Quality of Life/Patient Reported Outcomes

Patient Reported Outcomes (PRO) studies measure any aspect of a patient’s health status that is reported directly from the patient without any influence from a physician or outside agent. PROs can be used to measure the impact of a treatment on one or more aspects of patients’ health status, ranging from symptomatic to complex concepts such as quality of life. PRO instruments that are demonstrated to effectively measure a particular concept may generate evidence of a treatment benefit and may be used to support claims in approved product labeling.

Quality of Life studies (QOLs) are PROs that aim to evaluate how a treatment or disease affects a patient psychologically, socially, and physically. These studies take into consideration the patients’ own perspective of their treatment or disease. QOLs can identify specific healthcare needs, provide evidence that can lead to improved quality of care, and provide a rapid screening test to identify populations or individuals who might need a more detailed health needs assessment.

Outcome offers a hybrid of approaches to capture PRO data to meet the needs of diverse patient populations. Web-based diaries may be the perfect solution for some disease areas where relatively young patients are affected, whereas paper and IVRS solutions work better in older, more infirm patient groups. Our PRO solutions are designed to be easy-to-use and minimally burdensome to ensure patient compliance and participation. Outcome also offers significant scientific expertise in the development, validation, and evaluation of PRO-focused studies and registries.