Headline
Study found that the ‘metadata’ collected in randomised controlled trial registries can be expanded to include aspects of design, performance, results and costs. Tha National Institute for Health Research Health Technology Assessment programme should continue and expand the work reported.
Abstract
Background:
By 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.
Objectives:
The 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 sources:
Published monographs and internal HTA documents.
Review methods:
A 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.
Results:
One 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.
Limitations:
The study was limited by being confined to 125 randomised trials by one funder.
Conclusions:
Metadata 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.
Funding:
The National Institute for Health Research HTA programme.
Article history
The research reported in this issue of the journal was funded by the HTA programme as project number 08/117/01. The contractual start date was in November 2009. The draft report began editorial review in June 2012 and was accepted for publication in January 2014. The authors have been wholly responsible for all data collection, analysis and interpretation, and for writing up their work. The HTA editors and publisher have tried to ensure the accuracy of the authors’ report and would like to thank the reviewers for their constructive comments on the draft document. However, they do not accept liability for damages or losses arising from material published in this report.
Declared competing interests of authors
The Health Technology Assessment (HTA) programme commissioned this project following a bid by the authors, based at the Wessex Institute, University of Southampton. James Raftery is Professor of HTA at the Wessex Institute. He is a member of the HTA Editorial Board. Amanda Young has been employed by NETSCC since 2008. Louise Stanton was previously employed by NETSCC from 2008 to 2011. Ruairidh Milne is Director of the Wessex Institute and Head of NETSCC. He was employed by NETSCC from 2006 to 2012. Andrew Cook has been employed by NETSCC since 2006. David Turner was previously employed by the Wessex Institute from 2006 to 2011. Peter Davidson is a member of the HTA Editorial Board and has been Director of the HTA programme since 2006. As academics and professional researchers, the authors do not believe they have allowed bias to affect the design of the work, the analysis or the conclusions. Measures to prevent bias included an eminent advisory group and prospective specification of questions.
