DS07 (P066) Our journey to a successful NIHR grant application in dermatological surgery: the HEAL2 study protocol
Authors: McGinnis Elizabeth , Wernham Aaron , Gilbert Rachael , Ransom Myka , Brown Sarah , Bojke Chris , Muli Annah , Collier Howard , Wilkes Hollie , Dennett Joanna , Konwea Henrietta , Ashraf Iqra , Mann Jasmine , Pynn Emma , Nixon Jane , Veitch David 
Published: June 2024

Abstract
Building a successful National Institute for Health and Care Research (NIHR) grant application is a daunting task, typically requiring several years of development. Numerous smaller preliminary ‘feasibility’ studies are required, demonstrating the need for the study, its impact on patient care and whether recruitment will be successful. The study team needs to demonstrate clinician willingness to participate and recruit and provide evidence for clinician equipoise. There must also be sufficient evidence of an efficacy signal from the intervention and patient willingness to be recruited and undergo randomization of the intervention. Patient and public involvement throughout study development must also be evidenced. The road to successful Health Technology Assessment (HTA) funding of HEALS2 started in 2013 via the UK Dermatology Clinical Trials Network (DCTN) trainee programme – an idea seeded by a group of trainees in dermatology and presented at the UK Dermatology Clinical Trials Network trainee day. Clinical trials unit support led to the HEALS cohort study, assessing time to wound healing following excision of keratinocyte cancer. This demonstrated an average of 81 days to wound healing, informing the power calculation for the HEALS2 randomized controlled trial, and demonstrating sufficient patient numbers and willingness for recruitment. HEALS2 is a multicentre, prospective randomized controlled trial evaluating the clinical and cost-effectiveness of compression therapy in the healing of surgical wounds by secondary intention following excision of lower-limb keratinocyte cancers. The primary objective is to compare healing time with randomization of standard care (SC) vs. SC with compression therapy. Recruitment will be open from January 2024 to December 2025, with the study aiming to recruit at 20 sites. The sample-size estimates are based on the HEALS feasibility cohort. Assuming a median time to healing of 81 days in the SC arm, a total of 396 randomized participants (198 per group) will provide 90% power for detecting a target effect size of 30% reduction in time to healing in the compression therapy group (57 days, hazard ratio 1.43). Our journey demonstrates how a simple idea can be transformed into to a fully funded NIHR grant application and some of the challenges faced along the way. We hope this inspires a future generation of surgical dermatologists keen to develop research ideas, with the knowledge that HTA grants are achievable in this subspecialty, and with significant potential to improve patient outcomes from skin cancer surgery. The study was developed with support from the UK DCTN and is funded by the NIHR HTA (NIHR151863). The views expressed are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care.