http://repub.eur.nl/res/aut/50390/ List of Publications en http://repub.eur.nl/static-eur/img/logo.png http://repub.eur.nl http://repub.eur.nl/res/pub/39484/ 2012-08-01T00:00:00Z Purpose Displaced femoral neck fractures in healthy elderly patients have traditionally been managed with hemiarthroplasty (HA). Recent data suggest that total hip arthroplasty (THA) may be a better alternative. Methods A systematic review of the English literature was conducted. Randomized controlled trials comparing all forms of THA with HA were included. Three authors independently extracted articles and predefined data. Results were pooled using a random effects model. Results Eight trials totalling 986 patients were retrieved. After THA 4 % underwent revision surgery versus 7 % after HA. The one-year mortality was equal in both groups: 13 % (THA) versus 15 % (HA). Dislocation rates were 9 % after THA versus 3 % after HA. Equal rates were found for major (25 % in THA versus 24 % in HA) and minor complications (13 % THA versus 14 % HA). The weighted mean of the Harris hip score was 81 points after THA versus 77 after HA. The subdomain pain of the HHS (weighted mean score after THA was 42 versus 39 points for HA), the rate of patients reporting mild to no pain (75 % after THA versus 56 % after HA) and the score of WOMAC (94 points for THA versus 78 for HA) all favored THA. Quality of life measured with the EQ-5D favored THA (0.69 versus 0.57). Conclusions Total hip arthroplasty for displaced femoral neck fractures in the fit elderly may lead to higher patientbased outcomes but has higher dislocation rates compared with hemiarthroplasty. Further high-quality randomized clinical trails are needed to provide robust evidence and to definitively answer this clinical question. http://repub.eur.nl/res/pub/35015/ 2012-01-08T00:00:00Z Background: Surgeons in the Netherlands, Canada and the US participate in the FAITH trial (Fixation using Alternative Implants for the Treatment of Hip fractures). Dutch sites are managed and visited by a financed central trial coordinator, whereas most Canadian and US sites have local study coordinators and receive per patient payment. This study was aimed to assess how these different trial management strategies affected trial performance.Methods: Details related to obtaining ethics approval, time to trial start-up, inclusion, and percentage completed follow-ups were collected for each trial site and compared. Pre-trial screening data were compared with actual inclusion rates.Results: Median trial start-up ranged from 41 days (P25-P75 10-139) in the Netherlands to 232 days (P25-P75 98-423) in Canada (p = 0.027). The inclusion rate was highest in the Netherlands; median 1.03 patients (P25-P75 0.43-2.21) per site per month, representing 34.4% of the total eligible population. It was lowest in Canada; 0.14 inclusions (P25-P75 0.00-0.28), representing 3.9% of eligible patients (p < 0.001). The percentage completed follow-ups was 83% for Canadian and Dutch sites and 70% for US sites (p = 0.217).Conclusions: In this trial, a central financed trial coordinator to manage all trial related tasks in participating sites resulted in better trial progression and a similar follow-up. It is therefore a suitable alternative for appointing these tasks to local research assistants. The central coordinator approach can enable smaller regional hospitals to participate in multicenter randomized controlled trials. Circumstances such as available budget, sample size, and geographical area should however be taken into account when choosing a management strategy.Trial Registration: ClinicalTrials.gov: NCT00761813. http://repub.eur.nl/res/pub/39288/ 2012-01-01T00:00:00Z ABSTRACT Objective: Multicenter clinical trials can be organized in different ways. Multiple centers participated in the HEALTH trial (Hip Fracture Evaluation with ALternatives of Total Hip Arthroplasty versus Hemi-Arthroplasty). For the Dutch sites most study tasks are managed by a central trial coordinator, whereas Canadian and US sites use local study coordinators. The aim of this study was to analyze how these strategies affected trial performance. Design: Prospective observational study. Method: Data related to ethics approval, trial start-up time, inclusion rate and percentage of completed follow-ups were collected for each hospital and compared. Data from pre-trial screening were compared with actual inclusion rates. Results: The median start-up time of the trial after obtaining ethics approval was shorter in the Netherlands than in Canada and the US (4.6 versus 11.6 weeks). The inclusion rate was similar in both groups (0.62 versus 0.64/month). The median percentage of enrolled patients in the Netherlands was 27.3% versus 17.0% in Canada/US. The actual inclusion rates were lower than expected from pre-trial screening. The percentage of effectuated follow-up visits was >90% in both groups. Conclusion: In this study, central trial coordination contributed to faster trial start-up and higher inclusion rates, but had no effect on the effectuated follow-up visits. Central coordination is therefore a suitable alternative for appointing these tasks to local research assistants and per patient payment. Central coordination enables non-academic hospitals to participate in clinical trials. Limiting conditions for central coordination are budget availability, a manageable number of patients, and a manageable distance between participating sites. http://repub.eur.nl/res/pub/33473/ 2011-04-01T00:00:00Z Background: There is uncertainty regarding the prognostic value of troponin and creatine kinase muscle and brain isoenzyme measurements after noncardiac surgery. Methods: The current study undertook a systematic review and meta-analysis. The study used six search strategies and included noncardiac surgery studies that provided data from a multivariable analysis assessing whether a postoperative troponin or creatine kinase muscle and brain isoenzyme measurement was an independent predictor of mortality or a major cardiovascular event. Independent investigators determined study eligibility and abstracted data in duplicate. Results: Fourteen studies, enrolling 3,318 patients and 459 deaths, demonstrated that an increased troponin measurement after surgery was an independent predictor of mortality (odds ratio [OR] 3.4, 95% confidence interval [CI] 2.2-5.2), but there was substantial heterogeneity (I = 56%). The independent prognostic capabilities of an increased troponin value after surgery in the 10 studies that assessed intermediate-term (≤ 12 months) mortality was an OR = 6.7 (95% CI 4.1-10.9, I = 0%) and in the 4 studies that assessed long-term (more than 12 months) mortality was an OR = 1.8 (95% CI 1.4-2.3, I = 0%; P < 0.001 for test of interaction). Four studies, including 1,165 patients and 202 deaths, demonstrated an independent association between an increased creatine kinase muscle and brain isoenzyme measurement after surgery and mortality (OR 2.5, 95% CI 1.5-4.0, I = 4%). Conclusions: An increased troponin measurement after surgery is an independent predictor of mortality, particularly within the first year; limited data suggest an increased creatine kinase muscle and brain isoenzyme measurement also predicts subsequent mortality. Monitoring troponin measurements after noncardiac surgery may allow physicians to better risk stratify and manage their patients.