TABLE 3:
Tissue reflectance and vital staining 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. | 0 (0 to 150) | 0 (0 to 1,200) | 102 (1) | Low¶,#,** |
| False Negatives (Patients Incorrectly Classified as Not Having Need for Biopsy) | Appropriate diagnostic would be missed, worsening the prognosis of the disease. | 250 (100 to 250) | 2,000 (800 to 2,000) | ||
| True Negatives (Patients Without Need for Biopsy) | Patients will receive reassurance that they do not have a potentially malignant or malignant disorder. | 75,810 (65,835 to 83,790) | 74,480 (64,680 to 82,320) | 102 (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. | 23,940 (15,960 to 33,915) | 23,520 (15,680 to 33,320) | ||
Setting: primary care. Sensitivity, 0.00 (95% confidence interval [CI], 0.00 to 0.60). Specificity, 0.76 (95% CI, 0.66 to 0.84). Positive likelihood ratio, not available. Negative likelihood ratio, 1.32 (95% CI, 1.18 to 1.48). Source: Mehrotra and colleagues.28
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.
We judged the patient selection and index test domains as being at high risk of bias.
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 reference test in regard to dysplasia was unclear.