title: Development of a measure of the burden of pain due to herpes zoster and postherpetic neuralgia for prevention trials: adaptation of the brief pain inventory.
abstract: In preparation for clinical trials of a vaccine against herpes zoster (HZ), we conducted a prospective, observational study to evaluate (1) the Zoster Brief Pain Inventory (ZBPI), an HZ-specific questionnaire to quantify HZ pain and discomfort, (2) an operational definition of postherpetic neuralgia (PHN), and (3) a severity-duration measure of the burden of illness caused by HZ. HZ patients aged 60 years or older (n = 121) were enrolled within 14 days of rash onset and completed ZBPI, McGill Pain Questionnaire Present Pain Intensity (PPI), quality of life (QoL), and activities of daily living (ADL) questionnaires on a predetermined schedule. Reliability, measured by intraclass correlation coefficients within 14 days of rash onset, ranged between 0.63 and 0.78. ZBPI pain scores were strongly correlated with other pain measures, interference with ADL, and worsening QoL. The operational definition of PHN, a ZBPI pain score of 3 or greater occurring 90 or more days after rash onset, had high agreement with pain worse than mild on the PPI (kappa = 0.72). The ZBPI pain severity-duration measure had high correlations with severity-duration measures of ADL interference, worsening QoL, and other pain scales. These findings support the validity and utility of the ZBPI, the definition of PHN, and the severity-duration measure of the burden of HZ illness.
  
  
  CONCLUSIONS
  Herpes zoster pain, as measured by the ZBPI severity-duration measure, is associated with impairment in daily living activities and quality of life. The ZBPI measure appears useful for quantifying herpes zoster pain, postherpetic neuralgia, and impairment in daily living activities for clinical trials of herpes zoster prevention.
authors.affiliation: Merck Research Laboratories, West Point, Pennsylvania 19486, USA. alexander_nikas@merck.com
authors.forename: Paul M
authors.initials: PM
authors.lastname: Coplan
authors.forename: Kenneth
authors.initials: K
authors.lastname: Schmader
authors.forename: Alexander
authors.initials: A
authors.lastname: Nikas
authors.forename: Ivan S F
authors.initials: IS
authors.lastname: Chan
authors.forename: Peter
authors.initials: P
authors.lastname: Choo
authors.forename: Myron J
authors.initials: MJ
authors.lastname: Levin
authors.forename: Gary
authors.initials: G
authors.lastname: Johnson
authors.forename: Mark
authors.initials: M
authors.lastname: Bauer
authors.forename: Heather M
authors.initials: HM
authors.lastname: Williams
authors.forename: Karen M
authors.initials: KM
authors.lastname: Kaplan
authors.forename: Harry A
authors.initials: HA
authors.lastname: Guess
authors.forename: Michael N
authors.initials: MN
authors.lastname: Oxman
mesh_terms: D000553:Ambulatory Care / Q000379:methods / Q000523:psychology; D002986:Clinical Trials as Topic / Q000379:methods; D005260:Female; D006562:Herpes Zoster / Q000453:epidemiology* / Q000517:prevention & control / Q000523:psychology; D006801:Humans; D008137:Longitudinal Studies; D008297:Male; D009437:Neuralgia / Q000453:epidemiology* / Q000517:prevention & control / Q000523:psychology; D010147:Pain Measurement / Q000523:psychology / Q000706:statistics & numerical data; D011446:Prospective Studies; D018709:Statistics, Nonparametric