In cluster randomised trials (CRT), groups (rather than individuals) are randomised to intervention and control conditions. Since the publication of the Ottawa Statement on the Ethical Design and Conduct of CRTs, the accurate identification of research participants has continued to challenge researchers and research ethics committees.

In this article, we focus on CRTs involving healthcare providers and provide a practical framework for applying Ottawa Statement criteria for identifying research participants. We illustrate key lessons with example CRTs.

Study procedures should be analysed in relation to the study objective. A study intervention confers research participant status on healthcare providers if the study objective is to evaluate its effect and it is delivered to or targeted at healthcare providers. A data collection procedure confers research participant status on healthcare providers if it informs a study outcome used to achieve the study objective and it involves interactions between researchers and healthcare providers to collect their data, or the collection of healthcare providers’ identifiable private information.

In CRTs, healthcare providers may be research participants because of study interventions, data collection procedures, or both; conversely, they may simply be research collaborators. Some study interventions confer research participant status on both healthcare providers and patients. Collecting data on healthcare provider behaviour may confer research participant status on healthcare providers.

Accurately identifying research participants in CRTs is essential to their ethical conduct. When healthcare providers are research participants, their rights and welfare should be protected in accordance with research ethics guidelines.

Increasing evidence suggests that dolutegravir (DTG), endorsed by the WHO since 2018 for first-line antiretroviral therapy (ART), is associated with significant weight gain and potentially also with cardiometabolic disorders. In an effort to expand therapeutic options for people living with HIV (PLHIV), the EvaLuating the non-inferiority of DORAvirine vs DOlutegravir trial aims to compare the virologic efficacy of doravirine (DOR) and DTG-based regimens and to assess their safety, including a focus on cardiometabolic effects.

This is an international, phase III, multicentre, open-label, non-inferiority, randomised trial that will enrol 610 ART-naïve PLHIV (HIV RNA≥1000 copies/mL at screening) across six countries (Brazil, Cameroon, France, Côte d’Ivoire, Mozambique and Thailand) spanning four continents. Key inclusion criteria include age ≥18 years, confirmed HIV-1 infection with plasma RNA levels ≥1000 copies/mL, indication for ART initiation and no prior ART exposure. Participants will be randomised in a 1:1 ratio to receive either DOR 100 mg once daily in combination with tenofovir disoproxil fumarate (TDF) (300 mg daily) plus lamivudine (3TC) (300 mg daily) or DTG (50 mg daily) in combination with TDF (300 mg once daily) plus either emtricitabine (FTC) (200 mg daily) or 3TC (300 mg daily). Randomisation will be stratified by screening HIV-1 RNA load (≤100 000 or >100 000 copies/mL) and by country. The primary outcome is virological efficacy, defined as the proportion of participants achieving HIV-1 RNA

Primary outcome results (week 48) are expected in early 2028. The project was submitted to and approved by national ethics committees and pharmaceutical regulatory authorities in all participating countries: Brazil (CEP INI FIOCRUZ (21.040-900)/CEP HGNI (26.030-380)); Cameroon (CNERSH (2024/09/1717/CE/CNERSH/SP)/Ministry of Public Health (D30-1464/AAR/MINSANTE/SG/DROS/CRC); Côte d'Ivoire: (CNESVS (0018224/MSHPCMU/CNESVS-km)/AIRP (1329/AIRP/DISMP/Om/kbaag); France (CTIS CPP/ANSM (2023-508626-10-00)); Mozambique (CNBS (20/CNBS/25)/ANARME (4635/380/ANARME)); Thailand: (IHRP (08/1944)/Thai FDA: ongoing on 19 January 2026). The trial received authorisation from the French National Commission for Data Protection and Liberties (CNIL) under approval number 924 302. Written informed consent is obtained from all participants prior to any study-specific procedures and trial enrolment, in accordance with the Declaration of Helsinki and applicable national regulations. Study findings will be disseminated through publication in peer-reviewed journals and presentations at national and international scientific conferences. Results will also be communicated to policymakers, healthcare professionals, community stakeholders and study participants through appropriate dissemination activities, including policy briefs, stakeholder meetings and lay summaries on dedicated and easily accessible platforms.

NCT06203132; EU-CT, 2023-508626-10-00.

The objective of this study was to test whether an airtime reward increased tuberculosis (TB) Check screening uptake. This served as a feasibility study for the planned Phase 2, which aimed to test behavioural messaging to boost take-up of TB testing among users who were advised to get tested by TB Check.

The study was a randomised controlled trial with a parallel design.

This study assessed mHealth support to boost TB testing in high-burden Cape Town clinics.

Patients aged 18 or above with a valid mobile phone number that had been added within the last 5 years were invited by the Western Cape Department of Health and Wellness through unsolicited text messages to screen for TB using TB Check.

Patients in the intervention group (n=1250) were additionally offered R15 airtime for completing the screening and participating in the research study. Patients were allocated to the intervention or control group through parallel randomisation with equal group size.

The primary outcome was the number of TB Check screenings completed within 1 week of the SMS invitation being sent.

Messages were successfully delivered to 616 patients in the control group and 633 patients in the intervention group. Uptake of the invitation by the intended recipients was very low. Eight users in the control group and 20 users in the intervention group initiated a self-screening (1.3% vs 3.2% of delivered messages; 95% CI of difference (0.2 to 3.5)), but only three users in the control group and seven users in the intervention group successfully completed a self-screening (0.49% vs 1.11% of delivered messages; 95% CI of difference (–0.4 to 1.6)). Low delivery of text message invitations (50.0%) and low completion of users who started the screening (35.7%) posed additional challenges. No adverse events were recorded.

The addition of a small airtime participation reward to unsolicited text message invitations did not appear to be an effective tool to reach targeted individuals in this context. The results of Phase 1 reported here suggested that Phase 2 would not be feasible, so we did not proceed with the planned Phase 2. However, uptake of incentivised self-screening was unexpectedly high among users who were not originally invited (presumably known contacts of the original invitees). Within 5 days of the invitations being sent, 1962 unique self-screenings had taken place using the incentive code; only 7 of these users were originally invited. The lessons learnt from this study can help to inform future efforts to promote TB self-screening, mHealth initiatives and attempts to engage with patients via text message. 

The study was pre-registered with the South African National Clinical Trials Registry (Phase 1 trial no DOH-27-112023-9045, Phase 2 trial no DOH-27-112023-4944) and the Pan African Clinical Trials Registry (Phase 1 trial no PACTR202311529334858).

The objective of this scoping review is to map out what has been published in the scientific literature on the relationship between climate change-related events and how these overlap with associated changes in resource availability, transactional sex and HIV incidence and prevalence, within fishing communities in the Lake Victoria basin. This objective is informed by the fact that climate change and the associated natural resource strains in the Lake Victoria region have exacerbated existing inequities within fishing communities. Vulnerable populations, especially women, engage in strategies such as transactional sex to cope with the uncertainty of natural resource-dependent livelihoods. This practice greatly increases women’s risk of contracting HIV in this region, with prevalence rates four to five times the national averages. This scoping review will thus show how the existing empirical literature reports on climate change, transformation in natural resources and livelihoods, and transactional sex and HIV in the Lake Victoria region.

Studies that meet the following inclusion criteria will be included: align with at least two of the major concepts of interest, including climate change, transactional sex, HIV/AIDS, Lake Victoria Basin and/or empirical studies; are published in English and after 2012; and focus on the Lake Victoria basin. The scoping review will be guided by the JBI Manual for Evidence Synthesis: Scoping Reviews, supported by the standard principles of Arksey and O’Malley. The specific search strategies to be implemented were developed with guidance from an experienced research librarian to align with the inclusion criteria. The search will be conducted in relevant global databases, with two reviewers screening the results and extracting relevant data points. Finally, results will be reported using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews flow diagram, and summarised in figures, tables and text.

The scoping review is designed to comprehensively scope the existing literature and document the coverage of linkages between transactional sex, HIV/AIDS and sustainable livelihoods in the context of climate change with a view to informing health systems responses to human health specific to the HIV epidemic.

The proposed scoping review is registered with the Open Science Foundation (OSF), registration number:https://doi.org/10.17605/OSF.IO/9DTW4.

Few studies have examined how psychosocial risk and protective factors in adolescence shape mental health outcomes and other multimorbid conditions in adulthood, particularly among Canadian youth. The Research on Eating and Adolescent Lifestyle (REAL) 2.0 study was a 15-year follow-up cohort study designed to investigate how early etiological factors, including body image and disordered eating symptoms in adolescence, contribute to the development of eating, weight-related concerns, mental health and substance use health problems in early adulthood. In this paper, we describe the REAL 2.0 cohort’s demographic and clinical characteristics alongside an overview of the study procedures, laying the groundwork for collaboration on future learnings with this unique data.

The cross-sectional REAL study initially surveyed middle and high school students from 2004 to 2010 (n=3043) across 43 schools in the Ottawa, Canada region. Of those, respondents in grade 7 or 9 (n=1197 from 25 of the 43 original schools) were asked to participate in a longitudinal arm of the study that consisted of yearly follow-ups. From the longitudinal cohort, there were 278 participants (29.1% male; M_age=28.6) from those who consented to be re-contacted (n=912), who completed the REAL 2.0 survey electronically (30.4%), providing comprehensive data on demographic, clinical, eating and weight-related behaviour, psychological, social, environmental and substance use health factors in adulthood.

9.4% of REAL 2.0 participants met DSM-5 criteria for an eating disorder, while 17.6% met criteria for disordered eating. Moderate to severe anxiety was reported by 28% of participants, while 21.6% experienced moderate to severe depressive symptoms. Regarding substance use, 16.9% engaged in hazardous drinking, 16.9% used cannabis daily or almost daily, and 4.3% reported daily tobacco use.

REAL 2.0 has the potential to answer multiple research questions about several mental health outcomes, but its priority focus is to answer questions related to risk and protective factors of multimorbidity in adulthood. Additionally, profiling work, linked to health service utilisation data for systems planning work and predictive modelling studies are secondary goals. By leveraging the Health Data Nexus (HDN) platform, we welcome collaboration with interested researchers who would like to utilise the breadth of data both in adolescence and adulthood to answer other pertinent aetiological questions in mental health and substance use health outcomes. Future plans to conduct additional follow-ups remain feasible.

To evaluate the impact of public–private mix (PPM) models for tuberculosis (TB) on health, process and system outcomes, adopting the WHO’s definition of PPM, which is a strategic partnership between national TB programmes and healthcare providers, both public and private, to deliver high-quality TB diagnosis and treatment.

Systematic review without meta-analysis using the Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines.

EMBASE, MEDLINE, Health Management Information Consortium, Social Sciences Citation Index, Science Citation Index, Emerging Sources Citation Index, CENTRAL, Database of Disability and Inclusion Information Resources, WHO Library Database and 3ie.

We included all primary studies examining PPM models delivering TB services in urban health sectors in least-developed, low-income and lower–middle-income countries and territories.

17 reviewers were involved in data extraction in COVIDENCE using a prepiloted template. All extractions were completed by a single reviewer and checked by a second reviewer. Quality appraisal was carried out using the mixed-methods appraisal tool, covering mixed-methods, qualitative and quantitative study designs. Narrative synthesis was carried out by tabulating and summarising studies according to PPM models and reported in line with the synthesis without meta-analysis guidelines.

Of the 57 included studies, covering quantitative (n=41), qualitative (n=6) and mixed-method (n=10) designs, the majority were from Southeast Asia (n=37). PPM models had overall positive results on TB treatment outcomes, access and coverage and value for money. They are linked with improved TB health workers’ skills and service delivery. Most outcomes tended to favour interface models, although with considerable heterogeneity. Inconsistent implementation of national TB guidelines, uncoordinated referrals and lack of trust among partners were identified as areas of improvement. Evidence was lacking on the involvement of informal providers within PPM models.

PPM models can be effective and cost-effective for TB care in urban low- and middle-income countries contexts, particularly when levels of mistrust between public and private sectors are addressed through principles of equal partnership. The evidence indicates that this may be more achievable when an interface organisation manages the partnership.

CRD42021289509.

Transoral robotic surgery (TORS) is a minimally invasive technique for surgical removal of tumours of the tonsil and lateral oropharynx. Surgical defects after TORS lateral oropharyngectomy are traditionally left open to heal by secondary intention, resulting in significant postoperative pain and secondarily resulting in delayed swallowing and discharge. Although multimodal analgesia can improve postoperative pain control, no studies to date have assessed the impact of adjunct surgical interventions for reducing postoperative pain after TORS. Buccal fat rotation flap is a regional reconstruction option after TORS lateral oropharyngectomy and provides immediate coverage of the open surgical wound. However, the impact of buccal fat rotation flap reconstruction on postoperative pain and swallowing remains unclear. This trial aims to compare postoperative pain outcomes in patients who undergo TORS lateral oropharyngectomy with and without buccal fat rotation reconstruction.

This protocol outlines a single centre, parallel, unblinded, phase II, randomised control trial. Inclusion criteria include adult patient (≥18 years) undergoing TORS lateral oropharyngectomy for early to intermediate stage tonsillar squamous cell carcinoma (T1-2N0-1 p16+/–) or early to intermediate stage salivary gland tumours of the palatine tonsils. Exclusion criteria include a history of prior head and neck squamous cell carcinoma, prior head and neck radiotherapy, retropharyngeal lymphadenopathy, bilateral lymphadenopathy, need for bilateral neck dissection, baseline trismus, opioid use or drug addiction, need for open surgery (transcervical lateral oropharyngectomy), free tissue transfer, or alternative regional flap, and pregnancy. All patients are planned for a TORS lateral oropharyngectomy. The intervention group will have a buccal fat rotation flap reconstruction, and the control group will be allowed to heal via secondary intention. The allocation sequence will be created using a computer-generated random sequence with a permuted block strategy. The allocation sequence will be concealed until the time of assignment. The primary outcome is postoperative pain intensity during rest and swallowing using the visualised analogue scale. Secondary outcomes include postoperative complications, other adverse events, patient-reported speech and swallowing, opioid usage, length of hospital stay, feeding tube dependence and blood glucose levels. The trial has a target sample size of 40 patients. Statistical analysis of the primary outcome will be analysed in an intention to treat analysis using a linear mixed effects model.

The study was approved by the University Health Network Coordinated Approval Process for Clinical Research. Study number CAPCR ID: 24-5894. All participants will be required to provide written informed consent to participate. Findings will be presented at national conferences and published in medical journals.

NCT06965738.

Polysubstance use (PSU), particularly opioid-involved and stimulant-involved PSU, is a growing issue in the USA. PSU increases the risk of negative health consequences, including infectious diseases, worsening physical and mental health conditions, and overdose-related deaths. These consequences occur in the context of varying health risk behaviours, substance-related preferences, and treatment engagements among people with PSU. To inform improvements in prevention, harm reduction, and substance use disorder (SUD) treatment, additional research is needed to comprehensively understand the current context and drivers of PSU preferences, motivations, and behaviours.

Herein, we describe the protocol for a prospective cohort study designed to capture detailed patterns, profiles, and trajectories of PSU, with the aim of comprehensively examining the drivers of PSU behaviours and SUD treatment utilisation. Adults (ages 18–75; n=400) who engage in PSU will be recruited from healthcare institutions, an established participant database maintained by an adjacent SUD research team, and online advertisements. Study assessments will capture dynamic patterns, choice preferences, and motivators of PSU via behavioural economic (BE) measures, detailed Timeline Follow-Back (TLFB) interviews, and self-administered surveys. The assessment timeline will include a baseline survey and TLFB interview, weekly TLFB interviews for 4 weeks post-baseline, and follow-up surveys and TLFB interviews at 4-, 8-, and 12-months post-baseline.

The study is funded through the National Institutes of Health Helping to End Addiction Long-term (HEAL) initiative and was approved by the University of Michigan Medical Institutional Review Board. Findings will be disseminated to academic, clinical, and community partners through the Michigan Innovations in Addiction Care through Research and Education programme. Results from this study will inform actionable and practical insights relevant to the delivery of personalised care in the context of PSU.

This nested qualitative study (NQS) aimed to identify facilitators and barriers to the delivery of a substantive randomised controlled trial investigating the eradication of gastrointestinal tract carriage of antibiotic-resistant organisms using encapsulated faecal microbiota transplant (FMT).

NQS within a participant-blinded, randomised, placebo-controlled, single-centre, feasibility trial (RCT)—Feasibility of ERadicating gastrointestinal carriage of Antibiotic-Resistant Organisms (FERARO) (ISRCTN reg. no. 34 467 677)—with data collected via focus groups and analysed using thematic analysis.

RCT participants were recruited from a large academic tertiary referral hospital in central London. Focus groups were held at the hospital or via videoconferencing for those unable to travel.

This study included 13 FERARO study participants across two focus groups. 11 participants were under RCT follow-up and unaware of their treatment allocation, two participants had completed 6-month follow-up and knew whether they had received FMT or matched placebo. Additional data were opportunistically collected on reasons for declining RCT participation.

Participants found FMT to be an acceptable and holistic management strategy and noted positive impacts from RCT participation including enhanced personal health awareness and valuable support from the research team. The time and travel commitment presented the most substantial barrier to RCT participation. Many participants were motivated by a desire to give something back to the UK National Health Service and/or research. Patients’ current health status also influenced the decision-making process, and, while infrequently cited, the COVID-19 pandemic added extra complexity likely impacting individuals’ willingness to participate.

While FMT is generally acceptable to participants, logistical barriers such as the time and travel commitment associated with RCT participation need consideration. Effective communication, personal connections and participant education on antimicrobial resistance are likely to be crucial for enhancing recruitment and retention in future trials.

ISRCTN registration number 34 467 677 and EudraCT number 2019-001618-41.

To assess the prevalence and magnitude of undisclosed financial conflicts of interest (COIs) among physician-authors in high-impact US-based psychiatry journals.

Cross-sectional study comparing the author self-reported disclosures to the journal(s) with payments mandatorily reported in the Open Payments database.

We examined original research articles published between 1 January 2020 and 31 December 2022 in two prominent US-based psychiatry journals: the American Journal of Psychiatry (AJP) and Journal of the American Medical Association Psychiatry (JAMA-PSY). Of 2872 publications screened, 74 articles authored by 27 eligible US-based physician-authors met the inclusion criteria.

Total payments received by authors within the 3 years prior to publication and the proportion of undisclosed payments. Additional analyses assessed payment types (research vs general), author demographics and study characteristics associated with undisclosed COIs.

US$4.54 million was paid to authors in the two journals, of which US$645 135 (14.2%) were undisclosed. AJP authors received US$205 943 (7.5% of total payments) in undisclosed payments, while JAMA-PSY authors received US$439 192 (24.8%). Research payments constituted 82.3% of all undisclosed payments. Total undisclosed payments among the top 10 highest-earning authors accounted for 84.8% (AJP) and 99.6% (JAMA-PSY) of all undisclosed payments to journals. Nearly all undisclosed payments, 96.2%, were made to authors conducting randomised controlled trials.

Substantial undisclosed financial COIs were identified among the top 10 earners in high-impact psychiatry journals. These findings highlight potential risks to research transparency and integrity. Further research is needed to evaluate the effectiveness of disclosure policies and develop mechanisms to mitigate COIs in psychiatric research.

Preventable hospital patient harm events disproportionally affect certain patient populations. For some, harm extends beyond physical injury to include cultural, emotional or spiritual impacts. While these disparities are linked to socio-demographics (eg, race, education), they are driven by structural factors (eg, procedures and policies). Patient safety monitoring systems (eg, incident reporting, patient concerns) were not originally designed to identify equity-related harms and may inadvertently obscure or reinforce the injustices they should address. This study will examine how equity is currently considered within hospital incident reporting and patient concerns systems across Canada and will identify opportunities to strengthen these systems’ responsiveness to inequities in patient safety.

This 3-year exploratory sequential mixed-method study began in September 2024. Phase one involves qualitative interviews with patient safety and equity leads, patients/families/caregivers and leaders of innovative initiatives to explore current practices, gaps and innovations in how equity-related factors are identified and addressed within incident reporting and patient concerns systems. Findings will inform Phase 2, a modified Delphi process with patient safety and equity experts and persons with lived experience of equity-related harm events to refine and reach consensus on key equity-promoting features, considerations and recommendations for these systems. In Phase 3, consensus items will be used to develop a national cross-sectional survey assessing the extent to which equity is integrated into hospital incident reporting and patient concerns systems in Canada. A patient advisory committee will inform data collection, interpretation of findings and dissemination.

Ethics approval has been received for Phase 1, with subsequent approvals to be sought for later phases. Dissemination plans include peer-reviewed publications, presentations at international conferences and knowledge exchange activities to inform patient engagement, the design of incident reporting and patient concerns systems and policy development.

An estimated 262 million people lived with asthma globally in 2019. Similarly, in 2021, chronic obstructive pulmonary disease (COPD) was responsible for 3.5% million global deaths. They are usually distinct disorders, but the Global Initiative Chronic Obstructive Lung Disease (GOLD) 2024 strategy document asserts that asthma and COPD are conditions that may coexist in an individual and may require specific personalised approaches and treatments. It is acknowledged that they may share some common treatable traits and clinical features There are many challenges to manage asthma and COPD in the older population, including poor adherence to prescribed medications and poor inhaler techniques. The overall aim of this systematic review is to identify, appraise and synthesise available evidence around digital health interventions used to improve medication adherence in older people with asthma or COPD.

This systematic review will examine studies that evaluated digital health interventions for asthma or COPD in any setting (eg, primary or secondary care). To be included, studies must be reported in English, Arabic or French and published from the year 2000 onwards. A literature search will be performed in MEDLINE via Ovid, Cochrane Central Register of Controlled Trials (CENTRAL), CINAHL, EMBASE and PsycINFO via Ovid to identify relevant articles published since 2000 and up to December 2024. No language restrictions will be applied.

The Cochrane risk-of-bias tool for randomised trials will be used to assess the quality of retrieved randomised controlled trials and quasi-experimental studies. The quality of cross-sectional, cohort and case-control studies will be assessed using the Newcastle Ottawa Scale. Mixed-methods studies will be assessed using the Mixed Methods Appraisal Tool (MMAT). The quality of qualitative studies will be assessed using the Critical Appraisal Skills Programme (CASP) qualitative checklist.

Data will be synthesised using a convergent segregated approach, which involves an independent synthesis of quantitative and qualitative data leading to the generation of quantitative and qualitative evidence, which will then be integrated.

Ethics approval is not applicable for this study since no original data will be collected. The results will be disseminated through a peer-reviewed publication and conference presentations. Findings will be used in a bigger project aimed to answer the question on how to embed a pharmacist-led digital health service to support older people with asthma or COPD into the NHS (National Health Service) usual care.

CRD42024575924.

Practice guidelines recommend addressing patient non-medical drivers of health such as access to nutritious food and transportation as part of whole-person care. Emergent electronic health record (EHR)-based tools can enable non-medical needs care coordination, but adoption commonly faces workflow and infrastructure barriers. Targeted implementation support strategies (eg, training, practice facilitation) can enhance technology adoption in healthcare settings, but no prior research has assessed if implementation strategies can improve how care managers use enabling technologies for non-medical needs care coordination. This study will test whether providing implementation support to primary care health centre care management teams improves the adoption of EHR-based enabling technologies to address patients’ non-medical needs.

This hybrid implementation-effectiveness type 2 pragmatic trial has a mixed methods design. The primary outcomes include: (1) Whether patients enrolled in care management programmes have been screened for unmet non-medical health-related needs and (2) Whether patients with identified unmet non-medical health-related needs received a referral to a community organisation to address their need. The secondary outcomes include: (1) Whether referrals for financial-related non-medical needs had a documented outcome in the EHR, such as successful connection to services, service unavailability or other disposition statuses, (2) Whether the referral outcomes indicated ‘successful connection to services’ and (3) Clinical markers including hypertension and diabetes control. Formative evaluation of barriers and facilitators to using EHR tools to conduct non-medical needs screening, referrals and tracking of receipt of services will include semi-structured interviews and a ‘guided tour’ of enabling technology used by care managers. A modified Delphi process will then inform the development of a set of implementation strategies for inclusion in the intervention. The intervention will be piloted in three health centres, refined, then tested in a stepped-wedge cluster-randomised trial in 20 health centres.

We obtained ethics approval for all study activities from Advarra Institutional Review Board (registration number #00000971). Results will be disseminated to Health Centres and Health Centre network nationally at meetings and we will disseminate to researchers via manuscripts in peer-reviewed journals and scientific meetings.

NCT06489002.

Systematic reviews (SRs) on the management of temporomandibular disorders (TMDs) have predominantly focused on evaluating the effectiveness of various treatments, identifying those that provide the greatest benefits. However, the economic evaluation of these treatments has not been systematically explored. This SR aims to address this gap by evaluating the economic outcomes of the most common treatment modalities for TMDs, including cost-effectiveness, cost-utility, cost-benefit, cost-minimisation and the burden of illness.

This SR will be conducted using the following electronic databases Business Source Complete, CINAHL, EconLit (ProQuest), Embase (Ovid), MEDLINE (PubMed), MEDLINE (Ovid) and Scopus to identify studies evaluating the economic outcomes of treatments for TMDs. The eligibility criteria are as follows: (1) studies examining the costs and/or impact of treatments for TMDs and (2) articles published between 2000 and 2025. The primary outcomes of interest are the economic findings outlined earlier. Data extraction will include the following: author(s), year of publication, country, study objectives, study design, eligibility criteria, TMD diagnosis and screening, study groups, randomisation, blinding, sample size, number of participants invited, enrolled and completed, duration of treatment, follow-up, study duration, settings, assessment instruments, study outcomes, statistical analyses, results, limitations, strengths and funding sources. The quality of studies will be evaluated using the Consolidated Health Economic Evaluation Reporting Standards 2022 checklist, with risk of bias assessed using the Cochrane Effective Practice and Organization of Care’s risk-of-bias tool; where applicable, the Outcome Reporting Bias in Trials will be used to detect reporting biases. A narrative synthesis and summary tables will outline study characteristics, economic outcomes and the overall quality of evidence. We will conduct qualitative secondary and sensitivity analyses.

This SR does not require an ethics approval. The results will be disseminated through international and national conferences and peer-reviewed journals.

CRD42024613553.

To examine trends in preconception and pregnancy cardiometabolic risk factors and conditions, pregnancy and birth complications, obstetric interventions, and the impact of COVID-19, and to forecast future disease burden.

A multi-centre retrospective cohort study.

A large hospital network with three maternity hospitals serving ethnically diverse populations in Melbourne, Australia.

Pregnant women who gave birth between 2016 and 2022.

Trends in cardiometabolic conditions, birth complications and obstetric interventions.

Over 7 years, 63 232 women were included, of whom 40% were nulliparous, and 60.9% were born overseas from 167 countries. From 2016–2022, maternal age (30.2–31.3 years), obesity (21.0%–26.2%), gestational diabetes mellitus (GDM) (15.9%–28.1%) and caesarean delivery (28.5%–37.6%) increased, while average gestational weight gain, premature births and special care admissions declined from 12.6–11.6 kg, 6.3%–4.9% and 24.2%–14.1%, respectively; and was statistically significant (p

Prepregnancy and pregnancy cardiometabolic risk factors and conditions, pregnancy and birth complications, and obstetric interventions increased markedly over 7 years. Despite this, offspring complications, including special care admissions, stillbirths and prematurity, decreased, while pregnancy complications peaked during COVID-19. GDM is forecasted to increase to 43.0% by 2028, posing an unsustainable health and economic burden that necessitates urgent public health initiatives.

The number of people living with dementia is increasing worldwide. Alzheimer’s disease (AD) is the most common type of dementia. It typically manifests itself initially with cognitive impairment in the memory domain and gradually progresses towards affecting all activities of daily living. Active music interventions, particularly singing, may improve mood, social behaviour and quality of life. However, little is known about their effects on cognition, although some studies have provided promising results. The Memory for Music (M4M) project aims to fill this gap in research by measuring the effects of learning new songs on cognitive functioning. Specifically, M4M will examine memory for new songs in non-musician adults with AD after undergoing intensive versus minimal individual musical training based on singing novel songs.

Home-dwelling adults with AD, 65 years or older, will receive 5 months of intensive intervention (2x/week) and 5 months of minimal intervention (1x/month). In a crossover design, participants will be randomised to receive either the intensive or minimal intervention first, with 2 months between the intervention periods. Participants will receive individual music lessons to learn new songs, provided by a music instructor with adequate training. The main outcomes will be measured at the beginning and end of each intervention period. General cognition will be measured with the AD Assessment Scale – Cognitive by an assessor blinded to the randomisation. Participants’ memory for music will be measured using the N400 component of electroencephalographic (EEG) event-related potentials in response to music stimuli. Additional outcomes evaluated during intervention sessions include mood and musical performance observations. With 113 participants randomised, the trial will have 80% power to detect clinically meaningful effects. Relations between mood, memory for music and cognitive abilities will be examined, with sex, age, AD stage, previous musical training and education as covariates. M4M will be conducted in close collaboration between academic researchers, service providers and service users to ensure relevance and applicability.

Dissemination of findings will apply to local, national and international levels. The study has been approved by the Regional Committees for Medical and Health Research Ethics in Norway (reference number 759936) and by Mautalén Salud e Investigación, CECOM in Argentina (register code 14412).

Clinicaltrials.gov, NCT06611878.