Table 4.

Estimated Treatment effects

	Cox proportional hazard
	Hazard ratio (95% CI)	p‐value	p‐value of comparison RWD to RCT
RCT approach—trial data
Survival model 1	0.78 (0.68;0.89)	<0.01	NA
Multilevel survival model 1	0.77 (0.43;1.10)	0.13	Comparator
Survival model 2	0.93 (0.76;1.16)	0.55	NA
Multilevel survival model 2	0.93 (0.72;1.15)	0.55	NA
RWD approach—observational data unadjusted
Naive survival model	1.65 (1.13;2.42)	0.01	0.12
RWD approach—observational data adjusted based on propensity scores
PS matching—caliper 0
Multivariate survival model	0.95 (0.50;1.80)	0.88	0.49
PS matching—caliper 0.2*SD logit propensity
Multivariate survival model	1.00 (0.58;1.70)	0.98	0.41
PS inverse weighting
Multivariate survival model	0.88 (0.24;3.21)	0.99	0.71
PS stratification
Multivariate survival model	1.05 (0.04;2.06)	0.99	0.47

Survival model 1 refers to the analysis in which a treatment effect was estimated for a fluoropyrimidine regimen compared to control. IMPACT, QUASAR and Schippinger et al. were included in this analysis. Survival model 2 refers to the analysis in which a treatment effect was estimated for fluoropyrimidine in combination with oxaliplatin compared to fluoropyrimidine monotherapy. MOSAIC and NSABP C07 were included in this analysis. Bold results are considered as main results.

Abbreviations: NA, not applicable; PS, propensity score; RCT, randomized clinical trial; RWD, real‐world data; SD, standard deviation.