Translation, Cross-Cultural Adaptation, and Validation of the Lee Chronic Graft-versus-Host Disease Symptom Scale in a Brazilian Population

Abstract

The Lee chronic graft-versus-disease (cGVHD) Symptom Scale is a patient-reported instrument developed and validated in English to measure symptoms and functional impact of cGVHD. This tool has not been validated in a Latin America population. The Brazil-Seattle Chronic GVHD Consortium conducted a multicenter study at five Brazilian institutions to validate the Lee cGVHD Symptom Scale in adults with chronic GVHD. Study objectives included the translation and validation of the instrument in Brazilian Portuguese and evaluation of the correlation with other quality of life (QoL) tools (i.e., Medical Outcomes Study Short Form 36 [SF-36] and the Functional Assessment of Chronic Illness Therapy with Bone Marrow Transplant subscale [FACT-BMT]). Translation and validation were according to the American Association of Orthopedic Surgeons Outcome Committee guideline. Spearman’s correlation coefficient was used to measure construct validity. Reliability was assessed using Cronbach’s alpha and intraclass correlation coefficients. Between April 2011 and August 2012, 47 patients with cGVHD by the 2005 NIH criteria were enrolled in this study. Cohort median age was 48 (23–69) years and 29 (62%) were male. Lee cGVHD Symptom Scale reliability was adequate (Cronbach’s alpha 0.62–0.83). The correlations between similar domains of the Lee cGVHD Symptom Scale, SF-36 and FACT-BMT were moderate to high. The Brazilian Portuguese version of the Lee cGVHD Symptom Scale is valid and reliable and can be used in clinical trials of cGVHD in Brazil.

Classification systems for chronic graft-versus-host disease

“…The PRO surveys take a median of 10 to 15 minutes to complete 80 and include the Lee Symptom Scale, [82][83][84] and either the Short Form-36 (SF-36) 85 or the Functional Assessment of Chronic Illness Therapy Bone Marrow Transplant version (FACT-BMT) 86 plus the Human Activity Profile (HAP). 87 In addition, there is a patient chronic GVHD activity assessment form that captures skin itching, skin and/or joint tightening, mouth sensitivity, genital discomfort, eye symptoms, and global ratings of chronic GVHD severity and improvement.…”

Systematic Review of Patient-Reported Outcome Measures in Graft-versus-Host Disease

“…Higher scores indicate greater symptom burden [38]. The LSS was used in 24 included articles [6,9,27,28,30,[32][33][34][35][36][37][38]40,43,45,66,[70][71][72][73][74][75][76][77].…”

“…Internal consistency of the LSS was investigated by Lee et al in their seminal study [38] and by Vasconcellos de Souza et al [9] in their validation study of the Brazilian Portuguese translation of the LSS. The internal consistency of the summary score was good, with Cronbach's alpha of .90 and .86 (Table 6).…”

“…PROMs additionally enable the evaluation of a wide range of issues that go beyond the clinician's perspective of GVHD severity [8]. There are, however, challenges to collecting PROMs in GVHD patients, including age; gender; cultural and linguistic barriers [9]; the need to integrate PROMs into routine clinical workflow without increased workload; organizational issues such as staffing and data protection [10]; inconsistent use of PROMs in clinical trials [11]; lack of normal/reference values for some instruments that make interpretation difficult [12]; impact of external factors and personality on the outcomes, which can be variable over time [13]; and the need to minimize patient burden, particularly when patients are unwell [11]. Furthermore, PROMs require baseline evaluation to understand the relevance of changes over time [10], and the optimal timing of questionnaire collection is an important consideration [14].…”