Spiritual care for prevention of psychological disorders in critically ill patients: study protocol of a feasibility randomised controlled pilot trial

Introduction
A significant number of critically ill patients who survive their illness will experience new sequelae or a worsening of their baseline health status following their discharge from the hospital. These consequences may be physical, cognitive and/or psychological and have been labelled postintensive care syndrome (PICS). Prior research has demonstrated that spiritual care aligned with a specific creed during hospitalisation in the intensive care unit (ICU), as part of a comprehensive care plan, may be an effective strategy for preventing psychological sequelae in surviving critically ill patients. However, there is a gap in clinical literature regarding the effectiveness of generalist spiritual care in preventing psychological sequelae associated with PICS. This pilot study aims to explore the feasibility of implementing a generalist spiritual care strategy in the ICU and to evaluate its preliminary effectiveness in preventing anxiety and depression symptoms and post-traumatic stress disorder in critically ill patients.

Methods and analysis
This is a single-site, feasibility randomised controlled pilot trial of a generalist spiritual care intervention compared with the current standard of care. A total of 30 adults who are critically ill and have undergone invasive mechanical ventilation for a minimum of 72 hours without alterations in consciousness will be randomly assigned to either the spiritual care group or the usual care group at a ratio of 1:1. The primary outcome will be the feasibility and acceptability of the spiritual care strategy in critically ill patients. Secondary aims include evaluating the differences in anxiety and depression symptoms and post-traumatic stress disorder between the spiritual care group and the usual care control group at 3 months after ICU discharge. Subjects will be followed up until 3 months post-ICU discharge.

Ethics and dissemination
The Ethics Committee for Medical Sciences of Pontificia Universidad Católica de Chile (#220111005) and the Ethics Committee of Servicio de Salud Metropolitano Sur Oriente approved the study. Pontificia Universidad Católica de Chile funded the study (project number 105699/DPCC2021). The findings will be widely disseminated through peer-reviewed publications, academic conferences, local community-based presentations, partner organisations and the Chilean Intensive Care Society.

Trial registration number
NCT06048783.

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Outcomes of Transcatheter Aortic Valve Replacement in Low-Risk Patients in the United States: A Report From the STS/ACC TVT Registry

Circulation, Ahead of Print. BACKGROUND:Real-world low-risk transcatheter aortic valve replacement (TAVR) outcomes in the United States have not been assessed comprehensively versus pivotal trials, which is a key component of measuring the quality of clinical technology adoption.METHODS:We identified heart team–designated low-risk patients undergoing TAVR for trileaflet severe, symptomatic aortic stenosis in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Registry, as well as a subset of patients who met low-risk trial inclusion and exclusion criteria, from January 2020 to March 2024. Outcomes (mortality, stroke, new pacemaker, and “alive and well,” defined as alive at 1 year with Kansas City Cardiomyopathy Questionnaire score ≥60 and ≤10-point decrease from baseline) at 30 days and 1 year were assessed. Multivariable models were developed to assess predictors of death within 1 year after TAVR.RESULTS:Among 383 030 patients who underwent TAVR during the study period, 108 407 (28%) were designated low risk by the heart team, and 68 194 (18%) met other study inclusion and exclusion criteria. Of these, 62% (n=42 093) would have been eligible for the low-risk trials. In the overall heart team–designated low-risk population, 30-day outcomes included 0.8% mortality, 1.5% stroke, and 8.4% new permanent pacemaker requirement; 1-year outcomes included 4.6% mortality, 2.6% stroke, and 90% alive and well. In the trial-eligible population, 0.6% mortality, 1.4% stroke, and 8.0% new permanent pacemaker requirement had occurred by 30 days; values at 1 year included 3.1% mortality, 2.4% stroke, and 92% alive and well. Notable multivariable predictors of 1-year mortality were atrial fibrillation, nontransfemoral access, and lower baseline Kansas City Cardiomyopathy Questionnaire score.CONCLUSIONS:One-year outcomes among real-world trial-eligible patients are excellent, but adverse events are higher compared with published clinical trial data, likely because of greater comorbidity burden and lower baseline Kansas City Cardiomyopathy Questionnaire score. These data can help inform expected outcomes and health status after low-risk TAVR.

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Artificial intelligence-based personalised rituximab treatment protocol in membranous nephropathy (iRITUX): protocol for a multicentre randomised control trial

Introduction
Membranous nephropathy is an autoimmune kidney disease and the most common cause of nephrotic syndrome in non-diabetic Caucasian adults. Rituximab is now recommended as first-line therapy for membranous nephropathy. However, Kidney Disease Improving Global Outcomes guidelines do not recommend any specific protocol. Rituximab bioavailability is reduced in patients with membranous nephropathy due to urinary drug loss. Underdosing of rituximab is associated with treatment failure. We have previously developed a machine learning algorithm to predict the risk of underdosing. We have retrospectively shown that patients with a high risk of underdosing required higher doses of rituximab to achieve remission. The aim of this prospective study is to evaluate the efficacy of algorithm-driven rituximab treatment in patients with membranous nephropathy compared to standard treatment.

Methods
A multicentre, randomised, controlled, open-label, prospective superiority clinical trial will be conducted in 13 French hospitals. 130 consecutive patients with primary membranous nephropathy and active nephrotic syndrome will be randomised to either the standard protocol control group (two 1 g rituximab infusions on days 0 and 15) or the algorithm-driven rituximab treatment group. In the latter, the rituximab dose will depend on the algorithm-estimated risk of underdosing. Patients with an algorithm-estimated risk of underdosing ≤50% will receive 1 g of rituximab on days 0 and 15. Patients with an algorithm-estimated risk of underdosing between 51% and 75% will receive 1 g of rituximab on days 0, 15 and 30. Finally, patients with an estimated risk of underdosing >75% will receive 1 g of rituximab on days 0, 15, 30 and 45. The primary study outcome is the rate of clinical remission (complete or partial) at month 6 after treatment initiation. The secondary outcomes include clinical remission at month 12, immunological remission, proteinuria, albuminuria, serum creatinine, estimated glomerular filtration rate, phospholipase A2 receptor type 1 antibody titre, anti-rituximab antibody occurrence, lymphocyte count, serum rituximab level and related adverse events.

Ethics and dissemination
The trial received ethics approval from the local ethics boards. The results of this study will confirm whether algorithm-driven rituximab treatment is more effective in inducing remission than the standard regimen and thus may contribute to improving management of patients with membranous nephropathy. The results of our study will be submitted to a peer-review journal.

Trial registration number
NCT06341205 trial number. Registered on 2 April 2024.

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A Life course approach to investigate breast cancer and migration in the greater Paris area: the SENOVIE study protocol

Introduction
Breast cancer is a global public health challenge. It is the most commonly diagnosed cancer and the leading cause of cancer-related death in women. Several inequalities remain among women facing this disease, depending on their country of birth and their sociodemographic characteristics. The SENOVIE study (Therapeutic mobility and breast cancer) aims to understand the life trajectories of women born in France and in sub-Saharan Africa treated for breast cancer in four hospitals in the greater Paris area.

Methods and analysis
The SENOVIE study is a mixed methods study, combining a quantitative and a qualitative approach. A quantitative retrospective life-event survey is conducted in four hospital centres in the greater Paris area, France, to (1) understand how breast cancer (diagnosis, treatment and possibly reconstruction) impacts the life trajectories of women in many spheres (migration, family life, professional life, financial situation, etc); (2) study the access to healthcare by women living with breast cancer and their determinants; and (3) examine how gender relations may shape breast cancer experience. Women born in France and women born in sub-Saharan Africa are recruited: 1000 women, including 500 per group. In the standardised, face-to-face questionnaire, each dimension of interest is collected year by year from birth until the time of the survey. Clinical and laboratory information is documented with a short medical questionnaire filled out by the medical teams. The qualitative survey is conducted specifically with women born in sub-Saharan Africa who came to France for treatment to better understand their trajectories and the specific obstacles they faced. To analyse the quantitative data collected, descriptive analyses will be used to visualise trajectories (sequence analysis), along with longitudinal analysis methods (survival models and duration models).

Ethics and dissemination
The study is conducted in accordance with the Declaration of Helsinki. The French Data Protection Authority (Commission Nationale de l’Informatique et des Libertés, declaration number 2231238) and the Committee for Persons’ Protection East I (Comité de Protection des Personnes Est I, national number 2023-A01311-44) approved it. We will disseminate the findings through scientific publications, policy briefs, conferences and workshops.

Trial registration number
The SENOVIE France study is registered on Clinicaltrial.gov (NCT06503393; registration date: 7 September 2024; https://clinicaltrials.gov/study/NCT06503393).

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Risk and protective factors for the mental health of displaced Ukrainian families in the Netherlands: study protocol of a 4-year longitudinal study

Background
Over 6 million people have fled their homes in response to the full-scale invasion of Russian armed forces into Ukraine and are forcibly displaced since the start on 4 February 2022. Refugees, both adults and children, have a high risk of developing mental health disorders, in particular post-traumatic stress disorder, depression and anxiety disorders. Research into the mental health of Ukrainian families and their needs is urgently needed. The primary aim of this study is to increase our understanding of the consequences of potentially traumatic events for the mental health of parents and children. This may inform the development of mental health and psychosocial support interventions which can be readily implemented in the family context.

Methods and analysis
We will conduct a four-wave longitudinal online survey study among Ukrainian families displaced to the Netherlands. This study is a part of the Nadiya data collection, intended to assess the mental health responses of Ukrainian refugee families to the stress of war, forced migration, family separation and adaptation to new circumstances in their hosting country. Participants are assessed at four time points, approximately 6 months apart. Data collection for T1 started in May 2023. We aim to recruit a total of n=1500 participants at T1, of which n=1000 adults (18 years and older) and n=500 children (8–11 years) and teenagers (12–17 years). To investigate symptom profiles and associated risk and protective factors among parents and children, we will use latent class growth modelling.

Ethics and dissemination
The data collection procedure has been approved by the Ethical Committee of the Faculty of Social Sciences of Utrecht University. Data will be deposited, stored and shared using Utrecht University’s institutional research data repository Yoda. This research project is part of the Global Collaboration on Traumatic Stress; all authors are affiliated with this network. The findings will be published in peer-reviewed, open access journals and further disseminated through conference presentations, news updates at the project website and on the websites of the Dutch Society for Traumatic Stress Studies (www.ntvp.nl), and the European Society of Traumatic Stress Studies, as well as through media contributions.

Trial registration number
The current study was registered on 26 March 2024 on The Open Science Framework (OSF): https://doi.org/10.17605/OSF.IO/9FP7U.

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Risk, rate or rhythm control for new onset supraventricular arrhythmia during septic shock: protocol for the CAFS multicentre, parallel-group, open-label trial

Introduction
New-onset supraventricular arrhythmia (NOSVA) is the most common arrhythmia in patients with septic shock and is associated with haemodynamic alterations and increased mortality rates. With no data available from randomised trials, clinical practice for patient management varies widely. In this setting, rate control or rhythm control could be beneficial in limiting the duration of shock and preventing evolution to multiorgan dysfunction.

Methods and analysis
The Control Atrial Fibrillation in Septic shock (CAFS) study is a binational (French and Belgium), multicentre, parallel-group, open-label, randomised controlled superiority trial to compare the efficacy and safety of three management strategies in patients with NOSVA during septic shock. The expected duration of patient enrolment is 42 months, starting from November 2021. Patients will be randomised to receive either risk control (magnesium and control of risk factors for NOSVA), rate control (risk control and low dose of amiodarone) or rhythm control (risk control and cardioversion using high dose of amiodarone with external electrical shock if NOSVA persists) for 7 days. Patients with a history of SVA, NOSVA lasting more than 48 hours, recent cardiac surgery or a contraindication to amiodarone will not be included. We plan to recruit 240 patients. Patients will be randomised on a 1:1:1 basis and stratified by centre. The primary endpoint is a hierarchical criterion at day 28 including all-cause mortality and the duration of septic shock defined as time from randomisation to successful weaning of vasopressors. Secondary outcomes include: individual components of the primary endpoint; arterial lactate clearance at day 3; efficacy at controlling cardiac rhythm at day 7; proportion of patients free from organ dysfunction at day 7; ventricular arrhythmia, conduction disorders, thrombotic events, major bleeding events and acute hepatitis related to amiodarone at day 28; intensive care unit and hospital lengths of stay at day 28.

Ethics and dissemination
The study has been approved by the French (Comité Sud-Ouest et Outre-Mer II, France, registration number 2019-A02624-53) and Belgian (Comité éthique de l’hôpital Erasme, Belgium, registration number CCB B4062023000179) ethics committees. Patients will be included after obtaining signed informed consent. The results will be submitted for publication in peer-reviewed journals.

Trial registration number
NCT04844801.

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JAMA Psychiatry

Mission Statement: JAMA Psychiatry strives to publish original, state-of-the-art studies and commentaries of general interest to clinicians and researchers in psychiatry, mental health, behavioral science, and allied fields. The journal seeks to inform its readers, to stimulate discussion into the nature, causes, treatment, and public health importance of mental illness, and to promote equity and justice for those affected by mental illness and for society.

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Importance of Arm Position and Cuff Width

To the Editor I read with interest the article by Liu et al on the effect of arm position during blood pressure (BP) measurement. This randomized clinical trial confirms the importance of keeping the center of the cuff at heart level during the measurement. As expected, the authors observed an overestimation of BP when the center of the cuff was positioned below the heart. Although the authors considered several clinical variables, they did not investigate the effect of 2 factors that can affect the distance between the cuff and the heart. The BP difference between the reference position and the 2 incorrect positions was not related to the inner length of the upper arm, which is an important determinant of the heart mid-cuff distance. The longer the upper arm in relation to the patient height, the greater the vertical distance between the heart and the midpoint of the cuff, especially when the arm is positioned at the body side. Although the upper arm length is proportional to the patient’s height, arm length may differ among individuals of the same height. In our laboratory, we observed that among 59 patients with a height of 170 cm, inner arm length ranged from 20 to 25 cm, and in 52 patients 160 cm in height, it ranged from 17 to 24 cm.

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Importance of Arm Position and Cuff Width

To the Editor We were pleased to see the article reporting the results of the ARMS crossover randomized clinical trial. In a well-controlled clinical trial, Liu et al provide important empirical data pertinent to the issue of arm position in the measurement of blood pressure (BP). Improper arm position and support of the arm had been a long-standing serious error in the measurement of BP. We now recognize the value of automated BP assessment in home and clinic.

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Importance of Arm Position and Cuff Width—Reply

In Reply We greatly appreciate the comments by Palatini and Elias and Brown on the ARMS crossover randomized clinical trial. We described substantial errors in pressure measurement resulting from commonly used arm positions; ie, with the arm resting in the lap or hanging unsupported at the side. Blood pressure (BP) measurements obtained in these nonrecommended positions overestimated blood pressure by 4.4/4.0 mm Hg (lap) and 6.5/4.4 mm Hg (side), which has the potential to lead to misdiagnosis of hypertension and overtreatment with medications.

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What laparoscopic skills are necessary for the certificate of completion of training? A prospective nationwide cross-sectional survey of obstetrics and gynaecology and general surgery trainees and consultants in the UK

Objectives
To explore the views of obstetrics and gynaecology (O&G) and general surgery (GS) trainees and consultants on the laparoscopic skills considered necessary to achieve the certificate of completion of training (CCT) and identify any mismatch between consultants and trainees in their expectations of these skills.

Design
A prospective nationwide cross-sectional study in the UK.

Setting
A national survey distributed through Health Education, England and national training bodies such as the Royal College of Obstetricians & Gynaecologists, British Society for Gynaecological Endoscopy and the Association of Surgeons of Great Britain and Ireland.

Participants
O&G and GS consultants and specialty trainees in O&G and GS. Specialty trainees below ST3 level and consultants performing open surgery or minor laparoscopic surgery only were excluded.

Interventions
Trainees completed a 27-item questionnaire on their training characteristics, rated their confidence and perceived importance of 10 laparoscopic skills required for CCT using a 5-point Likert scale. Consultants answered a 36-item questionnaire on their demographic details, their views on the importance of the same 10 laparoscopic skills, their confidence and the standard of laparoscopic skills they observed among trainees approaching CCT.

Results
345 participants responded to the questionnaire: 117 O&G trainees, 95 O&G consultants, 57 GS trainees and 76 GS consultants. O&G trainees and consultants expected similar laparoscopic skills required for CCT for all 10 skills (p >0.050), while GS consultants had higher expectations of GS trainees for use of endovascular devices (p

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Mapping the evidence on the assessment of fitness to work at heights: a scoping review

Objectives
Falls from heights are a leading cause of workplace injuries and fatalities. Ensuring worker fitness is crucial, yet many countries lack formal guidelines for fitness for work (FFW) assessments, posing safety and legal risks. This scoping review sought to identify and map the existing evidence on the assessment of fitness to work at heights.

Design
Scoping review following the Joanna Briggs Institute Scoping Review Methodology and Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews guidelines.

Data sources
Searches were conducted in March 2024 across ProQuest Central, Google Scholar, PubMed, Scopus, ScienceDirect, Web of Science and PsycINFO. Grey literature was sourced from the websites of organisations including the International Labour Organisation, Safe Work Australia, Canadian Centre for Occupational Health and Safety, Health and Safety Executive (UK), Occupational Safety and Health Administration (USA), WHO, Centre for Construction Research and Training (USA), Institution of Occupational Safety and Health (UK), South African Society of Occupational Medicine, South African Society of Occupational Health Nursing and Institute for Work at Height (South Africa), in addition to general Google searches.

Eligibility criteria for selecting studies
Our inclusion criteria encompassed both peer-reviewed and grey literature that addressed either ‘fitness for work at heights’, ‘fitness for work in high-risk settings requiring work at heights’ or human risk factors associated with working at heights.

Data extraction and synthesis
A data extraction framework and guidance sheet were developed, piloted and refined through team discussions. An iterative review process was followed, with one author extracting and coding data while two authors conducted quality checks. Deductive qualitative content analysis was applied to the extracted data.

Results
68 articles met the inclusion criteria, but only 7 directly addressed fitness to work at heights, with the rest focusing on fitness to work in high-risk settings requiring work at heights or human risk factors associated with work at heights. This highlights a lack of peer-reviewed research specific to the topic. Key challenges included FFW assessments failing to reflect job demands, inconsistent application of FFW evaluations, lack of standardisation and inadequate stakeholder collaboration. Legal tensions between employer safety obligations and worker rights were also noted. Critical human risk factors—such as physical and mental limitations, adverse states, human error and rule violations—significantly affected worker safety, though evidence of their specific impact in this context remained limited. Findings on the economic implications of FFW assessments were also inconclusive.

Conclusion
Assessing FFW at heights is vital for worker safety, yet key challenges persist. This review highlights gaps in evidence on human risk factors and assessment methods. Findings emphasise the need for practice-based research, standardised fitness criteria and interdisciplinary protocols for preplacement assessment and ongoing monitoring.

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