| 1. |
- van Hoof, M., et al.
(författare)
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Clinical Outcomes of Soft Tissue Preservation Surgery With Hydroxyapatite-Coated Abutments Compared to Traditional Percutaneous Bone Conduction Hearing Implant Surgery-A Pragmatic Multi-Center Randomized Controlled Trial
- 2020
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Ingår i: Frontiers in Surgery. - : Frontiers Media SA. - 2296-875X. ; 7
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Tidskriftsartikel (refereegranskat)abstract
- Background: Soft tissue preservation using a hydroxyapatite-coated abutment in bone conduction hearing implant surgery may lead to improved clinical outcomes over the short (1 year) and long term (3 years). Methods: In this open multi-center, randomized (1:1), controlled clinical trial, subjects with conductive, mixed hearing loss or single-sided sensorineural deafness were randomly assigned to receive the conventional intervention, a titanium abutment with soft tissue reduction surgery (control), or a new intervention, a hydroxyapatite-coated abutment with soft tissue preservation surgery (test). The primary efficacy outcome was the combined endpoint of numbness, pain, peri-abutment dermatitis, and soft tissue thickening/overgrowth after 1 and 3 years. Results: The Intention-to-treat (ITT) population consisted of 52 control subjects and 51 test subjects. The difference between the groups after 1 year of follow-up as measured by the primary efficacy outcome was not statistically significant (p = 0.12) in the ITT population (n = 103), but did reach statistical significance (p = 0.03) in the per-protocol (PP) population (n = 96). It showed an advantage for the test group, with over twice as many subjects (29%) without these medical events during the first year compared to the control group (13%). After 3 years, the difference between the two groups had declined and did not reach statistical significance (24 vs. 10%, ITT p = 0.45). Secondary outcome measures which showed a statistical significant difference during the first year, such as surgical time (15 vs. 25 minutes, p < 0.0001), numbness (90 vs. 69% of subjects experienced no numbness at 1 year, p < 0.01), neuropathic pain at 3 months (p = 0.0087) and the overall opinion of the esthetic outcome (observer POSAS scale at 3 months, p < 0.01) were favorable for the test group. More soft tissue thickening/overgrowth was observed at 3 weeks for the test group (p = 0.016). Similar results were achieved for the long term follow up. Conclusions: Soft tissue preservation with a hydroxyapatite-coated abutment leads to a reduction in the combined occurrence of complications over the first year which is not statistically significant in the ITT population but is in the PP population. This effect decreased for the long-term study follow up of 3 years and did also not reach statistical significance.
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| 2. |
- den Besten, C. A., et al.
(författare)
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Stability, Survival, and Tolerability of an Auditory Osseointegrated Implant for Bone Conduction Hearing: Long-Term Follow-Up of a Randomized Controlled Trial
- 2016
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Ingår i: Otology & Neurotology. - : Ovid Technologies (Wolters Kluwer Health). - 1531-7129. ; 37:8, s. 1077-1083
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Tidskriftsartikel (refereegranskat)abstract
- Objective: To compare implant stability, survival, and soft tissue reactions for a novel (test) and previous generation (control) percutaneous auditory osseointegrated implant for bone conduction hearing at long-term follow-up of 5 years. Study Design: Single follow-up visit of a previously completed multicenter, randomized, controlled trial. Patients: Fifty-seven of the 77 participants of a completed randomized controlled trial on a new auditory osseointegrated implant underwent a single follow-up visit 5 years after implantation, which comprised implant stability measurements and collection of Holgers scores. Additionally, implant survival was recorded for all 77 patients from the original trial. Results: The test implant showed significantly higher implant stability quotient (ISQ) values compared with the control implant throughout the 5-year follow-up. Mean area under the curve of ISQ high from baseline to 5 years was 71.6 (standard deviation [SD] +/-2.0) and 66.7 (SD +/-3.4) for the test and control implant, respectively (p < 0.0001). For both implants, the mean ISQ value recorded at 5 years was higher compared with implantation (test group +2.03 [SD +/-2.55, within group p < 0.0001] and control group +2.25 [SD +/-4.95, within group p = 0.12]). No difference was noticed in increase from baseline between groups (p = 0.64). Furthermore, evaluation of soft tissue reactions continued to show superiority of the test implant. At the 5-year follow-up visit, one patient (2.5%) presented with a Holgers grade 2 in the test group, compared with four patients (23.5%) in the control group (p = 0.048); no patient presented with more severe soft tissue reactions. Excluding explantations, the survival rate was 95.8% for the test group and 95.0% for the control group. The corresponding rates including explantations were 93.9 and 90.0%. Conclusion: The test implant showed superiority in terms of higher mean ISQ values and less adverse soft tissue reactions, both at the single 5-year follow-up visit and during the complete follow-up. In addition, both implants showed an equally high implant survival.
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| 4. |
- Ruohoalho, J., et al.
(författare)
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Systematic review of tonsil surgery quality registers and introduction of the Nordic Tonsil Surgery Register Collaboration
- 2018
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Ingår i: European Archives of Oto-Rhino-Laryngology. - : Springer Science and Business Media LLC. - 0937-4477 .- 1434-4726. ; 275:6, s. 1353-1363
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Forskningsöversikt (refereegranskat)abstract
- 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. 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. 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. 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.
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| 5. |
- Stalfors, Joacim, 1966, et al.
(författare)
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Comparison of clinical practice of tonsil surgery from quality register data from Sweden and Norway and one clinic in Denmark
- 2022
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Ingår i: Bmj Open. - : BMJ. - 2044-6055. ; 12:4
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Tidskriftsartikel (refereegranskat)abstract
- 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.
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| 6. |
- Stalfors, J., et al.
(författare)
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National assessment of validity of coding of acute mastoiditis: a standardised reassessment of 1966 records
- 2013
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Ingår i: Clinical Otolaryngology. - : Wiley. - 1749-4486 .- 1749-4478. ; 38:2, s. 130-135
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Tidskriftsartikel (refereegranskat)abstract
- Objectives To investigate the internal validity of the diagnosis code used at discharge after treatment of acute mastoiditis. Design Retrospective national re-evaluation study of patient records 19932007 and make comparison with the original ICD codes. Setting All ENT departments at university hospitals and one large county hospital department in Sweden. Participants A total of 1966 records were reviewed for patients with ICD codes for in-patient treatment of acute (529), chronic (44) and unspecified mastoiditis (21) and acute otitis media (1372). Main outcome measures ICD codes were reviewed by the authors with a defined protocol for the clinical diagnosis of acute mastoiditis. Those not satisfying the diagnosis were given an alternative diagnosis. Results Of 529 records with ICD coding for acute mastoiditis, 397 (75%) were found to meet the definition of acute mastoiditis used in this study, while 18% were not diagnosed as having any type of mastoiditis after review. Review of the in-patients treated for acute media otitis identified an additional 60 cases fulfilling the definition of acute mastoiditis. Overdiagnosis was common, and many patients with a diagnostic code indicating acute mastoiditis had been treated for external otitis or otorrhoea with transmyringeal drainage. Conclusions The internal validity of the diagnosis acute mastoiditis is dependent on the use of standardised, well-defined criteria. Reliability of diagnosis is fundamental for the comparison of results from different studies. Inadequate reliability in the diagnosis of acute mastoiditis also affects calculations of incidence rates and statistical power and may also affect the conclusions drawn from the results.
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