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Short introduction An example of the use of survival analysis

Short introduction An example of the use of survival analysis.

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Short introduction An example of the use of survival analysis

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  1. Short introductionAn example of the use of survival analysis

  2. SPCG-4Expectation or radical prostatectomy on early prostate cancer.Patients: T0-2,Nx,M0,Gr1-2, age < 75 years and expected survival 10 years Treatment: Radical prostatectomy vs. expectants.Inclusion period: Sep. 1989 – May 1999. Number of patients: 695 patients, 14 CentersPrincipal investigator: Jan-Erik Johansson.Sponsor: SPCG, Swedish Cancer Foundation .

  3. Metastas Död av annan orsak PC-död Röd= Operation Blå= WW

  4. Händelser kan: • Ignoreras • Censoreras • Betraktas som ”competing risk”-händelse

  5. Advantages and limitations of an intention-to-treat (ITT) analysis • Advantages • Retains balance in prognostic factors arising from the original random treatment allocation • Gives an unbiased estimate of treatment effect • Admits non-compliance and protocol deviations, thus reflecting a real clinical situation • Limitations • Estimate of treatment effect is generally conservative because of dilution due to non-compliance • In equivalence trials (attempting to prove that two treatments do not differ by more than a certain amount), this analysis will favour equality of treatments • Interpretation becomes difficult if a large proportion of participants cross over to opposite treatment arms • Requirements for an ideal ITT analysis • Full compliance with randomised treatment • No missing responses • Follow-up on all participants • ITT analysis is highly desirable unless: • there is overwhelming justification for a different analysis policy (eg, an unacceptably high proportion of ineligible participants — those without the disease under study, for whom there is no potential benefit from the intervention. In these circumstances a “quasi” ITT approach (in which ineligible patients are excluded) is more appropriate.

  6. SUBGRUPPSANALYSER

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