Beatrice Setnik1, Carl L Roland2, Glenn C Pixton3, Kenneth W Sommerville4,5. 1. a Clinical Pharmacology , INC Research , Raleigh , NC , USA. 2. b Department of Clinical Sciences and Outcomes & Evidence , Pfizer Inc , Durham , NC , USA. 3. c Department of Statistics , Pfizer Inc , Durham , NC , USA. 4. d Department of Clinical Research , GW Pharmaceuticals , Research Triangle Park , NC , USA. 5. e Department of Neurology , Duke University Medical Center , Durham , NC , USA.
Abstract
OBJECTIVES: To compare the results of two open-label primary care-based studies that examined investigator assessment of patient risk for prescription opioid misuse, abuse, and diversion relative to patient self-reports and urine drug tests (UDTs). METHODS: Risk assessment data from two open-label, multicenter, primary care-based US studies in patients with chronic pain were compared. RESULTS: In one study (n = 1487), 54.4% of patients were at moderate, 24.8% at high, and 20.8% at low risk based on patients' self-reports at baseline on the Screener and Opioid Assessment for Patients with Pain®-Revised questionnaire. Investigators assigned 1.3% of patients as high risk despite 5.0% self-reporting prior illicit drug use and 15.3% with positive UDT(s) for an illicit drug at baseline. In the second study (n = 684), few patients were considered by investigators to be at high risk for misuse (1.6%), abuse (1.8%), or diversion (1.0%). However, 10.4% of patients reported prior illicit drug use; 23.4% had at least one abnormal baseline UDT; 60% of 537 patients reported on the Self-Reported Misuse, Abuse, and Diversion questionnaire they took more opioids than prescribed; and 10.9% reported chewing/crushing opioids in the past. Of patients completing the Current Opioid Misuse Measure, 40.6% were classified as having aberrant behaviors. CONCLUSION: A comparison of risk assessment across two studies indicates a tendency for investigators to assess patients as lower risk for opioid-related aberrant behaviors despite a significant proportion self-reporting aberrant behavior and/or presenting with illicit UDTs. These consistent findings underline the importance of appropriate implementation of objective measures and self-reporting tools when evaluating risk in patients. CLINICAL TRIAL REGISTRATION: www.clinicaltrials.gov identifiers: NCT00640042 and NCT01179191.
OBJECTIVES: To compare the results of two open-label primary care-based studies that examined investigator assessment of patient risk for prescription opioid misuse, abuse, and diversion relative to patient self-reports and urine drug tests (UDTs). METHODS: Risk assessment data from two open-label, multicenter, primary care-based US studies in patients with chronic pain were compared. RESULTS: In one study (n = 1487), 54.4% of patients were at moderate, 24.8% at high, and 20.8% at low risk based on patients' self-reports at baseline on the Screener and Opioid Assessment for Patients with Pain®-Revised questionnaire. Investigators assigned 1.3% of patients as high risk despite 5.0% self-reporting prior illicit drug use and 15.3% with positive UDT(s) for an illicit drug at baseline. In the second study (n = 684), few patients were considered by investigators to be at high risk for misuse (1.6%), abuse (1.8%), or diversion (1.0%). However, 10.4% of patients reported prior illicit drug use; 23.4% had at least one abnormal baseline UDT; 60% of 537 patients reported on the Self-Reported Misuse, Abuse, and Diversion questionnaire they took more opioids than prescribed; and 10.9% reported chewing/crushing opioids in the past. Of patients completing the Current Opioid Misuse Measure, 40.6% were classified as having aberrant behaviors. CONCLUSION: A comparison of risk assessment across two studies indicates a tendency for investigators to assess patients as lower risk for opioid-related aberrant behaviors despite a significant proportion self-reporting aberrant behavior and/or presenting with illicit UDTs. These consistent findings underline the importance of appropriate implementation of objective measures and self-reporting tools when evaluating risk in patients. CLINICAL TRIAL REGISTRATION: www.clinicaltrials.gov identifiers: NCT00640042 and NCT01179191.
Authors: Dokyoung Sophia You; Jennifer M Hah; Sophie Collins; Maisa S Ziadni; Ben W Domingue; Karon F Cook; Sean C Mackey Journal: Pain Med Date: 2019-10-01 Impact factor: 3.750
Authors: Shannon M Smith; Judith K Jones; Nathaniel P Katz; Carl L Roland; Beatrice Setnik; Jeremiah J Trudeau; Stephen Wright; Laurie B Burke; Sandra D Comer; Richard C Dart; Raymond Dionne; J David Haddox; Jerome H Jaffe; Ernest A Kopecky; Bridget A Martell; Ivan D Montoya; Marsha Stanton; Ajay D Wasan; Dennis C Turk; Robert H Dworkin Journal: J Pain Date: 2017-05-04 Impact factor: 5.820