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Patient-reported outcomes in randomised clinical trials of bladder cancer: an updated systematic review.

ABSTRACT: BACKGROUND:Despite international recommendations of including patient-reported outcomes (PROs) in randomised clinical trials (RCTs), a 2014 review concluded that few RCTs of bladder cancer (BC) report PRO as an outcome. We therefore aimed to update the 2014 review to synthesise current evidence-based knowledge of PROs from RCTs in BC. A secondary objective was to examine whether quality of PRO reporting has improved over time and to provide evidence-based recommendations for future studies in this area. METHODS:We conducted a systematic literature search using PubMed/Medline, from April 2014 until June 2018. We included the RCTs identified in the previous review as well as newly published RCTs. Studies were evaluated using a predefined electronic-data extraction form that included information on basic trial demographics, clinical and PRO characteristics and standards of PRO reporting based on recommendation from the International Society of Quality of Life Research. RESULTS:Since April 2014 only eight new RCTs for BC included PROs as a secondary outcome. In terms of methodology, only the proportion of RCTs documenting the extent of missing PRO data (75% vs 11.1%, p =?0.03) and the identification of PROs in trial protocols (50% vs 0%, p =?0.015) improved. Statistical approaches for dealing with missing data were not reported in most new studies (75%). CONCLUSION:Little improvement into the uptake and assessment of PRO as an outcome in RCTs for BC has been made during recent years. Given the increase in (immunotherapy) drug trials with a potential for severe adverse events, there is urgent need to adopt the recommendations and standards available for PRO use in bladder cancer RCTs.

SUBMITTER: Van Hemelrijck M

PROVIDER: S-EPMC6744649 | biostudies-literature | 2019 Sep

REPOSITORIES: biostudies-literature

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Patient-reported outcomes in randomised clinical trials of bladder cancer: an updated systematic review.

Van Hemelrijck Mieke M Sparano Francesco F Josephs Debra D Sprangers Mirjam M Cottone Francesco F Efficace Fabio F

BMC urology 20190914 1

<h4>Background</h4>Despite international recommendations of including patient-reported outcomes (PROs) in randomised clinical trials (RCTs), a 2014 review concluded that few RCTs of bladder cancer (BC) report PRO as an outcome. We therefore aimed to update the 2014 review to synthesise current evidence-based knowledge of PROs from RCTs in BC. A secondary objective was to examine whether quality of PRO reporting has improved over time and to provide evidence-based recommendations for future studi ...[more]

PMID: 31521149

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Project description:IntroductionDiabetes mellitus is the most common metabolic complication of pregnancy and its prevalence worldwide is rising. The number of randomised controlled trials (RCTs) being conducted in people with diabetes is also increasing. Many studies preferentially publish findings on clinical endpoints and do not report patient-reported outcomes (PROs). In studies that do include PROs, PRO reporting is often of poor quality.MethodsWe will conduct this systematic review following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Using a combination of medical subject headings and keywords (combined using Boolean operators), we will search web-based databases (PubMed, Cochrane and EMBASE) for RCTs published in English between 2013 and 2021. Two reviewers will review titles and abstracts. We will review the full texts of any relevant abstracts and extract the following data: date of publication or recruitment period, journal of publication, country of study, multicentre or single centre, population and number of participants, type of intervention, frequency of PRO assessment and type of PRO (or PRO measurement) used. We will also record if the PRO was a primary, secondary or exploratory outcome. We will exclude reviews, observational studies, unpublished data for example, conference abstracts and trial protocols. Any published RCT that includes data on a PRO as a primary or secondary outcome will then be compared against the Consolidated Standards of Reporting Trials-Patient-Reported Outcome extension checklist, a structured and approved framework for the publication of results of PROs.Ethics and disseminationEthical approval to conduct this study was obtained from the ethics committee at Galway University Hospitals on 24 March 2021 (CA 2592). We aim to publish our findings in a peer-reviewed journal and present our findings at national and international conferences.Systematic review registrationThis systematic review was registered prospectively with the International Prospective Register of Systematic Reviews (PROSPERO). Registration number CRD42021234917.

Project description:INTRODUCTION:The subjective assessment of the adequacy of informed consent for clinical trials, and the potential difficulties associated with it, has led several studies to develop objective measures of informed consent for clinical trials. These objective measures of informed consent are often specific to a particular population or clinical condition and largely focus on understanding of (some or all of) the key elements of informed consent. Many of the developed tools are study-specific, but some validated measures exist. Of these validated measures, those which are reported by participants are of particular interest. Whether these objective tools conceptualize and measure informed consent in the same way is not known. As such, it is not clear whether meta-analyzing data from studies reporting different tools is worthwhile. The aim of this systematic review was to critically appraise the evidence on the overall conceptualisation and item content of validated patient reported measures of informed consent for clinical trials, and to identify core domains of potential importance for informed consent. METHODS:A systematic search of the literature was conducted to identify relevant articles that described the development, and/or validation, of patient-reported measures of adequacy of informed consent for randomised controlled trials. Data was synthesised by classifying the items identified into domains and sub-domains which were determined by the nomenclature reported in included studies. Both for descriptions of included studies and of the instruments reported in those studies, descriptive statistics were used to describe general information and instrument detail. A narrative synthesis of the instruments and their inter-related domains and subdomains was conducted to identify areas of both convergence and divergence. RESULTS:The search identified 8193 citations. After screening titles and abstracts, 29 full text articles were retrieved for further assessment. Of these 29, 14 complied with our pre-specified inclusion criteria with 15 not being eligible. Of the 14 instruments, three explicitly reported a theoretical or conceptual framework underpinning their development, a further three implicitly referred to the 'conceptual dimensions of informed consent' or 'principles of research ethics' as informing their development and eight reported no guiding theoretical framework. Only three of the 14 studies reported patient or public involvement in the development of the tool. One hundred and seventy nine items were included across the 14 instruments. The primary focus of the instruments was on understanding. Five core domains were identified which included: Autonomy; Consequences; Expectations; Purpose; and Individualisation. There was substantial variability in the coverage of different domains across measures. CONCLUSIONS:This study demonstrated the variability in the theoretical underpinning, development and domain coverage of existing patient-reported measures of informed consent for clinical trials. The conceptualisation of informed consent could benefit from being extended from a narrow focus on understanding to include broader considerations of decision-making. Meaningful involvement of potential trial participants during development of measures critical for tool relevance is also lacking. The identification of the key domains relevant to all stakeholders which could be measured to assess the informed consent process for clinical trials is needed.

Project description:ObjectivesTo systematically assess the type of outcomes selected and the prevalence of patient reported outcomes in contemporary cardiovascular trials and to quantify any misuse or underuse of patient reported outcomes using a specially developed tool that would allow estimation of the relevance of such outcomes to clinical decision making.DesignSystematic review.Data sourcesMedline and Embase.Study selectionRandomised controlled trials of the treatment for or prevention of cardiovascular disease published in 10 leading general medical and cardiology journals from January 2005 to December 2008.ResultsPrimary outcomes were patient important (death, morbidity, or patient reported outcomes) in only 93 of 413 trials (23%, SE 2%), whereas another 92 (22%, SE 2%) combined these outcomes with other less important ones into a composite. Sixty five trials (16%; SE 2%) used at least one instrument to measure patient reported outcomes, mostly in trials where such information would have been important or crucial for clinical decision making (52 trials). Patient reported outcomes were judged to be of little incremental value to a large number of, mostly explanatory, cardiovascular trials (152 trials). However, many trials in which patient reported outcomes would have been important or crucial for clinical decision making did not report such outcomes (122 of 174 trials, 70%). These included several trials that primarily aimed to improve symptoms or functional status, trials that tested interventions with a considerable potential for causing harm (mainly bleeding) that were not meaningfully measured, and trials with composite outcomes that were dominated by outcomes of questionable importance to patients.ConclusionsDespite a continued rise in the reporting of patient reported outcomes with no evidence for their misuse in more recent cardiovascular trials, they seem to be still underused once their relevance to clinical decision making has been taken into account. This was largely explained by inappropriate use of composite outcomes and inadequate measurement of harms.

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Patient-reported outcomes in randomised clinical trials of bladder cancer: an updated systematic review.

Publications

Patient-reported outcomes in randomised clinical trials of bladder cancer: an updated systematic review.

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