A Core Domain Set For Hidradenitis Suppurativa Trial Outcomes

An International Delphi Process

HIdradenitis SuppuraTiva cORe outcomes set International Collaboration (HISTORIC)

Research output: Contribution to journalJournal articleResearchpeer-review

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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.

Original languageEnglish
JournalBritish Journal of Dermatology
Volume179
Issue number3
Pages (from-to)642-650
ISSN0007-0963
DOIs
Publication statusPublished - Sep 2018

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

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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
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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title = "A Core Domain Set For Hidradenitis Suppurativa Trial Outcomes: An International Delphi Process",
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.",
author = "L Thorlacius and Ingram, {J R} and B Villumsen and S Esmann and Kirby, {J S} and Gottlieb, {A B} and Merola, {J F} and R Dellavalle and Nielsen, {S M} and R Christensen and Amit Garg and Jemec, {G B E} and {HIdradenitis SuppuraTiva cORe outcomes set International Collaboration (HISTORIC)}",
note = "{\circledC} 2018 The Authors. British Journal of Dermatology published by John Wiley & Sons Ltd on behalf of British Association of Dermatologists.",
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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. / 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 journalJournal articleResearchpeer-review

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, Amit

AU - Jemec, G B E

AU - HIdradenitis SuppuraTiva cORe outcomes set International Collaboration (HISTORIC)

N1 - © 2018 The Authors. British Journal of Dermatology published by John Wiley & Sons Ltd on behalf of British Association of Dermatologists.

PY - 2018/9

Y1 - 2018/9

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

VL - 179

SP - 642

EP - 650

JO - British Journal of Dermatology

JF - British Journal of Dermatology

SN - 0007-0963

IS - 3

ER -

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