Validation of the Swedish Quality Register for Ear Surgery - SwedEar.

BACKGROUND: The Swedish Quality Register for Ear Surgery (SwedEar) is a national register monitoring surgical procedures and outcomes of ear surgery to facilitate quality improvement. The value of the register is dependent on the quality of its data. SwedEar has never been validated regarding data quality or missing entries. Therefor, the purpose of this study was to assess coverage, completeness and response rate in the register and validate the physicians' reported data accuracy. METHODS: In this validation study, the completeness, response rate and missing registrations were analysed. Data in SwedEar were compared with the yearly collected statistics of otosurgical procedures in The Swedish Otosurgical Society and the comparison of rates between groups was calculated with Fisher's exact test. Validation of registered data accuracy was performed on every 20th registered case during a five-year period. Data were reabstracted from medical records and compared with the original registration. Interrater agreement, reliability measures, Cohen's kappa, Gwet's AC1 and positive predictive value were calculated. RESULTS: SwedEar has a coverage of 100%. The completeness of registered cases was 84% and the response rate was 74%. The validation of data accuracy assessed 13 530 variables, including audiograms. Less than 3% of incorrect or missing variables were identified. For most of the pre- and postoperative variables the Kappa and Gwet´s AC1 results show an almost perfect agreement (> 0.80). For audiogram data the ICC shows an excellent reliability (> 0.9) for all but one value. CONCLUSION: This validation shows that SwedEar has excellent coverage, high completeness, and that the data in the register have almost perfect reliability. The data are suitable for both clinical and research purposes. Further efforts to improve completeness are warranted.

The impact of waiting time on hearing outcome and patients' satisfaction after cholesteatoma surgery.

BACKGROUND: Cholesteatoma is a formation of epithelium mass in the middle ear. Surgery aims to prevent complications while maintain or improve hearing. AIMS/OBJECTIVES: To determine if waiting time until cholesteatoma surgery affects hearing outcome and patients' satisfaction. MATERIAL AND METHODS: A retrospective cohort study performed at the only Ear Nose Throat clinic in one county in Sweden. Sixty concomitant surgeries, both first time and revisions, were included. RESULTS: Of the 60 surgeries, 33 (55%) were performed within a 3-month period. The mean waiting time was 1.4 months. In the remaining 27 cases, the mean waiting time was 8.6 months. Both groups had preoperatively similar air conduction pure tone average (AC PTA4), 47.3 dB and 47.0 dB respectively. The mean AC PTA4 gain was greater in the group with waiting time ≤3 months (8.6 dB) compared to the >3 months group (1.2 dB, p = 0.040). The patients' satisfaction was lower in the latter group, but the difference was not statistically significant. CONCLUSIONS: This study indicates that longer waiting time to cholesteatoma surgery has a negative impact on postoperative hearing results but not on patients' satisfaction. SIGNIFICANCE: The outcome of this study suggests that waiting time to surgery can be a factor determining postoperative hearing results.

Prophylactic antibiotics has no benefit for outcome in clean myringoplasty-A register-based cohort study from SwedEar.

OBJECTIVES: To investigate if prophylactic antibiotics (PA) in conjunction with myringoplasty of clean and uninfected ears entails a reduction of postoperative infections within 6 weeks after surgery, and whether it affects the healing rate of the tympanic membrane (TM) at follow-up, 6-24 months after surgery. DESIGN: A retrospective cohort study of prospectively collected data. SETTING: Data extracted from The Swedish Quality Register for Ear Surgery (SwedEar), the years 2013-2019. PARTICIPANTS: All patients in SwedEar with a registered clean conventional myringoplasty (tympanoplasty type I) including a follow-up visit. MAIN OUTCOME MEASURES: The effect of PA use on TM healing rate at follow-up and postoperative infection within 6 weeks of surgery. RESULTS: In the study group (n = 1665) 86.2% had a healed TM at follow-up. There was no significant difference between the groups that had PA administered (87.2%) or not (86.1%). A total of 8.0% had a postoperative infection within 6 weeks. Postoperative infection occurred in 10.2% of the group that received PA (n = 187) compared with 7.7% of the group that did not receive PA. However, this difference was not statistically significant. Postoperative infection within 6 weeks significantly lowered the frequency of healed TMs. CONCLUSION: PA administered during clean conventional myringoplasty does not improve the chance of having a healed TM at follow up, nor decrease the risk of having a postoperative infection within 6 weeks after surgery.

The Risk of Cholesteatoma in Individuals With First-degree Relatives Surgically Treated for the Disease.

Importance: Cholesteatoma in the middle ear is not regarded as a hereditary disease, but case reports of familial clustering exist in the literature, as well as observed familial cases in the clinical work. However, the knowledge regarding cholesteatoma as a hereditary disease is lacking in the literature. Objective: To assess the risk of cholesteatoma in individuals with a first-degree relative surgically treated for the same disease. Design, Setting, and Participants: In this nested case-control study in the Swedish population between 1987 and 2018 of first-time cholesteatoma surgery identified from the Swedish National Patient Register, 2 controls per case were randomly selected from the population register through incidence density sampling, and all first-degree relatives for cases and controls were identified. Data were received in April 2022, and analyses were conducted between April and September 2022. Exposure: Cholesteatoma surgery in a first-degree relative. Main Outcomes and Measures: The main outcome was first-time cholesteatoma surgery. The association between having a first-degree relative with cholesteatoma and the risk of cholesteatoma surgery in the index persons was estimated by odds ratios (ORs) and 95% CIs through conditional logistic regression analysis. Results: Between 1987 and 2018, 10 618 individuals with a first-time cholesteatoma surgery (mean [SD] age at surgery, 35.6 [21.5] years; 6302 [59.4%] men) were identified in the Swedish National Patient Register. The risk of having a cholesteatoma surgery was almost 4 times higher in individuals having a first-degree relative surgically treated for the disease (OR, 3.9; 95% CI, 3.1-4.8), but few cases were exposed overall. Among the 10 105 cases with at least 1 control included in the main analysis, 227 (2.2%) had at least 1 first-degree relative treated for cholesteatoma, while the corresponding numbers for controls were 118 of 19 553 control patients (0.6%). The association was stronger for individuals under the age of 20 years at first surgery (OR, 5.2; 95% CI, 3.6-7.6) and for a surgery involving the atticus and/or mastoid region (OR, 4.8; 95% CI, 3.4-6.2). There was no difference in the prevalence of having a partner with cholesteatoma between cases and controls (10 cases [0.3%] and 16 controls [0.3%]; OR, 0.92; 95% CI, 0.41-2.05), which implies that increased awareness does not explain the association. Conclusions and Relevance: In this Swedish case-control study using nationwide register data with high coverage and completeness, the findings suggest that the risk of cholesteatoma in the middle ear is strongly associated with a family history of the condition. Family history was nevertheless quite rare and can therefore only explain a limited number of all cases; these families could be an important source for information regarding the genetic background for cholesteatoma disease.

Prevalence of severe-to-Profound hearing loss in the adult Swedish population and comparison with cochlear implantation rate.

BACKGROUND: The prevalence of disabling hearing loss is increasing worldwide. However, previous studies on hearing loss prevalence have enrolled small populations or only provided estimates. AIM: To establish the prevalence of severe-to-profound hearing loss (STPHL) in the adult Swedish population and compare it with the cochlear implantation rate in Sweden. MATERIAL AND METHODS: We established a database containing over 15 million audiograms obtained from regions covering > 99% of the Swedish population by extracting audiogram data from the computer software application, Auditbase. We used this database to calculate the percentage of adult patients with bilateral hearing levels ≥ 70 dB. We collected data regarding cochlear implantations in Sweden from the National Board of Welfare and Health. RESULTS: The prevalence of STPHL in the adult Swedish population was 0.28%. There were regional variations in the prevalence and rate of cochlear implantation; however, there was no association between both parameters. CONCLUSIONS: This study presents an updated and reliable prevalence figure for STPHL in Sweden. SIGNIFICANCE: Patients with STPHL have extensive rehabilitation requirements; accordingly, it is important to determine the accurate prevalence of STPHL to inform the allocation of adequate resources.

Hearing outcome after myringoplasty in Sweden: A nationwide registry-based cohort study.

OBJECTIVES: To present hearing results after successful primary myringoplasty surgeries registered in the Swedish Quality Registry for Myringoplasty and to evaluate the chance of hearing improvement and the risk of hearing loss. DESIGN: A retrospective nationwide cohort study based on prospectively collected registry data between 2002 and 2012. SETTINGS: Registry data from secondary and tertiary hospitals performing myringoplasty. PARTICIPANTS: Patients with healed tympanic membrane after primary myringoplasty surgery performed from 2002 to 2012 in Sweden. MAIN OUTCOME MEASURES: Postoperative hearing results, hearing gain and air-bone gap (ABG). RESULTS: In 2226 myringoplasties, air conduction audiograms were recorded, and the average preoperative pure tone average (PTA4 ) of the group was 28.5 dB, which improved postoperatively to 19.6 dB with an average of 8.8 dB improvement. Bone conduction was measured for 1476 procedures. Closure of the ABG to 10 dB or less was achieved in 51% of the ears and to less than 20 dB in 89% of the ears. Sixty-one percent of patients with preoperatively deteriorated hearing experienced improved hearing, but 3% of all patients experienced deteriorated hearing. After the surgery, 93% of the patients were satisfied. CONCLUSIONS: Hearing results after successful myringoplasty surgery are often favourable, but although the tympanic membrane is healed, hearing improvement is not guaranteed, and hearing deterioration can also occur.

The status of Eustachian tube balloon dilations in Nordic countries.

There is no unanimous consensus for indications of eustachian tube balloon dilation (ETBD). Nordic countries have relatively similar hospital organizations and treatment guidelines. Therefore, it was logical to organize a consensus meeting of ETBD. The symposium: Nordic Experiences on Eustachian Tube Balloon Dilation, in Copenhagen, 30-31 March, 2017. The panellists from Denmark, Finland, Norway and Sweden and the attendees of the meeting agreed a consensus on the following issues: Candidates, Definition of Eustachian Tube Dysfunction, Diagnostic Work up, Differential Diagnosis, Contraindications, ETBD Procedure, Complications, Follow-up, and Outcomes. The article also presents the status for ETBD in each of these countries. Thereafter the consensus statement has been discussed in the national societies and meetings for ear surgeons in each of these countries. It can be assumed that surgeons in the hospitals of these Nordic countries generally follow the recommendations from the consensus meeting.

Tinnitus and taste disturbances reported after myringoplasty: Data from a national quality registry.

OBJECTIVES/HYPOTHESIS: Postoperative tinnitus and taste disturbances after myringoplasty are more common than previously reported. STUDY DESIGN: This study was a retrospective analysis of prospectively collected data from the Swedish National Quality Registry for Myringoplasty. METHODS: The analysis was performed on extracted data from all counties in Sweden collected from database A from 2002 to 2012 and database B from 2013 to 2016. Tinnitus and taste disturbance complications 1 year after myringoplasty were analyzed in relation to gender, age, procedure, and success rate. In database A, physicians reported tinnitus and taste disturbances. In database B, patients reported the complications. RESULTS: A major difference was found when the complications were reported by physicians compared to when the complications were reported by patients. In database A, tinnitus was reported in 1.2% of the patients and taste disturbances in 0.5%. In database B, the frequencies were 12.3% and 11.2%, respectively. Tinnitus and taste disturbances were more frequent after conventional myringoplasty compared to those after fat grafting and were more frequent after primary compared to those after revision surgery when reported by physicians. Patients, however, reported the same frequency of tinnitus after fat graft myringoplasty compared to that after conventional myringoplasty (12.0% vs. 12.6%) and fewer taste disturbances after revision surgery. In follow-up assessments, complications persisted after surgery over a long time period. CONCLUSION: Tinnitus and taste disturbances are more common after myringoplasty when patients report their symptoms than when physicians report the symptoms. LEVEL OF EVIDENCE: 2b Laryngoscope, 129:209-215, 2019.

Myringoplasty Outcomes From the Swedish National Quality Registry.

OBJECTIVES/HYPOTHESIS: Data from patients registered for myringoplasty during 2002 to 2012 in the Swedish National Quality Registry for Myringoplasty. STUDY DESIGN: Both conventional myringoplasty and fat-graft techniques were used aimed at healing the tympanic membrane in noninfected ears. METHODS: Analysis was performed on data in a national database collected from 32 ear, nose, and throat clinics. Surgical procedures and outcomes, and patient satisfaction from a questionnaire were studied. RESULTS: The database was comprised of 3,775 surgical procedures, with follow-up available for analysis. One-third were children under the age of 15 years. The most common indication for surgery was infection prophylaxis. The overall healing rate of the tympanic membrane after surgery was 88.5%, with a high mean patient satisfaction. Complications registered were postoperative infection, tinnitus, or taste disturbance that occurred in 5.8% of patients. CONCLUSIONS: Swedish results for a large number of patients who completed myringoplasty are presented. The success rate in this study is comparable to other studies, and good patient-reported outcome measures of myringoplasty are presented. Databases for surgical procedures and clinical audits are systematic processes for continuous learning in healthcare. This study shows that clinical databases can be utilized to analyze national results of surgical procedures. LEVEL OF EVIDENCE: 2b Laryngoscope, 127:2389-2395, 2017.

Assessment of antibacterial properties of polyvinylamine (PVAm) with different charge densities and hydrophobic modifications.

Hydrophobically modified and unmodified polyvinylamines (PVAm), including a total of five polymers, were tested against both gram-negative ( Escherichia coli ) and gram-positive ( Bacillus subtilis ) bacteria for antimicrobial activity. The assessment of PVAm in solution against bacteria is described, and the influence of the charge density and of the hydrophobic modification of the polyelectrolyte is discussed. The antimicrobial activity was found to depend upon the concentration of PVAm and also on the type of bacteria used. The results also indicated that no direct relationship exists between antimicrobial activity and charge density of the different PVAms. It was, however, observed that an alkyl chain length of six or eight alkane units had a substantial effect on the bacteria investigated. The best combined antibacterial activity for the two bacteria tested was achieved for PVAm with a C(6) alkane substituent (PVAm C(6)). To evaluate the antimicrobial activity on a solid substrate, PVAm C(6) was further studied after being deposited onto a glass slide and the results show a large reduction in bacterial infection.

Beta-lactamase-producing nontypeable Haemophilus influenzae fails to protect Streptococcus pneumoniae from amoxicillin during experimental acute otitis media.

Acute otitis media (AOM) is the most common reason for outpatient antimicrobial therapy. Mixed infections pose a potential problem, since the first-line drug used for the treatment of AOM, amoxicillin, can be neutralized by beta-lactamase-producing pathogens of the upper respiratory tract. To study the effects of a 5-day course of amoxicillin on a mixed middle ear infection, rats were challenged with Streptococcus pneumoniae alone or in combination with beta-lactamase-producing nontypeable Haemophilus influenzae. Amoxicillin was introduced at the clinical peak of the infection. Local and systemic changes were monitored by otomicroscopy, bacterial culture, and analysis of histological changes and the expression of the transforming growth factor beta (TGF-beta) gene. beta-Lactamase-producing H. influenzae did not demonstrate an ability to protect S. pneumoniae. Amoxicillin eradicated the pneumococci in all treated animals but increased to some degree the ability of H. influenzae to persist at the site of infection. Thus, only an insignificant acceleration of the resolution of the AOM caused by a mixture of pathogens was observed during treatment. Moderate to major morphological changes could not be avoided by treatment of the mixed infections, but a slight downregulation of TGF-beta expression was observed. In contrast to infections caused by a single pathogen, the mixed infections induced white plaques in the tympanic membrane at a remarkably high frequency independent of treatment. These experimental findings constitute support for further studies of antimicrobial drugs and AOM caused by bacteria with and without mechanisms of antibiotic resistance.

The treatment of Haemophilus influenzae acute otitis media with amoxicillin protects against reinfection but not against structural changes.

Acute otitis media (AOM) is the most common reason for outpatient antimicrobial therapy today. With increasing problems with antibiotic resistance, a more restrictive use of antibiotics has been advocated for both single and recurrent episodes. The arguments advanced have been immunological as well as ecological. To study the effects of a 5 day course of amoxicillin on recurrent AOM caused by non-typeable Haemophilus influenzae, Sprague-Dawley rats were used. Amoxicillin was introduced at the clinical peak of the first infection. One month later the animals were rechallenged. Local and systemic changes were monitored by otomicroscopy, bacterial cultures, and analyses of systemic IgG responses and histological changes. Antibiotic treatment accelerated the resolution of the primary infection. After resolution, only minor morphological changes were observed. The protective rate at rechallenge was 100% in the treatment group, compared with 80% in the untreated control group. Although the production of serum IgG antibodies was initially slightly impeded by the treatment, it was significantly higher in treated animals after rechallenge. Major structural changes could not be avoided at the second infection, however, and a significantly higher frequency of myringosclerosis was observed in treated animals. These experimental findings constitute support for further studies of antimicrobial drugs and recurrent AOM.