Abstract
BackgroundGiven 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.MethodsWe 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.ResultsA 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.ConclusionMany 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.
Highlights
Receiving a diagnosis of cancer and undergoing its subsequent treatments does have a detrimental impact on physical function, but may affect psychological and social well-being of the individual
In the context of prostate cancer (PCa), we have previously evaluated the completeness of patient-reported outcome (PRO) reporting of 65 randomized controlled trials (RCTs) published between January 2004 and March 2012, which reported on PROs.[3]
To assess the clinical impact of the RCTs, we first identified the proportion of high-quality RCTs with respect to PRO reporting, which was 43.6%, an increase since 2012 when it was 20% (P < .01)
Summary
Receiving a diagnosis of cancer and undergoing its subsequent treatments does have a detrimental impact on physical function, but may affect psychological and social well-being of the individual. Patient-reported outcomes (PROs) addressing these domains of well-being (including both physical and psychosocial components) are increasingly being incorporated in randomized controlled trials (RCTs) to assess the effectiveness of cancer treatments. A recent Cochrane systematic review on psychosocial well-being and care needs of people with cancer 1 concluded that there is a need for more uniformity in outcomes and reporting, but importantly for combining PROs with objective clinical outcomes. These conclusions are in line with a recent report of the US Food and Drug Administration and the Critical Path Institute—as they are “committed to collaborate with international drug development stakeholders to identify rigorous methods to incorporate the patient perspective into the development of cancer therapeutics.”[2]. Homogeneity in PROs collection and measurement tools will in turn enable “big data” Consortia to increase the patients’ voice in clinical research
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