Nigeria has the highest number of maternal deaths globally, and maternal peripartum sepsis is one of the leading causes of maternal mortality. A single oral dose of azithromycin (AZM; 2 g) is safe and effectively reduces 33%–60% of maternal sepsis during planned vaginal birth in low- and middle-income countries (LMICs). However, the clinical and cost-effectiveness of oral AZM during vaginal birth in Nigeria remains unknown in the context of poor antimicrobial stewardship practices, significant antimicrobial resistance and healthcare financing. Evidence is also lacking on the standard care for the prevention of maternal sepsis among pregnant women undergoing vaginal births in Nigeria. The AZIN-V trial is a hybrid type 2 effectiveness-implementation trial to determine the safety, clinical and cost-effectiveness of intrapartum oral AZM versus usual care in the prevention of peripartum maternal sepsis. The trial will also examine the impact of implementation strategies in enhancing adherence to the oral AZM protocol during planned vaginal births and identify effective strategies to improve adherence (fidelity) to the protocol in real-world LMIC settings.

This is a multicentre hybrid type 2 trial conducted in six Nigerian states: Ebonyi, Edo, Gombe, Kano, Kwara and Lagos. The study aims to simultaneously test the clinical and cost-effectiveness of AZM (clinical trial) and the impact of implementation strategies (implementation research) in Nigeria’s unique healthcare context. The clinical trial is a two-arm, cluster-randomised controlled trial conducted across 48 health facilities, randomly assigned (1:1) to either intrapartum administration of oral AZM (intervention group) or usual care—the current routine practice (control group). A total of 5040 study participants (2520 in each group) will be enrolled in the clinical trial. The implementation trial is a two-arm cluster non-randomised controlled trial conducted in 12 health facilities (1:1) allocated to either a bottom-up approach using the Plan-Do-Study-Act cycle or a usual top-down approach with a one-time training workshop and distribution of clinical guidelines, with both arms administering oral AZM during vaginal birth while assessing fidelity (primary outcome).

For the clinical trial, data will be analysed using intention-to-treat statistical methods. The cost-effectiveness outcome will be analysed using the Incremental Cost-Effectiveness Ratio. Implementation outcomes will be analysed using descriptive statistics and a thematic approach.

This study has been approved by the National Health Research Ethics Committee, Nigeria (NHREC/01/01/2007-30/09/2024), the ethics committees of the participating health institutions (Lagos University Teaching Hospital Research Ethics Committee: ADM/DSCST/HREC/APP/6325; University of Ilorin Teaching Hospital Health Research Ethics Committee: ERC/PAN/2025/03/0581; University of Benin Teaching Hospital Health Research Ethics Committee: ADM/E22/A/VOL. VII/483117141; Aminu Kano Teaching Hospital Research Ethics Committee: AKTH/MAC/SUB/12 A/P-3/VI/2509 and Irrua Specialist Teaching Hospital Research Ethics Committee: ISTH/HREC/20241507/605), the Ministries of Health of the six states and the National Agency for Food and Drug Administration and Control. Written informed consent will be obtained from all eligible study participants before enrolment. Results will be shared with communities and policy stakeholders and through peer-reviewed journals and will be presented at conferences.

ISRCTN16415327.

Prospective cohort study

In this pilot study, we recruited patients from a secondary pain clinic in Boston, Massachusetts.

In this pilot study, we recruited patients from a secondary pain clinic within the Spaulding Rehabilitation network in Boston, Massachusetts, USA. We enrolled 37 patients who initially came in for a clinical visit with the principal investigator of the study. Of the 37 patients, 14 patients who continued to enrol/join after December 2024 received the ‘DigitalPulse’ to drive engagement.

To present a roadmap for our efforts to contextualise engagement in our digital health technology study and showcase our attempts to incorporate an engagement approach inspired by the Method for Program Adaptation through Community Engagement. Building on this, we further incorporated continued feedback and revision beyond the prototype of the user-centred feedback form (‘DigitalPulse’) to include expanded stakeholders such as clinicians and research assistants.

From these patients, we observed that our approach produced highly variable changes in engagement with slight increases at the group level.

From our observations, we have found that it is important to incorporate iterative refinements and expanded stakeholder involvement in designing patient-centred digital health tools to improve engagement. Overall, we report a process to address engagement and emphasise the need for continuous personalisation in digital health interventions.

The objective of this study was to determine the association between viral subtype/clade and disease severity.

Multicentre retrospective cohort study.

This study used data from the Global Influenza Hospital Surveillance Network (GIHSN). The dataset comprised hospitalised influenza patients with viral sequencing data across 14 countries, collected from August 2022 through October 2023.

A total of 761 hospitalised patients were enrolled during the study period, and 745 patients were included in the analysis. We excluded patients with missing data on explanatory or outcome variables, those infected with viral clades represented by fewer than 11 sequences, and those enrolled at study sites contributing fewer than 5 patients.

Disease severity was defined by admission to intensive care unit (ICU), receipt of non-invasive oxygen supplementation, 3-variable definition (ICU, mechanical ventilation or death) or 4-variable definition (3-variable plus oxygen supplementation).

Outcomes were analysed in association with subtype or clade using the mixed-effects logistic regression models, adjusting for age group, sex, underlying medical conditions, influenza vaccination status, antiviral use, country income level and epidemic period, while study site was included as a random effect.

745 patients were included: 263 A(H1N1)pdm09, 380 A(H3N2), 102 B/Victoria. A(H1N1)pdm09 infection was associated with increased odds of ICU admission (adjusted ORs (aORs) 2.5, 95% CI 1.1 to 5.8) compared with A(H3N2). 6B.1A.5a.2a.1 clade of A(H1N1)pdm09 was associated with increased severity compared with 6B.1A.5a.2a clade (aOR 3.0, 95% CI 1.0 to 9.5) and (aOR 5.4, 95% CI 1.6 to 18.3) for the 3-variable and 4-variable definitions respectively. Among A(H3N2), the (3C.2a1b.2a.)2b clade showed a trend toward increased severity using the 4-variable definition compared with the 2a.1b clade (aOR 2.9, 95% CI 0.8 to 10.0).

This analysis highlights the differential impact of influenza subtypes and clades on disease severity in hospitalised patients. Future research should investigate the role of specific viral mutations of these clades in modulating immune evasion or disease severity. These findings reinforce the GIHSN’s critical role in global surveillance. Ongoing genomic surveillance is crucial for understanding the clinical impact of emerging influenza variants and informing public health responses.

Respiratory tract infections (RTIs) cause significant child morbidity and mortality. Periodical influenza vaccination and respiratory syncytial virus (RSV) prophylaxis can reduce this burden in risk groups. However, in the Caribbean, the optimal timing of these interventions is unclear due to a lack of epidemiological data. We aimed to investigate pathogens associated with RTI disease burden and pathogen specific seasonality in the Caribbean in the context of COVID-19 to achieve optimal timing of preventive measures.

We conducted a retrospective study using patient records and pathogen detection data from St. Maarten Medical Center from 1 September 2018 to 1 September 2023. We performed regression to associate pathogens with outcomes and seasonality.

RTI diagnoses accounted for 50.8% (N=7380) of outpatient cases and 28.0% (N=508) of inpatient cases. RSV and rhino/enterovirus were associated with more frequent oxygen requirement (OR 5.1 (95% CI 2.3 to 11) and OR 2.3 (95% CI 1.2 to 4.3), respectively) and tachypnoea/dyspnoea (OR 4.9 (95% CI 2.0 to 13) and OR 2.8 (95% CI 1.6 to 5.2), respectively) than other pathogens post-COVID-19. RSV consistently peaked during June/July and September/October, preceding RSV prophylaxis administration in October.

The overall burden on the healthcare system due to RTI visits and admissions was high. Higher disease severity was associated with RSV and rhino/enterovirus infections; therefore, universal RSV prophylaxis should be considered, and timing should be optimised based on seasonality.

Prescribing high-dose antipsychotics is typically reserved for individuals with treatment-resistant severe mental illnesses, such as schizophrenia, bipolar disorder and psychotic depression. It carries an increased risk of adverse drug effects, necessitating regular monitoring. Non-mental health specialist clinicians may not always be aware when the maximum recommended dose of antipsychotics is exceeded, leading to unintentional high-dose prescribing without recognising the need for additional monitoring or understanding the associated risks. Therefore, providing clinical decision support (CDS) tools to support clinicians and improve the appropriate prescribing of antipsychotics is important. The aim of this study is to understand current prescribing practices and assess the impact of high-dose antipsychotic prescribing on clinical outcomes among hospitalised patients. The findings from this study will shape a future project focused on developing an integrated computerised CDS tool.

This retrospective cohort study will examine antipsychotic prescribing among hospitalised patients using Hospital Electronic Prescribing and Medicines Administration data in Scotland from 2019 to 2023, in linkage with hospital records, Scottish Morbidity Records and primary care prescribing (Prescribing Information System). Patients will be grouped into those prescribed high-dose (exposed), defined as exceeding the 100% maximum recommended British National Formulary dose and normal-dose (unexposed) antipsychotics, followed from their first ever antipsychotic prescription date (index date) until the end of the study, study outcomes or death, whichever happens first. We will quantify high-dose antipsychotic prescribing, profile patient characteristics and use machine learning techniques to assess associations of high-dose antipsychotic prescribing with clinical outcomes, including harms and benefits, but will not attempt to establish causality.

The Health and Social Care Public Benefit and Privacy Policy Panel (HSC-PBPP) has granted ethical approval (ref. 2024-0239) following a Data Protection Impact Assessment, with data securely held and accessed in the National Safe Haven. The results will be published in international peer-reviewed journals and will be shared with clinicians.

Telerehabilitation (TR) programmes are increasingly recognised for their feasibility and potential benefits, such as eliminating travel time, reducing costs and providing a more comfortable rehabilitation experience at home. However, the comparative efficacy of remote physiotherapy compared with traditional in-person sessions for individuals with Parkinson’s disease (PD) remains uncertain. This study aims to evaluate the effects of TR compared with in-person physiotherapy in individuals with PD, focusing on both motor and non-motor outcomes.

This is a randomised, single-blind clinical trial with a mixed-methods approach. A total of 22 individuals diagnosed with PD will be randomly assigned to one of two groups. The experimental group will receive TR, consisting of remote physiotherapy sessions conducted once a week for 1 hour over a 4-month period. The control group will receive the same interventions in person. Interventions will include global muscle strengthening exercises, balance training, gait and motor coordination exercises, and cognitive training. The primary outcome will be motor function, measured using part III of the Movement Disorder Society–Unified Parkinson’s Disease Rating Scale. Secondary outcomes will include cognition (Montreal Cognitive Assessment), gait (Functional Gait Assessment), mobility (Timed Up and Go Test) and quality of life (Parkinson’s Disease Questionnaire). Data will be analysed using repeated measures analysis of variance to compare outcomes between groups across four assessment points (baseline, midpoint, postintervention and 2 months follow-up). Additionally, a qualitative phase will explore participants’ perceptions and experiences regarding TR and in-person interventions, with assessments carried out 2 months after the completion of the 24-week interventions, through semistructured interviews that will be analysed using Bardin’s Content Analysis technique.

This protocol was approved by the Research Ethics Committee of the Federal University of Rio Grande do Norte (approval number: 5.553.701). All participants will provide written informed consent before inclusion. Results will be disseminated through peer-reviewed publications, scientific conferences and communication with participants and healthcare professionals.

RBR-6h5knrj.

Value-based healthcare (VBHC) strives to improve the healthcare system by focusing on value of care, that is, patient relevant outcomes relative to the costs for achieving these outcomes. Within VBHC, patient participation is crucial to identify patient relevant outcomes and value improvement potential. However, patient participation in VBHC initiatives remains limited. Therefore, we aimed to improve patient participation within VBHC teams with the ultimate aim to develop a practical guide for patient participation in VBHC.

An action research study.

This study was conducted in seven collaborating Dutch hospitals from March 2023 to November 2024.

Seven VBHC teams were selected to participate in the cyclical action research steps, that is, orientation, planning, implementation, and evaluation, in which patient participation was implemented or improved. These included the following patient groups: prostate cancer, vulnerable elderly, breast cancer, diabetes, maternity care, colorectal cancer and chronic kidney disease.

Both qualitative and quantitative data were collected. Qualitative data included observations and minutes of meetings with the intervention teams. Quantitative data included responses to the Public and Patient Engagement Evaluation Tool (PPEET) by multiple members of the intervention (n=7) and control teams (n=94) at three time points (T1=6 months, T2=12 months, T3=end of study). Qualitative data were thematically analysed and quantitative data were analysed descriptively. Finally, the data were triangulated to create an overview of lessons learnt in improving patient participation.

Patient participation goals varied across teams, leading to diverse actions, such as establishing a diabetes patient panel and distributing questionnaires to patients with colorectal cancer. PPEET results show that 71% of intervention team members reported that patient participation had an impact on the team’s outcomes compared with 44% in control teams (T3). Furthermore, 80% of the intervention team members initially wanted training in patient participation (T1), which dropped to 29% at T3. Overall, 22 lessons in improving patient participation in multidisciplinary project teams were identified and compiled into a practical guide.

The action research process improved the process and impact of patient participation in the intervention teams. Furthermore, the results indicate that the action research process enhanced the team members’ knowledge and skills on patient participation. The practical guide developed in this study can be used to support implementation of patient participation in VBHC.

Approximately one in every six children and adolescents is affected by mental disorders, which impose significant costs on patients, their families and societies. Psychotherapy is the first-line treatment for many of these disorders, and systematic reviews of post-intervention effects show small to moderate favourable outcomes compared with control groups. However, the long-term effects of psychotherapy remain less well understood.

The LaKiJu META project aims to address this gap by developing an open-access database, which will subsequently be used for data synthesis. This database will be established through literature searches in nine databases for (cluster) randomised controlled trials (RCTs) investigating the long-term effects (≥6 months) of any type of psychotherapy in school-aged children and adolescents (ages 6;00 to 17;11 years) with mental disorders. Outcomes will be prioritised based on their relevance to patients, caregivers and clinicians and will encompass a broad range of measures, including symptom changes, response rates and reliable changes. Syntheses will use multilevel meta-analyses to compare intervention and control groups at follow-up assessments, across both transdiagnostic and disorder-specific symptom outcomes. In secondary analyses, we will examine changes within intervention groups over time. Moderator analyses will focus on the effects of study-, intervention- and patient-level characteristics.

Ethical approval for public involvement was obtained from the ethics committee of the Faculty of Psychology of the Ruhr University Bochum. For dissemination, we will employ tailored strategies to reach researchers, clinicians, patients and their caregivers, with all groups involved in the development of dissemination plans.

CRD420251003208 (preregistered on 10 March 2025).

This study aimed to investigate the factors influencing health-related quality of life (HRQoL) in patients undergoing haemodialysis, focusing on the association between HRQoL dimensions and sociodemographic variables, clinical parameters, mental health status and biochemical indicators.

A multicentre cross-sectional study conducted over 30 months.

The study was carried out in secondary care centres across multiple locations in the Community of Extremadura, Spain.

A total of 150 patients undergoing haemodialysis were recruited between March 2022 and September 2023. Inclusion criteria required patients to be diagnosed with chronic kidney disease (CKD) and undergoing haemodialysis. Patients unable to provide informed consent or with severe cognitive impairment were excluded.

HRQoL was assessed using the Kidney Disease Quality of Life 36-item Short Form scale. Mental health parameters, specifically anxiety and depression, were evaluated using the Hospital Anxiety and Depression Scale. Biochemical markers such as haemoglobin and haematocrit levels, as well as sociodemographic and clinical data, were analysed for their influence on HRQoL.

Symptoms of anxiety and depression were prevalent among patients undergoing haemodialysis. Anxiety had the greatest negative effect on HRQoL, being significantly associated with lower scores in the mental component summary (MCS) (β = –2.06; 95% CI –2.78 to –1.33; R² = 0.106; p

Depression and anxiety, along with older age, were identified as key factors negatively affecting HRQoL of patients undergoing haemodialysis. Management of mental health, alongside optimisation of clinical care to minimise complications, could enhance the HRQoL in this patient population. Further research is recommended to develop targeted interventions addressing anxiety and other modifiable factors influencing HRQoL in haemodialysis patients.

Chronic obstructive pulmonary disease (COPD) is characterised by progressive airflow limitation that is not fully reversible and is associated with an abnormal inflammatory response of lungs to noxious particles and gases. The inflammatory and reparative processes occurring in the lungs induce a ‘spill-over’ of inflammatory mediators into the circulation, resulting in an increase in systemic inflammation, which is further increased during acute exacerbations of COPD (AECOPD), leading to the development of extra-pulmonary comorbidities, such as cognitive impairment. Cognitive impairment affects up to 61% of people living with COPD. Heightened levels of inflammation have been linked to increased risk of cognitive impairments; however, the exact mechanisms remain unclear, thus hampering the development of therapeutics. This study aims to determine whether patients hospitalised with an acute COPD exacerbation show impaired cognitive function compared with recovery (~day 45), and whether such dysfunction is associated with systemic inflammation and oxidative stress.

A prospective, observational study will be conducted at Austin Health in Victoria, Australia. Eligible participants will be assessed during admission for AECOPD and following stabilisation (approximately day 45). The primary outcome is the difference in cognitive function between admission for AECOPD to recovery using non-verbal cognitive tests. Secondary outcomes are changes in systemic markers of inflammation, oxidative stress and ACE2 catalytic activity. Tertiary outcomes are anxiety and depression scores.

Ethical approval has been granted in Australia by Austin Health Human Research Ethics Committee (HREC 56099) with governance approval at Austin Hospital. The results will be published in peer-reviewed scientific journals and presented at national and international scientific conferences. Findings will be disseminated to consumers in publications for lay audiences.

Participation in physical activity (PA) is a cornerstone of the secondary prevention of stroke. Given the heterogeneous nature of stroke, PA interventions that are adaptive to individual performance capability and associated co-morbidity levels are recommended. Mobile health (mHealth) has been identified as a potential approach to supporting PA post-stroke. To this end, we used a Sequential Multiple Assignment Randomised Trial design to develop an adaptive, mHealth intervention to improve PA post-stroke – The Adaptive Physical Activity programme in Stroke (TAPAS) (Clinicaltrials.Gov NCT05606770). As the first trial in stroke recovery literature to use this design, there is an opportunity to conduct a process evaluation for this type of adaptive intervention. The aim of this process evaluation is to examine the implementation process, mechanism of change and contextual influences of TAPAS among ambulatory people with stroke in the community.

Guided by the Medical Research Council Framework for process evaluations, qualitative and quantitative methods will be used to examine the (1) implementation process and the content of TAPAS (fidelity adaptation, dose and reach); (2) mechanisms of change (participants’ response to the intervention; mediators; unexpected pathways and consequences) and (3) influence of the context of the intervention. Quantitative data will be presented descriptively, for example, adherence to exercise sessions. Qualitative data will be collected among TAPAS participants and the interventionist using semi-structured one-to-one or focus group interviews. Transcribed interviews will be analysed using reflexive thematic analysis. Key themes and sub-themes will be developed.

Ethical approval has been granted by the Health Service Executive Mid-Western Ethics Committee (REC Ref: 026/2022) (25/03/2024). The findings will be submitted for publication and presented at relevant national and international academic conferences.

Exacerbations of chronic obstructive pulmonary disease (COPD) can lead to reduced lung function and worse clinical outcomes. Previous studies have reported associations between severe exacerbations and increased risk of hospitalisation and/or mortality. This meta-analysis examined the impact of moderate exacerbations on the risk of future exacerbations and all-cause mortality.

This meta-analysis included seven observational studies from the EXACOS (EXAcerbations of COPD and their OutcomeS)/AVOIDEX (Impact of AVOIDing EXacerbations of COPD) programme studies.

This meta-analysis used data from regional claims databases or electronic healthcare records from seven countries.

The individual studies included patients with a diagnosis of COPD and ≥12 months of data availability before (regarded as baseline) and after the index (ie, the date of the first COPD diagnosis), with postindex data considered the follow-up period.

The number of COPD exacerbations experienced during the baseline period (ie, the exposure variable) was used to categorise patients into the following groups: no exacerbations, one moderate exacerbation only or two or more moderate/severe exacerbations. Outcomes assessed included risk of COPD exacerbations and all-cause mortality during follow-up as a function of baseline exacerbations. For meta-analyses, all rate ratios (RRs) were log-transformed, and associations were pooled across studies using random-effects meta-analysis models.

Among 2 733 162 patients with COPD, one moderate exacerbation was significantly associated with a twofold increased risk of future exacerbations compared with having no exacerbations during baseline, with pooled RRs (95% CIs) of 2.47 (1.47 to 4.14) at 1 year, 2.49 (1.38 to 4.49) at 2 years and 2.38 (1.30 to 4.34) at 3 years postindex. The pooled RR (95% CI) for all-cause mortality was 1.30 (1.05 to 1.62), indicating a 30% increase in risk following one moderate exacerbation versus no exacerbations.

Preventing moderate exacerbations in patients with COPD should be a priority that may improve patient trajectories and outcomes.

Prediabetes (PD), defined by impaired glucose tolerance or impaired fasting glucose, represents a growing global health challenge, with a prevalence projected to increase substantially. PD is a critical intervention target because of its high annual progression rate (5–10%) to type 2 diabetes mellitus (T2DM) and elevated cardiovascular disease (CVD) risk. Non-surgical interventions (NSIs), particularly lifestyle modifications (LMs) and pharmacological therapies, are the cornerstone of PD management, demonstrating efficacy and cost efficiency over surgical options. However, despite LM’s ability to reduce T2DM incidence by 40–70% in trials such as the Diabetes Prevention Program, real-world implementation faces barriers, including resource intensity and complex delivery requirements, which increase upfront costs. We aim to review scientific literature reporting on the effectiveness and cost-effectiveness of NSIs for preventing the progression of PD to T2DM among adults.

Alliance ruptures constitute a high risk of premature treatment termination and poor psychotherapy outcome. The Alliance-Focused Training (AFT) is a promising transtheoretical approach to enhance therapists’ skills in dealing with alliance ruptures.

To evaluate the effectiveness of Modified AFT with doubling (MAFT-D), a randomised, patient and evaluator-blinded, multicentre trial was designed comparing MAFT-D (delivered to trainee therapists and supervisors) and psychotherapy training/treatment as usual (TAU) for therapists (n=120) and their patients with depressive disorders (n=240). A total of 17 cooperating centres, each offering either cognitive-behavioural or psychodynamic psychotherapy training, will contribute to recruitment. Stratification by centre (both for therapists and patients) and hence therapeutic approach (cognitive-behavioural vs psychodynamic psychotherapies), and by comorbid personality disorder (yes vs no, for patients) will be carried out. The two hierarchically ordered primary hypotheses are: In MAFT-D compared with TAU, a stronger reduction of depressive symptoms and a lower rate of patient dropout is expected from baseline to 20 weeks after baseline. Follow-up assessments are planned at 35 weeks, 20 months and 36 months postbaseline to evaluate the persistence of effects. Secondary patient-related and therapist-related outcomes as well as predictors, moderators and mediators of change will be investigated. Mixed models with repeated measures will be used for the primary analyses.

Ethical approvals were obtained by the institutional ethics review board of the main study centre as well as by review boards in each federal state where one or more cooperating centres are located (secondary votes). Following the Consolidated Standards of Reporting Trials statement for non-pharmacological trials, results will be reported in peer-reviewed scientific journals and disseminated to patient organisations and media.

DRKS00014842; https://drks.de/search/de/trial/DRKS00014842.

Adolescent idiopathic scoliosis (AIS) often imposes a significant psychological burden on teenagers. Cognitive and behavioural strategies have demonstrated the potential to alleviate these challenges. Chatbots, with their real-time interaction capabilities, provide a promising and accessible approach to delivering psychological interventions for young people.

This pilot trial will evaluate a chatbot-delivered, structured psychological intervention (SPI-Bot) incorporating cognitive and behavioural strategies for teenagers with AIS. Conducted as a single-centre, parallel-group randomised controlled trial, the study aims to assess the feasibility, acceptability and preliminary effectiveness of SPI-Bot. Fifty-two teenagers with AIS and mild to moderate psychological symptoms will be block-randomised into two groups. The intervention group will complete an 8-week, evidence-based SPI-Bot programme, while the control group will engage in casual conversations with another chatbot that does not include specific psychological health content. Assessments will be conducted at baseline, postintervention (8 weeks) and follow-up (12 weeks). Primary outcomes include feasibility and acceptability, measured through recruitment rates, adherence rates, attrition rates, engagement, working alliance, usability, user experience and adverse events. Secondary outcomes focus on effectiveness, including psychological distress, psychological well-being, perceived social support and quality of life. Participants in the intervention group will be purposively sampled for semistructured interviews to explore their perceptions of the intervention process.

This study has been approved by the Institutional Review Board of the Hong Kong Polytechnic University (Reference: HSEARS20240919007). The results of this pilot study will be disseminated through peer-reviewed journals and conference presentations.

NCT06698952