2024
Qualitative Analysis of Inquiries Received by FDA Regarding Conduct of Clinical Trials during the Covid-19 Public Health Emergency
Kambere M, Vu H, Kappel D, Oh K, Budashewitz P, Concato J. Qualitative Analysis of Inquiries Received by FDA Regarding Conduct of Clinical Trials during the Covid-19 Public Health Emergency. Therapeutic Innovation & Regulatory Science 2024, 58: 987-995. PMID: 38913114, PMCID: PMC11335776, DOI: 10.1007/s43441-024-00674-x.Peer-Reviewed Original ResearchCOVID-19 public health emergencyPublic health emergencyFood and Drug AdministrationTrial participantsHealth emergencyClinical practice guidelinesAnalysis of inquirySafety of trial participantsClinical trialsTrial-related activityPractice guidelinesCOVID-19Industry trade associationsConduction of clinical trialsU.S. Food and Drug AdministrationClinical practiceInterested partiesTrade associationsPartiesMedical productsBackgroundThis reportRelated guidanceParticipantsQualitative methodsDrug Administration
2006
The Effectiveness of Screening for Prostate Cancer: A Nested Case-Control Study
Concato J, Wells CK, Horwitz RI, Penson D, Fincke G, Berlowitz DR, Froehlich G, Blake D, Vickers MA, Gehr GA, Raheb NH, Sullivan G, Peduzzi P. The Effectiveness of Screening for Prostate Cancer: A Nested Case-Control Study. JAMA Internal Medicine 2006, 166: 38-43. PMID: 16401808, DOI: 10.1001/archinte.166.1.38.Peer-Reviewed Original ResearchConceptsDigital rectal examinationCase-control studyCause-specific mortalityCase patientsProstate cancerControl patientsNested Case-Control StudyProstate-specific antigen (PSA) testVeterans Affairs Medical CenterAssociation of screeningBenefits of screeningEffectiveness of screeningVeterans Affairs facilitiesVerbal informed consentEffectiveness of PSADRE screeningCause mortalityPSA testingSurvival benefitRectal examinationAntigen testMedical CenterAmbulatory carePatientsClinical practice
2005
Diagnosis, Evaluation, and Treatment of Childhood Obesity in Pediatric Practice
Dorsey KB, Wells C, Krumholz HM, Concato J. Diagnosis, Evaluation, and Treatment of Childhood Obesity in Pediatric Practice. JAMA Pediatrics 2005, 159: 632-638. PMID: 15996996, DOI: 10.1001/archpedi.159.7.632.Peer-Reviewed Original ResearchConceptsBody mass indexRisk of overweightHospital-based clinicsHealth maintenance visitsRate of diagnosisType of treatmentComorbid diseasesMass indexOverweight childrenChildhood obesityMedical recordsTreatment recommendationsHigh burdenPediatric practiceRoutine screeningOverweightClinical practiceMaintenance visitsDiagnosisEncounter notesFormal diagnosisTreatmentChildrenSingle-parent householdsRisk