Table 3. Cox proportional hazard regression with patient mortality as the dependent variable.
Outcomes | Events | Person-year# | Incidence density* | Crude$ | Model A& | Model B% | |||
HR | 95% CI | HR | 95% CI | HR | 95% CI | ||||
Total cohort | |||||||||
Naïve patients | 4,018 | 110,097.3 | 36.5 | 1 | - | 1 | - | 1 | - |
Users | 4,540 | 110,622.9 | 41.0 | 1.124 | 1.08 – 1.17a | 1.183 | 1.13 – 1.24a | 1.183 | 1.13 – 1.24a |
Frail participants (Item ≥ 3) | |||||||||
Naïve patients | 137 | 1,646.2 | 83.2 | 1 | - | 1 | - | 1 | - |
Users | 126 | 1,707.4 | 73.8 | 0.886 | 0.7 – 1.13 | 1.08 | 0.83 – 1.4 | 1.079 | 0.83 – 1.41 |
Non-frail participants (Item < 3) | |||||||||
Naïve patients | 3,881 | 108,451.1 | 35.8 | 1 | - | 1 | - | 1 | - |
Users | 4,414 | 108,915.5 | 40.5 | 1.12 | 1.07 – 1.19a | 1.183 | 1.13 – 1.24a | 1.183 | 1.13 – 1.24a |
Non-frail participants (Item = 0) | |||||||||
Naïve patients | 444 | 24,638.9 | 18.0 | 1 | - | 1 | - | 1 | - |
Users | 743 | 23,874.6 | 31.1 | 1.727 | 1.54 – 1.94a | 1.503 | 1.33 – 1.69a | 1.503 | 1.33 – 1.69a |
Non-frail participants (Item = 1) | |||||||||
Naïve patients | 2,383 | 63,425.7 | 37.6 | 1 | - | 1 | - | 1 | - |
Users | 2,693 | 63,166.5 | 42.6 | 1.134 | 1.07 – 1.2a | 1.173 | 1.11 – 1.24a | 1.175 | 1.11 – 1.24a |
Non-frail participants (Item = 2) | |||||||||
Naïve patients | 1,054 | 20,386.5 | 51.7 | 1 | - | 1 | - | 1 | - |
Users | 978 | 21,874.5 | 44.7 | 0.866 | 0.79 – 0.95b | 1.026 | 0.94 – 1.12 | 1.024 | 0.94 – 1.12 |
aDCSI, adapted diabetes complications severity index; CI, confidence interval; HR, hazard ratio
#Cumulative follow-up duration
· per 1000 patient-year
$ Incorporating opioid use only
& Incorporating age/gender, lifestyle factors, all comorbidities, aDCSI, all medications, FRAIL item counts, treatment variables, and opioid use; findings without an attached superscript “a” or “b” denote insignificant results (p > 0.05)
% Incorporating model A components and individual FRAIL item status
a p < 0.001
b p < 0.01