Purpose: Enrolling traumatic brain injury (731) patients with an inability to provide informed consent in research is challenging. Alternatives to patient consent are not sufficiently embedded in... Show morePurpose: Enrolling traumatic brain injury (731) patients with an inability to provide informed consent in research is challenging. Alternatives to patient consent are not sufficiently embedded in European and national legislation, which allows procedural variation and bias. We aimed to quantify variations in informed consent policy and practice.Methods: Variation was explored in the CENTER-TBI study. Policies were reported by using a questionnaire and national legislation. Data on used informed consent procedures were available for 4498 patients from 57 centres across 17 European countries.Results: Variation in the use of informed consent procedures was found between and within EU member states. Proxy informed consent (N = 1377;64%) was the most frequently used type of consent in the ICU, followed by patient informed consent (N 426;20%) and deferred consent (N 334;16%). Deferred consent was only actively used in 15 centres (26%), although it was considered valid in 47 centres (82%).Conclusions: Alternatives to patient consent are essential for TBI research. While there seems to be concordance amongst national legislations, there is regional variability in institutional practices with respect to the use of different informed consent procedures. Variation could be caused by several reasons, including inconsistencies in clear legislation or knowledge of such legislation amongst researchers. (C) 2020 Published by Elsevier Inc. Show less
Essen, T.A. van; Boogert, H.F. den; Cnossen, M.C.; Ruiter, G.C.W. de; Haitsma, I.; Polinder, S.; ... ; Jagt, M. van der 2019
42 % of the abstracts that were accepted for podium presentation at the CSRS Europe resulted in a publication in peer-reviewed MEDLINE indexed journals. Publication rates are at the high end of the... Show more42 % of the abstracts that were accepted for podium presentation at the CSRS Europe resulted in a publication in peer-reviewed MEDLINE indexed journals. Publication rates are at the high end of the publication rate spectrum of abstracts accepted for European scientific meetings. Show less
Jacobs, W.; Willems, P.C.; Limbeek, J. van; Bartels, R.; Pavlov, P.; Anderson, P.G.; Oner, C. 2011
Background The number of surgical techniques for decompression and solid interbody fusion as treatment for cervical spondylosis has increased rapidly, but the rationale for the choice between... Show moreBackground The number of surgical techniques for decompression and solid interbody fusion as treatment for cervical spondylosis has increased rapidly, but the rationale for the choice between different techniques remains unclear. Objectives To determine which technique of anterior interbody fusion gives the best clinical and radiological outcomes in patients with single-or double-level degenerative disc disease of the cervical spine. Search strategy We searched CENTRAL (The Cochrane Library 2009, issue 1), MEDLINE (1966 to May 2009), EMBASE (1980 to May 2009), BIOSIS (2004 to May 2009), and references of selected articles. Selection criteria Randomised comparative studies that compared anterior cervical decompression and interbody fusion techniques for participants with chronic degenerative disc disease. Data collection and analysis Two review authors independently assessed risk of bias using the Cochrane Back Review Group criteria. Data on demographics, intervention details and outcome measures were extracted onto a pre-tested data extraction form. Main results Thirty-three small studies (2267 patients) compared different fusion techniques. The major treatments were discectomy alone, addition of an interbody fusion procedure (autograft, allograft, cement, or cage), and addition of anterior plates. Eight studies had a low risk of bias. Few studies reported on pain, therefore, at best, there was very low quality evidence of little or no difference in pain relief between the different techniques. We found moderate quality evidence for these secondary outcomes: no statistically significant difference in Odom's criteria between iliac crest autograft and a metal cage (6 studies, RR 1.11 (95% CI 0.99 to 1.24)); bone graft produced more effective fusion than discectomy alone (5 studies, RR 0.22 (95% CI 0.17 to 0.48)); no statistically significant difference in complication rates between discectomy alone and iliac crest autograft (7 studies, RR 1.56 (95% CI 0.71 to 3.43)); and low quality evidence that iliac crest autograft results in better fusion than a cage (5 studies, RR 1.87 (95% CI 1.10 to 3.17)); but more complications (7 studies, RR 0.33 (95% CI 0.12 to 0.92)). Authors' conclusions When the working mechanism for pain relief and functional improvement is fusion of the motion segment, there is low quality evidence that iliac crest autograft appears to be the better technique. When ignoring fusion rates and looking at complication rates, a cage has a weak evidence base over iliac crest autograft, but not over discectomy alone. Future research should compare additional instrumentation such as screws, plates, and cages against discectomy with or without autograft. Show less
Jacobs, W.; Willems, P.C.; Kruyt, M.; Limbeek, J. van; Anderson, P.G.; Pavlov, P.; ... ; Oner, C. 2011
Study Design. A systematic review of randomized controlled trials. Objective. To determine which technique of anterior cervical inter-body fusion (ACIF) gives the best outcome in patients with... Show moreStudy Design. A systematic review of randomized controlled trials. Objective. To determine which technique of anterior cervical inter-body fusion (ACIF) gives the best outcome in patients with cervical degenerative disc disease. Summary of Background Data. The number of surgical techniques for decompression and ACIF as treatment for cervical degenerative disc disease has increased rapidly, but the rationale for the choice between different techniques remains unclear. Methods. From a comprehensive search, we selected randomized studies that compared anterior cervical decompression and ACIF techniques, in patients with chronic single-or double-level degenerative disc disease or disc herniation. Risk of bias was assessed using the criteria of the Cochrane back review group. Results. Thirty-three studies with 2267 patients were included. The major treatments were discectomy alone and addition of an ACIF procedure (graft, cement, cage, and plates). At best, there was very low-quality evidence of little or no difference in pain relief between the techniques. We found moderate quality evidence for few secondary outcomes. Odom's criteria were not different between iliac crest autograft and a metal cage (risk ratio [RR]: 1.11; 95% confidence interval [CI]: 0.99-1.24). Bone graft produced more fusion than discectomy (RR: 0.22; 95% CI: 0.17-0.48). Complication rates were not different between discectomy and iliac crest autograft (RR: 1.56; 95% CI: 0.71-3.43). Low-quality evidence was found that iliac crest autograft results in better fusion than a cage (RR: 1.87; 95% CI: 1.10-3.17); but more complications (RR: 0.33; 95% CI: 0.12-0.92). Conclusion. When fusion of the motion segment is considered to be the working mechanism for pain relief and functional improvement, iliac crest autograft appears to be the golden standard. When ignoring fusion rates and looking at complication rates, a cage as a golden standard has a weak evidence base over iliac crest autograft, but not over discectomy. Show less
Nellensteijn, J.; Ostelo, R.; Bartels, R.; Peul, W.; Royen, B. van; Tulder, M. van 2010
Transforaminal endoscopic techniques have become increasingly popular in surgery of patients with lumbar stenosis. The literature has not yet been systematically reviewed. A comprehensive... Show moreTransforaminal endoscopic techniques have become increasingly popular in surgery of patients with lumbar stenosis. The literature has not yet been systematically reviewed. A comprehensive systematic literature review up to November 2009 to assess the effectiveness of transforaminal endoscopic surgery in patients with symptomatic lumbar stenosis was made. Two reviewers independently checked all retrieved titles and abstracts and relevant full text articles for inclusion criteria. Included articles were assessed for quality, and relevant data, including outcomes, were extracted by two reviewers independently. No randomized controlled trials were identified, but seven observational studies. The studies were of poor methodological quality and heterogeneous regarding patient selection, indications, operation techniques, follow-up period and outcome measures. Overall, 69-83% reported the outcome as satisfactory and a complication rate of 0-8.3%. The reported re-operation rate varied from 0 to 20%. At present, there is no valid evidence from randomized controlled trials on the effectiveness of transforaminal endoscopic surgery for lumbar stenosis. Randomized controlled trials comparing transforaminal endoscopic surgery with other surgical techniques are direly needed. Show less
Nellensteijn, J.; Ostelo, R.; Bartels, R.; Peul, W.; Royen, B. van; Tulder, M. van 2010
The study design includes a systematic literature review. The objective of the study was to evaluate the effectiveness of transforaminal endoscopic surgery and to compare this with open... Show moreThe study design includes a systematic literature review. The objective of the study was to evaluate the effectiveness of transforaminal endoscopic surgery and to compare this with open microdiscectomy in patients with symptomatic lumbar disc herniations. Transforaminal endoscopic techniques for patients with symptomatic lumbar disc herniations have become increasingly popular. The literature has not yet been systematically reviewed. A comprehensive systematic literature search of the MEDLINE and EMBASE databases was performed up to May 2008. Two reviewers independently checked all retrieved titles and abstracts and relevant full text articles for inclusion criteria. Included articles were assessed for quality and outcomes were extracted by the two reviewers independently. One randomized controlled trial, 7 non-randomized controlled trials and 31 observational studies were identified. Studies were heterogeneous regarding patient selection, indications, operation techniques, follow-up period and outcome measures and the methodological quality of these studies was poor. The eight trials did not find any statistically significant differences in leg pain reduction between the transforaminal endoscopic surgery group (89%) and the open microdiscectomy group (87%); overall improvement (84 vs. 78%), re-operation rate (6.8 vs. 4.7%) and complication rate (1.5 vs. 1%), respectively. In conclusion, current evidence on the effectiveness of transforaminal endoscopic surgery is poor and does not provide valid information to either support or refute using this type of surgery in patients with symptomatic lumbar disc herniations. High-quality randomized controlled trials with sufficiently large sample sizes are direly needed to evaluate if transforaminal endoscopic surgery is more effective than open microdiscectomy. Show less
