Metabolic Improvements in Obese Type 2 Diabetes Subjects Implanted for 1 Year with an Endoscopically Deployed Duodenal-Jejunal Bypass Liner

Background: The purpose of this study was to evaluate the effect of the duodenal-jejunal bypass liner (DJBL), a 60-cm, impermeable fluoropolymer liner anchored in the duodenum to create a duodenal-jejunal bypass, on metabolic parameters in obese subjects with type 2 diabetes. Methods: Twenty-two subjects (mean age, 46.2 +/- 10.5 years) with type 2 diabetes and a body mass index between 40 and 60 kg/m(2) (mean body mass index, 44.8 +/- 7.4 kg/m(2)) were enrolled in this 52-week, prospective, open-label clinical trial. Endoscopic device implantation was performed with the patient under general anesthesia, and the subjects were examined periodically during the next 52 weeks. Primary end points included changes in fasting blood glucose and insulin levels and changes in hemoglobin A1c (HbA1c). The DJBL was removed endoscopically at the end of the study. Results: Thirteen subjects completed the 52-week study, and the mean duration of the implant period for all subjects was 41.9 +/- 3.2 weeks. Reasons for early removal of the device included device migration (n = 3), gastrointestinal bleeding (n = 1), abdominal pain (n = 2), principal investigator request (n = 2), and discovery of an unrelated malignancy (n = 1). Using last observation carried forward, statistically significant reductions in fasting blood glucose (-30.3 +/- 10.2 mg/dL), fasting insulin (-7.3 +/- 2.6 mu U/mL), and HbA1c (-2.1 +/- 0.3%) were observed. At the end of the study, 16 of the 22 subjects had an HbA1c < 7% compared with only one of 22 at baseline. Upper abdominal pain (n = 11), back pain (n = 5), nausea (n = 7), and vomiting (n = 7) were the most common device-related adverse events. Conclusions: The DJBL improves glycemic status in obese subjects with diabetes and therefore represents a nonsurgical, reversible alternative to bariatric surgery.

Effect of age at disease onset in the clinical profile of spondyloarthritis: a study of 1424 Brazilian patients

Objectives To analyse demographic and clinical variables in patients with disease onset before and after 40, 45 and 50 years in a large series of Brazilian SpA patients. Methods A common protocol of investigation was prospectively applied to 1424 SpA patients in 29 centres distributed through the main geographical regions in Brazil. The mean age at disease onset was 28.56 +/- 12.34 years, with 259 patients (18.2%) referring disease onset after 40 years, 15.1 (10.6%) after 45 years and 81 (5.8%) after 50 years. Clinical and demographic variables and disease indices (BASDAI, BASFI, BASRI, MASES, ASQoL) were investigated. Ankylosing spondylitis was the most frequent disease (66.3%), followed by psoriatic arthritis (18%), undifferentiated SpA (6.7%), reactive arthritis (5.5%), and enteropathic arthritis (3.5%). Results Comparing the groups according to age of disease onset, those patients with later onset presented statistical association with female gender, peripheral arthritis, dactylitis, nail involvement and psoriasis, as well as negative statistical association with inflammatory low hack pain, alternating buttock pain, radiographic sacroiliitis, hip involvement, positive familial history, HLA-B27 and uveitis. BASDAI, BASFI and quality of life, as well as physicians and patient's global assessment, were similar in all the groups. Radiographic indices showed worse results in the younger age groups. Conclusion There are two different clinical patterns in SpA defined by age at disease onset: one with predominance of axial symptoms in the group with disease onset <= 40 years and another favouring the peripheral manifestations in those with later disease onset.

Contributions of ergonomics to the construction of bus drivers health and excellence in public transport and at work

This article is the product of research that analyzed the work of bus drivers of a public transportation company that is considered a benchmark reference in its field of operations, in which it strives to achieve operating excellence. Within this context, the authors sought to understand how such a company has managed to maintain a policy that is capable of reconciling quality public transport while also providing working conditions compatible with the professional development, comfort and health of its workers. Ergonomic work analysis and activity analysis were the guiding elements used in this study. Initial analyses indicate that the activity of drivers includes serving a population and providing mobility for it, which depends on driving the vehicle itself and on relationships with colleagues, users, pedestrians, drivers and others.

Incapacidade relacionada à dor lombar crônica: prevalência e fatores associados

A incapacidade relacionada à dor lombar crônica (DLC) é um fenômeno complexo e multifatorial. O objetivo desse estudo foi identificar a prevalência e os fatores associados à incapacidade em pacientes com dor lombar crônica. Estudo transversal com amostra composta por 177 pacientes com DLC, de três serviços de saúde; que responderam ao formulário com dados demográficos, ao Inventário de Depressão de Beck, às Escalas Oswestry Disability Index, de autoeficácia para dor crônica, Tampa de Cinesiofobia e de Fadiga de Piper. A prevalência de incapacidade foi de 65% (IC95%: 57,5 - 72,0) e era de moderada a grave em 80,7% dos pacientes. O modelo de regressão múltipla identificou três fatores independentemente associados à incapacidade: ausência de trabalho remunerado, autoeficácia baixa e depressão. Os fatores associados à incapacidade identificados são modificáveis. Intervenções como recolocação no trabalho, tratamento para a depressão e reconceitualização da crença de autoeficácia podem ter um impacto importante na prevenção e redução de incapacidade.

Estabilizações lombares dinâmicas

O funcionamento fisiológico normal da coluna depende da movimentação normal de cada unidade motora, que consiste em duas vértebras e o disco intervertebral interposto entre elas. Embora a artrodese da coluna vertebral venha sendo utilizada para o tratamento de diversas doenças da coluna, essa modalidade de tratamento acarreta a perda de movimentação dos níveis em que houve a fusão e como consequência pode sobrecarregar os níveis adjacentes podendo provocar a sua degeneração precoce. Proponentes das técnicas de estabilização dinâmicas acreditam que estas podem levar a correção dos problemas minimizando o risco de degeneração dos níveis adjacentes. Atualmente existem no mercado diversos métodos de estabilização dinâmica anteriores e posteriores. Já existem trabalhos biomecânicos que comprovam o benefício teórico de quase todos eles, porém ainda hoje, faltam ensaios clínicos que comprovem a sua utilidade e segurança por longos períodos de seguimento para o paciente. Portanto é fundamental que estes materiais sejam analisados de maneira acadêmica para que no futuro próximo possam ser utilizados em situações precisas e com segurança para os pacientes.

Benchmarking in the SWISSspine registry: results of 52 Dynardi lumbar total disc replacements compared with the data pool of 431 other lumbar disc prostheses

The SWISSspine registry is the first mandatory registry of its kind in the history of Swiss orthopaedics and it follows the principle of "coverage with evidence development". 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. Recently, developed and clinically implemented, the Dynardi total disc arthroplasty (TDA) accounted for 10% of the implanted lumbar TDAs in the registry. We compared the outcomes of patients treated with Dynardi to those of the recipients of the other TDAs in the registry. Between March 2005 and October 2009, 483 patients with single-level TDA were documented in the registry. The 52 patients with a single Dynardi lumbar disc prosthesis implanted by two surgeons (CE and OS) were compared to the 431 patients who received one of the other prostheses. Data were collected in a prospective, observational multicenter mode. Surgery, implant, 3-month, 1-year, and 2-year follow-up forms as well as comorbidity, NASS and EQ-5D questionnaires were collected. For statistical analyses, the Wilcoxon signed-rank test and chi-square test were used. Multivariate regression analyses were also performed. Significant and clinically relevant reduction of low back pain and leg pain as well as improvement in quality of life was seen in both groups (P < 0.001 postop vs. preop). There were no inter-group differences regarding postoperative pain levels, intraoperative and follow-up complications or revision procedures with a new hospitalization. However, significantly more Dynardi patients achieved a minimum clinically relevant low back pain alleviation of 18 VAS points and a quality of life improvement of 0.25 EQ-5D points. The patients with Dynardi prosthesis showed a similar outcome to patients receiving the other TDAs in terms of postoperative low back and leg pain, complications, and revision procedures. A higher likelihood for achieving a minimum clinically relevant improvement of low back pain and quality of life in Dynardi patients was observed. This difference might be due to the large number of surgeons using other TDAs compared to only two surgeons using the Dynardi TDA, with corresponding variations in patient selection, patient-physician interaction and other factors, which cannot be assessed in a registry study.

Development of a documentation instrument for the conservative treatment of spinal disorders in the International Spine Registry, Spine Tango

Spine Tango is the first and only International Spine Registry in operation to date. So far, only surgical spinal interventions have been recorded and no comparable structured and comprehensive documentation instrument for conservative treatments of spinal disorders is available. This study reports on the development of a documentation instrument for the conservative treatment of spinal disorders by using the Delphi consensus method. It was conducted with a group of international experts in the field. We also assessed the usability of this new assessment tool with a prospective feasibility study on 97 outpatients and inpatients with low back or neck pain undergoing conservative treatment. The new 'Spine Tango conservative' questionnaire proved useful and suitable for the documentation of pathologies, conservative treatments and outcomes of patients with low back or neck problems. A follow-up questionnaire seemed less important in the predominantly outpatient setting. In the feasibility study, between 43 and 63% of patients reached the minimal clinically important difference in pain relief and Core Outcome Measures Index at 3 months after therapy; 87% of patients with back pain and 85% with neck pain were satisfied with the received treatment. With 'Spine Tango conservative' a first step has been taken to develop and implement a complementary system for documentation and evaluation of non-surgical spinal interventions and outcomes within the framework of the International Spine Registry. It proved useful and feasible in a first pilot study, but it will take the experience of many more cases and therapists to develop a version similarly mature as the surgical instruments of Spine Tango.

The in vitro effects of dexamethasone, insulin and triiodothyronine on degenerative human intervertebral disc cells under normoxic and hypoxic conditions

Degeneration of intervertebral discs (IVD) is one of the main causes of back pain and tissue engineering has been proposed as a treatment. Tissue engineering requires the use of highly expensive growth factors, which might, in addition, lack regulatory approval for human use. In an effort to find readily available differentiation factors, we tested three molecules – dexamethasone, triiodothyronine (T3) and insulin – on human IVD cells isolated after surgery, expanded in vitro and transferred into alginate beads. Triplicates containing 40 ng/ml dexamethasone, 10 nM T3 and 10 µg/ml insulin, together with a positive control (10 ng/mL transforming growth factor (TGF)-beta 1), were sampled weekly over six weeks and compared to a negative control. Furthermore, we compared the results to cultures with optimized chondrogenic media and under hypoxic condition (2% O2). Glycosaminoglycan (GAG) determination by Alcian Blue assay and histological staining showed dexamethasone to be more effective than T3 and insulin, but less than TGF-beta1. DNA quantification showed that only dexamethasone stimulated cell proliferation. qPCR demonstrated that TGF-beta1 and the optimized chondrogenic groups increased the expression of collagen type II, while aggrecan was stimulated in cultures containing dexamethasone. Hypoxia increased GAG accumulation, collagen type II and aggrecan expression, but had no effect on or even lowered cell number. In conclusion, dexamethasone is a valuable and cost-effective molecule for chondrogenic and viability induction of IVD cells under normoxic and hypoxic conditions, while insulin and T3 did not show significant differences.

Evaluative comparison of physician-based vs. patient-based outcomes in posterior lumbar fusion

Posterior lumbar fusion is a frequently performed procedure in spinal surgery. High percentages of good and excellent results are indicated by physicians. On the other hand patient-based outcomes are reported. Little is known about the correlations of these two assessment types. We aimed at their comparison. The analysis included 1013 patients with degenerative spinal disease or spondylolisthesis from an international spine registry, treated with posterior lumbar fusion. All patients were pre/postop assessed by physician-based McNab criteria (‘excellent’, ‘good’, ‘fair’, ‘poor’). Of these patients, 210 (mean age 61 years; 57% females) were in addition assessed by patient-based Oswestry Disability Index (ODI). The remaining 803 patients (mean age 59 years; 56% females) were assessed by patient-based Core Outcome Measure Index (COMI), including Visual Analogue Scale (VAS) for back and leg pain as well as verbal self-rating (‘helped a lot’, ‘helped’, ‘helped only little’, ‘didn’t help’, ‘made things worse’). McNab criteria were compared to the Minimal Clinically Important Difference (MCID) in ODI (12.8), in VAS back (1.2) and leg pain (1.6). We investigated the correlations between McNab criteria and these patient-based outcomes. In the ‘excellent’ group as rated by physicians, the proposed MCID was reached in 83% of patients for ODI, in 69% for VAS back and in 83% for VAS leg pain. All patients said the treatment had ‘helped’ or ‘helped a lot’. In the ‘good’ group 56% (ODI), 66% (back pain) and 86% (leg pain) reached the MCID. 96% of patients perceived the treatment as positive. In the ‘fair’ group 37% (ODI), 55% (back pain) and 63% (leg pain) reached the MCID. 49% had positive treatment considerations. The ‘poor’ group revealed 30% (ODI), 35% (back pain) and 44% (leg pain) of patients with reached MCID. Only 15% rated the treatment as positive. The Spearman correlation coefficients between McNab criteria on the one hand and ODI, back and leg pain as well as patients’ verbal self-rating on the other hand were 0.57, 0.37, 0.36 and 0.46 respectively. The comparison of physician and patient-based outcomes showed the highest correlations between McNab criteria and ODI, somewhat weaker correlations with patients’ self-rating and the weakest correlations with back and leg pain. Based on these findings, physicians’ evaluation of patient outcomes can be considered a valuable part of patient assessment, corresponding very well with patients’ perceptions of success or failure of spinal surgery.

Hip abductor defect repair by means of a vastus lateralis muscle shift

Scarring or detachment of the hip abductors, particularly of the gluteus medius, from their insertion may lead to severe abductor weakness, recurrent dislocations, pain, and diminished quality of life. We performed a retrospective study to evaluate whether vastus lateralis shift is associated with satisfactory results and low rate of complications. Eleven adults underwent vastus lateralis shift to bridge a well-documented abductor muscles' insertion defect. Preoperative and postoperative hip functions were assessed applying the Merle d'Aubigne score, British Medical Council scale, and Visual Analog Scale. Significant postoperative improvement was noted in mean Merle d'Aubigne score, gluteus medius muscle force, and quality of life. Vastus lateralis shift represents a viable treatment option for hip abductor deficiency, significantly improving abductor strength and overall quality of life.

Long-Term Outcome After Monosegmental L4/5 Stabilization for Degenerative Spondylolisthesis With the Dynesys Device

STUDY DESIGN:: retrospective analysis of prospectively collected clinical data. OBJECTIVE:: To assess the long-term outcome of patients with monosegmental L4/5 degenerative spondylolisthesis treated with the dynamic Dynesys device. SUMMARY OF BACKGROUND DATA:: The Dynesys® system has been used as a semirigid, lumbar dorsal pedicular stabilization device since 1994. Good short-term results have been reported, but little is known about the long-term outcome following treatment for degenerative spondylolisthesis at the L4/5 level. METHODS:: 39 consecutive patients with symptomatic degenerative lumbar spondylolisthesis at the L4/5 level were treated with bilateral decompression and Dynesys instrumentation. At a mean follow-up of 7.2 years (range 5.0-11.2▒y) they underwent clinical and radiographic evaluation and quality of life assessment. RESULTS:: At final follow-up back pain improved in 89% and leg pain improved in 86% of patients compared to preoperative status. 83% of patients reported global subjective improvement. 92% would undergo the surgery again. 8 patients (21%) required further surgery due to symptomatic adjacent segment disease (6 cases), late onset infection (1 case), and screw breakage (1 case). In 9 cases radiological progression of spondylolisthesis at the operated segment was found. 74% of operated segments showed limited flexion-extension range of less than 4°. Adjacent segment pathology, though without clinical correlation, was diagnosed at the L5/S1 (17.9%) and L3/4 (28.2%) segments. In 4 cases asymptomatic screw loosening was observed. CONCLUSION:: Monosegmental Dynesys instrumentation of degenerative spondylolisthesis at L4/5 shows good long-term results. The rate of secondary surgeries is comparable to other dorsal instrumentation devices. Residual range of motion in the stabilized segment is reduced, and the rate of radiological and symptomatic adjacent segment degeneration is low. Patient satisfaction is high. Dynesys stabilization of symptomatic L4/5 degenerative spondylolisthesis is a possible alternative to other stabilization devices.

A qualitative study on the role of cultural background in patients perspectives on rehabilitation

Background Low back pain (LBP) is one of the major concerns in health care. In Switzerland, musculoskeletal problems represent the third largest illness group with 9.4 million consultations per year. The return to work rate is increased by an active treatment program and saves societal costs. However, results after rehabilitation are generally poorer in patients with a Southeast European cultural background than in other patients. This qualitative research about the rehabilitation of patients with LBP and a Southeast European cultural background, therefore, explores possible barriers to successful rehabilitation. Methods We used a triangulation of methods combining three qualitative methods of data collection: 13 semi-structured in-depth interviews with patients who have a Southeast European cultural background and live in Switzerland, five semi-structured in-depth interviews and two focus groups with health professionals, and a literature review. Between June and December 2008, we recruited participants at a Rehabilitation Centre in the German-speaking part of Switzerland. Results To cope with pain, patients prefer passive strategies, which are not in line with recommended coping strategies. Moreover, the families of patients tend to support passive behaviour and reduce the autonomy of patients. Health professionals and researchers propagate active strategies including activity in the presence of pain, yet patients do not consider psychological factors contributing to LBP. The views of physicians and health professionals are in line with research evidence demonstrating the importance of psychosocial factors for LBP. Treatment goals focusing on increasing daily activities and return to work are not well understood by patients partly due to communication problems, which is something that patients and health professionals are aware of. Additional barriers to returning to work are caused by poor job satisfaction and other work-related factors. Conclusions LBP rehabilitation can be improved by addressing the following points. Early management of LBP should be activity-centred instead of pain-centred. It is mandatory to implement return to work management early, including return to adapted work, to improve rehabilitation for patients. Rehabilitation has to start when patients have been off work for three months. Using interpreters more frequently would improve communication between health professionals and patients, and reduce misunderstandings about treatment procedures. Special emphasis must be put on the process of goal-formulation by spending more time with patients in order to identify barriers to goal attainment. Information on the return to work process should also include the financial aspects of unemployment and disability.

Aortic rupture in high-speed skiing crashes

BACKGROUND: New equipment and techniques in winter sports, such as carving skis and snowboards, have brought up new trauma patterns into the spectrum of leisure trauma. The injuries resemble high-energy trauma known from road crashes. The aim of the present study was to assess the incidence of acute traumatic descending aortic rupture in recreational skiing-crashes. MATERIAL: Between January 1995 and December 2004, 22 patients were admitted to our hospital for aortic rupture. Four patients had skiing crashes (18.2%). Mean age was 31 years, all patients were male. In two cases, aortic rupture was associated with fractures of the upper and lower extremities. One patient additionally had a cerebral contusion with an initial Glasgow Coma Scale score of 13. In two patients, isolated aortic rupture was diagnosed. RESULTS: Two patients were treated by graft interposition, and one by endograft. One patient arrived under mechanical resuscitation without blood pressure. He died at admission. He had been observed for 5 hours in another hospital, complaining of severe intrascapular back pain, before transport to our trauma unit for unknown bleeding. In the other three cases, treatment was successful. CONCLUSION: Rescue services and paramedics should be aware of this new type of injury. Acute aortic rupture has to be considered as possible injury in high velocity skiing crashes.

A review identifies and classifies reasons for ordering diagnostic tests

OBJECTIVE: To consider the reasons and context for test ordering by doctors when faced with an undiagnosed complaint in primary or secondary care. STUDY DESIGN AND SETTING: We reviewed any study of any design that discussed factors that may affect a doctor's decision to order a test. Articles were located through searches of electronic databases, authors' files on diagnostic methodology, and reference lists of relevant studies. We extracted data on: study design, type of analysis, setting, topic area, and any factors reported to influence test ordering. RESULTS: We included 37 studies. We carried out a thematic analysis to synthesize data. Five key groupings arose from this process: diagnostic factors, therapeutic and prognostic factors, patient-related factors, doctor-related factors, and policy and organization-related factors. To illustrate how the various factors identified may influence test ordering we considered the symptom low back pain and the diagnosis multiple sclerosis as examples. CONCLUSIONS: A wide variety of factors influence a doctor's decision to order a test. These are integral to understanding diagnosis in clinical practice. Traditional diagnostic accuracy studies should be supplemented with research into the broader context in which doctors perform their work.