A core domain set for hidradenitis suppurativa trial outcomes: an international Delphi process

TY - JOUR

T1 - A core domain set for hidradenitis suppurativa trial outcomes

T2 - an international Delphi process

AU - Thorlacius, L.

AU - Ingram, J. R.

AU - Villumsen, B.

AU - Esmann, S.

AU - Kirby, J. S.

AU - Gottlieb, A. B.

AU - Merola, J. F.

AU - Dellavalle, R.

AU - Nielsen, S. M.

AU - Christensen, R.

AU - Garg, A.

AU - Jemec, G. B.E.

AU - on behalf of the HIdradenitis SuppuraTiva cORe outcomes set International Collaboration (HISTORIC)

PY - 2018

Y1 - 2018

N2 - Background: There is no consensus on core outcome domains for hidradenitis suppurativa (HS). Heterogeneous outcome measure instruments in clinical trials likely leads to outcome-reporting bias and limits the ability to synthesize evidence. Objectives: To achieve global multistakeholder consensus on a core outcome set (COS) of domains regarding what to measure in clinical trials for HS. Methods: Six stakeholder groups participated in a Delphi process that included five anonymous e-Delphi rounds and four face-to-face consensus meetings to reach consensus on the final COS. The aim was for a 1 : 1 ratio of patients to healthcare professionals (HCPs). Results: A total of 41 patients and 52 HCPs from 19 countries in four continents participated in the consensus process, which yielded a final COS that included five domains: pain, physical signs, HS-specific quality of life, global assessment and progression of course. A sixth domain, symptoms, was highly supported by patients and not by HCPs but is recommended for the core domain set. Conclusions: Routine adoption of the COS in future HS trials should ensure that core outcomes of importance to both patients and HCPs are collected.

AB - Background: There is no consensus on core outcome domains for hidradenitis suppurativa (HS). Heterogeneous outcome measure instruments in clinical trials likely leads to outcome-reporting bias and limits the ability to synthesize evidence. Objectives: To achieve global multistakeholder consensus on a core outcome set (COS) of domains regarding what to measure in clinical trials for HS. Methods: Six stakeholder groups participated in a Delphi process that included five anonymous e-Delphi rounds and four face-to-face consensus meetings to reach consensus on the final COS. The aim was for a 1 : 1 ratio of patients to healthcare professionals (HCPs). Results: A total of 41 patients and 52 HCPs from 19 countries in four continents participated in the consensus process, which yielded a final COS that included five domains: pain, physical signs, HS-specific quality of life, global assessment and progression of course. A sixth domain, symptoms, was highly supported by patients and not by HCPs but is recommended for the core domain set. Conclusions: Routine adoption of the COS in future HS trials should ensure that core outcomes of importance to both patients and HCPs are collected.

U2 - 10.1111/bjd.16672

DO - 10.1111/bjd.16672

M3 - Journal article

C2 - 29654696

AN - SCOPUS:85050358570

SN - 0007-0963

VL - 179

SP - 642

EP - 650

JO - British Journal of Dermatology

JF - British Journal of Dermatology

IS - 3

ER -