title: A pooled analysis of quality of life measures and adverse events data in north central cancer treatment group lung cancer clinical trials.
abstract: BACKGROUND
  In this pooled analysis, the authors examined correlations between single-item and multiple-item quality of life (QOL) measures and assessed the agreement between clinically significant changes in QOL and patient-reported adverse events (AE).
  
  
  METHODS
  Data from 6 lung cancer clinical trials that involved 358 patients were pooled. All trials incorporated the Uniscale and 1 of 3 multiple-item assessments: the Functional Assessment for Cancer Therapy-Lung, the Lung Cancer Symptom Scale, or the Symptom Distress Scale. Spearman rank correlations and a Bland-Altman approach were used to assess agreement. Time-to-event analysis was performed using the Kaplan-Meier method.
  
  
  RESULTS
  Correlations between the Uniscale and multiple-item assessments were substantial (correlation coefficient = 0.49-0.66). At least 1 10-point decline was reported in the Uniscale and multiple-item assessments by 58% of patients and 39% of patients, respectively. At least 1 severe AE (grade >or=3) was reported in 35% of patients postbaseline. The percent agreement between experiencing a severe AE and a decline in QOL was 48% and 59% for the Uniscale and multiple-item assessments, respectively. The median time to the first 10-point decline in QOL for the Uniscale and multiple-item assessments was 67 days and 142 days, respectively, and the median time to the first occurrence of a severe AE was 304 days.
  
  
  CONCLUSIONS
  Information gleaned from the single-item Uniscale assessment was comparable to that gleaned from multiple-item global measures. There was moderate agreement between QOL and AE. A 10-point decline in QOL occurred earlier than Common Toxicity Criteria AE reporting. This suggests the need for inclusion of a QOL instrument in lung cancer clinical trials.
authors.affiliation: Division of Biostatistics, Mayo Clinic, Rochester, Minnesota 55905, USA. huschka.mashele@mayo.edu
authors.forename: Mashele M
authors.initials: MM
authors.lastname: Huschka
authors.forename: Sumithra J
authors.initials: SJ
authors.lastname: Mandrekar
authors.forename: Paul L
authors.initials: PL
authors.lastname: Schaefer
authors.forename: James R
authors.initials: JR
authors.lastname: Jett
authors.forename: Jeff A
authors.initials: JA
authors.lastname: Sloan
mesh_terms: D000203:Activities of Daily Living; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000009:adverse effects*; D023381:Endpoint Determination; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000523:psychology / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D011788:Quality of Life; D011878:Radiotherapy / Q000009:adverse effects*; D018434:Sickness Impact Profile
chemical_list: D000970:Antineoplastic Agents