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Table 3 Sensitivity of the HID coding compared to the reference events, over a 10-year period (2008–2018)

From: Development and validation of a follow-up methodology for a randomised controlled trial, utilising routine clinical data as an alternative to traditional designs: a pilot study to assess the feasibility of use for the BladderPath trial

 

Number of events

Year of event

No. false positives (PPV)

2008

2009

2010

2011

2012

2013

2014

2015

2016

2017

2018

Cystectomy

Reference

NA

NA

16

21

28

26

41

34

34

6

NA

8 (0.96)

Routine data (HID)

NA

NA

16

21

25

25

41

34

34

6

NA

Sensitivity (%)

–

–

100.0

100.0

89.3

96.2

100.0

100.0

100.0

100.0

-

Radiotherapy regimen

Reference

NA

NA

NA

74

83

72

67

79

93

68

32

20 (0.95)

Routine data (HID)

NA

NA

NA

1

1

55

66

79

92

68

29

Sensitivity (%)

–

–

–

1.4

1.2

76.4

98.5

100.0

98.9

100.0

90.6

Censor

Reference

NA

NA

1

5

4

8

16

11

9

27

19

0 (1.00)

Routine data (HID)

NA

NA

1

5

4

8

16

11

9

22

13

Sensitivity (%)

–

–

NA

100.0

100.0

100.0

100.0

100.0

100.0

81.5

68.4

BCG regimen

Reference

NA

NA

1

3

1

4

2

3

1

NA

NA

20 (0.41)

Routine data (HID)

NA

NA

1

3

0

4

2

3

1

NA

NA

Sensitivity (%)

–

–

NA

100.0

–

100.0

100.0

100.0

–

–

–

Cystoscopy

Reference

NA

3

8

8

21

20

15

15

9

5

2

6 (0.94)

Routine data (HID)

NA

2

6

6

19

17

12

11

9

5

2

Sensitivity (%)

–

66.7

75.0

75.0

90.5

85.0

80.0

73.3

100.0

100.0

100.0

Chemotherapy regimen

Reference

1

1

4

6

7

9

5

7

3

3

1

3 (0.94)

Routine data (HID)

0

0

4

5

7

9

5

7

3

3

1

Sensitivity (%)

–

–

100.0

83.3

100.0

100.0

100.0

100.0

100.0

100.0

–

  1. NA = no events were validated (due to the random sample selected, or due to the data censor, for example, surgery to bladder censor mid-2017). (-), if only one event, or none were validated, the sensitivity was not calculated due to the sample size. Only six cystectomies were validated in the 2017 data due to the reference data freeze