Patient-reported outcomes (PROs) assess a person’s experience, feelings, and thoughts about both their condition and its treatment. PROs are able to contribute to a benefit assessment of new medical products by introducing the patients’ subjective evaluation of medical products into the evaluation process. Thus, PROs are also the cornerstone of medical product development for understanding patients’ perceptions on medical products and/or its benefit assessment. In the past 15 years, PROs were also evaluated in most clinical trials performed with continuous glucose monitoring systems. However, in its recent evaluation of such trials, the German Institute for Quality and Efficiency in Health Care (IQWiG)—which has to provide an evidence-based review of the …
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Barnard et al. (2015) studied this question.