TABLE 9:
Tissue reflectance and vital staining adjuncts to evaluate clinically evident suspicious lesions.*
| TEST RESULT | DOWNSTREAM CONSEQUENCES | EFFECT PER 100,000 PATIENTS TESTED (95% CONFIDENCE INTERVAL [CI]) | NUMBER OF LESIONS (STUDIES) | QUALITY OF THE EVIDENCE (GRADE)§ | |
|---|---|---|---|---|---|
| Prevalence 0.25%† | Prevalence 2%‡ | ||||
| True Positives (Patients With Need for Biopsy) | Patients will be correctly identified as having a potentially malignant lesion, and timely referral to a specialist or biopsy will be performed. | 203 (178 to 223) | 1,620 (1,420 to 1,780) | 307 (4) | Low¶,#,** |
| False Negatives (Patients Incorrectly Classified as Not Having Need for Biopsy) | Appropriate diagnostic would be missed, worsening the prognosis of the disease. | 47 (27 to 72) | 380 (220 to 580) | ||
| True Negatives (Patients Without Need for Biopsy) | Patients will receive reassurance that they do not have a potentially malignant or malignant disorder. | 68,828 (62,843 to 74,813) | 67,620 (61,740 to 73,500) | 307 (4) | Low¶,#,** |
| False Positives (Patients Incorrectly Classified as Having Need for Biopsy) | Patients would be incorrectly identified as having a potentially malignant or malignant disorder and would undergo additional unnecessary testing and biopsy. | 30,922 (24,937 to 36,907) | 30,380 (24,500 to 36,260) | ||
Setting: primary care. Pooled sensitivity, 0.81 (95% confidence interval [CI], 0.71 to 0.89). Pooled specificity, 0.69 (95% CI, 0.63 to 0.75). Positive likelihood ratio, 2.62 (95% CI, 2.10 to 3.27). Negative likelihood ratio, 0.27 (95% CI, 0.17 to 0.44). Sources: Chainani-Wu and colleagues,62 Epstein and colleagues,67 Mojsa and colleagues,68 and Ujaoney and colleagues.65
We estimated the prevalence by using data from the National Cancer Institute Surveillance, Epidemiology, and End Results Program (300,682 people living with oral cavity and pharynx cancer in the United States in 2013) and the 2010 census data for adults 45 years or older collected by the US Census Bureau.
The panel provided illustrative prevalence as an estimation of the number of histopathologic diagnoses from dysplasia to cancer.
GRADE: Grading of Recommendations Assessment, Development and Evaluation.
Three of 4 studies showed high risk of bias in patient selection and the application of the index test.
Investigators conducted all studies in secondary care settings. Most patients had a higher probability of having a malignant or potentially malignant disorder.