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Ayer — Octubre 2nd 2025Tus fuentes RSS

Occurrence of advance care planning for persons with dementia, cancer and other chronic-progressive diseases in general practice: longitudinal analysis of data from health records linked with administrative data

Por: Hommel · D. · Azizi · B. · Visser · M. · Bolt · S. R. · Blom · J. W. · Janssen · D. J. A. · van Hout · H. P. J. · Francke · A. L. · Verheij · R. A. · Joling · K. J. · van der Steen · J. T.
Objectives

There are substantial barriers to initiate advance care planning (ACP) for persons with chronic-progressive disease in primary care settings. Some challenges may be disease-specific, such as communicating in case of cognitive impairment. This study assessed and compared the initiation of ACP in primary care with persons with dementia, Parkinson’s disease, cancer, organ failure and stroke.

Design

Longitudinal study linking data from a database of Dutch general practices’ electronic health records with national administrative databases managed by Statistics Netherlands.

Setting and participants

Data from general practice records of 199 034 community-dwelling persons with chronic-progressive disease diagnosed between 2008 and 2016.

Outcome measure

Incidence rate ratio (IRR) of recorded ACP planning conversations per 1000 person-years in persons with a diagnosis of dementia, Parkinson’s disease, organ failure, cancer or stroke, compared with persons without the particular diagnosis. Poisson regression and competing risk analysis were performed, adjusted for age, gender, migration background, living situation, frailty index and income, also for disease subsamples.

Results

In adjusted analyses, the rate of first ACP conversation for persons with organ failure was the lowest (IRR 0.70 (95% CI 0.68 to 0.73)). Persons with cancer had the highest rate (IRR 1.75 (95% CI 1.68 to 1.83)). Within the subsample of persons with organ failure, the subsample of persons with dementia and the subsample of stroke, a comorbid diagnosis of cancer increased the probability of ACP. Further, for those with organ failure or cancer, comorbid dementia decreased the probability of ACP.

Conclusions

Considering the complexity of initiating ACP for persons with organ failure or dementia, general practitioners should prioritise offering it to them and their family caregivers. Policy initiatives should stimulate the implementation of ACP for people with chronic-progressive disease.

What is the impact of an allied health service-learning programme for rural communities: a study protocol using the RE-AIM/PRISM framework

Por: McNeil · R. · McGrath · R. L. · Ackland · K. · Oates · R.-K. · Woodhart · L. · Wright · K.
Introduction

People in rural areas of Australia experience poorer health in almost every indicator compared with urban populations; however, rural communities have lower access to primary health, allied health and specialist healthcare. Timely access to care is compounded by persistent and widespread health workforce issues, including attracting and retaining staff.

Australian University Departments of Rural Health (UDRH) have been established to address the needs of rural populations with the goal of improving recruitment and retention of health professionals across rural and remote Australia. The work-integrated learning team within The University of Melbourne works with nursing and allied health university students on clinical placement to provide exposure to working in rural health, with a remit to build the capacity of the existing and future workforce. The service-learning model aims to provide reciprocal benefits to stakeholders through purposefully co-designed placements that respond to rural health needs by providing services to underserved communities and ensuring university students are exposed to real world, diverse practice settings.

The overarching aim of this project is to determine the impact of the SL programme for key stakeholders, predominately end users and those stakeholders involved in the delivery of the SL model. The key stakeholders are host site staff, allied health university students, allied health supervisors and the end users of the programme. End users are those individuals that have received allied health services through the programme, such as clients, residents and children.

Methods and analysis

This study will adopt a convergent mixed methods methodology underpinned by a RE-AIM (Reach, Effectiveness, Adoption, Implementation and Maintenance)/PRISM (Practical, Robust Implementation Sustainability Model) approach. Data collection will include document review, existing programme data review and primary data collection. This will involve conducting surveys and interviews with allied health university students, host organisations and allied health supervisors, and interviews with adult recipients of the service-learning programme. Art-based consultation will be conducted with school-aged children recipients of the service-learning programme. Analysis will be underpinned by the RE-AIM/PRISM framework to inform programme learnings and impact for key stakeholders.

Ethics and dissemination

This study has been approved by the University of Melbourne Human Research Ethics Committee (Project ID: 30409).

Findings will be published in a stakeholder project report and peer-review journals in the fields of rural health, implementation science and work integrated learning.

Investigation of prophylactic clip haemorrhage control for colorectal cold snare polypectomy in patients taking antithrombotic drugs (PERCOLD): study protocol--a multicentre prospective parallel-group non-inferiority RCT phase 3 trial

Por: Okimoto · K. · Matsumura · T. · Taida · T. · Ishikawa · T. · Koshibu · Y. · Shu · N. · Ozeki · Y. · Furuya · M. · Mamiya · Y. · Nakazawa · H. · Ohyama · Y. · Takahashi · S. · Horio · R. · Goto · C. · Kurosugi · A. · Sonoda · M. · Kaneko · T. · Ohta · Y. · Matsusaka · K. · Inaba · Y. · Kato · J.
Introduction

The effect of prophylactic clipping for colorectal cold snare polypectomy (CSP) on delayed bleeding (DB) in patients with antithrombotic drugs remains unverified. The aim of the PERCOLD study is to demonstrate the non-inferiority of DB rates in cases without prophylactic clips compared with cases with prophylactic clips in patients taking antithrombotic drugs for colorectal CSP through randomised controlled trial (RCT).

Methods and analysis

This study is a multicentre prospective parallel-group RCT phase 3 trial that is being conducted at 14 institutions in Japan at the time of writing this manuscript. After providing consent, patients will undergo screening and assessment for study enrolment eligibility. Patients taking antithrombotic drugs (aged 20 years or older at the time of consent and who have agreed to participate in this study) will be selected if they have a preoperative suspected adenoma (including sessile serrated lesion) with an endoscopic diameter of

Ethics and dissemination

The trial protocol has been approved by the Chiba University Certified Clinical Research Reviewer Board (CRB3180015), which serves as the central ethics committee, and registered with Japan Registry of Clinical Trials. The current protocol V.1.7, dated 4 October 2024. Written informed consent for participation in the study will be obtained from all participating patients. All participating institutions have formally agreed to conduct the study in accordance with this central approval, and local site permissions were obtained as required by each institution. The results of this study will be submitted for publication in international peer-reviewed journals and the key findings will be presented at international scientific conferences.

Trial registration number

Japan Registry of Clinical Trials (jRCT1032230086).

Barriers and enablers to healthcare access for older adults in Cambodia: perspectives of healthcare professionals - a qualitative study

Por: Maung · K. T. · Phou · S. · Hunsberger · M. · Santosa · A. · Ng · N. · Sopheab · H. · Chhea · C. · Eriksson · M.
Objective

To explore health professionals’ perspectives on the barriers and enablers of healthcare access for older adults in Cambodia.

Design

A qualitative study based on semi-structured interviews conducted in Khmer, recorded, transcribed, translated into English and analysed using an abductive thematic analysis approach.

Setting

Phnom Penh, Cambodia.

Participants

A purposive sample of 11 health professionals serving in diverse roles and sectors participated in the study.

Results

Three key barriers emerged: (1) institutional barriers, (2) patient-specific access barriers and (3) communication barriers. However, four key enablers were also identified: (1) supportive healthcare environment, (2) reaching out to improve access to health services, (3) peer and community engagement and (4) government direct support to access healthcare. Despite previous policy efforts, gaps in the implementation of healthcare services for older adults persist across all health facilities. Health professionals identified that improving healthcare access for older adults in Cambodia requires a multifaceted strategy involving proactive outreach, health promotion, financial assistance and stronger community and family support.

Conclusion

Effective policy implementation requires collaboration among stakeholders and the active involvement of older adults in programme design to enhance dignity and well-being in Cambodia’s ageing population.

Efficacy of a mobile app-based intervention to improve eating behaviours and lifestyle in infants of mothers with metabolic risk factors: study protocol of a randomised controlled trial

Por: Chan · D. · Leong · K. · Ong · C. · Ku · C. W. · Chan · J. K. Y. · Chua · M. C. · Yap · F. · Loy · S. L.
Introduction

Childhood obesity has surged globally, leading to various metabolic comorbidities and increased cardiovascular risks. Early intervention in lifestyle and feeding practices during infancy is crucial to mitigate these risks. This study evaluates the efficacy of a mobile web app-based intervention tool, named the Feeding, Lifestyle, Activity Goals (FLAGs) to promote healthier eating behaviours and lifestyle habits in infants from birth to 12 months.

Methods and analysis

This two-arm randomised controlled trial will enrol 220 caregiver-infant pairs per arm at KK Women’s and Children’s Hospital, Singapore, with recruitment expected from January to December 2025. Eligible participants include women at ≥34 weeks’ gestation or up to 3 days post delivery with pre-pregnancy overweight/obesity (body mass index (BMI) >23 kg/m2) and/or a diagnosis of diabetes. Caregiver-infant pairs will be randomised to the FLAGs intervention or control group. Over 12 months, both groups will receive standard infant care. The intervention group will undergo regular assessments via the FLAGs web app built-in assessment tool, assessing infant feeding practices, sedentary behaviour and physical activity. The intervention group will also receive FLAGs personalised guidance and weekly digital nudges. Maternal and infant data will be collected at baseline and at 12 months. Primary outcomes are infant BMI, weight-for-length and body composition at 12 months. Secondary outcomes include lifestyle behaviours and eating habits assessed through validated questionnaires when the infants are 1 year old. We will perform both intention-to-treat and per protocol analysis.

Ethics and dissemination

Ethical approval has been obtained from the SingHealth Centralised Institutional Review Board (Ref: 2024/3224). Written informed consent will be obtained from all participants. Study findings will be disseminated via peer-reviewed publications and academic conferences, with de-identified data available on reasonable request. This trial is registered on ClinicalTrials.gov (ID: NCT06457750).

Trial registration number

NCT06457750.

Intrauterine high-dose intravenous immunoglobulin therapy during pregnancy for women with a history of pregnancy ending in documented neonatal haemochromatosis (NH001): study protocol

Por: Sasaki · A. · Yachie · A. · Mizuta · K. · Takahashi · H. · Okada · N. · Toma · T. · Motomura · K. · Matsumoto · K. · Wada · Y. S. · Ito · Y. · Ito · R. · Kasahara · M. · Fukuda · A. · Inoue · E. · Yamaguchi · K. · Nakamura · H. · Wada · S. · Sako · M.
Introduction

Neonatal haemochromatosis, considered to be a gestational alloimmune liver disease (NH-GALD), is a rare but serious disease that results in fulminant hepatic failure. The recurrence rate of NH-GALD in a subsequent infant of a mother with an affected infant is 70%–90%. Recently, antenatal maternal high-dose intravenous immunoglobulin (IVIG) therapy has been reported as being effective for preventing recurrence of NH-GALD in a subsequent infant. However, no clinical trial has been conducted to date.

Methods and analysis

This is a multicentre open-label, single-arm study of antenatal maternal high-dose IVIG therapy in pregnant women with a history of documented NH in a previous offspring. The objective of this study is to evaluate the efficacy and safety of antenatal maternal high-dose IVIG therapy in preventing or reducing the severity of alloimmune injury to the fetal liver.

Ethics and dissemination

The clinical trial is being performed in accordance with the Declaration of Helsinki. The trial protocol was approved by the Clinical Research Review Board at four hospitals. Before enrolment, written informed consent would be obtained from eligible pregnant women. The results are expected to be published in a scientific journal.

Protocol version

28 October 2024, V.8.0.

Trial registration number

jRCT1091220353.

Investigating the use and impact of community Care (Education) and Treatment Reviews (C(E)TRs) in people with intellectual disability and autistic people: protocol for a cohort study using electronic health records

Por: McCoy · B. · Bell · L. · Wang · K. · Jin · H. · Hassiotis · A. · Strydom · A. · Downs · J. · Carter · B. · Shetty · H. · Stewart · R. · Ali · A. · Sheehan · R.
Introduction

Care (Education) and Treatment Reviews (C(E)TRs) are intended to reduce unnecessary psychiatric hospital admission and length of stay for people with intellectual disability and autistic people. The use and impact of C(E)TRs have not been systematically evaluated since their introduction in England in 2015. The aims of this study are to describe the demographic and clinical profiles of people who receive a community C(E)TR and to investigate their effects on admission, length of hospital stay and clinical and functional change.

Methods and analysis

We will conduct a retrospective cohort study using de-identified data from electronic health records derived from two large National Health Service mental health providers in London, England, including one replication site. Data will be extracted using the Clinical Record Interactive Search (CRIS) tool for all people with recorded intellectual disability and/or autism who received mental healthcare from 2015. We will identify community C(E)TR events using keyword searches. Community C(E)TRs will be examined in two ways: (1) In a community cohort, we will capture data in the 6-month periods before and after a community C(E)TR and compare this to a matched control group and (2) In a hospital cohort, we will compare groups who did and did not receive a community C(E)TR prior to their admission. We will describe the socio-demographic and clinical profiles of each group and their health service use, and compare C(E)TR and no C(E)TR groups using t-tests (or a non-parametric equivalent). The primary outcomes are admission to a psychiatric hospital (community cohort) and length of psychiatric hospital admission and clinical change (hospital cohort). Admission to psychiatric hospital will be estimated using propensity score weighting and difference-in-differences methods. Cox’s proportional hazard model will be used for length of hospital admission and repeated-measures analysis of variance (ANOVA) will be used to assess clinical change.

Ethics and dissemination

Use of CRIS to examine de-identified clinical data for research purposes has overarching ethical approval. This study has been granted local approval by the South London and Maudsley CRIS Oversight Committee. Findings will be disseminated in an open-access peer-reviewed academic publication, at conference presentations, and to service users and carers in accessible formats.

Understanding structured medication reviews delivered by clinical pharmacists in primary care in England: a national cross-sectional survey

Por: Agwunobi · A. J. · Seeley · A. E. · Tucker · K. L. · Bateman · P. A. · Clark · C. E. · Clegg · A. · Ford · G. · Gadhia · S. · Hobbs · F. D. R. · Khunti · K. · Lip · G. Y. H. · de Lusignan · S. · Mant · J. · McCahon · D. · Payne · R. A. · Perera · R. · Seidu · S. · Sheppard · J. P. · Willia
Objectives

This study explored how Structured Medication Reviews (SMRs) are being undertaken and the challenges to their successful implementation and sustainability.

Design

A cross-sectional mixed methods online survey.

Setting

Primary care in England.

Participants

120 clinical pharmacists with experience in conducting SMRs in primary care.

Results

Survey responses were received from clinical pharmacists working in 15 different regions. The majority were independent prescribers (62%, n=74), and most were employed by Primary Care Networks (65%, n=78), delivering SMRs for one or more general practices. 61% (n=73) had completed, or were currently enrolled in, the approved training pathway. Patient selection was largely driven by the primary care contract specification: care home residents, patients with polypharmacy, patients on medicines commonly associated with medication errors, patients with severe frailty and/or patients using potentially addictive pain management medication. Only 26% (n=36) of respondents reported providing patients with information in advance. The majority of SMRs were undertaken remotely by telephone and were 21–30 min in length. Much variation was reported in approaches to conducting SMRs, with SMRs in care homes being deemed the most challenging due to additional complexities involved. Challenges included not having sufficient time to prepare adequately, address complex polypharmacy and complete follow-up work generated by SMRs, issues relating to organisational support, competing national priorities and lack of ‘buy-in’ from some patients and General Practitioners.

Conclusions

These results offer insights into the role being played by the clinical pharmacy workforce in a new country-wide initiative to improve the quality and safety of care for patients taking multiple medicines. Better patient preparation and trust, alongside continuing professional development, more support and oversight for clinical pharmacists conducting SMRs, could lead to more efficient medication reviews. However, a formal evaluation of the potential of SMRs to optimise safe medicines use for patients in England is now warranted.

Co-designing, evaluating and implementing online supportive care for endometriosis in Australia: study protocol for the hybrid type 1 effectiveness, cost-effectiveness and implementation randomised controlled trial of the CodeEndo program

Por: Mikocka-Walus · A. · Naude · C. · Coitinho Biurra · Y. · Blake · L. · Bowring · J. · De Araugo · S. · Bassili · A. · Bennetts · S. K. · Hutchinson · A. M. · Ng · C. H. M. · Prasertsung · C. · Skvarc · D. · Aras · D. · Ciccia · D. · O · E. · Jacka · F. · Staudacher · H. M. · Varney · J. · A
Introduction

Endometriosis is a chronic condition affecting up to 11% of people presumed female at birth by the age of 44 years, characterised by the growth of tissue similar to the lining of the uterus on other organs. Endometriosis significantly impacts health-related quality of life (HRQoL) and imposes a substantial burden on both individuals and the healthcare system. International guidelines recommend the interdisciplinary management of endometriosis due to its significant biopsychosocial burden; however, research aimed at exploring psychological approaches for endometriosis is limited. This trial aims to evaluate the effectiveness of CodeEndo, an online co-designed interdisciplinary supportive care program, compared with a waitlist control (WLC), on HRQoL and biopsychosocial outcomes in people with a diagnosis of endometriosis.

Methods and analysis

A hybrid type 1 effectiveness and implementation randomised controlled trial (RCT) will be conducted. Eligible participants will be randomly allocated to either the CodeEndo program (n=176) or WLC group (n=176) for 8 weeks. The primary outcome will be HRQoL, and secondary outcomes will include psychological symptoms (anxiety, depression, stress), self-efficacy, menstrual, bladder and gastrointestinal symptoms, pain, fatigue, sleep, exercise, diet, symptom bothersomeness and physical and psychological well-being, measured at 8 weeks post-randomisation (T2) and 6-month follow-up (T3). Cost-effectiveness will also be examined. Longitudinal qualitative individual interviews (up to n=40) will be conducted with participants who complete the CodeEndo program to explore benefits, barriers and facilitators of ongoing use. Additionally, the CodeEndo program will undergo evaluation by a group of endometriosis healthcare providers, who will assess potential barriers and facilitators to its real-world implementation. Various process evaluation strategies will also be measured to inform future implementation. Data analyses will incorporate mixed-effects regression models on an intention-to-treat basis, cost-consequences and cost-utility, dietary and qualitative thematic analysis.

Ethics and dissemination

This protocol received ethics approval from Deakin University Research Ethics Committee (DUREC Ref: 2024-157). Dissemination is expected to include peer-reviewed journal articles, reports, conference presentations as well as websites or social media platforms of relevant chronic pain organisations. Participants will be sent a summary of trial results.

Trial registration number

ACTRN12623000598684p.

Assessing the impact of the COVID-19 pandemic among internally displaced persons in Burkina Faso, Mali and Niger: a cross-sectional study using respondent-driven sampling

Por: Pham · P. N. · Keegan · K. · Johnston · L. G. · Diallo · D. Y. · OMealia · T. · Goh · M. · Vinck · P.
Objectives

Documenting evidence on global health strategies and programmes that provide safeguards for vulnerable populations and strengthen overall pandemic preparedness is essential. This study aimed to identify factors associated with adherence to COVID-19 mitigation measures, COVID-19-related symptoms and testing, as well as pandemic-related income loss among internally displaced persons (IDPs) in urban and remote areas of Burkina Faso, Niger and Mali.

Design

This cross-sectional study used fixed-site respondent-driven sampling (RDS).

Setting

Primary care settings across six urban and remote locations in Burkina Faso, Mali and Niger.

Participants

4144 internally displaced adults, who had been forced from their homes within 5 years of the survey, participated in the study. The survey was conducted between August and October 2021 in two selected locations in three countries: Kaya (n=700) and Ouahigouya (n=715) in Burkina Faso; Bamako (n=707) and Ménaka (n=700) in Mali; and Niamey (n=733), and Diffa (n=589) in Niger. Participants were included if they were born in the study countries, displaced due to conflict, violence or disaster, aged 18 years or older, and living or working in the study site for at least 1 month.

Primary and secondary outcome measures

The primary outcomes measured were adherence to COVID-19 mitigation measures, presence of COVID-19 symptoms, COVID-19 testing and vaccination rates and pandemic-related income loss.

Results

Among 4144 IDPs surveyed across 6 sites in Burkina Faso, Mali and Niger, over half (52%) reported experiencing at least one COVID-19 symptom in the preceding 2 weeks. However, 8% had ever been tested for COVID-19, and fewer than 5% had received a vaccine in all sites except Diffa, where 54% reported vaccination. While willingness to be vaccinated was high (ranging from 56.6% in Bamako to 89.5% in Niamey), access remained limited. Compliance with public health measures varied; for example, 41.7% of IDPs were able to maintain physical distance from non-household members, and just 60.2% reported wearing a mask. Chronic health conditions were consistently associated with higher odds of COVID-19 symptoms (Ménaka OR: 14.65; 95% CI: 7.36 to 29.17). Economic vulnerability was widespread, with more than half of IDPs in Bamako (58.1%) and Niamey (66.4%) reporting income loss due to the pandemic, and average monthly income declining by over 50% in most sites. IDPs in urban areas generally reported greater exposure to COVID-19 risk factors, while those in remote settings reported lower adherence and poorer access to basic preventive measures.

Conclusions

This is the first known RDS study to explore the impact of the COVID-19 pandemic on IDPs. Findings suggest that IDPs in urban areas may face heightened risks of exposure and infection, underscoring the need to prioritise them in public health efforts. Low testing and vaccination rates and significant income loss call for advocacy and economic relief to address these vulnerabilities. Future pandemic responses should integrate health interventions with targeted support, especially mitigating income loss to bolster IDPs’ resilience.

Patient navigation programmes in cancer care in Africa: protocol for a scoping review

Por: Igibah · C. O. · Asogun · D. O. · Okoduwa · B. · Uzoma · V. I. · Agbabi · O. M. · Osinaike · T. · Shittabey · M.-S. K. · Oigiangbe · M. E. · Lawal · Q. O.
Introduction

Cancer remains a major public health concern worldwide. Patient navigation, developed in the 1990s to address disparities in cancer outcomes, aims to guide patients through the complex healthcare system and improve access to timely, quality care. Despite its proven benefits, little is known about the implementation or impact of patient navigation programmes in African settings.

This scoping review aims to map the current evidence on components, procedures, outcomes and impact, as well as barriers and challenges to implementation of patient navigation programmes in cancer care across Africa.

Methods and analysis

This scoping review will follow Arksey and O’Malley’s scoping review framework, as further developed by Levac et al. A systematic search will be conducted across PubMed, African Journals Online and Google Scholar to identify relevant studies published from database inception to the date of the final search, using a combination of relevant keywords and MeSH terms. Eligible studies must be reported in English, have been carried out in Africa, involved patients diagnosed with cancer or navigating the cancer care continuum, and report on the description, implementation or evaluation of patient navigation programmes. Screening will be managed with Rayyan and carried out through a two-stage process: screening by titles and abstracts, then by full-text screening based on the prespecified inclusion and exclusion criteria. Data will be extracted into a structured Excel spreadsheet and synthesised using qualitative content analysis to identify programme characteristics, outcomes, barriers and implementation challenges.

Ethics and dissemination

This scoping review does not require ethical approval. Our findings will be published in a peer-reviewed, open-access journal on completion.

Study protocol for a prospective diagnostic accuracy study to assess the feasibility and diagnostic accuracy of serial ankle handheld Doppler waveform assessment (Ankle HHD) for surveillance after lower-limb revascularisation: WAVE study

Por: Alodayni · H. M. · Smith · S. · Poushpas · S. · Swagell · K. · Mandic · D. · Johnson · N. A. · Jaffer · U. · Davies · A. · Normahani · P.
Introduction

Peripheral arterial disease (PAD) affects approximately one in five people over 60 in the UK. In severe cases, revascularisation, such as surgical bypass or endovascular methods, is often required to restore limb perfusion. Between 2000 and 2019, 527 131 revascularisation procedures were carried out in the UK. Postprocedural surveillance is essential to detect restenosis and maintain vessel patency. However, standard surveillance using duplex ultrasound (DUS) is resource intensive. Ankle Doppler waveform assessment is quick, inexpensive and accurate for PAD diagnosis, yet its role in postrevascularisation surveillance remains unexplored. This study aims to evaluate the diagnostic accuracy of ankle handheld Doppler waveform assessment (ankle HHD) for detecting restenosis after lower limb revascularisation, as compared with formal DUS.

Methods and analysis

This is a prospective diagnostic accuracy study (ClinicalTrials.gov Identifier NCT06619223). We aim to recruit 121 people with PAD undergoing planned lower limb revascularisation at Imperial College Healthcare NHS Trust. Follow-up assessments will take place at 3 months, 6 months and 12 months post revascularisation. At each visit, a vascular scientist will perform the index test (Ankle HHD) followed by DUS as the reference standard. A subset of participants will undergo repeat testing to assess interobserver and intraobserver reliability. Restenosis will be defined as one or more arterial lesions of ≥50% stenosis or tandem lesions with a combined value of ≥50%. The primary outcome is the sensitivity of ankle Doppler waveform assessment for detecting restenosis, compared with DUS.

Ethics and dissemination

The study has received approval from Health Research Authority (HRA) and Health and Care Research Wales (REC reference 24/LO/0462). Results will be disseminated through research presentations and papers.

Trial registration number

ClinicalTrials.gov, NCT06619223.

Mindsets and menses: decoding young womens attitudes towards menstrual leave - an observational study from South India

Por: George · N. · Mahendran · P. · Kulothungan · K. · Dharmaraj · R. B. · Muniyapillai · T. · Subramanian · T. · Muthu Ranga Babu · A. · Arumugam · A. · Subramanian · S. · Shabash Khan · S. · Selvam · S. · Veeraragavan Suresh Babu · A.
Objective

The primary objective of this study is to investigate the perceived need and attitudinal perspectives regarding menstrual leave policies among young women in rural South India. The secondary objective was to determine the socio-demographic, menstrual and workplace-related factors associated with attitudes towards menstrual leave among young women.

Design

An analytical cross-sectional study was performed from May 2023 to August 2023.

Setting

In a rural district of Tamil Nadu, South India.

Participants

The study encompassed 955 young female students above 18 years of age enrolled in educational institutions in a rural district of Tamil Nadu, India. Participants were pursuing diverse professional programmes including medical, dental, allied health sciences, pharmacy and engineering courses.

Outcome measures

The primary outcomes included assessment of basic menstrual characteristics (age of menarche, regularity, product usage and pain experiences), pain evaluation using the WaLIDD scale (which measured working ability, anatomical pain location, pain intensity via Wong Baker scale and pain duration) and attitude assessment through a 10-dimension Likert scale. The attitude assessment explored both supportive factors (pain management, environmental considerations, medical leave allocation, menstruation normalisation and performance impact) and potential concerns (medicalisation, perceptions of fragility, stigma, disclosure issues and abnormal leave usage). Secondary outcome measures encompassed the analysis of factors influencing these attitudes, followed by a multivariable linear regression model to identify significant predictors.

Results

Among 955 female students (mean age 19.56±1.33 years), the majority supported menstrual leave for maintaining hygiene (82.3%) and managing dysmenorrhoea (75.8%). A substantial proportion (64.4%) viewed it as a means of normalising menstruation discourse, while 61.6% believed it could enhance workplace performance. However, concerns existed about medicalising menstruation (47.9%) and reinforcing gender stereotypes (43.4%). Multivariate analysis revealed that medical students (B=0.67, 95% CI: 1.34 to 2.00), those with graduate-educated fathers (B=1.64, 95% CI: 0.31 to 2.97), earlier age at menarche (B=–0.23, 95% CI: –0.45 to –0.01) and participants reporting menstrual interference with daily activities (B=0.96, 95% CI: 0.02 to 0.89) held significantly more positive attitudes.

Conclusion

While young women generally support menstrual leave policies, particularly for hygiene and pain management, there are significant concerns about workplace stigmatisation and gender stereotyping. Educational background, parental education and personal menstrual experiences significantly influence attitudes toward menstrual leave. These findings suggest the need for carefully structured menstrual leave policies that balance biological needs with workplace/student place equality concerns.

Leveraging emotional intelligence to alleviate mental health: protocol of a cluster randomised controlled trial among parents of children with neurodevelopmental disorders in Bangladesh

Por: Salwa · M. · Chowdhury · S. M. · Rois · R. · Uddin · M. K. · Akhter · S. · Nahar · K. · Mullick · A. R. · Mannan · M. · Kundu · G. K. · Fatema · K. · Maruf Haque Khan · M. · Haque · M. A.
Background

Parents of children with neurodevelopmental disorders often experience high levels of stress that impact their mental health, yet few interventions focus on their well-being. To address this gap, we developed a mental health intervention based on emotional intelligence (EI), designed for delivery in healthcare settings. We hypothesise that enhancing EI can reduce parenting stress and improve psychological well-being. This study aims to assess the effectiveness, cost-effectiveness and feasibility of this EI-based intervention in Bangladesh.

Methods and analysis

This hybrid type 1 effectiveness-implementation study will include a cluster randomised controlled trial, an implementation analysis and an economic evaluation. Eight child development centres will be randomly assigned in a 1:1 ratio to intervention and waitlist control groups. A total of 480 parents (mothers and fathers) will be recruited. The intervention consists of interactive sessions on EI skills, supported by personal diaries and a mobile app. Data will be collected at baseline and 12 weeks postintervention using validated tools to assess EI, parenting stress, psychological well-being and other mental health outcomes. Implementation will be evaluated using mixed methods to assess feasibility, acceptability and fidelity. Cost-effectiveness will be determined through a cost–utility analysis of direct and indirect costs.

Ethics and dissemination

Ethical approval was granted by the Institutional Review Board of Bangladesh Medical University (BSMMU/2022/10733). Written informed consent will be obtained at each stage of data collection and intervention. Findings will be disseminated through open-access publications, plain-language summaries, academic conferences, community workshops and policy briefs. Data will be shared in open-access platforms to inform mental health strategies in low-resource settings globally.

Trial registration number

NCT06166550.

Australian research priorities for inherited retinal diseases: a James Lind Alliance priority setting partnership

Por: Robertson · E. G. · Hetherington · K. · Prain · M. · Ma · A. · Ayton · L. N. · Jamieson · R. V. · Shepard · E. · Boyd · L. · Hall · J. · Boyd · R. · Karandrews · S. · Feller · H. · Simunovic · M. P. · Grigg · J. R. · Yamamoto · K. · Wakefield · C. E. · Gonzalez-Cordero · A.
Objectives

Inherited retinal diseases (IRDs) are a broad range of diseases associated with abnormalities/degeneration of retinal cells. We aimed to identify the top 10 Australian research priorities for IRDs to ultimately facilitate more meaningful and potentially cost-effective research.

Design

We conducted a James Lind Alliance priority setting partnership that involved two Australian-wide surveys and online workshops.

Setting

Australia-wide.

Participants

Individuals aged 16 years or older were eligible to participate if they had an IRD, were caregivers of an individual with an IRD or were health professionals providing care to this community.

Outcome measure

In Survey 1, we gathered participants’ unanswered questions about IRDs. We grouped these into summary questions and undertook a literature review to verify if they were truly unanswered (ie, evidence uncertainties). In Survey 2, participants voted for the uncertainties that they considered a priority. Top-ranked uncertainties progressed for discussion and final prioritisation in two workshops.

Results

In Survey 1, we collected 223 questions from 69 participants. We grouped these into 42 summary questions and confirmed 41 as evidence uncertainties. In Survey 2, 151 participants voted, with the 16 uncertainties progressing to final prioritisation. The top 10 priorities, set by the 24 workshop participants, represented (1) treatment/cure; (2) symptoms and disease progression; (3) psychosocial well-being and (4) health service delivery. The #1 priority was for treatment to prevent, slow down or stop vision loss, followed by the #2 priority to address the psychological impact of having an IRD.

Conclusion

The top 10 research priorities highlight the need for IRD research that takes a whole-person, systems approach. Collaborations to progress priorities will accelerate the translation of research into real-world benefits.

ColoCap: determining the diagnostic accuracy of colon capsule endoscopy compared with standard colonoscopy in patients at risk of colorectal disease - a study protocol

Por: Ibrahim · H. · Haritakis · M. · Ballantine · L. · McCormack · K. · Cotton · S. · Hudson · J. · Atkin · K. · Rogers · S. · Nixon · L. S. · Verghese · A. · Holmes · H. · Treweek · S. · MacLennan · G. · Dolwani · S. · Gardner · G. · Hurt · C. · Watson · A. · Turvill · J.
Background

Lower gastrointestinal symptoms attributed to colorectal disease are common. Early diagnosis of serious colorectal disease such as colorectal cancer (CRC), precancerous growths (polyps) and inflammation is important to ensure the best possible outcomes for a patient. The current ‘gold standard’ diagnostic test is colonoscopy. Colonoscopy is an invasive procedure. Some people struggle to cope with it and require intravenous sedation and/or analgesia. It is also resource-intensive, needing to be performed in specialist endoscopy units by a trained team. Across the UK, the demand for colonoscopy is outstripping capacity and the diagnosis of colorectal disease is being delayed. A colon capsule endoscope (CCE) is an alternative colorectal diagnostic. It is a ‘camera in a pill’ that can be swallowed and which passes through the gastrointestinal tract, obtaining visual images on the colon. There is now established experience of CCE in the UK. CCE might provide a less invasive method to diagnose colorectal disease if found to be accurate and effective and provide a means by which to increase the National Health Service (NHS) diagnostic capacity.

Aims and objectives

The aim of this study is to determine the diagnostic accuracy of CCE when compared with colonoscopy in representative and clinically meaningful cohorts of patients. An evaluation of the experiences of CCE for the patient and clinical team and an assessment of cost effectiveness will be undertaken.

Methods

We will undertake three research workstreams (WS). In WS1, we shall perform a paired (back-to-back) study. Each participant will swallow the CCE and then later on the same day they will have a colonoscopy. The study has been designed in collaboration with our Patient Advisory Group and as closely mirrors standard care as is possible. 973 participants will be recruited from three representative clinical contexts; suspected CRC, suspected inflammatory bowel disease and postpolypectomy surveillance. Up to 30 sites across the UK will be involved to maximise inclusivity. Measures of diagnostic accuracy will be reported along with CCE completion rates, number of colonoscopy procedures potentially prevented and adverse events, such as capsule retention. A nested substudy of intraobserver and interobserver agreement will be performed. WS2 will develop models of cost-effectiveness and WS3 will evaluate the patient and clinician experience, with reference to acceptability and choice.

Anticipated impact

The study findings will provide the evidence base to inform future colorectal diagnostic services.

Ethics and dissemination

The study has approval from the North East—Tyne and Wear South research ethics committee (REC reference 24/NE/0178, IRAS 331349). The findings will be disseminated to the NHS, National Institute for Health and Care Excellence, other clinical stakeholders and participants, patients and the public.

Trial registration number

ISRCTN16126290.

Patient-reported outcome measured by EQ-5D and influencing factors among patients of systemic lupus erythematosus in China: a multicentre cross-sectional study from CSTAR Registry

Por: Li · L. · Bai · W. · Yu · B. · Zou · K. · Wang · Y. · Zuo · K. · Wang · L. · Wu · C.-Y. · Zhao · J. · Zeng · X. · Wang · Y. · Li · M.
Objectives

Until now, there has still been a lack of sufficient evidence on patient-reported outcomes (PROs) measured by the EuroQol-5 Dimension (EQ-5D) in patients with systemic lupus erythematosus (SLE) in China. This study aims to comprehensively assess EQ-5D outcomes and influencing factors in Chinese patients with SLE.

Design

A multicentre, cross-sectional study based on the Chinese Systemic Lupus Erythematosus Treatment and Research Group registry.

Setting

101 hospitals across 27 provinces of China.

Participants

1336 patients with SLE.

Outcome measures

The information on EQ-5D was collected via an online questionnaire. Medical records were obtained from the Chinese Rheumatology Data Centre (CRDC). Clinical influencing factors related to the reported health problems were identified using multivariate logistic regression. Then, each health state was converted into a health utility score based on the Chinese 2014 tariff. Given the ceiling effects, Tobit regression models were used to analyse the factors influencing health utility scores.

Results

A total of 1336 patients with SLE were included. Of them, 626 patients (46.9%) reported health problems using EQ-5D. The proportions of patients reporting problems in mobility, self-care, usual activities, pain/discomfort and anxiety/depression were 12.80%, 5.24%, 14.90%, 27.47% and 30.46%, respectively. The mean utility score was 0.89 (SD: 0.15), and the mean Visual Analogue Scale (VAS) score was 76.80 (SD: 16.54). There was a statistically significant correlation (r=0.503, p

Conclusions

EQ-5D may be a useful, preference-based PRO measure for SLE and could potentially be integrated into routine clinical monitoring of patients with SLE and applied in economic evaluations in the future.

Stunting incidence and reversal as metrics of postnatal linear growth faltering in low- and middle-income countries: a critical appraisal and simulation study

Por: Roth · D. E. · Watson · K. M. · Bassani · D. G.
Objectives

Length-for-age z-scores (LAZ) and stunting prevalence (%LAZ

Methods

We simulated a synthetic cohort with a harmonically downward-shifting LAZ trajectory from birth to 24 months of age, with mean LAZs similar to the HBGDki pooled South Asian cohorts, and without any input parameters intended to differentially affect individuals’ growth across the height distribution or at different ages. We compared HBGDki empirical estimates of age interval-specific frequencies of incident stunting onset and stunting reversal with those from the synthetic cohort. Using synthetic cohorts, we examined how estimates of incident onset and reversal were affected by missing data, magnitude of the whole-population shift in the LAZ distribution and strength of the between-time-point correlation. We also compared the 3–24 month pattern of linear growth faltering expressed as age-related trajectories of average growth delay (chronological age minus height–age), mean LAZ or stunting prevalence.

Results

Empirical estimates of age interval-specific incident stunting onset and stunting reversal in the HBGDki cohorts were similar to those observed in a synthetic cohort. Variability in LAZ threshold-crossing event rates is explained by starting LAZ, between-time-point correlation and the magnitude of the whole-population shift in the LAZ distribution. Incident stunting onset is also affected by missing data in preceding intervals. Stunting reversal occurs due to within-child variability (ie, imperfect between-time-point correlation) in the absence of any other phenomena that cause stunted children to become non-stunted at a later age. The linear growth faltering pattern based on growth delay differed from corresponding age-related trajectories of mean LAZ or stunting prevalence.

Conclusions

In longitudinal studies of linear growth faltering in LMICs, LAZ threshold-crossing indicators are byproducts of whole-population shifts in LAZ and within-child variability and should be interpreted accordingly. Reporting incident stunting onset and reversal rates, or analyses in which children are grouped by the timing of LAZ threshold-crossing events, may detract from efforts to understand when and why nearly all children in LMICs grow more slowly than expected for their age. Since mean LAZ and stunting prevalence are unsuitable for quantifying the rate and timing of population-average postnatal linear growth faltering, growth delay is recommended for consideration as a preferred metric.

Psychosis and self-harm in prison: a population-based case-control study

Por: Chowdhury · N. Z. · Hwang · Y. I. · Spike · E. · Kariminia · A. · Dean · K. · Adily · A. · Ellis · A. · Greenberg · D. M. · Grant · L. · Allnutt · S. · Butler · T.
Background

Self-harm and suicide are common among prison inmates, but less is known about these phenomena in those with psychosis.

Objectives

The aim of this study was to examine self-harm behaviour in New South Wales (NSW) prisons in Australia among inmates diagnosed with psychosis. This study also examined self-harm-related alerts applied by Corrective Services to assist staff with the management of the security and well-being of inmates.

Design and setting

A retrospective case-control data-linkage study was conducted using administrative data collections in NSW, Australia.

Participants

The study included all individuals diagnosed with psychosis and incarcerated between 2001 and 2020 in NSW as cases and an age and sex matched control group with no such diagnosis with a record of incarceration in the same time period.

Primary and secondary outcome measures

The primary outcome measure was self-harm among the cases and controls. The secondary outcome measure was the application of alerts by Corrective Services in relation to self-harm incidents.

Results

Multivariate regression analysis was used to examine predictors of self-harm in prison. Prisoners with psychosis (n=14 900) were more likely to self-harm than controls (n=2713), with 15.0% versus 3.6% engaging in self-harm (highest odds of self-harm observed in those with schizophrenia and related psychoses, aOR=4.84, 95% CI: 3.93 to 5.98). Those of Aboriginal heritage had an increased risk of self-harm (aOR=1.58, 95% CI: 1.43 to 1.75). Factors associated with a lower risk of self-harm were male sex and older age (≥25 years) at the time of their first incarceration. 35.6% of those released from prison with a prior psychosis diagnosis had at least one alert applied during incarceration compared with 10.1% of prisoners without a diagnosis of psychosis. Overall, 35 individuals with psychosis and 1 individual from the control group died while in prison between 2001 and 2020. 17 prison suicides were recorded from the study population; all occurred in the psychosis group.

Conclusions

Given the heightened risk of self-harm in those with histories of psychosis, consideration should be given to sharing mental health information between agencies to improve the care and management of this group during incarceration. Prison alerts may be a useful tool to help staff manage inmates’ well-being if used appropriately.

Retrospective analysis of value-driven outcomes of diabetic foot ulcer in a tertiary hospital in Singapore

Por: Chia · A. C. K. · Tan · I. E.-H. · Tan · Z. N. · Yeo · W. J. · Zhao · Y. · Yap · C. J. Q. · Ang · K. A. · Au · M. K. H. · Chong · T. T.
Objective

This study analysed the clinical outcomes and healthcare costs associated with diabetic foot ulcer (DFU) within a tertiary healthcare centre in Singapore.

Design

This is a retrospective, single-centre study. Patient data were extracted from the hospital’s electronic health system, including demographic, clinical and hospitalisation information. Hospitalisation costs were categorised into DFU-related and other hospitalisation costs. A one-way sensitivity analysis was performed to estimate the total healthcare costs associated with DFU.

Setting

Tertiary centre within a population suffering from a diabetic epidemic.

Participants

All patients aged 18 years or older who received DFU treatment between January 2019 and December 2023 at the Singapore General Hospital were included.

Results

A total of 2857 DFU patients were included in the study. In-hospital mortality remained stable at 5%–6% annually. Among the cohort, 39.1% underwent minor amputations, 19.6% had major amputations and 9.0% experienced both minor and major amputations. The median length of stay for surgical patients ranged from 10 (IQR 4–24) to 13 days (IQR 6–31), compared with 4 (IQR 2–8) to 5 (IQR 3–9.5) days for non-surgical patients. Total costs per admission for patients with DFU-related surgery ranged from US$28 588.96 to US$34 204.77, while for those without surgery, costs ranged from US$6637.59 to US$7955.23. Total hospitalisation costs for DFU during the study period ranged from US$65.87 million to US$72.16 million. All figures were inflation adjusted to 2023 US dollars.

Conclusions

DFU poses a significant clinical and economic burden in Singapore. Understanding the costs associated with DFU is essential for resource allocation and planning in DFU management.

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