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PubMed2026

Preemptive hematopoietic stem cell transplantation in RUNX1 familial platelet disorder: a shared decision-making framework.

RUNX1 familial platelet disorder (RUNX1-FPD) is associated with a 35-50% lifetime risk of hematologic malignancy (HM). Like all germline HM predisposition syndromes, RUNX1-FPD can only be cured with allogeneic hematopoietic stem cell transplantation (HSCT). Current genetic screening techniques allow for early detection of germline predisposition and, consequently, the opportunity for HSCT before overt development of HM (i.e., preemptive HSCT). However, there is as yet no consensus on the use of preemptive HSCT for RUNX1-FPD. Described here is the case of an individual with RUNX1-FPD and a family history of HM who underwent preemptive HSCT. We introduce a shared decision-making framework designed to support individuals with RUNX1-FPD, their families, and their multidisciplinary clinical teams in evaluating whether and when to pursue preemptive HSCT versus continued surveillance. The framework reviews key medical factors that influence the decisions regarding timing of HSCT, including germline and somatic variants, clonal changes over time, familial history of HM, early morphologic or hematologic features, impacts on bleeding-related quality of life, and donor availability. The framework also summarizes the major risks and uncertainties potentially associated with preemptive HSCT while highlighting the associated ethical challenges. Together, the case and framework provide a structured, patient-centered approach for navigating the complex clinical decision of preemptive HSCT. Ongoing collaborative efforts to define cytogenetic and clonal changes preceding malignant transformation in RUNX1-FPD will refine the framework and bolster individualized treatment strategies aimed at preventing HM and improving the quality of life of individuals with RUNX1-FPD.

Humans↗

PubMed2026

How do we counsel patients on short- and long-term complications after hypospadias repair? - A survey study.

INTRODUCTION: Hypospadias correction remains one of the most performed pediatric urologic procedures, affecting up to 1/150 males born in the United States. Current studies suggest that surgical counseling has a significant impact on shared decision making, decisional regret, and long-term follow-up. However, no set paradigm currently exists for long-term follow-up or counseling. We sought to obtain consensus from established pediatric urologists the optimal content and potential short, intermediate, and long-term complications to be considered when counseling patients and parents of patients with hypospadias. METHODS: We conducted an IRB-approved survey study, which sampled the responses of Pediatric Urologists from National and International listservs. A google scholar search was performed using key words including "hypospadias" and "long-term complications." Descriptions of pertinent short, intermediate and long-term complications were identified and compiled from existing patient handouts. Survey items were then developed asking respondents to rate proposed descriptions, provide potential edits, and describe their overall approach to counseling. RESULTS: A total of 290 surgeons were contacted with 120 (41 %) responding. In total, 89 respondents (74 %) identified as male and 105 (88 %) had undergone a pediatric urology fellowship. Most surgeons described a reliance on verbal counseling (95 %) with the assistance of hand-drawn diagrams (75 %) to explain long-term care, rather than electronic or audiovisual materials (3-12 %). Of note, fewer surgeons endorsed routine discussion of long-term complications (Range 29.2 %-50.8 %) than shorter-term complications (56.7 %-89.2 %). On a Likert scale, physicians reported that they were mostly satisfied (72 %) with their current approaches to counseling. DISCUSSION: Perioperative counseling has an important yet often overlooked role in surgical care. The aim of this study was to better understand current counseling practices in pediatric hypospadias to identify gaps in urologic care and areas for improvement as one of the most common conditions treated by pediatric urologists. Our results suggest that surgeons who perform hypospadias repairs have potential to include more comprehensive discussion during post-operative follow-up. We proposed a preliminary counselling guide for these concerns which incorporates language from the most commonly selected complication description by survey respondents. Future studies will involve expert consensus and patient input to confirm the adequacy of the content, the method of delivery, content appearance, and accommodations for health literacy. Limitations of the study include small sample size and response bias. The results are reflective of the summed responses of participants and are not reflective of individual providers or practices. Importantly, this study omits the input of other advanced practice providers (nurse practitioners, physician assistants, etc.), nurses, and ancillary staff who are also crucial to hypospadias care. The proposed counseling guide represents a first attempt at creating standardization of hypospadias counseling. CONCLUSION: Surgeons who perform hypospadias repair do not routinely discuss long-term complications after repair, though are overall satisfied with their counseling practices. Better tools, such as improved multimodal counseling guides, could be used to deliver this counseling efficiently and accurately to ensure patients receive optimal long-term care. Future studies will focus on developing educational materials for short, intermediate, and long-term counseling on complications after hypospadias repair with input from patients and clinicians.

Humans↗

PubMed2026

Characteristics of children with ureteroceles presenting for urological evaluation in the modern medical era.

INTRODUCTION: Historically, children with ureteroceles presented symptomatically and were managed surgically. It is unclear if this changed in the modern medical era of prenatal imaging and shared decision making. We aimed to describe the presentation and management of ureteroceles during initial urological evaluation of children in the era of widespread prenatal ultrasonography. PATIENTS AND METHODS: We retrospectively reviewed records of children (<18 years old [yo]) initially evaluated at our center with a ureterocele (2011-2020). We analyzed demographics, renal anatomy, initial presentation for evaluation, and initial management with non-parametric statistics. Febrile urinary tract infections (fUTIs, ≥ 38 °C) were classified as 1) urosepsis (positive urine culture admitted to pediatric intensive care), 2) documented (positive urine culture) or 3) family-reported. RESULTS: We identified 188 children (65% female). Median age at presentation was 1.2 months old (mo) (IQR 18 days-4.4 mo). Antenatally-detected congenital anomalies of the kidney and urinary tract (aCAKUT) were noted in 143 (76%) children with a confirmed postnatal diagnosis of ureterocele. Overall, 129/188 (69%) children presented without symptoms and 59 (31%) presented with symptoms. fUTI was the most common symptomatic presentation (46/188, 24%): urosepsis (6 children), documented (30), and family-reported (10). Children with aCAKUT presented earlier than those without aCAKUT (27 days vs. 1.6 yo, p < 0.0001). They were also less likely to present with symptoms (11% vs. 96%, p < 0.0001), including fUTIs (7% vs. 78%, p < 0.0001). In total, 108 children (57%) were initially managed with transurethral incision, 73 (39%) were observed, and 7 (4%) had reconstructive surgery. Asymptomatic children with aCAKUT (42%) and symptomatic children without aCAKUT (37%) were more likely to be observed than symptomatic children with aCAKUT (7%, p = 0.02). Among 143 children with aCAKUT, those on antibiotic prophylaxis were less likely to present with a history of a fUTI compared to those not on prophylaxis (4/106 vs. 6/37, 4% vs. 16%, p = 0.02). COMMENT: We present a large observational study describing clinical and anatomical characteristics of children presenting with ureteroceles in a medical era of ubiquitous prenatal ultrasonography. Our retrospective study was limited by incomplete documentation of all antenatal ultrasonography and adherence with antibiotic prophylaxis. Long-term clinical outcomes will be the focus of future work. CONCLUSION: In contrast to historical cohorts, most children presented to urologists with asymptomatic ureteroceles diagnosed with aCAKUT. Most children without aCAKUT presented with a fUTI. Overall, 39% of children were initially observed, indicating an increased use of observation in the modern medical era.

Humans↗

PubMed2026

Evaluating A Patient-Led Health Literacy Program for People Living With Metastatic Breast Cancer.

IntroductionLow cancer health literacy undermines patients' ability to interpret complex information and participate in shared decision making, and is associated with worse outcomes. Evidence for effective health literacy interventions in metastatic breast cancer (MBC) remains limited. We evaluated a patient-led, virtual health literacy program designed to strengthen MBC-specific knowledge and self-efficacy.MethodsWe conducted a mixed-methods, pre-post evaluation across two program iterations (Fall 2023; Spring 2024) delivered by a national, patient-led-MBC organization, Project Life. The five-week synchronous course called Spinning Science covered breast cancer subtyping, genetic/genomic testing, clinical trials, circulating tumor DNA, and information literacy, with small-group activities and polling. Program participants were adults living with MBC. De-identified pre/post surveys assessed (1) self-efficacy for engaging in health decisions, and (2) knowledge using items adapted from the Cancer Health Literacy Test aligned to course content. Paired two-sample t-tests examined pre-post changes (α=0.05). Open-ended responses were analyzed thematically.ResultsFifty-four people with MBC were enrolled (cohort 1, n=17; cohort 2, n=37); 46 provided matched pre- and post-surveys (14 and 32, respectively). Agreement with "I don't know enough to make my own medical decisions" declined from 43% pre to 13% post (p<0.05), indicating improved self-efficacy. Baseline knowledge scores were high, and knowledge item gains were not statistically significant, consistent with ceiling effects. Post-program items showed >80% agreement for increased confidence in self-advocacy, improved health literacy, and sense of community. Qualitative feedback highlighted strengths like digestible content, approachable patient facilitators and flexible scheduling, as well as priorities for refinement such as continued access to materials, and more MBC-specific and numeracy content.ConclusionsA patient-developed, virtual health literacy program for people living with MBC showed meaningful improvements in self-efficacy, with actionable, participant-driven refinements between cohorts. This model offers a practical, scalable pathway for advancing self-efficacy within and beyond MBC.

Humans↗

PubMed2025

Primary Care Provider Perspectives on Expanded Genomic Screening in Children.

OBJECTIVES: Expanding pediatric genomic screening beyond current newborn screening presents both opportunities and challenges to primary care providers. We are developing a novel paradigm called Age-Based Genomic Screening (ABGS), which will incorporate targeted genomic sequencing for select, highly actionable genetic conditions into routine care at relevant time-points throughout childhood. We surveyed pediatric primary care providers in North Carolina to identify potential ABGS implementation determinants and strategies to address them. STUDY DESIGN: We disseminated an electronic survey to family medicine and pediatric primary care clinicians. Survey items were modeled on constructs previously identified as important to genomic medicine and assessed perceived utility, benefits, barriers, and facilitators of implementing targeted genomic screening in pediatric primary care. Data were analyzed using descriptive statistics and content analysis, as appropriate. RESULTS: A total of 93 individuals completed the survey. Over 85% of respondents agreed that genomic screening was important and impactful in their patient care but about 30% lacked confidence in their ability to implement it in their practice. The most cited benefits of the ABGS program were related to readiness for implementation and the evidence, strength, and quality of the intervention. The most concerning barriers included cost for patients and available resources, with 87% and 75% of respondents having extreme or moderate concern for these barriers, respectively. CONCLUSIONS: Our findings have implications both for the design of the ABGS pilot program and directions for future research in genomic implementation. In particular, the blueprint for the pilot program must include specific plans for ensuring primary care providers have the time and resources available for shared decision making with their patients about engaging in genomic screening.

Journal Article↗

PubMed2025

Quantitative Outcomes for Shared Assessment and Management in Forensic Mental Health: A Meta-Analysis and Systematic Review.

Despite leading models of mental health care encouraging user involvement, users in forensic mental health (FMH) report poor involvement given the difficulty in reconciling shared approaches with risk-averse and legally mandated settings. While previous research has demonstrated qualitative benefits to shared approaches in FMH and has led to a proliferation of self-rated assessment tools, there remains to quantify agreement on self-rated tools and to clarify the impact of shared approaches on care. This meta-analysis examines (1) the correlation between clinician and user ratings, (2) the predictive validity of self-ratings for violence, and (3) the effects of shared risk management on violence and restriction in FMH. Five databases were searched from inception to April 2024, selecting for adult FMH inpatients, shared risk assessment, needs assessment or violence management as interventions, and quantitative outcomes (correlation, agreement, predictive validity, and effect on violence or restriction rates). Fifteen quantitative evaluations were retained. One of three planned meta-analyses could be conducted, with seven records providing paired clinician-user t-tests. Eleven more records provided clinical recommendations on operationalizing shared approaches. Random-effects meta-analysis showed a significant and large paired standard difference of .95 (95% CI = [.49,1.42]) across tools, with significant differences in DUNDRUM-3, DUNDRUM-4, and CANFOR sub-models. While acknowledging between-study heterogeneity, results substantiate quantitative differences where clinicians generally rate more needs and lesser progress than users across tools, showing that self-ratings can and should be used to broach collaborative discussions on needs and progress during FMH treatment. There remains an evidence gap for quantitative benefits in care outcomes and a need to standardize agreement measures for future comparisons and clinical sub-group analyses.

Humans↗

PubMed2026

Making patient-oriented decisions with collegial support as an anchor: Oncologists' experiences of late-line treatment selection in metastatic breast cancer.

BACKGROUND: Treatment guidelines support oncologists in treatment decision-making for patients with metastatic breast cancer (MBC). However, treatment decision-making is complicated by the rapid pace of therapeutic advances, the complexity of incorporating patient preferences, and the underrepresentation of diverse populations in clinical trials. This study explored oncologists' experiences of treatment selection in late-line MBC when evidence and guidelines provide limited guidance. MATERIALS AND METHODS: This qualitative study was conducted using a constructivist approach and involved individual interviews with twelve oncologists in Sweden. Participants had between five and forty years of experience in breast cancer care and worked within publicly funded healthcare across academic and regional hospitals. An inductive reflexive thematic analysis was used to identify themes, with attention to both manifest and latent meanings in the data. RESULTS: The overarching theme interpreted was: Making patient-oriented treatment decisions with collegial support as an anchor, reflecting how oncologists adapt their treatment decision-making to patient needs while relying on colleagues for professional stability. Four themes were elucidated: Offering to use professional knowledge and experience to decide; Inviting the patient to a dialogue to decide; Supporting the patient in making the final decision; and Turning to colleagues for advice and support. CONCLUSION: This study challenges the positivist evidence-based assumption that oncologists act as neutral facilitators who simply present treatment options for patients to choose. Instead, it positions oncologists as active decision-makers who clearly state their professional stance, retain responsibility for treatment decisions, and respect patient autonomy, moving beyond the traditional, dichotomized shared decision-making model. IMPLICATIONS TO PRACTICE: We argue that oncologists are active stakeholders in a value-led decision-making process and encourage them to clearly articulate the values underlying their recommendations. This approach enables patients to be addressed with full autonomy, while the ultimate responsibility for treatment decisions remains with the oncologist.

Humans↗

PubMed2026

The Moral of the Story-Perception of Leadership With Moral Distress in Registered Nurses: A Qualitative Systematic Review.

AIM: To understand how Registered Nurses perceive the impact of nursing leadership on managing moral distress and mitigating burnout. BACKGROUND: Moral distress and burnout are pervasive issues in nursing, compromising well-being, patient safety and workforce sustainability. Leadership is a critical factor in shaping workplace culture and mitigating these challenges, yet evidence remains limited. DESIGN: Qualitative systematic review. METHODS: A qualitative systematic review was conducted following JBI methodology and PRISMA guidelines. Comprehensive searches across MEDLINE, PsycINFO, Embase, CINAHL and Scopus identified 5927 articles, with two studies meeting the inclusion criteria. Data were appraised using the JBI Critical Appraisal Checklist and synthesised via meta-aggregation. Confidence in findings was assessed using the ConQual approach. RESULTS: Four major themes emerged: (1) Behind the barriers, (2) Breaking point, (3) Weathering the storm and (4) Leadership for lasting change. Leadership influenced nurses' psychological safety, ethical decision-making and resilience. Inadequate support amplified moral distress, and effective strategies included authentic communication, team solidarity and systemic interventions. CONCLUSIONS: Leadership plays a pivotal role in mitigating moral distress and burnout. Evidence highlights the need for structural changes and support to sustain registered nurses' well-being and retention. RELATIVE TO CLINICAL PRACTICE: Findings offer direction for leadership strategies that promote ethical workplaces, shared decision-making and mental health supports to enhance resilience and patient care. IMPLICATIONS FOR THE PROFESSION AND/OR PATIENT CARE: Strengthening leadership capability is vital for workforce sustainability, care quality and nurse retention. REPORTING METHOD: Authors have adhered to relevant EQUATOR guidelines. PATIENT OR PUBLIC CONTRIBUTION: This study did not involve patients or the public in its design, conduct or reporting.

Leadership↗

PubMed2026

Total ankle replacement versus nonoperative management for end-stage ankle osteoarthritis: A comparative analysis.

BACKGROUND: The optimal management of end-stage ankle osteoarthritis remains debated. This study compared short-term outcomes between non-operative treatment, total ankle replacement (TAR), and cases in which indicated surgery was delayed. METHODS: In this secondary analysis of prospectively collected data, treatment survival, Foot and Ankle Outcome Score (FAOS), and patient satisfaction were assessed at baseline and at 1- and 2-year follow-up. RESULTS: In a total of 316 patients one-year treatment survival was highest for TAR (99.3%), followed by NOM (94.4%) and delayed surgery (80.9%). TAR demonstrated significantly superior FAOS pain and quality-of-life scores compared with NOM and delayed surgery. Delayed surgery was associated with significantly worse pain and quality-of-life outcomes. Patient satisfaction was highest in the TAR group and lowest in the delayed surgery group. CONCLUSIONS: TAR provides superior pain relief, quality of life, and satisfaction compared with non-operative management in end-stage ankle OA. While NOM remains a valid option for selected patients, delaying indicated surgery results in inferior outcomes, underscoring the importance of timely, shared decision-making.

Humans↗

PubMed2026

Preoperative intramuscular testosterone and urethrocutaneous fistula formation after primary hypospadias repair.

INTRODUCTION: Preoperative androgen stimulation is widely used before hypospadias repair to increase penile dimensions and optimise surgical conditions. However, its impact on postoperative complications, particularly urethrocutaneous fistula formation, remains controversial. OBJECTIVE: To evaluate the association between preoperative intramuscular testosterone therapy and urethrocutaneous fistula formation in children undergoing primary hypospadias repair. STUDY DESIGN: This was a retrospective comparative analysis of prospectively collected clinical data from 111 boys undergoing primary hypospadias repair at a single tertiary pediatric urology center. Patients were divided into two groups: those who did not receive hormonal therapy (Group 1, n = 55) and those who received intramuscular testosterone enanthate (2 mg/kg administered 5 and 2 weeks before surgery; Group 2, n = 56). Preoperative penile measurements, operative characteristics, and postoperative complications were compared. The primary outcome was urethrocutaneous fistula formation. The mean follow-up duration was 11.9 months (median 7 months). RESULTS: Preoperative testosterone therapy was associated with significant increases in glans diameter and stretched penile length at the time of surgery. The hormone-treated group had a significantly higher proportion of proximal hypospadias (p = 0.001), underwent more complex urethroplasty procedures, and had longer operative times (p = 0.007). Postoperative edema and local inflammatory changes were more frequently observed in the hormone-treated group. Despite these differences, urethrocutaneous fistula occurred in four patients in each group (7.3% vs 7.1%, p = 0.357), with no statistically significant difference between groups. DISCUSSION: Despite greater baseline anatomical severity and operative complexity in the hormone-treated group, preoperative testosterone administration was not associated with an increased risk of urethrocutaneous fistula. These findings suggest that improved tissue bulk and vascularity may offset the potential adverse effects of transient inflammatory changes. CONCLUSION: Selective preoperative intramuscular testosterone therapy was not associated with increased urethrocutaneous fistula risk and may be considered a reasonable adjunct in appropriately selected patients undergoing primary hypospadias repair. CLINICAL/TRANSLATIONAL APPLICABILITY: These findings provide clinical reassurance that preoperative testosterone can be used selectively in patients with smaller penile dimensions or anticipated technical difficulty without increasing fistula risk, thereby supporting shared decision-making in clinical practice.

Humans↗

PubMed2026

Maternal vaccination with RSVpreF and risk of hypertensive disorders of pregnancy: a systematic review and meta-analysis.

BACKGROUND: A bivalent respiratory syncytial virus (RSV) prefusion F protein-based vaccine (RSVpreF) was approved in the United States in August 2023 for use during pregnancy to prevent infant RSV-associated lower respiratory tract disease. The pivotal phase 3 trial identified a numerical imbalance in hypertensive disorders of pregnancy (HDP) that did not reach statistical significance; postmarketing observational studies have since reported inconsistent findings. We conducted a systematic review and meta-analysis to assess this association. METHODS: We searched MEDLINE, Embase, CENTRAL, Scopus, ClinicalTrials.gov, and WHO ICTRP from inception to Jan 26, 2026, for randomized controlled trials (RCTs) and observational studies comparing HDP outcomes in RSVpreF-vaccinated versus unvaccinated or placebo-receiving pregnant individuals. Unadjusted risk ratios (RRs) were pooled using a random-effects model; adjusted estimates from observational studies were pooled separately by inverse variance methods. This study is registered with PROSPERO (CRD420251026835). RESULTS: Nine studies were included (3 RCTs, 6 retrospective cohort studies; n = 148,267). RSVpreF vaccination was associated with a small but statistically significant increase in overall HDP risk (RR 1·08, 95% CI 1·02-1·13; p = 0·004; I2 = 44%), driven by the observational studies group (1·08, 1·02-1·14; I2 = 61%); RCTs showed a directionally consistent but non-significant RR (1·12, 0·87-1·43; I2 = 0%). The association was attributable to gestational hypertension, with no significant association for preeclampsia/eclampsia. CONCLUSION: Maternal RSVpreF vaccination was associated with a small increase in HDP attributable to gestational hypertension and driven primarily by observational studies, in which residual confounding remains possible. The benefits of infant RSV prevention remain substantial, and these findings support continued postmarketing surveillance and informed shared decision-making.

Humans↗

PubMed2026

Health-related quality of life after risk-reducing hysterectomy: a randomised vignette study.

BACKGROUND: Risk-reducing hysterectomy (RRH) is the most effective endometrial cancer preventive strategy. Understanding health-related quality-of-life using health-related utility-scores (HRUS) is essential for counselling, shared decision-making, and informing health-economic evaluations of endometrial cancer prevention. This study aimed to determine HRUS for premenopausal RRH, with and without bilateral salpingo-oophorectomy (BSO). METHODS: Preventing Endometrial-Cancers: Comparing Risk-Reducing Strategies (PRESCORES) (ISRCTN17432105) part-2 is a UK-based randomised vignette study. Following a robust development process, vignettes described four postoperative health-states for a 40-year-old otherwise-healthy woman: "RRH at 1-month", "RRH at 1-year", "RRH-BSO at 1-month", "RRH-BSO at 1-year". These were valued using EQ-5D by participants recruited from the UK general-population and HRUS calculated. Utilities were subsequently adjusted by age-and sex-matched general-population reference values. Association of variables was explored with ordinary-least-squares regression with non-parametric bootstrapping. FINDINGS: Overall, 1001 women were included and randomised to 1-of-4 groups. The mean-age(±SD) was 53.6 (±11.4) years. Mean(±SD) HRUS were 0.942 (±0.072) for "RRH at 1-year", 0.841 (±0.137) for "RRH-BSO at 1-year", 0.670 (±0.149) for "RRH at 1-month", and 0.733 (±0.190) for "RRH-BSO at 1-month", with significant difference between each group (p < 0.001). Adjusting for age-sex-matched population reference utilities, HRUS were 1.000(95% CI:1.00-1.00), 0.994(95% CI:0.97-1.00), 0.866(95% CI:0.84-0.90) and 0.791(95% CI:0.77-0.81), respectively. Participant factors associated with vignette valuations included age, obesity, heavy menstrual-bleeding, higher income and mixed/other ethnicity. CONCLUSION: This randomised study provides HRUS following premenopausal RRH with and without BSO at two postoperative time-points, with adjustment against the age-and sex-matched general reference-population. These values are of relevance for informing counselling of women at increased endometrial cancer-risk regarding RRH and for health-economic evaluations.

Humans↗

PubMed2026

Risk prediction in patients with heart failure with preserved ejection fraction: the LIFE-Preserved model.

BACKGROUND AND AIMS: Heart failure (HF) with preserved ejection fraction (HFpEF) constitutes a heterogeneous disease with varying prognosis. Given the rising incidence of HFpEF, accurate risk prediction for these patients is needed to identify high-risk individuals, who may benefit the most from preventive treatments. The LIFE-Preserved model was developed and validated for the prediction of individual short-term and lifetime risk for HF hospitalization or cardiovascular (CV) death in patients with HFpEF. METHODS: LIFE-Preserved was derived in 20 332 patients aged 40-90 years with a left ventricular ejection fraction ≥ 50% from the Swedish HF Registry. Cause- and sex-specific Cox models were derived to predict the risk of HF hospitalization or CV death using 14 routinely available predictors. Use of age as the timescale allowed for predictions beyond the maximum follow-up duration in the derivation data, adjusted for competing risks. External validation was performed in two trials (EMPEROR-Preserved and TOPCAT-Americas) and three registries (NHS England Secure Data Environment, Veterans Affairs, and HF-Particles). Model performance was assessed by discrimination and calibration. RESULTS: During a median follow-up of 1.8 years (interquartile range .6-4.2, maximum 19 years), 9341 first HF hospitalizations or CV deaths (46%) were observed in Swedish HF Registry. External validation included data from 28 062 patients with HFpEF [9930 (35%) first HF hospitalizations or CV deaths]. Pooled C-statistics were .714 (95% confidence interval .652-.775) in trials and .658 (95% confidence interval .599-.717 in registries, with adequate calibration in all external validation sources. Performance was similar in men and women. An interactive calculator of the LIFE-Preserved model has been made available here. CONCLUSIONS: The LIFE-Preserved model enables prediction of short-term and lifetime risk of HF hospitalization or CV death in patients with HFpEF. The model could serve as a tool to identify high-risk HFpEF patients, guiding clinical management and shared decision-making.

Humans↗

PubMed2026

Approaches to thyroid nodules in paediatric cancer predisposition syndromes.

OBJECTIVE: The objective of this work was to summarize current evidence and practical management considerations for thyroid nodules in children and adolescents with cancer predisposition syndromes (CPSs), focusing on follicular cell-derived nodules and non-medullary thyroid carcinoma (NMTC). METHODS: We synthesized current paediatric guideline recommendations and recent cohort, pathology, and molecular studies addressing CPS-associated nodular thyroid disease, including PTEN hamartoma tumour syndrome (PHTS), DICER1 syndrome, familial adenomatous polyposis, and related endocrine neoplasia syndromes. RESULTS: Evidence quantifying syndrome-stratified malignancy risk among paediatric CPS patients presenting with nodules remains limited and is largely derived from mixed-age or retrospectively ascertained cohorts with surveillance and verification bias. High-resolution ultrasound (US) is central to risk stratification. US-guided fine-needle aspiration (FNA) is a cornerstone of evaluation yet frequently yields indeterminate results, particularly in follicular-patterned and encapsulated lesions (e.g. PHTS and DICER1 syndrome), and sampling error is accentuated in polyclonal multinodular disease. Molecular testing may aid aetiologic clarification and, in selected settings, risk refinement. However, panels optimized for sporadic adult disease may have reduced 'rule-out' utility in CPSs. Biochemical assessment (TSH ± free thyroxine) complements imaging, while routine thyroglobulin is not recommended, and thyroid autoantibodies should be viewed as adjunctive rather than directive markers in CPSs. CONCLUSION: Management of thyroid nodules in paediatric CPSs is best approached through integrated, multidisciplinary risk assessment that combines expert ultrasound, context-aware cytology and molecular interpretation, and shared decision-making. This review proposes a CPS-adapted, multidisciplinary risk assessment framework and highlights the need for prospective multicentre registries and harmonized protocols to define syndrome-specific outcomes and evidence-based thresholds for surveillance and intervention.

Humans↗

PubMed2026

Development of a Blockchain-Based Platform to Enable Indigenous Data Sovereignty and Shared Research Participation With Indigenous Communities: Technology Prototyping and Community Engagement Study.

BACKGROUND: Historic and ongoing problematic practices regarding the collection, storage, and use of Indigenous health data have led to the need to ensure principles of Indigenous Data Sovereignty (IDS) are followed in research practices and technology development. OBJECTIVE: This project, a partnership between UC San Diego and the Native BioData Consortium (NativeBio), sought to explore the practical application of blockchain technology and its potential to facilitate Indigenous-led research collaboration. METHODS: This project first undertook purposeful relationship building with NativeBio to form a Community Advisory Board (CAB) for identifying community and technology needs for a blockchain research collaboration platform with an initial focus on genomic data. Over a 2-year project period, a series of public meetings and presentations at Indigenous-led conferences introduced the concept of exploring compatibility between blockchain and IDS principles, followed by iterative prototyping and co-design of a blockchain platform with NativeBio, using Ethereum as the underlying protocol. RESULTS: Direct engagement with NativeBio and the CAB informed the initial design and development of a "b-IDS" proof-of-concept (POC) blockchain platform. The POC consists of three main components: (1) the web front-end layer, (2) the Ethereum network that executes the smart contract and blockchain storage aspects of the framework, and (3) the back-end database that stores off-chain interactions and data for future use with external genomic data repositories. After refinement of the POC, a community-based participatory research (CBPR) use case aligned with IDS principles was identified as a practical workflow and incorporated into the design of the POC for implementation. CONCLUSIONS: The findings from this project demonstrated the potential use of operationalizing IDS through blockchain technology with proactive and sustained engagement with Indigenous partners. Blockchain technology may have certain advantages over other data governance approaches and systems, facilitating timely oversight, shared decision-making and consent structures, and direct involvement of Indigenous communities in technology design, respecting the core principles of IDS and CBPR. Future development of the blockchain-IDS POC will need to incorporate other research practices and ethics frameworks to expand its use to other public health and biomedical research use cases.

Blockchain↗

PubMed2025

Estimated Long-Term Benefits of Finerenone in Heart Failure: A Prespecified Secondary Analysis of the FINEARTS-HF Randomized Clinical Trial.

IMPORTANCE: People living with heart failure (HF) with mildly reduced or preserved ejection fraction have substantially curtailed life expectancy free from clinical events compared with their peers of comparable age. The nonsteroidal mineralocorticoid receptor antagonist, finerenone, was recently shown to reduce risks of cardiovascular events in this population over a median follow-up of 2.6 years; as patients with HF typically continue treatment beyond this time frame, estimating the potential long-term benefits of finerenone could inform shared clinical decision-making. OBJECTIVE: To estimate the projected long-term treatment effects of finerenone in patients with HF with mildly reduced or preserved ejection fraction if treated over a patient's lifetime. DESIGN, SETTING, AND PARTICIPANTS: Prespecified analyses were conducted of the FINEARTS-HF trial, a phase 3 randomized clinical trial conducted across 653 sites in 37 countries. Adults 40 years and older with symptomatic HF and left ventricular ejection fraction of 40% or greater were randomized from September 2020 to January 2023. Median (IQR) follow-up was 2.6 (1.9-3.0) years. INTERVENTIONS: Finerenone (titrated to either 20 mg or 40 mg) or placebo. MAIN OUTCOMES AND MEASURES: The primary composite outcome was time to cardiovascular death or worsening HF event. The long-term gains in survival free from a primary end point with finerenone were iteratively estimated with age-based Kaplan-Meier curves using age at randomization rather than time from randomization. Differences in areas under the survival curves between the finerenone and placebo arms represented event-free survival gains. RESULTS: Among 6001 participants (median [IQR] age, 73 [66-79] years; 3269 male [54.5%]), mean survival free from the primary end point for a 55-year-old participant was 13.6 years (95% CI, 11.9-15.2 years) with finerenone and 10.5 years (95% CI, 6.8-11.3 years) with placebo, representing a gain in event-free survival of 3.1 years (95% CI, 0.8-5.4 years; P = .007). Mean event-free survival for a 65-year-old participant was 11.0 years (95% CI, 10.1-11.9 years) with finerenone and 8.9 years (95% CI, 8.1-9.8 years) with placebo, representing a gain of 2.0 years (95% CI, 0.8-3.3 years; P = .001). Projected mean event-free survival was numerically greater with finerenone than with placebo for every starting age between 50 to 80 years. Lifetime gains in event-free survival were observed even among individuals already treated with a sodium-glucose cotransporter 2 inhibitor (65-year-old participant: 3.1 years; 95% CI, 0.1-6.0 years; P = .04). CONCLUSIONS AND RELEVANCE: In this prespecified secondary analysis of the FINEARTS-HF randomized clinical trial, long-term treatment with finerenone was estimated to extend event-free survival by up to 3 years among people with HF with mildly reduced or preserved ejection fraction. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04435626.

Humans↗

PubMed2026

Perspectives of participating neurologists and study nurses - Mixed-methods process evaluation of a web-based program for relapse management in multiple sclerosis (POWER@M2).

BACKGROUND: Relapsing-remitting multiple sclerosis is a chronic inflammatory disease of the central nervous system and the leading cause of disability in young adults. In Germany, 90% of relapses are treated with high-dose intravenous glucocorticoids, despite limited evidence for long-term benefit and international preference for oral administration. Time constraints often hinder informed decision-making. The multicentre Randomized Controlled Trial (RCT) POWER@MS2 (N = 160, 2020-2023), conducted at 18 German MS-centres, aimed to promote self-determined relapse management through a complex intervention (dialogue-based decision aid, nurse-led webinar, online-chat). OBJECTIVE: While RCTs demonstrate effectiveness, process evaluations are essential to understand implementation, mechanisms of impact and contextual factors. This study explored healthcare professionals' experiences and attitudes toward implementing relapse self-management and self-medication in clinical practice. METHODS: A mixed-methods process evaluation followed the UK Medical Research Council- framework. Quantitative data were collected via validated questionnaires at up to three time points and analysed descriptively. Interview guides were developed based on these results. Qualitative data from neurologist and study nurse interviews were thematically analysed. Results were triangulated using a joint display. RESULTS: Data were collected from 55 neurologists and 17 study nurses (quantitative) and from 7 neurologists and 4 nurses (qualitative) (2020-2024). Most neurologists opposed routine steroid use, reserving it for severe relapses. Some voiced concerns about self-management, but informed patients were generally viewed as capable of safe self-medication. Study nurses gave mixed feedback on the intervention, citing overload and improved guidance. CONCLUSION: Clinicians showed openness toward implementing the intervention. Enhancing accessibility and addressing specific concerns may support broader adoption.

Humans↗

PubMed2026

Acceptability of capillary point-of-care testing: a systematic review.

OBJECTIVE: To identify and synthesise evidence on the acceptability and perceived experience of finger-prick point-of-care testing (POCT) among patients and clinicians across healthcare settings. DESIGN: Systematic review conducted in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA 2020) guidelines. DATA SOURCES: Medline, Embase, PsycInfo, CINAHL, Cochrane and Web of Science were searched from inception to January 2024 and re-run in July 2025, supplemented by citation tracking of relevant studies. ELIGIBILITY CRITERIA: Studies reporting patient and clinicians' experiences, perceptions, satisfaction or acceptability relating to finger-prick POCT for any health condition or blood parameter were eligible. Quantitative, qualitative and mixed-methods designs were included. DATA EXTRACTION AND SYNTHESIS: Data were extracted independently by two reviewers and synthesised using thematic analysis and narrative synthesis. Methodological quality was appraised using the Mixed-Methods Appraisal Tool. RESULTS: 21 studies met the inclusion criteria, encompassing 9128 participants (17 quantitative, 3 qualitative, 1 mixed methods). Across diverse clinical contexts, finger-prick POCT was reported as generally acceptable, less distressing and perceived as a convenient alternative to venous sampling in comparative studies. Thematic synthesis identified two major themes: (1) enhancing the patient-clinician relationship through improved engagement, communication and understanding of care and (2) clinical implications of finger-prick POCT on clinicians' workflow, confidence and skill acquisition. Finger-prick POCT was perceived to promote personalised consultations, enable immediate discussion of results and streamline decision-making. Clinicians highlighted its potential to expand task sharing, improve efficiency and strengthen continuity of care, although concerns regarding training, reliability and quality assurance were identified. CONCLUSIONS: Finger-prick POCT is generally acceptable to patients and clinicians, improving comfort, convenience, engagement and perceived efficiency. Implementation should prioritise training, infrastructure and quality assurance frameworks to maximise clinical and experiential benefits. PROSPERO REGISTRATION NUMBER: CRD42024512130.

Humans↗