J Clin Med Res

Journal of Clinical Medicine Research, ISSN 1918-3003 print, 1918-3011 online, Open Access

Article copyright, the authors; Journal compilation copyright, J Clin Med Res and Elmer Press Inc

Journal website http://www.jocmr.org

Original Article

Volume 8, Number 9, September 2016, pages 641-649

Summary of Glaucoma Diagnostic Testing Accuracy: An Evidence-Based Meta-Analysis

**Table 1.** Overall Assessment of Study Quality, Accuracy and Generalizability (QUADAS)
Items	% assessed as yes	% assessed as no	% assessed as unclear
1. Was the spectrum of patients representative of the patients who will receive the test in practice?	44	15	41
2. Were selection criteria clearly described?	82	1	17
3. Is the reference standard likely to correctly classify the target condition?	93	4	3
4. Is the time period between reference standard and index test short enough to be reasonably sure that the target condition did not change between the two tests?	93	0	7
5. Did the whole sample or a random selection of the sample, receive verification using a reference standard of diagnosis?	73	3	24
6. Did patients receive the same reference standard regardless of the index test result?	99	0	1
7. Was the reference standard independent of the index test (i.e. the index test did 1t form part of the reference standard)?	99	0	1
8. Was the execution of the index test described in sufficient detail to permit replication of the test?	97	1	2
9. Was the execution of the reference standard described in sufficient detail to permit its replication?	95	2	3
10. Were the index test results interpreted without knowledge of the results of the reference standard?	82	3	15
11. Were the reference standard results interpreted without knowledge of the results of the index test?	22	6	72
12. Were the same clinical data available when test results were interpreted as would be available when the test is used in practice?	26	2	72
13. Were un-interpretable/ intermediate test results reported?	69	9	22
14. Were withdrawals from the study explained?	42	21	37

Table 1. Overall Assessment of Study Quality, Accuracy and Generalizability (QUADAS)

Items

% assessed as yes

% assessed as no

% assessed as unclear

1. Was the spectrum of patients representative of the patients who will receive the test in practice?

2. Were selection criteria clearly described?

3. Is the reference standard likely to correctly classify the target condition?

4. Is the time period between reference standard and index test short enough to be reasonably sure that the target condition did not change between the two tests?

5. Did the whole sample or a random selection of the sample, receive verification using a reference standard of diagnosis?

6. Did patients receive the same reference standard regardless of the index test result?

7. Was the reference standard independent of the index test (i.e. the index test did 1t form part of the reference standard)?

8. Was the execution of the index test described in sufficient detail to permit replication of the test?

9. Was the execution of the reference standard described in sufficient detail to permit its replication?

10. Were the index test results interpreted without knowledge of the results of the reference standard?

11. Were the reference standard results interpreted without knowledge of the results of the index test?

12. Were the same clinical data available when test results were interpreted as would be available when the test is used in practice?

13. Were un-interpretable/ intermediate test results reported?

14. Were withdrawals from the study explained?

**Table 2.** Accuracy of Diagnostic Technologies (Listed By Number of Studies Reviewed)
	# Studies	Pooled results
Primary analysis
HRT	132	132	78.8 (76.6 - 80.8)	82.8 (80.6 - 84.7)	17.8 (15.2 - 20.8)
GDx (FCC and VCC)	103	103	84.5 (81.7 - 87.0)	85.6 (82.9 - 87.9)	32.4 (25.6 - 40.9)
OCT (all types)	84	84	83.2 (80.7 - 85.4)	89.4 (87.5 - 91.0)	41.8 (33.5 - 52.0)
FDT	57	57	84.7 (79.1 - 89.0)	91.2 (88.2 - 93.5)	57.7 (35.8 - 92.9)
Blue on yellow	5	6	87.2 (67.2 - 95.8)	83.2 (68.4 - 91.9)	46.7 (7.58 - 288.2)
Secondary analysis
HRT I and II	102	102	77.8 (75.3 - 80.0)	84.5 (82.2 - 86.6)	19.1 (15.7 - 23.1)
HRT III	30	30	81.9 (77.3 - 85.7)	76.3 (71.7 - 80.4)	14.6 (11.4 - 18.6)
GDx-VCC	98	98	84.9 (82.1 - 87.3)	85.7 (83.0 - 88.0)	33.7 (26.4 - 42.9)
GDx-FCC	5	5	76.6 (60.0 - 87.7)	84.2 (61.5 - 94.7)	17.5 (8.9 - 34.1)
OCT time domain stratus	67	67	83.2 (80.4 - 85.6)	88.7 (86.5 - 90.6)	38.7 (30.2 - 49.7)
OCT spectral domain cirrus	17	17	83.3 (77.2 - 88.0)	91.6 (87.8 - 94.2)	54.1 (34.9 - 83.9)
OCT-spectralis	1	1	Only one study - no pooled results
FDT	57	57	84.7 (79.1 - 89.0)	91.2 (88.2 - 93.5)	57.7 (35.8 - 92.9)
Blue on yellow	5	6	87.2 (67.2 - 95.8)	83.2 (68.4 - 91.9)	46.7 (7.58 - 288.2)

Table 2. Accuracy of Diagnostic Technologies (Listed By Number of Studies Reviewed)

# Studies

Pooled results

Sensitivity

Specificity

Sensitivity

Specificity

Diagnostic odds ratio

Primary analysis

HRT

132

78.8 (76.6 - 80.8)

82.8 (80.6 - 84.7)

17.8 (15.2 - 20.8)

GDx (FCC and VCC)

103

84.5 (81.7 - 87.0)

85.6 (82.9 - 87.9)

32.4 (25.6 - 40.9)

OCT (all types)

83.2 (80.7 - 85.4)

89.4 (87.5 - 91.0)

41.8 (33.5 - 52.0)

FDT

84.7 (79.1 - 89.0)

91.2 (88.2 - 93.5)

57.7 (35.8 - 92.9)

Blue on yellow

87.2 (67.2 - 95.8)

83.2 (68.4 - 91.9)

46.7 (7.58 - 288.2)

Secondary analysis

HRT I and II

102

77.8 (75.3 - 80.0)

84.5 (82.2 - 86.6)

19.1 (15.7 - 23.1)

HRT III

81.9 (77.3 - 85.7)

76.3 (71.7 - 80.4)

14.6 (11.4 - 18.6)

GDx-VCC

84.9 (82.1 - 87.3)

85.7 (83.0 - 88.0)

33.7 (26.4 - 42.9)

GDx-FCC

76.6 (60.0 - 87.7)

84.2 (61.5 - 94.7)

17.5 (8.9 - 34.1)

OCT time domain stratus

83.2 (80.4 - 85.6)

88.7 (86.5 - 90.6)

38.7 (30.2 - 49.7)

OCT spectral domain cirrus

83.3 (77.2 - 88.0)

91.6 (87.8 - 94.2)

54.1 (34.9 - 83.9)

OCT-spectralis

Only one study - no pooled results

FDT

84.7 (79.1 - 89.0)

91.2 (88.2 - 93.5)

57.7 (35.8 - 92.9)

Blue on yellow

87.2 (67.2 - 95.8)

83.2 (68.4 - 91.9)

46.7 (7.58 - 288.2)

**Table 3.** Sub-Analysis of Accuracy of Diagnostic Technology (Based on Outlier Removal, Funding Source, Age, Race and Gender)
DORs	Overall	Overall less outliers	Peer review	Industry	Age > 55	Age < 55	Cauc > 50%	Cauc < 50%	Fem > 50%	Fem < 50%	AUC
HRT	17.82	18.18	16.94	18.56	17.56	19.99	19	13.99	17.64	18.62	0.839
GDx	32.38	29.53	35.61	30.12	31.67	41.41	33.2	24.65	33.49	31.23	0.881
OCT	41.76	43.36	39.29	43.62	41.26	47.11	43.2	38.92	49.14	25.94	0.901
FDT	57.7	60.96	57.29	58.03	56.01	61.18	57.53	67.71	57.53	45.44	0.893
BY	46.7	NA	NA	NA	NA	NA	NA	NA	NA	NA	0.888
HRT I-II	19.05	19.87	16.41	22.96	19.11	17.81	18.45	16.35	18.45	22.25	0.843
HRT III	14.56	15.17	24.5	13.1	13.82	NA	16.89	10.72	15.31	13.07	0.829
GDx VCC	33.65	31.27	35.61	32.06	32.97	41.41	34.54	24.5	35.09	31.61	0.882
GDx FCC	17.46	17.46	NA	17.46	17.46	NA	15.03	NA	15.03	NA	0.859
OCT-T	38.73	38	34.15	42.92	38.66	50.13	41.28	31.63	45.34	23.91	0.898
OCT-C	54.12	54.12	95.27	46	54.2	56.79	62.28	47.8	66.99	31.98	0.907
OCT-S	NA	NA	NA	NA	NA	NA	NA	NA	NA	NA	0.88

Table 3. Sub-Analysis of Accuracy of Diagnostic Technology (Based on Outlier Removal, Funding Source, Age, Race and Gender)

DORs

Overall

Overall less outliers

Peer review

Industry

Age > 55

Age < 55

Cauc > 50%

Cauc < 50%

Fem > 50%

Fem < 50%

AUC

HRT

17.82

18.18

16.94

18.56

17.56

19.99

13.99

17.64

18.62

0.839

GDx

32.38

29.53

35.61

30.12

31.67

41.41

33.2

24.65

33.49

31.23

0.881

OCT

41.76

43.36

39.29

43.62

41.26

47.11

43.2

38.92

49.14

25.94

0.901

FDT

57.7

60.96

57.29

58.03

56.01

61.18

57.53

67.71

57.53

45.44

0.893

46.7

0.888

HRT I-II

19.05

19.87

16.41

22.96

19.11

17.81

18.45

16.35

18.45

22.25

0.843

HRT III

14.56

15.17

24.5

13.1

13.82

16.89

10.72

15.31

13.07

0.829

GDx VCC

33.65

31.27

35.61

32.06

32.97

41.41

34.54

24.5

35.09

31.61

0.882

GDx FCC

17.46

15.03

0.859

OCT-T

38.73

34.15

42.92

38.66

50.13

41.28

31.63

45.34

23.91

0.898

OCT-C

54.12

95.27

54.2

56.79

62.28

47.8

66.99

31.98

0.907

OCT-S

0.88

**Table 4.** Heterogeneity of Diagnostic Technology
Technology	Sensitivity I²	Specificity I²	Diagnostic odds ratio I²
Primary outcome
HRT	68.7	86.3	71.4
GDx	86.2	85.3	72.5
OCT	75.3	73.7	69.5
FDT	97.5	94.7	94.3
Blue on yellow	79.8	79.1	84.4
Secondary outcomes
HRT I and II	78.7	87.3	81.4
HRT III	60.9	85.3	62.1
Scanning laser VCC	86.6	85.2	74.5
Scanning laser FCC	85.5	83.3	84.0
Time domain OCT	76.7	75.6	70.5
Spectral domain OCT	73.0	63.7	65.9
FDT	97.5	94.7	94.3
Blue on yellow	79.8	79.1	84.4

Table 4. Heterogeneity of Diagnostic Technology

Technology

Sensitivity I²

Specificity I²

Diagnostic odds ratio I²

Primary outcome

HRT

68.7

86.3

71.4

GDx

86.2

85.3

72.5

OCT

75.3

73.7

69.5

FDT

97.5

94.7

94.3

Blue on yellow

79.8

79.1

84.4

Secondary outcomes

HRT I and II

78.7

87.3

81.4

HRT III

60.9

85.3

62.1

Scanning laser VCC

86.6

85.2

74.5

Scanning laser FCC

85.5

83.3

84.0

Time domain OCT

76.7

75.6

70.5

Spectral domain OCT

73.0

63.7

65.9

FDT

97.5

94.7

94.3

Blue on yellow

79.8

79.1

84.4

**Table 5.** Number of Cutoffs Used Stratified by Technology
Technology	Number of methods/cutoffs encountered
OCT	52
GDx	66
Blue on yellow	4
FDT	52
HRT I and II	43
HRT III	6

Table 5. Number of Cutoffs Used Stratified by Technology

Technology

Number of methods/cutoffs encountered

OCT

GDx

Blue on yellow

FDT

HRT I and II

HRT III