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

Narayana, Arvinda; Katz, Nathanielb,c; Shillington, Alicia C.d; Stephenson, Judith J.e; Harshaw, Qingd; Frye, Carla B.f; Portenoy, Russell K.g,*

doi: 10.1097/01.j.pain.0000460305.41078.7d
Research Paper

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.

Supplemental Digital Content is Available in the Text.Commercially insured community-dwelling patients with opioid-treated pain and breakthrough pain report worse health status, pain-related functional impairment, and disability than those without breakthrough pain.

aTeva Pharmaceuticals, Frazer, PA, USA

bTufts University School of Medicine, Boston, MA, USA

cAnalgesic Solutions, Natick, MA, USA

dEPI-Q, Inc, Oak Brook, IL, USA

eHealthCore, Inc, Wilmington, DE, USA

fThayer County Health Services, Hebron, NE, USA

gMJHS Institute for Innovation in Palliative Care, New York, NY, USA

Corresponding author. Address: MJHS Institute for Innovation in Palliative Care, 39 Broadway, 12th Floor, New York NY 10006, USA. Tel.: (212) 649-5560; fax: (212) 649-5544. E-mail address: (R. K. Portenoy).

Sponsorships or competing interests that may be relevant to content are disclosed at the end of this article.

Supplemental digital content is available for this article. Direct URL citations appear in the printed text and are provided in the HTML and PDF versions of this article on the journal's Web site (

Received April 18, 2014

Received in revised form September 24, 2014

Accepted October 16, 2014

© 2015 International Association for the Study of Pain
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