Outcome of tonsillotomy in children with obstructive sleep-disordered breathing.

OBJECTIVE/BACKGROUND: Most children treated for obstructive sleep disordered breathing (oSDB) are not systematically assessed by polysomnography (PSG) nor by structuredsymptom quantification before surgical treatment. The main objective of this study wasto investigate the effect of adeno-tonsillotomy (ATO) on symptom burden and PSGparameters. METHODS: Children aged 2-10 years with oSDB were selected for ATO based uponclinical findings according to current standards of care in Denmark. Each childunderwent standardized assessment before and 3 months after surgery, including aPSG, tonsil size assessment, and the Pediatric Sleep Questionnaire -Sleep RelatedBreathing Disorder (PSQ) to quantify symptom burden. Obstructive sleep apnea (OSA)was defined as an obstructive apnea-hypopnea index (oAHI) ≥2/h. Successfultreatment was defined as post-surgery oAHI ≤5/h, and complete cure as oAHI ≤2/h. RESULTS: Fifty-two children were included. Mean age was 5.0 years (SD ± 1.76). Thirteen children were identified with baseline oAHI <2/h. Significant improvement inOSA severity was observed in children with moderate-to-severe OSA, in whom oAHI decreased from 15.7/h to 2.6/h (p < 0.001). Treatment success was obtained in 85% and cure was obtained in 42% of children. PSQ-score significantly improved from 0.52 (CI 0.47-0.56) to 0.26 (CI 0.21-0.32) (p < 0.001). Baseline OSA severity was notcorrelated to baseline symptom burden nor to symptom relief after ATO. There were noserious adverse events. CONCLUSIONS: Adeno-tonsillotomy significantly reduced symptom burden in otherwise healthy children with oSDB symptoms. Significant improvement in oAHI was observedonly in children with moderate-to-severe OSA. We recommend combining clinicalevaluation with PSQ and oAHI.

Gathering validity evidence for a 3D-printed simulator for training of myringotomy and ventilation tube insertion.

Objectives: This study aimed to gather validity evidence according to Messick's framework for a novel 3D-printed simulator for myringotomy with ventilation tube insertion for use in technical skills training of otorhinolaryngology (ORL) residents. Methods: The study included 15 junior ORL residents (trainees) and 13 experienced teaching otolaryngologists (experts). Experts and trainees first received an identically structured introduction to the procedure, simulator, and simulation setup. Five procedures performed by each participant were video-recorded and ordered randomly for blinded rating by two independent raters. The rating tools used were a global rating scale (GBRS) and a task-specific checklist. Validity evidence was collected according to Messick's framework. Differences in time consumption and performance scores were analyzed. Finally, a pass/fail standard was established using the contrasting groups' method. Results: Trainees used significantly more time per procedure (109 s, 95% CI: 99-120) than experts (82 s, 95% CI: 71-93; p < .001). Adjusted for repetition and rater leniency, experts achieved an average GBRS score of 18.8 (95% CI: 18.3-19.2) out of 20 points, whereas trainees achieved an average of 17.1 points (95% CI: 16.6-17.5; p < .001). In contrast to the task-specific checklist, the GBRS score discriminated between repetition number and participant experience. The pass/fail standard for the GBRS was established at 18.4 points. Conclusion: We established educational validity evidence for a novel 3D-printed model for simulation-based training of ventilation tube insertion and established a reliable pass/fail standard. Level of Evidence: 1b.

Ear tubes in children with otitis media reduce parental sick leave from work and socioeconomic costs.

INTRODUCTION: This study aimed to investigate changes in parental sick leave after tympanostomy tube (TT) insertion in children with otitis media (OM) and to estimate the overall cost reduction in case of decreased caregiver sick leave from work during a 12-month period after TT insertion. METHODS: A total of 4,708 children less-than 12 years from the database of the Danish ENT Specialists Organisation were included. Questionnaires were sent two days prior to TT insertion and subsequently 1, 3, 6, 9, 12, 15, 18, 21 and 24 months after TT insertion. The questions included symptom duration, patient satisfaction and symptom relief. Furthermore, parental sick leave occurrence was registered before and after TT insertion. The overall cost reduction estimate was based on comparison of the direct and indirect costs of two treatment regimes. Treatment A was non-surgical and antibiotics only. Treatment B comprised TT insertion and antibiotics as needed. RESULTS: The main results were that the risk of parental sick leave decreased significantly (p less-than 0.005) one month after TT insertion compared with baseline; odds ratio = 0.21 (95% confidence interval: 0.19-0.24). The decrease remained stable during the entire follow-up period. The estimate of the total cost reduction between Treatment A (non-TT insertion) and Treatment B (TT insertion) was 3,118.34 DKK/child/year. CONCLUSION: TT insertion is associated with a significant decrease in parental sick leave and may possibly contribute to substantial socioeconomic savings. FUNDING: None. TRIAL REGISTRATION: Not relevant.

Specialists' adherence to guidelines on tympanostomy tube insertion.

INTRODUCTION: Tympanostomy tube insertion is very frequent in Denmark. Using electronic patient-reported outcome (ePRO) data, we investigated Danish ear, nose og throat (ENT) specialists' adherence to the 2015 national clinical guideline (NCG) on first-time tympanostomy tube (TT) insertion in children aged 0-5 years with otitis media (OM). METHODS: Data on children aged 0-5 years with OM undergoing first-time TT insertion were extracted from the Danish ENT Specialists Organisation (DØNHO) database. Pre-operative questionnaires were used to obtain information on symptom duration, and the number of acute OM (AOM) episodes was analysed. The following criteria were established to define NCG adherence: 1) A symptom duration of three months or longer, 2) three or more AOM episodes within six months and 3) four or more AOM episodes within 12 months. These criteria are in accordance with the NCG definition of chronic OM with effusion (COME) and recurrent AOM (RAOM). RESULTS: A total of 1,495 children were included in the study. In total, 91.0% of the parents reported a symptom duration of three months or more and/or RAOM within 6-12 months prior to TT insertion in accordance with the adherence criteria; 4.6% reported a symptom duration of less than three months with few or no episodes of AOM and did not meet the recommended TT insertion criteria. Finally, 4.4% of the parents were undecided with respect to symptom duration, number of AOM episodes or both at 6-12 months prior to TT insertion. CONCLUSIONS: Using solely ePRO data, we found that Danish practicing ENT specialists adhere to the 2015 NCG in regard to OM symptom duration and RAOM. FUNDING: none. TRIAL REGISTRATION: not relevant.

Parent satisfaction and symptom relief in children with otitis media undergoing tympanostomy tube insertion.

INTRODUCTION: The objective of this study was to investigate parent satisfaction and symptom relief in children younger than 12 years undergoing tympanostomy tube (TT) insertion for otitis media (OM) using electronic patient-reported outcome (ePRO) data in private ear, nose and throat (ENT) practice settings. METHODS: A total of 3,553 children aged 0-11 years and registered in the Danish ENT Specialists Organisation (DØNHO) database were included. Following parental consent to participate, we e-mailed a pre-surgical questionnaire two days prior to surgery. Follow-up questionnaires were sent one, three, six, nine and 12 months after surgery. The pre-operative questionnaire collected information on symptom duration, number of acute OM (AOM) episodes within one year before TT insertion and ear-related symptoms. The post-operative questionnaires collected information on symptom relief, number of AOM episodes and parental satisfaction. RESULTS: Pre- and post-operative questionnaires from 2,462 children were eligible for complete analysis. Before surgery, 89.8% of parents reported a symptom duration of three months or longer and/or recurrent AOM (RAOM). Complete symptom regression was reported in more than half of the children post-operatively. For the rest, significant symptom relief was reported 1-12 months following TT insertion. Parent satisfaction rose from 94.8% to 97.2% in the course of the observation period. CONCLUSIONS: We report a consistent, high rate of symptom relief 1-12 months following TT insertion in children < 12 years of age. Furthermore, parental satisfaction throughout the 12-month observation period was compelling. FUNDING: none. TRIAL REGISTRATION: The database was approved by the Danish Data Protection Agency as a private, clinical database (no. 2016-42-3152). According to Danish law, approval by the Danish Research Ethics Committee system was not necessary.

Validation of the Danish National Tympanostomy Tube Insertion Questionnaires.

INTRODUCTION: The objective of the present study was to validate two questionnaires (the Danish National Tympanostomy Tube Insertion Questionnaires (DANTIQ)) intended for use by the DØNHO database in the investigation of the effect of tympanic tube (TT) insertion on ear-related symptoms and the adherence of ear, nose and throat (ENT) specialists in Danish private practice to the Danish National Clinical Guideline on treatment of otitis media (OM) with TT insertion using electronic patient-reported outcome (ePRO) data. METHODS: The content validity of the questionnaires was assessed through discussion in a group of four active ENT specialists. Face and content validity analyses were conducted using data from semi-structured, single-person interviews with nine subjects. Reliability analysis was conducted as a three-day test/re-test study involving two groups of 117 individuals receiving and answering the same questionnaire twice. RESULTS: The overall face validity of both questionnaires was satisfactory. The reliability of the answers for both questionnaires was considered acceptable with a proportion of agreement ranging from 1.00 to 0.77. The correlation between first and second scores of the total number of symptoms reported in the test/re-test setup was acceptable with results ranging from 0.93 to 0.84. CONCLUSIONS: The DANTIQ are valid and reliable for measuring ear-related symptoms in children with OM undergoing TT insertion and for investigating Danish private ENT specialists' adherence to guidelines concerning TT insertion by use of ePRO data. FUNDING: non. TRIAL REGISTRATION: not relevant.

Good results after endonasal cartilage closure of nasal septal perforations.

INTRODUCTION: Surgical closure of nasal septal perforations is a challenging procedure. Several approaches and techniques have been described with different levels of success. We report our experience in nasal septal perforation surgery. MATERIAL AND METHODS: We reviewed a sample of 19 patients who underwent surgical closure of nasal septal perforations. The perforations varied in size from 3 mm to 25 mm (mean 13 mm). Outcome was assessed on the basis of a comparison of the preoperative and final follow-up assessment of perforation size and symptoms. The surgical technique is based on an endonasal approach with dissection of bilateral bipedicled mucoperichondrial/-periosteal advancement flaps and interposition of a septal or conchal cartilage graft. RESULTS: Symptomatic resolution was documented for 18 of the 19 patients (95%). Complete closure was accomplished in 16 patients (84%) without major complications. We observed no graft donor site morbidity. CONCLUSION: The technique described uses recognized surgical principles to reconstruct the original nasal architecture and physiology. The results achieved sustain that the method offers both durability and strength. The endonasal approach leaves no scars, reduces risk of tip-rotation and offers sufficient view and space for instrumentation. We conclude that this method is suitable for treatment of perforations up to a vertical height of at least 25 mm.