The Patient and Observer Scar Assessment Scale (POSAS) is one of the most robust instruments to assess scar quality, but there is no Italian version, and no other competing instruments are available in Italian. The aim of this study was to translate and validate an Italian version of POSAS (POSAS-I). POSASv2.0 was culturally adapted in accordance with international standards. The psychometric assessment included acceptability/feasibility, internal consistency, reproducibility, construct validity and sensitivity to change. Cultural equivalence of POSAS-I with the English version was confirmed. The validation study included 102 subjects with surgical scars. Both subscales demonstrated acceptable internal consistency (Cronbach's α = 0·72-0·80). Reproducibility of the OSAS-I (ICCs = 0·93-0·94; SEM = 1·8 points; MDC = 5·1 points) was superior to that of PSAS-I (ICC = 0·65; SEM = 5·7 points; MDC = 15·7 points). OSAS-I showed moderate to good correlations with the Vancouver Scar Scale (VSS), Global Rating of Change Scale (GRCS) and PSAS-I. Sensitivity to change was large for PSAS-I (effect size = 1·08; standardised response mean = 0·96) and moderate to large for OSAS-I (ES = 0·69; SRM = 0·92). This study confirmed that POSAS-I can be used to assess patients with surgical scars in the Italian population. OSAS-I is useful for clinical and research purposes, while PSAS-I should be better used to capture patients' own opinions and symptoms in clinical settings.
ImportanceSudden infant death syndrome (SIDS) remains a leading cause of death during the first year of life. The etiology of SIDS is complex and remains largely unknown.ObjectiveTo evaluate whether siblings of children who died of SIDS have a higher risk of SIDS compared with the general pediatric population.Design, Setting, and ParticipantsThis register-based cohort study used Danish nationwide registers. Participants were all infants (<1 year) in Denmark between January 1, 1978, and December 31, 2016, including siblings of children who died of SIDS. Siblings were followed up from the index cases’ date of SIDS, date of birth, or immigration, whichever came first, and until age 1 year, emigration, developing SIDS, death, or study end. The median (IQR) follow-up was 1 (1-1) year. Data analysis was conducted from January 2017 to October 2022.Main Outcomes and MeasuresStandardized incidence ratios (SIRs) of SIDS were calculated with Poisson regression models relative to the general population.ResultsIn a population of 2 666 834 consecutive births (1 395 199 [52%] male), 1540 infants died of SIDS (median [IQR] age at SIDS, 3 [2-4] months) during a 39-year study period. A total of 2384 younger siblings (cases) to index cases (first sibling with SIDS) were identified. A higher rate of SIDS was observed among siblings compared with the general population, with SIRs of 4.27 (95% CI, 2.13-8.53) after adjustment for sex, age, and calendar year and of 3.50 (95% CI, 1.75-7.01) after further adjustment for mother’s age (<29 years vs ≥29 years) and education (high school vs after high school).Conclusions and RelevanceIn this nationwide study, having a sibling who died of SIDS was associated with a 4-fold higher risk of SIDS compared with the general population. Shared genetic and/or environmental factors may contribute to the observed clustering of SIDS. The family history of SIDS should be considered when assessing SIDS risk in clinical settings. A multidisciplinary genetic evaluation of families with SIDS could provide additional evidence.
ObjectiveMorbidity and mortality due to heart failure (HF) as a complication of myocardial infarction (MI) is high, and remains among the leading causes of death and hospitalisation. This study investigated the association between family history of MI with or without HF, and the risk of developing HF after first MI.MethodsThrough nationwide registries, we identified all individuals aged 18–50 years hospitalised with first MI from 1997 to 2016 in Denmark. We identified 13 810 patients with MI, and the cohort was followed until HF diagnosis, second MI, 3 years after index MI, emigration, death or the end of 2016, whichever occurred first. HRs were estimated by Cox hazard regression models adjusted for sex, age, calendar year and comorbidities (reference: patients with no family history of MI).ResultsAfter adjustment, we observed an increased risk of MI-induced HF for those having a sibling with MI with HF (HR 2.05, 95% CI 1.02 to 4.12). Those having a sibling with MI without HF also had a significant, but lower increased risk of HF (HR 1.39, 95% CI 1.05 to 1.84). Parental history of MI with or without HF was not associated with HF.ConclusionIn this nationwide cohort, sibling history of MI with or without HF was associated with increased risk of HF after first MI, while a parental family history was not, suggesting that shared environmental factors may predominate in the determination of risk for developing HF.
Studies have shown higher survival rates for patients with Hodgkin lymphoma (HL) treated within clinical trials compared to patients treated outside clinical trials.However, endpoints are often limited to overall survival (OS). In this retrospective cohort study, we investigated the effect of trial participation on OS, the incidence of relapse, second cancer, and cardiovascular disease (CVD). The study population consisted of patients with HL, aged between 14 and 51 years at diagnosis, who started their treatment between 1962 and 2002 at three Dutch cancer centres. Patients were either included in the EORTC Lymphoma Group trials (H1-H9) or treated according to standard guidelines at the time. After adjusting for differences in baseline characteristics, trial participation was associated with longer OS (median OS: 29.4 years [95%CI: 27.0-31.6] for treatment inside trials versus 27.4 years [95%CI:26.0-28.5] for treatment outside trials, p = .046), a lower incidence of relapse (HR = 0.79, 95%CI: 0.63-0.98, p = .036) and a higher incidence of CVD (HR = 1.49, 95%CI: 1.23-1.79, p < .001). The trial effect for CVD was present only for patients treated before 1983. No evidence of differences in the incidence of second cancer was found. Consequently, essential results from clinical trials should be implemented into standard practice without undue delay.
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