2013
Error and Bias in the Evaluation of Prescription Opioid Misuse: Should the FDA Regulate Clinical Assessment Tools?
Meltzer E, Hall W, Fins J. Error and Bias in the Evaluation of Prescription Opioid Misuse: Should the FDA Regulate Clinical Assessment Tools? Pain Medicine 2013, 14: 982-987. PMID: 23594383, DOI: 10.1111/pme.12099.Peer-Reviewed Original ResearchConceptsFood and Drug AdministrationClinical assessment toolScreening toolAssessment toolOpioid-related aberrant behaviorsAberrant medication-related behaviorsOpioid-related risksChronic opioid therapyPrescription opioid misusePredictive of addictionMedication-related behaviorsOpioid therapyPain medicationStandardized questionnaireOpioid misuseIdentified patientsAt-riskDrug AdministrationDiagnose illnessAddictive disordersPatientsAberrant behaviorScreeningComprehensive planAddiction
2011
Misuse Of The FDA’s Humanitarian Device Exemption In Deep Brain Stimulation For Obsessive-Compulsive Disorder
Fins J, Mayberg H, Nuttin B, Kubu C, Galert T, Sturm V, Stoppenbrink K, Merkel R, Schlaepfer T. Misuse Of The FDA’s Humanitarian Device Exemption In Deep Brain Stimulation For Obsessive-Compulsive Disorder. Health Affairs 2011, 30: 302-311. PMID: 21289352, DOI: 10.1377/hlthaff.2010.0157.Peer-Reviewed Original ResearchConceptsObsessive-compulsive disorderHumanitarian Device ExemptionSevere obsessive-compulsive disorderUS Food and Drug AdministrationFDA humanitarian device exemptionNeuropsychiatric disordersFood and Drug AdministrationDeep brain stimulationClinical trialsBrain stimulationDrug AdministrationDisordersPatientsFederal regulationsPatient safeguardsProcedure—isExemption
2009
Chapter 9 Deep Brain Stimulation Ethical Issues in Clinical Practice and Neurosurgical Research
Fins J. Chapter 9 Deep Brain Stimulation Ethical Issues in Clinical Practice and Neurosurgical Research. 2009, 81-91. DOI: 10.1016/b978-0-12-374248-3.00010-0.Peer-Reviewed Original ResearchFood and Drug AdministrationFood and Drug Administration approvalDeep brain stimulationManagement of chronic painResearch of deep brain stimulationBenefit of neuromodulationTreatment of Parkinson's diseaseBrain stimulationRefractory Parkinson's diseaseChronic painParkinson's diseaseObsessive-compulsive disorderManagement of epilepsyClinical trialsClinical investigationDrug AdministrationEthical issuesPutative treatmentsClinical practiceTraumatic brain injuryClinical applicationMovement disordersEssential tremorTherapeutic deploymentPatients