42013-03-08 10:17:45localhostconverted to 1.6 markup32012-02-17 12:19:07PeterWatson22012-02-17 12:18:58PeterWatson12012-02-17 12:18:47PeterWatson

ITT is better regarded as a complete trial strategy for design, conduct and analysis rather than as an approach to analysis alone. Design Decide whether the aim is pragmatic or explanatory. For pragmatic trials, intention to treat is essential Justify in advance any inclusion criteria which when violated would merit exclusion from intention to treat analysis Conduct Minimise missing response on the primary outcome Follow up subjects who withdraw from treatment Analysis Include all randomised subjects in the groups to which they were allocated Investigate the potential effect of missing response Reporting Specify that intention to treat analysis has been carried out, explicitly describing the handling of deviations from randomised allocation and missing response Report deviations from randomised allocation and missing response Discuss the potential effect of missing response Base conclusions on the results of intention to treat analysis