A validation of clinical data captured from a novel Cancer Care Quality Program directly integrated with administrative claims data

Figures & data

Table 1 Characteristics and key validation statistics for breast, lung, and colorectal cancer patients

	Cancer type
	Breast	Lung	Colorectal
Cases identified in HIRE-Oncology, n	300	200	200
Cases confirmed from medical records, n	300	197	197
Age, mean (SD), years	53.0 (8.9)	59.9 (8.2)	57.3 (9.4)
Female, %	99.3%	47.2%	44.2%
Stage (according to HIRE-Oncology)
0	1	1	2
I	51	1	1
II	107	4	5
III	43	21	22
IV	98	167	167
Limited	0	3	0
Data available in both HIRE-Oncology and medical records, n
Stage	284	194	195
Biomarker 1	ER: 278	ALK: 74	KRAS: 114
Biomarker 2	PR: 261	EGFR: 69
Biomarker 3	HER2: 282
Histology		174
Key validation statistics
PPV of cancer type (95% CI)	1.00 (1.00–1.00)	0.99 (0.97–1.00)	0.99 (0.97–1.00)
Agreement of disease stage (95% CI)	0.85 (0.81–0.89)	0.90 (0.86–0.94)	0.94 (0.90–0.97)

Abbreviations: HIRE, HealthCore Integrated Research Environment; PPV, positive predictive value; CI, confidence interval; ER, estrogen receptor; PR, progesterone receptor; HER2, human epidermal growth factor receptor 2; ALK, anaplastic lymphoma kinase; EGFR, epidermal growth factor receptor; SD, standard deviation.

Table 2 Complete validation results within confirmed breast (n=300), lung (n=197), and colorectal cancer (n=197) patients

Breast cancer (n =300)				Lung cancer (n= 197)				Colorectal cancer (n =197)
	Estimate	95% CI			Estimate	95% CI			Estimate	95% CI
		Lower	Upper			Lower	Upper			Lower	Upper
Staging (n=284)				Staging (n=194)				Staging (n=195)
Agreement	0.849	0.807	0.890	Agreement	0.902	0.860	0.944	Agreement	0.939	0.905	0.972
PPV – stage I	0.938	0.869	1.000	PPV – stage III	0.810	0.642	0.978	PPV – stage II	0.800	0.449	1.000
PPV – stage II	0.900	0.841	0.959	PPV – stage IV	0.921	0.880	0.962	PPV – stage III	0.864	0.720	1.000
PPV – stage III	0.610	0.460	0.759					PPV – stage IV	0.970	0.944	0.996
PPV – stage IV	0.862	0.792	0.932
Estrogen receptor (n =278)				ALK mutation (n=74)				KRAS mutation (n =114)
Agreement	0.971	0.952	0.991	Agreement	0.919	0.857	0.981	Agreement	0.947	0.906	0.988
Sensitivity	0.975	0.953	0.997	Sensitivity	1.000	1.000	1.000	Sensitivity	0.925	0.843	1.000
Specificity	0.963	0.921	1.000	Specificity	0.910	0.842	0.979	Specificity	0.960	0.915	1.000
PPV	0.985	0.968	1.000	PPV	0.539	0.268	0.810	PPV	0.925	0.843	1.000
NPV	0.939	0.887	0.991	NPV	1.000	1.000	1.000	NPV	0.960	0.915	1.000
Progesterone receptor (n =261)				EGFR mutation (n= 69)
Agreement	0.923	0.891	0.956	Agreement	0.971	0.931	1.000
Sensitivity	0.958	0.925	0.991	Sensitivity	1.000	1.000	1.000
Specificity	0.881	0.823	0.940	Specificity	0.964	0.916	1.000
PPV	0.907	0.861	0.954	PPV	0.867	0.695	1.000
NPV	0.946	0.903	0.988	NPV	1.000	1.000	1.000
HER2 (n=282)				Histology, small cell or non-small cell (n = 174)
Agreement	0.922	0.891	0.953	Agreement	0.966	0.938	0.993
Sensitivity	0.928	0.876	0.979	Sensitivity	0.846	0.708	0.985
Specificity	0.939	0.904	0.974	Specificity	0.987	0.968	1.000
PPV	0.938	0.889	0.986	PPV	0.917	0.806	1.000
NPV	0.961	0.932	0.989	NPV	0.973	0.948	0.999

Abbreviations: PPV, positive predictive value; NPV, negative predictive value; CI, confidence interval; HER2, human epidermal growth factor receptor 2; ALK, anaplastic lymphoma kinase; EGFR, epidermal growth factor receptor.