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.

The Validating Outcomes by Including Consumer Experience (VOICE) project is developing patient reported experience measure (PREM) tools to collect consumer feedback for Indigenous primary healthcare (IPHC) services’ accreditation and quality improvement processes. This study aimed to explore the views of health service staff about: (1) optimising the feasibility of collection, analysis and interpretation of findings; and (2) resourcing requirements for implementation of the PREM.

A participatory action research qualitative study design, guided by an Indigenous advisory group. Our team of Indigenous and non-Indigenous researchers conducted semistructured focus groups and individual interviews with IPHC staff. Focus groups and interviews were recorded, transcribed and thematically analysed. Multiple sense-making meetings were conducted with the Indigenous advisory group.

Eight partner IPHC services across four Australian states and territories.

All staff were eligible and invited to participate in the study via purposive and snowball sampling. Administrative staff (eg, receptionist, programme facilitator), clinicians/practitioners (eg, general practitioner, nurse, Aboriginal and Torres Strait Islander health workers and practitioners) and service managers (eg, CEO, practice manager) from partner health services participated.

63 staff participated; 44 attended across 13 focus groups, with the remainder participating in individual interviews. The majority of participants were between 35 years and 55 years old (52%), female (66%) and working in frontline IPHC service delivery roles (56%). Equal numbers identified as Indigenous (50%) and non-Indigenous (50%). Many had worked in the Indigenous health and well-being sector for over 10 years (40%). ‘Culturally safe care’ and ‘accountability’ were identified as primary themes and key reasons for gathering consumer feedback. Subthemes identified were ‘Relationships’, ‘trust and respect’, ‘communication about consumer feedback’, ‘timing and frequency of requesting consumer feedback’, ‘health service systems’, ‘health service and staff capacity’, ‘staff skills’ and ‘structure and administration of the PREM’. All themes and subthemes need to be considered for the successful design and implementation of PREMs in IPHC settings.

Many of the issues identified are not currently considered in the process of collecting PREM data for accreditation yet, if addressed, would likely improve the quality and relevance of data collected. The findings from this study will inform the co-design and validation of Indigenous-specific PREM tools to collect consumer feedback. Critically, service and community input will ensure the PREM tools meet service needs for continuous quality improvement and accreditation and reflect the priorities and values of Indigenous peoples.

Transvaginal and transabdominal cerclage procedures have become established interventions to prevent mid-trimester pregnancy loss and preterm birth. Transabdominal cerclage seems to be superior to transvaginal cerclage in women with a history of a failed transvaginal cerclage. However, with the availability of a less invasive laparoscopic procedure, there is limited evidence concerning which type of cerclage to recommend to many other risk groups. The objective of this trial is to compare laparoscopic abdominal cerclage and transvaginal cerclage in women at moderate to high risk of spontaneous preterm birth.

The trial is an open, multicentre, superiority, parallel arm randomised controlled investigator-initiated trial with an embedded internal pilot. Women in whom the clinician has clinical equipoise between laparoscopic and transvaginal cerclage are randomised to either laparoscopic abdominal or transvaginal cerclage in a ratio of 1:1. The trial extends from sites in Denmark, Finland and Norway. The primary outcome is birth

The Central Denmark Region Committee on Biomedical Research Ethics, Denmark, Helsinki University Hospital Ethics committee, Finland and the Regional Committees for Medical and Health Research Ethics, Norway approved the trial. This protocol is published prior to complete data collection and analysis. Important protocol changes will be made publicly available on ClinicalTrials.org, on the trial website and distributed electronically to all active sites. Positive, inconclusive as well as negative results from the trial will be published in peer-reviewed international scientific journals.

NCT06122506.

Patients receiving long-term ventilation (LTV) in out-of-hospital intensive care facilities often suffer from persistent impairments of their cognition, mental health and physical health, limiting their social participation. Chronically ill patients are often unable to express their care preferences. Thus, their medical care often lacks integration of patients’ wishes and values. Telemedicine may be used to collect patient-reported outcome measures (PROMs) from these patients to align medical care with their preferences. Early integration of teleconsultation to provide rapid support for specific patient symptoms can reduce economic costs.

This is a multicentre, prospective, non-blinded, single-arm interventional trial with a pre-post design and follows the Standard Protocol Items: Recommendations for Interventional Trials statement. 10 out-of-hospital intensive care facilities in Berlin and Brandenburg, Germany, are grouped into three clusters. The study population includes adult patients (≥18 years) receiving LTV and residing in participating care facilities. During the preintervention phase, standard patient care remains unchanged. From the start of the intervention phase, enrolled patients receive telemedicine rounds in addition to standard care. These telemedicine rounds, conducted at least weekly, involve on-site healthcare professionals, patients and their relatives. Data are collected at predefined time points—study months 1,3, 9, 15 and 21—with a target of 57 participants at each time point. The study aims to evaluate whether a structured telemedicine intervention (1) increases the proportion of patients receiving record-documented PROMs in routine care and (2) reduces hospital readmissions. Secondary outcomes include the evaluation of post-intensive care syndrome, healthcare costs and the usability, applicability and perceived benefits of telemedicine. Additionally, qualitative interviews with patients, their relatives and healthcare professionals will explore individual experiences with chronic critical illness, the perceived quality of life of the patients and how team members manage moral distress in caregiving contexts. A mixed-effects logistic regression model will be used to analyse patients’ access to PROMs, while a mixed-effects Poisson regression model will be employed to evaluate hospital readmission rates. The findings may provide valuable insights into how telemedicine can improve patient-centred care for this particular patient group.

This study protocol received approval from the Ethics Committee of Charité—Universitätsmedizin Berlin, Germany (EA2/136/22). The findings will be disseminated through publication in a peer-reviewed scientific journal and presented at international conferences.

This study was registered in the ‘German Register of Clinical Studies’ (DRKS; DRKS00029326).

The Cardiometabolic function in Offspring, Mother and Placenta after Assisted Reproductive Technology (COMPART) study is a prospective cohort study aiming to explore health outcomes in mothers and children following assisted reproductive technology (ART), with a particular focus on frozen embryo transfer (FET) versus fresh embryo transfer (fresh-ET). The increasing prevalence of ART and FET emphasises the need to assess potential health risks associated with the procedures, both in pregnancy, such as pre-eclampsia and large for gestational age offspring, and in the children, such as obesity and cardiometabolic dysfunction.

The cohort will include 600 pregnant women, their potential partner and their offspring in a 1:1:1 ratio of pregnancies achieved after ART with FET, ART with fresh-ET and women who conceived naturally. The study will involve extensive data collection from electronic medical records; parental questionnaires; biochemical, genetic and epigenetic analyses in blood, urine and placental tissue; and medical imaging (fetal ultrasound and PEA POD scan) and clinical examinations. Outcomes are grouped into six work packages (WPs) related to fetal growth (WP1), pregnancy (WP2), placenta (WP3), offspring (WP4), genetics (WP5) and epigenetics (WP6).

The COMPART study aims to provide valuable insights into the impact of ART and FET on maternal and offspring health and the underlying mechanisms responsible. The study seeks to advance reproductive medicine, shape clinical practice and guidelines and ultimately ensure maternal-fetal health following ART. The study has been approved by the Danish Ethics Committee (H-23071266; February 2024).

NCT06334003

Fathers of preterm infants wish to be actively involved and attentive in caring for their children. The positive impacts of paternal caregiving on preterm infants’ cognitive and social development have been recognised. Awareness of the need to support fathers during early parenthood is increasing, but fathers may feel excluded when their infants are in the neonatal intensive care unit. Here, we present the protocol for a study involving the development and national implementation of a complex intervention supporting first-time fathers of preterm infants in early parenthood.

The study adheres to the Medical Research Council framework for complex interventions. A multicentre, prospective, non-blinded, quasi-experimental design will be applied to evaluate the effect of a clinical and technology-based intervention targeting both nurses and the fathers. Outcomes from participants enrolled during the control (2023–2024) and intervention (2025–2026) periods, comprising 295 fathers and their partners, will be compared. Effects on parental confidence, stress, depression and mood and family and reflective functioning as well as infants’ emotional and social development will be assessed. A comprehensive process evaluation will be applied using both qualitative and quantitative methods.

The study has been registered at Clinicaltrials.org [no. NCT0 6 116 747 (The SUPPORTED study – First-time Fathers of Preterm Infants), approved on 3 November 2023]. The Danish Data Protection Agency has approved the study (P-2022–792). The findings will be disseminated through peer-reviewed publications.

NCT06116747.

Millions of patients receive general anaesthesia every year with either propofol total intravenous anaesthesia (TIVA) or inhaled volatile anaesthesia (INVA). It is currently unknown which of these techniques is superior in relation to patient experience, safety and clinical outcomes. The primary aims of this trial are to determine (1) whether patients undergoing (a) major inpatient surgery, (b) minor inpatient surgery or (c) outpatient surgery have a superior quality of recovery after INVA or TIVA and (2) whether TIVA confers no more than a small (0.2%) increased risk of definite intraoperative awareness than INVA.

This protocol was co-created by a diverse team, including patient partners with personal experience of TIVA or INVA. The design is a 13 000-patient, multicentre, patient-blinded, randomised, comparative effectiveness trial. Patients 18 years of age or older, undergoing elective non-cardiac surgery requiring general anaesthesia with a tracheal tube or laryngeal mask airway will be eligible. Patients will be randomised 1:1 to one of two anaesthetic approaches, TIVA or INVA, using minimisation. The primary effectiveness endpoints are Quality of Recovery-15 (QOR-15) score on postoperative day (POD) 1 in patients undergoing (1) major inpatient surgery, (2) minor inpatient surgery or (3) outpatient surgery, and the primary safety endpoint is the incidence of unintended definite intraoperative awareness with recall in all patients, assessed on POD1 or POD30. Secondary endpoints include QOR-15 score on POD0, POD2 and POD7; incidence of delirium on POD0 and POD1; functional status on POD30 and POD90; health-related quality of life on POD30, POD90, POD180 and POD365; days alive and at home at POD30; patient satisfaction with anaesthesia at POD2; respiratory failure on POD0; kidney injury on POD7; all-cause mortality at POD30 and POD90; intraoperative hypotension; moderate-to-severe intraoperative movement; unplanned hospital admission after outpatient surgery in a free-standing ambulatory surgery centre setting; propofol-related infusion syndrome and malignant hyperthermia.

This study is approved by the ethics board at Washington University, serving as the single Institutional Review Board for all participating sites. Recruitment began in September 2023. Dissemination plans include presentations at scientific conferences, scientific publications, internet-based educational materials and mass media.

NCT05991453.

Relational continuity of care (RCC) refers to the sustained therapeutic relationship between a patient and a clinician, which fosters trust, enhances communication and facilitates the accumulation of knowledge about the patient. RCC is associated with enhanced patient outcomes, reduced hospital admissions, lower mortality rates, decreased healthcare costs and improved patient experience. Despite these benefits, reorganisations within the NHS and workforce challenges have led to an increased reliance on multidisciplinary and part-time working, resulting in fragmented care and a decline in RCC. Our study aims to explore who needs RCC, under what circumstances, to what extent and why, with the goal of informing optimal implementation strategies.

We will conduct a realist review to develop an evidence-based programme theory explaining the mechanisms underlying RCC, the populations that benefit most, the contextual factors influencing RCC and effective care models. Following Pawson’s five iterative stages, we will: (1) Locate existing theories, (2) Search for relevant evidence, (3) Select appropriate articles, (4) Extract and organise data and (5) Synthesise findings to draw conclusions. A stakeholder advisory group, comprising policymakers, healthcare professionals, public contributors and patients, will be engaged throughout the process. We will adhere to Realist And Meta-narrative Evidence Synthesis: Evolving Standards (RAMESES) for realist reviews to ensure methodological rigor.

Our findings will inform practical, evidence-based recommendations for optimising RCC within general practice. Outputs will include peer-reviewed publications, conference presentations, plain English summaries, social media infographics, a short video and end-of-study events. Collaborations with stakeholders and public involvement will ensure both accessibility and impact. Ethical approval is not required for this review.

Canadian guidelines recommend HIV testing for individuals being evaluated for syphilis. Our objective was to examine three aspects of HIV testing (ie, if an HIV test occurred, the timing of the HIV test in relation to the syphilis test and the proportion with a positive HIV test result) among syphilis tests between 2017 and 2022 from individuals with no evidence of a previous HIV diagnosis.

This study is a retrospective analysis of comprehensive laboratory testing data from Ontario’s provincial public health laboratory.

Direct fluorescent antibody (DFA) and serological non-prenatal syphilis tests were conducted from 1 January 2017 to 31 December 2022, from individuals aged ≥15 years with no evidence of a previous HIV diagnosis (n=3 001 058 total tests). Positive syphilis tests were categorised using the rapid plasma reagin (RPR) titre as ‘current’ (DFA+/RPR≥1:8) or ‘historical’ (RPR

The number and proportion of syphilis tests with a corresponding HIV test on the same day or within 7, 28, 90 or 180 days, and, among those with an HIV test within 28 days, the number and proportion with an HIV-positive test result.

From 2017 to 2022, 1 516 726 and 1 484 332 syphilis tests among males and females, respectively, were included in the analysis. Individuals with a positive syphilis result were less likely to be tested for HIV within 28 days of their syphilis test compared with those with a negative syphilis test result (74.7% vs 91.1% in males, 97.5% CI (–0.17 to –0.16); 65.2% vs 92.4% in females, 97.5% CI (–0.28 to –0.26)). Males with ‘current’ positive syphilis test results were less likely than males with ‘historical’ positive syphilis results to be tested for HIV within 28 days (69.1% vs 76.6%, 97.5% CI (–0.084 to –0.066)); this was not true in females (67.1% vs 64.4%, 97.5% CI (0.0062 to 0.049)). Males overall and males with ‘current’ syphilis were more likely to be diagnosed as HIV-positive (p

Most individuals who tested for syphilis at Public Health Ontario were also tested for HIV; however, those who tested positive for syphilis were less likely to be tested, representing an opportunity for enhanced HIV testing. Ensuring that individuals with syphilis are tested for HIV may help identify previously undiagnosed individuals living with HIV.

The emergency department (ED) often serves as a crucial pathway for cancer diagnosis. However, little is known about the management of patients with new suspected cancer diagnoses in the ED. The objective of this study was to explore emergency physicians’ experiences in managing patients with a newly suspected cancer diagnosis in the ED.

Between January and April 2024, we conducted a qualitative descriptive study. Interviews were conducted by trained research personnel using a semistructured interview guide. Interviews were conducted until thematic saturation was achieved. The interview transcripts were coded and thematic analysis was used to uncover key themes.

Emergency physicians practising in Ontario, Canada.

20 emergency physicians were interviewed. Four themes around the management of patients with new suspected cancer diagnoses in the ED were identified: (1) healthcare system-level factors that impact suspected cancer diagnosis through the ED, (2) institutional and provider-level challenges associated with managing patients with a suspected cancer diagnosis in the ED, (3) patient-level characteristics and experiences of receiving a cancer diagnosis in the ED and (4) the need for care coordination for patients with suspected cancer in the ED.

Physicians experienced several unique challenges in managing patients with a suspected cancer diagnosis in the ED. Overall, the findings of this study suggest these challenges often make the ED a difficult environment in which to deliver a suspected cancer diagnosis.

The rising burden of non-communicable diseases (NCDs), including mental health disorders (MHDs) such as anxiety and depression, poses a significant public health challenge globally. Evidence suggests that both diabetes and hypertension, the two most prevalent NCDs, are linked to a higher prevalence of MHDs. However, there is a lack of evidence on prevalence of generalised anxiety disorder (GAD) and depression among adults living with both diabetes and hypertension in Bangladesh. We aimed to assess the prevalence of GAD and depression and explore the associated factors among adults living with diabetes and hypertension comorbidity in rural Bangladesh.

We implemented a cross-sectional study.

The study was conducted in Chirirbandar, a sub-district of Dinajpur, Bangladesh.

We interviewed a total of 387 adults living with diabetes and hypertension comorbidity.

We had two primary outcome measures: GAD and depression. Individuals scoring ≥10 on the General Anxiety Disorder-7 scale were considered as having GAD and individuals scoring ≥10 on the Patient Health Questionnaire-9 scale were considered as having depression. The outcome variables were dichotomised based on these scores.

The prevalence of GAD was 7.24% (95% CI 5.04 to 10.29). Education level (grades 5–9) (adjusted OR (AOR): 3.40, 95% CI 1.26 to 9.19) and household wealth status (highest wealth tertile) (AOR: 0.12, 95% CI 0.02 to 0.62) were associated with GAD. The prevalence of depression was 17.83% (95% CI 14.32 to 21.98). Socioeconomic factors associated with depression included unemployment (AOR: 3.26, 95% CI 1.05 to 10.10) and household wealth status (highest wealth tertile) (AOR: 0.45, 95% CI 0.21 to 0.98). Higher odds of depression were also observed among participants with controlled hypertension (AOR: 3.88, 95% CI 1.81 to 8.35). Other factors, such as tobacco use, dietary diversity and physical activity, were not associated with GAD or depression.

A high prevalence of GAD and depression was observed among adults living with diabetes and hypertension comorbidity. The findings from the study emphasise the need for integration of mental health services into the existing non-communicable disease care. The identified factors associated with GAD or depression should be considered to develop targeted interventions for people with hypertension and diabetes comorbidity in Bangladesh.

Continuous glucose monitoring (CGM) provides real-time glucose data for people with diabetes. However, detailed knowledge of its use in daily life remains limited. We aim to investigate the interaction between people with type 1 diabetes (T1D) and their CGM data and the impact of the interaction on glycaemia and diabetes distress.

This is a two-centre observational study of adults (n=500) with T1D using FreeStyle Libre 2. Over a period of 14 days, participants will continue their regular CGM use, record insulin doses and timing with smart insulin pens, track activity and sleep with an activity tracker, log all food intake in the LibreLink app and answer questions about quality of life and hypoglycaemia two times per day. Before the study period, the participants will complete a survey of 11 validated questionnaires assessing diabetes distress, hypoglycaemia awareness and other patient-reported outcomes (PROs). After the study period, the participants will complete two additional questionnaires assessing diabetes distress and health literacy.

The collected data will be used in two substudies with the overall aims of:

Substudy 1: to investigate how CGM is used in practice and the impact of the interaction on diabetes distress and glycaemia.

Substudy 2: to investigate whether and how CGM functions as a technological substitute for impaired awareness of hypoglycaemia, focusing on alarm data.

Endpoints will include CGM metrics, alarm data and PROs.

The Danish Data Protection Agency approved the study (P-2024–15985), and the regional committee on health research ethics has granted an ethical waiver (H-24014662). All participants have signed written informed consent forms before participating. The results will be published in an international peer-reviewed scientific journal by the study investigators and shared via www.clinicaltrials.gov. Participants who agreed to receive information about the study will be sent the results after publication.

ClinicalTrials.gov (NCT06453434).

Prescribing patterns for hyperopia in children vary widely among eye care providers worldwide. This scoping review aims to identify and map the current literature on optical correction and catalogue outcomes reported, particularly in the domains of vision, vision-related functional outcomes and quality of life (QoL) in school-aged children with hyperopia.

This protocol was developed in accordance with the Joanna Briggs Institute’s Manual for Evidence Synthesis. We will include studies involving school-aged children with hyperopia without restrictions on sex, gender, race, ethnicity, type of optical correction, length of intervention, publication date or country of origin. We will include studies with internal or external comparison groups. We will exclude studies associated with myopia control treatments, ocular and visual pathway pathologies affecting vision or visual function. We will search Cochrane CENTRAL, Embase.com and PubMed. Examples of data to be extracted include population demographics, visual acuity, study-specific definitions for refractive error, treatment regimens for optical correction, vision and vision-related functional outcomes and QoL (general or vision-related) as quantified by validated instruments.

Informed consent and Institutional Review Board approval will not be required, as this scoping review will only use published data. The results from the scoping review will be disseminated by publication in a peer-reviewed scientific journal and at professional conferences.