The economic impact of two diagnostic strategies in the management of restorations in primary teeth : a health economic analysis plan for a trial-based economic evaluation

Background Different approaches have been used by dentists to base their decision. Among them, there are the aesthetical issues that may lead to more interventionist approaches. Indeed, using a more interventionist strategy (the World Dental Federation - FDI), more replacements tend to be indicated than using a minimally invasive one (based on the Caries Around Restorations and Sealants—CARS). Since the resources related to the long-term health effects of these strategies have not been explored, the economic impact of using the less-invasive strategy is still uncertain. Thus, this health economic analysis plan aims to describe methodologic approaches for conducting a trial-based economic evaluation that aims to assess whether a minimally invasive strategy is more efficient in allocating resources than the conventional strategy for managing restorations in primary teeth and extrapolating these findings to a longer time horizon. Methods A trial-based economic evaluation will be conducted, including three cost-effectiveness analyses (CEA) and one cost-utility analysis (CUA). These analyses will be based on the main trial (CARDEC-03/NCT03520309), in which children aged 3 to 10 were included and randomized to one of the diagnostic strategies (based on FDI or CARS). An examiner will assess children’s restorations using the randomized strategy, and treatment will be recommended according to the same criteria. The time horizon for this study is 2 years, and we will adopt the societal perspective. The average costs per child for 24 months will be calculated. Three different cost-effectiveness analyses (CEA) will be performed. For CEAs, the effects will be the number of operative interventions (primary CEA analysis), the time to these new interventions, the percentage of patients who did not need new interventions in the follow-up, and changes in children’s oral health-related quality of life (secondary analyses). For CUA, the effect will be tooth-related quality-adjusted life years (QALYs). Intention-to-treat analyses will be conducted. Finally, we will assess the difference when using the minimally invasive strategy for each health effect (∆effect) compared to the conventional strategy (based on FDI) as the reference strategy. The same will be calculated for related costs (∆cost). The discount rate of 5% will be applied for costs and effects. We will perform deterministic and probabilistic sensitivity analyses to handle uncertainties. The net benefit will be calculated, and acceptability curves plotted using different willingness-to-pay thresholds. Using Markov models, a longer-term economic evaluation will be carried out with trial results extrapolated over a primary tooth lifetime horizon. Discussion The main trial is ongoing, and data collection is still not finished. Therefore, economic evaluation has not commenced. We hypothesize that conventional strategy will be associated with more need for replacements of restorations in primary molars. These replacements may lead to more reinterventions, leading to higher costs after 2 years. The health effects will be a crucial aspect to take into account when deciding whether the minimally invasive strategy will be more efficient in allocating resources than the conventional strategy when considering the management of restorations in primary teeth. Finally, patients/parents preferences and consequent utility values may also influence this final conclusion about the economic aspects of implementing the minimally invasive approach for managing restorations in clinical practice. Therefore, these trial-based economic evaluations may bring actual evidence of the economic impact of such interventions. Trial registration NCT03520309. Registered May 9, 2018. Economic evaluations (the focus of this plan) are not initiated at the moment

The influence of cognitive bias on caries lesion detection in preschool children

We aimed to evaluate whether children’s caries experience exerts an influence on the performance of visual and radiographic methods in detecting nonevident proximal caries lesions in primary molars. Eighty children (3–6 years old) were selected and classified as having a lower (≤3 decayed, missing, or filled surfaces; dmf-s) or higher (> 3 dmf-s) caries experience. Two calibrated examiners then assessed 526 proximal surfaces for caries lesions using visual and radiographic methods. As a reference standard, 2 other examiners checked the surfaces after temporary separation. Noncavitated and cavitated lesion thresholds were considered and Poisson multilevel regression analyses were conducted to evaluate the influence of caries experience on the performance of diagnostic strategies. Accuracy parameters stratified by caries experience were also derived. A statistically significant influence of caries experience was observed only for visual inspection, with more false-positive results in children with a higher caries experience at the noncavitated lesion threshold, and more false results at the cavitated threshold. The detection of noncavitated caries lesions in children with a higher caries experience was overestimated (specificity = 0.696), compared to children with a lower caries experience (specificity = 0.918), probably due to confirmation bias. However, the examiners underestimated the detection of cavitated lesions in children with a higher caries experience (sensitivity = 0.143) compared to lower-caries-experience children (sensitivity = 0.222), possibly because of representativeness bias. The radiographic method was not influenced by children’s caries experience. In conclusion, children’s caries experience influences the performance of visual inspection in detecting proximal caries lesions in primary teeth, evidencing the occurrence of cognitive biases

Clinical Accuracy of Two Different Criteria for the Detection of Caries Lesions around Restorations in Primary Teeth

This is a delayed-type cross-sectional prospective accuracy study nested in a randomized clinical trial. The aim was to investigate the diagnostic accuracy of two visual criteria for caries lesions detection around restorations in primary teeth: the International Dental Federation (FDI) criteria, considering adaptation, staining, and the presence of caries, and the Caries Associated with Restorations and Sealants (CARS) system. For this, one examiner made the diagnosis and subsequent treatment decision using visual assessment in 163 children (3-10 years old) with both FDI and CARS criteria. The order of criteria used was defined by randomization. The reference standard was composed of two approaches: (1) the presence of carious tissue after restoration removal and (2) the presence of caries lesions after 6 and 12 months of follow-up. Sensitivity, specificity, and accuracy parameters were calculated at the dentin threshold. Poisson multilevel regression analyses were performed to evaluate the association of the diagnostic methods and other explanatory variables with the outcomes. Of the 651 restorations included, 480 were evaluated by the reference standard methods and were analyzed. The CARS system presented higher accuracy (0.721) than those obtained with FDI recurrence of caries (0.702), FDI marginal adaptation (0.700), and FDI marginal staining criteria (0.681). The FDI marginal staining showed the study's lowest sensitivity (0.280) and accuracy (0.681) values. The specificity values of FDI recurrence of caries and FDI marginal adaptation were lower than the CARS system. Restorations assessed after the follow-up period resulted in lower sensitivity but higher specificity than those replaced after initial evaluation. In conclusion, the CARS system is more accurate in detecting caries around restorations in primary teeth than the FDI system, in general. However, the FDI recurrence of caries and FDI marginal adaptation present similar performance to the CARS system when the dentin threshold is considered. On the other hand, marginal staining is not an accurate parameter to evaluate caries around restorations

Supplementary Material for: The Influence of Cognitive Bias on Caries Lesion Detection in Preschool Children

We aimed to evaluate whether children’s caries experience exerts an influence on the performance of visual and radiographic methods in detecting nonevident proximal caries lesions in primary molars. Eighty children (3–6 years old) were selected and classified as having a lower (≤3 decayed, missing, or filled surfaces; dmf-s) or higher (> 3 dmf-s) caries experience. Two calibrated examiners then assessed 526 proximal surfaces for caries lesions using visual and radiographic methods. As a reference standard, 2 other examiners checked the surfaces after temporary separation. Noncavitated and cavitated lesion thresholds were considered and Poisson multilevel regression analyses were conducted to evaluate the influence of caries experience on the performance of diagnostic strategies. Accuracy parameters stratified by caries experience were also derived. A statistically significant influence of caries experience was observed only for visual inspection, with more false-positive results in children with a higher caries experience at the noncavitated lesion threshold, and more false results at the cavitated threshold. The detection of noncavitated caries lesions in children with a higher caries experience was overestimated (specificity = 0.696), compared to children with a lower caries experience (specificity = 0.918), probably due to confirmation bias. However, the examiners underestimated the detection of cavitated lesions in children with a higher caries experience (sensitivity = 0.143) compared to lower-caries-experience children (sensitivity = 0.222), possibly because of representativeness bias. The radiographic method was not influenced by children’s caries experience. In conclusion, children’s caries experience influences the performance of visual inspection in detecting proximal caries lesions in primary teeth, evidencing the occurrence of cognitive biases