Hyperangulated videolaryngoscope for difficult airway management: a protocol for a systematic review with meta-analysis and trial sequential analysis

Introduction
Videolaryngoscopes are recommended as the top preference for tracheal intubation in adults, children, infants and neonates, and even in patients with anticipated difficult airways, since they are generally easier to use and quicker to master than fibreoptic bronchoscopes. Compared with standard videolaryngoscopes, hyperangulated videolaryngoscopes possess a more sharply curved blade or blade tip, resulting in a higher first-attempt success rate among patients with anticipated difficult airways. However, hyperangulated videolaryngoscopes also pose challenges in advancing the tracheal tube, which decreases the first-attempt success rate while increasing the tracheal intubation time when the tracheal tube introducer is unsuitable. Hence, controversy still remains regarding the efficiency of hyperangulated videolaryngoscopes as first-line devices in patients with anticipated difficult airways, owing to the inconsistent clinical findings. Consequently, we will conduct a protocol for a systematic review and meta-analysis to determine the usefulness of hyperangulated videolaryngoscopes in patients with anticipated difficult airways.

Methods and analysis
English-language databases (Web of Science, Cochrane Library, PubMed, Embase and Ovid Medline), Chinese electronic databases (VIP database, China National Knowledge Infrastructure, and Wanfang database) and clinical trial registry platforms will be scoured from their inception to May 2025 to locate randomised controlled trials of hyperangulated videolaryngoscopes in patients with anticipated difficult airways. For continuous data, mean differences or standardised mean differences, accompanied by their 95% CIs, and for dichotomous data, the risk ratio, accompanied by its 95% CI, will be calculated using Review Manager V.5.4. Either a fixed-effects model or a random-effects model will be used depending on the magnitude of statistical heterogeneity as evaluated via the I2 test. The risk of bias will be assessed via the Cochrane risk-of-bias tool 2. Additionally, the quality of evidence regarding each outcome will be evaluated using the Grading of Recommendations Assessment, Development and Evaluation. The reliability of all outcomes will be appraised via trial sequential analysis. Moreover, the publication bias of all outcomes will be examined using Funnel plots and Egger’s regression test.

Ethics and dissemination
Ethical approval was not required for this systematic review protocol. The results will be disseminated through peer-reviewed publications.

PROSPERO registration number
CRD42024627484

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Community-based type 2 diabetes screening programmes designed for priority populations: a scoping review protocol

Background
Type 2 diabetes is a growing public health concern, and it continues to disproportionately impact priority populations. Although earlier and more frequent screening of diabetes promotes early detection to prevent adverse outcomes, this is a significant barrier for priority populations due to inequities that hinder access to critical preventive screening in primary care settings. The purpose of this scoping review is to better understand the design and implementation of screening and early detection of type 2 diabetes in community settings for priority populations to reduce missed or delayed diagnoses and future potential adverse outcomes.

Methods
This scoping review will adopt the methodological framework of Arksey and O’Malley and be enhanced using Levac et al recommendations. A search strategy was designed using insights from experienced librarians through the Peer Review for Electronic Search Strategies to conduct a comprehensive search using the following databases: Medline, Embase, PsycINFO, Web of Science, Scopus, CINAHL and Google. The search will capture studies focused on community-based diabetes screening using point-of-care testing and deployed in community settings serving priority populations with undiagnosed diabetes. Studies will be excluded if priority populations were not a focus, individuals living with diabetes, the intervention is not implemented in a community setting and did not use point-of-care screening. Two authors will independently review and screen the articles (title, abstract and full-text), while a team-based approach will be applied to chart the data. A thematic analysis will be used to identify emerging themes and subthemes according to barriers and enablers of implementing an equitable community-based diabetes screening intervention.

Ethics and dissemination
The findings from this review will inform future diabetes screening interventions in community settings to enable an equity-informed approach in the design, planning and implementation of such strategies. Equally important, it will inform a larger project, in which the team plans to implement a community-based diabetes screening programme in Ontario, Canada.

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COSMOS: Interrater and Intrarater Reliability Study of a Novel Outcome Measure

Stroke, Volume 56, Issue 7, Page 1958-1964, July 1, 2025. The vast majority of patients with minor stroke achieve what are considered good or excellent outcomes on the modified Rankin Scale (0–1/0–2), yet many are dissatisfied with their outcomes. There is a need for a functional outcome measure tailored for minor stroke that better reflects the spectrum of clinical outcomes within this population. We developed the Canadian Outcome Scale for Minor Stroke (COSMOS) and performed an interrater and intrarater reliability study. COSMOS is a 7-point scale ranging from 0 (no symptoms) to 6 (loss of independence for an instrumental or basic activity of daily living or worse), which accounts for performance limitations and losses of a person’s hobbies or passions and of their employment, educational, service, or caregiving pursuits, besides just activities of daily living. One hundred test case vignettes were developed. Stroke physicians, fellows, and research nurses/staff were invited to review training materials and provide the COSMOS grade for 20 cases representing all COSMOS grades (0–6). After a minimum 2 weeks’ wash-out period, participants were asked to grade the same 20 cases again. Interrater and intrarater agreement were assessed using Cohen κ, weighted κ, percentage agreement, and intraclass correlation coefficient. Among 33 participants (18 attending physicians, 9 stroke fellows, and 6 research staff/nurses; median 12.5 years of experience), COSMOS had substantial interrater reliability (80.5% agreement [95% CI, 75.7%–85.3%]; Cohen κ, 0.77 [95% CI, 0.72–0.84]) and almost-perfect intrarater reliability overall (87.1% agreement [95% CI, 84.4%–89.7%]; Cohen κ, 0.85 [95% CI, 0.82–0.88]); weighted κ showed almost perfect agreement for both interrater (0.88 [95% CI, 0.85–0.92]) and intrarater reliability (0.92 [95% CI, 0.90–0.94]). The overall chance-adjusted simultaneous intrarater/interrater agreement using intraclass correlation coefficient was 0.95 (95% CI, 0.94–0.97). Results were similar with substantial to almost-perfect agreement when considering key subgroups based on position (attendings, fellows, research nurses/staff) and years of experience. In conclusion, the newly proposed COSMOS scale demonstrated substantial interrater and intrarater reliability. The scale merits further study in cohort studies and clinical trials of minor stroke.

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Poverty and Stroke: The Need for Socioeconomic Data in Hyperacute Care

Stroke, Volume 56, Issue 7, Page 1965-1968, July 1, 2025. Poverty profoundly influences stroke risk, access to care, and recovery, yet remains largely invisible in hyperacute stroke trials. Despite growing awareness of health inequities, current research and clinical frameworks rarely capture socioeconomic data at the point of care—particularly during the hyperacute phase, when decisions are time sensitive. This commentary highlights the urgent need to incorporate measures of poverty and social vulnerability into hyperacute stroke care and research. We briefly review existing evidence on the relationship between socioeconomic status and acute stroke outcomes, identify gaps in current data collection practices, and explore why capturing such information has remained a challenge. To address this gap, we propose a practical, rapid-assessment approach using brief, validated tools to measure economic strain in emergency or prehospital settings. These tools can be embedded into clinical workflows with minimal disruption while providing critical context for interpreting outcomes and guiding resource allocation. We envision incorporating such tools into future randomized controlled trials to ensure that socioeconomic factors are systematically captured and analyzed—ultimately enabling more inclusive trial designs, equitable care delivery, and data-driven policy change.

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Assessing the impact of novel social media policies in the USA restricting youth exposure to food and beverage advertisements: a protocol for a difference-in-difference study

Introduction
Social media is the most prominent source of online food and beverage advertisements (ads) seen by adolescents. Companies target adolescent social media users with ads that feature calorie-dense, nutrient-poor products, and exposure to ads drives poor diet and risk for future diet-related diseases. Black, Hispanic and lower socio-economic status youth are exposed to significantly more ads than White peers. Several state-level policies in the USA have passed restricting youth from accessing social media without parental approval, and some policies have banned advertising to youth. This protocol paper describes a current study that aims to understand the impact of such policies in two states, Louisiana and Texas, as they were among the first to be implemented with racially/ethnically diverse populations.

Methods and analysis
This study employs a repeated cross-sectional difference-in-difference design in which 700 youth ages 13–17 years are being recruited each year for 5 years (Louisiana n=175, Texas n=175, matched comparisons from other states n=350). Youth screen record their mobile devices for 60 minutes while they browse social media platforms (eg, TikTok, Instagram) or use the internet. They also complete a brief survey about a variety of topics (eg, health behaviours, mental health). Adolescents are compensated for screen recording ($75) and the survey ($25). Study team members are coding recordings for several characteristics, including media platforms used, appearances of food or beverages, and food or beverage type. We will estimate the impact of policies on food and beverage ads seen per hour using Ordinary Least Squares regression models and heterogeneity-robust standard errors clustered at the state level (by year and cumulatively). We will run additional models with interaction terms with income and race/ethnicity, separately, to test the role of the policies on health disparities.

Ethics and dissemination
Study procedures have been approved by the Institutional Review Board of the NYU Grossman School of Medicine. We will distribute findings in peer-reviewed journals and at local and national conferences. To complement traditional dissemination pathways, we will create infographics to share with relevant community stakeholders. We will also share findings with policymakers in states that have passed or considered similar policies.

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Exploring cognitive function and postoperative neurocognitive recovery after cardiac surgery in older adults (ECPON): a protocol for an observational study

Introduction
Cardiovascular disease is one of the most common health issues facing the older population, and the number of older adults undergoing cardiac surgery is expected to increase. Postoperative neurocognitive impairment is a frequent and often unrecognised complication that can adversely affect a patient’s recovery, quality of life and daily activities, as well as impact the lives of their family members. Patients may express cognitive difficulties as a feeling of ‘not being the same since the operation’. This study aims to investigate the factors that influence neurocognitive function and patient-reported cognitive symptoms among patients aged 65 and older following cardiac surgery, and explore the impact on the overall postoperative recovery. Additionally, the study aims to describe the perspectives of close relatives on the recovery process.

Methods and analysis
A longitudinal observational study with a mixed-methods approach will be conducted in two thoracic surgical departments in Sweden. A total of 220 patients and 1 close relative for each patient will participate. Neurocognitive function will be assessed preoperatively and at 1, 3 and 6 months postoperatively using a digitalised neurocognitive test battery. We will also evaluate postoperative patient-reported cognitive symptoms and signs, delirium, frailty, health-related quality of life, depression, perceived self-efficacy, fatigue and functional capacity. Each patient’s close relative will assess the observed cognitive function and report on caregiver burden. At the 6-month mark, a purposive sample of patients and their close relatives will be interviewed to explore their experiences of postoperative cognitive recovery.

Ethics and dissemination
The study has been approved by the Swedish Ethical Review Authority (Reference number: 2024-03380-01) and will adhere to the Helsinki Declaration and its amendments. The results will be disseminated through peer-reviewed journals and scientific conferences, as well as presented in various popular science forums and patient organisations.

Trial registration number
NCT06469515; Pre-results.

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A Stop Smoking In Schools Trial in three culturally different middle-income countries (ASSIST global): protocol for a randomised feasibility study

Introduction
Around 80% of the world’s smokers live in lower-middle income countries and smoking rates in China, Philippines and Indonesia are very high. Evidence suggests that most people begin smoking or become habitual smokers before reaching adulthood. This highlights the need for a smoking prevention intervention focused on young people. ASSIST (A Stop Smoking In Schools Trial) is a ‘peer-led’, school-based smoking prevention intervention, shown to be effective in the UK. The aim of the study is to assess the feasibility of conducting a full-scale effectiveness evaluation of an adapted version of the ASSIST intervention in China, Indonesia or the Philippines. However, due to issues with obtaining relevant approvals, China was removed from the trial with the approval of the funder and Trial Steering Committee, and the study will only be completed in Indonesia and the Philippines.

Methods and analysis
A feasibility mixed-methods cluster randomised controlled trial in 10 schools (six intervention, four control) in each of the two countries. Participants will be students aged c13–14 in mainstream (‘lower secondary’) schools. In addition to their usual education on smoking, intervention schools will receive the ASSIST intervention which is based on ‘diffusion of innovation’ theory, with new norms and behaviours promoted through: (1) peer modelling by locally influential individuals; and (2) information disseminated by them through their social networks. Control schools will continue with their usual education around smoking prevention.
The key outcome of the study is whether prespecified progression criteria relating to recruitment, retention, acceptability and feasibility have been met in order to progress to a larger cluster randomised controlled effectiveness trial in one or more of the countries. A mixed-methods process evaluation will assess acceptability, feasibility and fidelity of intervention delivery, exposure to and reach of the intervention. The feasibility of trial processes including outcome measurement will be assessed. An economic evaluation will estimate the costs of the ASSIST intervention. Statistical analyses will focus on feasibility criteria, and qualitative data will be analysed using a framework approach. Outcomes assessed will include self-reported smoking behaviour (own and that of friends and family); vaping and other forms of nicotine use; smoking-related attitudes and knowledge; smoking norms; self-esteem; self-efficacy; (all at baseline and 7 month follow-up) and exhaled carbon monoxide concentration (at follow-up only).

Ethics and dissemination
The trial has been approved by the University of Glasgow College of Medical, Veterinary and Life Sciences (MVLS) Ethics Committee (ref: 200210204), the De La Salle University Research Ethics Review Committee (ref: 2023-012C) and the Medical and Health Research Ethics Committee (MHREC); Faculty of Medicine, Public Health and Nursing; Universitas Gadjah Mada (ref: KE/FK/1205/EC/2022). The trial is sponsored by the University of Glasgow (Head of Research Regulation and Compliance—debra.stuart@glasgow.ac.uk). The sponsor will not have input in data collection, management, analysis and interpretation; write up and submissions for publication.
The study findings will be disseminated through peer-reviewed publications in expert journals and conference presentations and targeted communications to schools, policymakers and the public.

Trial registration number
ISRCTN99140476.

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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

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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.

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Development of prediction models for screening depression and anxiety using smartphone and wearable-based digital phenotyping: protocol for the Smartphone and Wearable Assessment for Real-Time Screening of Depression and Anxiety (SWARTS-DA) observational study in Korea

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).

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Factors influencing career plateau in nurses: a protocol for systematic review and meta-analysis

Introduction
Career plateau is a situation that has many negative effects on individual nurses, nursing management and nursing profession. Despite global research examining career plateaus among nurses, a comprehensive data synthesis on its prevalence and influential factors is still missing. The study aims to systematically analyse the prevalence of career plateau in nurses and explore the related influencing factors.

Methods and analysis
The anticipated start date for the study is December 2025, and the anticipated end date is August 2027. We will search PubMed, Web of Science, Embase, PsycINFO, CINAHL, Scopus, the China National Knowledge Infrastructure, the Wanfang database and the China Biomedical Literature Database (SinoMed) from the establishment of the database to the present for studies on the prevalence and influencing factors of career plateau in nurses. Two researchers will independently conduct literature screening and data extraction. They will evaluate the quality of the included studies using the Joanna Briggs Institute critical appraisal tool and the mixed-methods appraisal tool. If possible, we will conduct a meta-analysis, which is according to the data heterogeneity. If the heterogeneity is too large to be resolved, we will present them narratively and descriptively according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses criteria, summarise status and influencing factors of the career plateau in nurses.

Ethics and dissemination
No formal ethics approval is required for this protocol and no primary data will be collected. The results will be disseminated through peer-reviewed journals and presented at conferences.

PROSPERO registration number
CRD42024545439.

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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.

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Reproducibility of published model-based cancer drug cost-effectiveness analyses: a study protocol for a cross-sectional analysis

Introduction
Model-based cost-effectiveness analysis (CEA) of pharmaceuticals informs reimbursement and pricing in many healthcare systems, and it is essential that CEA evidence is valid and reliable. Several studies have reported lacking transparency in CEA studies. In this study protocol, we describe a study that will investigate whether model-based CEA studies of cancer drugs are transparent and informative enough to enable the reproduction of study findings.

Methods and analysis
This study protocol outlines a study where we will identify CEA studies indexed in MEDLINE from 2015 to 2023 based on predefined search terms. We will include English-language CEA studies evaluating pharmaceutical treatments based on decision-analytical modelling methods that report cost-effectiveness results using life-years, quality-adjusted life-years and/or disability-adjusted life-years as health outcome metric(s). Two authors will screen abstracts and full text for inclusion. We anticipate that a maximum of 150 studies will be included after a full-text review. A data extraction template is designed to capture information used to determine reproducibility together with other information that will be analysed as potential determinants of reproducibility in logistic and linear regression analyses.

Ethics and dissemination
This study design has been deemed exempt from ethical approval. All collected data will be made available in an online repository that will host the study protocol and other supplementary data. Results from this proposed study will be published in peer-reviewed journals and at scientific conferences and workshops.

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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.

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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.

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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.

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