OBJECTIVES: To assess the content validity and patient interpretation of the Self-Reported Misuse, Abuse and Diversion (SR-MAD) of Prescription (Rx) Opioids instrument. METHODS: A cross-sectional, qualitative study was conducted in patients with chronic or acute pain. Patients were recruited from 3 clinical sites based on three patient groups (opioid naïve, known opioid abusers, and chronic opioid non-abusers) to participate in a one-on-one cognitive interview.  Patients completed the SR-MAD instrument via web-administration and then participated in an in-depth discussion following a semi-structured interview guide to assess the patient’s understanding of the questionnaire. Descriptive statistics and content analysis were performed. RESULTS: Thirty-seven patients were interviewed: 11 opioid naïve; 13 known abusers; and 13 non-abusers.  Mean age was 55 ± 13.5 years (range 26 to 84); 33 patients (89%) experienced chronic pain, three (8%) experienced acute pain, and one (3%) experienced both chronic and acute pain. Overall, most patients (n=31, 84%) demonstrated a comprehensive understanding of the questionnaire’s content and reported the SR-MAD was easy to complete via web-administration. The majority of patients (n=28, 76%) reported they were truthful when completing the questionnaire and most (n=22, 59%) said they were comfortable completing the questionnaire using a secure internet site. Although some patients (n=15, 41% [opioid naïve n=5, known abusers n=7, and non-abusers n=3]) reported there were questions about opioid misuse that were not applicable to them, they all understood what was being asked and thought the questions would be relevant if they were abusing pain medication. Eight patients (known abusers n=4, non-abusers n=1, opioid naïve n=3) reported they were not comfortable answering the SR-MAD honestly in a clinic/doctor’s office. CONCLUSIONS: The SR-MAD was developed based on patient input and addresses opioid abuse, misuse, and diversion. Additional interviews with aberrant opioid abusers are underway to further examine the content validity of the SR-MAD.