Adverse events in facial plastic surgery: Data-driven insights into systems, standards, and self-assessment.

PURPOSE: Complications in facial plastic surgery can lead to pain, suffering, and permanent harm. Yet, the etiology and outcomes of adverse events are understudied. This study aims to determine the etiology and outcomes of adverse events reported in aesthetic facial plastic surgery and identify quality improvement opportunities. MATERIAL AND METHODS: A cross-sectional survey analysis was conducted using an anonymous 22-item questionnaire distributed to members of the American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS) and American Academy of Facial Plastic and Reconstructive Surgery (AAFPRS). Participants were queried on demographics, practice type, and adverse events related to aesthetic facial surgeries. RESULTS: Two hundred fifty-three individuals participated; nearly half of respondents (49.0%) held membership in both AAO-HNS and AAFPRS. Of these, 40.8% of respondents reported at least one adverse event within the past 12 months of practice. A total of 194 adverse events were reported, most commonly related to facelift (n = 59/194, 30.4%), rhinoplasty (n = 55/194, 28.4%), and injection procedures (n = 38/194, 19.6%), with hematoma or seroma being the most commonly described. Most adverse events were self-limited, but approximately 68% resulted in further procedures. Surgeon error or poor judgement (n = 42) and patient non-adherence (n = 18) were the most commonly ascribed reasons for adverse events; 37.1% of participants reported a change in clinical practice after the incident. CONCLUSIONS: Adverse events were not infrequent in facial plastic surgery. Understanding these adverse events can provide impetus for tracking outcomes, standardization, and engagement with lifelong learning, self-assessment, and evaluation of practice performance.

Improving tracheostomy care in the United Kingdom: results of a guided quality improvement programme in 20 diverse hospitals.

BACKGROUND: Inconsistent and poorly coordinated systems of tracheostomy care commonly result in frustrations, delays, and harm. Quality improvement strategies described by exemplar hospitals of the Global Tracheostomy Collaborative have potential to mitigate such problems. This 3 yr guided implementation programme investigated interventions designed to improve the quality and safety of tracheostomy care. METHODS: The programme management team guided the implementation of 18 interventions over three phases (baseline/implementation/evaluation). Mixed-methods interviews, focus groups, and Hospital Anxiety and Depression Scale questionnaires defined outcome measures, with patient-level databases tracking and benchmarking process metrics. Appreciative inquiry, interviews, and Normalisation Measure Development questionnaires explored change barriers and enablers. RESULTS: All sites implemented at least 16/18 interventions, with the magnitude of some improvements linked to staff engagement (1536 questionnaires from 1019 staff), and 2405 admissions (1868 ICU/high-dependency unit; 7.3% children) were prospectively captured. Median stay was 50 hospital days, 23 ICU days, and 28 tracheostomy days. Incident severity score reduced significantly (n=606; P<0.01). There were significant reductions in ICU (-;0.25 days month-1), ventilator (-;0.11 days month-1), tracheostomy (-;0.35 days month-1), and hospital (-;0.78 days month-1) days (all P<0.01). Time to first vocalisation and first oral intake both decreased by 7 days (n=733; P<0.01). Anxiety decreased by 44% (from 35.9% to 20.0%), and depression decreased by 55% (from 38.7% to 18.3%) (n=385; both P<0.01). Independent economic analysis demonstrated £33 251 savings per patient, with projected annual UK National Health Service savings of £275 million. CONCLUSIONS: This guided improvement programme for tracheostomy patients significantly improved the quality and safety of care, contributing rich qualitative improvement data. Patient-centred outcomes were improved along with significant efficiency and cost savings across diverse UK hospitals. CLINICAL TRIAL REGISTRATION: IRAS-ID-206955; REC-Ref-16/LO/1196; NIHR Portfolio CPMS ID 31544.

Global Tracheostomy Collaborative: data-driven improvements in patient safety through multidisciplinary teamwork, standardisation, education, and patient partnership.

There is growing recognition of the need for a coordinated, systematic approach to caring for patients with a tracheostomy. Tracheostomy-related adverse events remain a pervasive global problem, accounting for half of all airway-related deaths and hypoxic brain damage in critical care units. The Global Tracheostomy Collaborative (GTC) was formed in 2012 to improve patient safety and quality of care, emphasising knowledge, skills, teamwork, and patient-centred approaches. Inspired by quality improvement leads in Australia, the UK, and the USA, the GTC implements and disseminates best practices across hospitals and healthcare trusts. Its database collects patient-level information on quality, safety, and organisational efficiencies. The GTC provides an organising structure for quality improvement efforts, promoting safety of paediatric and adult patients. Successful implementation requires instituting key drivers for change that include effective training for health professionals; multidisciplinary team collaboration; engagement and involvement of patients, their families, and carers; and data collection that allows tracking of outcomes. We report the history of the collaborative, its database infrastructure and analytics, and patient outcomes from more than 6500 patients globally. We characterise this patient population for the first time at such scale, reporting predictors of adverse events, mortality, and length of stay indexed to patient characteristics, co-morbidities, risk factors, and context. In one example, the database allowed identification of a previously unrecognised association between bleeding and mortality, reflecting ability to uncover latent risks and promote safety. The GTC provides the foundation for future risk-adjusted benchmarking and a learning community that drives ongoing quality improvement efforts worldwide.

Tracheostomy care quality improvement in low- and middle-income countries: A scoping review.

Tracheostomy is a lifesaving, essential procedure performed for airway obstruction in the case of head and neck cancers, prolonged ventilator use, and for long-term pulmonary care. While successful quality improvement interventions in high-income countries such as through the Global Tracheostomy Collaborative significantly reduced length of hospital stay and decreased levels of anxiety among patients, limited literature exists regarding tracheostomy care and practices in low and middle-income countries (LMIC), where most of the world resides. Given limited literature, this scoping review aims to summarize published tracheostomy studies in LMICs and highlight areas in need of quality improvement and clinical research efforts. Based on the PRISMA guidelines, a scoping review of the literature was performed through MEDLINE/PubMed and Embase using terms related to tracheostomy, educational and quality improvement interventions, and LMICs. Publications from 2000-2022 in English were included. Eighteen publications representing 10 countries were included in the final analysis. Seven studies described baseline needs assessments, 3 development of training programs for caregivers, 6 trialed home-based or hospital-based interventions, and finally 2 articles discussed development of standardized protocols. Overall, studies highlighted the unique challenges to tracheostomy care in LMICs including language, literacy barriers, resource availability (running water and electricity in patient homes), and health system access (financial costs of travel and follow-up). There is currently limited published literature on tracheostomy quality improvement and care in LMICs. Opportunities to improve quality of care include increased efforts to measure complications and outcomes, implementing evidence-based interventions tailored to LMIC settings, and using an implementation science framework to study tracheostomy care in LMICs.

Oral Intubation Attempts in Patients With a Laryngectomy: A Significant Safety Threat.

It is impossible to secure the airway of a patient with "neck-only" breathing transorally or transnasally. Surgical removal of the larynx (laryngectomy) or tracheal rerouting (tracheoesophageal diversion or laryngotracheal separation) creates anatomic discontinuity. Misguided attempts at oral intubation of neck breathers may cause hypoxic brain injury or death. We present national data from the American Academy of Otolaryngology-Head and Neck Surgery, the American Head and Neck Society, and the United Kingdom's National Reporting and Learning Service. Over half of US otolaryngologist respondents reported instances of attempted oral intubations among patients with laryngectomy, with a mortality rate of 26%. UK audits similarly revealed numerous resuscitation efforts where misunderstanding of neck breather status led to harm or death. Such data underscore the critical importance of staff education, patient engagement, effective signage, and systems-based best practices to reliably clarify neck breather status and provide necessary resources for safe patient airway management.

Systems Science: A Primer on High Reliability.

In the 21st century, most medical care is not delivered by a single physician but rather, by a team. A team is a type of system, a set of people and things interacting together for a defined aim. The discipline of systems science concerns itself with how complex teams or organizations function. The application of systems science has had a major positive impact on safety and quality in such diverse disciplines as auto manufacturing, airline safety, and nuclear power generation. A modest understanding of how systems science applies to medical care can help improve safety and quality of care.

Multidisciplinary Tracheostomy Care: How Collaboratives Drive Quality Improvement.

There have been reports of successful quality-improvement initiatives surrounding tracheostomy care for more than a decade, but widespread adoption of best practices has not been universal. Five key drivers have been found to improve the quality of care for tracheostomy patients: multidisciplinary synchronous ward rounds, standardization of care protocols, appropriate interdisciplinary education and staff allocation, patient and family involvement, and use of data to drive improvement. The Global Tracheostomy Collaborative is a quality-improvement collaborative dedicated to improving the care of tracheostomy patients worldwide through communication, dissemination, and implementation of proven strategies based on these 5 key drivers.

Complications with hydroxyapatite cement in mastoid cavity obliteration.

OBJECTIVE: To determine whether hydroxyapatite (HA) bone cement is a suitable material for mastoid cavity obliteration. STUDY DESIGN & SETTING: Retrospective case review; tertiary care pediatric hospital. PATIENTS: Three patients, aged 11 to 16 years, underwent canal wall down mastoidectomy for removal of cholesteatomas. INTERVENTION: Mastoid cavity obliteration was performed with hydroxyapatite bone cement. MAIN OUTCOME MEASURES: Failure was defined as the necessity for HA explantation. RESULTS: All three patients required revision surgery to remove the HA cement. Two patients (one primary and one second look with obliteration) presented with granulations in the mastoid cavity, surrounding the cement. The third patient's intraoperative findings included extensive skull base osteitis with erosion of the posterior and middle fossa dural plates, and fistulae of the lateral and superior semicircular canals. All patients recovered fully after removal of the HA cement. CONCLUSION: This study raises concerns over the use of HA cement for mastoid cavity obliteration. Three of three implanted patients required revision surgery, two with delayed failure of integration and infection, and one with severe osteitis and significant complications.

Using a virtual reality temporal bone simulator to assess otolaryngology trainees.

OBJECTIVE: The objective of this study is to determine the feasibility of computerized evaluation of resident performance using hand motion analysis on a virtual reality temporal bone (VR TB) simulator. We hypothesized that both computerized analysis and expert ratings would discriminate the performance of novices from experienced trainees. We also hypothesized that performance on the virtual reality temporal bone simulator (VR TB) would differentiate based on previous drilling experience. STUDY DESIGN: The authors conducted a randomized, blind assessment study. METHODS: Nineteen volunteers from the Otolaryngology-Head and Neck Surgery training program at the University of Toronto drilled both a cadaveric TB and a simulated VR TB. Expert reviewers were asked to assess operative readiness of the trainee based on a blind video review of their performance. Computerized hand motion analysis of each participant's performance was conducted. RESULTS: Expert raters were able to discriminate novices from experienced trainees (P < .05) on cadaveric temporal bones, and there was a trend toward discrimination on VR TB performance. Hand motion analysis showed that experienced trainees had better movement economy than novices (P < .05) on the VR TB. CONCLUSION: Performance, as measured by hand motion analysis on the VR TB simulator, reflects trainees' previous drilling experience. This study suggests that otolaryngology trainees could accomplish initial temporal bone training on a VR TB simulator, which can provide feedback to the trainee, and may reduce the need for constant faculty supervision and evaluation.

Pulse transit time as a screening test for pediatric sleep-related breathing disorders.

OBJECTIVES: To evaluate a noninvasive measure of arousal, the pulse transit time (PTT), as a screening tool for obstructive sleep apnea/hypopnea syndrome (OSAHS) in an unselected population of symptomatic children, compared with overnight polysomnography (PSG). A secondary objective included comparing the diagnostic performance of PTT with continuous pulse oximetry recorded during PSG. DESIGN: Prospective, blinded diagnostic comparison study using the gold standard of overnight PSG. SETTING: Tertiary-care children's hospital sleep laboratory. PATIENTS: An unselected, volunteer sample of 59 patients (mean age, 7.8 years) with and without adenotonsillar tissue undergoing PSG and simultaneous PTT, including patients with obesity and craniofacial syndromes. MAIN OUTCOME MEASURES: The relationship between the PTT and polysomnographic measures of OSAHS to include pulse oximetry using correlation coefficients and receiver operating characteristic curve analysis. RESULTS: The correlation coefficient between the PTT arousal index and PSG apnea-hypopnea index (AHI) was 0.70 (P<.001). Linear regression resulted in a good fit (R2=0.73) between PTT arousal index and AHI. With the use of an AHI of 1 or greater (35.6% prevalence of OSAHS) as a criteria for OSAHS, the area under the receiver operating characteristic curve was 0.86 (95% confidence interval, 0.76-0.96). The optimal PTT arousal index threshold was 5.4 events per hour, which translated into a sensitivity of 81% and a specificity of 76%. CONCLUSIONS: The PTT arousal index is highly correlated with the PSG-derived AHI and demonstrated excellent diagnostic utility for moderate and severe OSAHS. However, for mild OSAHS, PTT was barely adequate and did not significantly outperform pulse oximetry. Pulse transit time may be a useful tool to evaluate moderate to severe sleep-related breathing disorders in children.

Light-emitting diode aspiration: Distinct radiographic features and approach to management.

Foreign body aspiration is a potentially life threatening problem. The successful removal of airway foreign bodies is dependent on positively identifying the object and developing a solution to its extraction prior to attempts at retrieval. Thus, pre-operative radiographic evaluation is essential in the diagnosis and management of foreign body aspiration. The current case report describes the unique challenges in the evaluation and management of an unusual foreign body within the airway. The distinctive radiographic appearance of this foreign body allows it to be easily identified pre-operatively, and this may decrease the likelihood of operative complications and patient morbidity.

Do post-tonsillectomy patients who report bleeding require observation if no bleeding is present on exam?

OBJECTIVE: Three to ten percent of tonsillectomy patients experience post-tonsillectomy hemorrhage. Examination of those patients who return to the Emergency Department (ED) with a history of hemorrhage may be found to have active bleeding, a coagulum within the fossa, or a normal post-operative exam. It is not known if those with a normal postoperative exam require inpatient observation. METHODS: This is a retrospective series from 1/1/2010 to 12/31/2014 at a tertiary pediatric hospital. We evaluated outcomes in patients who presented to our ED with a history of post tonsillectomy hemorrhage, but after a thorough inspection failed to demonstrate active bleeding or clot, and were thus deemed to have a normal postoperative exam. This cohort was then evaluated for subsequent active bleeding requiring cauterization. Demographics and clinical data were extracted from the medical record. RESULTS: In 337 visits with a history of bleeding, and a normal postoperative exam, 38 (11%) subsequently bled requiring cauterization. 32/38 (84%) bled within 24 h of admission to the ED. No demographic or clinical variables predicted an increased risk of bleeding during observation. CONCLUSIONS: Eleven percent of patients who presented to the ED with a history of bleeding at home but a normal postoperative exam subsequently bled and required cautery, usually within 24 h. Aside from the history of bleeding at home, we found no additional predictors of subsequent bleeding and recommend this group of patients should be considered for 24 hour in-hospital observation prior to discharge.

Complications of turbinate reduction surgery in combination with tonsillectomy in pediatric patients.

OBJECTIVES/HYPOTHESIS: To examine whether the addition of turbinoplasty to tonsillectomy and adenoidectomy (T&A) increases the risk of postoperative complications. STUDY DESIGN: Retrospective cohort study of children (18 years old and younger) who underwent tonsillectomy and/or turbinoplasty between July 1, 2013 and June 30, 2015 using the 2016 Pediatric Health Information System administrative database METHODS: Patients were divided into three groups: 1) T&A and turbinoplasty, 2) T&A alone, and 3) turbinoplasty alone. Postoperative revisit, hemorrhage requiring cautery, and blood transfusion rates were compared between groups. RESULTS: A total of 75,761 patients met inclusion criteria: 3,079 underwent both T&A and turbinoplasty, 72,043 underwent T&A alone, and 639 underwent turbinoplasty alone. The rate of 14-day relevant revisits after T&A in combination with turbinate reduction surgery was not significantly higher than that of T&A alone (9.4% vs. 8.6%; P = .11). The revisit rate after turbinoplasty alone was 1.4%. Indications for revisits did not differ between the T&A and turbinoplasty group versus T&A alone group (P = .23). Furthermore, the rates of hemorrhage requiring cauterization was similar between the two groups (1.4% vs. 1.5%; P = .64). Twenty-one patients who underwent T&A alone required blood transfusion after they were readmitted; no cases in the other two groups required blood transfusion. CONCLUSIONS: Turbinoplasty and T&A performed together do not increase the risk of postoperative revisit or hemorrhage requiring cauterization, and can therefore be considered as a combined procedure. Pediatric patients will benefit from avoiding the additional risk of multiple anesthetics and repeated intubation. LEVEL OF EVIDENCE: 4. Laryngoscope, 127:1920-1923, 2017.

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.

Evaluating the quality improvement impact of the Global Tracheostomy Collaborative in four diverse NHS hospitals.

Tracheostomies are predominantly used in Head & Neck Surgery and the critically ill. The needs of these complex patients frequently cross traditional speciality working boundaries and locations and any resulting airway problems can rapidly lead to significant harm. The Global Tracheostomy Collaborative (GTC) was formed in 2012 with the aim of bringing together international expertise in tracheostomy care in order to bring about rapid adoption of best practices and to improve the quality and safety of care to this vulnerable group. The primary aim of this project was to improve the safety and quality of care delivered to adult patients with new or existing tracheostomies. We implemented changes guided by the GTC using multiple PDSA cycles over a 12-month period. Interventions were across three themes: educational, patient-centred (earlier vocalisation and enteral intake) and organisational. We hypothesised that systematic healthcare improvements would reduce the severity of harm resulting from tracheostomy-related safety incidents and improve surrogate markers of the quality of patient-centred care. Furthermore, we hypothesised that raising the quality and safety of healthcare services would lead to more efficient care, measured by earlier tracheostomy decannulation times and reduced hospital lengths of stay. This Quality Improvement project implemented the GTC into four diverse NHS Trusts in Greater Manchester. Key drivers implemented included multidisciplinary tracheostomy steering groups, ward rounds and bedside teams, standardisation of tracheostomy protocols, staff education and meaningful involvement of patient and family. Surrogates for the quality and safety of care were captured for all patients using a bespoke database. Implementing the GTC into four NHS Trusts rapidly and positively impacted on patient safety metrics and surrogates for the quality of care delivered. It is likely that the comprehensive resources of the GTC will be of benefit to other NHS hospitals and indeed other healthcare systems around the world.

The histone deacetylase inhibitor sodium butyrate protects against cisplatin-induced hearing loss in guinea pigs.

OBJECTIVE: There is a need for otoprotective agents that can be administered systemically without compromising cancer treatment. Histone deacetylase inhibitors are anticancer agents that act by upregulating the expression of cell-cycle control genes. They are also neuroprotective, leading us to hypothesize that they might be otoprotective. The goal of this study was to determine if the antitumor agent sodium butyrate (a histone deacetylase inhibitor) protects against cisplatin ototoxicity when administered systemically. STUDY DESIGN: This was an animal study. METHODS: : Cisplatin was administered to guinea pigs who received either 12 days of sodium butyrate (7 d before and 5 d after cisplatin) or equivolume saline injections. Hearing was tested with distortion product otoacoustic emission (DPOAE) analysis before the start of the study and 2 weeks after cisplatin treatment. RESULTS: Guinea pigs given a single intraperitoneal injection of 14 mg/kg cisplatin experience a mean hearing loss of 8 dB across the frequencies of 3.5, 5, 7, 10, 14, and 20 kHz. Intraperitoneal injection of 1.2 mg/kg sodium butyrate per day for 7 days before and 5 days after cisplatin almost completely eliminates this threshold shift (P=.0011). CONCLUSIONS: The histone deacetylase inhibitor sodium butyrate gives almost complete protection in a single-dose model of cisplatin ototoxicity in guinea pigs. Because histone deacetylase inhibitors are anticancer agents with very few side effects, they may be candidates for clinical use during cisplatin chemotherapy.

Otolaryngologists' responses to errors and adverse events.

OBJECTIVES: The objectives of this study were to describe otolaryngologists' emotional reactions to errors and adverse events, their efforts to take responsibility, and their attempts to implement improvements. STUDY DESIGN AND METHODS: A retrospective, anonymous survey of 2,500 U.S. otolaryngologists who were members of the American Academy of Otolaryngology-Head and Neck Surgery about errors in their practice was conducted. Respondents were asked whether an error had occurred in their practice in the past 6 months and, if so, to describe the error, its consequences, and any corrective actions taken. Two aspects of these reports stood out, which were beyond the scope of the original study: the respondents' emotional responses and their corrective actions. RESULTS: The response rate was 18.6%. Two hundred ten (45%) respondents reported a total of 212 analyzable error reports and 230 corrective actions. Corrective actions included disclosure to the patient (20 [9%]), ameliorating the consequences of the event to the patient (107 [50%]), personal practice changes (14 [7%]), improvements in the respondent's practice or department (60 [28%]), and hospitalwide or broader corrective actions (19 [9%]). Emotional reactions to errors and adverse events were reported by 22 (10%) otolaryngologists, including regret, embarrassment, guilt, anxiety, loss of temper, and irritation. Legal action was mentioned by five physicians (2%). CONCLUSIONS: Otolaryngologists took actions not only to treat their patients, but also to improve patient care in their practice, department, hospital, or community. Emotional reactions to errors and adverse events are common and need to be addressed in medical training and practice.

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.