TABLE 2:
Cytologic adjuncts to evaluate clinically evident, seemingly innocuous, or nonsuspicious 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. | 240 (203 to 250) | 1,920 (1,620 to 2,000) | 79 (1) | Low¶,#,** |
| False Negatives (Patients Incorrectly Classified as Not Having Need for Biopsy) | Appropriate diagnostic would be missed, worsening the prognosis of the disease. | 10 (0 to 47) | 80 (0 to 380) | ||
| True Negatives (Patients Without Need for Biopsy) | Patients will receive reassurance that they do not have a potentially malignant or malignant disorder. | 89,775 (78,803 to 96,758) | 88,200 (77,420 to 95,060) | 79 (1) | 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. | 9,975 (2,992 to 20,947) | 9,800 (2,940 to 20,580) | ||
Setting: primary care. Sensitivity, 0.96 (95% confidence interval [CI], 0.81 to 1.00). Specificity, 0.90 (95% CI, 0.79 to 0.97). Positive likelihood ratio, 10.01 (95% CI, 4.34 to 23.12). Negative likelihood ratio, 0.04 (95% CI, 0.01 to 0.28). Source: Mehrotra and colleagues.36
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.
The sampling method, the positivity threshold for dysplasia in regard to the reference standard, and to what extent examiners were calibrated during interpretation of the index test are unclear.
The investigators conducted the study in a secondary care setting. Most patients had a higher probability of having a malignant or potentially malignant disorder.
The positivity threshold for the index test included atypical results.