JAMA dermatology最新文献

Importance: A critical need exists for developing a validated dermatologic-specific treatment satisfaction instrument.

Objective: To evaluate the structural validity, internal consistency, construct validity, and test-retest reliability of the 7-item dermatology-specific treatment satisfaction (DermSat-7) instrument in patients with psoriasis.

Design, setting, and participants: This survey study was conducted from July 2020 to April 2023 in dermatology outpatient clinics at the University of Southern California, Brigham and Women's Hospital, and Mount Sinai Union Square and included adults (aged ≥18 years) with psoriasis who were fluent in English. On day 1, the clinician at the study sites assessed psoriasis disease severity in person using the Psoriasis Area and Severity Index (PASI), body surface area (BSA), and Physician Global Assessment (PGA). On day 1, study participants completed the DermSat-7, the generic 9-item Treatment Satisfaction Questionnaire for Medication (TSQM-9), and the Dermatology Life Quality Index (DLQI). They also answered demographic questions and reported their own disease severity using the Patient Global Assessment (PtGA). On day 14 (±2 days), the patient then completed the DermSat-7 and PtGA a second time.

Main outcomes and measures: The DermSat-7 is a 7-item self-administered instrument with a recall period of 14 days that assesses patient satisfaction with their treatments across various inflammatory dermatology diseases, including psoriasis. Construct validity, structural validity, internal consistency, and test-retest reliability of DermSat-7 were assessed as defined by the Consensus-Based Standards for the Selection of Health Measurement Instruments (COSMIN) taxonomy and reported following the COSMIN reporting guideline for studies on measurement properties.

Results: The analysis included 142 patients with psoriasis (mean [SD] age, 51.1 [15.5] years; 77 males [54.2%]). Exploratory factor analysis and confirmatory factor analysis supported the unidimensionality of the DermSat-7 domains. The internal consistency of the effectiveness and convenience domains was high with a Cronbach α of 0.88 and 0.81, respectively. Regarding construct validity, differences between groups based on PASI/PGA scores were aligned with preexisting hypotheses, and the correlations between DermSat-7 and TSQM-9 subscores were strong to very strong (ρ = 0.75 for effectiveness; ρ = 0.66 for convenience; and ρ = 0.70 for overall satisfaction; all P < .001). Intraclass correlation was 0.85, indicating high test-retest reliability.

Conclusions and relevance: This survey study found that the DermSat-7 may be a valid and reliable instrument for measuring treatment satisfaction in patients with psoriasis.

Importance: Nicotinamide metabolites have recently been implicated in increased risk of major cardiovascular events (MACE). Supportive data about clinical risk of MACE for nicotinamide users is lacking.

Objective: To determine whether nicotinamide use results in an increase of MACE.

Design, setting, and participants: This study used retrospective electronic health record data of 2 patient cohorts, the Vanderbilt University Medical Center (VUMC) and Million Veteran Program (MVP). The risk of MACE in patients exposed to nicotinamide was compared with the risk of MACE in unexposed patients. In the VUMC cohort, patients were either exposed to nicotinamide based on keyword entry for nicotinamide or niacinamide and manual review of medical records or were unexposed but had documented recommendation for use. In the MVP cohort, those exposed to nicotinamide were matched via propensity scores to those who were not exposed. Data were collected from January 1989 to February 2024, and data were analyzed from March to December 2024.

Exposures: The primary exposure for the VUMC cohort was a confirmed exposure to nicotinamide on medical record review. The primary exposure for the MVP cohort was medication entry for nicotinamide or niacinamide.

Main outcomes and measures: The primary outcome was development of MACE based on a validated phenotype.

Results: Of 13 108 included patients, 11 926 (91.0%) were male, and the mean (SD) age was 66.8 (11.5) years. In the VUMC cohort, 1228 patients were exposed to nicotinamide and 253 were unexposed; in the MVP cohort, 4063 were exposed and 7564 were not. A total of 5291 had exposure to nicotinamide. Neither cohort had significant differences in mean age, sex, race, or ethnicity between the nicotinamide exposed and unexposed groups. There was no difference in the cumulative incidence of MACE after nicotinamide exposure in either the VUMC cohort or MVP cohorts. In adjusted cause-specific models stratified by history of prior MACE, there was no significant association between nicotinamide exposure and the primary outcome of MACE in either the VUMC cohort (no prior MACE: hazard ratio [HR], 2.02; 95% CI, 0.81-5.05; prior MACE: HR, 0.46; 95% CI, 0.22-0.95) or MVP cohort (no prior MACE: HR, 1.07; 95% CI, 0.75-1.17; prior MACE: HR, 1.04; 95% CI, 0.53-2.06).

Conclusions and relevance: In this retrospective cohort study of 13 108 adults from 2 different patient populations, there was no increased risk of MACE in patients with nicotinamide exposure.

Importance: Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) cause diffuse epidermal detachment and necrosis. Patients who survive the initial SJS/TEN episodes are affected by various sequelae.

Objective: To investigate the risks of cardiovascular morbidity and mortality in SJS/TEN survivors.

Design, setting, and participants: This was a nationwide population-based cohort study using data from Taiwan's National Health Research Institute Database linked to the National Register of Death databases for 1998 to 2021. Survivors of SJS/TEN were identified and matched with non-SJS/TEN participants by age, sex, and Charlson Comorbidity Index. Data analysis was performed from November 2023 to June 2024.

Exposure: Cerebrovascular accidents (CVA) or ischemic heart disease (IHD) after SJS/TEN survival.

Main outcomes and measures: Cox proportional hazards models were used to estimate the hazard ratios (HRs) of CVA and IHD morbidity and mortality after SJS/TEN survival.

Results: The CVA cohort included 10 571 SJS/TEN survivors (mean [SD] age, 56.1 [18.5] years; 5358 females [50.7%] and 5213 males [49.3%]). The IHD cohort included 11 084 SJS/TEN survivors (mean [SD] age, 56.6 [18.6] years; 5561 females [50.2%] and 5523 males [49.8%]). The Cox proportional hazards model and competing risk regression model showed that compared with non-SJS/TEN participants, patients with SJS/TEN had higher risks of cardiovascular morbidity (CVA: HR, 1.65 [95% CI, 1.57-1.72] and subdistribution HR [sHR], 1.40 [95% CI, 1.33-1.46]; IHD: HR, 1.58 [95% CI, 1.51-1.65] and sHR, 1.32 [95% CI, 1.26-1.38]) and death due to cardiovascular disease (CVA: HR, 1.69; 95% CI, 1.46-1.96; IHD: HR, 1.55; 95% CI, 1.32-1.82). The increased cardiovascular mortality risks peaked at 1 year after SJS/TEN and persisted for 4 to 7 years. Older survivors and survivors admitted to an intensive care unit at SJS/TEN diagnosis had significantly higher cardiovascular mortality risk.

Conclusions and relevance: In this cohort study, SJS/TEN had a lasting association with cardiovascular function after the acute phase. This suggests a need to mitigate the elevated cardiovascular morbidity and mortality risks among survivors. Further research using databases or registries with more comprehensive clinical data are needed to validate these results.

Importance: Therapies for individual keratinocyte carcinomas (KCs) do not prevent the onset of new KCs in a field of sun damage, and therefore the KC burden remains unchanged.

Objective: To investigate the association of immune checkpoint inhibitors (ICIs) with changes in field cancerization evaluated by the number of actinic keratoses (AKs) and KCs at baseline compared with 12 months after starting ICI therapy.

Design, setting, and participants: This prospective cohort study was performed at the outpatient oncology clinic of a single tertiary public hospital in Brisbane, Australia, from April 1, 2022, to November 30, 2023. Consecutive immunocompetent adults starting therapy with an inhibitor for programmed cell death 1 (PD-1) or programmed cell death ligand 1 (PDL-1) for any active cancer, with a planned treatment duration of at least 6 months, and who exhibited clinical AKs on their forearms were eligible. Those with immunosuppression, concurrent chemotherapy or radiotherapy, or recent topical fluorouracil use were excluded.

Exposures: Intravenous ICI therapy, either PD-1 or PDL-1 inhibitors with or without a cytotoxic T-lymphocyte-associated protein 4 inhibitor, with therapy duration determined by the treating oncologist.

Main outcomes and measures: Clinical AKs were counted and photographed before and 3, 6, and 12 months after starting ICI therapy. KC numbers were evaluated based on histopathology reports of all skin lesions excised 12 months before and after starting ICI therapy. Participants' medical history, primary cancer tumor response using Response Evaluation Criteria in Solid Tumors, and adverse events were recorded.

Results: A total of 23 participants were recruited, of whom 17 (73.9%) were male, with a mean (SD) age of 69.7 (9.6) years. No participants withdrew; however, 4 died during the study due to disease progression. The mean (SD) AK number significantly decreased from 47.2 (33.8) at baseline to 14.3 (12.0) at 12 months (P < .001). Younger patients (8 of 12 [66.7%] vs 4 of 12 [33.3%]; P = .007) and those with a history of blistering sunburn (12 of 12 [100%] vs 0; P = .005) were more likely to reduce their AK numbers by 65% or greater. KC total numbers decreased from 42 in the 12 months before starting ICI therapy to 17 in the 12 months after. The number of cutaneous squamous cell carcinomas decreased from 16 to 5 in the same period.

Conclusions and relevance: This pilot cohort study found that ICIs used for any cancer were associated with a significant reduction of AKs, suggesting potential as an immunopreventive strategy for high-risk individuals. Given the known effects of other chemopreventive agents on KCs, further investigation into ICIs managing field cancerization is required, especially considering toxicity and cost.