TABLE 6:
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. | 217 (200 to 235) | 1,740 (1,600 to 1,880) | 1,453 (15) | Low¶,#,** |
| False Negatives (Patients Incorrectly Classified as Not Having Need for Biopsy) | Appropriate diagnostic would be missed, worsening the prognosis of the disease. | 33 (15 to 50) | 260 (120 to 400) | ||
| True Negatives (Patients Without Need for Biopsy) | Patients will receive reassurance that they do not have a potentially malignant or malignant disorder. | 70,823 (60,848 to 81,795) | 69,580 (59,780 to 80,360) | 1,453 (15) | 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. | 28,927 (17,955 to 38,902) | 28,420 (17,640 to 38,220) | ||
Setting: primary care. Pooled sensitivity, 0.87 (95% confidence interval [CI], 0.80 to 0.94). Pooled specificity, 0.71 (95% CI, 0.61 to 0.82). Positive likelihood ratio, 3.04 (95% CI, 2.06 to 4.48). Negative likelihood ratio, 0.18 (95% CI, 0.10 to 0.32). Sources: Allegra and colleagues,48 Awan and colleagues,49 Cancela-Rodriguez and colleagues,50 Chaudhari and colleagues,51 Chen and colleagues,52 Cheng and Yang,53 Du and colleagues,54 Mashberg,55 Nagaraju and colleagues,56 Onofre and colleagues,57 Rahman and colleagues,42 Silverman and colleagues,58 Singh and Shukla,61 Upadhyay and colleagues,59 and Warnakulasuriya and Johnson.60
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.
Patient selection and exclusion from analysis were inappropriate. It was unclear whether all participants received the reference test. Poor-quality reporting did not provide sufficient information to judge key risk of bias domains.
Investigators conducted most studies in secondary and tertiary care settings. Most patients had a higher probability of having a malignant or potentially malignant disorder.