Iatrogenic esophageal perforations (IEP) are uncommon but potentially fatal complications, most frequently related to endoscopic procedures. Previous systematic reviews have evaluated esophageal perforations as a heterogeneous entity, frequently combining spontaneous, traumatic, surgical, and iatrogenic causes. However, outcome estimates specific to non-surgical, iatrogenic perforations remain less clearly defined. This study aimed to systematically review and meta-analyze the causes, management strategies, and outcomes of patients managed for non-surgical IEPs. A systematic search of MEDLINE, Embase, CENTRAL, Scopus, and ClinicalTrials.gov was performed from inception to September 2025 in accordance with PRISMA guidelines. Studies reporting clinical outcomes of adult patients with iatrogenic, non-surgical esophageal perforations were included. Postoperative surgical perforations and case reports were excluded. Primary outcomes were procedure type leading to perforation, overall mortality, and mortality according to treatment strategy. Random-effects meta-analyses were conducted for pooled estimates. Twenty-five studies encompassing 596 patients were included. Interventional procedures accounted for 71.1
AIMS:This report describes the baseline characteristics of the DECISION trial (Digoxin Evaluation in Chronic heart failure: Investigational Study In Outpatients in the Netherlands) and compares these with the other trials of cardiac glycosides in heart failure (HF): DIG and DIGIT-HF. METHODS:The DECISION trial is a randomized, double-blind, parallel-group, placebo-controlled outcome trial investigating of low-dose digoxin in contemporary patients with heart failure with a left ventricular ejection fraction (LVEF) ≤50%. Patients were randomized 1:1 to low-dose digoxin or placebo. During follow-up, serum digoxin concentrations were monitored to achieve concentrations of 0.5-0.9 ng/ml. The primary endpoint is a composite of cardiovascular mortality, total HF-hospitalizations and urgent HF hospital visits. RESULTS:A total of 1002 patients were randomized to digoxin or placebo and 1001 patients were included in the full analysis set. Mean age was 73 ± 9 years, 28% were women and 88% were in New York Heart Association class II. Mean LVEF was 33 ± 9%, and 79% had a LVEF ≤40%. At baseline, 71% had sinus rhythm and 29% had atrial fibrillation. Median N-terminal pro-B-type natriuretic peptide (NT-proBNP) was 1404 pg/ml [930-2359].Patients were well-treated with guideline-directed medical therapy (GDMT): beta-blockers (86%), ACE inhibitors or ARBs or angiotensin receptor-neprilysin inhibitors (89%), mineralocorticoid receptor antagonists (72%), and sodium-glucose co-transporter 2 inhibitors (41%) and loop-diuretics (74%). Compare to other digitalis trials, DECISION-patients were older, more often women and had high prevalence of GDMT. CONCLUSION:DECISION enrolled a contemporary and well-treated population of patients with HFrEF and HFmrEF and will provide important evidence regarding the efficacy and safety of low-dose digoxin on outcome in patients with reduced or mildly reduced LVEF.
AIMS:Female underrepresentation in clinical trials of acute coronary syndromes (ACS) may hinder the assessment of sex-based differences in the outcomes of long-term pharmacological therapy. The presence of these differences and their potential association with female representation in clinical trials remain unclear. METHODS AND RESULTS:A systematic search of Embase, Medline Ovid, and Cochrane Central was conducted through 1 July 2025, in accordance with the reporting standards of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Eligible randomized controlled trials (RCTs) compared long-term pharmacological therapy for ACS with placebo or standard care, included ≥1-year follow-up, and reported a clinical event as the primary outcome. Sex differences in treatment effects were analysed using a random-effects meta-analysis, while meta-regression was used to assess the association between the proportion of females in each trial and these differences. The main outcome was the sex difference in the relative effect measure (REM; mostly a hazard ratio) for the primary efficacy endpoint. Among 102 RCTs, female representation ranged from 10 to 52%. Forty-eight trials provided sex-stratified data. Pooled analysis showed no evidence of sex-related differences in efficacy: the mean difference in the log of the REM of males minus females was 0.00 (95% confidence interval, -0.05-0.05; P = 0.98; heterogeneity I² = 0%). Meta-regression indicated no relationship between female trial participation and sex-specific treatment effects. CONCLUSION:In RCTs of long-term pharmacological therapy after ACS, treatment efficacy was comparable between sexes, irrespective of sex distribution. These findings support current guidelines recommending equivalent long-term pharmacological strategies for secondary prevention in both sexes.
Abstract Background In burn care, one of the most debated topics is the optimal treatment of patients with deep partial-thickness burns. With these patients, the decision must be made to perform early surgery or to wait and potentially limit, or even avoid, surgery. Both options are available in Dutch burn care, and the best treatment option is decided on clinical outcomes as well as patients’ preferences. This complexity highlights the need for shared decision-making (SDM) and a decision aid (DA) to facilitate this process. Objective This study aimed to support patients and health care professionals (HPs) in the process of SDM regarding the treatment decision for deep partial-thickness burns by developing and implementing a DA. Methods This multimethod design was conducted in a Dutch burn care setting between September 2023 and October 2025 and included 3 phases. Phase 1 (needs assessment) included semistructured interviews with patients, analyzed using a qualitative descriptive approach with deductive and inductive coding, and an online survey of HPs with a descriptive analysis of closed-ended questions and inductive content analysis of open-ended questions by 2 researchers. Phase 2 (development) involved 5 co-design sessions with patients, HPs, and researchers. The think-aloud method was used for usability testing with patients and HPs. Additionally, HPs participated in acceptability testing using interviews guided by the Consolidated Framework for Implementation Research, and analyzed using deductive thematic analysis. Phase 3 (implementation) consisted of a 6-month pilot period, including patient interviews, 3 focus groups with HPs, usage data, and the Normalization Measure Development questionnaire to assess the level of normalization. Results Eight patient interviews revealed 2 distinct information needs: patients seeking detailed treatment information and those preferring to defer decisions to clinicians. The HPs survey (response rate 36%) showed that burn physicians typically make the final treatment decisions, although SDM was considered preferable, and 91.2% (31/34) supported the use of a DA. Usability testing with 4 patients and 7 HPs showed overall satisfaction, with minor revisions suggested, such as clarifying text and illustrations. Key implementation facilitators included professional engagement and local support, while infrastructure was the main barrier. The final DA comprised a paper handout sheet, an interactive website, and a summary sheet capturing patient preferences. During the pilot, the DA was distributed 42 times and used by 28 patients (67% participation rate). Both patients and HPs reported positive experiences, and the tool was considered feasible to integrate into routine care. Conclusions A DA for the treatment of deep partial-thickness burns was successfully developed and implemented using a comprehensive, user-centered approach. It supports SDM and patient-centered care by providing tailored information and helping patients participate more actively in treatment decisions.
The assessment of scar quality is an essential component of follow-up care and outcome evaluation in pediatric burn patients. The pediatric patient scale of the Patient and Observer Scar Assessment Scale (POSAS) is a recently developed patient-reported outcome measure (PROM) for this purpose. In pediatric care, proxy reports are commonly used when children are too young to self-report. However, the extent to which proxy reports reflect children’s own perception of scar quality is unclear. This study evaluated child-proxy agreement on the pediatric patient scale of the POSAS. In this clinimetric observational study, children aged 8–17 years with burn scars and their proxies (parent or other caregivers) were recruited at the Burn Center in Beverwijk, The Netherlands, and aftercare center OSCARE in Antwerp, Belgium. Both the child and a proxy independently completed the pediatric patient scale of the POSAS, with proxies instructed to report from the child’s perspective (proxy-patient perspective). Child and proxy item scores were described using medians and interquartile ranges (IQR) and compared using the Wilcoxon signed-rank test. Effect sizes were calculated to quantify the magnitude of differences. Agreement was examined at two levels: (1) presence or absence of complaints and (2) severity ratings. Subgroup analyses were performed for age category and proxy type. A total of 81 child-proxy pairs were included between January and April 2025. Agreement on item level ranged from fair to substantial (kappa 0.309–0.692) and was moderate for most items. Overall agreement on the presence or absence of complaints was high (mean 78
