Search Results for: Scompenso Cardiaco. Gestione in MG dalla diagnosi al follow-up

Introduction
Sleep disturbance is prevalent in pregnancy and can result in significant adverse outcomes for women and their infants. Numerous clinical trials of various nonpharmacotherapies for preventing or treating sleep disturbances have been conducted previously; however, previous systematic reviews with direct comparisons have failed to demonstrate the best options for different kinds of treatments. This systematic review and network meta-analysis (NMA) aims to explore the comparative efficacy and acceptability of nonpharmacological interventions for sleep disturbances in pregnancy and to assist clinical decision-making through ranking interventions concerning critical clinical outcomes.

Methods and analysis
We will follow the Preferred Reporting Items for Systematic Review and Meta-Analyses (PRISMA) statement. Two reviewers will systematically search five major bibliographic databases (PubMed, Embase, Cochrane Library, Web of Science and Cumulative Index to Nursing and Allied Health Literature) and registries for published and unpublished randomised controlled trials (RCTs) of any nonpharmacological interventions for sleep disturbances from inception to 24 June 2025. To ensure the search is up to date, we will also perform an updated search up to the time of final analysis submission. Primary outcomes will consider efficacy (the overall mean change of any predefined sleep disturbances, including sleep quality, sleep duration and sleep-specific symptoms) and acceptability (all-cause discontinuation). The risk of bias of each included RCT will be assessed using the Cochrane Risk of Bias 2.0 Tool (RoB2). Traditional pairwise meta-analyses and NMAs will be performed to compare the efficacy and acceptability of different nonpharmacological interventions. Surface under the cumulative ranking curve for the outcomes of interest will be used to rank the competing interventions. The Grading of Recommendations, Assessment, Development and Evaluation system will be used to assess the quality of evidence associated with the main results.

Ethics and dissemination
This review is a secondary analysis of published data and, therefore, does not require ethical approval. The results will be disseminated in a peer-reviewed journal.

PROSPERO registration number
CRD42024546340.

Objectives
The Idea, Development, Evaluation, Assessment and Long-term follow-up (IDEAL) framework was designed to improve the quality of surgical research and evaluation of surgical innovation. It has become a widely cited tool for evaluating innovative devices and procedures, yet challenges remain concerning the definition and reporting of incremental innovative modifications, hindering evolution and evaluation of innovations and potentially risking patient safety. This systematic review examined IDEAL studies to identify such modifications and establish recent practices around modification reporting to inform the development of future guidance to facilitate safe, transparent and efficient surgical innovation.

Design
Systematic review and thematic synthesis of studies reporting surgical innovation.

Data sources
Web of Science and Scopus were searched in July 2023 using citation tools to identify studies following the IDEAL framework (citing any of 13 key IDEAL/IDEAL framework publications and guideline papers).

Eligibility criteria
Primary research studies of any design that involved invasive innovative devices or procedures.

Data extraction and synthesis
Study characteristics and verbatim text for all reported modifications, including contextual information, were extracted. Data were analysed and synthesised using thematic synthesis.

Results
Of 1071 records screened, 104 studies published between 2011–2023 were included (n=87 (83.6%) study reports; n=17 (16.3%) protocols). 425 modifications were reported in 76 (73.1%) studies, including modifications to procedures (n=283, 66.6%), devices (n=94, 22.1%) and patient selection (n=48, 11.3%). Procedure/device modifications included technical, non-technical and cessation (conversion to other procedures or abandonment). Modifications were most often reported within IDEAL stage 2a (n=30/44, 68.2%), whereas there was considerable variation across other stages, such as stage 0 (n=2/3, 66%) and stage 2b (n=4/12, 33.3%).

Conclusion
Reporting modifications is imperative for evaluating surgical innovation. However, this review found inconsistent approaches to reporting and describing modifications. Findings will inform the development of a checklist for reporting modifications that aims to complement the IDEAL framework and further promote shared learning, avoiding the repetition of harmful/ineffective modifications and enhancing patient safety.

PROSPERO registration number
CRD42023427704.

Background
Most studies on bariatric patients to date have only examined mortality and morbidities in terms of surgery or no surgery. Few have investigated loss to follow-up in post-surgery patients.

Purpose
This study aimed to describe the dynamics behind non-adherence to follow-up in bariatric patients postsurgery.

Design
Using semi-structured interviews, we performed a qualitative study. Using a thematic analysis, we described themes involved in patient adherence to postsurgery follow-up.

Setting
Participants were recruited from a university hospital near Paris and via social networks.

Participants
17 patients who had undergone surgery, some of whom were lost to follow-up, 15 women and 2 men, were interviewed, during a mean time of 90 min. 10 were adherent, and 7 were lost to follow-up.

Results
Follow-up was seen as a support in which the care provider–patient relationship can act on the four following themes: (1) regaining control, (2) knowledge acquisition, (3) management of fears and (4) overall restructuring of one’s life postsurgery.

Conclusions
Patients’ experiences and representations of postsurgery follow-up should be documented in detail in order to define the specific roles of the various care providers offering support to this population, and to strengthen the coordination of care pathways between these actors. In addition, improving the quality of communication could improve adherence to follow-up after bariatric surgery.

Introduction
Aggressive natural killer cell leukaemia (ANKL) is a rare form of NK cell lymphoma with a very low incidence and poor prognosis. While multi-agent chemotherapy including L-asparaginase has been used to treat ANKL patients, they often cannot receive adequate chemotherapy at diagnosis due to liver dysfunction. PPMX-T003, a fully human monoclonal antibody targeting the transferrin receptor 1, shows promise in treating ANKL by helping patients recover from fulminant clinical conditions, potentially enabling a transition to chemotherapy. This study aimed to evaluate the tolerability, safety, efficacy, and pharmacokinetics of repeated continuous intravenous PPMX-T003 in patients with ANKL.

Methods and analysis
This multicentre, open-label, dose-escalation phase I/II study will be conducted at nine hospitals in Japan. Patients diagnosed with ANKL (whether as a primary or recurrent disease) and exhibiting abnormal liver function or hepatomegaly due to the primary disease will be included. The primary endpoint is the tolerability and safety of repeated continuous intravenous administration of PPMX-T003 in the first course, based on adverse events and dose-limiting toxicities. PPMX-T003 will be administered as a continuous intravenous infusion every 24 hours for five consecutive days, followed by a 2-day break. Pretreatment will be provided to minimise the risk of infusion-related reactions. Initial doses of PPMX-T003 will be 0.5, 1.0 or 2.0 mg/kg, with subsequent dose increases determined by the Data and Safety Monitoring Committee. The sample size is set at seven participants, with enrolment increased to up to 12 participants if dose-limiting toxicities occur, based on feasibility due to the rarity of ANKL. Descriptive statistics will summarise data according to initial dose, and pharmacokinetic analysis will be conducted based on administered dose.

Ethics and dissemination
This study was approved by the institutional review boards at participating hospitals. The results will be disseminated in peer-reviewed journals.

Trial registration number
jRCT2061230008 (jRCT); NCT05863234 (ClinicalTrials.gov).

Integra biologia molecolare, scienze omiche e bioinformatica

Per la fase avanzata. Al San Carlo di Potenza

Background
High blood pressure (BP) is a significant global health issue, with many treated patients failing to achieve BP control. The Triple Pill vs Usual Care Management for Patients with Mild-to-Moderate Hypertension (TRIUMPH) trial evaluated the effectiveness, cost-effectiveness and acceptability of early use of low-dose triple fixed-dose combination of BP-lowering drugs (‘triple pill’) compared with usual care in the management of hypertension. The TRIUMPH trial showed superior BP control with the triple pill strategy compared with usual care. This process evaluation of the TRIUMPH trial aimed to explore the contextual factors that influenced the trial outcomes, implementation of the triple pill strategy, mechanisms of its effects and potential barriers and facilitators for implementing the triple pill strategy in routine practice.

Methods
Guided by the UK Medical Research Council’s framework, semistructured interviews were conducted with 23 patients and 13 healthcare providers involved in the TRIUMPH trial. Data were analysed using the framework analysis method in NVivo.

Results
Hypertension care in Sri Lanka was hindered by the absence of systematic screening and overcrowded public clinics. Despite free medication provision at public clinics, long waiting times and occasional stock-outs posed challenges. In the TRIUMPH trial, both intervention and usual care were delivered in the context of ‘better than usual’ care, including team-based management, reduced waiting times, monetary assistance for travel, routine adherence monitoring and intensive follow-up. The triple pill strategy provided a simplified regimen, better access to BP-lowering medications and better BP-lowering efficacy. Key barriers to implementation in routine practice included the triple pill’s large size, therapeutic inertia and restrictive regulatory policies regarding fixed-dose combinations.

Conclusions
Implementation of the triple pill strategy into routine practice requires health system strengthening, provider training and supportive policy measures to replicate its effectiveness seen in the trial.

Trial registration number
ACTRN12612001120864, SLCTR/2015/020.

Objectives
This systematic review investigated available evidence on the stand-alone and incremental predictive performance of ophthalmic artery Doppler (OAD) for pre-eclampsia.

Design
Systematic review.

Data sources
We conducted a literature search from PubMed (Medline), the Cochrane CENTRAL, EMBASE and Scopus from inception to 8 April 2025.

Eligibility criteria
Studies eligible for inclusion were prospective or retrospective cohort studies, case-control studies or randomised controlled trials that reported on the predictive performance of OAD for pre-eclampsia in singleton pregnancies; and conducted in either high-income country (HIC) or low- and middle-income country (LMIC).

Data extraction and synthesis
Two reviewers independently screened and assessed articles for inclusion. One reviewer then extracted data using a standardised data extraction sheet, and any uncertainties were discussed with a second reviewer. The Prediction model Risk of Bias Assessment Tool was used for quality and risk of bias assessment. Findings were summarised and reported according to the Preferred Reporting Items for Systematic Review and Meta-Analyses statement and synthesised qualitatively.

Results
We identified and included 11 observational studies (3 from HIC and 8 from LMICs) with a total of 12 150 singleton pregnancies, of which 517 (4.3%) were complicated by pre-eclampsia at end of follow-up. The included studies were of varied quality, with three at low risk of bias, four at unclear risk and four at high risk. No interventional study was identified. Three studies (27.3%) recruited high-risk pregnancies (defined according to the American College of Obstetricians and Gynecologists (ACOG) criteria as one or more of the following: chronic hypertension, personal or family history of pre-eclampsia, early (≤18 years) or late (≥40 years) first pregnancy, primipaternity, chronic kidney disease, increased body mass index >30 kg/m2, presence of diabetes mellitus prior to pregnancy, autoimmune disease and thrombophilia), while eight studies (72.7%) recruited undetermined risk pregnancies. Stand-alone performance of OAD (interpreted by area under the receiver operating curve at 95% CI) showed that in the first trimester, the peak systolic velocity (PSV) ratio demonstrated very good predictive ability (0.97, 95% CI 0.92 to 1.0) (n=1 study), and the second PSV (PSV2) demonstrated very good predictive ability (0.91, 95% CI 0.82 to 0.99) (n=1 study). Also, PSV2 demonstrated fair predictive ability (0.61, 95% CI 0.42 to 0.79; and 0.53, 95% CI 0.40 to 0.66) for early and late pre-eclampsia, respectively (n=1 study). In the second trimester, the PSV ratio demonstrated very good predictive ability (0.88, 95% CI 0.84 to 0.91) (n=1 study), and PSV2 demonstrated good predictive ability (0.73, 95% CI 0.66 to 0.81; and 0.76, 95% CI 0.71 to 0.81) for pre-eclampsia (n=2 studies). In the third trimester, the PSV ratio demonstrated good predictive ability (0.82, 95% CI 0.73 to 0.89; and 0.77, 95% CI 0.71 to 0.82) for preterm and term pre-eclampsia, respectively (n=1 study). Also, PSV2 demonstrated good predictive ability 0.70 (0.57 to 0.84) (n=1 study).
Subsequently, in the second trimester, PSV ratio demonstrated better incremental predictive performance than uterine artery pulsatility index for preterm pre-eclampsia, when added to maternal factors and mean arterial pressure (MAP) (56.1%–80.2% vs 56.1%–74.8% detection rate (DR) at 10% FPR) (n=1 study). Also in the third trimester, adding PSV ratio to maternal factors and MAP was superior to soluble fms-like tyrosine kinase-1/placental growth factor ratio in predicting pre-eclampsia at

Objectives
Low-level viremia (LLV) is a risk factor affecting the prognosis of patients with chronic hepatitis B (CHB). The objective of this study was to systematically assess the prevalence of LLV, thereby providing robust evidence-based medical insights into effective clinical interventions and preventative measures against LLV.

Design
Systematic review and meta-analysis.

Data sources
A comprehensive literature search was conducted across various databases, including China National Knowledge Infrastructure, Wanfang Data (Wanfang), China Science And Technology Journal Database (VIP-CSTJ), China Biology Medicine disc (CBMdisc), PubMed, Embase, Web of Science and the Cochrane Library, spanning from the inception of these databases up to 5 January 2024.

Eligibility criteria
The research type included either a cross-sectional study or a cohort study focusing on the Chinese population, with the outcome being LLV. The languages were limited to both Chinese and English. Studies with any of the following were excluded: subjects with other comorbidities, original articles inaccessible or data unavailable, and duplicate publications.

Data extraction and synthesis
Literature management used EndNote X9.1, and an information extraction table was created using Microsoft Excel to record research information, including first author, year of publication and study type. The prevalence of LLV was assessed via meta-analysis. Meta-analyses were conducted in RStudio using the ‘metaprop ()’ function. Subgroup analysis and sensitivity analysis were used to identify sources of heterogeneity, and funnel plots and AS-Thompson tests were employed to evaluate publication bias.

Results
18 studies, encompassing a total sample of 9773 patients, were included in the analysis. Of these, 3336 patients were identified with LLV. The meta-analysis revealed that the prevalence of LLV among treated CHB patients stands at 33.6% (95% CI 30.2 to 37.0). The antigen status, antiviral treatment regimen (type of drugs and nucleos(t)ide analogues (NAs)), treatment duration, medication adherence and baseline hepatitis B virus DNA levels all affected the prevalence of LLV. Sensitivity analysis further corroborated the stability of these meta-analysis findings. The funnel plot and AS-Thompson test indicated no significant publication bias (t = –0.01, p=0.995).

Conclusions
The prevalence of LLV among CHB patients was established at 33.7% (95% CI 29.8% to 37.6%). Thus, it is imperative for clinical decision-makers to consider the various influencing factors of LLV when formulating treatment plans in order to mitigate any potential adverse outcomes.

Introduction
Though prior trials have shown the effectiveness of community-based hypertension detection and care delivery models, their adoption and translation to practice has been slow. In this study, we will develop and test strategies for the implementation and scale-up of a proven multicomponent hypertension intervention (MCHI) in Pakistan that comprises health education, blood pressure (BP) monitoring and referrals by lady health workers (LHWs) and hypertension management by physicians in primary care settings.

Methods and analysis
In this 24-month hybrid type III implementation-effectiveness cluster-randomised controlled trial, we will recruit 3000 adult hypertensive patients from two rural districts of Pakistan. We will engage public health sector managers, physicians and LHWs and use the Consolidated Framework for Implementation Research to identify barriers and facilitators to the implementation of an already proven-to-be-effective MCHI. Using Expert Recommendations for Implementing Change and the modified Delphi technique, a set of implementation strategies addressing barriers will be identified. The strategies will be categorised as level 1 (requiring a change in processes), level 2 (requiring a change in infrastructure) and level 3 (financial restructuring). Basic health units and 250–300 households from their catchment will be considered as clusters. Clusters will be randomised in a ratio of 1:1 to intervention and control. While MCHI will be offered in both trial arms (intervention and control), the aforementioned implementation strategies will be randomised to the intervention arm only, starting with level 1 and moving to levels 2 and 3 as needed. Baseline and 6-monthly follow-up surveys, each of 6 months duration, will be conducted to collect data from the recruited participants on sociodemographics, cardiovascular disease (CVD) risk factors, CVD-related expenses and quality of life. The primary outcome will be the mean difference in BP-lowering medications per participant between the intervention and control arms. The primary outcome will be analysed using a linear mixed model with fixed effects for baseline value of the outcome. Additional outcomes include implementation outcomes: proportion of LHWs conducting health education, BP screening and monitoring, facility referrals and proportion of physicians diagnosing and treating hypertensive patients; effectiveness outcomes: proportion of participants with controlled BP and improved EQ-5D-5L score.

Ethics and dissemination
Ethical approval has been obtained from the Ethics Review Committee of Aga Khan University Pakistan (ERC # 2023-9084-26739). Findings will be reported to: (1) study participants; (2) funding body and institutes collaborating and supporting the study; (3) provincial and district health departments to inform policy; (4) presented at local, national and international conferences and (5) disseminated by peer-review publications

Trial registration number
NCT06726057.

Introduction
Stress is omnipresent in our everyday lives and a key risk factor for our physical and mental health. Yet little is known about the impact of geographic life environments, linked to our daily activities and mobility patterns, on our momentary and daily stress levels.
We propose this review to gather evidence on the spatio-temporal determinants of momentary or daily stress in studies using ecological momentary assessment (EMA) or experience sampling methods (ESM) in addition to global positioning systems (GPS) tracking. We will focus on the spatio-temporal definition and modelling of environmental exposures accounting for participant daily activities and mobility patterns and their association with stress.

Methods and analysis
This scoping review will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses framework for scoping reviews (2018). We will search the PubMed/Medline, Web of Science, PsycInfo and Scopus databases. We will include papers using EMA or ESM and GPS measuring chronic, daily or momentary stress as an outcome; these methods are also referred to as geographically-explicit ecological momentary assessment.
Articles published from January 2000–June 2025 will be screened. Two independent reviewers will screen titles and abstracts to agree on the inclusion of articles. No geographical or population limitation will be imposed.

Ethics and dissemination
This study is a scoping review based on previously published and publicly available literature. It does not involve the collection of primary data, human participants, or the processing of personal or sensitive information. Therefore, ethical approval is not required in accordance with institutional and international research ethics guidelines. The results will be submitted in peer-reviewed journals and presented at international conferences.

Nella città di Archimede ‘dalla retorica al metodo scientifico’

Stroke, Ahead of Print. BACKGROUND:The impact of covert cerebrovascular disease on falls in the general population is not well-known. Here, we determine the time to a first fall following incidentally detected covert cerebrovascular disease during a clinical neuroimaging episode.METHODS:This longitudinal cohort study assessed computed tomography (CT) and magnetic resonance imaging from 2009 to 2019 of patients aged >50 years registered with Kaiser Permanente Southern California which is a healthcare organization combining health plan coverage with coordinated medical services, excluding those with before stroke/dementia. We extracted evidence of incidental covert brain infarcts (CBI) and white matter hyperintensities/hypoattenuation (WMH) from imaging reports using natural language processing. We examined associations of CBI and WMH with falls requiring medical attention, using Cox proportional hazards regression models with adjustment for 12 variables including age, sex, ethnicity multimorbidity, polypharmacy, and incontinence.RESULTS:We assessed 241 050 patients, mean age 64.9 (SD, 10.42) years, 61.3% female, detecting covert cerebrovascular disease in 31.1% over a mean follow-up duration of 3.04 years. A recorded fall occurred in 21.2% (51 239/241 050) during follow-up. On CT, single fall incidence rate/1000 person-years (p-y) was highest in individuals with both CBI and WMH on CT (129.3 falls/1000 p-y [95% CI, 123.4–135.5]), followed by WMH (109.9 falls/1000 p-y [108.0–111.9]). On magnetic resonance imaging, the incidence rate was the highest with both CBI and WMH (76.3 falls/1000 p-y [95% CI, 69.7–83.2]), followed by CBI (71.4 falls/1000 p-y [95% CI, 65.9–77.2]). The adjusted hazard ratio for single index fall in individuals with CBI on CT was 1.13 (95% CI, 1.09–1.17); versus magnetic resonance imaging 1.17 (95% CI, 1.08–1.27). On CT, the risk for single index fall incrementally increased for mild (1.37 [95% CI, 1.32–1.43]), moderate (1.57 [95% CI, 1.48–1.67]), or severe WMH (1.57 [95% CI, 1.45–1.70]). On magnetic resonance imaging, index fall risk similarly increased with increasing WMH severity: mild (1.11 [95% CI, 1.07–1.17]), moderate (1.21 [95% CI, 1.13–1.28]), and severe WMH (1.34 [95% CI, 1.22–1.46]).CONCLUSIONS:In a large population with neuroimaging, CBI and WMH are independently associated with greater risks of an index fall. Increasing severities of WMH are associated incrementally with fall risk across imaging modalities.

Introduction
This study investigates the rates of military sexual trauma (MST) and its associations with adverse mental health among a sample of UK female ex-service personnel who served during the Iraq/Afghanistan eras.

Methods and analysis
Female ex-service personnel, who participated in the fourth phase (Phase 4) of the King’s Centre for Military Health Research (KCMHR) Health and Well-being Cohort Study (2022–2023) and consented to be recontacted for follow-up studies (n=295), are being invited to participate in an online questionnaire between July 2024 and February 2025. The questionnaire contains surveys and questions related to experiences of sexual harassment and sexual assault during and outside of military service, disordered eating and broader female health issues. While the questionnaire relates to several female health topics, this study focuses on the surveys related to experiences of sexual trauma and eating disorders. Sociodemographic variables and some health variables, including post-traumatic stress disorder (PTSD), complex PTSD, common mental disorders, alcohol misuse, physical somatisation and social support, will be extracted from participants’ pre-existing data collected in Phase 4 of the KCMHR Cohort Study. Analyses will assess rates of MST, and hierarchical multiple logistic regressions will investigate associated health impacts. Rates and ORs, employing 95% CIs, will be reported.

Ethics and dissemination
This study has been granted full ethical approval by the King’s College London Research Ethics Committee (Ref: HR/DP-23/24–39040). Participants provide informed consent before participating and have access to a signposting booklet containing contact details for a range of support services. A risk protocol is in place, which outlines the procedure to be undertaken if a participant contacts the research team in distress. Findings will form part of a PhD thesis and will be further disseminated through peer-reviewed publication and dissemination with veteran mental health services and charities, and relevant government departments.

Introduction
Dental neglect in children and adolescents is a form of child maltreatment and can be an indicator of other forms of maltreatment. Early identification of dental neglect is essential to initiate preventive interventions and connect families to appropriate health and social services to avoid further harm and to reduce negative impacts on child development and well-being. Articles that systematically synthesise and compare models for early detection, intersectoral cooperation and care for dental neglect have not been published yet. This scoping review aims to map the evidence on strategies for the identification and prevention of dental neglect in children and adolescents.

Methods and analysis
The study is designed as a scoping review. Based on the Population, Concept and Context (PCC) scheme, the databases PubMed, PsycInfo and Scopus are searched for publications before July 2023. Publications in all languages will be considered in case an abstract in English or German is available. The review will include articles reporting on strategies for identification and prevention related to dental neglect in children and adolescents as conducted in health service and community settings. Data from included articles will be extracted to describe and categorise the available evidence. The review will follow recommendations of the Joanna Briggs Institute Reviewer’s Manual on scoping reviews and the Critical Appraisal Tool for Health Promotion and Prevention Reviews (CAT HPPR).

Ethics and dissemination
Ethical approval is not required, as no personal data will be collected in this literature-based study. The study’s findings will be disseminated through conference presentations, scientific publications and stakeholder meetings.

Importance
Background rates are critical for contextualising safety signals arising from COVID-19-related interventions in investigational or real-world settings.

Objective
To estimate background rates of medical events of interest (MEI) for which COVID-19 infection and/or COVID-19 interventions may be risk factors in two US claims databases.

Design, setting and participants
This retrospective cohort study spans the pre-COVID-19 (2018–2019) and COVID-19 (2020–2021) periods. We constructed three cohorts, in each of Inovalon/HealthVerity (Inovalon/HV) and Optum databases: a COVID-19-positive adult cohort (2020–2021), a paediatric cohort (2018–2021) and a high-risk cohort (2018–2021) comprising patients at increased risk for severe COVID-19. Participants were indexed on the day they first qualified to enter each cohort during the study period. Background rates of 17 MEI were estimated per 1000 person-years (PY) with 95% CIs.

Main outcomes and measures
Annual incidence rates (IRs) of 17 MEI.

Results
Overall, 758 414 (COVID-19-positive adults; 57.8% women), 12 513 664 (high-risk adults; 56.8% women) and 8 510 627 (paediatric patients; 49.1% women) patients were identified in the HV database. IRs of MEI varied substantially by year, data source, study cohort and duration of follow-up. The IRs of MEI were highest among COVID-19-positive adults and lowest among paediatric patients. For example, IR of myocarditis/pericarditis per 1000 PY was 3.0 (95% CI: 2.6 to 3.4) in the COVID-19-positive adult cohort vs 0.36 (95% CI: 0.34 to 0.37) among high-risk adults and 0.05 (95% CI: 0.05 to 0.06) among paediatric patients. In the COVID-19-positive adult cohort, we observed higher IRs during 90-day follow-up (eg, IR of acute myocardial infarction (AMI) 26.5 (95% CI: 25.3 to 27.7)) vs 365-day follow-up (eg, IR of AMI 20.0 (95% CI: 9.2 to 20.8)) and during 2020 compared with 2021. IRs were higher in the high-risk adult and paediatric populations during the pre-COVID-19 period than during the COVID-19 pandemic.

Conclusions
Substantial variability was observed in IRs of MEI by study cohort, year, data source and follow-up duration. When generating background rates for contextualising safety signals from COVID-19 interventions, careful consideration must be given to the indicated subpopulation of interest, COVID-19-related temporal variations and data sources.