIs and members of the TMG: Syed Haris Ahmed, Uazman Alam, David Bennett, Augustin Brookes, Marion Devers, Frances Game, Ravikanth Gouni, Christian Hariman, Pallavi Hegde, Edward Jude, Deirdre Maguire, Rory McCrimmon, Claire McDougall, David Price, Satyan Rajbhandari, Gerry Rayman, Abd Tahrani, Solomon Tesfaye, Vasileios Tsatlidis and Prashanth Vas.
The following contributed to participant recruitment, treatment delivery and data collection at sites: Quratul-ain Altaf, Samantha Anderson, Maureen Armstrong, Helen Atikins, Olabisi Awogbemila, Gayna Babington, Sarah Beck, Safia Begum, Elizabeth Bell, Dina Bell, Srikanth Bellary, Lyndsay Bibb, Sharron Birch, Hannah Bond, Elaine Brinkworth, Margaret Broome, Jamie Burbage, Charlotte Busby, Caroline Calver, Christine Cassidy, Tanith Changuion, Carolyn Chee, HoYee Cheung, Kamalakkannan Chokkalingham, Wahid Chugtai, Martyn Clark, Lynda Connor, Amanda Cook, Shirley Cooper, Martina Coulding, Joanna Cox, Helen Cross, Jacqueline Currie, Claire Davies, Caroline Davies, Rebecca Denyer, Laura Dinning, Julie Edwards, Branwen Ellison-Handley, Sarah Finbow, Annette Fleet, Kamini Gandhi, Laura Gardiner, Karyna Gibbons, Amanda Gillespie, Louisa Green, Peter Hammond, Gail Hann, Kate Harrington, Melanie Hayman, Stephanie Horler, Liew Huiling, Wanda Ingham, Ahmed Iqbal, Andrew Irwin, Khalid Jadoon, Victor Jardin, Helen Jenner, Jane Jiao, Katherine Jones, Frank Joseph, Joanne Kadziola, Maqsood Khan, Rosemary Kirk, Alistair Lamb, Rebecca Lenagh, Jonathan Lim, Jackie Lindsay, Linda Macliver, Ellen Malcolm, Barbara Martin, Shamiso Masuka, Alexandra McCarrick, Jacqueline McCormick, Carly McDonald, Nicky McRobert, Aye Min, Ahmad Moolla, Nadim Musah, Alison Musgrove, Sunil Nair, Kilimangalam Narayanan, Abida Nazir, Kelly Nicholson, Francis O’Rourke, Pedro Okoh, Matilde Pascal, Helen Permain, Shirley Peta Navein, Kristina Posadas, James Pratt, Tejpal Purewal, Taslima Rabbi, Sutapa Ray, Rustam Rea, Elsa Redfearn, Gillian Reekie, tephanie Ridgeway, Josephine Rosier, Daniel Rowlandson, Efisia Sais, Lorelei Salazar, Sunita Sandhu, Chandbi Sange, Vivienne Savage, Heather Savill, Caroline Scott, Susan Seal, Ruta Segamogaite, Dinesh Selvarajah, Ajmal Shakoor, Sanjeev Sharma, Gordon Sloan, Dawn Spick, Mara Sprengel, Lisa Stewart, Wendy Stoker, Sharon Storton, Kyla Story, Negar Tadayon, Garry Tan, Andreas Themistocleous, Sue Thomson, Viv Thornton-Jones, Nicola Tinker, Victoria Tobin, Kim Turner, Victoria Turner, Tom Vale, Joanne Vere, Janaka Vithanage, Lisa Wadeson, Taryn Ward, Rachel Whitham, Helen Wild, Andrew Williams, Annie Williamson, Jayne Willson, Ann Wilson, Charlene Wong, Noah Yogo and James Young.
The following contributed to pharmacy and IMP management at sites: Wendy Abbott, Fiona Ashworth, Bhavna Badiana, Liz Bedford, Michelle Beecroft, Sarah Bik, Nicola Blain, Sathan Boonyaprapa, Rachel Bower, Helen Bowler, Louise Brannon, Zara Brown, Shona Carson, Tom Carter, Katie Carter, Stuart Chandler, Vicky Chu, Irene Coburn, Amy Cox, Fionnuala Cunningham, Laura Cureton, Tori Donaldson, James Donworth, Samantha Eccles, Sharon Evans, Jordi Evans, Joanna Flanagan, Emma Galloway, Linda Gemmell, Dilbagh Gill, Marie Goldsworthy, Carlos Gonzalez, Alfonso Gonzalez-Blas, Joanne Gordon, Senait Haile, Clair Hammond, Benson Ho, Sheila Hodgson, Alison Hogan, Sam Holloway, Louise Hough, Matthew Howlett, Cath Hughes, Tracy Jackson, Sam Jackson, Carol Jaques, Dom Jimenez, Natalie Johnston, Paul Jones, Kelly Kauldhar, Laura Kirk, Paige Kissane, Caroline Loan, Jennifer Lynch, Helen Lyon, Jill Lyons, Greg Marchant, Steven Marshall, Peter Mason, Heather Michael, Laura Miller, Gaynor Notcheva, Samuel Nyabam, Matthew Quinn, Andrew Reid, Rosalind Roberts, Fiona Ross, Pam Rushworth, Nita Shah, Victoria Shakespeare, Tania Slater, David Sproates, Anita Stevenson, Kashmira Subramanian, Benham Tabrizi, Rebecca Tangney, Paul Taylor, Nichole Thompson, Christopher Waterhouse, Sue Wiles, Andrew Wilkinson and Elaine Wilson.
Erica Wallis was the sponsor representative and provided support on ethics and governance issues.
Rachel Glover, Jennifer Petrie, Katie Sutherland and Lizzie Swaby provided central trial management and monitoring.
Mike Bradburn provided the statistical support.
Tracey Young provided the health economics support.
Amanda Loban, Emily Turton and Simon Waterhouse provided central data management.
Zoe Furniss and Jess Welburn provided central administration.
Trial Steering Committee
Andrew Rice, independent chairperson (Professor of Pain Research, Imperial College London).
Ralf Baron (Professor of Pain Research, University Medical Centre Schleswig-Holstein).
Sarah Brown (Principal Statistician, University of Leeds).
Arthur Durrant (patient representative).
Nanna Finnerup (Professor of Pain Medicine, Aarhus University).
Roger Knaggs (Associate Professor in Clinical Pharmacy Practice, University of Nottingham).
Jane Lewis (Senior Lecturer in Podiatry, Cardiff School of Sport and Healthcare Science).
Data Monitoring and Ethics Committee
Troels Jensen, independent chairperson (Professor of Neurology and of Experimental and Clinical Pain Research, Aarhus University).
Zoe Hoare (Principal Statistician, Bangor University).
Martin Rutter (Professor of Cardiometabolic Medicine, University of Manchester).
Contributions of authors
Solomon Tesfaye (https://orcid.org/0000-0003-1190-1472) (Consultant Endocrinologist and Honorary Professor of Diabetic Medicine) produced the first draft of the report, was a member of the TMG, contributed to the delivery of the trial, was an applicant on the Health Technology Assessment grant, contributed to the study design and was an investigator at a participating site.
Gordon Sloan (https://orcid.org/0000-0001-6164-2662) (Clinical Research Fellow) produced the first draft of the report, was a member of the TMG and contributed to the delivery of the trial.
Jennifer Petrie (https://orcid.org/0000-0001-6150-6724) (Trial Manager) produced the first draft of the report, was a member of the TMG and contributed to the delivery of the trial.
David White (https://orcid.org/0000-0003-2871-7946) (Senior Research Fellow/Portfolio Lead) produced the first draft of the report, was a member of the TMG, contributed to the delivery of the trial, was an applicant on the Health Technology Assessment grant and contributed to the study design.
Mike Bradburn (https://orcid.org/0000-0002-3783-9761) (Senior Statistician) produced the first draft of the report, was a member of the TMG and contributed to the delivery of the trial.
Tracey Young (https://orcid.org/0000-0001-8467-0471) (Health Economist) produced the first draft of the report, was a member of the TMG and contributed to the delivery of the trial.
Satyan Rajbhandari (https://orcid.org/0000-0002-3995-5336) (Consultant Physician and Diabetologist) was an applicant on the Health Technology Assessment grant, contributed to the study design, was a member of the TMG and was an investigator at a participating site.
Sanjeev Sharma (https://orcid.org/0000-0001-6386-2052) (Consultant, Endocrinology and Diabetes) was an investigator at a participating site and was a member of the TMG.
Gerry Rayman (https://orcid.org/0000-0003-3331-7015) (Consultant Physician, Diabetes and Endocrinology) was an applicant on the Health Technology Assessment grant, contributed to the study design, was a member of the TMG and was an investigator at a participating site.
Ravikanth Gouni (https://orcid.org/0000-0002-5852-470X) (Consultant, Diabetes and Endocrinology) was an applicant on the Health Technology Assessment grant, contributed to the study design, was a member of the TMG and was an investigator at a participating site.
Uazman Alam (https://orcid.org/0000-0002-3190-1122) (Senior Clinical Lecturer and Honorary Consultant Physician, Cardiovascular and Metabolic Medicine) was an investigator at a participating site and was a member of the TMG.
Steven A Julious (https://orcid.org/0000-0002-9917-7636) (Professor of Medical Statistics) was an applicant on the Health Technology Assessment grant, contributed to the study design and was a member of the TMG.
Cindy Cooper (https://orcid.org/0000-0002-2995-5447) (Professor of Health Services Research and Clinical Trials) was an applicant on the Health Technology Assessment grant, contributed to the study design and was a member of the TMG.
Amanda Loban (https://orcid.org/0000-0001-7089-1580) (Lead Data Manager) was a member of the TMG and provided central data management.
Katie Sutherland (https://orcid.org/0000-0002-5162-8119) (Research Assistant) was a member of the TMG and contributed to the delivery of the trial.
Rachel Glover (https://orcid.org/0000-0002-2460-3354) (Trial Manager) was a member of the TMG and contributed to the delivery of the trial.
Simon Waterhouse (https://orcid.org/0000-0002-6303-9610) (Data Manager) was a member of the TMG and provided central data management.
Emily Turton (https://orcid.org/0000-0001-5763-9604) (Data Manager) was a member of the TMG and provided central data management.
Michelle Horspool (https://orcid.org/0000-0002-3069-6091) (Research Development Manager) was an applicant on the Health Technology Assessment grant, contributed to the study design and was a member of the TMG.
Rajiv Gandhi (https://orcid.org/0000-0002-2008-2301) (Consultant Diabetologist) was an applicant on the Health Technology Assessment grant, contributed to the study design, was a member of the TMG and was an investigator at a participating site.
Deirdre Maguire (https://orcid.org/0000-0001-6730-0997) (Consultant in Diabetes and Endocrinology) was an investigator at a participating site and was a member of the TMG.
Edward Jude (https://orcid.org/0000-0002-3186-4122) (Consultant Physician and Honorary Reader in Medicine) was an applicant on the Health Technology Assessment grant, contributed to the study design, was a member of the TMG and was an investigator at a participating site.
Syed Haris Ahmed (https://orcid.org/0000-0002-7815-2907) (Consultant Physician in Diabetes, Endocrinology and Metabolic Medicine) was an investigator at a participating site and was a member of the TMG.
Prashanth Vas (https://orcid.org/0000-0001-7448-2995) (Consultant Physician) was an applicant on the Health Technology Assessment grant, contributed to the study design, was a member of the TMG and was an investigator at a participating site.
Christian Hariman (https://orcid.org/0000-0001-6426-5807) (Consultant Physician, Diabetes and Endocrinology) was an investigator at a participating site and was a member of the TMG.
Claire McDougall (https://orcid.org/0000-0003-0138-5267) (Consultant Diabetologist) was an investigator at a participating site and was a member of the TMG.
Marion Devers (https://orcid.org/0000-0003-2605-4093) (Consultant Physician, Diabetes and Endocrinology) was an investigator at a participating site and was a member of the TMG.
Vasileios Tsatlidis (https://orcid.org/0000-0001-9413-5130) (Consultant, Endocrinology and Diabetes) was an investigator at a participating site and was a member of the TMG.
Martin Johnson (https://orcid.org/0000-0002-8398-5436) (Senior Medical Director, hVIVO) was an applicant on the Health Technology Assessment grant, contributed to the study design and was a member of the TMG.
Didier Bouhassira (https://orcid.org/0000-0001-6446-8719) (Director of Research, Inserm) was an applicant on the Health Technology Assessment grant, contributed to the study design and was a member of the TMG.
David L Bennett (https://orcid.org/0000-0002-7996-2696) (Professor of Neurology and Neurobiology) was an applicant on the Health Technology Assessment grant, contributed to the study design, was a member of the TMG and was an investigator at a participating site.
Dinesh Selvarajah (https://orcid.org/0000-0001-7426-1105) (Senior Clinical Lecturer in Diabetes and Honorary Consultant Physician) produced the first draft of the report, was a member of the TMG, contributed to the delivery of the trial, was an applicant on the Health Technology Assessment grant, contributed to the study design and was an investigator at a participating site.
Publications
Selvarajah D, Petrie J, White D, Julious S, Bortolami O, Cooper C, et al. Multicentre, double-blind, crossover trial to identify the Optimal Pathway for TreatIng neurOpathic paiN in Diabetes Mellitus (OPTION-DM): study protocol for a randomised controlled trial. Trials 2018;19:578. https://doi.org/10.1186/s13063-018-2959
Tesfaye S, Sloan G, Petrie J, White D, Bradburn M, Julious S, et al. Comparison of amitriptyline supplemented with pregabalin, pregabalin supplemented with amitriptyline, and duloxetine supplemented with pregabalin for the treatment of diabetic peripheral neuropathic pain (OPTION-DM): a multicentre, double-blind, randomised crossover trial. Lancet 2022;400:680–90.
Data-sharing statement
Requests for patient-level data and statistical code should be made to the corresponding author and will be considered on a case-by-case basis following the principles for sharing patient-level data.88
Patient data
This work uses data provided by patients and collected by the NHS as part of their care and support. Using patient data is vital to improve health and care for everyone. There is huge potential to make better use of information from people’s patient records, to understand more about disease, develop new treatments, monitor safety, and plan NHS services. Patient data should be kept safe and secure, to protect everyone’s privacy, and it’s important that there are safeguards to make sure that it is stored and used responsibly. Everyone should be able to find out about how patient data are used. #datasaveslives You can find out more about the background to this citation here: https://understandingpatientdata.org.uk/data-citation.
Disclaimers
This report presents independent research funded by the National Institute for Health and Care Research (NIHR). The views and opinions expressed by authors in this publication are those of the authors and do not necessarily reflect those of the NHS, the NIHR, the HTA programme or the Department of Health and Social Care. If there are verbatim quotations included in this publication the views and opinions expressed by the interviewees are those of the interviewees and do not necessarily reflect those of the authors, those of the NHS, the NIHR, the HTA programme or the Department of Health and Social Care.