Van Fenema E.M.,Leids Universitair Medisch Centrum
Tijdschrift voor Psychiatrie | Year: 2017
Background Treatment guidelines are widely used nowadays but it is not really clear whether or to what extent patients in routine care benefit from these guidelines. AIM To achieve a twofold objective: to measure in a routine clinical setting, the overall level of adherence to clinical guidelines by using a set of process indicators that are independent of the disorder under study, and to measure the clinical and psychosocial correlates of adherence among outpatients suffering from mood, anxiety and somatoform disorders. METHOD We developed a set of quality indicators and tested the set over a period of three years in a randomly selected sample of 300 outpatients who were about to receive treatment for a mood, anxiety and somatoform disorder. We used routine outcome monitoring (ROM) data to determine risk factors for non-adherence and to identify patients whose treatment outcomes were likely poor. RESULTS A high percentage of indicators were positive, indicating that many elements of treatment in this routine clinical practice had been carried out according to the guidelines. We observed that the combined treatment group showed significantly lower adherence than the two other treatment groups. Low-adherence was predicted independently by a low score on the vitality subscale of the SF-36. No significant differences relating to the degree of adherence were found in socio-demographic variables, comorbidity and the scores on the BSI subscales. Predictor indicators for poor treatment outcome included higher age, a comorbid axis I diagnosis, a number of dysfunctional personality traits and a (reported) poor general health status. CONCLUSION It is possible to assess guideline adherence by means of our set of process indicators that were independent of all type of disorder involved. Most factors hampering adherence could be identified. An understanding of the factors that affect treatment adherence to treatment guidelines may help to prevent non-adherence and can contribute to both the quality and the cost-effectiveness of care.
Koffeman A.R.,Leids Universitair Medisch Centrum
Nederlands Tijdschrift voor Geneeskunde | Year: 2017
The care for frail elderly is challenging and requires an individualised approach. To meet the complex care needs of these patients, interventions aimed at improving care often consist of multiple interacting components. Several recent RCTs investigating such complex interventions in a primary care setting were unable to show an effect. In this paper the challenges that arise when examining complex interventions in experimental trials are discussed. Standardisation of the content of the intervention is often not desirable. The context in which the intervention takes place cannot be controlled and is in itself complex. A thorough process evaluation is essential in order to interpret the findings correctly. The relevant outcomes in such trials are often multidimensional and difficult to capture with a quantitative instrument. Such complex interventions, therefore, require a combination of quantitative and qualitative research methods.
Hamming J.F.,Leids Universitair Medisch Centrum
Nederlands Tijdschrift voor Geneeskunde | Year: 2017
Structured assessments form a mandatory part of Dutch Medical Specialist Training, but create administrative workload for both the staff and supervisors. One could argue that the quality of the narrative feedback is more important than the extensive reporting in learning portfolios, and that the focus should be on continuous on-The-job coaching.
Stolk J.,Leids Universitair Medisch Centrum
Nederlands Tijdschrift voor Geneeskunde | Year: 2017
Health insurance organisations grant reimbursement for drug treatment on the basis of results of placebo-controlled randomised clinical trials showing a clinically meaningful and statistically significant effect over placebo. This often proves problematic in rare diseases as well as in many chronic diseases that are difficult to treat. Clinical scientists may address the issue by testing the drug on surrogate outcome parameters and ask for post-marketing studies conducted by expert reference centres as expediency research, using budgets provided by the government to show that the drug really works in terms of real-life patient experience. In the past 5 years, the pharmaceutical industry has released an increasing number of expensive drugs for rare diseases; this jeopardises the solidarity of health insurance cover for all EU citizens. To facilitate drug development, a new model might benefit all key players involved. The foundation Fair Medicine recently called for coalitions that jointly develop medicines based on contribution and complementarity, sharing responsibilities, risks and rewards.
Pieterse A.H.,Leids Universitair Medisch Centrum
Nederlands tijdschrift voor geneeskunde | Year: 2011
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.
Soonawala D.,Leids Universitair Medisch Centrum
Nederlands tijdschrift voor geneeskunde | Year: 2012
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.
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.
Braun J.,Leids Universitair Medisch Centrum |
Klautz R.J.M.,Leids Universitair Medisch Centrum
Current Opinion in Cardiology | Year: 2012
PURPOSE OF REVIEW: The optimal surgical treatment of chronic ischemic mitral regurgitation still is the subject of much debate in the surgical and cardiological communities. Although combined restrictive mitral annuloplasty and revascularization has demonstrated good results with regard to improvement of clinical status, low rates of recurrent mitral regurgitation and sustained left ventricular reverse remodeling, a survival benefit still has not been demonstrated. In addition, not all patients improve. Remaining issues in this field relate to identification of patients who will benefit from treatment, and to further improve and individualize treatment modalities. RECENT FINDINGS: More data support the use of restrictive mitral annuloplasty and revascularization. New surgical techniques to improve mitral competence (posterior leaflet augmentation) and to promote left ventricular reverse remodeling in severely dilated hearts (addressing the subvalvular apparatus) are promising. Disease-specific annuloplasty rings have not (yet) proven additional value. New imaging modalities are available to assess the many components that constitute the complex pathophysiology of remodeling. SUMMARY: The remaining challenge for cardiologists and surgeons is how to integrate data from different imaging techniques that assess mitral valve geometry and left ventricular size, geometry, function and potential functional recovery in order to individualize and optimize the surgical approach to patients with chronic ischemic mitral regurgitation. © 2012 Wolters Kluwer Health | Lippincott Williams & Wilkins.
The quality indicator tumour positive surgical margin following breast-conserving surgery does not provide transparent insight into care [De prestatie-indicator irradicaliteit na borstsparende operatie: geen zuiver zicht op goede zorg.]
Gooiker G.A.,Leids Universitair Medisch Centrum
Nederlands tijdschrift voor geneeskunde | Year: 2010
OBJECTIVE: To determine whether the quality indicator 'tumour positive surgical margin following breast-conserving surgery, consistently measured the quality of breast-cancer surgery independently of the different definitions used and differences in case mix, taking statistical random variation into account. DESIGN: Descriptive study. METHODS: Data was collected from 762 patients who underwent breast-conserving surgery for invasive or in situ carcinoma of the breast, in the period 1 July 2007 - 30 June 2008 in 1 of the 9 hospitals in the region of the Comprehensive Cancer Centre West in the Netherlands. We compared 3 definitions for 'tumour positive surgical margin': the one used by the Health Care Inspectorate, the one used by the organisation 'Zichtbare Zorg' ('transparent care') and the percentage of re-resection. For case mix correction we identified risk factors for tumour margin positivity with logistic regression. The results were presented in a funnel plot, using 95% confidence interval (CI) around the national standard of 20%. RESULTS: Depending on the definition used, the tumour positive surgical margin rate of the total group varied from 11 to 21%. Individual hospital rates varied by up to 19%. In situ carcinoma was associated with higher tumour positive surgical margin rates. Results differed significantly between hospitals for all 3 definitions. However, the funnel plot showed that results for most hospitals fell within the 95% CI of the standard. Whether a hospital fell within the 95% CI of the standard depended upon on the definition used and case mix correction. CONCLUSION: The lack of a single definition for the quality indicator 'tumour positive surgical margin following breast-conserving surgery' and the lack of case-mix correction undermine the validity of the indicator. Standardisation of definitions, uniform registration and the use of funnel plots can provide a more transparent insight into the quality of care.
Tno and Leids Universitair Medisch Centrum | Date: 2011-01-19
The present invention relates to a method for determining whether a urine sample has been obtained from a subject suffering from a kidney disorder involving kidney damage. The method is based on determining the level of a proteolytic enzyme in urine from the subject.sample and optionally comparing this level with a reference value. The proteolytic enzyme preferably is a matrix metalloproteases, in particular MMP-2 or MMP-9. The method is particularly suitable for subjects with a condition or disorder that is associated with an increased risk of kidney disorders, such as diabetes. The method may adavnatagcously be applied for early detection of kidney damage, in particular when the subject does not yet show any sign of microalbuminuria. The method may also be applied to a subject undergoing dialysis for determining whether the subject is suffering from remodelling of the peritoneal membrane. Thus, the method is particularly suited for patients undergoing continuous ambulatory peritoneal dialysis.