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GP Consultations for Menstrual Disorders after COVID-19 Vaccination-A Self-Controlled Cohort Study Based on Routine Healthcare Data from the Netherlands

Jajou, R., Lieber, T., Puijenbroek, E.P. van, Mulder, E., Overbeek, J.A., Hek, K., Hunsel, F.P.A.M., Kant, A. GP Consultations for Menstrual Disorders after COVID-19 Vaccination-A Self-Controlled Cohort Study Based on Routine Healthcare Data from the Netherlands. Pharmacoepidemiology and Drugs Safety: 2025. 33(suppl. 2), p. 118. Abstract of the 2024 ISPE Annual Meeting, Berlin, Germany, 24–28 August 2024: 324.

ABSTRACT:

Background
Mortality risk in the acute phase of SARS- CoV-2infection has been well characterised, however longer-termrisks associated with COVID-19 remain poorly understood.Here, the Evaluation of Post-Acute COVID-19 Health Outcomes(ECHOES) dataset is used to investigate post-acute COVID-19mortality in England. ECHOES is a nationwide cohort of individ-uals testing for SARS- CoV-2 designed to investigate post-acuteCOVID-19 health outcomes by linking test records to multiplereal world data sources.Objectives: To estimate risk of post-acute death > 28 days to1 year after SARS- CoV-2 infection, relative to those testingnegative.

Methods
Data was obtained via linkage of COVID-19 testingdata, the national vaccine registry, death registration data andHospital Episode statistics data (HES). Positive and negativeSARS- CoV-2 tests from May 2020 to April 2022 were matched1:1 on week of test, sex, age band, index of multiple deprivationand area of residence. Follow up began at earliest test and wascensored at end of study and death date, with negatives alsocensored if they subsequently tested positive. Individuals couldcontribute to both testing groups. Using this the matched co-hort, rate of death was calculated, and Cox proportional hazardsmodels stratified by matched sets were used to assess risk afteradjustment for ethnicity, acute severity and comorbidity indica-tors. Severity was determined by hospital attendances within−7 to +14 days of test, categorised as A&E attendance, hospitaladmission, or critical care, prioritising most severe category.Attendances for planned procedures, pregnancy, injury, or poi-soning- were dismissed. Comorbidities diagnosed prior to testwere categorised using the Charlson comorbidity index (CCI) asmild, moderate, or severe.

Results
The matched cohort comprised 8,419,574 positives and8,419,574 negatives. Post-acute rate of death was 9.76 per 1000 inpositives and 5.92 in negatives, with an absolute rate difference(ARD) of 3.83. The unadjusted Cox model produced a HazardRatio (HR) of 1.77 (95% CI:1.75–1.80). After adjustment, the HRattenuated to 1.68 (95% CI: 1.65–1.71). The highest HRs werein females (HR:1.81, 95% CI:1.77–1.86; ARD 4.03), and those aged over 80 (HR: 2.07, 95% CI:2.02–2.12; ARD:118.89) with nodifference seen in those under 50 (HR:0.98, 95% CI:0.90–1.07;ARD:0.10).

Conclusions
In this large, national cohort, we see a 70% in-crease in risk of post-acute death up to one year after testingpositive for SARS- CoV-2, accounting for comorbidities anddemographic and disease characteristics. This association isstronger in women and older people, with no increased risk inthose aged under 50. These findings emphasise the importanceof continued research into long-term morbidity and mortality ofCOVID-19.