Search Results for: Progressi nel trattamento della psoriasi: review

Objectives
Lung cancer is increasingly being diagnosed in non-smokers, with mounting evidence that household air pollution is a potential factor. Environmental risk factors for lung cancer in never-smokers (LCINS) in relation to combustion of biomass for heating and cooking in low-middle-income countries (LMICs) have been extensively explored. However, such evidence in high-income countries (HICs) is limited. We conducted a systematic review to explore potential relationships between exposure to cooking fumes, a type of household air pollution, and lung cancer, specifically in relation to never-smokers in HICs.

Design
Systematic review and narrative synthesis using the Critical Analysis Skills Programme (CASP) guidelines for case–control studies.

Data sources
Embase, Scopus, the Cochrane library and CINAHL were searched, from inception to March 2024. Reference lists of articles were hand searched for additional papers.

Eligibility criteria
Case–control studies focusing on household air pollution and its impact on LCINS in HICs were included.

Data extraction and synthesis
Two independent reviewers searched, screened and coded included studies using a bespoke table. Quality of evidence was assessed in the selected studies using the CASP tool for case–control studies. Retained studies used different exposure assessment and reporting methods which were sufficiently heterogeneous to preclude meta-analysis; therefore, narrative synthesis was performed.

Results
Three papers were included, with a total of 3734 participants. All studies were conducted in Taiwan or Hong Kong, focusing on Chinese women using traditional Chinese cooking methods. All three found a dose/response correlation between exposure to cooking fumes and the risk of developing LCINS.
Chen et al assessed the risk of lung cancer risk by ‘cooking time-years’, measuring exposure to cooking fumes over a participant’s lifetime, citing OR 3.17 (95% CI 1.34 to 7.68) for the highest levels of exposure. Yu et al used ‘cooking dish-years’ as a measure of exposure to cooking fumes, with OR 8.09 (95% CI 2.57 to 25.45) for the highest exposure levels, while Ko et al found that the number of dishes cooked daily was a greater indicator of risk than the number of cooking years, citing a threefold increased risk of lung cancer among women who cooked three meals per day compared with those who cooked one (OR 3.1, 95% CI 1.6 to 6.2).
Ventilation hoods were found to have a protective effect against LCINS with adjusted ORs of 0.49 (95% CI 0.32 to 0.76).

Conclusions
This review of three studies found a possible association between exposure to cooking fumes and the risk of developing LCINS in high-income settings. This corroborates the substantial body of evidence that links cooking fume exposure to LCINS in LMICs, with definitive confirmation of the exposure hazards.

PROSPERO registration number
CRD42024524445.

Introduction
RaCeR 2 is a pragmatic multicentre, open-label, randomised controlled trial, with full economic evaluation. The primary aim is to assess whether individualised (early) patient-directed rehabilitation (EPDR) results in less shoulder pain and disability at 12 weeks postrandomisation following surgical repair of full-thickness tears of the rotator cuff of the shoulder compared with the current standard (delayed) rehabilitation. This paper provides the protocol for the RaCeR 2 health economic evaluation.

Methods and analysis
The health economic analysis of RaCeR 2 is made up of three phases: (1) development of an initial state-transition model structure, (2) within-trial cost consequence analysis and (3) long-term model-based cost-effectiveness analysis (CEA) from the National Health Service and Personal Social Service perspective in England. Descriptive statistics (eg, mean, standard deviation, 95% confidence intervals and minimum and maximum values) will be reported for within-trial resource use, costs and health-related quality of life (HRQoL). Health state-specific costs and HRQoL will be estimated using regression model approaches and used to inform a state-transition simulation model designed to quantify the long-term costs and quality-adjusted life years (QALYs) experienced by patients over the model’s time horizon. Where appropriate, final CEA model results will be reported as cost per QALY gained for individualised EPDR versus standard (delayed) rehabilitation. Model assumptions and overall parameter uncertainty will be tested using probabilistic sensitivity analysis and scenario analyses. All regression analyses will be adjusted for baseline participant demographic and symptomatic characteristics.

Ethics and dissemination
A favourable ethical review was granted by London-Stanmore Research Ethics Committee (23/LO/0195) on 13 April 2023. Findings will be disseminated in peer-reviewed journals, at scientific conferences, and via the study website.

Trial registration number
ISRCTN11499185

Introduction
Depression and anxiety are highly prevalent mental health conditions that significantly affect quality of life and cause societal burdens. However, their detection and diagnosis rates remain low owing to the limitations of the current screening methods. With rapid technological advancements and the proliferation of consumer-grade wearable devices and smartphones, their integration into digital phenotyping research has enabled the unobtrusive screening for depression and anxiety in natural settings. The Smartphone and Wearable Assessment for Real-Time Screening of Depression and Anxiety study aims to develop prediction algorithms to identify individuals at risk for depressive and anxiety disorders, as well as those with mild-to-severe levels of either condition or both. By collecting comprehensive data using smartphones and smartwatches, this study aims to facilitate the translation of artificial intelligence-based early detection research into clinical impact, thereby potentially enhancing patient care through more accurate and timely interventions.

Methods and analysis
This cross-sectional observational study will enrol up to 2500 participants (at least 1000) aged 19-59 years from South Korea via social media outreach and clinical referrals. The eligible participants must use a compatible smartphone. Each participant will be followed up for 4 weeks. Data will be collected using a custom-developed smartphone application called PixelMood. Active data collection will include daily, weekly and monthly self-report questionnaires incorporating validated scales, such as the Patient Health Questionnaire-9 and Generalized Anxiety Disorder-7. Passive data from smartphones include information on physical activity, location, ambient light and smartphone usage patterns. Optionally, participants using the Apple Watch or Galaxy Watch devices can provide additional data on physiological responses and sleep health. The primary outcome will be the development of machine-learning algorithms to predict depression and anxiety based on these digital biomarkers. We will employ various machine-learning techniques, including random forest, support vector machine and deep-learning models. The secondary outcomes will include the association between digital biomarkers and clinical measures, and the feasibility and acceptability of data collection methods. Various features characterising mobile usage behaviours, physical/social activity, sleep patterns, resting physiological states and circadian rhythms will be exploited to serve as potential digital phenotyping markers. Advanced machine-learning and deep-learning techniques will be applied to multimodal data for model generation.

Ethics and dissemination
This study protocol was reviewed and approved by the Institutional Review Board of the Korea University Anam Hospital (approval number: 2023AN0506). The results of this study will be disseminated via multiple channels. The findings will be presented at local, national and international conferences in relevant fields, such as psychiatry, psychology and digital health. Manuscripts detailing the study results will be submitted to peer-reviewed journals for publication.

Trial registration number
The present study was registered with the Clinical Research Information Service (CRIS, https://cris.nih.go.kr; identifier: KCT0009183).

Introduction
Randomised controlled trials (RCTs) are considered the gold standard for evaluating the efficacy and safety of healthcare interventions. For valid systematic reviews and evidence-based clinical guidelines, it is essential that results of all eligible RCTs are accessible. However, articles about trials published in languages other than English are often not listed in well-known and open trial databases like Medline and therefore scarcely findable. Handsearching national journals is an important approach to identify these articles and enhance their global visibility. Consequently, the results of trials conducted and published in non-English-speaking countries are not lost but rather integrated into the global body of evidence.
The present study aims to evaluate the benefits of extensive handsearching in Hungary and to identify key medical fields for future efforts. We will also assess the extent of grey literature in Hungary. We will appraise the risk of bias in the identified RCTs and controlled clinical trials (CCTs; indicating quasi-randomised or possibly randomised controlled trials) and examine the reporting quality of articles in Hungarian medical journals. Additionally, we will explore whether the automation tool Paperfetcher, recommended by Cochrane for handsearching, can effectively support these efforts in a non-English language context.

Methods and analysis
We will conduct a cover-to-cover handsearch of all Hungarian medical journals publishing content in the year 2023 to identify all controlled clinical trials, including RCTs, CCTs and non-RCTs, which are trials that use a clearly non-random method for allocating participants to groups. We will also search conference proceedings submitted to the Hungarian National Széchényi Library, abstract supplements from journals available via the Hungarian Medical Bibliography database, preprints available on medRxiv, Hungarian theses and dissertations, as well as Google Scholar to identify grey literature.
Two independent researchers will screen the identified records, assess their eligibility, extract data and evaluate the risk of bias and reporting quality according to the CONSORT statement. To verify the availability of reports and publications derived from the identified trials in electronic databases, we will systematically search MEDLINE, the Cochrane Central Register of Controlled Trials (CENTRAL), Embase and Scopus. All identified RCTs and CCTs not yet included in CENTRAL will be added to the database. Additionally, we will compare handsearching supported by the Paperfetcher tool with unsupported handsearching to evaluate the tool’s effectiveness in a Hungarian language context.

Ethics and dissemination
Since the publication resulting from the handsearching activity is a retrospective review of publicly available sources of evidence, ethical approval is not required. The study findings will be submitted for publication in a peer-reviewed journal and will be presented at international conferences.

Sacroiliaca – L’alterata funzione dell’articolazione sacroiliaca si manifesta con dolore lombare e gluteo: quando e come operare se il dolore diventa invalidante?

Objectives
With recent efforts to eliminate visceral leishmaniasis in East Africa, we aimed to map the breadth of research on leishmaniases in Ethiopia, one of the high-endemic countries in the region, to help understand the current literature landscape and highlight priority areas for future research.

Design
The scoping review was conducted in accordance with the JBI Scoping Review Methodology Group’s guidance and reported following Preferred Reporting Items for Systematic Reviews and Meta-Analyses—Extension for Scoping Reviews guidelines.

Data sources
We searched the following databases and sources: PubMed, Embase, Web of Science, Cochrane Library, Global Medicus Index, PROSPERO, ClinicalTrials.gov and the Pan African Clinical Trials Registry and known local journals.

Eligibility criteria
We included studies addressing the issue of leishmaniasis in Ethiopia that were published in English language.

Data extraction and synthesis
Two reviewers independently extracted data from each study, with conflicts resolved by a third reviewer. The identified studies were analysed using an extensive codebook, which was previously developed by this team and adapted to the Ethiopian context to classify the research into different categories.

Results
A total of 8698 articles were identified. A stepwise review was conducted, and 639 papers were selected for inclusion. The research spans different themes and designs and has steadily increased over the past 14 years. Research on prevention and control, health systems/policies and post-kala-azar dermal leishmaniasis, as well as randomised controlled trials, was lacking. Studies on coinfections with other diseases accounted for 14% of research.

Conclusions
The findings underscore the growing amount of research on leishmaniasis in Ethiopia, addressing several themes and emphasising the need for more research in prevention, control, health systems/policy and high-quality studies for evidence-based treatment.

Objectives
To explore healthcare professionals’ perspectives and practices regarding informed consent during childbirth, particularly in the context of increased public awareness and discourse surrounding obstetric violence (OV) in France.

Design
A qualitative study based on semistructured interviews and non-participant observations.

Setting
Four maternity units in France, representing a diversity of institutional contexts.

Participants
A purposive sample of 32 participants, including midwives and obstetricians, was recruited across the four sites.

Methods
Data were collected through 32 semistructured interviews and in situ observations in labour and delivery rooms. A thematic analysis was conducted using a phenomenological approach, supported by NVivo software.

Results
Four main themes emerged: (1) relational malaise in the caregiver–patient relationship, reinforced by public discourse on OV, further hindered shared decision-making and open communication. (2) Challenges between caring values and systemic constraints (eg, lack of time, staffing shortages and protocol-driven care) limited professionals’ ability to engage in meaningful informed consent discussions. (3) Safety paradigm in obstetrics: fetal well-being emerged as a central and non-negotiable argument to justify medical interventions during childbirth. (4) Informed consent as a source of tension, where professionals struggled to balance legal and ethical obligations with clinical urgency, often leading to coercive or merely formal consent processes.

Conclusions
Informed consent during childbirth remains a critical and unresolved ethical challenge. This study highlights systemic, relational and emotional barriers that hinder shared decision-making and compromise the core ethical principles of autonomy, beneficence and justice. Addressing these issues requires structural changes, improved working conditions to support individualised care, better training in ethics and communication and greater recognition of the moral distress experienced by healthcare professionals.

Registration number
Registration number 22-219 from CEEI-IRB INSERM (Research Institutional Review Board INSERM, France) (IRB 00003888, IORG 0003254, FWA 00005831).

Introduction
Peripheral artery disease (PAD) is a chronic condition causing arterial narrowing or blockage, leading to significant morbidity and mortality. Hybrid revascularisation combines open surgical and endovascular techniques to manage multilevel disease by addressing inflow and outflow obstructions. Despite increasing adoption, evidence on the long-term outcomes of these procedures remains limited.

Objective
To evaluate the long-term outcomes of hybrid revascularisation procedures in PAD, including patency rates, limb salvage, survival, reintervention rates and complications, and to provide evidence-based insights for clinical practice and research.

Methods and analysis
This review will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. It will include randomised controlled trials, cohort studies, case-control studies and large case series (≥10 patients, with at least 1 year of follow-up) assessing adult patients undergoing hybrid revascularisation for PAD. Primary outcomes are patency rates, limb salvage and survival; secondary outcomes include complication rates, functional improvements and quality of life. Searches will be conducted in PubMed, Embase, Cochrane Library, CINAHL and ClinicalTrials.gov. Study selection, data extraction and quality assessment will be performed independently in duplicate by two reviewers. Meta-analyses with random-effects models will summarise findings where feasible, while narrative synthesis will address instances of insufficient data. Subgroup analyses will explore outcomes by demographics, lesion characteristics and procedural details. Risk of bias will be assessed using Cochrane and Newcastle-Ottawa tools.

Ethics and dissemination
Ethical approval is not required. Findings will be published in peer-reviewed journals and presented at conferences.

PROSPERO registration number
CRD42024615809.

Botox – Vuoi fare il botox? Ecco tutto quello che devi sapere: a chi è indicato e quanto dura il trattamento con tossina botulinica, cosa fare e non fare dopo.

Circulation, Ahead of Print. Poor diet quality is a leading risk factor for cardiometabolic disease (ie, diabetes and diseases associated with metabolism and inflammation), which is present in about half of American adults. Support has grown for incorporating the provision of healthy food as a complement to or a component of clinical care. Such “Food Is Medicine” programs provide free or subsidized healthy food directly to patients in close coordination with the health care system. In this review, we systematically examined published randomized controlled trials examining Food Is Medicine programs in the United States, categorizing them into different stages of development using the National Institutes of Health Model for Behavioral Intervention Development. This review identified a total of 14 randomized controlled trials of Food Is Medicine interventions in the United States with noncommunicable disease outcomes, more than one-third of which were early-stage smaller-scale trials (stage 1 randomized controlled trials). Broad variations in populations enrolled; intervention design, duration, and intensity; and outcomes precluded many direct comparisons between studies. Randomized controlled trial data were generally consistent with findings in the observational literature, indicating that common Food Is Medicine approaches often positively influence diet quality and food security, which are theorized to be key mediators for clinical outcomes. However, the impact on clinical outcomes was inconsistent and often failed to reach statistical significance. These observations highlight the need for larger, higher-quality Food Is Medicine studies focusing on the measurement of clinical outcomes within well-designed programs and the need for additional randomized controlled trials that more systematically map out the relationship between participation in different types of Food Is Medicine programs and health outcomes.

Introduction
Chronic heart failure management can involve considerable healthcare workload for the patient that impacts on well-being and results in treatment being perceived as burdensome. This can result in non-adherence to treatments. This systematic review aims to identify, appraise and synthesise the available qualitative evidence exploring the experience of treatment burden in heart failure patients participating in a self-care intervention. Findings will provide an in-depth understanding of the patient journey, providing knowledge that will enable the development of targeted interventions that reduce the burden of treatment for patients.

Method and analysis
The databases will include Medline, PsycINFO, Embase, CINAHL, Cochrane and Web of Science. The review protocol is registered in the International Prospective Register for Systematic Reviews (PROSPERO ID no 1052512). This review will systematically scour qualitative research studies in databases from 2010 to January 2025 with carefully chosen search terms such as heart failure, self-care and burden. Searches are limited to studies in English. Two reviewers, guided by the Joanna Briggs Institute Critical Appraisal Checklist for Qualitative Research, will independently appraise the methodological quality of the selected studies. Any disagreements will be resolved through discussion with a third reviewer. This review will employ a rigorous thematic synthesis approach informed by the burden of treatment theory, where two researchers will analyse and synthesise data by double-coding.

Ethics and dissemination
Ethical approval is not required for this systematic review as primary data will not be collected. The result of the review will be disseminated through publication in an academic journal and scientific conferences.

PROSPERO registration number
ID 1052512.

Introduction
Research on therapeutic mobility is abundant but the field of cancer has not yet been investigated thoroughly. This scoping review aims to examine the existing evidence on global therapeutic mobility and cancer, providing a comprehensive overview of the subject.

Methods
We conducted a scoping review and followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses methodological guidelines. We developed a comprehensive search strategy and discussed it with the research team. We searched for peer-reviewed papers on Medline, Embase, ERIC and American Psychological Association via the Dialogue interface and Google Scholar and CAIRN bibliographic database for peer-reviewed articles. We also included grey literature, such as unpublished work and relevant reports from Érudit. We considered studies that employed quantitative or qualitative methods.

Results
Among the 1615 references initially selected, 767 duplicates were excluded. Then, 849 studies were screened on title and abstract and 800 were excluded as they did not meet inclusion criteria. 49 studies were fully screened and 21 were excluded as they did not meet inclusion criteria based on full-text assessment. Ultimately, 28 references were included in the data synthesis. This scoping review has shown that publications on therapeutic mobilities have multiplied in recent years, with a turning point in 2019. A range of academic disciplines and research methodologies are currently employed to describe them. A significant proportion of fieldwork is concentrated in Asia, Africa, Europe and North America. Despite the heterogeneity of the approaches and fields, there are certain common features that emerge: first, the decision to migrate for healthcare is primarily made by the patient themselves and is perceived by them as being non-choice; second, the family plays a central role at all stages of the migration; and third, the migration has a catastrophic impact in terms of social and financial burden.

Conclusion
In conclusion, this scoping review highlights the underexplored relationship between global therapeutic mobility and cancer, emphasising the need for increased research efforts to understand the global dynamics of cancer care mobility.

Introduction
Balance and gait disorders represent the most frequent and disabling sequelae after stroke. Impaired body orientation with respect to gravity (lateropulsion) is one of the primary underlying mechanisms, increasingly investigated. After hemisphere stroke, lateropulsion is caused by an impaired internal representation of verticality, for which developing rehabilitation techniques has become a priority. Among various approaches, virtual reality appears to be a promising tool for modulating spatial reference frame. The objective of this study is to investigate the effects of immersion in virtual tilted reality (VTR) on the postural vertical (PV) as a primary outcome, as well as main secondary outcomes on the visual vertical (VV) and the active standing posture (body orientation with respect to gravity and weight-bearing (WB) distribution on lower limbs), both in healthy individuals and individuals exhibiting lateropulsion at the subacute phase after a hemispheric stroke. The cumulative effect of the VTR on the post-stroke lateropulsion will also be analysed.

Methods and analysis
This pilot study is a single-centre, within-person randomised trial conducted in the department of Physical and Rehabilitation Medicine of the University Hospital of Grenoble-Alpes (France). We will include 40 individuals from 18 to 85 years old, 20 healthy individuals and 20 individuals with lateropulsion tested 0.5 on the Scale for Contraversive Pushing), the study lasts 4 weeks: W1 for inclusion, randomisation, planning and conventional rehabilitation; W2 and W4 to collect clinical data and conventional rehabilitation; and W3 for the VTR intervention over four consecutive mornings at the same time: 2 to test the VTR effects on verticality perception (PV and VV) and 2 to test the VTR effects on active standing (body orientation and WB distribution on lower limbs). Immediate effects and post-effects of the VTR immersion are analysed by comparing results of the following time points: for verticality perception baseline, during and after VTR and for active standing at only baseline and during VTR immersion. Linear mixed-effect models will be run with different factors/covariates according to objectives. We will analyse the proportion and features of responders (PV modulation ≥2°). The cumulative effect of the 4 days of VTR sessions will be analysed by comparing scores of the SCAle for LAteropulsion assessed at the end of every week.

Ethics and dissemination
The study was approved by an institutional review board at the national level (Comité de Protection des Personnes Ile de France X; 2020-A02941-38, amendment 2024). All participants will provide written informed consent before enrolment. Findings will be submitted to peer-reviewed journals related to rehabilitation, stroke or neuroscience.

Trial registration number
ClinicalTrials.gov, NCT04911738.

Introduction
Concurrent with infants’ progression in dietary complexity and gut microbiome diversity, infants gradually change their defecation patterns during the first year of life. However, the links between bowel habits, the gut microbiota and early life nutrition remain unclear. The primary outcome is to characterise the gut microbiome development from birth to 1 year of age. Second, to investigate how bowel habits and nutrition in early life relate to the gut microbiome and metabolome during this period of life, and to explore how the development of the gut microbiome associates with host development.

Methods and analysis
The MOTILITY Mother-Child Cohort (MOTILITY) is a Danish prospective longitudinal cohort study enrolling up to 125 mother–infant dyads. Assessments occur at 36 weeks gestation (visit 1), birth (screening of infant) and 3, 6, 9 and 12 months (±2 weeks) post partum (visits 2–5). At visit 1, maternal anthropometrics, self-collected faecal and urine samples, and questionnaires on bowel habits and lifestyle are obtained. Between visits, infant faecal (biweekly), urine (monthly) and maternal breast milk (monthly until 6 months of age) samples are collected at home, and bowel habits and dietary intake are assessed biweekly by self-reported questionnaires. At visits 2–5, infant blood and saliva samples are collected, and anthropometric measurements are obtained. In addition, dietary intake is recorded thrice throughout the study period for mother and infant, respectively, and infant whole-gut transit time is estimated by sweet corn tests at 9 and 12 months of age. Birth, growth, motor development, sleep patterns, tooth development, overall health and well-being are assessed using questionnaires. Univariate and multivariate statistics will be applied to identify associations between the gut microbiome, early life nutrition and host physiology including bowel habits during the first year of life.

Ethics and dissemination
The MOTILITY study has been approved by the Research Ethics Committee for the Capital Region of Denmark (reference number: H-21063016). Selected results will be made available to the participants in the form of a summary document. Results will be published in peer-review journals and by means of national and international conferences.

Trial registration number
NCT05491161.

Objective
To evaluate the impact of heart valve clinics (HVCs) versus standard of care (SOC) on disease detection, timing of intervention and clinical outcomes in patients with valvular heart disease (VHD).

Design
A systematic review was conducted following Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines and registered in PROSPERO (CRD42024518787).

Data sources
PubMed, Embase, Web of Science, Scopus and the Cochrane Library from inception to 1 May 2025.

Eligibility criteria
Randomised controlled trials or cohort studies comparing patients managed in HVCs with those receiving SOC, and reporting on outcomes such as mortality, cardiac events, time to symptom reporting or symptom severity. Studies were excluded if they lacked detailed HVC protocols, single-arm designs or were published as abstracts only.

Data extraction and synthesis
Two reviewers independently screened titles, abstracts and full texts, with discrepancies resolved by a senior adjudicator. The Newcastle-Ottawa Scale (NOS) was used to assess the risk of bias. Meta-analysis was not conducted due to heterogeneity among studies.

Results
Three high-quality prospective cohort studies (N=1082) were included. Two studies reported mortality and cardiac events: one, a before-and-after controlled trial (n=382), recorded 11 deaths in the HVC group; the other reported 4 deaths in the HVC group (n=156) versus 17 deaths in the SOC group (n=156) (p

Introduction
Psychosis, characterised by chronic symptoms often emerging in youth, imposes a substantial burden on individuals and healthcare systems. While early detection and intervention can mitigate this burden, there is limited evidence on the cost-effectiveness of such approaches. To address this lack of evidence, this study protocol outlines the health economic implications of an artificial intelligence (AI)-based intervention, the Computer-Assisted Risk-Evaluation (CARE), designed to prevent psychosis. The intervention uses AI technologies to enhance the diagnosis and treatment quality for individuals at high risk of psychosis.

Methods and analysis
The health economic evaluation has been designed alongside a 12-month multicentre randomised controlled trial comparing CARE with treatment as usual from both payer and societal perspectives. An implementation cost analysis will complement the evaluation, and long-term consequences beyond the trial will be explored descriptively. Based on a literature review, an initial economic logic model will guide subsequent analyses by depicting CARE’s programme theory.
The cost-effectiveness assessment will include averted cases of manifest psychosis and quality-adjusted life-years using the EuroQol 5-Dimensions 3-Level instrument. Other effectiveness outcomes will also be incorporated into a cost–consequence analysis. Cost-effectiveness acceptability curves reflecting statistical uncertainty will be constructed, incorporating various payer and societal willingness-to-pay values. The implementation cost analysis will follow a mixed-methods approach to capture facility-specific costs.
A dark logic model, emphasising negative outcomes, will be developed to investigate long-term consequences. Further, the initial economic logic model will be refined using trial data and expert interviews. This comprehensive approach aims to provide decision-makers not only with evidence on the cost-effectiveness of CARE, but also with a broader understanding of the implications of the intervention.

Ethics and dissemination
The study has received ethical approval and plans to disseminate its findings through publication in a peer-reviewed journal and conference presentations.

Trial registration number
NCT05813080.