US Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health and Center for Biologics Evaluation and Research (2016) Patient Preference Information—Voluntary Submission, Review in Premarket Approval Applications, Humanitarian Device Exemption Applications, and de Novo Requests, and Inclusion in Decision Summaries and Device Labeling. Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders.
http://www.fda.gov/downloads/MedicalDevices/ DeviceRegulationandGuidance/GuidanceDocuments/ UCM446680.pdf

has been cited by the following article:

• TITLE: Patient and Physician Preferences for Treating Adjuvant Melanoma: A Discrete Choice Experiment

  AUTHORS: Kathleen Beusterien, Mark R. Middleton, Peter Feng Wang, Sumati Rao, Srividya Kotapati, Javier Sabater, Baiju Aurora, John F. P. Bridges

  KEYWORDS: Melanoma, Adjuvant Therapy, Discrete Choice Experiment

  JOURNAL NAME: Journal of Cancer Therapy, Vol.8 No.1, January 19, 2017

  ABSTRACT: Objective: To evaluate and compare patient and physician preferences for the benefits and risks of currently available adjuvant melanoma treatments. Methods: Patients with stage II/III melanoma and oncologists in the USA were recruited from 6 clinical sites and an online panel to complete a survey. Preferences were assessed using a paired comparison discrete choice experiment that allowed for opt-out (i.e. no treatment). The treatments comprised 7 attributes, each with 3 levels associated with pegylated interferon, high-dose interferon, and ipilimumab. Attributes included efficacy outcomes, dosing regimen, and risks of moderate to severe toxicities. In addition, open-ended maximum acceptable risk (MAR) questions assessed tradeoffs between toxicity risk and efficacy. Results: 142 patients (45 stage II; 97 stage III) chose a treatment in 78% of the choice tasks, while physicians (N = 127) chose treatment 79% of the time. The rankings of relative attribute importance were concordant between the patients and physicians for the top 4: 10-year survival in metastatic melanoma, fatigue risk, 3-year recurrence-free survival (RFS), and depression risk. Patients and physicians valued the difference in 21% survival versus no survival benefit about 3 and 4 times as much, respectively, as reducing diarrhea risk from 41% to 1% or reducing depression risk from 40% to 1%. The MAR of severe diarrhea and of a life-threatening event increased as the chance of 3-year RFS increased, with patients reporting higher risks than physicians. Conclusion: Patients and physicians were concordant in their preferences in adjuvant melanoma, preferring treatment versus none and judging potential efficacy to outweigh risks of toxicities.