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Outpatient Dermatology Productivity Measures by Patient Race, Sex, and Age.
IF 11.5 1区 医学 Q1 DERMATOLOGY Pub Date : 2024-12-23 DOI: 10.1001/jamadermatol.2024.5286
Lauren A V Orenstein, John S Barbieri, Meron Siira, Ethan Borre, Krittin J Supapannachart, Eric Viera, Courtney Ann Prestwood, Robert Swerlick, Rachel E Patzer, Suephy C Chen
<p><strong>Importance: </strong>Clinical productivity measures may incentivize clinical care to specific patient populations and thus perpetuate inequitable care. Before the 2021 Medicare physician fee schedule changes, outpatient dermatology encounters for patients who were younger, female, and races other than White systematically generated fewer work relative value units (wRVUs).</p><p><strong>Objective: </strong>To examine the association of patient race, age, and sex with wRVUs generated by outpatient dermatology encounters after 2021.</p><p><strong>Design, setting, and participants: </strong>This multi-institutional cross-sectional study evaluated demographic and billing data for outpatient dermatology encounters across 3 academic dermatology practices. The study compared wRVUs generated by outpatient general dermatology encounters in 6-month periods before and after the 2021 fee schedule updates (March 1 to August 31, 2019, and March 1 to August 31, 2021). Eligibility required an age of 18 years or older and available age, race, and sex data. Data analysis was performed from September 2022 to March 2024.</p><p><strong>Main outcomes and measures: </strong>The primary outcome was wRVUs generated per encounter.</p><p><strong>Results: </strong>This study included 89 656 encounters (47 607 before the 2021 Medicare physician fee schedule update and 42 049 after the update). Across all encounters, the mean (SD) patient age was 56.3 (17.8) years; 55 460 encounters (61.9%) were with female patients and 34 196 (38.1%) were with male patients; and 3457 encounters (3.9%) were with Asian patients, 10 478 (11.7%) with Black patients, 72 894 (81.3%) with White patients, and 2287 (3.2%) with patients of other race or ethnicity (Latino and multiracial). The mean (SD) wRVUs per outpatient dermatology encounter was 1.44 (0.88) before the update and 1.80 (0.99) after (P < .001). After 2021, adjusted analyses demonstrated significantly fewer wRVUs per encounter for female (β, -0.11; 95% CI, -0.13 to -0.10) compared with male patients, and for younger (β, 0.04 [95% CI, 0.04 to 0.05] per 10-year increase in age) compared with older patients. After the update, compared with White patients, visits with Asian patients generated fewer wRVUs (β, -0.12; 95% CI, -0.17 to -0.08) as did visits with Black patients (β, -0.14; 95% CI, -0.17 to -0.11), both statistically significant reductions compared with prior comparisons (P < .001 for both). After 2021, mediation analysis identified that premalignant destructions and biopsies mediated many of the remaining differences in wRVU generation by patient age, race, and sex.</p><p><strong>Conclusions and relevance: </strong>This study found that after the 2021 Medicare fee schedule updates, there was a persistent, albeit reduced, gap between wRVU productivity in outpatient dermatology visits for Asian and Black compared with White patients. These persisting differences were attributable to skin biopsies and cryotherapy of premal
{"title":"Outpatient Dermatology Productivity Measures by Patient Race, Sex, and Age.","authors":"Lauren A V Orenstein, John S Barbieri, Meron Siira, Ethan Borre, Krittin J Supapannachart, Eric Viera, Courtney Ann Prestwood, Robert Swerlick, Rachel E Patzer, Suephy C Chen","doi":"10.1001/jamadermatol.2024.5286","DOIUrl":"https://doi.org/10.1001/jamadermatol.2024.5286","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Importance: &lt;/strong&gt;Clinical productivity measures may incentivize clinical care to specific patient populations and thus perpetuate inequitable care. Before the 2021 Medicare physician fee schedule changes, outpatient dermatology encounters for patients who were younger, female, and races other than White systematically generated fewer work relative value units (wRVUs).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;To examine the association of patient race, age, and sex with wRVUs generated by outpatient dermatology encounters after 2021.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Design, setting, and participants: &lt;/strong&gt;This multi-institutional cross-sectional study evaluated demographic and billing data for outpatient dermatology encounters across 3 academic dermatology practices. The study compared wRVUs generated by outpatient general dermatology encounters in 6-month periods before and after the 2021 fee schedule updates (March 1 to August 31, 2019, and March 1 to August 31, 2021). Eligibility required an age of 18 years or older and available age, race, and sex data. Data analysis was performed from September 2022 to March 2024.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Main outcomes and measures: &lt;/strong&gt;The primary outcome was wRVUs generated per encounter.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;This study included 89 656 encounters (47 607 before the 2021 Medicare physician fee schedule update and 42 049 after the update). Across all encounters, the mean (SD) patient age was 56.3 (17.8) years; 55 460 encounters (61.9%) were with female patients and 34 196 (38.1%) were with male patients; and 3457 encounters (3.9%) were with Asian patients, 10 478 (11.7%) with Black patients, 72 894 (81.3%) with White patients, and 2287 (3.2%) with patients of other race or ethnicity (Latino and multiracial). The mean (SD) wRVUs per outpatient dermatology encounter was 1.44 (0.88) before the update and 1.80 (0.99) after (P &lt; .001). After 2021, adjusted analyses demonstrated significantly fewer wRVUs per encounter for female (β, -0.11; 95% CI, -0.13 to -0.10) compared with male patients, and for younger (β, 0.04 [95% CI, 0.04 to 0.05] per 10-year increase in age) compared with older patients. After the update, compared with White patients, visits with Asian patients generated fewer wRVUs (β, -0.12; 95% CI, -0.17 to -0.08) as did visits with Black patients (β, -0.14; 95% CI, -0.17 to -0.11), both statistically significant reductions compared with prior comparisons (P &lt; .001 for both). After 2021, mediation analysis identified that premalignant destructions and biopsies mediated many of the remaining differences in wRVU generation by patient age, race, and sex.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions and relevance: &lt;/strong&gt;This study found that after the 2021 Medicare fee schedule updates, there was a persistent, albeit reduced, gap between wRVU productivity in outpatient dermatology visits for Asian and Black compared with White patients. These persisting differences were attributable to skin biopsies and cryotherapy of premal","PeriodicalId":14734,"journal":{"name":"JAMA dermatology","volume":" ","pages":""},"PeriodicalIF":11.5,"publicationDate":"2024-12-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142877264","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Bullous Arthropod Reaction Secondary to Ctenocephalides felis.
IF 11.5 1区 医学 Q1 DERMATOLOGY Pub Date : 2024-12-23 DOI: 10.1001/jamadermatol.2024.5021
Arezki Izri, Mohammad Akhoundi
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引用次数: 0
Methotrexate and Interstitial Lung Disease-Reply.
IF 11.5 1区 医学 Q1 DERMATOLOGY Pub Date : 2024-12-23 DOI: 10.1001/jamadermatol.2024.5554
Jill T Shah, Alisa Femia
{"title":"Methotrexate and Interstitial Lung Disease-Reply.","authors":"Jill T Shah, Alisa Femia","doi":"10.1001/jamadermatol.2024.5554","DOIUrl":"https://doi.org/10.1001/jamadermatol.2024.5554","url":null,"abstract":"","PeriodicalId":14734,"journal":{"name":"JAMA dermatology","volume":" ","pages":""},"PeriodicalIF":11.5,"publicationDate":"2024-12-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142877261","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Methotrexate and Interstitial Lung Disease.
IF 11.5 1区 医学 Q1 DERMATOLOGY Pub Date : 2024-12-23 DOI: 10.1001/jamadermatol.2024.5564
Anuradha Bishnoi, Surender Singh, Davinder Parsad
{"title":"Methotrexate and Interstitial Lung Disease.","authors":"Anuradha Bishnoi, Surender Singh, Davinder Parsad","doi":"10.1001/jamadermatol.2024.5564","DOIUrl":"https://doi.org/10.1001/jamadermatol.2024.5564","url":null,"abstract":"","PeriodicalId":14734,"journal":{"name":"JAMA dermatology","volume":" ","pages":""},"PeriodicalIF":11.5,"publicationDate":"2024-12-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142877258","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Incidence of and Risk Factors for Cutaneous Malignant Neoplasms After Blood or Marrow Transplant.
IF 11.5 1区 医学 Q1 DERMATOLOGY Pub Date : 2024-12-18 DOI: 10.1001/jamadermatol.2024.5129
Kristy K Broman, Qingrui Meng, Anna Holmqvist, Nora Balas, Joshua Richman, Wendy Landier, Lindsey Hageman, Elizabeth Ross, Alysia Bosworth, Hok Sreng Te, Britany Hollenquest, F Lennie Wong, Ravi Bhatia, Stephen J Forman, Saro H Armenian, Daniel J Weisdorf, Smita Bhatia
<p><strong>Importance: </strong>Cutaneous malignant neoplasms are the most common subsequent neoplasm after blood or marrow transplant (BMT), but a full assessment among survivors is lacking.</p><p><strong>Objective: </strong>To identify risk factors for subsequent cutaneous malignant neoplasms using the BMT Survivor Study (BMTSS).</p><p><strong>Design, setting, and participants: </strong>This retrospective cohort study included patients who underwent transplant from 1974 to 2014 at City of Hope, University of Minnesota, or University of Alabama at Birmingham and survived 2 years or longer, as well as a comparison cohort of siblings. Both groups completed the BMTSS survey. Data analysis took place from October 2022 to October 2024.</p><p><strong>Exposures: </strong>Demographics, pre-BMT and BMT-related therapeutic exposures, chronic graft-vs-host disease (cGVHD), and posttransplant immunosuppression.</p><p><strong>Main outcomes and measures: </strong>Incident cutaneous malignant neoplasms (basal cell carcinoma [BCC], squamous cell carcinoma [SCC], and melanoma) after BMT. Exposures were evaluated for association with subsequent neoplasms using proportional subdistribution hazards models (reported as subdistribution hazard ratio [SHR] and 95% CI).</p><p><strong>Results: </strong>Among the 3880 BMT survivors (median [range] age at BMT, 44.0 [0-78.0] years; 2165 [55.8%] male; 190 [4.9%] Black, 468 [12.1%] Hispanic, 2897 [74.7%] non-Hispanic White, and 325 [8.4%] of other race [including Asian and Pacific Islander] and multiracial) who were followed up for a median (range) of 9.5 (2.0-46.0) years, 605 developed 778 distinct cutaneous neoplasms (BCC, 321; SCC, 231; melanoma, 78; and unknown type, 148). The 30-year cumulative incidence of any cutaneous malignant neoplasm was 27.4% (BCC, 18.0%; SCC, 9.8%; and melanoma, 3.7%). Seventy-year cumulative probabilities of BCC, SCC, and melanoma were considerably higher in BMT survivors than siblings (18.1% vs 8.2%, 14.7% vs 4.2%, and 4.2% vs 2.4%, respectively). Among BMT survivors, risk factors for subsequent cutaneous malignant neoplasms included age of 50 years and older at BMT (BCC: SHR, 1.76; 95% CI, 1.36-2.29; SCC: SHR, 3.37; 95% CI, 2.41-4.72), male sex (BCC: SHR, 1.39; 95% CI, 1.10-1.75; SCC: SHR, 1.85; 95% CI, 1.39-2.45), pre-BMT monoclonal antibody exposure (BCC: SHR, 1.71; 95% CI, 1.27-2.31), allogeneic BMT with cGVHD (BCC: SHR, 1.48; 95% CI, 1.06-2.08; SCC: SHR, 2.61; 95% CI, 1.68-4.04 [reference: autologous BMT]), post-BMT immunosuppression (BCC: SHR, 1.63; 95% CI, 1.24-2.14; SCC: SHR, 1.48; 95% CI, 1.09-2.02; melanoma: SHR, 1.90; 95% CI, 1.16-3.12), and transplant at City of Hope (BCC: SHR, 3.55; 95% CI, 2.58-4.89; SCC: SHR, 3.57; 95% CI, 2.34-5.47 [reference: University of Minnesota]) or University of Alabama at Birmingham (BCC: SHR, 2.35; 95% CI, 1.35-4.23; SCC: SHR, 2.63; 95% CI, 1.36-5.08 [reference: University of Minnesota]). Race and ethnicity other than non-Hispanic White were protective
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引用次数: 0
Self-Guided vs Clinician-Guided Online Cognitive Behavioral Therapy for Atopic Dermatitis: A Randomized Clinical Trial. 特应性皮炎的自我指导与医生指导在线认知行为疗法:随机临床试验
IF 11.5 1区 医学 Q1 DERMATOLOGY Pub Date : 2024-12-18 DOI: 10.1001/jamadermatol.2024.5044
Dorian Kern, Brjánn Ljótsson, Louise Lönndahl, Erik Hedman-Lagerlöf, Olof Molander, Björn Liliequist, Maria Bradley, Nils Lindefors, Martin Kraepelien

Importance: Clinician-guided online self-help based on cognitive behavioral therapy (CBT) has been shown to be effective at decreasing symptom severity for people with atopic dermatitis (AD). A brief online self-guided CBT intervention could be more cost-effective and allow for easy implementation and broader outreach compared with more comprehensive clinician-guided interventions.

Objective: To investigate whether a brief online self-guided CBT intervention is noninferior to a comprehensive online clinician-guided CBT treatment.

Design, setting, and participants: This single-blind randomized clinical noninferiority trial was conducted at Karolinska Institutet, Stockholm, Sweden. Adult individuals with AD were enrolled from November 2022 to April 2023. The last postintervention data were collected in December 2023.

Interventions: Participants randomized to the self-guided group had access to a self-guided online CBT intervention for 12 weeks without clinician support. Participants randomized to the clinician-guided group received online CBT for 12 weeks.

Main outcomes and measures: The primary outcome was change in score from baseline to postintervention to 12-week follow-up on the self-reported Patient-Oriented Eczema Measure (POEM). The predefined noninferiority margin was 3 points on POEM.

Results: Of 168 randomized participants, 142 (84.5%) were female, and the mean (SD) age was 39 (10.5) years. A total of 86 participants were randomized to the self-guided group and 82 were randomized to the clinician-guided group. A total of 151 (90.0%) completed the main outcome postintervention assessment. Postintervention, the clinician-guided group had improved 4.20 points (95% CI, 1.94-6.05) on POEM and the self-guided group improved 4.60 points (95% CI, 2.57-6.64), corresponding to an estimated mean difference in change of 0.36 points (1-sided 97.5% CI, -∞ to 1.75), which was below the noninferiority margin of 3 points. No serious adverse events were reported. In the clinician-guided group, clinicians spent a mean (SD) of 36.0 (33.3) minutes (95% CI, 29.2-41.7) on treatment guidance and 14.0 (6.0) minutes (95% CI, 12.9-15.6) on assessments compared to 15.8 (6.4) minutes on assessments in the self-guided group.

Conclusions and relevance: In this randomized clinical noninferiority trial, a brief self-guided CBT intervention was noninferior to clinician-guided CBT. Given the limited clinical resources required to deliver self-guided CBT, this treatment might be a promising means to disseminate evidence-based psychological treatment for patients with AD.

Trial registration: ClinicalTrials.gov Identifier: NCT05517850.

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引用次数: 0
Necrotic Plaque in a Patient With Malignant Hematologic Disease.
IF 11.5 1区 医学 Q1 DERMATOLOGY Pub Date : 2024-12-18 DOI: 10.1001/jamadermatol.2024.4868
Marika Matsuya, Motoshi Kinouchi, Yuzufumi Sekiguchi
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引用次数: 0
Interobserver and Intraobserver Agreement on the Treatment of Infantile Hemangiomas.
IF 11.5 1区 医学 Q1 DERMATOLOGY Pub Date : 2024-12-18 DOI: 10.1001/jamadermatol.2024.5125
María Colmenero-Sendra, Javier Del Boz-González, Mercè Grau-Pérez, Ricardo Ruiz-Villaverde, Miguel Ángel Descalzo-Gallego, Ignacio García-Doval, Eulalia Baselga Torres

Importance: Although clinical practice guidelines exist for the treatment of infantile hemangiomas (IHs), recommendations are heterogeneous, and wide practice variations in IH management have been reported.

Objective: To analyze the degree of agreement in treatment choices for IH among pediatric dermatologists in North America and Europe and assess whether there are differences across IH risk categories.

Design, setting, and participants: This cross-sectional interrater and intrarater agreement study was conducted through a survey based on the Spanish Academy of Dermatology and Venereology IH prospective cohort. The survey used 50 vignettes of IH cases that were randomly selected from the cohort. It was administered twice in 2023, 1 month apart, to allow for interrater and intrarater agreement assessments. Data were analyzed in January 2024. The study involved pediatric dermatologists from North America (via the Pediatric Dermatology Research Alliance) and Europe (via the European Society of Pediatric Dermatologists).

Exposures: Participants were asked to choose 1 of 3 treatment options (propranolol, topical timolol, or observation) for each vignette.

Main outcome and measure: The primary outcome was the interrater agreement in treatment choices for IH cases, measured using κ statistics (Gwet AC1 coefficient).

Results: The global interobserver agreement among 90 pediatric dermatologists was fair (AC1, 0.38; 95% CI, 0.29-0.46). In North America (45 pediatricians), agreement was moderate (AC1, 0.41; 95% CI, 0.33-0.49), while in Europe (45 pediatricians) it was fair (AC1, 0.37; 95% CI, 0.28-0.46). The degree of agreement varied depending on the risk category of IH, with excellent agreement in high-risk IH and only moderate agreement in intermediate-risk and low-risk IHs. Propranolol was predominantly chosen for high-risk IH, while observation was most frequent for low-risk IH (55.9%). The second survey had 61 respondents, with no significant intrarater differences.

Conclusions and relevance: The results of this survey study suggest that there is an important variability in the treatment of intermediate-risk and low-risk IH. The study findings support the need for more evidence regarding the role of topical timolol in IH treatment, which may help harmonize treatment approaches and improve consistency in IH management globally.

{"title":"Interobserver and Intraobserver Agreement on the Treatment of Infantile Hemangiomas.","authors":"María Colmenero-Sendra, Javier Del Boz-González, Mercè Grau-Pérez, Ricardo Ruiz-Villaverde, Miguel Ángel Descalzo-Gallego, Ignacio García-Doval, Eulalia Baselga Torres","doi":"10.1001/jamadermatol.2024.5125","DOIUrl":"https://doi.org/10.1001/jamadermatol.2024.5125","url":null,"abstract":"<p><strong>Importance: </strong>Although clinical practice guidelines exist for the treatment of infantile hemangiomas (IHs), recommendations are heterogeneous, and wide practice variations in IH management have been reported.</p><p><strong>Objective: </strong>To analyze the degree of agreement in treatment choices for IH among pediatric dermatologists in North America and Europe and assess whether there are differences across IH risk categories.</p><p><strong>Design, setting, and participants: </strong>This cross-sectional interrater and intrarater agreement study was conducted through a survey based on the Spanish Academy of Dermatology and Venereology IH prospective cohort. The survey used 50 vignettes of IH cases that were randomly selected from the cohort. It was administered twice in 2023, 1 month apart, to allow for interrater and intrarater agreement assessments. Data were analyzed in January 2024. The study involved pediatric dermatologists from North America (via the Pediatric Dermatology Research Alliance) and Europe (via the European Society of Pediatric Dermatologists).</p><p><strong>Exposures: </strong>Participants were asked to choose 1 of 3 treatment options (propranolol, topical timolol, or observation) for each vignette.</p><p><strong>Main outcome and measure: </strong>The primary outcome was the interrater agreement in treatment choices for IH cases, measured using κ statistics (Gwet AC1 coefficient).</p><p><strong>Results: </strong>The global interobserver agreement among 90 pediatric dermatologists was fair (AC1, 0.38; 95% CI, 0.29-0.46). In North America (45 pediatricians), agreement was moderate (AC1, 0.41; 95% CI, 0.33-0.49), while in Europe (45 pediatricians) it was fair (AC1, 0.37; 95% CI, 0.28-0.46). The degree of agreement varied depending on the risk category of IH, with excellent agreement in high-risk IH and only moderate agreement in intermediate-risk and low-risk IHs. Propranolol was predominantly chosen for high-risk IH, while observation was most frequent for low-risk IH (55.9%). The second survey had 61 respondents, with no significant intrarater differences.</p><p><strong>Conclusions and relevance: </strong>The results of this survey study suggest that there is an important variability in the treatment of intermediate-risk and low-risk IH. The study findings support the need for more evidence regarding the role of topical timolol in IH treatment, which may help harmonize treatment approaches and improve consistency in IH management globally.</p>","PeriodicalId":14734,"journal":{"name":"JAMA dermatology","volume":" ","pages":""},"PeriodicalIF":11.5,"publicationDate":"2024-12-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142846729","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Improving Diversity in a Novel Psoriasis Study: VISIBLE as a Framework for Clinical Trial Quality Improvement.
IF 11.5 1区 医学 Q1 DERMATOLOGY Pub Date : 2024-12-11 DOI: 10.1001/jamadermatol.2024.5103
Andrew Alexis, Amy McMichael, Neelam Vashi, Tina Bhutani, Adrian O Rodriguez, Jensen Yeung, Olivia Choi, Daphne Chan, Theodore Alkousakis, Denise N Bronner, Laura Park-Wyllie, Long-Long Gao, Pearl Grimes, Mona Shahriari, Geeta Yadav, Chesahna Kindred, Susan C Taylor, Seemal R Desai
<p><strong>Importance: </strong>Diverse racial and ethnic representation in clinical trials has been limited, not representative of the US population, and the subject of pending US Food and Drug Administration guidance. Psoriasis presentation and disease burden can vary by skin pigmentation, race and ethnicity, and socioeconomic differences. Overall, there are limited primary data on clinical response, genetics, and quality of life in populations with psoriasis and skin of color (SoC). The Varying Skin Tones in Body and Scalp Psoriasis: Guselkumab Efficacy and Safety trial (VISIBLE) is underway and uses strategies aimed at addressing this persistent gap.</p><p><strong>Objective: </strong>To assess the innovative strategies used in the VISIBLE trial to recruit and retain diverse participants in a randomized clinical trial of psoriasis in participants with SoC.</p><p><strong>Design, setting, and participants: </strong>This was an ad hoc quality improvement assessment of participant recruitment and retention approaches used by the VISIBLE trial. VISIBLE enrolled and randomized 211 participants (mean [SD] age, 43 [13] years; 75 females [36%] and 136 males [64%]) with SoC and moderate to severe plaque psoriasis from August 2022 to March 2023 to evaluate guselkumab treatment. The self-identified race and ethnicity of the participants was: 1 American Indian/Alaska Native (0.5%), 63 Asian (29.9%), 24 Black (11.4%), 94 Hispanic/Latino (44.5%), 13 Middle Eastern (6.2%), 1 Pacific Islander/Native Hawaiian (0.5%), 12 multiracial (5.7%), and 3 of other race and/or ethnicity (1.4%). Using a combination of objective (colorimetry to determine Fitzpatrick skin type) and self-reported (race and ethnicity consistent with SoC) parameters, VISIBLE sought to broaden inclusion of participants from various backgrounds.</p><p><strong>Results: </strong>Observed improvements were that participant enrollment occurred approximately 7 times faster than anticipated (vs historical recruitment data for psoriasis studies); 211 participants (100%) self-identified themselves as a race or ethnicity other than White; and more than 50% had skin tone in the darker half of the Fitzpatrick skin type spectrum (type IV-VI). Innovations implemented by VISIBLE were (1) assessment of the natural history of postinflammatory pigment alteration and improvements over time using combined objective colorimetry and clinician- and patient-reported outcomes; (2) evaluation of genetic and comorbidity biomarkers relevant to participants with SoC; (3) a diverse demographic-driven approach to site selection (emphasizing investigator and staff diversity and experience with populations with SoC); (4) provision of cultural competency training to enhance participant enrollment and retention; (5) collection of patient-reported outcomes data in participants' primary language; and (6) periodic, blinded central review and feedback on investigator efficacy scoring to promote consistency and accuracy in evaluating
{"title":"Improving Diversity in a Novel Psoriasis Study: VISIBLE as a Framework for Clinical Trial Quality Improvement.","authors":"Andrew Alexis, Amy McMichael, Neelam Vashi, Tina Bhutani, Adrian O Rodriguez, Jensen Yeung, Olivia Choi, Daphne Chan, Theodore Alkousakis, Denise N Bronner, Laura Park-Wyllie, Long-Long Gao, Pearl Grimes, Mona Shahriari, Geeta Yadav, Chesahna Kindred, Susan C Taylor, Seemal R Desai","doi":"10.1001/jamadermatol.2024.5103","DOIUrl":"https://doi.org/10.1001/jamadermatol.2024.5103","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Importance: &lt;/strong&gt;Diverse racial and ethnic representation in clinical trials has been limited, not representative of the US population, and the subject of pending US Food and Drug Administration guidance. Psoriasis presentation and disease burden can vary by skin pigmentation, race and ethnicity, and socioeconomic differences. Overall, there are limited primary data on clinical response, genetics, and quality of life in populations with psoriasis and skin of color (SoC). The Varying Skin Tones in Body and Scalp Psoriasis: Guselkumab Efficacy and Safety trial (VISIBLE) is underway and uses strategies aimed at addressing this persistent gap.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;To assess the innovative strategies used in the VISIBLE trial to recruit and retain diverse participants in a randomized clinical trial of psoriasis in participants with SoC.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Design, setting, and participants: &lt;/strong&gt;This was an ad hoc quality improvement assessment of participant recruitment and retention approaches used by the VISIBLE trial. VISIBLE enrolled and randomized 211 participants (mean [SD] age, 43 [13] years; 75 females [36%] and 136 males [64%]) with SoC and moderate to severe plaque psoriasis from August 2022 to March 2023 to evaluate guselkumab treatment. The self-identified race and ethnicity of the participants was: 1 American Indian/Alaska Native (0.5%), 63 Asian (29.9%), 24 Black (11.4%), 94 Hispanic/Latino (44.5%), 13 Middle Eastern (6.2%), 1 Pacific Islander/Native Hawaiian (0.5%), 12 multiracial (5.7%), and 3 of other race and/or ethnicity (1.4%). Using a combination of objective (colorimetry to determine Fitzpatrick skin type) and self-reported (race and ethnicity consistent with SoC) parameters, VISIBLE sought to broaden inclusion of participants from various backgrounds.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Observed improvements were that participant enrollment occurred approximately 7 times faster than anticipated (vs historical recruitment data for psoriasis studies); 211 participants (100%) self-identified themselves as a race or ethnicity other than White; and more than 50% had skin tone in the darker half of the Fitzpatrick skin type spectrum (type IV-VI). Innovations implemented by VISIBLE were (1) assessment of the natural history of postinflammatory pigment alteration and improvements over time using combined objective colorimetry and clinician- and patient-reported outcomes; (2) evaluation of genetic and comorbidity biomarkers relevant to participants with SoC; (3) a diverse demographic-driven approach to site selection (emphasizing investigator and staff diversity and experience with populations with SoC); (4) provision of cultural competency training to enhance participant enrollment and retention; (5) collection of patient-reported outcomes data in participants' primary language; and (6) periodic, blinded central review and feedback on investigator efficacy scoring to promote consistency and accuracy in evaluating ","PeriodicalId":14734,"journal":{"name":"JAMA dermatology","volume":" ","pages":""},"PeriodicalIF":11.5,"publicationDate":"2024-12-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142807129","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Risk of Death Due to Melanoma and Other Causes in Patients With Thin Cutaneous Melanomas.
IF 11.5 1区 医学 Q1 DERMATOLOGY Pub Date : 2024-12-11 DOI: 10.1001/jamadermatol.2024.4900
Serigne N Lo, Gabrielle J Williams, Anne E Cust, David W Ollila, Alexander H R Varey, Sydney Ch'ng, Richard A Scolyer, John F Thompson

Importance: Most patients who present with primary cutaneous melanomas have thin tumors (≤1.0 mm in Breslow thickness, ie, pT1a and pT1b). Although their prognosis is generally considered to be excellent, there is limited precise information on the association of risk of death with specific Breslow measurements in thin lesions.

Objective: To assess the relative effect of a 0.8-mm Breslow thickness threshold with respect to the incidence of both melanoma-related and nonmelanoma-related death.

Design, setting, and participants: Registry data for all Australians diagnosed with thin invasive primary melanomas between 1982 and 2014 were analyzed. Data were extracted from all 8 Australian state and territory population-based cancer registries. Dates and causes of death were obtained from the Australian National Death Index. Adults diagnosed with a first invasive primary melanoma of 1.0 mm or smaller in thickness were included.

Exposure: First invasive primary melanoma between 1982 and 2014.

Main outcomes and measures: The primary outcomes were melanoma-related deaths and nonmelanoma-related deaths. Competing-risk regression analyses and cause-specific analyses were performed to investigate the relationships between Breslow thickness subcategory (<0.8 mm versus ≥0.8 mm by 0.1-mm increments) and the primary outcomes.

Results: Overall, a cohort of 144 447 participants was included. The median (range) age was 56 (18-101) years and 78 014 (54.0%) were men. Median (IQR) follow-up was 15.0 (9.5-23.3) years. Crude incidence rates of melanoma-related death 20 years after diagnosis were 6.3% (95% CI, 6.1%-6.5%) for the whole cohort, 6.0% (95% CI, 5.7%-6.2%) for tumors smaller than 0.8 mm, and 12.0% (95% CI, 11.4%-12.6%) for tumors 0.8 to 1.0 mm. The corresponding 20-year melanoma-specific survival rates were 91.9% (95% CI, 91.6%-92.1%), 94.2% (95% CI, 94.0%-94.4%), and 87.8% (95% CI, 87.3%-88.3%), respectively. On multivariable analysis, tumor thickness of 0.8 to 1.0 mm was significantly associated with both a greater absolute risk of melanoma-related death (subdistribution hazard ratio, 2.92; 95% CI, 2.74-3.12) and a greater rate of melanoma-related death (hazard ratio, 2.98; 95% CI, 2.79-3.18) than thinner tumors (<0.8 mm). Risk of death from nonmelanoma-related causes was not associated with Breslow thickness.

Conclusions and relevance: In this study, the risk of melanoma-related death increased significantly for patients with primary tumors of 0.8 to 1.0 mm in thickness. The risk of death from nonmelanoma-ralated causes was similar across Breslow thicknesses of 0.1 to 1.0 mm. This analysis suggests that a 0.8-mm threshold for guiding the care of patients with thin primary melanomas.

{"title":"Risk of Death Due to Melanoma and Other Causes in Patients With Thin Cutaneous Melanomas.","authors":"Serigne N Lo, Gabrielle J Williams, Anne E Cust, David W Ollila, Alexander H R Varey, Sydney Ch'ng, Richard A Scolyer, John F Thompson","doi":"10.1001/jamadermatol.2024.4900","DOIUrl":"https://doi.org/10.1001/jamadermatol.2024.4900","url":null,"abstract":"<p><strong>Importance: </strong>Most patients who present with primary cutaneous melanomas have thin tumors (≤1.0 mm in Breslow thickness, ie, pT1a and pT1b). Although their prognosis is generally considered to be excellent, there is limited precise information on the association of risk of death with specific Breslow measurements in thin lesions.</p><p><strong>Objective: </strong>To assess the relative effect of a 0.8-mm Breslow thickness threshold with respect to the incidence of both melanoma-related and nonmelanoma-related death.</p><p><strong>Design, setting, and participants: </strong>Registry data for all Australians diagnosed with thin invasive primary melanomas between 1982 and 2014 were analyzed. Data were extracted from all 8 Australian state and territory population-based cancer registries. Dates and causes of death were obtained from the Australian National Death Index. Adults diagnosed with a first invasive primary melanoma of 1.0 mm or smaller in thickness were included.</p><p><strong>Exposure: </strong>First invasive primary melanoma between 1982 and 2014.</p><p><strong>Main outcomes and measures: </strong>The primary outcomes were melanoma-related deaths and nonmelanoma-related deaths. Competing-risk regression analyses and cause-specific analyses were performed to investigate the relationships between Breslow thickness subcategory (<0.8 mm versus ≥0.8 mm by 0.1-mm increments) and the primary outcomes.</p><p><strong>Results: </strong>Overall, a cohort of 144 447 participants was included. The median (range) age was 56 (18-101) years and 78 014 (54.0%) were men. Median (IQR) follow-up was 15.0 (9.5-23.3) years. Crude incidence rates of melanoma-related death 20 years after diagnosis were 6.3% (95% CI, 6.1%-6.5%) for the whole cohort, 6.0% (95% CI, 5.7%-6.2%) for tumors smaller than 0.8 mm, and 12.0% (95% CI, 11.4%-12.6%) for tumors 0.8 to 1.0 mm. The corresponding 20-year melanoma-specific survival rates were 91.9% (95% CI, 91.6%-92.1%), 94.2% (95% CI, 94.0%-94.4%), and 87.8% (95% CI, 87.3%-88.3%), respectively. On multivariable analysis, tumor thickness of 0.8 to 1.0 mm was significantly associated with both a greater absolute risk of melanoma-related death (subdistribution hazard ratio, 2.92; 95% CI, 2.74-3.12) and a greater rate of melanoma-related death (hazard ratio, 2.98; 95% CI, 2.79-3.18) than thinner tumors (<0.8 mm). Risk of death from nonmelanoma-related causes was not associated with Breslow thickness.</p><p><strong>Conclusions and relevance: </strong>In this study, the risk of melanoma-related death increased significantly for patients with primary tumors of 0.8 to 1.0 mm in thickness. The risk of death from nonmelanoma-ralated causes was similar across Breslow thicknesses of 0.1 to 1.0 mm. This analysis suggests that a 0.8-mm threshold for guiding the care of patients with thin primary melanomas.</p>","PeriodicalId":14734,"journal":{"name":"JAMA dermatology","volume":" ","pages":""},"PeriodicalIF":11.5,"publicationDate":"2024-12-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142807241","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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JAMA dermatology
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