TABLE 8:
Cytologic testing 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 or malignant disorder and a timely referral to a specialist or biopsy will be carried out. | 238 (215 to 248) | 1,900 (1,720 to 1,980) | 139 (2) | Very low¶,#,**,†† |
| False Negatives (Patients Incorrectly Classified as Not Having Need for Biopsy) | Appropriate diagnostic would be missed, worsening the prognosis of the disease. | 12 (2 to 35) | 100 (20 to 280) | ||
| True Negatives (Patients Without Need for Biopsy) | Patients will receive reassurance that they do not have a potentially malignant or malignant disorder. | 67,830 (55,860 to 77,805) | 66,640 (54,880 to 76,440) | 139 (2) | Very 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. | 31,920 (21,945 to 43,890) | 31,360 (21,560 to 43,120) | ||
Setting: primary care. Pooled sensitivity, 0.95 (95% confidence interval [CI], 0.86 to 0.99). Pooled specificity, 0.68 (95% CI, 0.56 to 0.78). Positive likelihood ratio, 2.97 (95% CI, 2.14 to 4.12). Negative likelihood ratio, 0.07 (95% CI, 0.02 to 0.22). Sources: Guneri and colleagues69 and Gupta and colleagues.70
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.
Poor-quality reporting prevented us from assessing risk of bias for key domains.
Investigators conducted all studies in secondary and tertiary care settings. Most patients had a higher probability of having a malignant or potentially malignant disorder.
There was a small sample size of only 139 lesions.