Building Consensus for a Shared Definition of Adverse Events: A Case Study in the Profession of Dentistry

BACKGROUND: To achieve high-quality health care, adverse events (AEs) must be proactively recognized and mitigated. However, there is often ambiguity in applying guidelines and definitions. We describe the iterative calibration process needed to achieve a shared definition of AEs in dentistry. Our alignment process includes both independent and consensus building approaches. OBJECTIVE: We explore the process of defining dental AEs and the steps necessary to achieve alignment across different care providers. METHODS: Teams from 4 dental institutions across the United States iteratively reviewed patient records after identification of charts using an automated trigger tool. Calibration across teams was supported through negotiated definition of AEs and standardization of evidence provided in review. Interrater reliability was assessed using descriptive and κ statistics. RESULTS: After 5 iterative cycles of calibration, the teams (n = 8 raters) identified 118 cases. The average percent agreement for AE determination was 82.2%. Furthermore, the average, pairwise prevalence and bias-adjusted κ (PABAK) was 57.5% (κ = 0.575) for determining AE presence. The average percent agreement for categorization of the AE type was 78.5%, whereas the PABAK was 48.8%. Lastly, the average percent agreement for categorization of AE severity was 82.2% and the corresponding PABAK was 71.7%. CONCLUSIONS: Successful calibration across reviewers is possible after consensus building procedures. Higher levels of agreement were found when categorizing severity (of identified events) rather than the events themselves. Our results demonstrate the need for collaborative procedures as well as training for the identification and severity rating of AEs

Near-infrared imaging of secondary caries lesions around composite restorations at wavelengths from 1300–1700-nm

Background and objectivesCurrent clinical methods for diagnosing secondary caries are unreliable for identifying the early stages of decay around restorative materials. The objective of this study was to access the integrity of restoration margins in natural teeth using near-infrared (NIR) reflectance and transillumination images at wavelengths between 1300 and 1700-nm and to determine the optimal NIR wavelengths for discriminating composite materials from dental hard tissues.Materials and methodsTwelve composite margins (n=12) consisting of class I, II and V restorations were chosen from ten extracted teeth. The samples were imaged in vitro using NIR transillumination and reflectance, polarization sensitive optical coherence tomography (PS-OCT) and a high-magnification digital microscope. Samples were serially sectioned into 200-μm slices for histological analysis using polarized light microscopy (PLM) and transverse microradiography (TMR). Two independent examiners evaluated the presence of demineralization at the sample margin using visible detection with 10× magnification and NIR images presented digitally. Composite restorations were placed in sixteen sound teeth (n=16) and imaged at multiple NIR wavelengths ranging from λ=1300 to 1700-nm using NIR transillumination. The image contrast was calculated between the composite and sound tooth structure.ResultsIntensity changes in NIR images at wavelengths ranging from 1300 to 1700-nm correlate with increased mineral loss measured using TMR. NIR reflectance and transillumination at wavelengths coincident with increased water absorption yielded significantly higher (P<0.001) contrast between sound enamel and adjacent demineralized enamel. In addition, NIR reflectance exhibited significantly higher (P<0.01) contrast between sound enamel and adjacent composite restorations than visible reflectance.SignificanceThis study shows that NIR imaging is well suited for the rapid screening of secondary caries lesions

Dental clinical research: an illustration of the value of standardized diagnostic terms

Abstract Objective: Secondary data are a significant resource for in‐depth epidemiologic and public health research. It also allows for effective quality control and clinical outcomes measurement. To illustrate the value of structured diagnostic entry, a use case was developed to quantify adherence to current practice guidelines for managing chronic moderate periodontitis (CMP). Methods: Six dental schools using the same electronic health record (EHR) contribute data to a dental data repository (BigMouth) based on the i2b2 data‐warehousing platform. Participating institutions are able to query across the full repository without being able to back trace specific data to its originating institution. At each of the three sites whose data are included in this analysis, the Dental Diagnostic System (DDS) terminology was used to document diagnoses in the clinics. We ran multiple queries against this multi‐institutional database, and the output was validated by manually reviewing a subset of patient charts. Results: Over the period under study, 1,866 patients were diagnosed with CMP. Of these, 15 percent received only periodontal prophylaxis treatment, 20 percent received only periodontal maintenance treatment, and only 41 percent received periodontal maintenance treatment in combination with other AAP guideline treatments. Conclusions: Our results showed that most patients with CMP were not treated according to the AAP guidelines. On the basis of this use case, we conclude that the availability and habitual use of a structured diagnosis in an EHR allow for the aggregation and secondary analyses of clinical data to support downstream analyses for quality improvement and epidemiological assessments

The dangers of dental devices as reported in the Food and Drug Administration Manufacturer and User Facility Device Experience Database.

BackgroundThe authors conducted a study to determine the frequency and type of adverse events (AEs) associated with dental devices reported to the Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) database.MethodsThe authors downloaded and reviewed the dental device-related AEs reported to MAUDE from January 1, 1996, through December 31,2011.ResultsMAUDE received a total of 1,978,056 reports between January 1, 1996, and December 31, 2011. Among these reports, 28,046 (1.4%) AE reports were associated with dental devices. Within the dental AE reports that had event type information, 17,261 reported injuries, 7,777 reported device malfunctions, and 66 reported deaths. Among the 66 entries classified as death reports, 52 reported a death in the description; the remaining were either misclassified or lacked sufficient information in the report to determine whether a death had occurred. Of the dental device-associated AEs, 53.5% pertained to endosseous implants.ConclusionsA plethora of devices are used in dental care. To achieve Element 1 of Agency for Healthcare Research and Quality's Patient Safety Initiative, clinicians and researchers must be able to monitor the safety of dental devices. Although MAUDE was identified by the authors as essentially the sole source of this valuable information on adverse events, their investigations led them to conclude that MAUDE had substantial limitations that prevent it from being the broad-based patient safety sentinel the profession requires.Practical implicationsAs potential contributors to MAUDE, dental care teams play a key role in improving the profession's access to information about the safety of dental devices

Dental Students' Clinical Experience Across Three Successive Curricula at One U.S. Dental School.

As dental schools continue to seek the most effective ways to provide clinical education for students, it is important to track the effects innovations have on students' clinical experience to allow for quantitative comparisons of various curricula. The aim of this study was to compare the impact of three successive clinical curricula on students' experience at one U.S. dental school. The three were a discipline-based curriculum (DBC), a comprehensive care curriculum (CCC), and a procedural requirement curriculum plus externships (PRCE). Students' clinic experience data from 1992 to 2013 were analyzed for total experience and in five discipline areas. Clinic experience metrics analyzed were patient visits (PVs), relative value units (RVUs), and equivalent amounts (EQAs). A minimum experience threshold (MET) and a high experience threshold (HET) were set at one standard deviation above and below the mean for the DBC years. Students below the MET were designated as low achievers; students above the HET were designated as high achievers. The results showed significant differences among the three curricula in almost all areas of comparison: total PVs, total EQAs, total RVUs, RVUs by discipline, and number of high and low achievers in total clinical experience and by discipline. The comprehensive care approach to clinical education did not negatively impact students' clinical experience and in many cases enhanced it. The addition of externships also enhanced student total clinical experience although more study is needed to determine their effectiveness. The insights provided by this study suggest that the methodology used including the metrics of PVs, EQAs, and RVUs may be helpful for other dental schools in assessing students' clinical experience

Evaluating quality of dental care among patients with diabetes: Adaptation and testing of a dental quality measure in electronic health records.

BackgroundPatients with diabetes are at increased risk of developing oral complications, and annual dental examinations are an endorsed preventive strategy. The authors evaluated the feasibility and validity of implementing an automated electronic health record (EHR)-based dental quality measure to determine whether patients with diabetes received such evaluations.MethodsThe authors selected a Dental Quality Alliance measure developed for claims data and adapted the specifications for EHRs. Automated queries identified patients with diabetes across 4 dental institutions, and the authors manually reviewed a subsample of charts to evaluate query performance. After assessing the initial EHR measure, the authors defined and tested a revised EHR measure to capture better the oral care received by patients with diabetes.ResultsIn the initial and revised measures, the authors used EHR automated queries to identify 12,960 and 13,221 patients with diabetes, respectively, in the reporting year. Variations in the measure scores across sites were greater with the initial measure (range, 36.4-71.3%) than with the revised measure (range, 78.8-88.1%). The automated query performed well (93% or higher) for sensitivity, specificity, and positive and negative predictive values for both measures.ConclusionsThe results suggest that an automated EHR-based query can be used successfully to measure the quality of oral health care delivered to patients with diabetes. The authors also found that using the rich data available in EHRs may help estimate the quality of care better than can relying on claims data.Practical implicationsDetailed clinical patient-level data in dental EHRs may be useful to dentists in evaluating the quality of dental care provided to patients with diabetes

How dental team members describe adverse events.

BackgroundAlthough some patients experience adverse events (AEs) resulting in harm caused by treatments in dentistry, few published reports have detailed how dental providers describe these events. Understanding how dental treatment professionals view AEs is essential to building a safer environment in dental practice.MethodsThe authors interviewed dental professionals and domain experts through focus groups and in-depth interviews and asked them to identify the types of AEs that may occur in dental settings.ResultsThe initial interview and focus group findings yielded 1,514 items that included both causes and AEs. In total, 632 causes were coded into 1 of the 8 categories of the Eindhoven classification, and 882 AEs were coded into 12 categories of a newly developed dental AE classification. Interrater reliability was moderate among coders. The list was reanalyzed, and duplicate items were removed leaving a total of 747 unique AEs and 540 causes. The most frequently identified AE types were "aspiration and ingestion" at 14% (n = 142), "wrong-site, wrong-procedure, wrong-patient errors" at 13%, "hard-tissue damage" at 13%, and "soft-tissue damage" at 12%.ConclusionsDental providers identified a large and diverse list of AEs. These events ranged from "death due to cardiac arrest" to "jaw fatigue from lengthy procedures."Practical implicationsIdentifying threats to patient safety is a key element of improving dental patient safety. An inventory of dental AEs underpins efforts to track, prevent, and mitigate these events