Search Results for: Follow-up ottimale dopo embolia polmonare acuta

Introduction
Cholecystitis is a highly prevalent disease that imposes a substantial burden on the healthcare system. Despite strong underlying evidence, guideline adherence in the treatment of cholecystitis remains low. Moreover, important gaps in knowledge persist that must be addressed to optimise existing guidelines. The primary aim is to assess the nationwide variation in cholecystitis treatment and identify opportunities to improve guideline adherence. Secondary aims include determining the best cystic duct closure method; the best model to predict concomitant choledocholithiasis; the optimal treatment for cholecystitis lasting 7 days or more at diagnosis and the optimal strategy for gallbladder drainage and post-drainage care.

Methods and analysis
The Dutch CHESS is a multicentre observational cohort study, including 67 out of 69 Dutch hospitals. From 1 April to 30 September 2024, all patients diagnosed with cholecystitis (Tokyo Guidelines definition) will be prospectively identified. Data on patient characteristics, treatment and outcome (with 6-month follow-up) will be collected to address the primary and secondary aims. For the primary aim, guideline adherence is defined as the percentage of patients who undergo early cholecystectomy for cholecystitis lasting 0–7 days. Current adherence, nationally and for each individual hospital, along with predictors of adherence, will be determined. The adherence of each hospital will be set against the national average and best practices. To further support improvement, the impact of guideline adherence on total hospital stay and morbidity will be determined. Three months after performance feedback to the participating hospitals, the impact on local practice will be assessed through questionnaires. Subgroup analyses and statistical methods for addressing both the primary and secondary aims are predefined in this protocol.

Ethics and dissemination
The Medical research Ethics Committees United reviewed the protocol and decided that the Dutch Medical Research Involving Human Subjects Act is not applicable (reference Number: W23.225). Approval was obtained from the institutional review board and board of directors at each participating hospital. Results will be disseminated through peer-reviewed publications and conference presentations.

Study registration number
ClinicalTrials.gov, NCT06349863; Pre-results.

Introduction
Child maltreatment (CM) is a major public health issue with lifelong consequences on mental health, quality of life, educational and economic prospects of children who experienced CM. Early identification of maltreated children is important to prevent further CM and ensure that children’s basic needs are met, as well as to address and avoid further consequences. However, above and beyond early identification, it is crucial to avoid the occurrence of CM. This may include the reduction of risk factors at the family and community level as well as creating supportive environments for growing up safely. Therefore, we need to understand the prevention of CM conceptually and view it not only from a medical perspective, but also from a population health perspective. The aim of this scoping review is to identify and describe theories, models or frameworks on the prevention of CM from a broad population health perspective, considering primary, secondary and tertiary prevention strategies.

Methods and analysis
A broad search in four databases (PubMed (NIH NLM), PsycInfo (Ovid), CINAHL Plus (EBSCOhost) and Web of Science (Clarivate)) will be conducted from 2009 to current. Additionally, the grey literature on websites from key public health organisations will be considered. Results will be reported following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews: Checklist and Explanation (2018). The review will include articles describing a theory, model or framework on prevention strategies for CM. Studies focussing on single interventions that do not describe prevention strategies conceptually, will be excluded. General characteristics of the frameworks, theories and models and information on types of prevention strategies they describe will be extracted. Findings will be presented in a structured table format as well as narratively.

Ethics and dissemination
As we will not collect any personal, confidential or sensitive data, ethical approval is not required. We will publish our results in a scientific journal, present them at conferences and use them for further knowledge translation activities. The scoping review is registered with the Open Science framework: https://osf.io/49g7z/.

Objective
To determine whether an enhanced community rehabilitation intervention (the Fracture in the Elderly Multidisciplinary Rehabilitation (FEMuR) intervention) was more effective than usual National Health Service care, following surgical repair of hip fracture, in terms of the recovery of activities of daily living (ADLs).

Design
Definitive, pragmatic, multisite, parallel-group, two-armed, superiority randomised controlled trial with 1:1 allocation ratio.

Setting
Participant recruitment in 13 hospitals across England and Wales, with the FEMuR intervention delivered in the community.

Participants
Patients aged over 60 years, with mental capacity, recovering from surgical treatment for hip fracture and living in their own home prior to fracture.

Interventions
Usual rehabilitation care (control) was compared with usual rehabilitation care plus the FEMuR intervention, which comprised a patient-held workbook and goal-setting diary to improve self-efficacy, and six additional therapy sessions delivered in-person in the community, or remotely during COVID-19 restrictions (intervention), to increase the practice of exercise and ADL.

Primary and secondary outcome measures
Primary outcome was the Nottingham Extended Activities of Daily Living (NEADL) scale at 12 months. Secondary outcomes included: Hospital Anxiety and Depression Scale, Falls Self-Efficacy-International scale, hip pain intensity, fear of falling, grip strength and Short Physical Performance Battery. Outcomes were collected by research assistants in participants’ homes, whenever possible, but had to be collected remotely during COVID-19 restrictions.

Results
In total, 205 participants were randomised (n=104 experimental; n=101 control). Trial processes were adversely affected by the COVID-19 pandemic. There were 20 deaths, 34 withdrawals and three lost to follow-up. At 52 weeks, there was no significant difference in NEADL score between the FEMuR intervention and control groups. Joint modelling analysis testing for difference in longitudinal outcome adjusted for missing values also found no significant difference with a mean difference of 0.1 (95% CI –1.1, 1.3). There were no significant between-group differences in secondary outcomes. Sensitivity analyses, examining the impact of COVID-19 restrictions, produced similar results. A median of 4.5 extra rehabilitation sessions were delivered to the FEMuR intervention group, with a median of two sessions delivered in-person. Instrumental variable regression did not find any effect of the amount of rehabilitation on the main outcome. There were 53 unrelated serious adverse events (SAEs) including 11 deaths in the control group: 41 SAEs including nine deaths in the FEMuR intervention group.

Conclusions
The FEMuR intervention was not more effective than usual rehabilitation care. The trial was severely impacted by COVID-19. Possible reasons for lack of effect included limited intervention fidelity (fewer sessions than planned and remote delivery), lack of usual levels of support from health professionals and families, and change in recovery beliefs and behaviours during the pandemic.

Trial registration number
ISRCTN28376407.

Objectives
Idiopathic pulmonary fibrosis (IPF) is a progressive interstitial lung disease. Chest high-resolution CT (HRCT) is instrumental in IPF management, and the Quantitative Lung Fibrosis (QLF) score is a computer-assisted metric for quantifying lung disease using HRCT. This study aimed to assess the change in QLF score associated with a minimum clinically important difference (MCID) of IPF symptoms and physiological lung function, and also determine the MCID of QLF change associated with all-cause mortality to serve as an imaging biomarker to confirm disease progression and response to therapy.

Design and study setting
We conducted post hoc analyses of prospective data from two IPF phase II studies of pamrevlumab, a fully human monoclonal antibody that binds to and inhibits connective tissue growth factor activity.

Participants
Overall, 152 patients with follow-up visits after week 24.

Methods
We used the anchor-based Jaeschke’s method to estimate the MCID of the QLF score that corresponded with the already established MCID of St. George’s Respiratory Questionnaire (SGRQ) and percent-predicted forced vital capacity (ppFVC). We also conducted a Cox regression analysis to establish a sensitive and robust MCID of the QLF score in predicting all-cause mortality.

Results
QLF changes of 4.4% and 3.6% corresponded to the established MCID of a 5-point increase in SGRQ and a 3.4% reduction in ppFVC, respectively. QLF changes of 1% (HR=4.98, p=0.05), 2% (HR=4.04, p=0.041), 20 mL (HR=6.37, p=0.024) and 22 mL (HR=6.38, p=0.024) predicted mortality.

Conclusion
A conservative metric of 2% can be used as the MCID of QLF for predicting all-cause mortality. This may be considered in IPF trials in which the degree of structural fibrosis assessed via HRCT is an endpoint. The MCID of SGRQ and FVC corresponds with a greater amount of QLF and may reflect that a greater amount of change in fibrosis is required before there is functional change.

Trial registration number
NCT01262001, NCT01890265.

Objectives
Idiopathic pulmonary fibrosis (IPF) is a progressive interstitial lung disease. Chest high-resolution CT (HRCT) is instrumental in IPF management, and the Quantitative Lung Fibrosis (QLF) score is a computer-assisted metric for quantifying lung disease using HRCT. This study aimed to assess the change in QLF score associated with a minimum clinically important difference (MCID) of IPF symptoms and physiological lung function, and also determine the MCID of QLF change associated with all-cause mortality to serve as an imaging biomarker to confirm disease progression and response to therapy.

Design and study setting
We conducted post hoc analyses of prospective data from two IPF phase II studies of pamrevlumab, a fully human monoclonal antibody that binds to and inhibits connective tissue growth factor activity.

Participants
Overall, 152 patients with follow-up visits after week 24.

Methods
We used the anchor-based Jaeschke’s method to estimate the MCID of the QLF score that corresponded with the already established MCID of St. George’s Respiratory Questionnaire (SGRQ) and percent-predicted forced vital capacity (ppFVC). We also conducted a Cox regression analysis to establish a sensitive and robust MCID of the QLF score in predicting all-cause mortality.

Results
QLF changes of 4.4% and 3.6% corresponded to the established MCID of a 5-point increase in SGRQ and a 3.4% reduction in ppFVC, respectively. QLF changes of 1% (HR=4.98, p=0.05), 2% (HR=4.04, p=0.041), 20 mL (HR=6.37, p=0.024) and 22 mL (HR=6.38, p=0.024) predicted mortality.

Conclusion
A conservative metric of 2% can be used as the MCID of QLF for predicting all-cause mortality. This may be considered in IPF trials in which the degree of structural fibrosis assessed via HRCT is an endpoint. The MCID of SGRQ and FVC corresponds with a greater amount of QLF and may reflect that a greater amount of change in fibrosis is required before there is functional change.

Trial registration number
NCT01262001, NCT01890265.

Introduction
Healthcare systems face the challenge of managing limited resources while addressing the growing demand for care and the need for equitable access. Traditional cost-effectiveness analyses focus on maximising health benefits but often fail to account for how these benefits are distributed across various populations, potentially increasing health inequities. As a result, there is increasing interest in distributional cost-effectiveness analysis (DCEA), which incorporates equity considerations by explicitly assessing how health outcomes and costs are shared among diverse populations. This scoping review explores the practical application of DCEA methodology in evaluating programs and interventions. We seek to learn more about the barriers to DCEA’s application, highlighting its practical challenges, limited use globally and the steps necessary to integrate equity more effectively into implementing and adopting programs and interventions into healthcare policy and resource allocation.

Methods and analysis
To evaluate the use of DCEA in the literature, a scoping review will follow Preferred Reporting Items for Systematic Reviews and Meta-Analyses—Scoping Review Extension guidelines. Systematic searches will be performed across scientific databases (MEDLINE, SCOPUS, BASE, APA Psych and JSTOR), grey literature sources (Google Custom Search Engine), and handsearching to identify eligible articles published from January 2015 to March 2025. No limits will be placed on language. Reviewers will independently chart data from eligible studies using standardised data abstraction. The collected information will be synthesised both quantitatively and narratively.

Ethics and dissemination
Formal ethical approval is not necessary as this study will not collect primary data. The findings will be shared with professional networks, published in conference proceedings and submitted for peer-reviewed publication.

Objective
Biological age assessed by the Klemera and Doubal method (KDM) and phenotypic age (PhenoAge) was considered as a marker for ageing-related outcomes because it reflects different aspects of biological ageing and health, which are associated with increased risk of death. proBNPage based on N-terminal pro-B-type natriuretic peptide (NT-proBNP) is a novel index for biological age estimation. However, the independence of its relationship with clinical outcomes from established risk factors, KDM or PhenoAge remains uncertain. Their identification could provide valuable information to prognosis.

Design, setting and participants
This study analysed data from the general population included in the National Health and Nutrition Examination Survey (NHANES). Participants who took part in the cross-sectional survey from 1999 to 2004 were included, and all-cause as well as cardiovascular mortality was recorded (up to 31 December 2019).

Outcome measures
All-cause and cardiovascular mortality were considered as outcomes. Clinical risk factors were collected, and biological age was estimated by proBNPage, KDM and PhenoAge. Cox proportional hazards models were used to determine the relationship between proBNPage and outcomes with adjustment for risk factors or other biological age indexes. Restricted cubic spline (RCS) analysis based on multivariate Cox regressions was performed to examine whether there was a non-linear relationship between proBNPage and outcomes.

Results
A total of 9 925 participants were included in this study. The association between proBNPage and outcomes remained significant after adjusting for risk factors, including NT-proBNP (for all-cause mortality, HR 1.14; 95% CI 1.10 to 1.17; for cardiovascular mortality, HR 1.20; 95% CI 1.14 to 1.27). Similar results were obtained after adjusting for KDM plus NT-proBNP (for all-cause mortality, HR 1.31; 95% CI 1.22 to 1.41; for cardiovascular mortality, HR 1.21; 95% CI 1.11 to 1.28) or PhenoAge plus NT-proBNP (for all-cause mortality, HR 1.21; 95% CI 1.16 to 1.28; for cardiovascular mortality, HR 1.35; 95% CI 1.24 to 1.47). These findings were confirmed in most subgroups. A non-linear relationship was observed between proBNPage and all-cause and cardiovascular mortality with an inflection point.

Conclusions
A non-linear positive relationship was observed between proBNPage and clinical outcomes. After adjusting for established risk factors and other biological age estimation indices (KDM or PhenoAge), proBNPage was significantly associated with mortality. The results remain similar after further adjustment for NT-proBNP. These results suggest that proBNPage is a useful surrogate for biological age estimation.

Objective
To determine whether an enhanced community rehabilitation intervention (the Fracture in the Elderly Multidisciplinary Rehabilitation (FEMuR) intervention) was more effective than usual National Health Service care, following surgical repair of hip fracture, in terms of the recovery of activities of daily living (ADLs).

Design
Definitive, pragmatic, multisite, parallel-group, two-armed, superiority randomised controlled trial with 1:1 allocation ratio.

Setting
Participant recruitment in 13 hospitals across England and Wales, with the FEMuR intervention delivered in the community.

Participants
Patients aged over 60 years, with mental capacity, recovering from surgical treatment for hip fracture and living in their own home prior to fracture.

Interventions
Usual rehabilitation care (control) was compared with usual rehabilitation care plus the FEMuR intervention, which comprised a patient-held workbook and goal-setting diary to improve self-efficacy, and six additional therapy sessions delivered in-person in the community, or remotely during COVID-19 restrictions (intervention), to increase the practice of exercise and ADL.

Primary and secondary outcome measures
Primary outcome was the Nottingham Extended Activities of Daily Living (NEADL) scale at 12 months. Secondary outcomes included: Hospital Anxiety and Depression Scale, Falls Self-Efficacy-International scale, hip pain intensity, fear of falling, grip strength and Short Physical Performance Battery. Outcomes were collected by research assistants in participants’ homes, whenever possible, but had to be collected remotely during COVID-19 restrictions.

Results
In total, 205 participants were randomised (n=104 experimental; n=101 control). Trial processes were adversely affected by the COVID-19 pandemic. There were 20 deaths, 34 withdrawals and three lost to follow-up. At 52 weeks, there was no significant difference in NEADL score between the FEMuR intervention and control groups. Joint modelling analysis testing for difference in longitudinal outcome adjusted for missing values also found no significant difference with a mean difference of 0.1 (95% CI –1.1, 1.3). There were no significant between-group differences in secondary outcomes. Sensitivity analyses, examining the impact of COVID-19 restrictions, produced similar results. A median of 4.5 extra rehabilitation sessions were delivered to the FEMuR intervention group, with a median of two sessions delivered in-person. Instrumental variable regression did not find any effect of the amount of rehabilitation on the main outcome. There were 53 unrelated serious adverse events (SAEs) including 11 deaths in the control group: 41 SAEs including nine deaths in the FEMuR intervention group.

Conclusions
The FEMuR intervention was not more effective than usual rehabilitation care. The trial was severely impacted by COVID-19. Possible reasons for lack of effect included limited intervention fidelity (fewer sessions than planned and remote delivery), lack of usual levels of support from health professionals and families, and change in recovery beliefs and behaviours during the pandemic.

Trial registration number
ISRCTN28376407.

Introduction
Healthcare systems face the challenge of managing limited resources while addressing the growing demand for care and the need for equitable access. Traditional cost-effectiveness analyses focus on maximising health benefits but often fail to account for how these benefits are distributed across various populations, potentially increasing health inequities. As a result, there is increasing interest in distributional cost-effectiveness analysis (DCEA), which incorporates equity considerations by explicitly assessing how health outcomes and costs are shared among diverse populations. This scoping review explores the practical application of DCEA methodology in evaluating programs and interventions. We seek to learn more about the barriers to DCEA’s application, highlighting its practical challenges, limited use globally and the steps necessary to integrate equity more effectively into implementing and adopting programs and interventions into healthcare policy and resource allocation.

Methods and analysis
To evaluate the use of DCEA in the literature, a scoping review will follow Preferred Reporting Items for Systematic Reviews and Meta-Analyses—Scoping Review Extension guidelines. Systematic searches will be performed across scientific databases (MEDLINE, SCOPUS, BASE, APA Psych and JSTOR), grey literature sources (Google Custom Search Engine), and handsearching to identify eligible articles published from January 2015 to March 2025. No limits will be placed on language. Reviewers will independently chart data from eligible studies using standardised data abstraction. The collected information will be synthesised both quantitatively and narratively.

Ethics and dissemination
Formal ethical approval is not necessary as this study will not collect primary data. The findings will be shared with professional networks, published in conference proceedings and submitted for peer-reviewed publication.

Objective
Biological age assessed by the Klemera and Doubal method (KDM) and phenotypic age (PhenoAge) was considered as a marker for ageing-related outcomes because it reflects different aspects of biological ageing and health, which are associated with increased risk of death. proBNPage based on N-terminal pro-B-type natriuretic peptide (NT-proBNP) is a novel index for biological age estimation. However, the independence of its relationship with clinical outcomes from established risk factors, KDM or PhenoAge remains uncertain. Their identification could provide valuable information to prognosis.

Design, setting and participants
This study analysed data from the general population included in the National Health and Nutrition Examination Survey (NHANES). Participants who took part in the cross-sectional survey from 1999 to 2004 were included, and all-cause as well as cardiovascular mortality was recorded (up to 31 December 2019).

Outcome measures
All-cause and cardiovascular mortality were considered as outcomes. Clinical risk factors were collected, and biological age was estimated by proBNPage, KDM and PhenoAge. Cox proportional hazards models were used to determine the relationship between proBNPage and outcomes with adjustment for risk factors or other biological age indexes. Restricted cubic spline (RCS) analysis based on multivariate Cox regressions was performed to examine whether there was a non-linear relationship between proBNPage and outcomes.

Results
A total of 9 925 participants were included in this study. The association between proBNPage and outcomes remained significant after adjusting for risk factors, including NT-proBNP (for all-cause mortality, HR 1.14; 95% CI 1.10 to 1.17; for cardiovascular mortality, HR 1.20; 95% CI 1.14 to 1.27). Similar results were obtained after adjusting for KDM plus NT-proBNP (for all-cause mortality, HR 1.31; 95% CI 1.22 to 1.41; for cardiovascular mortality, HR 1.21; 95% CI 1.11 to 1.28) or PhenoAge plus NT-proBNP (for all-cause mortality, HR 1.21; 95% CI 1.16 to 1.28; for cardiovascular mortality, HR 1.35; 95% CI 1.24 to 1.47). These findings were confirmed in most subgroups. A non-linear relationship was observed between proBNPage and all-cause and cardiovascular mortality with an inflection point.

Conclusions
A non-linear positive relationship was observed between proBNPage and clinical outcomes. After adjusting for established risk factors and other biological age estimation indices (KDM or PhenoAge), proBNPage was significantly associated with mortality. The results remain similar after further adjustment for NT-proBNP. These results suggest that proBNPage is a useful surrogate for biological age estimation.

Stroke, Ahead of Print. BACKGROUND:Accumulating evidence links air pollution exposure to late-life cognitive deterioration. Whether air pollution alters brain structure remains poorly understood. Thus, we aimed to quantify the association between long-term exposure to particulate matter ≤2.5 µm and ≤10 µm (PM2.5and PM10, respectively) and late-life brain structural changes.METHODS:In the Swedish National Study on Aging and Care in Kungsholmen, Stockholm, 555 participants free from dementia underwent brain magnetic resonance imaging (MRI) scans at baseline and after 6 years (cohorts 8.7 μg/m3had on average an annual shrinkage of total brain tissue volume of 0.22 (95% CI, −0.43 to −0.01) and an annual increase of 0.25 (95% CI, 0.07–0.43) of the white matter hyperintensities as compared with participants exposed to PM2.5

Stroke, Ahead of Print. BACKGROUND:Carotid web is a rare and likely underrecognized cause of ischemic stroke, particularly in young patients. Given the high risk of recurrence, diagnostic delays may have serious consequences. This study aimed to assess the incidence and impact of delayed carotid web diagnosis after a first ischemic event.METHODS:We conducted a retrospective analysis using data from the French ongoing multicenter prospective CAROWEB (Carotid Web registry). We included patients with a first-ever ischemic stroke or transient ischemic attack in the anterior circulation, attributed to an ipsilateral carotid web with no other identifiable cause, between September 2013 and April 2023. Patients with missing data on the date of the first ischemic event or carotid web diagnosis, or with prior stroke history, were excluded. Participants were categorized into early diagnosis (≤30 days) and delayed diagnosis ( >30 days) groups. Factors associated with diagnostic delay were investigated through univariable and multivariable analyses. Stroke recurrence was evaluated using Kaplan-Meier survival analysis.RESULTS:Of 280 patients in the registry, 225 met the inclusion criteria. A delayed diagnosis occurred in 57 patients (25.3%). Independent predictors of diagnostic delay included lower initial National Institutes of Health Stroke Scale score (odds ratio, 0.92;P=0.002), stroke occurring before 2019 (odds ratio, 0.19;P

Oltre 20mila dimessi in 9 mesi nel 2024, “punto di non ritorno”

Purpose
The PREgnancy Care Integrating translational Science, Everywhere Network was established to investigate specific placental disorders (pregnancy hypertension, preterm birth, fetal growth restriction and stillbirth) in sub-Saharan Africa. We created a repository of clinical and social data with associated biological samples from pregnant and non-pregnant women. Alongside this, local infrastructure and expertise in the field of maternal and child health research were enhanced.

Participants
Pregnant women were recruited in participating health facilities in The Gambia, Kenya and Mozambique at their first antenatal visit or at the time a placental disorder was diagnosed (Kenya and The Gambia only). Follow-up study visits were conducted in the third trimester, delivery and 6 weeks to 6 months postpartum. To elucidate the difference between pregnancy and non-pregnancy biology in these settings, non-pregnant nulliparous and parous women, aged 16–49 years, were recruited opportunistically primarily from family planning clinics in Kenya and Mozambique, and randomly through the Health and Demographic Surveillance System in The Gambia. Non-pregnant participants only had one study visit. Biological samples were processed rapidly and locally, stored initially in liquid nitrogen and then at –80°C, and details entered into an OpenSpecimen database linked to their social determinants and clinical research data.

Findings to date
A total of 6932 pregnant and 1825 non-pregnant women were recruited to the study, providing a repository of clinical and social data and a biorepository of 482 448 samples. To date, baseline descriptive analysis of the cohort has been undertaken, as well as a substudy on the prevalence of COVID-19 in the cohort.

Future plans
Analysis of data and samples will include an analysis of biomarker and social and physical determinants of health and how these interact in a systemic approach to understanding the origins of common placental disorders. The data from non-pregnant women will provide control data for comparison with the data from normal and complicated pregnancies. Findings will be disseminated to local stakeholders and communities through meetings and ongoing community engagement and globally by publication and presentations at scientific meetings.

Objectives
Prospective registration of randomised controlled trials (RCTs) is an international standard of good clinical practice but is often neglected by evidence synthesis producers. This study aims to assess prospective registration of RCTs included in evidence syntheses as part of a research integrity assessment and examine its impact on the study pool.

Design
Meta-epidemiological study.

Data sources
COVID-19 Cochrane reviews (CRs) and non-Cochrane systematic reviews (SRs) in MEDLINE via PubMed up to 9 June 2022.

Eligibility criteria
RCTs from CRs and SRs evaluating 13 investigational medicinal products for SARS-CoV-2 and COVID-19.

Data extraction and synthesis
We assessed prospective trial registration in RCTs according to domain 2 of the research integrity assessment tool. Prospective registration is defined as registration before participant enrolment. We extracted the trial registration number, registration date, study start date and inconsistencies in dates between study report and registration. RCTs were categorised as ‘no concern’, ‘awaiting classification’ and ‘exclude’. We also analysed the relationship between study settings, publishing journals and prospective registration.

Results
We included 188 RCTs. In the primary study report, 91% reported a trial registration number. In 84 RCTs, either not or retrospectively registered or with missing or inconsistent dates, we searched and/or contacted study authors for prospective registrations, resolving 17 RCTs. Ultimately, 58% of RCTs were prospectively registered and considered ‘no concern’, 15% were ‘awaiting classification’ due to inconsistent or missing information and 27% were either not registered or retrospectively registered and categorised as ‘exclude’. Prospective registration was higher in larger or international multicentre RCTs and in RCTs conducted in Europe.

Conclusions
If prospective trial registration is required for inclusion in evidence syntheses, only 6 out of 10 COVID-19 RCTs would be eligible. Restricting eligibility to prospectively registered RCTs would include most large and international multicentre RCTs but exclude many smaller and non-European RCTs.

Protocol registration
The protocol is available on OSF (https://osf.io/3bzeg).

Objectives
The use of antiretroviral therapy has been linked to the development of some components of metabolic syndrome (MetS), specifically glucose intolerance, weight gain and defective lipid metabolism. This study determined the relationship between dolutegravir (DTG) and MetS in a cohort of persons living with HIV (PWH) initiating DTG-based regimen in Ghana.

Design
A 2-year observational prospective study was conducted from September 2020 to August 2022.

Setting
Five HIV high-burden facilities providing antiretroviral therapy services at the district and tertiary levels of care in Ghana.

Participants
Persons with HIV who were newly enrolled onto DTG.

Primary and secondary outcome measures
Waist circumference, body mass index, blood pressure, fasting blood glucose and lipids were the primary outcomes measured at baseline, 3, 6, 12 and at 18 months follow-up to determine the incidence of MetS. MetS was defined using the Joint Consensus definition that combines the International Diabetes Federation and the National Cholesterol Education Programme Adult Treatment Panel III (ATP III) definitions. The Kaplan-Meier estimator was used to estimate the risk of developing MetS. The Cox proportional hazard model was used in estimating HRs.

Results
Of 3664 PWH screened at baseline, 31.4% (1152/3664) had MetS. Of the remaining 2512 with no MetS at baseline, there were 960 incident cases of MetS over the 1.5 years follow-up. The estimated MetS incident rate is 384.2 (95% CI: 360.6 to 409.2) per 1000 person-years with a median time to development of MetS at 6 months (IQR; 3–12 months). Being female (adjsuted HR, aHR: 1.42, 95% CI: 1.19 to 1.70), age ≥50 years (aHR: 1.30, 95% CI: 1.12 to 1.51), having a comorbidity at baseline (aHR: 1.39, 95% CI: 1.12 to 1.51) and being overweight (aHR: 1.46, 95% CI: 1.25 to 1.71) and obese (aHR: 1.62, 95% CI: 1.36 to 1.93) were associated with higher risk of MetS development.

Conclusions
The incidence of MetS was high among our patients, with elevated fasting blood sugar and elevated blood pressure being the most common developed MetS defining components. HIV programmes should institute targeted interventions at addressing central obesity to reduce the risk of MetS.