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Leusden, Netherlands

The aim of non-inferiority trials is to show that a new treatment is not less effective than standard treatment, in other words 'non-inferior'. The non-inferiority margin should be determined before a study commences. This margin determines the maximal magnitude of difference in effectiveness permissible if it is to be concluded that a new treatment is not less effective than the standard treatment. There is usually a good reason for a non-inferiority design. For example, because the new treatment is easier to use, provides better cost-effectiveness or has fewer side effects. The reader of a non-inferiority trial should consider a number of aspects critically: (a) the reason for use of this study design, (b) the assumed benefit of the new treatment, (c) the rationale for the choice of non-inferiority margin and (d) the choice of the standard therapy with which the new treatment is compared. Source


OBJECTIVE: To describe the epidemiological characteristics of Clostridium difficile infection (CDI) in the Netherlands. DESIGN: Descriptive. METHOD: After the first outbreaks in 2005 of Clostridium difficile infection (CDI) due to the hypervirulent PCR ribotype 027, a national reference laboratory was started in the Leiden University Medical Centre for typing and characterisation of C. difficile. Data were obtained from this national reference laboratory and from a continuous surveillance in 14 Dutch hospitals. The study period was January 2008-June 2009. RESULTS: In 2008, the incidence of CDI was 18 per 10.000 admissions (range: 14-23) in the 14 participating hospitals in the national surveillance study. In the study period, a total of 1867 cases of CDI were reported from 63 centres. The number of CDI outbreaks caused by type 027 decreased in the period January 2008 to June 2009, compared to the preceding years: type 027 was the cause of outbreaks in 4 Dutch hospitals in 2008-2009, whereas all 14 hospitals experienced an outbreak due to this type in the period 2005-2007. Although no systemic surveillance has been carried out in nursing homes, 24 Dutch nursing homes reported outbreaks of C. difficile in the period 2005-2009, in 12 of which type 027 was isolated. There was an increase of CDI detected in patients with diarrhoea outside health care facilities which appeared to coincide with the emergence of other types. In particular, type 078 increased since the end of 2006 and became the third most frequent type in the Netherlands. This type has also been recognised since 2007 as an important cause of CDI infection in animals, especially pigs. Recently there have also been reports that at least a third of the patients with CDI outside health care institutions do not have known risk factors for CDI such as an underlying disease, recent hospitalization or antibiotic use. CONCLUSION: CDI can also develop in the community The general practitioner should consider C. difficile in the differential diagnosis of elderly patients with diarrhoea. Source


la Chapelle C.F.,Leids Universitair Medisch Centrum
Nederlands tijdschrift voor geneeskunde | Year: 2013

More than 10 years after its first introduction, robot-assisted surgery is now performed in 17 Dutch hospitals. Robotic-assisted radical prostatectomy (RARP) is the most frequently performed, though its clinical superiority compared to open (RRP) and laparoscopic prostatectomy (LRP) has not been demonstrated. One randomized controlled trial showed better outcome in erectile function after RARP compared to LRP. The quality of the other studies into RARP is too limited to draw reliable conclusions on clinically relevant outcome measures such as survival, disease-free survival and quality of life. Given the high costs and small scientific evidence, the introduction of robotic surgery has been irresponsibly quick. Better scientific research of robotic surgery is needed before this technology can be broadly applied in clinical practice. Source


Adjuvant treatments can be added to primary curative cancer treatments to increase the probability of survival. However, these treatments have side effects. Research into what additional probability of survival cancer patients require from an adjuvant treatment before they consider it worthwhile, has been carried out in hypothetical situations. The published literature on this subject shows that the additional benefit which patients expect is small. Yet, variation in patient preferences within studies is large. Preferences regarding additional benefit are not consistently associated with patient socio-demographic or disease characteristics. It is very likely that new patients who face the choice of adjuvant treatment will greatly differ from each other in the benefit that they require from it. In order to give individualized recommendations, specialists need to ask the patient which benefits and disadvantages he or she considers to be important. Source


The case-crossover study is a relatively unknown way of identifying short-term transient risk factors for acute-onset diseases. In patients with the disease of interest, the frequency of exposure to a certain risk factor is compared between two time periods. If the exposure is more common in the period directly preceding disease onset than in an earlier period, the control period, it is likely that the exposure contributes to the development of the disease. The problem of confounding is minimized in case-crossover studies since the patient serves as his or her own control. A potential disadvantage is that sufficient biological knowledge of the clinical picture is needed to provide a good estimate of the risk period. As administrative databases are now commonly used for research purposes, future use of case-crossover methods is likely to increase. We illustrate the case-crossover study with the question of whether antibiotic use increases the risk of unwanted pregnancy in women who use the contraceptive pill. Source

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