Quality of Life Research (2006) 15:15191524 DOI 10.

1007/s11136-006-0009-9

Springer 2006

Brazilian version of the QLQ-LC13 lung cancer module of the European Organization for Research and Treatment of Cancer: preliminary reliability and validity report
Pereira Brabo1, Marcos Eduardo Machado Paschoal2, Irene Biasoli3, Fernanda Esteves Nogueira4, Eloa Magda Conceic a o B. Gomes4, Isabelle Pimentel Gomes5, Leila Cristina Andrade Martins6 & 3 Nelson Spector 1 Oncology Service, University Hospital, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil (E-mail: eloa@huc.ufrj.br); 2Pneumology Service, Institute of Thoracic Diseases, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil; 3Hematology Service, University Hospital and School of Medicine, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil; 4Resident from the Oncology Service, University Hospital, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil; 5Chemotherapy Unit from CETHO, Rio de Janeiro, Brazil; 6Chemotherapy Unit from Oncoclnica, Rio de Janeiro, Brazil
Accepted in revised form 22 April 2006

Abstract This study reports the reliability and validity of the Brazilian Portuguese version of QLQ-LC13. After translation and cross-cultural adaptation, the questionnaire was administered, together with the QLQ-C30 core questionnaire, to 82 patients with lung cancer. The analysis was based on 60 patients who completed two interviews, and who received chemotherapy alone or in combination with radiotherapy. The reliability or internal consistency of dyspnea scale was 0.79. The pain scale needed to be combined with the QLQ-C30 pain items to reach a satisfactory value of 0.73. The construct validity was supported by the ability of the questionnaire to discriminate patients regarding their performance status and type of treatment. However, the change over time, although in the expected direction for all items, was statistically signicant in four of the 10 items studied. The criterion-related validity was supported by the statistically signicant correlation between all four side eect items and the physicians reports of toxicity, while the evolutive changes in the performance status were statistically signicant in only four items. Most psychometric properties of the Brazilian version of the QLQ-LC13 were adequately supported in this analysis. However, a wider utilization of this module is necessary to fully ascertain its reliability and validity properties. Key words: Brazil, EORTC QLQ-LC13, Lung cancer, Quality of life

Introduction Lung cancer is the leading cause of cancer in Brazil, where more than 70% of the patients present with advanced disease [1]. Treatment approach for these patients is mostly palliative, and a number of therapeutic alternatives are available [2]. Quality of life is a major consideration in this context, and the

adequate evaluation of the quality of life is therefore an essential endpoint [3]. The Quality of Life Group of the EORTC has developed a number of questionnaires for this evaluation [4], which include the Quality of Life Core questionnaire (QLQ-C30) [5] and various cancer specic modules, such as the lung cancer module [6].

1520 Under the guidance of the EORTC Quality of Life Group, and following their written guidelines [7], we have performed the translation and cross-cultural adaptation of the lung cancer module (QLQ-LC13). The forward/backward translation process was provided by the EORTC and the cross-cultural adaptation was performed by pilot-testing and by structured interviews. The purpose of this study was the validation of the Brazilian Portuguese version of the QLQLC13, in order to allow Brazilian investigators to use this tool both in clinical trials and in clinical practice. The treating physician rated the performance status (PS) according to the Eastern Cooperative Oncology Group (ECOG) scale before and during treatment. Treatment toxicity was rated using selected items of the Common Toxicity Criteria (CTC) of the National Cancer Institute (dysphagia, mucositis and neuropathy-sensory) [8]. Patients were encouraged to self-complete the questionnaires, but an interview was oered and, if chosen, was performed by one of the authors. The Ethics Committee of the University Hospital approved the study, and all patients signed the informed consent form. The instrument Patients and methods Design This study was done in accordance to the procedure for module validation of the EORTC [7]. The QLQ-LC13 and the QLQ-C30 were prospectively administered to a cohort of patients with lung cancer at two points in time: before the rst cycle of chemotherapy, and during treatment, usually before the third cycle. Study population Patients were recruited from the public University Hospital of the Federal University of Rio de Janeiro, and from two private oncology clinics in Rio de Janeiro. Patients were included if they had a pathologic diagnosis of lung cancer and were candidates for chemotherapy. The questionnaires were administered to 82 patients, 67 in the University Hospital and 15 in the private clinics. Fifteen patients did not complete the second interview, due to death (10), no treatment (4) and confusion secondary to cerebral metastasis (1). Seven patients received radiotherapy only, and were excluded. The study analysis was done with the remaining 60 patients. The median age was 61 years (3686), 70% were men, and 56% had less than 8 years of education; only 13% had completed superior education. Among patients from the University Hospital, 79% had less than 8 years of education, versus 21% in the private setting (p = 0.001). The clinical characteristics are presented in Table 1. The QLQ-LC13 questionnaire consists of 13 items, 2 symptoms (cough and hemoptysis) and 4 side eects (dysphagia, hair loss, neuropathy and sore mouth), are covered by one item each. Two multi-item scales are formed for pain and dyspnea, respectively, comprising three items each. In summary, it has four items on side eects (sore mouth 1, dysphagia 1, neuropathy 1 and hair loss 1), eight items on symptoms (dyspnea 3, pain 3, cough 1 and hemoptysis 1) and one item on pain medication, which is not scored. All items employed a 1-week time frame and were scored on a 4-point categorical scale ranging from 1 to 4. All responses are linearly transformed to a 0 to 100 scale, according to the scoring manual provided by the EORTC, with higher scores representing increasing symptom levels [9]. Statistics The reliability, or internal consistency, of the pain and dyspnea multi-item scales was measured by the Cronbachs a coecient. Estimates of a magnitude 0.70 were considered acceptable [10]. QLQ-C30 items were included according to the manual [9]. Construct validity was examined by the discriminative property and by the responsiveness. The MannWhitney test was used to test the ability of the scores to distinguish between subgroups of patients with dierent clinical features (discriminative property). The Wilcoxon test was employed to compare pretreatment with on-treatment scores (responsiveness). Criterion-related validity was tested in two ways. The QLQ-LC13 score changes were com-

1521
Table 1. Clinical characteristics Characteristic Histopathologic type Non-small cell Small cell Others Stage Local Loco-regional Metastatic/relapsed Performance status (ECOG) 0 1 2 3 4 Weight loss None 10% >10% Treatment Chemotherapy Chemoradiotherapy N Percent

50 8 2 2 37 20 8 40 7 3 1 20 22 18 39 21

83% 13% 4% 3% 63% 34% 13% 68% 12% 5% 2% 33% 37% 30% 65% 35%

24 = bad), was signicantly related to pretreatment dyspnea (p = 0.004) and to shoulder/arm pain (p = 0.024), as shown in Table 3. Dysphagia had higher scores in patients receiving combined chemoradiotherapy, when compared to chemotherapy alone (p = 0.006). The symptoms decreased and the side eects increased over time, as expected. Two items in each group reached statistical signicance, as shown in Table 4. Sixty percent of the patients had no changes in their PS over time. The dyspnea scale, shoulder/arm pain, neuropathy and hair loss scores changed signicantly (Table 5). Finally, the side eect scores correlated signicantly with the CTC rated by the physician. The Spearman correlation coecients for sore mouth, dysphagia and neuropathy were 0.412, 0.726 and 0.724, respectively. All these tests were signicant at the 0.01 signicance level. Hair loss was evaluated according to the alopecia expected for each type of chemotherapy, and was signicant at the 0.01 level (correlation coecient = 0.524).

pared with changes in the performance status by the Friedman test. The on-treatment QLQ-LC13 side eects were correlated with the corresponding toxicity, as rated by the treating physician, using the Spearman Correlation coecient.

Discussion The Brazilian version of QLQ-LC13 was well accepted. The application was quick and easy to perform, conrming the usefulness of the module as a supplement to the core questionnaire. We were especially concerned with the patients understanding of the module. Patients were recruited in both public and private settings to
Table 2. Reliability of the multi-item scales of pretreatment QLQ- LC13 Scale Itemsa Mean score SDb Cronbachs a coecientc

Results The acceptability of the questionnaire was very good. The average time required to complete both questionnaires was 10 minutes. In the pretreatment and on-treatment data collections, only 23% and 12% of the patients selfcompleted the questionnaires, respectively; the others chose to have an interview. In the University Hospital group 17% self-completed the questionnaire while 46% did it in the private clinic group (p = 0.02). The reasons for the interview option (46 patients) were personal preference (27), reading diculties (16) and others (3). The internal consistency of the dyspnea and pain scales is presented in Table 2. The QLQLC13 pain scale did not perform reliably without the QLQ-C30 items. No signicant eect of disease stage was noted on the scores of symptoms. In contrast, the PS, when recoded into two levels (01 = good,

Dyspnea QLQ-LC13 QLQ-LC13 +QLQ-C30d Pain QLQ-LC13 QLQ-LC13 +QLQ-C30d

3 4 3 5

35.4 38.8 29.5 36.9

30.9 32.6 25.5 29.1

0.79 0.85 0.44 0.73

a Values correspond to the numbers of items of the scale in the questionnaires. b SD - standard deviation. c Alpha values 0.70 indicate adequate scale reliability. d QLQ-LC13 +QLQ-C30 combination of the items of dyspnea scale or pain scale from both questionnaires.

1522
Table 3. QLQ-LC13 pretreatment mean symptom scores by performance status (PS) Pretreatment PS PS 01 PS 23 p value MannWhitney Test. Coughing 30.0 29.9 0.992 Hemoptysis 30.1 29.2 0.824 Dyspnea 26.6 43.3 0.004 Chest pain 28.2 37.7 0.072 Shoulder/arm pain 27.8 39.5 0.024 Extrathoracic pain 29.5 26.6 0.569

allow an analysis of the impact of the educational level on the questionnaires functional properties. The Flesch Readability Index of the document was 57, which corresponds to the Time Magazine language, and requires high school for full understanding [11]. Brazilian ocial sources report that 25% of our 8th grade students have great diculty comprehending what they read [12]. This is probably the main reason for the high percentage (77%) of patients who opted for interviews. The data available [5, 13] suggest that the mode of administration (self vs. interview) does not inuence the

questionnaires performances. However, it is important to highlight that, in the present study, a choice was always oered and most patients opted for the interview. This does suggest that investigators should be cautious regarding patient self-administration of the Brazilian translation. As in the original report, the pain scale did not perform reliably. However, the dyspnea scale did support the reliability property of the instrument. The large percentage of patients with advanced loco-regional non-small cell lung cancer may account for the high pretreatment scores of

Table 4. QLQ-LC13 mean side eect scores and mean symptom scores over time Sore mouth Mean side eect scores over time Pretreatment 1.6 On-treatment 9.6 p value 0.031 Coughing Mean symptom scores over time Pretreatment 53.8 On-treatment 47.7 p value 0.148 Wilcoxon Signed Rank Sum Test. Table 5. Responsiveness of QLQ-LC13 mean scores to changes in performance status over time Improved Items/scales Coughing Hemoptysis Dyspnea Chest pain Shoulder/arm pain Extrathoracic pain Sore mouth Dysphagia Neuropathy Hair loss pre* 52.3 7.1 46.0 30.9 45.2 18.1 2.5 21.4 28.5 0 on** 38 2.3 23.0a 21.4 33.3 15.1 7.6 14.2 33.3 59.5b pre 56.1 6.6 33.0 28.4 25.7 30.3 0.9 10.4 24.7 7.6 Unchanged on 47.6 0.9 28.1 24.5 17.1a 23.2 7.6 17.1 15.2 68.5c pre 53.3 13.3 27.7 23.3 26.6 33.3 3.3 0 3.3 0 Deteriorated on 63.3 6.6 31.1 30.0 13.3 56.6 20.0 16.6 26.6a 66.6b Dysphagia Neuropathy Hair loss

11.1 16.1 0.306 Hemoptysis

21.6 22.2 0.955 Dyspnea

4.4 65.5 0.0001 Chest pain Shoulder/arm pain Extra thoracic pain

7.7 2.2 0.013

35.4 27.5 0.173

31.6 25.4 0.505

28.3 20.5 0.019

29.8 26.9 0.751

Friedman Test. * =pretreatment mean score; **=on-treatment mean score. a p<0.05; bp<0.01; cp<0.001.

1523 neuropathy and pain, when compared to the original report of QLQ-LC13, [6] and for the absence of statistically signicant dierences on the rating of symptoms by disease stage. The lack of statistical signicance of some measures is probably a consequence of the relatively small number of patients studied. However, the construct validity could be partially supported by the discrimination between patient subgroups that diered in their initial performance status. The item on dysphagia signicantly discriminated the two modalities of treatment, chemotherapy or combined chemoradiotherapy. The responsiveness was also conrmed, as the scores changed in the expected direction, although only four (sore mouth, hair loss, hemoptysis and shoulder/arm pain) reached statistical signicance. The criterion-related validity was conrmed by the signicant correlation observed when examining the items on side eects and the corresponding CTC toxicity, as rated by the physician. The change in performance status over time was statistically signicant only for the dyspnea, shoulder/arm pain, neuropathy and hair loss. More than 80% of the patients had an initial PS of 0 or 1, and 60% remained unchanged. As previously reported [5, 6], this modality of testing the validity cannot provide robust results, even with larger samples. In summary, the reliability and validity of the Brazilian Portuguese version of QLQ-LC13 could be demonstrated in this study, but additional work is needed to assess the self-administered approach and to ascertain its psychometric properties. The validation of this important instrument will allow Brazilian investigators to take part in national and international collaboration research projects, and to assess the quality of life of patients with lung cancer in clinical practice. Appendix Brazilian Version of QLQ-LC13

EORTC QLQ-LC13
Por vezes, os pacientes se queixam da ocorre ncia dos seguintes que ponto sentiu esses sintosintomas. Por favor, indique ate mas ou problemas na semana passada, fazendo um c rculo em volta do nu mero que melhor se aplica a voce . Durante a semana passada: Na o Pouco Modera damente Muito

Acknowledgements The authors wish to thank Ms. Karen West, from the Quality of Life Unit of the EORTC, for assistance throughout the translation and cultural adaptation phases of the study. We are also grateful to the staffs of Cetho and Oncocl nica for their kind cooperation.

1. Quanto tossiu? 1 2 3 2. Tossiu sangue? 1 2 3 3. Sentiu falta de 1 2 3 ar enquanto repousava? 4. Sentiu falta de ar 1 2 3 enquanto andava? 5. Sentiu falta de ar 1 2 3 enquanto subia escadas (se subisse)? 6. Sentiu sua boca 1 2 3 ou l ngua doloridas? 7. Sentiu diculd1 2 3 ade ao engolir? 8. Sentiu dorme ncia 1 2 3 (formigueiro) nas s? ma os ou nos pe 9. Teve queda de 1 2 3 cabelo? 10. Sentiu dores no 1 2 3 peito? 11. Sentiu dores no 1 2 3 brac o ou no ombro? 12. Sentiu dores em 1 2 3 outras partes de seu corpo? Em caso armativo, onde:____________ 13. Tomou algum medicamento para passar a dor? 1 Na o 2 Sim Em caso armativo, 1 2 3 que ponto a dor ate melhorou?

4 4 4

4 4

4 4

4 4 4

QLQ-LC13 Direitos Autorais 1994 EORTC Grupo de Estudo sobre Qualidade de Vida. Todos os direitos reservados.

1524 References
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