of the Sa˜o Paulo Hospital - Federal University of Sa˜o Paulo. This study was approved by the Institutional Review Board of our center, and a Term of Informed Consent was signed by all patients. The following inclusion criteria were used: histologically proven lung cancer; 18 years of age or older; a minimum score of 21 on the Mini Mental State Examination (MMSE);10,11 out of chemotherapy/radiotherapy treatment; and clinical stability during the study and at least 10 days before the beginning of the evaluations. Clinical stability was defined as the absence of change in cough, sputum, and dyspnea, assessed by a structured form filled out during outpatient follow-up, and no hospitalizations or modifica- tions in the therapeutic regimen. An exclusion criterion was the refusal to answer any questionnaire. The sample size was based on previous reliability studies of other quality of life questionnaires related to respiratory diseases in Brazil.12–15 Clinical evaluation and physical examination were per- formed by a team of physicians, based on a structured form. All patients met the stability criteria. The drug regimen used by the patients remained unchanged during the 15-day interval between questionnaire applications. In the first visit, the following independent variables were collected: gender (male and female proportion), age (in years), history of tobacco use (yes or no) and consumption (pack–years), histologic subtypes (adenocarcinoma, squa- mous cell, small cell lung cancer and others),16 staging according to the 1997 TNM classification for non-small cell lung cancer (NSCLC) patients (stratified from IA to IIIA and from IIIB to IV),17 Karnofsky Performance Status (KPS),18 spirometry (forced expiratory volume in the first second (FEV1) and forced vital capacity (FVC) percentage of predicted and FEV1/FVC percentage),19 MMSE, and FACT-L and FLSI scores.9 The Portuguese version of the FACT-L and FLSI was released for use by the FACIT group (the developer of the questionnaire). The translation into Brazilian Portuguese, back translation and review by an expert committee to access the semantic, conceptual, idiomatic, cultural and metabolic equivalences were previously done by that group.20,21 The FACT-L, version 4, is a combination of the 27-item FACT-General (FACT-G) and the 9-item Lung Cancer Subscale (LCS). A total FACT-G score is calculated by summing the physical well-being (PWB), social/family well-being (SWB), emotional well-being (EWB), and functional well-being (FWB) subscale scores, with a score ranging from 0 to 108. A total FACT-L score is obtained by summing the FACT-G score with the LCS (two of the nine items are not scored). The FACT-L score ranges from 0 to 136.6 The FACT-L Trial Outcome Index (FACT-L TOI) is, a priori, an index that sums the PWB, FWB, and LCS into a 21- item scale. Its score ranges from 0 to 84.6 The FLSI is a symptom index with six questions regarding the five most frequent symptoms reported by lung cancer patients, especially in the advanced stages: dyspnea, fatigue, pain, weight loss, and coughing. Its score ranges from 0 to 24. Higher scores generated by the FACT-L and FLSI correspond to better quality of life. The score on each aspect of the FACT-L and FLSI is obtained according to the option chosen by the patient. The available options were: ‘‘not at all’’, ‘‘a little bit’’, ‘‘some- 1248 CLINICS 2010;65(12):1247-1251 what’’, ‘‘quite a bit’’, or ‘‘very much’’. The higher the score obtained by each patient in question, the greater the final score of the subscale and the better the quality of life. However, these scores have a non-linear behavior. Patients answered the questionnaire after being read each question, all by the same interviewer. The process took place in a calm environment with no interruptions allowed. The questionnaires were reviewed at the end of the interview to avoid any missed questions. The response time was timed in the two visits. All doubts expressed by patients during the questionnaire were documented. Patients were also asked not only about what they felt in terms of question content, but also about the length of the questionnaire. The test–retest design was adopted for the reliability study. The questionnaire was administered by the same researcher twice with a 15-day interval. The scores obtained on different scales and subscales of FACT-G were compared with reference values established by the FACIT group.22 For this comparison, we used the minimal clinically significant difference, determined by the same group.6 Statistical analysis Variables were expressed as mean and standard devia- tion. The intraclass correlation coefficient (ICC) and Kappa reliability coefficient were calculated to assess the reliability of the questionnaire and questions respectively. To compare the two groups, we used the chi-square test for categorical variables, t test for parametric continuous variables, and Mann–Whitney test for nonparametric continuous variables. For the correlations between spirometry and questionnaire scores, the Spearman’s correlation coefficient was used. Statistical analysis was performed with SPSSH software version 13.0. All tests were two-tailed, and the level of significance was 5%. RESULTS The main characteristics of the 30 patients who completed the study are shown in Table 1. Some 63.3% of the patients were over 60 years of age. There was no statistically significant difference between genders regarding age, KPS, spirometry, staging, and histological type. Among patients who never smoked, only one had a history of passive smoking. There was a prevalence of smoking habits in males (p = 0.04), with a higher tobacco smoke load for men than for women, consuming a mean of 53.2 pack–years (SD = 31.6) and 29.6 pack–years (SD = 25.5) respectively (p = 0.02). Eight patients (26.7%) were diagnosed with chronic obstructive pulmonary disease (COPD), according to the GOLD guideline.23 The mean values for each scale of the FACT-L and FLSI are illustrated in Table 2. The intraclass correlation coefficient values for the different scales of the FACT-L and FLSI showed excellent correlations (Table 2). The kappa coefficient was used to test question reliability, which was less than 0.4 on questions GP1, GP5 (PWB), GS3, GS4, GS5 (SWB), GF1, GF2, GF3, GF5, GF6 (FWB), and LCL4 (LCS). The remaining questions had a moderate agreement. As for the FLSI, the kappa coefficient was moderate on