Identifying and Avoiding Risk of Bias in Caries Diagnostic Studies

Abstract

Caries diagnostic studies differ with respect to their design, included patients/tooth samples, use of diagnostic and reference methods, calibration, blinding and data reporting. Such heterogeneity makes comparisons between studies difficult and could represent a substantial risk of bias (RoB) when it is not identified. Therefore, the present report aims to describe the development and background of a RoB assessment tool for caries diagnostic studies. The expert group developed and agreed to use a RoB assessment tool during three workshops. Here, existing instruments (e.g., QUADAS 2 and the Joanna Briggs Institute Reviewers’ Manual) influenced the hierarchy and phrasing of the signalling questions that were adapted to the specific dental purpose. The tailored RoB assessment tool that was created consists of 16 signalling questions that are organized in four domains. This tool considers the selection/spectrum bias (1), the bias of the index (2) and reference tests (3), and the bias of the study flow and data analysis (4) and can be downloaded from the journal website. This paper explores possible sources of heterogeneity and bias in caries diagnostic studies and summarizes the relevant methodological aspects.

Automated caries detection in vivo using a 3D intraoral scanner

“…Since the diagnostic performance of the visual assessment employing the ICDAS criteria is widely investigated in the literature, and the examiner variability is well known, this aspect was not addressed in the present study. In fact, a substantial level of reproducibility and accuracy is reported when calibrated, well-trained examiners employ the ICDAS criteria, such as in the current study 13 , 35 , and therefore, based on consensus, one trained and calibrated examiner can reliably conduct the visual examination alone 35 .…”

Emerging Technologies for Dentin Caries Detection—A Systematic Review and Meta-Analysis

“…A risk of bias (RoB) assessment tool for caries diagnostic studies, developed by Kuhnisch et al [34], was used to assess the included studies' quality. The tool is based on existing assessment instruments, such as QUADAS-2 [35,36] and Joanna Briggs Institute Reviewers' Manual [37], but the signaling questions are tailored for the specific methodology of caries diagnostic studies.…”

“…Fewer in vivo DD pen studies evaluating occlusal surfaces met the inclusion criteria and indicated the more difficult nature of in vivo studies designs, due to limitations in the ability to accurately validate all types of caries and teeth [34]. The included in vivo studies of occlusal surfaces using a DD pen exhibited higher heterogeneity, probably generated by the variations in sample size and difficulties in obtaining a true representative sample.…”

“…For example, in case of DD pen for proximal NC dentin caries, in vivo studies used operative validation as the reference standard [53,61], and one study in the in vitro sub-group used visual examination and bitewing radiographs as the reference standard [47]. This less rigorous validation may also bring limitations and introduce heterogeneity [34].…”

“…Nevertheless, additional assessment of FOTI, QLF, LIF, ACIS, and PTR-LUM technologies is needed to determine their diagnostic performance in occlusal and proximal NC caries detection using the RoB criteria set out by Kuhnisch et al [34]. The RoB assessment tool was useful in the identification and synthesis of potential sources of bias.…”