Systematic evaluation of patient-reported outcome (PRO) protocol content and reporting in UK cancer clinical trials: the EPiC study protocol

Introduction Emerging evidence suggests that patient-reported outcome (PRO)-specific information may be omitted in trial protocols and that PRO results are poorly reported, limiting the use of PRO data to inform cancer care. This study aims to evaluate the standards of PRO-specific content in UK cancer trial protocols and their arising publications and to highlight examples of best-practice PRO protocol content and reporting where they occur. The objective of this study is to determine if these early findings are generalisable to UK cancer trials, and if so, how best we can bring about future improvements in clinical trials methodology to enhance the way PROs are assessed, managed and reported. Hypothesis: Trials in which the primary end point is based on a PRO will have more complete PRO protocol and publication components than trials in which PROs are secondary end points.

Methods and analysis Completed National Institute for Health Research (NIHR) Portfolio Cancer clinical trials (all cancer specialities/age-groups) will be included if they contain a primary/secondary PRO end point. The NIHR portfolio includes cancer trials, supported by a range of funders, adjudged as high-quality clinical research studies. The sample will be drawn from studies completed between 31 December 2000 and 1 March 2014 (n=1141) to allow sufficient time for completion of the final trial report and publication. Two reviewers will then review the protocols and arising publications of included trials to: (1) determine the completeness of their PRO-specific protocol content; (2) determine the proportion and completeness of PRO reporting in UK Cancer trials and (3) model factors associated with PRO protocol and reporting completeness and with PRO reporting proportion.

Ethics and dissemination The study was approved by the ethics committee at University of Birmingham (ERN_15-0311). Trial findings will be disseminated via presentations at local, national and international conferences, peer-reviewed journals and social media including the CPROR twitter account and UOB departmental website (http://www.birmingham.ac.uk/cpro0r).

The Great Transition:Climate, disease and society in the late-medieval world

In the fourteenth century the Old World witnessed a series of profound and abrupt changes in the trajectory of long-established historical trends. Trans-continental networks of exchange fractured and an era of economic contraction and demographic decline dawned from which Latin Christendom would not begin to emerge until its voyages of discovery at the end of the fifteenth century. In a major new study of this 'Great Transition', assessment is made of the contributions of commercial recession, war, climate change,and eruption of the Black Death to a far-reaching reversal of fortunes which spared no part of Eurasia. A wealth of new historical, palaeoecological and biological evidence are synthesised, including estimates of national income, reconstructions of past climates. and genetic analysis of DNA extracted from the teeth of plague victims, to provide a fresh account of the creation, collapse and realignment of western Europe's late-medieval commercial economy.