National Breakthrough Pain Study: prevalence, characteristics, and associations with health outcomes

The National Breakthrough Pain Study is a large observational study that assessed breakthrough pain (BTP) in a population of commercially insured community-dwelling patients with opioid-treated chronic pain. Eligible patients were identified from an administrative claims database, and consenting patients were asked to complete a structured telephone interview and several validated questionnaires. Questionnaires assessed pain interference with function (Brief Pain Inventory-Short Form), health status (Short Form 12 [SF-12] Health Survey), disability (Sheehan Disability Scale), work performance World Health Organization Health and Work Performance Questionnaire), and mood (Generalized Anxiety Disorder-7 Screener [GAD-7] and-Patient Health Questionnaire-2 [PHQ-2]). Of 2198 patients interviewed, 1278 patients had persistent pain controlled with opioid therapy; 1023 (80%) of these patients reported BTP. Patients had a median of 2.0 episodes of BTP per day (range, 1-50) and a median duration of BTP of 45 minutes (range, 1-720). Compared with patients without BTP, patients with BTP had more pain-related interference in function (Brief Pain Inventory, mean SD: 34.2 +/- 15.6 vs 25.0 +/- 15.7 [P<0.001]), worse physical health (SF-12 physical component score: 29.9 +/- 9.6 vs 35.1 +/- 10.4 [P<0.001]) and mental health (SF-12 mental component score: 47.4 +/- 11.3 vs 49.3 +/- 10.4 [P<0.001]), more disability (Sheehan Disability Scale global impairment score: 15.1 +/- 9.1 vs 10.6 +/- 8.5; World Health Organization Health and Work Performance Questionnaire absolute absenteeism: 12.4 +/- 59.9 vs 7.7 +/- 44.9 hours [both P<0.001]), and worse mood (GAD-7 score: 7.4 +/- 5.9 vs 5.9 +/- 5.4; PHQ-2 anhedonia score: 1.2 +/- 1.1 vs 0.9 +/- 1.0 [both P<0.001]). In this population of community-dwelling patients with opioid-treated chronic pain, BTP was highly prevalent and associated with negative outcomes. This burden of illness suggests the need for specific treatment plans.