Application of distributional cost-effectiveness analysis methodology in real-world studies: a scoping review protocol

Introduction
Healthcare systems face the challenge of managing limited resources while addressing the growing demand for care and the need for equitable access. Traditional cost-effectiveness analyses focus on maximising health benefits but often fail to account for how these benefits are distributed across various populations, potentially increasing health inequities. As a result, there is increasing interest in distributional cost-effectiveness analysis (DCEA), which incorporates equity considerations by explicitly assessing how health outcomes and costs are shared among diverse populations. This scoping review explores the practical application of DCEA methodology in evaluating programs and interventions. We seek to learn more about the barriers to DCEA’s application, highlighting its practical challenges, limited use globally and the steps necessary to integrate equity more effectively into implementing and adopting programs and interventions into healthcare policy and resource allocation.

Methods and analysis
To evaluate the use of DCEA in the literature, a scoping review will follow Preferred Reporting Items for Systematic Reviews and Meta-Analyses—Scoping Review Extension guidelines. Systematic searches will be performed across scientific databases (MEDLINE, SCOPUS, BASE, APA Psych and JSTOR), grey literature sources (Google Custom Search Engine), and handsearching to identify eligible articles published from January 2015 to March 2025. No limits will be placed on language. Reviewers will independently chart data from eligible studies using standardised data abstraction. The collected information will be synthesised both quantitatively and narratively.

Ethics and dissemination
Formal ethical approval is not necessary as this study will not collect primary data. The findings will be shared with professional networks, published in conference proceedings and submitted for peer-reviewed publication.

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Scoping review protocol of the use of eye movement desensitisation and reprocessing in the treatment of birth trauma

Introduction
A traumatic childbirth can have severe negative effects on the mental health of the mother and can negatively impact the child and partner. Eye movement desensitisation and reprocessing (EMDR) is a psychological intervention used to treat symptoms of trauma. The National Institute for Health and Care Excellence guidelines for antenatal and postnatal mental health recommend that trauma-focused cognitive behavioural therapy or EMDR should be offered to women who suffer from post-traumatic stress disorder resulting from a traumatic birth. However, the use of EMDR for birth trauma has not been clearly outlined in the literature.

Objectives
The aim of this scoping review is to explore the extent of the currently available research and to identify knowledge gaps in the use of EMDR for treating birth trauma.

Methods and analysis
The Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews guidelines will be followed to provide a comprehensive scoping review of the use of EMDR for birth trauma. Several databases will be searched, such as PsychInfo, Pubmed, the Cochrane Library, Embase, Scopus and CINAHL, from the date the database was developed, until approximately August 2026. The grey literature sources will also be searched, and searches will be limited to include studies written in the English language. Two researchers will independently screen and extract data from both quantitative and qualitative studies, which meet the inclusion criteria. Data will be analysed in a descriptive and thematic manner. Data extraction may include study characteristics, data collection procedures, outcomes and results. Findings will be presented in tabular and narrative formats.

Ethics and dissemination
Ethical Approval is not necessary for this review, as only secondary data will be used. It is expected that the review will be disseminated at psychological conferences and in relevant journal articles.

Trial registration number
This scoping review protocol has been registered on Open Science Framework. The registration DOI is: https://doi.org/10.17605/OSF.IO/UJZ52.

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Scoping review protocol of the use of eye movement desensitisation and reprocessing in the treatment of birth trauma

Introduction
A traumatic childbirth can have severe negative effects on the mental health of the mother and can negatively impact the child and partner. Eye movement desensitisation and reprocessing (EMDR) is a psychological intervention used to treat symptoms of trauma. The National Institute for Health and Care Excellence guidelines for antenatal and postnatal mental health recommend that trauma-focused cognitive behavioural therapy or EMDR should be offered to women who suffer from post-traumatic stress disorder resulting from a traumatic birth. However, the use of EMDR for birth trauma has not been clearly outlined in the literature.

Objectives
The aim of this scoping review is to explore the extent of the currently available research and to identify knowledge gaps in the use of EMDR for treating birth trauma.

Methods and analysis
The Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews guidelines will be followed to provide a comprehensive scoping review of the use of EMDR for birth trauma. Several databases will be searched, such as PsychInfo, Pubmed, the Cochrane Library, Embase, Scopus and CINAHL, from the date the database was developed, until approximately August 2026. The grey literature sources will also be searched, and searches will be limited to include studies written in the English language. Two researchers will independently screen and extract data from both quantitative and qualitative studies, which meet the inclusion criteria. Data will be analysed in a descriptive and thematic manner. Data extraction may include study characteristics, data collection procedures, outcomes and results. Findings will be presented in tabular and narrative formats.

Ethics and dissemination
Ethical Approval is not necessary for this review, as only secondary data will be used. It is expected that the review will be disseminated at psychological conferences and in relevant journal articles.

Trial registration number
This scoping review protocol has been registered on Open Science Framework. The registration DOI is: https://doi.org/10.17605/OSF.IO/UJZ52.

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The Positive Pharmacy Care Law revisited: an area-level analysis of the relationship between community pharmacy distribution, urbanicity and deprivation in England

Objectives
(1) Determine geographical access to community pharmacy in England, (2) explore the relationship between community pharmacy access and urbanity and multiple deprivation and (3) understand any changes in access over time.

Design
An area-level spatial analysis study exploring the relationship between spatial access to and availability of community pharmacies over the past 10 years from 2014 to 2023, deprivation and urbanicity, using Geographic Information System and descriptive statistics on a Middle layer Super Output Area level.

Primary outcome measure
Availability per 10 000 people of a community pharmacy in their local area.

Results
For geographical access, in 2014, 91.3% of people lived within a 20-minute walk to a community pharmacy and, in 2023, this number increased to 91.7%. There was a positive relationship between geographical community pharmacy access and urbanity and geographical community pharmacy access and deprivation. For availability, the median number of community pharmacies per 10 000 people in 2014 was 1.60, while in 2023, the number reduced to 1.51 community pharmacies per 10 000 people. The most deprived areas were more likely to lose a pharmacy, compared with the least deprived areas (OR 1.65 (1.38, 1.98)).

Conclusions
There is high access to community pharmacies in England with access to a community pharmacy greatest in the most deprived areas, showing that the ‘positive pharmacy care law’ remains. However, the ‘positive pharmacy care law’ is eroding as the availability of community pharmacies has reduced over time—particularly in deprived areas, with more people reliant on each community pharmacy.

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Effects of early factor XIII replacement in postpartum hae morrhage: study protocol for a multicentre, open-label, randomised, controlled, investigator-initiated trial

Introduction
The primary objective of this trial is to evaluate the effect of replenishing coagulation factor XIII (FXIII) in women with postpartum haemorrhage (PPH) on measured blood loss (MBL). Based on earlier research, we hypothesise that the administration of FXIII leads to a significant reduction in postpartum blood loss.

Methods and analysis
This is a randomised, controlled trial that will allocate eligible patients in the event of a PPH and after receiving tranexamic acid either to the treatment group, receiving FXIII, or to the control group (standard of care). The primary endpoint is the MBL within 24 hours using a standardised method. For the primary analysis, estimation of the OR under a proportional odds assumption is conducted simultaneously for all possible cut-off points. A corresponding estimate, along with a two-sided 95% CI and two-sided p value against the null hypothesis OR=1, is obtained from the Continuous Outcome Logistic Regression model. More than 7000 patients will be screened in order to include a total of 988 eligible patients into the trial. Secondary outcomes include the rate of adverse maternal outcomes related to PPH, the rate of women breastfeeding after PPH and the safety of the administration of FXIII in women with PPH. Dynamics of blood coagulation factors in women with PPH and their association with MBL will be assessed in specific centres. A preliminary overview on costs and potential savings through early treatment of PPH with FXIII is included in the analysis as well as a patient and public involvement report, asking for patients’ personal experience during PPH in the main study centre.

Ethics and dissemination
Ethics approval was granted by the central ethics committee (Kantonale Ethikkommission Zürich/Switzerland) on 16 June 2024, reference number: BASEC 2024-00374. Results will be disseminated via open-access publication in a relevant medical journal.

Trial registration number
ClinicalTrials.gov ID NCT06481995.

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At-home Breast Oncology care Delivered with EHealth solutions (ABODE) study protocol: a randomised controlled trial

Introduction
The COVID-19 pandemic disrupted healthcare delivery for patients with breast cancer. eHealth solutions enable remote care and may improve patient activation, which is defined as having the knowledge, skills and confidence to manage one’s health. Thus, we developed the Breast Cancer Treatment Application (app) for patients and practitioners to use throughout the cancer care continuum. The app facilitates virtual assistance, delivers educational resources, collects patient-reported outcome measures and provides individualised support via volunteer e-coaches. Among newly diagnosed patients with breast cancer, we will compare changes in patient activation, other patient-reported outcomes and health service outcomes over 1 year between those using the app and Fitbit, and those receiving standard care and Fitbit only.

Methods and analysis
This randomised controlled trial will include 200 patients with breast cancer seen at a tertiary care cancer centre in Ontario, Canada. The intervention group (n=100) will use the app in addition to standard care and Fitbit for 13 months following diagnosis. The control group (n=100) will receive standard care and Fitbit only. Patients will complete questionnaires at enrolment, 6 and 12 months post-diagnosis to measure patient activation (Patient Activation Measure-13 score), distress, anxiety, quality of life and experiences with their care and information received. All patients will also receive Fitbits to measure activity and heart rate. We will also measure wait times and number of visits to ambulatory care services to understand the impact of the app on the use of in-person services.

Ethics and dissemination
Ethics approval was obtained on 6 January 2023. Protocol version 2.0 was approved on 6 January 2023. The trial is registered with ClinicalTrials.gov. Study findings will be disseminated via publication in a peer-reviewed journal and shared with participants, patient programmes and cancer awareness groups. The app has also been approved as a secure communication method at our trial institution, thus we are well-positioned to support future integration of the app into standard care through collaboration with our hospital network.

Trial registration number
NCT05989477.

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Patient-facing online triage tools and clinician decision-making: a systematic review

Objective
To evaluate the role of using outputs from patient-facing online triage tools in clinical decision-making in primary care.

Design
Systematic review.

Data sources
Medline, Embase, Cumulative Index to Nursing and Allied Health Literature, Web of Science and Scopus were searched for literature published between 1 January 2002 and 31 December 2022 and updated for literature published up to end of November 2024.

Eligibility criteria for selecting studies
Studies of any design are included where the study investigates how primary care clinicians make clinical decisions in response to patient concerns reported using online triage tools.

Data extraction and synthesis
Data were extracted, and quality assessment was conducted using the Mixed Methods Appraisal Tool. Narrative synthesis was used to analyse the findings.

Results
14 studies were included, which were conducted in the UK (n=9), Sweden (n=3) and Spain (n=2). There were no studies that examined clinical decision-making as an outcome. Outcomes relating to the impact on clinical decision-making were grouped into three categories: patient clinical outcomes (n=9), primary care practitioner experience (n=11) and healthcare system outcomes (n=14). Studies reported faster clinical decisions made in response to patient concerns. Other studies reported clinicians offering unnecessary urgent appointments as patients learnt to ‘game’ the system. Clinicians felt confident managing patient requests as they can access additional information (such as a photo attachment). Moreover, clinicians’ time was freed up from appointments with limited clinical value. Contrarily, online triage was perceived as an additional step in the workflow.

Conclusion
Clinicians should be aware that their decision-making processes are likely to differ when using online triage tools. Developers can use the findings to improve the usability of the tools to aid clinical decision-making. Future research should focus on patient-facing online triage tools in general practice and the process of clinical decision-making.

PROSPERO registration number
CRD42022373944.

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Survival status and predictors of mortality among patients with breast cancer in Ethiopia: a systematic review and meta-analysis

Objectives
This study aimed to evaluate survival outcomes and identify key mortality predictors among patients with breast cancer in Ethiopia.

Study design
A systematic review and meta-analysis.

Study participants
The study used 11 primary studies, involving a total of 4131 participants.

Data sources
We searched PubMed, Embase, Web of Science, Scopus and Google Scholar until 7 March 2025, following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines.

Eligibility criteria for selecting studies
All observational studies that had reported the survival status and/or at least one predictor of mortality of women patients with breast cancer were considered.

Data extraction and synthesis
Three independent reviewers (HA, HKN and DGA) used a structured data extraction form to extract the data. To compute the pooled survival and mortality rates, the survival rates at different observation periods and the mortality rates reported in the included studies were extracted.

Results
Eleven studies were analysed. All studies were of good quality based on Newcastle-Ottawa Scale. However, heterogeneity was high (I² = 98.2%, p=0.00). Funnel plots showed significant publication bias. The Grading of Recommendations, Assessment, Development, and Evaluations assessment indicated moderate certainty for mortality rates and predictors, limited by heterogeneity and regional data gaps. The pooled mortality rate was 36% (95% CI: 25% to 46%). The survival rates at 1, 3 and 5 years were 85% (95% CI: 75% to 96%), 66% (95% CI: 48% to 84%) and 22% (95% CI: 1% to 43%), respectively. Key mortality predictors included advanced clinical stage (Adjusted Hazard Ratio (AHR): 4.14; CI: 2.53 to 6.78), rural residence (AHR: 1.65; 95% CI: 1.27 to 2.14), positive lymph node status (AHR: 2.85; 95% CI: 1.50 to 5.44), no hormonal therapy (AHR: 2.02; 95% CI: 1.59 to 2.56), histologic grade III (AHR: 1.76; 95% CI: 1.29 to 2.41), hormone receptor negativity (AHR: 1.54; 95% CI: 1.05 to 2.25) and comorbidities (AHR: 2.24; 95% CI: 1.41 to 3.56).

Conclusion
Breast cancer in Ethiopia poses a high mortality rate primarily due to late-stage diagnosis, rural residency, histologic grade III, positive lymph node status and comorbidities. To improve survival outcomes, it is crucial to expand access to early screening, particularly in rural areas, implement comprehensive treatment protocols and strengthen healthcare infrastructure to address these critical factors.

PROSPERO registration number
CRD42024575074.

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Sex-based outcomes of mitral surgery for ischaemic mitral regurgitation: protocol for a systematic review and meta-analysis

Introduction
Patients with ischaemic mitral regurgitation (MR) have markedly increased cardiovascular mortality compared with those with primary MR. The sex-based prognosis of patients with ischaemic MR undergoing mitral surgery remains unclear. The goal of this systematic review is to evaluate long-term mortality, reoperation, heart failure rehospitalisation and MR recurrence in women who undergo mitral valve surgery for chronic ischaemic MR, compared with men.

Methods and analysis
The MEDLINE, EMBASE, Scopus and Cochrane Central Register of Controlled Trials databases will be searched for studies reporting surgical outcomes for ischaemic MR. Studies published before 10 June 2024 and those stratifying outcomes by sex will be included. The primary outcome of this systematic review is long-term (≥1 year) mortality following mitral surgery. Secondary outcomes include operative mortality, mitral valve reintervention, heart failure rehospitalisation and MR recurrence, as assessed by echocardiography.
Risk of bias will be ascertained with the Newcastle–Ottawa scale. Heterogeneity will be assessed using Higgin’s I2 statistic. If the included studies demonstrate adequate homogeneity in their design and comparator, meta-analyses with a random-effects model will be conducted to combine estimates.

Ethics and dissemination
This systematic review uses data from previously published studies and does not involve interaction with human subjects or access to individual patient data. Therefore, ethical approval is not required for this study. The findings from this review will be disseminated through publication in a peer-reviewed journal and various media, including but not limited to, conferences, congresses and symposia.

Trial registration number
In accordance with the guidelines, our systematic review protocol was registered with the International Prospective Register of Systematic Reviews on 5 July 2024 and was last updated on 4 April 2025 (Registration number: CRD42024560892).

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[Articles] Identification and validation of clinical phenotypes in Staphylococcus aureus blood stream infection and their association with mortality (FEN-AUREUS cohort-based study)

Patients with SAB can be classified into phenotypes and sub-phenotypes, each exhibiting considerable variations in mortality rates. To facilitate clinical application, a validated open-access algorithm and calculator for phenotype and sub-phenotype assignment have been developed, enabling their use at the time of SAB confirmation. This tool aims to support timely and personalised patient care.

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PROtective ileoStomy versus ProtectivE colostomy in anterior Rectal resectIon: study protocol for a multicenter, open-label, randomised conTrolled studY (PROSPERITY)

Introduction
Loop ileostomy and loop colostomy are both used to form a protective stoma after anterior resection. Evidence regarding which of these two procedures is superior is lacking. Furthermore, no studies comparing changes in the microbiome after loop ileostomy or loop colostomy exist.

Methods and analysis
This multicentre, open-label, superiority, individually randomised controlled trial will include patients who undergo anterior rectal resection with primary anastomosis with a protective stoma. The exclusion criteria are patients who already have a stoma, technical inability to create either type of stoma, aged

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Dydrogesterone for preventing endometrial polyp recurrence after transcervical resection of polyps: protocol for a multicentre randomised controlled trial in China

Introduction
To assess the effects of oral dydrogesterone on the recurrence rate of endometrial polyps (EPs) and abnormal uterine bleeding (AUB) symptoms after transcervical resection of polyps (TCRP).

Methods and analysis
A randomised, parallel, open-label, multicentre study will be conducted across 12 hospitals in China, including general and women’s specialty hospitals. In this study, we will recruit female patients aged 18–46 years diagnosed with EPs using transvaginal ultrasonography during two menstrual cycles. Eligible participants who have not received other oestrogen or progesterone treatments will be randomly assigned in a 1:1 ratio to either an intervention or control group. All participants will undergo TCRP, with the time between randomisation and surgery not exceeding 14 days. The intervention group will receive oral dydrogesterone for three menstrual cycles, whereas the control group will receive no hormonal treatment. The primary outcome is the recurrence rate of EPs, which will be evaluated using follow-up transvaginal ultrasonography at 1, 3, 6, 12, 18 and 24 months postsurgery. Secondary outcomes include assessment of AUB and menstrual status. For statistical analyses, a multivariate regression will be used to adjust for confounding factors.

Ethics and dissemination
This study protocol adheres to the Declaration of Helsinki and has been approved by the Women’s Hospital, School of Medicine, Zhejiang University (IRB-20240077-R). All participants in the trial will provide written informed consent. The study findings will be published in peer-reviewed journals and presented at academic conferences.

Trial registration number
ChiCTR2400083097.

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Hidden gender-based violence and its causes among women in Okugu Refugee Camp, Ethiopia: a cross-sectional study

Background
Gender-based violence (GBV) is a pervasive global issue that transcends cultural, economic and educational boundaries, with an exceptionally high prevalence among refugees. Despite extensive research on GBV in Ethiopia, evidence of its occurrence in refugee settings remains limited.

Objective
To examine the prevalence and contributing factors of GBV among reproductive-age women in the Okugu Refugee Camp, Gambella, Ethiopia.

Study design
A facility-based cross-sectional study.

Participants
This study analysed 416 reproductive-age women living in Okugu Refugee Camp.

Setting
The study was conducted in the Okugu Refugee Camp from 15 March to 30 May 2023.

Primary and secondary outcome measures
The study’s primary outcome was gender-based violence, while the secondary outcome focused on the factors influencing it.

Result
A total of 422 reproductive-age women participated in the study, with a response rate of 98.6%. The prevalence of gender-based violence was 64.4% (95% CI: 59% to 69%). Among the participants, 51.9% experienced physical violence, while 34.9% had a history of sexual violence. Factors, illiterate women (AOR=2.73, 95% CI: 1.509 to 4.942), those who had lived in the camp for more than 4 years (AOR=3.24, 95% CI: 1.964 to 5.372), women who did not discuss sexual intercourse with their family or intimate partner (AOR=4.7, 95% CI: 2.83 to 7.80) and women who consumed alcohol (AOR=2.19, 95% CI: 1.30 to 3.69) were at significantly higher risk of experiencing gender-based violence.

Conclusion
Gender-based violence in the study area was highly prevalent. Key determinants included illiteracy, alcohol consumption, lack of discussion and prolonged stay in the camp. Stakeholders should prioritise interventions such as promoting female education, fostering open discussions and addressing substance use to mitigate gender-based violence in the refugee camp.

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Lived experiences of patients using positive airway pressure (PAP) therapy: a nested phenomenological study within the 3DPiPPIn randomised controlled trial

Background
Sleep disordered breathing is a chronic condition often requiring patient commitment to positive airway pressure (PAP) therapy. Understanding the lived experience of PAP therapy users is crucial for clinicians to support successful treatment and identify research priorities. There is a lack of evidence in this area, and published data predominantly explore the negative experiences of PAP. This study aims to explore the lived experiences of patients using PAP therapy.

Methods and analysis
This study employs a phenomenological approach, appropriate for researching human experiences where there is little existing research. Heideggerian theory underpins the research, recognising that the researcher’s beliefs influence meaning, allowing for rich analysis of the lived experience.
Participants will be recruited from a randomised controlled trial investigating the medium-term clinical impact of customised interfaces for patients requiring PAP therapy. Purposive sampling will be used to seek representation from various demographics, with a maximum of 30 participants.
Data collection will be via 1:1 semistructured interviews. Data will be analysed using Braun and Clarke’s six-phase reflexive thematic analysis. Data will be analysed inductively through an interpretivism lens. Data will be managed with computer-assisted qualitative data analysis software.

Ethics and dissemination
This protocol has been approved by the Hampshire B Research Ethics Committee (REC reference: 22/SC/0405). Results will be disseminated to healthcare professionals and patients through conferences, open-access journals, newsletters, the study webpage, infographics, animations, social media and healthcare awards. Tracy’s eight ‘big tent’ criteria for excellent qualitative research are comprehensive and encompassing, and this protocol has aimed to meet the criteria. The Consolidated Criteria for Reporting Qualitative Research has also been used. The findings of this study will contribute to a more holistic understanding of the lived experience of PAP therapy users, informing clinical practice and future research.

Trial registration number
ISRCTN74082423.

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