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 ResearchMeSH KeywordsCohort StudiesCOVID-19COVID-19 VaccinesEnglandHumansRetrospective StudiesState MedicineVaccinationConceptsCOVID-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 factorsAssociation between household composition and severe COVID-19 outcomes in older people by ethnicity: an observational cohort study using the OpenSAFELY platform
Wing K, Grint DJ, Mathur R, Gibbs HP, Hickman G, Nightingale E, Schultze A, Forbes H, Nafilyan V, Bhaskaran K, Williamson E, House T, Pellis L, Herrett E, Gautam N, Curtis HJ, Rentsch CT, Wong AYS, MacKenna B, Mehrkar A, Bacon S, Douglas IJ, Evans SJW, Tomlinson L, Goldacre B, Eggo RM. Association between household composition and severe COVID-19 outcomes in older people by ethnicity: an observational cohort study using the OpenSAFELY platform. International Journal Of Epidemiology 2022, 51: 1745-1760. PMID: 35962974, PMCID: PMC9384728, DOI: 10.1093/ije/dyac158.Peer-Reviewed Original ResearchComparative 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 ResearchMeSH KeywordsBNT162 VaccineCohort StudiesCOVID-19COVID-19 VaccinesHealth PersonnelHumansSARS-CoV-2Social SupportViral VaccinesConceptsCovid-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 typesDescribing the population experiencing COVID-19 vaccine breakthrough following second vaccination in England: a cohort study from OpenSAFELY
Green A, Curtis H, Hulme W, Williamson E, McDonald H, Bhaskaran K, Rentsch C, Schultze A, MacKenna B, Mahalingasivam V, Tomlinson L, Walker A, Fisher L, Massey J, Andrews C, Hopcroft L, Morton C, Croker R, Morley J, Mehrkar A, Bacon S, Evans D, Inglesby P, Hickman G, Ward T, Davy S, Mathur R, Tazare J, Eggo R, Wing K, Wong A, Forbes H, Bates C, Cockburn J, Parry J, Hester F, Harper S, Douglas I, Evans S, Smeeth L, Goldacre B. Describing the population experiencing COVID-19 vaccine breakthrough following second vaccination in England: a cohort study from OpenSAFELY. BMC Medicine 2022, 20: 243. PMID: 35791013, PMCID: PMC9255436, DOI: 10.1186/s12916-022-02422-0.Peer-Reviewed Original ResearchMeSH KeywordsChickenpox VaccineCohort StudiesCOVID-19COVID-19 VaccinesEnglandHumansRetrospective StudiesSARS-CoV-2VaccinationConceptsPositive SARS-CoV-2 testSARS-CoV-2 testBreakthrough COVID-19Vaccine breakthroughBreakthrough casesCohort studyIncidence rateCOVID-19COVID-19-related hospital admissionsCOVID-19-related deathsVaccine breakthrough casesRetrospective cohort studyChronic kidney diseaseCritical care admissionSARS-CoV-2 variantsDeath registry dataCorresponding incidence ratesRoutine clinical dataHigh rateMedian followVaccine waningCare admissionHospital admissionSecond vaccinationSecondary careSafety 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
2021
Trends and clinical characteristics of 57.9 million COVID-19 vaccine recipients: a federated analysis of patients’ primary care records in situ using OpenSAFELY
Curtis HJ, Inglesby P, Morton CE, MacKenna B, Green A, Hulme W, Walker AJ, Morley J, Mehrkar A, Bacon S, Hickman G, Bates C, Croker R, Evans D, Ward T, Cockburn J, Davy S, Bhaskaran K, Schultze A, Rentsch CT, Williamson EJ, Rowan A, Fisher L, McDonald HI, Tomlinson L, Mathur R, Drysdale H, Eggo RM, Wing K, Wong AY, Forbes H, Parry J, Hester F, Harper S, O’Hanlon S, Eavis A, Jarvis R, Avramov D, Griffiths P, Fowles A, Parkes N, Douglas IJ, Evans SJ, Smeeth L, Goldacre B, . Trends and clinical characteristics of 57.9 million COVID-19 vaccine recipients: a federated analysis of patients’ primary care records in situ using OpenSAFELY. British Journal Of General Practice 2021, 72: bjgp.2021.0376. PMID: 34750106, PMCID: PMC8589463, DOI: 10.3399/bjgp.2021.0376.Peer-Reviewed Original ResearchConceptsVaccine recipientsVaccine coverageCOVID-19 vaccine recipientsFirst COVID-19 vaccinationNHS EnglandPre-existing medical conditionsPrimary care recordsLow vaccination coverageCOVID-19 vaccinationSevere mental illnessCare home residentsClinical characteristicsCohort studySecond doseVaccination coverageHome residentsMedical conditionsGeneral practiceMass vaccinationNHS dataCare recordsPatientsJoint CommitteeVaccine rolloutMental illness