The SHOW RESPECT adaptable framework of considerations for planning how to share trial results with participants, based on qualitative findings from trial participants and site staff.

BACKGROUND: Sharing trial results with participants is a moral imperative, but too often does not happen in appropriate ways. METHODS: We carried out semi-structured interviews with patients (n = 13) and site staff (n = 11), and surveyed 180 patients and 68 site staff who were part of the Show RESPECT study, which tested approaches to sharing results with participants in the context of the ICON8 ovarian cancer trial (ISRCTN10356387). Qualitative and free-text data were analysed thematically, and findings used to develop the SHOW RESPECT adaptable framework of considerations for planning how to share trial results with participants. This paper presents the framework, with illustrations drawn from the Show RESPECT study. RESULTS: Our adaptable 'SHOW RESPECT' framework covers (1) Supporting and preparing trial participants to receive results, (2) HOw will the results reach participants?, (3) Who are the trial participants?, (4) REsults-what do they show?, (5) Special considerations, (6) Provider-who will share results with participants?, (7) Expertise and resources, (8) Communication tools and (9) Timing of sharing results. While the data upon which the framework is based come from a single trial, many of our findings are corroborated by findings from other studies in this area, supporting the transferability of our framework to trials beyond the UK ovarian cancer setting in which our work took place. CONCLUSIONS: This adaptable 'SHOW RESPECT' framework can guide researchers as they plan how to share aggregate trial results with participants. While our data are drawn from a single trial context, the findings from Show RESPECT illustrate how approaches to communication in a specific trial can influence patient and staff experiences of feedback of trial results. The framework generated from these findings can be adapted to fit different trial contexts and used by other researchers to plan the sharing of results with their own participants. TRIAL REGISTRATION: ISRCTN96189403. Registered on February 26, 2019. Show RESPECT was supported by the Medical Research Council (MC_UU_12023/24 and MC_UU_00004/08) and the NIHR CRN.

Long-term persistence of seroprotection against measles following measles-mumps-rubella vaccination administered before and after pediatric liver transplantation.

Liver transplant (LT) recipients are susceptible to infections, including measles. Concerns about the safety and efficacy of live-attenuated vaccines, such as the measles-mumps-rubella (MMR) vaccine, have led to hesitancy among providers in administering them to immunocompromised patients. This 9-year interventional study assessed seroprotection against measles following MMR vaccination in pediatric LT recipients. Of 119 participants enrolled, 60 (50%) were seroprotected against measles after transplantation. Among the 59 non-seroprotected participants, 56 fulfilled safety criteria and received MMR vaccination with a seroprotection rate of 90% (95%CI 73-98%) after a first dose, 95% (95%CI 85-99%) after primary vaccination with 1 to 3 doses, comparable to non-immunocompromised populations. However, measles antibodies declined over time, suggesting the need for regular monitoring, and booster doses. Half of the vaccinees (26/53, 49%) subsequently lost seroprotection. Among them, 23 received additional doses of MMR, with high seroconversion rate. At their last follow up (median 6.1 years, IQR 3.0-8.1 after inclusion), 63% (95%CI 49-75%) of all vaccinees were seroprotected against measles. In conclusion, MMR vaccination in pediatric LT recipients offers seroprotection against measles, but long-term immunity should be monitored closely. CLINICAL TRIAL REGISTRATION: The trial is registered at the US National Institutes of Health (Clinicaltrials.gov) number NCT01770119.

Prognostic impact of quantitative flow ratio (QFR)-consistent complete revascularization in patients with myocardial infarction and multivessel coronary artery disease.

BACKGROUND: Complete revascularization is associated with improved outcomes in patients with myocardial infarction and multivessel coronary artery disease. Quantitative flow ratio (QFR) represents an emerging angiography-based tool for functional lesion assessment. The present study investigated the prognostic impact of QFR-consistent complete revascularization in patients with myocardial infarction and multivessel disease. METHODS: A total of 792 patients with myocardial infarction and multivessel disease were enrolled in the analysis. Post-hoc QFR analyses of 1320 non-culprit vessels were performed by investigators blinded to clinical outcomes. The primary endpoint was a composite of all-cause death, non-culprit vessel related non-fatal myocardial infarction, and ischemia-driven revascularization at two years after index myocardial infarction. Patients were stratified into a QFR-consistent PCI group (n=646) and a QFR-inconsistent PCI group (n=146), based on whether the intervention was congruent with the QFR-determined functional significance of the non-culprit lesions. RESULTS: The primary endpoint occurred in a total of 22 patients (3.4%) in the QFR-consistent PCI group and in 27 patients (18.5%) in the QFR-inconsistent group (HR 0.17, 95%CI 0.10-0.30, p<0.001).The difference in the primary endpoint was driven by reduced rates of non-fatal myocardial infarction (2.0% vs. 15.1%; HR 0.13, 95%CI 0.06-0.25; p<0.001) and ischemia-driven revascularization (1.2% vs. 5.5%; HR 0.21, 95%CI 0.08-0.57; p=0.001) in the QFR-consistent PCI group. CONCLUSIONS: Among patients with myocardial infarction and multivessel disease, a QFR-consistent complete revascularization was associated with a reduced risk of all-cause mortality, non-fatal myocardial infarction, and ischemia-driven revascularization. These findings underline the value of angiography-based functional lesion assessment for personalized revascularization strategies.

Evaluating the delivery of care by telemedicine for incarcerated people living with HIV: a cohort study.

BACKGROUND: The use of telemedicine has grown significantly since the COVID-19 pandemic and has the potential to improve access to specialized care for otherwise underserved populations. Incarcerated people living with HIV (PLWH) could potentially benefit from expanded access to HIV care through telemedicine. METHODS: All PLWH who were incarcerated within the Tennessee Department of Corrections and received care through the HIV telemedicine clinic at Regional One Hospital between 5/1/2019 through 2/28/2022 were identified from the electronic health records (EHR). Demographics, laboratory data, vaccine history, and treatment outcomes were abstracted from the EHR. Retention in care and viral suppression were defined using Centers for Disease Control and Prevention definitions. RESULTS: Of the 283 incarcerated PLWH receiving care from this telemedicine clinic, 78% remained retained in care and 94% achieved or maintaining viral suppression at 12 months. Many preventative care measures remained unperformed or undocumented, including vaccinations and testing for concurrent sexually transmitted infections. There were 56 patients (20%) found to have chronic hepatitis C in this population, with 71% either cured or still on treatment in this study period. CONCLUSIONS: Retention in care and viral suppression rates were excellent among incarcerated PLWH receiving telemedicine care for their HIV. HIV related primary health care screenings and vaccinations, however, were less consistently documented and represent areas for improvement.

Incorporating social determinants of health into transmission modeling of COVID-19 vaccine in the US: a scoping review.

During COVID-19 in the US, social determinants of health (SDH) have driven health disparities. However, the use of SDH in COVID-19 vaccine modeling is unclear. This review aimed to summarize the current landscape of incorporating SDH into COVID-19 vaccine transmission modeling in the US. Medline and Embase were searched up to October 2022. We included studies that used transmission modeling to assess the effects of COVID-19 vaccine strategies in the US. Studies' characteristics, factors incorporated into models, and approaches to incorporate these factors were extracted. Ninety-two studies were included. Of these, 11 studies incorporated SDH factors (alone or combined with demographic factors). Various sets of SDH factors were integrated, with occupation being the most common (8 studies), followed by geographical location (5 studies). The results show that few studies incorporate SDHs into their models, highlighting the need for research on SDH impact and approaches to incorporating SDH into modeling. Funding: This research was funded by the Centers for Disease Control and Prevention (CDC).

Rangewide occupancy of a flagship species, the Coastal California Gnatcatcher (Polioptila californica californica) in southern California: Habitat associations and recovery from wildfire.

The Coastal California Gnatcatcher (Polioptila californica californica), a federally threatened species, is a flagship species for regional conservation planning in southern California (USA). An inhabitant of coastal sage scrub vegetation, the gnatcatcher has declined in response to habitat loss and fragmentation, exacerbated by catastrophic wildfires. We documented the status of gnatcatchers throughout their California range and examined post-fire recovery of gnatcatchers and their habitat. We used GIS to develop a habitat suitability model for Coastal California Gnatcatchers using climate and topography covariates and selected over 700 sampling points in a spatially balanced manner. Bird and vegetation data were collected at each point between March and May in 2015 and 2016. Presence/absence of gnatcatchers was determined during three visits to points, using area searches within 150 x 150 m plots. We used an occupancy framework to generate Percent Area Occupied (PAO) by gnatcatchers, and analyzed PAO as a function of time since fire. At the regional scale in 2016, 23% of the points surveyed were occupied by gnatcatchers, reflecting the effect of massive wildfires in the last 15 years. Similarly, PAO in the post-fire subset of points was 24%, with the highest occupancy in unburned (last fire <2002) habitat. Positive predictors of occupancy included percent cover of California sagebrush (Artemisia californica), California buckwheat (Eriogonom fasciculatum), and sunflowers (Encelia spp., Bahiopsis laciniata), while negative predictors included laurel sumac (Malosma laurina) and total herbaceous cover; in particular, non-native grasses. Our findings indicate that recovery from wildfire may take decades, and provide information to speed up recovery through habitat restoration.

Role of imaging in third aortic valve implantation: TAV-in-TAV-in-SAV.

Coronary obstruction remains a primary concern for redo transcatheter aortic valve implantation (TAVI) due to supra-annular leaflets. Hereby, we present two valve-in-valve-in-valve cases, initially incorporating a surgical valve implanted to clarify our concept that the surgical valve serves to safeguard against the coronary ostium obstruction.

Long-term outcomes after echocardiography versus fluoroscopy-guided left atrial appendage closure: Is there still a role for a simplified approach?

BACKGROUND: Left atrial appendage closure (LAAC) represents an alternative to oral anticoagulation for stroke prevention in patients with non-valvular atrial fibrillation (AF). While transoesophageal echocardiography is the current standard for guiding LAAC procedures, several centers have employed fluoroscopic guidance alone. However, data on long-term outcomes are lacking. METHODS: A total of 536 patients with AF undergoing LAAC and with available data on long-term follow-up were included in the retrospective, single-center analysis. Outcomes of patients undergoing fluoroscopy-guided LAAC were compared with those undergoing echocardiography guided LAAC. Time-dependent analysis was performed with the Kaplan-Meier method. RESULTS: A total of 234 (44%) and 302 (56%) patients were treated with echocardiography and fluoroscopy guidance, respectively. Baseline characteristics did not differ between the two groups. Procedural success rates were high in both groups (97% of fluoroscopy vs. 98% of echocardiography guided procedures; p = 0.92) and rates of relevant peri-device leaks (p = 0.50) and device-related thrombus formation (p = 0.22) did not differ between groups. Median clinical follow-up time was 48 (IQR 19-73) months. Rates of all-cause mortality (p = 0.15, HR 0.83, CI 0.64-1.07) and stroke (p = 0.076, HR 2.23, CI 0.90-5.54) were comparable among groups. CONCLUSION: LAAC with fluoroscopy guidance alone is equally safe and leads to similar clinical outcome compared to LAAC with additional echocardiography guidance.

Accelerated cardiac magnetic resonance imaging using deep learning for volumetric assessment in children.

BACKGROUND: Ventricular volumetry using a short-axis stack of two-dimensional (D) cine balanced steady-state free precession (bSSFP) sequences is crucial in any cardiac magnetic resonance imaging (MRI) examination. This task becomes particularly challenging in children due to multiple breath-holds. OBJECTIVE: To assess the diagnostic performance of accelerated 3-RR cine MRI sequences using deep learning reconstruction compared with standard 2-D cine bSSFP sequences. MATERIAL AND METHODS: Twenty-nine consecutive patients (mean age 11 ± 5, median 12, range 1-17 years) undergoing cardiac MRI were scanned with a conventional segmented 2-D cine and a deep learning accelerated cine (three heartbeats) acquisition on a 1.5-tesla scanner. Short-axis volumetrics were performed (semi-)automatically in both datasets retrospectively by two experienced readers who visually assessed image quality employing a 4-point grading scale. Scan times and image quality were compared using the Wilcoxon rank-sum test. Volumetrics were assessed with linear regression and Bland-Altman analyses, and measurement agreement with intraclass correlation coefficient (ICC). RESULTS: Mean acquisition time was significantly reduced with the 3-RR deep learning cine compared to the standard cine sequence (45.5 ± 13.8 s vs. 218.3 ± 44.8 s; P < 0.001). No significant differences in biventricular volumetrics were found. Left ventricular (LV) mass was increased in the deep learning cine compared with the standard cine sequence (71.4 ± 33.1 g vs. 69.9 ± 32.5 g; P < 0.05). All volumetric measurements had an excellent agreement with ICC > 0.9 except for ejection fraction (EF) (LVEF 0.81, RVEF 0.73). The image quality of deep learning cine images was decreased for end-diastolic and end-systolic contours, papillary muscles, and valve depiction (2.9 ± 0.5 vs. 3.5 ± 0.4; P < 0.05). CONCLUSION: Deep learning cine volumetrics did not differ significantly from standard cine results except for LV mass, which was slightly overestimated with deep learning cine. Deep learning cine sequences result in a significant reduction in scan time with only slightly lower image quality.

Timing of multivessel revascularization in stable patients with STEMI: a systematic review and network meta-analysis.

INTRODUCTION AND OBJECTIVES: Multivessel percutaneous coronary intervention (MV-PCI) is recommended in patients with ST-segment elevation myocardial infarction (STEMI) and multivessel coronary artery disease (CAD) without cardiogenic shock. The present network meta-analysis investigated the optimal timing of MV-PCI in this context. METHODS: We pooled the aggregated data from randomized trials investigating stable STEMI patients with multivessel cad treated with a strategy of either MV-PCI or culprit vessel-only PCI. The primary outcome was all-cause death. The main secondary outcomes were cardiovascular death, myocardial infarction, and unplanned ischemia-driven revascularization. This study is registered at PROSPERO (CRD42023457794). RESULTS: Among 11 trials, a total of 10 507 patients were randomly assigned to MV-PCI (same sitting, n = 1683; staged during the index hospitalization, n = 3460; staged during a subsequent hospitalization within 45 days, n = 3275) or to culprit vessel-only PCI (n = 2089). The median follow-up was 18.6 months. In comparison with culprit vessel-only PCI, MV-PCI staged during the index hospitalization significantly reduced all-cause death (risk ratio, 0.73; 95%CI, 0.56-0.92; P = .008) and ranked as possibly the best treatment option for this outcome compared with all other strategies. In comparison with culprit vessel-only PCI, a MV-PCI reduced cardiovascular mortality without differences dependent on the timing of revascularization. MV-PCI within the index hospitalization, either in a single procedure or staged, significantly reduced myocardial infarction and unplanned ischemia-driven revascularization, with no significant difference between each other. CONCLUSIONS: In patients with STEMI and multivessel CAD without cardiogenic shock, multivessel PCI within the index hospitalization, either in a single procedure or staged, represents the safest and most efficacious approach. The different timings of multivessel PCI did not result in any significant differences in all-cause death.

High protein intake on later outcomes in preterm children: a systematic review and meta-analysis.

BACKGROUND: Appropriate protein intake is crucial for growth and development in children born preterm. We assessed the effects of high (HP) versus low protein (LP) intake on neurodevelopment, growth, and biochemical anomalies in these children. METHODS: Randomised and quasi-randomised trials providing protein to children born preterm (<37 completed weeks of gestation) were searched following PRISMA guideline in three databases and four registers (PROSPERO registration CRD42022325659). Random-effects model was used for assessing the effects of HP (≥3.5 g/kg/d) vs. LP (<3.5 g/kg/d). RESULTS: Data from forty-four studies (n = 5338) showed HP might slightly reduce the chance of survival without neurodisability at ≥12 months (four studies, 1109 children, relative risk [RR] 0.95 [95% CI 0.90, 1.01]; P = 0.13; low certainty evidence) and might increase risk of cognitive impairment at toddler age (two studies; 436 children; RR 1.36 [0.89, 2.09]; P = 0.16; low certainty evidence). At discharge or 36 weeks, HP intake might result in higher weight and greater head circumference z-scores. HP intake probably increased the risk of hypophosphatemia, hypercalcemia, refeeding syndrome and high blood urea, but reduced risk of hyperglycaemia. CONCLUSIONS: HP intake for children born preterm may be harmful for neonatal metabolism and later neurodisability and has few short-term benefits for growth. IMPACT STATEMENT: Planned high protein intake after birth for infants born preterm might be harmful for survival, neurodisability and metabolism during infancy and did not improve growth after the neonatal period. Protein intake ≥3.5 g/kg/d should not be recommended for children born preterm.

Automating detection of diagnostic error of infectious diseases using machine learning.

Diagnostic error, a cause of substantial morbidity and mortality, is largely discovered and evaluated through self-report and manual review, which is costly and not suitable to real-time intervention. Opportunities exist to leverage electronic health record data for automated detection of potential misdiagnosis, executed at scale and generalized across diseases. We propose a novel automated approach to identifying diagnostic divergence considering both diagnosis and risk of mortality. Our objective was to identify cases of emergency department infectious disease misdiagnoses by measuring the deviation between predicted diagnosis and documented diagnosis, weighted by mortality. Two machine learning models were trained for prediction of infectious disease and mortality using the first 24h of data. Charts were manually reviewed by clinicians to determine whether there could have been a more correct or timely diagnosis. The proposed approach was validated against manual reviews and compared using the Spearman rank correlation. We analyzed 6.5 million ED visits and over 700 million associated clinical features from over one hundred emergency departments. The testing set performances of the infectious disease (Macro F1 = 86.7, AUROC 90.6 to 94.7) and mortality model (Macro F1 = 97.6, AUROC 89.1 to 89.1) were in expected ranges. Human reviews and the proposed automated metric demonstrated positive correlations ranging from 0.231 to 0.358. The proposed approach for diagnostic deviation shows promise as a potential tool for clinicians to find diagnostic errors. Given the vast number of clinical features used in this analysis, further improvements likely need to either take greater account of data structure (what occurs before when) or involve natural language processing. Further work is needed to explain the potential reasons for divergence and to refine and validate the approach for implementation in real-world settings.

An investigation into gender distributions in scholarly publications among dental faculty members in Iran.

BACKGROUND: Research on gender inequality is crucial as it unveils the pervasive disparities that persist across various domains, shedding light on societal imbalances and providing a foundation for informed policy-making. AIM: To investigate gender differences in scientometric indices among faculty members in dental schools across Iran. This included overall data and speciality-specific data. METHODS: The publication profiles of academic staff in all dental schools were examined using the Iranian Scientometric Information Database (ISID, http://isid.research.ac.ir). Variables analyzed were working field, academic degree, the total number of papers, papers per year, total number of citations, percentage of self-citation, h-index, g-index, citations per paper, gender, university type, number of years publishing, proportion of international papers, first-author papers, and corresponding-author papers. Mann-Whitney and Kruskal-Wallis nonparametric tests were used to analyze the relationship between background characteristics and scientometric indicators. The extracted data were analyzed using R v4.0.1. RESULTS: The database included 1850 faculty members, of which about 60% (1104 of 1850) were women. Men (n = 746) had a higher number of papers (6583 vs. 6255) and citations (60410 vs. 39559) compared with women; 234 of the 376 faculty members with no papers were women. Almost half of the women (N = 517 of 1104) were in Type 2 universities, and nearly half of the men (N = 361 of the 746) were faculty members at Type 1 universities (Type 1 universities ranking higher than Type 2 and 3 universities). The medians of scientometric indices were higher in men, except for self-citation percentage (0 (IQR = 2) vs. 0 (IQR = 3), P = 0.083), international papers percentage (0 (IQR = 7.5) vs. 0 (IQR = 16.7), P<0.001). The proportion of corresponding-author papers was more than 62% higher in women (25 (IQR = 50) vs. 15.4 (IQR = 40), P<0.001). Men had a two-fold higher median h-index (2 (IQR = 4) vs. 1 (IQR = 3), P<0.001). Restorative dentistry and pediatric dentistry had the highest men-to-women ratios (1.5 for both). Dental materials and oral and maxillofacial surgery showed the lowest men-to-women ratios (0.42 and 0.5, respectively). CONCLUSIONS: Women made up the majority of dental faculty members in Iran. Nevertheless, men showed better scientometric results in several significant indices. Having identified scientometric information reflecting differences across faculty members, further research is now needed to better understand the drivers of these differences.

Neutrophils insert elastase into hepatocytes to regulate calcium signaling in alcohol-associated hepatitis.

Neutrophil infiltration occurs in a variety of liver diseases, but it is unclear how neutrophils and hepatocytes interact. Neutrophils generally use granule proteases to digest phagocytosed bacteria and foreign substances or neutralize them in neutrophil extracellular traps. In certain pathological states, granule proteases play a destructive role against the host as well. More recently, non-destructive actions of neutrophil granule proteins have been reported, such as modulation of tissue remodeling and metabolism. Here we report a completely different mechanism by which neutrophils act non-destructively, by inserting granules directly into hepatocytes. Specifically, elastase-containing granules were transferred to hepatocytes where elastase selectively degraded intracellular calcium channels to reduce cell proliferation without cytotoxicity. In response, hepatocytes increased expression of serpin E2 and A3, which inhibited elastase activity. Elastase insertion was seen in patient specimens of alcohol-associated hepatitis, and the relationship between elastase-mediated ITPR2 degradation and reduced cell proliferation was confirmed in mouse models. Moreover, neutrophils from patients with alcohol-associated hepatitis were more prone to degranulation and more potent in reducing calcium channel expression than neutrophils from healthy subjects. This non-destructive and reversible action on hepatocytes defines a previously unrecognized role for neutrophils in the transient regulation of epithelial calcium signaling mechanisms.

Respiratory Syncytial Virus-Associated Hospitalizations in Children <5 Years: 2016-2022.

BACKGROUND: The coronavirus disease 2019 pandemic disrupted respiratory syncytial virus (RSV) seasonality resulting in early, atypical RSV seasons in 2021 and 2022, with an intense 2022 peak overwhelming many pediatric healthcare facilities. METHODS: We conducted prospective surveillance for acute respiratory illness during 2016-2022 at 7 pediatric hospitals. We interviewed parents, reviewed medical records, and tested respiratory specimens for RSV and other respiratory viruses. We estimated annual RSV-associated hospitalization rates in children aged <5 years and compared hospitalization rates and characteristics of RSV-positive hospitalized children over 4 prepandemic seasons (2016-2020) to those hospitalized in 2021 or 2022. RESULTS: There was no difference in median age or age distribution between prepandemic and 2021 seasons. Median age of children hospitalized with RSV was higher in 2022 (9.6 months vs 6.0 months, P < .001). RSV-associated hospitalization rates were higher in 2021 and 2022 than the prepandemic average across age groups. Comparing 2021 to 2022, RSV-associated hospitalization rates were similar among children <2 years of age; however, children aged 24 to 59 months had significantly higher rates of RSV-associated hospitalization in 2022 (rate ratio 1.68 [95% confidence interval 1.37-2.00]). More RSV-positive hospitalized children received supplemental oxygen and there were more respiratory virus codetections in 2022 than in prepandemic seasons (P < .001 and P = .003, respectively), but there was no difference in the proportion hypoxemic, mechanically ventilated, or admitted to intensive care. CONCLUSIONS: The atypical 2021 and 2022 RSV seasons resulted in higher hospitalization rates with similar disease severity to prepandemic seasons.

Optimizing the design of spatial genomic studies.

Spatial genomic technologies characterize the relationship between the structural organization of cells and their cellular state. Despite the availability of various spatial transcriptomic and proteomic profiling platforms, these experiments remain costly and labor-intensive. Traditionally, tissue slicing for spatial sequencing involves parallel axis-aligned sections, often yielding redundant or correlated information. We propose structured batch experimental design, a method that improves the cost efficiency of spatial genomics experiments by profiling tissue slices that are maximally informative, while recognizing the destructive nature of the process. Applied to two spatial genomics studies-one to construct a spatially-resolved genomic atlas of a tissue and another to localize a region of interest in a tissue, such as a tumor-our approach collects more informative samples using fewer slices compared to traditional slicing strategies. This methodology offers a foundation for developing robust and cost-efficient design strategies, allowing spatial genomics studies to be deployed by smaller, resource-constrained labs.

Incidence, management and outcomes in hepatic artery complications after paediatric liver transplantation: protocol of the retrospective, international, multicentre HEPATIC Registry.

INTRODUCTION: Hepatic artery complications (HACs), such as a thrombosis or stenosis, are serious causes of morbidity and mortality after paediatric liver transplantation (LT). This study will investigate the incidence, current management practices and outcomes in paediatric patients with HAC after LT, including early and late complications. METHODS AND ANALYSIS: The HEPatic Artery stenosis and Thrombosis after liver transplantation In Children (HEPATIC) Registry is an international, retrospective, multicentre, observational study. Any paediatric patient diagnosed with HAC and treated for HAC (at age <18 years) after paediatric LT within a 20-year time period will be included. The primary outcomes are graft and patient survivals. The secondary outcomes are technical success of the intervention, primary and secondary patency after HAC intervention, intraprocedural and postprocedural complications, description of current management practices, and incidence of HAC. ETHICS AND DISSEMINATION: All participating sites will obtain local ethical approval and (waiver of) informed consent following the regulations on the conduct of observational clinical studies. The results will be disseminated through scientific presentations at conferences and through publication in peer-reviewed journals. TRIAL REGISTRATION NUMBER: The HEPATIC registry is registered at the ClinicalTrials.gov website; Registry Identifier: NCT05818644.

Proposed Increases in Government Authority Over Research Misconduct Proceedings.

This Viewpoint discusses changes proposed by the US Department of Health and Human Services' Office of Research Integrity that would shift control of research misconduct proceedings from institutional oversight to federal authority.

Acupuncture for hot flashes in hormone receptor-positive breast cancer: A pooled analysis of individual patient data from parallel randomized trials.

BACKGROUND: Hot flashes are a common side effect of endocrine therapy (ET) that contribute to poor quality of life and decreased treatment adherence. METHODS: Patients with breast cancer wo were receiving ET and experiencing hot flashes were enrolled through three parallel, randomized trials conducted in the United States, China, and South Korea. Participants were randomized to either immediate acupuncture (IA) or delayed acupuncture control (DAC). IA participants received 20 acupuncture sessions over 10 weeks, whereas DAC participants received usual care, then crossed over to acupuncture with a reduced intensity. The primary end point was a change in score on the endocrine symptom subscale of the Functional Assessment of Cancer Therapy (FACT)-Endocrine Symptoms between baseline and week 10. Secondary end points included the hot flash score and the FACT-Breast score. A planned pooled analysis of individual patient data was performed using longitudinal mixed models. RESULTS: In total, 158 women with stage 0-III breast cancer were randomized (United States, n = 78; China, n = 40; South Korea, n = 40). At week 10, IA participants reported statistically significant improvements in the endocrine symptom subscale score (mean change ± standard error: 5.1 ± 0.9 vs. 0.2 ± 1.0; p = .0003), the hot flash score (-5.3 ± 0.9 vs. -1.4 ± 0.9; p < .003), and the FACT-Breast total score (8.0 ± 1.6 vs. -0.01 ± 1.6; p = .0005) compared with DAC participants. The effect of the acupuncture intervention differed by site (p = .005). CONCLUSIONS: Acupuncture led to statistically and clinically meaningful improvements in hot flashes, endocrine symptoms, and breast cancer-specific quality of life in women undergoing ET for breast cancer in the United States, China, and South Korea.