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 ResearchMeSH KeywordsAmbulatory Care FacilitiesBreast NeoplasmsFabaceaeFemaleHumansLymphomaMedical OncologyProspective StudiesUnited StatesConceptsPhysical 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
Emulating the GRADE trial using real world data: retrospective comparative effectiveness study
Deng Y, Polley EC, Wallach JD, Dhruva SS, Herrin J, Quinto K, Gandotra C, Crown W, Noseworthy P, Yao X, Lyon TD, Shah ND, Ross JS, McCoy RG. Emulating the GRADE trial using real world data: retrospective comparative effectiveness study. The BMJ 2022, 379: e070717. PMID: 36191949, PMCID: PMC9527635, DOI: 10.1136/bmj-2022-070717.Peer-Reviewed Original ResearchConceptsSecondary outcomesMetformin monotherapyTreatment groupsRetrospective comparative effectiveness studyCox proportional hazards regressionPropensity scoreIncident microvascular complicationsNationwide claims databaseProportional hazards regressionType 2 diabetesComparative effectiveness studiesMacrovascular complicationsMicrovascular complicationsProspective trialAdverse eventsGlycemic controlHospital admissionInsulin glarginePrimary outcomeMedian timeHazards regressionClaims databaseObservational studyInverse propensity scoreEligibility criteriaPreScription DigitaL ThErapEutic for Patients with Insomnia (SLEEP-I): a protocol for a pragmatic randomised controlled trial
Dreyer RP, Berkowitz A, Yaggi HK, Schneeberg L, Shah ND, Emanuel L, Kolla B, Jeffery MM, Deeg M, Ervin K, Thorndike F, Ross JS. PreScription DigitaL ThErapEutic for Patients with Insomnia (SLEEP-I): a protocol for a pragmatic randomised controlled trial. BMJ Open 2022, 12: e062041. PMID: 35940841, PMCID: PMC9364397, DOI: 10.1136/bmjopen-2022-062041.Peer-Reviewed Original ResearchConceptsPrescription digital therapeuticPatient-reported outcomesHealthcare utilisationClinical outcomesDigital therapeuticsIndividual patient-reported outcomesReal-world patient experienceInsomnia Severity Index scoreSeverity Index scoreHealth utility scoresInstitutional review boardCognitive behavioral therapyPeer-reviewed journalsSecondary outcomesPrimary outcomeTrial protocolDaytime sleepinessChronic insomniaMayo ClinicHealth centersDepressive symptomsPatient experienceSleep outcomesIndex scoreSleep diaryAcute 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
Heart Watch Study: protocol for a pragmatic randomised controlled trial
Dhruva SS, Shah ND, Vemulapalli S, Deshmukh A, Beatty AL, Gamble GM, Freeman JV, Hummel JP, Piccini JP, Akar JG, Ervin K, Arges KL, Emanuel L, Noseworthy PA, Hu T, Bartlett V, Ross JS. Heart Watch Study: protocol for a pragmatic randomised controlled trial. BMJ Open 2021, 11: e054550. PMID: 35234659, PMCID: PMC8719216, DOI: 10.1136/bmjopen-2021-054550.Peer-Reviewed Original ResearchConceptsHealthcare utilisationSecondary outcomesAtrial fibrillationAtrial flutterDuke University Health SystemRoutine clinical care settingsAtrial Fibrillation EffectLife global scoresTime of cardioversionAdditional secondary outcomesPopulation of patientsPatient-reported outcomesClinical care settingsUniversity Health SystemQuality of lifeInstitutional review boardMulticentre pragmaticPeer-reviewed journalsPrimary outcomePatients' qualityTrial protocolClinical trialsMayo ClinicECG featuresCare settingsUS 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
2016
Compliance with prospective trial registration guidance remained low in high-impact journals and has implications for primary end point reporting
Dal-Ré R, Ross JS, Marušić A. Compliance with prospective trial registration guidance remained low in high-impact journals and has implications for primary end point reporting. Journal Of Clinical Epidemiology 2016, 75: 100-107. PMID: 26820559, DOI: 10.1016/j.jclinepi.2016.01.017.Commentaries, Editorials and LettersConceptsPrimary end pointInterim analysisTRIAL REGISTRATIONEnd pointHigh-impact general medicine journalsICMJE policyMain outcome measuresPublic trials registryPredictors of complianceProspective trial registrationTrials of FDACross-sectional analysisPercent of trialsTrials RegistryGeneral medicine journalsProspective registrationOutcome measuresClinical researchStudy designTrial resultsHigh-impact journalsRetrospective registrationTrialsAscertainmentMedicine journals
2014
High Incarceration Rates Among Black Men Enrolled In Clinical Studies May Compromise Ability To Identify Disparities
Wang EA, Aminawung JA, Wildeman C, Ross JS, Krumholz HM. High Incarceration Rates Among Black Men Enrolled In Clinical Studies May Compromise Ability To Identify Disparities. Health Affairs 2014, 33: 848-855. PMID: 24799583, PMCID: PMC4065793, DOI: 10.1377/hlthaff.2013.1325.Peer-Reviewed Original ResearchConceptsClinical studiesHealth outcomesBlack menProspective clinical studyObservational clinical researchBlood InstituteNational HeartClinical researchWhite womenRacial disparitiesWhite menMinimal riskMenBlack womenHigh rateJail inmatesMinority populationsWomenOutcomesEffects of incarcerationImpact of incarcerationHigh incarceration ratesIncarcerationLungFollow
2013
Evaluation of the Mobile Acute Care of the Elderly (MACE) Service
Hung WW, Ross JS, Farber J, Siu AL. Evaluation of the Mobile Acute Care of the Elderly (MACE) Service. JAMA Internal Medicine 2013, 173: 990-996. PMID: 23608775, PMCID: PMC3691362, DOI: 10.1001/jamainternmed.2013.478.Peer-Reviewed Original ResearchMeSH KeywordsAcute DiseaseAged, 80 and overCohort StudiesFemaleHealth Services for the AgedHospitalizationHumansMaleProspective StudiesQuality of Health CareConceptsUsual care groupShorter hospital stayAdverse eventsMACE groupUsual careHospital stayAcute careFunctional statusOlder adultsPatient outcomesCatheter-associated urinary tract infectionsTertiary acute care hospitalCare Transitions MeasureHospitalized older adultsUrinary tract infectionPairs of patientsAcute medical problemsGeneral medical servicesLength of stayAcute care hospitalsMount Sinai HospitalLower ratesElderly servicesAcute illnessCohort studyUse of Hospital-Based Acute Care Among Patients Recently Discharged From the Hospital
Vashi AA, Fox JP, Carr BG, D’Onofrio G, Pines JM, Ross JS, Gross CP. Use of Hospital-Based Acute Care Among Patients Recently Discharged From the Hospital. JAMA 2013, 309: 364-371. PMID: 23340638, PMCID: PMC3598620, DOI: 10.1001/jama.2012.216219.Peer-Reviewed Original ResearchConceptsAcute care hospitalsHospital-based acute careAcute care encountersED visitsHospital readmissionAcute careCare hospitalRelease visitsIndex hospitalizationReasons patientsCare encountersED treatUncomplicated benign prostatic hypertrophyUtilization Project State InpatientAcute care visitsDays of dischargeEmergency department visitsCommon reason patientsHospital readmission ratesAcute care servicesBenign prostatic hypertrophyUse of hospitalHealth care focusEffectiveness of transitionCare visits
2012
Financial Stress and Outcomes after Acute Myocardial Infarction
Shah SJ, Krumholz HM, Reid KJ, Rathore SS, Mandawat A, Spertus JA, Ross JS. Financial Stress and Outcomes after Acute Myocardial Infarction. PLOS ONE 2012, 7: e47420. PMID: 23112814, PMCID: PMC3480393, DOI: 10.1371/journal.pone.0047420.Peer-Reviewed Original ResearchConceptsAcute myocardial infarctionSeattle Angina QuestionnaireLong-term outcomesMyocardial infarctionAMI patientsWorse long-term outcomesMulticenter US studyPost-AMI outcomesYear post-AMIDisease-specific QoLImportant risk factorHealth status outcomesWorse physical healthHealth care outcomesAngina QuestionnaireProspective registryInitial hospitalizationSecondary outcomesPrimary outcomeReadmission ratesPost-AMIRisk factorsCare characteristicsCare outcomesStatus outcomes
2010
Health Care Insurance, Financial Concerns in Accessing Care, and Delays to Hospital Presentation in Acute Myocardial Infarction
Smolderen KG, Spertus JA, Nallamothu BK, Krumholz HM, Tang F, Ross JS, Ting HH, Alexander KP, Rathore SS, Chan PS. Health Care Insurance, Financial Concerns in Accessing Care, and Delays to Hospital Presentation in Acute Myocardial Infarction. JAMA 2010, 303: 1392-1400. PMID: 20388895, PMCID: PMC3020978, DOI: 10.1001/jama.2010.409.Peer-Reviewed Original Research