Successfully reported this slideshow.
We use your LinkedIn profile and activity data to personalize ads and to show you more relevant ads. You can change your ad preferences anytime.
International DErmatology Outcomes Measures
Modeled after OMERACT: Outcomes Measures in
Rheumatology
1992 original intent:...
• Recognized that most effectiveness trials
evaluate whether an intervention is effective
and safe
• Choice of measures to...
Rigorous methodology to gain consensus,
for a disease state:
WHAT to measure (CORE DOMAINS)
HOW to measure (CORE
MEASUREME...
Truth: Does the outcome tool measure
what it is supposed to in an unbiased and
relevant manner?
Discrimination: Does the o...
Important:
choice of
additional
Domains,
Depending on
study
question
Research:
additional
Domains of
interest
one Domain f...
Areas of interest:
Dactylitis
Enthesitis
Spinal
Fatigue
Radiology
Acute phase reactants
Research:
MRI
CT
Ultrasound
Tissue...
OMERACT working
groups
Large Vessel
Vasculitis Low Back
Pain Myositis Osteoporosi
s Polymylagia
Rheumatica Psoriatic
Arthr...
• 501c3
• Current psoriasis working group and board of directors:
• Alice Gottlieb MD,PhD
• Kristina Callis Duffin MD, MS
...
IDEOM’s Inaugural Meeting:
Boston, MA January 2013
100 attendees, representation from many
stakeholder groups:
Dermatologi...
LITERATURE REVIEW and
GENERATION of
CANDIDATE
DOMAINS/SUBDOMAINS
DEVELOP CONCEPTUAL
MODEL of
DOMAINS/SUBDOMAINS
CONSENSUS ...
additional Domains,
Depending on study
question:
• Resource Use
• Scalp activity
• Inverse activity
• Palmar-plantar
activ...
DOMAIN: INSTRUMENT
Skin acdtivity: PASI?
Nail activity: NAPSI?
Investigator global: PGA? PGA x BSA?
Patient global: VAS?
P...
IDEOM short and long term objectives
Establish Core
Domains
psoriasis clinical
trials
Establish Core
Measurement sets
for ...
Upcoming SlideShare
Loading in …5
×

IDEOM overview

1,107 views

Published on

IDEOM Overview

Published in: Health & Medicine
  • Be the first to comment

  • Be the first to like this

IDEOM overview

  1. 1. International DErmatology Outcomes Measures Modeled after OMERACT: Outcomes Measures in Rheumatology 1992 original intent: obtain agreement on the minimum number of outcome measures to be included in all rheumatoid arthritis clinical trials. Global organization, applied rigorous methodologies to determine core measures in all areas of rheumatology
  2. 2. • Recognized that most effectiveness trials evaluate whether an intervention is effective and safe • Choice of measures to reflect benefit and harm • In most areas: • choices not standardized • heterogeneity between trials • potential for bias (selective outcome reporting) • choice of measures less relevant to users (e.g. PASI75)
  3. 3. Rigorous methodology to gain consensus, for a disease state: WHAT to measure (CORE DOMAINS) HOW to measure (CORE MEASUREMENT SET) In WHICH setting (trial, longitudinal study, clinical practice)
  4. 4. Truth: Does the outcome tool measure what it is supposed to in an unbiased and relevant manner? Discrimination: Does the outcome measure discriminate between situations? e.g., measures changes with treatment, comparison with active or placebo control Reliability and sensitivity to change are important Feasibility: Is this a practical measure? Factors include time, money, etc. OMERACT Filter
  5. 5. Important: choice of additional Domains, Depending on study question Research: additional Domains of interest one Domain from each of 4 CORE AREAS: Pathophysiologic manifestations Life Impact Death Resource Use Core set
  6. 6. Areas of interest: Dactylitis Enthesitis Spinal Fatigue Radiology Acute phase reactants Research: MRI CT Ultrasound Tissue analysis Participation CORE: Peripheral joint activity Skin activity Patient global Pain Physical Function Health Related Quality of Life Psoriatic Arthritis Core set From Gladman DD, Mease PJ, Strand V, et al. Consensus on a ore set of domains for psoriatic arthritis. J Rheumatol. 2007 May;34(5):1167-70
  7. 7. OMERACT working groups Large Vessel Vasculitis Low Back Pain Myositis Osteoporosi s Polymylagia Rheumatica Psoriatic Arthritis Remission in RA Systemic Lupus Erythematosus Systemic Sclerosis Vasculitis
  8. 8. • 501c3 • Current psoriasis working group and board of directors: • Alice Gottlieb MD,PhD • Kristina Callis Duffin MD, MS • April Armstrong MD, MPH • Amit Garg MD • Joe Merola MD, MMSc • Patient members of working group: • Courtney Schneider • Ellen Clements • NPF Volunteers assisting with IDEOM efforts: Leah North, Leah Howard • OMERACT advisors: Maarten Boers, Philip Mease, Dafna Gladman, Robin Christensen
  9. 9. IDEOM’s Inaugural Meeting: Boston, MA January 2013 100 attendees, representation from many stakeholder groups: Dermatologists Rheumatologists OMERACT Advisors (Philip Mease, Maarten Boers) National Psoriasis Foundation GRAPPA Patients Industry American Academy of Dermatology Missing: payers/CMS, FDA
  10. 10. LITERATURE REVIEW and GENERATION of CANDIDATE DOMAINS/SUBDOMAINS DEVELOP CONCEPTUAL MODEL of DOMAINS/SUBDOMAINS CONSENSUS PROCESS (DELPHI): to determine the CORE DOMAIN SET DETERMINATION OF Core Outcome Measurement Set FOR CLINICAL TRIALS 1st IDEOM Meeting, Boston, MA January 2013: • Literature Review, generation of items Post meeting: • Preliminary Delphi to generate items 2nd IDEOM Meeting, Toronto, Ontario, Canada, July 2013: • Further expansion and refinement of candidate items for domains/subdomains Post meeting: • Delphi on 21 proposed domains 3rd IDEOM Meeting, Rome, Italy April 2014 • Presentation of first Delphi results Post meeting: • Revision of conceptual model to prepare for new Delphi 4th IDEOM Meeting, Washington, DC February 2014 • Presentation and vote on Core Domain Set • Initiate determination of Core Measurement Set for psoriasis clinical trials
  11. 11. additional Domains, Depending on study question: • Resource Use • Scalp activity • Inverse activity • Palmar-plantar activity Research: additional Domains of interest: • Comorbidities • Participation • Tissue analysis One Domain from each of 4 CORE AREAS: • Pathophysiologic manifestations: • Skin activity • Nail activity • Musculoskeletal activity • Investigator global • Life Impact: • Psoriasis symptoms • patient global • HRQOL • Death Example: what a Psoriasis Core Domain set might look like when finished – after rounds of Delphi
  12. 12. DOMAIN: INSTRUMENT Skin acdtivity: PASI? Nail activity: NAPSI? Investigator global: PGA? PGA x BSA? Patient global: VAS? Psoriatic arthritis: ? Psoriasis symptoms: PSI? PSD? HRQOL: DLQI Apply OMERACT Filter: TRUTH DISCRIMINATION FEASIBILITY CONSENSUS on WHICH MEASURES If doesn’t meet criteria DEVELOPMENT of NEW MEASURE EXAMPLE: Potential psoriasis core set
  13. 13. IDEOM short and long term objectives Establish Core Domains psoriasis clinical trials Establish Core Measurement sets for psoriasis Apply IDEOM methodology to other settings and skin conditions Hidradenitis supporativa, lupus, pemiphigus, acne, others Psoriasis clinical practice Psoriasis registries For second layer and research agenda, establish working groups to develop or guide development of new measures

×