SWISSspine: a nationwide registry for health technology assessment of lumbar disc prostheses

SWISSspine is a so-called pragmatic trial for assessment of safety and efficiency of total disc arthroplasty (TDA). It follows the new health technology assessment (HTA) principle of "coverage with evidence development”. It is the first mandatory HTA registry of its kind in the history of Swiss orthopaedic surgery. Its goal is the generation of evidence for a decision by the Swiss federal office of health about reimbursement of the concerned technologies and treatments by the basic health insurance of Switzerland. During the time between March 2005 and 2008, 427 interventions with implantation of 497 lumbar total disc arthroplasties have been documented. Data was collected in a prospective, observational multicenter mode. The preliminary timeframe for the registry was 3years and has already been extended. Data collection happens pre- and perioperatively, at the 3months and 1-year follow-up and annually thereafter. Surgery, implant and follow-up case report forms are administered by spinal surgeons. Comorbidity questionnaires, NASS and EQ-5D forms are completed by the patients. Significant and clinically relevant reduction of low back pain VAS (70.3-29.4 points preop to 1-year postop, p<0.0001) leg pain VAS (55.5-19.1 points preop to 1-year postop, p<0.001), improvement of quality of life (EQ-5D, 0.32-0.73 points preop to 1-year postop, p<0.001) and reduction of pain killer consumption was revealed at the 1-year follow-up. There were 14 (3.9%) complications and 7 (2.0%) revisions within the same hospitalization reported for monosegmental TDA; there were 6 (8.6%) complications and 8 (11.4%) revisions for bisegmental surgery. There were 35 patients (9.8%) with complications during followup in monosegmental and 9 (12.9%) in bisegmental surgery and 11 (3.1%) revisions with new hospitalization in monosegmental and 1 (1.4%) in bisegmental surgery. Regression analysis suggested a preoperative VAS "threshold value” of about 44 points for increased likelihood of a minimum clinically relevant back pain improvement. In a short-term perspective, lumbar TDA appears as a relatively safe and efficient procedure concerning pain reduction and improvement of quality of life. Nevertheless, no prediction about the long-term goals of TDA can be made yet. The SWISSspine registry proofs to be an excellent tool for collection of observational data in a nationwide framework whereby advantages and deficits of its design must be considered. It can act as a model for similar projects in other health-care domain

Distribuição horizontal da produtividade de soja em sistema de integração lavoura-pecuária-floresta

O sistema de integração lavoura-pecuária-floresta (ILPF) possibilita aumentar a renda da propriedade, devido a intensificação do uso da terra e o aumento da eficiência dos sistemas de produção. No entanto, com o crescimento das árvores, há uma diminuição progressiva da luminosidade disponível para o sub&#8209;bosque que pode influenciar a produtividade do componente agrícola. O objetivo do presente trabalho foi avaliar a distribuição horizontal da produtividade de soja no sistema ILPF e compará-la ao cultivo exclusivo. O experimento foi conduzido no município de Sinop/MT, avaliando-se os seguintes tratamentos: lavoura com cultivo de soja na safra e milho consorciado com Brachiaria brizantha na safrinha e o sistema de ILPF, com cultivo de eucalipto em faixas de linhas triplas (3,5 x 3,0 m orientação Leste Oeste), com soja safra na faixa de agricultura (entrerenques), seguido de milho safrinha consorciado com B. brizantha. Os tratamentos foram implantados na safra 2011/2012 sendo que as árvores foram plantadas em novembro de 2011. O experimento seguiu o delineamento de blocos casualizados (DBC) com 4 repetições. As avaliações foram realizadas no segundo ano agrícola, após implantação do experimento, na safra 2012/2013. As características agronômicas da soja foram realizadas no estágio de desenvolvimento R8, avaliando-se duas linhas de 5 m em oito posições aleatórias no cultivo exclusivo de soja. No tratamento ILPF, as duas linhas de 5 m foram avaliadas em quatro transectos equidistantes, posicionadas no sentido transversal às linhas da espécie florestal, nas distâncias de 3, 6, 10 e 15 m das florestais, para ambos os lados (face norte e face sul). Foram avaliados: número de plantas, índice de acamamento com notas de 1 a 5 (1: > 90% de plantas eretas e 5: > 80% de plantas acamadas), massa de 100 grãos e produtividade (kg ha -1 com 13% de umidade). No segundo ano agrícola, o eucalipto estava com 12 meses de idade, altura média de 4 m e DAP médio de 5,1 cm. A projeção máxima de sombra na face norte foi de 4 m às 09:30 h. Não houve diferenças significativas entre a soja cultivada em sistema exclusivo e a soja cultivada no sistema ILPF para o número de plantas (p>0,37), peso de 100 grãos (p>0,24) e índice de acamamento (p>0,24). A produtividade média de soja foi de 4.041 kg ha -1 na lavoura exclusiva e 3.999 kg ha -1 na ILPF e também não diferiu significativamente (p> 0,26). Na avaliação da distribuição horizontal, a faixa de árvores do sistema ILPF não afetou a produtividade do componente agrícola no segundo ano de condução do sistema

Distribuição horizontal e vertical de fósforo em sistemas de cultivos exclusivos de soja e de integração lavoura-pecuária-floresta.

O objetivo deste trabalho foi avaliar a distribuição horizontal e vertical do fósforo no solo e a produtividade de soja em sistemas de cultivos exclusivos e de integração lavoura-pecuária-floresta (ILPF). Foram avaliados os tratamentos: floresta plantada de eucalipto; lavoura de soja e milho safrinha consorciado com Urochloa brizantha 'Marandu'; pastagem de U. brizantha; sistema de ILPF; e duas áreas controle, com floresta nativa e pousio. O solo foi coletado nas camadas de 0-5, 5-10, 10-20 e 20-30 cm, para determinação das características químicas. As avaliações foram realizadas no segundo ano agrícola após a implantação do experimento. No sistema de ILPF, solo e produtividade foram avaliados em quatro transectos equidistantes, no centro do renque e a 3, 6, 10 e 15 m do renque, nas faces norte e sul. Os teores de P disponível (Mehlich-1) foram maiores nas camadas superficiais do solo, nos sistemas com soja/milho safrinha e com ILPF. No ILPF, os teores de P disponível não diferiram entre as distâncias do renque das árvores, e a produtividade de soja não diferiu da observada no sistema com soja/milho safrinha. Portanto, com dois anos de implantação, o sistema ILPF ainda não é capaz de interferir marcadamente nas características químicas do solo e na produtividade da soja

Negative Effect of Smoking on the Performance of the QuantiFERON TB Gold in Tube Test.

False negative and indeterminate Interferon Gamma Release Assay (IGRA) results are a well documented problem. Cigarette smoking is known to increase the risk of tuberculosis (TB) and to impair Interferon-gamma (IFN-γ) responses to antigenic challenge, but the impact of smoking on IGRA performance is not known. The aim of this study was to evaluate the effect of smoking on IGRA performance in TB patients in a low and high TB prevalence setting respectively. Patients with confirmed TB from Denmark (DK, n = 34; 20 smokers) and Tanzania (TZ, n = 172; 23 smokers) were tested with the QuantiFERON-TB Gold In tube (QFT). Median IFN-γ level in smokers and non smokers were compared and smoking was analysed as a risk factor for false negative and indeterminate QFT results. Smokers from both DK and TZ had lower IFN-γ antigen responses (median 0.9 vs. 4.2 IU/ml, p = 0.04 and 0.4 vs. 1.6, p < 0.01), less positive (50 vs. 86%, p = 0.03 and 48 vs. 75%, p < 0.01) and more false negative (45 vs. 0%, p < 0.01 and 26 vs. 11%, p = 0.04) QFT results. In Tanzanian patients, logistic regression analysis adjusted for sex, age, HIV and alcohol consumption showed an association of smoking with false negative (OR 17.1, CI: 3.0-99.1, p < 0.01) and indeterminate QFT results (OR 5.1, CI: 1.2-21.3, p = 0.02). Cigarette smoking was associated with false negative and indeterminate IGRA results in both a high and a low TB endemic setting independent of HIV status

Intravenous ibandronate reduces the incidence of skeletal complications in patients with breast cancer and bone metastases

Background: This phase III study compared the efficacy of the new potent bisphosphonate, ibandronate, with placebo as intravenous (i.v.) therapy in metastatic bone disease due to breast cancer. Patients and methods: A total of 466 patients were randomised to receive placebo (n = 158), or 2 mg (n = 154) or 6 mg (n = 154) ibandronate every 3-4 weeks for up to 2 years. The primary efficacy parameter was the number of 12-week periods with new bone complications, expressed as the skeletal morbidity period rate (SMPR). Bone pain, analgesic use and safety were evaluated monthly. Results SMPR was lower in both ibandronate groups compared with the placebo group; the difference was statistically significant for the ibandronate 6 mg group (P = 0.004 versus placebo). Consistent with the SMPR, ibandronate 6 mg significantly reduced the number of new bone events (by 38%) and increased time to first new bone event. Patients on ibandronate 6 mg also experienced decreased bone pain scores and analgesic use. Treatment with ibandronate was well tolerated. Conclusions: These results indicate that 6 mg i.v. ibandronate is effective and safe in the treatment of bone metastases from breast cance

Uloga testova otpuštanja interferona gama u nadzoru nad tuberkulozom

Tuberculosis is still one of the major global public health threats. Countries with low incidence must focus on exhausting the reservoir of future cases by preventing reactivation. Therefore, it is important to identify and effectively treat those individuals who have latent tuberculosis infection and who may develop active disease. The tuberculin skin test has been the standard for detection of immune response against M. tuberculosis since the beginning of the 20th century. The new millennium has brought advancement in the diagnosis of latent tuberculosis infection. The name of the new blood test is interferon-gamma release assay (IGRA). Croatia is a middle-incidence country with a long decreasing trend and developed tuberculosis control. To reach low incidence and finally eliminate tuberculosis, its tuberculosis programme needs a more aggressive approach that would include intensive contact investigation and treatment of persons with latent tuberculosis infection. This article discusses the current uses of IGRA and its role in tuberculosis control.Tuberkuloza je i danas jedan od vodećih javnozdravstvenih problema. Zemlje s niskom incidencijom fokusiraju se na iscrpljivanje rezervoara budućih slučajeva sprječavanjem reaktivacije bolesti. To se odnosi na traženje i učinkovito liječenje infi ciranih osoba, primarno onih koje su u riziku od obolijevanja nakon infekcije. Tuberkulinski test je od početka 20. stoljeća bio standard u otkrivanju imunosnog odgovora na kontakt s Mycobacterium tuberculosis. Novo tisućljeće donijelo je određeni napredak u obliku novih testova za dijagnozu latentne tuberkulozne infekcije, krvne testove otpuštanja interferona gama. Hrvatska je zemlja srednje incidencije tuberkuloze s dugogodišnjim silaznim trendom i razvijenim protutuberkuloznim aktivnostima. U težnji prema niskoj incidenciji i u konačnici eliminaciji tuberkuloze potrebne su opsežnije aktivnosti unutar državnog programa nadzora nad tuberkulozom, uključujući intenzivnu obradu kontakata i probir na postojanje latentne tuberkulozne infekcije. Ovaj rad razmatra trenutačnu uporabu IGRE (engl. interferon - gamma release assay) i njezinu ulogu u nadzoru nad tuberkulozom

Increased fibrosis in a mouse model of anti-laminin 332 mucous membrane pemphigoid remains unaltered by inhibition of aldehyde dehydrogenase

Mucous membrane pemphigoid (MMP) is an autoimmune blistering disease characterized by autoantibodies against the basal membrane zone of skin and surface-close epithelia and predominant mucosal lesions. The oral cavity and conjunctivae are most frequently affected, albeit clinical manifestations can also occur on the skin. MMP-associated lesions outside the oral cavity typically lead to scarring. Mechanisms underlying scarring are largely unknown in MMP and effective treatment options are limited. Herein, we assessed the collagen architecture in tissue samples of an antibody-transfer mouse model of anti-laminin-332 MMP. In MMP mice, increased collagen fibril density was observed in skin and conjunctival lesions compared to mice injected with normal rabbit IgG. The extracellular matrix of MMP skin samples also showed altered post-translational collagen cross-linking with increased levels of both lysine- and hydroxylysine-derived collagen crosslinks supporting the fibrotic phenotype in experimental MMP compared to control animals. In addition, we evaluated a potential anti-fibrotic therapy in experimental anti-laminin-332 MMP using disulfiram, an inhibitor of the aldehyde dehydrogenase (ALDH), which has been implicated in immune-mediated mucosal scarring. In addition, disulfiram also acts as a copper chelator that was shown to block lysyl oxidase activity, an enzyme involved in formation of collagen crosslinks. Topical use of disulfiram (300 μM in 2 [w/v] methocel) did not improve ocular lesions in experimental MMP over the 12-day treatment period in disulfiram-treated mice compared to vehicle-treated mice (n=8/group). Furthermore, C57BL6/J mice (n=8/group) were treated prophylactically with 200 mg/kg p.o. disulfiram or the solvent once daily over a period of 12 days. Systemic treatment did not show any reduction in the severity of oral and ocular lesions in MMP mice, albeit some improvement in skin lesions was observed in disulfiram- vs. vehicle-treated mice (p=0.052). No reduction in fibrosis was seen, as assessed by immunohistochemistry. Whilst blocking of ALDH failed to significantly ameliorate disease activity, our data provide new insight into fibrotic processes highlighting changes in the collagenous matrix and cross-linking patterns in IgG-mediated MMP

Adoption Issues in DevOps from the Perspective of Continuous Delivery Pipeline

DevOps and Continuous Delivery (CD) are the terms that are always related to each other in Software Delivery and Operation Process area. DevOps introduces a significant agile perspective to deliver the software product in short cycle time that will reduce technical debt that is caused by delay. Continuous Delivery is one of the DevOps' practices that enables software organization to release new features and new products rapidly. However, the correct practices are still in ambiguity to the current CD process. This paper investigates the advantages and limitation of DevOps adoption to improve the CD process. A qualitative web survey has been conducted to identify the DevOps and Continuous Delivery advantages and adoption problems. 13 respondents' feedbacks have been collected and analyzed. Based on the survey, there are four significant DevOps' practices that need to be considered and developed as a proper guideline to introduce to practitioners

The role of bisphosphonates in breast cancer: The present and future role of bisphosphonates in the management of patients with breast cancer

At least 25% of patients with breast cancer develop skeletal metastases, with bone the site of disease producing the greatest morbidity. It is apparent that the bisphosphonates present an important component of the treatment strategy. They are now the treatment of choice in tumour-induced hypercalcaemia, and they can reduce bone pain and skeletal complications such as pathological fractures. In addition, bisphosphonates are being increasingly evaluated in the prevention of bone metastases and to prevent and treat cancer therapy-induced osteoporosis. Ongoing research is aimed at trying to define the optimum route, dose, schedule and type of bisphosphonate