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Protocol for the Adolescent Menstrual Experiences and Health Cohort (AMEHC) Study in Khulna, Bangladesh: A Prospective cohort to quantify the influence of menstrual health on adolescent girls health and education outcomes.

Por: Hennegan · J. · Hasan · M. T. · Jabbar · A. · Jalil · T. · Kennedy · E. · Hunter · E. · Kaiser · A. · Akter · S. · Zaman · A. · Rahman · M.-u. · Dunstan · L. · Head · A. · Scott · N. · Weiss · H. A. · Win · T. M. · Melendez-Torres · G. J. · Than · K. K. · Hughes · C. L. · Grover · S. · Hasan
Background

Menstrual health is essential for gender equity and the well-being of women and girls. Qualitative research has described the burden of poor menstrual health on health and education; however, these impacts have not been quantified, curtailing investment. The Adolescent Menstrual Experiences and Health Cohort (AMEHC) Study aims to describe menstrual health and its trajectories across adolescence, and quantify the relationships between menstrual health and girls’ health and education in Khulna, Bangladesh.

Methods and analysis

AMEHC is a prospective longitudinal cohort of 2016 adolescent girls recruited at the commencement of class 6 (secondary school, mean age=12) across 101 schools selected through a proportional random sampling approach. Each year, the cohort will be asked to complete a survey capturing (1) girls’ menstrual health and experiences, (2) support for menstrual health, and (3) health and education outcomes. Survey questions were refined through qualitative research, cognitive interviews and pilot survey in the year preceding the cohort. Girls’ guardians will be surveyed at baseline and wave 2 to capture their perspectives and household demographics. Annual assessments will capture schools’ water, sanitation and hygiene, and support for menstruation and collect data on participants’ education, including school attendance and performance (in maths, literacy). Cohort enrolment and baseline survey commenced in February 2023. Follow-up waves are scheduled for 2024, 2025 and 2026, with plans for extension. A nested subcohort will follow 406 post-menarche girls at 2-month intervals throughout 2023 (May, August, October) to describe changes across menstrual periods. This protocol outlines a priori hypotheses regarding the impacts of menstrual health to be tested through the cohort.

Ethics and dissemination

AMEHC has ethical approval from the Alfred Hospital Ethics Committee (369/22) and BRAC James P Grant School of Public Health Institutional Review Board (IRB-06 July 22-024). Study materials and outputs will be available open access through peer-reviewed publication and study web pages.

Ultrasound measurement of traumatic scar and skin thickness: a scoping review of evidence across the translational pipeline of research-to-practice

Por: Meikle · B. · Simons · M. · Mahoney · T. · Reddan · T. · Dai · B. · Kimble · R. M. · Tyack · Z.
Objectives

To identify the ultrasound methods used in the literature to measure traumatic scar thickness, and map gaps in the translation of these methods using evidence across the research-to-practice pipeline.

Design

Scoping review.

Data sources

Electronic database searches of Ovid MEDLINE, Embase, Cumulative Index of Nursing and Allied Health Literature and Web of Science. Grey literature searches were conducted in Google. Searches were conducted from inception (date last searched 27 May 2022).

Data extraction

Records using brightness mode (B-mode) ultrasound to measure scar and skin thickness across the research-to-practice pipeline of evidence were included. Data were extracted from included records pertaining to: methods used; reliability and measurement error; clinical, health service, implementation and feasibility outcomes; factors influencing measurement methods; strengths and limitations; and use of measurement guidelines and/or frameworks.

Results

Of the 9309 records identified, 118 were analysed (n=82 articles, n=36 abstracts) encompassing 5213 participants. Reporting of methods used was poor. B-mode, including high-frequency (ie, >20 MHz) ultrasound was the most common type of ultrasound used (n=72 records; 61% of records), and measurement of the combined epidermal and dermal thickness (n=28; 24%) was more commonly measured than the epidermis or dermis alone (n=7, 6%). Reliability of ultrasound measurement was poorly reported (n=14; 12%). The scar characteristics most commonly reported to be measured were epidermal oedema, dermal fibrosis and hair follicle density. Most records analysed (n=115; 97%) pertained to the early stages of the research-to-practice pipeline, as part of research initiatives.

Conclusions

The lack of evaluation of measurement initiatives in routine clinical practice was identified as an evidence gap. Diverse methods used in the literature identified the need for greater standardisation of ultrasound thickness measurements. Findings have been used to develop nine methodological considerations for practitioners to guide methods and reporting.

Caregiving experiences of family caregivers of patients with schizophrenia in a community: a qualitative study in Beijing

Por: Pan · Z. · Li · T. · Jin · G. · Lu · X.
Objectives

This study aims to understand the caregiving experiences of family caregivers of people with schizophrenia in a community.

Design

A qualitative study based on phenomenological analysis was conducted through in-depth interviews.

Setting

This study was carried out from May to June 2023 in two community health service centres in urban Beijing, China.

Participants

We selected 16 family caregivers for interviews using purposive sampling method.

Results

Four themes and 10 subthemes were identified: (1) psychosocial distress of family caregivers (feeling unprepared and helpless at the beginning, confronting negative emotions in long-term care and straying away from social life); (2) adverse impacts on the whole family (poor cooperation within the family, insufficient family involvement in professional care); (3) coping with family caregiving (accepting the reality of the patients’ illness, struggling with family life balance and having realistic expectations); (4) concerns about future care (daily living support, physical health management).

Conclusion

Family caregivers experienced psychosocial distress and family stress in the process of caregiving. They had to cope with caregiving stress and were concerned about the long-term care of people with schizophrenia. These findings provide implications for intervention programmes to strengthen social support, family involvement, and active coping for caregivers and develop long-term care mechanisms for people with schizophrenia.

Spatial variation and associated factors of inadequate counselling regarding pregnancy danger signs during antenatal care visits among pregnant women in Ethiopia: a Geographically Weighted Regression Model

Por: Alemayehu · M. A. · Derseh · N. M. · Tesfie · T. K. · Abuhay · H. W. · Yismaw · G. A. · Agimas · M. C.
Introduction

Inadequate counselling of pregnant women regarding pregnancy danger signs contributes to a delay in deciding to seek care, which causes up to 77% of all maternal deaths in developing countries. However, its spatial variation and region-specific predictors have not been studied in Ethiopia. Hence, the current study aimed to model its predictors using geographically weighted regression analysis.

Methods

The 2019 Ethiopian Mini Demographic and Health Survey data were used. A total weighted sample of 2922 women from 283 clusters was included in the final analysis. The analysis was performed using ArcGIS Pro, STATA V.14.2 and SaTScan V.10.1 software. The spatial variation of inadequate counselling was examined using hotspot analysis. Ordinary least squares regression was used to identify factors for geographical variations. Geographically weighted regression was used to explore the spatial heterogeneity of selected variables to predict inadequate counselling.

Results

Significant hotspots of inadequate counselling regarding pregnancy danger signs were found in Gambella region, the border between Amhara and Afar regions, Somali region and parts of Oromia region. Antenatal care provided by health extension workers, late first antenatal care initiation and antenatal care follow-up at health centres were spatially varying predictors. The geographically weighted regression model explained about 66% of the variation in the model.

Conclusion

Inadequate counselling service regarding pregnancy danger signs in Ethiopia varies across regions and there exists within country inequality in the service provision and utilisation. Prioritisation and extra efforts should be made by concerned actors for those underprivileged areas and communities (as shown in the maps), and health extension workers, as they are found in the study.

Armed conflicts and experience of intimate partner violence among women in Afghanistan: analysis of the 2015 Afghanistan DHS data

Por: Khatir · A. G. · Ge · T. · Ariyo · T. · Jiang · Q.
Objective

Armed conflicts and intimate partner violence (IPV) impose a burden on individual and societal well-being. Given the history of armed conflict in Afghanistan and the high prevalence of IPV, this study aims to examine the influence of armed conflicts on IPV among Afghan women.

Methods

Multilevel logistic regression models were applied to the 2015 Afghanistan Demographic and Health Survey (N=10 414 women aged 15–49). Armed conflict severity was measured using the conflict index issued by the Office for the Coordination of Humanitarian Affairs, IPV was measured by three types of violence, including emotional, physical and sexual violence. All analyses were conducted by using STATA V.15.1.

Results

Over 52% of women experienced at least one type of IPV, with 33.01%, 49.07%, and 8.99% experiencing emotional, physical, and sexual violence, respectively. The regression results show that armed conflicts were significantly and positively associated with the experience of all types of IPV. In addition, the association between armed conflicts and the experience of emotional IPV was positively moderated by women’s attitudes towards IPV.

Conclusion

Our findings suggest that women living in high-conflict regions were more prone to experience IPV, particularly women with positive attitudes towards IPV. Promoting progressive gender roles, women’s empowerment, awareness of IPV and inclusion of women in conflict resolution will help deal with the issue of IPV.

Protocol for evaluating the effects of the Reducing Cardiometabolic Diseases Risk dietary pattern in the Chinese population with dyslipidaemia: a single-centre, open-label, dietary intervention study

Por: Wu · Q. · Zhang · L. · Cheng · C. · Chen · X. · Bian · S. · Huang · L. · Li · T. · Li · Z. · Liu · H. · Yan · J. · Du · Y. · Chen · Y. · Zhang · M. · Cao · L. · Li · W. · Ma · F. · Huang · G.
Introduction

Cardiometabolic disease (CMD) is the leading cause of mortality in China. A healthy diet plays an essential role in the occurrence and development of CMD. Although the Chinese heart-healthy diet is the first diet with cardiovascular benefits, a healthy dietary pattern that fits Chinese food culture that can effectively reduce the risk of CMD has not been found.

Methods/design

The study is a single-centre, open-label, randomised controlled trial aimed at evaluating the effect of the Reducing Cardiometabolic Diseases Risk (RCMDR) dietary pattern in reducing the risk of CMDs in people with dyslipidaemia and providing a reference basis for constructing a dietary pattern suitable for the prevention of CMDs in the Chinese population. Participants are men and women aged 35–45 years with dyslipidaemia in Tianjin. The target sample size is 100. After the run-in period, the participants will be randomised to the RCMDR dietary pattern intervention group or the general health education control group with a 1:1 ratio. The intervention phases will last 12 weeks, with a dietary intervention of 5 working days per week for participants in the intervention group. The primary outcome variable is the cardiometabolic risk score. The secondary outcome variables are blood lipid, blood pressure, blood glucose, body composition indices, insulin resistance and 10-year risk of cardiovascular diseases.

Ethics and dissemination

The study complies with the Measures for Ethical Review of Life Sciences and Medical Research Involving Human Beings and the Declaration of Helsinki. Signed informed consent will be obtained from all participants. The study has been approved by the Medical Ethics Committee of the Second Hospital of Tianjin Medical University (approval number: KY2023020). The results from the study will be disseminated through publications in a peer-reviewed journal.

Trial registration number

Chinese Clinical Trial Registry (ChiCTR2300072472).

Diagnostic values of contrast-enhanced MRI and contrast-enhanced CT for evaluating the response of hepatocellular carcinoma after transarterial chemoembolisation: a meta-analysis

Por: Zhang · C. · Chen · X. · Wang · J. · Luo · T.
Objectives

To assess and compare the diagnostic value of contrast-enhanced MRI (CEMRI) and contrast-enhanced CT (CECT) for evaluating the response of hepatocellular carcinoma (HCC) after transarterial chemoembolisation (TACE).

Design

Systematic review and meta-analysis.

Data sources

PubMed, Embase, the Cochrane Library, CNKI and Wanfang databases were systematically searched from inception to 1 August 2023.

Eligibility criteria

Studies with any outcome that demonstrates the diagnostic performance of CEMRI and CECT for HCC after TACE were included.

Data extraction and synthesis

Two authors independently extracted the data and assessed the quality of included studies. Study quality was assessed using Quality Assessment of Diagnostic Accuracy Studies-2. The diagnostic performance of CEMRI and CECT for the response of HCC was investigated by collecting true and false positives, true and false negatives, or transformed-derived data from each study to calculate specificity and sensitivity. Other outcomes are the positive likelihood ratio/negative likelihood ratio (NLR), the area under the receiver operating characteristic curve (AUC) for diagnostic tests and the diagnostic OR (DOR). Findings were summarised and synthesised qualitatively according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines.

Results

This study included 5843 HCC patients diagnosed with CEMRI or CECT and treated with TACE from 36 studies. The mean proportion of men in the total sample was 76.3%. The pool sensitivity, specificity and AUC of CEMRI in diagnosing HCC after TACE were 0.92 (95% CI: 0.86 to 0.96), 0.94 (95% CI: 0.86 to 0.98) and 0.98 (95% CI: 0.96 to 0.99). The pool sensitivity, specificity and AUC of CECT in diagnosing HCC after TACE were 0.74 (95% CI: 0.68 to 0.80), 0.98 (95% CI: 0.93 to 1.00) and 0.90 (95% CI: 0.88 to 0.93).

Conclusions

In conclusion, this study found that both CEMRI and CECT had relatively high predictive power for assessing the response of HCC after TACE. Furthermore, the diagnostic value of CEMRI may be superior to CECT in terms of sensitivity, AUC, DOR and NLR.

Alpha 2 agonists for sedation to produce better outcomes from critical illness (A2B trial): protocol for a mixed-methods process evaluation of a randomised controlled trial

Por: Aitken · L. M. · Emerson · L. M. · Kydonaki · K. · Blackwood · B. · Creagh-Brown · B. · Lone · N. I. · McKenzie · C. A. · Reade · M. C. · Weir · C. J. · Wise · M. P. · Walsh · T. S.
Introduction

An association between deep sedation and adverse short-term outcomes has been demonstrated although this evidence has been inconsistent. The A2B (alpha-2 agonists for sedation in critical care) sedation trial is designed to determine whether the alpha-2 agonists clonidine and dexmedetomidine, compared with usual care, are clinically and cost-effective. The A2B intervention is a complex intervention conducted in 39 intensive care units (ICUs) in the UK. Multicentre organisational factors, variable cultures, perceptions and practices and the involvement of multiple members of the healthcare team add to the complexity of the A2B trial. From our pretrial contextual exploration it was apparent that routine practices such as type and frequency of pain, agitation and delirium assessment, as well as the common sedative agents used, varied widely across the UK. Anticipated challenges in implementing A2B focused on the impact of usual practice, perceptions of risk, ICU culture, structure and the presence of equipoise. Given this complexity, a process evaluation has been embedded in the A2B trial to uncover factors that could impact successful delivery and explore their impact on intervention delivery and interpretation of outcomes.

Methods and analysis

This is a mixed-methods process evaluation guided by the A2B intervention logic model. It includes two phases of data collection conducted during and at the end of trial. Data will be collected using a combination of questionnaires, stakeholder interviews and routinely collected trial data. A framework approach will be used to analyse qualitative data with synthesis of data within and across the phases. The nature of the relationship between delivery of the A2B intervention and the trial primary and secondary outcomes will be explored.

Ethics and dissemination

All elements of the A2B trial, including the process evaluation, are approved by Scotland A Research Ethics Committee (Ref. 18/SS/0085). Dissemination will be via publications, presentations and media engagement.

Trial registration number

NCT03653832.

Evaluating patient factors, operative management and postoperative outcomes in trauma laparotomy patients worldwide: a protocol for a global observational multicentre trauma study

Por: Bath · M. F. · Kohler · K. · Hobbs · L. · Smith · B. G. · Clark · D. J. · Kwizera · A. · Perkins · Z. · Marsden · M. · Davenport · R. · Davies · J. · Amoako · J. · Moonesinghe · R. · Weiser · T. · Leather · A. J. M. · Hardcastle · T. · Naidoo · R. · Nördin · Y. · Conway Morris · A. · Lak
Introduction

Trauma contributes to the greatest loss of disability-adjusted life-years for adolescents and young adults worldwide. In the context of global abdominal trauma, the trauma laparotomy is the most commonly performed operation. Variation likely exists in how these patients are managed and their subsequent outcomes, yet very little global data on the topic currently exists. The objective of the GOAL-Trauma study is to evaluate both patient and injury factors for those undergoing trauma laparotomy, their clinical management and postoperative outcomes.

Methods

We describe a planned prospective multicentre observational cohort study of patients undergoing trauma laparotomy. We will include patients of all ages who present to hospital with a blunt or penetrating injury and undergo a trauma laparotomy within 5 days of presentation to the treating centre. The study will collect system, patient, process and outcome data, following patients up until 30 days postoperatively (or until discharge or death, whichever is first). Our sample size calculation suggests we will need to recruit 552 patients from approximately 150 recruiting centres.

Discussion

The GOAL-Trauma study will provide a global snapshot of the current management and outcomes for patients undergoing a trauma laparotomy. It will also provide insight into the variation seen in the time delays for receiving care, the disease and patient factors present, and patient outcomes. For current standards of trauma care to be improved worldwide, a greater understanding of the current state of trauma laparotomy care is paramount if appropriate interventions and targets are to be identified and implemented.

Personalised Exercise-Rehabilitation FOR people with Multiple long-term conditions (PERFORM): protocol for a randomised feasibility trial

Por: Simpson · S. A. · Evans · R. A. · Gilbert · H. R. · Branson · A. · Barber · S. · McIntosh · E. · Ahmed · Z. · Dean · S. G. · Doherty · P. J. · Gardiner · N. · Greaves · C. · Daw · P. · Ibbotson · T. · Jani · B. · Jolly · K. · Mair · F. · Ormandy · P. · Smith · S. · Singh · S. J. · Taylor · R.
Introduction

Personalised Exercise-Rehabilitation FOR people with Multiple long-term conditions (PERFORM) is a research programme that seeks to develop and evaluate a comprehensive exercise-based rehabilitation intervention designed for people with multimorbidity, the presence of multiple long-term conditions (MLTCs). This paper describes the protocol for a randomised trial to assess the feasibility and acceptability of the PERFORM intervention, study design and processes.

Methods and analysis

A multicentre, parallel two-group randomised trial with individual 2:1 allocation to the PERFORM exercise-based intervention plus usual care (intervention) or usual care alone (control). The primary outcome of this feasibility trial will be to assess whether prespecified progression criteria (recruitment, retention, intervention adherence) are met to progress to the full randomised trial. The trial will be conducted across three UK sites and 60 people with MLTCs, defined as two or more LTCs, with at least one having evidence of the beneficial effect of exercise. The PERFORM intervention comprises an 8-week (twice a week for 6 weeks and once a week for 2 weeks) supervised rehabilitation programme of personalised exercise training and self-management education delivered by trained healthcare professionals followed by two maintenance sessions. Trial participants will be recruited over a 4.5-month period, and outcomes assessed at baseline (prerandomisation) and 3 months postrandomisation and include health-related quality of life, psychological well-being, symptom burden, frailty, exercise capacity, physical activity, sleep, cognition and serious adverse events. A mixed-methods process evaluation will assess acceptability, feasibility and fidelity of intervention delivery and feasibility of trial processes. An economic evaluation will assess the feasibility of data collection and estimate the costs of the PERFORM intervention.

Ethics and dissemination

The trial has been given favourable opinion by the West Midlands, Edgbaston Research Ethics Service (Ref: 23/WM/0057). Participants will be asked to give full, written consent to take part by trained researchers. Findings will be disseminated via journals, presentations and targeted communications to clinicians, commissioners, service users and patients and the public.

Trial registration number

ISRCTN68786622.

Protocol version

2.0 (16 May 2023).

Machine learning methods, applications and economic analysis to predict heart failure hospitalisation risk: a scoping review protocol

Por: Seringa · J. · Abreu · J. · Magalhaes · T.
Introduction

Machine learning (ML) has emerged as a powerful tool for uncovering patterns and generating new information. In cardiology, it has shown promising results in predictive outcomes risk assessment of heart failure (HF) patients, a chronic condition affecting over 64 million individuals globally.

This scoping review aims to synthesise the evidence on ML methods, applications and economic analysis to predict the HF hospitalisation risk.

Methods and analysis

This scoping review will use the approach described by Arksey and O’Malley. This protocol will use the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) Protocol, and the PRISMA extension for scoping reviews will be used to present the results. PubMed, Scopus and Web of Science are the databases that will be searched. Two reviewers will independently screen the full-text studies for inclusion and extract the data. All the studies focusing on ML models to predict the risk of hospitalisation from HF adult patients will be included.

Ethics and dissemination

Ethical approval is not required for this review. The dissemination strategy includes peer-reviewed publications, conference presentations and dissemination to relevant stakeholders.

Effect of nutritional supplementation on bone mineral density in children with sickle cell disease: protocol for an open-label, randomised controlled clinical trial

Por: Conde · M. · Lespessailles · E. · Wanneveich · M. · Allemandou · D. · Boulain · T. · Dimitrov · G.
Introduction

Children with sickle cell disease show a significant decrease in bone mineral density, an increase in resting energy expenditure of more than 15%, a decrease in fat and lean mass as well as a significant increase in protein turnover, particularly in bone tissue. This study aims to evaluate the effectiveness of an increase in food intake on bone mineral density and the clinical and biological complications of paediatric sickle cell disease.

Methods and analysis

The study is designed as an open-label randomised controlled clinical trial conducted in the Paediatrics Unit of the Orléans University Hospital Centre. Participants aged 3–16 years will be randomly divided into two groups: the intervention group will receive oral nutritional supplements (pharmacological nutritional hypercaloric products) while the control group will receive age-appropriate and gender-appropriate nutritional intake during 12 months. Total body less head bone mineral density will be measured at the beginning and the end of the trial. A rigorous nutritional follow-up by weekly 24 hours recall dietary assessment and planned contacts every 6 weeks will be carried out throughout the study. A school absenteeism questionnaire, intended to reflect the patient’s school productivity, will be completed by participants and parents every 3 months. Blood samples of each patient of both groups will be stocked at the beginning and at the end of the trial, for future biological trial. Clinical and biological complications will be regularly monitored.

Ethics and dissemination

The protocol has been approved by the French ethics committee (Comité de Protection des Personnes Sud-Ouest et Outre-Mer 2, Toulouse; approval no: 2-20-092 id9534). Children and their parents will give informed consent to participate in the study before taking part. Results will be disseminated through peer-reviewed journals or international academic conferences.

Trial registration number

NCT04754711.

Predictive value of admission D-dimer levels in patient with acute ischaemic stroke and COVID-19: a second-wave prospective cohort study

Por: Rasyid · A. · Harris · S. · Kurniawan · M. · Mesiano · T. · Hidayat · R. · Wiyarta · E.
Objectives

This study aimed to evaluate the predictive value of admission D-dimer levels for in-hospital mortality in patients with COVID-19 and acute ischaemic stroke.

Design

Cohort (prospective).

Setting

Tertiary referral hospital in the capital city of Indonesia conducted from June to December 2021.

Participants

60 patients with acute ischaemic stroke and COVID-19 were included. Patients were classified into D-dimer groups (low and high) according to a 2 110 ng/mL cut-off value, determined via receiver operating characteristic analysis.

Primary and secondary outcome measures

The primary outcome was in-hospital mortality, with admission D-dimer levels as the major predictor. Secondary outcomes included associations between other demographic and clinical variables and the admission D-dimer value. Kaplan-Meier method was used to carry out survival analysis, with univariable and multivariable Cox regression performed to assess the association of D-dimer levels and other confounding variables (including demographic, clinical and laboratory parameters) with in-hospital mortality.

Results

The findings demonstrated an association between elevated admission D-dimer levels (≥2 110 ng/mL) and an increased likelihood of death during hospitalisation. The adjusted HR was 14.054 (95% CI 1.710 to 115.519; p=0.014), demonstrating an increase in mortality risk after accounting for confounders such as age and diabetes history. Other significant predictors of mortality included a history of diabetes and increased white blood cell count.

Conclusions

Admission D-dimer levels may be a useful predictive indicator for the likelihood of death during hospitalisation in individuals with COVID-19 and acute ischaemic stroke.

Caring burden and coping with haemodialysis: a qualitative study with family caregivers in Sri Lanka

Por: Lasanthika · C. · Janlöv · A.-C. · Amarasekara · T. · Larsson · H.
Objective

The number of patients with end-stage kidney disease (ESKD) requiring renal replacement therapy in Sri Lanka is significantly rising. Most of these patients depend on haemodialysis, carrying a significant burden on their family caregivers. To develop care and support for both the patient and their family caregiver, it is crucial to understand how caregivers experience their caregiving situation. Therefore, this study aimed to explore family caregivers’ experiences of burden and coping when caring for a family member receiving haemodialysis in the Sri Lankan context.

Design

Qualitative study with an exploratory design.

Setting

Family caregivers were recruited at a haemodialysis unit of a main government sector hospital in Sri Lanka between October and November 2021.

Participants

A purposive sampling of 11 family caregivers who cared for a family member receiving haemodialysis in a main government teaching hospital in Sri Lanka for at least 3 consecutive months. Data were collected through individual semistructured telephone interviews and analysed using qualitative content analysis.

Results

The results showed an overarching theme, ‘striving to hold on and not let go’, with four categories: (1) feeling exhausted by the care burden, (2) feeling burdened as failing the care responsibility, (3) striving to cope and find meaning in caregiving, and (4) coping with caregiving through others’ support.

Conclusion

The results show that the family caregivers have a multifaceted burden. They continued caring for their family member receiving haemodialysis while making adjustments to the burdensome caregiving situation despite many constraints and suffering. Psychosocial support and financial assistance, including family counselling, are needed by family caregivers, through a community support system, to ensure endurance during their family members’ illness trajectory. Advance care planning is vital to alleviate care uncertainty and to meet the care needs of patients with ESKD, particularly in resource-constrained settings.

Perioperative mental health intervention for depression and anxiety symptoms in older adults study protocol: design and methods for three linked randomised controlled trials

Por: Holzer · K. J. · Bartosiak · K. A. · Calfee · R. P. · Hammill · C. W. · Haroutounian · S. · Kozower · B. D. · Cordner · T. A. · Lenard · E. M. · Freedland · K. E. · Tellor Pennington · B. R. · Wolfe · R. C. · Miller · J. P. · Politi · M. C. · Zhang · Y. · Yingling · M. D. · Baumann
Introduction

Preoperative anxiety and depression symptoms among older surgical patients are associated with poor postoperative outcomes, yet evidence-based interventions for anxiety and depression have not been applied within this setting. We present a protocol for randomised controlled trials (RCTs) in three surgical cohorts: cardiac, oncological and orthopaedic, investigating whether a perioperative mental health intervention, with psychological and pharmacological components, reduces perioperative symptoms of depression and anxiety in older surgical patients.

Methods and analysis

Adults ≥60 years undergoing cardiac, orthopaedic or oncological surgery will be enrolled in one of three-linked type 1 hybrid effectiveness/implementation RCTs that will be conducted in tandem with similar methods. In each trial, 100 participants will be randomised to a remotely delivered perioperative behavioural treatment incorporating principles of behavioural activation, compassion and care coordination, and medication optimisation, or enhanced usual care with mental health-related resources for this population. The primary outcome is change in depression and anxiety symptoms assessed with the Patient Health Questionnaire-Anxiety Depression Scale from baseline to 3 months post surgery. Other outcomes include quality of life, delirium, length of stay, falls, rehospitalisation, pain and implementation outcomes, including study and intervention reach, acceptability, feasibility and appropriateness, and patient experience with the intervention.

Ethics and dissemination

The trials have received ethics approval from the Washington University School of Medicine Institutional Review Board. Informed consent is required for participation in the trials. The results will be submitted for publication in peer-reviewed journals, presented at clinical research conferences and disseminated via the Center for Perioperative Mental Health website.

Trial registration numbers

NCT05575128, NCT05685511, NCT05697835, pre-results.

Inter-facility transfers for emergency obstetrical and neonatal care in rural Madagascar: a cost-effectiveness analysis

Por: Franke · M. A. · Nordmann · K. · Frühauf · A. · Ranaivoson · R. M. · Rebaliha · M. · Rapanjato · Z. · Bärnighausen · T. · Muller · N. · Knauss · S. · Emmrich · J. V.
Context

There is a substantial lack of inter-facility referral systems for emergency obstetrical and neonatal care in rural areas of sub-Saharan Africa. Data on the costs and cost-effectiveness of such systems that reduce preventable maternal and neonatal deaths are scarce.

Setting

We aimed to determine the cost-effectiveness of a non-governmental organisation (NGO)-run inter-facility referral system for emergency obstetrical and neonatal care in rural Southern Madagascar by analysing the characteristics of cases referred through the intervention as well as its costs.

Design

We used secondary NGO data, drawn from an NGO’s monitoring and financial administration database, including medical and financial records.

Outcome measures

We performed a descriptive and a cost-effectiveness analysis, including a one-way deterministic sensitivity analysis.

Results

1172 cases were referred over a period of 4 years. The most common referral reasons were obstructed labour, ineffective labour and eclampsia. In total, 48 neonates were referred through the referral system over the study period. Estimated cost per referral was US$336 and the incremental cost-effectiveness ratio (ICER) was US$70 per additional life-year saved (undiscounted, discounted US$137). The sensitivity analysis showed that the intervention was cost-effective for all scenarios with the lowest ICER at US$99 and the highest ICER at US$205 per additional life-year saved. When extrapolated to the population living in the study area, the investment costs of the programme were US$0.13 per person and annual running costs US$0.06 per person.

Conclusions

In our study, the inter-facility referral system was a very cost-effective intervention. Our findings may inform policies, decision-making and implementation strategies for emergency obstetrical and neonatal care referral systems in similar resource-constrained settings.

Intraoperative intensive blood pressure management strategy and the outcome of patients who had an acute ischaemic stroke undergoing endovascular treatment under general anaesthesia: study protocol for a prospective randomised controlled trial

Por: Li · B. · Niu · T. · Dai · Y. · Bu · L. · Pan · K. · Lu · L. · Bo · L.
Background

Endovascular thrombectomy is the recommended treatment for acute ischaemic stroke, but the optimal blood pressure management strategy during the procedure under general anaesthesia remains controversial. In this study protocol, we propose an intraoperative intensive blood pressure range (110–140 mm Hg systolic blood pressure) based on a retrospective analysis and extensive literature review. By comparing the outcomes of patients who had an acute ischaemic stroke undergoing mechanical thrombectomy under general anaesthesia with standard blood pressure management (140–180 mm Hg systolic blood pressure) versus intensive blood pressure management, we aim to determine the impact of intraoperative intensive blood pressure management strategy on patient prognosis.

Methods and analysis

The study is a double-blinded, randomised, controlled study, with patients randomised into either the standard blood pressure management group or the intensive blood pressure management group. The primary endpoint of the study will be the sequential analysis of modified Rankin Scale scores at 90 days after mechanical thrombectomy.

Ethics and dissemination

The study has been approved by the ethics committee of Shanghai Changhai Hospital with an approval number CHEC2023-015. The results of the study will be published in peer-reviewed international journals.

Trial registration number

ChiCTR2300070764.

Using digital tools in clinical, health and social care research: a mixed-methods study of UK stakeholders

Por: Clohessy · S. · Arvanitis · T. N. · Rashid · U. · Craddock · C. · Evans · M. · Toro · C. T. · Elliott · M. T.
Objective

The COVID-19 pandemic accelerated changes to clinical research methodology, with clinical studies being carried out via online/remote means. This mixed-methods study aimed to identify which digital tools are currently used across all stages of clinical research by stakeholders in clinical, health and social care research and investigate their experience using digital tools.

Design

Two online surveys followed by semistructured interviews were conducted. Interviews were audiorecorded, transcribed and analysed thematically.

Setting, participants

To explore the digital tools used since the pandemic, survey participants (researchers and related staff (n=41), research and development staff (n=25)), needed to have worked on clinical, health or social care research studies over the past 2 years (2020–2022) in an employing organisation based in the West Midlands region of England (due to funding from a regional clinical research network (CRN)). Survey participants had the opportunity to participate in an online qualitative interview to explore their experiences of digital tools in greater depth (n=8).

Results

Six themes were identified in the qualitative interviews: ‘definition of a digital tool in clinical research’; ‘impact of the COVID-19 pandemic’; ‘perceived benefits/drawbacks of digital tools’; ‘selection of a digital tool’; ‘barriers and overcoming barriers’ and ‘future digital tool use’. The context of each theme is discussed, based on the interview results.

Conclusions

Findings demonstrate how digital tools are becoming embedded in clinical research, as well as the breadth of tools used across different research stages. The majority of participants viewed the tools positively, noting their ability to enhance research efficiency. Several considerations were highlighted; concerns about digital exclusion; need for collaboration with digital expertise/clinical staff, research on tool effectiveness and recommendations to aid future tool selection. There is a need for the development of resources to help optimise the selection and use of appropriate digital tools for clinical research staff and participants.

Analysis on the willingness and influencing factors of choosing hospice care service institutions among among older people in Wuhu, China: a cross-sectional study

Por: Yang · L. · Zhou · Q. · Hong · T. · Zhang · L. · Che · H.
Objective

The purpose of this study was to evaluate the inclination and determinants influencing the selection of hospice care service institutions among elderly individuals in China.

Design

The study conducted has a cross-sectional design.

Setting

The study was conducted at four urban community centres in Wuhu, Anhui Province, China.

Participants

The sample consisted of 642 older adults, with ages ranging from 60 to over (mean age=71.03 years, SD=7.18).

Method

This study, based on the Anderson model, developed a questionnaire after conducting a preliminary survey and engaging in several group discussions. The final questionnaire encompassed the basic information, health status, attitude towards hospice care, choice of hospice care institutions and reasons of the older people. A regional population study was conducted using the Logistic regression model to estimate the ORs (OR) of influencing factors selected by hospice services.

Results

38.5% of respondents expressed their willingness to receive hospice care, while 22.3% were unwilling and 39.3% felt ambivalent towards it. The acceptance rate of older people in hospice care increases with higher levels of education and monthly income. 47.0% of older people opted for hospice care in a general hospital ward, indicating that demand for hospice services among older people in Wuhu City is primarily focused on such wards. The univariate analysis revealed significant differences in the willingness of older individuals to accept hospice care services based on gender, age, educational attainment and income levels. Regardless of the location of hospice care, older men had a lower likelihood of being willing to use hospice services compared with older women. The proportion of older women choosing a hospice ward or general hospital was 53.8%, which was higher than that of older men at 42.0%. The proportion of older men choosing a community health service institution was 31.6%, higher than 23.3% of women. The educational level differences significantly influence the older people’s inclination towards receiving hospice care.

Conclusion

With the ageing population of Wuhu City on the rise, there is an increasing demand for hospice services. In their final journey, older individuals require multilevel hospice care services, which necessitates equipping general hospitals with hospice wards and using community health service centres to meet their specific needs.

Relationship among core competency, self-efficacy and transition shock in Chinese newly graduated nurses: a cross-sectional study

Por: Tong · Y. · Wang · T. · Tong · S. · Tang · Z. · Mao · L. · Xu · L. · Shi · X.
Objectives

To investigate how core competency and self-efficacy of newly graduated nurses affect their experience of transition shock, and to determine the relationship between these factors.

Design

A cross-sectional study.

Methods

262 newly graduated nurses participated in a cross-sectional study by using demographic data, the transition shock scale, the competency inventory for registered nurses scale and the self-efficacy scale.

Results

Among newly graduated nurses, the score of transition shock was 77.641±24.140, the score of core competency was 125 (109.5, 163.5) and the score of self-efficacy was 2.5 (2,3), all of which were at a moderate level. The core competency and self-efficacy of the newly graduated nurses had a negative impact on the transition shock (β=–0.151, p=0.026; β=–0.379, p

Conclusions

The transition shock of newly graduated nurses was at a moderate level, with the highest level of transition shock occurring within the first year of employment. Self-efficacy plays a mediating role in the relationship between core competency and transition shock. Nursing managers should create standardised training for newly graduated nurses within the first year of employment to reduce their transition shock. This will help improve newly graduated nurses’ core competency, enhance self-efficacy and support the graduates. This will alleviate the impact of transition shock on newly graduated nurses, helping them transition smoothly and successfully.

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