2023
Challenges in Estimating the Effectiveness of COVID-19 Vaccination Using Observational Data
Hulme W, Williamson E, Horne E, Green A, McDonald H, Walker A, Curtis H, Morton C, MacKenna B, Croker R, Mehrkar A, Bacon S, Evans D, Inglesby P, Davy S, Bhaskaran K, Schultze A, Rentsch C, Tomlinson L, Douglas I, Evans S, Smeeth L, Palmer T, Goldacre B, Hernán M, Sterne J. Challenges in Estimating the Effectiveness of COVID-19 Vaccination Using Observational Data. Annals Of Internal Medicine 2023, 176: m21-4269. PMID: 37126810, PMCID: PMC10152408, DOI: 10.7326/m21-4269.Peer-Reviewed Original ResearchConceptsCOVID-19 vaccineRandomized trialsObservational studyCOVID-19 vaccinationDuration of protectionBooster vaccinationFirst doseTrial emulationNew virus variantsVaccinated personsEligible personsVaccine rolloutVaccinationTarget trialsVirus variantsTrialsVaccineTime-varying variablesBaselineRobust evidenceSingle trial approachRapid uptakePersonsConfoundersDose
2022
Recording of ’COVID-19 vaccine declined‘: a cohort study on 57.9 million National Health Service patients’ records in situ using OpenSAFELY, England, 8 December 2020 to 25 May 2021
Curtis HJ, Inglesby P, MacKenna B, Croker R, Hulme WJ, Rentsch CT, Bhaskaran K, Mathur R, Morton CE, Bacon SC, Smith RM, Evans D, Mehrkar A, Tomlinson L, Walker AJ, Bates C, Hickman G, Ward T, Morley J, Cockburn J, Davy S, Williamson EJ, Eggo RM, Parry J, Hester F, Harper S, O’Hanlon S, Eavis A, Jarvis R, Avramov D, Griffiths P, Fowles A, Parkes N, Evans SJ, Douglas IJ, Smeeth L, Goldacre B. Recording of ’COVID-19 vaccine declined‘: a cohort study on 57.9 million National Health Service patients’ records in situ using OpenSAFELY, England, 8 December 2020 to 25 May 2021. Eurosurveillance 2022, 27: 2100885. PMID: 35983770, PMCID: PMC9389857, DOI: 10.2807/1560-7917.es.2022.27.33.2100885.Peer-Reviewed Original ResearchConceptsCOVID-19 vaccinationCOVID-19 vaccineCohort studyPriority patientsRetrospective cohort studyPrimary care recordsMore deprived areasUnvaccinated patientsSubsequent vaccinationSouth Asian peopleSouth Asian populationGeneral practicePatientsCare recordsClinical record systemsVaccinationNHS EnglandPatient recordsVaccineDeprived areasAsian populationsOpenSAFELYDemographic subgroupsRecord systemDemographic factorsComparative effectiveness of ChAdOx1 versus BNT162b2 covid-19 vaccines in health and social care workers in England: cohort study using OpenSAFELY
Hulme WJ, Williamson EJ, Green ACA, Bhaskaran K, McDonald HI, Rentsch CT, Schultze A, Tazare J, Curtis HJ, Walker AJ, Tomlinson LA, Palmer T, Horne EMF, MacKenna B, Morton CE, Mehrkar A, Morley J, Fisher L, Bacon SCJ, Evans D, Inglesby P, Hickman G, Davy S, Ward T, Croker R, Eggo RM, Wong AYS, Mathur R, Wing K, Forbes H, Grint DJ, Douglas IJ, Evans SJW, Smeeth L, Bates C, Cockburn J, Parry J, Hester F, Harper S, Sterne JAC, Hernán MA, Goldacre B. Comparative effectiveness of ChAdOx1 versus BNT162b2 covid-19 vaccines in health and social care workers in England: cohort study using OpenSAFELY. The BMJ 2022, 378: e068946. PMID: 35858680, PMCID: PMC9295078, DOI: 10.1136/bmj-2021-068946.Peer-Reviewed Original ResearchConceptsCovid-19 related hospital admissionCOVID-19 vaccineCOVID-19 diseaseRelated hospital admissionsCumulative incidenceHospital admissionSocial care workersCare workersCohort studyHealthcare workersPositive SARS-CoV-2 testBNT162b2 COVID-19 vaccineChAdOx1 COVID-19 vaccineSARS-CoV-2 positive testSARS-CoV-2 infectionSARS-CoV-2 alpha variantSARS-CoV-2 testCOVID-19First vaccine doseComparative effectiveness trialFirst dose vaccinationBNT162b2 mRNAHospital attendanceVaccine doseVaccine typesSafety of COVID-19 vaccination and acute neurological events: A self-controlled case series in England using the OpenSAFELY platform
Walker JL, Schultze A, Tazare J, Tamborska A, Singh B, Donegan K, Stowe J, Morton CE, Hulme WJ, Curtis HJ, Williamson EJ, Mehrkar A, Eggo RM, Rentsch CT, Mathur R, Bacon S, Walker AJ, Davy S, Evans D, Inglesby P, Hickman G, MacKenna B, Tomlinson L, Ca Green A, Fisher L, Cockburn J, Parry J, Hester F, Harper S, Bates C, Evans SJ, Solomon T, Andrews NJ, Douglas IJ, Goldacre B, Smeeth L, McDonald HI. Safety of COVID-19 vaccination and acute neurological events: A self-controlled case series in England using the OpenSAFELY platform. Vaccine 2022, 40: 4479-4487. PMID: 35715350, PMCID: PMC9170533, DOI: 10.1016/j.vaccine.2022.06.010.Peer-Reviewed Original ResearchConceptsGuillain-Barré syndromeAcute neurological eventsBell's palsyCOVID-19 vaccinationTransverse myelitisChAdOx1 vaccineOpenSAFELY platformFirst doseNeurological eventsRate of GBSSelf-controlled case series designIncidence rate ratiosPrimary care dataRare adverse eventsSelf-controlled case seriesConditional Poisson regressionCOVID-19 vaccineCase series designBNT162b2 vaccineesChAdOx1 vaccinationVaccine recipientsAdverse eventsHospital admissionCase seriesAbsolute risk