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Table 1 Statistical and Endpoint Considerations from QUANTEC [5]

From: A systematic review of dose-volume predictors and constraints for late bowel toxicity following pelvic radiotherapy

Statistical considerations
1 Basic statistical data provided on incidence of toxicity
 -Both number of subjects and number of events should be reported
 -If an estimate of incidence is given the standard error should be supplied
2 Numerical labeling of response histogram – if into groups eg. quartiles must state number of patients in each quartile
3 When predictive models are correlated with complications parameter estimates must be stated with their standard error
4 Complication rates associated with constraints must be reported
5 “Goodness of fit” to be reported such as Chi-squared
6 Discriminator statistics reported such as receiver operating characteristic curves
7 Full organ volumes (rather than partial) should be used
 -If this is not possible absolute volumes should be used or a standard method of normalization
 -A clear statement of organ volume definition should be given
Toxicity Endpoint considerations
1 Symptom-specific information rather than a portmanteau endpoint (eg. RTOG gr 2) should be used
2 Consideration that symptoms may be attributed to pre-radiotherapy co-morbidities
3 Patient-reporting of symptoms may be important