Psoriasis Core Domain Set |
Domains that are considered required to measure in every psoriasis clinical trial:
Skin manifestations Primary (BSA/erythema/induration/scale) Location of skin lesions
Palmar-plantar psoriasis Scalp psoriasis
Investigator global Psoriasis and PsA symptoms PtGA Treatment satisfaction HRQOL
Domains that are not required but may be important depending on the study objectives:
Skin manifestations
Nail psoriasis Inverse psoriasis Genital psoriasis Guttate psoriasis Secondary manifestations
Domains that are considered for the research agenda:
PsA signs Economic effect
Direct cost Indirect cost
Work productivity/participation Cardiovascular disease
Workgroups established to identify the best-suited outcome measurement instruments for each core domain:
Treatment Satisfaction Workgroup: An SLR of the measurement prop erties of treatment satisfaction instruments used in dermatology revealed that neither of the existing instruments meet the minimum quality criteria standards. A new treatment satisfaction instrument is under development. PsA Symptoms Workgroup: Through a Delphi consensus exercise, it was agreed that all patients enrolling in a psoriasis clinical trial should be screened for PsA and that the PsAID-9 meets the necessary quality criteria standards to measure PsA symptoms in psoriasis clinical trials. The RAPID-3 was considered an acceptable alternative pending further validation. Investigator PtGA Workgroup: An SLR of the measurement properties of global assessment instruments did not identify instruments meeting the minimum quality criteria standards. A consensus exercise to define next steps is under way. HRQOL Workgroup: An SLR of the measurement properties of HRQOL measures is under way.
|
|
Hidradenitis Suppurativa Workgroup (HISTORIC) |
|
Hidradenitis Suppurativa Core Domain Set |
Domains that are considered required to measure in every psoriasis clinical trial:
Pain Physical signs
Anatomic location Surface area Total lesion count Inflammatory lesion count Number of abscesses Number of inflamed nodules Number of sinus tracts Number of fistulae
Hidradenitis Suppurativa QOL
Physical functioning Psychological functioning Psychosocial functioning Emotional well-being Ability to work or study
Global assessment
PtGA Investigator global
Progression of course
Flare frequency and duration Time to recurrence
Domains that reached “consensus in” for patients or healthcare providers only:
Symptoms1
Drainage Fatigue
Sleep disturbance Number of chronic areas
Domains that are considered for the research agenda or important in specific trials:
Biomarkers Time to heal
Workgroups were established to identify the best-suited outcome measurement instruments for each core domain. When measures do not exist for the specified items, or when measures may not be sufficiently validated, workgroups have been charged with developing new measures.
Hidradenitis Suppurativa-Specific QOL Workgroup: HISTORIC has developed the HiSQOL, the first disease-specific QOL instrument in hidradenitis suppurativa. HiSQOL has been accepted into the FDA qualification program and will be further tested in phase III trials. Investigator Global Assessment Workgroup: An Investigator Global Assessment for Hidradenitis Suppurativa was developed in PIONEER I study and will be validated in PIONEER II, as well as externally.
|
|
Acne Workgroup: ACORN |
|
Acne Core Domain Set |
Domains that are considered required to measure in every acne clinical trial:
Satisfaction with appearance HRQOL Extent of scars/dark marks Signs and symptoms Adverse events Satisfaction with treatment received Longterm control of acne
|
|
IDEOM-AAD Collaboration |
|
IDEOM collaborated with the AAD to meet consensus on valid, feasible, and meaningful outcome measures that could be incorporated into quality measures for inflammatory dermatoses. The collaboration conducted 2 consecutive modified Delphi processes:
Delphi process to achieve consensus on a physician-assessed outcome measure.
Consensus was reached for a single, 5-point ordinal physician global assessment instrument without anchoring descriptors to measure clinical outcomes in acne, eczema, and psoriasis patients: clear = 0; almost clear = 1; mild = 2; moderate = 3; severe = 4. Descriptors could potentially be provided to individual groups on a local level to guide disease severity assessment.
Delphi process to achieve consensus on a patient-reported outcome measure.
A combination of a PtGA with Skindex instruments (Skindex-16 or Skindex Mini) or other measure of HRQOL was recommended to measure clinical outcomes in acne, eczema, and psoriasis patients. Future work will focus on conducting further evaluation of the measurement properties of identified outcome measures and incorporating them into quality measures.
|
|
NAAF Collaboration |
|
Development of a patient-reported outcome measure for alopecia areata. |