Cochrane · intervention · CD004150
Screening programmes for the early detection and prevention of oral cancer
Brocklehurst, P, Kujan, O, O'Malley, L, et al. · Cochrane Database of Systematic Reviews · 2013 · Cochrane Library
Full textEvery question was extracted from the full review (methods and results), not only its Summary of Findings table.
Questions
14
current version
GRADE rated
1
No studies
5
Included studies
1
as reported
No studies 5 · 35.7%Ungraded 8 · 57.1%Very low 0 · 0%Low 1 · 7.1%Moderate 0 · 0%High 0 · 0%
Ungraded means an effect was reported without a GRADE rating; it is not a gap. No studies means the review found nothing to answer the question. The six categories are a display order, not a score.
Review question
| Element | Planned (methods) | Found (results) |
|---|---|---|
| Population | Participants involved in population, selective (high-risk) or opportunistic screening programmes | Apparently healthy adults aged 35 years or older living in 13 clusters (average 14,759 each) in rural areas of Trivandrum city, Kerala, India. n=191,873. Screening 96,517; control 95,356 |
| Intervention | Any health technology used in a screening programme for detection of oral cancer or PMD: visual screening; visual staining using toluidine blue; oral cytology using brush biopsies; fluorescence imaging and light-based techniques | Visual screening by trained and qualified health workers (n=96517) |
| Comparison | No screening intervention | No screening (n=95356) |
| Outcomes | Oral cancer mortality (primary); incidence of oral cancer or PMD; stage at diagnosis; adverse effects (outcomes from false positive or false negative results, if known); cost data (where reported) | Oral cancer incidence (n=523); Oral cancer mortality (n=292 deaths); Stage at diagnosis (n=523); 5-year survival rate (n=523); Sensitivity (n=1); High-risk subgroup mortality, incidence and stage shift with RR (n=1); Adherence (cycles) subgroup (n=1); Cost-effectiveness (n=1) |
| Study designs | Randomised controlled trials (RCTs) of screening programmes for the early detection of oral cancer or PMD, which report on the associated mortality rates subsequent to the screen | 1 cluster-randomised controlled trial (Trivandrum Oral Cancer Screening Study; Sankaranarayanan 2000; Kerala, India), four screening cycles (n=1) |
| Timing | Not specified | 15 years follow up (four screening cycles) |
Search date: 22 July 2013. Databases: The Cochrane Oral Health Group's Trials Register (to 22 July 2013); CENTRAL (The Cochrane Library 2013 Issue 6); MEDLINE via OVID (1946 to 22 July 2013); EMBASE via OVID (1980 to 22 July 2013); CANCERLIT via PubMed (1950 to 22 July 2013)
Questions and results
Current version onlyVisual screening (oral visual inspection) by trained health workers vs No screening
Population: Apparently healthy adults aged 35 years or older (general population), living in 13 clusters in rural areas of Trivandrum city, Kerala, India
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Oral cancer mortality (disease-specific) 15-year follow-up | RR 0.88 [0.69, 1.12] | 1 study · 191873 participants | Low Downgraded: risk of bias |
Costs 9 years (three cycles) | The costs associated with the screening programme were reported after three cycles (nine years) (Subramanian 2009) (Additional Table 8). The benefit produced by a screen was 269.31 life-years saved per 100,000 for all… | 1 study | Ungraded |
Harms of screening (false-positive/false-negative outcomes) 15-year follow-up | No harms were reported. | 0 studies | No studies |
Quality of life 15-year follow-up | Data on quality of life were not reported. | 0 studies | No studies |
Oral cancer incidence 15-year follow-up | RR 1.14 [0.91, 1.44] | 1 study · 191873 participants | Ungraded |
Test performance (sensitivity and specificity) 15-year follow-up | Across the four cycles (15 years), the reported sensitivity of the visual examination in detecting oral cancer was 67.4% (188/279). No information on the specificity or the positive predictive value of the programme… | 1 study | Ungraded |
Stage at diagnosis (early-stage detection) 15-year follow-up | RR 0.81 [0.70, 0.93] | 1 study · 523 participants | Ungraded |
Stage at diagnosis (early-stage detection) 15-year follow-up · High-risk individuals (tobacco and/or alcohol users) | RR 0.82 [0.71, 0.95] | 1 study · 486 participants | Ungraded |
Survival (proportion alive after diagnosis) 5-year survival | A significantly higher five-year survival rate was reported in the screened group (55.5%) compared to the control (43.4%) (P value = 0.003). | 1 study · 523 participants | Ungraded |
Oral cancer mortality (disease-specific) 15-year follow-up · High-risk individuals (tobacco and/or alcohol users) | RR 0.76 [0.60, 0.97] | 1 study | Ungraded |
Oral cancer incidence 15-year follow-up · High-risk individuals (tobacco and/or alcohol users) | RR 0.97 [0.79, 1.19] | 1 study | Ungraded |
Toluidine blue (visual staining) vs No screening
Population: Planned population: general population or high-risk / opportunistic screening groups (no eligible study)
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Outcome NR | There was no evidence to support the use of adjunctive technologies like toluidine blue, brush biopsy or fluorescence imaging as a screening tool to reduce oral cancer mortality; no eligible randomised controlled trial… | 0 studies | No studies |
Fluorescence imaging / light-based techniques vs No screening
Population: Planned population: general population or high-risk / opportunistic screening groups (no eligible study)
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Outcome NR | There was no evidence to support the use of adjunctive technologies like toluidine blue, brush biopsy or fluorescence imaging as a screening tool to reduce oral cancer mortality; no eligible randomised controlled trial… | 0 studies | No studies |
Brush biopsy (oral cytology) vs No screening
Population: Planned population: general population or high-risk / opportunistic screening groups (no eligible study)
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Outcome NR | There was no evidence to support the use of adjunctive technologies like toluidine blue, brush biopsy or fluorescence imaging as a screening tool to reduce oral cancer mortality; no eligible randomised controlled trial… | 0 studies | No studies |
Visual screening (oral visual inspection) by trained health workers vs No screening
Population: Apparently healthy adults aged 35 years or older (general population), living in 13 clusters in rural areas of Trivandrum city, Kerala, India
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Oral cancer mortality (disease-specific) 9-year follow-up · High-risk individuals (tobacco and/or alcohol users) | For individuals that used tobacco, alcohol or both, a significant reduction of 43% in mortality rates for men (from 42.9 to 24.6 per 100,000 person years). For women, a 22% reduction (from 50.7 to 39.4 per 100,000… | 1 study | Ungraded |
Test performance (sensitivity and specificity) 9-year follow-up | Reported sensitivity of the visual examination in detecting oral cancer was 64% (131/205). No information on the specificity or the positive predictive value of the programme was recorded. | 1 study | Ungraded |
Survival (proportion alive after diagnosis) 5-year survival | A significantly higher 5-year survival rate was reported in the intervention group (50%) than in the control group (34%) (P = 0.009). | 1 study · 363 participants | Ungraded |
Oral cancer incidence 9-year follow-up · High-risk individuals (tobacco and/or alcohol users) | High-risk individuals incidence (per 100,000 person years): men 65.7 (intervention) vs 81.2 (control); women 108.7 (intervention) vs 87.9 (control). | 1 study | Ungraded |
Quality of life 9-year follow-up | Data on quality of life was not reported. | 0 studies | No studies |
Oral cancer incidence 9-year follow-up | 205 oral cancer patients (intervention) and 158 (control); crude incident rate 43.7 vs 37.6 per 100,000 person-years. | 1 study · 191873 participants | Ungraded |
Stage at diagnosis (early-stage detection) 9-year follow-up | Statistically significant stage shift: 42% of intervention cases in stage I or II vs 24% of control cases (P = 0.004); 66% of control cases in stage III or IV vs 41% of intervention cases. | 1 study · 363 participants | Ungraded |
Oral cancer mortality (disease-specific) 9-year follow-up | There was no statistically significant difference in the mortality rate for oral cancer between the intervention group and control. Over the 9-year period, 77 of 205 (intervention) and 87 of 158 (control) died;… | 1 study · 191873 participants | Ungraded |
Harms of screening (false-positive/false-negative outcomes) 9-year follow-up | Harms of screening from false positive or false negative results (a planned outcome) were not reported. | 0 studies | No studies |
Positive predictive value 9-year follow-up | Positive predictive value calculated from published data was 74% for oral cancer. | 1 study | Ungraded |
Costs 9 years (three cycles) | Cost-effectiveness reported in a later study (Subramanian 2009) (Table 7). The benefit produced by a screen was 269.31 life-years saved per 100,000 for all individuals and 1437.64 for those at high risk. The… | 1 study | Ungraded |
Toluidine blue (visual staining) vs No screening
Population: Planned population: general population or high-risk / opportunistic screening groups (no eligible study)
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Outcome NR | No robust evidence was identified to support the use of adjunctive technologies like toluidine blue, brush biopsy or fluorescence imaging; no eligible randomised controlled trial of this modality was found. | 0 studies | No studies |
Fluorescence imaging / light-based techniques vs No screening
Population: Planned population: general population or high-risk / opportunistic screening groups (no eligible study)
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Outcome NR | No robust evidence was identified to support the use of adjunctive technologies like toluidine blue, brush biopsy or fluorescence imaging; no eligible randomised controlled trial of this modality was found. | 0 studies | No studies |
Brush biopsy (oral cytology) vs No screening
Population: Planned population: general population or high-risk / opportunistic screening groups (no eligible study)
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Outcome NR | No robust evidence was identified to support the use of adjunctive technologies like toluidine blue, brush biopsy or fluorescence imaging; no eligible randomised controlled trial of this modality was found. | 0 studies | No studies |
Visual screening (oral visual inspection) by trained health workers vs No screening
Population: Apparently healthy adults aged 35 years or older (general population), living in 13 clusters in rural areas of Trivandrum city, Kerala, India
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Test performance (sensitivity and specificity) 9-year follow-up | The programme's sensitivity in detecting oral cancer was 64%. No information on the specificity of the programme was recorded. | 1 study | Ungraded |
Harms of screening (false-positive/false-negative outcomes) 9-year follow-up | The study did not provide any information related to harms of screening from false-positive or false-negative findings. | 0 studies | No studies |
Oral cancer mortality (disease-specific) 9-year follow-up | There was no statistically significant difference in death rate from oral cancer between the intervention group and control. Over the 9-year period, 77 of 205 subjects with oral cancer in the intervention group and 87… | 1 study · 191873 participants | Ungraded |
Oral cancer mortality (disease-specific) 9-year follow-up · High-risk individuals (tobacco and/or alcohol users) | High-risk group (tobacco or alcohol users): deaths 70 (intervention) vs 85 (control); mortality rate 29.9/100,000 person-years vs 45.4/100,000. A significant 34% reduction in mortality was recorded in the high-risk… | 1 study · 84600 participants | Ungraded |
Quality of life 9-year follow-up | The study did not provide any information related to quality of life. | 0 studies | No studies |
Oral cancer incidence 9-year follow-up · High-risk individuals (tobacco and/or alcohol users) | High-risk individuals: oral cancer cases 190 (intervention) vs 156 (control); incidence rate 81.1/100,000 person-years vs 83.3/100,000. | 1 study · 84600 participants | Ungraded |
Costs 9-year follow-up | The study did not provide any information related to costs. | 0 studies | No studies |
Stage at diagnosis (early-stage detection) 9-year follow-up | 42% of intervention cases were in stage I or II, as opposed to 24% of control cases (P = 0.004); 66% of control cases were in stage III or IV vs 41% of intervention cases. | 1 study · 363 participants | Ungraded |
Oral cancer incidence 9-year follow-up | 205 oral cancer patients in the intervention group and 158 in the control group. Crude incident rate 43.7/100,000 person-years (intervention) and 37.6/100,000 person-years (control). | 1 study · 191873 participants | Ungraded |
Positive predictive value 9-year follow-up | Positive predictive value of prevalence screening was 74% for oral cancer. | 1 study | Ungraded |
Survival (proportion alive after diagnosis) 5-year survival | A significantly higher 5-year survival rate was reported in the intervention group (50%) than in the control group (34%) (P = 0.009). | 1 study · 363 participants | Ungraded |
Toluidine blue (visual staining) vs No screening
Population: Planned population: general population or high-risk / opportunistic screening groups (no eligible study)
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Outcome NR | No randomised controlled trial of this modality for oral cancer screening met the inclusion criteria; the only included study evaluated visual screening. | 0 studies | No studies |
Fluorescence imaging / light-based techniques vs No screening
Population: Planned population: general population or high-risk / opportunistic screening groups (no eligible study)
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Outcome NR | No randomised controlled trial of this modality for oral cancer screening met the inclusion criteria; the only included study evaluated visual screening. | 0 studies | No studies |
Brush biopsy (oral cytology) vs No screening
Population: Planned population: general population or high-risk / opportunistic screening groups (no eligible study)
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Outcome NR | No randomised controlled trial of this modality for oral cancer screening met the inclusion criteria; the only included study evaluated visual screening. | 0 studies | No studies |
Visual screening (oral visual inspection) by trained health workers vs No screening
Population: Apparently healthy adults aged 35 years or older (general population), living in 13 clusters in rural areas of Trivandrum city, Kerala, India
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Survival (proportion alive after diagnosis) 3-year survival | The 3-year survival rate was 57.5% in the intervention group and 38.8% in the control group (p > 0.05). | 1 study · 255 participants | Ungraded |
Oral cancer incidence 6-year follow-up | Trivandrum cancer registry recorded 355 patients with oral cancer; 149 in the intervention group and 106 in the control group. Crude incident rate of oral cancer 43.3/100,000 person years (intervention) and… | 1 study · 130779 participants | Ungraded |
Harms of screening (false-positive/false-negative outcomes) 6-year follow-up | This study did not raise any issues with regard to the harms of screening from false positive or false negative findings. | 0 studies | No studies |
Oral cancer mortality (disease-specific) 6-year follow-up | There was no statistical significant difference in death rate from oral cancer between the intervention group and control. Over the 6-year period, 65 of 149 subjects with oral cancer in the intervention group and 62 of… | 1 study · 130779 participants | Ungraded |
Stage at diagnosis (early-stage detection) 6-year follow-up | In the intervention group, 37.6% of cases were in stage I or II, as opposed to 18.9% of cases in the control group (p < 0.001). 57.5% of control cases were in stage III or IV corresponding to 42.3% of intervention cases. | 1 study · 255 participants | Ungraded |
Positive predictive value 6-year follow-up | Positive predictive value of prevalence screening (screen-selected oral cancers as a proportion of total screen positive subjects confirmed by biopsy) was 39.6% for oral cancer. | 1 study | Ungraded |
Test performance (sensitivity and specificity) 6-year follow-up | The programme's sensitivity and specificity in detecting oral cancer were 81.5% and 84.8% respectively. | 1 study | Ungraded |
Quality of life 6-year follow-up | Data on quality of life were not reported. | 0 studies | No studies |
Costs 6-year follow-up | Data on costs were not reported. | 0 studies | No studies |
Toluidine blue (visual staining) vs No screening
Population: Planned population: general population or high-risk / opportunistic screening groups (no eligible study)
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Outcome NR | There are no included studies with regard to brush biopsy, fluorescence imaging and toluidine blue; no randomised controlled trial of this modality met the inclusion criteria. | 0 studies | No studies |
Fluorescence imaging / light-based techniques vs No screening
Population: Planned population: general population or high-risk / opportunistic screening groups (no eligible study)
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Outcome NR | There are no included studies with regard to brush biopsy, fluorescence imaging and toluidine blue; no randomised controlled trial of this modality met the inclusion criteria. | 0 studies | No studies |
Brush biopsy (oral cytology) vs No screening
Population: Planned population: general population or high-risk / opportunistic screening groups (no eligible study)
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Outcome NR | There are no included studies with regard to brush biopsy, fluorescence imaging and toluidine blue; no randomised controlled trial of this modality met the inclusion criteria. | 0 studies | No studies |