2025
Assessing patient withdrawal in cancer clinical trials: A systematic evaluation of reasons and transparency in reporting.
Argulian A, Karol A, Paredes R, Oguntuyo K, Weintraub L, Miller J, Fujiwara Y, Joshi H, Doroshow D, Galsky M. Assessing patient withdrawal in cancer clinical trials: A systematic evaluation of reasons and transparency in reporting. Journal Of Clinical Oncology 2025, 43 DOI: 10.1200/jco.2025.43.16_suppl.e23003.Peer-Reviewed Original ResearchCancer clinical trialsOncology clinical trialsPhase III oncology clinical trialsSupportive care trialsPatient withdrawalClinical trialsLack of standard practicesPrimary cancer typeCare trialsFollow-upPatient-initiatedHigh attrition ratesPatients' intentionStandard careCONSORT diagramControl armDocumented reasonsOncology trialsAttrition ratesMedian Follow-UpTrial integrityWithdrawal reasonsConsent documentsTrial designSelection bias
2024
Observational study protocol for an arrhythmia notification feature
Kumar S, Weinstein J, Melchinger H, Smith A, Capodilupo E, Akar J, Garg K, O’Connor K, Staunton M, Martin M, Akhlaghi N, Edeh O, Perez S, Lee V, Lee K, Wilson F. Observational study protocol for an arrhythmia notification feature. BMJ Open 2024, 14: e075110. PMID: 38830741, PMCID: PMC11149124, DOI: 10.1136/bmjopen-2023-075110.Peer-Reviewed Original ResearchConceptsAtrial fibrillationInstitution of appropriate treatmentGold standardClinical research journalsAssessment of risk factorsObservational study protocolRecruited participantsEthics BoardGeneral populationDiagnosed AFHealthy controlsPrimary outcomeAppropriate treatmentStudy protocolRisk factorsConsent documentsWHOOP strapParticipantsArrhythmiasDetect AFWearable technology
2020
An instrument for assessing the quality of informed consent documents for elective procedures: development and testing
Spatz ES, Suter LG, George E, Perez M, Curry L, Desai V, Bao H, Geary LL, Herrin J, Lin Z, Bernheim SM, Krumholz HM. An instrument for assessing the quality of informed consent documents for elective procedures: development and testing. BMJ Open 2020, 10: e033297. PMID: 32434933, PMCID: PMC7247404, DOI: 10.1136/bmjopen-2019-033297.Peer-Reviewed Original ResearchQuality of informed consent documents among US. hospitals: a cross-sectional study
Spatz ES, Bao H, Herrin J, Desai V, Ramanan S, Lines L, Dendy R, Bernheim SM, Krumholz HM, Lin Z, Suter LG. Quality of informed consent documents among US. hospitals: a cross-sectional study. BMJ Open 2020, 10: e033299. PMID: 32434934, PMCID: PMC7247389, DOI: 10.1136/bmjopen-2019-033299.Peer-Reviewed Original ResearchConceptsInformed consent documentsHOSPITAL scoreUS hospitalsMean hospital scoresRetrospective observational studyConsent documentsCross-sectional studyEight-item instrumentService patientsElective proceduresProcedure typeObservational studySurgical proceduresMedicare feeHospitalHospital qualityMeasure scoresInformed consentMost hospitalsSpearman correlationScoresFace validityIndependent ratersOutcomesStakeholder feedback
2014
Improving the process of informed consent for percutaneous coronary intervention: Patient Outcomes from the Patient Risk Information Services Manager (ePRISM) study
Spertus JA, Bach R, Bethea C, Chhatriwalla A, Curtis JP, Gialde E, Guerrero M, Gosch K, Jones PG, Kugelmass A, Leonard BM, McNulty EJ, Shelton M, Ting HH, Decker C. Improving the process of informed consent for percutaneous coronary intervention: Patient Outcomes from the Patient Risk Information Services Manager (ePRISM) study. American Heart Journal 2014, 169: 234-241.e1. PMID: 25641532, PMCID: PMC4315511, DOI: 10.1016/j.ahj.2014.11.008.Peer-Reviewed Original ResearchMeSH KeywordsAgedCoronary DiseaseDecision MakingFemaleHumansInformation LiteracyInformation ServicesInformed ConsentMaleMiddle AgedOutcome and Process Assessment, Health CarePatient NavigationPatient ParticipationPercutaneous Coronary InterventionQuality ImprovementRisk AssessmentSociometric TechniquesConceptsPercutaneous coronary interventionCoronary interventionInformed consentRoutine clinical careBenefits of treatmentConsent documentsInformed consent formMore frequent reviewsPCI patientsPatient outcomesPatients' perceptionsUS CentersClinical careIndividualized estimatesPatientsConsent formMarked heterogeneityConsentFrequent reviewInterventionOutcomesTreatmentRiskPhysiciansOpting out: confidentiality and availability of an ‘alibi’ for potential living kidney donors in the USA
Thiessen C, Kim YA, Formica R, Bia M, Kulkarni S. Opting out: confidentiality and availability of an ‘alibi’ for potential living kidney donors in the USA. Journal Of Medical Ethics 2014, 41: 506. PMID: 25368413, DOI: 10.1136/medethics-2014-102184.Peer-Reviewed Original Research
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