title: An observational study of health-related quality of life and pain outcomes in chronic low back pain patients treated with fentanyl transdermal system.
abstract: BACKGROUND
  The analgesic effect of long-acting opioids, such as transdermal fentanyl, has been demonstrated in patients with cancer, neuropathic pain and chronic low back pain (CLBP). However, the broader effect of long-acting opioids on the patient's health-related quality of life (HRQoL) is less well known.
  
  
  OBJECTIVE
  To evaluate HRQoL outcomes in CLBP patients treated with transdermal fentanyl.
  
  
  METHODS
  An observational study was conducted at 17 clinical centers in the US. Eligible patients had CLBP diagnosis for at least 3 months and were taking short-acting opioids chronically, and then initiated transdermal fentanyl treatment. Patients completed the Treatment Outcomes in Pain Survey (TOPS), which includes the SF-36 Health Survey, at baseline and > or = 9 weeks of treatment. The HRQoL burden of CLBP was determined by comparing CLBP patients' SF-36 scores to the general US population and low back pain patient norms. HRQoL outcomes were determined by comparing baseline and follow-up TOPS and SF-36 scores. Additionally, HRQoL outcomes were evaluated across patient groups stratified by changes in pain intensity ratings as measured by an 11-point numerical rating scale.
  
  
  RESULTS
  At baseline CLBP patients (N = 131) scored one-to-two standard deviations (SD) below age and gender adjusted SF-36 general population norms (MANOVA F = 127.1, p < 0.0001) and significantly lower than low back pain norms (MANOVA F = 125.3, p < 0.0001). At follow-up, significant improvement (p < 0.05) was observed on six of the SF-36 scales and both SF-36 summary measures and five of the six TOPS pain-related scales. The magnitude of change in scores in effect size units among these scales ranged from 0.17 to 0.80, which are considered small to large effect size changes. HRQoL score improvement was greatest among patients experiencing the greatest pain relief.
  
  
  CONCLUSIONS
  CLBP patients who chronically used short-acting opioids showed tremendous HRQoL burden. Favorable HRQoL outcomes were observed among patients who reported pain relief.
authors.affiliation: QualityMetric Incorporated, Lincoln, RI, USA. mkosinski@qualitymetric.com
authors.forename: Mark R
authors.initials: MR
authors.lastname: Kosinski
authors.forename: Jeff R
authors.initials: JR
authors.lastname: Schein
authors.forename: Sue M
authors.initials: SM
authors.lastname: Vallow
authors.forename: Steven
authors.initials: S
authors.lastname: Ascher
authors.forename: Clare
authors.initials: C
authors.lastname: Harte
authors.forename: Richard
authors.initials: R
authors.lastname: Shikiar
authors.forename: Lori
authors.initials: L
authors.lastname: Frank
authors.forename: Mary Kay
authors.initials: MK
authors.lastname: Margolis
authors.forename: Gary
authors.initials: G
authors.lastname: Vorsanger
mesh_terms: D000279:Administration, Cutaneous; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000701:Analgesics, Opioid / Q000008:administration & dosage / Q000627:therapeutic use*; D002908:Chronic Disease; D003625:Data Collection; D005260:Female; D005283:Fentanyl / Q000008:administration & dosage / Q000627:therapeutic use*; D006801:Humans; D017116:Low Back Pain / Q000188:drug therapy* / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D011788:Quality of Life; D014481:United States
chemical_list: D000701:Analgesics, Opioid; D005283:Fentanyl