Kristine Schulz

Studying Life Effects & Effectiveness of Palatopharyngoplasty (SLEEP) study: subjective outcomes of isolated uvulopalatopharyngoplasty.

Objective. To test the hypothesis that uvulopalatopharyngoplasty (UPPP) improves sleep apnea–related quality of life (measured on the Functional Outcomes of Sleep Questionnaire [FOSQ]) at 3-month follow-up. Secondary objectives were to test (1) the stability of the outcomes at 6 months, (2) the effect on global sleep apnea quality-of-life change, and (3) the effect on sleep apnea symptoms. Study Design. Multicenter, prospective, longitudinal case series. Setting. Diverse university- and community-based otolaryngology practices. Subjects and Methods. The cohort included 68 patients from 17 practices, with a mean ± standard deviation age of 44 ± 12 years and mean apnea-hypopnea index of 35 ± 32 events/hour. All patients underwent UPPP, defined as an open procedure modifying the shape and size of the palate, pharynx, and uvula, with or without tonsillectomy. Baseline data were collected on site before surgery, and outcome data were collected by mail 3 and 6 months after surgery, with follow-up rates of 51% and 50%, respectively. Results. FOSQ scores improved from 14.3 ± 3.4 (scale 5-20, normal ≥17.9) at baseline to 17.2 ± 2.7 at 3 months (mean improvement 2.9; 95% confidence interval, 1.8-4.0; P < .001) and 17.5 ± 2.5 at 6 months (mean improvement 3.1; 95% confidence interval, 2.0-4.2; P < .001). All quality-of-life and symptom measures improved significantly at 3 and 6 months (all P < .05). Conclusion. This prospective, multicenter, university- and community-based study provides evidence that UPPP significantly improves disease-specific quality of life and sleep apnea symptoms in patients with sleep apnea. Validity may be limited by significant loss to follow-up and absence of an unoperated control group.

Impact of Otitis Media Severity on Children’s Quality of Life

Objective Children with otitis media (OM) suffer sleep disturbances, loss of appetite, earache, and behavioral problems. Our objective was to quantitate the average burden of OM and to compare the associated impact of tympanostomy tubes on infant health related quality of life (HR-QoL). Study Design Multi-institutional prospective cross-sectional study. Setting Otolaryngology, family practice, and pediatric clinics. Subjects and Methods Children ages 6 to 24 months of age with or without recurrent OM. Patient history, the PedsQL Infant QoL survey, and the 6-item child with OM survey (Otitis Media 6 [OM-6]) were collected from providers and parents. Results Data from 1208 patients were analyzed. Mean age was 14.7 months, and 54% were male. The mean OM-6 score of children with recurrent OM was 3.3, whereas similarly aged well-children had a mean OM-6 score of 2.5. The mean PedsQL Infant scores of recurrent OM patients were significantly worse than those of children from well-child visits. Worse OM-6 scores were correlated with poorer PedsQL Infant scores, Pearson r = −0.581 (1-12 months) and −0.558 (13-24 months), P < .001. Otolaryngology patients who were recommended to undergo ear tube placement had significantly poorer OM-6 scores and worse PedsQL Infant scores, whereas patients with prior tube placement had significantly better OM-6 and PedsQL Infant scores. Conclusion Children with recurrent OM had significantly worse HR-QoL than similarly aged healthy children. Increased burden of OM strongly affected HR-QoL, and recommendation for tube placement was associated with increased disease burden and poorer HR-QoL. The presence of tympanostomy tubes was associated with better OM-6 and PedsQL Infant scores.

Implementation and Testing of Research Infrastructure for Practice-Based Research in Hearing and Communication Disorders

Objective. To describe site capability and experience of the CHEER network (Creating Healthcare Excellence through Education and Research) to rapidly collect descriptive data on patients with tinnitus and dizziness visiting participating CHEER sites. Study Design. Prospective observational data collection study over 6 months. Setting. Twenty one community otology and otolaryngology practices in the United States. Subjects and Methods. As proof of concept, a data collection study was developed for patients with tinnitus and dizziness (presenting with or without associated migraine) through a collaborative effort of the CHEER principal investigator (PI) and co-PIs. The 9-page questionnaire included validated instruments and additional patient- and physician-reported information. Information was captured electronically via REDCap by each site’s CHEER research coordinator. Site initiation, data entry rates, and research coordinator feedback were also collected. Results. Of the 21 CHEER sites, 15 participated in the study. Nine sites entered a patient within the first 31 days of study initiation, and all 15 sites were entering patients and corresponding clinical data within 72 days. During the 6-month study, 1044 patients were entered into the REDCap database. Research coordinator engagement was a major driver for success, whereas time and resources were deterrents. Incentives included altruism, professional development, and future financial opportunities. Conclusion. The CHEER research network has significant capability and infrastructure to collect prospective data in a practice-based environment. Research coordinator engagement undergirds network success; however, future efforts will cultivate stronger collaboration of the coordinator and site PI. Central coordination of practice-based research through a hub and spoke concept can be successful.

Building a national research network for clinical investigations in otology and neurotology.

Background: Practice-based research networks (PBRNs) are the preferred research setting for descriptive/epidemiologic studies and studies that explore the effectiveness of treatments for disease that are managed in community settings, away from the rubric of the academic medical center. A PBRN in otology/neurotology, established upon a sustainable research infrastructure, addresses the challenges of performing community-based research through enhanced support for data collection and facilitated research regulatory adherence. A strategic alignment of a PBRN with an established research infrastructure allows for successful implementation of a variety of study methodologies and a framework for successful competition for research funding in hearing and balance disorders. Our goal is to develop a centralized, high-quality research infrastructure that supports a dynamic research alliance between regional centers for research excellence, community physicians, allied health professionals, and patients. Objective: We describe herein current plans and progress toward the goal of developing a network of academic- and community-based research sites to facilitate the conduct of clinical research in hearing and balance disorders. We have formed a PBRN that we call the CHEER Network: Creating Healthcare Excellence through Education and Research. Creating healthcare excellence through education and research was proposed in response to a request for applications from the National Institute for Deafness and other Communication Disorders to further develop clinical research in otolaryngology, specifically focusing on disorders in hearing and balance. Conclusion: Our expectation is that a network organized and focused around regional research alliances between academic institutions and community practitioners will have broad appeal to community-based health care professionals and patients, resulting in enhanced communications, interoperability, and success in the conduct of high-quality multicenter clinical research in hearing and balance disorders.

The Otology Data Collection Project Report from the CHEER Network

Objective. To describe and communicate data collected in the CHEER (Creating Healthcare Excellence through Education and Research) infrastructure proof-of-concept study to facilitate understanding of the potential capabilities of practice-based research networks and to present pilot data for development of future research initiatives. Study Design. Prospective observational study of CHEER infrastructure operational capacity using a convenience sample of all patients presenting to the practices with tinnitus, dizziness, or a combination of these symptoms. Setting. The CHEER network of community and academic practice sites. Subjects and Methods. The data collection exercise collected demographic, clinical, treatment, and health-related quality-of-life surveys on tinnitus, dizziness, and migraine disorders. Descriptive analysis of the data is presented. Results. Of the sites in the CHEER network, 73% (16/22) successfully enrolled subjects; a total of 1532 patients were enrolled in 8 months. Tinnitus alone, dizziness alone, and both occurred in 28%, 34%, and 29%, respectively. Patients complaining of tinnitus and dizziness had lower quality of life than those sufferers with 1 disorder. Migraine was associated with 27% of patients. The most frequent diagnoses for patients with tinnitus and dizziness were Ménière disease (34%), vertiginous migraine (18%), and benign paroxysmal positional vertigo (16%). Conclusion. Descriptive data on patients with common disorders can be rapidly collected within the framework of a practice-based research network. The data in this study provide valuable pilot information on the targeted disorders, providing a baseline for development of future epidemiological data and clinical trials.

Evaluation of Compliance for Treatment of Sudden Hearing Loss A CHEER Network Study

Objective The objective of this study is to describe the presentation and management of sudden sensorineural hearing loss for patients seen in academic and community-based practices within the context of the American Academy of Otolaryngology—Head and Neck Surgery Foundation’s “Clinical Practice Guideline: Sudden Hearing Loss.” The intention is to use these findings to guide implementation strategies and quality improvement initiatives and as pilot data for the development of clinical research initiatives. Study Design A cross-sectional study of patients with sudden hearing loss. Setting Patients were recruited from practices within the Creating Healthcare Excellence through Education and Research (CHEER) network. The CHEER network is an National Institutes of Health–funded network of 30 otolaryngology sites across the country, half of which are community based and half of which are academic practices. Subjects and Methods A total of 173 patients were recruited. Data were gathered via custom questionnaires collected by study site coordinators and entered into a secure online platform. Descriptive analyses and correlation statistics were run with SAS 9.3.1. Results Of the 13 guideline statements in the American Academy of Otolaryngology—Head and Neck Surgery Foundation’s clinical practice guideline on sudden hearing loss, 11 statements were evaluable through this study. Compliance for otolaryngologists was >95% for key action statements (KASs) 1, 3, and 6; 90% to 95% for KASs 5 and 10; and <90% for KASs 7 and 13. Compliance was <45% for nonotolaryngologists for KASs 3 and 5-7. Conclusions There is opportunity for nonotolaryngologists to improve for statements 3 and 5-7. Otolaryngologists are compliant with many of the KASs overall, but there is significant room for improvement.

Factors influencing pursuit of hearing evaluation: Enhancing the health belief model with perceived burden from hearing loss on communication partners

Abstract Objective: There is limited application of health behavior-based theoretical models in hearing healthcare, yet other fields utilizing these models have shown their value in affecting behavior change. The health belief model (HBM) has demonstrated appropriateness for hearing research. This study assessed factors that influence an individual with suspected hearing loss to pursue clinical evaluation, with a focus on perceived burden of hearing loss on communication partners, using the HBM as a framework. Design: Cross-sectional design collecting demographics along with three validated hearing-loss related questionnaires. Study sample: Patients from Duke University Medical Center Otolaryngology Clinic aged 55–75 years who indicated a communication partner had expressed concern about their hearing. A final sample of 413 completed questionnaire sets was achieved. Results: The HBM model construct ‘cues to action’ was a significant (p <0.001) predictor of pursuing hearing evaluation. Perceived burden of hearing loss on communication partners was a significant (p <0.001) predictor of pursuing hearing evaluation and improves the model fit when added to the HBM: 72.0% correct prediction when burden is added versus 66.6% when not (p <0.0001). Conclusions: Hearing healthcare initiatives that incorporate these factors may improve hearing help-seeking behavior. More research using sound theoretical models in hearing healthcare is warranted.

Caregiver Quality of Life Is Related to Severity of Otitis Media in Children

Objective Otitis media (OM) in children is the most frequent reason for physician visits in developed countries and burdens caregivers, society, and the child. Our objective was to describe the impact of OM severity on parent/caregiver quality of life (QoL). Study Design Multi-institutional prospective cross-sectional study. Setting Otolaryngology, family, and pediatric practices. Subjects and Methods Children 6 to 24 months old with and without a primary diagnosis of recurrent OM and their caregivers. Physicians provided patient history, and parents/caregivers completed a Family Information Form, the PedsQL Family Impact survey, the Patient Reported Outcomes Measurement Information System (PROMIS) survey, and the OM 6-item severity survey (OM-6). Results A total of 2413 subjects were enrolled and data from 1208 patients and physician were analyzed. The average child age was 16 months, and 54% were male. The mean OM-6 score was 3.2. The mean PedsQL Family Impact score for parents was 66.9 from otolaryngology sites and 78.8 from pediatrics/family practice sites (P < .001). Higher (worse) OM-6 scores correlated significantly with worse PedsQL Family Impact scores (Pearson r = −0.512, P < .01). Similarly, increasing OM-6 scores strongly correlated with increased parental anxiety, depression, and fatigue, as well as decreased satisfaction (all P < .01). Conclusions Worse PedsQL Family Impact and PROMIS scores were highly correlated with elevated OM-6 scores, suggesting that severity of childhood OM significantly affects parent/caregiver QoL. Understanding the impact of a child’s illness on parent/caregiver QoL can help physicians counsel patients and families and provide better family-centered, compassionate care.

Surgical Training and Education in Promoting Professionalism: a comparative assessment of virtue-based leadership development in otolaryngology-head and neck surgery residents

Introduction Surgical Training and Education in Promoting Professionalism (STEPP) was developed in 2011 to train tomorrows leaders during residency. It is based on virtue ethics and takes an approach similar to West Point military academy. The purpose of this research was: (i) to compare the virtue profiles of our residents with that of the military cohort using a standardized virtue assessment tool; and (ii) to assess the value of virtue education on residents. Methods As part of STEPP, otolaryngology residents participated in a virtue-based validated assessment tool called Virtue in Action (VIA) Inventory. This was completed at the initiation of STEPP in July 2011 as well as 1 year later in June 2012. Comparison of the VIA to a military cohort was performed. Leadership ‘Basic Training’ is a series of forums focused on virtues of initiative, integrity, responsibility, self-discipline, and accountability. A pre- and post-test was administered assessing resident perceptions of the value of this ‘Basic Training’. Results Virtues are shared between otolaryngology residents (n=9) and military personnel (n=2,433) as there were no significant differences in strength scores between two military comparison groups and otolaryngology-head and neck surgery (OHNS) residents. There was a significant improvement (p<0.001) in the understanding of components of the leadership vision and a significant improvement in the understanding of key leadership concepts based on ‘Basic Training’. All residents responded in the post-test that the STEPP program was valuable, up from 56%. Conclusions A virtue-based approach is valued by residents as a part of leadership training during residency.

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.