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.

Classifying Adverse Events in the Dental Office.

BACKGROUND: Dentists strive to provide safe and effective oral healthcare. However, some patients may encounter an adverse event (AE) defined as "unnecessary harm due to dental treatment." In this research, we propose and evaluate two systems for categorizing the type and severity of AEs encountered at the dental office. METHODS: Several existing medical AE type and severity classification systems were reviewed and adapted for dentistry. Using data collected in previous work, two initial dental AE type and severity classification systems were developed. Eight independent reviewers performed focused chart reviews, and AEs identified were used to evaluate and modify these newly developed classifications. RESULTS: A total of 958 charts were independently reviewed. Among the reviewed charts, 118 prospective AEs were found and 101 (85.6%) were verified as AEs through a consensus process. At the end of the study, a final AE type classification comprising 12 categories, and an AE severity classification comprising 7 categories emerged. Pain and infection were the most common AE types representing 73% of the cases reviewed (56% and 17%, respectively) and 88% were found to cause temporary, moderate to severe harm to the patient. CONCLUSIONS: Adverse events found during the chart review process were successfully classified using the novel dental AE type and severity classifications. Understanding the type of AEs and their severity are important steps if we are to learn from and prevent patient harm in the dental office.

Feasibility of Electronic Health Record-Based Triggers in Detecting Dental Adverse Events.

BACKGROUND: We can now quantify and characterize the harm patients suffer in the dental chair by mining data from electronic health records (EHRs). Most dental institutions currently deploy a random audit of charts using locally developed definitions to identify such patient safety incidents. Instead, selection of patient charts using triggers and assessment through calibrated reviewers may more efficiently identify dental adverse events (AEs). OBJECTIVE: Our goal was to develop and test EHR-based triggers at four academic institutions and find dental AEs, defined as moderate or severe physical harm due to dental treatment. METHODS: We used an iterative and consensus-based process to develop 11 EHR-based triggers to identify dental AEs. Two dental experts at each institution independently reviewed a sample of triggered charts using a common AE definition and classification system. An expert panel provided a second level of review to confirm AEs identified by sites reviewers. We calculated the performance of each trigger and identified strategies for improvement. RESULTS: A total of 100 AEs were identified by 10 of the 11 triggers. In 57% of the cases, pain was the most common AE identified, followed by infection and hard tissue damage. Positive predictive value (PPV) for the triggers ranged from 0 to 0.29. The best performing triggers were those developed to identify infections (PPV = 0.29), allergies (PPV = 0.23), failed implants (PPV = 0.21), and nerve injuries (PPV = 0.19). Most AEs (90%) were categorized as temporary moderate-to-severe harm (E2) and the remainder as permanent moderate-to-severe harm (G2). CONCLUSION: EHR-based triggers are a promising approach to unearth AEs among dental patients compared with a manual audit of random charts. Data in dental EHRs appear to be sufficiently structured to allow the use of triggers. Pain was the most common AE type followed by infection and hard tissue damage.

How dental team members describe adverse events.

BACKGROUND: Although 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. METHODS: The 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. RESULTS: The 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%. CONCLUSIONS: Dental 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 IMPLICATIONS: Identifying 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.

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

BACKGROUND: The 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. METHODS: The authors downloaded and reviewed the dental device-related AEs reported to MAUDE from January 1, 1996, through December 31,2011. RESULTS: MAUDE 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. CONCLUSIONS: A 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 IMPLICATIONS: As 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.

Jelly Belly trans-synaptic signaling to anaplastic lymphoma kinase regulates neurotransmission strength and synapse architecture.

In Drosophila, the secreted signaling molecule Jelly Belly (Jeb) activates anaplastic lymphoma kinase (Alk), a receptor tyrosine kinase, in multiple developmental and adult contexts. We have shown previously that Jeb and Alk are highly enriched at Drosophila synapses within the CNS neuropil and neuromuscular junction (NMJ) and postulated a conserved intercellular signaling function. At the embryonic and larval NMJ, Jeb is localized in the motor neuron presynaptic terminal whereas Alk is concentrated in the muscle postsynaptic domain surrounding boutons, consistent with anterograde trans-synaptic signaling. Here, we show that neurotransmission is regulated by Jeb secretion by functional inhibition of Jeb-Alk signaling. Jeb is a novel negative regulator of neuromuscular transmission. Reduction or inhibition of Alk function results in enhanced synaptic transmission. Activation of Alk conversely inhibits synaptic transmission. Restoration of wild-type postsynaptic Alk expression in Alk partial loss-of-function mutants rescues NMJ transmission phenotypes and confirms that postsynaptic Alk regulates NMJ transmission. The effects of impaired Alk signaling on neurotransmission are observed in the absence of associated changes in NMJ structure. Complete removal of Jeb in motor neurons, however, disrupts both presynaptic bouton architecture and postsynaptic differentiation. Nonphysiologic activation of Alk signaling also negatively regulates NMJ growth. Activation of Jeb-Alk signaling triggers the Ras-MAP kinase cascade in both pre- and postsynaptic compartments. These novel roles for Jeb-Alk signaling in the modulation of synaptic function and structure have potential implications for recently reported Alk functions in human addiction, retention of spatial memory, cognitive dysfunction in neurofibromatosis, and pathogenesis of amyotrophic lateral sclerosis.

Herpesviruses in abscesses and cellulitis of endodontic origin.

Acute apical abscesses and cellulitis are severe endodontic diseases caused by opportunistic bacteria with possible coinfection with latent herpesviruses. The objectives of this study are to identify herpesviruses, including human cytomegalovirus (HCMV), Epstein-Barr virus (EBV), herpes simplex virus-1 (HSV-1), and Varicella zoster virus (VZV) in patients (n = 31) presenting with acute apical abscesses and cellulitis of endodontic origin. Primary and nested polymerase chain reaction (PCR) was conducted using virus-specific primers and DNA isolated from cell-free abscess fluid. From patients exhibiting concurrent spontaneous pain (n = 28), nine abscesses contained HCMV, two abscesses contained EBV, one abscess contained HSV-1, and no abscesses contained VZV. Control PCR using genomic or recombinant templates showed detection limits to a single genomic copy of HCMV, 100 genomic copies for EBV, and 1 to 10 copies for HSV-1 with no cross-amplification between herpesviral DNA targets. Nested PCR was required for detection of herpesviral DNA in the abscess specimens, indicating that these viruses were present in low copy number. Filtration of abscess specimens and virus transfer experiments using human fibroblastic MRC-5 cells confirmed the presence of HCMV particles in several abscess specimens. We conclude that herpesviruses are present but not required for the development of acute apical abscesses and cellulitis of endodontic origin.

Remodeling of an identified motoneuron during metamorphosis: hormonal influences on the growth of dendrites and axon terminals.

During metamorphosis of the tobacco hawkmoth Manduca sexta, the femoral depressor motoneuron (FeDe MN) undergoes remodeling of its dendrites and motor terminals. Previous studies have established that remodeling of MNs during metamorphosis is mediated by the same hormones that control metamorphosis: the ecdysteroids and juvenile hormone (JH). During the pupal stage, the ecdysteroids promote adult-specific growth of MNs in the absence of JH, but JH or its synthetic mimics can interfere with ecdysteroid-mediated growth if applied during early sensitive periods. Hence, the application of a JH mimic (JHM) either systemically or locally to a target muscle has been used to distinguish those aspects of motor-terminal remodeling that are controlled by ecdysteroid action on the CNS from those that are influenced by ecdysteroid action on the peripheral targets. Here, we have extended the analysis of central and peripheral hormonal influences on MN remodeling by injecting JHM locally into the CNS thus altering the hormonal environment of the FeDe MN soma without altering the hormonal environment of its target muscle. Our results demonstrate that adult dendritic growth and motor-terminal growth can be experimentally uncoupled, suggesting that each is regulated independently. JHM application to the CNS perturbed dendritic growth, but had no measurable impact on motor-terminal growth. Peripheral actions of ecdysteroids, therefore, appear sufficient to promote the development of adult-specific motor terminals but not the development of an adult-specific dendritic arbor.

Remodeling of an identified motoneuron during metamorphosis: central and peripheral actions of ecdysteroids during regression of dendrites and motor terminals.

During metamorphosis of the moth Manduca sexta, an identified leg motoneuron, the femoral depressor motoneuron (FeDe MN), undergoes reorganization of its central and peripheral processes. This remodeling is under the control of two insect hormones: the ecdysteroids and juvenile hormone (JH). Here, we asked whether peripheral or central actions of the ecdysteroids influenced specific regressive aspects of MN remodeling. We used stable hormonal mimics to manipulate the hormonal environment of either the FeDe muscle or the FeDe MN soma. Our results demonstrate that motor-terminal retraction and dendritic regression can be experimentally uncoupled, indicating that central actions of ecdysteroids trigger dendritic regression whereas peripheral actions trigger terminal retraction. Our results further demonstrate that discrete aspects of motor-terminal retraction can also be experimentally uncoupled, suggesting that they also are regulated differently.