British Journal of Dermatology最新文献

Background: Patient-reported outcome measures (PROMs) are crucial in assessing the impact of dermatological conditions on people's lives, but the existing dermatology-specific PROMs are not recommended for use, according to COSMIN. We developed the Patient-Reported Impact of Dermatological Diseases (PRIDD) measure in partnership with patients. It has strong evidence of content validity, structural validity, internal consistency, acceptability and feasibility.

Objectives: To test the remaining measurement properties of the PRIDD and establish the interpretability of scores against the COSMIN criteria, using classic and modern psychometric methods.

Methods: A global longitudinal study consisting of two online surveys administered 2-4 weeks apart was carried out. Adults (≥ 18 years of age) living with a dermatological condition were recruited via the International Alliance of Dermatology Patient Organizations' (GlobalSkin) membership network. Participants completed PRIDD, a demographics questionnaire and other related measures, including the Dermatology Life Quality Index. We tested the criterion validity, construct validity and responsiveness (Spearman's ρ, independent-samples t-tests and Anova); test-retest reliability [interclass correlation coefficient (ICC)]; measurement error [smallest detectable change or limits of agreement (LoA), distribution-based minimally important change (MIC)]; floor and ceiling effects (number of minimum and maximum scores and person-item location distribution maps), score bandings (κ coefficient of agreement) and the anchor-based MIC of the PRIDD.

Results: In total, 504 people with 35 dermatological conditions from 38 countries participated. Criterion validity (ρ = 0.79), construct validity (76% hypotheses met), test-retest validity (ICC = 0.93) and measurement error (LoA = 1.3 < MIC = 4.14) were sufficient. Floor and ceiling effects were in the acceptable range (< 15%). Score bandings were determined (κ = 0.47); however, the anchor-based MIC could not be calculated owing to an insufficient anchor.

Conclusions: PRIDD is a valid and reliable tool to evaluate the impact of dermatological disease on people's lives in research and clinical practice. It is the first dermatology-specific PROM to meet the COSMIN criteria. These results support the value of developing and validating PROMs with a patient-centred approach and using classic and modern psychometric methods. Further testing of responsiveness and MIC, cross-cultural translation, linguistic validation and global data collection are planned.

Background: Psoriatic disease (PsD) is closely associated with cardiovascular (CV) disease. The Life's Essential 8 (LE8) score is a new metric to assess CV health (CVH), where a higher score indicates better CVH. However, the longitudinal association between LE8 score and the risk of PsD remains uncertain.

Objectives: To investigate, in a cohort study, the association between LE8 score, genetic susceptibility and the risk of PsD.

Methods: This cohort study included 261 642 participants in the UK Biobank without PsD at baseline. LE8 comprises eight indicators: diet, physical activity, nicotine exposure, sleep health, body mass index, blood lipids, blood glucose and blood pressure. Cox proportional hazard models were used to examine the association between participants' LE8 scores, genetic risk of PsD and the risk of PsD. Hazard ratios (HRs) and 95% confidence intervals (CIs) were calculated.

Results: During an average follow-up of 12.3 years, 1501 participants developed PsD. Compared with participants with low LE8 scores, the HRs of developing PsD for those with moderate and high LE8 scores were 0.51 (95% CI 0.43-0.59) and 0.34 (95% CI 0.27-0.42) after adjustments, respectively. Dose-response analysis revealed a linear negative association between continuous LE8 score and the risk of developing PsD (P < 0.001), with no evidence of nonlinear association detected. Genetic susceptibility to PsD did not modify this association (P-interaction = 0.63). Subgroup analyses revealed that women had a more pronounced beneficial association between LE8 scores and PsD risk (P-interaction = 0.02).

Conclusions: Our study suggests that a higher LE8 score, regardless of genetic risk, is associated with a lower risk of PsD, particularly in women. Consequently, maintaining good CVH status is recommended to prevent PsD and assess associated risks.

Background: Observational studies in cutaneous melanoma (CM) have indicated an inverse relationship between levels of 25-hydroxyvitamin D and Breslow thickness, in addition to a protective effect of high 25-hydroxyvitamin D levels on clinical outcome.

Objectives: To evaluate whether high-dose vitamin D supplementation in curatively resected CM reduces melanoma relapse.

Methods: In a prospective randomized double-blind placebo-controlled trial, 436 patients with resected CM stage IA to III (8th American Joint Committee on Cancer staging) were randomized. Among them, 218 received a placebo while 218 received monthly 100 000 IU cholecalciferol for a minimum of 6 months and a maximum of 42 months (treatment arm). Following randomization, patients were followed for a median of 52 months, with a maximum follow-up of 116 months. The primary endpoint was relapse-free survival. Secondary endpoints were melanoma-related mortality, overall survival, and the evolution of 25-hydroxyvitamin D serum levels over time.

Results: In our population (mean age 55 years, 54% female sex) vitamin D supplementation increased 25-hydroxyvitamin D serum levels after 6 months of supplementation in the treatment arm by a median 17 ng mL-1 [95% confidence interval (CI) 9-26] compared with 0 ng mL-1 (95% CI 6-8) in the placebo arm (P < 0.001, Wilcoxon test) and remained at a steady state during the whole treatment period. The estimated event rate for relapse-free survival at 72 months after inclusion was 26.51% in the vitamin D supplemented arm (95% CI 19.37-35.64) vs. 20.70% (95% CI 14.26-29.52) in the placebo arm (hazard ratio 1.27, 95% CI 0.79-2.03; P = 0.32). After adjusting for confounding factors (including baseline stage, body mass index, age, sex and baseline season), the hazard ratio was 1.20 (95% CI 0.74-1.94, P = 0.46). The number of deaths from progression of CM and nonmelanoma-related deaths was similar in both the vitamin D supplemented and placebo groups (deaths from progression of CM, n = 10 and n = 11, respectively; nonmelanoma-related deaths, n = 3 and n = 2, respectively). No major adverse events were observed during the study.

Conclusions: In patients with CM, monthly high-dose vitamin D supplementation was safe, resulted in a sustained increase in 25-hydroxyvitamin D levels during the treatment period, but did not improve relapse-free survival, melanoma-related death or overall survival.

Background: Hyaluronidase is an ubiquitous enzyme, present, among others, in hymenoptera venom and in medical formulations. The latter include use as an emergency treatment or to correct undesired outcomes of medical and aesthetic procedures using hyaluronic acid fillers.

Objectives: By performing detailed allergy work-ups including skin-prick tests (SPTs) we investigated whether patients with a history of allergic reaction to hymenoptera venom are also sensitized to medical grade hyaluronidase.

Methods: Ninety patients with a history of type-1 reaction to hymenoptera venom with and without a history of previous specific venom immunotherapy were included in the study. All underwent SPTs for medical hyaluronidase. All patients also underwent serological analysis for Api m2, the only commercially available IgE test for a hymenoptera hyaluronidase.

Results: Of the 90 patients with previous type-1 reactions to hymenoptera venom hyaluronidase included in the study, 60 had undergone previous venom immunotherapy; 30 did not. The majority (73 of 90) were allergic to wasps, followed by honeybees (14 of 90) and three were allergic to both. Neither patients having undergone previous immunotherapy nor those allergic to bees showed positive SPTs to medical hyaluronidase. Of those with a wasp allergy and naïve to immunotherapy, over 20% (5 of 23) showed positive SPTs to medical hyaluronidase. Healthy controls (0 of 30) without previous allergic reactions to hymenoptera did not show positive SPTs to medical hyaluronidase.

Conclusions: Sensitization to hyaluronidase is most common in wasp-allergic patients who have not had previous specific immunotherapy. As allergic reactions to medical hyaluronidase are reported to be scarce, this group is probably at the highest risk to develop anaphylaxis to medical hyaluronidase. While all patients with untreated anaphylaxis to hymenoptera venom should consult an allergy specialist, it is particularly important that those with untreated wasp allergies seek specialist advice before treatment with medical hyaluronidase is initiated.