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

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. Plain English Summary: While survival rates are routinely used to evaluate treatment outcomes in oral cancer, increased understanding of the human cost of this disease highlights the need to also consider the impact of the disease and therapy on patients' quality of life (QoL). Measurement of quality of life outcomes requires a validated QoL questionnaire with proven applicability in that specific context. Little research has been undertaken on the QoL of cancer patients in Sudan and no published research exists to date on the QoL of Sudanese oral cancer patients. While an Arabic version of the FACT-G general questionnaire exists, the FACT-H&N module was not previously available in Arabic. This paper describes the translation of the FACT-H&N from English into Arabic to suit Sudanese patients and other Arabic-speaking patients, with a detailed pre-test review by 10 patients, a pilot study with 60 patients and further validation with 130 patients. This study represents the first QoL research undertaken in oral cancer patients in Sudan and provides some insight into the impact of oral cancer on their lives. Findings from this study indicate that the Arabic version of the FACT-H&N questionnaire is a valid, reliable and acceptable method for assessing health related QoL in Arabic-speaking Sudanese oral cancer patients. This work will benefit future researchers working with Arabic-speaking oral cancer patients. [ABSTRACT FROM AUTHOR]