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).

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

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

Phnom Penh, Cambodia.

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

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

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

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.

Colonoscopy is an essential procedure for the early diagnosis of colorectal conditions; however, over 60% of patients undergoing non-sedated colonoscopy report moderate to severe pain. This study aims to investigate the central analgesic mechanisms of transcutaneous electrical nerve stimulation based on wrist-ankle acupuncture theory (TENS-WAA). A multimodal approach combining electroencephalography (EEG) and functional near-infrared spectroscopy (fNIRS) will be employed to assess pain-related brain activity, with artificial intelligence applied to model the relationship between objective neurophysiological signals and subjective pain experience.

This is a single-centre, randomised, double-blind, controlled trial involving 60 patients undergoing colonoscopy without anaesthesia. Participants will be randomly allocated (1:1) to either an electrical stimulation group receiving TENS-WAA or a sham stimulation group. EEG and fNIRS data will be acquired before, during and after the procedure. The primary outcome is the analysis of EEG-fNIRS signals to characterise cerebral responses associated with pain modulation. Secondary outcomes include patient-reported pain using the Visual Analogue Scale (VAS), total colonoscopy duration and the correlation between EEG-fNIRS indicators and VAS scores. A deep learning framework will be used to enhance pain prediction accuracy.

This study has received ethical approval from the Ethics Committee of Changhai Hospital, Shanghai (approval reference CHEC2025-006), and has been registered at ClinicalTrials.gov. Written informed consent will be obtained from all participants. Findings will be disseminated in peer-reviewed academic journals and at relevant scientific conferences, regardless of outcome, contributing to evidence-based, non-pharmacological pain management strategies.

ClinicalTrials.gov, NCT06813703.

Care pathways are crucial for patients with mental health disorders and should be designed to support integrated rehabilitation while reducing the burden of these disorders. The contemporary shift toward an outpatient follow-up model of care presents an opportunity to improve mental health care beyond the stagnation in advancements in pharmacological treatments. Various pharmacist-led interventions exist and can serve as levers to address ongoing challenges in mental health care pathways: they could help manage difficult transitions, ensure continuity between inpatient and outpatient care, and reduce high rehospitalisation rates. However, the contexts in which these solutions benefit patients and improve care outcomes remain unclear. Thus, the primary objective of this study will be to identify how pharmaceutical solutions contribute to improving mental health care pathways, what works, for whom and in what context. The secondary objective will be to identify the key outcomes currently used to evaluate the impact of pharmaceutical solutions on care pathways.

A systematic realist review will be conducted, following 5 iterative steps to synthesise heterogeneous evidence: (1) Scope definition with a general review of the literature and experts’ discussions, (2) Initial programme theory development based on the preliminary searches, (3) Systematic review for evidence, to refine and test initial programme theory across PubMed, Embase and Web Of Science, (4) Data extraction, including context-mechanism-outcome configurations, and evidence appraisal and (5) Data analysis, synthesis and refined programme theory construction with the realist logic. This process will involve consensus among expert researchers, incorporating insights from individuals with lived experience.

The final programme theory modelling will result in a new framework for pharmaceutical solutions applied in diverse mental health contexts. The findings of this systematic realist review could serve as a guide for implementing pharmaceutical solutions across healthcare settings, ensuring that interventions are evidence-based, contextually relevant and grounded in real-world needs.

As this realist review will collect previously published data and will not involve human or animal participants, no ethical approval is required. Since this manuscript is a review protocol, no datasets were generated or analysed. All data extraction forms will be made available as part of the publication of the realist review.

Systematic review registration PROSPERO 2025 CRD420251011954.

Dates of the study: September 2025 to September 2026.

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.

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

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

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

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

Shift work sleep disorder is a circadian rhythm sleep-wake disorder characterised by insomnia and/or excessive sleepiness associated with a shift work schedule that overlaps with habitual sleep time. This study aimed to assess the prevalence of shift work sleep disorders and associated factors among healthcare professionals working at Jimma University Medical Center, Southwest Ethiopia.

Institutional-based cross-sectional study.

Tertiary hospital in Southwest Ethiopia.

The data were collected using a self-administered questionnaire from health professionals recruited using a simple random sampling technique.

Shift work-sleep disorder was assessed by the International Classification of Sleep Disorders, the Insomnia Severity Index and/or the Epworth Sleepiness Scale. A logistic regression analysis was conducted to determine the association between the predictor and the outcome variable. The ORs and 95% CIs were determined. Variables with a p value

370 participants were involved in the study, yielding a response rate of 97.6%. The prevalence of shift work sleep disorder was 35.9% (n=133). Working in three shifts (Adjusted OR (AOR) 3.25, 95% CI=1.92 to 5.57), more than 11-night shifts per month (AOR 2.83, 95% CI=1.49 to 5.37), absence of nap (AOR 2, 95% CI=1.14 to 3.52), stress (AOR 4.4, 95% CI=2.36 to 8.2), fatigue (AOR 2.7, 95% CI=1.26 to 3.73), alcohol (AOR 3.9, 95% CI=1.79 to 8.47) and khat (AOR 4.40, 95% CI=1.76 to 10.96) use in the last 3 months was significantly associated with shift work sleep disorder.

One in three healthcare professionals working at Jimma University Medical Center had a sleep disorder related to shift work. Working in three shifts per day, having more than 11-night shifts per month, lack of naps, presence of stress, fatigue and substance use were found to be associated with shift work sleep disorder.

Medication returned by patients to healthcare facilities is a critical aspect of reverse logistics, intersecting healthcare delivery, patient safety and environmental sustainability, especially in low- and middle-income countries (LMICs) where systemic inefficiencies and socio-cultural factors may exacerbate the issue. While emerging medication return programmes are recognised for their potential to enhance resource efficiency and prevent misuse, they also signal inefficiencies in medical supply chains, prescribing practices and patient-provider interactions. This scoping review aims to systematically map the incidence and drivers of medication returned to health facilities by patients in LMICs.

This review follows Arksey and O'Malley’s scoping review framework and the PRISMA-ScR reporting guidelines. Searches will be conducted in Google Scholar, PubMed, CINAHL, Embase, Web of Science and Scopus, supplemented by grey literature sources and reference list screening. Searches will include studies from January 2005 to December 2025 and English-language publications, reflecting both the relevance of recent evidence and practical considerations for screening and analysis. Eligible studies must address the incidence or drivers of medication returned in LMICs and meet predefined inclusion criteria based on the Population, Concept, Context framework. Data will be extracted using a standardised charting form and analysed using narrative synthesis, supported by descriptive statistics and thematic analysis.

No ethical approval is required as this scoping review will analyse publicly available literature. Findings will be disseminated through peer-reviewed publications, academic conferences and healthcare organisations, with all data and search strategies made openly accessible through Springer Nature’s protocols.io preprint repository to support transparency and future research.

Springer Nature’s protocols.io dx.doi.org/10.17504/protocols.io.3byl4wd5ovo5/v1.

Chagas disease (CD) is one of the most neglected diseases in the world. In Latin America, CD is endemic in 21 countries, with an estimated 70 million people at risk of infection. Current treatments are limited to two nitroheterocyclic compounds: nifurtimox and benznidazole (BZN). Each has significant limitations, including long duration and safety concerns. However, data from recently completed studies suggest that reduced-duration regimens may be equally effective while enhancing safety.

NuestroBen is a phase III, randomised, multicentre clinical trial designed to assess whether shorter (2- and 4-week) regimens of BZN are non-inferior to the standard 8-week treatment. A total of 540 adult participants with no evidence of organ damage (the indeterminate form) or with mild cardiac progression (mild electrocardiographic alterations and without systolic dysfunction or symptoms), all in the chronic phase of CD, will be recruited at six study sites in Argentina and two study sites in Bolivia. Participants will be randomised to receive one of the two shortened regimens of BZN (300 mg per day for 2 or 4 weeks) or standard treatment (300 mg per day for 8 weeks). The primary endpoint is sustained elimination of parasitaemia from the end of treatment through 12 months of follow-up. Secondary endpoints will assess sustained clearance of parasitaemia at 1, 4, 6 and 8 months of follow-up from the end of treatment, drug tolerability and adherence to treatment. NuestroBen will also evaluate whether two shortened regimens of BZN improve drug tolerability and treatment adherence compared with the current standard treatment while maintaining efficacy in participants with the indeterminate form of CD or with mild cardiac involvement.

In Argentina, this study was approved by Fundación de Estudios Farmacológicos y Medicamentos ‘Luis M. Zieher’ for its conduct at the Instituto de Cardiología de Corrientes ‘Juana Francisca Cabral’ (reference: NuestroBen-2020/2021) and the Instituto Nacional de Parasitología ‘Dr. Mario Fatala Chaben’ (reference: NuestroBen-2020/2021) by Comité Institucional de Ética de Investigación en Salud for the Centro de Chagas y Patología Regional de Santiago del Estero (reference: NuestroBen-2020-088/2021), by Comité de Ética en Investigación for the Hospital de Infecciosas F.J. Muñiz (reference: NuestroBen-2020–4037) and the Hospital General de Agudos D.F. Santojanni (reference: NuestroBen-2020–4039) and by Comité de Bioética for the Fundación Huésped (reference: NuestroBen-2020/2021). In Bolivia, it was approved by Comité de Ética en Investigación en Salud from the Universidad Autónoma Juan Misael Saracho (reference: NuestroBen-2020/2025). All participants are asked to provide written informed consent to participate. Recruitment processes started in July 2023, and as of 15 June 2025, 140 participants have been recruited. Findings will be shared with Argentinian and Bolivian public health officials and with the Chagas and tropical medicine communities via international conferences. Findings will also be published in medical journals.

NCT04897516.

There are global concerns about the rise in opioid prescribing. Patients undergoing potentially curative surgery for colorectal cancer (CRC) are at high risk of adverse outcomes from opioid-related complications, including delayed discharge and adjuvant chemotherapy, long-term opioid use and reduced cancer-free survival. We aimed to develop a set of actionable quality indicators for opioid stewardship for patients undergoing CRC surgery, and an implementation toolkit to support professional behaviour change to improve appropriateness of perioperative opioid prescribing.

A five-round modified RAND consensus process was conducted in 2021–2024.

14 secondary care trusts across the UK Yorkshire and Humber region.

Consultant anaesthetists and national perioperative opioid stewardship experts (expert panel) and patient and public panel.

Potential indicators were identified from a literature review, guideline search and expert panel. All potential indicators were rated on relevance and actionability (online survey, expert panel) and importance to patient care (online meeting, patient panel). A hybrid consensus meeting involving a patient representative and the expert panel discussed and rerated the indicators. An online expert survey identified potential barriers to implementation. An actionable toolkit was developed using implementation strategies and supporting resources developed where appropriate.

73 potential indicators were identified. All indicators remained in the process through the online survey and patient panel. After the final meeting, four indicators remained: (1) hospital trust presence of an opioid stewardship protocol; (2) inpatient functional post-operative pain assessments; (3) patient education and discharge leaflet; and (4) senior clinician review of ‘strong’ opioids on discharge (British National Formulary definition). The number of barriers identified ranged from 8 to 22 per indicator. 49 different implementation strategies were identified for the toolkit (range 32–45 per indicator).

We identified four actionable quality indicators and developed an implementation toolkit that represents consensus in defining quality of care in opioid stewardship for CRC surgery.

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.

Breast cancer is the most common cancer among women globally. While the impact of lifestyle factors like smoking and obesity on breast cancer risk and survival is well documented, the effect of working conditions is not fully understood. Moreover, breast cancer can reduce employability, making it crucial to identify factors that facilitate return to work and improve life satisfaction. Since breast cancer is affected by sleep and lifestyle, which are related to working conditions, understanding how they affect breast cancer outcomes is key. This study aims to explore the relationship between working conditions and breast cancer outcomes, including incidence, mortality and survival within a causal framework. Our specific aims are to understand the relationship between (1) working conditions and occupational groups and breast cancer outcomes, including the extent to which sleep, lifestyle and breast cancer screening uptake explain these relationships and (2) prediagnosis working conditions, sleep and lifestyle and their effect on return to work and life satisfaction among breast cancer survivors.

We will use data from the UK Biobank, a large-scale cohort study with data on 273 825 women between 40 and 69 years old at baseline, followed from 2006 to 2022. The data has been linked with death and cancer registries and includes 8309 incident breast cancer cases. To quantify the effect of working conditions on breast cancer outcomes (aim 1) and their effect on return to work and life satisfaction (aim 2), we will implement g-methods to estimate the average causal effect and employ counterfactual-based mediation analysis to quantify how much mediating factors, such as sleep and lifestyle, explain this effect.

UK Biobank received ethical approval from the North West Multi-Centre Research Ethics Committee. No further ethical approval was required for the proposed research project. In line with the two aims, four original research manuscripts will be published in open-access peer-reviewed journals to disseminate the findings. In addition, findings will be disseminated at international conferences and scientific meetings.

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).