Barriers and facilitators to offering palliative care to patients with heart failure: a mixed-methods systematic review using the COM-B model and theoretical domains framework

Objectives
Despite palliative care (PC) potentially improving quality of life, only a tiny proportion of patients with heart failure (HF) are receiving PC. Globally, PC for HF patients faces several challenges; however, a systematic assessment of the barriers and facilitators to PC of patients suffering from HF is lacking. We aimed to identify barriers and facilitators to offering PC to HF patients.

Design
The mixed-methods systematic review was reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analysis statement.

Data sources
PubMed, CINAHL, MEDLINE, PsycINFO, Web of Science were searched from onset of literature database to 24 March 2025.

Eligibility criteria
We included both qualitative studies and quantitative studies addressing barriers and facilitators to offering PC to patients with HF reported by healthcare providers, patients, family members and caregivers.

Data extraction and synthesis
Data extraction was done independently by two reviewers, and quality assessment was completed using the mixed-methods appraisal tool. The Capabilities-Opportunities-Motivations-Behaviour (COM-B) model and the Theoretical Domain Framework (TDF) were used to identify potential barriers and facilitators.

Results
48 studies were included out of 4168. 289 items related to barriers and 88 items related to facilitators were categorised into 72 themes. These themes were found to align with at least one of the 14 TDF domains and the COM-B model. ‘Environmental context and resources’ (eg, lack of time, human, facilities and equipment resources; 77.2% of barriers vs 22.8% of facilitators), ‘knowledge’ (eg, insufficient awareness and knowledge of PC and/or needs; 91.8% of barriers vs 8.2% of facilitators) and “‘social influences’ (eg, limited communication and collaboration between healthcare professionals; 58.7% of barriers vs 41.3% of facilitators) were the three TDF domains that encoded the largest amount of data.

Conclusions
This review identified key barriers to PC for HF patients, primarily involving resource limitations, knowledge gaps and poor interdisciplinary collaboration. Findings highlight the need for targeted interventions addressing systemic and knowledge-related challenges.

PROSPERO registration number
CRD42023484807.

Read More

What is the added value of handsearching Hungarian medical journals and grey literature for identifying controlled clinical trials? Protocol for a meta-epidemiological study

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.

Read More

Protocol for the economic evaluation of individualised (early) patient-directed rehabilitation versus standard rehabilitation after surgical repair of the rotator cuff of the shoulder (RaCeR 2)

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

Read More

Medicines support and social prescribing to address patient priorities in multimorbidity (MIDAS): protocol for a definitive, multi-arm, cluster randomised, controlled trial in Irish general practice

Background
There is increasing awareness of the impact of living with multiple long-term conditions (referred to as multimorbidity) on patients and health systems. Managing multimorbidity remains a challenge for primary care providers; necessitating tailored interventions that are both clinically and cost effective. In the Irish health system, two pilot trials have demonstrated promising results for patients living with multimorbidity. The first, MultimorbiditY COllaborative Medication Review And DEcision making (MyComrade), involved pharmacists supporting the management of polypharmacy, and the second, Link MultiMorbidity (LinkMM), involved link workers delivering social prescribing. This definitive trial aims to evaluate the clinical and cost effectiveness of both these interventions, as well as conduct a process evaluation.

Methods
This is a pragmatic, multi-arm, definitive, cluster randomised controlled trial in Irish general practices. The trial will include three arms: (1) MyComrade; (2) LinkMM and (3) usual care, acting as an efficient shared control arm for both interventions. For this trial, 672 patients will be recruited from 48 general practices. The eligibility criteria for the patients will be: (1) over 18 years of age; (2) has two or more chronic conditions; (3) taking 10 or more regular medicines and (4) attending their general practice team for chronic disease management. Outcome data will be collected for all participants, across all trial arms at baseline and 6 months. Primary outcomes include the number of medicines (reflecting the MyComrade intervention) and patient capability (reflecting the LinkMM intervention). Secondary outcomes include proportions and types of potentially inappropriate medications, patient experience of care, patient activation, self-rated health, health-related quality of life, mortality and healthcare utilisation. Quantitative and qualitative data will be collected to inform the process evaluation. Additionally, an economic evaluation will be conducted to evaluate the cost-effectiveness of both interventions compared with the control arm.

Ethics and dissemination
The trial protocol was approved by the Irish College of General Practice (ICGP) Ethical Review Board (ref: ICGP_Rec_2023_016). A formal knowledge dissemination plan has been developed for the trial, which includes peer-reviewed publications, conference presentations and reports to healthcare professionals, commissioners and policymakers.

Trial registration number
ISRCTN11585238.

Read More

Effects of microgravity on neuromuscular control of the spine: a protocol for a systematic review and meta-analysis

Introduction
As spaceflight missions become more frequent and prolonged, the effects of microgravity on the musculoskeletal system represent a critical concern for astronauts’ health given their increased risk of spinal pain and injury. A better understanding of the adaptations induced by microgravity on neuromuscular control of the spine is essential to guide the development of effective countermeasures. Thus, this systematic review will aim to investigate the effects of microgravity on the neuromuscular control of the spine.

Methods and analysis
This protocol has been developed following the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols. MEDLINE, EMBASE, CINAHL, Web of Science, PubMed, grey literature and specialised space research resources will be searched from inception up to December 31, 2024. Screening processes, data extraction and risk of bias assessment will be conducted by two independent reviewers. Studies investigating the acute and long-term effects of microgravity on neuromuscular control of the spine will be included. Studies investigating spaceflight conditions or other protocols simulating microgravity, such as parabolic flights, dry immersion and long-term bed rest, will be considered eligible. Non-randomised studies of intervention with before-and-after design will represent the main studies of interest, and their risk of bias will be evaluated with the Risk Of Bias In Non-randomised Studies-of Interventions tool. Random-effect meta-analyses will be conducted for quantitative synthesis when clinical and methodological consistency is ensured. The certainty of evidence will be evaluated using the Grading of Recommendations, Assessment, Development and Evaluation guidelines.

Ethics and dissemination
As this systematic review is based on previously published studies, no ethical approval is required. The findings will be disseminated through publication in an international peer-reviewed journal and presented at conferences. All data relevant to the study will be included in the article or uploaded as supplementary information.

PROSPERO registration number
CRD42024608544.

Read More

Relationship between household air pollution and lung cancer in never smokers in high-income countries: a systematic 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.

Read More

Short-term and long-term outcomes of hybrid revascularisation procedures in peripheral artery disease: a systematic review protocol

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.

Read More

Leishmaniases in Ethiopia: a scoping review

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.

Read More

Barriers to informed consent in obstetric care during childbirth from practitioners perspective: a qualitative study

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).

Read More

A Systematic Review of “Food Is Medicine” Randomized Controlled Trials for Noncommunicable Disease in the United States: A Scientific Statement From the American Heart Association

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.

Read More

Experiences of adopting remote technologies for blood pressure control among women with pre-eclampsia and healthcare providers: a systematic review of qualitative studies

Introduction
Pre-eclampsia is a harmful and potentially life-threatening condition affecting maternal health and fetal well-being. In response to the need for timely and continuous monitoring, remote health technologies have been implemented for blood pressure control among this group over the last decades. The purpose of this study is to synthesise qualitative evidence on the experiences of adopting remote technologies for blood pressure control among women with pre-eclampsia and their healthcare providers.

Methods
Peer-reviewed publications published in English from January 2013 to March 2023 were searched using seven electronic databases: PubMed, Nursing & Allied Health Premium (ProQuest), Scopus, ScienceDirect, Taylor & Francis Online, Google Scholar and EBSCO Open Dissertations. The findings were subjected to meta-synthesis using the Joanna Briggs Institute meta-aggregation approach, whereby credible and unequivocal findings supported by participant quotations were extracted, grouped into categories and then integrated into synthesised findings through consensus among reviewers. A total of 4827 studies were identified in the initial database search. Twelve eligible studies were included in the meta-synthesis.

Results
Among 12 studies, five synthesised findings were elicited from women’s experiences with remote monitoring, including reassurance and increased self-confidence in health, a sense of autonomy, enhanced awareness of their health, acceptability and satisfaction with telehealth and reduced anxiety and stress. Providers’ perspectives on telehealth were presented in four synthesised findings: increasing value for oneself and work, strengthening knowledge and skills on pre-eclampsia, improving quality of care and concerns about technology challenges.

Conclusion
Healthcare providers reported professional growth and improved care delivery, though technical challenges persist. These findings support the integration of remote monitoring into maternal healthcare.

Read More

Screening for depression among Spanish-speaking patients in primary care settings within the USA: a scoping review protocol to inform clinical practices

Introduction
In 2016, the United States Preventive Services Task Force (USPSTF) recommended depression screening for all adults in the public sector, with screening frequency determined by clinical judgement and patient circumstances. This practice aims to enable timely diagnosis and treatment, reducing long-term healthcare costs associated with this chronic health condition. However, the USPSTF offered no written recommendations for primary care settings serving non-English-speaking populations, particularly where providers speak English and patients speak Spanish. While some research exists on depression screening in linguistically diverse settings, the use of validated Spanish-language screenings in primary care settings is underexplored when it comes to implementing the USPSTF’s recommendation. This scoping review addresses this knowledge gap by (1) assessing the extent to which Spanish-speaking patients in the USA receive depression screening in Spanish and (2) using the Consolidated Framework for Implementation Research (CFIR) 2.0 to categorise barriers and facilitators to implementing Spanish-language depression screening tools in USA primary care settings. The findings will identify areas needing further research to improve depression screening guidelines for primary care practices serving Spanish-speaking patients.

Methods and analysis
This scoping review follows the Joanna Briggs Institute Manual for Evidence Synthesis and the Arksey and O’Malley scoping review methodology, updated by Levac and colleagues. The reporting protocol adheres to PRISMA-ScR. A systematic search will be conducted in PubMed, Embase, APA PsycINFO, CINAHL and Web of Science Core Collection for studies on Spanish-language depression screening for adults in non-Veterans Affairs Medical Centers in the USA, excluding those focused on youth or adolescents. We will extract data from qualitative, quantitative and mixed-methods studies on screening. We will also examine studies addressing provider-reported comfort and competency in screening Spanish-speaking patients. We hypothesise that primary care clinics have implemented strategies for screening Spanish-speaking patients for depression driven by healthcare provider initiatives, local policies, research funding or community needs. The review will extract data on sample size, study methodology, primary care settings, patient and provider demographics, depression screeners used, and barriers and facilitators to screening. The quality of the studies will be appraised using the Mixed Methods Appraisal Tool (MMAT).

Ethics and dissemination
At Brown University, scoping reviews that analyse and synthesise existing research do not require Institutional Review Board (IRB) approval, provided they do not involve primary data collection or direct interaction with human subjects. Findings will be disseminated through peer-reviewed journals, conference presentations and community workshops to improve practices and policies addressing language barriers in depression screening and care.

Registration details
This scoping review protocol is registered with the Open Science Framework (OSF) at https://osf.io/dyru5.

Read More

The MOTILITY Mother-Child Cohort: a Danish prospective longitudinal cohort study of the infant gut microbiome, nutrition and bowel habits – a study protocol

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.

Read More

Patient-informed outpatient intervention to improve pregnancy outcomes through connections to social services: protocol for the BETTER randomised controlled trial

Introduction
A substantial portion of the 3.6 million births per year in the USA (approximately 25%–30%) occur in the context of adverse pregnancy outcomes (APOs), including preterm birth (PTB), hypertensive disorders of pregnancy (HDP) and small-for-gestational-age (SGA) birth. Black individuals have a 2–3-fold higher risk of APOs and a similarly increased risk of maternal morbidity and mortality compared with White individuals. Adverse social determinants of health (SDoH) are at the root of this disparity and contribute to it through multiple mechanisms. Maternal anaemia is an upstream factor associated with severe maternal morbidity, maternal mortality and other APOs and is also associated with adverse SDoH. Effectively and efficiently addressing social needs arising from adverse SDoH in the obstetric setting can be difficult due to varying patient preferences, resource accessibility and clinic workflows. The Better Birth Outcomes Through Technology, Education and Reporting (BETTER) intervention attempts to account for these barriers by encouraging patients to address social needs through motivational interviewing and by sending recurring text messages that provide links to multiple kinds of social service resources.

Methods and analysis
We will use a two-arm randomised controlled trial to evaluate the effects of providing patients with a motivational interviewing session and text messages with links to multiple resources to address their social needs compared with patients receiving usual care. We will recruit 550 pregnant individuals less than 21 weeks of gestation from two university prenatal clinics that primarily serve Medicaid-covered individuals in an urban city in the Midwestern USA. We will assess whether the intervention reduces the primary outcome of maternal anaemia measured as haemoglobin

Read More

Timely post-discharge medication reviews to Improve Continuity–the Transitions Of Care stewardship (TIC TOC) study in rural and regional Australia: a parallel-group randomised controlled trial study protocol

Introduction
Transition of care from hospital is a period when the risks of medication errors and adverse events are high, with 50% of adults discharged having at least one medication-related problem. Pharmacist-led medication reviews can reduce medication errors and unplanned readmission when completed promptly post-discharge; however, they are underutilised. A Transition of Care Stewardship pharmacist has been proposed to facilitate and coordinate a patient’s discharge process and facilitate a timely post-discharge medication review. Access to pharmacist medication review in rural and regional areas can be limited. This protocol describes a randomised controlled trial (RCT) to determine whether a virtual Transition of Care Stewardship pharmacist reduces medication-related harm in rural and regional Australia.

Method and analysis
Multicentre RCT involving patients at high risk of medication-related harm discharged from regional and rural hospitals to a domiciliary residence. Eligible patients must be aged≥18 years, admitted under a medical specialty, be discharged to a domiciliary setting, have a regular general practitioner (GP) or be willing to visit a GP or an Aboriginal Medical Service after discharge for medical follow-up, have a Medicare card and be at high risk of readmission. High risk of readmission is defined as either a previous admission to the hospital or Emergency Department (ED) presentation in the past 6 months AND≥three regular medications OR on at least ONE high-risk medication. A total of 922 participants will be recruited into the study. Enrolled participants will be randomised to the intervention or control (usual care). The intervention will include a virtual Transition Of Care Stewardship pharmacist to ensure that patients receive discharge medication reconciliation, medication counselling, medication list and communicate directly with primary care providers to facilitate a timely post-discharge medication review. Usual care will include informing the patient’s clinical inpatient treating team that the patient is at high risk of medication misadventure and may benefit from a post-discharge Home Medicines Review (a GP-referred pharmacist medication review funded by the Australian Government).
Data analysis will be performed on a modified intent-to-treat basis. The primary outcome assessed is a composite of a first unplanned medication-related hospitalisation or ED presentation within 30 days of hospital discharge. Comparisons between the intervention and usual care groups for the primary outcome will be made using a mixed-effects logistic regression model, adjusting for site-level clustering as a random effect.

Ethics and dissemination
This study is approved to be conducted at the Western New South Wales Local Health District via the Research Ethics and Governance Information System (approval number: 2023/ETH00978). To ensure the needs of Aboriginal and Torres Strait Islander patients are appropriately addressed, ethics for this study were submitted and approved by the Aboriginal Health and Medical Research Council (approval number: 2148/23). Manuscripts resulting from this trial will be submitted to peer-reviewed journals. Results may also be disseminated at scientific conferences and meetings with key stakeholders.

Trial registration number
ACTRN12623000727640.

Read More

Benefits of heart valve clinics for patients: a systematic review

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

Read More