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Patient-reported outcomes in randomised controlled trials of prostate cancer: methodological quality and impact on clinical decision making.

ABSTRACT: Patient-reported outcomes (PRO) data from randomised controlled trials (RCTs) are increasingly used to inform patient-centred care as well as clinical and health policy decisions.The main objective of this study was to investigate the methodological quality of PRO assessment in RCTs of prostate cancer (PCa) and to estimate the likely impact of these studies on clinical decision making.A systematic literature search of studies was undertaken on main electronic databases to retrieve articles published between January 2004 and March 2012. RCTs were evaluated on a predetermined extraction form, including (1) basic trial demographics and clinical and PRO characteristics; (2) level of PRO reporting based on the recently published recommendations by the International Society for Quality of Life Research; and (3) bias, assessed using the Cochrane Risk of Bias tool. Studies were systematically analysed to evaluate their relevance for supporting clinical decision making.Sixty-five RCTs enrolling a total of 22 071 patients were evaluated, with 31 (48%) in patients with nonmetastatic disease. When a PRO difference between treatments was found, it related in most cases to symptoms only (n=29, 58%). Although the extent of missing data was generally documented (72% of RCTs), few reported details on statistical handling of this data (18%) and reasons for dropout (35%). Improvements in key methodological aspects over time were found. Thirteen (20%) RCTs were judged as likely to be robust in informing clinical decision making. Higher-quality PRO studies were generally associated with those RCTs that had higher internal validity.Including PRO in RCTs of PCa patients is critical for better evaluating the treatment effectiveness of new therapeutic approaches. Marked improvements in PRO quality reporting over time were found, and it is estimated that at least one-fifth of PRO RCTs have provided sufficient details to allow health policy makers and physicians to make critical appraisals of results.In this report, we have investigated the methodological quality of PCa trials that have included a PRO assessment. We conclude that including PRO is critical to better evaluating the treatment effectiveness of new therapeutic approaches from the patient's perspective. Also, at least one-fifth of PRO RCTs in PCa have provided sufficient details to allow health policy makers and physicians to make a critical appraisal of results.

SUBMITTER: Efficace F

PROVIDER: S-EPMC4150854 | biostudies-literature | 2014 Sep

REPOSITORIES: biostudies-literature

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Patient-reported outcomes in randomised controlled trials of prostate cancer: methodological quality and impact on clinical decision making.

Efficace Fabio F Feuerstein Michael M Fayers Peter P Cafaro Valentina V Eastham James J Pusic Andrea A Blazeby Jane J

European urology 20131030 3

<h4>Context</h4>Patient-reported outcomes (PRO) data from randomised controlled trials (RCTs) are increasingly used to inform patient-centred care as well as clinical and health policy decisions.<h4>Objective</h4>The main objective of this study was to investigate the methodological quality of PRO assessment in RCTs of prostate cancer (PCa) and to estimate the likely impact of these studies on clinical decision making.<h4>Evidence acquisition</h4>A systematic literature search of studies was und ...[more]

PMID: 24210091

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Project description:BackgroundIn the past few decades, there has been an increasing focus on the importance of patient involvement in the health care system. Patient participation executed through patient-reported outcomes (PROs) and the integration of such into clinical practice has been framed as positive for patients, care providers, and the health care system as a whole. This review aims to elucidate and discuss the current and future use of PROs in clinical practice and to identify the most common types of PRO measures (PROMs) used for patients with hip or knee osteoarthritis in different treatment settings.MethodsThe following databases were searched: PubMed, Embase, CINAHL, Scopus, the Cochrane Library, and EconLit. For inclusion in the study, studies had to cover either knee or hip osteoarthritis and report on PROs. The type of PROM, treatment setting, and study design of each included study were extracted from their respective abstracts. Additionally, the full text of studies concerning PROs as an integrated part of clinical practice was examined and information on the year of publication, study design, topic, and use of PROMs was extracted.ResultsIt was found that only two pilot studies reported on the use of PROs as an integrated part of patient treatment within hip or knee osteoarthritis. In 349 studies, a total of 38 different PROMs relevant for patients with either hip or knee osteoarthritis were identified. The EQ-5D, WOMAC, and VAS questionnaires were the most commonly reported generic, disease-specific, and domain-specific PROMs, respectively. However, a large variation in the use of different PROMs both within and between surgical and nonsurgical settings was found.ConclusionLimited evidence on the use of PROs as an integrated part of clinical practice for patients with hip and knee osteoarthritis was found. Further research is necessary to clarify the effects on patient outcomes of using PROs in clinical practice. In addition, there is limited agreement on a joint standard for the use of PROMs both within and across the sectorial boarders. Further exploration of PROMs to generate future standardisation is suggested.

Project description:IntroductionWhile there is mounting evidence of the independent prognostic value of patient-reported outcomes (PROs) for overall survival (OS) in patients with cancer, it is known that the conduct of these studies may hold a number of methodological challenges. The aim of this systematic review is to evaluate the quality of published studies in this research area, in order to identify methodological and statistical issues deserving special attention and to also possibly provide evidence-based recommendations.Methods and analysisAn electronic search strategy will be performed in PubMed to identify studies developing or validating a prognostic model which includes PROs as predictors. Two reviewers will independently be involved in data collection using a predefined and standardised data extraction form including information related to study characteristics, PROs measures used and multivariable prognostic models. Studies selection will be reported following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, with data extraction form using fields from the Critical Appraisal and Data Extraction for Systematic Reviews of Prediction Modelling Studies (CHARMS) checklist for multivariable models. Methodological quality assessment will also be performed and will be based on prespecified domains of the CHARMS checklist. As a substantial heterogeneity of included studies is expected, a narrative evidence synthesis will also be provided.Ethics and disseminationGiven that this systematic review will use only published data, ethical permissions will not be required. Findings from this review will be published in peer-reviewed scientific journals and presented at major international conferences. We anticipate that this review will contribute to identify key areas of improvement for conducting and reporting prognostic factor analyses with PROs in oncology and will lay the groundwork for developing future evidence-based recommendations in this area of research.Prospero registration numberCRD42018099160.

Dataset Information

Patient-reported outcomes in randomised controlled trials of prostate cancer: methodological quality and impact on clinical decision making.

Publications

Patient-reported outcomes in randomised controlled trials of prostate cancer: methodological quality and impact on clinical decision making.

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