Postoperative pancreatic fistula (POPF) remains the most common and serious complication after distal pancreatectomy. Many attempts at lowering fistula rates have led to unrewarding insignificant results as still up to 30% of the patients suffer from clinically relevant POPF. Therefore, the development of new innovative methods and procedures is still a cornerstone of current surgical research.

The cavitron ultrasonic surgical aspirator (CUSA) device is a well-known ultrasound-based parenchyma transection method, often used in liver and neurosurgery which has not yet been thoroughly investigated in pancreatic surgery, but the first results seem very promising.

The CUSA-1 trial is a randomised controlled pilot trial with two parallel study groups. This single-centre trial is assessor and patient blinded. A total of 60 patients with an indication for open distal pancreatectomy will be intraoperatively randomised after informed consent. The patients will be randomly assigned to either the control group with conventional pancreas transection (scalpel or stapler) or the experimental group, with transection using the CUSA device. The primary safety endpoint of this trial will be postoperative complications ≥grade 3 according to the Clavien-Dindo classification. The primary endpoint to investigate the effect will be the rate of POPF within 30 days postoperatively according to the ISGPS definition. Further perioperative outcomes, including postpancreatectomy haemorrhage, length of hospital stay and mortality will be analysed as secondary endpoints.

Based on the available literature, CUSA may have a beneficial effect on POPF occurrence after distal pancreatectomy. The rationale of the CUSA-1 pilot trial is to investigate the safety and feasibility of the CUSA device in elective open distal pancreatectomy compared with conventional dissection methods and gather the first data on the effect on POPF occurrence. This data will lay the groundwork for a future confirmatory multicentre randomised controlled trial.

The CUSA-1 trial protocol was approved by the ethics committee of the University of Heidelberg (No. S-098/2022). Results will be published in an international peer-reviewed journal and summaries will be provided in lay language to study participants and their relatives.

DRKS00027474.

To determine General Practice (GP) recording of carer status and the number of patients self-identifying as carers, while self-completing an automated check-in screen prior to a GP consultation.

A descriptive cross-sectional study.

11 GPs in the West Midlands, England. Recruitment commenced in September 2019 and concluded in January 2020.

All patients aged 10 years and over, self-completing an automated check-in screen, were invited to participate during a 3-week recruitment period.

The current coding of carers at participating GPs and the number of patients identifying themselves as a carer were primary outcome measures. Secondary outcome measures included the number of responses attained from automated check-in screens as a research data collection tool and whether carers felt supported in their carer role.

80.3% (n=9301) of patients self-completing an automated check-in screen participated in QUantifying the identification Of carers in general practice (STATUS QUO Study) (62.6% (n=5822) female, mean age 52.9 years (10–98 years, SD=20.3)). Prior to recruitment, the clinical code used to denote a carer was identified in 2.7% (n=2739) of medical records across the participating GPs.

10.1% (n=936) of participants identified themselves as a carer. They reported feeling supported with their own health and social care needs: always 19.3% (n=150), a lot of the time 13.2% (n=102), some of the time 40.8% (n=317) and never 26.7% (n=207).

Many more participants self-identified as a carer than were recorded on participating GP lists. Improvements in the recording of the population’s caring status need to be actioned, to ensure that supportive implementation strategies for carers are effectively received. Using automated check-in facilities for research continues to provide high participation rates.

Twin registries and cohorts face numerous challenges, including significant resource allocation, twins’ recruitment and retention. This study aimed to assess expert feedback on a proposed pragmatic idea for launching a continuous health promotion and prevention programme (HPPP) to establish and maintain twin cohorts.

A qualitative study incorporating an inductive thematic analysis.

Tehran University of Medical Sciences.

Researchers with expertise in twin studies participated in our study.

Expert opinions were gathered through focus group discussions (FGDs). Thematic analysis was employed to analyse the findings and develop a model for designing a comprehensive, long-term health promotion programme using ATLAS.ti software. Additionally, a standardised framework was developed to represent the conceptual model of the twin HPPP.

Eight FGDs were conducted, involving 16 experts. Thematic analysis identified eight themes and seven subthemes that encompassed the critical aspects of a continuous monitoring programme for twin health. Based on these identified themes, a conceptual framework was developed for the implementation of an HPPP tailored for twins.

This study presented the initial endeavour to establish a comprehensive and practical solution in the form of a continuous HPPP designed to tackle the obstacles of twins’ cohorts.

Non-communicable diseases cause 74% of global deaths, with cardiovascular diseases as the major contributor. Hypertension, a primary risk factor for cardiovascular disease, is highly prevalent in Africa. Diagnosis, treatment and control rates are notably limited in rural areas. This limitation results in increased risks of premature mortality and complications such as stroke due to socioeconomic, cultural and geographical challenges. Progress in African countries enhancing hypertension services through primary health care interventions exists. However, a comprehensive review of all primary health care interventions addressing undiagnosed and uncontrolled hypertension in rural African settings is lacking. This scoping review aims to categorise primary health care interventions targeting undiagnosed and uncontrolled hypertension in rural African adults. Intervention components will be mapped to the four stages outlined in the hypertension care cascade to develop a pilot intervention logic model for rural African adults with hypertension.

The scoping review protocol will adhere to the Joanna Briggs Institute methodology and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews. Studies considered for inclusion will include any intervention delivered by any healthcare provider in a rural African primary care setting targeting any stage of hypertension care. Eight databases will be searched without date restrictions, supplemented by grey literature and reference list searches. A two-stage screening process (title/abstract and full text) will determine evidence source eligibility. All eligible sources of evidence will be extracted, charted and evaluated using the Template for Intervention Description and Replication checklist. A pilot logic model categorising and mapping interventions to the four stages of the hypertension care cascade will be visually presented and analysed using narrative synthesis.

No primary data will be collected; therefore, ethics approval is not required. Findings will be disseminated to local health authorities in Ghana and other African Regions and through national and international conferences and publications in peer-reviewed journals.

Globally, guideline-recommended antenatal care for smoking cessation is not routinely delivered by antenatal care providers. Implementation strategies have been shown to improve the delivery of clinical practices across a variety of clinical services but there is an absence of evidence in applying such strategies to support improvements to antenatal care for smoking cessation in pregnancy. This study aims to determine the effectiveness and cost effectiveness of implementation strategies in increasing the routine provision of recommended antenatal care for smoking cessation in public maternity services.

A non-randomised stepped-wedge cluster-controlled trial will be conducted in maternity services across three health sectors in New South Wales, Australia. Implementation strategies including guidelines and procedures, reminders and prompts, leadership support, champions, training and monitoring and feedback will be delivered sequentially to each sector over 4 months. Primary outcome measures will be the proportion of: (1) pregnant women who report receiving a carbon monoxide breath test; (2) smokers or recent quitters who report receiving quit/relapse advice; and (3) smokers who report offer of help to quit smoking (Quitline referral or nicotine replacement therapy). Outcomes will be measured via cross-sectional telephone surveys with a random sample of women who attend antenatal appointments each week. Economic analyses will be undertaken to assess the cost effectiveness of the implementation intervention. Process measures including acceptability, adoption, fidelity and reach will be reported.

Ethics approval was obtained through the Hunter New England Human Research Ethics Committee (16/11/16/4.07; 16/10/19/5.15) and the Aboriginal Health and Medical Research Council (1236/16). Trial findings will be disseminated to health policy-makers and health services to inform best practice processes for effective guideline implementation. Findings will also be disseminated at scientific conferences and in peer-reviewed journals.

Australian New Zealand Clinical Trials Registry—ACTRN12622001010785.

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

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

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

NCT05575128, NCT05685511, NCT05697835, pre-results.

Newborn bloodspot screening (NBS) is a highly successful public health programme that uses biochemical and other assays to screen for severe but treatable childhood-onset conditions. Introducing genomic sequencing into NBS programmes increases the range of detectable conditions but raises practical and ethical issues. Evidence from prospectively ascertained cohorts is required to guide policy and future implementation. This study aims to develop, implement and evaluate a genomic NBS (gNBS) pilot programme.

The BabyScreen+ study will pilot gNBS in three phases. In the preimplementation phase, study materials, including education resources, decision support and data collection tools, will be designed. Focus groups and key informant interviews will also be undertaken to inform delivery of the study and future gNBS programmes. During the implementation phase, we will prospectively recruit birth parents in Victoria, Australia, to screen 1000 newborns for over 600 severe, treatable, childhood-onset conditions. Clinically accredited whole genome sequencing will be performed following standard NBS using the same sample. High chance results will be returned by genetic healthcare professionals, with follow-on genetic and other confirmatory testing and referral to specialist services as required. The postimplementation phase will evaluate the feasibility of gNBS as the primary aim, and assess ethical, implementation, psychosocial and health economic factors to inform future service delivery.

This project received ethics approval from the Royal Children’s Hospital Melbourne Research Ethics Committee: HREC/91500/RCHM-2023, HREC/90929/RCHM-2022 and HREC/91392/RCHM-2022. Findings will be disseminated to policy-makers, and through peer-reviewed journals and conferences.

The community-based, longitudinal, Canadian HIV Women’s Sexual and Reproductive Health Cohort Study (CHIWOS) explored the experiences of women with HIV in Canada over the past decade. CHIWOS’ high-impact publications document significant gaps in the provision of healthcare to women with HIV. We used concept mapping to analyse and present a summary of CHIWOS findings on women’s experiences navigating these gaps.

Concept mapping procedures were performed in two steps between June 2019 and March 2021. First, two reviewers (AY and PM) independently reviewed CHIWOS manuscripts and conference abstracts written before 1 August 2019 to identify main themes and generate individual concept maps. Next, the preliminary results were presented to national experts, including women with HIV, to consolidate findings into visuals summarising the experiences and care gaps of women with HIV in CHIWOS.

British Columbia, Ontario and Quebec, Canada.

A total of 18 individual CHIWOS team members participated in this study including six lead investigators of CHIWOS and 12 community researchers.

Overall, a total of 60 peer-reviewed manuscripts and conference abstracts met the inclusion criteria. Using concept mapping, themes were generated and structured through online meetings. In total, six composite concept maps were co-developed: quality of life, HIV care, psychosocial and mental health, sexual health, reproductive health, and trans women’s health. Two summary diagrams were created encompassing the concept map themes, one for all women and one specific to trans women with HIV. Through our analysis, resilience, social support, positive healthy actions and women-centred HIV care were highlighted as strengths leading to well-being for women with HIV.

Concept mapping resulted in a composite summary of 60 peer-reviewed CHIWOS publications. This activity allows for priority setting to optimise care and well-being for women with HIV.

Treatment for abdominal pain in patients with chronic pancreatitis (CP) remains challenging in the setting of central nervous system sensitisation, a phenomenon of remodelling and neuronal hyperexcitability resulting from persistent pain stimuli. This is suspected to render affected individuals less likely to respond to conventional therapies. Endotherapy or surgical decompression is offered to patients with pancreatic duct obstruction. However, the response to treatment is unpredictable. Pancreatic quantitative sensory testing (P-QST), an investigative technique of standardised stimulations to test the pain system in CP, has been used for phenotyping patients into three mutually exclusive groups: no central sensitisation, segmental sensitisation (pancreatic viscerotome) and widespread hyperalgesia suggestive of supraspinal central sensitisation. We will test the predictive capability of the pretreatment P-QST phenotype to predict the likelihood of pain improvement following invasive treatment for painful CP.

This observational clinical trial will enrol 150 patients from the University of Pittsburgh, Johns Hopkins and Indiana University. Participants will undergo pretreatment phenotyping with P-QST. Treatment will be pancreatic endotherapy or surgery for clearance of painful pancreatic duct obstruction. Primary outcome: average pain score over the preceding 7 days measured by Numeric Rating Scale at 6 months postintervention. Secondary outcomes will include changes in opioid use during follow-up, and patient-reported outcomes in pain and quality of life at 3, 6 and 12 months after the intervention. Exploratory outcomes will include creation of a model for individualised prediction of response to invasive treatment.

The trial will evaluate the ability of P-QST to predict response to invasive treatment for painful CP and develop a predictive model for individualised prediction of treatment response for widespread use. This trial was approved by the University of Pittsburgh Institutional Review Board. Data and results will be reported and disseminated in conjunction with National Institutes of Health policies.

NCT04996628.

The need for public research funding to be more accountable and demonstrate impact beyond typical academic outputs is increasing. This is particularly challenging and the science behind this form of research is in its infancy when applied to collaborative research funding such as that provided by the Australian National Health and Medical Research Council to the Centre for Research Excellence in Digestive Health (CRE-DH).

In this paper, we describe the protocol for applying the Framework to Assess the Impact from Translational health research to the CRE-DH. The study design involves a five-stage sequential mixed-method approach. In phase I, we developed an impact programme logic model to map the pathway to impact and establish key domains of benefit such as knowledge advancement, capacity building, clinical implementation, policy and legislation, community and economic impacts. In phase 2, we have identified and selected appropriate, measurable and timely impact indicators for each of these domains and established a data plan to capture the necessary data. Phase 3 will develop a model for cost–consequence analysis and identification of relevant data for microcosting and valuation of consequences. In phase 4, we will determine selected case studies to include in the narrative whereas phase 5 involves collation, data analysis and completion of the reporting of impact.

We expect this impact evaluation to comprehensively describe the contribution of the CRE-DH for intentional activity over the CRE-DH lifespan and beyond to improve outcomes for people suffering with chronic and debilitating digestive disorders.

This impact evaluation study has been registered with the Hunter New England Human Research Ethics Committee as project 2024/PID00336 and ethics application 2024/ETH00290. Results of this study will be disseminated via medical conferences, peer-reviewed publications, policy submissions, direct communication with relevant stakeholders, media and social media channels such as X (formely Twitter).

Subjects with schizophrenia have a 2–3 fold higher mortality rate than the general population and a reduced life expectancy of 10–20 years. Approximately one-third of this excess mortality has been attributed to obesity-related type 2 diabetes (T2D) and to cardiovascular disease. Glucagon-like peptide-1 (GLP-1) analogues increase satiety and delay gastric emptying, thereby reducing food intake and weight. GLP-1 analogues also exert beneficial effects on cardiovascular outcomes in high-risk patients with T2D.

Our aim is to investigate whether 30 weeks add-on treatment with the GLP-1 analogue semaglutide can reduce HbA1c sufficiently to reverse pre-diabetes and the metabolic syndrome in overweight schizophrenic patients.

We will perform a 30 week, two-armed, multicentre, superiority, double-blinded, randomised trial investigating the effect of weekly injections of semaglutide versus placebo in mental health facilities in Region of Southern Denmark and Region of Zealand, Denmark. In total, 154 adults with schizophrenia spectrum disease, aged 18–60 years treated with second generation antipsychotic treatment, HbA1c 39–47 mmol/mol and body mass index >27 kg/m² will be randomised to injections of 1.0 mg semaglutide or placebo. The primary outcome is changes in HbA1c. Secondary outcomes encompass metabolic measures, psychotic symptoms and quality of life. Exploratory outcomes encompass insulin sensitivity, cardiovascular risk profile, medication adherence, general well-being and physical activity.

This study will be carried out in accordance with the Declaration of Helsinki and Good Clinical Practice guidelines. This research has obtained approval from both the Danish Medicines Agency and The Regional Committees on Health Research Ethics for Southern Denmark.

NCT05193578 European Clinical Trials Database Number (EudraCT) 2020-004374-22, Regional Ethical Committee number S-20200182.

Peritoneal dialysis (PD) allows patients increased autonomy and flexibility; however, both infectious and non-infectious complications may lead to technique failure, which shortens treatment longevity. Maintaining patients on PD remains a major challenge for nephrologists. This study aims to describe nephrologists’ perspectives on technique survival in PD.

Qualitative semistructured interview study. Transcripts were thematically analysed.

30 nephrologists across 11 countries including Australia, the USA, the UK, Hong Kong, Canada, Singapore, Japan, New Zealand, Thailand, Colombia and Uruguay were interviewed from April 2017 to November 2019.

We identified four themes: defining patient suitability (confidence in capacity for self-management, ensuring clinical stability and expected resilience), building endurance (facilitating access to practical support, improving mental well-being, optimising quality of care and training to reduce risk of complications), establishing rapport through effective communications (managing expectations to enhance trust, individualising care and harnessing a multidisciplinary approach) and confronting fear and acknowledging barriers to haemodialysis (preventing crash landing to haemodialysis, facing concerns of losing independence and positive framing of haemodialysis).

Nephrologists reported that technique survival in PD is influenced by patients’ medical circumstances, psychological motivation and positively influenced by the education and support provided by treating clinicians and families. Strategies to enhance patients’ knowledge on PD and communication with patients about technique survival in PD are needed to build trust, set patient expectations of treatment and improve the process of transition off PD.