Use of Patient-Reported Outcomes in Acne Vulgaris and Rosacea Clinical Trials From 2011 to 2021

Ly, Sophia; Miller, John P.; Tong, Lauren; Blake, Lindsay; Mostaghimi, Arash; Barbieri, John S.

doi:10.1001/jamadermatol.2022.3911

Cited by 7 publications

(6 citation statements)

References 206 publications

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“…Prior to accessing the survey, patients reviewed an online fact sheet explaining the research study and gave their consent by agreeing to the terms. To identify a reasonable set of PROMIS domains to include in a best-worst scaling exercise, a preliminary set of domains was selected based on previous systematic review and content analyses of current PROMs . The preliminary set was refined to a final set of 14 domains in conjunction with patient stakeholders with chronic skin diseases (K.D., K.S., and S.B.).…”

Section: Methodsmentioning

confidence: 99%

“…To identify a reasonable set of PROMIS domains to include in a best-worst scaling exercise, a preliminary set of domains was selected based on previous systematic review and content analyses of current PROMs. [9][10][11] The preliminary set was refined to a final set of 14 domains in conjunction with patient stakeholders with chronic skin diseases (K.D., K.S., and S.B.). Based on the PROMIS item bank content and in collaboration with an expert in qualitative research (F.K.B.…”

Section: Survey Designmentioning

confidence: 99%

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Identifying Core Outcome Domains in Chronic Skin Disease Using the Best-Worst Scaling Method

Shields,

Barg,

Begolka

et al. 2024

JAMA Dermatol

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ImportanceThe use of patient-reported outcome measures (PROMs) potentially holds promise as an opportunity to improve outcomes and quality of care for patients with skin disease, but the routine use of PROMs remains limited. While the Patient-Reported Outcomes Measurement Information System (PROMIS) has several strengths and domains relevant to those with chronic skin disease, it is not clear which are most useful.ObjectiveTo determine which PROMIS domains are most meaningful to those with chronic skin disease to develop a PROMIS profile that effectively captures the experience of living with these skin diseases.Design, Setting, and ParticipantsThis cross-sectional study was based on data gathered from an internet survey that was administered to a sample of adult respondents in the US on the Prolific Platform and ResearchMatch and through the National Psoriasis Foundation. A list of PROMIS domains relevant to chronic skin disease was developed through literature review. These domains were included in a best-worst scaling exercise, in which participants were shown 12 sets of 4 domains and asked to choose which domain in each set was the most important and least important to their experience. Participants completed the survey between December 2022 and June 2023. Data were analyzed in June 2023.Main Outcomes and MeasuresRatio-scaled preference score for each of the domains.ResultsOf 939 total participants, 559 (59.5%) were female, 20 (2.1%) gender nonconforming, 7 (0.7%) transgender men, and 1 (0.1%) transgender women; there were 4 American Indian/Alaska Native (0.4%), 50 Asian (5.3%), 63 Black (6.7%), 66 Hispanic or Latino/a/x (7.0%), 2 Native Hawaiian/Pacific Islander (0.2%), 749 White (79.8%), and 42 multiracial individuals (4.5%). The survey was completed by 200 participants with acne, 316 with psoriasis, 199 with atopic dermatitis, and 224 with various chronic skin diseases. For those with acne, the highest-scored domains were body image (15.66), appearance (14.96), life satisfaction (11.29), depression (9.25), and anxiety (9.18). For those with psoriasis, the highest-scored domains were life satisfaction (11.31), appearance (11.05), itch (10.98), pain (9.97), and body image (8.75). For those with atopic dermatitis, the highest-scored domains were itch (12.60), life satisfaction (11.65), appearance (11.40), body image (11.25), and pain (10.03).Conclusion and RelevanceThe results of this study suggest that body image, appearance, life satisfaction, itch, pain, anxiety, and depression were highly rated across the surveys. By identifying the PROMIS domains most important to individuals with chronic skin disease, clinicians can choose the domains that are most relevant to patients. In addition, this may guide the construction of a PROMIS profile that effectively captures the experience of living with these skin diseases and can serve as a patient-reported measure of disease severity and treatment effectiveness.

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Section: Methodsmentioning

confidence: 99%

Section: Survey Designmentioning

confidence: 99%

Identifying Core Outcome Domains in Chronic Skin Disease Using the Best-Worst Scaling Method

Shields,

Barg,

Begolka

et al. 2024

JAMA Dermatol

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“…Their development and use are valuable to the specialty, shifting the focus of clinical outcomes from investigator assessments to patient-centered outcomes in clinical research and care settings. The use of PROs in acne and rosacea trials is still limited, especially as a primary outcome, 10 indicating an important opportunity for the field. Qualitative work done by Tan and colleagues 11 in reporting thematic analysis of letters writ-ten by patients to their acne and acne scars (a technique known as the projective personification) presented a creative, rigorous, and foundational approach to understanding the lived experiences of patients with this common condition, work that may inform PRO development.…”

Section: Recipients Of Electronicmentioning

confidence: 99%

JAMA Dermatology—The Year in Review, 2022

Shinkai

2023

JAMA Dermatol

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JAMA Dermatology continued to thrive in 2022. The editorial leadership team carefully evaluated 2745 article submissions during the past year (Table ).A total of 1300 of 2745 submissions (47%) were research articles, which was similar to the previous year. Acceptance rates also remained stable, with 10% of submissions overall and 11% of research articles accepted for publication. With an ongoing commitment to pub-lishing excellence and process improvement, the journal continued to maintain its goal of reducing the time to publication, keeping the median days of acceptance to publication to 61 days while offering timely editorial decisions, including maintaining its median receipt-to-rejection time of 4 days and median receipt to first decision with peer review of 42 days. The editorial leadership team continued to strive to find ways to improve authors' experience to ensure authors the fastest and best publication of their work. As predicted in last year's review, many of the top dermatology journals achieved substantial increases in impact factors, which was likely a reflection of COVID-19 skinrelated publications, and in line with trends seen across the medical literature. JAMA Dermatology's impact factor increased from 10.3 to 11.8.The journal broadened its digital reach, with more than 5.2 million full-text views and downloads in the past year (an approximately 20% increase), and expanded its connections to more than 68 000 followers on the social media channels Twitter, Facebook, and Instagram, a 15% increase compared with the

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“…4,5 However, PROs are often not included in clinical trials or routinely collected in clinical practice, highlighting a potential opportunity to better capture the patient's perspective. 6 Patient-reported outcome measures (PROMs) can measure a single concept such as itch intensity or multiple domains (eg, Skindex, 4 which measures 3 health-related quality of life domains: emotional, symptoms-based, and rolefunctioning). In a secondary analysis of 2 randomized clinical trials in this issue of JAMA Dermatology, Kwatra et al 7 evaluated the validity of the Worst Itch Numeric Rating Scale (WI-NRS) in evaluating itch severity among patients with prurigo nodularis.…”

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confidence: 99%