Context The Edmonton Symptom Assessment System (ESAS) is one of the most commonly used symptom batteries in clinical practice and research. Objectives We used the anchor-based.approach to identify the minimal clinically important difference (MCID) for improvement and deterioration for ESAS physical, emotional and total symptom distress scores. Methods In this multicenter prospective study, we asked patients with advanced cancer to complete their ESAS at the first clinic visit and at a second visit three weeks later. The anchor for MCID determination was Patient's Global Impression regarding their physical, emotional and overall symptom burden (“better,” “about the same,” or “worse”). We identified the optimal sensitivity/specificity cutoffs for both improvement and deterioration for the three ESAS scores and also determined the within-patient changes. Results A total of 796 patients were enrolled from six centers. The ESAS scores had moderate responsiveness, with area under the receiver-operating characteristic curve between 0.69 and 0.76. Using the sensitivity-specificity approach, the optimal cutoffs for ESAS physical, emotional and total symptom distress scores were ≥3/60, ≥2/20 and ≥3/90 for improvement, and ≤−4/60, ≤−1/20 and ≤−4/90 for deterioration, respectively. These cutoffs had moderate sensitivities (59%-68%) and specificities (62%-80%). The within-patient change approach revealed the MCID cutoffs for improvement/deterioration to be 3/−4.3 for the physical score, 2.4/−1.8 for the emotional score, and 5.7/−2.9 for the total symptom distress score. Conclusion We identified the MCIDs for physical, emotional and total symptom distress scores, which have implications for interpretation of symptom response in clinical trials.

clinicaltrials.gov Identifier: NCT02357108.

UDTs were used infrequently among outpatients with advanced cancer who were receiving chronic opioid therapy. Younger age, positive CAGE questionnaire results, early stage cancer or no evidence of disease status, higher pain intensity, and lower fatigue scores were significant predictors of UDT ordering. More than 50% of UDT results were abnormal. More research is necessary to better characterize aberrant opioid use in patients with advanced cancer. Cancer 2016;122:3732-9. © 2016 American Cancer Society.

The current results indicate a high frequency of an elevated risk of ADB among patients with cancer. Men and patients who have anxiety, financial distress, and a prior history of alcoholism/illicit drug use are at increased risk of ADB.

There are currently no well-defined and evidence-based strategies to manage cancer patients on chronic opioid therapy who demonstrate aberrant opioid-related behavior. The findings of this study offer a promising starting point for the creation of a standardized strategy for clinicians and provides valuable information to guide their practice regarding these patients. The study results will also help clinicians to better understand the types and frequencies of the most common aberrant behaviors observed among patients with cancer who are receiving chronic opioid therapy. This will enhance the process of timely patient identification, management, or referral to the appropriate specialist teams.