AMI-Sleep: protocol for a prospective study of sleep-disordered breathing/sleep apnoea syndrome and incident cardiovascular events after acute myocardial infarction

Introduction
Sleep-disordered breathing (SDB) and the related clinical syndrome, sleep apnoea syndrome (SAS), are highly prevalent in patients with ischaemic heart disease and often remain undiagnosed. The AMI-Sleep study will describe its prevalence in patients with acute myocardial infarction (AMI) and assess the independent contribution of the type and severity of SDB/SAS to subsequent incident cardiovascular events and mortality.

Methods and analysis
This prospective study will include patients hospitalised for AMI enrolled in the multicentre nationwide prospective French Cohort of Myocardial Infarction Evaluation (FRENCHIE) registry. A nightly simplified polygraphy is performed before discharge from the index AMI admission, and participants complete two self-administered sleep questionnaires. Baseline data are obtained from the FRENCHIE registry. Each participant will be subsequently followed based on data from the National Health Data System (SNDS). Over a period of 4 years, the AMI-Sleep study is expected to recruit approximately 2000 participants. Assuming at least a 10% rate of incident cardiovascular events over 1 year, there would be an estimated 200 events during the first year of follow-up that would be sufficient in multivariable analysis. The primary objective is to describe the prevalence and severity of SDB in AMI and to analyse the association between the type and severity of SDB (based on the apnoea-hypopnoea index) and the occurrence of cardiovascular events (incident acute coronary syndrome, transient ischaemic attack, stroke) or all-cause death after AMI. Secondary objectives include determining the association between the presence of SAS and coronary artery disease severity, in-hospital mortality, morbidity events, healthcare consumption and related costs.

Ethics and dissemination
Eligible individuals are provided with information about the AMI-Sleep study and provided written informed consent. The protocol was approved by the regional Ethics Committee (CPP Ouest II – Angers, RCB N°2018-A00719-46) on 17 February 2019, is registered on ClinicalTrials.gov (NCT04064593) and started in January 2019 with the expected publication of primary outcome results in 2025.

Trial registration number
ClinicalTrials.gov, NCT04064593.

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Assessing the effectiveness of continuous glucose monitoring compared with conventional monitoring in enhancing surgical outcomes for patients with diabetes: protocol for a multicentre, parallel-arm, randomised, pragmatic trial in China

Introduction
The Comprehensive Complication Index (CCI) is an internationally recognised indicator of postoperative complications. During the perioperative period, patients with diabetes mellitus (DM) or impaired glucose tolerance (IGT) may experience a significant increase in the CCI associated with glucose-related complications and increased mortality. Continuous glucose monitoring (CGM) offers advantages such as portability, accuracy, real-time monitoring and rich information. However, few large-scale studies have investigated the effectiveness and safety of CGM in reducing CCI during major surgeries.

Methods and analysis
This study is a multicentre, parallel-arm, randomised pragmatic trial to investigate whether CGM improves clinical outcomes in patients with type 1 or type 2 DM or IGT undergoing major surgery relative to conventional monitoring. This study is planned to be conducted in 50 secondary or tertiary hospitals in China. Eligible patients aged 18 years or older with DM or IGT undergoing elective major surgery will be recruited during a baseline screening period of 3 days before surgery. Eligible patients will be randomly assigned to receive CGM or conventional monitoring in a 1:1 ratio. The primary endpoint measure is the CCI score within 30 postoperative days. The margin of superiority is –12.0. A total of 10 168 participants will achieve 90% power to detect a clinically important difference of –13.0 between the means in the primary outcome. This trial includes multiple statistical analysis steps. For the primary outcome, a covariance model will be used to compare the difference in CCI within 30 days postoperatively between the two groups after adjusting for baseline and centre effects.

Ethics and dissemination
This trial has been approved by the Ethics Committee of Beijing Tsinghua Changgung Hospital (No. 23684-0-02) and its corresponding branch centres. Informed consent will be obtained from all subjects involved in the study. The primary trial results will be submitted for publication to a peer-reviewed journal.

Trial registration number
NCT06331923.

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National yearly cost of breast cancer screening in the USA and projected cost of advocated guidelines: a simulation study with life table modelling

Objective
The aim of this study was to estimate the total national direct cost of breast cancer screening from 2019 to 2022 and project the total national cost and average lifetime cost of screening per woman for three current guidelines.

Design
We estimated the national cost of screening from 2019 to 2022, and per cancer detected in 2022, using real-world data on the number of mammograms performed per year. We also projected the national cost of screening using life table modelling for three guidelines: 2021/2023 American College of Radiology (ACR), 2023 American Cancer Society (ACS) and 2024 United States Preventative Services Task Force (USPSTF). The average lifetime cost to screen one woman until age 74 years with each guideline was also estimated. The Optum Labs Data Warehouse was used to estimate commercial and Medicare costs and recall rates. Sensitivity analyses were used to estimate uncertainty and determine which inputs had the largest impact on total national costs.

Setting
This study was conducted for the USA.

Participants
Women eligible for breast cancer screening.

Interventions
Digital mammograms (2D) or digital breast tomosynthesis (3D) and/or MRI.

Primary outcome measure
Total national cost of screening calculated as the sum of screening and recall costs. Average lifetime cost of screening per woman until 74 years.

Results
Nationally, screening cost approximately US$11 billion (B) per year from 2019 to 2022 with approximately 37% of eligible women screened each year. In 2022, screening cost US$55 471 per 3D-detected and US$44 000 per 2D-detected invasive or ductal carcinoma in situ case. Using target yearly participation rates of 54%–78% by age of women, the projected cost of screening was US$30B for ACR, US$18B for ACS and US$8B for USPSTF guidelines. The average lifetime cost to screen an average-risk woman was: US$13 416 for ACR, US$7946 for ACS and US$6931 for USPSTF. Participation rates, the proportion of women with a lifetime risk >20% and commercial MRI and 3D costs had the largest impact on total costs.

Conclusion
The cost of screening varies significantly by guideline (US$8B–US$30B) and was most influenced by participation rates, high-risk population proportions and technology costs. Future work can investigate whether risk-based screening strategies being tested in ongoing clinical trials can reduce national screening costs while improving outcomes.Cite Now

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Coproducing a culturally sensitive storytelling video intervention to improve psychosocial well-being: a multimethods participatory study with Nepalese migrant workers

Objective
This study aimed to coproduce a culturally adaptive storytelling video intervention to support the psychosocial well-being of Nepalese migrant workers.

Design
A multimethods participatory study was conducted involving three different but interconnected phases: (1) formative research involving a systematic review, pilot survey and stakeholder consultations; (2) exploration and analysis of Nepalese literature relevant to contemporary migration; and (3) coproduction of a storytelling video intervention, using participatory workshops.

Participants and settings
Convenience sample of outgoing and returnee migrant workers from the Gulf Cooperation Council (GCC) countries, their families and other relevant stakeholders in Dhading District of Bagmati Province, Nepal.

Results
The systematic review of 33 included studies identified five key health issues: mental health; occupational hazards; sexual health; healthcare access; and infectious diseases. In the survey (n=60), workers reported various health problems including fever/common cold (42%); mental health problems (25%); and verbal abuse (35%). Twenty interviewees identified issues related to physical health (eg, pneumonia, kidney disease) as well as mental health (eg, anxiety, depression). Nepalese literary resources primarily portrayed themes of: separation; hopelessness and helplessness; and poor workplace environments. Drawing on these findings and iterative workshops with stakeholders, a culturally sensitive storytelling video intervention was coproduced to support the psychosocial well-being of Nepalese migrant workers in GCC countries. The intervention used an animated video format with audio narration and subtitles, presenting a story centred around the struggles of an archetypal male migrant worker and their use of coping strategies for dealing with adversities.

Conclusions
This is a feasibility study conducted in a single district of Nepal; as such, the findings should be generalised cautiously. Despite these limitations, the project is testament to the value of participatory methods in the development of culturally sensitive public health interventions for marginalised groups, and points to the utility of coproduced storytelling formats in migrant health contexts. Future research is needed to evaluate feasibility and acceptability of the intervention as well as the outcomes and experiences of migrant workers who engaged with the video.

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Mixed-methods study to develop extensions to the SPIRIT and CONSORT statements for factorial randomised trials: the Reporting Factorial Trials (RAFT) study

Background
Extensions to Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) and Consolidated Standards of Reporting Trials (CONSORT) reporting recommendations specifically for factorial trials have been developed by the Reporting Factorial Trials (RAFT) study group. This article describes the processes and methods used to develop the extensions.

Objective
To develop SPIRIT and CONSORT extensions for factorial trials.

Design and participants
A four-phase, consensus-based approach was used: phase 1: scoping review, phase 2: Delphi survey (n=104 respondents in round 1), phase 3: consensus meeting (n=15 members) and phase 4: checklist finalisation.

Results
In phase 1, the scoping review identified 31 reporting recommendations, which formed a long list of 50 concepts (19 applied to the SPIRIT extension and 31 applied to the CONSORT extension) to include in the guideline development. In phase 2, a three-round Delphi survey resulted in two new concepts being added and ended with 49 concepts (19 applied to SPIRIT and 30 applied to CONSORT) reaching consensus to remain, with only three concepts meeting the exclusion criteria. In phase 3, the concepts were further refined and translated into specific extension item wording, through an extensive review process conducted by the core RAFT team and leading trial experts, who attended a 2-day hybrid meeting. The resulting 9 SPIRIT items and 17 CONSORT items were further evaluated and developed through an iterative process in phase 4, to promote user acceptance and uptake.

Conclusion
Uptake of the CONSORT and SPIRIT extensions will improve the conduct of factorial trials, as well as understanding and interpretation of such trials. By reporting on how these extensions were developed, we promote transparency of this process and share learning experiences to develop best practice when developing reporting guidelines.

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Vision Restoration through transorbital electrical stimulation in Optic Neuropathy in patients with significant optic atrophy due to primary open-angle glaucoma–a randomised, controlled, double-blind, multicentre clinical trial: the VIRON study protocol

Introduction
Glaucoma is one of the most common causes of blindness and affects more than 70 million people worldwide. The disease is characterised by the loss of retinal ganglion cells associated with a progressive optic neuropathy, resulting in an impairment of visual functions, for example, visual field loss. Nowadays, the only modifiable risk factor is the increase in intraocular pressure, and its treatment is to lower this pressure by medication, laser treatment or surgery to avoid disease progression. New methods for preventing and reversing vision loss are thus urgently needed. Several small and two multicentre studies have presented evidence that repetitive transorbital alternating current stimulation (rtACS) can lead to long-lasting visual field improvement. This could open a new and inexpensive therapeutic option for optic atrophy. However, the level of evidence for this method is still fairly rather poor, and further trials are needed. Therefore, this clinical trial aims to prove the effectiveness of rtACS compared with sham stimulation in patients with primary open-angle glaucoma (POAG).

Methods and analysis
VIRON (Vision Restoration in Optic Neuropathy) is a national, multicentre, prospective, randomised, placebo-controlled, double-blind trial with three arms. The primary objective is to assess the effectiveness of rtACS in patients with POAG compared with sham stimulation. The primary outcome is the change in mean defect (MD) in the visual field immediately after 10 sessions of rtACS (days 9, 16 and 23) compared with the values of initial perimetry (days –21 to –14 and 0) after applying electrical stimulation with a classical montage, compared with sham and electrical stimulation using individualised montage. Secondary outcome measures comprise a long-term effect with changes in MD at 24 weeks after stimulation, and data from the National Eye Institute Visual Function-25 and quality of life (Short Form 36) questionnaires. The target population are patients with glaucomatous optic atrophy and significant glaucomatous visual field defects (MD of 5–22 dB) due to POAG.
After randomisation, patients received either classical rtACS (group 1), individual rtACS (group 2) or sham stimulation (group 3) in daily 25 min stimulation sessions in two series of five consecutive days separated by a weekend interval. In group 1, active stimulation will be via the routinely applied montage using two electrodes affixed on the right and left side of the head, next to the eyes, with straightforward fixation. In group 2, the current flow will be individually modelled (MRI-based) to target areas of partial visual field defects by optimising electrode positions in conjunction with an optimised visual fixation direction. Group 3 with sham stimulation will serve as control.
The calculated sample size required to achieve a statistical power of 80% for a relevant effect size and allow for dropouts was 300 (100 per group). The trial has already begun with the first patient in July 2023. The planned recruitment period is 24 months with an estimated end of the study in November 2025 (last patient out). An adjusted extension of the study period is planned.

Ethics and dissemination
VIRON was approved by the Central Ethics Committee of the University Medical Center Göttingen (19 October 2022) and those of the individual participating centres (Bonn: 446/23-EP, Hamburg: 2023-200889-BO-bet, Cologne: 23-1487 and Mainz: 2023-17399-§23b). The study protocol complies with the Declaration of Helsinki, the national medicine device regulation (MDR) laws and the international standards of good clinical practice (GCP).
The study protocol (V.5, 24 November 2023) was designed following the Standard Protocol Items: Recommendations for Interventional Trials guidelines and is registered on https://drks.de/search/de/trial/DRKS00029129.
As study initiatior the University Medical Center Göttingen (UMG) is responsible for data ownership and data management of the VIRON study. The study data will be published within 6 months of the study being completed. After the publication of the primary results, all data are anonymised and published in an open-access journal to ensure access to the data for third parties.

Trial registration number
https://drks.de/search/de/trial/DRKS00029129.

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Association between calcium and vitamin D supplementation and increased risk of kidney stone formation in patients with osteoporosis in Southwest China: a cross-sectional study

Objectives
This cross-sectional study aims to evaluate the association between calcium and vitamin D supplementation for osteoporosis treatment and the development of kidney stones while investigating the impact of urinary calcium excretion on kidney stone risk among patients receiving this supplementation treatment.

Design
The study involved collecting data from 204 Chinese Han patients aged 50–89 with osteoporosis in the southwest region of China. These patients had been on daily doses of 600 mg of calcium carbonate and 0.5 µg alfacalcidol for at least 1 year. The study employed univariate analysis and multivariable logistic regression to identify risk factors for kidney stones, with independent t-tests used to compare differences between groups.

Setting
Data were collected from patients in the southwest region of China, covering the period from July 2019 to December 2023.

Participants
The study included 204 patients with osteoporosis, all of whom had been receiving the specified calcium and vitamin D supplements for the duration of the study.

Results
The study found that a history of recurrent kidney stones was an independent risk factor for the development of kidney stones. Patients with kidney stones who had a history of recurrent stones exhibited significantly higher levels of 24-hour urinary calcium excretion (1.00±0.62 vs 0.57±0.54, p=0.026) compared with those without such a history.

Conclusions
The results suggest that a history of recurrent kidney stones independently increases the risk of kidney stones in patients undergoing calcium and vitamin D supplementation for osteoporosis, likely due to increased urinary calcium excretion.

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Burden of oesophageal cancer attributed to alcohol use in 204 countries and territories, 1990-2019: results from the Global Burden of Disease Study 2019

Objectives
This study aimed to assess the global burden of oesophageal cancer (EC) attributable to alcohol consumption across 204 countries and territories from 1990 to 2019. Alcohol use is a major modifiable risk factor for EC, with unique biological and epidemiological effects compared with other contributors such as smoking, necessitating a focused analysis of its global impact.

Design
We analysed trends in EC attributable to alcohol consumption from 1990 to 2019 using data from the Global Burden of Disease (GBD) 2019 study.

Setting
Data were obtained from the GBD Results Tool, covering 204 countries and territories across 21 GBD regions.

Participants
Patients with EC attributable to alcohol consumption.

Main outcomes and measures
The number and age-standardised rates of deaths and disability-adjusted life-years (DALYs) due to EC attributable to alcohol consumption are presented by region for 1990 and 2019, along with the number of deaths, age-standardised mortality rates (ASMR) and age-standardised DALY rates (ASDR) in 204 countries and territories in 2019. Geographical variations were visualised using maps, and linear regression analyses were performed to assess the association between the Socio-Demographic Index (SDI) and EC mortality and DALY rates.

Results
In 2019, there were 113 600.3 deaths (95% uncertainty intervals (UIs): 84 062.5–144 685.6), contributing to 2818.2×103 DALYs (95% UI: 2109.6–3573.6). From 1990 to 2019, total deaths and DALYs associated with EC increased, while age-standardised rates decreased. ASMR and ASDR decreased in high SDI populations but plateaued in low-middle or low SDI populations for both genders. China recorded the highest death toll (61 887.7, 95% UI: 42 882.6–84 201.3), while Uganda had the highest ASMR (4.48, 95% UI: 3.06–6.26) and ASDR (119.21, 95% UI: 80.72–167.22). Males accounted predominantly for EC attributed to alcohol use.

Conclusions
Globally, there was a decline in ASMR and ASDR but an increase in overall deaths and DALYs related to EC from 1990 to 2019. The burden of EC varied across regions and countries, with Uganda exhibiting the highest ASMR, and China having the highest fatalities. The association between alcohol and EC was more pronounced in males than females.

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Cross-sectional evaluation of host biomarkers for guiding antibiotic use in bacterial and non-bacterial acute febrile illness in low- and middle-income tropical settings

Objectives
To evaluate the effectiveness of 18 different host biomarkers in differentiating bacterial from non-bacterial acute febrile illness (AFI) in resource-limited settings, specifically in Brazil, Malawi and Gabon.

Design
Multinational, cross-sectional study.

Setting
The study was carried out across multiple primary healthcare facilities, including urban and rural settings, with a total of three participating centres. Recruitment took place from October 2018 to July 2019 in Brazil, May to November 2019 in Gabon and April 2017 to April 2018 in Malawi.

Participants
A total of 1915 participants, including children and adults aged 21–65 years with a fever of≤7 days, were recruited through convenience sampling from outpatient clinics in Brazil, Gabon and Malawi. Individuals with signs of severe illness were excluded. Written consent was obtained from all participants or their guardians.

Intervention
This is not applicable as the study primarily focused on biomarker evaluation without specific therapeutic interventions.

Primary and secondary outcome measures
The primary outcome measure was the ability of each host biomarker to differentiate between bacterial and non-bacterial AFI, as evaluated by area under the receiver operating characteristic (AUROC) curves. Secondary outcomes included the performance of individual biomarkers across the different study sites and in a multivariable setting.

Results
A Kruskal-Wallis test, adjusted by Benjamini-Hochberg, was performed for each biomarker to identify covariates with a significant difference in the distribution of biomarker values. The analysis revealed that country of origin (Brazil, Gabon, Malawi), age, sex and malaria status significantly impacted biomarker distribution (p≤0.001). The most widely known biomarkers, such as white blood cell (WBC) count and C-reactive protein (CRP), demonstrated the best performance in distinguishing between bacterial and non-bacterial infections, with AUROCs reaching up to 0.83 (0.77–0.88) for WBC count and 0.71 (0.59–0.82) for CRP. However, none of the evaluated novel host biomarkers exhibited high performance (AUROC

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Antimicrobial resistance in Malaysia: a cross-sectional study analysing trends and economic impacts

Objective
This national study assessed the economic impact of treating patients with antimicrobial resistance (AMR) pathogens within Malaysia’s Ministry of Health (MoH) hospitals.

Design
A cross-sectional study design and top-down costing approach, analysing Malaysian diagnosis-related group (DRG) data for AMR patients admitted to MoH hospitals from 2017 to 2020.

Setting and participants
A total of 1190 cases were identified using International Statistical Classification of Diseases-10 version 2010 codes for AMR pathogens.

Outcome measures
The study aims to estimate direct healthcare costs for treating AMR patients. Costs per admission were calculated based on each patient’s length of stay (LOS). A binary logistic regression model identified cost determinants, with significant factors (p

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Trends in depression and anxiety prevalence by cancer status among US adults: analyses of the 2019-2022 National Health Interview Survey

Objective
To examine trends in the prevalence of depression and anxiety during the COVID-19 pandemic among US adult cancer patients and survivors (CPS) in comparison to those of non-CPS (NCPS).

Methods and analysis
National Health Interview Survey 2019–2022 data were analysed using spline logistic regression.

Results
A total of 115 664 participants completed the survey (mean age (SD), 52.8 (18.4) years; 54.3% female; 12.6% CPS). The age-adjusted prevalence of depression significantly increased from 26.53% in 2019 to 29.78% in 2022 among CPS, while that of anxiety increased from 24.02% in 2019 to 28.08% in 2022. Throughout the pandemic, there were consistently significant annual increases in the prevalence of both depression and anxiety with CPS experiencing significantly faster rates of increase compared with NCPS (average annual absolute increase 0.72% in NCPS vs 1.08% in CPS, p

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Cardiovascular Disease in Anabolic Androgenic Steroid Users

Circulation, Ahead of Print. BACKGROUND:Use of anabolic androgenic steroids (AASs) is associated with increased mortality, and case reports have suggested that some of these deaths are due to cardiovascular disease. However, the epidemiology of cardiovascular disease in AAS users is still relatively unexplored. This study aimed to measure the incidence of cardiovascular disease in male AAS users and to compare these rates with those of a cohort from the general population matched by age and sex.METHODS:Men sanctioned in an antidoping program for AAS use in Danish fitness centers between 2006 and 2018 were included and matched for age and sex with 50 times as many controls from the general Danish population. The cohort was followed until June 30, 2023. Using the nationwide registries, we obtained information on admissions, prescriptions, educational length, and occupational status for both the AAS users and controls. This study investigated the incidence of acute myocardial infarction, percutaneous coronary intervention, or coronary artery bypass graft, venous thromboembolism, ischemic stroke, arrhythmia, cardiomyopathy, heart failure, and cardiac arrest during the follow-up period.RESULTS:During an average of 11 years of follow-up, AAS users (n=1189) demonstrated a significantly higher incidence of several cardiovascular events compared with controls (n=59 450). Correspondingly, AASs were associated with an increased risk of acute myocardial infarction (adjusted hazard ratio [aHR] 3.00 [95% CI, 1.67–5.39]), percutaneous coronary intervention or coronary artery bypass graft (aHR 2.95 [95% CI, 1.68–5.18]), venous thromboembolism (aHR 2.42 [95% CI, 1.54–3.80]), arrhythmias (aHR 2.26 [95% CI, 1.53–3.32]), cardiomyopathy (aHR 8.90 [95% CI, 4.99–15.88]), and heart failure (aHR 3.63 [95% CI, 2.01–6.55]). Due to the limited number of ischemic stroke and cardiac arrest cases among AAS users, these outcomes were not reportable.CONCLUSIONS:AAS use is associated with a substantially increased risk of cardiovascular disease in a large cohort with a long follow-up period.

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Rates, causes and predictors of all-cause and avoidable mortality in 514 878 adults with and without intellectual disabilities in Scotland: a record linkage national cohort study

Background
Studies on avoidable mortality in adults with intellectual disabilities are limited, as are studies on causes of death.

Objectives
We aimed to quantify mortality rates, and causes, and identify factors (i.e., age, sex, Scottish Index of Multiple Deprivation (SIMD)) related to avoidable mortality in adults with intellectual disabilities.

Design
A record linkage national cohort study.

Setting
A cohort of adults with intellectual disabilities with or without co-occurring autism, aged 25+ years and a randomly selected comparison group aged 25+ years without intellectual disabilities or autism identified from Scotland’s Census, 2011. Census records were linked to the National Records of Scotland Statutory Register of Deaths database to ascertain all deaths from 2011 to 2019.

Participants
We analysed data on 14 477 adults with intellectual disabilities aged 25+ years and a randomly selected comparison group of 506 207 adults aged 25+ without intellectual disabilities identified from Scotland’s Census 2011.

Primary and secondary outcome measures
We ran 2 tests and t-tests to investigate individual characteristics and differences in age at death for adults with intellectual disabilities compared with peers in the general population. Cox proportional hazard models were fitted to calculate risk of mortality (all-cause, avoidable, treatable, preventable) unadjusted and adjusted for age, sex and SIMD. We then calculated mortality rates, using crude and indirect standardisation methods.

Results
During the 8.5-year follow-up, 23.7% (crude death rate of 3033.3 per 100 000) of adults with intellectual disabilities died compared with 13.8% of controls. The median age at death among adults aged 25+ with intellectual disabilities was 65.0 years compared with 80.0 years for adults without intellectual disabilities. For all-cause mortality, the age-standardised mortality ratio (SMR) in the population with intellectual disabilities was 3.1 (95% CI 3.0 to 3.2). The SMRs were higher for the youngest age groups, women and in the most affluent areas. This was also the case for SMRs for avoidable, treatable and preventable deaths. For the population of adults with intellectual disabilities, 31.7% of recorded deaths were considered avoidable, 21.1% were treatable and 19.9% were preventable. In the controls, 18.2% of deaths were considered avoidable, 8.8% treatable and 14.7% preventable. Down syndrome and dementia were the two most commonly recorded underlying causes of death for people with intellectual disabilities while malignant neoplasm of bronchus and lung and acute myocardial infarction were most commonly recorded in the general population.

Conclusions
Risk of all-cause, avoidable, treatable and preventable mortality was higher for adults with intellectual disabilities than their peers. The highest SMRs were observed for youngest adults, women and individuals living in the most affluent areas.

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Integration of healthcare services for HIV and non-communicable diseases in sub-Saharan Africa: protocol for a scoping review of randomised controlled trials

Introduction
Stand-alone HIV clinics in sub-Saharan Africa (SSA) have effectively expanded antiretroviral therapy since the 2000s, transforming HIV from a deadly infection into a chronic condition. However, over the past decade, there has been a significant rise in the prevalence of non-communicable diseases (NCDs) globally and in SSA. People living with HIV are at higher risk for some NCDs, including hypertension, diabetes and different cancers. The region’s current healthcare infrastructure is not equipped to address this growing burden. Integrating health services for HIV and NCDs (ie, combining services for HIV with services for hypertension, diabetes, depression and mental health, substance use disorder or cancer) could be one strategy for responding to these challenges. In this scoping review, we aim to identify randomised controlled trials on HIV-NCD integration, assess implemented integration models and measured outcomes and highlight evidence gaps.

Methods and analysis
This scoping review will follow the Arksey and O’Malley (2005) methodological framework. Reporting will be guided by the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews (PRISMA-ScR) checklist. We will conduct a systematic search of the databases OVID Medline, Embase, Web of Science, Global, Africa Index Medicus, including terms related to HIV, NCDs and healthcare integration. Included trials must have been conducted within SSA and have been published in English or French after 1 January 2010. We will not select based on sample size or number of clusters. Both the title and abstract screening and full-text screening will be done in Covidence by at least two reviewers working independently. Data extraction will focus on key variables, including study design, geographical location, integration intervention, measured outcomes and reported findings.

Ethics and dissemination
This scoping review aims to generate new insights from publicly available research. Therefore, ethical approval is not required. Study findings will be shared through discussion with policymakers, implementation science researchers and healthcare providers. The results of this study are intended to be published in a peer-reviewed journal.

Trial registration
This protocol has been registered with Center for Open Science OSF Registry (DOI: 10.17605/OSF.IO/RGQSN). The search was conducted on 25 March 2024 and updated on 21 October 2024. The review is expected to be completed by March 2025.

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