FAQ/itt/fsugs - CBU statistics Wiki

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Recommendations for intention to treat analysis (Hollis and Campbell, 1999)

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