OBJECTIVES: Desferal (DFO), the most common CT for IO, requires infusions of 8-12 hours, 5-7 days per week. Oral formulations are in development. Consequences of the high burden of current chelation therapy with Desferal are poor treatment adherence and satisfaction potentially leading to sub-optimal clinical outcome. However, CT-specific satisfaction questionnaires have not been developed. METHODS: Five steps were taken to develop the satisfaction questionnaire: literature review, patient interviews, clinician interviews, item generation and content validity testing. Three IO expert interviews and four patient interview transcripts were reviewed to assess satisfaction with DFO and reactions to a hypothetical oral CT. Items were developed based on these steps and tested in nine patients (US/UK). Patients also provided their opinions of current CT with DFO to ensure that no major concepts were omitted. RESULTS: The literature review revealed no IO or CT specific questionnaires, though several articles recounted DFO's inconvenience and impact. Patient and clinician interviews suggested that patients were most concerned about the efficacy, side effects, convenience and costs of any new IO treatment. Satisfaction with DFO was low, primarily due to local site reactions, inconvenience, and the constraining nature of the therapies. Presented with a hypothetical oral CT, patients unanimously preferred oral CT. A 40-item questionnaire was developed that assessed patients' expectations of and satisfaction with attributes identified as important including efficacy, safety, convenience and side effects, along with costs, overall satisfaction, treatment impact, patient compliance, and preferences. Results from the content validity testing resulted in additions to the instructions and the rewording of six items. CONCLUSION: To accurately assess satisfaction, patient input should be obtained. In the absence of real-life experience with the proposed therapy, unbiased hypothetical product profiles were used to elicit the dimensions important to patients, and this is consistent with established methods. Psychometric validation is currently underway.