Translation and validation of the Hindi, Marathi, and Bangla versions of the European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire: Anal Cancer (QLQ-ANL27) module: A prospective cohort study

Abstract

ABSTRACT Background: The European Organization for the Research and Treatment of Cancer (EORTC) has developed a commonly used validated questionnaire specific to anal cancer (EORTC QLQ-ANL27). It is used as an adjunct to the core EORTC quality-of-life (QoL) questionnaire QLQ-C30. This validated questionnaire was not available in any Indian language, and therefore, Indian patients not familiar with English could not fill it. Objective: We aimed to translate and validate the EORTC QLQ-ANL27 module in Hindi, Marathi, and Bangla languages. Materials and Methods: This study was conducted in the Department of Radiation Oncology at the Tata Memorial Hospital, a tertiary cancer center in Mumbai, India, from September 01, 2022, to March 31, 2023. The QLQ-ANL27 questionnaire was translated into Hindi, Marathi, and Bangla languages using the standard EORTC guidelines. The overall process comprised two independent forward translations of the original English questionnaire into the target languages, followed by reconciliation between the two forward translations. The reconciled version was then back translated to English. The report generated was sent to the EORTC translation unit (TU) for review. Once approved by the EORTC TU, these translated versions were pilot tested on 30 patients (10 for each language) with cancer of the rectum or anal canal. After responding to the questionnaires, each patient was individually interviewed to explore any difficulty encountered while answering the QoL questionnaire. The interviewer specifically asked whether the patients found any words or sentences difficult to answer, confusing, or upsetting, and for suggestions on better phrasing. Results: The EORTC QLQ-ANL27 was translated to Hindi, Marathi, and Bangla, followed by back translation into English within a period of 2 months between September 2022 and October 2022. The translated versions were approved by the EORTC TU in October 2022. Validation of the translated versions was conducted between December 2022 and March 2023 in 30 patients diagnosed with anorectal cancer. The median age of the patients was 55 (interquartile range, 29–77); the male-to-female ratio was 2:1. There were no suggestions or doubts in the Hindi, Marathi, and Bangla questionnaires during the pilot testing. After reviewing the pilot testing reports, the EORTC TU approved the translated versions of QLQ-ANL27. The reliability of the translated questionnaires was confirmed using Cronbach’s alpha, which were 0.838, 0.743, and 0.808 for the Hindi, Marathi, and Bangla versions, respectively. Conclusions: The Hindi, Marathi, and Bangla translations of the QLQ-ANL27 module have been validated and approved by the EORTC and are now available for use (Clinical Trials Registry-India, CTRI/2022/12/047970).