Figure 1 and Table 1 show a schematic diagram of the trial design, procedures, stages and data collection, and all trial periods.
Developing successful cultivars from a set of potential parents depends on intuition, experience, sensibility, and luck, as much as it does on systematic data collection and dogged trial and error.
SF and KP undertook recruitment and data collection and managed trial processes.
The study design, data collection and analysis, trial management and preparation of the manuscript were performed by the authors.
SS helped design the study and manage the trial, FW contributed to the development of the intervention and helped manage the trial, JN helped with data collection and contributed to the trial management, CB conceived of the study, helped design the study, and provided overall leadership to the project.
The sequence and decode of treatment allocations were concealed until all interventions were assigned and recruitment, data collection and all other trial-related assessments were completed and study files locked.
While a secondary use of the information, these claims databases are of great benefit for observational research as they provide information on large, heterogeneous populations of insured patients that are geographically dispersed at generally lower costs than those would be gathered by prospective data collection and randomized clinical trials [ 1, 2].
77 To ensure accuracy, completeness and reliability, trained assessors collect outcome data during interviews in person or by phone by following standard operating procedures for data collection and transfer to the trial office in Southampton.
To ensure the accuracy and reproducibility of the outcome, two investigators who have already participated in a 2-day meeting, focusing on the rationale, surgical procedures and data collection and management of the trial, will perform the outcome assessment.
We limited the estimation of the used resources narrowly, because we wanted to study whether the costs of data collection and setting up a trial could be made cheaper.
