A HOME Group 2016 - Medical Dermatology Society€¦ · A HOME Group Update 2016 Eric L. Simpson,...
Transcript of A HOME Group 2016 - Medical Dermatology Society€¦ · A HOME Group Update 2016 Eric L. Simpson,...
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A HOME Group Update 2016
Eric L. Simpson, MD, MCRProfessor, Dermatology
Oregon Health & Science UniversityPortland, OR USA
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Overview
• The problem• Core outcome sets in medicine• HOME and the HOME roadmap• Progress to date• Future plans
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Outcome measures – a real mess• Too many – at least 20 named scales
• Many not tested at all (Charman C, JID 2003)
• Data synthesis and comparison difficult
• 40–62% of publications had at least one primary outcome changed (Dwan et al, PLoS ONE 2008)
Schmitt J, Langan S, Williams HC. What are the best outcome measurements for atopic eczema? A systematic review JACI 2007;120:1389-98.
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What we need are core outcomes that are used in all trials
SCORADEASI
SASSAD
IGA
TISSSS
POEM
DLQI
SKINDEX
BCSS
ADAM
ADQADASIW‐AZS
VAS
5‐D
QOLIAD
SCORAD
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Core Outcome Sets in Medicine
• Agreed‐upon minimum set of outcomes for all trials
• Does not preclude the use of other outcomes• Should be:
– Meaningful to patients– Relevant to those making decisions about health care– Appropriate to setting
• Need to be valid, reliable, sensitive to change, easy to use
Williamson, et al. Developing core outcome sets for clinical trials: issues to consider. Trials, 2014.
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Overview
• The problem• Core outcome sets in medicine• HOME and the HOME roadmap• Progress to date• Future plans
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Core Outcome Set Groups• IMMPACT‐ pain• WOMBAT – women’s health• PROFANE‐ prevention of falls• EWMA‐ wound management• ADQI‐ nephrology• EUSCLE‐ cutaneous lupus• IMACS‐myositis• PRINTO‐ pediatric rheumatology• OMERACT‐ rheumatology• Asthma, CHF, acute MI, etc…..
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Why do we do this?
They say, “don’t touch me‐ I don’t want to get that.”
They say, “don’t touch me‐ I don’t want to get that.”
Don’t want to tackle the day.”
Don’t want to tackle the day.”
I avoided pool parties. Don’t want to go outside.I avoided pool parties.
Don’t want to go outside.
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Core Outcome Measures in Effectiveness Trials
www.comet‐initiative.org
• To raise awareness of current problems with outcomes in clinical trials
• To encourage COS development and uptake
• To provide resources to allow practitioners to develop COS, e.g. COMET database
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Improvements over time (Kirkham et al, Trials 2013)
Studies reporting full RA COS (%)
WHO/ILARRA COS
EMAguideline
FDAguideline
100
80
60
40
20
1985 1990 1995 2000 2005 2010
0
Mean number of clinical outcomes
6.0
6.5
7.0
0.0
drug studies
non-drug studies
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The world of medicine is moving on –what about eczema?
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Overview
• The problem• Core outcome sets in medicine• HOME and the HOME roadmap• Progress to date• Future plans
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Harmonizing Outcome Measures in Atopic Eczema (HOME)
Hywel Williams (UK) Jochen Schmitt (Germany)
Christian Apfelbacher(Germany)
KimThomas (UK)
PhyllisSpuls
(Netherlands)
Eric Simpson(USA)
MasutakaFurue(Japan)
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Harmonizing Outcome Measures in Eczema (HOME)
Epidemiologists
Clinicians
Industry
Regulatory
Patients
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HOME IV ConferenceMalmo, Sweden 2015
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The HOME RoadmapA Methodological Framework for Developing Core Outcome Sets
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J Invest Dermatol, 2014
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The HOME Roadmap
Schmitt, et al. J Invest Dermatol 2014
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Overview
• The problem• Core outcome sets in medicine• HOME and the HOME roadmap• Progress to date• Future plans
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HOME I‐Munich, 2009Schmitt, Williams,et al. BJD, 2010
HOME II‐ Amsterdam, 2011Schmitt, et al. Allergy, 2012
HOME III‐ San Diego, 2013Chalmers, et al. BJD, 2014
HOME IV‐Malmo, 2015In Review, BJD, 2016
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Schmitt, et al. Journal Invest Dermatol, 2011
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Clinical Signs
SymptomsQuality of Life
Long‐termControl
Consensus Domains to be Measured
Schmitt, et al. Allergy, 2012
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Clinical Signs
SymptomsQuality of Life
Long‐termControl
HOME Domains and Instruments
Schmitt, et al. Allergy, 2012
2 SRs+ ConsensusMeeting
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JACI, 2007
JACI, 2013
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The COSMIN ChecklistConsensus Standards for the Selection of Health Status
Measurement Instruments (Qual Life Rsch 2010)
EpidemiologistPsychologistsStatisticiansClinicians
Reliability Feasibility
ValidityResponsiveness
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EASI SCORAD
POEMSASSAD
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Jean‐Francois Stalder‐ Hero of HOME III
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Clinical Signs
SymptomsQuality of Life
Long‐termControl
Consensus Domains
Schmitt, et al. Allergy, 2012
EASI
2 SRs+ ConsensusMeeting
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Disseminationhomeforeczema.org
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BJD, 2015
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HOME IVMalmo, April 2015
• Reviewed QOL and symptoms SR• POEM picked as instrument for signs• No instrument for QOL agreed upon• Andrew Finlay the hero
Sanna Prinsen, PhD Louise GerbensMD/PhD candidate
Daniel Heinl
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Clinical Signs
SymptomsQuality of Life
Long‐termControl
Consensus Domains
EASI POEM
2 SRs+ Consensus
2 SRs+ Consensus
2 SRs 1 SR
DLQI,Skindex,QoLiAD? ????
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Future Work
• Dissemination / implementation work for POEM
• HOME V 2017 in Sao Paulo• Achieve consensus on QOL instruments and long‐term control
• Begin a core outcome set for clinical practice/ record keeping
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Take Home Points
• International effort needed• Industry are equal partners• Need for systematic approach• Methodologists needed• Establish voting procedures • Third party moderator• Use resources from COMET, CSG‐COUSIN
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Summary
• Developing a COS improves research quality
• Leads to more informed decision‐making for you and your patients
• Time‐consuming but extremely rewarding
• Brings together passionate people from around the world interested in your disease state
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Join us for HOME V in Brazil 2017!homeforeczema.org
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HOME Objectiveshomeforeczema.org
• Develop core sets of outcomes for AD to be used in all clinical trials and clinical settings
• Involve multiple stakeholders including clinicians, researchers, industry, regulatory agencies, and patients
• Open membership
• OMERACT presence and guidance
• Use a systematic and democratic approach based on state of the current evidence