PROPOSE. Development and validation of a prediction model for shared decision making for patients with lumbar spinal stenosis.

Background: Decompression for lumbar spinal stenosis (LSS) is the most frequently performed spine surgery in Denmark. According to the Danish spine registry DaneSpine, at 1 year after surgery, about 75% of patients experiences considerable pain relief and around 66% improvement in quality of life. However, 25% do not improve very much. We have developed a predictive decision support tool, PROPOSE. It is intended to be used in the clinical conversation between healthcare providers and LSS patients as a shared decision-making aid presenting pros and cons of surgical intervention. This study presents the development and evaluation of PROPOSE in a clinical setting. Methods: For model development, 6.357 LSS patients enrolled in DaneSpine were identified. For model validation, predictor response and predicted outcome was collected via PROPOSE from 228 patients. Observed outcome at 1 year was retrieved from DaneSpine. All participants were treated at 3 Danish spine centers. The outcome measures presented are improvement in walking distance, the Oswestry Disability Index, EQ-5D-3L and leg/back pain on the Visual Analog Scale. Outcome variables were dichotomized into success (1) and failure (0). With the exception of walking distance, a success was defined as reaching minimal clinically important difference at 1-year follow-up. Models were trained using Multivariate Adaptive Regression Splines. Performance was assessed by inspecting confusion matrix, ROC curves and comparing GCV (generalized cross-validation) errors. Final performance of the models was evaluated on independent test data. Results: The walking distance model demonstrated excellent performance with an AUC of 0.88 and a Brier score of 0.14. The VAS leg pain model had the lowest discriminatory performance with an AUC of 0.67 and a Brier score of 0.22. Conclusions: PROPOSE works in a real-world clinical setting as a proof of concept and demonstrates acceptable performance. It may have the potential of aiding shared decision making.

Usability and performance expectancy govern spine surgeons' use of a clinical decision support system for shared decision-making on the choice of treatment of common lumbar degenerative disorders.

Study design: Quantitative survey study is the study design. Objectives: The study aims to develop a model for the factors that drive or impede the use of an artificial intelligence clinical decision support system (CDSS) called PROPOSE, which supports shared decision-making on the choice of treatment of ordinary spinal disorders. Methods: A total of 62 spine surgeons were asked to complete a questionnaire regarding their behavioral intention to use the CDSS after being introduced to PROPOSE. The model behind the questionnaire was the Unified Theory of Acceptance and Use of Technology. Data were analyzed using partial least squares structural equation modeling. Results: The degree of ease of use associated with the new technology (effort expectancy/usability) and the degree to which an individual believes that using a new technology will help them attain gains in job performance (performance expectancy) were the most important factors. Social influence and trust in the CDSS were other factors in the path model. r2 for the model was 0.63, indicating that almost two-thirds of the variance in the model was explained. The only significant effect in the multigroup analyses of path differences between two subgroups was for PROPOSE use and social influence (p = 0.01). Conclusion: Shared decision-making is essential to meet patient expectations in spine surgery. A trustworthy CDSS with ease of use and satisfactory predictive ability promoted by the leadership will stand the best chance of acceptance and bridging the communication gap between the surgeon and the patient.

6.2 l of residual urine without recognized pathology in the urinary tract before knee arthroplasty.

This is a rare case report in an elective orthopaedic setting, in which a 72-year-old man without known urologic disorders presented with a 6.2 l post-void residual urine (PVR) before a planned knee arthroplasty surgery. The PVR was found because of a newly established local guideline in an orthopaedic department regarding examination and treatment for PVR. The guideline was made in collaboration with urologists to improve the quality of treatment. Early diagnosis and treatment may prevent chronic bladder injury, urinary tract infections, urosepsis and kidney damage.

New growth rod concept provides three dimensional correction, spinal growth, and preserved pulmonary function in early-onset scoliosis.

INTRODUCTION: This study aims to describe a novel minimal invasive early-onset scoliosis (EOS) growth rod concept, the Cody Bünger (CB) Concept, which combines concave interval distraction and contralateral-guided growth with apical control and to investigate the 3D deformity correction, the spinal growth, and the pulmonary development. METHOD: A series of 38 children with progressive EOS and growth potential, receiving a highly specialized surgical treatment, including primary and conversion cases. Mean age was 10.2 years (4.4-15.8) with a mean follow-up of 5.6 years, and they underwent 168/184 open/magnetic lengthening procedures. Outcomes were as follows: scoliosis, kyphosis, and lordosis angles; apical rotation; spinal length; apical translation; coronal and sagittal vertical alignment; complications; and pulmonary function in a subgroup. RESULTS: Scoliosis improved from mean 76° (46-129) to 35° (8-74) post-op and was 42° (13-83) at end of treatment. Apical rotation was reduced by 30% but was partially lost during treatment. Thoracic kyphosis initially decreased by mean 15° and was partially lost during treatment. Lordosis was largely unaltered during treatment. Mean T1-S1 height increased from 30.7 cm (22.7-39.2) to 34.6 cm (27.8-45.1) postop and further increased to 38.5 cm (30.1-48.1) during treatment. This corresponded to a T1-S1 growth rate of 12 mm/year, and positive growth rates were found in all height parameters evaluated. Frontal balance and apical translation improved, whereas sagittal balance was unaltered. Complications occurred in 22/38 patients, and 11/38 had an unintended reoperation. Pulmonary function (FVC and FEV) increased but the relative lung function was unchanged. CONCLUSION: The new growth rod concept provided 3D correction and spinal growth at complication rates comparable with other growth-friendly techniques for EOS, while pulmonary function was preserved. Single magnetic rod distraction was incorporated successfully, replacing surgical elongations.

3-Year follow-up of a single magnetically controlled growing rod with contralateral gliding system and apical control for early onset scoliosis.

STUDY DESIGN: Two-center retrospective cohort study. OBJECTIVE: The aim of this study is to investigate the clinical effectiveness and safety of the MCGR hybrid in terms of spinal growth, 3D correction, balance, and complications. The magnetic-controlled growing-rod (MCGR) growth instrumentation method has gained popularity for early onset scoliosis (EOS) treatment in the past years due to the non-invasiveness of the subsequent interval elongation procedures. To improve 3D correction and reduce the costs, we combined a single concave MCGR with a sliding rod on the convex side to control the apex. METHODS: A retrospective cohort study of 18 EOS children with an average 3-year follow-up (range 2.0-3.7) from two European spine centers treated with the single MCGR hybrid concept; 14 primary and 4 conversion cases. The primary and conversion cases were both evaluated preoperatively, postoperatively, 1 year, 2 years, and last follow-up. RESULTS: Mean age was 9.9 (SD ± 2.9 years). The average frontal Cobb angle was reduced from mean 65° to 30° postoperatively, and had increased to 37° at latest follow-up. Rotation of the apical vertebra improved from mean 27° to 20° postoperatively which was partially lost to 23°. Kyphosis and lordosis both increased by an average of 5° during the time of follow-up. Spinal balance was improved. The post-implantation T1-S1 spine growth rate averaged 10 mm/year at last follow-up. There were 13 implant-related complications in 6 out of 18 patients. No screw pull-outs and nor surgical site infections were registered. CONCLUSIONS: This is the first medium-term results of a single MCGR hybrid construct. Maintenance of correction and growth are reasonable, and the complication rate is relatively low as compared to bilateral MCGR application. LEVEL OF EVIDENCE: III.

Lengthening of magnetically controlled growing rods caused minimal pain in 25 children: pain assessment with FPS-R, NRS, and r-FLACC.

STUDY DESIGN: Descriptive case series. OBJECTIVE: The aim of the study is to investigate the pain associated with magnetically controlled growing rod (MCGR) lengthening procedures. MCGRs have gained popularity because they offer non-surgical lengthening procedures in early-onset scoliosis (EOS) instead of semi-annual open surgery elongations with traditional growing rods. Many aspects of MCGR treatment have been investigated, but pain in conjunction with distraction is only sparsely described in the literature. METHODS: Pain intensity was assessed in 25 EOS patients before, during and after MCGR lengthening procedures in an outpatient setup. They underwent at least two (range 2-16) lengthening procedures prior to this study. The pain intensity was estimated using patient-reported Faces Pain Scale (FPS-R), caregiver-reported pain numeric rating scale (NRS), and NRS and revised Face, Legs, Activity, Cry, Consolability scale (r-FLACC) by two medically trained observers. The inter-rater reliability and correlation between instruments were analyzed. RESULTS: 23 of 25 EOS patients (8- to 16-year old) with mixed etiology were able to self-report pain. The average pain intensity was mild: median 1 (range 0-6) on all four instruments on a 0-to-10 scale. Afterward, 22/25 patients (88%) were completely pain free and the remaining 3 patients had a pain score of 1. MCGR stalling (i.e. clunking) was encountered in 14/25 (56%) of the patients without impact on the pain intensity. CONCLUSIONS: The average maximum pain intensities during the lengthening procedures were mild and pain ceased within few minutes. The inter-rater reliability was good to excellent for NRS and r-FLACC, and there were high correlations between all the four pain instruments, indicating high criterion validity. LEVEL OF EVIDENCE: Level IV, case series.

Percutaneous needle fasciotomy in Dupuytren contracture: a register-based, observational cohort study on complications in 3,331 treated fingers in 2,257 patients.

Background and purpose - Percutaneous needle fasciotomy (PNF) is a minimally invasive treatment option for Dupuytren contracture, which has gained momentum worldwide in recent years. However, evidence regarding safety and severe complications associated with PNF is sparse. Thus, we evaluated safety of a specific PNF method in the largest cohort reported in literature.Patients and methods - This is a single-center, register-based, observational study on PNF treatments between 2007 and 2015. The study cohort was identified by the Danish National Patient Registry, and diagnosis codes and procedure codes were used to identify potential severe postoperative complications such as: tendon rupture, nerve damage, infection, amputation, and reflex dystrophy for all index treatments. The Danish National Prescription Registry was used to identify non-hospital-treated infections. All index treatments and postoperative complications were verified by review of medical records.Results - 2,257 patients received PNF treatment of 3,331 treated finger rays. Median follow-up was 7.2 years (interquartile range: 4.9-9.5 years, range 1-12 years). 4 patients sustained flexor tendon rupture. 1 patient had digital nerve damage. 2 patients had an infection treated in hospital, while 31 patients received antibiotics in the primary sector for an infection or based on suspicion of an infection after PNF. None of the infections required surgical intervention. No finger amputations or ipsilateral upper limb reflex dystrophy cases were registered in relation to the procedure.Interpretation - Percutaneous needle fasciotomy for Dupuytren contracture is a safe procedure with a low rate of severe postoperative complications when a specific PNF method is applied.

Treatment of early-onset scoliosis with a hybrid of a concave magnetic driver (magnetic controlled growth rod) and a contralateral passive sliding rod construct with apical control: preliminary report on 17 cases.

BACKGROUND CONTEXT: Magnetic controlled growth rods (MCGRs) are increasingly popular for surgical treatment of severe early-onset scoliosis (EOS), because they allow noninvasive extensions with good growth maintenance. We combined an MCGR with a contralateral passive sliding rod construct with apical control on the convex side to improve efficiency in terms of costs and three-dimensional (3D) correction. PURPOSE: To investigate the feasibility, 3D correction, spinal growth, and complications of the apical control MCGR sliding rod hybrid. STUDY DESIGN: Two-center retrospective cohort study. PATIENT SAMPLE: A consecutive series of 17 children with EOS from two European spine centers were treated with the hybrid principle: 13 primary cases and 4 conversion cases from other growth instrumentation. Median age at surgery was 9 years (range: 6-18). Median follow-up time was 24 months (range: 12-31). OUTCOMES: Cobb angles (frontal Cobb, kyphosis, lordosis), rotation, spinal length gain, growth rate, and complications. METHODS: Radiographs and patient files were reviewed. All the patients received fully financed treatment within the national public health-care systems. RESULTS: Mean preoperative frontal Cobb angle was 59°, reduced postoperatively to 30° and was maintained throughout follow-up. Mean rotation of the apical vertebra improved from 27° to 18°, but was partially lost over time. Kyphosis decreased and lordosis was largely unaltered. Instrumented spine growth was maintained at a mean of 12 mm per year. One child had surgical revision because of progressive trunk shift, unrelated to the technique. The same child fell and sustained T1 and T2 fractures that were treated conservatively. Another child is planned for revision because of MCGR distraction failure. CONCLUSION: These early results show satisfactory frontal Cobb curve reduction and maintenance of spinal growth after using a new hybrid concept of a single magnetic growth rod and contralateral apical control sliding rods. A single magnetic growth rod in this combination may work equally well as traditional or dual magnetic growth rods. This new concept may represent a significant gain in both cost-effectiveness of growth rod treatment and 3D correction in EOS.

Injectable Collagenase Versus Percutaneous Needle Fasciotomy for Dupuytren Contracture in Proximal Interphalangeal Joints: A Randomized Controlled Trial.

PURPOSE: Collagenase Clostridium histolyticum (CCH) injection was introduced commercially as a treatment for Dupuytren contracture following initial phase-3 investigations in 2009 with promising results. However, the efficacy of CCH has not been prospectively investigated in a direct comparison to other active treatments of Dupuytren contracture with more than 1-year follow-up, despite a wide and increasing clinical use. METHOD: In this prospective, independent, open-label, randomized controlled trial, (Clinicaltrials.gov; NCT 01538017), percutaneous needle fasciotomy (PNF) was directly compared with CCH. Fifty patients with primary isolated proximal interphalangeal joint Dupuytren contractures were enrolled and followed for 2 years. The primary outcome was clinical improvement defined as a reduction in contracture by 50% or more relative to baseline. Secondary outcomes included change in contracture, recurrence, adverse events, complications, and Disabilities of the Arm, Shoulder, and Hand questionnaire score. RESULTS: Clinical improvement at 2 years was maintained in 7% of CCH patients (2 of 29) and 29% of PNF patients (6 of 21). Collagenase Clostridium histolyticum led to more, mainly transient, complications, in 93% of patients versus 24% of the patients treated with PNF. No other differences were observed. CONCLUSIONS: This study provides evidence that CCH is not superior to PNF in the treatment of isolated proximal interphalangeal joint Dupuytren contracture regarding clinical outcome, and it led to more complications than PNF. TYPE OF STUDY/LEVEL OF EVIDENCE: Therapeutic I.

Wood ash application increases pH but does not harm the soil mesofauna.

Application of bioash from biofuel combustion to soil supports nutrient recycling, but may have unwanted and detrimental ecotoxicological side-effects, as the ash is a complex mixture of compounds that could affect soil invertebrates directly or through changes in their food or habitat conditions. To examine this, we performed laboratory toxicity studies of the effects of wood-ash added to an agricultural soil and the organic horizon of a coniferous plantation soil with the detrivore soil collembolans Folsomia candida and Onychiurus yodai, the gamasid predaceous mite Hypoaspis aculeifer, and the enchytraeid worm Enchytraeus crypticus. We used ash concentrations spanning 0-75 g kg-1 soil. As ash increases pH we compared bioash effects with effects of calcium hydroxide, Ca(OH)2, the main liming component of ash. Only high ash concentrations above 15 g kg-1 agricultural soil or 17 t ha-1 had significant effects on the collembolans. The wood ash neither affected H. aculeifer nor E. crypticus. The estimated osmolalities of Ca(OH)2 and the wood ash were similar at the LC50 concentration level. We conclude that short-term chronic effects of wood ash differ among different soil types, and osmotic stress is the likely cause of effects while high pH and heavy metals is of minor importance.

Change in airway inflammatory markers in Danish energy plant workers during a working week.

INTRODUCTION: It is well known that exposure to organic dust can cause adverse respiratory effect. The pathogen-associated molecular patterns (PAMPS) in the organic dust, such as endotoxin from Gram-negative bacteria cell wall and fungal components, can trigger the release of cytokine (e.g. Interleukin 1ß (IL-1ß)) and chemokine (e.g. Interleukin 8 (IL-8)) from the immune cells in the airways. OBJECTIVE: To evaluate the potential inflammatory effects of organic dust exposure in energy plants in Denmark. MATERIALS AND METHODS: Nasal lavage (NAL) and exhaled breath condensate (EBC) were sampled at Monday morning (referred to as before work) and again at Thursday afternoon (referred to as after work). NAL IL-8, EBC pH, IL-1ß concentration were measured. Personal exposure to endotoxin and dust was calculated from time spent on different tasks and measured average work area exposures. RESULTS: Before work, workers from biofuel plants had a higher IL-1ß and IL-8 concentration compared to conventional fuel plants (control group). Specifically, the IL-1ß level of moderately and most exposed group, and IL-8 level of the least exposed group were higher compared to the control group. The changes of IL-1ß, pH and IL-8 during a work week were not significant. Workers with rhinitis had a lower percentage change of IL-8 compared to healthy workers. CONCLUSIONS: An increased level of EBC IL-1ß in biofuel energy plant workers before work indicated a chronic or sub-chronic inflammation. The percentage change of IL-8 was lower in workers with rhinitis compared to healthy workers.

Sensitisation to common allergens and respiratory symptoms in endotoxin exposed workers: a pooled analysis.

OBJECTIVE: To test the hypotheses that current endotoxin exposure is inversely associated with allergic sensitisation and positively associated with non-allergic respiratory diseases in four occupationally exposed populations using a standardised analytical approach. METHODS: Data were pooled from four epidemiological studies including 3883 Dutch and Danish employees in veterinary medicine, agriculture and power plants using biofuel. Endotoxin exposure was estimated by quantitative job-exposure matrices specific for the study populations. Dose-response relationships between exposure, IgE-mediated sensitisation to common allergens and self-reported health symptoms were assessed using logistic regression and generalised additive modelling. Adjustments were made for study, age, sex, atopic predisposition, smoking habit and farm childhood. Heterogeneity was assessed by analysis stratified by study. RESULTS: Current endotoxin exposure was dose-dependently associated with a reduced prevalence of allergic sensitisation (ORs of 0.92, 0.81 and 0.66 for low mediate, high mediate and high exposure) and hay fever (ORs of 1.16, 0.81 and 0.58). Endotoxin exposure was a risk factor for organic dust toxic syndrome, and levels above 100 EU/m(3) significantly increased the risk of chronic bronchitis (p<0.0001). Stratification by farm childhood showed no effect modification except for allergic sensitisation. Only among workers without a farm childhood, endotoxin exposure was inversely associated with allergic sensitisation. Heterogeneity was primarily present for biofuel workers. CONCLUSIONS: Occupational endotoxin exposure has a protective effect on allergic sensitisation and hay fever but increases the risk for organic dust toxic syndrome and chronic bronchitis. Endotoxin's protective effects are most clearly observed among agricultural workers.

Does the use of biofuels affect respiratory health among male Danish energy plant workers?

OBJECTIVES: To study asthma, respiratory symptoms and lung function among energy plant employees working with woodchip, straw or conventional fuel. METHODS: Respiratory symptoms in 138 woodchip workers, 94 straw workers and 107 control workers from 85 heating- or combined heating and power plants were collected by questionnaire. Spirometry, metacholine provocation tests and skin prick tests were performed on 310 workers. The work area concentrations of 'total dust' (n=181), airborne endotoxin (n=179), cultivable Aspergillus fumigatus (n=373) and cultivable fungi (n=406) were measured at each plant. Personal exposure was calculated from the time spent on different tasks and average work area exposures. RESULTS: Median (range) average personal exposures in biofuel plants were 0.05 (0 to 0.33) mg/m³ for 'total' dust and 3.5 (0 to 294) endotoxin units/m³ for endotoxin. Fungi were cultivated from filters (straw plants) or slit samplers (woodchip plants); the average personal exposures were 5.230×10³ (118 to 1.85×104) and 1.03×10³ (364 to 5.01×10³) colony-forming units/m³ respectively. Exposure levels were increased in biofuel plants compared with conventional plants. The prevalence of respiratory symptoms among conventional plant and biofuel plant workers was comparable, except for asthma symptoms among non-smokers, which were higher among straw workers compared with controls (9.4 vs 0%, p<0.05). A trend for increasing respiratory symptoms with increasing endotoxin exposure was seen with ORs between 3.1 (1.1 to 8.8) (work-related nose symptoms) and 8.1 (1.5 to 44.4) (asthma symptoms) for the most exposed group. Associations between fungal exposure and respiratory symptoms were less clear but suggested cultivable fungi to be associated with asthma symptoms and work-related respiratory symptoms. No associations were seen between lung function and the level of endotoxin or fungal exposure. CONCLUSIONS: Working with biofuel at an energy plant does not generally enhance the prevalence of respiratory symptoms. However, the exposure level to micro-organisms has an impact on the occurrence of respiratory symptoms among biofuel workers.