study protocol for a randomized controlled trial

Background Osteoarthritis (OA) is a heterogeneous group of conditions with disturbed integrity of articular cartilage and changes in the underlying bone. The pathogenesis of OA is multifactorial and not just a disease of older people. Hydroxychloroquine (HCQ) is a disease-modifying anti-rheumatic drug (DMARD) typically used for the treatment of various rheumatic and dermatologic diseases. Three studies of HCQ in OA, including one abstract and one letter, are available and use a wide variety of outcome measures in small patient populations. Despite initial evidence for good efficacy of HCQ, there has been no randomized, double-blind, and placebo-controlled trial in a larger patient group. In the European League Against Rheumatism (EULAR), evidence-based recommendations for the management of hand OA, HCQ was not included as a therapeutic option because of the current lack of randomized clinical trials. Methods/Design OA TREAT is an investigator-initiated, multicenter, randomized, double-blind, placebo-controlled trial. A total of 510 subjects with inflammatory and erosive hand OA, according to the classification criteria of the American College of Rheumatology (ACR), with recent X-ray will be recruited across outpatient sites, hospitals and universities in Germany. Patients are randomized 1:1 to active treatment (HCQ 200 to 400 mg per day) or placebo for 52 weeks. Both groups receive standard therapy (non-steroidal anti-inflammatory drugs [NSAID], coxibs) for OA treatment, taken steadily two weeks before enrollment and continued further afterwards. If disease activity increases, the dose of NSAID/coxibs can be increased according to the drug recommendation. The co-primary clinical endpoints are the changes in Australian-Canadian OA Index (AUSCAN, German version) dimensions for pain and hand disability at week 52. The co-primary radiographic endpoint is the radiographic progression from baseline to week 52. A multiple endpoint test and analysis of covariance will be used to compare changes between groups. All analyses will be conducted on an intention-to-treat basis. Discussion The OA TREAT trial will examine the clinical and radiological efficacy and safety of HCQ as a treatment option for inflammatory and erosive OA over 12 months. OA TREAT focuses on erosive hand OA in contrast to other current studies on symptomatic hand OA, for example, HERO [Trials 14:64, 2013]

Organization of audit management in the computer aided quality management of the Vanguard AG

Im Zeitalter der Globalisierung sehen sich Unternehmen mit einer stetig wachsenden Anzahl von Informationen konfrontiert, auf die sie reagieren müssen. Auch in den Firmen selbst sind immer mehr davon zu verarbeiten und zu verwalten. Schnell können relevante Informationen übersehen werden, wenn eine durchstrukturierte Ablage - unabhängig ob auf Papier oder auf dem Rechner - fehlt. Um ihr Wissen optimal nutzen zu können, setzen immer mehr Unternehmen auf die Unterstützung durch Computer. Doch die Erarbeitung einer Ablagestruktur ist nicht zu umgehen, denn auch auf dem Rechner können Informationen verloren gehen. Wurde eine Ablagestruktur geschaffen, kann sie z. B. in einem Dokumentenmanagementsystem abgebildet werden. Die Arbeit besteht aus einem theoretischen und einem praktischen Teil. Sie beginnt mit der Darstellung der wissenschaftlichen Grundlagen des Qualitätsmanagements. Dazu gehören Begriffsklärungen und unterschiedliche theoretische Ansätze.Da computergestützte Systeme in der Zukunft an Bedeutung gewinnen werden, ist ihnen ein eigener Abschnitt gewidmet. Dem Auditmanagement als wesentlichen Bestandteil eines Qualitätsmanagementsystems gilt die Aufmerksamkeit im nächsten Kapitel. Mit diesem Wissen konnte ich das Softwaremodul Auditmanagement an die Bedürfnisse der Vanguard AG anpassen. Die Dokumentation der dazu notwendigen Schritte bildet den Inhalt des folgenden Kapitels. Der Schluss dieser Arbeit umfasst eine kurze Auflistung der Vorteile und möchte auf Grundlage der vom Autor gemachten Erfahrungen einen Ausblick geben

25-hydroxyvitamin D and 1,25-dihydroxyvitamin D at baseline, day 8, day 36, day 50 and change from baseline.

<p>25-hydroxyvitamin D and 1,25-dihydroxyvitamin D at baseline, day 8, day 36, day 50 and change from baseline.</p

Baseline characteristics of subject group.

<p>Baseline characteristics of subject group.</p

Individual Vitamin D status as expressed by 25-hydroxyvitamin D concentration in plasma during the study.

<p>Individual Vitamin D status as expressed by 25-hydroxyvitamin D concentration in plasma during the study.</p

Scatterplot diagram, relationship between POMS subscale Vigor/Activity and the increment in 1,25-dihydroxyvitamin D at day 8 (linear regression analysis, r² = 0.445, p<0.001). The solid line is the linear fit and dashed lines are the 95% confidence limits to the fit.

<p>Scatterplot diagram, relationship between POMS subscale Vigor/Activity and the increment in 1,25-dihydroxyvitamin D at day 8 (linear regression analysis, r² = 0.445, p<0.001). The solid line is the linear fit and dashed lines are the 95% confidence limits to the fit.</p

Scatterplot diagram, relationship between increase in 25-hydroxyvitamin D at day 8 and baseline 25-hydroxyvitamin D levels (quadratic regression analysis, r² = 0.607, p<0.001) The solid line is the quadratic fit, and dashed lines are the 95% confidence limits to the fit.

<p>Scatterplot diagram, relationship between increase in 25-hydroxyvitamin D at day 8 and baseline 25-hydroxyvitamin D levels (quadratic regression analysis, r² = 0.607, p<0.001) The solid line is the quadratic fit, and dashed lines are the 95% confidence limits to the fit.</p