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. 2017 Feb 20;7(2):e014733.
doi: 10.1136/bmjopen-2016-014733.

Protocol for the development of a core domain set for hidradenitis suppurativa trial outcomes

Linnea Thorlacius  1   2   3 , John R Ingram  4 , Amit Garg  5 , Bente Villumsen  6 , Solveig Esmann  1   2 , Joslyn S Kirby  7 , Alice B Gottlieb  8 , Joseph F Merola  9   10 , Robert Dellavalle  11 , Robin Christensen  3 , Gregor B E Jemec  1   2
Affiliations

Protocol for the development of a core domain set for hidradenitis suppurativa trial outcomes

Linnea Thorlacius et al. BMJ Open. .

Abstract

Introduction: Randomised controlled trials (RCTs) should have well-defined primary and secondary outcomes to answer questions generated by the main hypotheses. However, for the chronic, inflammatory skin disease hidradenitis suppurativa (HS), the reported outcome measures are numerous and diverse. A recent systematic review found a total of 30 outcome measure instruments in 12 RCTs. This use of a broad range of outcome measures can increase difficulties in interpretation and comparison of results and may potentially obstruct appropriate evidence synthesis by causing reporting bias. One strategy for dealing with these problems is to develop a core outcome set (COS). A COS is a list of outcomes that are meant as mandatory and should be measured and reported in all clinical trials. The aim of this study is to develop a COS for the management of HS.

Method and analysis: An international steering group of researchers, clinicians and a patient research partner will guide the COS development. 6 stakeholder groups are involved: patients, dermatologists, surgeons, nurses, industry representatives and drug regulatory authorities. A 1:1 ratio of patients:healthcare professionals is aimed for. The initial list of candidate items will be obtained by combining three data sets: (1) a systematic review of the literature, (2) US and Danish qualitative interview studies involving patients with HS and (3) an online healthcare professional (HCP) item generation survey. To reach consensus on the COS, 4 anonymous online Delphi rounds are then planned together with 2 face-to-face consensus meetings (1 in Europe and 1 in the USA) to ensure global representation.

Ethics and dissemination: The study will be performed according to the Helsinki declaration. All results from the study, including inconclusive or negative results, will be published in peer-reviewed indexed journals. The study will involve different stakeholder groups to ensure that the developed COS will be suitable and well accepted.

Keywords: Consensus study; Core Domain Set; Core Outcome Set; Delphi study; Hidradenitis suppurativa.

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Conflict of interest statement

Competing interests: None declared.

Figures

Figure 1
Figure 1
Study summary. See the text for details. HCP, healthcare professional.
See this image and copyright information in PMC

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References

    1. Jemec GB. Clinical practice. Hidradenitis suppurativa. N Engl J Med 2012;366:158–64. 10.1056/NEJMcp1014163 - DOI - PubMed
    1. Jemec GB, Heidenheim M, Nielsen NH. The prevalence of hidradenitis suppurativa and its potential precursor lesions. J Am Acad Dermatol 1996;35(2 Pt 1):191–4. 10.1016/S0190-9622(96)90321-7 - DOI - PubMed
    1. Revuz JE, Canoui-Poitrine F, Wolkenstein P et al. . Prevalence and factors associated with hidradenitis suppurativa: results from two case–control studies. J Am Acad Dermatol 2008;59:596–601. 10.1016/j.jaad.2008.06.020 - DOI - PubMed
    1. Vinding GR, Miller IM, Zarchi K et al. . The prevalence of inverse recurrent suppuration: a population-based study of possible hidradenitis suppurativa. Br J Dermatol 2014;170:884–9. 10.1111/bjd.12787 - DOI - PubMed
    1. Dufour DN, Emtestam L, Jemec GB. Hidradenitis suppurativa: a common and burdensome, yet under-recognised, inflammatory skin disease. Postgrad Med J 2014;90:216–21; quiz 20 10.1136/postgradmedj-2013-131994 - DOI - PMC - PubMed