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

BACKGROUND: 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. OBJECTIVE: Because patient-reported outcome measures are also important, we aimed to achieve consensus on 1 of these measures for clinical practice. METHODS: 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, patient global assessments (PtGAs), Skindex instruments, and final instrument selection for quality improvement. RESULTS: 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. LIMITATIONS: A small number of patients and caregivers were involved and a consensus was not reached on all items. CONCLUSION: 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.

International Dermatology Outcome Measures (IDEOM): Report from the 2020 Annual Meeting.

BACKGROUND: The International Dermatology Outcome Measures (IDEOM) initiative is a non-profit organization that aims to develop evidence-based outcome measurements to evaluate the impact of treatments for patients with dermatological disease. IDEOM includes all key stakeholders in dermatology (patient, physician, industry, insurer, and government) during the process of developing such outcome measurements. SUMMARY: Here, we provide an update of IDEOM activities that were presented at the 2020 IDEOM Virtual Annual Meeting (October 23-24, 2020). During the meeting, multiple IDEOM workgroups (psoriasis, psoriatic arthritis, hidradenitis suppurativa, acne, pyoderma gangrenosum, and actinic keratosis) shared their progress to date, as well as future directions in developing and validating Patient-Reported Outcome Measures. Updates on demonstrating efficacy in clinicals trials by the US Food and Drug Administration are also summarized. KEY MESSAGES: In this report, we summarize the work presented by each IDEOM workgroup (psoriasis, psoriatic arthritis, hidradenitis suppurativa, acne, pyoderma gangrenosum, and actinic keratosis) at the 2020 IDEOM Virtual Annual Meeting.

Proceeding report of the Fourth Symposium on Hidradenitis Suppurativa Advances 2019.

The Fourth Annual Symposium on Hidradenitis Suppurativa (SHSA) took place on November 1-3, 2019, at the Westin Book Cadillac Hotel in Detroit, Michigan. This symposium was a joint meeting of the US Hidradenitis Suppurativa Foundation and the Canadian Hidradenitis Suppurativa Foundation. This cross-disciplinary meeting with experts from around the world was an opportunity to discuss the most recent advances in the study of hidradenitis suppurativa (HS) pathogenesis, clinical trials, classification, scoring systems, complementary/alternative medical treatments, diet, pain management, surgical and laser treatment, and ultrasonographic assessment. A special preconference workshop was held on the use of neodymium-doped yttrium-aluminum-garnet laser hair reduction, sinus tract deroofing, and carbon dioxide laser excision with ultrasonographic mapping and tumescent anesthesia for the treatment of HS. The focused workshops on establishing an HS clinic, setting up an HS support group, the Hidradenitis Suppurativa Prospective Observational Registry and Biospecimen Repository, and wound care were held during the meeting. A special program called HS Ambassadors was established for patients who may have questions about the conference presentations, and in addition, a meet and greet for patients and HS Ambassadors was arranged. To facilitate networking between those early in their careers and clinical and research experts, a mentoring reception was held.

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.

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.

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.

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.

Report of the Skin Research Working Groups from the GRAPPA 2017 Annual Meeting.

At the 2017 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 cutaneous domain of psoriatic arthritis (PsA) projects. First, the group presented an overview of IDEOM's work to establish psoriasis outcome measures that satisfy the needs of all those involved. Second, the group discussed replacements for the Psoriasis Area and Severity Index (PASI) that can be used in clinical practice, including data that support the use of the physician's global assessment × body surface area measurement score as a PASI surrogate. Third, the group discussed the contribution of skin disease to composite measures of PsA. Last, the group summarized the National Psoriasis Foundation's efforts to establish treat-to-target strategies for psoriasis care.

Using the IDEOM Workflow for LCMS-Based Metabolomics Studies of Drug Mechanisms.

Rapid advancements in metabolomics technologies have allowed for application of liquid chromatography mass spectrometry (LCMS)-based metabolomics to investigate a wide range of biological questions. In addition to an important role in studies of cellular biochemistry and biomarker discovery, an exciting application of metabolomics is the elucidation of mechanisms of drug action (Creek et al., Antimicrob Agents Chemother 60:6650-6663, 2016; Allman et al., Antimicrob Agents Chemother 60:6635-6649, 2016). Although it is a very useful technique, challenges in raw data processing, extracting useful information out of large noisy datasets, and identifying metabolites with confidence, have meant that metabolomics is still perceived as a highly specialized technology. As a result, metabolomics has not yet achieved the anticipated extent of uptake in laboratories around the world as genomics or transcriptomics. With a view to bring metabolomics within reach of a nonspecialist scientist, here we describe a routine workflow with IDEOM, which is a graphical user interface within Microsoft Excel, which almost all researchers are familiar with. IDEOM consists of custom built algorithms that allow LCMS data processing, automatic noise filtering and identification of metabolite features (Creek et al., Bioinformatics 28:1048-1049, 2012). Its automated interface incorporates advanced LCMS data processing tools, mzMatch and XCMS, and requires R for complete functionality. IDEOM is freely available for all researchers and this chapter will focus on describing the IDEOM workflow for the nonspecialist researcher in the context of studies designed to elucidate mechanisms of drug action.

Prologue: 2016 Annual Meeting of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA).

The 2016 annual meeting of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) was held in Miami, Florida, USA, and attended by rheumatologists, dermatologists, and representatives of biopharmaceutical companies and patient groups. As in previous years, GRAPPA members held a symposium for trainees to discuss their research in psoriatic disease with experts in the field. A strategic planning session was convened by the Steering Committee this year to review the work of GRAPPA since its inception in 2003. Other subjects featured during the annual meeting included a partnership with KPMG LLP (UK) to conduct interviews at research centers worldwide to analyze the process of care in psoriasis and psoriatic arthritis (PsA); a discussion of the effects of interleukin 17-related pathways on the skin and joints in psoriasis and PsA; summaries of recently published treatment recommendations and related guides; 4 separate discussions of psoriasis patient examinations; updates from working groups in the Outcome Measures in Rheumatology and the International Dermatology Outcome Measures; a discussion of patient centricity from GRAPPA's patient research partners; and an update of research and educational projects from GRAPPA. In this prologue, we introduce the papers that summarize that meeting.

Defining Outcome Measures for Psoriasis: The IDEOM Report from the GRAPPA 2016 Annual Meeting.

The International Dermatology Outcome Measures (IDEOM) psoriasis working group was established to develop core domains and measurements sets for psoriasis clinical trials and ultimately clinical practice. At the 2016 annual meeting of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis, the IDEOM psoriasis group presented an overview of its progress toward developing this psoriasis core domain set. First, it summarized the February 2016 meeting of all involved with the IDEOM, highlighting patient and payer perspectives on outcome measures. Second, the group presented an overview of the consensus process for developing the core domain set for psoriasis, including previous literature reviews, nominal group exercises, and meeting discussions. Future plans include the development of working groups to review candidate measures for at least 2 of the domains, including primary pathophysiologic manifestations and patient-reported outcomes, and Delphi surveys to gain consensus on the final psoriasis core domain set.

International Dermatology Outcome Measures Initiative as Applied to Psoriatic Disease Outcomes: An Update.

Previous publications have described the International Dermatology Outcome Measures (IDEOM) group, comprising patients, physicians, health economists, participating pharmaceutical industry partners, payers, and regulatory agencies. The goal of IDEOM is to create patient-centered, validated measures of dermatologic disease progression and treatment efficacy for use in both clinical trials and clinical practice. We provide an update of IDEOM activities as of our 2015 IDEOM meeting in Washington, DC, USA.