Background incidence rates of health outcomes of interest for COVID-19 vaccine safety monitoring in a US population: a claims database analysis

Objective
To evaluate background incidence rates of 59 health outcomes of interest (HOI) in a diverse population, including important subpopulations, during the pre-COVID-19 era (1 January 2017–31 December 2019) and the COVID-19 era (1 March 2020–31 December 2020), before the introduction of COVID-19 vaccines.

Design
Observational retrospective cohort study. Annual incidence rates and 95% confidence intervals (CIs) of HOIs were estimated for each population of interest, stratified by: age, sex, age and sex and seasonality.

Data source
Optum’s de-identified Clinformatics Data Mart Database (CDM).

Participants
Individuals from the US general population and four subgroups of interest: influenza-vaccinated, paediatric (

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Luglio 2024

Waitlist Outcomes for Pediatric Heart Transplantation in the Current Era: An Analysis of the Pediatric Heart Transplant Society Database

Circulation, Ahead of Print. BACKGROUND:Waitlist mortality (WM) remains elevated in pediatric heart transplantation. Allocation policy is a potential tool to help improve WM. This study aims to identify patients at highest risk for WM to potentially inform future allocation policy changes.METHODS:The Pediatric Heart Transplant Society database was queried for patients 0.7 m2BSA groups. VAD support was associated with lower WM other than in the single ventricle cohort, where VAD was associated with higher WM. Extracorporeal membrane oxygenation and mechanical ventilation were associated with increased risk of WM in all cohorts.CONCLUSIONS:There is significant variability in WM among status-1A patients. Potential refinements to current allocation system should factor in the increased WM risk we identified in patients supported by extracorporeal membrane oxygenation or mechanical ventilation, single ventricle congenital heart disease on VAD support and small children with congenital heart disease, restrictive cardiomyopathy, or hypertrophic cardiomyopathy.

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Giugno 2024

Self-reported gastrointestinal adverse effects of non-steroidal anti-inflammatory drugs in female students with dysmenorrhoea at Makerere University: prevalence, discontinuation and associated factors. a cross sectional study

Background
Primary dysmenorrhoea occurs in up to 50% of menstruating females. Non-steroidal anti-inflammatory drugs (NSAIDs) are the most commonly used therapeutic remedies for dysmenorrhoea in Uganda. However, NSAIDs are associated with a 3–5 fold increase in the risk of gastrointestinal (GI) adverse drug effects.

Objectives
We aimed to determine the prevalence and associated factors of self-reported NSAID-related GI adverse effects in female students who use NSAIDs in managing dysmenorrhoea-associated pain at Makerere University.

Design
A cross-sectional study.

Setting
Makerere University’s main campus, situated North of Kampala, Uganda.

Participants
314 female students pursuing an undergraduate programme at Makerere University and residing in different halls of residence and hostels.

Outcomes
Social demographic data, menstrual history and treatment data.

Results
Overall, 314 valid responses were received from female students with a median age of 22 years (IQR: 18–29 years). The median age at menarche was 13 years (IQR: 9–18 years). 41% (n=129/314) of the respondents had used medication for dysmenorrhoea and 32% (n=41/129) of whom reported NSAID-associated GI adverse effects with nausea being the most frequently reported (44%, n=18/41)
Factors independently associated with GI adverse effects were: age at menarche (p=0.026), duration of menstruation (p=0.030) and use of ibuprofen (p=0.005). Females taking ibuprofen for dysmenorrhoea were about four times as likely to have NSAID-associated GI adverse effects (adjusted OR 3.87, 95% CI 1.51 to 9.91) than those who did not receive ibuprofen. Logistic regression was used to determine factors associated with self-reported adverse effects of NSAIDs among the female students. A p

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Giugno 2024

Protocol for the Development and Analysis of the Oxford and Reading Cognitive Comorbidity, Frailty and Ageing Research Database-Electronic Patient Records (ORCHARD-EPR)

Background
Hospital electronic patient records (EPRs) offer the opportunity to exploit large-scale routinely acquired data at relatively low cost and without selection. EPRs provide considerably richer data, and in real-time, than retrospective administrative data sets in which clinical complexity is often poorly captured. With population ageing, a wide range of hospital specialties now manage older people with multimorbidity, frailty and associated poor outcomes. We, therefore, set-up the Oxford and Reading Cognitive Comorbidity, Frailty and Ageing Research Database-Electronic Patient Records (ORCHARD-EPR) to facilitate clinically meaningful research in older hospital patients, including algorithm development, and to aid medical decision-making, implementation of guidelines, and inform policy.

Methods and analysis
ORCHARD-EPR uses routinely acquired individual patient data on all patients aged ≥65 years with unplanned admission or Same Day Emergency Care unit attendance at four acute general hospitals serving a population of >800 000 (Oxfordshire, UK) with planned extension to the neighbouring Berkshire regional hospitals ( >1 000 000). Data fields include diagnosis, comorbidities, nursing risk assessments, frailty, observations, illness acuity, laboratory tests and brain scan images. Importantly, ORCHARD-EPR contains the results from mandatory hospital-wide cognitive screening (≥70 years) comprising the 10-point Abbreviated-Mental-Test and dementia and delirium diagnosis (Confusion Assessment Method—CAM). Outcomes include length of stay, delayed transfers of care, discharge destination, readmissions and death. The rich multimodal data are further enhanced by linkage to secondary care electronic mental health records. Selection of appropriate subgroups or linkage to existing cohorts allows disease-specific studies. Over 200 000 patient episodes are included to date with data collection ongoing of which 129 248 are admissions with a length of stay ≥1 day in 64 641 unique patients.

Ethics and dissemination
ORCHARD-EPR is approved by the South Central Oxford C Research Ethics Committee (ref: 23/SC/0258). Results will be widely disseminated through peer-reviewed publications and presentations at conferences, and regional meetings to improve hospital data quality and clinical services.

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Maggio 2024