A Core Domain Set For Hidradenitis Suppurativa Trial Outcomes: An International Delphi Process

HIdradenitis SuppuraTiva cORe outcomes set International Collaboration (HISTORIC)

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Resumé

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.

OriginalsprogEngelsk
TidsskriftBritish Journal of Dermatology
Vol/bind179
Udgave nummer3
Sider (fra-til)642-650
ISSN0007-0963
DOI
StatusUdgivet - sep. 2018

Fingeraftryk

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

Bibliografisk note

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

Citer dette

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. I: British Journal of Dermatology. 2018 ; Bind 179, Nr. 3. s. 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)}",
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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, bind 179, nr. 3, s. 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).

I: British Journal of Dermatology, Bind 179, Nr. 3, 09.2018, s. 642-650.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer 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

C2 - 29654696

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