Globally, guideline-recommended antenatal care for smoking cessation is not routinely delivered by antenatal care providers. Implementation strategies have been shown to improve the delivery of clinical practices across a variety of clinical services but there is an absence of evidence in applying such strategies to support improvements to antenatal care for smoking cessation in pregnancy. This study aims to determine the effectiveness and cost effectiveness of implementation strategies in increasing the routine provision of recommended antenatal care for smoking cessation in public maternity services.

A non-randomised stepped-wedge cluster-controlled trial will be conducted in maternity services across three health sectors in New South Wales, Australia. Implementation strategies including guidelines and procedures, reminders and prompts, leadership support, champions, training and monitoring and feedback will be delivered sequentially to each sector over 4 months. Primary outcome measures will be the proportion of: (1) pregnant women who report receiving a carbon monoxide breath test; (2) smokers or recent quitters who report receiving quit/relapse advice; and (3) smokers who report offer of help to quit smoking (Quitline referral or nicotine replacement therapy). Outcomes will be measured via cross-sectional telephone surveys with a random sample of women who attend antenatal appointments each week. Economic analyses will be undertaken to assess the cost effectiveness of the implementation intervention. Process measures including acceptability, adoption, fidelity and reach will be reported.

Ethics approval was obtained through the Hunter New England Human Research Ethics Committee (16/11/16/4.07; 16/10/19/5.15) and the Aboriginal Health and Medical Research Council (1236/16). Trial findings will be disseminated to health policy-makers and health services to inform best practice processes for effective guideline implementation. Findings will also be disseminated at scientific conferences and in peer-reviewed journals.

Australian New Zealand Clinical Trials Registry—ACTRN12622001010785.

HIV drug resistance (DR) is a growing threat to the durability of current and future HIV treatment success. DR testing (DRT) technologies are very expensive and specialised, relying on centralised laboratories in most low and middle-income countries. Modelling for laboratory network with point-of-care (POC) DRT assays to minimise turnaround time (TAT), is urgently needed to meet the growing demand.

We developed a model with user-friendly interface using integer programming and queueing theory to improve the DRT system in Kisumu County, Kenya. We estimated DRT demand based on both current and idealised scenarios and evaluated a centralised laboratory-only network and an optimised POC DRT network. A one-way sensitivity analysis of key user inputs was conducted.

In a centralised laboratory-only network, the mean TAT ranged from 8.52 to 8.55 working days, and the system could not handle a demand proportion exceeding 1.6%. In contrast, the mean TAT for POC DRT network ranged from 1.13 to 2.11 working days, with demand proportion up to 4.8%. Sensitivity analyses showed that expanding DRT hubs reduces mean TAT substantially while increasing the processing rate at national labs had minimal effect. For instance, doubling the current service rate at national labs reduced the mean TAT by only 0.0%–1.9% in various tested scenarios, whereas doubling the current service rate at DRT hubs reduced the mean TAT by 37.5%–49.8%. In addition, faster batching modes and transportation were important factors influencing the mean TAT.

Our model offers decision-makers an informed framework for improving the DRT system using POC in Kenya. POC DRT networks substantially reduce mean TAT and can handle a higher demand proportion than a centralised laboratory-only network, especially for children and pregnant women living with HIV, where there is an immediate push to use DRT results for patient case management.

SCALE-UP II aims to investigate the effectiveness of population health management interventions using text messaging (TM), chatbots and patient navigation (PN) in increasing the uptake of at-home COVID-19 testing among patients in historically marginalised communities, specifically, those receiving care at community health centres (CHCs).

The trial is a multisite, randomised pragmatic clinical trial. Eligible patients are >18 years old with a primary care visit in the last 3 years at one of the participating CHCs. Demographic data will be obtained from CHC electronic health records. Patients will be randomised to one of two factorial designs based on smartphone ownership. Patients who self-report replying to a text message that they have a smartphone will be randomised in a 2x2x2 factorial fashion to receive (1) chatbot or TM; (2) PN (yes or no); and (3) repeated offers to interact with the interventions every 10 or 30 days. Participants who do not self-report as having a smartphone will be randomised in a 2x2 factorial fashion to receive (1) TM with or without PN; and (2) repeated offers every 10 or 30 days. The interventions will be sent in English or Spanish, with an option to request at-home COVID-19 test kits. The primary outcome is the proportion of participants using at-home COVID-19 tests during a 90-day follow-up. The study will evaluate the main effects and interactions among interventions, implementation outcomes and predictors and moderators of study outcomes. Statistical analyses will include logistic regression, stratified subgroup analyses and adjustment for stratification factors.

The protocol was approved by the University of Utah Institutional Review Board. On completion, study data will be made available in compliance with National Institutes of Health data sharing policies. Results will be disseminated through study partners and peer-reviewed publications.

ClinicalTrials.gov: NCT05533918 and NCT05533359.

We aimed to define the epidemiology of COVID-19 outbreaks in aged care facilities (ACFs) during the postvaccine period, including vaccine effectiveness (VE) for this high-risk group.

Systematic review and meta-analysis.

Ovid Medline, Ovid Embase, Scopus, Web of Science and Cochrane databases were searched through 1 September 2023.

Any original observational studies and trials reporting data on COVID-19 outbreaks among the partially/fully vaccinated residents from ACFs during or after the worldwide implementation of vaccine roll-out.

We estimated the attack rate, case fatality rate, mortality rate and VE during postvaccine period. Random effect model was adopted for meta-analysis. Quality assessment on all included studies was performed using the Meta Quality Appraisal Tool.

38 articles were included from 12 countries reporting 79 outbreaks with 1708 confirmed cases of COVID-19 from 78 ACFs. The pooled attack rate was 28% (95% CI 20% to 37%) among the fully vaccinated residents. Two-thirds (62.5%) of the index cases were unvaccinated healthcare professionals (eg, physicians, nurses) and caregivers. Unvaccinated residents had a significantly higher rates (12%) (95% CI 7% to 19%) of mortality compared with the vaccinated residents (2%) (95% CI% 1 to 4%) and the post-COVID-19 vaccine estimates for case fatality rate (13% vs 23%) and hospitalisation rate (17% vs 37%) were substantially lower. VE in preventing disease among residents in ACFs was 73% (95% CI 49% to 86). Overall, the included studies were heterogeneous in nature, however, the risk of bias was low to moderate.

Our study reaffirmed the impact of vaccination as a key public health measure to minimise the burden of COVID-19 in ACFs. Facilities with higher crowding indexes should be prioritised for vaccination and should advocate for higher vaccination targets among staff and residents as a critical intervention strategy to minimise disease burden in this vulnerable population.

Obesity increases the risk of morbidity and mortality. A major driver has been the increased availability of ultra-processed food (UPF), now the main UK dietary energy source. The UK Eatwell Guide (EWG) provides public guidance for a healthy balanced diet but offers no UPF guidance. Whether a healthy diet can largely consist of UPFs is unclear. No study has assessed whether the health impact of adhering to dietary guidelines depends on food processing. Furthermore, our study will assess the impact of a 6-month behavioural support programme aimed at reducing UPF intake in people with overweight/obesity and high UPF intakes.

UPDATE is a 2x2 cross-over randomised controlled trial with a 6-month behavioural intervention. Fifty-five adults aged ≥18, with overweight/obesity (≥25 to 2), and ≥50% of habitual energy intake from UPFs will receive an 8-week UPF diet and an 8-week minimally processed food (MPF) diet delivered to their home, both following EWG recommendations, in a random order, with a 4-week washout period. All food/drink will be provided. Participants will then receive 6 months of behavioural support to reduce UPF intake. The primary outcome is the difference in weight change between UPF and MPF diets from baseline to week 8. Secondary outcomes include changes in diet, waist circumference, body composition, heart rate, blood pressure, cardiometabolic risk factors, appetite regulation, sleep quality, physical activity levels, physical function/strength, well-being and aspects of behaviour change/eating behaviour at 8 weeks between UPF/MPF diets, and at 6-month follow-up. Quantitative assessment of changes in brain MRI functional resting-state connectivity between UPF/MPF diets, and qualitative analysis of the behavioural intervention for feasibility and acceptability will be undertaken.

Sheffield Research Ethics Committee approved the trial (22/YH/0281). Peer-reviewed journals, conferences, PhD thesis and lay media will report results.

NCT05627570

The prevalence of gestational diabetes mellitus (GDM) is rising in the UK and is associated with maternal and neonatal complications. National Institute for Health and Care Excellence guidance advises first-line management with healthy eating and physical activity which is only moderately effective for achieving glycaemic targets. Approximately 30% of women require medication with metformin and/or insulin. There is currently no strong evidence base for any particular dietary regimen to improve outcomes in GDM. Intermittent low-energy diets (ILEDs) are associated with improved glycaemic control and reduced insulin resistance in type 2 diabetes and could be a viable option in the management of GDM. This study aims to test the safety, feasibility and acceptability of an ILED intervention among women with GDM compared with best National Health Service (NHS) care.

We aim to recruit 48 women with GDM diagnosed between 24 and 30 weeks gestation from antenatal clinics at Wythenshawe and St Mary’s hospitals, Manchester Foundation Trust, over 13 months starting in November 2022. Participants will be randomised (1:1) to ILED (2 low-energy diet days/week of 1000 kcal and 5 days/week of the best NHS care healthy diet and physical activity advice) or best NHS care 7 days/week until delivery of their baby. Primary outcomes include uptake and retention of participants to the trial and adherence to both dietary interventions. Safety outcomes will include birth weight, gestational age at delivery, neonatal hypoglycaemic episodes requiring intervention, neonatal hyperbilirubinaemia, admission to special care baby unit or neonatal intensive care unit, stillbirths, the percentage of women with hypoglycaemic episodes requiring third-party assistance, and significant maternal ketonaemia (defined as ≥1.0 mmol/L). Secondary outcomes will assess the fidelity of delivery of the interventions, and qualitative analysis of participant and healthcare professionals’ experiences of the diet. Exploratory outcomes include the number of women requiring metformin and/or insulin.

Ethical approval has been granted by the Cambridge East Research Ethics Committee (22/EE/0119). Findings will be disseminated via publication in peer-reviewed journals, conference presentations and shared with diabetes charitable bodies and organisations in the UK, such as Diabetes UK and the Association of British Clinical Diabetologists.

NCT05344066.

Patients with kidney failure with replacement therapy (KFRT) suffer premature cardiovascular (CV) mortality and events with few proven pharmacological interventions. Omega-3 polyunsaturated essential fatty acids (n-3 PUFAs) are associated with a reduced risk of CV events and death in non-dialysis patients and in patients with established CV disease but n-3 PUFAs have not been evaluated in the high risk KFRT patient population.

This multicentre randomised, placebo controlled, parallel pragmatic clinical trial tests the hypothesis that oral supplementation with n-3 PUFA, when added to usual care, leads to a reduction in the rate of serious CV events in haemodialysis patients when compared with usual care plus matching placebo. A target sample size of 1100 KFRT patients will be recruited from 26 dialysis units in Canada and Australia and randomised to n-3 PUFA or matched placebo in a 1:1 ratio with an expected intervention period of at least 3.5 years. The primary outcome to be analysed and compared between intervention groups is the rate of all, not just the first, serious CV events which include sudden and non-sudden cardiac death, fatal and non-fatal myocardial infarction, stroke, and peripheral vascular disease events.

This study has been approved by all institutional ethics review boards involved in the study. Participants could only be enrolled following informed written consent. Results will be published in peer-reviewed journals and presented at scientific and clinical conferences.

ISRCTN00691795

To compare the contribution of physician associates (PAs) to the outcomes of emergency medicine consultations with that of foundation year 1 doctors-in-training (FY1s).

A quantitative study using retrospective chart review of adult patients seen by PAs or FY1s from August 2018 to January 2020 using 16 months of anonymised clinical record data.

One emergency department (ED) in England.

The outcomes of 7405 patients seen by 11 PAs and 7 FY1s were recorded, with n=4580 PAs and n=2825 FY1s having complete records.

The study aimed to evaluate wait times to consultation as the primary outcome. Secondary outcomes included length of stay (LOS), patients leaving without being seen (LWBS) and unplanned returns to the ED within 72 hours with the same complaint.

PAs working in an ED in England treated patients mainly in Majors and Resus and saw more patients out of hours compared with FY1s. Following adjustments for confounding factors, there was no significant difference in wait times to consultation between those PAs or FY1s patients (116 min vs 109 min, respectively, p=0.84). Patients seen by PAs versus FY1s had a significantly longer LOS (52 min); 237 min vs 185 min, p

PAs working in an ED in England managed patients with a range of conditions with a similar level of impact on three emergency medicine outcome measures as FY1s (wait times to consultation, numbers of patients LWBS or returning within 72 hours with the same presenting complaint). However, patients seen by PAs had a longer LOS.

The health and well-being of Aboriginal Australians is inextricably linked to culture and Country. Our study challenges deficit approaches to health inequities by seeking to examine how cultural connection, practice and resilience among Aboriginal peoples through participation in ‘cultural camps’ held on sites of cultural significance promotes health and well-being.

The study will be undertaken in close collaboration and under the governance of traditional cultural knowledge holders from Yuwaalaraay, Gamilaraay and Yuin nation groups in New South Wales, Australia. Three cultural camps will be facilitated, where participants (n=105) will engage in activities that foster a connection to culture and cultural landscapes. A survey assessing connection to culture, access to cultural resources, resilience, self-rated health and quality of life will be administered to participants pre-camp and post-camp participation, and to a comparative group of Aboriginal adults who do not attend the camp (n=105). Twenty participants at each camp (n=60) will be invited to participate in a yarning circle to explore cultural health, well-being and resilience. Quantitative analysis will use independent samples’ t-tests or ² analyses to compare camp and non-camp groups, and linear regression models to determine the impact of camp attendance. Qualitative analysis will apply inductive coding to data, which will be used to identify connections between coded concepts across the whole data set, and explore phenomenological aspects. Results will be used to collaboratively develop a ‘Model of Cultural Health’ that will be refined through a Delphi process with experts, stakeholders and policymakers.

The study has ethics approval from the Aboriginal Health and Medical Research Council (#1851/21). Findings will be disseminated through a combination of peer-reviewed articles, media communication, policy briefs, presentations and summary documents to stakeholders.

In recent years, discussions on the importance and scope of therapeutic value of new medicines have intensified, stimulated by the increase of prices and number of medicines entering the market. This study aims to perform a scoping review identifying factors contributing to the definition of the therapeutic value of medicines.

Scoping review.

We searched the MEDLINE, CINAHL, Embase, Business Source Premier, EconLit, Regional Business News, Cochrane, Web of Science, Scope and Pool databases through December 2020 in English, German, French, Italian and Spanish.

Studies that included determinants for the definition of therapeutic value of medicines were included.

Data were extracted using the mentioned data sources. Two reviewers independently screened and analysed the articles. Data were analysed from April 2021 to May 2022.

Of the 1883 studies screened, 51 were selected and the identified factors contributing to the definition of therapeutic value of medicines were classified in three categories: patient perspective, public health perspective and socioeconomic perspective. More than three-quarters of the included studies were published after 2014, with the majority of the studies focusing on either cancer disorders (14 of 51, 27.5%) or rare diseases (11 of 51, 21.6%). Frequently mentioned determinants for value were quality of life, therapeutic alternatives and side effects (all patient perspective), prevalence/incidence and clinical endpoints (all public health perspective), and costs (socioeconomic perspective).

Multiple determinants have been developed to define the therapeutic value of medicines, most of them focusing on cancer disorders and rare diseases. Considering the relevance of value of medicines to guide patients and physicians in decision-making as well as policymakers in resource allocation decisions, a development of evidence-based factors for the definition of therapeutic value of medicines is needed across all therapeutic areas.

Parkinson’s disease (PD) is a debilitating neurological disorder for which the identification of disease-modifying interventions represents a major unmet need. Diverse trial designs have attempted to mitigate challenges of population heterogeneity, efficacious symptomatic therapy and lack of outcome measures that are objective and sensitive to change in a disease modification setting. It is not clear whether consensus is emerging regarding trial design choices. Here, we report the protocol of a scoping review that will provide a contemporary update on trial design variability for disease-modifying interventions in PD.

The Population, Intervention, Comparator, Outcome and Study design (PICOS) framework will be used to structure the review, inform study selection and analysis. The databases MEDLINE, Web of Science, Cochrane and the trial registry ClinicalTrials.gov will be systematically searched to identify published studies and registry entries in English. Two independent reviewers will screen study titles, abstracts and full text for eligibility, with disagreements being resolved through discussion or by a third reviewer where necessary. Data on general study information, eligibility criteria, outcome measures, trial design, retention and statistically significant findings will be extracted into a standardised form. Extracted data will be presented in a descriptive analysis. We will report our findings using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Scoping Review extension.

This work will provide an overview of variation and emerging trends in trial design choices for disease-modifying trials of PD. Due to the nature of this study, there are no ethical or safety considerations. We plan to publish our findings in a peer-reviewed journal.

Preterm birth (PTB) is among the leading causes of perinatal and childhood morbidity and mortality. Therefore, accurate identification of pregnant women at high risk of PTB is key to enable obstetric healthcare professionals to apply interventions that improve perinatal and childhood outcomes. Serial transvaginal cervical length measurement is used to screen asymptomatic pregnant women with a history of PTB and identify those at high risk for a recurrent PTB. Cervical length measurement, fetal fibronectin test or a combination of both can be used to identify women at high risk of PTB presenting with symptoms of threatened PTB. The predictive capacity of these methods can be improved. Cervical softening is a precursor of cervical shortening, effacement and dilatation and could be a new marker to identify women a high risk of PTB. However, the predictive value of cervical softening to predict spontaneous PTB still needs to be determined.

This is a single-centre, prospective cohort study, conducted at the Amsterdam University Medical Centers in the Netherlands. Cervical softening will be investigated with a non-invasive CE-marked device called the Pregnolia System. This device has been developed to evaluate consistency of the cervix based on tissue elasticity. Two different cohorts will be investigated. The first cohort includes women with a history of spontaneous PTB

The study is approved by the Medical Ethics Committee of Amsterdam UMC (METC2022.0226). All patients will give oral and written informed consent prior to study entry. Results will be disseminated via a peer-reviewed journal.

NCT05477381.

We aimed to prospectively describe incident cardiovascular events among people living with HIV (PLWH) in northern Tanzania. Secondary aims of this study were to understand non-communicable disease care-seeking behaviour and patient preferences for cardiovascular care and education.

A prospective observational study.

This study was conducted at the Majengo HIV Care and Treatment Clinic, an outpatient government-funded clinic in Moshi, Tanzania

Adult patients presenting to an HIV clinic for routine care in northern Tanzania were enrolled from 1 September 2020 to 1 March 2021.

At enrolment, participants completed a survey and a resting 12-lead ECG was obtained. At 6 month follow-up, a repeat survey regarding interim health events and repeat ECG was obtained.

Interim major adverse cardiovascular events (MACE) were defined by: self-reported interim stroke, self-reported hospitalisation for heart failure, self-reported interim myocardial infarction, interim myocardial infarction by ECG criteria (new pathologic Q waves in two contiguous leads) or death due to cardiovascular disease (CVD).

Of 500 enrolled participants, 477 (95.4%) completed 6 month follow-up and 3 (0.6%) died. Over the 6 month follow-up period, 11 MACE occurred (3 strokes, 6 myocardial infarctions, 1 heart failure hospitalisation and 1 cardiovascular death), resulting in an incidence rate of 4.58 MACE per 100 person-years. Of participants completing 6 month follow-up, 31 (6.5%) reported a new non-communicable disease diagnosis, including 23 (4.8%) with a new hypertension diagnosis.

The incidence of MACE among PLWH in Tanzania is high. These findings are an important preliminary step in understanding the landscape of CVD among PLWH in Tanzania and highlight the need for interventions to reduce cardiovascular risk in this population.

In this study, we used the information generated by community members during an intervention design process to understand the features needed for a successful community participatory intervention to improve child health.

We conducted a concurrent mixed-methods study (November 2019–March 2020) to inform the design and evaluation of a community–facility linkage participatory intervention.

Kiyawa Local Government Area (Jigawa State, Nigeria)—population of 230 000 (n=425 villages).

Qualitative data included 12 community conversations with caregivers of children under-5 (men, older and younger women; n=9 per group), 3 focus group discussions (n=10) with ward development committee members and interviews with facility heads (n=3). Quantitative data comprised household surveys (n=3464) with compound heads (n=1803) and women (n=1661).

We analysed qualitative data with thematic network analysis and the surveys with linear regression—results were triangulated in the interpretation phase. Participants identified the following areas of focus: community health education; facility infrastructure, equipment and staff improvements; raising funds to make these changes. Community involvement, cooperation and empowerment were recognised as a strategy to improve child health, and the presence of intermediate bodies (development committees) was deemed important to improve communication and solve problems between community and facility members. The survey showed functional community relations’ dynamics, with high levels of internal cohesion (78%), efficacy in solving problems together (79%) and fairness of the local leaders (82%).

Combining the results from this study and critical theories on successful participation identified community-informed features for a contextually tailored community–facility link intervention. The need to promote a more inclusive approach to future child health interventions was highlighted. In addition to health education campaigns, the relationship between community and healthcare providers needs strengthening, and development committees were identified as an essential feature for successfully linking communities and facilities for child health.

ISRCTN39213655.