Collectively, the team included expertise in psychosocial oncology research, electronic PROMs, clinical oncology, nursing, data management, cancer registration, health informatics and multimedia production.
The study research team and wider steering group collectively includes expertise in psychosocial oncology research, (electronic) PROMs, clinical oncology, nursing, data management, statistics, epidemiology, health informatics and cancer registration.
This included funding for a study nurse; data management and statistics services provided by Koordinierungszentrum Klinische Studien (KKS) Heidelberg; trial medication and laboratory assays.
The TMG will include those individuals responsible for the day-to-day management of the trial, such as the Chief Investigator, statistician, trial manager, research nurse, data manager.
Lack of clinical trial support has been frequently cited as a barrier to clinical trial involvement (Somkin et al, 2005; Schroen and Brenin, 2008) but this issue does not explain the findings in this study as all the MDTs involved in the study were supported by the Wales Cancer Trials Network whose infrastructure (research nurse time, data management support, etc).
The panel comprised members with a broad range of expertise including health research, general medical practice, psychology, nursing, psychometrics, and data management.
Annika Baldauf, study nurse, Department of General Practice and Health Services Research, for data management.
The research nurse will use the trial data management system to enter and store data on all eligible individuals.
The PCT also recruited community support workers (CSWs) to assist nurses with equipment installation and data management.
AS and RAA performed the data analysis and wrote the manuscript; GW was responsible for the primary data management (study nurse); UB and GF contributed substantially to the final version of the manuscript.
Diarrhoea was defined as the elimination of at least three liquid stools per day, and was reported by ICU nurses on the computerised information data management system (CliniSoft 6.2; General Electric, Milwaukee, WI, USA).
