Keywords
triggers - adverse events - dentistry - harm - patient safety
Background and Significance
Background and Significance
At the turn of the 21st century, two landmark reports from the National Academy of
Medicine reignited the country's commitment to patient safety and health care quality
by quantifying the adverse events (AEs) exacted upon the patient population.[1]
[2]
[3] Like medicine, dentistry's exceedingly sophisticated procedures entail conceivable
risk to patients,[4] which may ultimately result in harm.[5] The highlighted deficits in patient safety and quality improvement have initiated
considerable growth in health care performance evaluation; however, the virtues of
that work have not permeated the U.S. dental health care delivery system.[5] Only the most serious of dental AEs are known due to legal cases, case reports,[6] or reports in the news media.
“Measurement forms the basis of evaluation and has become one of the foundations of
current efforts to improve health care.”[7] The trigger tool methodology was developed, recognizing that “conventional approaches
to identifying and quantifying harm such as individual chart audits, incident reports,
or voluntary administrative reporting have often been less successful in improving
the detection of adverse events.”[8] In 2003, the Global Trigger Tool (GTT) was developed to measure inpatient AEs using
a paper-based format.[9]
[10] A systematic review in 2016 showed that “substantial differences in AE rates were
evident across studies, most likely associated with methodological differences and
disparate reviewer interpretations.”[11] Recently, a broadly applicable pediatric trigger tool was developed to facilitate
the identification of AEs in pediatric inpatients.[12] Informed by the development of the medical outpatient trigger tool,[13] the authors have been able to detect nonmortality-related dental AEs using electronic
health record (EHR) based triggers.[14] Dentistry as a profession is slowly embracing the patient safety era, with a few
dental care researchers focusing on AE reduction.[15]
[16]
[17]
A “trigger” is an opportunity or clue to identify AEs in a patient's EHR. However,
triggers themselves do not represent AEs. Using triggers for targeted retrospective
review, though, provides health care providers with crucial information regarding
potential safety risks. As such, patient records are a valuable source of data that
can help identify AEs. Traditionally, a random sample of health records is selected
for audit. However, Classen et al found that a focused chart review identifies more
AEs than random chart review.[18] Some medical records may be more likely to contain AEs, hence the use of a targeted
trigger. For example, one would use a trigger specifically designed to find medication
errors such as the administration of a reversal drug like naloxone if looking for
harm due to an overdose. Consequently, it is of the utmost importance to take great
care in developing each trigger. Triggers were first developed as paper-based tools,[8] but the increased use of EHRs among large dental institutions makes them a promising
approach to more efficiently identify patient harm.[19]
Objective
The objective of this study was to develop EHR-based targeted dental triggers to allow
for the identification of AEs from electronic dental records.
Methods
Trigger Development
Inspired by the Institute for Healthcare Improvement (IHI) GTT, we used an iterative
process to develop 11 EHR-based triggers to identify dental AEs. [Table 1] shows the triggers developed by a team of experts with collective experience in
dentistry, quality improvement, and informatics. Some triggers targeted specific AEs
such as aspiration or ingestion of foreign bodies. Others, such as multiple visits,
were general purpose triggers that cast a wider net. We used an iterative consensus-based
process to develop and finalize the logic for each trigger ([Appendix A]). The triggers relied on both structured and unstructured data from the EHR. All
site reviewers used the same EHR, axiUm (Exan, Vancouver, British Columbia, Canada).
Structured data included medications, treatment (CDT [Code on Dental Procedures and
Nomenclature]) codes,[20] and diagnostic terms (SNODDS[21]
[22]) that are neatly encoded in the EHR. When structured data were not available, we
used the rich descriptions in the unstructured clinical notes. The triggers were automated
queries run against the electronic dental records in a specific calendar year.
Table 1
Definition and classification system used to identify dental AEs
|
AE definition
|
Physical harm that is moderate or severe due to treatment within a specific time frame
|
|
AE type
|
1. Allergy/toxicity/foreign body response
|
|
2. Aspiration/ingestion of foreign bodies
|
|
3. Infections
|
|
4. Wrong-site, wrong-procedure, and wrong-patient errors
|
|
5. Bleeding
|
|
6. Pain
|
|
7. Hard tissue injury
|
|
8. Soft tissue injury
|
|
9. Nerve injury
|
|
10. Other systemic complications
|
|
11. Other orofacial complications
|
|
12. Other harm
|
|
AE severity
|
E1: temporary minimal harm
E2: temporary moderate-to-severe harm
G1: permanent minimal harm
G2: permanent moderate-to-severe harm
|
Abbreviation: AE, adverse event.
Appendix A
Trigger logic to identify dental adverse events
|
Trigger name
|
Trigger description
|
|
Allergy/toxicity/foreign body response
|
Patients who had “foreign body” text in their notes and had received at least one
treatment in a given calendar year
|
|
Aspiration/ingestion of foreign bodies
|
Patients who had terms such as “aspiration” and “aspirated” in their notes and had
received at least one treatment in a given calendar year
|
|
Extraction following a crown or RCT or filling
|
Patients who had an extraction in a given calendar year and also had a procedure for
crown, RCT, or filling on the same tooth within the last 365 days from the extraction
|
|
Failed implant
|
Patients who had a failed implant diagnosis or implant removal procedure code on any
tooth in a given calendar year
|
|
Infections
|
Patients having either surgical extractions or periodontal surgical procedures and
(1) received any prescription medications such as antibiotics, steroids, or pain killers
(except chlorhexidine) 1 to 7 days after dental treatment or (2) recorded a dental
treatment 1 to 7 days after the aforementioned treatments
|
|
Multiple visits
|
Patients who had 12 or more visits in 6 months in a given calendar year
|
|
Nerve injury
|
Patients who had “paresthesia” noted in the clinical notes within 1 to 5 days after
receiving treatment in a given calendar year
|
|
Post- surgical extraction complications or postperiodontal treatment complications
|
Patients who received an extraction or a periodontal surgical procedure and then received
any (1) prescription medication 1 to 5 days after dental treatment or (2) had an emergency
visit or a follow-up visit with complications
|
|
Repeated restorations
|
Patients who received a repeated restoration on the same tooth with an overlap of
one surface within the past 2 years
Patients with two or more completed fillings on the same tooth with an overlap of
one surface in a given calendar year who also received fillings on the same or another
tooth within past 2 years
|
|
Soft tissue injury or inflammation
|
Patients who had “laceration,” “ulcer,” “swelling,” or “burn” noted in their clinical
notes within 1 to 5 days after receiving treatment in a given calendar year
|
|
Untreated periodontitis
|
Patients having either (1) chronic periodontitis diagnosis
or (2) periodontal initial examination in a given calendar year, with 30% of teeth present
having clinical attachment loss ≥ 5 mm and the patient has received an FPD/RPD/crown
treatment, and (3) no periodontal treatment (SRP) within 12 months of diagnosis
|
Abbreviations: FPD, fixed partial denture; RCT, root canal treatment; RPD, removable
partial denture; SRP, scaling and root planning.
Chart Review Process
Once the automated trigger script identified relevant charts, a sample of charts retrieved
by each trigger was independently reviewed by two dental experts at each site using
a common AE definition ([Table 1]). At two sites more than 100 charts were triggered; in these instances 50 charts
were reviewed at random. Otherwise, all triggered charts were reviewed. The reviewers
determined if the trigger was actually present in the chart (to assess the validity
of the automated query). The chart was then manually reviewed for any and all AEs
within the time frame, regardless of whether the AE was directly related to the trigger
or not. When an AE was found, chart reviewers abstracted pertinent information and
summarized the case, categorized the type of AE, and assigned a severity score ([Table 1]). [Appendix B] shows the chart abstraction form developed in REDCap.[23] Chart reviewers then met to compare their findings and to finalize the AEs.
Appendix B RedCAP data capture forms.
Expert Panel Review
Chart reviewers from each site and additional senior investigators in the research
team formed an expert panel to provide a second level of review for each AE identified
by the sites. First, expert panelists independently reviewed each AE case. The group
then connected together on conference calls to make a final determination if the case
was an AE. The group also determined a category that best described the AE and assigned
a severity rating.
Statistical Analysis
A descriptive analysis of the “triggered” charts and AEs detected will be reported.
Among the identified triggered charts, a small sample was reviewed to determine the
AE status, type, and severity by the 11 calibrated reviewers. A sample of approximately
one in four triggered charts was reviewed. Sample sizes were estimated according to
the resources and available capacity of the reviewers at the specific institution.
Estimation of the agreement among the individual expert panelists was established
using the appropriate Kappa coefficient. Before the expert panel group review, data
from the individual reviews were compiled, and the percent agreement and the Prevalence
and Bias-Adjusted Kappa (PABAK) were estimated. The ratings from all reviewers at
each of the sites were included in the kappa calculations, and the PABAK was estimated
for all triggers in aggregate. The average percent agreement for AE determination
was 81.9% and the PABAK was 55.2% (κ = 0.55) for determining AE presence. The average percent agreement for categorization
of the AE type was 79.6%, whereas the PABAK was 48.4%. Lastly, the average percent
agreement for categorization of AE severity was 82.8%, and the corresponding PABAK
was 69.1%. According to the standards for interrater reliability, κ ranging from 0.40 to 0.60 constitutes moderate agreement ([Table 2]).[24]
[25] To evaluate the effectiveness of each trigger, the overall sensitivity was calculated.
The positive predictive value (PPV) diagnostic measure was calculated for each trigger
along with the 95% confidence intervals. All analysis was performed using R version
3.4.1 (2017, The R Foundation for Statistical Computing).
Table 2
Interrater reliability among reviewers within the expert panel
|
Category
|
Percent agreement
|
PABAK
|
|
AE determination
|
81.8%
|
55.2%
|
|
AE type
|
79.6%
|
48.4%
|
|
AE severity
|
82.8%
|
69.1%
|
Abbreviations: AE, adverse event; PABAK, Prevalence and Bias-Adjusted Kappa.
Results
As shown in [Table 3], a total of 3,283 charts were triggered after executing the 11 triggers at the four
institutions over the 1-year time frame. Of these, a random sample of 859 charts was
manually reviewed and a total of 100 AEs were identified ([Table 4]). In our sample of confirmed AEs where we knew the AE type, the triggers were able
to detect the appropriate chart containing the intended trigger AE 78.3% (0.68–0.86)
of the time, and the false-negative rate of AE detection was 21.8% (0.14–0.32). PPV
for the individual triggers ranged from 0 to 0.29. Only the repeated restoration trigger
failed to identify any AE. The best performing triggers were those that developed
to identify infections with PPV = 0.29 (0.20–0.39), allergy/toxicity/foreign body
response with PPV = 0.23 (0.11–0.40), failed implants PPV = 0.21 (0.09–0.38), and
nerve injuries with PPV = 0.19 (0.09–0.37).
Table 3
Trigger performance
|
Trigger name
|
Charts triggered
|
Charts reviewed
|
Charts with AE
|
Positive predictive value (95% CI)
|
|
1. Infections
|
430
|
100
|
29
|
0.29 (0.20–0.39)
|
|
2. Allergy/toxicity/foreign body response
|
36
|
35
|
8
|
0.23 (0.11–0.40)
|
|
3. Failed implant
|
34
|
34
|
7
|
0.21 (0.09–0.38)
|
|
4. Nerve injury
|
36
|
36
|
7
|
0.19 (0.09–0.37)
|
|
5. Postsurgical extraction complications or postperiodontal treatment complications
|
377
|
100
|
16
|
0.16 (0.09–0.25)
|
|
6. Extraction following a crown or RCT or filling
|
110
|
99
|
9
|
0.09 (0.05–0.17)
|
|
7. Soft tissue injury
|
1449
|
100
|
7
|
0.07 (0.031–0.14)
|
|
8. Untreated periodontitis
|
224
|
100
|
7
|
0.07 (0.03–0.14)
|
|
9. Multiple visits
|
60
|
58
|
1
|
0.017 (0.009–0.10)
|
|
10. Aspiration/ingestion of foreign bodies
|
136
|
68
|
1
|
0.015 (0.007–0.09)
|
|
11. Repeated restorations
|
391
|
129
|
0
|
0 (0–0.29)
|
Abbreviations: AE, adverse event; CI, confidence interval; RCT, root canal treatment.
Table 4
Classification of dental adverse events
|
AE categories
|
AE count
|
Examples
|
|
Pain
|
57
|
Severe pain, pain due to dehiscence
|
|
Infection
|
16
|
Abscess, trismus, dry socket, infection postperiodontal procedure
|
|
Hard tissue damage
|
11
|
Tooth damage, root canal perforation, bone damage after implant placement
|
|
Nerve injury
|
6
|
Numbness, paresthesia
|
|
Soft tissue injury
|
5
|
Necrosis, laceration
|
|
Other orofacial complications
|
2
|
Facial pain, sinus perforation
|
|
Allergy/toxicity/foreign body response
|
1
|
Drug allergy
|
|
Aspiration/ingestion of foreign bodies
|
1
|
Ingestion of foreign bodies such as prosthesis
|
|
Other systemic complications
|
1
|
Vomiting
|
|
Wrong-site, wrong-procedure, wrong-patient errors
|
0
|
|
|
Bleeding
|
0
|
|
|
Other harm
|
0
|
|
|
Total
|
100
|
|
Abbreviation: AE, adverse event.
Each of the identified AEs was classified further ([Tables 4] and [5]). Pain (57%) was the most frequently identified AE type followed by infection (16%)
and hard tissue damage (11%). Most AEs (90%) were categorized as temporary moderate-to-severe
harm (E2) and the remainder as permanent moderate-to-severe harm (G2). No AEs were
categorized as mild, temporary harm (E1), and mild, permanent harm (G1).
Table 5
Severity of adverse events
|
AE categories
|
AE count
|
|
E2 (temporary moderate-to-severe harm)
|
90
|
|
G2 (permanent moderate-to-severe harm)
|
10
|
|
Total
|
100
|
Abbreviation: AE, adverse event.
Discussion
We demonstrated the feasibility of using EHR-based triggers to identify patient records
that contain AEs. Using structured EHR data fields, such as CDT procedure codes, prescription
data fields, and standardized diagnostic terms, greatly facilitate the development
of triggers. With the adoption of the SNODDS terminology as an American National Standards
Institute standard, it is our assumption that the use of dental diagnostic terms will
become more conventional. We also benefited from the use of a standardized tooth numbering
system that helped to better specify trigger logic. Some of our triggers included
data from the periodontal chart. Using periodontal charting has proven to be quite
complex as a clinical measure; clinical attachment level, one of the periodontal measures,
has six values (one for each surface) for each tooth. And lastly, we also resorted
to text mining of the clinical notes to identify key words for a few triggers, such
as nerve injury trigger. Not surprisingly, the challenge of this approach was the
large number of false-positives. For example, just the word “anesthesia” and its wildcard
variations (*) were not possible to use as many notes included sentences such as “no
permanent anesthesia noted” or “sufficient anesthesia was obtained.” Despite these
limitations, some triggers that relied on text mining such as “allergy/toxicity/foreign
body response” and “nerve injury” were among the better performing triggers with higher
PPVs. In our next phase, we look forward to using natural language processing techniques
to further improve the performance of these triggers. Our trigger scripts were developed
for the axiUm EHR used by many large academic dental institutions. We expect that
the logic of the scripts can be translated to other EHRs including those used by small
dental practices. However, there may be challenges due to the lack of consistent data
standards and controlled vocabularies currently used in dentistry, and more research
is needed to determine their applicability and performance.
Two-stage chart review, while lengthy, provides an avenue to fully discuss cases.
At both stages, the individual case reviews included a consensus phase. Hence, by
the time our reviewers classified an incident as an AE, multiple perspectives had
been provided through various consensus processes. The limitation, of course, is that
this process is time-consuming, cumbersome, and thus inherently expensive. However,
the process was critical for the team to learn how to apply a common definition for
AEs, how to categorize the type of harm, and apply the severity scale. Like the IHI,
we have adapted the harm severity rating created by the National Coordinating Council
for Medication Error Reporting and Prevention, and for this study, we included only
those AEs for which the harm was classified as moderate to severe (E2 or G2). Therefore,
minimal harm (E1, G1) was not included. This resulted in lengthy discussions by the
expert panel if certain cases were indeed minimal or more moderate harm in nature
and should thus be excluded or included. Additionally, there were several cases that
fell under the “quality-of-care” rubric and not harm, such as poor chair-site manners.
These too led to lengthy discussions. We acknowledge that tracking such quality-of-care
events is enormously important as we would not want to lose the ability to study and
improve upon them.
Clearly, some EHR-based triggers identify charts with dental AEs better than others.
Triggers seeking to identify infections, allergy/toxicity/foreign body response, failed
implants, nerve injury, and postsurgery complications had the highest PPVs (0.29–0.16).
While the repeated restoration, aspiration/ingestion, and multiple visit trigger performed
poorly (PPV = 0.02 to 0), we found that having multiple visits in a short period of
time were characteristic of academic dental institutions where trainees require patients
to come back multiple times. Our purpose was to determine the potential for these
triggers to identify both general and specific AEs, but while the triggers were designed
to find specific AEs, in some case they identified other types of harm. In the future
work, we will work to revise the triggers and conduct a larger-scale review to determine
the performance of these triggers on a statistically appropriate sample.
We found that 57 of the 100 AEs were classified as pain. At the outset of the study,
we did not intend to create a separate pain category. We included pain as an AE when
it was not just severe, indicated by specific words or sentences such as “kept me
up at night,” “10 out of 10,” :unbearable,” and so on, but also when the pain was
unexpected or not well managed, that is, the patient returned for an emergency visit.
We understand that pain is a complex AE. Patients come to the dentist not always in
pain but often will leave with some level of discomfort. There is an understanding
that dentistry is “painful.” However, there is school of thought that suggests that
all pain should and can be managed and that proper expectations can be set to make
sure the patient is well managed during this episode of aftercare.[26] We have started a separate project to further analyze these pain cases and explore
this topic more as pain management is paramount to the well-being of our patients
and our quest to minimize harm.
The ultimate goal of using triggers is not only to understand the AEs that have happened
due to dental procedures but also to move to the next step and perform root cause
analyses specifically for instances when we see multiple cases of the same AE. The
root cause analysis should allow us to better understand the underlying system issues
that need to be addressed to facilitate improvement.
Conclusion
EHR-based triggers are a promising methodology to unearth AEs among dental patients.
Using standardized fields in the EHR as part of the trigger logic greatly improves
the PPV of the trigger. In this pilot study, pain was the most common AE unearthed,
followed by infection and hard tissue damage.
Clinical Relevance Statement
Clinical Relevance Statement
Running triggers against dental clinic records will allow for the detection of harm
caused by dental procedures. This, in turn, will provide an opportunity for the clinician
to explore underlying system issues to make lasting improvements.
Multiple Choice Questions
Multiple Choice Questions
-
Please indicate the answer that best describes what a trigger is when used as trigger
logic to develop a script to run against an EHR.
-
A trigger is an AE
-
A trigger is an underlying system issue
-
A trigger is a clue to identify AEs in a patient's EHR
-
A trigger represents a safety hazard
Correct Answer: The correct answer is option c. A “trigger” is an opportunity or clue to identify
AEs in a patient's EHR. However, triggers themselves do not represent AEs. Using triggers
for targeted retrospective review, though, provides health care providers with crucial
information regarding potential safety risks. As such, patient records are a valuable
source of data that can help identify AEs.
-
What is the ultimate goal to use EHR-based triggers in your practice?
-
Triggers can identify charts that may hold an AE
-
Triggers are a first step toward understanding why AEs happen
-
Triggers improve the functionality of the EHR
-
Use of triggers will shortly be made mandatory by professional bodies
Correct Answer: The correct answer is option a. The ultimate goal of using triggers is not only to
understand the AEs that have happened due to dental procedures but also to move to
the next step and perform root cause analyses specifically for instances when we see
multiple cases of the same AE. The root cause analysis should allow us to better understand
the underlying system issues that need to be addressed to facilitate improvement.