A Peer Review Intervention for Monitoring and Evaluating sites (PRIME) that improved randomized controlled trial conduct and performance

Lane, J. Athene; Wade, Julia; Down, L; Bonnington, Susan; Holding, Peter; Lennon, T; Jones, Amanda; Salter, C Elizabeth; Neal, David E.; Hamdy, Freddie C.; Donovan, Jenny

doi:10.1016/j.jclinepi.2010.10.003

Cited by 18 publications

(17 citation statements)

References 27 publications

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“…449 Further work focused on using qualitative analysis of recruitment interviews, followed by feedback to recruiting staff in other trials to see if it could be used to improve recruitment. 450 However, difficulties relating to both logistics and acceptability limited effectiveness.…”

Section: Discussionmentioning

confidence: 99%

“…Third, use of a checklist during review of recruitment recordings improved the consistency and completeness of information given verbally to potential participants. It would have been difficult to identify these issues using other quality control methods 449 and, without this structured process during the initial pilot phase, problems may have continued for some time. Fourth, compliance with good clinical practice was enhanced by developing strategies to check participant understanding of trial information and key concepts, ensuring equipoise and gaining better evidence of informed voluntary consent, all of which can impact on trial recruitment and retention.…”

Section: Discussionmentioning

confidence: 99%

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Improving patients’ experience and outcome of total joint replacement: the RESTORE programme

Blom

Artz

Beswick

et al. 2016

Programme Grants Appl Res

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General rightsThis document is made available in accordance with publisher policies. Please cite only the published version using the reference above. Full terms of use are available: http://www.bristol.ac.uk/pure/about/ebr-terms PROGRAMME GRANTS FOR APPLIED RESEARCH VOLUME 4 ISSUE 12 AUGUST 2016 ISSN 2050 DOI 10.3310/pgfar04120Improving patients' experience and outcome of total joint replacement: the RESTORE programme Ashley W Blom, Neil Artz, Andrew D Beswick, Amanda Burston, Paul Dieppe, Karen T Elvers, Rachael Gooberman-Hill, Jeremy Horwood, Paul Jepson, Emma Johnson, Erik Lenguerrand, Elsa Marques, Sian Noble, Mark Pyke, Catherine Sackley, Gina Sands, Adrian Sayers, Victoria Wells and Vikki Wylde Improving patients' experience and outcome of total joint replacement: the RESTORE programme ISSN 2050-4330 (Online) This journal is a member of and subscribes to the principles of the Committee on Publication Ethics (COPE) (www.publicationethics.org/).Editorial contact: nihredit@southampton.ac.ukThe full PGfAR archive is freely available to view online at www.journalslibrary.nihr.ac.uk/pgfar. Print-on-demand copies can be purchased from the report pages of the NIHR Journals Library website: www.journalslibrary.nihr.ac.uk Criteria for inclusion in the Programme Grants for Applied Research journalReports are published in Programme Grants for Applied Research (PGfAR) if (1) they have resulted from work for the PGfAR programme, and (2) they are of a sufficiently high scientific quality as assessed by the reviewers and editors. Programme Grants for Applied Research programmeThe Programme Grants for Applied Research (PGfAR) programme, part of the National Institute for Health Research (NIHR), was set up in 2006 to produce independent research findings that will have practical application for the benefit of patients and the NHS in the relatively near future. The Programme is managed by the NIHR Central Commissioning Facility (CCF) with strategic input from the Programme Director.The programme is a national response mode funding scheme that aims to provide evidence to improve health outcomes in England through promotion of health, prevention of ill health, and optimal disease management (including safety and quality), with particular emphasis on conditions causing significant disease burden.For more information about the PGfAR programme please visit the website: http://www.nihr.ac.uk/funding/programme-grants-forapplied-research.htm This reportThe research reported in this issue of the journal was funded by PGfAR as project number RP-PG-0407-10070. The contractual start date was in December 2008. The final report began editorial review in September 2014 and was accepted for publication in August 2015. As the funder, the PGfAR programme agreed the research questions and study designs in advance with the investigators. The authors have been wholly responsible for all data collection, analysis and interpretation, and for writing up their work. The PGfAR editors and production house have tried to ensure the accurac...

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Improving patients’ experience and outcome of total joint replacement: the RESTORE programme

Blom

Artz

Beswick

et al. 2016

Programme Grants Appl Res

View full text Add to dashboard Cite

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“…There are potentially useful on-site procedures that have not been explored within this empirical comparison. For example, the PRIME process [12] used observation by peer reviewers to improve protocol adherence and train site staff, which increased trial performance and consistency. As further empirical research is undertaken, decisions regarding the optimal use of resources during on-site visits will more likely be evidence based and risk proportionate.…”

Section: Discussionmentioning

confidence: 99%

The Value of Source Data Verification in a Cancer Clinical Trial

et al. 2012

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BackgroundSource data verification (SDV) is a resource intensive method of quality assurance frequently used in clinical trials. There is no empirical evidence to suggest that SDV would impact on comparative treatment effect results from a clinical trial.MethodsData discrepancies and comparative treatment effects obtained following 100% SDV were compared to those based on data without SDV. Overall survival (OS) and Progression-free survival (PFS) were compared using Kaplan-Meier curves, log-rank tests and Cox models. Tumour response classifications and comparative treatment Odds Ratios (ORs) for the outcome objective response rate, and number of Serious Adverse Events (SAEs) were compared. OS estimates based on SDV data were compared against estimates obtained from centrally monitored data.FindingsData discrepancies were identified between different monitoring procedures for the majority of variables examined, with some variation in discrepancy rates. There were no systematic patterns to discrepancies and their impact was negligible on OS, the primary outcome of the trial (HR (95% CI): 1.18(0.99 to 1.41), p = 0.064 with 100% SDV; 1.18(0.99 to 1.42), p = 0.068 without SDV; 1.18(0.99 to 1.40), p = 0.073 with central monitoring). Results were similar for PFS. More extreme discrepancies were found for the subjective outcome overall objective response (OR (95% CI): 1.67(1.04 to 2.68), p = 0.03 with 100% SDV; 2.45(1.49 to 4.04), p = 0.0003 without any SDV) which was mostly due to differing CT scans.InterpretationQuality assurance methods used in clinical trials should be informed by empirical evidence. In this empirical comparison, SDV was expensive and identified random errors that made little impact on results and clinical conclusions of the trial. Central monitoring using an external data source was a more efficient approach for the primary outcome of OS. For the subjective outcome objective response, an independent blinded review committee and tracking system to monitor missing scan data could be more efficient than SDV.

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“…The team developed a framework, known as the Peer Review Intervention for Monitoring and Evaluating sites (PRIME), to assess site performance, training needs and good clinical practice adherence of the recruiting sites. 75 Each of the eight sites in the trial was assessed annually, looking at its recruitment processes but also its adherence to follow-up protocols. A review of PRIME found that it enhanced study conduct and consistency, manifested in a more complete follow-up for ProtecT.…”

Section: Retention and Follow-upmentioning

confidence: 99%

Clinical trial metadata: defining and extracting metadata on the design, conduct, results and costs of 125 randomised clinical trials funded by the National Institute for Health Research Health Technology Assessment programme

Raftery

Young

Stanton

et al. 2015

Health Technology Assessment

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BackgroundBy 2011, the Health Technology Assessment (HTA) programme had published the results of over 100 trials with another 220 in progress. The aim of the project was to develop and pilot ‘metadata’ on clinical trials funded by the HTA programme.ObjectivesThe aim of the project was to develop and pilot questions describing clinical trials funded by the HTA programme in terms of it meeting the needs of the NHS with scientifically robust studies. The objectives were to develop relevant classification systems and definitions for use in answering relevant questions and to assess their utility.Data sourcesPublished monographs and internal HTA documents.Review methodsA database was developed, ‘populated’ using retrospective data and used to answer questions under six prespecified themes. Questions were screened for feasibility in terms of data availability and/or ease of extraction. Answers were assessed by the authors in terms of completeness, success of the classification system used and resources required. Each question was scored to be retained, amended or dropped.ResultsOne hundred and twenty-five randomised trials were included in the database from 109 monographs. Neither the International Standard Randomised Controlled Trial Number nor the term ‘randomised trial’ in the title proved a reliable way of identifying randomised trials. Only limited data were available on how the trials aimed to meet the needs of the NHS. Most trials were shown to follow their protocols but updates were often necessary as hardly any trials recruited as planned. Details were often lacking on planned statistical analyses, but we did not have access to the relevant statistical plans. Almost all the trials reported on cost-effectiveness, often in terms of both the primary outcome and quality-adjusted life-years. The cost of trials was shown to depend on the number of centres and the duration of the trial. Of the 78 questions explored, 61 were well answered, 33 fully with 28 requiring amendment were the analysis updated. The other 17 could not be answered with readily available data.LimitationsThe study was limited by being confined to 125 randomised trials by one funder.ConclusionsMetadata on randomised controlled trials can be expanded to include aspects of design, performance, results and costs. The HTA programme should continue and extend the work reported here.FundingThe National Institute for Health Research HTA programme.

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A Peer Review Intervention for Monitoring and Evaluating sites (PRIME) that improved randomized controlled trial conduct and performance

Cited by 18 publications

References 27 publications

Improving patients’ experience and outcome of total joint replacement: the RESTORE programme

Improving patients’ experience and outcome of total joint replacement: the RESTORE programme

The Value of Source Data Verification in a Cancer Clinical Trial

Clinical trial metadata: defining and extracting metadata on the design, conduct, results and costs of 125 randomised clinical trials funded by the National Institute for Health Research Health Technology Assessment programme

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