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Ayer — Mayo 14th 2024Tus fuentes RSS

Nursing assessment of mental health issues in the general clinical environment: A descriptive study

Abstract

Aims

To evaluate the effectiveness of a mental health screening form for early identification and care escalation of mental health issues in general settings. A secondary aim was to explore general nurses' use of the form and their confidence to discuss mental health issues with patients.

Methods

A cross-sectional design comprising a review of clinical records to determine use of the form, instances of missed care and escalation to the mental health team. The survey focused on nurses' confidence in general settings to engage in discussions with patients about mental health. Data were collected from April to December 2022. The Strengthening the Reporting of Observational Studies in Epidemiology Statement guided this study.

Results

Of 400 patient records, 397 were analysed; 293 (73.8%) of those had mental health screening by nurses. Age was a significant factor, with younger patients more likely to be screened although concerns were typically recognized in older patients. Of the 20 patients identified with mental health concerns, 9 (45%) were referred for further evaluation by the Clinical Liaison Team. While nurses were proactive in assessing physical risks, assessing risk factors that required deeper conversations with patients, including psychiatric history, was lacking. The survey highlighted fewer than half of the respondents (46%, n = 10) felt competent to engage in discussions about mental health; however, most (59%, n = 13) knew when to seek a mental health referral.

Conclusions

General nurses have a role in the early identification and referral of patients with mental health challenges. However, training is imperative to facilitate deeper patient interactions concerning mental health. Integrating mental health checks within general settings is crucial for early detection and intervention, aligning with global quality care standards.

Reporting Method

STROBE guidelines.

Patient or Public Contribution

We received feedback that shaped the research protocol from a consumer representative.

Nursing/midwifery students' perceptions of caring pedagogy and online learning during the COVID‐19 pandemic

Abstract

Aim

This study aimed to gain a better understanding of nursing/midwifery students' perspectives on a pedagogy of caring and online learning during the COVID-19 pandemic. In addition, it aimed to determine if the COVID-19 pandemic impacted students' perceptions and experience of online learning and students' desire to enter the nursing/midwifery workforce.

Design

Mixed methods.

Methods

A multi-centre cross-sectional survey of Australian nursing and midwifery students was undertaken to explore students’ experience of learning during the COVID-19 pandemic.

Results

There are several key findings from this study that may be relevant for the future delivery of undergraduate health education, students transitioning to practice and healthcare workforce retention. The study found that although students were somewhat satisfied with online learning during COVID-19, students reported significant issues with knowledge/skill acquisition and barriers to the learning process. The students reported feeling less prepared for practice and identified how clinical staff were unable to provide additional guidance and support due to increased workloads and stress. The textual responses of participants highlighted that connection/disconnection, empathy and engagement/disengagement had an impact on learning during COVID-19.

Conclusion

Connection, engagement and isolation were key factors that impacted nursing students’ online learning experiences. In addition, graduates entering the workforce felt less prepared for entry into practice due to changes in education delivery during COVID-19 that they perceived impacted their level of clinical skills, confidence and ability to practice as new graduate nurses/midwives.

Patient or Public Contribution

Not applicable.

Impact

Attention must be given to the transition of new graduate nurses and midwives whose education was impacted by pandemic restrictions, to support their professional career development and to ensure retention of future healthcare workforce. Connection, engagement and isolation were key factors that impacted nursing students' online learning experiences. Educators should consider how connection and engagement can be actively embedded in the online learning environment.

Particularity, Engagement, Actionable Inferences, Reflexivity, and Legitimation tool for rigor in mixed methods implementation research

Abstract

Background

Implementation science helps generate approaches to expedite the uptake of evidence in practice. Mixed methods are commonly used in implementation research because they allow researchers to integrate distinct qualitative and quantitative methods and data sets to unravel the implementation process and context and design contextual tools for optimizing the implementation. To date, there has been limited discussion on how to ensure rigor in mixed methods implementation research.

Purpose

To present Particularity, Engagement, Actionable Inferences, Reflexivity, and Legitimation (PEARL) as a practical tool for understanding various components of rigor in mixed methods implementation research.

Data Sources

This methodological discussion is based on a nurse-led mixed methods implementation study. The PEARL tool was developed based on an interpretive, critical reflection, and purposive reading of selected literature sources drawn from the researchers' knowledge, experiences of designing and conducting mixed methods implementation research, and published methodological papers about mixed methods, implementation science, and research rigor.

Conclusion

An exemplar exploratory sequential mixed methods study in nursing is provided to illustrate the application of the PEARL tool. The proposed tool can be a useful and innovative tool for researchers and students intending to use mixed methods in implementation research. The tool offers a straightforward approach to learning the key rigor components of mixed methods implementation research for application in designing and conducting implementation research using mixed methods.

Clinical Relevance

Rigorous implementation research is critical for effective uptake of innovations and evidence-based knowledge into practice and policymaking. The proposed tool can be used as the means to establish rigor in mixed methods implementation research in nursing and health sciences.

A Scoping Review of Studies Using Artificial Intelligence Identifying Optimal Practice Patterns for Inpatients With Type 2 Diabetes That Lead to Positive Healthcare Outcomes

imageThe objective of this scoping review was to survey the literature on the use of AI/ML applications in analyzing inpatient EHR data to identify bundles of care (groupings of interventions). If evidence suggested AI/ML models could determine bundles, the review aimed to explore whether implementing these interventions as bundles reduced practice pattern variance and positively impacted patient care outcomes for inpatients with T2DM. Six databases were searched for articles published from January 1, 2000, to January 1, 2024. Nine studies met criteria and were summarized by aims, outcome measures, clinical or practice implications, AI/ML model types, study variables, and AI/ML model outcomes. A variety of AI/ML models were used. Multiple data sources were leveraged to train the models, resulting in varying impacts on practice patterns and outcomes. Studies included aims across 4 thematic areas to address: therapeutic patterns of care, analysis of treatment pathways and their constraints, dashboard development for clinical decision support, and medication optimization and prescription pattern mining. Multiple disparate data sources (i.e., prescription payment data) were leveraged outside of those traditionally available within EHR databases. Notably missing was the use of holistic multidisciplinary data (i.e., nursing and ancillary) to train AI/ML models. AI/ML can assist in identifying the appropriateness of specific interventions to manage diabetic care and support adherence to efficacious treatment pathways if the appropriate data are incorporated into AI/ML design. Additional data sources beyond the EHR are needed to provide more complete data to develop AI/ML models that effectively discern meaningful clinical patterns. Further study is needed to better address nursing care using AI/ML to support effective inpatient diabetes management.

Artificial Intelligence and the National Violent Death Reporting System: A Rapid Review

imageAs the awareness on violent deaths from guns, drugs, and suicides emerges as a public health crisis in the United States, attempts to prevent injury and mortality through nursing research are critical. The National Violent Death Reporting System provides public health surveillance of US violent deaths; however, understanding the National Violent Death Reporting System's research utility is limited. The purpose of our rapid review of the 2019-2023 literature was to understand to what extent artificial intelligence methods are being used with the National Violent Death Reporting System. We identified 16 National Violent Death Reporting System artificial intelligence studies, with more than half published after 2020. The text-rich content of National Violent Death Reporting System enabled researchers to center their artificial intelligence approaches mostly on natural language processing (50%) or natural language processing and machine learning (37%). Significant heterogeneity in approaches, techniques, and processes was noted across the studies, with critical methods information often lacking. The aims and focus of National Violent Death Reporting System studies were homogeneous and mostly examined suicide among nurses and older adults. Our findings suggested that artificial intelligence is a promising approach to the National Violent Death Reporting System data with significant untapped potential in its use. Artificial intelligence may prove to be a powerful tool enabling nursing scholars and practitioners to reduce the number of preventable, violent deaths.

Analgesia for the treatment of acute pancreatitis: a protocol for a systematic review and network meta-analysis

Por: Subramani · S. S. · Berg · A. C. · Kral · L. A. · Murad · M. H. · Smith · A. · Phillips · A. E. · Yadav · D. · Uc · A. · Imdad · A.
Introduction

Gastrointestinal hospitalisations in the USA cause over US$130 billion in expenditures, and acute pancreatitis is a leading cause of these hospitalisations. Adequate pain control is one of the primary treatment goals for acute pancreatitis. Though opioids are commonly used for analgesia in these patients, there have been concerns about short-term and long-term side effects of using opioids. Recently, non-opioid medications have been studied to treat pain in patients with acute pancreatitis. This systematic review and network meta-analysis aims to assess the comparative efficacy of analgesic medication for non-severe, acute pancreatitis.

Methods and analysis

We will search multiple electronic databases for randomised controlled trials that study pain management in patients with non-severe, acute pancreatitis. The intervention will be any analgesic for acute pancreatitis in the hospital setting. The comparison group will be patients who received a placebo or other active interventions for pain management. The primary outcomes of interest include pain scores and the need for supplementary analgesia. The secondary outcomes will be serious adverse events, local complications, progression to severe pancreatitis, transfer to the intensive care unit, length of hospitalisation, time to start enteral feeds, 30-day all-cause mortality and Quality of Life Scale scores. If sufficient homogeneity exists among included studies, the findings will be pooled using a traditional pairwise and network meta-analysis. The risk of bias in randomised control trials will be evaluated using the Cochrane Risk of Bias Tool 2.0. The Grading of Recommendations, Assessment, Development, and Evaluation approach will be used to report the certainty of evidence.

Ethics and dissemination

This systematic review will not involve direct contact with human subjects. The findings of this review will be published in a peer-reviewed journal. They will give healthcare providers a better awareness of the optimal analgesic medication for pain treatment in non-severe, acute pancreatitis.

Effectiveness and cost-effectiveness of community-based directly observed treatment (DOT) versus health facility-based DOT of tuberculosis in Africa: protocol for a systematic review and meta-analysis

Por: Baye · T. · Kassaw · A. T. · Gebrie · D. · Girmaw · F. · Ashagrie · G.
Background

Tuberculosis (TB) remains a significant global health challenge, especially prevalent in the WHO African region. The WHO’s End TB Strategy emphasises effective treatment approaches such as directly observed therapy (DOT), yet the optimal implementation of DOT, whether through health facility-based (HF DOT) or community-based (CB DOT) approaches, remains uncertain.

Objective

To conduct a systematic comparison of the effectiveness and cost-effectiveness of Community-Based Directly Observed Treatment (CB DOT) versus Health Facility-Based Directly Observed Treatment (HF DOT) for tuberculosis (TB) treatment in African settings.

Methods

We will conduct a systematic review and meta-analysis following Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols guidelines. We will search PubMed, Embase, Web of Science, Scopus and the Cochrane Library for articles published up to 30 March 2023, without date restrictions. Eligible studies must be full economic evaluations conducted in African countries, comparing CB DOT to HF DOT regarding treatment outcomes and costs. Exclusion criteria include non-English, non-peer-reviewed or studies lacking caregiver involvement in CB DOT, health facility-based DOT comparison, direct comparability between CB DOT and HF DOT, significant selection bias or non-economic evaluations. Data extraction will be performed independently by reviewers, and meta-analyses will use STATA software. To pool the data, a random-effect model will be applied, and quality assessment of the studies will be conducted.

Ethics and dissemination

Ethical approval is not required as the study will use previously published articles available publicly. Findings will be presented at international and national conferences and published in open-access, peer-reviewed journals.

PROSPERO registration number

CRD42023443260.

'Its just my knee: a qualitative study investigating the process of reframing and young athletes perceived quality of life between anterior cruciate ligament injury and surgery

Por: Marmura · H. · Bryant · D. · Getgood · A. · Webster · F.
Objectives

To understand the factors influencing young athletes’ perceptions of quality of life (QOL) following an anterior cruciate ligament (ACL) rupture, prior to reconstructive surgery.

Design

Qualitative descriptive study using semi-structured interviews and thematic analysis of data.

Setting

Tertiary sports medicine clinic with patients recruited from the practices of three specialist orthopaedic surgeons.

Participants

Twenty athletes aged 14–25 provided consent to participate in the study and completed interviews prior to their ACL reconstruction surgery. Participants were eligible to participate if they were scheduled to undergo ACL reconstruction, were 25 years of age or younger, identified as athletes (participated in any level of organised sport), could communicate in English and agreed to be audio recorded. Participants were not eligible if they had experienced a multiligament injury or fracture.

Results

Young athletes shared common factors that made up their QOL; social connections and support, sport, health, and independence. However, participants’ perceptions of their current QOL were quite variable (13–95/100 on a Visual Analogue Scale). Participants who were able to reframe their injury experience by shifting focus to the positive or unaffected aspects of their lives tended to have more favourable perceptions of their QOL than participants who shifted focus to the losses associated with injury.

Conclusions

Young athletes who have experienced an ACL injury define their QOL based on social support, sport, health and independence. Individual processes of adaptation and cognitive reframing in response to an ACL injury may exert a greater influence on postinjury QOL than the physical ramifications of the injury itself. Understanding individual perceptions may help target potential interventions or supports to enhance athletes’ adaptation to injury.

Six aspects of female genital mutilation education (SAFE) model: findings from a qualitative study

Por: Waigwa · S. · Bradbury-Jones · C. · Doos · L. · Taylor · J.
Objectives

Recent figures show that over 200 million women and girls, globally, live with the consequences of female genital mutilation (FGM). Complex debilitating physical, psychological and social problems result from the practice. Health education interventions have proven to be essential in both preventing the practice and informing support of survivors. In this study, we aimed to explore factors that affect the effectiveness of health education interventions.

Design

A generic qualitative approach was applied using semistructured individual and focus group interviews with women and men from communities with a history of FGM in Birmingham, UK. Framework analysis was used to group recurring themes from the data. Intersectionality was used as a theoretical lens to synthesise findings.

Participants

Twenty-one individuals (18 women and 3 men) participated in semistructured individual and focus group interviews about their views and experiences of health and well-being intervention programmes related to FGM.

Results

Six themes emerged from the data and were developed into a model of issues relating to FGM education. These six themes are (1) active communication, (2) attitudes and beliefs, (3) knowledge about FGM, (4) social structures, (5) programme approach and (6) the better future. A combined discussion of all these issues was compressed into three groupings: social structures, culture and media.

Conclusion

The results of this study depict aspects associated with FGM education that should be considered by future interventions aiming to prevent the practice and inform support services for survivors in a holistic way.

Cohort profile: the Environmental Reproductive and Glucose Outcomes (ERGO) Study (Boston, Massachusetts, USA) -- a prospective pregnancy cohort study of the impacts of environmental exposures on parental cardiometabolic health

Por: Preston · E. V. · Quinn · M. R. · Williams · P. L. · McElrath · T. F. · Cantonwine · D. E. · Seely · E. W. · Wylie · B. J. · Hacker · M. R. · O'Brien · K. · Brown · F. M. · Powe · C. E. · Bellavia · A. · Wang · Z. · Tomsho · K. S. · Hauser · R. · James-Todd · T. · the Environmental Rep
Purpose

Pregnancy and the postpartum period are increasingly recognised as sensitive windows for cardiometabolic disease risk. Growing evidence suggests environmental exposures, including endocrine-disrupting chemicals (EDCs), are associated with an increased risk of pregnancy complications that are associated with long-term cardiometabolic risk. However, the impact of perinatal EDC exposure on subsequent cardiometabolic risk post-pregnancy is less understood. The Environmental Reproductive and Glucose Outcomes (ERGO) Study was established to investigate the associations of environmental exposures during the perinatal period with post-pregnancy parental cardiometabolic health.

Participants

Pregnant individuals aged ≥18 years without pre-existing diabetes were recruited at

Findings to date

We enrolled 653 unique pregnancies and retained 633 through delivery. Participants had a mean age of 33 years, 10% (n=61) developed gestational diabetes and 8% (n=50) developed pre-eclampsia. Participant pregnancy and postpartum urinary phthalate metabolite concentrations and postpartum glycaemic biomarkers were quantified. To date, studies within ERGO found higher exposure to phthalates and phthalate mixtures, and separately, higher exposure to radioactive ambient particulate matter, were associated with adverse gestational glycaemic outcomes. Additionally, certain personal care products used in pregnancy, notably hair oils, were associated with higher urinary phthalate metabolite concentrations, earlier gestational age at delivery and lower birth weight.

Future plans

Future work will leverage the longitudinal data collected on pregnancy and cardiometabolic outcomes, environmental exposures, questionnaires, banked biospecimens and paediatric data within the ERGO Study.

Cohort profile: the Adverse Childhood Experiences cohort of the Malawi Longitudinal Study of Families and Health

Por: Kidman · R. · Mwera · J. · Rui · Y. · Breton · E. · Zulu · A. · Behrman · J. · Kohler · H.-P.
Purpose

The Adverse Childhood Experiences (ACE) cohort of the Malawi Longitudinal Study of Families and Health (MLSFH-ACE) is a study of adolescents surveyed during 2017–2021. It provides an important opportunity to examine the longitudinal impact of ACEs on health and development across the early life course. The MLSFH-ACE cohort provides rich data on adolescents, their children and adult caregivers in a low-income, high-HIV-prevalence context in sub-Saharan Africa (SSA).

Participants

The MLSFH-ACE cohort is a population-based study of adolescents living in three districts in rural Malawi. Wave 1 enrolment took place in 2017–2018 and included 2061 adolescents aged 10–16 years and 1438 caregivers. Wave 2 took place in 2021 and included data on 1878 adolescents and 208 offspring. Survey instruments captured ACEs during childhood and adolescence, HIV-related behavioural risk, mental and physical health, cognitive development and education, intimate partner violence (IPV), marriage and aspirations, early transitions to adulthood and protective factors. Biological indicators included HIV, herpes simplex virus and anthropometric measurements.

Findings to date

Key findings include a high prevalence of ACEs among adolescents in Malawi, a low incidence of HIV and positive associations between ACE scores and composite HIV risk scores. There were also strong associations between ACEs and both IPV victimisation and perpetration.

Future plans

MLSFH-ACE data will be publicly released and will provide a wealth of information on ACEs and adolescent outcomes in low-income, HIV-endemic SSA contexts. Future expansions of the cohort are planned to capture data during early adulthood.

Risk and time preferences in individuals with lifestyle-related and non-lifestyle-related cardiovascular diseases: a pilot study

Por: Kairies-Schwarz · N. · Mussio · I. · Bulla-Holthaus · N. · Wankmüller · E. · Wolff · G. · Gontscharuk · V. · Heinen · Y. · Perings · S. · Brockmeyer · M. · Kelm · M. · Icks · A.
Objectives

To (1) pilot a study of behavioural characterisation based on risk and time preferences in clinically well-characterised individuals, (2) assess the distribution of preferences in this population and (3) explore differences in preferences between individuals with ‘lifestyle-related’ (LS) and ‘non-lifestyle-related’ (NLS) cardiovascular diseases.

Design

Cross-sectional study with an economic online experiment to collect risk and time preferences, a detailed clinical characterisation and a sociodemographic and lifestyle survey. A definition of LS and NLS groups was developed.

Setting

Specialist outpatient clinics of the clinic for cardiology and pneumology of the University Hospital Düsseldorf and patients from a cardiology practice in Düsseldorf.

Participants

A total of 74 individuals with cardiovascular diseases.

Outcomes

Risk and time preferences.

Results

The implementation of the study process, including participant recruitment and data collection, ran smoothly. The medical checklist, the survey and the time preference instrument were well received. However, the conceptual understanding of the risk preference instrument resulted in inconsistent choices for many participants (47%). The remaining individuals were more risk averse (27%) than risk seeking (16%) and risk neutral (10%). Individuals in our sample were also more impatient (49%) than patient (42%). The participant classification showed that 65% belonged to the LS group, 19% to the NLS group and 16% could not be assigned (unclear allocation to lifestyle (ULS) group). Excluding the ULS group, we show that individuals in the LS group were more risk seeking, and unexpectedly, more patient than those in the NLS group.

Conclusions

The process of the pilot study and its results can be used as a basis for the design of the main study. The differences in risk and time preferences between the LS and NLS groups provide us with a novel hypothesis for unhealthy behaviours: individuals never give up a bad habit, they simply postpone the latter, which can be tested alongside other additional research questions.

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.
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.

Contextually appropriate nurse staffing models: a realist review protocol

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.

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.
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

Australian trial of behavioural activation for people with schizophrenia experiencing negative symptoms: a feasibility randomised controlled trial protocol

Por: Muyambi · K. · Walsh · S. · Dettwiller · P. · Tan · K. L. · Dennis · S. · Bressington · D. · Gray · R. J. · McCall · A. · Jones · M.
Introduction

Negative symptoms are frequently experienced by people with schizophrenia. People with negative symptoms often have impaired social functioning and reduced quality of life. There is some evidence that cognitive–behavioural therapy results in a modest reduction in negative symptoms. Behavioural activation may be an effective alternative treatment for negative symptoms.The study aims to examine the feasibility and acceptability of implementing a behavioural activation trial delivered in three community mental health services in South Australia to support adult consumers experiencing negative symptoms of schizophrenia.

Method and analysis

This randomised controlled study will recruit a total of 60 consumers aged 18 years or above with mild-moderate negative symptoms of schizophrenia. The consumers will be randomly allocated to receive behavioural activation plus usual mental healthcare or usual mental healthcare alone. The intervention group will receive twelve 30 min sessions of behavioural activation, which will be delivered twice weekly over 6 weeks. In addition, we aim to recruit nine mental health workers from the three rural mental health services who will complete a 10-week online training programme in behavioural activation. Changes in negative symptoms of schizophrenia and depressive symptoms will be assessed at three time points: (a) at baseline, at 6 weeks and 3 month follow-ups. Changes in health-related quality of life (Short Form F36; secondary outcome) will be assessed at two time points: (a) at baseline and (b) immediately at postintervention after 6 weeks. At the end of the trial, interviews will be conducted with purposively selected mental health workers and consumers. Descriptive statistics and thematic analysis will be used to assess feasibility and acceptability.

Ethics and dissemination

The findings from our feasibility study will inform the design of a fully powered randomised controlled trial to test the effectiveness of behavioural activation as a treatment for negative symptoms in schizophrenia. The study protocol was approved by the Central Adelaide Local Health Network Human Research Ethics Committee. The findings from this study will be disseminated through peer-reviewed scientific journals and conferences.

Trial registration number

ACTRN12623000348651p.

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.
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.

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