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John R Ingram, Janine Bates, Rebecca Cannings-John, Fiona Collier, Angela Gibbons, Ceri Harris, Kerenza Hood, Laura Howells, Rachel Howes, Paul Leighton, Muhammad Riaz, Jeremy Rodrigues, Helen Stanton, Kim S Thomas & Emma Thomas-Jones.

John R Ingram ^1,*, Janine Bates ², Rebecca Cannings-John ², Fiona Collier ³, Angela Gibbons ⁴, Ceri Harris ⁴, Kerenza Hood ², Laura Howells ⁵, Rachel Howes ⁶, Paul Leighton ⁵, Muhammad Riaz ², Jeremy Rodrigues ^6,7, Helen Stanton ², Kim S Thomas ⁵, Emma Thomas-Jones ¹

¹ Division of Infection and Immunity, Cardiff University, Cardiff, UK
² Centre for Trials Research, College of Biomedical and Life Sciences, Cardiff University, Cardiff, UK
³ NHS Forth Valley, Stirling, UK
⁴ Centre for Trials Research, College of Biomedical and Life Sciences, Cardiff University, Cardiff, UK
⁵ Centre of Evidence Based Dermatology, School of Medicine, University of Nottingham, Nottingham, UK
⁶ Burns and Plastic Surgery, Stoke Mandeville Hospital, Aylesbury, UK
⁷ Warwick Clinical Trials Unit, University of Warwick, Warwick, UK
^* Corresponding author Email: IngramJR@cardiff.ac.uk

Disclosure of interests

Full disclosure of interests: Completed ICMJE forms for all authors, including all related interests, are available in the toolkit on the NIHR Journals Library report publication page at https://doi.org/10.3310/HWNM2189.

Primary conflict of interest: John R Ingram: Health Technology Assessment (HTA) grant 17/98/01, Consultant for Abbvie Boehringer Ingelheim, ChemoCentryx, Citryll, Novartis, UCB Pharma, and UNION Therapeutics (paid). Authorship honorarium from UpToDate (paid). Co-copyright holder of HiSQOL, Investigator Global Assessment and Patient Global Assessment instruments for HS (no payments as yet). Department receives income from copyright of the Dermatology Life Quality Instrument (DLQI) and related instruments (institution receives payments). Participation in Novartis Data Monitoring Committee (paid). Advisory boards – Insmed, Kymera Therapeutics, Viela Bio (paid). Receives a stipend as Editor-in-Chief of the British Journal of Dermatology (paid). Unpaid officer of British Association of Dermatologists. Janine Bates: Nothing to declare. Rebecca Cannings-John: Past member of HTA Associate Board. Fiona Collier: NIHRTHESEUS (subcontractor payment); British Dermatology Nursing Group Expert Panel on hidradenitis suppurativa (HS; paid). Angela Gibbons: Novartis: HS Patient Advisory Board (paid), THESEUS Study Management Group (honoraria payment). Ceri Harris: Novartis: HS Patient Advisory Board (paid), THESEUS Patient experience representative (honoraria payment). Kerenza Hood: Member of HTA General Committee, HTA Funding Committee Policy Group and NIHR Research Professors Panel. NIHRHTA funding (Research Grant to Cardiff University). Laura Howells: NIHRHTA funding (research grant to University of Nottingham), consultation fees from the University of Oxford on an educational grant funded by Pfizer, unrelated to submitted work. Rachel Howes: Nothing to declare. Paul Leighton: Member of NIHR Research for Patient Benefit East Midlands Advisory Board (unpaid). Muhammad Riaz: THESEUS has funded my poster presentation and attendance at ICTMC2022. Jeremy Rodrigues: NIHR postdoctoral fellowship (paid by institution). Helen Stanton: Nothing to declare. Kim Suzanne Thomas: NIHRHTA funding (research grant to University of Nottingham). Emma Thomas-Jones: Nothing to declare.

Equality, diversity and inclusion

Participant representation

Entry criteria for THESEUS were designed to be as inclusive as possible and the baseline demographics of THESEUS participants closely reflects the HS secondary care population in the UK. THESEUS recruited women of childbearing age, with a four to one female to male ratio and an average participant age of 36 years. Regarding smoking and obesity, again, THESEUS participants reflected the overall HS patient population, two-thirds being current or ex-smokers and 86% having a raised body mass index. There was broad representation across socioeconomic groups with half of the THESEUS participants in the most deprived and second-most deprived deprivation quintiles. Just over 20% of THESEUS participants had non-white ethnicity, slightly higher than overall UK population statistics. The 10 recruitment sites chosen for THESEUS were purposively spread across the UK, including sites in southern England, northeast England, northwest England, Scotland and Wales, to ensure that most regions of the UK were involved in the study. Our study centres ranged in size from large tertiary hospitals to smaller district general hospitals, demonstrating that future HS trials can be conducted in a range of settings. During the COVID-19 pandemic, conversion of follow-up to remote appointments if needed ensured that the participants’ access to their study team was not interrupted. Remote appointments also helped participants with mobility problems and transport difficulties. Our study results reveal that meetings and other patient meetings were also held online, again improving access for those with physical disabilities. On discussion with THESEUS patient research partners, we chose a hybrid model for the end-of-study workshop. In-person attendance was felt to maximise workshop contributions; however, some of our patient participants preferred to join online due to work or child-care commitments and because of physical disability. The solution was to select a venue with good videoconferencing facilities and, for the small group discussions, there were two in-person groups and one online, each with a facilitator. The potential financial impact of attending the workshop was mitigated by compensating patient attendees at the Involving People daily rate. Male patient representation was specifically sought for the workshop in the context that while HS is a condition in the UK predominantly affecting females, males are also affected as a minority. Only one person with HS featured in the deroofing video so there was not the chance to include a wide range of patient demographics in this aspect of the study. Ensuring that materials and videos for future studies encompass a full range of diversity will be an important element to consider.

Reflections on the research team and wider involvement

The THESEUS research team had substantial patient and public involvement (PPI) in study planning, funding application, study delivery and organising the end-of-study workshop. We were fortunate that one of our research partners is an expert in equality, diversity and inclusion (EDI) and they guided THESEUS regarding EDI considerations. We were able to involve a HS patient carer in the study planning process to ensure representation from this stakeholder group as well. Participant recruitment involved junior doctors, whenever possible, to help provide clinical trial training to the next generation of researchers.

Final approval was provided by Dr J Ingram.