“If dermatologists don’t participate in a meaningful collection of real-world data, then other entities, government and insurance providers, for example, will set for us unsubstantiated and invalidated standards of care”
(from Dermatology World. Jan 2019, p. 5)
IDEOM is a non-profit organisation with a mission “to establish patient-centered measurements to enhance research and treatment for those with dermatologic disease” including perspectives of patients, health economists, payers, non-profits, physicians and regulatory agencies are included from the onset.
IDEOM’s goal is to establish validated and standardized outcome measures that satisfy the needs of all stakeholders and can be applied to clinical research and clinical practice.
IDEOM deliverables:
Domains for psoriasis for clinical trials selected [1].
Collaboration with and obtained funding support for HISTORIC, an international consortium of healthcare professionals and patients, provided domains for hidradenitis suppurativa clinical trials [2].
Published results of a stakeholders meeting with payers to get their perspective on unmet issues [3].
Ongoing selected deliverables:
Working with acne outcome group (ACORN) to establish global measures for clinical practice.
Multi-year direct involvement with the FDA’s Dermatology Division at IDEOM meetings.
Initiated a continuing collaboration with the American Academy of Dermatology and patients to establish healthcare professionals- and patient provided global measures for clinical practice [4].
Of the core domain issues identified among stakeholders, psoriatic arthritis symptoms and treatment satisfaction were identified as hardly ever reported, so 2 active working groups were established:
Psoriatic arthritis symptoms:
Delphi process completed. PSAID 9 and 12 chosen.
PSAID part of Corrona data collection and psoriasis clinical trials.
Universally accepted, published outcome measures, useful in clinical practice, and mandated to perform in published guidelines issued by major professional societies.
Clinically meaningful outcome measures (i.e., not enough to be better than placebo).
Outcomes which justify cost.
Outcomes which measure overall cost of care
e.g., Reduce incidence of psoriatic arthritis or cardiovascular morbidity/mortality.
Outcomes which measure effects on patient productivity.
Outcomes which reduce variability in practice.
Would like to see a measure which “would look like a diagnostic test”
Treat to target is an example.
Electronic medical records are obstacles currently.
Dermatologists need to prove the value of care they provide and current quality measures for inflammatory skin diseases have limited validity (do they measure what they are supposed to?) and feasibility (are they practical?).
In the absence of robust quality measures, cost becomes the major determinant of quality.
IDEOM & American Academy of Dermatology aimed to reach a consensus on a valid and feasible provider-assessed global disease severity outcome measure to be incorporated into a quality measure for inflammatory dermatoses.
The top 3 voted diseases for global Physician Global Assessment (PGA) included acne, atopic dermatitis and psoriasis.
An overwhelming consensus (>90%) was achieved for the need for both a provider- and a patient-reported outcome measure for every patient encounter, and that treat to target strategies should also be based upon both of these measures.
The global patient-reported outcome measure was developed.
Perspectives
IDEOM will continue to work on validating simple and electronic medical records-friendly measurement tools that can be used by community dermatologists and their patients to quantitate outcomes of their treatments.
Regulatory approval and publications are just the beginning.
The true finish line is when the patient gets to the right doctor and the right treatment and their disease has minimal to no impact on their quality of life.
Callis Duffin K, Merola JF, Christensen R, et al. Identifying a core domain set to assess psoriasis in clinical trials: a combined Delphi Consensus Survey from the International Dermatology Outcome Measures initiative. JAMA Dermatology. 2018:154:1137-44.
Thorlacius L, Garg A, Ingram JR, et al. Towards global consensus on core outcomes for hidradenitis suppurativa research: An update from the HISTORIC consensus meetings I and II. Br. J. Dermatol. 2018;178:715-21.
Gottlieb AB, Salame N, Armstrong AW, et al. A provider global assessment quality measure for clinical practice for inflammatory skin disorders. J Am Acad Dermatol. 2019 Mar;80(3):823-8
With this collection of summaries from selected presentations at SPIN 2019, and interviews with international experts, we hope to share with you some of the highlights of this year’s congress. The international network met … [ Read all ]
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