2024
Integrating 4 methods to evaluate physical function in patients with cancer (In4M): protocol for a prospective cohort study
Thanarajasingam G, Kluetz P, Bhatnagar V, Brown A, Cathcart-Rake E, Diamond M, Faust L, Fiero M, Huntington S, Jeffery M, Jones L, Noble B, Paludo J, Powers B, Ross J, Ritchie J, Ruddy K, Schellhorn S, Tarver M, Dueck A, Gross C. Integrating 4 methods to evaluate physical function in patients with cancer (In4M): protocol for a prospective cohort study. BMJ Open 2024, 14: e074030. PMID: 38199641, PMCID: PMC10806877, DOI: 10.1136/bmjopen-2023-074030.Peer-Reviewed Original ResearchConceptsPhysical function assessmentPhysical functionFunctional assessmentEvaluation of physical functionElectronic health record dataEvaluate physical functionHealth record dataSpanish-speaking patientsDigital health technologiesBreast cancerProspective cohort studyClinician-reported outcomesCancer clinical trialsClinical decision-makingStudy questionnairePatient-centred evaluationHealth technologiesMeasure symptomsOncology practiceCohort studyRecord dataPatient's impressionMayo ClinicEnglish-speakingWearable sensors
2022
Acute pain pathways: protocol for a prospective cohort study
Jeffery MM, Ahadpour M, Allen S, Araojo R, Bellolio F, Chang N, Ciaccio L, Emanuel L, Fillmore J, Gilbert GH, Koussis P, Lee C, Lipkind H, Mallama C, Meyer T, Moncur M, Nuckols T, Pacanowski MA, Page DB, Papadopoulos E, Ritchie JD, Ross JS, Shah ND, Soukup M, St. Clair CO, Tamang S, Torbati S, Wallace DW, Zhao Y, Heckmann R. Acute pain pathways: protocol for a prospective cohort study. BMJ Open 2022, 12: e058782. PMID: 35790333, PMCID: PMC9258513, DOI: 10.1136/bmjopen-2021-058782.Peer-Reviewed Original ResearchConceptsAcute painOpioid analgesicsMulticentre prospective observational studyLittle high-quality evidenceNon-cancer painOpioid analgesic useResolution of painProspective cohort studyProspective observational studyPatient-centered outcomesElectronic health record dataEvidence-based guidelinesHigh-quality evidenceHealth record dataDiverse clinical settingsLong-term useClinician prescribingLeftover opioidsAnalgesic usePain controlCohort studyPain conditionsPain managementPain treatmentCommon diagnosis
2021
US Food and Drug Administration utilization of postmarketing requirements and postmarketing commitments, 2009–2018
Skydel JJ, Zhang AD, Dhruva SS, Ross JS, Wallach JD. US Food and Drug Administration utilization of postmarketing requirements and postmarketing commitments, 2009–2018. Clinical Trials 2021, 18: 488-499. PMID: 33863236, PMCID: PMC8292154, DOI: 10.1177/17407745211005044.Peer-Reviewed Original ResearchConceptsClinical studiesPostmarketing requirementsUS FoodDrug AdministrationNew therapeuticsClinical evidenceNew prospective cohort studyProspective cohort studyCross-sectional studyDrug Administration approvalCohort studyRetrospective studyUnapproved indicationsAdministration approvalClinical indicationsClinical trialsBACKGROUND/Median numberDisease populationTherapeutic safetyTherapeutic indicationsSecondary analysisNovel therapeuticsSmall molecule drugsOriginal approval
2020
Aggregating multiple real-world data sources using a patient-centered health-data-sharing platform
Dhruva SS, Ross JS, Akar JG, Caldwell B, Childers K, Chow W, Ciaccio L, Coplan P, Dong J, Dykhoff HJ, Johnston S, Kellogg T, Long C, Noseworthy PA, Roberts K, Saha A, Yoo A, Shah ND. Aggregating multiple real-world data sources using a patient-centered health-data-sharing platform. Npj Digital Medicine 2020, 3: 60. PMID: 32352038, PMCID: PMC7170944, DOI: 10.1038/s41746-020-0265-z.Peer-Reviewed Original ResearchElectronic health recordsCatheter-based atrial fibrillation ablationPatient-reported outcome measures (PROMs) dataAdditional health systemsPost-procedure recoveryProspective cohort studyTertiary care hospitalU.S. tertiary care hospitalDisease-specific symptomsAtrial fibrillation ablationOutcome measure dataDigital weight scaleBariatric surgeryCohort studyCare hospitalFibrillation ablationPharmacy dataWalgreens pharmaciesReal-world data sourcesActivity monitorHealth systemPatientsHealth recordsEHR dataWeight scale
2018
Postmarket studies required by the US Food and Drug Administration for new drugs and biologics approved between 2009 and 2012: cross sectional analysis
Wallach JD, Egilman AC, Dhruva SS, McCarthy ME, Miller JE, Woloshin S, Schwartz LM, Ross JS. Postmarket studies required by the US Food and Drug Administration for new drugs and biologics approved between 2009 and 2012: cross sectional analysis. The BMJ 2018, 361: k2031. PMID: 29794072, PMCID: PMC5967364, DOI: 10.1136/bmj.k2031.Peer-Reviewed Original ResearchConceptsProspective cohort studyCohort studyClinical trialsPostmarketing requirementsTimeliness of registrationNew drugsUS FoodDrug AdministrationFDA approvalStudy designNumber of patientsSectional analysisPostmarket studiesFirst approvalRegistrySecondary analysisTrialsBiologicsDrugsComparator typeAdministrationApprovalFDAFDA's authority