Clinical effectiveness and cost-effectiveness of the rehabilitation enablement in chronic heart failure facilitated self-care rehabilitation intervention for people with heart failure with preserved ejection fraction and their caregivers: rationale and protocol for a multicentre randomised controlled trial – REACH-HFpEF trial

Introduction
Heart failure with preserved ejection fraction (HFpEF) is common and causes functional limitation, poor health-related quality of life (HRQoL) and impairs prognosis. Exercise-based cardiac rehabilitation is a promising intervention for HFpEF, but there is currently insufficient evidence to support its routine use. This trial will assess the clinical and cost-effectiveness of a 12-week health professional-facilitated, home-based rehabilitation intervention (REACH-HF), in people with HFpEF, for participants and their caregivers.

Methods and analysis
REACH-HFpEF is a parallel two group multicentre randomised controlled trial with 1:1 individual allocation to the REACH-HF intervention plus usual care (intervention group) or usual care alone (control group) with a target sample size of 372 participants with HFpEF and their caregivers recruited from secondary care centres in United Kingdom. Outcome assessment and statistical analysis will be performed blinded; outcomes will be assessed at baseline and 4-month and 12-month follow-up. The primary outcome measure will be patients’ disease-specific HRQoL, measured using the Minnesota Living with Heart Failure questionnaire, at 12 months. Secondary outcomes include patient’s exercise capacity, psychological well-being, level of physical activity, generic HRQoL, self-management, frailty, blood biomarkers, mortality, hospitalisations, and serious adverse events, and caregiver’s HRQoL and burden. A process evaluation and substudy will assess the fidelity of intervention delivery and adherence to the home-based exercise regime and explore potential mediators and moderators of changes in HRQoL with the intervention. Qualitative studies will describe facilitators’ experiences of delivery of the intervention. A cost-effectiveness analysis (CEA) of the REACH-HF intervention in participants with HFpEF will estimate incremental cost per quality-adjusted life year at 12 months. The CEA will be conducted from a UK NHS and Personal Social Services perspective and a wider societal perspective. The adequacy of trial recruitment in an initial 6-month internal pilot period will also be checked.

Ethics and dissemination
The study is approved by the West of Scotland Research Ethics Committee (ref 21/WS/0085). Results will be disseminated via peer-reviewed journal publication and conference presentations to researchers, service users and policymakers.

Trial registration number
ISRCTN47894539.

Read More

Association between patient activation, self-management behaviours and clinical outcomes in adults with type 2 diabetes: a systematic review with narrative synthesis

Objectives
Patient activation (PAct)—a measure assessing an individual’s perceived knowledge, skills and confidence in managing their health and well-being—is often used to personalise and evaluate care, although its causal link to self-management behaviours (SMBs) and clinical outcomes remains uncertain. We aimed to synthesise the evidence on the causal association between PAct, SMBs and clinical outcomes in type 2 diabetes (T2D).

Design
Systematic review and narrative synthesis of data summarised in a harvest plot.

Data sources
We searched Medline, Embase, CENTRAL, PsycInfo, Web of Science and CINAHL up to April 2024 for relevant English articles.

Eligibility criteria
We included studies of any quantitative design that reported on the association of PAct with clinical outcomes or SMBs in adult patients with T2D.

Data extraction and synthesis
Two independent reviewers were involved, and any disagreements were discussed and resolved collaboratively. Risk-of-bias (RoB) was assessed using an adapted RoB Assessment Tool for Nonrandomised Studies. Levels of evidence were evaluated for each T2D-related outcome.

Results
We identified 21 studies published between 2009 and 2023, including 15 cross-sectional studies and no randomised controlled trials. Eleven studies were conducted in the USA. Seventeen studies used the Patient Activation Measure questionnaire. There is moderate evidence that higher PAct scores are associated with better glycated haemoglobin levels (studies reporting on this association, n=14). There is very limited evidence that PAct improves diet (n=5) and physical activity (n=6). All other clinical outcomes and SMBs had inconclusive results due to either inconsistent or insufficient evidence, or both.

Conclusion
A causal relationship between PAct, clinical outcomes and SMBs in T2D cannot be established due to inconsistent evidence and a lack of high-quality studies. Thus, the use of PAct scores as a tailoring tool and an outcome measure in healthcare services requires further evaluation.

PROSPERO registration number
CRD42021230727.

Read More

Effect of low-molecular-weight heparin on pregnancy outcomes in Chinese women with recurrent implantation failure undergoing frozen embryo transfer: a double-blind, randomised, placebo-controlled trial

Introduction
The incidence of recurrent implantation failure (RIF) can reach up to 10% among patients undergoing in vitro fertilisation and embryo transfer worldwide. However, the clinical efficacy of low-molecular-weight heparin (LMWH) in RIF remains a subject of controversy. Currently, there is a lack of high-quality clinical research validating the effectiveness of LMWH in treating patients with RIF, particularly during frozen embryo transfer (FET) cycles. Therefore, this randomised controlled trial aimed to investigate the impact of LMWH on pregnancy outcomes in women with RIF undergoing FET.

Methods and analysis
This prospective, single-centre, double-blind randomised, placebo-controlled clinical trial will be conducted in the Second Hospital of Shandong University, China. A total of 414 women with RIF, aged ≤40 years, who are undergoing FET cycles will be recruited and randomly assigned to the study group (LMWH) or the control group (placebo). Only one blastocyst which is from day 5 or day 6 and has a Gardner morphology score ≥4 BC will be transferred. LMWH 4000–6000 IU per day or placebo will be administered by subcutaneous injection from the day of transplantation. The primary outcome is the live birth rate. The secondary outcomes include the clinical pregnancy rate, biochemical pregnancy rate, embryo implantation rate, early miscarriage rate, ongoing pregnancy rate, ectopic pregnancy rate, pregnancy-related complications, perinatal complications, fetal birth weight, congenital malformations and other adverse reactions.

Ethics and dissemination
The protocol received approval from the Ethics Committee of the Second Hospital, Cheeloo College of Medicine, Shandong University (KYLL-2023-442). The findings will be disseminated in peer-reviewed publications.

Trial registration number
Chinese Clinical Trial Registry, ChiCTR2400083577.

Read More

Randomised controlled trial with parallel process evaluation and health economic analysis to evaluate a nutritional management intervention, OptiCALS, for patients with amyotrophic lateral sclerosis: study protocol

Introduction
Amyotrophic lateral sclerosis (ALS) is a devastating illness that leads to muscle weakness and death usually within around 3 years of diagnosis. People with ALS (pwALS) often lose weight due to raised energy requirements and symptoms of the disease presenting significant challenges to taking adequate oral diet, with those who lose more weight being at a greater chance of earlier death. There is also some evidence to suggest that a higher calorie diet may benefit the disease course in pwALS, but further research is needed.

Methods and analysis
Two armed, parallel group, superiority, open labelled, randomised controlled trial, with internal pilot, to assess the effectiveness of an early high calorie diet on functional outcomes in ALS, comprising two treatment arms: (1) standard care, (2) standard care with additional active management using the OptiCALS complex intervention to achieve a high calorie diet (initially randomised 1:1, then 1:2 following a protocol amendment). Using a food first approach, pwALS will be encouraged and supported to follow a diet that meets an individualised calorie target from food before prescribing oral nutritional supplements. 259 pwALS will be recruited from up to 20 ALS centres across the United Kingdom and Ireland and followed up for a period of 12 months. Primary outcome is functional change measured over 12 months, using the Revised Amyotrophic Lateral Sclerosis Functional Rating Scale. Secondary end points include measures of functional health, quality of life, calorie intake and weight, as well as time to gastrostomy and survival. A health economic analysis and process evaluation will also be undertaken. Participant recruitment is expected to complete in September 2025, and participant follow-up is expected to complete in September 2026. The results of this study are expected in March 2027.

Ethics and dissemination
The trial was approved by Greater Manchester—North West Research Ethics Committee, reference 20/NW/0334 on 8 September 2020. We will publish the study findings in peer-reviewed academic journals and present at local, national and international conferences where possible.

Trial registration number
ISRCTN30588041.

Read More

Prehospital antibiotics and intravenous fluids for patients with sepsis: protocol for a 2×2 factorial randomised controlled trial

Introduction
Prompt recognition and treatment of patients with sepsis improve survival. Patients transported to hospital with sepsis often do not receive treatment until they are assessed in emergency departments. Initiation of treatments by paramedics at the point of first contact may improve outcomes for these patients.

Methods and analysis
The study design involves two randomised controlled trials (RCTs) conducted using a 2×2 factorial design comparing use of (1) early intramuscular ceftriaxone versus placebo and (2) an early liberal intravenous fluid strategy (up to 2 L normal saline) versus usual care resuscitation guided by paramedic medical directives. Patients who are ≥18 years of age will be eligible for inclusion if they have sepsis, defined as (1) paramedic suspicion of infection, (2) fever (temperature ≥38.0°C measured by paramedic or history of fever during the previous 24 hours), and (3) hypotension: SBP 250 mL) within 24 hours of hospital arrival; total amount of crystalloid infused during transport and first 24 hours of hospitalisation; and proportion of enrolled patients not suspected to have sepsis or infection by emergency department physicians. Safety outcomes include the proportion of patients with pulmonary oedema during transport to hospital and on initial chest X-ray and the proportion of patients with anaphylaxis or suspected allergic reactions to study medication.

Ethics and dissemination
This study has been approved through Clinical Trials Ontario’s streamlined ethics review process (board of record, Sunnybrook Health Sciences Centre). It will be conducted in accordance with the Declaration of Helsinki, Good Clinical Practice guidelines and regulatory requirements. The final results will be disseminated to participating paramedic services through educational materials, presentations and interactive training. We anticipate our trial will achieve wide dissemination through publication in a peer-reviewed medical journal and presentation at international conferences targeting the fields of prehospital and emergency medicine, resuscitation and critical care.

Trial registration number
NCT03068741.

Read More

Does paired genetic testing improve targeted therapy choices and screening recommendations for patients with upper gastrointestinal cancers and their families? A prospective cohort of 42 patients

Objectives
Our study was designed to assess whether paired normal-tumour testing increased access to targeted therapy, clinical trials and influenced cancer screening recommendations given to patients and their families.

Design
Prospective cohort study.

Setting
Academic cancer centre in the Pacific Northwest region of the USA.

Participants
Patients newly diagnosed between 01 January 2021 and 31 December 2022 with cancers of the oesophagus, gastro-oesophageal junction and stomach (CEGEJS) were included. All other cancer diagnoses such as head and neck, duodenal and lower gastrointestinal tract cancers were excluded.

Intervention
Paired germline and tumour genetic test within 90 days of new patient visit.

Primary outcome measures
Number of targeted therapies received (or not) when eligible, follow-up treatment data and number of inherited predispositions to cancers identified. No secondary outcome measures.

Results
Of 42 patients, 32 (76.2%) were eligible for at least one targeted therapy. 19 patients received immunotherapy, when 16 had a biomarker predicting immunotherapy benefit, and benefit of immunotherapy was unclear for 3. Another 11 did not have this biomarker, and 6 of them received immunotherapy. Six pathogenic variants were identified in four high-risk genes. By 01 January 2024, 18 patients (42.9%) had died of complications of cancer.

Conclusion
More than 75% of patients who received tumour testing were eligible for a targeted therapy regardless of their stage at diagnosis, emphasising the need to expand access to testing with staging workup to improve survival outcomes. Six families received personalised screening recommendations, thanks to this study.

Read More

'Shared efforts, brighter smiles: a protocol for a randomised controlled study on the effectiveness of a parent-child orofacial myofunctional therapy programme post-adenoidectomy

Introduction
Adenoid hypertrophy has a high prevalence in children, often causing early orofacial muscle dysfunction that worsens facial deformities over time. While adenoidectomy (AT) alleviates airway obstruction, it only partially addresses the condition, leaving persistent neuromuscular habits. Orofacial myofunctional therapy is necessary for post-AT recovery but faces challenges such as poor adherence and ineffective parent-child communication. Dyadic interventions, which actively involve both parents and children, have shown advantages in improving treatment adherence and enhancing orofacial muscle function. Evidence suggests that dyadic intervention addresses both the child’s recovery needs and the caregiving capacity of parents, offering a more comprehensive solution for long-term intervention. Therefore, our team developed a parent-child dyadic orofacial myofunctional therapy (PCD-OMT) programme, offering insights into its potential application in paediatric healthcare to support comprehensive family-centred care.

Method and analysis
This two-arm, parallel-design, randomised controlled trial will recruit 80 dyads whose children performed AT from two hospitals in Qingdao, China. Dyads will be randomly allocated to two arms. Dyads randomly assigned to the intervention group will receive the PCD-OMT programme. Dyads randomly assigned to the control group will receive regular care. The primary outcomes are orofacial myofunction in children and parental care abilities. The secondary outcomes are children’s engagement and parental functioning. A feasibility and acceptability process will be employed to evaluate the viability in clinical practice. Outcomes will be collected at three checkpoints: baseline (T0), postintervention (T1) and after a 12-week follow-up phase (T2).

Ethics and dissemination
This study was approved by the Ethics Committee of Medical College of Qingdao University (QDU-HEC-2023216). The results will be published in peer-reviewed publications and presented in international conferences.

Trial registration number
ChiCTR2400091466.

Read More

Development of risk prediction equations for 5-year diabetes incidence using Japanese health check-up data: a retrospective cohort study

Objectives
This study aimed to develop risk prediction equations for the 5-year incidence of diabetes among the Japanese population using health check-up data. We hypothesised that demographic and laboratory data from health check-ups could predict diabetes onset with high accuracy.

Design
Retrospective cohort study.

Setting
Data from a health examination in Japan between 2008 and 2016.

Participants
Data were analysed from 31 084 participants aged 30–69 years. The presence of baseline diabetes and endocrine disease was included in the exclusion criteria, as were participants with missing data for the analysis. The study population was randomly divided into derivation and validation cohorts in a 1:1 ratio.

Primary outcome measures
The primary outcome was the incidence of diabetes at the 5-year follow-up, defined as a fasting blood glucose level ≥126 mg/dL, glycosylated haemoglobin A1c (National Glycohemoglobin Standardization Program (NGSP)) ≥6.5%, or initiation of diabetes treatment. Predictor variables included age, sex, body mass index, blood pressure, underlying diseases, lifestyle factors and laboratory measurements. The primary measure was the area under the receiver operating characteristic curve (AUC) for the predictive equations.

Results
In the derivation cohort, diabetes incidence was 5.0%. The prediction equation incorporating age, sex, body mass index, fasting blood glucose and glycosylated haemoglobin A1c showed good discriminatory ability with an AUC of 0.89, sensitivity of 0.81 and specificity of 0.81 in the validation cohort.

Conclusions
The equation with laboratory measures effectively predicted the 5-year diabetes risk in the general Japanese population. It has potential clinical utility for identifying individuals at high risk of diabetes and guiding preventive interventions.

Read More

Camrelizumab vs Placebo in Patients With Triple-Negative Breast Cancer

To the Editor A recent trial reported that camrelizumab in combination with chemotherapy significantly improved the pathological complete response (pCR) compared with placebo in combination with chemotherapy among patients with early or locally advanced triple-negative breast cancer (TNBC), with pCR rates of 56.8% vs 44.7%, respectively. However, the 18-month event-free survival rates were 86.6% vs 83.6% (hazard ratio, 0.80 [95% CI, 0.46-1.42]), showing no statistical significance, and the wide CI indicates that the study had a relatively short follow-up period and immature survival data.

Read More

[Viewpoint] The importance of long-term studies in children following viral infection of the central nervous system

Viruses are a major cause of central nervous system (CNS) infections in pediatric patients, often resulting in significant rates of morbidity and mortality. Many viruses have been implicated in neurodevelopmental disorders with long-term consequences that significantly impact families, healthcare systems, economies, and society. Unfortunately, however, long-term follow-up studies evaluating neurodevelopmental outcomes in pediatric survivors of viruses affecting the nervous system are limited. The disease burden of CNS infection is often highest in regions where resources are lowest, such as in low- and middle-income countries (LMICs).

Read More

Cohort profile: AMBulatoRy blOod preSsure in older adults (AMBROSIA) and AMBROSIA-HOME

Purpose
The AMBulatoRy blOod preSsure In older Adults (AMBROSIA) study cohort was designed to determine whether ambulatory blood pressure (BP) monitoring (ABPM) is useful for identifying older adults with hypertension taking antihypertensive medication who are at increased risk for falls. The association of home BP monitoring (HBPM) with falls was assessed in an ancillary study (AMBROSIA-HOME).

Participants
AMBROSIA was a prospective observational study of adults aged 65 years and older taking antihypertensive medication for hypertension. Participants were recruited from Kaiser Permanente Southern California (KPSC), an integrated healthcare delivery system, and enrolled from May 2019 to November 2022. Demographic and clinical characteristics and geriatric assessments were collected over the course of two consecutive study visits. Participants completed a 24-hour ABPM and 1 week of HBPM. Over the following year, falls were assessed using a monthly falls calendar, and serious fall injuries were assessed from the KPSC electronic health record (EHR).

Findings to date
We enrolled 670 participants; 656 completed 24-hour ABPM and 536 also completed HBPM. The mean (SD) age of the AMBROSIA cohort was 75 (6) years, 16% were over 80 years of age and 56% were female. There were 13% non-Hispanic Asian or Pacific Islander, 22% non-Hispanic Black, 18% Hispanic and 44% non-Hispanic White participants. Nearly 72% had mild cognitive impairment, 50% were pre-frail and 4% were frail. Overall, 87% of participants returned all monthly calendars during follow-up.

Future plans
The AMBROSIA cohort can be updated with longitudinal data from the EHR including antihypertensive medication to explore the relationship of fall risk and white coat effect, defined as the difference between clinic BP and out-of-clinic BP, BP variability over 24 hours and postprandial BP decline with antihypertensive medication intensification during follow-up. Additionally, the cohort can be updated to include outcomes data from the EHR such as cardiovascular events to examine BP phenotypes as potential predictors of cardiovascular events.

Read More

An adaptive multiarm randomised trial of biomedical and psychosocial interventions to improve convalescence following severe acute malnutrition in sub-Saharan Africa: Co-SAM trial protocol

Introduction
Children discharged from hospital following management of complicated severe acute malnutrition (SAM) have a high risk of mortality, readmission and failed nutritional recovery. Current management approaches fail to sufficiently promote convalescence after inpatient nutritional rehabilitation. Novel interventions during the post-discharge period could enhance convalescence to help children survive and thrive.

Methods and analysis
The Co-SAM trial is an adaptive, multicountry, phase III, individually randomised clinical trial, based on the principles that (i) interacting biological and social factors drive multimorbidity in children with SAM, and (ii) both medical and psychosocial interventions may therefore ameliorate underlying causal pathways to reduce morbidity and mortality and improve recovery. Children aged 6–59 months with complicated SAM, who have stabilised and started the transition to ready-to-use therapeutic food (RUTF), will be enrolled and randomised to one of five trial arms (standard-of-care alone; antimicrobials; reformulated RUTF; psychosocial support; or a combination of all strategies). Standard-of-care, which is provided in all trial arms, includes RUTF until nutritional recovery (defined as weight-for-height Z-score >–2, mid-upper arm circumference >12.5 cm and oedema-free since the last study visit), and other management recommended in WHO guidelines. The 12-week antimicrobial package provides daily co-formulated rifampicin and isoniazid (with pyridoxine) and 3 days of azithromycin monthly. The reformulated RUTF, which incorporates medium-chain triglycerides and hydrolysed protein to increase nutrient bioavailability and reduce metabolic stress, is provided at the same dose and duration as standard RUTF. The 12-week psychosocial package includes caregiver problem-solving therapy, educational modules, peer support groups and child play. The combined arm includes all interventions. Children start their intervention package prior to hospital discharge, with follow-up data collection in study clinics at 2, 4, 6, 8, 12 and 24 weeks. The primary composite outcome is death, hospitalisation or failed nutritional recovery within 24 weeks post-randomisation. An interim analysis will allow unpromising arms to be dropped, while the final analysis will be conducted when 1266 children have completed the study. Embedded process evaluation and laboratory substudies will explore the mechanisms of action of the interventions.

Ethics and dissemination
The trial has been approved by ethics committees in Zimbabwe, Zambia, Kenya and UK. Dissemination will be via community advisory boards in each country; Ministries of Health; and dialogue with policymakers including UNICEF.

Trial registration number
Clinicaltrials.gov: NCT05994742; Pan African Clinical Trials Registry: PACTR202311478928378.

Read More

Characterising physical activity patterns in community-dwelling older adults using digital phenotyping: a 2-week observational study protocol

Introduction
Physical activity (PA) is crucial for older adults’ well-being and mitigating health risks. Encouraging active lifestyles requires a deeper understanding of the factors influencing PA, which conventional approaches often overlook by assuming stability in these determinants over time. However, individual-level determinants fluctuate over time in real-world settings. Digital phenotyping (DP), employing data from personal digital devices, enables continuous, real-time quantification of behaviour in natural settings. This approach offers ecological and dynamic assessments into factors shaping individual PA patterns within their real-world context. This paper presents a study protocol for the DP of PA behaviour among community-dwelling older adults aged 65 years and above.

Methods and analysis
This 2-week multidimensional assessment combines supervised (self-reported questionnaires, clinical assessments) and unsupervised methods (continuous wearable monitoring and ecological momentary assessment (EMA)). Participants will wear a Garmin Vivosmart V.5 watch, capturing 24/7 data on PA intensity, step count and heart rate. EMA will deliver randomised prompts four times a day via the Smartphone Ecological Momentary Assessment3 application, collecting real-time self-reports on physical and mental health, motivation, efficacy and contextual factors. All measurements align with the Behaviour Change Wheel framework, assessing capability, opportunity and motivation. Machine learning will analyse data, employing unsupervised learning (eg, hierarchical clustering) to identify PA behaviour patterns and supervised learning (eg, recurrent neural networks) to predict behavioural influences. Temporal patterns in PA and EMA responses will be explored for intraday and interday variability, with follow-up durations optimised through random sliding window analysis, with statistical significance evaluated in RStudio at a threshold of 0.05.

Ethics and dissemination
The study has been approved by the ethical committee of Hasselt University (B1152023000011). The findings will be presented at scientific conferences and published in a peer-reviewed journal.

Trial registration number
NCT06094374.

Read More

PlacEntal Acute atherosis RefLecting Subclinical systemic atherosclerosis in women up to 20 years after pre-eclampsia (PEARLS): research protocol for a cohort study

Introduction
Despite being a leading cause of female morbidity and mortality, female-specific cardiovascular disease (CVD) is understudied, underdiagnosed and undertreated. Pregnancy complications involving the placenta, including pre-eclampsia, pregnancy-induced hypertension and foetal growth restriction, are thought to reflect global maternal vascular derangements that indicate a twofold to eightfold increased risk of future CVD. This calls for a better understanding of female cardiovascular pathophysiology to allow development of targeted screening and prevention strategies.
Acute atherosis is a placental vascular lesion, which histologically resembles systemic atherosclerosis. The PlacEntal Acute atherosis RefLecting Subclinical atherosclerosis study investigates the association between placental acute atherosis lesions and subclinical systemic atherosclerosis up to 20 years postpartum.
This study will improve our understanding of the relationship between pregnancy complications and CVD to identify potential prevention targets and treatments. In addition, it could determine whether the placenta can improve identification of young women at high risk of CVD. These women could benefit from risk-reducing interventions.

Methods and analysis
This longitudinal prospective cohort study will include women who are either currently pregnant or from a historical cohort. Both groups will have placental histopathology and a single postpartum CVD assessment. The CVD assessment will include medical history taking, blood tests, electrocardiography and echocardiography. Additionally, coronary CT angiography focusing on the presence of atherosclerotic plaques and calcium score will be carried out.
The currently pregnant women will either have a pre-eclamptic pregnancy (pre-eclamptic group) or an uncomplicated normotensive pregnancy (uncomplicated group), and their placenta will be collected prospectively. The single CVD assessment will be carried out 6–36 months postpartum.
Women from the historical cohort had a pre-eclamptic pregnancy 10–20 years ago. Placental tissue is available for reanalysis. The single CVD assessment will take place immediately and corresponds with 10–20 years postpartum.
Exclusion criteria are contraindications to diagnostic assessment necessities: iodinated contrast, beta-blockers or glyceryl trinitrate. Women with uncomplicated pregnancies will be excluded if they have a pre-existing auto-immune condition, chronic hypertension or diabetes mellitus. In the pre-eclamptic group, there are no additional exclusion criteria.

Ethics and dissemination
Ethical approval was granted by the Medical Ethics Committee in Maastricht University Medical Centre+ (NL52556.068.15/METC152019). Participants will give written informed consent. Results will be shared in peer-reviewed journals and conference presentations.

Trial registration number
NCT05500989; ClinicalTrials.gov Identifier.

Read More

Study protocol for an internahaational prospective non-randomised trial evaluating the long-term outcomes of transcatheter aortic valve implantation versus surgical aortic valve replacement for aortic-valve stenosis in patients at risk to severe valve obstruction: the TAVISAR trial

Background
Aortic valve stenosis (AVS) represents the most prevalent primary valvular lesion necessitating surgical intervention or transcatheter intervention in Europe and North America. Its prevalence is increasing at a rapid rate as a consequence of the ageing population. A variety of mechanical interventions are available to determine the management of AVS; however, there is currently a paucity of robust data with which to perform a comparative analysis of the efficacy of surgical aortic valve replacement (SAVR) and that of conventional stented xenograft bioprostheses (BP) or sutureless aortic valves (SAV) and transcatheter aortic valve implantation (TAVI). The present study aims to compare the effectiveness and clinical outcomes of SAVR using BP or SAV technique and TAVI in patients with severe AVS.

Methods and analysis
A collaboration between three cardiac surgery centres across two European countries has resulted in the conception of the Transcatheter Aortic Valve Implantation vs Surgical Aortic Valve Replacement trial. This prospective non-randomised trial is designed to evaluate the long-term outcomes of TAVI in comparison to SAVR for AVS in patients at risk of severe valve obstruction. The registry will enrol successive patients who have undergone mechanical intervention for AVS between January 2015 and December 2025. Investigators will assess the difference between replacement procedures for both the standard surgical approach and the transcatheter procedure. The principal clinical outcome under consideration will be the composite degree of all-cause mortality, ischaemic stroke or rehospitalisation at 10 years. The present study will also have a number of secondary endpoints, including all-cause mortality, followed by functional status, hospitalisation, neurocognition, physiological measures (echocardiographic assessment), adverse events and reoperation.

Ethics and dissemination
It is hypothesised that the nature of the trials will serve to minimise bias related to institutional volume and surgical experience. Each participating centre is required to have an aortic valve programme that enables proper follow-up and management of any late aortic events following replacement surgery for the AVS. The data collected will provide valuable insight into the comparative effectiveness of various surgical approaches, both standardised and advanced, in aortic valve surgery and TAVI. This comprehensive analysis will contribute significantly to the development of robust international guidelines.

Trial registration number
Clinical Trial Gov.Com. ID: NCT05261204 IRB. ID: 2022011057

Read More

Physicians experiences of the process leading to their sick leave for exhaustion disorder in Sweden: a narrative design

Objectives
The aim of this study was to explore physicians’ experiences of the process leading up to their sick leave due to exhaustion disorder (ED).

Design
A qualitative study with a narrative approach was conducted.

Setting
The study was conducted in Sweden. Interviews with physicians were conducted face-to-face during the Spring and Autumn of 2022. Each interview lasted between 35 and 60 min.

Participants
Purposive sampling was employed to recruit physicians on long-term sick leave for ED. We used an interview guide with open-ended questions.

Results
12 physicians shared their experiences of the process leading to their ED-related sick leave. Four themes related to different phases of the process: Theme 1. Strongly motivated to become a physician, Theme 2. Demands delivering best practice, Theme 3. Symptoms of ill health and Theme 4. Managing symptoms of ED. The narrative analyses showed a holistic understanding of the personal consequences for the physicians and their families as well as the consequences in working life.

Conclusions
Politicians and leaders at different healthcare levels must take responsibility for strengthening the working environment, which is important for creating long-term and sustainable healthcare services.

Read More