To understand general practitioners’ (GPs’) experience of existing care pathways for people with moderate-severe Alzheimer’s Disease (AD) and explore their attitudes towards potential modifications to these pathways.

Secondary thematic analysis of qualitative interviews, originally conducted with GPs to explore prescribing of memantine in general practice. The theoretical domains framework was used to structure the data.

The study participants were recruited via an online survey completed by GPs across England.

Semi-structured, qualitative interviews were conducted with thirteen male and ten female GPs from a range of general practices in England.

Insights into GPs’ views and experiences regarding existing and possible care pathways for individuals with moderate to severe AD.

Gaps in GPs’ current levels of knowledge and skill in respect of caring for patients with moderate-to-severe AD affect their confidence and ability to identify opportunities for additional treatments. While GPs emphasise their role as providers of holistic care, features of the current healthcare context, including a lack of additional funding, inhibit their willingness to assume additional responsibilities as part of a revised pathway.

A considerable knowledge, skills and confidence gap must be addressed to support the implementation of new care pathways that include revised responsibilities for GPs. GPs need appropriate support and resources to manage their patients’ changing needs and to provide the best possible pharmacological management as the disease develops.

Mycobacteroides abscessus (MABS) is within the non-tuberculous mycobacteria family. It inhabits soil and water, exhibits multi-antibiotic resistance and causes opportunistic lung infections, which may progress to symptomatic MABS-pulmonary disease (MABS-PD) associated with substantial morbidity, increased healthcare utilisation, impaired quality of life and increased mortality. Treatment regimens for MABS-PD are highly variable, not evidence-based and involve complex, expensive drug combinations administered for prolonged periods (>12 months) with frequent adverse effects and treatment failure. There is an urgent need for safe, efficacious and cost-effective MABS-PD therapy. Here, we describe the Master Protocol for the Finding the Optimal Regimen for Mycobacteroides abscessus Treatment (FORMaT) trial. FORMaT aims to determine the most effective and best tolerated treatment for MABS-PD as defined by MABS clearance from respiratory samples with good treatment tolerance.

FORMaT is an international multicentre, adaptive platform trial evaluating treatment combinations for MABS-PD. Participants are randomised multiple times during the trial, with assessment of the primary outcome of clearance of MABS infection with good treatment tolerance. Initially, therapies recommended in international consensus guidelines are being tested. Data obtained will eliminate therapies lacking efficacy or causing unacceptable toxicity. Novel treatments can then be added and tested against previously determined optimal approaches, leading in an iterative fashion to improved microbiological clearance and health outcomes. In parallel, an Observational cohort and several integrated and discovery studies are embedded in FORMaT to identify biomarkers of MABS-PD and MABS clearance, clinical and radiographic treatment response, drug pharmacokinetics and Mycobacteroides genomics and resistome.

The FORMaT Master Protocol and related documents are approved by regulatory authorities in each participating jurisdiction and/or site. Results will be published in peer-reviewed journals and presented at scientific meetings. De-identified, aggregated data will be shared on an approved online platform.

NCT04310930, ANZCTR12618001831279, 2020-000050-10, ISRCTN67303903.

To evaluate an innovative approach to recruit 40 hospitals to a cluster randomised controlled trial (RCT) to improve discharge antibiotic prescribing.

This study describes the design, implementation and impact of a theory-informed recruitment approach for hospitals participating in the Reducing Overuse of Antibiotics at Discharge (ROAD) Home trial.

An inperson meeting of a quality improvement collaborative of acute care hospitals in the state of Michigan.

Representatives from acute care hospitals that are part of the Michigan Hospital Medicine Safety Consortium.

Small group recruitment sessions that combined deliberative participation and credible messengers to recruit hospitals to participate in a cluster RCT on a single date (1 November 2023).

The primary outcome was the number of hospitals which agreed to participate in the trial. We also assessed participant feedback, effectiveness of recruitment methods and resources required for implementation of this approach.

We recruited 51 (74%) of 69 eligible hospitals. Survey participants reported: sessions made clear the purpose of the trial (94%, 64/68) and time commitment required (87%, 59/68); agreed deliberative participation was helpful (82%, 56/68) and were ‘very satisfied’ with the session (82%, 56/68). Investigators largely reported credible messengers were a positive influence, though this varied across sessions. Hospital recruitment was time intensive, taking 179.5 total person hours. The recruitment process involved 3 months of preparation for the sessions and 2 months of follow-up prior to closing recruitment.

We demonstrated the feasibility and impact of a novel approach to recruit hospitals from an existing collaborative to a cluster RCT using the principles of deliberative participation and credible messengers. While the approach was time-consuming, we achieved success at over-recruiting hospitals in a relatively short period of time. Strategies presented here may assist future trial organisers in implementing hospital-based cluster RCTs.

The ROAD Home trial is registered on Clinical.Trials.gov (NCT06106204).

Elevated lipid profiles increase the risk of atherosclerotic cardiovascular disease (ASCVD), a leading cause of mortality worldwide. Despite the availability of lipid-lowering therapy (LLT), adherence to therapy and achievement of Low-Density Lipoprotein Cholesterol (LDL-C) target levels remain suboptimal. Coronary artery disease (CAD) presents substantial public health challenges, with LDL-C goal attainment rates reported to be between 30.0% and 54.0%. The EDHIPO MARCA (Evaluación De adherencia a la terapia HIPOlipemiante en pacientes de Muy Alto Riesgo CArdiovascular) study aims to evaluate LDL-C target achievement among Colombian patients with CAD.

This is a retrospective and multicentre study aiming to evaluate LDL-C target achievement within 12 months of coronary angiography across multiple Colombian institutions. Data will be retrospectively extracted from medical records corresponding to the years 2011, 2012, 2016, 2017, 2021 and 2022, which were selected to correspond with the European Society of Cardiology/European Atherosclerosis Society guideline updates. Inclusion criteria included patients ≥18 years old with confirmed CAD and LDL-C reports recorded during outpatient follow-up. The study will evaluate a minimum sample size of 5000 patients, with data collected through medical records and managed using the REDCap platform. Statistical analyses will be conducted to assess LDL-C target achievement, associated factors and temporal trends using mixed-effects models. Uncertainty will also be explored through sensitivity analysis. The EDHIPO MARCA study will provide key insights into LDL-C target achievement in Colombia, contributing to both regional and global CAD management. Its findings will be used to help shape public health policies and serve as a foundation for future prospective research and interventions aimed at mitigating the burden of cardiovascular disease.

This study was approved by the Comité de Ética en Investigación Biomédica of Fundación Valle del Lili, the coordinating institution and creator of the study protocol. Each participating centre will obtain approval from its local ethics committee prior to data collection. Data will be collected in a de-identified manner, ensuring confidentiality. In accordance with Colombian Resolution 8430, this study is classified as 'no-risk', and informed consent was not required. The findings will be disseminated through scientific events and published in international peer-reviewed journals to contribute to cardiovascular disease management and public health policies.

Selecting an optimal initial dosage of opioid agonist treatment (OAT) balances effectiveness and safety, as initial doses that are too low may be insufficient, potentially prompting clients to seek unregulated drugs to alleviate withdrawal symptoms, which may increase the likelihood of treatment discontinuation. Conversely, initial doses that are too high carry a risk of overdose. As opioid tolerance levels have risen in the fentanyl era, linked population-level data capturing initial doses in the real world provide a valuable opportunity to refine existing guidance on optimal OAT dosing at treatment initiation. Our objective is to determine the comparative effectiveness of alternative initial doses of methadone, buprenorphine-naloxone and slow-release oral morphine at OAT initiation, as observed in clinical practice in British Columbia (BC), Canada.

We propose a population-level retrospective observational study with a linkage of nine provincial health administrative databases in BC, Canada (1 January 2010 to 31 December 2022). Our study includes two time-to-event primary outcomes: OAT discontinuation and all-cause mortality during follow-up. We propose ‘initiator’ target trial analyses for each medication using both propensity score weighting and instrumental variable analyses to compare the effect of different initial OAT doses on the hazard of time-to-OAT discontinuation and all-cause mortality. A range of sensitivity analyses will be used to assess the robustness of the results.

The protocol, cohort creation and analysis plan have been classified and approved as a quality improvement initiative by Providence Health Care Research Ethics Board and the Simon Fraser University Office of Research Ethics. Results will be disseminated to local advocacy groups and decision-makers, national and international clinical guideline developers, presented at international conferences and published in peer-reviewed journals electronically and in print.

Ventilation tube insertion for paediatric otitis media (POM), including acute otitis media (AOM) and otitis media with effusion (OME), has been signalled in the past for potential unwarranted treatment variation. Quality improvement initiatives, like Audit & Feedback (A&F), often ignore the care pathway when identifying such variation, possibly overestimating variation at a specific care step. To gain more insight into the effect of prior care steps, this study examined (1) the degree of regional variation in each step of the care pathway (general practitioner (GP) contacts, referrals and surgeries) and (2) investigated the effect of adjusting for prior care steps.

Observational study using general practice electronic health record data linked to specialist claims data.

272 790 children ≤12 years with and without POM registered in 320 GP practices between 2017 and 2018.

Using multilevel logistic regression, the degree of regional variation in each step of the POM care pathway was assessed by calculating the coefficient of variation (CV).

The effect of adjusting for prior care steps was determined by estimating correlations between subsequent care steps and analysing the impact on the CV.

Regional variation in POM treatment was larger in each subsequent step in the care pathway (CV POM GP contacts 0.110; referral 0.179; surgery 0.239). In regions with a higher proportion of children with frequent AOM/persistent OME, referral rates were higher (POM: OR: 1.06; 95% CI: 1.02 to 1.11) and surgical rates were higher (for OME only: OR: 1.08; 95% CI: 1.02 to 1.15). Regional variation in referrals and surgery decreased after adjusting for the regional frequent AOM/persistent OME rate (CV referrals POM 0.103 vs 0.128; CV surgery OME 0.047 vs 0.059).

Regional variation is observed in GP contact rates for POM and is larger in referrals and surgeries. Adjusting for the proportion of frequent AOM/persistent OME significantly reduces regional variation in POM treatment. Future A&F should adjust for prior care processes and develop tailored interventions for quality improvement.

The inadequate handling of obstetrical complications may be attributed to the suboptimal quality of prenatal care (PC) and a lack of trust in healthcare provider (HP) among pregnant women.

This study explores the perceptions of satisfaction among women without social security regarding the PC provided by public health services, and compares the dimensions of satisfaction between those who received group prenatal care (GPC) and those who received individual prenatal care (IPC), as well as to identify the dimensions of satisfaction most valued by women to support the inclusion of said dimensions in primary health guidelines.

We performed a qualitative analysis to explore women’s satisfaction perception regarding PC. Satisfaction was explored using the following dimensions: women-HP relationship, educational support, opportunity of PC, emotional support and perception of clinical procedures.

The study was conducted between 2015 and 2018 across eight primary health facilities, from which four implemented IPC and four implemented GPC. Semi-structured interviews were applied: 28 for women with IPC and 18 for women with GPC. The sample size was defined by theoretical saturation. Content analysis was performed using a combination of deductive–inductive process into dimensions and attributes. To analyse the relationship among dimensions and attributes, we performed onto semiotic networks. ATLAS.ti was used to analyse the information.

Women without social security who received PC care in public health facilities.

Women who received GPC reported higher satisfaction than those who received IPC. In GPC, the most valued dimensions were (1) women-HP relationship, particularly the continuity of care delivered by the same HP and (2) the trust in that same provider. According to semiotic networks, these dimensions showed interconnections with each other, but also connected with attributes of other dimensions. Therefore, they have the potential to enhance trust, communication, the effectiveness of educational activities and emotional support.

A holistic approach to GPC is essential for ensuring a positive prenatal experience. However, a hybrid model that incorporates elements of both IPC can further enhance overall satisfaction among women. Consistency in care, particularly by providing services in public health facilities with the same HP, should be a fundamental strategy in PC, as it can significantly improve women’s satisfaction.

To investigate discrepancies in perceptions regarding the accessibility and availability of rest and relaxation (R&R) spaces between hospital doctors in Scotland and NHS Scotland regional health boards (HBs), with the intention of informing best practices for organisational policy on the provision of R&R spaces both now and in the future.

A qualitative study, through an inhabited institutionalism (II) lens, of semi-structured interviews of hospital doctors across the career continuum in Scotland and all NHS regional HBs in Scotland providing written information relating to R&R space provision.

NHS Scotland during the COVID-19 pandemic and beyond.

Hospital doctors (n=30) who had participated in a larger qualitative study and provided specific insights on R&R spaces. All NHS Scotland regional HBs (n=14).

Although HBs reported the provision of R&R spaces, numerous doctors reported R&R spaces had been removed, relocated or were inaccessible. Furthermore, limited awareness of their availability attributed to inadequate communication, compounded the issue. This divergence between institutional reporting and front-line experience can be interpreted through the lens of II, which posits that institutional polices are often interpreted and implemented differently.

This study emphasises how crucial R&R spaces are to promoting doctors’ well-being especially during the time of high stress. HBs must not only guarantee the accessibility and physical availability of R&R spaces but also enhance their communication regarding the provision.

Excessive sedentary behaviour (SB) is highly prevalent among children and adolescents and young adults (AYAs) treated for cancer. Although SB is associated with adverse health outcomes in adults with cancer, little is known about SB in younger cancer patients and survivors. In this scoping review, we aim to summarise current literature on (1) the association between SB and clinical outcomes and (2) results of intervention trials to reduce SB, specifically in paediatric and AYA cancer patients and survivors.

The scoping review will follow the five stages described in the Arksey and O’Malley methodology framework. We will conduct a comprehensive search in five varied electronic databases (PubMed, Embase, Web of Science, CINAHL and SportDiscus) for original articles published in peer-reviewed journals since 1 January 2000, and search reference lists of identified articles and previous review articles. All original research article types will be considered (ie, cross-sectional, cohort, interventional trials). Two reviewers will independently screen all articles based on predetermined inclusion and exclusion criteria, including (1) more than half the sample at the time of study must have been children (0–14 years old) and/or adolescent and young adults (AYAs, 15–39-year old) who were being or had been previously treated for cancer and (2) reporting of SB. Data will be extracted as a descriptive and quantitative summary of each study’s key characteristics and results. Study-specific quality assessment will be performed using established tools. Results will be presented in evidence tables with an accompanying narrative summary.

Ethics approval is not required as only publicly available data will be analysed. Results will be published in a peer-reviewed journal and may be presented at a scientific conference.

The protocol is registered in Open Science Framework (https://osf.io/ua8z9).

Opioid use disorder (OUD) during pregnancy is associated with increased rates of adverse perinatal, foetal and neonatal health events. Opioid agonist treatment (OAT) can substantially reduce the risk of these potential harms. In British Columbia (BC), methadone and buprenorphine/naloxone are first-line treatment options for pregnant people with OUD. However, the comparative effectiveness of these regimens during pregnancy remains poorly understood, particularly in terms of how dosage may impact clinical outcomes. This protocol outlines a proposed population-based retrospective study to evaluate the comparative effectiveness of methadone compared with buprenorphine/naloxone during pregnancy on perinatal and neonatal health outcomes.

We propose to conduct a retrospective observational study using population-based data from individuals who received methadone or buprenorphine/naloxone during pregnancy between 1 April 2010 and 31 March 2022. Data will be collected from 10 linked population-level administrative databases. We will emulate target trials using intention-to-treat and per-protocol approaches. We will use a pooled logistic regression approach to assess the impact of methadone versus buprenorphine/naloxone on time to OAT episode discontinuation and a dose-response marginal structural model to evaluate neonatal health at delivery. An exploratory observational analysis will also be conducted to describe the impact of methadone vs buprenorphine exposure during the first trimester of pregnancy on congenital malformations and anomalies.

This study has been determined to meet the criteria for exemption per Article 2.5 of the 2018 Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans. Study databases have been made available by the BC Ministries of Health and Mental Health and Addiction as part of the provincial opioid overdose public health emergency response. Results will be disseminated to policymakers, clinical partners, community programmes and people with lived and living experience of substance use and published in peer-reviewed journals.

Opioid agonist treatment (OAT) prescribing patterns have shifted in recent years in British Columbia (BC), Canada due to the increasingly toxic unregulated drug supply. Experimental evidence to support guidelines on the effectiveness of maintaining clients at different maintenance dosage levels is incomplete and outdated for the fentanyl era. Our objective is to assess the risk of treatment discontinuation and mortality among individuals receiving different maintenance dosage strategies for OAT with methadone, buprenorphine/naloxone or slow-release oral morphine (SROM) at the population level in BC, Canada.

We propose a retrospective population-level study of BC residents initiating OAT on methadone, buprenorphine/naloxone or SROM between 1 January 2010 and 31 December 2022 who were ≥18 years of age with no known pregnancy, no history of cancer diagnosis or receiving palliative care and not currently incarcerated. Our study will employ health administrative databases linked at the individual level to emulate a target trial per OAT type where individuals will be assigned to discrete maintenance dosing strategies, according to the full range observed in BC during the study period. Primary outcomes include treatment discontinuation and all-cause mortality. To determine the effectiveness of alternative maintenance doses, we will emulate a ‘per-protocol’ trial using a clone-censor-weight approach to adjust for measured time-dependent confounding by indication.

The protocol, cohort creation and analysis plan have been classified and approved as a quality improvement initiative by Providence Health Care Research Ethics Board and the Simon Fraser University Office of Research Ethics. All data are deidentified, securely stored and accessed in accordance with provincial privacy regulations. Results will be disseminated and shared with local advocacy groups and decision-makers, developers of national and international clinical guidelines, presented at national and international conferences and published in peer-reviewed journals electronically and in print.

Cervical cancer remains a significant global health concern and is the fourth most prevalent cancer among women. In South Africa, it is the leading cause of cancer-related deaths in women aged 15–44 years. The disease is typically preceded by persistent high-risk HPV infection, leading to cervical intraepithelial neoplasia and eventually cancer. Currently, in South Africa, management primarily involves excision, particularly through large loop excision of the transformation zone, which has associated risks and limitations. Thermal ablation is an alternative cost-effective treatment method, providing a straightforward approach to treatment, particularly advantageous in environments characterised by limited resources. The study aims to assess the efficacy, safety and patient experience of thermal ablation, providing valuable data for potential integration into South Africa’s cervical cancer prevention policies.

Randomised controlled trial in which 420 women living with HIV aged 30–60 years will be recruited from the Colposcopy Clinic at Tygerberg Hospital and will be followed up for a period of two years. The primary study endpoint is a test of cure that will be assessed by HPV genotyping, cervical cytology and histology at six month intervals. Other endpoints include the occurrence of adverse events.

The study protocol has been approved by the Health Research Ethics Committee of Stellenbosch University (Ethics Reference No: M20/11/035) and by the Western Cape Department of Health and Wellness via the National Health Research Database (WC_202109_016). All study procedures comply with the Declaration of Helsinki, South African Good Clinical Practice Guidelines and the Medical Research Council’s ethical guidelines. Trial results will be disseminated through peer-reviewed journals, national and international conference presentations and professional associations. A lay summary will be shared with the Community Advisory Board to guide community-level dissemination.

Pan African Clinical Trial Registry: PACTR202504820339039.

Chronic low back pain (CLBP) and depressive symptoms (DS) are highly prevalent, burdensome, costly and comorbid health conditions. Osteopathic manipulative treatment (OMT) was shown to improve pain and disability in patients with CLBP; however, the effect on comorbid DS remains less certain. Interestingly, CLBP and DS seem to be associated with changes in interoception, which may be reversed by OMT.

The study protocol proposes a single-blinded, parallel-group, randomised controlled trial to investigate the effect of OMT on clinical symptoms (depression, pain and disability) and interoceptive functions (interoceptive accuracy, sensibility and awareness) in patients with CLBP and comorbid DS. A sample of 60 adult subjects with CLBP and comorbid DS shall be recruited from osteopathic, orthopaedic and physiotherapeutic practices and educational institutes for osteopathy, sports science, psychology and medicine in Hamburg, Germany. Participants will be randomly allocated (1:1 ratio) to receive six 45 min treatment sessions of either OMT (standard-OMT group) or sham treatment imitating OMT (sham-OMT group). Primarily, symptoms of depression, pain and disability will be assessed with the Beck’s Depression Inventory, Second Edition (BDI-II), Numeric Rating Scale (NRS) and Oswestry Disability Index (ODI). Secondarily, interoceptive accuracy, sensibility and awareness will be evaluated using the Heartbeat Tracking Task (HTT), Multidimensional Assessment of Interoceptive Awareness (MAIA-2) and confidence-accuracy correspondence (CAC). Ancillary, the therapeutic alliance will be investigated with the Helping Alliance Questionnaire. Data will be collected at baseline (t₀), the first, third and sixth treatment sessions (t₁, t₃, t₆) and at 3 months follow-up (t₇). The findings will be analysed for between-group differences using descriptive (mean and SD) and inductive statistics (mixed analysis of variance). It is hypothesised that standard-OMT, compared with sham-OMT, will reduce depression, pain and disability (BDI-II, NRS, ODI) and increase interoceptive accuracy, sensibility and awareness (HTT, MAIA-2, CAC) in patients with CLBP and comorbid DS.

The study was approved by the ethics committee of the Medical School Hamburg (MSH-2023/288). The anonymised dataset will be published in an online repository, and the results will be published in peer-reviewed scientific journals.

DRKS00031694.

In this case study conducted in a Danish general practice, we aimed to explore how patients with obesity experience a novel treatment approach: group consultations (GCs) for weight loss, lifestyle changes and semaglutide treatment. To receive semaglutide treatment, patients were required to participate in GCs focused on lifestyle changes.

A qualitative study design comprising individual, semistructured interviews was used. Patients were asked to reflect on and describe their past experiences with participating in GCs. Thematic analysis was used as an analytical strategy.

A general practice located in a larger city in the Region of Southern Denmark.

12 patients (eight women and four men) with obesity, aged between 27 years and 69 years, who met the Danish obesity treatment criteria for semaglutide (body mass index over 30 kg/m² or over 27 kg/m² with comorbidities), were included. Data were collected from 1 November 2023 to 31 January 2024.

Before attending GCs, patients were worried about sharing personal information with other patients and losing their confidentiality. They also feared being judged by the others in the group, possibly due to previous experiences of stigmatisation. However, after participating in GCs, patients reported positive experiences with peer sharing, had no issues with confidentiality and found the consultations beneficial. Most patients indicated a preference for GCs over one-on-one consultations in the future.

Despite initial concerns about confidentiality and stigmatisation, patients ultimately had positive experiences and gained valuable peer support during group GCs in general practice. Various aspects of the group design, such as the hybrid consultation format and the role of the facilitator, may impact the effectiveness of peer support and influence patients’ overall experience of GCs.

Methadone and buprenorphine/naloxone are effective medications for people with opioid use disorder; however, interruptions in daily dosing are common and diminish the benefits of these medications. While clinical guidelines in most North American jurisdictions, including British Columbia (BC), recommend dose adjustment after treatment interruptions to varying levels of specificity, the evidence to support these recommendations is limited. We aim to estimate the comparative effectiveness of alternative dose adjustment strategies on subsequent overdose-related acute care visits and discontinuation of opioid agonist treatment in BC, Canada.

Using a linkage of nine health administrative databases, we propose a population-level retrospective cohort study of adults aged 18 years or older in BC who initiated methadone or buprenorphine/naloxone between 1 January 2010 and 31 December 2022. We will specify parallel hypothetical trials, known as target trials, for methadone interruptions of 1–3 days, 4 days and 5–14 days, and buprenorphine/naloxone interruptions of 1–5 days and 6–14 days. Following the index interruption, the primary outcomes are the time to overdose-related acute care visits and treatment discontinuation (interruptions lasting >14 days), with time to all-cause acute care visits as a secondary outcome. The intention-to-treat effect will be estimated using both propensity score and instrumental variable approaches. A range of sensitivity analyses will assess the robustness of our results, including cohort and timeline restriction, alternative definitions of exposure and outcome and alternative estimation strategies.

The protocol, cohort creation and analysis plan have been classified and approved as a quality improvement initiative by Providence Health Care Research Institute and the Simon Fraser University Office of Research Ethics. All data are deidentified, securely stored and accessed in accordance with provincial privacy regulations. Results will be disseminated to local advocacy groups and decision-makers, national and international clinical guideline developers, presented at international conferences and published in peer-reviewed journals electronically and in print.

Secondary and tertiary renal hyperparathyroidism (RHPT) are common sequelae of chronic kidney disease and are associated with worse patient mortality and quality of life. Clinical guidelines remain lacking with regard to recommendations for using intraoperative parathyroid hormone (IOPTH) during surgery for RHPT. A prospective randomised study will help evaluate the role of IOPTH in guiding surgery for secondary and tertiary RHPT.

Intraoperative parathyroid hormone monitoring to guide surgery in renal hyperparathyroidism is a pragmatic, multicentre, five-arm, parallel-group, patient-blinded and outcome assessor-blinded prospective pilot trial used to evaluate the feasibility of performing a definitive trial. Eligible participants include adult patients diagnosed with secondary or tertiary hyperparathyroidism who are candidates for subtotal or total parathyroidectomy. Consenting patients will be randomly assigned, through central allocation, in a 1:1:1:1:1 fashion to undergo surgery with IOPTH monitoring (four experimental arms: postexcision IOPTH samples taken at 10, 15, 20 or 25 min) or to undergo surgery without IOPTH monitoring (control arm). The primary feasibility objective is to estimate the percentage of eligible patients that are randomised: ≥70% proceed; 50–69% modify protocol before proceeding;

Ethics approval was obtained from the Hamilton Integrated Research Ethics Board. Pilot trial results will be shared widely through local, national and international academic and clinical networks and will be disseminated through conference presentations and publication in peer-reviewed journals.

NCT06542315, registered on 6 August 2024.

Congenital cytomegalovirus (cCMV) is an important cause of long-term childhood disability. In Australia, the identification and treatment practices and the long-term clinical and neurodevelopmental outcomes of children with cCMV are unknown. The Australasian cCMV Register (ACMVR) is a longitudinal register and resource for research that aims to describe and explore, in Australian children with cCMV: (1) their clinical characteristics over time, (2) antiviral therapy use/prescribing up to 1 year of age and (3) risk factors and potential avenues for prevention of adverse sequelae of the virus.

Children

Ethics and governance approvals, study database and a steering group have been established. Data collection is active in five sites across Australia.

The ACMVR will inform our understanding of the long-term outcomes for children with cCMV in Australia and provide a sampling frame and resource for recruitment in future clinical and epidemiological research to inform practice and policy. New opportunities for the establishment of additional study sites and collaborations with Australian maternity and fetal medicine researchers and with cCMV registries in other countries are currently being explored.

We aimed to estimate prevalence and identify determinants of hypertension in adults aged 15–49 years in Tanzania.

We analysed cross-sectional survey data from the 2022 Tanzania Demographic and Health Survey and Malaria Indicator Survey conducted between February and July 2022. Descriptive statistical analysis, logistic regression, machine learning and geospatial methods were used to estimate prevalence and determine determinants of hypertension.

Tanzania.

A total of 13 385 participants aged 15–49 years were included in the analysis.

The primary outcome variable was hypertension, defined as either systolic blood pressure (BP)≥140 and/or diastolic BP≥90 mm Hg or under anti-hypertensive drugs.

The prevalence of hypertension among adults of reproductive age was 11% (95% CIs 10.09 to 11.56) in Tanzania, varying significantly across risk factors. Prevalence was high in people aged 40–49 (22.11%, 95% CI 20.07 to 24.29) and obese (23.69%, 95% CI 20.67 to 27.00). The mean prevalence of hypertension was also high in the southern, eastern, western, southern highlands, north-west and north-eastern part of the country, correlating with the spatial distribution of older age (30–49) and higher body mass index (BMI) (≥25). Individuals aged 40–49 had nearly six times (adjusted OR (AOR): 5.68, 95% CI 4.10 to 7.83) the odds of hypertension relative to those aged 15–19. Obese individuals had higher odds (AOR: 2.88, 95% CI 2.01 to 4.13) compared with overweight individuals (AOR: 1.93, 95% CI 1.36 to 2.74). Machine learning results showed age and BMI as the most important determinants of hypertension and that significant interactions between risk factors exist.

The prevalence of hypertension varied across risk factors and the strongest determinants of hypertension in adults of reproductive age were age and BMI.

Urinary tract infections (UTIs) are highly prevalent and pose a significant burden among older adults. Accurate diagnosis in this population is challenging due to the high prevalence of pre-existing lower urinary tract symptoms, inability to express symptoms and asymptomatic bacteriuria. Current diagnostic tests are unreliable, often resulting in over- and underdiagnosis. A previous pilot study proposed a higher cut-off for pyuria and identified five promising biomarkers for the diagnosis of UTIs in older adults. The UTI-GOLD study aims to validate these five new biomarkers and the higher leucocyte cut-off as a diagnostic tool for UTIs in older people in a real-world setting.

Between August 2024 and December 2027, an observational multicentre diagnostic accuracy study is being conducted across primary, secondary and tertiary healthcare facilities in the Netherlands and the UK. Adults ≥65 years with a suspected UTI will be considered eligible. Patients with pre-existing decision-making incapacity or an indwelling catheter will be excluded. UTI will be defined according to an international consensus-based reference standard. Biomarkers will be measured by liquid chromatography-mass spectrometry (neutrophil gelatinase-associated lipocalin, tissue inhibitor of metalloproteinase 2 and CXC motif chemokine ligand 9) and enzyme-linked immunosorbent assay (interleukin 6 and azurocidin). Pyuria will be quantified by automated microscopy and/or flow cytometry. Diagnostic accuracy measures will be calculated using the receiver operating characteristic curves, and sensitivity, specificity, likelihood ratios and predictive values will be reported for optimal cut-offs.

The protocol was reviewed by the local Leiden University Medical Center research committee, who declared on 15 April 2024 that the medical research involving human subject act (Dutch abbreviation: WMO) does not apply to the current study (reference number nWMODIV2_2024025). The study also received approval from the NHS Research Ethics Committee in the UK (reference number 24/LO/0649).

The study findings will be published in a peer-reviewed journal, presented at academic congresses and shared with healthcare providers.

The study was registered at clinicaltrial.gov on the 24 September 2024 with registration number: NCT06610721.