Patient Reported Outcomes in Clinical Trials and Practice with Older Patients
Patient-reported outcomes (PRO) retrieve information directly from the patient on their perception and experience with a therapeutic intervention. PRO concepts are developed case-by-case for their specific application. They are being used in clinical rese
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Abstract Patient-reported outcomes (PRO) retrieve information directly from the patient on their perception and experience with a therapeutic intervention. PRO concepts are developed case-by-case for their specific application. They are being used in clinical research and clinical practice to support a variety of different purposes like labeling claims, comparative effectiveness research, patient communication, therapeutic decision making, and health policy development. Some remaining challenges with PRO measures are being addressed and will continue to drive the implementation into research and clinical practice over the coming years. Applying and integrating PRO measures, especially in older patient populations, early on in the development of a new drug product can provide the opportunity for enhanced drug product design, including additional label claims. Keywords Patient reported outcomes Older adults
Patient perception Patient expectation
Introduction The traditional medical and pharmaceutical perspective of developing a new drug product as well as its prescription to patients later on have been focused on the medicine’s potential to modify the physiological deviation underlying the disease or its symptoms [1]. This perspective assumed that, by correcting the physiological and clinical parameter, the disease and the symptoms could be sufficiently controlled to enhance the patient’s health and wellbeing. With the advances in pharmaceutical and medical sciences in the past decade, the clinical parameter as the sole indicator for the clinical outcome of a therapeutic intervention has been shifted S. Stegemann (&) Graz University of Technology, Graz, Austria e-mail: [email protected] S. Stegemann Capsugel, Bornem, Belgium © American Association of Pharmaceutical Scientists 2016 S. Stegemann (ed.), Developing Drug Products in an Aging Society, AAPS Advances in the Pharmaceutical Sciences Series 24, DOI 10.1007/978-3-319-43099-7_9
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to a broader context by including the patient’s perception of the disease conditions and the effects of the related treatment on their quality of life. This is recognizing the fact that health and wellbeing composes the objective as well as the subjective endpoints of the physical, mental and social domains. The World Health Organization Quality of Life Assessment group (WHOQOL) published a position paper in 1995 on assessing a patient’s personal perception of a therapeutic intervention. This position paper considered the patient’s life in the context of culture, values, goals, expectations, concerns and other personal aspects of life [2]. This concept of Health related Quality of Life (HRQoL) has further evolved into the Patient Reported Outcomes (PRO) that are defined as, “(…) any report of the status of a patient’s health condition that comes directly from the patient, without interpretation of the patient’s response by a clinician or anyone else.” [3]. Originally targeted to investigate the therapeutic outcomes and the risk-benefit for the patient i
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