Diagnostic Accuracy Studies of Fine-Needle Aspiration Show Wide Variation in Reporting of Study Population Characteristics: Implications for External Validity

Abstract

Context.-Study comparisons rest on the assessment of applicability or external validity. Population characteristics are an important component of external validity and, although there has been a heightened awareness of deficiencies in reporting in diagnostic test accuracy (DTA) studies, the reporting of populations in DTA studies has not been investigated.Objective.-To assess the quality of reporting of population descriptions in DTA studies for fine-needle aspiration cytology (FNAC).Design.-Literature survey of common population parameters and usage patterns in FNAC DTA studies. We randomly selected 20 FNAC DTA studies in 4 categories (salivary glands, lung, thyroid, and pancreas) and determined the frequency of parameter usage.Results.-Studies showed considerable variability in reporting patterns. On average, studies reported 2 to 4 parameters to describe study populations. Age, sex, and lesion size were most frequently reported. Sixteen percent of studies did not provide any population description. Population parameters were used to describe the sample population more frequently than to describe the selection process (P ¼ .001). There were significant differences in the number of parameters specified by anatomic site (P ¼ .001). Only 21% of studies provided a flow diagram. Thirty-three percent of studies mentioned the target population.Conclusions.-Studies show considerable variability in the description of sample populations and the population selection process. Studies often fail to provide flow diagrams or to provide a clear statement of the research problem. There is considerable opportunity for studies to improve both descriptions of sample populations and the process used to select them.

Assessing the diagnostic accuracy for pleomorphic adenoma and Warthin tumor by employing the Milan System for Reporting Salivary Gland Cytopathology: An international, multi‐institutional study

“…However, the ROM before FNA should be site‐dependent because of the increased incidence of malignant salivary gland neoplasms in nonparotid major salivary glands and minor salivary glands. For example, although 20% to 25% of parotid tumors are malignant, as many as 50% of submandibular gland tumors and 75% of sublingual and minor salivary gland tumors are malignant 2,4,10,17‐20 . An institutional series from Finland by Tommola et al 21 showed that the ROM for the SUMP category was 22% for the parotid gland and 100% for the submandibular gland, respectively.…”

Milan system for reporting salivary gland cytopathology: An experience with the implication for risk of malignancy

“…[1234] Many studies have reported excellent sensitivity and specificity of FNAC to differentiate neoplastic vs. non-neoplastic lesions as well as benign and malignant neoplasms; among different studies, the sensitivity of FNAC ranges from 86% to 100%, and specificity ranges between 90%–100%. [5678910] Apart from this, FNAC is an useful tool to differentiate between primary vs. metastatic lesions specially head and neck malignancies and thus helping in deciding the treatment plan. [11]…”

Practical implication of risk based categorization of salivary gland lesions on FNAC by Milan system: A two year retrospective study

“…Its role is well established in diagnosing and management of salivary gland lesions. It has high sensitivity (86%-100%) and high specificity (90%-100%) as reported in many studies [4][5][6][7][8][9] . However, despite being a useful technique, minimal invasion and cost-effectiveness cytopathologists continuously face challenges in reporting due to diversity and heterogeneity of salivary gland lesions [10][11][12][13] .…”