A validation study of the 30-day questionnaire in the national Norwegian Tonsil Surgery Register: can we trust the data reported by the patients?

PURPOSE: The aim of this study was to validate the Patient Reported Outcome Measure (PROM) in the Norwegian Tonsil Surgery Register (NTSR) and to examine whether any improvements to the questionnaire could be useful. METHODS: This is a prospective, descriptive study. NTSR collects data from patients who undergo tonsil surgery and the intention of the register is to improve the quality of treatment and to contribute to research. The patients answers questions about admission due to postoperative haemorrhage, infection and pain 30 days after surgery. 305 patients were contacted on phone 1-2 weeks after answering the questionnaires electronically (ePROM) and asked the same questions. 180 of 305 patients we contacted had some kind of complications after surgery. They were asked additional questions to search for possible points for improvement of the questionnaire. RESULTS: When comparing the results on the ePROM with the answers on phone, we found that 12 out of 14 variables achieve almost perfect agreement (AC1 ≥ 0.81). Two variables are categorized to be substantial agreement (AC1 = 0.61-0.80). The additional questions showed us that the questionnaire can be improved with more detailed information regarding the severity of the postoperative haemorrhage and the need of better treatment against postoperative pain. CONCLUSION: This study shows that the information from the 30-day ePROM has high reliability. The questions were understood as they were intended, and the answers reflect what the patients had of complications. Some changes can be done to improve the questionnaire and to open up for more research around the tonsillectomy procedure.

Reducing post-tonsillectomy haemorrhage: a multicentre quality improvement programme incorporating video-based cold technique instruction.

OBJECTIVE: Data from the Norwegian Tonsil Surgery Register (NTSR) showed large differences between the hospitals in Norway in the readmission rate due to post-tonsillectomy haemorrhage (rrPTH; range, 0%-25%; national average, 8%). Because of these large variations in the rrPTH, we conducted a quality improvement project involving hospitals with good and bad readmission rates. METHODS: Seven hospitals with readmission rates greater than 10% and four with rates lower than 5% participated in this project. We recorded videos of ear, nose and throat surgeons from the hospitals with low readmission rates when they performed extracapsular tonsillectomy, and these videos of cold dissection tonsillectomy were used as teaching material for examples of good surgical skills for the other hospitals. After a 2-day workshop, all participants from the hospitals went back to their institutions and prepared local plans to improve their results. We used the Plan-Do-Study-Act model. The primary outcome variable was the patient-reported rrPTH in the NTSR. As secondary goal, we aimed to identify aspects of the tonsillectomy procedure that could help achieve a lower rrPTH. RESULTS: The participating hospitals reduced their rrPTH from 18% at baseline (2017/2018) to 7% in 2020. Six of seven hospitals changed their dissection technique significantly to more use of cold dissection. CONCLUSION: By learning cold dissection tonsillectomy from surgeons with low rrPTH, it seems possible to decrease the rates of bleeding complications after tonsillectomy. A combination of videos as a teaching tool, new treatment plans, and focus on quality and improvement may effectively improve surgical results. The videos can show details that are difficult to convey in the literature. Quality registers can be used to identify areas requiring improvement and evaluate the effects of changes in practice.

Comparison of clinical practice of tonsil surgery from quality register data from Sweden and Norway and one clinic in Denmark.

OBJECTIVES: To compare the application of indications, demographics, surgical and haemostatic techniques in tonsil surgery in three countries. DESIGN: Non-randomised, prospective, observational cohort. SETTING: All patients registered in the National Tonsil Surgery Quality Registers in Sweden, Norway and West Jutland, Denmark. PARTICIPANTS: Data were retrieved from 2017 to 2019; registered surgeries: Sweden: 20 833; Norway: 10 294 and West Jutland, Denmark: 505. RESULTS: Tonsil surgery for obstruction was twice as common in Sweden (62.2%) compared with Norway (31%) and Denmark (27.7%). Recurrent tonsillitis was registered twice as frequently in Norway (35.7%) and Denmark (39%) compared with Sweden (16.7%). Chronic tonsillitis was registered more frequently in Norway (29.8%) than in Sweden (13.8%) and Denmark (12.7%). Day surgery (>76%) was comparable. The higher frequency of obstruction in Sweden affected age and gender distributions: Sweden (7 years, 50.4% boys), Norway (17 y, 42.1%) and Denmark (19 y, 38.4%). For obstructive disorders, tonsillotomy with adenoidectomy was used in a majority of Swedish children (72%), whereas tonsillectomy with or without adenoidectomy dominated in Norway (53.5%) and Denmark (57.9%). Cold steel was the technique of choice for tonsillectomy in all three countries. For tonsillotomy, hot dissection techniques dominated in all countries. Disparities were observed with regard to haemostatic techniques. Bipolar diathermy was commonly used in all countries. Monopolar diathermy was practically only used in Sweden. Infiltration with epinephrine in the tonsillar bed was registered in Sweden and Norway but not at all in Denmark. Combined cold surgical and cold haemostatic techniques were more commonly used in Sweden (22.7%) than in Norway (10.4%) and Denmark (6.2%). CONCLUSIONS: This study demonstrates disparities among the Nordic countries in tonsil surgery in terms of indications plus surgical and haemostatic techniques. Increased coverage and further monitoring of outcomes is needed to identify best practices and ideal guidelines for improved care.

Corrigendum to "Health-Related Quality of Life and Sleep Quality after 12 Months of Treatment in Nonsevere Obstructive Sleep Apnea: A Randomized Clinical Trial with Continuous Positive Airway Pressure and Mandibular Advancement Splints".

[This corrects the article DOI: 10.1155/2020/2856460.].

Health-Related Quality of Life and Sleep Quality after 12 Months of Treatment in Nonsevere Obstructive Sleep Apnea: A Randomized Clinical Trial with Continuous Positive Airway Pressure and Mandibular Advancement Splints.

In this randomized controlled trial, patients with nonsevere obstructive sleep apnea (OSA) were treated with continuous positive airway pressure (CPAP) or a twin block mandibular advancement splint (MAS). The primary objective was to compare how CPAP and MAS treatments change the health-related quality of life (HRQoL) and self-reported sleep quality of patients after 12 months of treatment. In total, 104 patients were recruited: 55 were allocated to the CPAP treatment group and 49 to the MAS treatment group. We used the SF36 questionnaire to evaluate HRQoL and the Pittsburgh Sleep Quality Index (PSQI) to evaluate sleep quality. All patients were included in the intention-to-treat analyses. These analyses showed improvements in the SF36 physical component score (from 48.8 ± 7.6 at baseline to 50.5 ± 8.0 at follow-up, p=0.03) in the CPAP treatment group and in the mental component score (from 44.9 ± 12.1 to 49.3 ± 9.2, p=0.009) in the MAS treatment group. The PSQI global score improved in both the CPAP (from 7.7 ± 3.5 to 6.6 ± 2.9, p=0.006) and the MAS (8.0 ± 3.1 to 6.1 ± 2.6, p < 0.001) treatment groups. No difference was found between the treatment groups in any of the SF36 scores or PSQI global score at the final follow-up (p > 0.05) in any analysis. The improvement in the SF36 vitality domain moderately correlated to the improvement in the PSQI global score in both groups (CPAP: |r|=0.47, p < 0.001; MAS: |r|=0.36, p=0.01). In the MAS treatment group, we also found a weak correlation between improvements in the SF36 mental component score and PSQI global score (|r|=0.28, p=0.05). In conclusion, CPAP and MAS treatments lead to similar improvements in the HRQoL and self-reported sleep quality in nonsevere OSA. Improvements in aspects of HRQoL seem to be moderately correlated to the self-reported sleep quality in both CPAP and MAS treatments.

Friedman Score in Relation to Compliance and Treatment Response in Nonsevere Obstructive Sleep Apnea.

Nonsevere obstructive sleep apnea (OSA) is most often treated with a continuous positive airway pressure (CPAP) device or a mandibular advancement splint (MAS). However, patient compliance with these treatments is difficult to predict. Improvement in apnea-hypopnea index (AHI) is also somewhat unpredictable in MAS treatment. In this study, we investigated the association between Friedman tongue position score (Friedman score) and both treatment compliance and AHI improvement in patients with nonsevere OSA receiving CPAP or MAS treatment. 104 patients with nonsevere OSA were randomly allocated to CPAP or MAS treatment and followed for 12 months. Data were collected through a medical examination, questionnaires, sleep recordings from ambulatory type 3 polygraphic sleep recording devices, and CPAP recordings. Associations between Friedman score, treatment compliance, and AHI improvement were analysed with logistic regression analyses. Friedman score was not associated with treatment compliance (odds ratio [OR]: 0.85, 95% confidence interval [CI]: 0.59-1.23), or AHI improvement (OR: 1.05, 95% CI: 0.62-1.76) in the overall study sample, the CPAP treatment group, or the MAS treatment group. Adjustment for socioeconomic factors, body mass index, and tonsil size did not significantly impact the results. Although Friedman score may predict OSA severity and contribute to the prediction of success in uvulopalatopharyngoplasty, we found no association between Friedman score and treatment compliance in patients with nonsevere OSA receiving CPAP or MAS treatment, nor did we find any association between Friedman score and AHI improvement. Factors other than Friedman score should be considered when deciding whether a patient with nonsevere OSA should be treated with CPAP or MAS.

General health, vitality, and social function after sinus surgery in chronic rhinosinusitis.

OBJECTIVES: Chronic rhinosinusitis (CRS) has an impact on health-related quality of life (HRQOL). The objective of this study was to examine generic and disease-specific HRQOL and symptoms in CRS patients with (CRSwNP) and without (CRSsNP) nasal polyps before and 6 months after sinus surgery, and to identify preoperative patient factors associated with HRQOL outcome in the two groups separately. METHODS: This prospective, observational study consisted of 220 CRSwNP and 196 CRSsNP patients. Generic and disease-specific HRQOL were measured using the Short-Form-Health-Survey (SF-36) and Sino-Nasal-Outcome-Test (SNOT-20). Symptoms were assessed on a visual analog scale. RESULTS: Preoperatively, CRSwNP patients reported worse score in general health (SF-36), rhinologic subset (SNOT-20): nasal obstruction, nasal discharge, and altered sense of smell compared to CRSsNP patients, who reported worse score in physical role, bodily pain, ear/face subset, and facial pain. After surgery, generic and disease-specific HRQOL and symptoms improved in both groups. CRSwNP patients had greater improvement in general health, vitality and social function, nasal obstruction, and altered sense of smell, compared to CRSsNP-patients. In both groups, higher age, daily smoking, and having had sinus surgery previously were associated with less generic HRQOL improvement, in addition to female sex and allergy in CRSsNP patients. CONCLUSION: The greater improvement in general health, vitality, and social function after surgery may indicate a greater potential for generic HRQOL improvement in CRSwNP patients compared to CRSsNP patients. Female sex and allergy was associated with less improvement of generic HRQOL in the CRSsNP group, but not in the CRSwNP group. LEVEL OF EVIDENCE: 2c outcome research.

Providing quality data in health care - almost perfect inter-rater agreement in the Norwegian tonsil surgery register.

BACKGROUND: The Norwegian Tonsil Surgery Register (NTSR) was launched in January 2017. The purpose of the register is to present data on tonsil surgery to facilitate improvements in patient care. Data used for evaluating the quality of medical care needs to be of high reliability. This study aims to assess the inter-rater reliability (IRR) of the variables reported to the register by medical professionals. METHODS: The study population consists of the first 137 tonsil surgery patients who were included in the NTSR at St. Olav's University Hospital in Trondheim. An experienced rater completed the register's paper form for all 137 patients based on their electronic medical records, blinded for the data already in the register. To assess the inter-rater reliability between the register and the external rater, we calculated observed agreement, Cohen's kappa and Gwet's AC1 coefficients with 95% confidence intervals. RESULTS: All tested variables in the NTSR have almost perfect reliability except for the variable for the cold steel technique, which had a substantial to almost perfect reliability. The inter-rater agreement was substantial to almost perfect for every variable, with substantial (kappa/AC1 > 0.61) to almost perfect (kappa/AC1 > 0.81) agreement for all the examined variables. CONCLUSION: This study shows that the reliability of the NTSR is high for all variables registered by the professionals at the hospital immediately after surgery.

Improvement in minimal cross-sectional area and nasal-cavity volume occurs in different areas after septoplasty and radiofrequency therapy of inferior turbinates.

PURPOSE: Septoplasty and radiofrequency therapy for inferior turbinate hypertrophy (RFIT) are common techniques used to improve nasal patency. Our aim was to compare nasal geometry and function using acoustic rhinometry and peak nasal inspiratory flow (PNIF) in three patients groups undergoing surgery for nasal obstruction, and to investigate if the improvement in minimal cross-sectional area (MCA) and nasal-cavity volume (NCV) occurred in different cavity areas in the groups. Finally, we evaluated the correlation between the objective measurements and the patients' assessment of nasal obstruction (SNO). METHODS: This prospective, observational study investigated 148 patients pre-operatively and 6 months post-operatively. Fifty patients underwent septoplasty (group 1), 51 underwent septoplasty combined with RFIT (group 2), and 47 underwent RFIT alone (group 3). The MCA and NCV were measured at two distances (MCA/NCV0-3.0 and MCA/NCV3-5.2), in addition to measuring PNIF and SNO. RESULTS: Pre-operatively, groups 1 and 2 had narrower MCA0-3.0 on one side than group 3 (0.31 ± 0.14 and 0.31 ± 0.14) versus (0.40 ± 0.16) cm2. Post-operatively, total MCA0-3.0 and MCA/NCV3-5.2 increased in group 1. In group 2, MCA/NCV0-3.0 at the narrow side and total MCA/NCV3-5.2 increased, while total MCA/NCV3-5.2 increased in group 3. PNIF improved from 106 ± 49 to 150 ± 57 l/min post-operatively. We found a correlation between increased MCA and NCV and less SNO in the septoplasty group (p < 0.01). CONCLUSION: Surgery produced an improvement in MCA and NCV in all groups. The improvement occurred in different areas of the nasal cavity in the patient groups. Both anterior and posterior areas increased in the septoplasty groups, while only the posterior area increased in the RFIT group. PNIF improved in all three patient groups, indicating that surgery produced an improvement in nasal patency.

Systematic review of tonsil surgery quality registers and introduction of the Nordic Tonsil Surgery Register Collaboration.

PURPOSE: Surgical quality registers provide tools to measure and improve the outcome of surgery. International register collaboration creates an opportunity to assess and critically evaluate national practices, and increases the size of available datasets. Even though millions of yearly tonsillectomies and tonsillotomies are performed worldwide, clinical practices are variable and inconsistency of evidence regarding the best clinical practice exists. The need for quality improvement actions is evident. We aimed to systematically investigate the existing tonsil surgery quality registers found in the literature, and to provide a thorough presentation of the planned Nordic Tonsil Surgery Register Collaboration. METHODS: A systematic literature search of MEDLINE and EMBASE databases (from January 1990 to December 2016) was conducted to identify registers, databases, quality improvement programs or comprehensive audit programs addressing tonsil surgery. RESULTS: We identified two active registers and three completed audit programs focusing on tonsil surgery quality registration. Recorded variables were fairly similar, but considerable variation in coverage, number of operations included and length of time period for inclusion was discovered. CONCLUSION: Considering tonsillectomies and tonsillotomies being among the most commonly performed surgical procedures in otorhinolaryngology, it is surprising that only two active registers could be identified. We present a Nordic Tonsil Surgery Register Collaboration-an international tonsil surgery quality register project aiming to provide accurate benchmarks and enhance the quality of tonsil surgery in Denmark, Finland, Norway and Sweden.

A comparison of symptoms and quality of life before and after nasal septoplasty and radiofrequency therapy of the inferior turbinate.

BACKGROUND: The primary goal of this study is to compare pre- and postoperative symptoms and health related quality of life (HQOL) in 57 patients who underwent septoplasty (group-1), 56 patients who underwent septoplasty combined with radiofrequency therapy of inferior turbinates (RFIT) (group-2) and 58 patients who underwent RFIT alone (group-3). The secondary goal is to investigate if the change in symptoms and HQOL differed between these three patient groups after surgery. METHODS: All patients reported symptoms on a visual analogue scale (VAS) and HQOL on Sino-Nasal-Outcome-Test-20 (SNOT-20) and Short-Form-Health-Survey-36 (SF-36) before and 6 months after surgery. The pre- and postoperative scores and improvement were compared within and between the three patient groups. RESULTS: Preoperatively the three patient groups had a fairly similar symptom burden and HQOL, except for group-1 which reported more symptoms of oral breathing than group-3 (p < 0.01) and group-3 which reported more problems in the ear/facial--subset of SNOT-20 and in the general-mental-health-domain of SF-36 than group-1 (p < 0.01).Postoperatively all patient groups reported improved symptom scores of nasal obstruction, nasal discharge, snoring, oral breathing and reduced general health (p < 0.01), and better HQOL (p < 0.05). Patients in group-2 had less symptoms of nasal obstruction than group-3 (p < 0.05). Postoperative symptom score for nasal obstruction was 29.1 (SD67.6) in group-1, 27.5 (SD22.5) in group-2 and 37.2 (SD24.8) in group-3. Revision cases reported more nasal obstruction postoperatively; 41.3 (SD27) than non revision cases; 28.6 (SD24) (p < 0.01).The HQOL after surgery was about the same in all three patient groups, but we found that patients with comorbidities as sleep apnea and asthma reported worse HQOL than other patients (p < 0.01). CONCLUSION: Surgical treatment of nasal obstruction led to less symptoms and better HQOL for all three patient groups. Comparing the postoperative scores between the patient groups we find that all groups reached the same level of HQOL. Regarding symptoms, the patients who underwent septoplasty combined with RFIT reported postoperatively less nasal obstruction than patients who underwent RFIT alone which may indicate that a combined procedure of septoplasty and RFIT is better than RFIT alone to treat nasal obstruction. Furthermore, revision cases, patients with sleep apnea and asthma patients seem to have poorer outcome after surgery than other patients. Both disease specific and general QOL instruments add valuable information for identifying factors influencing outcome.

Sinonasal Characteristics in Patients with Obstructive Sleep Apnea Compared to Healthy Controls.

Background. The difference in nasal obstruction between OSA patients and healthy individuals is not adequately documented. Our aim was to describe the sinonasal quality of life and nasal function in OSA patients and healthy controls using the sinonasal outcome test-20 (SNOT-20), nasal obstruction visual analog scale (NO-VAS), and peak nasal inspiratory flow (PNIF). Methodology and Principal. Ninety-three OSA patients and 92 controls were included in a case-control study from 2010 to 2015. Results. Mean SNOT-20 score in the OSA group was 1.69 (SD 0.84) compared to 0.55 (SD 0.69) in controls (p < 0.001, 95% CI [0.9, 1.4]). The mean NO-VAS score was 41.3 (SD 12.8) and 14.7 (SD 14.4) in the OSA group and controls, respectively, (p < 0.001, 95% CI [22.7, 30.6]). PNIF measured 105 litres/minute in the OSA group and 117 litres/minute in controls (p < 0.01, 95% CI [-21.8, -3.71]). There was a positive correlation between subjective nasal obstruction and change in PNIF after decongestion in the control group alone. Conclusions. OSA patients have a reduced sinonasal QoL and lower peak nasal inspiratory flow compared to controls. Treatment of nasal obstruction in OSA patients should be made a priority along with treatment of the ailment itself.

Paranasal sinus opacification in headache sufferers: A population-based imaging study (the HUNT study-MRI).

Background The association between headache and paranasal sinus disease is still unclear. Because of symptom overlap, the two conditions are not easily studied on the basis of symptoms alone. The aim of the present study was to investigate whether paranasal sinus opacification on magnetic resonance imaging (MRI) was associated with migraine, tension-type headache (TTH) or unclassified headache. Methods This was a cross-sectional study of 844 randomly selected participants (442 women, age range 50-65 years, mean age 57.7 years). Based on 14 headache questions, participants were allocated to four mutually exclusive groups: migraine, TTH, unclassified headache or headache free. On MRI, opacifications as mucosal thickening, polyps/retention cysts and fluid in the five paired sinuses were measured and recorded if ≥1 mm. For each participant, opacification thickness was summed for each sinus and, in addition, a total sum of all sinuses was calculated. Opacification in each sinus was compared between headache-free participants and the headache groups using non-parametric tests, and the total sum was compared by logistical regression. Results No significant association was found between paranasal sinus opacification and headache in general, nor when headache was differentiated into migraine, TTH and unclassified headache. This was also true in separate analyses of mucosal thickening and fluid and of opacification from each paranasal sinus. Conclusion Migraine, TTH and unclassified headache were found not to be associated with an increased degree of paranasal sinus opacification at MRI.

Quality of life and symptoms before and after nasal septoplasty compared with healthy individuals.

BACKGROUND: The goal of this study is to compare quality of life (Qol) and symptoms in 91 patients with a deviated nasal septum preoperatively and postoperatively with a control group of 93 healthy individuals. METHODS: All patients reported Qol on Sino-Nasal-Outcome-Test-20 (SNOT-20) and symptoms on visual analogue scale (VAS) preoperatively and 6 months after surgery and the results were compared with the controls. RESULTS: Mean SNOT-20 score improved from 1.8(SD0.9) preoperatively to 0.9(SD0.8) postoperatively (p < 0.000) but did not reach the same level as the controls 0.4(SD0.5). Septum surgery leads to a significant symptom improvement for all symptoms investigated (p < 0.000) on VAS. The patients reached the same level as the healthy controls in 6 of 11 symptoms (headache, facial pain, sneezing, trouble with rhinosinusitis, cough and snoring) but the patients group had significantly more trouble with nasal blockage (VAS 29 vs 9), change in sense of smell (VAS 12 vs5), nasal discharge (VAS 22 vs 11), oral breathing (VAS 23 vs 13) and reduced general health (VAS 12 vs 5) also postoperatively (p < 0.01). Sub analyses showed that allergic patients reported a VAS score of 36 (SD30) for nasal blockage and 17 (SD22) for facial pressure postoperatively versus 23(SD22) and 6(SD13) in non-allergic patients (p < 0.03 and p < 0.01). Patients with obstructive sleep apnea syndrome (OSAS) reported more trouble with snoring on VAS postoperatively than other patients, 42(SD28) versus 20(SD23) (p < 0.002). CONCLUSION: Septoplasty leads to a highly significant improvement in Qol and symptoms. The patients do not reach the same level of Qol as healthy controls. All symptoms are reported as mild on VAS postoperatively. Allergic patients tend to report more nasal blockage and facial pressure postoperatively than other patients and a focus on medical treatment should be kept also postoperatively. Patients with obstructive sleep apnea report more trouble with snoring postoperatively and alterative treatment options for snoring may be considered in these patients.

Paranasal sinus opacification at MRI in lower airway disease (the HUNT study-MRI).

The study builds on the concept of united airways, which describes the link between the upper and lower airways. Explorations of this concept have mainly related to asthma and less to chronic obstructive pulmonary disease (COPD). The aim of this study was to investigate paranasal sinus opacification at magnetic resonance imaging (MRI) in COPD, self-reported asthma and respiratory symptoms. In this cross-sectional study, 880 randomly selected participants in the Nord-Trøndelag health survey (HUNT) (mean age 57.7 years, range 50-66 years, 463 women) were investigated using MRI of the paranasal sinuses. Participants were allocated to four mutually exclusive groups: (1) COPD (n = 20), (2) asthma (n = 89), (3) respiratory symptoms (n = 199), and (4) reference group (n = 572). Paranasal sinus opacifications were categorised as mucosal thickening, polyps and retention cysts, and fluid. In each participant, measurements ≥1 mm from all sinuses were summed to give a total for each category of opacities. The sums for these three categories were further added together, and referred to as the total sum. Using the 75th percentile cut-off values, the likelihood of having paranasal sinus opacifications was more than six times higher in participants with COPD and twice as high in participants with asthma than among the reference group. Respiratory symptoms were only associated with mucosal thickening. The present study shows that paranasal sinus opacification is associated not only with asthma, but also with COPD and respiratory symptoms. This is in accordance with the united airways hypothesis, and should be kept in mind when handling patients with these conditions.

Pilot study of sphenopalatine injection of onabotulinumtoxinA for the treatment of intractable chronic cluster headache.

OBJECTIVE: The main object of this pilot study was to investigate the safety of administering onabotulinumtoxinA (BTA) towards the sphenopalatine ganglion (SPG) in intractable chronic cluster headache. Efficacy data were also collected to provide indication on whether future placebo-controlled studies should be performed. METHOD: In a prospective, open-label, uncontrolled study, we performed a single injection of 25 IU (n = 5) or 50 IU BTA (n = 5) towards the SPG in 10 patients with intractable chronic cluster headache with a follow-up of 24 weeks. The primary outcome was adverse events (AEs) and the main efficacy outcome was attack frequency in weeks 3 and 4 post-treatment. RESULTS: A total of 11 AEs were registered. There was one severe adverse event (SAE): posterior epistaxis. The number of cluster headache attacks (main efficacy outcome) was statistically significantly reduced in the intention-to-treat analysis from 18 ± 12 per week in baseline to 11 ± 14 (p = 0.038) in weeks 3 and 4, and five out of 10 patients had at least 50% reduction of attack frequency compared to baseline. The cluster attack frequency was significantly reduced for five out of six months post-treatment. CONCLUSION: Randomised, placebo-controlled studies are warranted to establish the potential of this possible novel treatment of cluster headache.

Can general practitioners do the follow-ups after surgery with ventilation tubes in the tympanic membrane? Two years audiological data.

BACKGROUND: A university hospital in Mid-Norway has modified their guidelines for follow-up after insertion of ventilation tubes (VTs) in the tympanic membrane, transferring the controls of the healthiest children to general practitioners (GPs). The aim of this study was to evaluate the implementation of these guidelines by exploring audiological outcome and subjective hearing complaints two years after surgery, assessing if follow-ups in general practice resulted in poorer outcome. METHODS: A retrospective observational study was performed at the university hospital and in general practice in Mid-Norway. Children below 18 years who underwent surgery with VTs between Nov 1st 2007 and Dec 31st 2008 (n = 136) were invited to participate. Pure tone audiometry, speech audiometry and tympanometry were measured. A self-report questionnaire assessed subjective hearing, ear complaints and the location of follow-ups. This study includes enough patients to observe group differences in mean threshold (0.5-1-2-4 kHz) of 9 dB or more. RESULTS: There were no preoperative differences in audiometry or tympanometry between the children scheduled for follow-ups by GPs (n = 23) or otolaryngologists (n = 50). Two years after surgery there were no differences between the GP and otolaryngologist groups in improvement of mean hearing thresholds (12.8 vs 12.6 dB, p = 0.9) or reduction of middle ears with effusion (78.0 vs 75.0%, p = 0.9). We found no differences between the groups in terms of parental reports of child hearing or ear complaints. CONCLUSIONS: Implementation of new clinical guidelines for follow-ups after insertion of VTs did not negatively affect audiological outcomes or subjective hearing complaints two years after surgery.

Incidental findings in MRI of the paranasal sinuses in adults: a population-based study (HUNT MRI).

BACKGROUND: Diagnostic imaging of the head is used with increasing frequency, and often includes the paranasal sinuses, where incidental opacifications are found. To determine the clinical relevance of such findings can be challenging, and for the patient such incidental findings can give rise to concern if they are over-reported. Studies of incidental findings in the paranasal sinuses have been conducted mostly in patients referred for diagnostic imaging, hence the prevalence in the general population is not known. The purpose of this study was to determine the prevalence and size of incidental opacification in the paranasal sinuses in a non-selected adult population using magnetic resonance imaging (MRI) without medical indication, and to relate the results to sex and season. METHODS: Randomly and independent of medical history, 982 participants (518 women) with a mean age of 58.5 years (range, 50-66) underwent MRI of the head as part of a large public health survey in Norway. The MRIs included 3D T1 weighted volume data and 2D axial T2 weighted image (WI). Opacifications, indicating mucosal thickenings, polyps, retention cysts, or fluid, were recorded if measuring more than 1 mm. RESULTS: Opacifications were found in 66% of the participants. Mucosal thickenings were found in 49%, commonly in the maxillary sinuses (29%) where 25% had opacifications that were less than 4 mm in size. Other opacifications occurred in the anterior ethmoid (23%), posterior ethmoid (21%), frontal sinus (9%), and sphenoid (8%). Polyps and retention cysts were also found mainly in the maxillary sinuses in 32%. Fluid was observed in 6% of the MRIs. Mucosal thickening was observed more frequently in men than in women (P <0.05). No seasonal variation was found. CONCLUSIONS: In this large non-selected sample, incidental opacification in the paranasal sinuses was seen in two out of three participants, and mucosal thickening was seen in one out of two. Fluid was rare. Knowledge of incidental opacification is important because it can affect clinical practice.

Nasal flow, volumes, and minimal cross sectional areas in asthmatics.

BACKGROUND: The Unified Airways hypothesis suggests an involvement of the upper airways in asthma. Critical parameters of the nasal airway can be quantified objectively with acoustic rhinometry (AR) and peak nasal inspiratory flow (PNIF). OBJECTIVE: We aimed to investigate nasal airway patency in asthmatics compared to non-asthmatic controls. Nasal volume, cross sectional area and flow were measured using acoustic rhinometry (AR) and peak nasal inspiratory flow (PNIF) in 87 asthmatics and 93 non-asthmatic controls before and after decongestion with xylometazoline. Nasal congestion index (NCI) was calculated, and allergy status was assessed by skin prick test or specific IgE. RESULTS: We found significantly smaller minimum cross sectional area and nasal cavity volume in asthmatics than controls, and the cross sectional area is at its minimum at 2-3 cm from the nasal orifice in both groups. AR and PNIF measurements are not different in allergic and non allergic subjects in either group. The effect of xylometazoline is not significantly different between the 2 groups with regard to AR, but there is a significant improvement in PNIF for the asthmatics when assessed by the NCI. CONCLUSION: The present study demonstrates a significantly smaller nasal airway when assessed by minimum cross sectional area and nasal cavity volume in asthmatics than controls, and these findings apply to asthmatics and controls irrespective of allergy status.