Proposal of a trigger tool to assess adverse events in dental care

The aim of this study was to propose a trigger tool for research of adverse events in outpatient dentistry in Brazil. The tool was elaborated in two stages: (i) to build a preliminary set of triggers, a literature review was conducted to identify the composition of trigger tools used in other areas of health and the principal adverse events found in dentistry; (ii) to validate the preliminarily constructed triggers a panel of experts was organized using the modified Delphi method. Fourteen triggers were elaborated in a tool with explicit criteria to identify potential adverse events in dental care, essential for retrospective patient chart reviews. Studies on patient safety in dental care are still incipient when compared to other areas of health care. This study intended to contribute to the research in this field. The contribution by the literature and guidance from the expert panel allowed elaborating a set of triggers to detect adverse events in dental care, but additional studies are needed to test the instrument’s validity.


Introduction
"Health care will never be risk-free", stated Margaret Chan 1 , Chinese physician when Director-General of the World Health Organization (WHO).Dr. Chan's statement expresses the concern with adverse events, which are incidents resulting from health care that affect patients, causing them harm 2 .The problem involves harm not only to patients but also to their families and all of society 3 .The magnitude of this phenomenon became even more evident since publication of the report To Err is Human: Building a Safer Health System 4 , showing that it is essential to take measures to minimize such events.
Numerous studies have been conducted with this purpose.According to a systematic review, an estimated 10% of all hospitalized patients suffered at least one adverse events, and 7% of these died 5 .Incidents associated with patient care were also observed in primary care, where the most frequent types of adverse events were related to diagnostic errors and management of medication 6 .
Methods that aim to identify and elucidate the problem of adverse events include retrospective reviews of patient charts.The method assumes two phases: the first with triggers based on explicit criteria and the other with implicit criteria 7 .In the first phase, trained professionals selected patient charts with potential adverse events, based on a set of triggers.The presence of one or more such factors triggers the patient chart for the second phase, in which a reviewer confirms or rules out the presence of an adverse event 3 .
Specifically in dentistry, some tools have been developed to assist services administration and dental practice with a focus on patient safety 8 .The issue has received little focus to date, although some studies have emerged recently 9,10,11 .
The current study is thus justified by the need to expand knowledge on patient safety in dental care.The objective was to propose a trigger tool to detect potential adverse events to be used in the explicit phase of a retrospective review of patients' dental charts in the Brazilian outpatient setting.Despite some limitations, this method is considered the gold standard for detecting adverse events 12,13 and has been widely used to measure the harms resulting from health care worldwide, including in Brazil, with consistent results 14 .

Method
This was a qualitative study that used the expert consensus technique and was conducted in two stages.The first involved a literature view to identify the principal adverses events resulting from dental care and the triggers for adverse events used in other areas of health, with the purpose of backing the adaptation of a preliminary dental clinic trigger tool.In the second stage, this trigger tool was assessed by an expert panel using the modified Delphi method.
To identify the principal adverse events in dental care, the following scientific databases were searched from 2000 to 2016: (i) Library of the Regional Board of Dentistry, Rio de Janeiro (CRO-RJ), Brazilian Library of Dentistry (BBO), and Latin American and Caribbean Literature in Health Sciences (LILACS) with the terms for accidents, errors, and complications associated with dental specialties and (ii) Public/Publisher MEDLINE (PubMed) with the MeSH terms patient safety and dental care.The search was saturated as the incidents began to appear repeatedly and no more new records appeared in the articles.
In order to identify the triggers, the following were consulted: website of the Institute for Healthcare Improvement (IHI), WHO publications, and articles that described studies of retrospective patient chart reviews.Based on the resulting information, a preliminary set of fourteen triggers was developed, seeking to include the largest amount of adverse event types with the smallest number of triggers, explaining their rationale and providing examples to facilitate understanding by the experts.
Elaboration of final triggers drew on expertise from a panel of experts from the fields of dentistry and patient safety using the modified Delphi method.The method involves the anonymous exchange of information between the experts and possibility of revising individual views 15 based on the assumption that a collective judgment, adequately conducted, is better than a single individual's opinion 16 .The changes to the original method were the authors' interactive mediation with the panel members and information exchange via email.The choice was made for interaction because the Cad.Saúde Pública 2017; 33 (11):e00053217 subject addressed was highly specific and required technical explanations, especially for the experts who were less familiar with dentistry terms.The use of email facilitated the information exchange and streamlined the process.
Seven experts were invited to join the panel: five dentists who had graduated more than twenty years previously, with clinical and academic experience as well as administration of dental services, and two experts in patient safety with extensive research experience in the area.
The expert panel proceeded as follows: in the first round, the preliminarily adapted triggers were presented to the experts through an online form, where they were supposed to answer three questions for each of the fourteen triggers: (i) Is the trigger a good signal for detecting adverse events?(ii) Is the trigger consistent with the Brazilian reality?(iii) Is the trigger worded in clear language and correct terminology?
The experts' assessment was planned to follow to a Likert scale from 1 to 5, meaning: 1 (definitely not); 2 (probably not); 3 (probably yes); 4 (very probably yes); and 5 (definitely yes).There was also a box for suggestions below each of the triggers, providing the possibility for the experts to amend, add, or delete triggers.A trigger that scored 3 or more on all the questions was considered valid.A trigger that scored 1 or 2 on any of the three questions was submitted to new rounds.
The graphic depiction of the study's methodological process is in Figure 1.
The research project was approved by the Institutional Review Board of the Sergio Arouca National School of Public Health, Oswaldo Cruz Foundation (ENSP/Fiocruz), under case review 1.513.249CEP/ENSP, April 25, 2016.

Results
The reports of incidents and complications identified in the literature review and the results of studies on adverse events from dental care served as the basis for creating a classification with the principal types of adverse events as shown next (Table 1).
Fourteen triggers were created and presented in the first round to the expert panel members.All of these fourteen were kept, and most were modified and/or received new examples.Twelve triggers were defined by consensus and two by majority vote of the experts (triggers 10 and 11).
The conclusion of the expert panel required four rounds of questions and answers from September 15 to November 6, 2016.The method allowed substantial improvement in the triggers initially proposed.The patient safety experts experienced some difficulty in the use of specific dentistry terms, but with the mediation this did not compromise the content.For the experts in dentistry, specific reading in patient safety was recommended, and they did not experience any difficulty dealing with the subject.All the panel members responded on schedule and the communication via email helped the process flow smoothly and satisfactorily throughout all four rounds.
In the second round, the answers from the first round were presented with graphs and the experts' observations were described, along with the changes made due to the answers.The experts were asked to reassess the new proposal, using the same scale as before.This time, if the answer was 1 or 2 or there were disagreements, they were asked to explain the reason and suggest the changes.
In the third round, the answers given in the two previous rounds were presented again in graphs and the observations on the second round were described.The experts had still not reached a consensus on some triggers, and they were asked to respond again according to the Likert scale.For the triggers that had already reached a consensus in the two previous rounds, the experts were asked to reassess them, answering yes or no to the following question: Is this version of the trigger adequate?If the answer was no, they were supposed to suggest changes.As in the previous rounds, there was a space to include suggestions for all the triggers.Trigger 10 (death), which had received a 2 for adequacy to the Brazilian reality, could not have been reworded because it was completely straightforward, so the experts were asked whether it should be kept, and they were supposed to answer yes or no to the question: Should this trigger be kept?They were also asked if there should be a new round and whether it should be face-to-face or online.Two experts expressed the need for a new online round.
In the fourth round were presented the graphs of the answers of the third round, during which, of the fourteen triggers, eleven were approved unanimously.Thus, in this round three triggers remained to be defined.The experts were supposed to answer yes or no to the following: Do you think a new round is needed?If the majority of the experts answered no, this would be the last round, and the outcome would be determined by the majority.Otherwise there would be another online round.The experts felt unanimously that there was no need for another round, and the expert panel's work was thus finished.

Table 1
Classification and examples of types of adverse events in dental care.

Types of adverse events in dental care Examples of adverse events
Infections associated with dental care Alveolitis; peri-implantitis; root canal infection; more complex tooth infections such as Ludwig's angina.Table 2 presents the expert panel's discussion, based on which a trigger tool was proposed (Figure 2).This information can serve as the basis for preparing a manual for use in future studies on adverse events in dental care that employ the retrospective patient chart review method.

Support from the literature for the identification of adverse events in dental care
The literature review allowed gathering information on the incidents, specifically on adverse events in dental care.
One of the most common procedures in dental practice, namely local anesthesia, presents adverse events that vary greatly in severity and temporality.The literature includes reports of local and/or systemic alterations that range from the most common situations, like hematomas and fainting, to rarer situations like methehemoglobinemia, allergic reactions, and toxic reactions, even resulting in death 17,18,19 .
Manipulating foreign bodies inside the oral cavity during dental treatment facilitates the occurrence of a type of accident with great potential to cause adverse events: swallowing and/or aspirating foreign bodies (dental fragments and pieces of fillings, fragments of impression materials, endodontic filings, drill bits, parts of dental implants, orthodontic clips).Some circumstances also favor the occurrence: age (children, elderly); motor disabilities; and some psychiatric and neurological disorders 20,21 .Importantly, patients require care in chairs that immobilize them, and dexterity is needed in case of obstruction of the upper airways to quickly unbuckle the safety belt in this type of apparatus 22 .
Due to the proximity of roots in the posterior teeth, during tooth extractions or endodontic treatments, the maxillary sinus may be injured.Tooth fragments, drill bits, and endodontic materials can be pushed inside the sinus, causing inflammatory processes and even triggering chronic sinusitis, leading to the need for surgical access and removal of the foreign body using the Caldwell-Luc technique, for example 23,24 .
The removal of impacted or semi-impacted third molars can result in complications and accidents, including: ulceration of the mucosa, alveolitis; dentoalveolar fractures; injuries to the adjacent teeth and/or temporomandibular joint disorders (TMJ); infections; fractured maxillary tuberosity and/or mandible; oro-antral communication; dislodging of the tooth to vital anatomical structures; and temporary or permanent paresthesia 25 .
Alveolitis; infections can lead to serious complications such as Ludwig's angina; dissemination of infectious and contagious diseases.Law suits against dentists at the civil, criminal, or administrative level are not harm or adverse events per se, but the motive should be investigated.
(continues) Due to delays or failures in dental treatment, tooth infections can spread to underlying facial spaces and cause serious complications that require hospitalization, like Ludwig's angina 26 .
Subcutaneous emphysema associated with tooth extraction can occur when air from the highspeed motor is forced inside the soft tissues; although rarely, the air can spread to the pterygomaxillary region and lateral pharyngeal space of the retromolar region and reach the mediastinum, with a possible fatal outcome.This access is not limited to tooth extractions, and the air can also be introduced through root canals during endodontic treatment, through the periodontal ligament or lacerations of the intraoral soft tissues 27 .
Haji-Hassani et al. 28 analyzed the frequency of errors made by students in the last year of dentistry school during endodontic procedures.The authors analyzed x-rays from a total of 1,335 endodontic treatments performed from October 2011 to October 2012, and errors were observed in 880 (66%) of the cases.In this specialty, due to the tooth's anatomical complexity, accidents and complications can occur even in experienced hands 29 .One such accident that can compromise the treatment's evolution is breakage of endodontic instruments inside the root canal 30 .In addition, tears and perforations of the dental roots can also compromise the prognosis 29 .
The literature review identified the need to pay closer attention to the processes used in dental care.Drug prescription is one of these processes.Drug-drug interactions can cause adverse events 31 , and some medicines used by the patient deserve heightened attention, such as bisphosphonates, which can lead to maxillary osteonecrosis following invasive dental procedures 32 .
Various chemical substances have the potential to harm the oral soft tissues.An example is the acid used for enamel etching, which can lead to gingival necrosis 33 .Another example is sodium hypochlorite, very useful for treating the root canal system; however, when in inadvertent contact with the tissues it can cause intense pain, edema, bruising, tissue necrosis, and paresthesia 34   1.Need for retreatment of the same tooth or need to redo same procedure concluded less than 12 months before.
2. Lesions occurring in the treatment setting (dental clinic/office) that were not caused by the dental treatment itself (e.g., falls from height or patient's body colliding with equipment/instruments).
3. Complications from the procedure during dental treatment (e.g., extraction of wrong tooth; soft tissue lacerations; lesion from leakage of chemical substances; ocular lesion; aspiration and/or swallowing of foreign body).
4. Systemic complications during or after dental treatment.
5. Infections resulting from dental treatment.
6.Return for urgent care due to pain, edema, or other reasons.
7. complications related to drug prescription.
8. Dissatisfaction expressed or documented by patient or family (including documents, documented complaints, conflicts between patient/family and healthcare professionals).
9. Unforeseen changes to treatment plan.
11. Instrument failure or breakage during treatment.
14. any other complications not included in the previous items.
Describe the finding that motivated the trigger's choice: Check with an X next to each trigger found.In the space at the end of the table, briefly describe the finding(s) and write the date on which the annotation was recorded on the patient's chart.You may find more than one trigger on the same patient chart, and you should mark all of them.

Figure 2
Proposed dental clinic trigger tool for adverse events.
Another problem is the allergic reactions that can involve unpredictable evolution or may be related to an incomplete patient history.A common example of this type of event is allergic reaction to the latex from procedure gloves or the rubber dam used in the treatment 9 .
Many adverse events can occur during orthodontic treatment, which usually lasts months, ranging from dental caries associated with the treatment to severe root reabsorption with tooth loss, temporomandibular dysfunction 35 and anorexia nervosa 9 .
One specialty that relies particularly on the technique employed by the professional is implantology.Although the success of a dental implant depends on individual patient factors like tissue repair and osseointegration, the technique requires precise planning and execution.Any misstep has a significant negative impact on the procedure's outcome 36 .Various situations can contribute to treatment failure 37 , including: (i) tooth extractions with limited preservation of the bone plate, with esthetic harm and the need for bone and/or mucosal grafts; (ii) labial and/or gingival paresthesia due to nerve injury; (iii) problems involving the soft tissue such as degeneration of the donor bed for autologous tissue grafts; (iv) tissue emphysema caused by inadvertent propulsion of air under the skin or mucosa; (v) harm to the blood supply of adjacent teeth, potentially leading to tooth death and damage to the implant itself; (vi) infections surrounding the implant (peri-implantitis); (vii) perforations of the sinus membrane during osteotomy to raise the maxillary sinus floor or sinus perforated by the implant; and (viii) bone fractures.
Finally, alterations in the components of the stomatognathic system can influence the body as a whole, e.g.: restorations that produce inadequate contact between opposing teeth will require adapta-Cad.Saúde Pública 2017; 33 (11):e00053217 tion of the dental arches to the new articular pattern, and if this does not happen, painful reflexes can appear in the head and neck's postural muscles or even lead to dental wear and/or fractures, injury to the periodontium, or temporomandibular joint disorders 38 .

The triggers that served as the basis for the study
Trigger tools have been widely used in the field of patient safety with the purpose of facilitating the detection of adverse events.Triggers are based on identifying terms in the health records that may be associated with adverse events, and based on this signaling, conducting a search to confirm whether harm occurred, besides determining the severity and contributing factors.
In the studies, trigger tools were first used in the explicit assessment phase of the Harvard Medical Practice Study 39 .The methodology was later replicated in other studies 14,40,41,42 and acknowledged as an important approach to document and assist the identification of patient harm.
From this perspective, since 2003 the IHI has developed a program for elaborating trigger tools which now includes a broad set for measuring adverse events in specific circumstances, for example triggers for adverse events in intensive care units and triggers for adverse events from medication in mental health services 43 .Inspired by the tool proposed by the IHI for outpatients, a study performed at the Harvard School of Dentistry adapted and tested a set of triggers for detecting adverse events in dental records ("dental clinic trigger tools") through a retrospective review of electronic patient records, but which would also apply to manual records, according to the authors 44 .
The Harvard study 44 only considered three indicators for its trigger tool, while the IHI tools and those used in studies retrieved in the current study contain 11 to 20 triggers.The dental clinic trigger tool in the Harvard study included procedures for incision and drainage, failed implants, and multiple-visit.The authors ran the trigger tool for six months, and the triggers selected 315 records, of which 158 (50%) were positive for one or more adverse events, while of the 50 records randomly selected and assessed, 17 (34%) were positive for at least one adverse event.
A form with a set of triggers was recommended in a document published in 2010 by experts in the WHO Patient Safety Program called Assessing and Tackling Patient Harm: A Methodological Guide for Data-poor Hospitals 3 .This publication was targeted to researchers, quality managers, clinicians, and other professionals interested in understanding and tackling patient safety issues in hospitals.The objective was to offer devices that are not tied to the good quality of health records or to the available material and human resources, more adequate for the Brazilian reality.This helped the WHO proposal serve as a guiding thread for the triggers presented here, although other publications also served as the basis.

Conclusion
Dental care, although essentially surgical, with close contact with secretions like saliva and blood, the possibility of generating medical emergencies, requiring concentration and great manual dexterity, thus extremely dependent on the dentist's skill and working conditions, i.e., a broad set of circumstances that favor adverse events, has not evolved greatly in the field of patient safety when compared to other areas of health.
However, there is sufficient evidence to show that dental care entails risks that require patient safety interventions to improve the quality of patient care.Further, as recommended by the WHO, it is necessary to begin by measuring the harm in order to proceed to search for understanding the causes of the problem and identify appropriate solutions.A trigger tool can be quite useful for identifying adverse events in dental care.
The modified Delphi method proved quite useful for developing the tool used here and allowed for the trigger tools for adverse events already used in the hospital and outpatient setting in various areas of health to be adapted to assist in the specific detection of adverse events in dentistry.However, the triggers require testing for their validation, which was beyond the scope of this study.

6 .
Return for urgent care due to pain, edema, or other reason.When patients feel pain or discomfort to the point of returning for urgent care or require a new unscheduled visit, they may not have been properly oriented as to what to expect while waiting for their next appointment, or something unexpected may have happened.Painful manifestation caused by infection or excessive manipulation of the treatment site; fractured tooth wall between endodontic/prosthetic treatment sessions; soft tissue injury caused by remaining tooth fragment after temporary filling falls out; post-anesthesia traumatic ulcers in pediatric dentistry.

7 .
complications related to drug prescription Lapses/errors can lead to switched medication, and faulty patient history can lead to unexpected drug reaction.Harmful drug-drug interaction 8. Dissatisfaction expressed or documented by patient or family (includes documents, documented complaints, conflicts between patient or family and health professionals).Difficult patient/provider relations or communication can lead to an adverse event. .

Table 2
Decisions by expert panel on triggers, rationale, and examples of situations that can be identified by each trigger.
Paresthesia caused by nerve injury during tooth extraction; lesions to other teeth, whether or not leading to unplanned extraction (luxation/fracture/ avulsion of other teeth; aspiration and/or swallowing of foreign body; ocular lesion due to lack of protective

Table 2 (continued)
Any other circumstances that do not fit the previous items.Interruption of procedures in progress due to power or water shortage, e.g.: interruption of a photopolymerizable restoration or a surgical intervention.