Reliability and Validity of the Perioperative Opioid-Related Symptom Distress Scale

Abstract

A reduction in opioid use may reduce the incidence and severity of opioid-related side effects. However, no published studies have demonstrated this relationship. In a prospective, placebo-controlled, randomized trial of analgesia for laparoscopic cholecystectomy, we validated an opioid-related symptom distress scale (SDS) questionnaire and clinically meaningful events (CMEs). A total of 193 patients completed the SDS questionnaire every 24 h after discharge for 7 days. This analysis was based on data from Day 1 only. The SDS assessed 12 common opioid-related symptoms, including nausea, vomiting, and difficulty passing urine, by 3 ordinal measures: frequency, severity, and bothersomeness. Patients with responses of “frequently” to “almost constantly,” “moderate” to “very severe,” or “quite a bit” to “very much bothered” were considered to have a CME. A detailed postoperative recovery survey of patient functional status and experience ofadverseeffectswasusedtovalidatetheSDS.Validation measures in the recovery survey were categorized as non-specific (e.g., level of normal activities) and specific (e.g., number of times vomited in 24 h, minutes of nausea in 24 h, and ability to void normally). SDS scores and CMEs for nausea, vomiting, and difficulty passing urine were strongly associated with three related validation measures from the recovery survey: minutes of nausea within 24 h, number of times vomited within 24 h, and ability to void normally, respectively (P