Harnessing the patient voice in prostate cancer research: Systematic review on the use of patient‐reported outcomes in randomized controlled trials to support clinical decision‐making

Abstract

Background Given the growing importance of patient‐reported outcomes (PROs) as part of “big data” in improving patient care, there is a need to provide a state‐of‐the‐art picture of the added value of using PROs in prostate cancer (PCa) randomized controlled trials (RCTs). We aimed to synthetize the most recent high‐quality PRO evidence‐based knowledge from PCa RCTs and to examine whether quality of PRO reporting in PCa research improved over time. Methods We conducted a systematic literature search using PubMed, from April 2012 until February 2019. For benchmarking purposes, we also included RCTs identified in our previously published review of RCTs (2004‐2012). Methodology for study identification and evaluation followed standardized criteria and a predefined data extraction form was used to abstract information. PRO quality of the studies was evaluated using the International Society of Quality of Life Research (ISOQOL) recommended criteria. Results A total of 55 new RCTs were published between April 2012 and February 2019. About 24 (43.6%) RCTs were found to be of high‐quality regarding PRO assessments. Of these, 13 (54.2%) have been reported in the most recent European Association of Urology (EAU) PCa Guidelines. Overall QoL and sexual, urinary, and bowel function were the most commonly reported PROs. FACT‐P, EPIC‐26, and EORTC QLQ‐C30 and/or its module PR25 were most frequently used as measurement tools. An overall improvement in the completeness of PRO reporting was noted over time. Conclusion Many PRO trials are currently not included in the EAU guidelines. Our findings suggest that there has to be a better consensus on the use of PRO data for PCa patients, which will then be reflected in the PCa Guidelines and future data collection. Homogeneity in PROs collection and measurement tools will in turn enable “big data” Consortia to increase the patients’ voice in clinical research.

Health-Related Quality of Life Assessment in Prostate Cancer Patient Undergoing Androgen Deprivation Therapy: Real-World Experience in the READT Study

“…We provide the first documented evidence of health state utility index scores during ADT initiation across various Asian populations at real-world setting, impacting both clinical practice and policy making. Health utility index scores serve as valuable information in patient-centered treatment recommendation consisting of both clinical and HRQOL outcomes [ 30 ]. This is crucial for clinicians to integrate patients’ perspectives and experiences in formulating an optimal treatment strategy during the shared decision-making process.…”

Assessment of Health-Related Quality of Life in Patients with Advanced Prostate Cancer—Current State and Future Perspectives

“…From 2004 to 2019, almost one out of three of the n = 120 studies reporting HRQOL from PC randomized-controlled trials used QLQ-C30 and/or its related PR25 module. This makes the QLQ-C30 one of the most frequently used HRQOL measure for PC together [ 26 ]. Conversely, in recent trials evaluating HRQOL in advanced PC, the use of EORTC-based questionnaires was less consistent (3 of 14 RCTs) [ 18 ].…”

Development and validation of the patient-reported outcome scale for chronic kidney disease

“…The use of patient-reported outcomes (PROs) in clinical care has gained an increasing amount of attention due to patient advocacy and the increasing appreciation of the central role that patients’ symptoms, emotions, and goals play in disease cognition [ 1 – 3 ]. PROs can describe specific symptoms, treatment preferences or aspects of overall health and provide insights into a patient’s well-being that cannot be captured by laboratory data alone [ 4 – 7 ]. PROs are particularly relevant to CKD patients’ care and health, as CKD patients have poorer functional status than those with other chronic conditions; thus, providers are largely unaware of the presence and severity of these symptoms [ 8 , 9 ].…”