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Ayer — Octubre 14th 2025Tus fuentes RSS

Nurse Roles Implementing the Choice for Self‐Collection Cervical Screening in Rural Settings: A Qualitative Study Following National Policy Change

ABSTRACT

Aim

To explore the key factors influencing nurses' capability, opportunity and motivation to offer the choice for self-collection for cervical screening within rural primary care services, following a national policy change in Australia.

Design

A qualitative study informed by implementation and behavioural change frameworks.

Methods

Primary health nurses working in Victoria were invited to participate in semi-structured interviews via video or telephone between December 2022 and March 2023. Eighteen nurses from 18 clinics participated. Interview data were analysed following a Framework analysis approach, and themes were mapped to the COM-B model.

Results

Nurses were highly motivated to offer the choice for self-collection due to perceived advantages for their patients and potential opportunities for reaching people hesitant to screen. There was variation in how nurses offered this choice, and to whom. Some nurses were concerned about lost opportunities to visualise the vulval area or cervix, or to have broader health and wellbeing conversations with patients. Views were mixed about how self-collection would impact nurse roles, and several external factors were impacting their opportunities as cervical screening providers.

Conclusions

Appropriately trained nurses have the capability and motivation to incorporate the choice for self-collection within their screening practice; however, their opportunity to maximise equity and increase participation is impacted by funding models and structures that limit their autonomy.

Impact

People living outside major cities experience greater healthcare inequities. Australia introduced access to the choice for self-collection for all eligible individuals in 2022, in part to achieve greater equity in the national screening program. Nurses can play a key role in program delivery. Understanding how they incorporate self-collection into their practice, and the key factors influencing implementation in rural primary care settings, can inform future program implementation and improve outcomes for patients.

Reporting Method

We have adhered to COREQ reporting guidelines.

Patient or Public Involvement

This study did not include patient or public involvement in its design, conduct or reporting.

The Historical Foundations of Advanced Practice Nursing: Tracing American Origins for Global Understanding

ABSTRACT

Aim(s)

To examine the historical origins of ‘advanced’ nursing as a concept.

Design

Historical analysis using primary source documentation.

Methods

Historical analysis of articles published in the American Journal of Nursing by the National League of Nursing Education from 1928 to 1950, supplemented by books and articles addressing nursing specialisation history. Articles were analysed chronologically to trace terminology development and strategic decision-making processes during this foundational period.

Results and Discussion

‘Advanced’ terminology was first introduced in 1933 by Isabel Stewart to distinguish university-based clinical specialisation from exploitative hospital ‘postgraduate courses’. The term served as a strategic tool for legitimacy and professional differentiation. World War II accelerated development through federal funding and increased specialisation demands. Louise McManus provided the first conceptual framework in 1949, defining ‘advanced’ education as ‘planned forward movement’ requiring new learning experiences beyond basic preparation. Master's degree requirements were established in 1952, creating educational structures that persist today.

Conclusion

The strategic introduction of ‘advanced’ terminology in the 1930s established foundational concepts that continue to influence contemporary advanced practice nursing development internationally.

Implications for the Profession and/or Patient Care

Understanding these historical origins enables more informed policy development for countries implementing advanced nursing roles and helps resolve ongoing definitional confusion in international nursing practice.

Impact

This research addresses the gap in historical understanding of advanced practice nursing terminology origins. Main findings reveal the strategic nature of professional language in nursing's professionalisation. The research impacts international nursing education policy and contemporary advanced nursing role development across diverse healthcare systems.

Reporting Method

This study adhered to guidelines for historical research methodology.

Patient or Public Contribution

This study did not include patient or public involvement in its design, conduct, or reporting.

Immediate versus gradual TocilizuMab discontinuAtion in GIant Cell Arteritis: protocol of the multicentre randomised open-label MAGICA trial

Por: Samson · M. · Fournel · I. · Bourredjem · A. · Cortier · M. · Galizzi · E. · Cransac · A. · Cladiere · C. · Fleck · C. · Brayer · M. · Carpentier · M. · Alberini · J.-L. · Devilliers · H. · Bonnotte · B.
Introduction

Giant cell arteritis (GCA) is a large-vessel vasculitis occurring in people aged over 50 years. Recent studies have shown that tocilizumab (TCZ), an anti-IL-6 receptor monoclonal antibody, is remarkably effective in treating GCA and allows significant dose sparing of glucocorticoids. However, it makes it difficult to monitor disease activity. Furthermore, treatment is often prolonged over 1 year due to the fear of relapse after stopping TCZ and/or the absence of an optimal discontinuation scheme.

Methods and analysis

This study aims at comparing two discontinuation regimens in a population of GCA patients who have been treated with TCZ for 12–36 months and have discontinued glucocorticoids for at least 12 weeks. Patients will be randomised with a 1:1 ratio between two arms: immediate discontinuation (cessation) versus gradual discontinuation of TCZ (162 mg subcutaneously every 2 weeks for 12 weeks and then every 4 weeks for 12 additional weeks). Patients will be followed up for 78 weeks. The primary endpoint is relapse-free survival after 26 weeks of follow-up. A total of 120 patients will be randomised (60 in each group) for a period of 3 years.

Ethics and dissemination

The trial was approved by an independent ethics committee (CPP Sud Ouest et Outre Mer IV) and the French health authority (French National Agency for Medicines and Health Products Safety—ANSM) through the Clinical Trials Information System (CTIS) provided by the European Medicines Agency (EMA). The informed consent complies with the ICH GCP guideline and regulatory requirements. Eligible patients may only be included in the study after providing informed consent. Findings will be published in peer-reviewed journals and conference presentations.

Trial registration number

NCT06037460.

Rebozo and maternal postures to prevent persistent occiput posterior position of the fetal head: protocol for a randomised clinical trial 'the ReMaP-POPP RCT

Por: Ornaghi · S. · Fumagalli · S. · Antolini · L. · Panzeri · M. · Spandrio · R. · Ferrini · S. · Nespoli · A. · Maini · M. · Locatelli · A.
Introduction

Occiput posterior position is the most common fetal malposition, complicating up to 35% of initial labours, and its persistence can lead to increased risks of adverse maternal and perinatal outcomes. The role of maternal postures, such as lateral recumbent and hands-and-knees, in promoting the anterior rotation of the fetal head has been investigated in several randomised trials in the last two decades, with mostly negative results. However, both methodological and study design limitations may have contributed to such findings. Recently, the use of forward-leaning inversion and side-lying release procedures and of the Rebozo technique has been implemented into clinical practice as a non-invasive alternative to promote the anterior rotation of the fetal head. Yet, neither intervention has been rigorously assessed in a controlled study. Our aim is to conduct a randomised controlled trial to assess whether a combination of forward-leaning inversion and side-lying release procedures and the Rebozo technique in a pre-specified sequence during the first stage of labour of women with a posterior fetus would favour its anterior rotation.

Methods and analyses

The ReMaP-POPP (Rebozo and maternal procedures to prevent persistent occiput posterior position of the fetal head) trial will be an open-label single-centre randomised controlled trial with two parallel groups. Women will be eligible if they are ≥18 years old, in labour (3 to 8 cm) and with a singleton term fetus (≥370/7 weeks) in an occiput posterior position confirmed by transabdominal sonography. Eligible women will be randomised into two groups: (1) intervention, a sequence of forward-leaning inversion and side-lying release procedures and Rebozo technique (duration 90–105 min); and (2) control, standard of care (maternal postures, including upright, lateral recumbent and hands-and-knees). Blinding will be guaranteed only for the physician assessing the fetal head position by sonography. Randomisation will be performed using randomly permuted blocks of varying sizes (4, 6 and 8), stratified by parity, in a 1:1 ratio. The primary outcome will be the probability of occiput posterior position of the fetal head 3 hours and 30 min after randomisation, diagnosed by sonography. Secondary outcomes will include the probability of occiput posterior position at full cervical dilation and at birth, maternal and neonatal health-related outcomes, as well as maternal pain intensity and ability to cope with pain and birth satisfaction level. We will also assess safety outcomes regarding challenges in adequate fetal heart rate monitoring during the time interval between randomisation and primary outcome assessment. Sample size estimation considered the possibility to decrease the probability of occiput posterior position from 35.8% (control, based on prior retrospective data at our Institution) to 22% with the proposed intervention. With a power of 0.90 and a two-sided value of 0.05, the estimated sample size will be n=462 (n=231/arm). Considering a potential attrition rate of 20%, n=578 women will be needed. Enrolment will require approximately 16 months. Primary and secondary outcomes will be analysed on an intention-to-treat basis. The effects of the intervention will be estimated by relative risks and their 95% CI.

Ethics and dissemination

The study has been approved by the Lombardy Ethics Committee n.3 (n. 5499, 20 December 2024). Written informed consent will be obtained from all participants. Women will be free to decline participation or to withdraw at any time. Findings will be presented at scientific meetings and published in peer-reviewed scientific journals in the field of midwifery and obstetrics. Also, they will be disseminated to the public through outreach activities involving families and healthcare specialists.

Trial registration number

The study has been registered in the Clinical Trials database (NCT06887634).

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Effect of prophylactic fibrinogen concentrate in scoliosis surgery (EFISS): a randomised pilot trial

Por: Hudec · J. · Vrbica · K. · Hrdy · O. · Galko · M. · Repko · M. · Stepanova · R. · Demlova · R. · Kubelova · M. · Gal · R.
Objectives

The goal of this study is to assess the safety, feasibility and clinical outcomes of prophylactic fibrinogen administration in paediatric scoliosis surgery.

Design

Prospective, two-arm, randomised, double-blind pilot trial.

Setting

Single-centre study conducted at a tertiary care hospital specialising in scoliosis surgery.

Participants

32 children undergoing scoliosis surgery entered and completed the study. The inclusion criteria were elective scoliosis surgery, age

Interventions

Participants were randomised 1:1 to a standard group, receiving standard blood and coagulation management, or a fibrinogen group, receiving a single prophylactic dose of fibrinogen concentrate in addition to standard care.

Primary and secondary outcome measures

Safety, the primary objective, was assessed according to adverse events, serious adverse events and other safety parameters. Secondary objectives included feasibility and clinical outcomes.

Results

In the fibrinogen group, 101 adverse events across 19 types were observed, whereas in the standard group, 95 adverse events across 21 types (p>0.9999) and one serious adverse event were observed. No adverse events of special interest or deaths occurred in either group. Blood loss did not significantly differ between the fibrinogen (1021.88 mL (SD 473.63)) and standard (859.38 mL (SD 713.03)) groups (p=0.1677). The mean length of hospital stay was 8.88 (SD 0.81) days in the fibrinogen group and 9.25 (SD 1.88) days in the standard group (p=0.9210). No statistically significant differences in the use of blood transfusions, blood derivatives, crystalloids or colloids were observed between groups.

Conclusions

This study demonstrates that the prophylactic administration of fibrinogen during scoliosis surgery in children is feasible and appears to be safe. Due to the limited sample size, no conclusions can be drawn regarding the efficacy of pre-emptive fibrinogen administration on clinical outcomes. However, the results provide valuable data to inform sample size calculation for a future full-scale randomised controlled trial.

Trial registration number

CliniacalTrials.gov NCT05391412.

Exploring the delivery of care to people living with chronic pain and opioid use disorder in a western population

Por: Galligan · M.

Commentary on:Archambault et al (2024) The current state of knowledge on care for co-occurring chronic pain and opioid use disorders: a scoping review.

IMPLICATIONS FOR PRACTICE AND RESEARCH

  • Research is needed to explore the impact of combined management of opioid use disorder (OUD) and chronic non-cancer pain.

  • There is a need to support healthcare professionals when caring for those with OUD and chronic non-cancer pain to ensure they have adequate knowledge and awareness of treatment options.

  • Context

    Over the last decade, there has been a growing focus on the use of opioids in the management of pain across clinical practice and media outlets. The incidence of chronic non-cancer pain is estimated between 35% and 51%.1 It is estimated that around 22% of patients with chronic non-cancer pain received a prescription for an opioid, with 8%–12% showing signs of OUD.2...

    Routine loneliness screening in adults with atherosclerotic cardiovascular disease in a large national health plan: a retrospective cohort study

    Por: Galper · K. · Nudy · M. · Sinoway · L. · Brignone · E.
    Objectives

    To investigate the association between loneliness and all-cause mortality and inpatient hospitalisation among adults with atherosclerotic cardiovascular disease (ASCVD) in a real-world setting, and to explore the potential implications of routine loneliness screening. The primary hypothesis was that loneliness is associated with increased all-cause mortality.

    Design

    Observational retrospective cohort study.

    Setting

    Analysis of linked administrative claims and routinely collected loneliness screening data from a large health plan.

    Participants

    7484 adult health plan members with documented ASCVD and ≥10 months of continuous enrolment around the screening date. Selection criteria included ASCVD diagnosis and sufficient enrolment for baseline assessment.

    Primary and secondary outcome measures

    The primary outcome measure was 365-day all-cause mortality. The secondary outcome measure was the 365-day all-cause inpatient hospitalisation rate.

    Results

    881 deaths occurred during follow-up (18% in the lonely group vs 11% in the non-lonely group). The lonely group had a lower proportion of men (54% vs 65%, p

    Conclusions

    Our findings corroborate the association between loneliness and morbidity and mortality among those with known ASCVD. The effect for loneliness was similar in magnitude to clinical comorbidities and smoking, suggesting that routine screening for loneliness may provide valuable information for assessing and managing the risk of death among patients with ASCVD.

    Use of real-world data and real-world evidence in NICE (UK) health technology appraisals of new therapeutics in oncology: a systematic review

    Por: Tunaru · F. · Robinson · D. E. · MacDougall · A. · Carpenter · L.
    Objectives

    To quantify and describe the use of real-world data (RWD) in National Institute for Health and Care Excellence (NICE) oncology technology appraisal (TA) final appraisal determination documents.

    Design

    A systematic literature review was conducted on pharmaceutical NICE oncology TAs published between April 2000 and March 2024 (covering financial years 2000/2001 to 2023/2024 inclusive) extracted on 22 August 2023 (2000/2001 - 2022/2023) and 8 August 2024 (2023/2024).

    Data sources

    NICE TA final appraisal determination documents.

    Eligibility criteria

    All pharmaceutical oncology TAs published between April 2000 and March 2024 (financial years 2000/2001 to 2023/2024) that did not go on to be terminated.

    Data extraction and synthesis

    The data required for eligibility screening was extracted from an Excel file directly from the NICE website, where data related to each TA was extracted using an automated script derived from published sources. TAs were assessed based on prespecified review criteria covering whether an RWD submission was reported by the committee, and if so, which RWD sources were used, alongside the methods reported and any feedback from the committee regarding the use of RWD. Bias was not assessed as part of the study.

    Results

    Of 310 TAs identified, 135 (48.0%) used RWD. A variety of RWD types were used, mostly from UK or US data sources. 47 TAs (34.8%) leveraged RWD from multiple sources. RWD was mostly used in comparisons of survival (41.5%), to inform utility values (26.7%) and to compare baseline characteristics (19.3%), with matched adjusted indirect comparisons (MAICs) and external control arms (ECAs), seen from 2015 and 2018, respectively. The committee expressed concerns around the RWD presented by the company in 53 TAs (39.2%), the most common being a lack of generalisability to the UK population and/or National Health Service practice and comprehensiveness of the RWD.

    Conclusions

    This study quantifies the increasing use of diverse RWD sources in NICE oncology TAs, as well as the shift towards more complex methods like MAICs and ECAs. The feedback of the NICE committee highlights key areas of improvement as the generalisability and maturity of the RWD presented.

    Challenges of Parents While Providing Complex Medical Care at Home to Children With Cancer: A Cross‐Sectional Convergent Mixed Methods Study

    ABSTRACT

    Aim

    To explore challenges parents of children with cancer encounter while providing complex medical care at home.

    Methods

    Design: Cross-sectional convergent mixed-methods study. Instruments: Questionnaire and open interviews that mirrored and complemented each other.

    Results

    Parents (n = 32), with no prior medical training, were expected to remain constantly vigilant as they monitored and managed rapidly changing situations. Regardless of time from diagnosis, they detected a mean of 3.3 ± 1.4 (0–6) symptoms, reported administering up to 22 daily medications, including cytotoxics, narcotics and injections, and dealt with many related challenges. Parents described needing responsive communication channels, especially when dealing with bleeding and infection emergency situations during off-hours.

    Conclusions

    Findings highlight the constantly shifting demands when managing a child with cancer at home. Educational programmes that address parental needs throughout treatment, tailored to protocol changes and individual circumstances, should be expanded and further developed.

    Patient Care Implications

    Parents need continual education regarding home management throughout their children's illness and treatment.

    Impact

    This study addresses challenges parents of children with cancer encounter while providing complex medical care at home. The findings demonstrated that parents, responsible for administering numerous medications via various routes and managing symptoms and side effects, did not feel confident performing these tasks regardless of time from diagnosis. Nurses should adapt ongoing parental education regarding complex medical tasks, symptoms, side effects, emergency detection and management for children with cancer at home. The study adhered to the Mixed Methods Appraisal Tool (MMAT) and STROBE reporting method.

    Patient Contribution

    Parents of children with cancer participated in the design and questionnaire validation.

    A Borate‐Based Bioactive Glass Advances Wound Healing in Non‐Healing Wagner Grade 1 Diabetic Foot Ulcers: A Randomised Controlled Clinical Trial

    ABSTRACT

    A novel advanced synthetic bioactive glass matrix was studied in patients with non-healing diabetic foot ulcers (DFUs). Bioactive glasses can be constructed to be biocompatible, with water-soluble materials in multiple geometries including fibre scaffolds that mimic the 3D architecture of a fibrin clot. In this trial, chronic, Wagner Grade 1 DFUs were randomised to receive borate-based bioactive glass Fibre Matrix (BBGFM) plus standard of care (SOC) therapy for 12 weeks or SOC alone. The primary study endpoint was the proportion of subjects that obtained complete wound closure at 12 weeks. Secondary endpoints included time to achieve complete wound closure at 12 weeks. In the modified intent-to-treat (mITT) analysis, 48% (32/67) treated with BBGFM plus SOC healed at 12 weeks compared to 24% (16/66) with SOC alone (p = 0.007). In the per protocol (PP) population, 73% (32/44) of subjects treated with BBGFM plus SOC healed versus 42% (16/38) in the SOC group (p = 0.007). Based on the success of this trial, BBGFM demonstrates faster healing of DFUs compared to SOC and should be considered in the treatment armamentarium for Wagner Grade 1 DFUs. Future trials should investigate the use of BBGFM for healing deeper chronic DFUs, other wound aetiologies, or complex surgical wounds.

    Use of Artificial Intelligence‐Driven Wound Care Management to Enhance Access to Care Rural and Northern Communities

    ABSTRACT

    Wound care remains a high-priority area for improvement in the Canadian health care system. Older adults aged 65 and older are disproportionately affected by chronic and non-healing wounds and often experience multiple co-morbid conditions, challenges which can be further complicated by living in rural and northern areas. A workshop-based multi-methods study was conducted to describe rural and northern perspectives on opportunities and feasibility to implement innovative wound care technologies. Each workshop included pre- and post- workshop surveys, a live demonstration of Swift Skin and Wound, a Q&A session, and facilitated discussion exploring the technology's feasibility, usability, and accessibility in northern and rural care contexts. Participants who volunteered for the study included care staff and healthcare executives (N = 11), described their perspectives on implementing AI-driven digital wound care management solutions with a focus on integration into health care settings. Three themes were identified including: confidence and optimism in improving wound care management, recognition of the superiority of AI-driven digital wound care solutions over current practices, and the importance of adaptable change processes for successful adoption. While generalizability may be limited, findings suggest that adopting AI-driven wound care tools could improve wound assessment accuracy and streamline care for aging populations in rural and northern areas.

    Research Capability and Influencing Factors Among Clinical Nurses: A Multicentre Cross‐Sectional Study

    ABSTRACT

    Aim

    To evaluate the research capability of clinical nurses in China and identify the determinants associated with their capability.

    Background

    As nursing evolves into an increasingly independent discipline, the research capability of clinical nurses has become critical for the development of the profession, advancing evidence-based practice and improving patient care quality.

    Methods

    A multicentre cross-sectional survey was conducted using convenience sampling from September 2023 to February 2024, among clinical nurses in tertiary hospitals across three provinces in China. The Nursing Research Capability Self-Assessment Scale was used to assess the research capability of the nurses. Chi-square tests, one-way analysis of variance and multiple linear regression were used to examine factors associated with research capability. The Strengthening the Reporting of Observational Studies in Epidemiology was followed.

    Results

    A total of 1074 clinical nurses participated. The mean research capability score was 89.11 ± 27.69, reflecting a moderate level of research capability. However, two dimensions of research questions and literature review received lower scores. Multiple linear regression analysis identified that education level, professional title, administrative position and nursing job title (all p < 0.05) were independent predictors of research capability.

    Conclusions

    Clinical nurses exhibit moderate research capability, with notable deficiencies in formulating research questions and conducting literature reviews. Key factors influencing research capability include education, professional title, administrative position, and job title. Targeted training and development programmes should address these factors to enhance nurses' research competence and advance nursing science.

    Impact of Traumatic Stress on Nurses' Work Ability, Job Satisfaction, Turnover and Intention to Leave: A Cross‐Sectional Study

    ABSTRACT

    Aims

    This study aimed to explore the direct and indirect effects of secondary traumatic stress (STS) on nurses' perceived work ability and the effect of these two variables on job satisfaction, organisational turnover intention and intention to leave the nursing profession.

    Design

    A cross-sectional study was conducted from June to November 2023.

    Method

    Data were collected by sending an online survey to a convenience sample of nurses. Instruments for data collection included a 37-item questionnaire divided into three sections: (i) socio-demographics, job satisfaction, organisational turnover intention, and intention to leave the profession; (ii) perceived work ability assessed through the Work Ability Index (WAI); (iii) STS measured with the Secondary Traumatic Stress Scale.

    Results

    Two hundred seventy-one nurses completed the questionnaire. STS negatively and statistically impacted on WAI, and it was a direct determinant of intention to leave the nursing profession. WAI showed a direct, positive and significant impact on job satisfaction and it was a significant partial mediator in the relationship between STS and job satisfaction. Job satisfaction mediated between WAI, the intention to leave the nursing profession, and the organisational turnover intention.

    Conclusion

    STS negatively impacted nurses' work ability, influencing their job satisfaction through the mediation of WAI, whereas job satisfaction independently affected nurses' organisational turnover intention. Moreover, STS was a positive and direct determinant of the intention to leave the nursing profession.

    Impact

    Nurses, as helping professionals, are exposed to extreme stressful events resulting from the traumatic experiences of patients. STS in nurses can lead to emotional exhaustion, turnover intention, job dissatisfaction and reduced work ability. The findings from this study offer insights that can help shape organisational health policies aimed at reducing STS, preserving nurses' work ability, enhancing job satisfaction and mitigating turnover intentions within and outside the nursing profession.

    Reporting Method

    This study followed the STROBE checklist guidelines for cross-sectional studies.

    Patient or Public Contribution

    No Patient or Public Contribution.

    Impact of Indias publicly funded health insurance scheme on financial risk protection: a case-control study from Haryana state in India

    Por: Kumar · A. P. · Yerram · A. · Chugh · Y. · Rana · S. · Mudgal · D. · Prinja · S. · V R · M.
    Objective

    This paper examines the impact of India’s National Publicly Funded Health Assurance Scheme, Ayushman Bharat Pradhan Mantri Jan Aarogya Yojana (PM-JAY), in Haryana on out-of-pocket (OOP) expenses and catastrophic health expenditure (CHE).

    Design

    We conducted a case-control study using a stratified random sampling approach.

    Settings

    Six districts in Haryana, based on utilisation, were selected: Mewat, Faridabad, Sonipat, Ambala, Kurukshetra and Karnal.

    Participants

    A total sample size of 772 individuals, that is, 386 PM-JAY beneficiaries (cases) and non-beneficiaries (controls) each.

    Intervention

    Data were collected using a semistructured questionnaire covering household demographics and expenditure details. The interview gathered information on hospitalisation within the past year, types of ailments, the type of empanelled facility visited, expenditure details and borrowing/selling of assets for treatment.

    Primary and secondary outcomes

    Mean OOP expenditure was calculated for beneficiaries and non-beneficiaries based on the type of healthcare provider. The impact of PM-JAY on OOP expenditure was analysed using a generalised linear model controlling for religion, caste, type of house, type of family, morbidity patterns, type of disease, type of health facility, hospital stay duration, average distance to the facility and travel time. CHE was defined as OOP payments ≥30% of household income. Logistic regression was used to assess the determinants of CHE.

    Results

    We found that direct medical expenses incurred for hospitalisations were 65% lower for beneficiaries (11 131 rupees) compared with non-beneficiaries (31 675 rupees). While OOP expenditures are similar for both groups in public empanelled hospitals, non-beneficiaries incur OOP costs three times higher than PM-JAY beneficiaries in private empanelled hospitals. Factors, including the disease type, average distance from home to the facility, average travel time and type of hospital, significantly influence these expenses. Furthermore, the prevalence of CHE is significantly lower among PM-JAY beneficiaries (13.3%) compared with non-beneficiaries (45.9%), with an OR of 7.15 (95% CI: 4.74 to 10.80; p

    Conclusions

    Our analysis shows the scheme’s impact on decreasing OOP expenditure and CHE. To enhance the scheme’s effectiveness, the study highlights the necessity of addressing non-medical expenses and expanding coverage for indirect costs, such as food, accommodation and transportation. Additionally, strengthening the supply side through improved drug availability at healthcare facilities is crucial for enhancing financial protection and access to care.

    Evaluating a population-based screening programme for early detection of liver fibrosis and cirrhosis in primary care in Germany: a cost assessment study

    Por: Ortner · J. · Van Ewijk · R. · Velthuis · L. · Labenz · C. · Arslanow · A. · Nguyen-Tat · M. · Wörns · M.-A. · Reichert · M. C. · Farin-Glattacker · E. · Binder · H. · Fichtner · U. A. · Graf · E. · Stelzer · D. · Galle · P. R. · Lammert · F.
    Objectives

    Structured Early detection of Asymptomatic Liver fibrosis and cirrhosis (SEAL) is a population-based screening programme using non-invasive tests for the early detection of liver fibrosis. This study evaluates the cost implications if the SEAL programme were to be implemented in routine care in Germany.

    Design

    This study models cost differences with and without the SEAL screening programme. We regress costs of care on patient characteristics (age, comorbidities, sex, liver diseases, liver cancer and liver fibrosis and cirrhosis (LCI) stage) using statutory health insurance (SHI) data from routine care patients with LCI (n=4177). Based on these results, we predict per-patient costs for the patients newly diagnosed with LCI by SEAL (n=45). Costs with and without screening are estimated using patient age and LCI stage distributions from either SEAL or routine care.

    Setting

    SEAL was conducted in two German states. Initial screening was performed by patients’ primary care physicians.

    Participants

    Individuals insured by SHI without a prior diagnosis of LCI, eligible for Check-up 35, a general health check-up programme primarily targeting adults aged 35 and older, conducted by primary care physicians.

    Interventions

    Screening via aspartate aminotransferase to platelet ratio index in primary care, for further evaluation serological diagnostics and ultrasound examinations in secondary care and specific assessment for definite diagnosis including transient elastography and liver biopsy for selected cases in tertiary care.

    Primary and secondary outcome measures

    Primary outcome measures: expected 5-year cost changes for SEAL patients diagnosed with fibrosis or cirrhosis compared to costs without a screening programme. Secondary outcome measures: case mix of leading chronic liver disease and LCI stages among patients diagnosed with advanced fibrosis or cirrhosis in SEAL versus routine care without screening.

    Results

    Screening leads to fewer decompensated cases at initial diagnosis (4.6% in SEAL vs 22.8% in routine care) and thus savings in the costs of care within the first years of diagnosis: total expected costs per case were 2175 lower (bias-corrected bootstrap CIs (BCI): 527 to 3734), and LCI-associated costs were reduced by 1218 (BCI: 296 to 2164). Comparing the savings to the additional costs of diagnosis (range: 1575–1726 per detected LCI case) reveals that average changes in costs with screening range from moderate savings to moderate extra costs.

    Conclusions

    SEAL liver screening identifies patients in less advanced stages of LCI. If only costs were considered that are directly attributable to LCI, savings within 5 years are unlikely to fully outweigh the costs of screening. However, since this approach might miss additional LCI-related costs, SEAL appears to be cost-neutral compared with routine care when considering total healthcare costs.

    Registration number

    The SEAL registration number is DRKS00013460. This study relates to its results.

    Evaluating the health and well-being effects of increasing biodiversity within multiple small parks in Edinburgh, UK: a protocol for a mixed-methods, longitudinal, pre-post natural experiment

    Por: Malden · S. · McDougall · C. W. · Ward Thompson · C. · Wendelboe-Nelson · C. · Ross-Perez · A. · Clemens · T. · Mason · S. · Villegas-Diaz · R. · Hoadley · A. · Hunter · A. · Jepson · R. · Williams · A. J.
    Introduction

    Recent legislation in the UK regarding requirements for new developments to increase biodiversity may have significant implications for the environment and population health. Despite this, relatively little is known regarding the health and social benefits of increasing biodiversity in densely populated urban areas.

    Methods and analysis

    This protocol outlines plans for a mixed-method, longitudinal, natural experiment study which will evaluate the planned, biodiversity-focused redevelopment of six small urban parks in Edinburgh, Scotland (UK). Using systematic observation (at baseline, 1 month post-intervention and 1 year post-baseline) and a longitudinal household survey (at baseline and 1 year post-baseline), the primary outcomes of personal well-being, and secondary outcomes of nature connectedness and park usage behaviours, will be assessed, respectively. Consent for data linkage of respondent’s health records will also be sought. Process evaluation will employ semi-structured, qualitative interviews with stakeholders and walk-along interviews with local residents in order to understand implementation processes. Space-related well-being will also be assessed using citizen science approaches.

    Ethics and dissemination

    This study was approved by the University of Edinburgh’s School of Health in Social Sciences ethics committee. This study will provide further evidence for policymakers, the public and researchers of the health and social well-being effects of urban biodiversity interventions. Study findings will be disseminated via public forums such as community workshops and through publication in peer-reviewed journals and presentation at scientific conferences.

    Picture perfect: study protocol for assessing the accuracy, feasibility and acceptability of intraoral photographs captured by parents for remote dental screening in children - an observational mixed-methods study

    Por: Al-Yaseen · W. · Haghi Ashtiani · G. · Pattinson · R. · Pritchard · M. F. · Pickles · T. · Galloway · J. · Innes · N.
    Background

    Children with limited access to dental care can be negatively impacted by reduced frequency of oral health monitoring, delays in diagnosis of dental disease and increased waits for dental care, resulting in them experiencing more disease (extent and amount). Smartphone-based intraoral photography has been cited as having the potential to improve oral health monitoring for children through screening; however, it has not been well evaluated, and its limitations are unclear. The picture-perfect study aims to assess diagnostic accuracy, feasibility and acceptability to determine whether remote photographic monitoring can be effectively integrated into pathways of dental care for children aged 6-16 years.

    Methods

    Observational, cross-sectional, mixed-methods study with three workflows: Workflow 1: development of user-friendly, comprehensive guidance to help parent/carers (parents) take high-quality intraoral photographs of their children’s mouths. The guidance will be codesigned with parents and healthcare professionals. Workflow 2: diagnostic accuracy using intraoral photographs taken by a parent of their children will be evaluated by comparing clinicians' diagnoses from the photographs to gold-standard clinical visual-tactile examinations. Parent–child dyads (n=110) will be recruited to capture intraoral photographs using positioning aids, guidance and smartphones provided by the research team. The diagnoses will focus on plaque accumulation, gingival health, restoration status and dental caries. Diagnostic accuracy will be assessed using sensitivity, specificity, positive predictive value, negative predictive value and area under the curve. Workflow 3: assessment of feasibility and acceptability will be through task completion rates, photograph quality and participant feedback. Qualitative interviews and an online survey will capture parents’ and children’s experiences. Observational data will provide insights into practical challenges.

    Ethics and dissemination

    This study, approved by the National Health Service (NHS) Research Ethics Committee (Integrated Research Application System [IRAS]: 24/EE0137), will be conducted in adherence to the Declaration of Helsinki and Good Clinical Practice (GCP) guidelines. Written informed consent will be obtained from all participating parents, with age-appropriate assent from children prior to enrolment. Participants have the right to withdraw at any time without explanation, and their data will be anonymised to ensure privacy and confidentiality. Study findings will be disseminated through peer-reviewed journals, conference presentations and reports to relevant stakeholders.

    Trial registration

    The study protocol has been registered on the Open Science Framework: https://doi.org/10.17605/OSF.IO/WX29D.

    Protocol for a systematic review and meta-analysis on utilisation of palliative care service and predictors among adult cancer patients in Ethiopia

    Por: Demeke · A. D. · Yeshiwas · A. · Gebrie · H. · Ayehu Akele · M. · Gashaw · A. · Dessie Gesssess · A. · Melkie · T. T. · Bogale · N. · Eba · W. W.
    Introduction

    Palliative cancer care is comprehensive, specialised medical care of patients that aims to alleviate physical, mental and emotional distress based on patients’ needs rather than on prognosis. In Ethiopia, the federal ministry of health started palliative care (PC) in 2016. Since then, services have been developed and integrated as important components of the Health Sector Transformation Plan II. However, there is a scarcity of nationally summarised data regarding PC service utilisation in Ethiopia. Therefore, this protocol describes a planned systematic review and meta-analysis that will evaluate utilisation of PC services and its predictors among adult cancer patients in Ethiopia.

    Methods and materials

    The online databases of PubMed, Hinari, EMBASE, CINHAL, Science Direct, Scopus and Google Scholar will be comprehensively searched from inception to 31 February 2025. To assess the quality of included studies, the Joanna Briggs Institute critical appraisal tools will be used. The statistical software STATA V.17 will be used for data analyses. To examine the heterogeneity between studies, inverse variance (I2) will be used. To calculate the pooled prevalence of PC service utilisation, a fixed or random effects meta-analyses model will be used with a 95% CI, depending on the presence or absence of heterogeneity between included studies. To look for publication bias, a visual inspection of the funnel plot and Egger and Begg’s regression test and a 5% level of significance will be used.

    Ethics and dissemination

    Ethical approval is not applicable. The results will be disseminated to academic beneficiaries and the public.

    Developing an Intervention to Improve Sexual Health Assessment and Care in Men With Inflammatory Bowel Disease

    ABSTRACT

    Aim

    To co-produce a prototype intervention to help nurses improve the assessment and care of the sexual health needs of men with inflammatory bowel disease.

    Background

    Inflammatory bowel disease can have a significant impact on the sexual health and well-being of men, but has largely been neglected in research and clinical guidelines. Men with the disease report that sexual health is not discussed during consultations, while healthcare practitioners describe a lack of confidence to initiate sexual health assessments. At present, no evidence-based tool exists to support nurses in detecting, assessing, and providing care for the sexual health of men with the disease.

    Design

    A mixed-methods study shaped by phase 1 of the Medical Research Council's framework for the development of complex interventions.

    Methods

    (1) Cross-sectional surveys of (i) men with inflammatory bowel disease, (ii) nurses, and (iii) inflammatory bowel disease services to determine the current state of sexual health provision across the UK National Health Service. (2) Semi-structured interviews with men and the partners of men with IBD and asynchronous focus groups with health professionals to explore appropriate and acceptable ways to provide sexual healthcare. (3) Three consecutive co-production workshops inclusive of men with the disease, healthcare professionals, and stakeholders to formulate a prototype intervention.

    Implications for the Profession and/or Patient Care

    This study will create an evidence-based prototype intervention that will provide nurses with the knowledge and skills required to effectively assess the sexual health needs of men with inflammatory bowel disease and provide appropriate, patient-centred care.

    Patient Contribution

    The study design was supported by a patient group. The study delivery will be supported by a patient co-investigator and stakeholder group inclusive of men with lived experience of the disease.

    Reporting Method

    This report adheres to the SPIRIT 2013 checklist for standard protocol items for clinical trials.

    Trial Registration

    clinicaltrials.gov ID: NCT06562751

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