Sleep problems are an escalating global health concern, with prevalence estimates ranging from 8.3% to 45%. Physicians are disproportionately affected, with rates around 44% compared with 36% in the general population. In Bangladesh, reported rates range from 32% to 58%, with physicians being particularly vulnerable. Poor sleep among physicians is strongly linked to burnout, medical errors and increased mental health risks. Despite these serious implications, existing evidence from Bangladesh remains fragmented and inconsistent, limiting its utility for health policy and workforce interventions. This review therefore seeks to generate reliable pooled prevalence estimates and identify key determinants of sleep problems among Bangladeshi physicians.

The research team will search the PubMed, Scopus, Web of Science, EMBASE, PsycInfo, ProQuest Medical, CINAHL, Google Scholar and BanglaJOL electronic and regional databases following Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols guidelines for published studies from inception until 1 August 2025, using truncated and phrase-searched keywords, relevant medical subject headings and citation chaining from grey literature. Observational cross-sectional studies published within the predefined timeframe, using validated assessment tools, and published in English or other major international languages will be prioritised for inclusion. Review papers, case reports, case series, intervention studies, commentaries, preprints, meeting abstracts, protocols, unpublished articles and letters will be excluded. Two independent reviewers will screen the retrieved papers using the Rayyan web-based application, with any disagreements resolved by a third reviewer. Quantitative estimates of sleep problems, including prevalence, duration, quality and associated risk factors among Bangladeshi physicians will be extracted. A narrative synthesis and meta-analysis will be performed to assess the pooled prevalence using a random effects meta-analysis model. Forest and funnel plots will be generated for visualisation. Heterogeneity will be assessed using the I² statistic, with sensitivity or subgroup analysis conducted as required. The quality of included studies will be evaluated using Joanna Briggs Institute critical appraisal tools for observational study designs. All statistical analysis will be conducted using Jamovi V2.7.6, R V4.3.2 ‘meta’ packages and GraphPad Prism V9.0.2.

This review will synthesise evidence from existing published literature. While completing the findings, the findings will be submitted to an international peer-reviewed journal and disseminated through conferences, policy forums and stakeholders’ networks to inform future research and interventions.

CRD420251123294.

This study assessed the association between fine particulate matter (PM_2.5) exposure during pregnancy and stillbirth in Pakistan. We hypothesised that higher PM_2.5 exposure is linked to increased stillbirth risk.

A cross-sectional study using secondary data from the 2017 to 2018 Pakistan Demographic and Health Survey (PDHS), combined with satellite-derived PM_2.5 exposure data.

The study covered urban and rural areas across Pakistan, including all four provinces (Punjab, Sindh, Khyber Pakhtunkhwa and Baluchistan) and administrative regions (Gilgit-Baltistan (GB), Islamabad, Federally Administered Tribal Areas and Azad Jammu Kashmir).

The study included 9172 married women aged 15–49 with at least one birth in the past 5 years. Women with incomplete pregnancy outcome data were excluded.

PM_2.5 exposure was estimated using satellite data, matching PDHS clusters with the nearest air quality point via MATLAB. Monthly average exposure was categorised into quartiles.

Stillbirth, defined as pregnancy loss at ≥28 weeks gestation.

Multivariable logistic regression was used to assess the association between PM_2.5 and stillbirth, adjusting for maternal age, gravidity, wealth index, birth interval, previous adverse pregnancy outcome and region of residence. The stillbirth rate in Pakistan for the most recent pregnancy was 17.0 (14.5–19.9) per 1000 births, with highest rates (28.9) in Baluchistan province. The mean level of PM_2.5 exposure in Pakistan was 53.96 (SD 20.42; range 5.9–209.4) µg/m³. PM_2.5 exposure was higher for urban (56.43) than rural (51.87) pregnancies, highest in Sindh (78.06) and lowest in GB (13.41) provinces. For every 1 µg/m³ average increase in PM_2.5 during the pregnancy period, there was approximately 1% increase in stillbirth.

Increased PM_2.5 exposure was strongly associated with stillbirth risk. This underscores the need for targeted public health interventions, such as government regulations, emission controls and clean energy initiatives to protect pregnant women in high-risk areas.

Pneumonia remains a leading cause of under-5 mortality in sub-Saharan Africa, accounting for approximately 14% of deaths in this age group. In Malawi, pneumonia accounts for 12% of under-5 deaths, with recent data revealing a concerning trend of over 110 000 new cases reported in 6 months. The Malawi government has made significant strides in reducing childhood mortality through the Integrated Community Case Management (iCCM) strategy, resulting in an 11% reduction in under-5 mortality over a 5-year period. However, the current iCCM strategy does not include the management of chest indrawing pneumonia in children aged 2–59 months and fast-breathing pneumonia in infants aged up to 2 months. This implementation research aims to increase pneumonia treatment coverage for under-5 year-old children in Kasungu District, Malawi, by expanding the community-based management of pneumonia by the iCCM-trained Health Surveillance Assistants (HSAs).

The current implementation research using both qualitative and quantitative data collection methods will assess the feasibility and acceptability of iCCM-trained HSAs managing chest indrawing pneumonia and fast-breathing pneumonia in children under 5 with oral amoxicillin at the community level in district Kasungu using the existing district health system. The study will employ a district health system model, leveraging existing trained iCCM HSAs to enrol and manage infants aged 7–59 days with fast-breathing pneumonia and 2–59-month-old children with chest indrawing pneumonia in the community with 7-day and 5-day oral amoxicillin, respectively. HSAs will also use pulse oximetry to identify hypoxaemic children for prompt referral to a hospital for further care. Sociodemographic features of enrolled children will be documented. Enrolled children will be followed up on treatment compliance using follow-up forms. The pneumonia treatment coverage will be assessed using baseline, midline and end-line surveys using both qualitative and quantitative data collection methods.

Ethical approval was obtained from the National Health Research Sciences Committee and the WHO Ethics Committee. The implementation research findings will be disseminated to national-level stakeholders and specifically targeted at District Health Offices, which are responsible for implementing the interventions.

Psychosocial stress is a major public health concern, contributing to significant suffering and costs to society. There is a lack of effective interventions that could be offered at an early stage to people who need to reduce their stress in life. Recent advances in psychology have provided evidence-based exercises suitable for testing in an entirely digital intervention. This study aims to estimate the effectiveness of a 12-week digital course in mindfulness- and acceptance-based stress reduction.

The effectiveness of the 12-week digital course will be estimated in a parallel-groups randomised controlled trial, in which the control group will receive referrals to self-studies on mental health information found online. The study population will be individuals 15 or older, seeking help online for stress and who have access to a mobile phone. Employing a Bayesian sequential design, the primary outcome will be monitored monthly, after the 6-month follow-up, to calculate target criteria for when to stop recruiting. Perceived stress (Cohen’s 10-item version) will be the primary outcome, with estimands of interest being differences between groups at 3 (immediate), 6 (prolonged) and 12 months (maintained). Mediation analysis will reveal if differences between groups are mediated by acquired equanimity. Effectiveness will be analysed with Bayesian regression models, and mediation will be analysed by using a causal inference framework.

The research was approved by the Swedish Ethical Review Authority on 2024-05-07 (2024-01974-01). The study will reach out to a vulnerable population, and participation may displace efforts to seek professional help. We have built-in automatic advice to seek additional help for participants scoring high on the depression scale at baseline, before allocation to study groups. The findings from this study will be submitted to peer-reviewed journals and presented at relevant national and international meetings.

ISRCTN39222610.

To evaluate the cost-effectiveness of implementing a penicillin allergy assessment pathway (PAAP) versus usual care within the NHS.

A decision tree analysis over a 5-year time-period, informed by a randomised controlled trial (RCT) of PAAP and systematic review. Value of information analysis was also conducted to estimate the value of conducting a new trial.

Model inputs were informed by the ALABAMA RCT participants included in the primary analysis, 811 adults with penicillin allergy labels and recent antibiotic prescriptions, and data from published literature.

Participants in the ALABAMA trial included in the primary analysis: PAAP (n=401) and usual care (n=410).

Costs are presented in GBP (£) at 2022–2023 prices, quality-adjusted life years (QALYs), incremental cost-effectiveness ratio, incremental net monetary benefit (INMB), the probability of cost-effectiveness at the £20,000 and £30,000 per QALY threshold, and the cost effectiveness of a new follow-on trial.

PAAP had incremental costs of £–83 (probability of cost saving 47.5%) and incremental QALYs of 0.036 (probability of positive benefits 47.5%). The INMBs (probability of cost-effectiveness) were £806 (48%) and £1167 (48%) under the decision thresholds of £20,000 and £30,000 per QALY, respectively. PAAP was more cost-effective among females, people aged >65 years, and more frequent antibiotic users. A new follow-on trial involving 1267 participants was estimated to cost £2.4 million and, by reducing uncertainty in the evidence, would avoid £19.6 million in costs of incorrect management decisions for eligible patients over the next 10 years.

The PAAP was considered cost-effective, but significant uncertainty remained. Future trials with adequate power and longer follow-up are needed to determine the most cost-effective models for penicillin allergy testing.

ISRCTN20579216.

Coronary revascularisation practices have evolved over the last three decades. This study sought to examine the variations in percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG) rates, alongside mortality from acute myocardial infarction (AMI) across a group of 16 high-income countries between 2006 and 2020.

Retrospective observational analysis using data from the Organisation for Economic Co-operation and Development (OECD) database between 2006 and 2020. Estimated annual percent change in revascularisation was analysed using Joinpoint regression model, and mortality rates were evaluated using the locally weighted scatterplot smoothing model.

Publicly available data on PCI and CABG procedure rates alongside AMI mortality rate from 2006 to 2020.

16 countries from the OECD database.

Not applicable.

Standardised PCI and CABG procedure rates and AMI age-standardised mortality rate (ASMR) from 2006 to 2020.

Over the 15 year period, 14.0 million PCI and 2.8 million CABG procedures were collectively recorded across 16 countries. PCI rates varied among nations, but from 2006 to 2020 increased in 11 of the 16 nations overall, led by Finland (+36.0%), Ireland (+34.5%) and France (+31.5%). Meanwhile, CABG rates declined in 14 out of the 16 countries, with Luxembourg (–71.3%), the UK (–62.6%) and Finland (–60.6%) experiencing the most substantial decreases. Throughout the study period, the PCI-to-CABG ratio increased, while AMI ASMR decreased consistently across all countries.

Despite evidence supporting CABG over PCI in specific scenarios, CABG rates have declined, and PCI rates have increased. Possible factors for this trend may include patient preference and advancement in interventional techniques. The varied use of PCI among these nations, alongside a sustained decline in AMI mortality rates, may be expected given the importance of optimal medical therapy in the management of ischaemic heart disease. The results further suggest the significance of factors beyond revascularisation in driving improved outcomes.

Epilepsy prevalence varies widely across Nigeria, with rates ranging from 3.1 to 37.0/1000 population. There have been no studies on epilepsy prevalence and treatment gap in the Northeast Region of Nigeria. This study aimed to study epilepsy prevalence and the epilepsy treatment gap (ETG) in an urban and a rural community in Northeast Nigeria.

Cross-sectional, community-based survey.

Epilepsy screening of residents in two communities in Northeast Nigeria using a WHO screening tool and a validated study questionnaire from 1 March to 10 June 2022.

8599 community residents aged ≥2 years.

Prevalence of epilepsy, active epilepsy, ETG and associated factors.

We screened 8599 residents, of whom 88 had epilepsy. Crude epilepsy prevalence was 10.2 per 1000 and was three times higher in the rural than in the urban community (18.5 vs 6.4; ²=26.79, p2=0.087, p=0.768). Logistic regression analysis showed that the ETG was associated with a lack of counselling (OR 15.8, 95% CI 3.5 to 70.7, p

The prevalence of epilepsy in Bauchi State was within the range reported in Nigeria but three times higher in the rural than in the urban community. A high ETG was associated with poor counselling of people with epilepsy. Epilepsy counselling, health education and wider access to neurology services could reduce the burden of epilepsy in Northeast Nigeria.

A large bowel cancer chemoprevention potential has been demonstrated by the consumption of carrots, which represent the major dietary source of polyacetylenes. Their interaction with cancer cells and enzyme systems of animals and humans has been systematically investigated over the last 15 years and has now been characterised as anti-inflammatory compounds with antineoplastic effect. Our objective is to investigate whether selected carrot species with a high content of the polyacetylenes falcarinol (FaOH) and falcarindiol (FaDOH) prevent neoplastic transformation and growth in humans, without side effects.

We will conduct a multicentre prospective binational (Denmark and Sweden) randomised controlled trial, with the aim to test the clinical effects of adjuvant treatment with carrot juice in patients who had an excision of high-risk colon adenomas. Patients from six centres will be randomised to receive either anti-inflammatory juice made of carrots high in FaOH and FaDOH or placebo. We will compare the proportion of participants with recurrent adenoma and mean size of them, found in the 1-year follow-up colonoscopy between the two randomised groups.

Informed written consent will be obtained from all participants before randomisation. The study was approved by the regional ethics committee in Denmark (ref. S-20230072) and Sweden (ref. 2024-04732-01). After completion of the trial, we plan to publish two articles in high-impact journals: one article on primary and secondary outcomes, respectively.

NCT06335420.

People with severe mental illness (SMI) experience substantially reduced life expectancy, largely due to cardiovascular disease (CVD). Sedentary behaviour is a major risk factor for CVD, and people with SMI spend significantly more time sedentary and are less physically active than the general population. While interventions to increase physical activity have focused on structured exercise, these are not accessible or acceptable to many consumers. The sedentary time elimination with periodic activity snacks (STEPS) study aims to test and evaluate the feasibility of a codesigned novel intervention using ‘activity snacks’ to interrupt sedentary behaviour in people with SMI.

The STEPS study is a single-arm feasibility trial. We will recruit 20 participants with SMI to complete a 6-week intervention. The intervention will include the use of the STEPS smartphone app to prompt short bouts of movement across the day, the type of which are personalised to the individual. Feasibility will be assessed through recruitment and retention rates, adherence to the intervention and acceptability measured via qualitative interviews. Secondary outcomes include changes in sedentary time, physical activity, mood and quality of life, with pre–post variables analysed via either a t-test or Mann’s Whitney U test, dependent on the normality of the data. Effect sizes for secondary outcomes will be calculated as Cohen’s d.

This trial has received ethical clearance from the Metro South Human Research Ethics Committee (HREC/2025/QMS/117193) and was prospectively registered with the Australia New Zealand Clinical Trials Registry (ACTRN12625000265471p). Results from this trial will be published in a peer-reviewed journal.

Australia New Zealand Clinical Trials Registry (ACTRN12625000265471p).

Depression, anxiety and stress are major contributors to the global burden of diseases. The ageing population faces an escalating burden of these conditions, and half of the cases are largely undiagnosed. Yet a paucity of epidemiological data limits understanding the full scope of the disease burden among older adults. This protocol outlines a systematic review to estimate the prevalence and incidence of anxiety, depression and stress among older people (60 years and above) and to identify contributing factors across South-East Asian countries.

A study protocol for a systematic review and meta-analysis has been registered in PROSPERO. The research team will systematically search, appraise and synthesise observational studies following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Comprehensive searches will be conducted from inception to May 2025 across PubMed (NCBI), MEDLINE (Ovid), Web of Science, Cochrane Library, Scopus (Elsevier) and PsycINFO (APA), supplemented by grey literature from government reports, the WHO Library and Google Scholar. Two investigators will independently screen titles and abstracts, review full-text articles published in the English language and extract data, with discrepancies resolved by a third reviewer. Methodological quality and risk of bias of the included studies will be assessed using standardised tools. Primary outcomes are the prevalence and incidence of depression, anxiety and stress. Secondary outcomes include variations in the prevalence and incidence of these conditions based on sociodemographic factors, as well as associated risk factors that differ across regional contexts. Data will be pooled via meta-analysis where feasible or narratively synthesised if heterogeneity precludes quantitative synthesis. The systematic review will provide a comprehensive understanding of the burden of anxiety, depression and stress among older people in South-East Asia. This novel evidence will guide policymakers and healthcare practitioners in developing targeted interventions and generating essential evidence for supporting policy development in the region.

Ethical approval will not be required as this study will not involve collection of original data. The findings will be disseminated through publications in a peer-reviewed journal and presentations at scientific conferences.

CRD42024609033.

Crohn’s disease (CD) and ulcerative colitis (UC) are chronic, inflammatory bowel diseases (IBDs) of unknown origin, affecting the gastrointestinal tract and often causing extraintestinal symptoms. Conventional treatments (eg, glucocorticosteroids, immunomodulators) and targeted advanced treatments, including anti-TNFα, antibodies to p40 subunit of IL-12/23, antibodies to p19 subunit of IL-23, anti-α4β7 integrin, Janus kinase inhibitors (JAKis) and sphingosine-1-phosphate receptor (S1PR) modulators, do not achieve sustained responses for all patients, leaving significant unmet therapeutic needs.

This prospective, multi-centre observational study will follow a cohort of 240 patients across multiple study centres within NHS trusts in the UK who are initiating or switching biologics, specifically anti-TNFα and anti-α4β7 integrin for UC, and anti-TNFα, antibodies to p40 subunit of IL-12/2 and JAKi for CD. Through comprehensive profiling of immunological, transcriptional, microbiome, genetic and proteomic markers at baseline, week 12, and week 52, this study aims to uncover non-invasive biomarkers that predict response to these drug classes, ultimately advancing personalised medicine in IBD.

Ethical approval for the Nottingham/AstraZeneca study was granted by the West of Scotland Research Ethics Committee. Recruitment began in December 2022 and is currently ongoing at 10 NHS Trust sites across the UK. Study findings will be disseminated by publication in peer-reviewed journals and presentations at relevant national and international conferences.

To assess the level of knowledge, attitudes and practices (KAP) among patients with type 2 diabetes mellitus (T2DM) regarding cardiovascular risk factors (CVRF) and diabetes-related complications in two hospitals in the West Region of Cameroon during the COVID-19 pandemic.

This was a prospective cross-sectional study conducted over 5 months from April to September 2022.

This study was conducted in two tertiary hospitals in the West Region of Cameroon, in Central Africa.

It included all patients with T2DM receiving care at these two hospitals, having agreed to participate and followed up in both hospitals for at least 3 months.

Sociodemographic, clinical and treatment data were collected using a data sheet, and KAP scores were based on the Essi and Njoya framework. Data collection and analysis were performed using SPSS V.23.0 software. Logistic regression was used to identify the factors associated with unacceptable KAP (p

A total of 140 participants (71 women) with an average age of 63 years and an average diabetes duration of 6.14±5.7 years were included. Most (55%) were managed by general practitioners. The main CVRFs identified were hypertension (11%) and overweight (6%), while the leading complications included visual disorders (10.7%), hypoglycaemia (6.4%) and erectile dysfunction (2.1%). Knowledge was good in 34.3% of participants, only 25.7% demonstrated correct attitudes, and merely 15.7% engaged in adequate practices. Unacceptable knowledge was associated with diabetes duration between 3 months and 5 years (OR: 0.34 (95% CI 0.14 to 0.85), p=0.021), follow-up by a specialist (OR: 0.31 (95% CI 0.13 to 0.74), p=0.009), the presence of at least one CVRF (OR: 0.03 (95% CI 0.00 to 0.23), p

Few people with T2DM presented good knowledge, right attitudes and adequate practices. Enhanced patient education and increasing specialist numbers are essential to promote self-management of the condition and to decrease the incidence of complications and mortality.

To investigate whether treatment with oral corticosteroids and intravenous immunoglobulin (IVIg) improves pregnancy outcomes in women with unexplained recurrent pregnancy loss (RPL) following assisted reproduction technology (ART) treatment.

A randomised, double-blinded, parallel-group, placebo-controlled trial conducted from January 2021 to February 2024.

A single-centre trial at a Danish tertiary clinic for RPL management.

80 women with at least two consecutive early pregnancy losses following ART, age 18–41 years, body mass index below 35, and no identified cause of RPL. Forty participants were allocated to each group, with 37 fulfilling the protocol criteria in each group.

Participants were randomised to receive either a combination of low-dose oral prednisolone starting on the first day of menstruation and IVIg given the first time around the time of embryo transfer; or matching placebo tablets and albumin infusions. Treatment continued until gestational week 8+4 in those who conceived with a total of four infusions.

The primary outcomes were the ongoing pregnancy rate (OPR) defined as a living fetus in gestational week 13 among all randomised participants and in those who conceived after embryo transfer, respectively, based on intention-to-treat (ITT) and per-protocol (PP) analyses. Secondary outcomes included safety outcomes related to pregnancy complications and neonatal health.

OPR was equal to live birth rate. Among all randomised participants (ITT), the OPR was 25.0% in the treatment group and 15.0% in the placebo group (relative risk 1.67; 95% CI 0.67 to 4.15; p=0.26). Among participants without major protocol deviations (PP), OPRs were 21.6% and 16.2%, respectively (relative risk 1.33; 95% CI 0.51 to 3.47; p=0.55). Among participants who became pregnant following embryo transfer, ongoing pregnancy occurred in 83.3% of the treatment group and 42.9% of the placebo group (relative risk 1.94; 95% CI 1.01 to 3.75; p=0.05). No differences in adverse events or neonatal outcomes were observed between the two groups.

The combination of oral corticosteroids and IVIg did not improve overall pregnancy rates in women with RPL after ART. However, among those who achieved pregnancy after embryo transfer, the risk of pregnancy loss appeared reduced. Larger randomised trials are needed to confirm these findings.

ClinicalTrials.Gov: NCT04701034. Registration date: 5 January 2021

EudraCT number: 2020-000256-35; Registration date: 11 November 2020

The North Denmark Region Committee on Health Research Ethics: N-20200066, Registration date: 16 December 2020

The Data Protection Agency: 2020-156; Registration date: 4 November 2020

WHO universal trial number: U1111-1273-8585

Date of first patient’s enrolment: 28 January 2021.

To assess the pooled prevalence of self-reported sexually transmitted infections (STIs) and their associated factors among adults in South and Southeast Asia, using the Demographic and Health Survey data collected between 2015 and 2023.

A community-based cross-sectional study design was conducted using a multistage cluster sampling approach. Multilevel multivariable logistic regression analysis was employed to identify predictors of self-reported sexually transmitted infections (STIs). Model selection was guided by Akaike’s information criterion, and adjusted odds ratios (AORs) with 95% CIs were estimated to determine statistically significant associations.

South and Southeast Asia.

This analysis included a weighted sample of 791 019 adults aged 15–49 who reported ever having had sexual intercourse. The majority of the participants were female (n=6 87 880; 87%), and most were from Southeast Asia (n=7 00 539; 89%).

The pooled prevalence of self-reported STIs among adults in South and Southeast Asia was 12.94% (95% CI 7.73% to 18.14%). At the individual level, higher odds of reporting STIs were associated with being female (AOR 1.84; 95% CI1.68 to 2.02), having middle (AOR 1.11; 95% CI 1.04 to 1.19) or high wealth status (AOR 1.15; 95% CI 1.07 to 1.24]), being employed (AOR 1.14; 95% CI 1.07 to 1.22), having multiple sexual partners (AOR 2.79; 95% CI 2.22 to 3.52) and having undergone HIV testing (AOR 1.10; 95% CI: 1.02 to 1.20). Conversely, lower odds of self-reported STIs were observed among individuals aged 35–39 years (AOR 0.78; 95% CI 0.66 to 0.92), 40–44 years (AOR 0.68; 95% CI 0.58 to 0.82) and 45–49 years (AOR 0.61; 95% CI 0.52 to 0.73); those who had ever been in a union (AOR 0.71; 95% CI 0.62 to 0.83); individuals with higher education (AOR 0.84; 95% CI 0.76 to 0.93); and those with comprehensive HIV knowledge (AOR 0.82; 95% CI 0.77 to 0.87). At the community level, high illiteracy rates (AOR 1.25; 95% CI 1.15 to 1.35) and high media non-exposure (AOR 1.11; 95% CI 1.02 to 1.20) were positively associated with STIs, while rural residence (AOR 0.81; 95% CI 0.74 to 0.89) and living in Southeast Asia (AOR: 0.47; 95% CI 0.42 to 0.53) were linked to lower odds of self-reported STIs.

A substantial prevalence of self-reported STIs was observed among adults in South and Southeast Asia. Both individual- and community-level factors influence STI risk. The individual-level determinants include socio-demographic characteristics, sexual behaviours, HIV-related knowledge and testing history, while community-level factors reflect disparities in geographic location, educational attainment and media exposure.

Rheumatological diseases represent a widespread heterogeneous group of disorders, united by chronic musculoskeletal inflammatory processes. Despite the increasing effectiveness of new therapies, the lack of adequate treatments for certain conditions and the occurrence of adverse drug reactions have led to the need for alternative strategies, including food supplements. These products are perceived by the patient as a valuable aid without adverse effects. However, adverse reactions to food supplements have been reported, although their incidence cannot be established due to the lack of consumption data. In this context, the IntegraRE project aims at collecting information on the use of food supplements in rheumatology, considering both physicians and patients.

A survey-based cross-sectional study has been designed into two consecutive phases: Phase 1 aims to investigate rheumatologists’ knowledge, attitudes and recommendations to patients regarding food supplements, while Phase 2 focuses on estimating patients’ intake of food supplements, including the specific products used, unit consumed and reasons for their consumption. Questionnaires will be collected from at least 287 rheumatologists and 2000 patients, geographically distributed in proportion to the Italian population. These will gather information on sociodemographic variables, lifestyle factors, knowledge, clinical practices and supplement consumption.

The study protocol has been approved by the Ethics Committee of the Italian National Institute of Health (approval no. AOO 0032395 on 24 July 2024). The results, which will be widely disseminated through conference presentations, peer-reviewed publications and dedicated project webpage, will provide an understanding of the use of food supplements in rheumatology and allow guidelines to be drawn up on their correct use in the clinical practice of rheumatological diseases. Overall, this survey will increase people’s awareness of the effects of food supplements and encourage their safe and conscious use.

Parkinson’s disease (PD) is a chronic neurodegenerative condition that affects approximately 10 million people worldwide. As the second most common neurodegenerative disease, its prevalence is expected to double in the next 30 years. PD is characterised by both motor and non-motor symptoms that significantly impact patients’ quality of life. The disease leads to physical disabilities and can strain the social and emotional well-being of patients and caregivers. While pharmacological and surgical treatments are essential, non-pharmacological approaches, including self-care strategies, play a critical role in managing the disease. This study protocol aims to describe methodological steps required to explore the self-care behaviours of patients with PD and their caregivers, with a particular focus on the dimensions of self-care maintenance, monitoring and management.

This mixed-method study will involve dyads of patients with PD and their caregivers. Participants will be recruited from the PD and Movement Disorders Centre of the "Azienda Socio Sanitaria Territoriale (ASST) Gaetano Pini-Centro Traumatologico Ortopedico (CTO)". Validated questionnaires, such as the WHOQOL-Bref, the version 2 Self-Care of Chronic Illness Inventory, and the Caregiver Self-Efficacy in Contributing to Self-Care Scale, will be administered. The study will also include semistructured interviews to collect qualitative data on patients’ and caregivers’ perceptions of self-care. A non-probabilistic convenience sampling method will be employed, encompassing both patients at any stage of disease and their primary caregivers. The estimated sample size is 311 dyads, calculated to provide a 5% margin of error.

The study has been approved by the Lombardia 3 ethics committee (identification (ID) study 5732 12.03.2025 P bis). All participants will sign a written informed consent document. Ethical considerations include ensuring participant confidentiality, voluntary participation and the right to withdraw at any time without consequence. The study results will be disseminated through national and international conferences and published in clinical research journals to contribute to the broader understanding of self-care in the management of PD.

NCT06953050 (clinicaltrials.gov).

Due to the documented benefits of peripheral resistance training (RT) and inspiratory resistance training, known as inspiratory muscle training (IMT), in patients with cardiovascular disease, both exercise forms are regularly used in cardiac rehabilitation. However, little is known about the haemodynamic responses to different intensities of dynamic RT, isometric RT, and IMT in patients with coronary artery disease (CAD). This study is designed to evaluate and compare the acute haemodynamic responses elicited by different RT and IMT modalities in patients with CAD.

This study design is a prospective, single-centre, randomised crossover trial. A total of 20 participants with CAD will be included. All participants will undergo four different exercise training interventions: IMT, isometric wall squat training (IWS), dynamic leg press training (DLP) and isometric handgrip training (IHG). For each intervention, participants will perform two intensity modalities in randomised order: IMT (low vs high), IWS (low vs moderate), DLP (low vs high) and IHG (low vs moderate). The primary outcomes are the acute exercise-induced haemodynamic responses (esp. systolic blood pressure, pulse rate, stroke volume, cardiac output) across the different exercise training interventions, as well as the changes in haemodynamic responses during the recovery phase for each intervention. Secondary outcomes include changes in tissue oxygen saturation, oxygen saturation, and perceived dyspnoea and exertion. The study period is planned for 2025.

The study has been approved by the Ethics Committee of the German Sport University Cologne (Ethical Approval Code: 209/24). The findings will be disseminated through international peer-reviewed publications. This study is supported by the Alexander von Humboldt Foundation via the partnership with the Coordenacão de Aperfeicoamento de Pessoal de Nível Superior (CAPES)(CAPES-Humboldt Research Fellowship for Experienced Researchers) and by research funding from Edwards Lifesciences LLC (Limited Liability Company).

German Clinical Trials Register DRKS00035668.