Translation, linguistic validation and reliability of FACT-H&N questionnaire in Oral Cancer patients in Sudan

Abstract

Background: This study aimed to translate and validate an Arabic version of the Functional Assessment of Cancer Therapy Head and Neck Scale (FACT-H&N, v-4) for use among Sudanese oral cancer patients. Methods: The instrument underwent translation and validation following the standard FACT translation methodology. The translated instrument was pre-tested for face validity and content validity using semi-structured, in-depth interviews with ten oral cancer patients to assess acceptability. The questionnaire was pilot tested with 60 patients; reliability was tested for internal consistency with Cronbach’s alpha while construct validity was tested using ‘known-group validity’. Results: The pre-test study revealed no major issues, apart from a reluctance to answer questions on sexual satisfaction. The FACT-H&N demonstrated good internal consistency, it considered five particular constructs: PWB, SWB, EWB, FWB and FACT-H&N, their Cronbach’s α values were positive and close to 1 with values of 0.85, 0.788, 0.86, 0.895 and 0.703 respectively, indicating that the questionnaire was valid and the responses consistent. Sixty patients were asked the global health-related quality of life item, 36.3% rated their QOL as very good or good (36.3%), while 41.7% rated it as average, and 21.7% as poor or very poor. Then FACT subscale mean scores were tabulated against three categories; patients with very poor/poor recorded significantly lower scores indicating construct validity. Some psychometric properties were consistent with other FACT-H&N translations such as the Chinese, French, Pakistani and Malaysian. Conclusions: This study validates the Arabic version of the FACT-H&N. It is a reliable tool and, will assist further QoL research in other Arabic-speaking countries.