Development of the Functional Assessment of Chronic Illness Therapy - Liver Transplant (FACT-LT) Scale.

Background: This study aims to propose an initial development of the FACT-Liver Transplant (FACT-LT) scale to assess the major physical and emotional concerns of patients before and after Orthotopic Liver transplant (OLT) due to acute and chronic liver failure and hepatocellular carcinoma. Methods: The FACT-LT was developed in two phases. In Phase I, items were generated: 1) through interviews with 10 OLT experts and 15 candidates for or recipients of both oncological and non-oncological OLT which identified relevant topics; 2) from the FACIT item bank. In Phase II, a questionnaire to assess item frequency, applicability, and comprehension was administered to 20 OLT experts and, to assess item difficulty, embarrassment and content irrelevance, to 30 transplant recipients or candidate patients (15 oncological, 15 non-oncological). Results: In Phase I, 44 items were formulated/reviewed, and 30 items were maintained. All the healthcare professionals interviewed rejected the recommendation to develop two different modules for cancer and non-cancer patients. In Phase II, the majority of the experts and patients expressed an overall satisfaction with the questionnaire, indicating that the items were relevant, comprehensible and not embarrassing (range 75% - 99%). The first version of the FACT-LT includes 28 items defining four QOL domains: 5 items relating to Physical Well-Being, 8 to Functional Well-Being, 13 to Emotional Well-Being, and 2 to Social/Family Well-Being. Conclusion: The preliminary results obtained were promising; however further studies are needed, in order to proceed with a FACT-LT validation process.