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.

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

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

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.

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.

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.

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).

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

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.

Japan Registry of Clinical Trials (jRCT1032230086).

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.

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.

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).

NCT06457750.

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.

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.

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.

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

A cross-sectional mixed methods online survey.

Primary care in England.

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

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.

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.

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.

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.

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.

ACTRN12623000598684p.

To evaluate the effectiveness of levosimendan in promoting weaning from veno-arterial extracorporeal membrane oxygenation (VA-ECMO) in patients with refractory cardiogenic shock through a meta-analysis of clinical trials.

Systematic review and meta-analysis.

PubMed, Embase, the Cochrane Library and Web of Science were systematically searched from inception to January 2025.

Studies were included if they were clinical trials comparing outcomes between patients receiving levosimendan and those not receiving it during VA-ECMO support. Eligible studies reported on at least one of the predefined outcomes.

Two independent reviewers extracted data and assessed study quality. The primary outcome was successful VA-ECMO weaning. Secondary outcomes included 30-day mortality, in-hospital mortality, duration of ECMO support and length of stay in the intensive care unit (ICU). A random-effects model was used to synthesise data and estimate pooled effect sizes, with heterogeneity assessed using the I² statistic.

Involving 2083 patients across 16 studies, levosimendan significantly improved VA-ECMO weaning success (OR=2.44, 95% CI: 1.72 to 3.48; p2=57%) compared with the control group. Additionally, it notably reduced 30-day mortality (OR=0.48, 95% CI: 0.29 to 0.81; p=0.006; I²=56%) and in-hospital mortality (OR=0.47, 95% CI: 0.26 to 0.88; p=0.02; I²=70%). Noteworthy, however, is the association of levosimendan with prolonged VA-ECMO support (days; n=1314; weighted mean difference (WMD): 2.86, 95% CI: 1.73 to 4.00; p2=60%) and extended ICU stay (days; n=629; WMD: 5.69, 95% CI: 2.19 to 9.20; p=0.001; I²=61%).

Levosimendan improves VA-ECMO weaning success and reduces mortality. Further high-quality randomised controlled trials (RCTs) are required to confirm its clinical benefits in VA-ECMO patients. While the findings consolidate existing evidence favouring levosimendan, they also highlight residual heterogeneity and moderate-to-high risk of bias in several included studies. Therefore, future investigations, particularly well-powered RCTs with robust methodology, may help further delineate its role in specific patient populations.

Chronic venous disease, particularly lower extremity varicose veins (VVs) and incompetent perforating veins (IPVs), is a prevalent condition associated with significant morbidity, including venous ulcers and post-surgical recurrence. Current diagnostic modalities for IPVs—such as digital subtraction angiography, CT venography, magnetic resonance venography and conventional ultrasound—are limited by ionising radiation, operator dependency or inadequate spatial resolution. Ultrasound tomography (UT), an emerging automated 3D imaging technology, offers comparable resolution, wider field of view and reduced operator bias compared with conventional ultrasound. Preliminary studies suggest UT improves IPV detection rates, yet its diagnostic accuracy and clinical utility remain unvalidated in large-scale trials. This study aims to evaluate UT’s diagnostic performance and its impact on surgical outcomes in a paired-design and randomised controlled trial (RCT), addressing a critical gap in non-invasive venous assessment.

This study combines a paired diagnostic trial and a prospective, triple-blind RCT. In the paired trial (n=84), patients with VVs (Clinical-Etiological-Anatomical-Pathophysiological C2–C5) receive both conventional ultrasound and UT combined with Doppler examination to compare IPV detection sensitivity against surgical findings. The RCT (n=264) randomises patients to conventional ultrasound group (control group) or conventional ultrasound＋UT group (intervention group). After examination, all patients undergo standardised treatment (radiofrequency ablation with sclerotherapy and selective IPV ligation), with follow-up extending to 5 years. The primary endpoint is 1-year recurrence rates and secondary endpoints, including 3-month, 3-year and 5-year recurrence rates, as well as Venous Clinical Severity Scores, quality of life and Aberdeen Varicose Vein Questionnaire scores.

The study has been approved by the Ethics Committee of Shanghai Sixth People’s Hospital (approval number: 2024-132). Written informed consent will be obtained from each participant, and final results will be published in peer-reviewed journals.

The study has been registered on Chinese Clinical Trial Registry (http://www.chictr.org.cn), identifier: ChiCTR2500097289.

The incidence of acute pain subsequent to modified radical mastectomy (MRM) for breast cancer approximates 40%, with more than half of these cases evolving into chronic pain. Currently, the commonly employed analgesic schemes in clinical practice still have inadequacies. Liposomal bupivacaine (LB) is bupivacaine encapsulated in liposomes, and it is reported that its duration of action can extend up to 72 hours. This study will investigate the analgesic efficacy of LB in combination with bupivacaine hydrochloride (BHCl) for transversus thoracic muscle plane (TTP) block and pectoral nerves (PECS) block after MRM for breast cancer.

In this prospective, randomised, controlled trial, we will enrol 80 female patients aged 30 to 65 years who are scheduled to undergo MRM under general anaesthesia in combination with nerve block. They will be randomly assigned in a 1:1 ratio to the LB+BHCl group (Group A) and the BHCl group (Group B). All patients will undergo ultrasound-guided TTP+PECS block prior to surgery. The primary outcomes are the cumulative pain visual analogue scale (VAS) scores from 6 to 72 hours post-surgery and the quality of recovery, assessed using the QoR-40 score at 72 hours post-surgery. The secondary outcomes include the time to first analgesic rescue, the consumption of analgesic drugs within 72 hours postoperatively, the occurrence of adverse events and the VAS scores at 6 and 12 months postoperatively.

Ethical approval was obtained from the Ethics Committee of the Affiliated Hospital of Yangzhou University (2024 Ke Lun Shen (2024-07-01)). All patients will provide written informed consent. The results of this study will be published in a peer-reviewed journal.

Chinese Clinical Trial Registry (ChiCTR2400089933).

Post-chronic pancreatitis (CP) diabetes mellitus (PPDM-C) is a distinct form of diabetes, in which complex pathogenesis hampers adequate glycaemic control. This study aimed to identify risk factors for poor glycaemic status in PPDM-C to guide clinical management.

Cross-sectional study.

Shanghai, China.

Between January 2018 and March 2023, 1677 patients with CP were enrolled in the CP database of the National Clinical Research Center. After application of strict exclusion criteria, 302 patients diagnosed with PPDM-C were included in the study.

The primary outcome was glycaemic control. The secondary outcomes were factors that affect glycaemic control among patients with PPDM-C.

This retrospective study was conducted in patients with PPDM-C. Poor glycaemic status was defined as a glycated haemoglobin A1c level of >7% at admission. Patients were stratified into those with and without diabetes treatment. Multivariate logistic regression was performed to identify risk factors. The area under the curve (AUC) analysis was used to evaluate the predictive efficacy of these risk factors.

A total of 302 patients with PPDM-C were analysed. Poor glycaemic status was observed in 72.6% (61/84) of patients without diabetes treatment and 52.8% (115/218) of those with diabetes treatment. For those without diabetes treatment, a history of acute pancreatitis (AP) attacks (OR: 4.838, p=0.014) and smoking (1–20 pack-years, OR: 4.418; >20 pack-years, OR: 9.989; p0.001). In patients with diabetes treatment, AP attack history (OR: 5.640, p20 pack-years, OR: 11.395; p

Patients with PPDM-C in China exhibited a high prevalence of poor glycaemic status. Smoking and a history of AP attacks were significantly associated with an increased risk of poor glycaemic control. The early identification of patients with PPDM-C at elevated risk of poor glycaemic control may facilitate timely and optimised management of glycaemia.

Hepatitis C virus (HCV) remains a leading cause of infectious disease-related morbidity in the USA, disproportionately affecting people who inject drugs and people who are incarcerated. Despite the availability of highly effective, highly tolerated direct-acting antivirals, treatment uptake in jails remains limited due to short stays, unpredictable release dates and system-level barriers. The original MINMON trial demonstrated that a low barrier ‘minimal monitoring"’ model can achieve high cure rates in community settings. This study, MINMON-J, aims to adapt and evaluate a modified version of the MINMON model for use in a jail setting, addressing the urgent need for scalable, low-barrier treatment approaches among justice-involved individuals.

MINMON-J is a single-arm, hybrid effectiveness-implementation pilot study protocol planned to recruit at the Rhode Island Department of Corrections. 40 people who are incarcerated with positive HCV RNA, who are treatment-naïve, without cirrhosis and awaiting trial, will receive 12 weeks of sofosbuvir/velpatasvir with no required lab monitoring during treatment. If released before treatment completion, participants will receive their remaining medication at discharge. Community health workers will provide post-release support. Mixed-methods evaluation will be guided by the Reach, Effectiveness, Adoption, Implementation and Maintenance/Practical, Robust Implementation and Sustainability Model framework. Primary outcomes include feasibility, acceptability and adherence. Data will be collected through administrative records, surveys (Acceptability of Intervention Measure, Feasibility of Intervention Measure, Brief Adherence Rating Scale) and qualitative interviews with participants and other relevant parties. This study was reviewed and approved by the Brown University Health Institutional Review Board (2240400) and the Rhode Island Department of Corrections Medical Research Advisory Group.

This study was reviewed and approved by the Brown University Health Institutional Review Board (2240400) and the Rhode Island Department of Corrections (RIDOC) Medical Research Advisory Group. All participants will provide written informed consent prior to enrolment. People who are incarcerated will be assured that participation is voluntary, will not impact their clinical care and that they may withdraw at any time without penalty. Study procedures follow ethical principles outlined in the Declaration of Helsinki and comply with federal regulations regarding research involving vulnerable populations.

Dissemination of findings will include peer-reviewed publications and presentations at national conferences focused on infectious diseases, implementation science and/or correctional health. Lay summaries will be shared with RIDOC leadership and community partners. De-identified data and associated metadata may be archived in a publicly accessible repository in accordance with National Institutes of Health data sharing policies, contingent on final institutional review board approval and participant protections.

NCT06953479.

Diabetic retinopathy (DR) in pregnancy can cause blindness. National guidelines recommend at least one eye examination in early pregnancy, then ideally 3-monthly, through to the postpartum for pregnant women with pregestational diabetes. Here we examined adherence rates, barriers and enablers to recommended DR screening guidelines.

Cross-sectional survey study, as part of a larger prospective cohort study.

Participants were recruited from two tertiary maternity hospitals in Melbourne, Australia.

Of the 173 pregnant women with type 1 (T1D) or type 2 diabetes (T2D) in the main cohort study, with an additional four who participated solely in this survey study, 130 (74.3%) completed the survey.

This study calculated rates of adherence to guideline-recommended DR screening schedules and collected data on the enablers and barriers to attendance using a modified Compliance with Annual Diabetic Eye Exams Survey. Each of the 5-point Likert-scale survey items was compared between adherent and non-adherent participants using the Wilcoxon rank-sum test and logistic regression models were constructed to quantify associations as ORs.

A retinal assessment was undertaken at least once during pregnancy in 86.3% of participants, but only 40.9% attended during their first trimester and only 21.2% attended the recommended number of examinations. Competing priorities were the main barriers to adherence, with eye examinations ranked as the fourth priority (IQR 4th–5th) among other health appointments during pregnancy. Meanwhile, knowledge of the benefits of eye screening examinations, eye-check reminders and support from relatives was identified as enablers.

Despite the risk of worsening DR during pregnancy, less than half of the participants adhered to recommended screening guidelines, suggesting that eye health is not a priority. Proactive measures to integrate care are needed to prevent visual loss in this growing population.

This study aims to assess the feasibility of respondent-driven sampling (RDS) to recruit participants with recent abortion experiences in humanitarian contexts, and describe the composition of the study sample generated with this sampling method.

This was a three-phase mixed-methods community-engaged research study employing an exploratory and explanatory sequential approach. We conducted in-depth interviews, focus group discussions, an interviewer-administered questionnaire on abortion experiences and a health facility assessment.

Bidibidi Refugee Settlement, Uganda and Kakuma Refugee Camp, Kenya from November 2021 to December 2022.

Using RDS, we recruited 600 participants in Kakuma and 601 participants in Bidibidi with recent abortion experiences. In Kakuma, participants were primarily from Burundi, the Democratic Republic of the Congo and South Sudan; participants in Bidibidi were primarily from South Sudan. Most participants in both sites had completed at least some primary school and were not employed.

RDS recruitment dynamics: convergence and bottlenecks on key sociodemographic variables, recruitment and population homophily, reciprocity of social ties, success and experiences recruiting.

There were minor violations of RDS assumptions, particularly regarding assumptions of reciprocity of ties and seed composition independent of sample. In addition, there was a strong tendency of participants to recruit those from the same home country and living within the same camp zone. However, sample proportions for age, home country, marital status, zone of residence and student status reached equilibrium (stabilised) by around 500 participants at each site, and we were able to quickly attain the study sample size.

While the true representativeness of our sample remains unknown, RDS is a practical and effective recruitment method in humanitarian contexts for sensitive topics, particularly for research questions in which no data or sampling frames exist. However, attention to representativeness and community engagement is essential to optimising its application and ensuring success.

Influenza is a major global health concern, responsible for up to 650 000 respiratory-related deaths annually. Although influenza is often perceived as mild in healthy adults, it can cause severe outcomes in high-risk groups, such as older adults, young children, pregnant women and those with underlying medical conditions. Various clinical, sociodemographic and environmental factors influence the progression to severe outcomes, whereas resilience factors, such as vaccination, may reduce risks. Despite growing research, the evidence base regarding risk and resilience is spread across many different aspects of the literature. This umbrella review will synthesise evidence from existing systematic reviews and meta-analyses to identify key risk and resilience factors associated with the progression of influenza to severe outcomes in the general population.

This umbrella review follows the Joanna Briggs Institute (JBI) and Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols guidelines. We will include systematic reviews and meta-analyses reporting host-related risk or resilience factors for severe influenza outcomes. Four databases (EMBASE, Scopus, Medline and CINAHL) will be searched for English-language publications. Study quality will be assessed using AMSTAR 2, and the body of evidence will be evaluated using Grading of Recommendations Assessment, Development and Evaluation. Due to heterogeneity, findings will be analysed narratively. Risk and resilience factors will be grouped into demographic, clinical, behavioural, social and psychological domains.

No ethical approval is required. The completed review will be shared through peer-reviewed journals and conference presentations.

CRD420250644475.

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.

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

Australia-wide.

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.

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.

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.

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.

The Quadrivalent human papillomavirus (HPV) Vaccine Evaluation Study with Addition of the Nonavalent Vaccine Study (QUEST-ADVANCE) aims to provide insight into the long-term immunogenicity and effectiveness of one, two and three HPV vaccine doses. Here, we describe the protocol for QUEST-ADVANCE.

QUEST-ADVANCE is an observational cohort study including males and females who are unvaccinated or vaccinated with the quadrivalent or nonavalent HPV vaccine in British Columbia, Canada. Female participants who are unvaccinated or vaccinated with 1–3 doses of the quadrivalent or nonavalent HPV vaccine at 9–14 years of age will be recruited approximately 5 or 12 years postvaccination eligibility. Male participants who are unvaccinated or vaccinated with 1 or 2 doses of the nonavalent HPV vaccine at 9–14 years of age will be recruited at approximately 5 years postvaccination eligibility. The study involves a maximum of four visits over a period of 4–5 years for female participants, and two visits over a 12-month period for male participants. At each visit, self-collected swabs (cervico-vaginal or penile) and questionnaire data will be collected. In each study group, a subset of participants will be invited to participate in a substudy evaluating the long-term humoral immunogenicity of the HPV vaccine. Additional blood samples will be collected from participants who are part of the immunogenicity substudy. The total required sample size is 7180 individuals. The primary objectives are (1) to examine vaccine effectiveness in males and females against prevalent genital HPV infections for one, two and three doses of the HPV vaccine compared with unvaccinated participants and (2) to evaluate if there is non-inferior immunogenicity as indicated by type-specific antibody response of one dose of the HPV vaccine in 20–27-year-old females vaccinated at 9–14 years of age compared with historical data of three doses of the HPV vaccine females vaccinated at 16–26 years of age up to 12 years postvaccination.

QUEST-ADVANCE was approved by the Research Ethics Board of the University of British Columbia/Children’s and Women’s Health Centre of British Columbia (H20-02111). Individual electronic informed consent or assent will be obtained from each participant before any study-specific procedures are undertaken. Results will be published in an international peer-reviewed journal and on the study website.

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.

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.

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.

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

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.

ISRCTN16126290.

Oliceridine is a novel μ-opioid receptor selective agonist that provides analgesia while reducing μ-receptor-mediated adverse effects such as postoperative nausea and vomiting (PONV). Evidence in abdominal surgery remains limited. This study aims to determine whether oliceridine reduces PONV and improves recovery in abdominal surgery.

This is a prospective, multicentre, two-arm, randomised trial. Participants aged 18–65 years, with American Society of Anesthesiologists physical status I–III and a body mass index of 18.5–23.9 kg/m², undergoing elective major abdominal surgery, will be eligible for inclusion. Gynaecological surgeries are excluded. All patients must require postoperative intravenous patient-controlled analgesia (PCIA) and give written consent. 494 participants will be randomised to oliceridine group or sufentanil group. The primary outcome is the incidence of PONV within 48 hours postsurgery. Secondary outcomes include vomiting frequency, nausea severity score, use of rescue antiemetics, resting numerical rating scale (NRS) pain score, Quality of Recovery-15 (QoR-15) score, time to first postoperative flatus, intensive care unit (ICU) length of stay (LOS), hospital LOS and PCIA metrics (effective attempts and total volume used). Safety outcomes include other opioid-related adverse effects (ORAEs) (eg, respiratory depression, pruritus, dizziness, headache), complications related to PONV (eg, electrolyte disturbances, wound dehiscence) and other perioperative complications.

This protocol was approved (Version V3.0, 2025-01-14) by the Ethics Committee of Changhai Hospital (CHEC-2025–069), the Shanghai Public Health Clinical Centre (2025-S024-01) and the Wusong Central Hospital of Baoshan District, Shanghai (2025-17-01). It complies with the Declaration of Helsinki. Results will be shared via conferences and peer-reviewed journals.

Chinese Clinical Trial Registry (ID: ChiCTR2400089262).

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.

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

101 hospitals across 27 provinces of China.

1336 patients with SLE.

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.

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

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.

Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV) entails substantial morbidity and mortality, yet no epidemiologic evidence exists on its outcomes in Mexico. This study assessed national hospitalisations (2005–2022) and mortality (2000–2022) related to AAV using data from the General Board of Health Information.

Retrospective, population-based time-trend analysis on administrative health data.

Mexico’s national hospital discharge and mortality registries, covering 1 January 2000 through 31 December 2022.

All individuals aged ≥ 15 years with a primary or secondary International Classification of Diseases, 10th revision, diagnosis of AAV recorded during hospitalisation or on death certificates nationwide.

The study’s primary outcomes were the age-standardised hospitalisation and mortality rates for AAV (expressed per 100 000 population, overall and by sex), with temporal trends in both rates quantified using Joinpoint regression to calculate annual percent change (APC) and average APC (AAPC).

We identified 2804 hospitalisations and 599 deaths. Females accounted for 49.7% of hospitalisations, while males represented 48.7% of deaths. Although the overall age-standardised hospitalisation rate (ASHR) and mortality rate (ASMR) AAPCs were not statistically significant, relevant trends emerged. From 2010 to 2022, ASHR declined significantly (APC: –5.2%; 95% CI –9.7, –0.5; p=0.03), whereas mortality rates remained stable from 2000 to 2022 (AAPC: +3%; 95% CI –4.6, 11.3; p=0.45). Nevertheless, mortality increased among males (APC: +6.4%; 95% CI 0.9, 12.2; p=0.02) and individuals over 45 years (APC: +8.6%; 95% CI 1.7, 16.0; p=0.02) from 2008 onwards.

Overall, these findings indicate no major changes in national rates but reveal a decline in hospitalisations since 2010 and a rise in mortality for specific subgroups since 2008. Targeted interventions, particularly for older adults and men, appear warranted to address this evolving disease burden. Future research should explore underlying risk factors and evaluate tailored strategies to improve clinical outcomes in AAV across Mexico.