The TRAjectory of knee heaLth in runners (TRAIL) study is a prospective cohort study investigating the long-term knee health trajectories of runners with and without a heightened osteoarthritis risk. This study aims to describe the recruitment results and baseline characteristics of the TRAIL cohort.

Runners aged 18–50 years and running ≥3 times and ≥10 km per week on average in the past 6 months were eligible. Participants were recruited via running podcasts, running clubs and social media between July 2020 and August 2023. Data were collected at study enrolment and at a face-to-face baseline testing session, which occurred a median of 33 weeks (IQR 18 to 86 weeks) after enrolment. Follow-up data collection is ongoing.

Out of 462 runners who completed an online registration form, 268 runners enrolled, of which 135 had a history of knee surgery (46% females) and 133 were non-surgical controls (50% females). 60% of the surgery group had undergone anterior cruciate ligament reconstruction, 33% meniscus and/or cartilage surgery, and 7% other knee surgery. 54 participants previously enrolled were unable to continue in the study before attending baseline data collection. Of the 214 runners who remained in the study and attended baseline data collection, 108 had a history of knee surgery (49% females) and 106 did not have a history of knee surgery (51% females).

Participants will be followed for 10 years through ongoing patient-reported outcomes and continuous monitoring of training loads using wearable devices. At baseline, 4- and 10-year follow-up, knee MRI and knee-health patient-reported outcomes will be collected to evaluate structural and symptomatic knee osteoarthritis progression. Data will inform guidelines for safe running practices and rehabilitation post-knee surgery.

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.

Gestational diabetes mellitus (GDM) is an emerging public health concern in low and middle-income countries, including Nigeria, because of the associated pregnancy complications, increased healthcare costs and long-term health sequelae among women of reproductive age and their offspring. We determined the cumulative incidence, risk factors and pregnancy outcomes of GDM in Ibadan, Nigeria.

Prospective cohort study.

Ibadan, Southwest Nigeria.

721 pregnant women from the Ibadan Pregnancy Cohort Study participated in the one-step 75 g-oral glucose tolerance test at 24–28 weeks’ gestation.

The primary outcome of the study is the cumulative incidence of GDM. GDM was diagnosed according to the International Association of Diabetes and Pregnancy Study Groups criteria. Secondary outcomes were pregnancy outcomes, which included modes of delivery (CS, spontaneous vaginal delivery), macrosomia (birth weight ≥4.0 kg), gestational age at delivery and birth asphyxia. The risk factors (exposures) examined included sociodemographic, obstetric, clinical, behavioural and lifestyle factors. Bivariate and multivariate Log-binomial regression models were used to identify the independent risk factors of GDM (adjusted for maternal age ≥35 years, income, maternal body mass index, history of pregnancy loss and congenital anomaly) and the associated pregnancy outcomes of GDM (adjusted for maternal age, income and maternal body mass index). Adjusted relative risk (aRR) and 95% CI, used to assess the strength of associations, were reported.

The cumulative incidence of GDM was 20.7%, 95% CI (17.9% to 23.9%). The mean time for the diagnosis of GDM is 25.4±1.42 weeks of gestation. After adjusting for other variables, maternal age ≥35 years: (aRR: 1.48). 95% CI (1.07 to 1.97) p=0.016), maternal obesity (aRR: 1.85, 95% CI (1.26 to 2.30) p=0.002) and a previous history of congenital anomaly (aRR: 2.83, 95% CI (1.97 to 4.07) p

The cumulative incidence of GDM is high among pregnant women in Ibadan. Maternal age ≥35 years, maternal obesity and a history of congenital anomaly were significant independent risk factors for GDM. These factors should be targeted for public health interventions, including lifestyle modification among pregnant women with obesity and early screening and diagnosis of GDM.

The objective of this scoping review is to map and synthesise existing literature on interventions aimed at promoting healthy screen use among adolescents. This review identifies the types, functions and settings of interventions, explores the diversity of targeted outcomes and highlights equity considerations and research gaps.

We conducted a scoping review in accordance with the Arksey and O’Malley framework and reported following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews guidelines.

We systematically searched Medline, PsycINFO and ERIC from January 2013 to June 2024. Reference lists of included studies were also manually screened.

We included peer-reviewed experimental, quasi-experimental, observational and qualitative studies reporting on interventions designed to promote healthy screen use among adolescents aged 10–19 years.

One author extracted data using a structured charting form, and a second author verified all entries. Results were synthesised descriptively across key themes including target populations, theoretical frameworks, intervention components and reported outcomes.

From 6433 records, we identified 93 articles on 81 interventions, mainly conducted in high school settings in the USA and Australia. Most examined short-term interventions targeting recreational screen time. Outcomes included media literacy, cyberbullying, internet and gaming addiction, safe internet use, social media use and mental and sexual health. Seventy-eight per cent of interventions attempted to educate adolescents, while 34% offered training activities (eg, educational sessions to elevate risk awareness and skill-based training to enhance digital literacy and self-regulation). Interventions targeting external influences were used less frequently. About 20% of studies showed no statistically significant findings, highlighting the need to promote evidence-based interventions.

This review identifies a need for broader, multilevel strategies that account for contextual factors and social determinants in influencing screen use and its related health issues. Future research should explore long-term effectiveness while examining the potential moderating and mediating effects of social determinants. Equity considerations were not a primary focus of most interventions, underscoring an important gap in this literature. Future interventions could incorporate equity-focused design and evaluation to ensure they respond to the needs of diverse adolescent populations.

(1) Analyse in depth an exemplar safety-critical task required of newly qualified doctors (prescribing insulin) and (2) Provide transferable insights into how undergraduate education could better educate medical students to meet the demands of practice when they become postgraduate trainees.

Document analysis of doctors’ reported experiences of insulin prescribing, an everyday task that has an emergent logic of practice and harms not just patients but (psychologically) new doctors. Application of third-generation (social emergence) complexity theory to explore why practice can be ‘mutually unsafe’.

A system of care comprising all five Northern Irish (UK) Health and Social Care Trusts, which together provide healthcare to a population of nearly two million people.

68 postgraduate year 1 and year 2 trainees (PGY1/2s), mainly PGY1s.

Thick description of new doctors’ contexts of action, reasons for acting and specific actions. We present this as a narrative compiling all 68 stories, 13 detailed exemplar stories and a diagram summarising how multiple factors interacted to make practice complex.

Situations that required PGY1/2s to act had interacting layers of complexity: (1) disease trajectories; (2) social dynamics between stakeholders and (3) contextual influences on stakeholders’ interactions. Out-of-hours working and unsuitable wards intensified troublesome contextual influences. All three individually complex layers ‘crystallised’ briefly to create ‘moments of action’. At best, PGY1/2s responded proactively, ‘stretched time’ and checked the results of their actions. At worst, PGY1/2s ‘played safe’ in unsafe ways (eg, took no action), acted on unsafe advice or defaulted to actions protecting them from criticism. Informal, pervasive rules emerged from, and perpetuated, unsafe practice.

New doctors’ work includes acting on indeterminate, emergent situations whose complexity defies rules that are determinate enough to be taught off the job. If new doctors are to perform capably in moments of action, medical students need ample, supervised, situated experience of what it is like to take responsibility in such moments.

Coronary artery disease (CAD) is a major cause of morbidity and mortality worldwide, and detecting CAD in stable chest pain patients is challenging but crucial for early intervention. Strain and strain rate (S/SR) imaging offers a non-invasive method to assess myocardial function and detect coronary stenosis before symptoms occur. In this study, we aimed to demonstrate how effectively and accurately resting strain echocardiography can diagnose CAD.

We conducted a prospective diagnostic accuracy study of patients with chest pain who were referred for CT coronary angiography (CCTA).

Single-centre study conducted in the University Hospital of North Norway in Tromsø, Norway between 2016 and 2021.

A total of 510 patients with chest pain were included in the present study.

Echocardiography examination with S/SR imaging was performed.

Echocardiography findings were compared with CCTA and coronary angiography findings. A novel scoring model incorporating S/SR parameters was developed to assess diagnostic accuracy.

In this study, we showed that receiver operating characteristic curve analysis of early diastolic strain rate (SRe), systolic strain rate (SRs) and peak longitudinal strain (PLS) has high sensitivity and specificity with area under the curve (AUC) scores: SRe, 0.91; PLS, 0.81; SRs, 0.71 in identifying patients undergoing coronary artery bypass graft (CABG). However, these parameters showed lower sensitivity and specificity with AUC scores: SRe, 0.580; SRs, 0.539; PLS, 0.552 in detecting patients undergoing percutaneous coronary intervention (PCI).

Our study emphasises the potential of S/SR imaging in detecting CAD, particularly in high-risk CABG patients. However, its diagnostic utility in PCI patients is limited. Our study highlights the need for comprehensive approaches in coronary disease prediction.

Physicians frame medical information for patients in different ways, impacting patient outcomes. What underlies their framing choices has not been investigated. 

To explore the use and function of information framing practices in medical interactions.

Explorative, quantitative observational study with a mixed-methods design.

28 videorecorded hospital interactions, ranging from short-term/acute (orthopaedic surgery, gynaecology) to long-term/chronic care (oncology, gastroenterology) and involving 14 physicians and 28 patients.

Using a previously developed coding system, we analysed physicians’ framing practices. We extracted information sharing functions qualitatively, checking 10% of the analysis with an independent assessment from the physicians. To explore whether variation in physicians’ use of information frames stemmed from individual or clinical specialty differences, we estimated intraclass correlations. To assess how their use of information frames varied at the macro level (across clinical specialties) and micro (the immediate function in the interaction), we estimated linear mixed models adjusted for the number of words.

Variation in framing practices was mainly observed at the level of physicians nested within the same clinical unit (9.5% of the overall variance explained vs 1.3% for the unit level and 0.7% for the individual level). Physicians from different clinical units differed significantly in how they framed information, with the main differences between the gastroenterology and oncology units (mean difference=1.88; 95% CI 0.97; 2.79; p2 tests). Physicians from more short-term care units were oriented towards shared understanding, from gastroenterology towards inviting and convincing efforts and from oncology towards personal communication.

Results revealed signature marks of clinical units in terms of information sharing practices. Physicians’ information framing choices were driven both by the macro level (the clinical unit) and micro (the specific function for sharing information at that moment), thus highlighting potential areas for future interventions.

Injury is a major cause of death in Rwanda, with many deaths occurring before hospital admission. Timely transport of injured patients to appropriate hospitals is crucial, ideally within an hour for severely injured patients. However, delays in reaching treatment facilities are common, with ambulance services using inefficient mobile phone communication. This project aims to evaluate the effectiveness and implementation of an innovative electronic communication platform (912Rwanda).

The study will be conducted through the public ambulance service, Service d’Aide Médicale d’Urgence (SAMU), and receiving health facilities in Kigali city and Musanze district in Rwanda. The 912Rwanda intervention will be rolled out in the two locations at different times. The primary effectiveness outcome is the time from ambulance deployment to patient arrival at the health facility. Secondary effectiveness outcomes include disaggregated times of the primary outcome and clinical outcomes, such as length of stay and requirement for intensive care. These outcomes will be evaluated using an interrupted time series analysis, accounting for non-homogeneous variances, auto-regressive errors and non-linear trends where appropriate. Implementation outcomes will be evaluated using the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) Qualitative Evaluation for Systematic Translation (QuEST) framework. Cost-effectiveness will be evaluated using a cost-consequence analysis with consequences as determined by the interrupted time series analysis.

Ethical approval was obtained from the Rwanda National Research Ethics Committee (Ref No: 99/RNEC/2023). Dissemination will occur through open-access peer-reviewed publications, relevant national and international conferences.

ISRCTN97674565.

Cohort studies of ageing and cognitive decline typically do not begin fielding comprehensive cognitive assessments until older adulthood. However, for identifying preventable dementia risk factors, there is strong value in beginning at earlier ages. The case is especially compelling in sub-Saharan Africa, where the number of older individuals is expected to triple in the next three decades, and where risk factors may operate more intensively at earlier ages. This study reports on the adaptation and validity of the Harmonised Cognitive Assessment Protocol (HCAP) approach in the Kenya Life Panel Survey (KLPS), collected among middle-aged respondents.

To evaluate the validity of the HCAP approach in Kenya, this study assesses model fit statistics from confirmatory factor analyses (CFA) and tests measurement invariance by respondent characteristics.

Both rural and urban areas in Kenya.

A sample of n=5878 individuals from the KLPS, who have been surveyed regularly since they were schoolchildren in the 1990s. The HCAP assessment was administered in 2023 at an average age of 37 years (10–90 range 34 to 41).

For each individual, the CFA generates a general cognitive performance score, and cognitive performance scores for five distinct domains, including memory, executive functioning, language, orientation to time and place, and visuospatial functioning.

Fit of the models to the data was adequate for general cognitive performance (root mean squared error of approximation (RMSEA)=0.03; comparative fit index (CFI)=0.94; standardised root mean residual (SRMR)=0.05), language (RMSEA=0.02; CFI=0.95; SRMR=0.05) and good for memory (RMSEA=0.05; CFI=0.99; SRMR=0.02) and executive functioning (RMSEA=0.03; CFI=0.98; SRMR=0.03). The CFA indicate that the factor structure is consistent with findings from other countries and that reliability for the general cognitive performance score was high. Statistical models also suggest invariance at the scalar level for leading demographic (gender, age) and socioeconomic (education, occupational complexity) characteristics.

This study demonstrates that the cognitive functioning of mid-age Kenyans appears to be well captured by the adapted protocol. While there is a moderate decline in cognitive performance among older individuals, this relationship appears to be mediated by education, indicating that this KLPS HCAP provides a valuable baseline for studying future cognitive decline.

Diagnosing pulmonary tuberculosis (PTB) in children is challenging owing to paucibacillary disease, non-specific symptoms and signs and challenges in microbiological confirmation. Chest X-ray (CXR) interpretation is fundamental for diagnosis and classifying disease as severe or non-severe. In adults with PTB, there is substantial evidence showing the usefulness of artificial intelligence (AI) in CXR interpretation, but very limited data exist in children.

A prospective two-stage study of children with presumed PTB in three sites (one in South Africa and two in Pakistan) will be conducted. In stage I, eligible children will be enrolled and comprehensively investigated for PTB. A CXR radiological reference standard (RRS) will be established by an expert panel of blinded radiologists. CXRs will be classified into those with findings consistent with PTB or not based on RRS. Cases will be classified as confirmed, unconfirmed or unlikely PTB according to National Institutes of Health definitions. Data from 300 confirmed and unconfirmed PTB cases and 250 unlikely PTB cases will be collected. An AI-CXR algorithm (qXR) will be used to process CXRs. The primary endpoint will be sensitivity and specificity of AI to detect confirmed and unconfirmed PTB cases (composite reference standard); a secondary endpoint will be evaluated for confirmed PTB cases (microbiological reference standard). In stage II, a multi-reader multi-case study using a cross-over design will be conducted with 16 readers and 350 CXRs to assess the usefulness of AI-assisted CXR interpretation for readers (clinicians and radiologists). The primary endpoint will be the difference in the area under the receiver operating characteristic curve of readers with and without AI assistance in correctly classifying CXRs as per RRS.

The study has been approved by a local institutional ethics committee at each site. Results will be published in academic journals and presented at conferences. Data will be made available as an open-source database.

PACTR202502517486411

While group, task-oriented, community-based exercise programs (CBEPs) delivered in-person can increase exercise and social participation in people with mobility limitations, challenges with transportation, cost and human resources, threaten sustainability. A virtual delivery model may help overcome challenges with accessing and delivering in-person CBEPs. The study objective is to estimate the short-term effect of an 8-week, virtual, group, task-oriented CBEP called TIME™ (Together in Movement and Exercise) at Home compared with a waitlist control on improving everyday function in community-dwelling adults with mobility limitations.

A randomised controlled trial incorporating a type 1 effectiveness-implementation hybrid design is being conducted in four Canadian metropolitan centres. We aim to stratify 200 adults with self-reported mobility limitations by site, participation alone or with a partner, and functional mobility level, and randomise them using REDCap software to either TIME™ at Home or a waitlist control group. During TIME™ at Home classes (2 classes/week, 1.5 hours/class), two trained facilitators stream a 1-hour exercise video and facilitate social interaction prevideo and postvideo using Zoom. A registered healthcare professional at each site completes three e-visits to monitor and support implementation. Masked evaluators with physical therapy training evaluate participants and their caregivers at 0, 2 and 5 months using Zoom. The primary outcome is the change in everyday function from 0 to 2 months, measured using the physical scale of the Subjective Index of Physical and Social Outcome. The study is powered to detect an effect size of 0.4, given α=0.05, power=80% and a 15% attrition rate. Secondary outcomes are mobility, well-being, reliance on walking aids, caregiver assistance, caregiver mood, caregiver confidence in care-recipient balance and cost-effectiveness. A multimethod process evaluation is proposed to increase understanding of implementation fidelity, mechanisms of effect and contextual factors influencing the complex intervention. Qualitative data collection immediately postintervention involves interviewing approximately 16 participants and 4 caregivers from the experimental group, and 8 participants and 4 caregivers from the waitlist control group, and all healthcare professionals, and conducting focus groups with all facilitators to explore experiences during the intervention period. A directed content analysis will be undertaken to help explain the quantitative results.

TIME™ at Home has received ethics approval at all sites. Participants provide verbal informed consent. A data safety monitoring board is monitoring adverse events. We will disseminate findings through lay summaries, conference presentations, reports and journal articles.

NCT06245135.

Older crime victims may be particularly vulnerable to psychological distress.

To compare the clinical effectiveness of a Victim Improvement Package (VIP) to treatment as usual (TAU) for reducing continued crime-associated distress.

A three-step parallel-group single-blind randomised controlled trial.

Police-reported victims of community crime aged 65 and over were recruited from 12 local authority areas in a major urban city in England, UK.

Selection criteria—inclusion: victims of community crime aged 65 years or more, with significant Generalised Anxiety Disorder (GAD-2) and Patient Health Questionnaire (PHQ-2) distress associated with the crime. Exclusion: type of crime, diagnosis, receipt of cognitive–behavioural therapy (CBT) in the last 6 months; an inability to participate in CBT; cognitive impairment. Participants were typical of our local authority population; 71% were female, 69% white, with the majority of crimes associated with burglary (35%) and theft (26%). 67% (88/131) of the randomised participants were included in the primary analysis.

TAU was compared with TAU plus up to 10 sessions of a cognitively-behaviourally informed VIP, delivered by a mental health charity over 12 weeks.

Timings are in relation to the crime; baseline (3 months), post-VIP intervention (6 months) and follow-up (9 months). The primary outcome was a composite of the Beck Anxiety and Beck Depression Inventories. The primary endpoint was 6 months.

24% (4255/17 611) of reported crime victims were screened, 35% (1505/4255) were distressed. Of 60% (877/1505) rescreened at 3 months, 49% (427/877) remained distressed. Out of our target of 226, 131 participants were randomised; 65 to VIP and 66 to TAU alone. 68% (89/131) completed the primary outcome (post-intervention). The VIP showed no overall benefit; mean VIP –0.41 (SD 0.89) vs mean TAU –0.19 (SD 1.11); standardised mean difference –0.039; 95% CI (–0.39, 0.31), although stratified analyses suggested an effect in burglary victims (n=27, standardised mean difference –0.61; 95% CI (–1.22, –0.002), p=0.049).

Community crime had long-lasting impacts. The police are ideally placed to screen for distress, present in 35% of victims, but only 58% of participants were recruited and the cognitive–behavioural therapy was not delivered competently. Further research on victim care and improving the delivery and quality of therapy is required.

All procedures were approved by the University College London (UCL) Research Ethics Committee on 17 March 2016 (6960/001). International Standard Randomised Controlled Trial Number is ISRCTN16929670: https://doi.org/10.1186/ISRCTN16929670.

The association between smoking and patients with schizophrenia has been established through epidemiological studies on various populations. This behaviour not only increases the risk of medical comorbidities associated with smoking, but it can also interfere with treatment and ultimately worsen prognosis. This study aims to determine if nicotine use affects the cumulative number of psychiatric hospitalisations in patients with schizophrenia.

This is a retrospective cohort study using 2018–2023 electronic medical record data.

Data was collected at an inpatient psychiatric hospital in Central California.

There were a total of 825 patients with diagnoses of schizophrenia or schizoaffective disorder who were admitted to the mental health hospital between 2018 and 2023.

The primary outcome of interest was the number of psychiatric hospitalisations observed among the patients who were smokers versus those who were non-smokers. Our secondary objective was to determine the prevalence of certain medical comorbidities between these two groups.

60.7% of patients had a lifetime smoking history. Accounting for matching, patients who smoked had significantly (p

Patients with schizophrenia and a lifetime smoking history had significantly more hospitalisations compared with patients with schizophrenia who were non-smokers. This can inform disease course in vulnerable populations with a greater propensity to self-medicate with substances. However, further research should be conducted to investigate other factors that can affect this relationship.

Transporting critically ill patients between medical facilities can be hazardous and costly. Whether by road, fixed-wing aircraft or helicopter, many professional associations have proposed strategies to efficiently and safely transport patients at high risk of instability. Although these strategies have been assessed in some studies, no comprehensive synthesis of their benefits has been conducted to date. The aim of this study is to assess the effect of strategies to improve the safety and costs of interhospital transports for critically ill patients.

We will conduct a systematic review according to the Cochrane guidelines. The review will include randomised controlled trials (RCTs), cohort studies and case-control studies assessing the effect of interventions to improve interhospital transports of critically ill patients on safety and costs. We will search multiple electronic databases (PubMed, EMBASE, CINAHL, Web of Science, Cochrane Library) from inception to 6 months prior to the submission of the final manuscript. Screening by title and abstract, full-text screening, data extraction and quality assessment will be performed by two independent reviewers. We will assess the risk of bias with the Cochrane revised tool for RCTs and with the risk of bias in non-randomised studies of interventions tool. If possible, we will calculate pooled effect estimates and 95% CIs to assess the effect of the interventions. We will also assess heterogeneity using the I² index and rate the certainty of evidence with the Grading of Recommendations Assessment, Development and Evaluation tool and trial sequential analysis.

Ethics approval is not required for this review. The results of this systematic review will be shared through publication in a peer-reviewed journal, conference presentations and our network of knowledge user collaborators.

International Prospective Register of Systematic Reviews (CRD42024595080).

Raltegravir is a potent HIV-integrase strand transfer inhibitor (INSTI). Despite its strong activity against HIV-1 strains resistant to other antiretroviral drug classes, it is usually used in combination with other antiretroviral drugs due to the empirical requirement for anti-HIV drug combinations to ensure effective anti-retroviral therapy (ART). As an early-arriving INSTI, raltegravir is clinically familiar for its safety, tolerability and treatment effectiveness. High-dose calcium carbonate formulated as an antacid (as opposed to a supplement formulation) taken orally together with raltegravir is known to reduce systemic raltegravir exposure due to chelation and reduced absorption. This study aims to assess the effect of daily calcium carbonate antacid as TUMS Ultra Strength (US) administration in lower doses, as currently used for oral calcium supplementation, on the steady-state pharmacokinetics (PKs) of once-daily oral raltegravir.

This is an open-label, three-treatment series in three periods in a single group, fixed-sequence PK study in 12 healthy adult volunteers with HIV on ART. Subjects will take 1200 mg of raltegravir single QD oral dose alone for 7 days (period one), then raltegravir 1200 mg with calcium carbonate 500 mg from day 8 to day 14 (period two) and raltegravir 1200 mg with calcium carbonate 1000 mg from day 15 to day 22 (period three). We will conduct serial PK sampling from observed dosing on days 7, 14 and 21, with 24-hour PK sampling scheduled for days 8, 15 and 22. Follow-up will continue until day 51.

This study will adhere to the ICH GCP Guidelines and the Declaration of Helsinki. Ethics approval was obtained from the Ottawa Health Science Network Research Ethics Board under study ID 20190750–01 hour. Informed consent will be obtained from all participants prior to enrolment. This protocol will be published in a peer-reviewed journal prior to the study’s completion and closure. Results generated from this activity will also be reported in a peer-reviewed journal.

NCT04258475.

Delays in getting injured patients to the hospital in a timely manner can increase avoidable death and disability. Like many low-income or middle-income countries, Rwanda experiences delays related to a lack of efficient prehospital communication and formal guidelines to triage patients for hospital care. This study describes the protocol to develop, roll-out and evaluate the effectiveness of a destination decision support algorithm (DDSA) integrated in an electronic communication platform, ‘912Rwanda’. The DDSA will facilitate the linkage of patients to health facilities able to treat their condition(s).

Work will be conducted in the prehospital emergency service ‘Service d'Aide Médicale Urgente’ and health facilities in Kigali city and Musanze district, which serve predominantly urban and rural populations, respectively. We will develop interfaces to capture facility and patient-relevant data, which feed into a guideline-based electronic DDSA to match patients to hospitals. We will assess existing trauma care processes using qualitative and quantitative methodologies. This will be followed by a series of consensus workshops to develop at-scene triage guidelines and agree on variables to capture in the interfaces. The DDSA will be developed based on outputs from these workshops and will be tested against historical ambulance data and expert opinion until acceptable thresholds of performance are achieved. User interfaces will be developed and tested using human–computer interface design principles.

The combined collaborative approach of bringing together experts and software developers, and with deep engagement of Rwandan stakeholders, including leadership of Rwanda Ministry of Health through its technical arm, Rwanda Biomedical Center, should lead to an ambulance communication system which is used, sustained and effective.

The project was approved by the Rwanda National Research Ethics Committee. Annual reports will be disseminated to relevant stakeholders, followed by the public. Publications will be open access as per the funding policy.

ISRCTN97674565. Registered on 29 July 2024. https://doi.org/10.1186/ISRCTN97674565.