Cochrane · DTA · CD010173
Clinical assessment for the detection of oral cavity cancer and potentially malignant disorders in apparently healthy adults
Walsh, T, Warnakulasuriya, S, Lingen, MW, et al. · Cochrane Database of Systematic Reviews · 2021 · Cochrane Library
Full textEvery question was extracted from the full review (methods and results), not only its Summary of Findings table.
Questions
20
current version
GRADE rated
11
No studies
9
Included studies
18
as reported
No studies 9 · 45%Ungraded 0 · 0%Very low 4 · 20%Low 2 · 10%Moderate 5 · 25%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 | Apparently healthy adults not reporting symptoms of OPMD or OSCC, attending an organised screening or surveillance programme, or screened during attendance at a dental or physician examination | 18 studies, 72,202 participants, published between 1986 and 2019 |
| Intervention | Eligible index tests: COE/visual inspection; vital staining/rinsing (toluidine blue, tolonium chloride); oral cytology (e.g. OralCDx brush biopsy, CytID); light-based detection (VELscope, Orascoptic DK, Identafi 3000, ViziLite Plus, Microlux/DL); mouth self-examination; remote clinical examination (including telemedicine); and blood and saliva analyses | Conventional oral examination/visual inspection (n=10); Mouth self-examination (n=4); COE with vital rinsing (n=1); Remote screening (mobile application) (n=3) |
| Comparison | Comparator test: COE alone. Reference standard: examination and clinical evaluation by a clinician with specialist knowledge/training, or extended follow-up for those screened negative (any level of dysplasia classified as disease-positive) | Reference standard: specialist clinician examination/clinical evaluation or trained health worker; biopsy and long-term follow-up/National Cancer Registry (n=18) |
| Outcomes | Diagnostic test accuracy (sensitivity, specificity) for OSCC and OPMD (leukoplakia, erythroplakia, proliferative verrucous leukoplakia, oral lichen planus/lichenoid lesions, oral submucous fibrosis, actinic keratosis) | Diagnostic accuracy (sensitivity, specificity) with GRADE certainty for COE, mouth self-examination, remote screening; comparative accuracy and detection rate for COE plus vital rinsing vs COE alone (n=1 RCT) |
| Study designs | Cross-sectional studies (or prospective consecutive series); randomised controlled trials of test accuracy | Cross-sectional studies or consecutive series (n=17); randomised controlled trial of test accuracy (n=1) |
| Timing | Not reported | Not reported |
Search date: 2020-10. Databases: Cochrane Oral Health's Trials Register; MEDLINE Ovid; Embase Ovid; ClinicalTrials.gov; World Health Organization International Clinical Trials Registry Platform
Questions and results
Show all 3 versionsConventional oral examination (COE)/visual inspection vs Reference standard: examination and clinical evaluation by a physician/clinician with specialist knowledge or training (long-term follow-up accepted for those screened negative)
Population: Apparently healthy adults not reporting symptoms of OPMD or OSCC, attending an organised screening or surveillance programme, or screened during attendance at a dental or physician examination
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Specificity for detection of oral cavity cancer/OPMD | Summary of findings 1 (no pooled analysis): for the 7 low-prevalence studies specificity ranged from 0.94 (95% CI 0.88 to 0.97) to 0.99 (95% CI 0.98 to 1.00); for the 3 higher-prevalence studies specificity ranged from… | 10 studies · 25568 participants | Low Downgraded: inconsistency, indirectness |
Sensitivity for detection of oral cavity cancer/OPMD | Summary of findings 1 (no pooled analysis): for the 7 studies with low prevalence (<=10%) sensitivity ranged from 0.50 (95% CI 0.07 to 0.93) to 0.99 (95% CI 0.97 to 1.00); for the 3 higher-prevalence studies… | 10 studies · 25568 participants | Low Downgraded: inconsistency, indirectness |
COE with vital rinsing (toluidine blue/tolonium chloride) vs Reference standard: examination and clinical evaluation by a physician/clinician with specialist knowledge or training (long-term follow-up accepted for those screened negative)
Population: Apparently healthy adults not reporting symptoms of OPMD or OSCC, attending an organised screening or surveillance programme, or screened during attendance at a dental or physician examination
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Outcome NR | No eligible study evaluated COE with vital rinse as a stand-alone screen against the reference standard in this version. | 0 studies | No studies |
COE with light-based detection (e.g. ViziLite Plus, Microlux/DL, VELscope, Identafi 3000) vs Reference standard: examination and clinical evaluation by a physician/clinician with specialist knowledge or training (long-term follow-up accepted for those screened negative)
Population: Apparently healthy adults not reporting symptoms of OPMD or OSCC, attending an organised screening or surveillance programme, or screened during attendance at a dental or physician examination
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Outcome NR | There were no eligible studies evaluating light-based detection. | 0 studies | No studies |
COE with blood/salivary (biomarker) analysis vs Reference standard: examination and clinical evaluation by a physician/clinician with specialist knowledge or training (long-term follow-up accepted for those screened negative)
Population: Apparently healthy adults not reporting symptoms of OPMD or OSCC, attending an organised screening or surveillance programme, or screened during attendance at a dental or physician examination
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Outcome NR | There were no eligible studies evaluating blood or salivary sample analysis (which tests for the presence of biomarkers for OPMD and OSCC). | 0 studies | No studies |
COE with vital rinsing (toluidine blue/tolonium chloride) vs Conventional oral examination (COE) alone
Population: OSCC or OPMD symptom-free individuals with tobacco habits
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Detection rate of oral pre-malignant and malignant lesions after referral (COE+vital rinsing vs COE alone) | Rate ratio 1.05 [0.74, 1.41] 4.4% (44 per 1000), COE alone vs 4.6% (46 per 1000), COE plus vital rinsing | 1 study · 7975 participants | Moderate Downgraded: indirectness |
Specificity (COE plus vital rinsing arm) | Specificity 0.91 [0.90, 0.91] | 1 study · 4080 participants | Moderate Downgraded: indirectness |
Specificity (COE alone arm) | Specificity 0.92 [0.91, 0.93] | 1 study · 3895 participants | Moderate Downgraded: indirectness |
Sensitivity (COE alone arm) | Sensitivity 0.50 [0.12, 0.88] | 1 study · 3895 participants | Moderate Downgraded: indirectness |
Sensitivity (COE plus vital rinsing arm) | Sensitivity 0.40 [0.05, 0.85] | 1 study · 4080 participants | Moderate Downgraded: indirectness |
COE with light-based detection (e.g. ViziLite Plus, Microlux/DL, VELscope, Identafi 3000) vs Conventional oral examination (COE) alone
Population: Apparently healthy adults not reporting symptoms of OPMD or OSCC, attending an organised screening or surveillance programme, or screened during attendance at a dental or physician examination
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Outcome NR | No eligible studies; planned comparative analysis (COE vs COE with light-based detection) not populated in this version. | 0 studies | No studies |
COE with blood/salivary (biomarker) analysis vs Conventional oral examination (COE) alone
Population: Apparently healthy adults not reporting symptoms of OPMD or OSCC, attending an organised screening or surveillance programme, or screened during attendance at a dental or physician examination
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Outcome NR | No eligible studies; planned comparative analysis (COE vs COE with blood/salivary analysis) not populated in this version. | 0 studies | No studies |
COE with light-based detection (e.g. ViziLite Plus, Microlux/DL, VELscope, Identafi 3000) vs COE with vital rinsing (toluidine blue/tolonium chloride)
Population: Apparently healthy adults not reporting symptoms of OPMD or OSCC, attending an organised screening or surveillance programme, or screened during attendance at a dental or physician examination
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Outcome NR | No eligible studies; planned comparative analysis (COE with vital rinse vs COE with light-based detection) not populated in this version. | 0 studies | No studies |
COE with blood/salivary (biomarker) analysis vs COE with vital rinsing (toluidine blue/tolonium chloride)
Population: Apparently healthy adults not reporting symptoms of OPMD or OSCC, attending an organised screening or surveillance programme, or screened during attendance at a dental or physician examination
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Outcome NR | No eligible studies; planned comparative analysis (COE with vital rinse vs COE with blood/salivary analysis) not populated in this version. | 0 studies | No studies |
COE with blood/salivary (biomarker) analysis vs COE with light-based detection (e.g. ViziLite Plus, Microlux/DL, VELscope, Identafi 3000)
Population: Apparently healthy adults not reporting symptoms of OPMD or OSCC, attending an organised screening or surveillance programme, or screened during attendance at a dental or physician examination
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Outcome NR | No eligible studies; planned comparative analysis (COE with light-based detection vs COE with blood/salivary analysis) not populated in this version. | 0 studies | No studies |
Mouth self-examination (MSE) vs Reference standard: examination and clinical evaluation by a physician/clinician with specialist knowledge or training (long-term follow-up accepted for those screened negative)
Population: Apparently healthy adults not reporting symptoms of OPMD or OSCC, attending an organised screening or surveillance programme, or screened during attendance at a dental or physician examination
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Specificity for detection of oral cavity cancer/OPMD | Summary of findings 2 (no pooled analysis): specificity 1.00 (95% CI 1.00 to 1.00), 0.95 (95% CI 0.88 to 0.99), 0.44 (95% CI 0.20 to 0.70), and 0.54 (95% CI 0.37 to 0.69) across the 4 studies. Certainty VERY LOW. | 4 studies · 35059 participants | Very low Downgraded: imprecision, inconsistency, indirectness |
Sensitivity for detection of oral cavity cancer/OPMD | Summary of findings 2 (no pooled analysis): sensitivity 0.18 (95% CI 0.13 to 0.24), 0.09 (95% CI 0.04 to 0.15), 0.43 (95% CI 0.24 to 0.63), and 0.33 (95% CI 0.10 to 0.65) across the 4 studies. Prevalence 0.6% to 63.6%.… | 4 studies · 35059 participants | Very low Downgraded: imprecision, inconsistency, indirectness |
Remote screening of the oral cavity (mobile application/telemedicine) vs Reference standard: examination and clinical evaluation by a physician/clinician with specialist knowledge or training (long-term follow-up accepted for those screened negative)
Population: Apparently healthy adults not reporting symptoms of OPMD or OSCC, attending an organised screening or surveillance programme, or screened during attendance at a dental or physician examination
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Sensitivity for detection of oral cavity cancer/OPMD | Summary of findings 4 (no pooled analysis): sensitivity 0.85 (95% CI 0.81 to 0.88), 0.82 (95% CI 0.57 to 0.96), and 0.94 (95% CI 0.70 to 1.00) across the 3 studies. Prevalence 12.2% to 30.9%. Certainty VERY LOW. | 3 studies · 3600 participants | Very low Downgraded: inconsistency, indirectness |
Specificity for detection of oral cavity cancer/OPMD | Summary of findings 4 (no pooled analysis): specificity 0.99 (95% CI 0.99 to 1.00), 1.00 (95% CI 0.91 to 1.00), and 0.72 (95% CI 0.63 to 0.80) across the 3 studies. Certainty VERY LOW. | 3 studies · 3600 participants | Very low Downgraded: inconsistency, indirectness |
Oral cytology (e.g. OralCDx brush biopsy, CytID) vs Reference standard: examination and clinical evaluation by a physician/clinician with specialist knowledge or training (long-term follow-up accepted for those screened negative)
Population: Apparently healthy adults not reporting symptoms of OPMD or OSCC, attending an organised screening or surveillance programme, or screened during attendance at a dental or physician examination
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Outcome NR | Oral cytology (e.g. brush biopsy) was added to the list of eligible index tests in this update; no eligible studies evaluated it (evidence gap). | 0 studies | No studies |