Validation of myocarditis diagnoses in the Swedish patient register for analyses of potential adverse reactions to COVID-19 vaccines
Background: Coronavirus disease 2019 (COVID-19) mRNA vaccines are associated with an increased risk of myocarditis using hospital discharge diagnoses as an outcome. The validity of these register-based diagnoses is uncertain. Methods: Patient records for subjects < 40 years of age and a diagnosis...
| Main Authors: | , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Upsala Medical Society
2023-05-01
|
| Series: | Upsala Journal of Medical Sciences |
| Subjects: | |
| Online Access: | https://ujms.net/index.php/ujms/article/view/9290/15593 |
| _version_ | 1797696998453805056 |
|---|---|
| author | Rolf Gedeborg Lennart Holm Nils Feltelius Anders Sundström Kai M Eggers Marja-Leena Nurminen Maria Grünewald Nicklas Pihlström Björn Zethelius Rickard Ljung |
| author_facet | Rolf Gedeborg Lennart Holm Nils Feltelius Anders Sundström Kai M Eggers Marja-Leena Nurminen Maria Grünewald Nicklas Pihlström Björn Zethelius Rickard Ljung |
| author_sort | Rolf Gedeborg |
| collection | DOAJ |
| description | Background: Coronavirus disease 2019 (COVID-19) mRNA vaccines are associated with an increased risk of myocarditis using hospital discharge diagnoses as an outcome. The validity of these register-based diagnoses is uncertain. Methods: Patient records for subjects < 40 years of age and a diagnosis of myocarditis in the Swedish National Patient Register were manually reviewed. Brighton Collaboration diagnosis criteria for myocarditis were applied based on patient history, clinical examination, laboratory data, electrocardiograms, echocardiography, magnetic resonance imaging and myocardial biopsy. Poisson regression was used to estimate incidence rate ratios, comparing the register-based outcome variable to validated outcomes. Interrater reliability was assessed by a blinded re-evaluation. Results: Overall, 95.6% (327/342) of cases registered as myocarditis were confirmed (definite, probable or possible myocarditis according to Brighton Collaboration diagnosis criteria, positive predictive value 0.96 [95% CI 0.93–0.98]). Of the 4.4% (15/342) cases reclassified as no myocarditis or as insufficient information, two cases had been exposed to the COVID-19 vaccine no more than 28 days before the myocarditis diagnosis, two cases were exposed >28 days before admission and 11 cases were unexposed to the vaccine. The reclassification had only minor impact on incidence rate ratios for myocarditis following COVID-19 vaccination. In total, 51 cases were sampled for a blinded re-evaluation. Of the 30 randomly sampled cases initially classified as either definite or probably myocarditis, none were re-classified after re-evaluation. Of the in all 15 cases initially classified as no myocarditis or insufficient information, 7 were after re-evaluation re-classified as probable or possible myocarditis. This re-classification was mostly due to substantial variability in electrocardiogram interpretation. Conclusion: This validation of register-based diagnoses of myocarditis by manual patient record review confirmed the register diagnosis in 96% of cases and had high interrater reliability. Reclassification had only a minor impact on the incidence rate ratios for myocarditis following COVID-19 vaccination. |
| first_indexed | 2024-03-12T03:34:03Z |
| format | Article |
| id | doaj.art-ba7b5861d16543c399d65a6f7a7f87a8 |
| institution | Directory Open Access Journal |
| issn | 0300-9734 2000-1967 |
| language | English |
| last_indexed | 2024-03-12T03:34:03Z |
| publishDate | 2023-05-01 |
| publisher | Upsala Medical Society |
| record_format | Article |
| series | Upsala Journal of Medical Sciences |
| spelling | doaj.art-ba7b5861d16543c399d65a6f7a7f87a82023-09-03T13:21:36ZengUpsala Medical SocietyUpsala Journal of Medical Sciences0300-97342000-19672023-05-011281610.48101/ujms.v128.92909290Validation of myocarditis diagnoses in the Swedish patient register for analyses of potential adverse reactions to COVID-19 vaccinesRolf Gedeborg0Lennart Holm1Nils Feltelius2Anders Sundström3Kai M Eggers4Marja-Leena Nurminen5Maria Grünewald6Nicklas Pihlström7Björn Zethelius8Rickard Ljung9Department of Efficacy and Safety 1, Division of Licensing, Medical Products Agency, Uppsala, SwedenOffice of Use and Information, Division of Use and Information, Medical Products Agency, Uppsala, SwedenOffice of Use and Information, Division of Use and Information, Medical Products Agency, Uppsala, SwedenDepartment of Drug Safety, Division of Use and Information, Medical Products Agency, Uppsala, SwedenDepartment of Medical Sciences, Uppsala University, Uppsala, SwedenDepartment of Drug Safety, Division of Use and Information, Medical Products Agency, Uppsala, SwedenStatistics group, Department of Efficacy and Safety 2, Division of Licensing, Medical Products Agency, Uppsala, SwedenStatistics group, Department of Efficacy and Safety 2, Division of Licensing, Medical Products Agency, Uppsala, SwedenOffice of Use and Information, Division of Use and Information, Medical Products Agency, Uppsala, SwedenOffice of Use and Information, Division of Use and Information, Medical Products Agency, Uppsala, SwedenBackground: Coronavirus disease 2019 (COVID-19) mRNA vaccines are associated with an increased risk of myocarditis using hospital discharge diagnoses as an outcome. The validity of these register-based diagnoses is uncertain. Methods: Patient records for subjects < 40 years of age and a diagnosis of myocarditis in the Swedish National Patient Register were manually reviewed. Brighton Collaboration diagnosis criteria for myocarditis were applied based on patient history, clinical examination, laboratory data, electrocardiograms, echocardiography, magnetic resonance imaging and myocardial biopsy. Poisson regression was used to estimate incidence rate ratios, comparing the register-based outcome variable to validated outcomes. Interrater reliability was assessed by a blinded re-evaluation. Results: Overall, 95.6% (327/342) of cases registered as myocarditis were confirmed (definite, probable or possible myocarditis according to Brighton Collaboration diagnosis criteria, positive predictive value 0.96 [95% CI 0.93–0.98]). Of the 4.4% (15/342) cases reclassified as no myocarditis or as insufficient information, two cases had been exposed to the COVID-19 vaccine no more than 28 days before the myocarditis diagnosis, two cases were exposed >28 days before admission and 11 cases were unexposed to the vaccine. The reclassification had only minor impact on incidence rate ratios for myocarditis following COVID-19 vaccination. In total, 51 cases were sampled for a blinded re-evaluation. Of the 30 randomly sampled cases initially classified as either definite or probably myocarditis, none were re-classified after re-evaluation. Of the in all 15 cases initially classified as no myocarditis or insufficient information, 7 were after re-evaluation re-classified as probable or possible myocarditis. This re-classification was mostly due to substantial variability in electrocardiogram interpretation. Conclusion: This validation of register-based diagnoses of myocarditis by manual patient record review confirmed the register diagnosis in 96% of cases and had high interrater reliability. Reclassification had only a minor impact on the incidence rate ratios for myocarditis following COVID-19 vaccination.https://ujms.net/index.php/ujms/article/view/9290/15593covid-19 vaccinesmyocarditisdiagnosisvalidation study |
| spellingShingle | Rolf Gedeborg Lennart Holm Nils Feltelius Anders Sundström Kai M Eggers Marja-Leena Nurminen Maria Grünewald Nicklas Pihlström Björn Zethelius Rickard Ljung Validation of myocarditis diagnoses in the Swedish patient register for analyses of potential adverse reactions to COVID-19 vaccines Upsala Journal of Medical Sciences covid-19 vaccines myocarditis diagnosis validation study |
| title | Validation of myocarditis diagnoses in the Swedish patient register for analyses of potential adverse reactions to COVID-19 vaccines |
| title_full | Validation of myocarditis diagnoses in the Swedish patient register for analyses of potential adverse reactions to COVID-19 vaccines |
| title_fullStr | Validation of myocarditis diagnoses in the Swedish patient register for analyses of potential adverse reactions to COVID-19 vaccines |
| title_full_unstemmed | Validation of myocarditis diagnoses in the Swedish patient register for analyses of potential adverse reactions to COVID-19 vaccines |
| title_short | Validation of myocarditis diagnoses in the Swedish patient register for analyses of potential adverse reactions to COVID-19 vaccines |
| title_sort | validation of myocarditis diagnoses in the swedish patient register for analyses of potential adverse reactions to covid 19 vaccines |
| topic | covid-19 vaccines myocarditis diagnosis validation study |
| url | https://ujms.net/index.php/ujms/article/view/9290/15593 |
| work_keys_str_mv | AT rolfgedeborg validationofmyocarditisdiagnosesintheswedishpatientregisterforanalysesofpotentialadversereactionstocovid19vaccines AT lennartholm validationofmyocarditisdiagnosesintheswedishpatientregisterforanalysesofpotentialadversereactionstocovid19vaccines AT nilsfeltelius validationofmyocarditisdiagnosesintheswedishpatientregisterforanalysesofpotentialadversereactionstocovid19vaccines AT anderssundstrom validationofmyocarditisdiagnosesintheswedishpatientregisterforanalysesofpotentialadversereactionstocovid19vaccines AT kaimeggers validationofmyocarditisdiagnosesintheswedishpatientregisterforanalysesofpotentialadversereactionstocovid19vaccines AT marjaleenanurminen validationofmyocarditisdiagnosesintheswedishpatientregisterforanalysesofpotentialadversereactionstocovid19vaccines AT mariagrunewald validationofmyocarditisdiagnosesintheswedishpatientregisterforanalysesofpotentialadversereactionstocovid19vaccines AT nicklaspihlstrom validationofmyocarditisdiagnosesintheswedishpatientregisterforanalysesofpotentialadversereactionstocovid19vaccines AT bjornzethelius validationofmyocarditisdiagnosesintheswedishpatientregisterforanalysesofpotentialadversereactionstocovid19vaccines AT rickardljung validationofmyocarditisdiagnosesintheswedishpatientregisterforanalysesofpotentialadversereactionstocovid19vaccines |