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

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

Carbon cost of pragmatic randomised controlled trials: retrospective analysis of sample of trials

Objective To calculate the global warming potential, in carbon dioxide (CO2) equivalent emissions, from a sample of pragmatic randomised controlled trials

A novel approach to sharing all available information from funded health research: the NIHR Journals Library

Abstract Background Relevant information on health research must be made publicly available in an accurate, timely and accessible manner if evidence is to inform practice and benefit patient care. Failure to publish research information represents a significant waste of research funds. However, recent studies have demonstrated that non-publication and selective or biased reporting remains a significant problem. The role of online publications in rectifying these issues by providing open access to study information is increasingly recognised. Objective This paper details a novel approach to publishing research information developed by the National Institute for Health Research (NIHR), a major funder of health research in the United Kingdom. The NIHR has enhanced its Journals Library (www.journalslibrary.nihr.ac.uk), providing an online repository of information from research funded through five programmes. We describe how the NIHR Journals Library provides a ‘thread’ of relevant information for each study, including protocols, participant information sheets, data linkages, final reports, publications and diverse knowledge products. We also discuss the Library as a ‘living’ resource, one that is updated as each study progresses from inception to completion. Finally, we consider the implications of the Library for the NIHR, other journals and research teams submitting information. Conclusion Openly publishing information from funded research in the NIHR Journals Library serves as a model of knowledge sharing, maximising return on investment and enhancing the usability and replicability of research findings for different evidence-user communities. The Library also supports wider ‘research on research’ ambitions, enabling users to interrogate the repository of NIHR-funded studies, enhancing the understanding of research commissioning, design, dissemination and impact. Video abstract: www.youtube.com/watch?v=8H03uxN_iTE

Impact of discussion on preferences elicited in a group setting

BACKGROUND: The completeness of preferences is assumed as one of the axioms of expected utility theory but has been subject to little empirical study. METHODS: Fifteen non-health professionals was recruited and familiarised with the standard gamble technique. The group then met five times over six months and preferences were elicited independently on 41 scenarios. After individual valuation, the group discussed the scenarios, following which preferences could be changed. Changes made were described and summary measures (mean and median) before and after discussion compared using paired t test and Wilcoxon Signed Rank Test. Semi-structured telephone interviews were carried out to explore attitudes to discussing preferences. These were transcribed, read by two investigators and emergent themes described. RESULTS: Sixteen changes (3.6%) were made to preferences by seven (47%) of the fifteen members. The difference between individual preference values before and after discussion ranged from -0.025 to 0.45. The average effect on the group mean was 0.0053. No differences before and after discussion were statistically significant. The group valued discussion highly and suggested it brought four main benefits: reassurance; improved procedural performance; increased group cohesion; satisfying curiosity. CONCLUSION: The hypothesis that preferences are incomplete cannot be rejected for a proportion of respondents. However, brief discussion did not result in substantial number of changes to preferences and these did not have significant impact on summary values for the group, suggesting that incompleteness, if present, may not have an important effect on cost-utility analyses

A pilot Internet "Value of Health" Panel: recruitment, participation and compliance

Objectives To pilot using a panel of members of the public to provide preference data via the Internet Methods A stratified random sample of members of the general public was recruited and familiarised with the standard gamble procedure using an Internet based tool. Health states were perdiodically presented in "sets" corresponding to different conditions, during the study. The following were described: Recruitment (proportion of people approached who were trained); Participation (a) the proportion of people trained who provided any preferences and (b) the proportion of panel members who contributed to each "set" of values; and Compliance (the proportion, per participant, of preference tasks which were completed). The influence of covariates on these outcomes was investigated using univariate and multivariate analyses. Results A panel of 112 people was recruited. 23% of those approached (n = 5,320) responded to the invitation, and 24% of respondents (n = 1,215) were willing to participate (net = 5.5%). However, eventual recruitment rates, following training, were low (2.1% of those approached). Recruitment from areas of high socioeconomic deprivation and among ethnic minority communities was low. Eighteen sets of health state descriptions were considered over 14 months. 74% of panel members carried out at least one valuation task. People from areas of higher socioeconomic deprivation and unmarried people were less likely to participate. An average of 41% of panel members expressed preferences on each set of descriptions. Compliance ranged from 3% to 100%. Conclusion It is feasible to establish a panel of members of the general public to express preferences on a wide range of health state descriptions using the Internet, although differential recruitment and attrition are important challenges. Particular attention to recruitment and retention in areas of high socioeconomic deprivation and among ethnic minority communities is necessary. Nevertheless, the panel approach to preference measurement using the Internet offers the potential to provide specific utility data in a responsive manner for use in economic evaluations and to address some of the outstanding methodological uncertainties in this field