The development and demand for effective vaccines have witnessed an exponential growth over the last century. In the meantime, the vaccine market involves more knowledgeable stakeholders, with a shift in emphasis by regulatory agencies on understanding the patient perception and experience. The Food and Drug Administration’s publication of the patient-reported outcomes (PRO) guidance has elevated the discipline of PROs and has resulted in a transition from clinician reports of patient outcomes to PROs. This review reports various research methods, which utilize PROs, including qualitative and quantitative research, clinical trials, and patient preference studies. With the advancement of electronic PRO data capture, additional advantages of PROs are being observed and utilized (e.g. as a trigger for clinical endpoints). We discuss uses and advantages of including PROs into the clinical trial program to improve efficiencies, clinical relevance and overall validity of the program in the vaccine field. (See Plain Language Summary)

Objectives: Herpes zoster (HZ) is a painful condition caused by the reactivation of the varicella-zoster virus, negatively affecting the lives of patients. In this post hoc analysis, we describe the impact of HZ pain on the health-related quality of life (HRQoL) and activities of daily living (ADL) of immunocompetent individuals 50 years of age and older and in hematopoietic stem cell transplantation (HSCT) recipients age 18 years of age and older. Materials and Methods: ZOE-50 (NCT01165177), ZOE-70 (NCT01165229), and ZOE-HSCT (NCT01610414) were phase III, randomized studies conducted in immunocompetent adults 50 years of age and older and 70 years of age and older and in HSCT recipients age 18 years of age and older, respectively. This analysis was performed on patients who experienced an HZ episode in the placebo groups. The impact of varying levels of HZ pain on HRQoL and ADL was analyzed using data from the Zoster Brief Pain Inventory (ZBPI) and the Short Form Health Survey 36 (SF-36) and EQ-5D questionnaires. Results: A total of 520 immunocompetent and 172 HSCT individuals with HZ were included. SF-36 and EQ-5D domain scores showed a significant relationship between increased HZ pain and worsening HRQoL. For every increase of 1 in the ZBPI pain score, the estimated mean decrease (worsening) in score in the ZOE-50/70 and ZOE-HSCT, respectively, was 2.0 and 2.4 for SF-36 Role Physical; 2.1 and 1.8 for SF-36 Social Functioning; and 0.041 and 0.045 for EQ-5D utility. Sleep and General activities were the ADL components most affected. Discussion: Moderate and severe HZ pain had a substantial negative impact on all aspects of HRQoL and ADL. This impact was independent of age and immunosuppression.

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