grant
Creation and Validation of the Dose-Opioid-Source Evaluation tool (DOSE) - a Robust Opioid Use Clinical Outcome Assessment for Qualification as an FDA Medical Device Development Tool (MDDT)
NIHUS FederalResearch GrantFY2026Acute PainAcutely painfulAdherenceAlgorithmsAnalgesia TestsAssessment instrumentAssessment toolClinicClinical TrialsCodeCoding SystemCollectionComprehensionComputer softwareDataData CollectionData SetDevicesDoseEquationEvaluationFamilyFormulationFriendsGoalsGrantGuidelinesHomeHourIRBIRBsInformed ConsentInstitutional Review BoardsIntakeInterventionInterviewInvestigatorsLanguageLegislationLogicMapsMeasuresMedicalMedical DeviceMethodsNociception TestsOn-Line SystemsOnline SystemsOpiatesOpioidOut-patientsOutcomeOutpatientsPainPain AssessmentPain CentersPain ClinicsPain MeasurementPain Relief UnitsPain measurePainfulPaperPatientsPhasePhase 2 Clinical TrialsPhase II Clinical TrialsPhysiatricsPhysiatryPhysical MedicinePhysiciansPublic HealthQualifyingReadabilityRecordsRegulatory approvalRehabilitation MedicineReportingResearchResearch PersonnelResearchersSecureSiteSoftwareSourceStandardizationStatutes and LawsStructureSubstance Use DisorderSurvey InstrumentSurveysTestingTextTherapeuticTimeValidationValidity and ReliabilityWritingassessment appassessment applicationchronic painclinical outcome assessmentclinical practiceclinical validationcognitive assessmentcognitive testingdata standardizationdata standardsdiariesdigital healthhomesimprovedinnovateinnovationinnovativeinteroperabilitylicit opioidmilligrammorphine equivalencemorphine equivalentonline computeropiate consumptionopiate drug useopiate intakeopiate medicationopiate useopioid consumptionopioid drug useopioid intakeopioid medicationopioid sparingopioid usepain assaypain reductionpain reliefphase II protocolpillprescribed opiateprescribed opioidprescription opiateprescription opioidproduct developmentprogramsreduce painreduced substance usereduction in substance useregulatory authorizationregulatory certificationregulatory clearancerelieve painresponsesubstance use and disordersubstance use reductiontooltool developmentusabilityvalidationsweb basedweb pagewebpage
Description preview
Project Summary
This project will develop a Clinical Outcome Assessment (COA) for the FDA’s Medical Device
Development Tool (MDDT) program assessing patient-reported outpatient opioid use, then
calculating the gold standard metric of milligrams of morphine equivalents (MME) using the CDC
MME Conversion dataset. In the qualified context of use of a…
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