title: Symptom assessment in relapsed small cell lung cancer: cross-validation of the patient symptom assessment in lung cancer instrument.
abstract: BACKGROUND
  Lung cancer symptoms can be burdensome for patients with small cell lung cancer (SCLC). Patient Symptom Assessment in Lung Cancer (PSALC), a self-report scale for assessing SCLC symptom burden, was developed and validated previously using intravenous topotecan clinical trial data. This study cross-validates the PSALC using oral topotecan (OT) trial data.
  
  
  METHODS
  Data were analyzed from a randomized, open-label, multicenter trial including 71 patients with relapsed SCLC receiving OT with best supportive care and 70 patients receiving best supportive care alone. PSALC and EQ-5D were administered at baseline and at 3-week intervals. Internal consistency, reliability, construct validity, and responsiveness were evaluated.
  
  
  RESULTS
  Only one factor was indicated in factor analysis, hence PSALC total score (PSALC-TS) was used for psychometric analysis. Internal consistency was supported by Cronbach's alpha of 0.78. Construct validity was supported by significant associations of higher PSALC-TS (higher symptom burden) with worse Eastern Cooperative Oncology Group performance status and by correlations of PSALC-TS with EQ-5D utility index and visual analog scale score (all p < 0.001). Reliability was supported by intraclass correlation coefficient of 0.68 (using PSALC-TS before clinical status change) and concordance correlation coefficient of 0.69 (using PSALC-TS at baseline and before first visit). PSALC-TS was responsive to clinical status change from baseline to tumor response (responsiveness statistic = -0.99) and to tumor progression (responsiveness statistic = 0.94).
  
  
  CONCLUSIONS
  Consistent with prior psychometric results, this cross-validation study using OT trial data showed acceptable validity, reliability, and responsiveness of the PSALC scale, further supporting its use to measure symptom burden in previously treated SCLC.
authors.affiliation: Analysis Group, Inc., Boston, Massachusetts, USA.
authors.forename: Lei
authors.initials: L
authors.lastname: Chen
authors.forename: Lucia
authors.initials: L
authors.lastname: Antras
authors.forename: Mei Sheng
authors.initials: MS
authors.lastname: Duh
authors.forename: Maureen
authors.initials: M
authors.lastname: Neary
authors.forename: Mary E R
authors.initials: ME
authors.lastname: O'Brien
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000627:therapeutic use; D017326:Clinical Trials, Phase III as Topic; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000175:diagnosis* / Q000188:drug therapy / Q000473:pathology; D008297:Male; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D009364:Neoplasm Recurrence, Local / Q000175:diagnosis* / Q000188:drug therapy / Q000473:pathology; D010166:Palliative Care; D016032:Randomized Controlled Trials as Topic; D012647:Self-Assessment; D012720:Severity of Illness Index; D018434:Sickness Impact Profile; D055752:Small Cell Lung Carcinoma / Q000175:diagnosis* / Q000188:drug therapy / Q000473:pathology; D011795:Surveys and Questionnaires; D019772:Topotecan / Q000627:therapeutic use
chemical_list: D000970:Antineoplastic Agents; D019772:Topotecan