Early vs Late Inguinal Hernia Repair in Preterm Infants—Reply

In Reply We thank Dr Montalva and colleagues for their comments regarding apnea occurrence and anesthetic approach for inguinal hernia repair in response to our multicenter randomized clinical trial examining the timing of hernia repair in preterm infants. We enrolled smaller and more immature infants than most available studies, including the General Anesthesia compared to Spinal anesthesia (GAS) study. The surgical and anesthetic methods were used at the discretion of the clinicians and the finding that 99% of the cases received general anesthesia is consistent with current practice for the trial population at the 39 participating sites.

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Luglio 2024

Early vs Late Inguinal Hernia Repair in Preterm Infants

To the Editor We read with great interest the recent article by Dr Blakely and colleagues reporting the results of their randomized clinical trial on the timing of inguinal hernia repair in preterm infants. Delaying hernia repair until after hospital discharge and when the infants were older than 55 weeks’ postmenstrual age resulted in fewer serious adverse events compared with performing an early hernia repair before discharge from the neonatal intensive care unit. As a result, the authors advocate for delaying inguinal hernia repair until after initial discharge from the neonatal intensive care unit.

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Luglio 2024

Protocol for a hybrid effectiveness-implementation clinical trial evaluating video-assisted electronic consent vs standard consent for patients initiating and continuing haemodialysis in Australia (eConsent HD)

Introduction
Communicating complex information about haemodialysis (HD) and ensuring it is well understood remains a challenge for clinicians. Informed consent is a high-impact checkpoint in augmenting patients’ decision awareness and engagement prior to HD. The aims of this study are to (1) develop a digital information interface to better equip patients in the decision-making process to undergo HD; (2) evaluate the effectiveness of the co-designed digital information interface to improve patient outcomes; and (3) evaluate an implementation strategy.

Methods and analysis
First, a co-design process involving consumers and clinicians to develop audio-visual content for an innovative digital platform. Next a two-armed, open-label, multicentre, randomised controlled trial will compare the digital interface to the current informed consent practice among adult HD patients (n=244). Participants will be randomly assigned to either the intervention or control group. Intervention group: Participants will be coached to an online platform that delivers a simple-to-understand animation and knowledge test questions prior to signing an electronic consent form. Control group: Participants will be consented conventionally by a clinician and sign a paper consent form. Primary outcome is decision regret, with secondary outcomes including patient-reported experience, comprehension, anxiety, satisfaction, adherence to renal care, dialysis withdrawal, consent time and qualitative feedback. Implementation of eConsent for HD will be evaluated concurrently using the Consolidation Framework for Implementation Research (CFIR) methodology. Analysis: For the randomised controlled trial, data will be analysed using intention-to-treat statistical methods. Descriptive statistics and CFIR-based analyses will inform implementation evaluation.

Ethics and dissemination
Human Research Ethics approval has been secured (Metro North Health Human Research Ethics Committee B, HREC/2022/MNHB/86890), and Dissemination will occur through partnerships with stakeholder and consumer groups, scientific meetings, publications and social media releases.

Trial registration number
Australian and New Zealand Clinical Trials Registry (ACTRN12622001354774).

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Luglio 2024

Coronary In-Stent Restenosis Treated With Paclitaxel-Coated Balloon vs Uncoated Balloon

To the Editor We write to express our concern with the conclusion of the AGENT IDE (A Clinical Trial to Assess the Agent Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis) study, which reported drug-coated balloons to be superior to uncoated balloons based on a composite end point of 1-year target lesion failure—defined as the composite of ischemia-driven target lesion revascularization, target vessel–related myocardial infarction, or cardiac death. This composite end point was driven by the first 2 subjective and operator-dependent outcomes; however, the objective component, rate of cardiac death, was twice as high in the paclitaxel group as the control group, raising concerns for serious adverse events related to this coated balloon. Previous studies have raised concern about coated balloons, and their use remains controversial. A study comparing the AGENT drug-coated balloon with the older SeQuent drug-coated balloon reported a 1-year mortality rate of 3.1% and 1.7%, respectively.

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Luglio 2024

Coronary In-Stent Restenosis Treated With Paclitaxel-Coated Balloon vs Uncoated Balloon—Reply

In Reply In the AGENT IDE trial, treatment of in-stent restenosis with a coronary paclitaxel-coated balloon significantly reduced the rate of the primary end point of 1-year target lesion failure compared with conventional balloon angioplasty. Among the components of the primary end point, target lesion revascularization was required to be adjudicated as ischemia-driven by an independent clinical events committee. Absolute rates of this end point may potentially be influenced by operator practice patterns; however, differences in rates between treatment groups are attributable to the effectiveness of the device at preventing recurrent restenosis. Importantly, the rate of target vessel–related myocardial infarction was also significantly lower in the paclitaxel-coated vs uncoated balloon group. The occurrence of this end point is neither subjective nor dependent on operator decisions.

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Luglio 2024

Medical Management vs Bariatric Surgery in Type 2 Diabetes—Reply

In Reply We agree with Dr Fujieda that weight during childhood and adolescence is an important phenotypic variable, given that birth weight and early-life weight trajectories are associated with risk of obesity, type 2 diabetes, and cardiovascular outcomes. Unfortunately, the ARMMS-T2D Collaborative study, which pooled data from 4 separate randomized clinical trials, did not collect weight trajectory data from participants for the years prior to their enrollment in these studies. Future studies that are adequately powered to address cardiovascular health outcomes could include early-life weight trajectories as a potential mediating factor.

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Luglio 2024