Title: Treatment of Hidradenitis Suppurativa Evaluation Study (THESEUS)
Funder: Health and Care Research Wales (Welsh Government)

Abstract: Hidradenitis suppurativa (HS) is a long term, painful skin condition. It involves boils in areas such as the arm pits and groins. It affects young adults of working age. HS has a big effect on quality of life due to pain, scarring and release of pus. It also affects sex and relationships._x000D_ _x000D_ Our planned study will provide vital information to answer questions that were identified as priority areas for research by patients with HS and the doctors and nurses who treat them._x000D_ _x000D_ Aim_x000D_ _x000D_ To inform the design of future HS trials and to understand how HS treatments are currently used. This involves five steps:_x000D_ (1) Describe the treatments used around the country (particularly the type of operation, which can vary from centre to centre);_x000D_ (2) See whether patients might consider joining a research study in the future and which treatment(s) they would prefer;_x000D_ (3) Define how patients with HS are currently seen within the health service. Learn what influences_x000D_ patients’ and clinicians’ treatment choices;_x000D_ (4) Select the best ways of measuring response to treatment (outcome measures);_x000D_ (5) Ask patients and doctors to agree the best design for future HS studies._x000D_ _x000D_ _x000D_ Design & methods _x000D_ _x000D_ The HTA are interested in funding a study on “Management of HS”. We have designed this study in response to the funders. Our team includes people with HS and the leader of a patients’ group, skin doctors, GPs, surgeons and research experts. We are supported by a Clinical Trials Unit to make sure that the research is high quality. We are backed by two networks that coordinate skin doctors and plastic surgery doctors around the country._x000D_ _x000D_ We have already run surveys of people with HS, skin doctors and surgeons about HS treatment. From these surveys, we have picked five main treatments that future research is likely to want to compare. _x000D_ We will invite people with HS to join the study as volunteers. By inviting people who are treated by skin doctors and those treated by surgeons, we should receive information about a range of treatments. The volunteers will be able to pick from the range of treatments available locally and, for the year after, we will record what happens to them._x000D_ _x000D_ We will measure how well the treatment has worked using recommended questionnaires and will help to interpret the questionnaire results by checking what changes in score matter to patients and whether the questionnaires are suitable for normal clinical practice._x000D_ _x000D_ During the study we will video record the surgical and laser operations to make a training video for future trials._x000D_ _x000D_ Patient & public involvement_x000D_ _x000D_ The President of the HS Trust has been a member of our bid team from the beginning and will be part of the group that manages the study. She led our patient survey, using the HS Trust website and social media. The survey, completed by 358 people, helped to shape our study plan._x000D_ _x000D_ Throughout our study, we will interview participants about their study experiences. We will ask about reasons why they might, or might not, take part in future studies. A group of people with HS and doctors/nurses/ researchers involved in the study will meet in a workshop. This will be used to agree the best designs for future HS research._x000D_ _x000D_ Dissemination_x000D_ _x000D_ We will present the findings from our study at international meetings of doctors and researchers. We will publish them openly in journals, where anybody can see them. The HS Trust patient support group will host links to these publications on its website, including a plain language summary and podcasts.

Lay abstract: Research question_x000D_ _x000D_ What are the best management options for hidradenitis suppurativa (HS) when first line treatments fail?_x000D_ _x000D_ Background_x000D_ _x000D_ HS is a relatively common, often painful chronic skin disease characterised by recurrent boils in flexural sites. Many second line therapies are used, including medical, surgical and laser, with a limited evidence base. Previously there was considerable heterogeneity in HS outcome measure instruments (OMIs)._x000D_ _x000D_ Aims and objectives_x000D_ _x000D_ To inform the design of future HS randomised controlled trials (RCTs) and to understand how HS treatments are currently used._x000D_ _x000D_ Methods_x000D_ _x000D_ Adults with active HS of any severity will be recruited into a non-randomised, prospective cohort study with 12-months’ follow-up. They will be offered a range of five medical and surgical interventions, selecting their preferred option in partnership with the clinician: (i) oral doxycycline 200mg OD for 6 months (ii) oral clindamycin and rifampicin both 300mg twice daily as a combined course for 10 weeks, (iii) laser treatment, (iv) deroofing of sinus tracts, and (v) conventional surgery. Our primary outcome will be the Proportion of participants who are eligible, and hypothetically willing, to use the different treatment options. Efficacy outcomes will be based on the HISTORIC HS core outcome domains consensus process and we will contribute to instrument validation._x000D_ _x000D_ Nested mixed methods studies will characterise the interventions used in clinical practice, understand facilitators and barriers to recruitment into future HS RCTs, and examine patients’ and clinicians’ perspectives on HS treatments. Videos will be produced documenting best practice for the surgical/ laser interventions, interviews will be conducted with patients and clinicians, and a consensus workshop will be undertaken. The workshop will prioritise the interventions, study designs and OMIs for future HS trials. _x000D_ _x000D_ Timelines for delivery_x000D_ _x000D_ The anticipated duration of the study is 36 months. Regulatory steps are expected to take 6 months. A sample size of 150 participants for the cohort study will provide meaningful results and, based on 10 already-identified recruiting centres, 12 months will be required for recruitment. Our qualitative work will take place in parallel with the cohort study. Participants will be followed up for 12 months, allowing 6 months for analysis and dissemination. _x000D_ _x000D_ Anticipated impact and dissemination_x000D_ _x000D_ Abstracts will be submitted to international dermatology and surgical conferences, and publication in high impact general medical, dermatology and surgical journals is anticipated. Our training videos can be used to promote best practice in performing HS procedures. The consensus workshop will produce a short list of prioritised study designs for future HS RCTs. Dissemination to patients and the public will be achieved with a plain language summary hosted on both the THESEUS study and HS Trust websites and promoted via social media.

Research activity codes: 7.1 INDIVIDUAL CARE NEEDS
Health categories: SKIN