TABLE 7:
Tissue reflectance 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. | 180 (155 to 203) | 1,440 (1,240 to 1,620) | 390 (5) | Low¶,#,** |
| False Negatives (Patients Incorrectly Classified as Not Having Need for Biopsy) | Appropriate diagnostic would be missed, worsening the prognosis of the disease. | 70 (47 to 95) | 560 (380 to 760) | ||
| True Negatives (Patients Without Need for Biopsy) | Patients will receive reassurance that they do not have a potentially malignant or malignant disorder. | 30,923 (24,938 to 35,910) | 30,380 (24,500 to 35,280) | 390 (5) | 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. | 68,827 (63,840 to 74,812) | 67,620 (62,720 to 73,500) | ||
Setting: primary care. Pooled sensitivity, 0.72 (95% confidence interval [CI], 0.62 to 0.81). Pooled specificity, 0.31 (95% CI, 0.25 to 0.36). Positive likelihood ratio, 1.04 (95% CI, 0.90 to 1.20). Negative likelihood ratio, 0.91 (95% CI, 0.63 to 1.30). Sources: Awan and colleagues,66 Chainani-Wu and colleagues,62 Farah and McCullough,63 McIntosh and colleagues,64 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.
Only 1 of 4 studies had a low risk of bias. Poor-quality reporting did not provide sufficient information to judge key risk of bias 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.