De Richtlijn oneerlijke bedingen en haar plaats in het Nederlandse recht

Bijdragen van een aantal onderzoekbijeenkomsten en van een congres dat op 23 juni 2006 aan de Juridische Faculteit van Erasmus Universiteit Rotterdam werd gehouden (Reeks Rotterdam Institute of Private Law, ISSN 1873-9512)Deze bijdrage gaat over EU-richtlijn 93/13 met betrekking tot oneerlijke bedingen in consumentenovereenkomsten

The validity and reliability of school-based fundamental movement skills screening to identify children with motor difficulties

Aim Assess whether school-based teacher-led screening is effective at identifying children with motor difficulties. Methods Teachers tested 217 children aged between 5 and 11 years old, after a one hour training session, using a freely available tool (FUNMOVES). Four classes (n = 91) were scored by both researchers and teachers to evaluate inter-rater reliability. Researchers assessed 22 children using the Movement Assessment Battery for Children (MABC-2; considered to be the ‘gold standard’ in Europe for use as part of the diagnostic process for Developmental Coordination Disorder) to assess concurrent and predictive validity. Results Inter-rater reliability for all individual activities within FUNMOVES ranged from 0.85–0.97 (unweighted Kappa; with 95%CI ranging from 0.77–1). For total score this was lower (κ = 0.76, 95%CI = 0.68–0.84), however when incorporating linear weighting, this improved (κ = 0.94, 95%CI = 0.89–0.99). When evaluating FUNMOVES total score against the MABC-2 total score, the specificity (1, 95%CI = 0.63–1) and positive predictive value (1; 95%CI = 0.68–1) of FUNMOVES were high, whereas sensitivity (0.57, 95%CI = 0.29–0.82) and negative predictive values (0.57, 95%CI = 0.42–0.71) were moderate. Evaluating only MABC-2 subscales which are directly related to fundamental movement skills (Aiming &amp; Catching, and Balance) improved these values to 0.89 (95%CI = 0.52–1) and 0.93 (95%CI = 0.67– 0.99) respectively. Interpretation Teacher-led screening of fundamental movement skills (via FUNMOVES) is an effective method of identifying children with motor difficulties. Such universal screening in schools has the potential to identify movement difficulties and enable earlier intervention than the current norm.</p

De netwerkkracht van de Rotterdammer in het sociale domein

In Hoofdstuk 1 worden de achtergronden van het NWO programma Slimme sturing (Smart governance) en de Zorgtransitie besproken, die de aanleiding vormden voor de opzet van het onderzoek ‘Lokaal bestuur en eigen kracht in Rotterdam’, dat resulteerde in het hier voorliggende eindrapport. Vervolgens wordt de oorsprong van de Family Group Conference besproken en hoe deze zich wereldwijd heeft verspreid en heeft geresulteerd in een aantal internationale studies, waarin de Family Group Conference is gecontrasteerd met professionele hulpverlening. Een aantal toonaangevende studies is geschematiseerd weergegeven in Hoofdstuk 1. Hoe de vragen van de maatschappelijke partners in de definitieve onderzoeksopzet werden vertaald en welke uitkomstmaten gekozen werden, wordt beschreven in Hoofdstuk 2: Onderzoeksopzet. In Hoofdstuk 3 worden de uitkomsten van het empirische onderdeel van het onderzoek onder zorgvragers gepresenteerd. Hoofdstuk 4 bespreekt de uitkomsten van het onderzoek onder zorgprofessionals en Eigen Kracht coördinatoren. In een aantal zaken bleken het netwerk en de zorgprofessional ondersteuningstaken specifiek verdeeld te hebben. In Hoofdstuk 5 zijn deze patronen van taakverdeling op basis van gemeenschappelijke elementen gestileerd in een drietal scenario’s, waarvan de kostenimplicaties zijn berekend, in het bijzonder het potentieel aan besparingen. In Hoofdstuk 6 worden de bevindingen van het onderzoek geplaatst tegen de achtergrond van het NWO Slimme sturing programma, met accent op de sturingsinstrumenten die centraal staan in het sociale domein: regulering en budgettering. Bezien wordt wat exact de reikwijdte is van het nog vrijwel onbekende recht op een Familiegroepsplan. Hoofdstuk 7 sluit het rapport af met een slotbeschouwing en een aantal aanbevelingen, voor de betrokken maatschappelijke partners en voor de wetenschap

De netwerkkracht van de Rotterdammer in het sociale domein

In de periode 2015-2019 is met medewerking van de Gemeente Rotterdam en de Eigen Kracht Centrale te Zwolle een meerjarig onderzoek verricht naar de mate waarin het sociale network van Rotterdammers met een zorgvraag wordt geactiveerd voor (een deel van) de benodigde ondersteuning. Dit onderzoek vond plaats binnen het Slimme sturing programma van de Nederlandse Organisatie voor Wetenschappelijk Onderzoek (NWO) en is uitgevoerd door de Erasmus School of Law (EUR), samen met onderzoekers van de TU Delft en MOOZ Onderzoek te Utrecht/Arnhem

Standardized, Modular Parallelization Platform for Microfluidic Large-Scale Integration Cell Culturing Chips

Standardized high-throughput devices for microfluidic cell cultures are necessary to translate discoveries made in academia to applications in pharmaceutical industry. Here we present a platform with integrated pneumatic valves for standardized parallelization of multichamber chips (SPARC). In total, 192 chambers divided over three microfluidic building blocks (MFBBs) can be filled and purged with spatial and temporal independence. The dimensions of both the MFBB and the platform are standardized and thus compatible with common lab equipment. We characterize the valves at different pumping and gate pressures and show that the MFBBs are suitable for culturing human umbilical vein endothelial cells (HUVECs)

Retention versus sacrifice of the posterior cruciate ligament in total knee arthroplasty for treating osteoarthritis

Background The functional and clinical basis on which to choose whether or not to retain the posterior cruciate ligament during total knee arthroplasty surgery remained unclear after a Cochrane systematic review and meta-analysis in 2005, which contained eight clinical trials. Several new trials have been conducted since then. Hence, an update of the review was performed. Objectives Our aim was to assess the benefits and harms of retention compared to sacrifice of the posterior cruciate ligament in total knee arthroplasty in patients with osteoarthritis of the knee. Search methods An extensive search was conducted in CENTRAL, MEDLINE (PubMed), EMBASE, Web of Science, CINAHL, Academic Search Premier, Current Contents Connect and Science Direct. All databases were searched, without any limitations, up to 6 December 2012. References of the articles were checked and citation tracking was performed. Selection criteria Randomised and quasi-randomised controlled trials comparing retention with sacrifice of the posterior cruciate ligament in primary total knee arthroplasty in patients with osteoarthritis of the knee. Data collection and analysis Data were collected with a pre-developed form. Risk of bias was assessed independently by two authors (WV, LB). The level of evidence was graded using the GRADE approach. Meta-analysis was performed by pooling the results of the selected studies, when possible. Subgroup analyses were performed for posterior cruciate ligament retention versus sacrifice using the same total knee arthroplasty design, and for studies using a posterior cruciate ligament retaining or posterior stabilised design, and when sufficient studies were available subgroup analyses were performed for the same brand. Main results Seventeen randomised controlled trials (with 1810 patients and 2206 knees) were found, described in 18 articles. Ten of these were new studies compared to the previous Cochrane Review. One study from the original Cochrane review was excluded. Most new studies compared a posterior cruciate ligament retaining design with a posterior stabilised design, in which the posterior cruciate ligament is sacrificed (a posterior stabilised design has an insert with a central post which can engage on a femoral cam during flexion). The quality of evidence (graded with the GRADE approach) and the risk of bias were highly variable, ranging from moderate to low quality evidence and with unclear or low risk of bias for most domains, respectively. The performance outcome 'range of motion' was 2.4 degrees higher in favour of posterior cruciate ligament sacrifice (118.3 degrees versus 115.9 degrees; 95% confidence interval (CI) of the difference 0.13 to 4.67; P = 0.04), however the results were heterogeneous. On the item 'knee pain' as experienced by patients, meta-analysis could be performed on the Knee Society knee pain score; this score was 48.3 in both groups, yielding no difference between the groups. Implant survival rate could not be meta-analysed adequately since randomised controlled trials lack the longer term follow-up in order to evaluate implant survival. A total of four revisions in the cruciate-retention and four revisions in the cruciate-sacrifice group were found. The well-validated Western Ontario and McMaster Universities osteoarthritis index (WOMAC) total score was not statistically significantly different between the groups (16.6 points for cruciate-retention versus 15.0 points for cruciate-sacrifice). One study reported a patient satisfaction grade (7.7 points for cruciate-retention versus 7.9 points for cruciate-sacrifice on a scale from 0 to 10, 10 being completely satisfied) which did not differ statistically significantly. Complications were distributed equally between both groups. Only one study reported several re-operations other than revision surgery; that is patella luxations, surgical manipulation because of impaired flexion. The mean functional Knee Society Score was 2.3 points higher (81.2 versus 79.0 points; 95% CI of the difference 0.37 to 4.26; P = 0.02) in the posterior cruciate ligament sacrificing group. Results from the outcome Knee Society functional score were homogeneous. All other outcome measures (extension angle, knee pain, adverse effects, clinical questionnaire scores, Knee Society clinical scores, radiological rollback, radiolucencies, femorotibial angle and tibial slope) showed no statistically significant differences between the groups. In the subgroup analyses that allowed pooling of the results of the different studies, no homogeneous statistically significant differences were identified. Authors' conclusions The methodological quality and the quality of reporting of the studies were highly variable. With respect to range of motion, pain, clinical, and radiological outcomes, no clinically relevant differences were found between total knee arthroplasty with retention or sacrifice of the posterior cruciate ligament. Two statistically significant differences were found; range of motion was 2.4 degrees higher in the posterior cruciate ligament sacrificing group, however results were heterogeneous; and the mean functional Knee Society Score was 2.3 points higher in the posterior cruciate ligament sacrificing group. These differences are clinically not relevant

Insulin treatment guided by subcutaneous continuous glucose monitoring compared to frequent point-of-care measurement in critically ill patients: a randomized controlled trial

Glucose measurement in intensive care medicine is performed intermittently with the risk of undetected hypoglycemia. The workload for the ICU nursing staff is substantial. Subcutaneous continuous glucose monitoring (CGM) systems are available and may be able to solve some of these issues in critically ill patients. In a randomized controlled design in a mixed ICU in a teaching hospital we compared the use of subcutaneous CGM with frequent point of care (POC) to guide insulin treatment. Adult critically ill patients with an expected stay of more than 24 hours and in need of insulin therapy were included. All patients received subcutaneous CGM. CGM data were blinded in the control group, whereas in the intervention group these data were used to feed a computerized glucose regulation algorithm. The same algorithm was used in the control group fed by intermittent POC glucose measurements. Safety was assessed with the incidence of severe hypoglycemia ( <2.2 mmol/L), efficacy with the percentage time in target range (5.0 to 9.0 mmol/L). In addition, we assessed nursing workload and costs. In this study, 87 patients were randomized to the intervention and 90 to the control group. CGM device failure resulted in 78 and 78 patients for analysis. The incidence of severe glycemia and percentage of time within target range was similar in both groups. A significant reduction in daily nursing workload for glucose control was found in the intervention group (17 versus 36 minutes; P <0.001). Mean daily costs per patient were significantly reduced with EUR 12 (95% CI -32 to -18, P = 0.02) in the intervention group. Subcutaneous CGM to guide insulin treatment in critically ill patients is as safe and effective as intermittent point-of-care measurements and reduces nursing workload and daily costs. A new algorithm designed for frequent measurements may lead to improved performance and should precede clinical implementation. Clinicaltrials.gov, NCT01526044. Registered 1 February 201

Similar outcome after retention or sacrifice of the posterior cruciate ligament in total knee arthroplasty:A systematic review and meta-analysis

Background and purpose - To retain or to sacrifice the posterior cruciate ligament (PCL) in total knee arthroplasty (TKA) remains a matter of discussion. In this systematic review, we wanted to find differences in functional and clinical outcome between the 2 methods. Methods - We conducted a systematic review and meta-analysis including all randomized controlled trials (RCTs) and quasi-RCTs that have compared PCL retention with PCL sacrifice in TKA with a minimum of 1-year follow-up. Primary outcome was range of motion. Secondary outcomes were knee pain and clinical scoring systems that were preferably validated. Quality of evidence was graded using the GRADE approach. All outcomes available for data pooling were used for meta-analysis. Results - 20 studies involving 1,877 patients and 2,347 knees were included. In meta-analysis, the postoperative flexion angle had a mean difference of 2 degrees (95% CI: 0.23-4.0; p = 0.03) and the KSS functional score was 2.4 points higher in favor of PCL sacrifice (95% CI: 0.41-4.3; p = 0.02). There were no statistically significant differences regarding other measured clinical outcomes such as WOMAC, KSS pain, clinical and overall score, HSS score, SF-12, radiolucencies, femoro-tibial angle, and tibial slope. The quality of the studies varied considerably. Risk of bias in most studies was unclear; 5 were judged to have a low risk of bias and 5 to have a high risk of bias. Interpretation - We found no clinically relevant differences between retention and sacrifice of the PCL in TKA, in terms of functional and clinical outcomes. The quality of the studies ranged from moderate to low. Based on the current evidence, no recommendation can be made as to whether to retain or to sacrifice the PCL

A cluster-randomized trial of mass drug administration with a gametocytocidal drug combination to interrupt malaria transmission in a low endemic area in Tanzania

Contains fulltext : 96570.pdf (publisher's version ) (Open Access)BACKGROUND: Effective mass drug administration (MDA) with anti-malarial drugs can clear the human infectious reservoir for malaria and thereby interrupt malaria transmission. The likelihood of success of MDA depends on the intensity and seasonality of malaria transmission, the efficacy of the intervention in rapidly clearing all malaria parasite stages and the degree to which symptomatic and asymptomatic parasite carriers participate in the intervention. The impact of MDA with the gametocytocidal drug combination sulphadoxine-pyrimethamine (SP) plus artesunate (AS) plus primaquine (PQ, single dose 0.75 mg/kg) on malaria transmission was determined in an area of very low and seasonal malaria transmission in northern Tanzania. METHODS: In a cluster-randomized trial in four villages in Lower Moshi, Tanzania, eight clusters (1,110 individuals; cluster size 47- 209) were randomized to observed treatment with SP+AS+PQ and eight clusters (2,347 individuals, cluster size 55- 737) to treatment with placebo over three days. Intervention and control clusters were 1 km apart; households that were located between clusters were treated as buffer zones where all individuals received SP+AS+PQ but were not selected for the evaluation. Passive case detection was done for the entire cohort and active case detection in 149 children aged 1-10 year from the intervention arm and 143 from the control arm. Four cross-sectional surveys assessed parasite carriage by microscopy and molecular methods during a five-month follow-up period. RESULTS: The coverage rate in the intervention arm was 93.0% (1,117/1,201). Parasite prevalence by molecular detection methods was 2.2-2.7% prior to the intervention and undetectable during follow-up in both the control and intervention clusters. None of the slides collected during cross-sectional surveys had microscopically detectable parasite densities. Three clinical malaria episodes occurred in the intervention (n = 1) and control clusters (n = 2). CONCLUSIONS: This study illustrates the possibility to achieve high coverage with a three-day intervention but also the difficulty in defining suitable outcome measures to evaluate interventions in areas of very low malaria transmission intensity. The decline in transmission intensity prior to the intervention made it impossible to assess the impact of MDA in the chosen study setting. TRIAL REGISTRATION: ClinicalTrials.gov: NCT00509015

Laparoscopic ileocolic resection versus infliximab treatment of distal ileitis in Crohn's disease: a randomized multicenter trial (LIR!C-trial)

Contains fulltext : 69534.pdf (publisher's version ) (Open Access)BACKGROUND: With the availability of infliximab, nowadays recurrent Crohn's disease, defined as disease refractory to immunomodulatory agents that has been treated with steroids, is generally treated with infliximab. Infliximab is an effective but expensive treatment and once started it is unclear when therapy can be discontinued. Surgical resection has been the golden standard in recurrent Crohn's disease. Laparoscopic ileocolic resection proved to be safe and is characterized by a quick symptom reduction.The objective of this study is to compare infliximab treatment with laparoscopic ileocolic resection in patients with recurrent Crohn's disease of the distal ileum with respect to quality of life and costs. METHODS/DESIGN: The study is designed as a multicenter randomized clinical trial including patients with Crohn's disease located in the terminal ileum that require infliximab treatment following recent consensus statements on inflammatory bowel disease treatment: moderate to severe disease activity in patients that fail to respond to steroid therapy or immunomodulatory therapy. Patients will be randomized to receive either infliximab or undergo a laparoscopic ileocolic resection. Primary outcomes are quality of life and costs. Secondary outcomes are hospital stay, early and late morbidity, sick leave and surgical recurrence. In order to detect an effect size of 0.5 on the Inflammatory Bowel Disease Questionnaire at a 5% two sided significance level with a power of 80%, a sample size of 65 patients per treatment group can be calculated. An economic evaluation will be performed by assessing the marginal direct medical, non-medical and time costs and the costs per Quality Adjusted Life Year (QALY) will be calculated. For both treatment strategies a cost-utility ratio will be calculated. Patients will be included from December 2007. DISCUSSION: The LIR!C-trial is a randomized multicenter trial that will provide evidence whether infliximab treatment or surgery is the best treatment for recurrent distal ileitis in Crohn's disease. TRIAL REGISTRATION: Nederlands Trial Register NTR1150