American Academy of Otolaryngology-Head and Neck Surgery/Foundation Reg-ent Registry: Purpose, Properties, and Priorities.

OBJECTIVE: (1) To describe the patient and membership cohort captured by the otolaryngology-based specialty-specific Reg-ent registry. (2) To outline the capabilities of the Reg-ent registry, including the process by which members can access evidence-based data to address knowledge gaps identified by the American Academy of Otolaryngology-Head and Neck Surgery/Foundation and ultimately define "quality" for our field of otolaryngology-head and neck surgery. METHODS: Data analytics was performed on Reg-ent (2015-2020). RESULTS: A total of 1629 participants from 239 practices were enrolled in Reg-ent, and 42 health care specialties were represented. Reg-ent encompassed 6,496,477 unique patients and 24,296,713 encounters/visits: the 45- to 64-year age group had the highest representation (n = 1,597,618, 28.1%); 3,867,835 (60.3%) patients identified as Caucasian; and "private" was the most common insurance (33%), followed by Blue Cross/Blue Shield (22%). Allergic rhinitis-unspecified and sensorineural hearing loss-bilateral were the top 2 diagnoses (9% each). Overall, 302 research gaps were identified from 17 clinical practice guidelines. DISCUSSION: Reg-ent benefits are vast-from monitoring one's practice to defining otolaryngology-head and neck surgery quality, participating in advocacy, and conducting research. Reg-ent provides mechanisms for benchmarking, quality assessment, and performance measure development, with the objective of defining and guiding best practice in otolaryngology-head and neck surgery. To be successful, patient diversity must be achieved to include ethnicity and socioeconomic status. Increasing academic medical center membership will assist in achieving diversity so that the quality domain of equitable care is achieved. IMPLICATIONS FOR PRACTICE: Reg-ent provides the first ever registry that is specific to otolaryngology-head and neck surgery and compliant with HIPAA (Health Insurance Portability and Accountability Act) to collect patient outcomes and define evidence-based quality care.

Intraoperative Sentinel Events in the Era of Surgical Safety Checklists: Results of a National Survey.

OBJECTIVE: Despite the implementation of advanced health care safety systems including checklists, preventable perioperative sentinel events continue to occur and cause patient harm, disability, and death. We report on findings relating to otolaryngology practices with surgical safety checklists, the scope of intraoperative sentinel events, and institutional and personal response to these events. STUDY DESIGN: Survey study. SETTING: Anonymous online survey of otolaryngologists. METHODS: Members of the American Academy of Otolaryngology-Head and Neck Surgery were asked about intraoperative sentinel events, surgical safety checklist practices, fire safety, and the response to patient safety events. RESULTS: In total, 543 otolaryngologists responded to the survey (response rate 4.9% = 543/11,188). The use of surgical safety checklists was reported by 511 (98.6%) respondents. At least 1 patient safety event in the past 10 years was reported by 131 (25.2%) respondents; medication errors were the most commonly reported (66 [12.7%] respondents). Wrong site/patient/procedure events were reported by 38 (7.3%) respondents, retained surgical items by 33 (6.4%), and operating room fire by 18 (3.5%). Although 414 (79.9%) respondents felt that time-outs before the case have been the single most impactful checklist component to prevent serious patient safety events, several respondents also voiced frustrations with the administrative burden. CONCLUSION: Surgical safety checklists are widely used in otolaryngology and are generally acknowledged as the most effective intervention to reduce patient safety events; nonetheless, intraoperative sentinel events do continue to occur. Understanding the scope, causes, and response to these events may help to prioritize resources to guide quality improvement initiatives in surgical safety practices.

COVID-19 Anosmia Reporting Tool: Initial Findings.

There is accumulating anecdotal evidence that anosmia and dysgeusia are associated with the COVID-19 pandemic. To investigate their relationship to SARS-CoV2 infection, the American Academy of Otolaryngology-Head and Neck Surgery developed the COVID-19 Anosmia Reporting Tool for Clinicians for the basis of this pilot study. This tool allows health care providers to confidentially submit cases of anosmia and dysgeusia related to COVID-19. We analyzed the first 237 entries, which revealed that anosmia was noted in 73% of patients prior to COVID-19 diagnosis and was the initial symptom in 26.6%. Some improvement was noted in 27% of patients, with a mean time to improvement of 7.2 days in this group (85% of this group improved within 10 days). Our findings suggest that anomia can be a presenting symptom of COVID-19, consistent with other emerging international reports. Anosmia may be critical in timely identification of individuals infected with SARS-CoV2 who may be unwittingly transmitting the virus.

A pathway to value-based care of chronic rhinosinusitis using a claims database.

OBJECTIVE: To construct a comprehensive picture of the typical chronic rhinosinusitis (CRS) patient in the United States including the demographics, comorbidities, and geographic prevalence. The study will also identify the diagnostic and treatment regimens, their cost, and pattern of use for both medically and surgically managed patients. STUDY DESIGN: Historical cohort study utilizing private and public payer databases. METHODS: Medical claims data from the Truven Health MarketScan Research Databases from the years 2010 to 2012 for patients with acute rhinosinusitis (ARS) and CRS 18 and older were analyzed. RESULTS: There were 54 million unique patients in the databases from 2010 to 2012. Approximately 8 million had at least one diagnosis of ARS and 298,337 had a diagnosis of CRS. Females represented 63.7% of patients with ARS and 59.4% with CRS. Medicare patients represented 6.7% of the ARS population and 10.2% of the CRS population. The mean cost of a CRS episode for those commercially insured was $1024 and $762 in Medicare. CRS patients underwent diagnostic procedures including diagnostic endoscopy (55.1%), cultures (23.6%), sinus CT scan (82.1%) and MRI (0.2%). Endoscopic sinus surgery (ESS) was performed on 14.4% of those patients with CRS. Change in frequency of medication use from the 6 months prior to ESS to the 6 months post-ESS yielded a reduction in total costs of 34.2% or $3.9 M. The most commonly operated sinuses (with or without septoplasty on same day as ESS) were the maxillary (94%/76.1%); followed by ethmoid (82.1%/66.6%); frontal (38.8%/35.1%); and sphenoid (28.5%/28.1%). In total, 16.6% had one sinus operated on, 39.1% had two, 24.6% had three, and 18.7% had four sinuses operated on. CONCLUSIONS: This data paints a much clearer understanding of the current medical and surgical management. This study confirms the previously described "value proposition" for the surgical management of those CRS patients refractory to medical management. LEVEL OF EVIDENCE: 4.

A Novel Patient Safety Event Reporting Tool in Otolaryngology.

Objective To report the results of a preliminary analysis of a quality improvement initiative aimed to identify potential latent systems defects. Methods A pilot study of an anonymous, voluntary, event reporting system made available to all members of the American Academy of Otolaryngology-Head and Neck Surgery was performed. The National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP) index was used to classify error types. Descriptive statistics were used to summarize submissions to the database. Results In the 53 cases reported to the database over 22 months, the majority involved errors that had resulted in harm (n = 34, 64%), followed by errors that occurred and did not result in harm (n = 7, 13%). Errors occurred predominantly in the hospital (n = 23, 44%) and operating room (n = 19, 35%). Most entries were classified as either technical (n = 21, 39%) or related to postoperative care (n = 15, 30%). Discussion This preliminary descriptive analysis of a novel otolaryngology patient safety event reporting tool shows that this platform brings unique value to the identification of errors and adverse events in our specialty. Most reported events were classified as errors resulting in harm. The most common type of reported event was a technical error, most often resulting in a nerve injury. Implications for Practice This reporting tool will likely allow for identification and prioritization of improvement opportunities. This example may serve as a guide for other societies to create similar platforms as we strive for a standardized process for event reporting.

Responses to errors and adverse events: The need for a systems approach in otolaryngology.

OBJECTIVES/HYPOTHESIS: To report otolaryngologists' reactions to errors and adverse events and determine if temporal changes in physician efforts to assume responsibility; ameliorate patients' conditions; or change personal, group-wide, or hospital practices have occurred. STUDY DESIGN: Mixed-methods analysis of survey entries detailing responses to errors and adverse events. METHODS: Members of the American Academy of Otolaryngology-Head and Neck Surgery were asked to report errors or adverse events. Responses to open- and closed-ended questions from a similar, previously distributed, anonymous national survey were included for analysis. Responses were enumerated and reported descriptively and then analyzed by reviewers using an interpretive phenomenological approach. Responses were compared to those from an identical survey distributed a decade prior. RESULTS: Otolaryngologists reported 226 adverse events. Responsibility was attributed to the physician surveyed in 74 cases (32.0%), to ancillary staff in 58 cases (25.1%), to consulting physicians in 24 cases (10.4%), and to trainees in 16 cases (6.9%). The undertaking of corrective actions was reported by 175 physicians (75.8%). These events led to changes in personal, group/departmental, and hospital practice in 78 (33.8%), 37 (16.0%), and 11 (4.8%) cases, respectively. CONCLUSION: Following errors and adverse events, otolaryngologists continue to employ corrective actions to ameliorate harm. Responses are directed toward ameliorating the patient injury and also toward efforts to change personal practice and/or improve systems performance. Efforts to change personal practice are much more common than efforts to improve systems. Education about systems-based change represents a large opportunity for improvement in our specialty. LEVEL OF EVIDENCE: N/A Laryngoscope, 126:1999-2002, 2016.

Quality in otolaryngology: where we have been and where we are going.

The patient safety and quality improvement era began in 1999, and it has exploded in otolaryngology in the last decade. Although there have been some successes, it is not clear that, overall, otolaryngology is much safer than 15 years ago. We discuss why a prolonged lag between improvement efforts and improvements is not surprising and how the safety and quality movement is likely to evolve in the upcoming years.

Errors in otolaryngology revisited.

OBJECTIVE: A decade ago, a survey study identified areas of risk and proposed a classification schema for otolaryngology errors. The objective of the present study is to obtain current data for comparison using a similar methodology. STUDY DESIGN: Survey study. SETTING: An anonymous online survey was distributed via the American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS) weekly email. SUBJECTS AND METHODS: Members of the AAO-HNS were asked to describe any event in their practice that they felt should not have happened. Events were classified using the prior schema with minor modifications. RESULTS: Of 681 respondents, 445 (66%) reported an event within the past 6 months, from which 222 reports were extracted. The mean age of the affected patients was 41 ± 24 years. An adverse consequence occurred in more than half of events, with corrective action taken in 82.8%. Of the respondents, 68% subsequently changed their practice patterns. The domains with the most reported errors were technical (27.9% of all events, 71% with major morbidity), administrative (12.2%, 3.7%), diagnostic testing (10.8%, 8.3%), and surgical planning (9.9%, 45.5%). There were 8 wrong-site surgeries, 23 cranial nerve injuries (91.3% major morbidity), and 9 errors during endoscopic sinus surgery (55.6% major morbidity). There were 4 deaths. CONCLUSION: There has been disappointingly little overall change. Otolaryngologists remain vulnerable to errors and related adverse events. The domains with the greatest risk for error-related major morbidity have changed little and include errors in technical, administrative, diagnostic testing, surgical planning, and surgical equipment. Awareness of high-risk areas may help to focus preventive efforts in these domains.

Mortality and major morbidity after tonsillectomy: etiologic factors and strategies for prevention.

OBJECTIVE/HYPOTHESIS: To report data on death or permanent disability after tonsillectomy. STUDY DESIGN: Electronic mail survey. METHODS: A 32-question survey was disseminated via the American Academy of Otolaryngology-Head and Neck Surgery electronic newsletter. Recipients were queried regarding adverse events after tonsillectomy, capturing demographic data, risk factors, and detailed descriptions. Events were classified using a hierarchical taxonomy. RESULTS: A group of 552 respondents reported 51 instances of post-tonsillectomy mortality, and four instances of anoxic brain injury. These events occurred in 38 children (71%), 15 adults (25%), and two patients of unstated age (4%). The events were classified as related to medication (22%), pulmonary/cardiorespiratory factors (20%), hemorrhage (16%), perioperative events (7%), progression of underlying disease (5%), or unexplained (31%). Of unexplained events, all but one occurred outside the hospital. One or more comorbidities were identified in 58% of patients, most often neurologic impairment (24%), obesity (18%), or cardiopulmonary compromise (15%). A preoperative diagnosis of obstructive sleep apnea was not associated with increased risk of death or anoxic brain injury. Most events (55%) occurred within the first 2 postoperative days. Otolaryngologists who reported performing <200 tonsillectomies per year were more likely to report an event (P < .001). CONCLUSIONS: This study, the largest collection of original reports of post-tonsillectomy mortality to date, found that events unrelated to bleeding accounted for a preponderance of deaths and anoxic brain injury. Further research is needed to establish best practices for patient admission, monitoring, and pain management. LEVEL OF EVIDENCE: N/A.

Choosing wisely: our list.

In February 2013, the American Academy of Otolaryngology-Head and Neck Surgery Foundation (AAO-HNSF) released its list of 5 recommendations of diagnostic and therapeutic interventions that physicians and patients should question, as part of the American Board of Internal Medicine (ABIM) Foundation's Choosing Wisely campaign. This commentary outlines the impetus for the AAO-HNSF to join the campaign, our list of 5 recommendations, how they were developed, and our future involvement with the campaign. The AAO-HNSF's 5 recommendations are (1) don't order a computed tomography (CT) scan of the head/brain for sudden hearing loss, (2) don't prescribe oral antibiotics for uncomplicated acute tympanostomy tube otorrhea, (3) don't prescribe oral antibiotics for uncomplicated acute external otitis, (4) don't routinely obtain radiographic imaging for patients who meet diagnostic criteria for uncomplicated acute rhinosinusitis, and (5) don't obtain CT or magnetic resonance imaging in patients with a primary complaint of hoarseness prior to examining the larynx.

Consumer assessment of healthcare providers and systems surgical care survey: benefits and challenges.

OBJECTIVE: To describe the feasibility and initial results of the implementation of a continuous quality improvement project using the newly available Consumer Assessment of Healthcare Providers and Systems Surgical Care Survey (S-CAHPS), in a small cohort of otolaryngology-head and neck surgery practices. STUDY DESIGN: Prospective observational study using a newly validated health care consumer survey. SETTING: Two community-based and 2 university-based otolaryngology-head and neck surgery outpatient clinic practices. METHODS: Fourteen board-certified otolaryngology, head and neck surgeons from 4 practice sites voluntarily participated in this project. All adult patients scheduled for surgery during a 12-month period were asked to complete the S-CAHPS survey through an electronic data capture (EDC) system 7 to 28 days after surgery. The surgeons were not directly involved in administration or collection of survey data. RESULTS: Three sites successfully implemented the S-CAHPS project. A 39.9% response rate was achieved for the cohort of surgical patients entered into the EDC system. While most patients rated their surgeons very high (mean of 9.5 or greater out of 10), subanalysis revealed there is variability among sites and surgeons in communication practices. From these data, a potential surgeon Quality Improvement report was developed that highlights priority areas to improve surgeon-patient rapport. CONCLUSIONS: The S-CAHPS survey can be successfully implemented in most otolaryngology practices, and our initial work holds promise for how the survey can be best deployed and analyzed for the betterment of both the surgeon and the patient.

Surveillance and management practices in tracheotomy patients.

OBJECTIVES/HYPOTHESIS: To ascertain the surveillance and management practices for tracheotomy patients. STUDY DESIGN: Survey of tracheotomy management. METHODS: An electronically distributed 26-question survey was distributed under the auspices of the American Academy of Otolaryngology-Head and Neck Surgery Foundation. RESULTS: There were 478 responses. The mean number of years in practice was 21.2 years (standard deviation [SD], 11.0 years). Sixty-five percent of respondents perform mainly adult tracheotomy. There is variation in surveillance patterns of immediate, postoperative, intermediate, and long-term surveillance. On average, respondents follow a fresh tracheotomy daily for about 6 days, monthly for about 3 months, and long-term surveillance every 4 months on average. Almost all respondents perform long-term surveillance during routine tracheotomy changes; 61.4% perform this surveillance with an endoscope, and a minority rely on history and examination. The mean frequency of tracheotomy tube changes was 2 months (SD, 2.2 months; median, 1.1 month; range, 0.06-12 months). Two hundred sixty-one respondents have or have used a decannulation algorithm. The vast majority, 96.2%, are comfortable with their current management practices. Over half of the respondents perceive value in a clinical practice guideline to help them with standardizing care, and 80% of respondents feel that it would assist other specialties in the care and surveillance of tracheotomy patients. CONCLUSIONS: There is marked variability in the surveillance and management of tracheotomy patients. There exists opportunity to improve care through standardization of surveillance and management of these patients.

Wrong-site sinus surgery in otolaryngology.

OBJECTIVE: To determine the scope of wrong-site sinus surgery. STUDY DESIGN: Electronic mail survey. SETTING: E-mailed via the American Academy of Otolaryngology-Head and Neck Surgery's weekly newsletter. SUBJECTS AND METHODS: Members were asked about wrong-site sinus surgery in an 11-item survey. RESULTS: A total of 455 members responded (response rate 19.8%). Forty-two (9.3%) have heard of a case of wrong-site sinus surgery occurring. Twenty-one cases were analyzed; of these, 10 (48%) implicated radiographic error, and the Universal Protocol was followed in one third. In seventeen reports (81%), there was disclosure to the family, one case with delayed disclosure; there was no disclosure in three cases. Sixty-one percent (n = 266) are concerned about operating on the wrong sinus or side. Forty-nine percent (n = 216) routinely use a checklist preoperatively. There is large variation in site marking for sinus surgery. Sixty-five percent (n = 282) routinely review the computed tomography scan prior to surgery. CONCLUSION: Approximately 10 percent of survey respondents know of a case of wrong-site sinus surgery occurring; the majority of respondents are concerned about a wrong-sinus or wrong-sided surgery occurring in their practice. Otolaryngologists should be vigilant regarding the potential for inverted computed tomography images; there should be national efforts to address this latent systems defect. Surgeons should be trained in understanding the role of and engaging in disclosure and in other techniques that are of greatest support to the patient. Consideration of sinus-specific checklists should be led by the societies representing sinus surgeons.