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

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

Research output: Contribution to journalArticle

20 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
Pages (from-to)642-650
Number of pages9
JournalBritish Journal of Dermatology
Volume179
Issue number3
DOIs
StatePublished - Sep 2018

Fingerprint

Hidradenitis Suppurativa
Consensus
Delivery of Health Care
Clinical Trials
Aptitude
Quality of Life
Outcome Assessment (Health Care)
Pain

All Science Journal Classification (ASJC) codes

  • Dermatology

Cite this

on behalf of the HIdradenitis SuppuraTiva cORe outcomes set International Collaboration (HISTORIC) (2018). A core domain set for hidradenitis suppurativa trial outcomes: an international Delphi process. British Journal of Dermatology, 179(3), 642-650. https://doi.org/10.1111/bjd.16672
on behalf of the HIdradenitis SuppuraTiva cORe outcomes set International Collaboration (HISTORIC). / A core domain set for hidradenitis suppurativa trial outcomes : an international Delphi process. In: British Journal of Dermatology. 2018 ; Vol. 179, No. 3. pp. 642-650.
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abstract = "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.",
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on behalf of the HIdradenitis SuppuraTiva cORe outcomes set International Collaboration (HISTORIC) 2018, 'A core domain set for hidradenitis suppurativa trial outcomes: an international Delphi process', British Journal of Dermatology, vol. 179, no. 3, pp. 642-650. https://doi.org/10.1111/bjd.16672

A core domain set for hidradenitis suppurativa trial outcomes : an international Delphi process. / on behalf of the HIdradenitis SuppuraTiva cORe outcomes set International Collaboration (HISTORIC).

In: British Journal of Dermatology, Vol. 179, No. 3, 09.2018, p. 642-650.

Research output: Contribution to journalArticle

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T2 - an international Delphi process

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

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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.

PY - 2018/9

Y1 - 2018/9

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on behalf of the HIdradenitis SuppuraTiva cORe outcomes set International Collaboration (HISTORIC). A core domain set for hidradenitis suppurativa trial outcomes: an international Delphi process. British Journal of Dermatology. 2018 Sep;179(3):642-650. https://doi.org/10.1111/bjd.16672