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Enhancing communication with bereaved relatives about emergency and critical care trials (ENHANCE): a mixed-methods study

Por: Doughty · H. · Deja · E. · Young · B. · Welters · I. · Shepherd · V. · Milosevic · S. · OHara · K. · Carman · J. · Sankar · V. · Thomas-Jones · E. · Euden · J. · Woolfall · K.
Objectives

Clinical research in emergency and critical care is vital, but recruitment and consent are complex. Research may be conducted without prior consent when patients are critically ill, and interventions are time critical. Some patients may die before research participation can be discussed with relatives, leaving the bereaved unaware of their involvement. This study explored potential communication strategies for informing bereaved relatives when a patient has died following enrolment into an emergency or critical care study without prior consent.

Design and setting

A mixed-methods study using a telephone survey and semi-structured interviews conducted simultaneously. The survey was conducted within a National Health Service Trust in North West England with relatives of deceased study participants. Semi-structured interviews were conducted with bereaved relatives and research and clinical staff across the UK, and medical examiner (ME)/ME officers based in England and Wales. Quantitative data were analysed descriptively, and qualitative data were analysed using reflexive thematic analysis. Data were synthesised using a constant comparison approach.

Participants

11 bereaved relatives completed the survey. 53 individuals (21 research and clinical staff, 18 relatives and 14 MEs/officers) participated in semi-structured interviews.

Results

Although many trials do not include a process for notifying bereaved relatives about research participation, most relatives valued the opportunity to learn about their family member’s participation, emphasising the importance of transparency and trust. However, some raised concerns over the potential burden of automatic disclosure by the ME service. Offering bereaved relatives the option to receive sensitively worded information about research involvement at an appropriate time, soon after death, was recommended.

Conclusion

Bereaved relatives should have the choice to be informed about research participation without prior consent. Our findings support the need for transparent and sensitive communication and will contribute to future guidance for the design and conduct of adult emergency and critical care studies.

Protocol for a mixed-methods modified Delphi study for the development of a core domain set to assess the health-related quality of life of patients with mycosis fungoides and Sezary syndrome in clinical trials

Por: Asare · C. · Raymundo · C. · Chen · J. · Perez-Chada · L. · Tawa · M. · Thornton · S. · Ottevanger · R. · Scarisbrick · J. · Olsen · E. · Khan · N. · Kim · E. J. · Shinohara · M. M. · Larocca · C. · International Dermatology Outcomes Measures Cutaneous Lymphoma Working Group Addi
Introduction

Cutaneous T cell lymphoma (CTCL) is a group of non-Hodgkin lymphomas that primarily affects the skin and can mimic inflammatory dermatoses. Unlike many skin diseases, CTCL can lead to disabling symptoms, and advanced CTCL can even be fatal. Early studies investigating health-related quality of life (HRQOL) in patients with mycosis fungoides (MF) and Sézary syndrome (SS), common subtypes of CTCL, demonstrated significant impairment across numerous domains. The aim of this current study is to develop a core domain set (CDS) to identify the essential aspects of MF/SS that influence HRQOL that should be measured in therapeutic clinical trials. In the future, this set of core concepts will be used to identify the best patient- reported outcome measure(s) (PROM) for HRQOL for MF/SS clinical research.

Methods and analysis

Multiple strategies will be used to generate candidate concepts: systematic review of the literature, qualitative study and a survey study of healthcare providers. A Delphi consensus process including a comprehensive group of stakeholders (patients, caregivers/care partners, a multidisciplinary group of healthcare professionals, patient advocacy groups, pharmaceutical industry representatives, methodologists and government agencies) will be used to achieve consensus. Statistical corrections for multiple significance testing and false positive findings will be undertaken.

Ethics and dissemination

The study was submitted for and received institutional review board approval at the University of Washington (IRB# STUDY00018890 and STUDY00019407). Informed consent will be obtained from all participants where necessary. We will disseminate our findings through peer-reviewed, open access publications and presentations at national/international conferences. We will provide a plain language summary in lay terms for patients and families to patient advocacy groups for distribution to their network.

Registration details

The protocol is registered in the Core Outcome Measures in Effectiveness Trials (COMET) database.

Impact of redeployment on healthcare staff well-being and retention: a survey of staff in the UK National Health Service

Por: Weyman · A. · Glendinning · R. · OHara · R.
Background

The redeployment of healthcare staff from their normal place of work and duties to alternative activities is not a new phenomenon and has typically been used as a temporary measure to address capacity gaps. While redeployment supports the mobilisation of a flexible healthcare workforce, it also presents as a source of tension in relation to staff well-being and retention. This paper reports findings from a survey of staff in the UK National Health Service (NHS), exploring the impact of redeployment.

Method

An online survey was administered by YouGov (2023), addressing contemporary evidence on variables impacting staff health, well-being and disposition to remain in NHS employment. The sample comprised NHS employees representing the principal healthcare job families and grades across acute hospitals, mental health, community and ambulance services. Statistical analysis (SPSS V.29.0.2.0) compared (independent samples t-test, z-test and 2 test for trend) redeployed and non-redeployed staff response profiles.

Results

The staff who had experienced redeployment in the 6 months prior to spring 2023 showed higher rates of submitting applications for non-NHS jobs (22%; non-redeployed staff 12%). Redeployed staff reported higher stress, lower morale and less ability to switch off from work than non-redeployed staff (p

Conclusions

The findings highlight the negative impacts associated with staff redeployment and challenges to staff health, well-being and disposition to remain employed in healthcare. Despite a growing consensus regarding the need to support the redeployed, evidence regarding ‘what works’ remains under-researched. Such insight is particularly pertinent given the growing interest in technological solutions for a more agile workforce, where deployment flexibility is a key feature.

Protocol for a cervical screening implementation trial comparing two approaches for delivering HPV self-collection in low-resource settings in India: a type 3 hybrid cluster randomised controlled trial (SHE-CAN)

Por: Oommen · A. M. · Ashfaq · M. · Tonsing · M. V. · Cherian · A. G. · Singarayar · P. · Viswanathan · V. · Muniswamy · V. · Hawkes · D. · Abraham · P. · Pricilla · R. A. · Manoharan · R. · Zomawia · E. · Oldenburg · B. · Saville · M. · Krishnaraj · K. · T S · S. · Basu · P. · Brotherton · J.
Background

Although multiple studies have offered self-collection for human papillomavirus (HPV)-based cervical screening in community settings, there are no randomised controlled trials (RCTs) that have compared implementation outcomes of programme approaches for self-collection. This trial will compare two such approaches in low-resource settings in the states of Tamil Nadu and Mizoram, India.

Methods

A cluster RCT will be conducted over a year, offering self-collection to 3000 women aged 30–49 from 28 clusters (average size 101) in selected districts. Clusters in tribal, rural and urban low-income settings will be randomised to two arms. The intervention arm, co-designed with multiple stakeholders, will involve campaigns to offer self-collection in the community. The comparison arm will be offered self-collection at the nearest health facilities.

HPV-based cervical screening will be performed at central laboratories using clinically validated screening assays that can identify the highest risk carcinogenic HPV types (Group 1a–c - HPV16/18/31/33/45/52/58, ±35). Ablative treatment will be based on positivity with this extended genotyping triage, while those with any of the lower carcinogenic HPV types (Group 1d - 39, 51, 56, 59, ±35, Groups 2a/b - 66, 68) will undergo further assessment with visual inspection with acetic acid. Outcomes will be evaluated quantitatively and qualitatively using RE-AIM and the Theoretical Framework of Acceptability.

Analysis

The primary outcome will be percentage of women well-managed (screened and appropriately treated) in both arms, with secondary outcomes including proportion screened, proportion treated, acceptability (willingness to screen, rescreen, and/or recommend to others) to women, community and healthcare providers, adoption (by providers), implementation fidelity, costs, sustainability assessment and systematically identified implementation barriers and facilitators. The reach, effectiveness and acceptability of community-based self-collection and the use of extended genotyping for triage in resource-constrained, hard-to-reach populations will be assessed, with lessons that can inform future statewide and national programmes.

Ethics and dissemination

Ethics approval has been obtained from the Institutional Review Board (IRB) and Ethics Committee of the Christian Medical College Vellore, Tamil Nadu, India (IRB Min. No 14314; INTERVEN), the Alfred Hospital Ethics Committee (HREC Ref 80134, Local Reference: project 601/21), Melbourne, Australia, the IARC Ethics Committee (IEC 21-32), Lyon, France, the Salem Polyclinic Institutional Ethics Committee (SPCIEC/2022/June/01/02), Tamil Nadu, India and the Institutional Ethics Committee, Civil Hospital, Aizawl, Mizoram, India (No.B.12018/1/13-CHA(A)/IEC/115). The study is also approved by the State Scientific Advisory Committee, Directorate of Public Health and Preventive Medicine, Chennai, Tamil Nadu (R. No. 011575/HEB/A2/2023). The Alfred Hospital Approval, as an authorised Australian ethics committee for national mutual recognition, is recognised and registered with the University of Melbourne Human Research Ethics Committee (2024-25255-57650-1). Written informed consent will be obtained from participants. The results of the trial will be disseminated through a peer-reviewed medical journal, and also through workshops, reports and conferences.

Trial registration number

The trial has been registered with the Clinical Trials Registry - India: CTRI/2022/04/042327.

Housing environment bilaterally alters transcriptomic profile in the rat hippocampal CA1 region

by Azusa Kubota, Kentaro Kojima, Shinnosuke Koketsu, Takayuki Kannon, Takehiro Sato, Kazuyoshi Hosomichi, Yoshiaki Shinohara, Atsushi Tajima

Brain asymmetry is a fundamental feature of neural organization. However, the molecular basis of hippocampal lateralization in response to environmental stimuli remains poorly understood. Here, we examined the transcriptomic profiles of the left and right hippocampal CA1 regions in rats reared under isolated or enriched housing conditions to elucidate hemisphere-specific responses and shared molecular adaptations. RNA-sequencing analysis revealed lateralized differences in the number and identity of differentially expressed genes, accompanied by distinct biological themes, as indicated by overrepresentation and gene set enrichment analysis. The left CA1 region was prominently engaged in pathways related to synaptic organization and mitochondrial function, whereas the right CA1 region exhibited enrichment in transcriptional regulation and RNA metabolic processes. Despite these asymmetries, co-expression and protein–protein interaction network analyses revealed shared molecular architectures. Immediate early genes formed consistent central hubs across both hemispheres, and a common Mecp2–Grin2b–Cdkl5–Tet3 protein interaction cluster was identified as a potential integrative regulatory module. Additional enrichment analysis of differentially expressed genes shared between hemispheres further highlighted conserved responses, particularly in synaptic plasticity and cell–cell communication. Together, these findings demonstrate that the left and right CA1 regions employ distinct yet partially convergent transcriptional programs to adapt to environmental stimuli. This coordinated molecular asymmetry provides novel insights into hippocampal lateralization and its role in experience-dependent brain plasticity.

Exploring Health Care Needs and HR‐QOL Among Women With Cancer: A Principal Component Analysis Before and 6 Months After Treatment Initiation

ABSTRACT

Aim

To examine the characteristics of the health care needs corresponding to the medical care process and HR-QOL of women with cancer.

Design

A descriptive design was adopted.

Methods

The study's participants were 122 women with cancer who completed a survey before and 6 months after treatment initiation. A principal component analysis (PCA) was conducted on a set of 12 health care satisfaction scores at each point. Correlations were examined between the resulting components and HR-QOL indicators, including subjective well-being, symptoms, symptom-related interference, anxiety and depression.

Results

Most participants reported high health care satisfaction in both phases. PCA indicated the presence of 3 distinct domains: satisfaction with health care, health care management and supportive care. In both phases, these domains accounted for about 60% of the variance, while the remaining 40% was unexplained. Only satisfaction with health care was correlated with HR-QOL at both phases, with particularly strong associations observed for subjective well-being and depression at 6 months. Before treatment initiation, the item of ‘nursing care and practice’ received the highest average score, but demonstrated a negative loading on the component of ‘satisfaction with health care management’. The component of ‘satisfaction with supportive care needs’ was retained at both phases.

Conclusion

Health care plays a pivotal role in maintaining patients' quality of life, while supportive care and the integration of nursing practice within health care management remain essential.

Implications for Patient Care

High satisfaction scores do not necessarily mean that all health care needs are met. Addressing unmet needs from the perspective of HR-QOL and ensuring continuous supportive care throughout the treatment process is imperative.

Patient Contribution

Data provided by women with cancer was used.

Intensive care with endovascular catheter rewarming for accidental severe hypothermia (ICE-CRASH II): a protocol for a randomised controlled study

Por: Takauji · S. · Hayakawa · M. · Yokobori · S. · Kano · H. · Shimizu · K. · Horikoshi · Y. · Shimazaki · J. · Tachino · J. · Inoue · A. · Moriyama · T. · Sawano · H. · Fukushima · H. · Sugiyama · K. · Sunada · D. · Toyohara · T. · Sawamoto · K. · Isokawa · S. · Morikawa · M. · Suzuki · G. · Om
Introduction

Accidental hypothermia (AH) can occur in mild-to-severe cases; however, its management is crucial in severe cases as it can cause ventricular fibrillation and lead to death. Among various rewarming therapies for AH, endovascular catheter rewarming has been the focus of recent studies as a minimally invasive alternative to invasive internal rewarming, such as extracorporeal membrane oxygenation (ECMO). However, no study has demonstrated the efficacy and safety of endovascular catheter rewarming therapy. This study aimed to validate the efficacy and safety of endovascular catheter rewarming for patients with AH.

Methods and analyses

The intensive care with endovascular catheter rewarming in accidental severe hypothermia (ICE-CRASH II) study is a multicentre, randomised study of patients with AH. This study will include patients with AH (age ≥65 years, core temperature

Ethics and dissemination

This study was approved by the Hokkaido University Certified Review Board (approval number: 024-00013). Written informed consent will be obtained from all the participants or their legally acceptable representatives. The results will be disseminated through publications and presentations.

Trial registration number

Japan Registry of Clinical Trials (jRCT1012240051).

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