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☐ ☆ ✇ BMJ Open

Insomnia symptom prevalence in England: a comparison of cross-sectional self-reported data and primary care records in the UK Biobank

Por: de Lange · M. A. · Richmond · R. C. · Eastwood · S. V. · Davies · N. M. — Mayo 8th 2024 at 00:50
Objectives

We aimed to use a large dataset to compare self-reported and primary care measures of insomnia symptom prevalence in England and establish whether they identify participants with similar characteristics.

Design

Cross-sectional study with linked electronic health records (EHRs).

Setting

Primary care in England.

Participants

163 748 UK Biobank participants in England (aged 38–71 at baseline) with linked primary care EHRs.

Outcome measures

We compared the percentage of those self-reporting ‘usually’ having insomnia symptoms at UK Biobank baseline assessment (2006–2010) to those with a Read code for insomnia symptoms in their primary care records prior to baseline. We stratified prevalence in both groups by sociodemographic, lifestyle, sleep and health characteristics.

Results

We found that 29% of the sample self-reported having insomnia symptoms, while only 6% had a Read code for insomnia symptoms in their primary care records. Only 10% of self-reported cases had an insomnia symptom Read code, while 49% of primary care cases self-reported having insomnia symptoms. In both primary care and self-reported data, prevalence of insomnia symptom cases was highest in females, older participants and those with the lowest household incomes. However, while snorers and risk takers were more likely to be a primary care case, they were less likely to self-report insomnia symptoms than non-snorers and non-risk takers.

Conclusions

Only a small proportion of individuals experiencing insomnia symptoms have an insomnia symptom Read code in their primary care record. However, primary care data do provide a clinically meaningful measure of insomnia prevalence. In addition, the sociodemographic characteristics of people attending primary care with insomnia were consistent with those with self-reported insomnia, thus primary care records are a valuable data source for studying risk factors for insomnia. Further studies should replicate our findings in other populations and examine ways to increase discussions about sleep health in primary care.

☐ ☆ ✇ BMJ Open

Sex and gender-based analysis and diversity metric reporting in acute care trials published in high-impact journals: a systematic review

Por: Granton · D. · Rodrigues · M. · Raparelli · V. · Honarmand · K. · Agarwal · A. · Friedrich · J. O. · Perna · B. · Spaggiari · R. · Fortunato · V. · Risdonne · G. · Kho · M. · VanderKaay · S. · Chaudhuri · D. · Gomez-Builes · C. · D'Aragon · F. · Wiseman · D. · Lau · V. I. · Lin · C. · Reid — Mayo 8th 2024 at 00:30
Objective

To characterise sex and gender-based analysis (SGBA) and diversity metric reporting, representation of female/women participants in acute care trials and temporal changes in reporting before and after publication of the 2016 Sex and Gender Equity in Research guideline.

Design

Systematic review.

Data sources

We searched MEDLINE for trials published in five leading medical journals in 2014, 2018 and 2020.

Study selection

Trials that enrolled acutely ill adults, compared two or more interventions and reported at least one clinical outcome.

Data abstraction and synthesis

4 reviewers screened citations and 22 reviewers abstracted data, in duplicate. We compared reporting differences between intensive care unit (ICU) and cardiology trials.

Results

We included 88 trials (75 (85.2%) ICU and 13 (14.8%) cardiology) (n=111 428; 38 140 (34.2%) females/women). Of 23 (26.1%) trials that reported an SGBA, most used a forest plot (22 (95.7%)), were prespecified (21 (91.3%)) and reported a sex-by-intervention interaction with a significance test (19 (82.6%)). Discordant sex and gender terminology were found between headings and subheadings within baseline characteristics tables (17/32 (53.1%)) and between baseline characteristics tables and SGBA (4/23 (17.4%)). Only 25 acute care trials (28.4%) reported race or ethnicity. Participants were predominantly white (78.8%) and male/men (65.8%). No trial reported gendered-social factors. SGBA reporting and female/women representation did not improve temporally. Compared with ICU trials, cardiology trials reported significantly more SGBA (15/75 (20%) vs 8/13 (61.5%) p=0.005).

Conclusions

Acute care trials in leading medical journals infrequently included SGBA, female/women and non-white trial participants, reported race or ethnicity and never reported gender-related factors. Substantial opportunity exists to improve SGBA and diversity metric reporting and recruitment of female/women participants in acute care trials.

PROSPERO registration number

CRD42022282565.

☐ ☆ ✇ BMJ Open

Diversity, equity and inclusion considerations in mental health apps for young people: protocol for a scoping review

Por: Figueroa · C. A. · Perez-Flores · N. J. · Guan · K. W. · Stiles-Shields · C. — Mayo 7th 2024 at 18:05
Introduction

After COVID-19, a global mental health crisis affects young people, with one in five youth experiencing mental health problems worldwide. Delivering mental health interventions via mobile devices is a promising strategy to address the treatment gap. Mental health apps are effective for adolescent and young adult samples, but face challenges such as low real-world reach and under-representation of minoritised youth. To increase digital health uptake, including among minoritised youth, there is a need for diversity, equity and inclusion (DEI) considerations in the development and evaluation of mental health apps. How well DEI is integrated into youth mental health apps has not been comprehensively assessed. This scoping review aims to examine to what extent DEI considerations are integrated into the design and evaluation of youth mental health apps and report on youth, caregiver and other stakeholder involvement.

Methods and analysis

We will identify studies published in English from 2009 to 29 September 2023 on apps for mental health in youth. We will use PubMed, Global Health, APA PsycINFO, SCOPUS, CINAHL PLUS and the Cochrane Database and will report according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses-Scoping Review Extension guidelines. Papers eligible for inclusion must be peer-reviewed publications in English involving smartphone applications used by adolescents or young adults aged 10–25, with a focus on depression, anxiety or suicidal ideation. Two independent reviewers will review and extract articles using a template developed by the authors. We will analyse the data using narrative synthesis and descriptive statistics. This study will identify gaps in the literature and provide a roadmap for equitable and inclusive mental health apps for youth.

Ethics and dissemination

Ethics approval is not required. Findings will be disseminated through academic, industry, community networks and scientific publications.

☐ ☆ ✇ BMJ Open

Impact of androgenic anabolic steroid use on cardiovascular and mental health in Danish recreational athletes: protocol for a nationwide cross-sectional cohort study as a part of the Fitness Doping in Denmark (FIDO-DK) study

Por: Buhl · L. F. · Lehmann Christensen · L. · Diederichsen · A. · Lindholt · J. S. · Kistorp · C. M. · Glintborg · D. · Andersen · M. · Frystyk · J. — Mayo 7th 2024 at 18:05
Introduction

The use of androgenic anabolic steroids (AASs) among recreational athletes is steadily increasing. However, knowledge regarding the potentially harmful effects of AAS primarily originates from case reports and small observational studies. This large-scale study aims to investigate the impact of AAS use on vascular plaque formation, preclinical coronary disease, cardiac function, circulating cardiovascular risk markers, quality of life (QoL) and mental health in a broad population of illicit AAS users.

Methods and analyses

A nationwide cross-sectional cohort study including a diverse population of men and women aged ≥18 years, with current or previous illicit AAS use for at least 3 months. Conducted at Odense University Hospital, Denmark, the study comprises two parts. In part A (the pilot study), 120 recreational athletes with an AAS history will be compared with a sex-matched and age-matched control population of 60 recreational athletes with no previous AAS use. Cardiovascular outcomes include examination of non-calcified coronary plaque volume and calcium score using coronary CT angiography, myocardial structure and function via echocardiography, and assessing carotid and femoral artery plaques using ultrasonography. Retinal microvascular status is evaluated through fundus photography. Cardiovascular risk markers are measured in blood. Mental health outcomes include health-related QoL, interpersonal difficulties, body image concerns, aggression dimensions, anxiety symptoms, depressive severity and cognitive function assessed through validated questionnaires. The findings of our comprehensive study will be used to compose a less intensive investigatory cohort study of cardiovascular and mental health (part B) involving a larger group of recreational athletes with a history of illicit AAS use.

Ethics and dissemination

The study received approval from the Regional Committee on Health Research Ethics for Southern Denmark (S-20210078) and the Danish Data Protection Agency (21/28259). All participants will provide signed informed consent. Research outcomes will be disseminated through peer-reviewed journals and scientific conferences.

Trial registration number

NCT05178537.

☐ ☆ ✇ BMJ Open

Efficiency assessment of follow-up methodology of patients with knee replacement to predict post-surgical functionality: a protocol for randomised control PROKnee trial

Por: San Martin Valenzuela · C. · Tabares-Seisdedos · R. · Paya Rubio · A. · Correa-Ghisays · P. · Pedrero-Sanchez · J.-F. · Silvestre Munoz · A. — Mayo 7th 2024 at 18:05
Introduction

Even when total knee arthroplasty (TKA) is an extended treatment, most patients experience a suboptimal evolution after TKA. The objectives of this study are the following: (1) to determine the effectiveness of two different prosthesis stabilisation systems on the functionality in activities of daily life, and (2) to determine prognostic biomarkers of knee prosthesis function based on radiological information, quantification of cytokines, intra-articular markers and biomechanical functional evaluation to predict successful evolution.

Methods and analysis

The PROKnee trial was designed as a randomised controlled patient-blinded trial with two parallel groups that are currently ongoing. The initial recruitment will be 99 patients scheduled for their first TKA, without previous prosthesis interventions in lower limbs, who will be randomly divided into two groups that differed in the stabilisation methodology incorporated in the knee prosthesis: the MEDIAL-pivot group and the CENTRAL-pivot group. The maximum walking speed will be reported as the primary outcome, and the secondary results will be patient-reported questionnaires related to physical status, cognitive and mental state, radiological test, laboratory analysis and biomechanical instrumented functional performance, such as the 6-minute walking test, timed up-and-go test, gait, sit-to-stand, step-over, and ability to step up and down stairs. All the results will be measured 1 week before TKA and at 1.5, 3, 6 and 12 months after surgery.

Ethics and dissemination

All procedures were approved by the Ethical Committee for Research with Medicines of the University Clinical Hospital of Valencia on 8 October 2020 (order no. 2020/181). Participants are required to provide informed consent for the study and for the surgical procedure. All the data collected will be treated confidentially since they will be blinded and encrypted. The results from the trial will be published in international peer-reviewed scientific journals, regardless of whether these results are negative or inconclusive.

Trial registration number

ClinicalTrials.gov Registry (NCT04850300).

☐ ☆ ✇ BMJ Open

Mapping scoping reviews in neurosurgery: a scoping review protocol

Por: Lee · C.-Y. · Lai · H.-Y. · Chen · M.-M. · Lee · C.-H. — Mayo 7th 2024 at 18:05
Introduction

The realm of neurosurgery is currently witnessing a surge in primary research, underscoring the importance of adopting evidence-based approaches. Scoping reviews, as a type of evidence synthesis, offer a broad perspective and have become increasingly vital for managing the ever-expanding body of research in swiftly evolving fields. Recent research has indicated a rising prevalence of scoping reviews in healthcare literature. In this context, the concept of a ‘review of scoping reviews’ has emerged as a means to offer a higher level synthesis of insights. However, the field of neurosurgery appears to lack a comprehensive integration of scoping reviews. Therefore, the objective of this scoping review is to identify and evaluate the extent of scoping reviews within neurosurgery, pinpointing research gaps and methodological issues to enhance evidence-based practices in this dynamic discipline.

Methods

The method framework of Arksey and O’Malley will be used to conduct the scoping review. A thorough literature search will be performed on Medline, Scopus and Web of Science to find eligible studies using the keywords related to neurosurgery, scoping review and its variants. Two reviewers will independently revise all of the full-text articles, extract data and evaluate the study extent. A narrative overview of the findings from included studies will be given.

Ethics and dissemination

This review will involve secondary analysis of published literature, and therefore ethics approval is not required. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews checklist will be used to guide translation of findings. Results will be disseminated through peer-reviewed journals and presented in conferences via abstract and presentation.

☐ ☆ ✇ BMJ Open

Implementation of the WHO Safe Childbirth Checklist: a scoping review protocol

Por: Gama · Z. A. d. S. · Lima · M. T. S. d. · Semrau · K. E. A. · Tuller · D. E. · Fifield · J. · Fernandez-Elorriaga · M. · Saraiva · C. O. P. d. O. · Freitas · M. R. d. · Pellense · M. C. d. S. · Rosendo · T. M. S. d. S. · Molina · R. L. — Mayo 7th 2024 at 18:05
Introduction

The WHO Safe Childbirth Checklist (WHO SCC) was developed to accelerate adoption of essential practices that prevent maternal and neonatal morbidity and mortality during childbirth. This study aims to summarise the current landscape of organisations and facilities that have implemented the WHO SCC and compare the published strategies used to implement the WHO SCC implementation in both successful and unsuccessful efforts.

Methods and analysis

This scoping review protocol follows the guidelines of the Joanna Briggs Institute. Data will be collected and reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews report. The search strategy will include publications from the databases Scopus, PubMed, Embase, CINAHL and Web of Science, in addition to a search in grey literature in The National Library of Australia’s Trobe, DART-Europe E-Theses Portal, Electronic Theses Online Service, Theses Canada, Google Scholar and Theses and dissertations from Latin America. Data extraction will include data on general information, study characteristics, organisations involved, sociodemographic context, implementation strategies, indicators of implementation process, frameworks used to design or evaluate the strategy, implementation outcomes and final considerations. Critical analysis of implementation strategies and outcomes will be performed with researchers with experience implementing the WHO SCC.

Ethics and dissemination

The study does not require an ethical review due to its design as a scoping review of the literature. The results will be submitted for publication to a scientific journal and all relevant data from this study will be made available in Dataverse.

Trial registration number

https://doi.org/10.17605/OSF.IO/RWY27.

☐ ☆ ✇ BMJ Open

Experiences of living with overweight/obesity and early type 2 diabetes in Singapore--a qualitative interview study

Por: Lee · M. · Khoo · H. S. · Krishnasamy · C. · Loo · M. E. · Wong · S. K. W. · Cheng · S. C. · Bei · E. · Tan · S. Y. · Xie · P. · Lee · E. S. · Tang · W. E. — Mayo 7th 2024 at 18:05
Objectives

To understand the lived experience of adults with overweight/obesity and early type 2 diabetes in a modern urban environment, and the interrelations among the various aspects of these experiences and participants’ attitudes to weight management.

Design

Qualitative inductive approach to analysing data thematically from semistructured interviews and interpreted from a socioecological perspective.

Setting

Primary care clinics located in northern and central Singapore.

Participants

21 patients between 29 and 59 years old who are living with overweight/obese (Body Mass Index of 25.3–44.0kg/m2) and type 2 diabetes for 6 years or less.

Results

The main themes everyday life, people around me and within me pointed to a combination of barriers to weight and health management for participants. These included environmental factors such as easy physical and digital access to unhealthy food, and high-stress work environments; social factors such as ambiguous family support and dietary practices of peers; and individual factors such as challenges with self-regulation, prioritising work, dealing with co-existing medical conditions and the emotional significance of food. While lack of motivation and cultural dietary practices are hard to change, a problem-solving attitude, and presence of role models, may enable behaviour change.

Conclusion

An exploration of the lifeworld of patients with overweight/obese and early type 2 diabetes revealed that work demands, dietary practices in the workplace and at home, and the easy availability of calorie-dense foods afforded by a technology-infused environment hindered the individual’s efforts at maintaining a healthy weight and lifestyle. Policy and initiatives promoting work-life balance as well as individualised interventions can support participants’ stress management, and problem-solving capability for behaviour change. These barriers stemmed from the various domains of the environmental, interpersonal and intrapersonal but were interrelated. They underscored the need for an integrated approach to weight and diabetes management.

☐ ☆ ✇ BMJ Open

Where does physical activity fit into preschool postpandemic? A qualitative exploration with parents, teachers and administrators

Por: Zulauf-McCurdy · C. · Tessema · B. · Tang · R. · Almeida · S. · Tandon · P. S. — Mayo 7th 2024 at 18:05
Objectives

During the preschool years, children depend on adult caregivers to provide opportunities for physical activity (PA). Research has focused on measuring PA in preschool, as well as barriers and facilitators to children’s PA but caregiver perceptions remain largely unknown especially in light of the COVID-19 pandemic. This study aims to understand the value of PA in preschool following the pandemic from three types of adult caregivers, parents of a young child (n=7), preschool teachers (n=7) and preschool administrators (n=7).

Methods

In-depth qualitative interviews were conducted to explore the following research questions: (a) how do caregivers describe the importance of PA in preschool postpandemic? (b) how do caregivers support and prioritise PA in preschool postpandemic and what challenges do they face in doing so? and (c) how do caregivers interact with one another to promote PA? Qualitative answers were coded using a codebook developed to answer the research questions of interest.

Results

Parents, teachers and administrators all described valuing PA for preschoolers, but each caregiver type described a different way of promoting it. All the caregivers listed barriers that inhibit their ability to prioritise and promote PA, some heightened postpandemic. Lastly, there were limited caregiver interactions when it came to promoting PA, with the burden largely falling on teachers.

Conclusion

Our findings indicate that one particularly important area for intervention is supporting parents, teachers and preschool administrators in creating a shared understanding of the importance of PA for young children and ways to collaborate to promote it.

☐ ☆ ✇ BMJ Open

DORIS study: domestic violence in orthopaedics, a prospective cohort study at a Swedish hospital on the annual prevalence of domestic violence in orthopaedic emergency care

Por: Svensson Malchau · K. · Caragounis · E.-C. · Sundfeldt · M. — Mayo 7th 2024 at 18:05
Background

Domestic violence (DV) is a major problem which despite many efforts persists globally. Victims of DV can present with various injuries, whereof musculoskeletal presentation is common.

Objectives

The DORIS study (Domestic violence in ORthopaedIcS) aimed to establish the annual prevalence of DV at an orthopaedic emergency department (ED) in Sweden.

Design

Female adult patients with orthopaedic injuries seeking treatment at a tertiary orthopaedic centre between September 2021 and 2022 were screened during their ED visit.

Setting

This is a single-centre study at a tertiary hospital in Sweden.

Participants

Adult female patients seeking care for acute orthopaedic injuries were eligible for the study. During the study period, 4192 female patients were provided with study forms and 1366 responded (32.5%).

Primary and secondary outcome measures

The primary outcome measure was to establish the annual prevalence of injuries due to DV and second, to establish the rate of current experience of any type of DV.

Results

One in 14 had experience of current DV (n=100, 7.5%) and 1 in 65 (n=21, 1.5%) had an injury due to DV.

Conclusions

The prevalence of DV found in the current study is comparable to international findings and adds to the growing body of evidence that it needs to be considered in clinical practice. It is important to raise awareness of DV, and frame strategies, as healthcare staff have a unique position to identify and offer intervention to DV victims.

☐ ☆ ✇ BMJ Open

Morbidity and mortality outcomes of patients requiring isolated tricuspid valve surgery: a retrospective cohort study of 537 patients in New South Wales between 2002 and 2018

Por: Harvey · G. · Chow · V. · Rubenis · I. · Brieger · D. · Kritharides · L. · Ng · A. C. C. — Mayo 7th 2024 at 18:05
Objectives

The aim of the study was to evaluate mortality and morbidity outcomes following open-heart isolated tricuspid valve surgery (TVSx) with medium to long-term follow-up.

Design

Retrospective cohort study.

Setting

New South Wales public and private hospital admissions between 1 January 2002 and 30 June 2018.

Participants

A total of 537 patients underwent open isolated TVSx during the study period.

Primary and secondary outcome measures

Primary outcome was all-cause mortality tracked from the death registry to 31 December 2018. Secondary morbidity outcomes, including admission for congestive cardiac failure (CCF), new atrial fibrillation (AF), infective endocarditis (IE), pulmonary embolism (PE) and insertion of a permanent pacemaker (PPM) or implantable cardioverter-defibrillator (ICD), were tracked from the Admitted Patient Data Collection database. Independent mortality associations were determined using the Cox regression method.

Results

A total of 537 patients underwent open isolated TVSx (46% male): median age (IQR) was 63.5 years (43.9–73.8 years) with median length of stay of 16 days (10–31 days). Main cardiovascular comorbidities were AF (54%) and CCF (42%); 67% had rheumatic tricuspid valve. In-hospital and total mortality were 7.4% and 39.3%, respectively (mean follow-up: 4.8 years). Cause-specific deaths were evenly split between cardiovascular and non-cardiovascular causes. Predictors of mortality included a history of CCF (HR=1.78, 95% CI 1.33 to 2.38, p

Conclusion

Open isolated TVSx carries significant mortality risk, with decompensated CCF and new AF the most common morbidities encountered after surgery. This report forms a benchmark to compare outcomes with newer percutaneous tricuspid interventions.

☐ ☆ ✇ BMJ Open

Risk of transmission of HIV to infants during breast/chest feeding when mothers/birthing parents living with HIV are on antiretroviral therapy: a protocol for a rapid review

Por: Djiadeu · P. · Begum · H. · Archibald · C. · Ekmekjian · T. · Busa · G. · Dansoh · J. · Van Nguyen · P. · Merckx · J. · Fleurant · A. — Mayo 6th 2024 at 18:42
Introduction

HIV is a major public health issue affecting millions globally. Women and girls account for 46% of new HIV infections in 2022 and approximately 1.3 million females become pregnant every year. Vertical transmission of HIV from persons living with HIV (PLHIV) to infants may occur through different modalities, such as through breast/chest feeding. Notably, 82% of PLHIV who chose to breast/chest feed are on antiretroviral therapy (ART) when feeding their infants. Precise estimates of the risk of postpartum transmission to infants during breast/chest feeding at varying viral load levels remain a significant gap in the literature.

Methods and analysis

A rapid systematic search of electronic databases will be conducted from January 2005 to the present, including Medline, Embase and Global Health. The objective of this rapid review is to explore and assess the available evidence on the effect of varying viral load levels on the risk of HIV transmission to infants during breast/chest feeding when the birthing or gestational parent living with HIV is on ART. Study characteristics will be summarised and reported to support the narrative summary of the findings. The focus will be on the absolute risk of HIV transmission from birthing parent to infant during chest/breast feeding. The findings will also be stratified by month, including the risk of HIV transmission for 6 months and greater than 6 months postpartum. We will ascertain the risk of bias using A Measurement Tool to Assess Systematic Reviews 2, Quality of Prognosis Studies and Downs and Black checklist for the appropriate study type. A summary score will not be calculated, rather the strengths and limitations of the studies will be narratively described.

Ethics and dissemination

No human subjects will be involved in the research. The findings of this rapid review will inform a future systematic review and will be disseminated through peer-reviewed publications, presentations and conferences.

PROSPERO registration number

CRD42024499393.

☐ ☆ ✇ BMJ Open

Contextually appropriate nurse staffing models: a realist review protocol

Por: Tate · K. · Penconek · T. · Booth · A. · Harvey · G. · Flynn · R. · Lalleman · P. · Wolbers · I. · Hoben · M. · Estabrooks · C. A. · Cummings · G. G. · ReSoNANCE (Realist Synthesis of Nursing in Australia Netherlands Canada and England) · Cummings · Raymond · Kitson · Harvey · L — Mayo 6th 2024 at 18:42
Introduction

Decisions about nurse staffing models are a concern for health systems globally due to workforce retention and well-being challenges. Nurse staffing models range from all Registered Nurse workforce to a mix of differentially educated nurses and aides (regulated and unregulated), such as Licensed Practical or Vocational Nurses and Health Care Aides. Systematic reviews have examined relationships between specific nurse staffing models and client, staff and health system outcomes (eg, mortality, adverse events, retention, healthcare costs), with inconclusive or contradictory results. No evidence has been synthesised and consolidated on how, why and under what contexts certain staffing models produce different outcomes. We aim to describe how we will (1) conduct a realist review to determine how nurse staffing models produce different client, staff and health system outcomes, in which contexts and through what mechanisms and (2) coproduce recommendations with decision-makers to guide future research and implementation of nurse staffing models.

Methods and analysis

Using an integrated knowledge translation approach with researchers and decision-makers as partners, we are conducting a three-phase realist review. In this protocol, we report on the final two phases of this realist review. We will use Citation tracking, tracing Lead authors, identifying Unpublished materials, Google Scholar searching, Theory tracking, ancestry searching for Early examples, and follow-up of Related projects (CLUSTER) searching, specifically designed for realist searches as the review progresses. We will search empirical evidence to test identified programme theories and engage stakeholders to contextualise findings, finalise programme theories document our search processes as per established realist review methods.

Ethics and dissemination

Ethical approval for this study was provided by the Health Research Ethics Board of the University of Alberta (Study ID Pro00100425). We will disseminate the findings through peer-reviewed publications, national and international conference presentations, regional briefing sessions, webinars and lay summary.

☐ ☆ ✇ BMJ Open

Peroperative administration of tranexamic acid in Roux-en-Y and one-anastomosis gastric bypass to reduce haemorrhage in patients with morbid obesity: protocol for randomised controlled trial (PATRY trial)

Por: 't Hart · J. W. H. · Noordman · B. J. · Palsgraaf-Huisbrink · J. · Dunkelgrun · M. · Zengerink · H. F. · Birnie · E. · van Det · M. J. · Boerma · E.-J. G. · de Castro · S. M. M. · Hazebroek · E. J. · Langenhoff · B. S. · Verhoef · C. · Apers · J. A. — Mayo 6th 2024 at 18:42
Introduction

By implementation of Enhanced Recovery After Bariatric Surgery protocols and day-care surgery, early discharge poses a challenge if excessive bleeding occurs after bariatric surgery. Tranexamic acid (TXA) has demonstrated efficacy in other surgical fields and in bariatric pilot studies. This trial aims to assess the efficacy of peroperative administration of TXA in reducing haemorrhage in patients undergoing gastric bypass surgery.

Method and analysis

This is a multicentre, phase III, double-blind randomised controlled trial in six high-volume bariatric centres in the Netherlands. A total of 1524 eligible patients, aged 18 years or older, undergoing primary gastric bypass surgery (either Roux-en-Y gastric bypass or one-anastomosis gastric bypass) will be randomised between TXA and placebo (1:1, variable block, stratified for centre, day-care/overnight stay and type of surgery) after obtaining informed consent (2.5% less haemorrhage, power 80%, 2-sided-α 0.05 and 10% dropout). Exclusion criteria are pregnancy, amedical history of acute bleeding (without cause), venous thrombotic events (VTEs), epilepsy, anticoagulant use and iatrogenic bleeding during surgery (aside from staple line). The primary outcome is postoperative haemorrhage requiring intervention within 30 days postoperatively. Secondary outcome measures are staple line reinforcement, blood loss, duration of surgery, postoperative haemoglobin, vital parameters, minor and major complications, side effects of TXA (nausea, hypotension and VTE), length of hospital stay and directly made costs.

Ethics and dissemination

Written informed consent will be obtained from all participants. The protocol has been approved by the Medical Research Ethics Committees United, Nieuwegein, on 7 February 2023 (registration number: R22.102). Results will be disseminated through peer-reviewed publications and conferences.

Trial registration number

NCT05464394

☐ ☆ ✇ BMJ Open

Effectiveness and cost-effectiveness of a 12-month automated text message intervention for weight management in postpartum women with overweight or obesity: protocol for the Supporting MumS (SMS) multisite, parallel-group, randomised controlled trial

Por: Gallagher · D. · Spyreli · E. · Anderson · A. S. · Bridges · S. · Cardwell · C. R. · Coulman · E. · Dombrowski · S. U. · Free · C. · Heaney · S. · Hoddinott · P. · Kee · F. · McDowell · C. · McIntosh · E. · Woodside · J. V. · McKinley · M. C. — Mayo 6th 2024 at 18:42
Introduction

The reproductive years can increase women’s weight-related risk. Evidence for effective postpartum weight management interventions is lacking and engaging women during this life stage is challenging. Following a promising pilot evaluation of the Supporting MumS intervention, we assess if theory-based and bidirectional text messages to support diet and physical activity behaviour change for weight loss and weight loss maintenance, are effective and cost-effective for weight change in postpartum women with overweight or obesity, compared with an active control arm receiving text messages on child health and development.

Methods and analysis

Two-arm, parallel-group, assessor-blind randomised controlled trial with cost-effectiveness and process evaluations. Women (n=888) with body mass index (BMI) ≥25 kg/m2 and within 24 months of giving birth were recruited via community and National Health Service pathways through five UK sites targeting areas of ethnic and socioeconomic diversity. Women were 1:1 randomised to the intervention or active control groups, each receiving automated text messages for 12 months. Data are collected at 0, 6, 12 and 24 months. The primary outcome is weight change at 12 months from baseline, compared between groups. Secondary outcomes include weight change (24 months) and waist circumference (cm), proportional weight gain (>5 kg), BMI (kg/m2), dietary intake, physical activity, infant feeding and mental health (6, 12 and 24 months, respectively). Economic evaluation examines health service usage and personal expenditure, health-related quality of life and capability well-being to assess cost-effectiveness over the trial and modelled lifetime. Cost–utility analysis examines cost per quality-adjusted life-years gained over 24 months. Mixed-method process evaluation explores participants’ experiences and contextual factors impacting outcomes and implementation. Stakeholder interviews examine scale-up and implementation.

Ethics and dissemination

Ethical approval was obtained before data collection (West of Scotland Research Ethics Service Research Ethics Committee (REC) 4 22/WS/0003). Results will be published via a range of outputs and audiences.

Trial registration number

ISRCTN16299220.

☐ ☆ ✇ BMJ Open

EvolvRehab-MoveWell telerehabilitation for stroke survivors: study protocol for a feasibility with embedded initial proof-of-concept study

Por: Perks · J. · McBride · P. · Mansoubi · M. · Clatworthy · P. · Hulme · C. · Taylor · G. · Warner · M. · Dawes · H. — Mayo 6th 2024 at 18:42
Introduction

Stroke is a leading cause of disability throughout the world. Unilateral upper limb impairment is common in people who have had a stroke. As a result of impaired upper limb function, people who have had a stroke often employ abnormal ‘compensatory’ movements. In the short term, these compensatory movements allow the individual to complete tasks, though long-term movement in this manner can lead to limitations. Telerehabilitation offers the provision of rehabilitation services to patients at a remote location using information and communication technologies. ‘EvolvRehab’ is one such telerehabilitation system, which uses activities to assess and correct compensatory upper body movements, although the feasibility of its use is yet to be determined in National Health Service services. Using EvolvRehab, we aim to assess the feasibility of 6 weeks telerehabilitation in people after a stroke.

Methods and analysis

A multisite feasibility study with embedded design phase. Normally distributed data will be analysed using paired samples t-tests; non-normally distributed data will be analysed using related samples Wilcoxon signed rank tests. Thematic content analysis of interview transcripts will be used to investigate the usability and perceived usefulness of the EvolvRehab kit.

Ethics and dissemination

This study has received ethical approval from Solihull Research Ethics Committee (REC reference: 23/WM/0054). Dissemination will be carried out according to the dissemination plan co-written with stroke survivors, including academic publications and presentations; written reports; articles in publications of stakeholder organisations; presentations to and publications for potential customers.

Trial registration number

NCT05875792.

☐ ☆ ✇ BMJ Open

Do patients with nephrotic syndrome have an increased risk of osteoporosis? A nationwide population-based retrospective cohort study in Taiwan

Por: Liao · C.-Y. · Chung · C.-H. · Wei · K.-Y. · Tseng · M.-F. · Lin · F.-H. · Tsao · C.-H. · Chien · W.-C. · Chu · P. · Wu · C.-C. — Mayo 6th 2024 at 18:42
Objectives

To evaluate whether nephrotic syndrome (NS) and further corticosteroid (CS) use increase the risk of osteoporosis in Asian population during the period January 2000–December 2010.

Design

Nationwide population-based retrospective cohort study.

Setting

All healthcare facilities in Taiwan.

Participants

A total of 28 772 individuals were enrolled.

Interventions

26 614 individuals with newly diagnosed NS between 2000 and 2010 were identified and included in out study. 26 614 individuals with no NS diagnosis prior to the index date were age matched as controls. Diagnosis of osteoporosis prior to the diagnosis of NS or the same index date was identified, age, sex and NS-associated comorbidities were adjusted.

Primary outcome measure

To identify risk differences in developing osteoporosis among patients with a medical history of NS.

Results

After adjusting for covariates, osteoporosis risk was found to be 3.279 times greater in the NS cohort than in the non-NS cohort, when measured over 11 years after NS diagnosis. Stratification revealed that age older than 18 years, congestive heart failure, hyperlipidaemia, chronic kidney disease, liver cirrhosis and NS-related disease including diabetes mellitus, hepatitis B infection, hepatitis C infection, lymphoma and hypothyroidism, increased the risk of osteoporosis in the NS cohort, compared with the non-NS cohort. Additionally, osteoporosis risk was significantly higher in NS patients with CS use (adjusted HR (aHR)=3.397). The risk of osteoporosis in NS patients was positively associated with risk of hip and vertebral fracture (aHR=2.130 and 2.268, respectively). A significant association exists between NS and subsequent risk for osteoporosis.

Conclusion

NS patients, particularly those treated with CS, should be evaluated for subsequent risk of osteoporosis.

☐ ☆ ✇ BMJ Open

Association between non-alcoholic fatty liver disease and risk of sarcopenia: a systematic review and meta-analysis

Por: Deng · C. · Ou · Q. · Ou · X. · Pan · D. — Mayo 6th 2024 at 18:42
Objectives

To determine the association of non-alcoholic fatty liver disease (NAFLD) with the incidence of sarcopenia.

Design

Systematic review and meta-analysis of observational clinical studies.

Setting and participants

Adults with NAFLD.

Methods

Databases such as PubMed, Embase, Cochrane and Web of Science were searched for eligible studies published from the inception of each database up to 4 April 2023. All cross-sectional studies on the association between NAFLD and sarcopenia were included in this study. The quality of the included studies and risk of bias was assessed using the Agency for Healthcare Research and Quality checklist. STATA V.15.1 software was used for statistical analysis.

Results

Of the 1524 retrieved articles, 24 were included in this review, involving 88 609 participants. Our findings showed that the prevalence of sarcopenia was higher in the NAFLD group than in the control group (pooled OR 1.74, 95% CI 1.39 to 2.17). In a subgroup analysis by region, patients with NAFLD showed an increased risk of sarcopenia (pooled OR 1.97, 95% CI 1.54 to 2.51) in the Asian group, whereas patients with NAFLD had no statistically significant association with the risk of sarcopenia in the American and European groups, with a pooled OR of 1.31 (95% CI 0.71 to 2.40) for the American group and a pooled OR of 0.99 (95% CI 0.21 to 4.69) for the European group. Similar results were observed in the sensitivity analysis, and no evidence of publication bias was observed.

Conclusions and implications

The current study indicated a significant positive correlation between NAFLD and sarcopenia, which may be affected by regional factors. This study provides the correlation basis for the relationship between NAFLD and sarcopenia and helps to find the quality strategy of sarcopenia targeting NAFLD.

☐ ☆ ✇ BMJ Open

Feasibility of continuous glucose monitoring in patients with type 1 diabetes at two district hospitals in Neno, Malawi: a randomised controlled trial

Por: Gomber · A. · Valeta · F. · Coates · M. M. · Trujillo · C. · Ferrari · G. · Boti · M. · Kumwenda · K. · Mailosi · B. · Nakotwa · D. · Drown · L. · Wroe · E. B. · Thapa · A. · Mithi · V. · Matanje · B. · Msekandiana · A. · Park · P. H. · Kachimanga · C. · Bukhman · G. · Ruderman · T. · Adler — Mayo 6th 2024 at 18:42
Objectives

To assess the feasibility and change in clinical outcomes associated with continuous glucose monitoring (CGM) use among a rural population in Malawi living with type 1 diabetes.

Design

A 2:1 open randomised controlled feasibility trial.

Setting

Two Partners In Health-supported Ministry of Health-run first-level district hospitals in Neno, Malawi.

Participants

45 people living with type 1 diabetes (PLWT1D).

Interventions

Participants were randomly assigned to Dexcom G6 CGM (n=30) use or usual care (UC) (n=15) consisting of Safe-Accu glucose monitors and strips. Both arms received diabetes education.

Outcomes

Primary outcomes included fidelity, appropriateness and severe adverse events. Secondary outcomes included change in haemoglobin A1c (HbA1c), acceptability, time in range (CGM arm only) SD of HbA1c and quality of life.

Results

Participants tolerated CGM well but were unable to change their own sensors which resulted in increased clinic visits in the CGM arm. Despite the hot climate, skin rashes were uncommon but cut-out tape overpatches were needed to secure the sensors in place. Participants in the CGM arm had greater numbers of dose adjustments and lifestyle change suggestions than those in the UC arm. Participants in the CGM arm wore their CGM on average 63.8% of the time. Participants in the UC arm brought logbooks to clinic 75% of the time. There were three hospitalisations all in the CGM arm, but none were related to the intervention.

Conclusions

This is the first randomised controlled trial conducted on CGM in a rural region of a low-income country. CGM was feasible and appropriate among PLWT1D and providers, but inability of participants to change their own sensors is a challenge.

Trial registration number

PACTR202102832069874.

☐ ☆ ✇ BMJ Open

Effect of passive leg raising on the cross-sectional area of the right internal jugular vein in patients with obesity: a randomised controlled trial protocol

Por: Pei · D. · Wang · S. · Sun · C. — Mayo 6th 2024 at 18:42
Background

Venous access in patients with obesity presents significant challenges. The success of central venous catheterisation largely depends on the cross-sectional area (CSA) of the internal jugular vein (IJV). While techniques like the Trendelenburg position have been traditionally used to increase IJV CSA, recent studies suggest its ineffectiveness in patients with obesity. Conversely, the potential of the effect of passive leg raising (PLR) has not been thoroughly investigated in this group of patients.

Methods

This protocol outlines a planned randomised controlled trial to evaluate the effect of PLR on the CSA of the IJV in patients with obesity slated for central venous catheterisation. The protocol involves dividing 40 participants into two groups: one undergoing PLR and another serving as a control group without positional change. The protocol specifies measuring the CSA of the IJV via ultrasound as the primary outcome. Secondary outcomes will include the success rates of right IJV cannulation. The proposed statistical approach includes the use of t-tests to compare the changes in CSA between the two groups, with a significance threshold set at p

Ethics approval

This study has been approved by the Institutional Review Board of Shanghai Tongren Hospital. All the participants will provide informed consent prior to enrolment in the study. Regarding the dissemination of research findings, we plan to share the results through academic conferences and peer-reviewed publications. Additionally, we will communicate our findings to the public and professional communities, including patient advocacy groups.

Trial registration number

ChiCTR: ChiCTR2400080513.

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