Translation and cultural adaptation of the patient disease and treatment assessment form: A novel quality of life instrument for use in Taiwan

Aim: Quality of Life (QoL) is an important end‐point in cancer clinical trials, but its collection in multinational trials requires properly translated and validated instruments. We describe the development, piloting and planned validation of a traditional Chinese version of the Patient Disease Treatment and Assessment Form (Pt DATA Form) for use in Taiwan. Methods: The Pt DATA Form is a simple, multi‐item QoL instrument based on 11‐point numeric rating scales for a range of relevant symptoms and functions and aspects of well‐being, designed for use in routine clinical practice and clinical trials. The instrument underwent forward translation in Sydney and backward translation in Taiwan. A reconciled version was pre‐tested on healthy volunteers and then on 20 cancer patients in a Taiwanese clinic. Results: One hundred percent of patients reported that the items were clear and did not cause upset. Eighty five percent had no difficulty in completing the form while 10% found it fairly difficult. There were no difficulties with the instructions. Conclusion: This questionnaire was acceptable for use in Taiwan in its current format and will allow the collection of innovative data on Chinese cancer patients' experiences.