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Nafisa Ali,1 Mette S Sørensen,2 Torben L Sørensen,1,3 Panteleimon Mortzos1 1Department of Ophthalmology, Copenhagen University Hospital Roskilde, Roskilde, 2Research Unit for Women’s and Children’s Health, National University Hospital, 3Faculty of Health Sciences, University of Copenhagen, Copenhagen, Denmark Purpose: Assessing health-related quality of life in patients with strabismus is important in evaluating the clinical benefits of strabismus treatment. The purpose of this study was to translate the Adult Strabismus Quality of Life Questionnaire (AS-20) into Danish and evaluate its reliability and validity in adult patients with strabismus in Denmark.Methods: The AS-20 was translated into Danish in accordance with standard international adopted methods. We presented the questionnaire to 64 adults with strabismus and to 13 nonstrabismic adult controls. We tested the reliability of the Danish version by reassuring test–retest reliability, estimated the internal consistency, and analyzed the validity (discriminatory power) of the questionnaire by comparing patient scores with scores from control individuals.Results: The Danish AS-20 produced high level of internal consistency (Cronbach’s α values) for both subscales (psychosocial: 0.95 and functional: 0.85). We found good discriminatory power of the AS-20. The patients scored significantly lower not only on AS-20 composite score (median =63, interquartile range [IQR] =44–79) compared to healthy individuals (median =98, IQR =93–100) (P

Small peptides that perturb intracellular signalling pathways are useful tools in the identification and validation of new drug targets. To facilitate the analysis of biologically active peptides, we have developed retroviral vectors expressing an intracellular scaffold protein that significantly enhances the stability of small peptides in mammalian cells. This approach was chosen because retroviral transduction results in efficient and controlled delivery of the gene encoding the effector peptide, while the scaffold protein not only stabilises the peptide but also facilitates the analysis and potential isolation of the target protein. Here, we have adapted a p53-responsive reporter assay to flow cytometry to demonstrate the versatility of this approach by using peptides with known Mdm2-binding activities inserted into a stable scaffold protein that is suitable for intracellular expression in multiple compartments of mammalian cells. This strategy should be generally applicable to the study of small biologically active peptides in diverse functional assays. [ABSTRACT FROM AUTHOR]

Background: Preventing lower-extremity amputations (LEAs) is pivotal. In the present study, we aimed to examine the recent trends in nontraumatic LEAs seen in the Northern Danish Region., Methods: Using data from the regional Business Intelligence unit, we identified all nontraumatic LEAs (n = 689) performed in people above 50 years of age in the Northern Danish Region between January 2016 and December 2021 (approximately 600,000 inhabitants). Persons with diabetes (n = 26,025) were identified based on International Classification of Diseases-10 codes and data from the National Health Insurance Service Registry, while preventive vascular procedures (n = 1,097) were identified using surgical codes. Major LEA was defined as any amputation above the ankle. Incidence rates were expressed as events per 1,000 person-years. Trends were described as differences between the periods 2016-2018 and 2019-2021., Results: A total of 249 (36%) major LEAs were performed in people with diabetes. People with diabetes were younger (71 vs 77 years, P < 0.001) and more frequently male (70% versus 54%, P < 0.001). Between 2016-2018 and 2019-2021, the incidence of major LEA declined from 1.76 (95% CI: 1.75-1.76) to 1.39 (1.39-1.39) in people with diabetes and from 0.47 (0.47-0.47) to 0.20 (0.20-0.20) in people without diabetes (all P < 0.001). Simultaneously, the incidence of preventive vascular surgery increased from 2.26 (2.26-2.26) to 3.48 (3.48-3.48) in people with diabetes and declined slightly in people without 0.49 (0.49-0.49) to 0.47 (0.47-0.47) (all P < 0.001)., Conclusions: Despite significant declines in major LEA in both people with and without diabetes, most of the decline was driven by a large reduction in major LEAs in people without diabetes., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Denosumab is a monoclonal anti-RANKL antibody that inhibits bone resorption, increases bone mass, and reduces fracture risk. Denosumab discontinuation causes an extensive wave of rebound resorption, but the cellular mechanisms remain poorly characterized. We utilized in situ hybridization (ISH) as a direct approach to identify the cells that activate osteoclastogenesis through the RANKL/OPG pathway. ISH was performed across species, skeletal sites, and following recombinant OPG (OPG:Fc) and parathyroid hormone 1-34 (PTH) treatment of mice. OPG:Fc treatment in mice induced an increased expression of RANKL mRNA mainly in trabecular, but not endocortical bone surface cells. Additionally, a decreased expression of OPG mRNA was detected in bone surface cells and osteocytes of both compartments. A similar but more pronounced effect on RANKL and OPG expression was seen one hour after PTH treatment. These findings suggest that bone surface cells and osteocytes conjointly regulate the activation of osteoclastogenesis, and that OPG:Fc treatment induces a local accumulation of osteoclastogenic activation sites, ready to recruit and activate osteoclasts upon treatment discontinuation. Analysis of publicly available single-cell RNA sequencing (scRNAseq) data from murine bone marrow stromal cells revealed that Tnfsf11 + cells expressed high levels of Mmp13, Limch1, and Wif1, confirming their osteoprogenitor status. ISH confirmed co-expression of Mmp13 and Tnfsf11 in bone surface cells of both vehicle- and OPG:Fc-treated mice. Under physiological conditions of human/mouse bone, RANKL is expressed mainly by osteoprogenitors proximate to the osteoclasts, while OPG is expressed mainly by osteocytes and bone-forming osteoblasts., (© 2024. The Author(s).)

Objective: Assessment is key in modern surgical education to monitor progress and document sufficient skills. Virtual reality (VR) temporal bone simulators allow automated tracking of basic metrics such as time, volume removed, and collisions. However, adequate performance assessment further includes compound rating of the stepwise bony excavation, and exposure and preservation of soft tissue structures. Such complex assessment requires further development of automated assessment routines in the VR simulation environment. In this study, we present the integration of automated mastoidectomy final-product assessment with validation against manual rating., Methods: At two international temporal bone courses, 33 ORL trainees performed anatomical mastoidectomies in the Visible Ear (VR) Simulator with automatic performance assessment using a newly implemented rating routine based on the modified Welling Scale. Automated assessment was compared with manual ratings by experts using absolute agreement, intraclass correlation, and generalizability analysis to establish validity and reliability., Results: The overall average agreement between manual and automatic assessment was 83.9% compared with the inter-rater agreement of 88.9%. A majority of items (15 out of 26) showed high agreement between automated and manual rating (>85%). Intraclass correlation coefficients were found to be high. Generalizability analysis with D-studies found that five repetitions per participant are needed for a G coefficient >0.8, which is considered necessary for high-stakes assessments., Conclusion: We have demonstrated the feasibility, validity, and reliability of an automatic assessment system integrated into a VR temporal bone simulator. This can prove to be an important tool for future self-directed training with skills certification., Competing Interests: The authors disclose no conflicts of interest., (Copyright © 2024, Otology & Neurotology, Inc.)

Purpose: To investigate the impact of 3D-printed temporal bone models with two different material transparencies on trainees' mastoidectomy performance., Methods: Eleven ORL residents performed two anatomical mastoidectomies with posterior tympanotomy on two 3D-printed models with different transparency and VR simulation training. Participants where divided into two groups based on their experience. Within each group participants were randomized to start with the model printed in a completely opaque material or in a material featuring some degree of transparency. After drilling on 3D-printed models, the participants performed two similar mastoidectomies on human cadavers: one on the left side of one cadaver and one on the right side of another cadaver. After drilling 3D-printed models and cadavers, the final-product performances were evaluated by two experienced raters using the 26-item modified Welling Scale. Participants also evaluated the models using a questionnaire., Results: Overall, the participants performed 25 % better on the 3D-printed models featuring transparency compared to the opaque models (18.6 points vs 14.9 points, mean difference = 3.7, 95 % CI 2.0-5.3, P < 0.001)). This difference in performance was independent of which material the participants had drilled first. In addition, the residents also subjectively rated the transparent model to be closer to cadaver dissection. The experienced group starting with the 3D-printed models scored 21.5 points (95 % CI 20.0-23.1), while the group starting with VR simulation training score 18.4 points (95 % CI 16.6-20.3)., Conclusion: We propose that material used for 3D-printing temporal bone models should feature some degree of transparency, like natural bone, for trainees to learn and exploit key visual cues during drilling., Competing Interests: Declaration of competing interest None., (Copyright © 2024. Published by Elsevier B.V.)

Background and Purpose: Dislocation is a severe complication following total hip arthroplasty (THA). Hip precautions have been recommended in the initial postoperative period but evidence supporting this practice is limited. We therefore conducted a population-based study to evaluate the association between discontinuing recommending postoperative hip precautions and the risk of early dislocation., Methods: This is a cohort study with data from the Danish Hip Arthroplasty Register and the Danish National Patient Register. We included patients who underwent primary THA for osteoarthritis in 2004-2019 in public hospitals in the Capital Region of Denmark. The cohort was divided into the hip precautions group, comprising patients operated on between 2004 and 2009, and the no-precautions group operated on between 2014 and 2019. The primary outcome was the difference in the absolute risk of dislocation within 3 months post-surgery. The secondary outcome assessed the same risk within 2 years. We evaluated the difference in absolute risk using absolute risk regression (ARR)., Results: The cumulative incidence of dislocation within 3 months was 2.9% (confidence interval [CI] 2.5-3.3) in the hip precautions group and 3.5% (CI 3.1-3.9) in the no-precautions group. The risk of dislocation was higher in the no-precautions group but failed to reach statistical significance in the crude (ARR 1.2, CI 0.9-1.6) and multivariate model (ARR 1.4, CI 0.9-2.2)., Conclusion: We found a higher but statistically insignificant increase in the risk of early dislocation in the no-precautions group. The lack of significance in the association may be explained by the increased use of 36-mm femoral heads after the guideline revision.

Pseudomonas aeruginosa, a Gram-negative bacterium known to induce severe infections, is seldomly reported in scientific literature as a contributor of osteomyelitis. In this case report, a 71-year-old woman exhibited recurring infections and enduring forearm pain. A subsequent MRI revealed osteomyelitis in the distal ulna, linked to an arterial blood gas sample taken months earlier. Despite undergoing multiple extended courses of antibiotic treatment, the patient eventually underwent surgery on her left forearm. Biopsy cultures conclusively confirmed the presence of P. aeruginosa., (Published under Open Access CC-BY-NC-BD 4.0. https://creativecommons.org/licenses/by-nc-nd/4.0/.)

Introduction: The decision to treat metastatic bone disease (MBD) surgically depends in part on patient life expectancy. We are unaware of an international analysis of how life expectancy among these patients has changed over time. Therefore, we asked (1) how has the life expectancy for patients treated for MBD changed over time, and (2) which, if any, of the common primary cancer types are associated with longer survival after treatment of MBD?, Methods: We reviewed data collected from 2000 to 2022 in an international MBD database, as well as data used for survival model validation. We included 3,353 adults who underwent surgery and/or radiation. No patients were excluded. Patients were grouped by treatment date into period 1 (2000 to 2009), period 2 (2010 to 2019), and period 3 (2020 to 2022). Cumulative survival was portrayed using Kaplan-Meier curves; log-rank tests were used to determine significance at P < 0.05. Subgroup analyses by primary cancer diagnosis were performed., Results: Median survival in period 2 was longer than in period 1 ( P < 0.001). Median survival (at which point 50% of patients survived) had not been reached for period 3. Median survival was longer in period 2 for all cancer types ( P < 0.001) except thyroid. Only lung cancer reached median survival in period 3, which was longer compared with periods 1 and 2 ( P < 0.001). Slow-growth, moderate-growth, and rapid-growth tumors all demonstrated longer median survival from period 1 to period 2; only rapid-growth tumors reached median survival for period 3, which was longer compared with periods 1 and 2 ( P < 0.001)., Discussion: Median duration of survival after treatment of MBD has increased, which was a consistent finding in nearly all cancer types. Longer survival is likely attributable to improvements in both medical and surgical treatments. As life expectancy for patients with MBD increases, surgical methods should be selected with this in mind., Level of Evidence: VI., (Copyright © 2024 by the American Academy of Orthopaedic Surgeons.)

Background: Several factors might be associated with risk of dislocating following uncemented hemiarthroplasty (HA) due to femoral neck fracture (FNF). Current evidence is limited with great variance in reported incidence of dislocation (1-15%). Aim of this study was to identify the cumulative incidence of first-time dislocation following HA and to identify the associated risk factors., Method: We performed a retrospective cohort study of patients receiving an HA (BFX Biomet stem, posterior approach) at Copenhagen University Hospital, Bispebjerg, in 2010-2016. Patients were followed until death or end of study (dec 2018). Dislocation was identified by code extraction from the Danish National Patient Registry. Variables included in the multivariate model were defined pre-analysis to include: age, sex and variables with a p-value < 0.1 in univariate analysis. A regression model was fitted for 90 days dislocation as the assumption of proportional hazard rate (HR) was not met here after., Results: We identified 772 stems (some patients occurred with both right and left hip) and 58 stems suffered 90 dislocations during the observation period, resulting in a 7% (CI 5-9) incidence of dislocation 90 days after index surgery. 55 of the 58 stems (95%) experienced the first dislocation within 90 days after surgery. Only absence of dementia was identified as an independent protective factor in the cause-specific model (HR 0.46 (CI 0.23-0.89)) resulting in a 2.4-fold cumulative risk of experiencing a dislocation in case of dementia. Several other variables such as age, sex, various medical conditions, surgery delay and surgical experience were eliminated as statistical risk factors. We found a decrease in survival probability for patients who experienced a dislocation during follow-up., Conclusions: The incidence of first-time dislocation of HA (BFX Biomet stem, posterior approach) in patients with a hip fracture is found to be 7% 90 days after surgery. Due to the non-existing attribution bias, we claim it to be the true incidence. Dementia was among several variables identified as the only risk factor for dislocation. In perspective, we may consider treating patients with dementia by other methods than HA e.g., HA with cement or with a more constrained solution. Also, a surgical approach that reduce the risk of dislocation should be considered., (© 2024. The Author(s).)

Aims: We first sought to compare survival for patients treated surgically for solitary and multiple metastases in the appendicular skeleton, and second, to explore the role of complete and incomplete resection (R0 and R1/R2) in patients with a solitary bony metastasis in the appendicular skeleton., Methods: We conducted a retrospective study on a population-based cohort of all adult patients treated surgically for bony metastases of the appendicular skeleton between January 2014 and December 2019. We excluded patients in whom the status of bone metastases and resection margin was unknown. Patients were followed until the end of the study or to their death. We had no loss to follow-up. We used Kaplan-Meier analysis (with log-rank test) to evaluate patient survival. We identified 506 operations in 459 patients. A total of 120 operations (in 116 patients) were for solitary metastases and 386 (in 345 patients) for multiple metastases. Of the 120 operations, 70 (in 69 patients) had no/an unknown status of visceral metastases (solitary group) and 50 (in 49 patients) had visceral metastases. In the solitary group, 45 operations (in 44 patients) were R0 (resections for cure or complete remission) and 25 (in 25 patients) were R1/R2 (resections leaving microscopic or macroscopic tumour, respectively). The most common types of cancer in the solitary group were kidney (n = 27), lung (n = 25), and breast (n = 20)., Results: The one-year patient survival was 47% (95% confidence interval (CI) 38 to 57) for the solitary bony metastases and 34% (95% CI 29 to 39) for multiple bone metastases (p < 0.001). The one-year patient survival was 64% (95% CI 52 to 75) for solitary bony metastases without/with unknown visceral metastases and 23% (95% CI 11 to 36) for solitary bony metastases with visceral metastases (p < 0.001). The one-year patient survival was 75% (95% CI 62 to 89) for a solitary bony metastasis after R0 surgery and 42% (95% CI 22 to 61) for a solitary bony metastasis with R1/R2 surgery (p < 0.001)., Conclusion: Our study suggests that the surgical treatment of patients with a solitary bony metastasis to the appendicular skeleton results in better survival than for patients with multiple bony metastases. Furthermore, aggressive treatment of a solitary bony metastasis with R0 surgery may improve patient survival., Competing Interests: The authors declare no conflict of interest. The funders had no role in the design of the study, collection of data, analyses, interpretation of data, writing of the manuscript or in decision to publishing results. M. M. Petersen reports institutional research grants from Zimmer Biomet, and travel support from Cancers, unrelated to this article. M. M. Petersen is also President of the Danish Orthopaedic Society, Topic Editor for Cancers, and Editorial Board member of the Orthopedics Section in The Scientific World Journal., (© 2023 The British Editorial Society of Bone & Joint Surgery.)

Background and Purpose: Surgery for bone metastases in the appendicular skeleton (aBM) is a trade-off between limb function and survival. A previous study from a highly specialized center found that extended surgery is not a risk for 30-day mortality and hypothesized that wide resection and reconstruction might reduce postoperative mortality. The study aimed to investigate whether parameters describing the surgical trauma (blood loss, duration of surgery, and degree of bone resection) pose a risk for 30-day mortality in patients treated with endoprostheses (EPR) or internal fixation (IF) in a population-based cohort., Patients and Methods: A population-based cohort having EPR/IF for aBM in the Capital Region of Denmark 2014-2019 was retrospectively assessed. Intraoperative variables and patient demographics were evaluated for association with 30-day mortality by logistic regression analysis. Kaplan-Meier estimate was used to evaluate survival with no loss to follow-up., Results: 437 patients had aBM surgery with EPR/IF. No parameters describing the magnitude of the surgical trauma (blood loss/duration of surgery/degree of bone resection) were associated with mortality. Overall 30-day survival was 85% (95% confidence interval [CI] 81-88). Univariate analysis identified ASA group 3+4, Karnofsky score < 70, fast-growth primary cancer, and visceral and multiple bone metastases as risk factors for 30-day mortality. Male sex (OR 2.8, CI 1.3-6.3), Karnofsky score < 70 (OR 4.2, CI 2.1-8.6), and multiple bone metastases (OR 3.4, CI 1.2-9.9) were independent prognostic factors for 30-day-mortality in multivariate analysis., Conclusion: The parameters describing the surgical trauma were not associated with 30-day mortality but, instead, general health status and extent of primary cancer influenced survival post-surgery.

Purpose: The aim of this study was to evaluate work ability, activity limitations and physical activity in adults that had gone through major bone sarcoma resection and reconstruction surgery in hip and knee., Materials and Methods: Twenty patients, of 72 enrolled, and 20 controls were included in this cross-sectional study. Work Ability Index scores (general [0-10 points], physical and mental [1-5 points]), the Patient Specific Functional Scale (0-10 points), step counts and the International Physical Activity Questionnaire (IPAQ) were assessed. Adjusted and unadjusted general linear models were applied., Results: The patients had a mean age of 43 (range, 20-71) years and were assessed 7 years (range, 2-12) after surgery (proximal femoral n  = 9, distal femoral n  = 7, proximal tibia n  = 4). Compared with controls, patients had lower general work ability (mean difference [95%CI], -1.3 points [-2.1, -0.5]) and work ability in relation to physical demands at work (-1.4 points [-2.0, -0.8]). The patients reported higher severities of activity limitation (-6.7 points [-7.9, -5.4]). There were no between-group differences in step counts or IPAQ-scores., Conclusion: Despite similar levels of physical activity, patients showed poorer work ability and severe activity limitation. Post-operative rehabilitation in patients of the working-age population should include assessments of work ability and activities important to the individual.IMPLICATIONS FOR REHABILITATIONAdults that have gone through resection and reconstruction surgery following bone sarcoma in lower extremity show clinically relevant reductions in work ability and self-selected activitiesTo tailor post-operative rehabilitation at short and long term, initial assessment and monitoring should include work ability and activities important to the individual patient.

Objective: 3-D printing offers convenient and low-cost mastoidectomy training; nonetheless, training benefits using 3-D-printed temporal bones remain largely unexplored. In this study, we have collected validity evidence for a low-cost, 3-D-printed temporal bone for mastoidectomy training and established a credible pass/fail score for performance on the model., Study Design: A prospective educational study gathering validity evidence using Messick's validity framework., Setting: Seven Danish otorhinolaryngology training institutions., Participants: Eighteen otorhinolaryngology residents (novices) and 11 experienced otosurgeons (experts)., Intervention: Residents and experienced otosurgeons each performed two to three anatomical mastoidectomies on a low-cost, 3-D-printed temporal bone model produced in-house. After drilling, mastoidectomy performances were rated by three blinded experts using a 25-item modified Welling scale (WS)., Main Outcome Measure: Validity evidence using Messick's framework including reliability assessment applying both classical test theory and Generalizability theory., Results: Novices achieved a mean score of 13.9 points; experienced otosurgeons achieved 23.2 points. Using the contrasting groups method, we established a 21/25-point pass/fail level. The Generalizability coefficient was 0.91, and 75% of the score variance was attributable to participant performance, indicating a high level of assessment reliability. Subsequent D studies revealed that two raters rating one performance or one rater rating two performances were sufficiently reliable for high-stakes assessment., Conclusion: Validity evidence supports using a low-cost, 3-D-printed model for mastoidectomy training. The model can be printed in-house using consumer-grade 3-D printers and serves as an additional training tool in the temporal bone curriculum. For competency-based training, we established a cut-off score of 21 of 25 WS points using the contrasting groups method., Competing Interests: The authors disclose no conflicts of interest., (Copyright © 2023, Otology & Neurotology, Inc.)

Introduction: Reliability is pivotal in surgical skills assessment. Video-based assessment can be used for objective assessment without physical presence of assessors. However, its reliability for surgical assessments remains largely unexplored. In this study, we evaluated the reliability of video-based versus physical assessments of novices' surgical performances on human cadavers and 3D-printed models-an emerging simulation modality., Methods: Eighteen otorhinolaryngology residents performed 2 to 3 mastoidectomies on a 3D-printed model and 1 procedure on a human cadaver. Performances were rated by 3 experts evaluating the final surgical result using a well-known assessment tool. Performances were rated both hands-on/physically and by video recordings. Interrater reliability and intrarater reliability were explored using κ statistics and the optimal number of raters and performances required in either assessment modality was determined using generalizability theory., Results: Interrater reliability was moderate with a mean κ score of 0.58 (range 0.53-0.62) for video-based assessment and 0.60 (range, 0.55-0.69) for physical assessment. Video-based and physical assessments were equally reliable (G coefficient 0.85 vs. 0.80 for 3D-printed models and 0.86 vs 0.87 for cadaver dissections). The interaction between rater and assessment modality contributed to 8.1% to 9.1% of the estimated variance. For the 3D-printed models, 2 raters evaluating 2 video-recorded performances or 3 raters physically assessing 2 performances yielded sufficient reliability for high-stakes assessment (G coefficient >0.8)., Conclusions: Video-based and physical assessments were equally reliable. Some raters were affected by changing from physical to video-based assessment; consequently, assessment should be either physical or video based, not a combination., Competing Interests: The authors declare no conflict of interest., (Copyright © 2022 Society for Simulation in Healthcare.)

Background: 3D-printed temporal bone models can potentially provide a cost-effective alternative to cadaver surgery that can be manufactured locally at the training department. The objective of this study was to create a cost-effective 3D-printed model suitable for mastoidectomy training using entry level and commercially available print technologies, enabling individuals, without prior experience on 3D-printing, to manufacture their own models for basic temporal bone training., Methods: Expert technical professionals and an experienced otosurgeon identified the best material for replicating the temporal bone and created a cost-effective printing routine for the model using entry-level print technologies. Eleven participants at a temporal bone dissection course evaluated the model using a questionnaire., Results: The 3D-printed temporal bone model was printed using a material extrusion 3D-printer with a heat resistant filament, reducing melting during drilling. After printing, a few simple post-processing steps were designed to replicate the dura, sigmoid sinus and facial nerve. Modifying the 3D-printer by installing a direct-drive and ruby nozzle resulted in more successful prints and less need for maintenance. Upon evaluation by otorhinolaryngology trainees, unanimous feedback was that the model provided a good introduction to the mastoidectomy procedure, and supplementing practice to cadaveric temporal bones., Conclusion: In-house production of a cost-effective 3D-printed model for temporal bone training is feasible and enables training institutions to manufacture their own models. Further, this work demonstrates the feasibility of creating new temporal bone models with anatomical variation to provide ample training opportunity., (© 2023. The Author(s).)

Background: Patients receiving total hip arthroplasty (THA) due to metastatic bone disease of the hip (MBD) are at an increased risk of post-operative joint dislocation compared to other populations. Different joint solutions have been developed with the purpose of reducing the dislocation risk compared to regular THAs. One of these solutions, the constrained liner (CL), has been used increasingly at our department in recent years. This design, however, is prone to polyethylene wear and higher revision rates. An alternative is the dual mobility cup (DM), which has been shown to reduce the risk of dislocation in other high-risk populations. Few studies have investigated DM for THA due to MBD, and no studies have directly compared these two treatments in this population. We therefore decided to conduct a trial to investigate whether DM is non-inferior to CL regarding the post-operative joint dislocation risk in patients receiving THA due to MBD., Materials and Methods: This study is a single-center, randomized, open-label, two-arm, non-inferiority trial. We will include 146 patients with MBD of the hip who are planned for THA at the Department of Orthopedic Surgery, Rigshospitalet. Patients with previous osteosynthesis or endoprosthetic surgery of the afflicted hip, or who are planned to receive partial pelvic reconstruction or total femoral replacement, will be excluded. Patients will be stratified by whether subtrochanteric bone resection will be performed and allocated to either CL or DM in a 1:1 ratio. The primary outcome is the 6 months post-operative joint dislocation rate. Secondary outcomes include overall survival, implant survival, the rate of other surgical- and post-operative complications, and quality of life and functional outcome scores., Discussion: This study is designed to investigate whether DM is non-inferior to CL regarding the risk of post-operative dislocation in patients receiving THA due to MBD. To our knowledge, this trial is the first of its kind. Knowledge gained from this trial will help guide surgeons in choosing a joint solution that minimizes the risk of dislocation and, ultimately, reduces the need for repeat surgeries in this patient population., Trial Registration: ClinicalTrials.gov Identifier: NCT05461313. Registered on July 15 2022. This trial is reported according to the items in the WHO Trial Registration Data Set (Version 1.3.1)., (© 2023. The Author(s).)

Background and Purpose: Joint stability after hip replacement (HR) in patients with metastatic bone disease (MBD) is of special importance. Dislocation is the second leading cause of implant revision in HR, while survival after MBD surgery is poor with an expected 1-year survival of around 40%. As few studies have investigated the dislocation risk across different articulation solutions in MBD, we conducted a retrospective study on primary HR for patients with MBD treated in our department., Patients and Methods: The primary outcome is the 1-year cumulative incidence of dislocation. We included patients with MBD who received HR at our department in 2003-2019. We excluded patients with partial pelvic reconstruction, total femoral replacement, and revision surgery. We assessed the incidence of dislocation with competing risk analysis with death and implant removal as competing risks., Results: We included 471 patients. Median follow-up was 6.5 months. The patients received 248 regular total hip arthroplasties (THAs), 117 hemiarthroplasties, 70 constrained liners, and 36 dual mobility liners. Major bone resection (MBR), defined as resection below the lesser trochanter, was performed in 63%. The overall 1-year cumulative incidence of dislocation was 6.2% (95% CI 4.0-8.3). Dislocation stratified by articulating surface was 6.9% (CI 3.7-10) for regular THA, 6.8% (CI 2.3-11) for hemiarthroplasty, 2.9% (CI 0.0-6.8) for constrained liner, and 5.6% (CI 0.0-13) for dual mobility liners. There was no significant difference between patients with and without MBR (p = 0.5)., Conclusion: The 1-year cumulative incidence of dislocation is 6.2% in patients with MBD. Further studies are needed to determine any real benefits of specific articulations on the risk of postoperative dislocation in patients with MBD.

Background: Mastoidectomy is a complex procedure which can be trained on human cadaveric temporal bones or simulation models. The number of repetitions offered in most training curricula is considerably less than what is normally required for motor skills acquisition in crafts or sports. Directed, self-regulated virtual reality simulation training may provide unlimited repetitions but the effect on learning of extended but unsupervised training is unknown. This study recorded extended learning curves of novices in virtual reality simulation mastoidectomy training., Methods: Six medical students used the visible ear temporal bone simulator at home for 100 repetitions. Virtual temporal bones were later assessed by 2 blinded experts on a 26-point modified Welling Scale., Results: Four participants completed 100 procedures each and 2 participants completed 50 procedures. Learning curves and plots of time demonstrated great variation: one participant improved gradually during the first 50 procedures and sustained a high performance; another participant achieved only 16 points after 50 procedures; a third participant demonstrated mediocre performances between 10 and 15 points but only used about 5 minutes per procedure. The remaining 3 participants achieved high but fluctuating scores with very limited time use per procedure. Their score per time exceeds the performance of experienced otosurgeons and suggests the use of save/restore gaming strategies to inflate their performance., Conclusion: Deliberate learners may reach proficiency in virtual reality simulation of mastoidectomy after 50 repetitions. However, even 100 repetitions cannot guarantee proficiency if motivation fails. Creative "gaming" behavior must be considered and opposed by motivation, supervision, testing, and certification.

Background: Otosclerosis is a common ear disease that causes fixation of the stapes and conductive hearing impairment. However, the pathogenesis of otosclerosis is still unknown. Otosclerosis could be associated with the unique bony environment found in the otic capsule. Normal bone remodelling is almost completely absent around the inner ear after birth allowing degenerative changes and dead osteocytes to accumulate. High levels of inner ear anti resorptive osteoprotegerin (OPG) is most likely responsible for this capsular configuration. Studies have demonstrated how osteocyte lifespan variation creates occasional clusters of dead osteocytes, so-called cellular voids, at otosclerotic predilection sites in the human otic capsule. These cellular voids have been suggested as possible starting points of otosclerosis., Aim: To describe the cellular viability in otosclerotic lesions and compare it to that of cellular voids., Materials and Methods: The study was based on unbiased stereological quantifications in undecalcified human temporal bones with otosclerosis., Results: Osteocyte viability was found to vary within the otosclerotic lesions. Furthermore, the results presented here illustrate that inactive otosclerotic lesions consist of mainly dead interstitial bone, much like cellular voids., Conclusions and Significance: Focal degeneration in the otic capsule may play an important role in the pathogenesis of otosclerosis.

Purpose: Temporal bone surgery requires excellent surgical skills and simulation-based training can aid novices' skills acquisition. However, simulation-based training is challenged by early stagnation of performance after few performances. Structured self-assessment during practice might enhance learning by inducing reflection and engagement in the learning task. In this study, structured self-assessment was introduced during virtual reality (VR) simulation of mastoidectomy to investigate the effects on subsequent performance during cadaveric dissection., Methods: A prospective educational study with comparison with historical controls (reference cohort). At a temporal bone dissection course, eighteen participants performed structured self-assessment during 3 h of VR simulation mastoidectomy training before proceeding to cadaver dissection (intervention cohort). At a previous course, eighteen participants received identical VR simulation training but without the structured self-assessment (reference cohort). Final products from VR simulation and cadaveric dissection were recorded and assessed by two blinded raters using a 19-point modified Welling Scale., Results: The intervention cohort completed fewer procedures (average 4.2) during VR simulation training than the reference cohort (average 5.7). Nevertheless, the intervention cohort achieved a significantly higher average performance score both in VR simulation (11.1 points, 95% CI [10.6-11.5]) and subsequent cadaveric dissection (11.8 points, 95% CI [10.7-12.8]) compared with the reference cohort, who scored 9.1 points (95% CI [8.7-9.5]) during VR simulation and 5.8 points (95% CI [4.8-6.8]) during cadaveric dissection., Conclusions: Structured self-assessment is a valuable learning support during self-directed VR simulation training of mastoidectomy and the positive effect on performance transfers to subsequent cadaveric dissection performance., (© 2022. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Knee joint functional deficits are common after anterior cruciate ligament (ACL) injury, but different assessment methods of joint function seem to provide contradicting information complicating recovery monitoring. We previously reported improved perceived knee function and functional performance (forward lunge ground contact time) in patients with an ACL injury from pre to 10 months post ACL reconstruction without improvement in knee-specific biomechanics. To further investigate this discrepancy, we additionally analyzed knee extensor and flexor muscle strength, and movement quality in the forward lunge (subjective and objective evaluations) and performed a full lower limb biomechanical analysis of the forward lunge movement. We included 12 patients with an ACL injury (tested before and after ACL reconstructive surgery) and 15 healthy controls from the previous study to the current investigation. Outcome measures were obtained pre and ~11 months post ACL reconstruction for the patients and at a single time point for the controls. Objective movement quality in the patients with an ACL injury showed an improvement from their pre reconstruction surgery visit to the post reconstruction visit but this was not observable in the subjective evaluation. Knee extensor muscle strength declined after the ACL reconstruction by 29% ( p = 0.002) and both knee extensors ( p < 0.001) and flexors ( p = 0.027) were weaker in the patients post ACL reconstruction compared to healthy controls. ACL injured patients had an altered movement strategy in the forward lunge with reduced knee extensors contribution and increased hip extensor contribution compared to the controls both before and after the reconstruction. The altered movement strategy was associated with knee extensor muscle strength. This explorative study with a limited sample size found that clinicians should be aware that significant functional deficits in the knee extensor muscles, both in isolated muscle strength testing and during a functional movement, may be present although patients perceive an improvement in their knee function and present good functional performance without obvious movement quality issues., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2022 Stenroth, Bartholdy, Schwarz Larsen, Sørensen, Smale, Flaxman, Benoit, Krogsgaard and Alkjær.)

Objective: This study aimed to describe the spatial distribution of osteocyte-depleted areas, so-called cellular voids, in the human otic capsule and compare it with that of otosclerosis., Background: Systematic histological studies of the bony otic capsule have revealed an osteoprotegerin (OPG)-mediated inhibition of normal bone remodeling around the inner ear. The resulting accumulation of bony degeneration and dead osteocytes has been thoroughly documented, and the spatial distribution of dead osteocytes and matrix microcracks resembles that of the human ear disease otosclerosis. Clusters of dead osteocytes that may interfere with osteocyte connectivity and thereby the OPG signaling pathway have been described in human temporal bones. It is possible that these cellular voids create disruptions in the antiresorptive OPG signal that may give rise to local pathological remodeling., Methods: Recently, a method of detecting cellular voids was developed. This study uses unbiased stereology to document the spatial distribution of cellular voids in bulk-stained undecalcified human temporal bone., Results: Cellular voids accumulate around the inner ear and increase in number and size with age. Furthermore, cellular voids are more frequently found in the anterior and lateral regions of the otic capsule, which are known predilection sites of otosclerosis., Conclusion: This colocalization of cellular voids and otosclerosis suggests a causal relationship between focal degeneration and otosclerotic remodeling., Competing Interests: The authors disclose no conflicts of interest., (Copyright © 2022, Otology & Neurotology, Inc.)

Objective: Virtual reality (VR) simulation-based training effectively improves novices' mastoidectomy skills. Unfortunately, learning plateaus at an insufficient level and knowledge on optimizing mastoidectomy training to overcome this plateau is needed. In this study, we aim to investigate how training on anatomically different temporal bone cases affects learning, including the effect on retention and transfer of skills., Study Design: Randomized controlled trial of an educational intervention., Setting: The Simulation Center at Copenhagen Academy for Medical Education and Simulation., Participants: Twenty-four medical students from the University of Copenhagen., Intervention: Participants were randomized to practice mastoidectomy on either 12 anatomically varying (intervention group) or 12 identical (control group) cases in a VR simulator. At the end of training and again ~ 3 weeks after training (retention), learners were tested on a new VR patient case and a three-dimensional printed model., Main Outcome Measure: Mastoidectomy performance evaluated by blinded expert raters using a 26-item modified Welling Scale., Results: The intervention and control groups' performance results were comparable at the end of training. Likewise, retention and transfer performances were similar between groups. The overall mean score at the end of training corresponded to approximately 70% of the possible maximum score., Conclusions: Simulation-based training using anatomical variation was equivalent to training on a single case with respect to acquisition, retention, and transfer of mastoidectomy skills. This suggests that efforts to expose novices to variation during initial training are unnecessary as this variation has limited effect, and-conversely-that educators can expose novices to naturally different anatomical variations without worry of hindered learning., Competing Interests: The authors disclose no conflicts of interest., (Copyright © 2022, Otology & Neurotology, Inc.)

Diabetes care during institutional hours is a major challenge affecting the whole family. The aim of this study was to highlight challenges and potentials regarding municipal support in relation to diabetes care of children in school, kindergarten, and daycare. The dataset consists of 80 semi-structured online interviews with 121 municipal employees from 74 (of 98) municipalities in Denmark. Data were analysed using qualitative content analysis. The analysis produced four main themes: (1) Institutional staff initially feel insecure about diabetes care responsibilities, (2) There is a high degree of parental involvement and responsibilities during institutional hours, (3) The roles of health employees vary, and (4) Fluctuating allocation of special needs assistants (SNAs) creates challenges. The findings of this nationwide qualitative study show that, even though Denmark guarantees, by law, the child's right to support in diabetes self-care in school and childcare institutions, diabetes management in Denmark still needs to be improved, with a view to ensuring equal support for all children with diabetes.

Introduction: The aim of this study was to externally validate the 2013-SPRING model, a survival prediction tool for patients treated surgically for bone metastases in a retrospective patient cohort from a single institution. Moreover, subgroup analyses on patients treated with (A) endoprostheses or (B) osteosynthesis, as well as (C) upper limb and (D) lower limb metastases, were performed., Methods: Altogether, 303 cancer patients (mean age: 67.6 ± 11.1 years; 140 males (46.2%)) with bone metastases to the extremities, treated surgically between March 2000 and June 2018 at a single tertiary sarcoma centre, were retrospectively included. Median follow-up amounted to 6.3 (interquartile range (IQR): 2.3-21.8) months, with all patients followed-up for at least one year or until death. The 2013-SPRING model was applied to assess the prognostication accuracy at 3, 6 and 12 months. Models were validated with area under the curve receiver operator characteristic (AUC ROC; the higher the better), as well as Brier score., Results: Of the 303 patients, 141 had been treated with osteosynthesis (46.5%), and the remaining 162 patients with endoprosthesis (53.5%). Sixty-five (21.5%) metastases were located in the upper limbs, and two hundred and thirty-eight (78.5%) in the lower limbs. Using the 2013-SPRING model for the entire cohort, the accuracy of risk of death prediction at 3, 6 and 12 months, determined by the AUC ROC, was 0.782 (95% CI: 0.729-0.843), 0.810 (95% CI: 0.763-0.858) and 0.802 (95% CI: 0.751-0.854), respectively. Corresponding Brier scores were 0.170, 0.178 and 0.169 at 3, 6 and 12 months. In the subgroup analyses, predictive accuracy of the 2013-SPRING model was likewise encouraging, albeit being slightly higher in the osteosynthesis subgroup as compared with the endoprosthesis subgroup, and also higher in the upper limb in comparison to the lower limb metastasis subgroup., Conclusions: The current validation study of the 2013-SPRING model shows that this model is clinically relevant to use in an external cohort, also after stratification for surgical procedure and metastasis location.

Purpose: 3D-printing (three-dimensional printing) is an emerging technology with promising applications for patient-specific interventions. Nonetheless, knowledge on the clinical applicability of 3D-printing in otology and research on its use remains scattered. Understanding these new treatment options is a prerequisite for clinical implementation, which could improve patient outcomes. This review aims to explore current applications of 3D-printed patient-specific otologic interventions, including state of the evidence, strengths, limitations, and future possibilities., Methods: Following the PRISMA statement, relevant studies were identified through Pubmed, EMBASE, the Cochrane Library, and Web of Science. Data on the manufacturing process and interventions were extracted by two reviewers. Study quality was assessed using Joanna Briggs Institute's critical appraisal tools., Results: Screening yielded 590 studies; 63 were found eligible and included for analysis. 3D-printed models were used as guides, templates, implants, and devices. Outer ear interventions comprised 73% of the studies. Overall, optimistic sentiments on 3D-printed models were reported, including increased surgical precision/confidence, faster manufacturing/operation time, and reduced costs/complications. Nevertheless, study quality was low as most studies failed to use relevant objective outcomes, compare new interventions with conventional treatment, and sufficiently describe manufacturing., Conclusion: Several clinical interventions using patient-specific 3D-printing in otology are considered promising. However, it remains unclear whether these interventions actually improve patient outcomes due to lack of comparison with conventional methods and low levels of evidence. Further, the reproducibility of the 3D-printed interventions is compromised by insufficient reporting. Future efforts should focus on objective, comparative outcomes evaluated in large-scale studies., (© 2022. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Background: Sarcomas are a heterogeneous group of rare malignant tumors of mesenchymal origin in the musculoskeletal system. The main treatment is surgery often supplemented with pre-or postoperative radiotherapy. A retrospective study by Bedi et al. indicated that negative pressure wound therapy (NPWT) reduced the risk of postoperative wound complications in patients treated with preoperative radiation followed by surgical tumor removal of lower extremity soft tissue sarcomas (STS), and the use of NPWT was not associated with an increased risk of local recurrence. Previous studies have shown that NPWT can reduce postoperative complications. STS surgeries are a high-risk procedure concerning wound complications., Methods: Non-blinded single-center randomized controlled trial comparing NPWT versus conventional wound dressing and postoperative wound complications after surgical removal of deep-seated high-malignant STS of the extremities or trunk wall Sample-size calculation: 154 STS patients (80% risk of avoiding type II error, 5% risk of type I error, and an 80% wound complication risk) Block randomization of 8 into: Group A: Conventional wound dressing Group B: NPWT (PREVENA PLUS™ Incision Management System) Inclusion criteria: Surgery for a deep-seated STS of an extremity or the trunk wall Exclusion criteria: Age < 18 years, plastic surgery, low malignant/borderline STS, chemotherapy, preoperative radiotherapy, allergic/hypersensitive to acrylic adhesives or silver, unwilling/unable to provide informed consent, metastatic disease, and ischemic surgeries Primary study endpoints were set as major wound complications defined by O'Sullivan et al. as a secondary surgery under anesthesia for wound repairs and wound management without secondary surgery within 4 months postoperatively. Secondary study endpoints among others are Musculoskeletal Tumor Society Score (MSTS), Toronto Extremity Salvage Score (TESS), and European Quality of Life - 5 Dimensions (EQ-5D). Approval from the Scientific Ethical Committee and the Data Protection Agency has been obtained, and the study is registered at clinicaltrial.gov . This study did not apply for external funding., Discussion: Many new medical devices and technical solutions are currently being introduced, and even though some documentation regarding the use of NPWT, e.g., in joint replacement surgery exist, it is also important to seek documentation for this treatment principle in STS surgery., Trial Registration: Registered at ClinicalTrials.gov NCT04960332 and approved on 11 July 2021., (© 2022. The Author(s).)

Background: Pain is a common complication for patients with metastatic bone disease. Animal models suggest that the pain, in part, is driven by pathological sprouting and reorganization of the nerve fibers innervating the bone. Here, we investigate how these findings translate to humans., Methods: Bone biopsies were collected from healthy volunteers ( n = 7) and patients with breast cancer and metastatic bone disease (permissions H-15000679, S-20180057 and S-20110112). Cancer-infiltrated biopsies were from patients without recent anticancer treatment ( n = 10), patients with recent anticancer treatment ( n = 10), and patients with joint replacement surgery ( n = 9). Adjacent bone sections were stained for (1) protein gene product 9.5 and CD34, and (2) cytokeratin 7 and 19. Histomorphometry was used to estimate the area of bone marrow and tumor burden. Nerve profiles were counted, and the nerve profile density calculated. The location of each nerve profile within 25 μm of a vascular structure and/or cancer cells was determined., Results: Cancer-infiltrated bone tissue demonstrated a significantly higher nerve profile density compared to healthy bone tissue. The percentage of nerve profiles found close to vascular structures was significantly lower in cancer-infiltrated bone tissue. No difference was found in the percentage of nerve profiles located close to cancer between the subgroups of cancer-infiltrated bone tissue. Interestingly, no correlation was found between nerve profile density and tumor burden., Conclusions: Together, the increased nerve profile density and the decreased association of nerve profiles to vasculature strongly suggests that neuronal sprouting and reorganization occurs in human cancer-infiltrated bone tissue., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2022 Hansen, Sayilekshmy, Sørensen, Jørgensen, Kanneworff, Bengtsson, Grum-Schwensen, Petersen, Ejersted, Andersen, Andreasen and Heegaard.)

Background: Cochlear implantation requires excellent surgical skills; virtual reality simulation training is an effective method for acquiring basic competency in temporal bone surgery before progression to cadaver dissection. However, cochlear implantation virtual reality simulation training remains largely unexplored and only one simulator currently supports the training of the cochlear implantation electrode insertion. Here, we aim to evaluate the effect of cochlear implantation virtual reality simulation training on subsequent cadaver dissection performance and self-directedness., Methods: This was a randomized, controlled trial. Eighteen otolaryngology residents were randomized to either mastoidectomy including cochlear implantation virtual reality simulation training (intervention) or mastoidectomy virtual reality simulation training alone (controls) before cadaver cochlear implantation surgery. Surgical performance was evaluated by two blinded expert raters using a validated, structured assess- ment tool. The need for supervision (reflecting self-directedness) was assessed via post-dissection questionnaires., Results: The intervention group achieved a mean score of 22.9 points of a maximum of 44 points, which was 5.4% higher than the control group's 21.8 points (P = .51). On average, the intervention group required assistance 1.3 times during cadaver drilling; this was 41% more frequent in the control group who received assistance 1.9 times (P = .21)., Conclusion: Cochlear implantation virtual reality simulation training is feasible in the context of a cadaver dissection course. The addition of cochlear implantation virtual reality training to basic mastoidectomy virtual reality simulation training did not lead to a significant improvement of performance or self-directedness in this study. Our findings suggest that learning an advanced temporal bone procedure such as cochlear implantation surgery requires much more training than learning mastoidectomy.

In cochlear implantation (CI), excellent surgical technique is critical for hearing outcomes. Recent advances in temporal bone Virtual Reality (VR) training allow for specific training of CI and through introduction of new digital microscopes with ultra-high-fidelity (UHF) graphics. This study aims to investigate whether UHF increases performance in VR simulation training of CI electrode insertion compared with conventional, screen-based VR (cVR)., Methods: Twenty-four medical students completed a randomized, controlled trial of an educational intervention. They performed a total of eight CI electrode insertions each in blocks of four using either UHF-VR or cVR, in randomized order. CI electrode insertion performances were rated by two blinded expert raters using a structured assessment tool supported by validity evidence., Results: Performance scores in cVR were higher than in the UHF-VR simulation although this was not significant (19.8 points, 95% CI [19.3-20.3] vs. 18.8 points, 95% CI [18.2-19.4]; P  = 0.09). The decisive factor for performance was participants' ability to achieve stereovision (mean difference = 1.1 points, 95% CI [0.15-2.08], P  = 0.02)., Discussion: No additional benefit was found from UHF-VR over cVR training of CI electrode insertion for novices. Consequently, standard cVR simulation should be used for novices' basic skills acquisition in CI surgery. Future studies should instead explore the effects of other improvements in CI surgery training and if the lacking benefit of UHF-VR also applies for more experienced learners., Conclusion: The increased graphical perception and the superior lifelikeness of UHF-VR does not improve early skills acquisition of CI insertion for novices.

Background: Population-based studies of patients with bone metastases in the appendicular skeleton (aBM) requiring surgery for complete or impending fracture are rare. In this epidemiologically-based observational study we created a large population-based cohort of patients treated for aBM, aiming to: (1) monitor possible time-related changes of the incidence of surgical treatment of aBM-lesions, (2) examine differences in the population and care of patients treated at different treatment centers and (3) examine if findings from a previous pilot study regarding absence of a suitable biopsy of the lesions representing debut of cancer or a relapse has improved the awareness of aBM and hereby increased the focus on regular tumor biopsies and follow-up imaging of cancer patients. Methods: We examined a population-based cohort consisting of all patients treated for aBM 2014−2019. Procedures were performed at five secondary surgical centers (SSC) or one tertiary referral Musculoskeletal Tumor Center (MTC). Patients were followed until end of study (30 September 2021) or death. No patients were lost to follow-up. Results: Four-hundred-fifty-seven patients (493 primary aBM-lesions, 482 procedures) were included. Annual incidence of aBM-surgery was 46 aBM-lesions/million. MTC-patients had a significant better preoperative status than SSC-patients considering factors known for survival. Patients with complete fracture experienced longer surgical delay when treated at MTC compared to SSC: 4 (1−9) and 1 (1−3) days (p < 0.001), respectively. Overall survival for the entire cohort was 37% and 11% at 1 and 5 years (MTC and SSC 1 and 5 year respectively: 44% and 15% vs. 29% and 5%, p < 0.001). In patients with debut or relapse of cancer, 8% and 9% had insufficient biopsies, and 21% and 12% had no biopsy, respectively. Comparison showed no change over time. Conclusions: The current study highlights the low awareness on treating aBM at SSC and emphasizes the importance of caution in interpretation of studies not representing an entire population, thus introducing selection bias.

Purpose: To develop and gather validity evidence for a novel tool for assessment of cochlear implant (CI) surgery, including virtual reality CI surgery training., Methods: Prospective study gathering validity evidence according to Messick's framework. Four experts developed the CI Surgery Assessment Tool (CISAT). A total of 35 true novices (medical students), trained novices (residents) and CI surgeons performed two CI-procedures each in the Visible Ear Simulator, which were rated by three blinded experts. Classical test theory and generalizability theory were used for reliability analysis., Results: The CISAT significantly discriminated between the three groups (p < 0.001). The generalizability coefficient was 0.76 and most of the score variance (53.3%) was attributable to the participant and only 6.8% to the raters. When exploring a standard setting for CI surgery, the contrasting groups method suggested a pass/fail score of 36.0 points (out of 55), but since the trained novices performed above this, we propose using the mean CI surgeon performance score (45.3 points)., Conclusion: Validity evidence for simulation-based assessment of CI performance supports the CISAT. Together with the standard setting, the CISAT might be used to monitor progress in competency-based training of CI surgery and to determine when the trainee can advance to further training., (© 2021. The Author(s), under exclusive licence to Springer-Verlag GmbH, DE part of Springer Nature.)

Objective: Mastoidectomy is a cornerstone in the surgical management of middle and inner ear diseases. Unfortunately, training is challenged by insufficient access to human cadavers. Three-dimensional (3D) printing of temporal bones could alleviate this problem, but evidence on their educational effectiveness is lacking. It is largely unknown whether training on 3D-printed temporal bones improves mastoidectomy performance, including on cadavers, and how this training compares with virtual reality (VR) simulation. To address this knowledge gap, this study investigated whether training on 3D-printed temporal bones improves cadaveric dissection performance, and it compared this training with the already-established VR simulation., Study Design: Prospective cohort study of an educational intervention., Setting: Tertiary university hospital, cadaver dissection laboratory, and simulation center in Copenhagen, Denmark., Methods: Eighteen otorhinolaryngology residents (intervention) attending the national temporal bone dissection course received 3 hours of mastoidectomy training on 3D-printed temporal bones. Posttraining cadaver mastoidectomy performances were rated by 3 experts using a validated assessment tool and compared with those of 66 previous course participants (control) who had received time-equivalent VR training prior to dissection., Results: The intervention cohort outperformed the controls during cadaver dissection by 29% ( P < .001); their performances were largely similar across training modalities but remained at a modest level (~50% of the maximum score)., Conclusion: Mastoidectomy skills improved from training on 3D-printed temporal bone and seemingly more so than on time-equivalent VR simulation. Importantly, these skills transferred to cadaveric dissection. Training on 3D-printed temporal bones can effectively supplement cadaver training when learning mastoidectomy., (© The Authors 2021.)

Objective: Mastering Cochlear Implant (CI) surgery requires repeated practice, preferably initiated in a safe - i.e. simulated - environment. Mastoidectomy Virtual Reality (VR) simulation-based training (SBT) is effective, but SBT of CI surgery largely uninvestigated. The learning curve is imperative for understanding surgical skills acquisition and developing competency-based training. Here, we explore learning curves in VR SBT of CI surgery and transfer of skills to a 3D-printed model., Methods: Prospective, single-arm trial. Twenty-four novice medical students completed a pre-training CI inserting test on a commercially available pre-drilled 3D-printed temporal bone. A training program of 18 VR simulation CI procedures was completed in the Visual Ear Simulator over four sessions. Finally, a post-training test similar to the pre-training test was completed. Two blinded experts rated performances using the validated Cochlear Implant Surgery Assessment Tool (CISAT). Performance scores were analyzed using linear mixed models., Results: Learning curves were highly individual with primary performance improvement initially, and small but steady improvements throughout the 18 procedures. CI VR simulation performance improved 33% ( p  < 0.001). Insertion performance on a 3D-printed temporal bone improved 21% ( p  < 0.001), demonstrating skills transfer., Discussion: VR SBT of CI surgery improves novices' performance. It is useful for introducing the procedure and acquiring basic skills. CI surgery training should pivot on objective performance assessment for reaching pre-defined competency before cadaver - or real-life surgery. Simulation-based training provides a structured and safe learning environment for initial training., Conclusion: CI surgery skills improve from VR SBT, which can be used to learn the fundamentals of CI surgery.

Objective: 3D-printed models hold great potential for temporal bone surgical training as a supplement to cadaveric dissection. Nevertheless, critical knowledge on manufacturing remains scattered, and little is known about whether use of these models improves surgical performance. This systematic review aims to explore (1) methods used for manufacturing and (2) how educational evidence supports using 3D-printed temporal bone models., Data Sources: PubMed, Embase, the Cochrane Library, and Web of Science., Review Methods: Following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, relevant studies were identified and data on manufacturing and validation and/or training extracted by 2 reviewers. Quality assessment was performed using the Medical Education Research Study Quality Instrument tool; educational outcomes were determined according to Kirkpatrick's model., Results: The search yielded 595 studies; 36 studies were found eligible and included for analysis. The described 3D-printed models were based on computed tomography scans from patients or cadavers. Processing included manual segmentation of key structures such as the facial nerve; postprocessing, for example, consisted of removal of print material inside the model. Overall, educational quality was low, and most studies evaluated their models using only expert and/or trainee opinion (ie, Kirkpatrick level 1). Most studies reported positive attitudes toward the models and their potential for training., Conclusion: Manufacturing and use of 3D-printed temporal bones for surgical training are widely reported in the literature. However, evidence to support their use and knowledge about both manufacturing and the effects on subsequent surgical performance are currently lacking. Therefore, stronger educational evidence and manufacturing knowhow are needed for widespread implementation of 3D-printed temporal bones in surgical curricula.

Background: Schwannoma is a benign, encapsulated and slowly growing tumor originating from Schwann cells and is rarely seen in the peripheral nerve system. Typical symptoms are soreness, radiating pain and sensory loss combined with a soft tissue mass., Aim: To evaluate pre- and postoperative symptoms in patients operated for schwannomas in the extremities and investigate the rate of malignant transformation., Methods: In this single center retrospective study design, all patients who had surgery for a benign schwannoma in the extremities from May 1997 to January 2018 were included. The location of the tumor in the extremities was divided into five groups; forearm, arm, shoulder, thigh and leg including foot. The locations of the tumor in the nerves were also categorized as either; proximal, distal, minor or major nerve. During the pre- and postoperative clinical evaluation, symptoms were classified as paresthesia, local pain, radiating pain, swelling, impairment of mobility/strength and asymptomatic tumors that were found incidentally (with magnetic resonance imaging). The patients were evaluated after surgery using the following categories: Asymptomatic or symptomatic patients (radiating and/or local pain) and those with complications. The follow up period was from the time of surgery until last examination of the particular physician. Multivariate logistic regression analysis was performed to identify independent prognostic factors for postoperative significant symptoms at follow-up., Results: We identified 858 cases from the institutional pathology register. We excluded cases with duplicate diagnoses ( n = 407), pathology not including schwannomas ( n = 157), lesions involving the torso, spine and neck ( n = 150) leaving 144 patients for further analysis. In this group 99 patients underwent surgery and there were five complications recorded: 2 infections (treated with antibiotics) and 3 nerve palsies (2 involving the radial nerve and one involving the median nerve) that recovered spontaneously. At the end of follow-up, 1.4 mo (range 0.5-76) postoperatively, we recorded a post-operative decrease in clinical symptoms: Local pain 76% (6/25), radiating pain 97% (2/45), swelling 20% (8/10). Symptoms of paresthesia increased by 2.8% (37/36) and there was no change in motor weakness before and after surgery 1% (1/1). Multivariate analysis showed that tumors located within minor nerves had a significantly higher prevalence of postoperative symptoms compared with tumors in major nerves (odds ratio: 2.63; confidence intervals: 1.22-6.42, P = 0.029). One patient with schwannoma diagnosed by needle biopsy was diagnosed to have malignant transformation diagnosed in the surgically removed tumor. No local recurrences were reported., Conclusion: Surgery of schwannomas can be conducted with low risk of postoperative complications, acceptable decrease in clinical symptoms and risk of malignant transformation is low., Competing Interests: Conflict-of-interest statement: All authors have nothing to disclose., (©The Author(s) 2021. Published by Baishideng Publishing Group Inc. All rights reserved.)

Background and purpose - It is believed that in uncemented primary total hip arthroplasty (THA) the anchorage of the stem is dependent on the level of bone mineral density (BMD) of the femoral bone. This is one of the reasons for the widely accepted agreement that a cemented solution should be selected for people with osteoporosis or age > 75 years. We evaluated whether preoperative BMD of the femur bone is related to femoral stem migration in uncemented THA.Patients and methods - We enrolled 62 patients (mean age 64 years (range 49-74), 34 males) scheduled for an uncemented THA. Before surgery we undertook DEXA scans of the proximal femur including calculation of the T- and Z-scores for the femoral neck. Evaluation of stem migration by radiostereometric analysis (RSA) was performed with 24 months of follow-up. In 56 patients both preoperative DEXA data and RSA data were available with 24 months of follow-up.Results - None of the patients had a T-score below -2.5. We found no statistically significant relationship between preoperative BMD and femoral stem subsidence after 3 or 24 months. When comparing the average femoral stem subsidence between 2 groups with T-score > -1 and T-score ≤ -1, respectively, we found no statistically significant difference after either 3 or 24 months when measured with RSA.Interpretation - In a cohort of people ≤ 75 years of age and with local femur T-score > -2.5 we found no relationship between preoperative BMD and postoperative femoral stem subsidence of a cementless THA.

Background: Patients with a bone sarcoma who undergo limb-sparing surgery and reconstruction with a tumor prosthesis in the lower extremity have been shown to have reduced self-reported physical function and quality of life (QoL). To provide patients facing these operations with better expectations of future physical function and to better evaluate and improve upon postoperative interventions, data from objectively measured physical function have been suggested., Questions/purposes: We sought to explore different aspects of physical function, using the International Classification of Functioning, Disability, and Health (ICF) as a framework, by asking: (1) What are the differences between patients 2 to 12 years after a bone resection and reconstruction surgery of the hip and knee following resection of a bone sarcoma or giant cell tumor of bone and age-matched controls without walking limitations in ICF body functions (ROM, muscle strength, pain), ICF activity and participation (walking, getting up from a chair, daily tasks), and QoL? (2) Within the patient group, do ICF body functions and ICF activity and participation outcome scores correlate with QoL?, Methods: Between 2006 and 2016, we treated 72 patients for bone sarcoma or giant cell tumor of bone resulting in bone resection and reconstruction with a tumor prosthesis of the hip or knee. At the timepoint for inclusion, 47 patients were alive. Of those, 6% (3 of 47) had undergone amputation in the lower limb and were excluded. A further 32% (14 of 44) were excluded because of being younger than 18 years of age, pregnant, having long transportation, palliative care, or declining participation, leaving 68% (30 of 44) for analysis. Thus, 30 patients and 30 controls with a mean age of 51 ± 18 years and 52 ± 17 years, respectively, were included in this cross-sectional study. Included patients had been treated with either a proximal femoral (40% [12 of 30]), distal femoral (47% [14 of 30]), or proximal tibia (13% [4 of 30]) reconstruction. The patients were assessed 2 to 12 years (mean 7 ± 3 years) after the resection-reconstruction. The controls were matched on gender and age (± 4 years) and included if they considered their walking capacity to be normal and had no pain in the lower extremity. Included outcome measures were: passive ROM of hip flexion, extension, and abduction and knee flexion and extension; isometric muscle strength of knee flexion, knee extension and hip abduction using a hand-held dynamometer; pain intensity (numeric rating scale; NRS) and distribution (pain drawing); the 6-minute walk test (6MWT); the 30-second chair-stand test (CST); the Toronto Extremity Salvage Score (TESS), and the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). The TESS and the EORTC QLQ-C30 were normalized to 0 to 100 points. Higher scoring represents better status for TESS and EORTC global health and physical functioning scales. Minimum clinically important difference for muscle strength is 20% to 25%, NRS 2 points, 6MWT 14 to 31 meters, CST 2 repetitions, TESS 12 to 15 points, and EORTC QLQ-C30 5 to 20 points., Results: Compared with controls, the patients had less knee extension and hip abduction strength in both the surgical and nonsurgical limbs and regardless of reconstruction site. Mean knee extension strength in patients versus controls were: surgical limb 0.9 ± 0.5 Nm/kg versus 2.1 ± 0.6 Nm/kg (mean difference -1.3 Nm/kg [95% CI -1.5 to -1.0]; p < 0.001) and nonsurgical limb 1.7 ± 0.6 Nm/kg versus 2.2 ± 0.6 Nm/kg (mean difference -0.5 Nm/kg [95% CI -0.8 to -0.2]; p = 0.003). Mean hip abduction strength in patients versus controls were: surgical limb 1.1 ± 0.4 Nm/kg versus 1.9 ± 0.5 Nm/kg (mean difference -0.7 Nm/kg [95% CI -1.0 to -0.5]; p < 0.001) and nonsurgical limb 1.5 ± 0.4 Nm/kg versus 1.9 ± 0.5 Nm/kg (-0.4 Nm/kg [95% CI -0.6 to -0.2]; p = 0.001). Mean hip flexion ROM in patients with proximal femoral reconstructions was 113° ± 18° compared with controls 130° ± 11° (mean difference -17°; p = 0.006). Mean knee flexion ROM in patients with distal femoral reconstructions was 113° ± 29° compared with patients in the control group 146° ± 9° (mean difference -34°; p = 0.002). Eighty-seven percent (26 of 30) of the patients reported pain, predominantly in the knee, anterior thigh, and gluteal area. The patients showed poorer walking and chair-stand capacity and had lower TESS scores than patients in the control group. Mean 6MWT was 499 ± 100 meters versus 607 ± 68 meters (mean difference -108 meters; p < 0.001), mean CST was 12 ± 5 repetitions versus 18 ± 5 repetitions (mean difference -7 repetitions; p < 0.001), and median (interquartile range) TESS score was 78 (21) points versus 100 (10) points (p < 0.001) in patients and controls, respectively. Higher pain scores correlated to lower physical functioning of the EORTC QLQ-C30 (Rho -0.40 to -0.54; all p values < 0.05). Less muscle strength in knee extension, knee flexion, and hip abduction correlated to lower physical functioning of the EORTC QLQ-C30 (Rho 0.40 to 0.51; all p values < 0.05)., Conclusion: This patient group demonstrated clinically important muscle weaknesses not only in resected muscles but also in the contralateral limb. Many patients reported pain, and they showed reductions in walking and chair-stand capacity comparable to elderly people. The results are relevant for information before surgery, and assessments of objective physical function are advisable in postoperative monitoring. Prospective studies evaluating the course of physical function and which include assessments of objectively measured physical function are warranted. Studies following this patient group with repetitive measures over about 5 years could provide information about the course of physical function, enable comparisons with population norms, and lead to better-designed, targeted, and timely postoperative interventions., Level of Evidence: Level III, therapeutic study., Competing Interests: All ICMJE Conflict of Interest Forms for authors and Clinical Orthopaedics and Related Research® editors and board members are on file with the publication and can be viewed on request., (Copyright © 2021 by the Association of Bone and Joint Surgeons.)

The otic capsule consists of dense highly mineralized compact bone. Inner ear osteoprotegerin (OPG) effectively inhibits perilabyrinthine remodeling and otic capsular bone turnover is very low compared to other bone. Consequently, degenerative changes like dead osteocytes and microcracks accumulate around the inner ear. Osteocytes are connected via canaliculi and need a certain connectivity to sustain life. Consequently, stochastic osteocyte apoptosis may disrupt the osteocytic network in unsustainable patterns leading to widespread cell death. When studying bulk-stained undecalcified human temporal bone, large clusters of dead osteocytes have been observed. Such "cellular voids" may disrupt the perilabyrinthine OPG mediated remodeling inhibition possibly leading to local remodeling. In the common ear disease otosclerosis pathological bone remodeling foci are found exclusively in the otic capsule. We believe the pathogenesis of otosclerosis is linked to the unique bony dynamics of perilabyrinthine bone and cellular voids may represent a starting point for otosclerotic remodeling. This study aims to identify and characterize cellular voids of the human otic capsule. This would allow future cellular void quantification and comparison of void and otosclerotic distribution to further elucidate the yet unknown pathogenesis of otosclerosis., (© 2021. Association for Research in Otolaryngology.)

Background: Virtual reality (VR) simulation is an established option for temporal bone surgical training. Most VR simulators are based on computed tomography imaging, whereas the Visible Ear Simulator (VES) is based on high-fidelity cryosections of a single temporal bone specimen. Recently published OpenEar datasets combine cone-beam computed tomography (CBCT) and micro-slicing to achieve similar model quality. This study explores integration of OpenEar datasets into VES to enable case variation in simulation with implications for patient-specific modeling based on CBCT., Methods: The OpenEar dataset consists of segmented, coregistered, multimodal imaging sets of human temporal bones. We derived drillable bone segments from the dataset as well as triangulated surface models of critical structures such as facial nerve or dura. Realistic visualization was achieved using coloring from micro-slicing, custom tinting, and texture maps. Resulting models were validated by clinical experts., Results: Six of the eight OpenEar datasets could be integrated in VES complete with instructional guides for various temporal bone surgical procedures. Resulting models were of high quality because of postprocessing steps taken to increase realism including colorization and imaging artifact removal. Bone artifacts were common in CBCT, resulting in dehiscences that most often could not be found in the ground truth micro-slicing data., Conclusion: New anatomy models are included in VES version 3.5 freeware and provide case variation for training which could help trainees to learn more quickly and transferably under variable practice conditions. The use of CBCT for VR simulation models without postprocessing results in bone artifacts, which should be considered when using clinical imaging for patient-specific simulation, surgical rehearsal, and planning., Competing Interests: Dr. S.A.W.A. has received a postdoc grant by the Independent Research Fund Denmark (8026-00003B). The Visible Ear Simulator is developed with support from Oticon Medical, MED-EL, and the Oticon Foundation. The other authors disclose no conflicts of interest., (Copyright © 2021 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of Otology & Neurotology, Inc.)

Background: Plasma IL-6 and YKL-40 are prognostic biomarkers for OS in patients with different types of solid tumors, but they have not been studied in patients before surgery of metastatic bone disease (MBD) of the extremities. The aim was to evaluate the prognostic value of plasma IL-6 and YKL-40 in patients undergoing surgery for MBD of the extremities., Patients and Methods: A prospective study included all patients undergoing surgery for MBD in the extremities at a tertiary referral center during the period 2014-2018. Preoperative blood samples from index surgery were included. IL-6 and YKL-40 concentrations in plasma were determined by commercial ELISA. A total of 232 patients (median age 66 years, IQR 58-74; female 51%) were included., Results: Cox regression analysis was performed to identify independent prognostic factors for OS. IL-6 correlated with YKL-40 (rho = 0.46, p < 0.01). In univariate analysis (log 2 continuous variable) IL-6 (HR = 1.26, 95% CI 1.16-1.37), CRP (HR = 1.20, 95% CI 1.12-1.29) and YKL-40 (HR = 1.25, 95% CI 1.15-1.37) were associated with short OS. In multivariable analysis, adjusted for known risk factors for survival, only log 2 (IL-6) was independently associated with OS (HR = 1.24, 95% CI 1.08-1.43), whereas CRP and YKL-40 were not., Conclusion: High preoperative plasma IL-6 is an independent biomarker of short OS in patients undergoing surgery for MBD.

Background: Limb salvage surgery (LSS) is the preferred method for treatment of patients with sarcomas and to a greater extent also to patients with metastatic bone disease. The aim of the present study was to evaluate the adaptive remodeling of the periprosthetic cortical bone after insertion of a tumor prosthesis with cemented stem., Methods: A prospective study of 21 patients (F/M = 12/9), mean age 55 years (range 15-81) with metastatic bone disease (n = 9), sarcomas (n = 8) or aggressive benign tumors (n = 4) who underwent bone resection due to a tumor, and reconstruction with a tumor-prosthesis (Zimmer® Segmental 130 mm straight fluted cemented stem with trabecular metal (TM) collars) in the proximal femur (n = 10), distal femur (n = 9) or proximal tibia (n = 2). Measurements of bone mineral density (BMD) (g/cm 2 ) were done postoperatively and after 3, 6, and 12 months using dual-energy X-ray absorptiometry. BMD was measured in 4 regions of interest around the cemented stem and in one region of interest 1 cm proximal from the ankle joint of the affected limb and measurement of the contralateral ankle was used as reference. Repeated measures ANOVA and students paired t-test was used to evaluate BMD changes over time., Results: At 1-year follow-up, BMD decreased compared to baseline in all four regions of interest with a statistically significant bone loss of 8-15%. The bone loss was most pronounced (14-15%) in the 2 regions of interest closest to the trabecular metal (TM) collar and lowest (8%) adjacent to the tip of the stem., Conclusion: After 1 year the decrease in bone mineral density of the ankle on the affected limb was 9% and the contralateral ankle was close to baseline, thus suggesting that the periprosthetic bone mineral density changes during follow-up, mainly are caused by stress shielding and immobilization., Trial Registration: The study was approved by the Scientific Ethical Committee of the Capital Region of Denmark (J. No. H-2-2014-105) and the Danish Data Protection Agency (J. No.: 2012-58-00004 ).

Background: The bony otic capsule is comprised of highly mineralized and dense compact bone. It is rarely remodelled and degenerative changes, therefore, accumulate around the inner ear. It is also a predilection site for the pathological remodelling seen in otosclerosis. Morphometric studies have documented increased numbers of dead osteocytes and microcracks in the human otic capsule. Microcracks may disrupt the lacuno-canalicular network and cause osteocyte apoptosis ultimately breaking up the perilabyrinthine bone signalling pathways and dynamics. This may be important to understand the pathogenesis of remodelling diseases like otosclerosis., Aims/objectives: This study describes the spatial and regional distribution of microcrack surface density in relation to the inner ear and compares it to that previously recorded for otosclerosis., Material and Methods: Forty-two temporal bones and five ribs were used. All samples were undecalcified, bulk stained in basic fuchsin and plastic embedded. Unbiased stereology was used to estimate the true surface density of microcracks (mm 2 /mm 3 ) in perilabyrinthine bone., Results: The surface density of microcracks accumulates around the inner ear spaces, particularly in the lateral window regions, and increases with age., Conclusions and Significance: This study documents the spatial and temporal association between microfractures and otosclerosis in the otic capsule.

Bone is continuously remodeled to repair and strengthen degenerative bone with accumulating dead osteocytes and microfractures. Inner ear osteoprotegerin (OPG)-mediated inhibition of otic capsular bone remodeling causes excessive perilabyrinthine bone degeneration. Consequently, microcracks accumulate around the inner ear. Microcracks cause osteocyte apoptosis and may disrupt the canalicular network connecting osteocytes. Despite their linear microscopic appearance, microcracks are three-dimensional disruption planes and represent surface areas inside a tissue space. With an elevated microcrack burden the number of disconnected osteocytes is expected to increase. This may prove relevant to ongoing research in otic focal pathologies like otosclerosis. Therefore, an unbiased quantification of the microcrack surface density (mm 2 /mm 3 ) in the human otic capsule is essential. In this study unbiased stereology was applied to undecalcified bulk stained human temporal bones to demonstrate its feasibility in describing the three-dimensional reality behind two dimensional observations of microcracks. A total of 28 human temporal bones and five ribs were bulk stained in basic fuchsin, serially sectioned and hand-ground to a thickness of 80-120 μm. Both horizontal and vertical sections were produced and compared. This study showed that surface density of microcracks was significantly higher around the inner ear compared to ribs. Furthermore, no significant difference in microcrack surface density between horizontal and vertical sections in the temporal bone was demonstrated., (© 2021 American Association for Anatomy.)

Objective: Self-directed training represents a challenge in simulation-based training as low cognitive effort can occur when learners overrate their own level of performance. This study aims to explore the mechanisms underlying the positive effects of a structured self-assessment intervention during simulation-based training of mastoidectomy., Methods: A prospective, educational cohort study of a novice training program consisting of directed, self-regulated learning with distributed practice (5x3 procedures) in a virtual reality temporal bone simulator. The intervention consisted of structured self-assessment after each procedure using a rating form supported by small videos. Semi-structured telephone interviews upon completion of training were conducted with 13 out of 15 participants. Interviews were analysed using directed content analysis and triangulated with quantitative data on secondary task reaction time for cognitive load estimation and participants' self-assessment scores., Results: Six major themes were identified in the interviews: goal-directed behaviour, use of learning supports for scaffolding of the training, cognitive engagement, motivation from self-assessment, self-assessment bias, and feedback on self-assessment (validation). Participants seemed to self-regulate their learning by forming individual sub-goals and strategies within the overall goal of the procedure. They scaffolded their learning through the available learning supports. Finally, structured self-assessment was reported to increase the participants' cognitive engagement, which was further supported by a quantitative increase in cognitive load., Conclusions: Structured self-assessment in simulation-based surgical training of mastoidectomy seems to promote cognitive engagement and motivation in the learning task and to facilitate self-regulated learning., Competing Interests: The general development of the Visible Ear Simulator software has been financially supported by the 10.13039/501100007696Oticon Foundation. The foundation did not play a role in the design or conduct of the study. The authors have no conflicts of interest to disclose., (© 2019 PLA General Hospital Department of Otolaryngology Head and Neck Surgery. Production and hosting by Elsevier (Singapore) Pte Ltd.)

Purpose: Reliable assessment of surgical skills is vital for competency-based medical training. Several factors influence not only the reliability of judgments but also the number of observations needed for making judgments of competency that are both consistent and reproducible. The aim of this study was to explore the role of various conditions-through the analysis of data from large-scale, simulation-based assessments of surgical technical skills-by examining the effects of those conditions on reliability using generalizability theory., Method: Assessment data from large-scale, simulation-based temporal bone surgical training research studies in 2012-2018 were pooled, yielding collectively 3,574 assessments of 1,723 performances. The authors conducted generalizability analyses using an unbalanced random-effects design, and they performed decision studies to explore the effect of the different variables on projections of reliability., Results: Overall, 5 observations were needed to achieve a generalizability coefficient > 0.8. Several variables modified the projections of reliability: increased learner experience necessitated more observations (5 for medical students, 7 for residents, and 8 for experienced surgeons), the more complex cadaveric dissection required fewer observations than virtual reality simulation (2 vs 5 observations), and increased fidelity simulation graphics reduced the number of observations needed from 7 to 4. The training structure (either massed or distributed practice) and simulator-integrated tutoring had little effect on reliability. Finally, more observations were needed during initial training when the learning curve was steepest (6 observations) compared with the plateau phase (4 observations)., Conclusions: Reliability in surgical skills assessment seems less stable than it is often reported to be. Training context and conditions influence reliability. The findings from this study highlight that medical educators should exercise caution when using a specific simulation-based assessment in other contexts.