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We identified reasons for the low follow-up rate in the Danish Knee ligament Reconstruction Register (DKRR) and evaluated its influence on the data quality. All 946 primary ACL-reconstructed patients in the Capital Region of Denmark during 2012 were identified in the databases of 8 participating hospitals. We studied the patient files and compared them to figures reported to the DKRR. 92.5% of the operated patients was registered in DKRR. The 1-year follow-up rate reported to DKRR was 33.4%, and 14.5% filled in patient reported outcomes (KOOS and Tegner) at 1 year. Only 65% had actually been invited for follow-up, but among the patients who had been invited 91% were seen. 41% of existing follow-up data was not reported. Contemporary technology and structured motivation should be introduced to increase validity of data in national clinical databases. Follow-up >90% in the DKRR is realistic if patents are invited and reported. The unreported data is potentially a serious bias. It is suggested that data from clinics with low follow-up should not be used in studies involving outcomes based on national databases because of risk of bias.

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The present study investigated the changes in contractile rate of force development (RFD) and the neural drive following a single bout of eccentric exercise. Twenty-four subjects performed 15 × 10 maximal isokinetic eccentric knee extensor contractions. Prior to and at 24, 48, 72, 96, and 168 h during post-exercise recovery, isometric RFD (30, 50 100, and 200 ms), normalized RFD [1/6,1/2, and 2/3 of maximal voluntary contraction (MVC)] and rate of electromyography rise (RER; 30, 50, and 75 ms) were measured. RFD decreased by 28-42% peaking at 48 h (P < 0.01-P < 0.001) and remained depressed at 168 h (P < 0.05). Normalized RFD at 2/3 of MVC decreased by 22-39% (P < 0.01), peaked at 72 h and returned to baseline at 168 h. These changes in RFD were associated with a decrease in RER at 48 h-96 h (P < 0.05-P < 0.001). Accumulated changes (area under curve) revealed a greater relative decrease in accumulated RFD at 100 ms by -2727 ± 309 (%h; P < 0.05) and 200 ms by -3035 ± 271 (%h; P < 0.001) compared with MVC, which decreased, by -1956 ± 234 (%h). In conclusion, RFD and RER are both markedly reduced following a bout of maximal eccentric exercise. This association suggests that exercise-induced decrements in RFD can, in part, be explained decrements in neural drive.

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BACKGROUND: Oral propranolol is widely prescribed as first-line treatment for infantile haemangiomas (IHs). Anecdotally, prescribing practice differs widely between centres. OBJECTIVES: The Propranolol In the Treatment of Complicated Haemangiomas (PITCH) Taskforce was founded to establish patterns of use of propranolol in IHs. METHODS: Participating centres entered data on all of their patients who had completed treatment with oral propranolol for IHs, using an online data capture tool. RESULTS: The study cohort comprised 1097 children from 39 centres in eight European countries. 76·1% were female and 92·8% had a focal IH, with the remainder showing a segmental, multifocal or indeterminate pattern. The main indications for treatment were periocular location (29·3%), risk of cosmetic disfigurement (21·1%) and ulceration and bleeding (20·6%). In total 69·2% of patients were titrated up to a maintenance regimen, which consisted of 2 mg kg(-1) per day (85·8%) in the majority of cases. 91·4% of patients had an excellent or good response to treatment. Rebound growth occurred in 14·1% upon stopping, of whom 53·9% were restarted and treatment response was recaptured in 91·6% of cases. While there was no significant difference in the treatment response, comparing a daily maintenance dose of < 2 mg kg(-1) vs. 2 mg kg(-1) vs. > 2 mg kg(-1) , the risk of adverse events was significantly higher: odds ratio (OR) 1 vs. adjusted OR 0·70, 95% confidence interval (CI) 0·33-1·50, P = 0·36 vs. OR 2·38, 95% CI 1·04-5·46, P = 0·04, Ptrend < 0·001. CONCLUSIONS: The PITCH survey summarizes the use of oral propranolol across 39 European centres, in a variety of IH phases, and could be used to inform treatment guidelines and the design of an interventional study.

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Recombinant factor VIIa is indicated for treatment of bleeding episodes in patients with haemophilia A or B with inhibitors; in FVII deficiency and in Glanzmann's thrombasthenia. The aim of the study reported here was to compare the pharmacokinetic profiles between two formulations of rFVIIa that are produced in two different cell lines and media: Chinese hamster ovary cells cultured in a serum-free medium (CHO-rFVIIa) and baby hamster kidney cells cultured in a non-human serum-based medium (BHK-rFVIIa). Two clinical trials were performed; one in healthy subjects and the other in patients with congenital haemophilia A or B, with or without inhibitors. Subjects were recruited into a two-way crossover trial and were randomized to receive a dose of CHO-rFVIIa and BHK-rFVIIa. Healthy subjects received one dose of 90 µg CHO-rFVIIa kg(-1) bodyweight (bw) in the newly developed room-temperature stable rFVIIa formulation and one dose of 90 µg BHK-rFVIIa kg(-1) bw, in the original rFVIIa formulation. Patients with haemophilia received one dose of 270 µg CHO-rFVIIa kg(-1) and one dose of 270 µg BHK-rFVIIa kg(-1), both in the room-temperature stable formulation. The trials showed higher FVII activity levels [higher area under the plasma concentration-time curve (AUC)] following administration of CHO-rFVIIa than after BHK-rFVIIa. Therefore, bioequivalence could not be established. The difference in FVII activity levels is believed to be a result of different glycosylation patterns between the two products. Neither the use of CHO-rFVIIa nor the use of one single dose of 270 µg kg(-1) of the newly developed room-temperature stable rFVIIa raised any safety concerns.

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Recombinant factor VIIa (rFVIIa), a haemostatic bypassing agent, has been shown to be effective and well-tolerated in patients with haemophilia at standard doses of 90 and 270 mcg kg(-1). A new room temperature stable formulation of rFVIIa was recently developed that was shown to be bioequivalent to and maintain the safety and efficacy profiles of the original formulation at a dose of 90 mcg kg(-1). The aim of this study was to examine the pharmacokinetics and safety of rFVIIa-RT at a 270 mcg kg(-1) dose. The pharmacokinetics and safety of a 270 mcg kg(-1) dose of the newly formulated room-temperature stable recombinant activated factor VII (BHK-rFVIIa-RT) was evaluated in 23 subjects with congenital haemophilia A or B. The pharmacokinetic profile for the 270 mcg kg(-1) dose of BHK-rFVIIa-RT was in line with what was previously observed for the 90 mcg kg(-1) dose. The AUC(last) and C(max) of BHK-rFVIIa-RT at 270 mcg kg(-1) (346.65 h IU mL(-1) and 146.12 IU mL(-1) respectively) were proportionally higher than those observed at the lower 90 mcg kg(-1) dose of BHK-rFVIIa-RT (113.26 h IU mL(-1) and 52.83 IU mL(-1)) demonstrating the dose-dependent nature of BHK-rFVIIa-RT activity. There were no thromboembolic events or related serious adverse events reported with the increased dose of BHK-rFVIIa-RT, and no patients withdrew because of adverse events. This indicates that BHK-rFVIIa-RT was well tolerated at a higher dosage and maintains the favourable safety profile established by rFVIIa. Therefore, the 270 mcg kg(-1) dose of BHK-rFVIIa-RT shows dose-dependent pharmacokinetic effects that do not appear to increase the risk of serious adverse events.

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Recombinant coagulation factor VIII (rFVIII) concentrates provide a safe and efficacious replacement therapy for treatment and prevention of bleeding in patients with severe haemophilia A. The aim of this study was to compare the pharmacokinetic (PK) and safety profiles of two serum-free rFVIII products: N8, a new rFVIII manufactured by Novo Nordisk and Advate(®), a marketed product. Patients with severe haemophilia A with >150 exposure days to FVIII, without current or past inhibitors, were enrolled in an open-label, first human dose (FHD), multicentre trial. Twenty-three patients first received a single dose of 50 IU kg(-1) body weight Advate(®) followed by 50 IU kg(-1) body weight N8 at the next visit. A 4-day washout period was required prior to each dosing. Blood samples for PK and safety analyses were drawn prior to dosing and at intervals up until 48 h postdosing. The PK parameters were based on FVIII clotting activity (FVIII:C) measurements. Occurrence of adverse events was closely monitored. The mean profiles of FVIII:C and all primary and secondary parameters for Advate(®) and N8 were comparable. The 90% CI for the treatment ratio (Advate(®)/N8) for all primary endpoints (incremental recovery, t(1/2), AUC and Cl), and the secondary endpoints (AUC(last) and C(max)) were within the bioequivalence interval of 0.8-1.25. There were no safety concerns in the study and no reports of inhibitor formation in the 72-h period following exposure to a single N8 dose. In conclusion, N8 is bioequivalent to Advate(®). Furthermore, N8 is well tolerated in the FHD trial.

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OBJECTIVE: To assess the risk and risk factors for respiratory syncytial virus (RSV) hospitalisation and determinants of the severity of RSV disease in children with heart disease. METHODS: By using a database on RSV tests in Denmark all children with RSV diagnosed with heart disease in Denmark from January 1996 to April 2003 were identified. For each case child one control child matched for age and centre was drawn from the population of children with heart disease. Clinical information was obtained through a review of all records. RESULTS: Data were obtained on 313 pairs. Median age at admission was 280 days (range 15-2379). In the multivariate analysis predictors of RSV hospitalisation were Down syndrome (odds ratio (OR) 3.24, 95% CI 1.80 to 5.80), cardiomyopathy (OR 5.84, 95% CI 1.26 to 27.16) and haemodynamically significant heart disease (OR 1.53, 95% CI 1.04 to 2.26). During RSV hospitalisation predictors of the need for respiratory support (supplemental oxygen, nasal continuous positive airway pressure or mechanical ventilation) were young age (relative risk (RR) 0.47, 95% CI 0.32 to 0.67 per additional year of age) and cardiac decompensation (RR 1.81, 95% CI 1.02 to 3.23). The incidence rate of RSV hospitalisation among children with any heart disease aged 0-23 months was 5.65 per 100 child-years. CONCLUSION: In children with heart disease risk factors for RSV admission are Down syndrome, cardiomyopathy and haemodynamically significant heart disease. Young age and cardiac decompensation are associated with a more severe course of RSV disease.

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We present the case of a 51-year-old woman suffering from septic arthritis of a lumbar facet joint, which was probably caused by an infected central venous catheter. Increased uptake on the bone scintigraphy was an early finding. Magnetic resonance imaging (MRI) of the spine contributed to the diagnosis by showing lesions of the facet joint and involvement of the surrounding soft tissues. Percutaneous needle aspiration guided by computed tomography established a bacteriological diagnosis. The positive response to antibiotic therapy was confirmed by MRI.

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We report a case of Takayasu's arteritis as a cause of fever of unknown origin in a woman from Somalia. In patients with fever of unknown origin, it is important to consider the rare differential diagnoses and repeat physical examination despite easy access to high-technological examination methods.

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The left common coronary arterial trees of eight pig hearts were dissected. The zero-stress state (the state of the organ when the external loads are removed) of the coronary arteries was determined by first cutting the arteries into short, ring-shaped segments perpendicular to the longitudinal axis of the blood vessel and then making a radial cut. This procedure caused the ring to open into a sector whose opening angle (theta), internal and external lengths (circumferences), and wall thickness were measured. Morphometric and theta data were organized in the framework of a diameter-defined Strahler system. We investigated 4 rings from the left common coronary artery (LCCA), 185 from the left anterior descending artery (LAD) and its branches, and 159 from the left circumflex artery (LCX) and its branches. The inner circumferences of the rings ranged over six orders for the LAD arterial tree and five orders for the LCX arterial tree, corresponding to a diameter range of about one order of magnitude for both arteries. theta demonstrates viscoelastic behavior and was measured 30 min after cutting. Our results show that the inner and outer circumference and the wall thickness increase as geometric sequences with the order number. theta is found to decrease linearly toward the smaller orders with a slope of 7.3 degrees/order in the range of the six largest orders. Strain calculations showed that the inner part of the arterial wall is in compression, whereas the outer part of the wall is in tension in the no-load (zero transmural pressure) state. This study provides basic data on the zero-stress state that are necessary for understanding the mechanics of the coronary artery.

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A case report describing a child with a primary pyogenic liver abscess is presented. Primary pyogenic liver abscess is a rare disease at this age. Furthermore the clinical picture only rarely reveals indications of liver disease. To establish the correct diagnosis within the proper time, one must remember this diagnostic possibility. The recommended treatment is shortly discussed.

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A case story describing tension pneumothorax after intercostal local anaesthetic blockade is presented. This complication has not been reported earlier. The importance of recommending that the patient subjected to intercostal blockade should contact a physician if symptoms of pneumothorax occur is emphasized. Hereby the risk of tension pneumothorax--a rare but potentially lethal complication--is reduced.

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