Help for future research: Lessons learned in trial design, recruitment, and delivery from the "hELP" Study

Rosalind C. Simpson; Ruth Murphy; Daniel J. Bratton; Matthew R. Sydes; Sally Wilkes; Helen Nankervis; Shelley Dowey; Hazel Bell; Margaret Cruickshank; Karen Gibbon; Cathy M. Green; Christina Wong; Caroline M. Owen; Kate London; Shaheen Haque; Kim S. Thomas

doi:10.1097/LGT.0000000000000407

Help for future research: Lessons learned in trial design, recruitment, and delivery from the "hELP" Study

Rosalind C. Simpson^*, Ruth Murphy, Daniel J. Bratton, Matthew R. Sydes, Sally Wilkes, Helen Nankervis, Shelley Dowey, Hazel Bell, Margaret Cruickshank, Karen Gibbon, Cathy M. Green, Christina Wong, Caroline M. Owen, Kate London, Shaheen Haque, Kim S. Thomas

^*Corresponding author for this work

Research output: Contribution to journal › Comment/debate › peer-review

6 Citations (Scopus)

Abstract

The aim of this commentary is to document our experience and lessons learned of running a randomized controlled trial (RCT) in vulvar erosive lichen planus (ELPV), an uncommon and underresearched condition. Vulvar erosive lichen planus causes painful vulvovaginal erosions, which affect daily function and quality of life.1 Response to standard first-line therapy (superpotent topical corticosteroids) is often inadequate, and there are no RCTs to guide second-line treatment.2 The “hELP” (Systemic Therapy for Vulvar Erosive Lichen Planus) trial was a pilot study to assess feasibility of a definitive trial comparing systemic treatments for ELPV. Ethical approval (14/YH/0046), prospective trial registration (ISRCTN: 81883379), and protocol publication3 occurred...

Original language	English
Pages (from-to)	405-408
Number of pages	4
Journal	Journal of Lower Genital Tract Disease
Volume	22
Issue number	4
DOIs	https://doi.org/10.1097/LGT.0000000000000407
Publication status	Published - 1 Oct 2018

Bibliographical note

Funding Information:
This research was developed with the help and support of the University of Nottingham and the UK Dermatology Clinical Trials Network (UK DCTN). The UK DCTN is grateful to the British Association of Dermatologists and the University of Nottingham for financial support of the Network. Additional trial administrative support was provided by the University of Nottingham. Thank you to Natasha Rogers for assistance with data cleaning. Research nurse support was provided through the NIHR Clinical Research Networks.

Funding Information:
This study was funded by the National Institute of Health Research as part of a Doctoral Research Fellowship (DRF-2012-05-166). This report is independent research arising from a Doctoral Research Fellowship supported by the National Institute for Health Research (NIHR). The views expressed in this publication

Keywords

erosive lichen planus
randomized controlled trial
systemic treatment
vulvar
vulvovaginal

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10.1097/LGT.0000000000000407

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Simpson, R. C., Murphy, R., Bratton, D. J., Sydes, M. R., Wilkes, S., Nankervis, H., Dowey, S., Bell, H., Cruickshank, M., Gibbon, K., Green, C. M., Wong, C., Owen, C. M., London, K., Haque, S., & Thomas, K. S. (2018). Help for future research: Lessons learned in trial design, recruitment, and delivery from the "hELP" Study. Journal of Lower Genital Tract Disease, 22(4), 405-408. https://doi.org/10.1097/LGT.0000000000000407

Simpson, RC, Murphy, R, Bratton, DJ, Sydes, MR, Wilkes, S, Nankervis, H, Dowey, S, Bell, H, Cruickshank, M, Gibbon, K, Green, CM, Wong, C, Owen, CM, London, K, Haque, S & Thomas, KS 2018, 'Help for future research: Lessons learned in trial design, recruitment, and delivery from the "hELP" Study', Journal of Lower Genital Tract Disease, vol. 22, no. 4, pp. 405-408. https://doi.org/10.1097/LGT.0000000000000407

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abstract = "The aim of this commentary is to document our experience and lessons learned of running a randomized controlled trial (RCT) in vulvar erosive lichen planus (ELPV), an uncommon and underresearched condition. Vulvar erosive lichen planus causes painful vulvovaginal erosions, which affect daily function and quality of life.1 Response to standard first-line therapy (superpotent topical corticosteroids) is often inadequate, and there are no RCTs to guide second-line treatment.2 The “hELP” (Systemic Therapy for Vulvar Erosive Lichen Planus) trial was a pilot study to assess feasibility of a definitive trial comparing systemic treatments for ELPV. Ethical approval (14/YH/0046), prospective trial registration (ISRCTN: 81883379), and protocol publication3 occurred...",

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Help for future research: Lessons learned in trial design, recruitment, and delivery from the "hELP" Study

Abstract

Bibliographical note

Keywords

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