International Dermatology Outcome Measures Research Articles

International Dermatology Outcome Measures (IDEOM) - Report from the 2022 Annual Meeting.

The International Dermatology Outcome Measures (IDEOM) is a non-profit organization dedicated to the advancement of evidence-based, consensus-driven outcome measures in dermatological diseases. Researchers and stakeholders from various backgrounds collaborate to develop these objective benchmark metrics to further advance treatment and management of dermatological conditions. The 2022 IDEOM Annual Meeting was held on June 17-18, 2022. Leaders and stakeholders from the hidradenitis suppurativa, acne, vitiligo, actinic keratosis, alopecia areata, itch, cutaneous lymphoma, and psoriatic disease workgroups discussed the progress of their respective outcome-measures research. This report summarizes each workgroup's updates from 2022 and their next steps as established during the 2022 IDEOM Annual Meeting. J Drugs Dermatol. 2023;22(12):1153-1159 doi:10.36849/JDD.7615.

Report of the Skin Research Workgroups From the IDEOM Breakout at the GRAPPA 2022 Annual Meeting.

The International Dermatology Outcome Measures (IDEOM) organization presented an update on its progress related to patient-centered outcome measures for psoriasis (PsO) and psoriatic arthritis (PsA) at the 2022 annual meeting of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA). The Musculoskeletal (MSK) Symptoms working group presented an update on the development of the IDEOM Musculoskeletal Questionnaire (IDEOM MSK-Q). The IDEOM MSK-Q is a patient-reported outcome measure intended to capture MSK symptoms and describe their intensity and impact on health-related quality of life in patients with psoriatic disease. IDEOM also presented the progress of the integration of the Psoriasis Epidemiology Screening Tool (PEST) and Psoriatic Arthritis Impact of Disease (PsAID) questionnaires into the Epic electronic health record system. This will allow for automated PsA screening and symptom measurement in the hopes of improving disease detection and treat-to-target strategies. The Treatment Satisfaction working group discussed the development of the DermSat-7, a 7-item treatment satisfaction questionnaire specific for dermatological conditions. The DermSat-7 is currently being validated in a multicenter study of patients with PsO.

Prologue: Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) 2022 Annual Meeting.

The 2022 annual meeting of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) was held from July 14 to 17, 2022, in New York City, New York, USA, and was attended by 420 rheumatologists, dermatologists, basic scientists, allied health professionals, patient research partners, and industry partners from 31 countries. A GRAPPA executive retreat, a Trainee Symposium, and the Patient Research Partners Network meeting were held prior to the annual meeting. Presentations included updates in basic research, focusing on biomarkers, personalization of treatments, and the promise of single-cell omics, elucidating the pathogenesis of psoriatic disease (PsD). Presentations also highlighted guttate and plaque psoriasis (PsO), the impact of coronavirus disease 2019 (COVID-19) and its treatments on patients with PsD globally, and the effects of sex and gender in PsD. Reports of ongoing projects included an update on the recently published treatment recommendations, educational initiatives, and the Diagnostic Ultrasound Enthesitis Tool (DUET) study. A session on early identification of psoriatic arthritis (PsA) among patients with PsO included an update on PsA screening tools. Debates were held on whether early intervention for PsO will reduce PsA, whether interleukin (IL)-17 or IL-23 inhibition is a better treatment for PsO and PsA, similarities and differences between axial PsA and axial spondyloarthritis with PsO, and data affecting the understanding of guttate and plaque PsO. Reports from the International Dermatology Outcome Measures (IDEOM) and Young GRAPPiAns concurrent sessions were presented in addition to reports of several other partner groups. Here, we highlight features of the annual meeting and introduce the manuscripts published together as a meeting report.

International Dermatology Outcome Measures (IDEOM): Report from the 2021 Annual Meeting.

International Dermatology Outcome Measures (IDEOM) is a non-profit organization founded in 2013. It is composed of researchers and stakeholders who work to develop evidenced-based outcome measures to enhance research and treatment recommendations of dermatologic diseases. The 2021 IDEOM Virtual Annual Meeting occurred from November 19-20, 2021. Contributions were made by leaders and stakeholders from the psoriasis, psoriatic arthritis, pediatric hidradenitis suppurativa, acne, vitiligo, actinic keratosis, alopecia areata, itch, and cutaneous lymphoma workgroups. The psoriasis, psoriatic arthritis, and actinic keratosis workgroups provided an overview of their respective instruments for treatment satisfaction and symptom measurement. The inaugural meetings of the itch, alopecia areata, and cutaneous lymphoma workgroups identified unmet needs of their respective diseases and future goals. The acne, vitiligo, and pediatric hidradenitis suppurativa workgroups discussed concerns of quality of life, instruments for symptom measurement, and screening tools. Additionally, a representative from the US Food and Drug Administration was in attendance and presented an update on topical drugs and generics. This report provides a summary of workgroup updates from the past year and future directions established during the meeting. This report summarizes progress made by each IDEOM workgroup at the 2021 IDEOM Virtual Annual Meeting. J Drugs Dermatol. 2022;21(8):867-874. doi:10.36849/JDD.6974.

Report of the Skin Research Working Groups from the GRAPPA 2021 Annual Meeting.

The International Dermatology Outcome Measures (IDEOM) initiative presented an update on their progress related to instruments for psoriasis (PsO) and psoriatic arthritis (PsA) patient-centered outcome measures at the 2021 annual meeting of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA). The Treatment Satisfaction working group presented the development of a 7-item treatment satisfaction questionnaire specific for dermatological conditions. The group is beginning by assessing the validity and reliability of the instrument in PsO patient populations, with the ultimate goal of validating it for use in multiple dermatological diseases. The Musculoskeletal Symptoms working group discussed how implementation of a screening measurement tool in patients with PsO can help identify unknown diagnoses of PsA or prevent worsening of symptoms.

2020 IDEOM Annual Meeting: Actinic Keratosis Stakeholders Survey Identifies Gaps in Research and Care.

This is a report of the survey results from the International Dermatology Outcome Measures (IDEOM) actinic keratosis (AK) workgroup. The purpose of the survey was to compile a list of gaps within AK care and management that require refinement. The results were discussed at the IDEOM annual meeting held virtually on October 23–24, 2020. This built a framework with which the AK workgroup, which consisted of physicians, patients, and pharmaceutical scientists, discussed at length in their breakout session at the meeting. The electronic survey was distributed to patients, pharmaceutical scientists, and leading physician experts in the field via email on September 22, 2020, with a deadline of October 2, 2020. The survey consisted of three open-ended prompts concerning key gaps and/or unmet needs in (1) the care of AKs, (2) outcome measurement of AKs in clinical trials and, (3) the measurement of AKs in clinical practice. The results were qualitative, with a response rate of 47%. Responses included reform of outcome measures for clinical trials, a methodology for evaluating the efficacy of preventative measures, and a comparison of treatments to establish a treatment protocol, among other efforts. This paper will also provide a brief overview of the current state of the AK outcome measures, emphasizing the heterogeneity of the measures and detailing the AK workgroup's future efforts to create a reliable and applicable core outcome measure set. J Drugs Dermatol. 2022;21(2):128-134. doi:10.36849/JDD.6360.

Report of the Skin Research Working Groups From the GRAPPA 2020 Annual Meeting.

At the 2020 annual meeting of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA), the International Dermatology Outcome Measures (IDEOM) Initiative Psoriasis (PsO) Working Group presented an update on its work to agree on meaningful, valid, and feasible outcome measures for PsO randomized controlled trials and longitudinal observational studies. The Treatment Satisfaction Working Group presented the development of a treatment satisfaction instrument to be utilized in PsO clinical trials. The Musculoskeletal Symptoms Working Group presented an overview of their work conducted to date to define how to best measure musculoskeletal symptoms in PsO clinical studies, and discussed next steps during an open-panel discussion, which included PsO and psoriatic arthritis experts.

Prologue: 2020 Annual Meeting of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA).

The Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) held its annual meeting in 2020 in an online format due to travel restrictions during the coronavirus disease 2019 (COVID‑19; caused by SARS-CoV-2) pandemic. The virtual meeting was attended by 351 rheumatologists, dermatologists, representatives of biopharmaceutical companies, and patient research partners. Similar to previous years, GRAPPA's annual meeting focused on the 3 overlapping missions of education, research, and clinical care of psoriatic disease. Trainee sessions this year included the annual trainee symposium and a grant-writing workshop. Plenary sessions included updates on COVID-19 and psoriatic disease from multispecialty and patient perspectives, and updates on pustular psoriasis and associated musculoskeletal manifestations. Progress on research and updates were presented for the following groups: Collaborative Research Network, Outcome Measures in Rheumatology (OMERACT) Psoriatic Arthritis Working Group, International Dermatology Outcome Measures, Composite Measures, Education Committee, and Treatment Guidelines. New this year were 3 concurrent workshops on ultrasound assessment of joints and entheses, magnetic resonance imaging of psoriatic arthritis, and pustular psoriasis efficacy endpoints; 6 "Meet the Expert" sessions; and facilitated "poster tours." In our prologue, we introduce the papers that summarize this meeting.

Report from the International Dermatology Outcome Measures Initiative.

The International Dermatology Outcome Measures is a nonprofit organization dedicated to developing evidence-based, patient-centered outcome measures for dermatologic conditions. At the 2018 Alopecia Areata Research Summit, Dr Gottlieb, President of the International Dermatology Outcome Measures, presented an overview of their work in psoriasis, hidradenitis suppurativa, acne, and eczema and discussed the potential areas of mutual interest with the National Alopecia Areata Foundation. Herein, we present a summary of the topics discussed.

Report of the Skin Research Workgroups from the GRAPPA 2019 Annual Meeting.

The International Dermatology Outcome Measures (IDEOM) initiative is a nonprofit organization dedicated to enhancing clinical care and research in dermatology by developing evidence-based, patient-centered outcome measures. At the 2019 annual meeting of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA), the IDEOM psoriasis working group presented an overview of its selected deliverables and discussed its efforts to agree on meaningful, valid, and feasible outcome measures for quality measurement in psoriasis. The psoriatic arthritis (PsA) workgroup focused on the measurement of PsA symptoms in psoriasis clinical trials, and the measurement of nonspecific musculoskeletal symptoms among patients with psoriasis in psoriasis longitudinal clinical trials and cohort studies.

Prologue: 2019 Annual Meeting of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA).

The 2019 Annual Meeting of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) was held in Paris, France, and was attended by rheumatologists, dermatologists, representatives of biopharmaceutical companies, and patients. As in previous years, GRAPPA members held a symposium for trainees to discuss their research in psoriatic disease with experts in the field. Other subjects featured during the annual meeting included a composites workshop to review continuous composite measures; the GRAPPA-Collaborative Research Network's third annual meeting; the need for a precision medicine approach to the treatment of psoriatic disease; updates from working groups in International Dermatology Outcome Measures and Outcome Measures in Rheumatology; a debate on the effectiveness of methotrexate in the treatment of psoriatic arthritis (PsA); updating recommendations for optimal treatment approaches for patients with PsA; an update on GRAPPA's research and educational projects; and the GRAPPA ultrasound (US) working group's goal to optimize the evaluation of enthesitis in patients with PsA using US through the development of a diagnostic US enthesitis tool. In this Prologue, we introduce the papers that summarize that meeting.

Examination of Treatment Satisfaction Instruments in Psoriasis: 2017 Results from the Psoriasis Working Group of the International Dermatology Outcome Measures (IDEOM)

Background/Aims: In dermatology clinical trials, assessment of patients’ treatment satisfaction is crucial but often lacking. To address this need, IDEOM’s Psoriasis Working Group seeks to evaluate, develop, and validate treatment satisfaction instruments for the psoriasis population. The Psoriasis Working Group aimed to determine (1) factors affecting psoriasis patients’ satisfaction with their therapies, (2) adequacy of two commonly used generic treatment satisfaction instruments in reflecting the psoriasis patients’ perspective, and (3) whether a need exists to develop a new treatment satisfaction instrument. Methods: Patient perspectives on satisfaction with treatment efficacy, safety, convenience, and overall satisfaction were elicited.Stakeholders were presented with information regarding the feasibility and content validity of two generic treatment instruments, the Treatment Satisfaction Questionnaire for Medication (TSQM) and the Treatment Satisfaction with Medicines Questionnaire (SATMED-Q). We conducted a nominal group discussion and survey to determine whether stakeholders considered these instruments feasible and adequate to address treatment satisfaction for psoriasis therapies. Results: Forty-five stakeholders participated in the nominal group discussion and survey. 53% of participants voted that the TSQM and SATMED-Q are not adequate and that we should create a new dermatology-specific treatment satisfaction instrument. Patients and other stakeholders also provided feedback on aspects of treatment satisfaction important to them. These include speed of onset and durability of therapeutic effect of a medication, permanence of side effects, and convenience of administering the medication. Conclusion: Stakeholders, including patients and providers, determined that generic treatment satisfaction questionnaires are not adequate to evaluate treatment satisfaction in psoriasis patients.

Achieving consensus on patient-reported outcome measures in clinical practice for inflammatory skin disorders

International Dermatology Outcome Measures and the American Academy of Dermatology recently agreed on a physician-reported global severity measure to demonstrate quality of care in inflammatory dermatoses. Because patient-reported outcome measures are also important, we aimed to achieve consensus on 1 of these measures for clinical practice. Patients and providers participated in a consensus-building study involving a modified-Delphi technique. Voting was focused on identifying a minimal set of assessments for clinical practice, patientglobal assessments (PtGAs), Skindex instruments, and final instrument selection for quality improvement. Among 53 stakeholders, >70% agreed that identification of patient goals, assessment of treatment harm, and assessment of the adequacy of treatment response were the minimal assessments needed for clinical practice. The most preferred PtGA was a 5-point PtGA (scale 0-4; 0=clear, 4=severe) having an optional check-box for worst ever. A new metric to assess change since treatment initiation, which we called a trajectory measure, was proposed. Stakeholders preferred Skindex instruments over PtGAs and a trajectory measure for clinical practice. A small number of patients and caregivers were involved and a consensus was not reached on all items. PtGAs as standalone measures do not adequately capture the patient's assessment of disease severity or the effect of care. The combination of a PtGA with a Skindex instrument or another measure of health-related quality of life might provide a more comprehensive evaluation of patients in clinical practice.

Measurement properties of the investigator and patient global assessment measures in psoriasis: A systematic review from International Dermatology Outcome Measures (IDEOM)

Measurement properties of the investigator and patient global assessment measures in psoriasis: A systematic review from International Dermatology Outcome Measures (IDEOM)

Report of the Skin Research Workgroups from the GRAPPA 2018 Annual Meeting.

At the 2018 annual meeting of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA), the International Dermatology Outcome Measures (IDEOM) Psoriasis Working Group presented an overview of its efforts to enhance clinical care and research in both the clinical setting as well as in clinical trials for psoriasis. First, the group discussed the results of a Delphi survey conducted in collaboration with the American Academy of Dermatology to agree on a unique physician-reported global assessment to measure the quality of care delivered to patients with psoriasis and other chronic inflammatory dermatoses. Second, the group summarized its efforts to select outcome measures for "PsA symptoms" and "treatment satisfaction," 2 of the domains of the psoriasis core domain set that were established by IDEOM. Finally, the Psoriasis and Psoriatic Arthritis Clinics Multicenter Advancement Network (PPACMAN) presented an update on its clinical, educational, and research missions to foster the development of combined clinics for psoriatic disease, increase disease awareness, and accelerate management.

Prologue: 2018 Annual Meeting of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA).

The 2018 Annual Meeting of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) was held in Toronto, Ontario, Canada, and was attended by rheumatologists, dermatologists, and representatives of biopharmaceutical companies and patients. As in previous years, GRAPPA members held a symposium for trainees to discuss their research in psoriatic disease with experts in the field. Other subjects featured during the annual meeting included GRAPPA-Collaborative Research Network's second annual meeting; the association between psoriatic disease and cardiovascular events; updates from working groups in International Dermatology Outcome Measures (IDEOM) and Outcome Measures in Rheumatology (OMERACT); a 2016 study that benchmarked care in psoriatic arthritis (PsA); the genetic contribution to PsA and strong need for genome-wide association studies on patients with PsA; the GRAPPA Ultrasound Working Group's goal to optimize the evaluation of enthesitis in patients with PsA using ultrasound through the development and validation of new instruments; and an update on GRAPPA's research and educational projects. In this prologue, we introduce the papers that summarize the meeting.

Measuring psoriatic arthritis symptoms: A core domain in psoriasis clinical trials

The International Dermatology Outcome Measures established a set of core domains to be measured in all psoriasis trials. This set requires that symptoms of psoriatic arthritis (PsA) be measured in all psoriasis studies. To identify the approach to PsA screening and the most appropriate outcome measure for capturing PsA symptoms. Following guidelines (ie, the COnsensus-based Standards for the selection of health Measurement INstruments, Core Outcome Measures in Effectiveness Trials Initiative, and Outcome Measures in Rheumatology Handbook), we conducted a consensus-building study that included patients, physicians, industry partners, and patient association representatives. The process consisted of a literature review and quality appraisal of measures for PsA symptoms, a pre-Delphi exercise, a Delphi survey, and a consensus meeting. Among the 297 expert participants in the Delphi survey, 87.5% agreed that all patients in a psoriasis trial should be screened for PsA with a validated screening tool. Regarding the measurement of PsA symptoms, the preferred instrument was the Psoriatic Arthritis Impact of Disease-9 (PsAID9), with the Routine Assessment Patient Index Data-3 (RAPID3) representing an acceptable alternative. Only International Dermatology Outcome Measures members participated in the consensus meeting. The overwhelming majority of expert stakeholders agreed that all psoriasis trial participants should be screened for PsA, with PsA symptoms measured by using PsAID9 (or alternatively with RAPID3).

A provider global assessment quality measure for clinical practice for inflammatory skin disorders

In our evolving health care system, dermatologists are increasingly being asked to prove the value of care they provide to patients with severe skin diseases. Current quality measures for inflammatory dermatoses have limited validity and feasibility. Through collaboration and a modified Delphi process, International Dermatology Outcome Measures and the American Academy of Dermatology sought to reach consensus on a valid and feasible provider-assessed global disease severity metric to be incorporated into a quality measure for inflammatory dermatoses. To inform the modified Delphi process, a review of the literature was performed, and data were collected on current provider-assessed global disease severity metrics. After literature review, 36 members of International Dermatology Outcome Measures and the American Academy of Dermatology participated in the modified Delphi process to reach consensus on features of the metric. Psoriasis, atopic dermatitis, and acne achieved overwhelming consensus for inflammatory dermatoses that could be measured in a global disease severity metric. Consensus was also reached on the use of a 5-point ordinal scale with descriptors provided through referenced electronic platforms. Expert development of quality measures incorporating this metric and its inclusion in data collection platforms are critical to enabling dermatologists to prove the value of care provided to patients with severe inflammatory dermatoses.

Achieving international consensus on the assessment of psoriatic arthritis in psoriasis clinical trials: an International Dermatology Outcome Measures (IDEOM) initiative.

Psoriatic arthritis (PsA) is rarely assessed in psoriasis randomized controlled trials (RCT); thus, the effect of psoriasis therapy on PsA is unknown. The International Dermatology Outcome Measures (IDEOM) has included "PsA Symptoms" as part of the core domains to be measured in psoriasis RCT. This study aimed to achieve consensus about screening for PsA and how to measure for "PsA Symptoms" in psoriasis RCT. At the IDEOM 2017 Annual Meeting, stakeholders voted on the role of PsA screening in psoriasis RCT. To select measures for "PsA Symptoms", we adapted the Consensus-Based Standards for the Selection of Health Measurement Instruments (COSMIN) guidelines. Three potential measures were selected. At the meeting, stakeholders voted on the validity, feasibility, and responsiveness of these measures. Of the 47 stakeholders, 93% voted that all psoriasis trial participants should be screened for PsA. "PsA Symptoms" measures included Patient Global (PG)-arthritis, Routine Assessment Patient Index Data (RAPID)-3, and Psoriatic Arthritis Impact of Disease (PsAID)-9. During the voting, more than 50% of the voters agreed that RAPID3 and PsAID9 were good measures for PsA Symptoms, able to capture all its essential elements. PsAID9 was considered the most feasible instrument, followed by RAPID3 and PG-arthritis, respectively. Finally, most participants agreed that RAPID3 and PsAID9 were responsive measures. Most study participants voted that all subjects in a psoriasis clinical trial should be screened for PsA. RAPID3 and PsAID9 outperformed PG-arthritis in measuring PsA Symptoms. This will be followed by a Delphi survey involving a larger stakeholder group.

Core Outcome Sets for Psoriasis Clinical Trials

Standardized and relevant psoriasis-specific outcome measures would contribute to a better understanding of the benefits of a growing list of highly effective therapies. To this end, in this issue of JAMA Dermatology, Callis Duffin et al1 present the results of an effort to define core outcome sets (COSs) for clinical trials of psoriasis. Under the auspices of the International Dermatology Outcome Measures group, the authors conducted a Delphi survey and determined that the following 6 domains should be addressed in all psoriasis trials: (1) psoriatic skin manifestations (including location), (2) an investigator global assessment, (3) an evaluation of signs and symptoms of both psoriasis and psoriatic arthritis, (4) a patient global assessment of his or her condition, (5) an assessment of treatment satisfaction, and (6) a measure of health-related quality of life.