CONSORT PRO Extension Published in JAMA

A successful collaboration between the MRC Midland and ConDuCT Hubs for Trials Methodology Research, UK, ISOQOL Reporting Guidelines Taskforce and the CONSORT Executive has led to the new CONSORT PRO Extension being published in JAMA. The new guidance informed by key international stakeholders aims to facilitate the transparent reporting of PRO data from trials to inform patient care and health policy.

Calvert M, Blazeby J , Altman D , Revicki D , Moher D, Brundage Reporting of Patient Reported Outcomes in Randomised Trials: the CONSORT PRO Extension. JAMA 2013; 309 (8) 814-822

Centre selection for clinical Trials

The results of the group's research on centre selection in RCTs have now been published in PLOS One. Using a mixed methods study comprising a systematic review of NIHR HTA-funded RCTs, focus groups with trialists and an electronic survey of CRCUK Clinical Trials Units, we mapped the considerations that trialists account for when including centres in RCTs. We found that generalisability often plays only a small role in this process at the detriment of pragmatic issues, thus threatening the external validity of trial findings. The potential impact of this practice on the generalisability of trial-based cost-effectiveness results and possible ways forward will be the subject of a panel at the ISPOR (International Society for Pharmacoeconomics and Outcomes Research) Annual Meeting in New Orleans, USA (May 2013), where Adrian Gheorghe will join a panel of prominent health economists in discussing the issue.

Gheorghe A, Roberts TE, Ives JC, Fletcher BR, Calvert M (2013) Centre Selection for Clinical Trials and the Generalisability of Results: A Mixed Methods Study. PLoS ONE 8(2): e56560. doi:10.1371/journal.pone.0056560.