[Decisive factors for an accomplished clinical claims and risk management]. / Entscheidende Faktoren des gelingenden klinischen Schaden- und Risikomanagements.

Damage to health caused by complications and errors is part of the reality of medical treatment. In order to avoid further negative consequences in the event of legal claims as a result of excessive processing times or unjustified refusals, a good cooperation between the physician and claims management in the clinic and the legal processor in liability insurance is required. In order to avoid false assumptions in claims processing, a critical analysis of the facts of the case is necessary. In addition, findings from claims management must be recorded and effectively implemented in the clinical practice.

The effect of peer review on mortality rates.

OBJECTIVE: Lowering of mortality rates in hospitals with mortality rates higher than accepted reference values for acute myocardial infarction (AMI), congestive heart failure (CHF), pneumonia, stroke, mechanical ventilation (MV) and colorectal surgery by using an external peer review process that identifies areas requiring rectification and implements protocols directed at improving these areas. DESIGN: Retrospective, observational, quality management study using administrative data to compare in-hospital mortality rates (pre and post an external peer review process that included adoption of improvement protocols) with reference values. SETTING: German general hospitals of a large, private group. PARTICIPANTS: Hospitals with mortality rates higher than reference values. INTERVENTIONS: Peer review of medical records by experienced, outside physicians triggered by in-hospital mortality rates higher than expected. Inadequacies were identified, improvement protocols enforced and mortality rates subsequently re-examined. MAIN OUTCOME MEASURES: Mortality rates 1 year before and 1 year after peer review and protocol use. RESULTS: For AMI, CHF, pneumonia, stroke, MV and colorectal surgery, the mortality rates 1 year post-peer review were significantly decreased as compared to pre-peer review mortality rates. The standardized mortality ratio for all of the above diagnoses was 1.45, 1 year before peer review, and 0.97, 1 year after peer review. The absolute risk reduction of 7.3% translates into 710 deaths in this population which could have been prevented. CONCLUSIONS: Peer review triggered and conducted in the manner described here is associated with a significant lowering of in-hospital mortality rates in hospitals that previously had higher than expected mortality rates.

Molecular signatures and new candidates to target the pathogenesis of rheumatoid arthritis.

Rheumatoid arthritis (RA) is a chronic, inflammatory joint disease of unknown etiology and pronounced interpatient heterogeneity. To characterize RA at the molecular level and to uncover pathomechanisms, we performed genome-wide gene expression analysis. We identified a set of 1,054 genes significantly deregulated in pair-wise comparisons between RA and osteoarthritis (OA) patients, RA and normal donors (ND), or OA and ND. Correlation analysis revealed gene sets regulated identically in all three groups. As a prominent example secreted phosphoprotein 1 (SPP1) was identified to be significantly upregulated in RA compared with both OA and ND. SPP1 expression was found to correlate with genes expressed during an inflammatory response, T-cell activation and apoptosis, suggesting common underlying regulatory networks. A subclassification of RA patients was achieved on the basis of proteoglycan 4 (PRG4) expression, distinguishing PRG4 high and low expressors and reflecting the heterogeneity of the disease. In addition, we found that low PRG4 expression was associated with a more aggressive disease stage, which is in accordance with PRG4 loss-of-function mutations causing camptodactyly-arthropathy-coxa vara-pericarditis syndrome. Altogether we provide evidence for molecular signatures of RA and RA subclasses, sets of new candidate genes as well as for candidate gene networks, which extend our understanding of disease mechanisms and may lead to an improved diagnosis.

Differential expression of Ia antigens by rheumatoid synovial lining cells.

The differential expression of Ia antigens was studied in freshly isolated rheumatoid nonlymphoid synovial lining cells (SLC) and rheumatoid synovial fibroblast cell lines cultured in the presence of Interferon-gamma, using a large panel of anti-Ia reagents with monomorphic or polymorphic specificities. All the HLA-DR or -DQ specificities detectable on the corresponding peripheral blood B cells were also expressed in freshly isolated SLC. However, in all instances, the number of DR-positive SLC exceeded the percentage of cells expressing DQ antigens. In addition, the epitope expression of Ia antigens varied within the DR or DQ populations of Ia molecules as revealed by polymorphic reagents. Double-label experiments or using the ingestion of Latex particles as a marker demonstrated that the synovial macrophages (type I SLC) primarily bear the DR+DQ+ phenotype, while there is an additional population of nonphagocytic SLC (previously termed type II SLC) that has a DR+ and monocyte marker negative phenotype but did not have detectable levels of DQ antigens as analyzed by both fluorescence microscopy and cell sorter analysis. This latter population frequently had a morphology showing dendritic processes and rapidly lost the expression of Ia antigens upon culture. Cells with a similar, primarily DR+ phenotype were readily obtained in synovial fibroblast cultures after treatment with Interferon-gamma. These data suggest that there are two populations of Ia+ synovial lining cells: the synovial macrophages (type I cells) with the DR+DQ+ phenotype, and cells probably related to fibroblasts with a DR+ phenotype without detectable DQ antigens (type II cells). The fact that the latter phenotype could be induced by Interferon-gamma treatment of cultured synovial fibroblasts suggests that this mediator may have a similar role in vivo in the activation of certain synovial cell populations.

Effect of field of view on the levitation illusion.

Supine subjects inside a furnished room in which both they and the room are pitched 90 degrees backwards may experience themselves and the room as upright relative to gravity. This effect is known as the levitation illusion because observers report that their arms feel weightless when extended, and objects hanging in the room seem to "levitate". This illusion is an extreme example of a visually induced illusion of static tilt. Visually induced tilt illusions are commonly experienced in wide-screen movie theatres, flight simulators, and immersive virtual reality systems. For technical reasons an observer's field of view is often constrained in these environments. No studies have documented the effect of field-of-view (FOV) restriction on the incidence of the levitation illusion. Preliminary findings suggest that when concurrently manipulating the FOV and observer position within an environment, the incidence of levitation illusions depends not only on the field of view but also on the visible scene content.

Efficacy of lumiracoxib in osteoarthritis: a review of nine studies.

Lumiracoxib is a cyclooxygenase-2 selective inhibitor in development for the treatment of osteoarthritis (OA), rheumatoid arthritis and acute pain. We reviewed nine clinical studies of 1-52 weeks' duration demonstrating the efficacy of lumiracoxib in OA. Male and female patients aged > or = 18 years with primary OA of the hand, hip or knee received lumiracoxib, placebo or active comparators (diclofenac, celecoxib or rofecoxib). Lumiracoxib provided consistent reductions in OA pain intensity and improvements in the patient's global assessment of disease activity and functional status (assessed using the Western Ontario and McMaster Universities Osteoarthritis Index questionnaire or the Australian/Canadian OA Hand Index). These results were superior to placebo and similar to the active comparators tested. In addition, lumiracoxib was consistently superior to placebo and generally similar to active comparators in terms of the new Outcome Measures in Clinical Trials and Osteoarthritis Research Society International criteria. These were used to provide a single measure of response to treatment, taking into account pain, the patient's global assessment of disease activity and functional status.

The relative role of visual and non-visual cues in determining the perceived direction of "up": experiments in parabolic flight.

In order to measure the perceived direction of "up", subjects judged the three-dimensional shape of disks shaded to be compatible with illumination from particular directions. By finding which shaded disk appeared most convex, we were able to infer the perceived direction of illumination. This provides an indirect measure of the subject's perception of the direction of "up". The different cues contributing to this percept were separated by varying the orientation of the subject and the orientation of the visual background relative to gravity. We also measured the effect of decreasing or increasing gravity by making these shape judgements throughout all the phases of parabolic flight (0 g, 2 g and 1 g during level flight). The perceived up direction was modeled by a simple vector sum of "up" defined by vision, the body and gravity. In this model, the weighting of the visual cue became negligible under microgravity and hypergravity conditions.

Gravity and perceptual stability during translational head movement on earth and in microgravity.

We measured the amount of visual movement judged consistent with translational head movement under normal and microgravity conditions. Subjects wore a virtual reality helmet in which the ratio of the movement of the world to the movement of the head (visual gain) was variable. Using the method of adjustment under normal gravity 10 subjects adjusted the visual gain until the visual world appeared stable during head movements that were either parallel or orthogonal to gravity. Using the method of constant stimuli under normal gravity, seven subjects moved their heads and judged whether the virtual world appeared to move "with" or "against" their movement for several visual gains. One subject repeated the constant stimuli judgements in microgravity during parabolic flight. The accuracy of judgements appeared unaffected by the direction or absence of gravity. Only the variability appeared affected by the absence of gravity. These results are discussed in relation to discomfort during head movements in microgravity.

Primary repair in transection of duodenum with avulsion of the common duct.

In combined pancreatoduodenal trauma, the surgeon usually chooses a diverting or resectional procedure at substantial risk. Simple closure of the duodenum and transposition of the common duct was accomplished at early operation in an 18-year-old boy who had almost complete transection of the duodenum with avulsion of the ampulia of Vater from blunt abdominal trauma. Transgastrojejunostomy and use of Chaffin tubes were discontinued prior to discharge from the hospital three weeks later. The postoperative course was complicated only by a brief pancreatitis. The excellent result persists more than two years later. In similar anatomic situations, consideration might be given to this operative approach.

A comparison of the therapeutic efficacy and tolerability of etoricoxib and diclofenac in patients with osteoarthritis.

OBJECTIVE: To evaluate and compare the efficacy and tolerability of etoricoxib and diclofenac in patients with osteoarthritis of the knee or hip. METHODS: In this 6-week double-blind, active comparator controlled, parallel-group study eligible osteoarthritis patients were randomised to receive either etoricoxib 60 mg once daily (n = 256) or diclofenac 50 mg three times daily (n = 260). The primary study endpoint was the Western Ontario McMaster osteoarthritis index (WOMAC) pain subscale. Other endpoints included were the WOMAC stiffness and physical function subscales, and the Patient's Global Assessment of Response to Therapy (PGART) questionnaire. Early efficacy was evaluated using WOMAC first question (pain walking on a flat surface) and PGART 4 h after the morning dose of each drug on days 1 and 2. Rescue medication (paracetamol) used was also recorded. The study was designed to show comparable efficacy between etoricoxib 60 mg once daily and diclofenac 50 mg three times daily with respect to the primary endpoint and was conducted outside the United States at 67 centres in 29 countries. RESULTS: Etoricoxib (60 mg once daily) was comparable in efficacy to diclofenac (150 mg daily) on all the above parameters. The one exception was in the assessment of early efficacy where etoricoxib demonstrated significantly greater benefit within 4 h of taking the first dose on the first day of therapy (p = 0.007) as evaluated by the percentage of patients with good or excellent (PGART) responses. The treatment effects of both drugs were similar by the time day 2 was reached and were sustained throughout the 6 weeks of therapy. Both treatments were generally well tolerated. CONCLUSIONS: Etoricoxib is clinically effective in the therapy of osteoarthritis providing a magnitude of effect comparable to that of the maximum recommended daily dose of diclofenac. The onset of clinical benefit with etoricoxib on day one is more rapid than that of diclofenac. Both drugs were generally well tolerated.

Efficacy and tolerability of lumiracoxib versus placebo in patients with osteoarthritis of the hand.

OBJECTIVE: This multicentre, randomized, double-blind, placebo-controlled parallel-group study was undertaken to investigate the efficacy, safety and tolerability of lumiracoxib (Prexige), a cyclooxygenase-2 selective inhibitor, in patients with primary osteoarthritis (OA) of the hand. METHODS: The study randomized 594 patients aged > or = 18 years with symptomatic OA of the hand. Patients underwent a 3 to 7-day washout for previous nonsteroidal anti-inflammatory drugs and those with pain intensity > or = 40 mm on a 100 mm Visual Analogue Scale (VAS) in the target hand during the 24 hours prior to baseline and an increase in pain intensity of either > or = 20% or > or = 10 mm VAS since screening (whichever was greater) were randomized to lumiracoxib 200 mg once daily (od) (n=205), lumiracoxib 400 mg od (n=193) or placebo (n=196). The primary efficacy variable was overall OA pain intensity (VAS mm) in the target hand after 4 weeks of treatment. Safety and tolerability assessments were performed. RESULTS: After 4 weeks of treatment, overall OA pain intensity in the target hand was significantly lower for patients treated with lumiracoxib compared with patients treated with placebo (both doses p<0.001). There was no significant difference between lumiracoxib doses in terms of the reduction in overall OA pain intensity. Lumiracoxib was well tolerated. The incidence of adverse events was similar for active treatment groups and placebo. CONCLUSIONS: Lumiracoxib 200 and 400 mg od were effective and well tolerated treatments for OA of the hand. Lumiracoxib significantly improved overall OA pain intensity in the target hand versus placebo, with a tolerability profile similar to placebo.

Colour Doppler ultrasonography to detect pannus in knee joint synovitis.

OBJECTIVE: To determine if colour Doppler ultrasonography can characterise the nature of intraarticular echogenic structures and synovial villi more precisely than conventional ultrasonography. METHODS: This is a prospective study on 20 patients--10 with rheumatoid arthritis and 10 with osteoarthritis. Colour Doppler ultrasonography of the knee joints was performed prior to total prosthetic replacement. Two independent, trained physician ultrasonographers examined the knee to be replaced with different ultrasound equipment using colour Doppler and power Doppler ultrasonography. The existence and extent of pannus were then assessed surgically and histologically. RESULTS: All 9 patients with histologically detected pannus had perfused, echogenic, intraarticular structures (ultrasonographer 2; ultrasonographer 1: 8 out of 9 patients). Sparse perfusion was detected in 1 patient (investigator 1) and in 5 patients (investigator 2) with extensive non-destructive synovial proliferation. Colour Doppler and power Doppler ultrasonography were equivalent in detecting small intraarticular vessels. CONCLUSION: Colour Doppler ultrasonography improves the differentiation of intraarticular structures compared to conventional ultrasonography.

Management of injuries of the distal phalanx.

A series of 90 injured fingertips is presented with a practical approach to the treatment of these injuries, along with a discussion of their complications.