FreshRSS

🔒
☐ ☆ ✇ BMJ Open

Artificial intelligence driven malnutrition diagnostic model for patients with acute abdomen based on GLIM criteria: a cross-sectional research protocol

Por: Ma · W. · Cai · B. · Wang · Y. · Wang · L. · Sun · M.-W. · Lu · C. D. · Jiang · H. — Marzo 9th 2024 at 02:25
Background

Patients with acute abdomen often experience reduced voluntary intake and a hypermetabolic process, leading to a high occurrence of malnutrition. The Global Leadership Initiative on Malnutrition (GLIM) criteria have rapidly developed into a principal methodological tool for nutritional diagnosis. Additionally, machine learning is emerging to establish artificial intelligent-enabled diagnostic models, but the accuracy and robustness need to be verified. We aimed to establish an intelligence-enabled malnutrition diagnosis model based on GLIM for patients with acute abdomen.

Method

This study is a single-centre, cross-sectional observational investigation into the prevalence of malnutrition in patients with acute abdomen using the GLIM criteria. Data collection occurs on the day of admission, at 3 and 7 days post-admission, including biochemical analysis, body composition indicators, disease severity scoring, nutritional risk screening, malnutrition diagnosis and nutritional support information. The occurrence rate of malnutrition in patients with acute abdomen is analysed with the GLIM criteria based on the Nutritional Risk Screening 2002 and the Mini Nutritional Assessment Short-Form to investigate the sensitivity and accuracy of the GLIM criteria. After data cleansing and preprocessing, a machine learning approach is employed to establish a predictive model for malnutrition diagnosis in patients with acute abdomen based on the GLIM criteria.

Ethics and dissemination

This study has obtained ethical approval from the Ethics Committee of the Sichuan Academy of Medical Sciences and Sichuan Provincial People’s Hospital on 28 November 2022 (Yan-2022–442). The results of this study will be disseminated in peer-reviewed journals, at scientific conferences and directly to study participants.

Trial registration number

ChiCTR2200067044.

☐ ☆ ✇ BMJ Open

Prevalence and correlates of paediatric guideline non-adherence for initial empirical care in six low and middle-income settings: a hospital-based cross-sectional study

Por: Shawon · R. A. · Denno · D. · Tickell · K. D. · Atuhairwe · M. · Bandsma · R. · Mupere · E. · Voskuijl · W. · Mbale · E. · Ahmed · T. · Chisti · M. J. · Saleem · A. F. · Ngari · M. · Diallo · A. H. · Berkley · J. · Walson · J. · Means · A. R. — Marzo 9th 2024 at 02:25
Objectives

This study evaluated the prevalence and correlates of guideline non-adherence for common childhood illnesses in low-resource settings.

Design and setting

We used secondary cross-sectional data from eight healthcare facilities in six Asian and African countries.

Participants

A total of 2796 children aged 2–23 months hospitalised between November 2016 and January 2019 with pneumonia, diarrhoea or severe malnutrition (SM) and without HIV infection were included in this study.

Primary outcome measures

We identified children treated with full, partial or non-adherent initial inpatient care according to site-specific standard-of-care guidelines for pneumonia, diarrhoea and SM within the first 24 hours of admission. Correlates of guideline non-adherence were identified using generalised estimating equations.

Results

Fully adherent care was delivered to 32% of children admitted with diarrhoea, 34% of children with pneumonia and 28% of children with SM when a strict definition of adherence was applied. Non-adherence to recommendations was most common for oxygen and antibiotics for pneumonia; fluid, zinc and antibiotics for diarrhoea; and vitamin A and zinc for SM. Non-adherence varied by site. Pneumonia guideline non-adherence was more likely among patients with severe disease (OR 1.82; 95% CI 1.38, 2.34) compared with non-severe disease. Diarrhoea guideline non-adherence was more likely among lower asset quintile groups (OR 1.16; 95% CI 1.01, 1.35), older children (OR 1.10; 95% CI 1.06, 1.13) and children presenting with wasting (OR 6.44; 95% CI 4.33, 9.57) compared with those with higher assets, younger age and not wasted.

Conclusions

Non-adherence to paediatric guidelines was common and associated with older age, disease severity, and comorbidities, and lower household economic status. These findings highlight opportunities to improve guidelines by adding clarity to specific recommendations.

☐ ☆ ✇ BMJ Open

Diabetes care in the pandemic era in the Midwestern USA: a semi-structured interview study of the patient perspective

Por: Gonzalez Bravo · C. · Sabree · S. A. · Dukes · K. · Adeagbo · M. J. · Edwards · S. · Wainwright · K. · Schaeffer · S. E. · Villa · A. · Wilks · A. D. · Carvour · M. L. — Marzo 9th 2024 at 02:25
Objectives

To understand patients’ experiences with diabetes care during the COVID-19 pandemic, with an emphasis on rural, medically underserved, and/or minoritised racial and ethnic groups in the Midwestern USA.

Design

Community-engaged, semi-structured interviews were conducted by medical student researchers trained in qualitative interviewing. Transcripts were prepared and coded in the language in which the interview was conducted (English or Spanish). Thematic analysis was conducted, and data saturation was achieved.

Setting

The study was conducted in communities in Eastern and Western Iowa.

Participants

Adults with diabetes (n=20) who were fluent in conversational English or Spanish were interviewed. One-third of participants were residents of areas designated as federal primary healthcare professional shortage areas and/or medically underserved areas, and more than half were recruited from medical clinics that offer care at no cost.

Results

Themes across both English and Spanish transcripts included: (1) perspectives of diabetes, care providers and care management; (2) challenges and barriers affecting diabetes care; and (3) participant feedback and recommendations. Participants reported major constraints related to provider availability, costs of care, access to nutrition counselling and mental health concerns associated with diabetes care during the pandemic. Participants also reported a lack of shared decision-making regarding some aspects of care, including amputation. Finally, participants recognised systems-level challenges that affected both patients and providers and expressed a preference for proactive collaboration with healthcare teams.

Conclusions

These findings support enhanced engagement of rural, medically underserved and minoritised groups as stakeholders in diabetes care, diabetes research and diabetes provider education.

☐ ☆ ✇ BMJ Open

Students perceptions and experiences of an online well-being programme: a phenomenological study protocol

Por: Escuadra · C. J. · Chiong Maya · A. · Nava · J. B. P. · Vergara · J. A. · Bea · T. C. · Javier · A. M. · Karamihan · F. · Padilla · D. P. · Reyes · A. J. · Samonte · J. · Serrano · S. I. — Marzo 9th 2024 at 02:25
Background

The pandemic has ensued challenges across all sections of the human population such as livelihood and educational changes, which involve the abrupt shift to online learning, immensely affecting the students’ well-being. Negative health consequences of e-learning among students stem from the increased demand for new technological skills, productivity, information overload and restriction of students to spend time with their peers.

Objective

To explore the experiences of the students from the University of Santo Tomas—College of Rehabilitation Sciences (UST-CRS) who participated in the online well-being programme.

Methodology

A phenomenological design will be used to determine the participants’ perceptions and experiences. Purposive sampling will be used to recruit 8–10 undergraduate students from UST-CRS ages 18–22 years, who participated in the well-being programme, and completed the study’s quantitative counterpart. Semistructured, in-depth questions will be used to conduct a focus group discussion. The transcripts will be analysed using thematic analysis via the NVivo V.12 software.

Ethics and dissemination

The study protocol is approved by the UST-CRS Ethical Review Committee (Protocol Number: SI-2022–034 (V.4)). It will be implemented in accordance with the Declaration of Helsinki and the National Ethical Guidelines for Health and Health-Related Research, and Data Privacy Act. Findings will be published in accredited journals and presented in related scientific fora.

Registration ID

PHRR230214-005419; Philippine Health Research Registry.

☐ ☆ ✇ BMJ Open

Brain Re-Irradiation Or Chemotherapy: a phase II randomised trial of re-irradiation and chemotherapy in patients with recurrent glioblastoma (BRIOChe) - protocol for a multi-centre open-label randomised trial

Por: Hudson · E. M. · Noutch · S. · Webster · J. · Brown · S. R. · Boele · F. W. · Al-Salihi · O. · Baines · H. · Bulbeck · H. · Currie · S. · Fernandez · S. · Hughes · J. · Lilley · J. · Smith · A. · Parbutt · C. · Slevin · F. · Short · S. · Sebag-Montefiore · D. · Murray · L. — Marzo 9th 2024 at 02:25
Introduction

Glioblastoma (GBM) is the most common adult primary malignant brain tumour. The condition is incurable and, despite aggressive treatment at first presentation, almost all tumours recur after a median of 7 months. The aim of treatment at recurrence is to prolong survival and maintain health-related quality of life (HRQoL). Chemotherapy is typically employed for recurrent GBM, often using nitrosourea-based regimens. However, efficacy is limited, with reported median survivals between 5 and 9 months from recurrence. Although less commonly used in the UK, there is growing evidence that re-irradiation may produce survival outcomes at least similar to nitrosourea-based chemotherapy. However, there remains uncertainty as to the optimum approach and there is a paucity of available data, especially with regards to HRQoL. Brain Re-Irradiation Or Chemotherapy (BRIOChe) aims to assess re-irradiation, as an acceptable treatment option for recurrent IDH-wild-type GBM.

Methods and analysis

BRIOChe is a phase II, multi-centre, open-label, randomised trial in patients with recurrent GBM. The trial uses Sargent’s three-outcome design and will recruit approximately 55 participants from 10 to 15 UK radiotherapy sites, allocated (2:1) to receive re-irradiation (35 Gy in 10 daily fractions) or nitrosourea-based chemotherapy (up to six, 6-weekly cycles). The primary endpoint is overall survival rate for re-irradiation patients at 9 months. There will be no formal statistical comparison between treatment arms for the decision-making primary analysis. The chemotherapy arm will be used for calibration purposes, to collect concurrent data to aid interpretation of results. Secondary outcomes include HRQoL, dexamethasone requirement, anti-epileptic drug requirement, radiological response, treatment compliance, acute and late toxicities, progression-free survival.

Ethics and dissemination

BRIOChe obtained ethical approval from Office for Research Ethics Committees Northern Ireland (reference no. 20/NI/0070). Final trial results will be published in peer-reviewed journals and adhere to the ICMJE guidelines.

Trial registration number

ISRCTN60524.

☐ ☆ ✇ BMJ Open

National cross-sectional cluster survey of tuberculosis prevalence in Timor-Leste: a study protocol

Por: Lopes · C. · Joao · J. C. · Lowbridge · C. · Martins · N. · dos Santos · R. I. G. · da Silva · E. · Dias · J. · Ramalingam · S. · Amaral · S. · Oakley · T. · Ico · L. d. C. · Sarmento · N. · Yan · J. · Francis · J. R. — Marzo 9th 2024 at 02:25
Introduction

Timor-Leste has one of the world’s highest estimated tuberculosis (TB) incidences, yet the data which informs this estimate is limited and the true burden of TB disease is not known. TB prevalence surveys offer the best means of determining robust estimates of disease burden. This study aims to provide an estimate of the prevalence of bacteriologically confirmed pulmonary TB in Timor-Leste and provide additional insights into diagnostic coverage and health-seeking behaviour of persons with symptoms suggestive of TB.

Methods and analysis

A national population-based cross-sectional cluster survey will be conducted in which participants aged 15 years and older will be screened for pulmonary TB using an algorithm consisting of symptom screening and digital X-ray of the chest with computer-aided detection software for X-ray interpretation. Xpert Ultra and liquid culture methods will be used to confirm survey TB cases. Additional data will be collected from persons reporting symptoms suggestive of TB to assess health-seeking behaviour and access to TB diagnosis and care. The survey aims to screen a target sample population of 20 068 people, living within 50 clusters, representing every municipality of Timor-Leste. Bacteriologically confirmed pulmonary TB prevalence will be estimated using WHO-recommended methods.

Ethics and dissemination

Research ethics approval has been granted by the human research ethics committee of the Northern Territory, Australia, and the Instituto Nacional da Saúde, Timor-Leste. The results will be published in a peer-reviewed scientific journal and disseminated with relevant stakeholders.

Trial registration number

ACTRN12623000718640.

☐ ☆ ✇ BMJ Open

Home-based mobile-guided exercise-based cardiac rehabilitation among patients undergoing transcatheter aortic valve replacement (REHAB-TAVR): protocol for a randomised clinical trial

Por: Shen · Z. · Mi · S. · Huang · C. · Zhou · D. · Pan · W. · Xu · X. · Lin · Y. · Zhang · Y. — Marzo 7th 2024 at 11:36
Introduction

Transcatheter aortic valve replacement (TAVR) is a standard treatment for aortic stenosis, particularly in older adults. Reduced exercise capacity and frailty significantly impact outcomes in TAVR patients, yet current management lacks strategies to address these issues. This study aims to assess the effectiveness of home-based mobile-guided exercise-based cardiac rehabilitation in TAVR patients, led by a multidisciplinary team with clear progression milestones.

Methods and analysis

The study involves 90 patients aged 60–89 in a single centre who will be randomised to a 3-month novel multidomain exercise intervention or routine care. Outcome assessors will be blinded towards group allocation. The primary outcome is the 6-min walk distance at month 3. The secondary outcomes include the 6-min walk distance at month 6, physical function measured by total Short Physical Performance Battery score and exercise adherence measured by the Exercise Adherence Rating Scale at months 3 and 6. Additional outcome measures, including rehospitalisations, death, handgrip strength, frailty (Fried Criteria and Essential Toolset), cognitive function (Mini-Mental State Examination), quality of life (EuroQol 5-Dimension 5-Level), nutritional status (Mini-Nutritional Assessment), anxiety (General Anxiety Disorder-7), depression (Geriatric Depression Scale), sleep (Pittsburgh Sleep Quality Index), functional capacity (Duke Activity Status Index), clinical indices (body mass index, symptoms, signs, left ventricular ejection fraction (LVEF), N-Terminal Pro-Brain Natriuretic Peptide, etc) and social support (Lubben Social Network Scale-6), along with comprehensive cost analysis, enhance the study’s significance. The study’s findings hold crucial implications for crafting an effective exercise-focused cardiac rehabilitation strategy for TAVR patients. Community implementation not only deepens understanding but also fosters the potential integration of exercise-based cardiac rehabilitation into self-care, promising enhanced patient adherence and overall cardiovascular health management.

Ethics and dissemination

Ethical approval was obtained from the Zhongshan Hospital, Fudan University Ethics Committee (B2022-062R). Results will be disseminated to local stakeholders and the research community through publications and conferences.

Trial registration number

NCT05989594

☐ ☆ ✇ BMJ Open

Coutilisation of oral rehydration solution and zinc for treating diarrhoea and its associated factors among under-five children in East Africa: a multilevel robust Poisson regression

Por: Legesse · B. T. · Wondie · W. T. · Gedefaw · G. D. · Workineh · Y. T. · Seifu · B. L. — Marzo 7th 2024 at 10:14
Objective

This study aimed to assess the coutilisation of oral rehydration solution (ORS) and zinc for treating diarrhoea and its associated factors among under-5 children in East Africa.

Design

Cross-sectional study design. Multilevel Poisson regression analysis with robust variance was fitted to identify predictors of zinc and ORS coutilisation. An adjusted prevalence ratio (aPR) with a 95% CI was reported to declare the statistical significance.

Setting

Twelve East African countries.

Participants

16 850 under-5 children who had diarrhoea were included in the study.

Result

In East African nations, the coutilisation of ORS and zinc for the treatment of diarrhoea in children under 5 was 53.27% with a 95% CI (52.54% to 54.01%). Children of mothers with primary education (aPR 1.15, 95% CI 1.09 to 1.20), secondary education (aPR 1.08, 95% CI 1.02 to 1.14), higer education (aPR 1.19, 95% CI 1.10 to 1.29), those from maternal age category of 20–24 (aPR 1.14, 95% CI 1.07 to 1.21), age category of 25–29 (aPR 1.13, 95% CI 1.06 to 1.21), age category of 30–34 (aPR 1.09, 95% CI 1.02 to 1.16), those from wealthy households (aPR 1.04, 95% CI 1.01 to 1.09) and those who have a media exposure (aPR 1.04, 95% CI 1.01 to 1.08) were more likely to receive combination.

Conclusion

Only half of the under-5 children with diarrhoea in East Africa were treated with a combination of ORS and zinc. To increase the use of the suggested combination therapy of ORS with zinc, it is important to empower women through education and prevent teen pregnancy.

☐ ☆ ✇ BMJ Open

Feasibility of quality indicators on prehospital advanced airway management in a physician-staffed emergency medical service: survey-based assessment of the provider point of view

Por: Kottmann · A. · Pasquier · M. · Carron · P.-N. · Maudet · L. · Rouve · J.-D. · Suppan · L. · Caillet-Bois · D. · Riva · T. · Albrecht · R. · Krüger · A. · Sollid · S. J. M. — Marzo 7th 2024 at 10:14
Objective

We aimed to determine the feasibility of quality indicators (QIs) for prehospital advanced airway management (PAAM) from a provider point of view.

Design

The study is a survey based feasibility assessment following field testing of QIs for PAAM.

Setting

The study was performed in two physician staffed emergency medical services in Switzerland.

Participants

42 of the 44 emergency physicians who completed at least one case report form (CRF) dedicated to the collection of the QIs on PAAM between 1 January 2019 and 31 December 2021 participated in the study.

Intervention

The data required to calculate the 17 QIs was systematically collected through a dedicated electronic CRF.

Primary and secondary outcome measures

Primary outcomes were provider-related feasibility criteria: relevance and acceptance of the QIs, as well as reliability of the data collection. Secondary outcomes were effort to collect specific data and to complete the CRF.

Results

Over the study period, 470 CRFs were completed, with a median of 11 per physician (IQR 4–17; range 1–48). The median time to complete the CRF was 7 min (IQR 3–16) and was considered reasonable by 95% of the physicians. Overall, 75% of the physicians assessed the set of QIs to be relevant, and 74% accepted that the set of QIs assessed the quality of PAAM. The reliability of data collection was rated as good or excellent for each of the 17 QIs, with the lowest rated for the following 3 QIs: duration of preoxygenation, duration of laryngoscopy and occurrence of desaturation during laryngoscopy.

Conclusions

Collection of QIs on PAAM appears feasible. Electronic medical records and technological solutions facilitating automatic collection of vital parameters and timing during the procedure could improve the reliability of data collection for some QIs. Studies in other services are needed to determine the external validity of our results.

☐ ☆ ✇ BMJ Open

Attrition from longitudinal ageing studies and performance across domains of cognitive functioning: an individual participant data meta-analysis

Por: Hernandez · R. · Jin · H. · Lee · P.-J. · Schneider · S. · Junghaenel · D. U. · Stone · A. A. · Meijer · E. · Gao · H. · Maupin · D. · Zelinski · E. M. — Marzo 7th 2024 at 10:14
Objectives

This paper examined the magnitude of differences in performance across domains of cognitive functioning between participants who attrited from studies and those who did not, using data from longitudinal ageing studies where multiple cognitive tests were administered.

Design

Individual participant data meta-analysis.

Participants

Data are from 10 epidemiological longitudinal studies on ageing (total n=209 518) from several Western countries (UK, USA, Mexico, etc). Each study had multiple waves of data (range of 2–17 waves), with multiple cognitive tests administered at each wave (range of 4–17 tests). Only waves with cognitive tests and information on participant dropout at the immediate next wave for adults aged 50 years or older were used in the meta-analysis.

Measures

For each pair of consecutive study waves, we compared the difference in cognitive scores (Cohen’s d) between participants who dropped out at the next study wave and those who remained. Note that our operationalisation of dropout was inclusive of all causes (eg, mortality). The proportion of participant dropout at each wave was also computed.

Results

The average proportion of dropouts between consecutive study waves was 0.26 (0.18 to 0.34). People who attrited were found to have significantly lower levels of cognitive functioning in all domains (at the wave 2–3 years before attrition) compared with those who did not attrit, with small-to-medium effect sizes (overall d=0.37 (0.30 to 0.43)).

Conclusions

Older adults who attrited from longitudinal ageing studies had lower cognitive functioning (assessed at the timepoint before attrition) across all domains as compared with individuals who remained. Cognitive functioning differences may contribute to selection bias in longitudinal ageing studies, impeding accurate conclusions in developmental research. In addition, examining the functional capabilities of attriters may be valuable for determining whether attriters experience functional limitations requiring healthcare attention.

☐ ☆ ✇ BMJ Open

Interventions in adult patients with multimorbidity in low-income and middle-income countries: protocol for a mixed-methods systematic review

Por: George · T. · Manski-Nankervis · J.-A. · Klaic · M. · Kang · G. · Sudarsanam · T. D. — Marzo 6th 2024 at 05:12
Introduction

Multimorbidity, the coexistence of two or more chronic conditions in the same individual, is a major public health problem in low-income and middle-income countries (LMICs). The use of single-disease guidelines contributes to polypharmacy, fragmented care and increased treatment burden. Health systems in LMICs are very different from those in high-income countries, and adapting interventions from one to the other may not be feasible. This review aims to systematically present the current evidence for interventions for multimorbidity in the LMIC setting.

Methods and analysis

In this mixed-methods systematic review, we will include all studies of interventions for the care of adults (>18 years of age) with multimorbidity (defined as the presence of two or more chronic illnesses in an individual) in any healthcare organisation (primary, secondary or tertiary care) in an LMIC (as defined by the World Bank), published between 2000 and March 2023. All primary study designs will be included. Studies reported in languages other than English and those describing interventions classified as ‘financial’ or ‘governance arrangement’ according to the Cochrane Effective Practice and Organisation of Care classification will be excluded. MEDLINE, PubMed, Cochrane Library, TRIP, SCOPUS and the 3ie databases will be searched. The titles will be screened by one author, and two authors will independently screen all included abstracts and full texts. A third author will resolve conflicts at every stage. Studies will be reviewed for quality of evidence using appropriate tools. Epidemiological, intervention and outcome data will be extracted and summarised. Outcomes of interest for LMICs defined by the Global Alliance for Chronic Diseases research group will be analysed. Subgroup analysis according to study types and study settings will be done.

Ethics and dissemination

No ethics approval is required for this systematic review. Results will be disseminated through publication in an open-access journal and presentation at conferences.

PROSPERO registration number

CRD42023391897.

☐ ☆ ✇ BMJ Open

Self-management needs, strategies and support for sickle cell disease in developing countries: a scoping review protocol

Por: Druye · A. A. · Boso · C. M. · Amoadu · M. · Obeng · P. · Nabe · B. · Kagbo · J. E. · Doe · P. F. · Okantey · C. · Ofori · G. O. · Opoku-Danso · R. · Agyare · D. F. · Osei Berchie · G. · Owusu · G. · Nsatimba · F. · Abraham · S. A. — Marzo 6th 2024 at 05:12
Introduction

Sickle cell disease (SCD) poses a significant global health burden, particularly affecting individuals in developing countries with constrained healthcare resources. While research on self-management in the context of SCD is emerging, it has predominantly focused on primary studies, and there is a notable dearth of evidence synthesis on SCD self-management in developing countries. This scoping review aims to identify and map self-management needs of individuals living with SCD, the strategies they employed to meet those needs, and the support systems available to them.

Methods and analysis

The review will be conducted following the Arksey and O’Malley’s (2005) 29 framework to comprehensively examine the landscape of SCD self-management research. Searches will be performed in PubMed, Scopus, Embase and Dimensions AI, with additional searches in other databases and grey literature. Indexed literature published in English from inception to January 2024 will be included. Reference list from included studies will also be searched manually. Two teams will be constituted to independently screen titles, abstracts and full text against the eligible criteria. Data will be extracted from included studies onto a customised data extraction form.

Ethics and dissemination

Ethical approval is not required for this review due to the fact that it synthesises information from available publications. The findings will be disseminated through publication in a peer-reviewed journal. Also, the findings will possibly be presented at relevant international and national conferences. This protocol has already been registered with the Open Science Framework. The study characteristics such as design and setting will be descriptively analysed and presented as graphs, tables and figures. Thematic analysis will also be conducted based on the study objectives and presented as a narrative summary.

☐ ☆ ✇ BMJ Open

Effectiveness of an online intervention for parents/guardians of children aged 4-7 years who are concerned about their childs emotional and behavioural development: protocol for an online randomised controlled trial (EMERGENT study)

Por: Frings · D. · Reavey · P. · Chew · J. · Leahy · M. · Allabyrne · C. · Herteliu · C. — Marzo 6th 2024 at 05:12
Introduction

The demand for resources to support emotional and behavioural development in early childhood is ever increasing. However, conventional interventions are lacking in resources and have significant barriers. The Embers the Dragon programme helps address the growing unmet need of children requiring support. The delivery of the current project seeks to help support parents, reduce the burden placed on pressed services (eg, Child and Adolescent Mental Health Services) and to help improve the emotional and behavioural development of children.

Methods and analysis

This project aims to investigate the efficacy and acceptability of Embers on parenting and children’s psychosocial outcomes. 364 parents/guardians of children aged between 4 and 7 will be recruited via the internet, schools and general practitioners (GPs). This is an online waitlist-controlled trial with three arms: (1) control arm, (2) access to Embers arm and (3) access to Embers+school. Participants will be randomised (1:1) into (1) or (2) to evaluate the use of Embers at home. To evaluate scalability in schools, (3) will be compared with (2), and (1) to test efficacy against treatment as usual (not receiving the intervention). Qualitative interviews will also be conducted. Primary outcomes are the Parental Self-efficacy Scale, Strengths and Difficulties Questionnaire and qualitative interviews. Outcomes will be compared between the three groups at baseline, 8, 16 and 24 weeks.

Ethics and dissemination

Ethical approval has been granted by the London South Bank University ethics panel (ETH2324-0004). To recruit via GPs, NHS ethical approval has been applied for, and the IRAS (331410) application is under consideration by the Central Bristol REC. The results of the project will be submitted for publication in a peer-reviewed journal. Parents/guardians will provide informed consent online prior to taking part in the study. For the interviews, assent will be taken from children by the researchers on the day.

Trial registration number

ISRCTN58327872

☐ ☆ ✇ BMJ Open

Protocol for venoarterial ExtraCorporeal Membrane Oxygenation to reduce morbidity and mortality following bilateral lung TransPlantation: the ECMOToP randomised controlled trial

Por: Messika · J. · Eloy · P. · Boulate · D. · Charvet · A. · Fessler · J. · Jougon · J. · Lacoste · P. · Mercier · O. · Portran · P. · Roze · H. · Sage · E. · Thes · J. · Tronc · F. · Vourc'h · M. · Montravers · P. · Castier · Y. · Mal · H. · Mordant · P. · Investigators from the ECMOToP Study — Marzo 6th 2024 at 05:12
Introduction

Lung transplantation (LTx) aims at improving survival and quality of life for patients with end-stage lung diseases. Venoarterial extracorporeal membrane oxygenation (VA-ECMO) is used as intraoperative support for LTx, despite no precise guidelines for its initiation. We aim to evaluate two strategies of VA-ECMO initiation in the perioperative period in patients with obstructive or restrictive lung disease requiring bilateral LTx. In the control ‘on-demand’ arm, high haemodynamic and respiratory needs will dictate VA-ECMO initiation; in the experimental ‘systematic’ arm, VA-ECMO will be pre-emptively initiated. We hypothesise a ‘systematic’ strategy will increase the number of ventilatory-free days at day 28.

Methods and analysis

We designed a multicentre randomised controlled trial in parallel groups. Adult patients with obstructive or restrictive lung disease requiring bilateral LTx, without a formal indication for pre-emptive VA-ECMO before LTx, will be included. Patients with preoperative pulmonary hypertension with haemodynamic collapse, ECMO as a bridge to transplantation, severe hypoxaemia or hypercarbia will be secondarily excluded. In the systematic group, VA-ECMO will be systematically implanted before the first pulmonary artery cross-clamp. In the on-demand group, VA-ECMO will be implanted intraoperatively if haemodynamic or respiratory indices meet preplanned criteria. Non-inclusion, secondary exclusion and VA-ECMO initiation criteria were validated by a Delphi process among investigators. Postoperative weaning of ECMO and mechanical ventilation will be managed according to best practice guidelines. The number of ventilator-free days at 28 days (primary endpoint) will be compared between the two groups in the intention-to-treat population. Secondary endpoints encompass organ failure occurrence, day 28, day 90 and year 1 vital status, and adverse events.

Ethics and dissemination

The sponsor is the Assistance Publique–Hôpitaux de Paris. The ECMOToP protocol version 2.1 was approved by Comité de Protection des Personnes Ile de France VIII. Results will be published in international peer-reviewed medical journals.

Trial registration number

NCT05664204.

☐ ☆ ✇ BMJ Open

Knowledge, attitude and practice of contraceptive methods among women with an unplanned pregnancy

Por: Sheng · B. · Yao · D. · Zhang · H. · Tang · J. · Du · X. — Marzo 6th 2024 at 05:12
Objectives

The study aimed to investigate the knowledge, attitude and practice (KAP) of contraceptive methods among women with an unplanned pregnancy, aiming to improve their reproductive health and increase their understanding of contraceptive methods.

Design

This is a cross-sectional study.

Setting

The study was conducted at the Maternity and Child Healthcare Hospital of Hubei between 20 November 2022 and 20 January 2023.

Participants

Women with an unplanned pregnancy were included.

Primary and secondary outcome measures

The questionnaire was in the Chinese language and included demographic data, KAP assessments. Multivariate linear regression was performed to explore the factors associated with knowledge or practice scores.

Results

During the study period, 510 participants with valid questionnaires were included. The KAP scores were 7.30±2.91, 32.61±3.13 and 28.58±3.59, respectively. Place of residence (urban vs non-urban; B=0.66, 95% CI 0.02 to 1.29, p=0.043) and educational level (master’s degree or above vs post secondary or below; B=1.07, 95% CI 0.17 to 1.96, p=0.020) were positively associated with knowledge. Knowledge (B=0.25, 95% CI 0.17 to 0.32, p

Conclusions

This study indicates a low level of KAP regarding contraceptive methods among women facing unplanned pregnancies. Place of residence and educational level were positively associated with knowledge scores. These findings may help improve future sex education policies and programmes.

☐ ☆ ✇ BMJ Open

A scoping review to map the research on the mental health of students and graduates during their university-to-work transitions

Por: Edmonds · D. M. · Zayts-Spence · O. · Fortune · Z. · Chan · A. · Chou · J. S. G. — Marzo 5th 2024 at 04:40
Objectives

This scoping review maps the extant literature on students’ and graduates’ mental health experiences throughout their university-to-work transitions. The current review investigates the methodological features of the studies, the main findings, and the theories that the studies draw on to conceptualise mental health and transitions.

Design

This project used a scoping review methodology created and developed by Peters and colleagues and the Joanna Briggs Institute. The review searched academic databases and screened existing studies that met predetermined inclusion criteria.

Data sources

Seven academic databases and Google Scholar were searched with sets of search terms.

Eligibility

The included studies examined participants who were final-year university students or those who had graduated from university within a 3-year period. Studies published in English since 2000 and from any country were included. The review included studies examining the negative dimensions of mental health. The review excluded studies focusing on medical students and graduates.

Data extraction

Basic information about the studies and their findings on mental health and university-to-work transitions was retrieved. The findings are presented in tables and in a qualitative thematic summary.

Results

The scoping review included 12 studies. Mental health was often not explicitly defined and it’s theoretical foundations were not clearly articulated. The review identified factors, including a lack of social support and economic precarity, as sources of adverse mental health. Other protective factors in these studies—variables that guard against mental health problems—were identified, such as career preparedness and having a good job.

Conclusions

Despite the methodological focus on the negative aspects of mental health, people’s mental health experiences during university-to-work transitions are not uniformly negative. Clear conceptualisations of mental health in future studies will aid in developing resources to improve well-being.

Trial registration number

This scoping review adhered to a protocol previously published in this journal and that is registered on the Open Science Framework website (https://osf.io/gw86x).

☐ ☆ ✇ BMJ Open

DEcreased Cognitive functiON, NEurovascular CorrelaTes and myocardial changes in women with a history of pre-eclampsia (DECONNECT): research protocol for a cross-sectional pilot study

Por: Brandt · Y. · Alers · R.-J. · Canjels · L. P. W. · Jorissen · L. M. · Jansen · G. · Janssen · E. B. N. J. · van Kuijk · S. M. · Went · T. M. · Koehn · D. · Gerretsen · S. C. · Jansen · J. F. · Backes · W. H. · Hurks · P. P. M. · van de Ven · V. · Kooi · M. E. · Spaanderman · M. E. A. — Marzo 5th 2024 at 04:40
Introduction

Pre-eclampsia is a hypertensive disorder affecting up to 8% of pregnancies. After pre-eclampsia, women are at increased risk of cognitive problems, and cerebrovascular and cardiovascular disorders. These sequelae could result from microvascular dysfunction persisting after pre-eclampsia. This study will explore differences in cerebral and myocardial microvascular function between women after pre-eclampsia and women after normotensive gestation. We hypothesise that pre-eclampsia alters cerebral and myocardial microvascular functions, which in turn are related to diminished cognitive and cardiac performance.

Methods and analysis

The cross-sectional ‘DEcreased Cognitive functiON, NEurovascular CorrelaTes and myocardial changes in women with a history of pre-eclampsia’ (DECONNECT) pilot study includes women after pre-eclampsia and controls after normotensive pregnancy between 6 months and 20 years after gestation. We recruit women from the Queen of Hearts study, a study investigating subclinical heart failure after pre-eclampsia. Neuropsychological tests are employed to assess different cognitive domains, including attention, processing speed, and cognitive control. Cerebral images are recorded using a 7 Tesla MRI to assess blood–brain barrier integrity, perfusion, blood flow, functional and structural networks, and anatomical dimensions. Cardiac images are recorded using a 3 Tesla MRI to assess cardiac perfusion, strain, dimensions, mass, and degree of fibrosis. We assess the effect of a history of pre-eclampsia using multivariable regression analyses.

Ethics and dissemination

This study is approved by the Ethics Committee of Maastricht University Medical Centre (METC azM/UM, NL47252.068.14). Knowledge dissemination will include scientific publications, presentations at conferences and public forums, and social media.

Trial registration number

NCT02347540.

☐ ☆ ✇ BMJ Open

Study protocol for a cross-sectional online survey investigating patient preferences and experiences of waiting for elective cardiac surgery

Por: Russo · M. · Watson · K. · Richards · K. · Olive · R. R. · Krausova · B. · Kumar · R. · Burridge · J. · Goulding · L. · Chua · K.-C. · Hardy · D. · Vassilios · A. · Kamran · B. · Bhudia · S. · Alia · N. · Habib · K. · Sevdalis · N. · Petrou · M. — Marzo 5th 2024 at 04:40
Introduction

Being on a waiting list for elective (planned) cardiac surgery can be physically and psychologically challenging for patients. Research suggests that stress associated with waiting for surgery is dependent on different individual and contextual factors. However, most data on patients’ experiences of waiting for surgery and preferences for waiting list management derives from non-cardiac clinical populations. The aim of the current study is to explore patients’ experiences of being on a waiting list for elective cardiac surgery, and their views on how the waiting experience could be improved in the future. This work will inform the patient management strategy during the waiting period for surgery across the four major hospitals in London directly involved in this study, and potentially beyond by transferring learning to other services.

Methods and analysis

This is a mixed-methods study that will collect quantitative and qualitative data using a cross-sectional online survey. Patients who are on waiting lists for elective surgery across four major cardiac surgery departments in London hospitals, and are at least 18 years old, will be invited by their healthcare team via text message or letter to complete the survey. The target sample size of non-randomly selected participants will be 268. Bivariable and multivariable regression models will be used to assess associations between survey items measuring the impact of the cardiac condition on specific life domains (eg, daily activities, social and family relationships, hobbies, sexual life), anxiety and depression symptoms as measured by the Patient Health Questionnaire-4 and survey items evaluating experiences of health services. Data on experience and preferences for improvements to the waiting experience will be analysed with qualitative content analysis using an inductive approach.

Ethics and dissemination

This study was reviewed and granted ethical approval by the East of England—East Cambridge Research Ethics Committee. Findings from this study will be disseminated through peer-reviewed journals, a research website and social media and with an online event engaging patients, members of the public, healthcare professionals and other relevant stakeholders.

Trial registration numb

NCT05996640

☐ ☆ ✇ BMJ Open

Combined MRI-TRUS fusion targeted and systematic biopsy versus systematic biopsy alone for the detection of prostate cancer: protocol for a prospective single-centre trial

Por: Liu · W. · Kadier · A. · Shen · D. · He · Y. · Dong · S. · Zhu · K. · Xu · G. · Zhao · B. · Mao · S. · Guo · C. · Yao · X. · Wei · Q. · Han · D. · Yang · B. — Marzo 2nd 2024 at 04:33
Introduction

The classic way of diagnosing prostate cancer (PCa) is by conducting the 12-core systematic biopsy (SB). However, it has a low detection rate for clinically significant PCa (csPCa) and can lead to the detection of clinically insignificant PCa (cisPCa). Although MRI-transrectal ultrasound (MRI-TRUS) fusion targeted biopsy (TB) can effectively improve the detection rate of csPCa, it may still miss some cases. Therefore, we propose using a combination of TB and SB methods to enhance the detection rate of csPCa while minimising the detection rate of cisPCa.

Methods and analysis

This study is a prospective, single-centre investigation that aims to assess and compare the detection rate of csPCa using MRI-TRUS fusion TB combined with SB versus TRUS 12-core SB alone. Biopsy-naïve men with suspected PCa will be subjected to multiparametric MRI. Patients with Prostate Imaging Reporting and Data System (V.2.1) score ≥3 will be enrolled in the TB-SB combination group. The sample size is established as 660 participants, considering a 10% drop-out rate. The primary outcome is the detection rate of csPCa in men without prior biopsy using MRI-TRUS fusion TB combined with the standard TRUS-guided 12-core SB method. CsPCa will be defined as International Society of Urological Pathology Grade ≥2.

Ethics and dissemination

This study has been approved by the Ethics Committee at the Shanghai Tenth People’s Hospital, an affiliated hospital of Tongji University School of Medicine. The research results will be published in a peer-reviewed international journal.

Trial registration number

ChiCTR2000036089.

☐ ☆ ✇ BMJ Open

Voluntariness of consent in paediatric HIV clinical trials: a mixed-methods, cross-sectional study of participants in the CHAPAS-4 and ODYSSEY trials in Uganda

Por: Makumbi · S. · Bajunirwe · F. · Ford · D. · Turkova · A. · South · A. · Lugemwa · A. · Musiime · V. · Gibb · D. · Tamwesigire · I. K. — Marzo 2nd 2024 at 04:33
Objectives

To examine the voluntariness of consent in paediatric HIV clinical trials and the associated factors.

Design

Mixed-methods, cross-sectional study combining a quantitative survey conducted concurrently with indepth interviews.

Setting and participants

From January 2021 to April 2021, we interviewed parents of children on first-line or second-line Anti-retroviral therapy (ART) in two ongoing paediatric HIV clinical trials [CHAPAS-4 (ISRCTN22964075) and ODYSSEY (ISRCTN91737921)] at the Joint Clinical Research Centre Mbarara, Uganda.

Outcome measures

The outcome measures were the proportion of parents with voluntary consent, factors affecting voluntariness and the sources of external influence. Parents rated the voluntariness of their consent on a voluntariness ladder. Indepth interviews described participants’ lived experiences and were aimed at adding context.

Results

All 151 parents randomly sampled for the survey participated (84% female, median age 40 years). Most (67%) gave a fully voluntary decision, with a score of 10 on the voluntariness ladder, whereas 8% scored 9, 9% scored 8, 6% scored 7, 8% scored 6 and 2.7% scored 4. Trust in medical researchers (adjusted OR 9.90, 95% CI 1.01 to 97.20, p=0.049) and male sex of the parent (adjusted OR 3.66, 95% CI 1.00 to 13.38, p=0.05) were positively associated with voluntariness of consent. Prior research experience (adjusted OR 0.31, 95% CI 0.12 to 0.78, p=0.014) and consulting (adjusted OR 0.25. 95% CI 0.10 to 0.60, p=0.002) were negatively associated with voluntariness. Consultation and advice came from referring health workers (36%), spouses (29%), other family members (27%), friends (15%) and researchers (7%). The indepth interviews (n=14) identified the health condition of the child, advice from referring health workers and the opportunity to access better care as factors affecting the voluntariness of consent.

Conclusions

This study demonstrated a high voluntariness of consent, which was enhanced among male parents and by parents’ trust in medical researchers. Prior research experience of the child and advice from health workers and spouses were negatively associated with the voluntariness of parents’ consent. Female parents and parents of children with prior research experience may benefit from additional interventions to support voluntary participation.

❌