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Study flow diagram.

Figuras y tablas -
Figure 1

Study flow diagram.

Table 1. Important potentially malignant disorders (PMDs)

The following were identified as PMDs by the World Health Organization's Working Group on Oral Cancer (Warnakulasuriya 2007).

  • Leukoplakia.

  • Erythroplakia.

  • Palatal lesion of reverse cigar smoking.

  • Oral lichen planus.

  • Oral submucous fibrosis.

  • Discoid lupus erythematosus.

  • Hereditary disorders such as dyskeratosis congenita and epidermolysis bullosa.

Figuras y tablas -
Table 1. Important potentially malignant disorders (PMDs)
Table 2. Comparison of risk factors between the intervention and control groups after three cycles (nine years) follow‐up

Trivandrum Oral Cancer Screening Study

Screening group

Control group

Number of interviewed participants

n = 7 clusters (87,829: 91%)

n = 6 clusters (80,086: 84%)

Gender

35,687 male

52,142 female

31,281 male

48,805 female

Income (< 1500 rupees (USD 35) per month)

42,415 (49%)

30,849 (40%)

Occupation (manual workers)

68,645 (78%)

55,811 (71%)

Education

68,263 (78%)

64,291 (78%)

Age (years; mean (SD, range))

49 (0.7, 48‐50)

49 (0.8, 48‐50)

No habits

10,933 male (27%)

39,923 female (73%)

13,996 male (33%)

42,361 female (79%)

Chewing habits

12,329 male (30%)

14,570 female (27%)

10,586 male (24.9%)

10,748 female (20%)

Smoking habits

26,133 male (63%)

1610 female (3%)

23,270 male (56%)

609 female (1%)

Drinking habits

17,738 male (43%)

133 female (0.2%)

15,472 male (37%)

127 female (0.1%)

SD = standard deviation.
Note: Data on risk factors not available after 4 cycles (15 years), but authors report that the participants had a similar distribution.

Figuras y tablas -
Table 2. Comparison of risk factors between the intervention and control groups after three cycles (nine years) follow‐up
Table 3. Screening history after four cycles (15 years) follow‐up

Screening history

Screening group

Control

Number recruited

7 clusters

(n = 96,517)

6 clusters

(n = 95,356)

Not screened

7695

51,365

Screened once

25,144

43,992

Screened twice

22,382

Screened three times

22,008

Screened four times

19,288

Number of screen positive individuals

5586

1163

Individuals complied with referral

3298

189

Figuras y tablas -
Table 3. Screening history after four cycles (15 years) follow‐up
Table 4. Oral cancer experience after four cycles (15 years) follow‐up

Trivandrum Oral Cancer Screening Study

Screening group

Control group

Risk ratio (95% confidence interval)

Total number participants

96,517

95,356

Person‐years of observation

895,310

898,280

Number of oral cancers

279

244

Screen detected cases

188

Nil

Deaths from oral cancer

138

154

Case fatality rate

49.5%

63.1%

Crude incidence rate / 100,000 person‐years of observation

31.2

27.2

1.14 (0.91 to 1.44)

Age‐standardised incidence rate / 100,000 person‐years

37.1

30.8

Crude mortality rate from oral cancer /100,000 person‐years of observation

15.4

17.1

0.88 (0.69 to 1.12)

Age‐standardised mortality rate / 100,000 person‐years

18.9

19.7

Proportion of cancers at stage III or worse1

52.6%

65.2%

0.81 (0.70 to 0.93)

1Does not include individuals for whom stage unknown (22 in screening group; 19 in control group).

Figuras y tablas -
Table 4. Oral cancer experience after four cycles (15 years) follow‐up
Table 5. Oral cancer experience in high‐risk individuals after four cycles (15 years) follow‐up

Trivandrum Oral Cancer Screening Study

Screening group

Control group

Risk ratio (95% confidence interval)

Person‐years of observation

429,620

377,350

Number of oral cancer cases

254

232

Deaths from oral cancer

129

147

Case fatality rate

50.8%

63.4%

Crude incidence rate/ 100,000 person‐years

59.2

61.6

0.97 (0.79 to 1.19)

Age‐standardised incidence rate/ 100,000 person‐years

57.3

58.5

Crude mortality rate/ 100,000 person‐years

30.0

39.0

0.76 (0.60 to 0.97)

Age‐standardised mortality rate/ 100,000 person‐years

29.1

37.1

Age‐standardised mortality rate/ 100,000 person‐years

18.9

19.7

Proportion of cancers at stage III or worse1

54.3%

66.4%

0.82 (0.71 to 0.95)

1Does not include individuals for whom stage unknown (22 in screening group; 19 in control group).

Figuras y tablas -
Table 5. Oral cancer experience in high‐risk individuals after four cycles (15 years) follow‐up
Table 6. Oral cancer mortality rate by number of times screened

Risk type

Arm

Cycles

Mortality rate*

Hazard ratio (95% confidence interval)**

All participants

Control

n/a

17.1

1.00

Screening group

0

37.2

1.46 (0.78 to 2.73)

1

44.1

2.26 (1.66 to 3.09)

2

16.2

0.94 (0.68 to 1.30)

3

10.4

0.62 (0.37 to 1.04)

4

3.0

0.21 (0.13 to 0.35)

High‐risk participants

Control

n/a

39.0

1.00

Screening group

0

59.4

1.27 (0.68 to 2.37)

1

74.7

1.90 (1.45 to 2.49)

2

31.0

0.83 (0.62 to 1.12)

3

20.6

0.53 (0.34 to 0.84)

4

7.1

0.19 (0.11 to 0.31)

*Per 100,000 person‐years of observation

**Adjusted for age, sex and number of residents.

Figuras y tablas -
Table 6. Oral cancer mortality rate by number of times screened
Table 7. Distribution of stage over four cycles (15 years)

Arm

Cycles

Clinical stage

Total

I

II

III

IV

Unknown

Intervention group

Baseline

0

3 (16%)

3 (16%)

7 (37%)

6 (32%)

19

1

9 (11%)

10 (13%)

18 (23%)

32 (41%)

10 (13%)

79

2

10 (15%)

11 (17%)

17 (26%)

25 (38%)

3 (5%)

66

3

23 (32%)

12 (17%)

9 (13%)

25 (35%)

3 (4%)

72

4

17 (40%)

15 (35%)

4 (9%)

7 (34%)

0

43

Total

59 (21%)

51 (18%)

51 (18%)

96 (34%)

22 (8%)

279

Control group

1996 ‐ 2004 (detected not due to screening)

21 (13%)

19 (12%)

34 (22%)

72 (46%)

12 (8%)

158

Not screened

0

7 (16%)

12 (27%)

20 (44%)

6 (13%)

45

Screened

10 (24%)

9 (22%)

6 (15%)

15 (37%)

1 (2%)

41

Total

31 (13%)

35 (14%)

52 (21%)

107 (44%)

19 (8%)

244

Figuras y tablas -
Table 7. Distribution of stage over four cycles (15 years)
Table 8. Cost‐effectiveness of the screening programme after three cycles (nine years)

Detail

Cost of intervention less cost of control (US$)

Total cost per 100,000 individuals

224,964

Cost per additional cancer detected by the screen

All individuals

4817

Cost per additional cancer detected by the screen

High‐risk individuals

9394

Cost per life‐year saved by the screen

All individuals

835

Cost per life‐year saved by the screen

High‐risk individuals

156

Costs based on the calender year of 2004 (Subramanian 2009).

Figuras y tablas -
Table 8. Cost‐effectiveness of the screening programme after three cycles (nine years)