Quality scores do not predict discrepant statistical significances among meta-analyses on different targets of glycemic control in type 2 diabetes.

OBJECTIVES: To examine differences in conclusions, statistical significances, and quality of systematic reviews on preventive effects of different targets of blood glucose lowering on macrovascular events in patients with type 2 diabetes. STUDY DESIGN AND SETTING: We searched MEDLINE, the Cochrane Database of Systematic Reviews, and Embase until October 15, 2011. Systematic reviews using meta-analyses to compare macrovascular events in patients with type 2 diabetes randomized to different therapeutic targets of blood glucose were eligible for inclusion in this study. Effect measures were extracted and quality was assessed by Overview Quality Assessment Questionnaire, Assessment of Multiple Systematic Reviews, and Preferred Reporting Items for Systematic Reviews and Meta-Analyses. An additional checklist was used to control for completeness and suitability of included trials, correctness of data extraction, and choice of outcome parameters. RESULTS: The 16 included systematic reviews were partially discrepant in statistical significances of reported outcome parameters. Twelve systematic reviews did not include available relevant trials and included eight systematic reviews that should not have been included according to the systematic review's aim and search strategies. Quality differed considerably among systematic reviews. CONCLUSION: Physicians, researchers, and policy makers should bear in mind that common quality assessment instruments are necessary but not sufficient to guarantee reliable results and conclusions obtained from meta-analyses.

The German health care system in international comparison: the primary care physicians' perspective.

BACKGROUND: In 2009, the U.S. Commonwealth Fund conducted a survey of primary care physicians in a number of different countries to determine their views on aspects of their daily work and their perceptions of their countries' health care systems as a whole. A similar survey had been carried out in 2006. METHODS: From February to July 2009, the survey was carried out by interview in representative samples of primary care physicians, general practitioners, internists providing primary care, and pediatricians in 11 countries: Australia, Canada, France, Germany, Italy, the Netherlands, New Zealand, Norway, Sweden, the UK, and the USA. RESULTS: A total of 10 320 interviews were conducted. Only in the Netherlands and Norway did most respondents (60% and 56%, respectively) consider their health care system to be functioning well. Everywhere else, many of the respondents-in particular, 82% of the respondents in Germany-saw a fundamental need for change. 73% of the German physicians stated that recent changes in the health care system had brought about a decline in the quality of care. In all countries but Germany, the percentage of respondents sharing this opinion was 41% at the highest. Nevertheless, most of the German physicians had a positive opinion of the patient care that they themselves delivered. CONCLUSION: The 2009 survey, like its predecessor in 2006, revealed major differences in physicians' perceptions of their health care systems from one country to another. The German respondents' dissatisfaction with, and negative evaluation of, their health care system as a whole contrast with their positive views of their own patient care.

Comparative effectiveness research and evidence-based health policy: experience from four countries.

CONTEXT: The discussion about improving the efficiency, quality, and long-term sustainability of the U.S. health care system is increasingly focusing on the need to provide better evidence for decision making through comparative effectiveness research (CER). In recent years, several other countries have established agencies to evaluate health technologies and broader management strategies to inform health care policy decisions. This article reviews experiences from Britain, France, Australia, and Germany. METHODS: This article draws on the experience of senior technical and administrative staff in setting up and running the CER entities studied. Besides reviewing the agencies' websites, legal framework documents, and informal interviews with key stakeholders, this analysis was informed by a workshop bringing together U.S. and international experts. FINDINGS: This article builds a matrix of features identified from the international models studied that offer insights into near-term decisions about the location, design, and function of a U.S.-based CER entity. While each country has developed a CER capacity unique to its health system, elements such as the inclusiveness of relevant stakeholders, transparency in operation, independence of the central government and other interests, and adaptability to a changing environment are prerequisites for these entities' successful operation. CONCLUSIONS: While the CER entities evolved separately and have different responsibilities, they have adopted a set of core structural, technical, and procedural principles, including mechanisms for engaging with stakeholders, governance and oversight arrangements, and explicit methodologies for analyzing evidence, to ensure a high-quality product that is relevant to their system.

A randomized trial comparing INR monitoring devices in patients with anticoagulation self-management: evaluation of a novel error-grid approach.

BACKGROUND: In addition to the metrological quality of international normalized ratio (INR) monitoring devices used in patients' self-management of long-term anticoagulation, the effectiveness of self-monitoring with such devices has to be evaluated under real-life conditions with a focus on clinical implications. An approach to evaluate the clinical significance of inaccuracies is the error-grid analysis as already established in self-monitoring of blood glucose. Two anticoagulation monitors were compared in a real-life setting and a novel error-grid instrument for oral anticoagulation has been evaluated. METHODS: In a randomized crossover study 16 patients performed self-management of anticoagulation using the INRatio and the CoaguChek S system. Main outcome measures were clinically relevant INR differences according to established criteria and to the error-grid approach. RESULTS: A lower rate of clinically relevant disagreements according to Anderson's criteria was found with CoaguChek S than with INRatio without statistical significance (10.77% vs. 12.90%; P = 0.787). Using the error-grid we found principally consistent results: More measurement pairs with discrepancies of no or low clinical relevance were found with CoaguChek S, whereas with INRatio we found more differences with a moderate clinical relevance. A high rate of patients' satisfaction with both of the point of care devices was found with only marginal differences. CONCLUSIONS: A principal appropriateness of the investigated point-of-care devices to adequately monitor the INR is shown. The error-grid is useful for comparing monitoring methods with a focus on clinical relevance under real-life conditions beyond assessing the pure metrological quality, but we emphasize that additional trials using this instrument with larger patient populations are needed to detect differences in clinically relevant disagreements.

[Evaluation of an internal guideline for the diagnostics of deep vein thrombosis]. / Evaluation einer abteilungsinternen Leitlinie zur Diagnostik der tiefen Beinvenenthrombose.

BACKGROUND AND PURPOSE: In line with the application of evidence-based medicine as part of the day-to-day clinical practice of a community hospital internal guidelines concerning relevant diagnostic or therapeutic problems were developed. The authors retrospectively compared all data of patients with the tentative diagnosis of deep vein thrombosis (DVT), who underwent further diagnostics before and after implementation of an internally developed guideline for the diagnostics of DVT. The aim was to evaluate if the internal guideline was applied by the doctors in the daily routine and if the implementation led to a change and rationalization of the diagnostic process, in particular with regard to reducing invasive examinations. METHODS: In a retrospective controlled cohort study the medical records of in- and outpatients (n = 371) receiving further diagnostics following a tentative diagnosis of DVT were screened. The kind of examinations, the duration of the diagnostic process and the rate of hospitalization for DVT were compared between the intervention group (n = 185), treated in the initial 10 months following guideline implementation, and the control group (n = 186), treated in the 10 months prior to implementation. Furthermore, the physicians' compliance with the internal guideline was assessed. RESULTS: After implementation in 114 of 185 cases (62%) the treating doctors based their diagnostic procedure on the internal guideline. There was a significant decrease of phlebographies (45.4% vs. 74.2%; RR 0.61 [95% CI 0.51; 0.73]). By contrast, the number of D-dimer tests (81.6% vs. 33.3%; RR 2.45 [95% CI 1.98; 3.03]) and of duplex sonographies (42.2% vs. 21.5%; RR 1.96 [95% CI 1.42; 2.71]) increased significantly. A reduction of the hospitalization rate for further diagnostics of primary ambulant patients (51.3% vs. 60.4% of the tentative cases; RR 0.85 [95% CI 0.69; 1,04]) without a significant change in the final number of DVT diagnoses (33.3% vs. 27.6%; RR 0,83 [95% CI 0,61; 1,13]) was found. There was a slight increment in the mean length of diagnostic process (2.12 vs. 1.84 days). CONCLUSION: The implementation of an internal guideline for the diagnostics of DVT led to a significant reduction of the hospitalization rate and to a considerable change of the diagnostic procedure in favor of noninvasive diagnostic tests, for patients presenting with a diagnosis of suspected DVT.

Influence of nebivolol and enalapril on metabolic parameters and arterial stiffness in hypertensive type 2 diabetic patients.

OBJECTIVE: To compare the effects of a cardioselective beta-blocker (nebivolol) with those of an angiotensin-converting enzyme inhibitor (enalapril) on parameters of insulin sensitivity, peripheral blood flow and arterial stiffness during one extended glucose clamp experiment. DESIGN: A randomized, double-blind crossover trial, consisting of two 12-week treatment phases separated by a 4-week wash-out phase. METHODS: Patients with type 2 diabetes and arterial hypertension were randomly assigned to one of two treatment sequences (nebivolol-enalapril, enalapril-nebivolol). Haemodynamic, metabolic and other laboratory measurements were carried out on the first and last day of each treatment period by means of a glucose clamp experiment that also involved the measurement of blood flow and arterial stiffness. RESULTS: Twelve patients were included in this study, of which two dropped out early. Efficacy parameters were therefore available for 10 patients. There was no significant difference in any of the primary efficacy parameters. Moreover, the effects on blood pressure did not significantly differ between both treatments. Six adverse events happened during treatment with nebivolol compared with two during treatment with enalapril, but only one was regarded as possibly related to the treatment. CONCLUSIONS: This pilot study shows that the combined measurement of insulin sensitivity, blood flow and arterial stiffness is feasible. Nebivolol and enalapril did not show different effects with regard to these parameters in hypertensive diabetic patients. If these results are confirmed in larger clinical trials, this would argue against the reservations against beta-blockers as drugs of first choice in patients with diabetes because of potential metabolic side-effects.