Linkage of the CHHiP randomised controlled trial with primary care data: a study investigating ways of supplementing cancer trials and improving evidence-based practice

Table 4 Exploratory analysis using mixed-effects logistic regression of longitudinal bladder, bowel and sexual toxicity recorded with LENT/SOM in CHHiP, to analyse the association with comorbidities and medications recorded in primary care at entry to CHHiP. Separate models are fitted for each of the independent variables (comorbidities and medications yes / no [reference]) accounting for age at entry and trial randomisation arm. *statistically significant at a level of p < 0.01 (cut-off used in this study). ACE, angiotensin converting enzyme; LENT/SOM, Late Effects on Normal Tissues: Subjective/Objective/Management

Dependent variable	Independent variable	Coefficient estimate	Lower 95% CI	Upper 95% CI	OR	P-value
LENT/SOM bladder toxicity (yes / no)	Diabetes	0.70	−0.54	1.94	2.02	0.27
	Hypertension	0.46	−0.55	1.46	1.58	0.38
	Metformin	0.54	−1.20	2.28	1.72	0.54
	Aspirin	0.20	−0.88	1.28	1.22	0.72
	Statins	−0.14	−1.04	0.76	0.87	0.76
	ACE inhibitors	−0.12	−1.27	1.03	0.89	0.84
	PDE5 inhibitors	0.99	0.02	1.95	2.68	0.05
LENT/SOM bowel toxicity (yes / no)	Diabetes	0.39	−0.79	1.57	1.48	0.52
	Hypertension	−0.01	−0.90	0.87	0.99	0.98
	Metformin	−0.05	−1.50	1.40	0.95	0.95
	Aspirin	0.26	−0.66	1.18	1.30	0.58
	Statins	−0.91	−1.73	−0.08	0.40	0.03
	ACE inhibitors	0.53	−0.53	1.58	1.69	0.33
	PDE5 inhibitors	0.14	−0.78	1.06	1.15	0.76
LENT/SOM sexual toxicity (yes / no)	Diabetes	−1.87	−3.26	−0.480	0.15	0.008*
	Hypertension	0.29	−0.65	1.220	1.33	0.55
	Metformin	−3.08	−5.36	−0.800	0.05	0.008*
	Aspirin	−0.49	−1.46	0.480	0.62	0.33
	Statins	−0.42	−1.24	0.400	0.66	0.32
	ACE inhibitors	−0.98	−2.04	0.080	0.37	0.07
	PDE5 inhibitors	−0.27	−1.14	0.600	0.76	0.54

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