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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) - 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 CLINICAL TRIAL WITH INFORMED CONSENT TO REPORT ALL OPIOID USE, THE TOOL WILL BE A ROBUST SURVEY MODULE CAPABLE OF CAPTURING AND STANDARDIZING USE OF PRESCRIBED, PURCHASED OR BORROWED OPIOIDS. SUCH A RESEARCH TOOL WILL SUPPORT INVESTIGATORS AND MEDICAL PRODUCT DEVELOPERS SEEKING REGULATORY APPROVAL FOR OPIOID-SPARING AND SUBSTANCE USE DISORDER (SUD) INTERVENTIONS. DEVICES, DIGITAL HEALTH SOLUTIONS AND OVER THE COUNTER PHYSICAL INTERVENTIONS REDUCE PAIN,[1-3] BUT PHYSICIANS AND PAYOR PROGRAMS NEED CODES TO IMPLEMENT PROVEN SOLUTIONS, AND REGULATORY AGENCIES INCREASINGLY PRIORITIZE PROOF OF OPIOID REDUCTION IN ADDITION TO PAIN RELIEF. TO FACILITATE MEDICAL PRODUCT DEVELOPMENT AND EVALUATION, THERE IS A PUBLIC HEALTH NEED FOR A ROBUST OPIOID USE MEASURE QUALIFIED BY THE FDA TO ENCOURAGE MEDICAL DEVICE INNOVATION AND ALLOW FOR INTRA-TRIAL STANDARDIZATION. CURRENT METHODS OF GATHERING OPIOID USE INFORMATION INCLUDE PAPER SURVEYS, WEB-BASED SURVEYS, AND APPS. THESE NON-VALIDATED COLLECTION METHODS ARE OFTEN PRE-LOADED WITH A SPECIFIC SET OF OPIOIDS LIMITED TO THOSE COMMONLY PRESCRIBED BY THE PRACTICE WHERE THE CLINICAL TRIAL IS TAKING PLACE AND ARE OFTEN UNIQUE TO THE TRIAL. WHILE THESE TOOLS AND METHODS FAIL TO CAPTURE OF OPIOIDS FROM OTHER SOURCES, NOR ARE THEY ROBUST ENOUGH TO BE A STANDARD DATA COLLECTION TOOL FOR THIS CONTEXT OF USE. OVER 90% OF OPIOID PRESCRIBED IN PREVIOUS YEARS ARE UNUSED;[4] ONLY 22% SAY THEY GOT THEIR OPIOIDS FROM A PRESCRIBER RATHER THAN FRIENDS AND FAMILY.[5] PHASE 1 WILL CONFIRM WITH THE FDA TO CONFIRM THAT THE PHASE 2 PROJECT MEETS THE MDDT GUIDELINES, ESTABLISH CDC COMPLIANCE, CONDUCT EXPERT CONTENT MAPPING, AND OBTAIN IRB APPROVAL FOR PHASE 2 CLINICAL TRIALS. DURING PHASE 2, AFTER STRUCTURED USABILITY INTERVIEWS OF ANY EDITS OF THE EXISTING SURVEY, PROGRAMMED LOGIC WILL OPTIMIZE INTEROPERABILITY WITH EXISTING CLINICAL TRIAL DATA COLLECTION SOFTWARE. THE SURVEY WILL BE VALIDATED IN THE CONTEXT OF USE OF A PAIN-RELIEVING MEDICAL DEVICE TRIAL, AND WILL BE VALIDATED FOR RELIABILITY, INTERNAL CONSISTENCY, MME ALGORITHM ACCURACY, AND CONVERGENT AND DIVERGENT VALIDITY IN A SUBSTANCE USE REDUCTION CLINIC. THE DOSE TOOL WILL THEN BE INCORPORATED INTO A SECURE WEB-BASED SERVER FOR ACCESSED USE AS AN MDDT.

ADDRESSING OPIOID USE DISORDER WITH AN EXTERNAL MULTIMODAL NEUROMODULATION DEVICE: DEVELOPMENT AND CLINICAL EVALUATION OF DUOTHERM FOR OPIOID-SPARING IN ACUTE AND CHRONIC LOW BACK PAIN. - PROJECT SUMMARY THE GOAL OF THIS PROJECT IS TO DEVELOP A MULTIMODAL NEUROMODULATORY OPIOID-SPARING DEVICE FOR LOW BACK PAIN, DEMONSTRATE EFFECTIVE PAIN RELIEF, THEN EVALUATE OPIOID REDUCTION FOR PATIENTS WITH ACUTE OR CHRONIC BACK PAIN PRESENTING FOR TREATMENT. PAIN AND OPIOID USE DISORDER (OUD) ARE INTRICATELY RELATED: DEPENDENCE BEGINS FOR UP TO 80% WITH MEDICATIONS PRESCRIBED FOR PAIN, EITHER DIRECTLY OR THROUGH PILLS LEFT IN CIRCULATION. CURRENTLY, THERE IS NO PROVEN APPROACH TO HELP REDUCE LONG-TERM OPIOID USE FOR PATIENTS WITH CHRONIC NON-CANCER PAIN. WHAT IS KNOWN IS THAT PRESCRIPTIONS OF OPIOIDS FOR ACUTE LOW BACK PAIN ARE A FACTOR IN EVENTUAL OUD, AND UNUSED OPIOIDS IN CIRCULATION ARE INCREASINGLY ABUSED FOR NON-MEDICAL REASONS. FOR THE ALREADY DEPENDENT WITH CHRONIC PAIN, ONE BARRIER TO REDUCTION IS FEAR OF ONGOING OR INCREASING PAIN. AN EFFECTIVE NON-PHARMACEUTICAL PAIN RELIEVER COULD REDUCE HOME OPIOID PRESCRIPTIONS FOR ACUTE PAIN, AND AID CHRONIC PAIN PATIENTS SEEKING TO WEAN. ACUTE AND CHRONIC LOW BACK PAIN ARE AMONG THE MOST COMMON SOURCES OF SHORT AND LONG TERM DISABILITY. OPIOIDS ARE COMMONLY PRESCRIBED, BUT NO BETTER THAN NON- ADDICTIVE SOLUTIONS FOR CHRONIC LOW BACK PAIN. NEUROMODULATION (COLD, HIGH FREQUENCY VIBRATION, LOW FREQUENCY WHOLE BODY VIBRATION, ACUPRESSURE), HEAT, AND SUPPORT ARE EFFECTIVE FOR MANY, BUT NO CURRENT DEVICE COMBINES THESE MULTIPLE MODALITIES OF PAIN RELIEF. ONE RECENT STUDY FOUND A SURGICALLY PLACED NEUROMODULATORY DEVICE SIGNIFICANTLY DECREASED OPIOID USE FOR PATIENTS WITH CHRONIC LOW BACK PAIN. LOW BACK PAIN WOULD BE THE MOST IMPACTFUL CLINICAL SCENARIO IN WHICH TO TEST AN EXTERNAL MULTI-MODAL NEUROMODULATORY PAIN RELIEVER FOR ITS IMPACT ON INITIAL AND CHRONIC OPIOID USE. PATIENTS WITH CHRONIC PAIN REPORT BENEFITTING FROM MULTIPLE PAIN RELIEF STRATEGIES OVER TIME. BECAUSE HAVING OPTIONS IMPROVES THE PERCEPTION OF CONTROL, THE IDEAL PAIN RELIEF DEVICE WOULD INCORPORATE MULTIPLE PAIN RELIEVING MODALITIES TO REDUCE CATASTROPHIZING. TO RELIEVE SHARP PAIN, WE CREATED AN NICHD-FUNDED “BUZZY” NEUROMODULATORY DEVICE COMBINING HIGH FREQUENCY VIBRATION AND ICE, NOW PROVEN EFFECTIVE IN OVER 28 INDEPENDENT CLINICAL TRIALS. TO ADDRESS LOW BACK PAIN, OUR “DUOTHERM” DEVICE INCORPORATES THE BUZZY FREQUENCY, COLD, HEAT, ACUPRESSURE, AND TWO ADDITIONAL FREQUENCIES. PRELIMINARY DATA FROM 32 SUBJECTS DEMONSTRATED SUBSTANTIAL AND SUSTAINED PAIN REDUCTION, DISTINCT PREFERENCES FOR VIBRATION FREQUENCIES, AND STRONG COMMERCIAL DESIRE FOR THE PRODUCT. THIS PROJECT WILL DEVELOP AND CLINICALLY EVALUATE DUOTHERM, AN INNOVATIVE OPIOID-SPARING THERAPEUTIC. THIS PATIENT-CONTROLLED EXTERNAL NEUROMODULATION DEVICE WILL BE DESIGNED TO ADDRESS ACUTE AND CHRONIC LBP. AFTER VALIDATING EFFECTIVE PAIN RELIEF WITH DUOTHERM COMPARED TO PLACEBO, WE WILL TEST WHETHER AN EFFECTIVE LOW BACK PAIN RELIEF DEVICE REDUCES OPIOID USE FOR ACUTE AND CHRONIC LOW BACK PAIN PATIENTS.

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) - 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 CLINICAL TRIAL WITH INFORMED CONSENT TO REPORT ALL OPIOID USE, THE TOOL WILL BE A ROBUST SURVEY MODULE CAPABLE OF CAPTURING AND STANDARDIZING USE OF PRESCRIBED, PURCHASED OR BORROWED OPIOIDS. SUCH A RESEARCH TOOL WILL SUPPORT INVESTIGATORS AND MEDICAL PRODUCT DEVELOPERS SEEKING REGULATORY APPROVAL FOR OPIOID-SPARING AND SUBSTANCE USE DISORDER (SUD) INTERVENTIONS. DEVICES, DIGITAL HEALTH SOLUTIONS AND OVER THE COUNTER PHYSICAL INTERVENTIONS REDUCE PAIN,[1-3] BUT PHYSICIANS AND PAYOR PROGRAMS NEED CODES TO IMPLEMENT PROVEN SOLUTIONS, AND REGULATORY AGENCIES INCREASINGLY PRIORITIZE PROOF OF OPIOID REDUCTION IN ADDITION TO PAIN RELIEF. TO FACILITATE MEDICAL PRODUCT DEVELOPMENT AND EVALUATION, THERE IS A PUBLIC HEALTH NEED FOR A ROBUST OPIOID USE MEASURE QUALIFIED BY THE FDA TO ENCOURAGE MEDICAL DEVICE INNOVATION AND ALLOW FOR INTRA-TRIAL STANDARDIZATION. CURRENT METHODS OF GATHERING OPIOID USE INFORMATION INCLUDE PAPER SURVEYS, WEB-BASED SURVEYS, AND APPS. THESE NON-VALIDATED COLLECTION METHODS ARE OFTEN PRE-LOADED WITH A SPECIFIC SET OF OPIOIDS LIMITED TO THOSE COMMONLY PRESCRIBED BY THE PRACTICE WHERE THE CLINICAL TRIAL IS TAKING PLACE AND ARE OFTEN UNIQUE TO THE TRIAL. WHILE THESE TOOLS AND METHODS FAIL TO CAPTURE OF OPIOIDS FROM OTHER SOURCES, NOR ARE THEY ROBUST ENOUGH TO BE A STANDARD DATA COLLECTION TOOL FOR THIS CONTEXT OF USE. OVER 90% OF OPIOID PRESCRIBED IN PREVIOUS YEARS ARE UNUSED;[4] ONLY 22% SAY THEY GOT THEIR OPIOIDS FROM A PRESCRIBER RATHER THAN FRIENDS AND FAMILY.[5] PHASE 1 WILL CONFIRM WITH THE FDA TO CONFIRM THAT THE PHASE 2 PROJECT MEETS THE MDDT GUIDELINES, ESTABLISH CDC COMPLIANCE, CONDUCT EXPERT CONTENT MAPPING, AND OBTAIN IRB APPROVAL FOR PHASE 2 CLINICAL TRIALS. DURING PHASE 2, AFTER STRUCTURED USABILITY INTERVIEWS OF ANY EDITS OF THE EXISTING SURVEY, PROGRAMMED LOGIC WILL OPTIMIZE INTEROPERABILITY WITH EXISTING CLINICAL TRIAL DATA COLLECTION SOFTWARE. THE SURVEY WILL BE VALIDATED IN THE CONTEXT OF USE OF A PAIN-RELIEVING MEDICAL DEVICE TRIAL, AND WILL BE VALIDATED FOR RELIABILITY, INTERNAL CONSISTENCY, MME ALGORITHM ACCURACY, AND CONVERGENT AND DIVERGENT VALIDITY IN A SUBSTANCE USE REDUCTION CLINIC. THE DOSE TOOL WILL THEN BE INCORPORATED INTO A SECURE WEB-BASED SERVER FOR ACCESSED USE AS AN MDDT.

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) - 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 CLINICAL TRIAL WITH INFORMED CONSENT TO REPORT ALL OPIOID USE, THE TOOL WILL BE A ROBUST SURVEY MODULE CAPABLE OF CAPTURING AND STANDARDIZING USE OF PRESCRIBED, PURCHASED OR BORROWED OPIOIDS. SUCH A RESEARCH TOOL WILL SUPPORT INVESTIGATORS AND MEDICAL PRODUCT DEVELOPERS SEEKING REGULATORY APPROVAL FOR OPIOID-SPARING AND SUBSTANCE USE DISORDER (SUD) INTERVENTIONS. DEVICES, DIGITAL HEALTH SOLUTIONS AND OVER THE COUNTER PHYSICAL INTERVENTIONS REDUCE PAIN,[1-3] BUT PHYSICIANS AND PAYOR PROGRAMS NEED CODES TO IMPLEMENT PROVEN SOLUTIONS, AND REGULATORY AGENCIES INCREASINGLY PRIORITIZE PROOF OF OPIOID REDUCTION IN ADDITION TO PAIN RELIEF. TO FACILITATE MEDICAL PRODUCT DEVELOPMENT AND EVALUATION, THERE IS A PUBLIC HEALTH NEED FOR A ROBUST OPIOID USE MEASURE QUALIFIED BY THE FDA TO ENCOURAGE MEDICAL DEVICE INNOVATION AND ALLOW FOR INTRA-TRIAL STANDARDIZATION. CURRENT METHODS OF GATHERING OPIOID USE INFORMATION INCLUDE PAPER SURVEYS, WEB-BASED SURVEYS, AND APPS. THESE NON-VALIDATED COLLECTION METHODS ARE OFTEN PRE-LOADED WITH A SPECIFIC SET OF OPIOIDS LIMITED TO THOSE COMMONLY PRESCRIBED BY THE PRACTICE WHERE THE CLINICAL TRIAL IS TAKING PLACE AND ARE OFTEN UNIQUE TO THE TRIAL. WHILE THESE TOOLS AND METHODS FAIL TO CAPTURE OF OPIOIDS FROM OTHER SOURCES, NOR ARE THEY ROBUST ENOUGH TO BE A STANDARD DATA COLLECTION TOOL FOR THIS CONTEXT OF USE. OVER 90% OF OPIOID PRESCRIBED IN PREVIOUS YEARS ARE UNUSED;[4] ONLY 22% SAY THEY GOT THEIR OPIOIDS FROM A PRESCRIBER RATHER THAN FRIENDS AND FAMILY.[5] PHASE 1 WILL CONFIRM WITH THE FDA TO CONFIRM THAT THE PHASE 2 PROJECT MEETS THE MDDT GUIDELINES, ESTABLISH CDC COMPLIANCE, CONDUCT EXPERT CONTENT MAPPING, AND OBTAIN IRB APPROVAL FOR PHASE 2 CLINICAL TRIALS. DURING PHASE 2, AFTER STRUCTURED USABILITY INTERVIEWS OF ANY EDITS OF THE EXISTING SURVEY, PROGRAMMED LOGIC WILL OPTIMIZE INTEROPERABILITY WITH EXISTING CLINICAL TRIAL DATA COLLECTION SOFTWARE. THE SURVEY WILL BE VALIDATED IN THE CONTEXT OF USE OF A PAIN-RELIEVING MEDICAL DEVICE TRIAL, AND WILL BE VALIDATED FOR RELIABILITY, INTERNAL CONSISTENCY, MME ALGORITHM ACCURACY, AND CONVERGENT AND DIVERGENT VALIDITY IN A SUBSTANCE USE REDUCTION CLINIC. THE DOSE TOOL WILL THEN BE INCORPORATED INTO A SECURE WEB-BASED SERVER FOR ACCESSED USE AS AN MDDT.