[Local approval procedures act as a brake on RCTs]. / Lokale toestemmingsprocedures zetten een rem op RCT's.

OBJECTIVE: Large multicentre randomised controlled trials (RCTs) in the Netherlands are increasingly being impeded by major differences between local approval procedures. However, no national agenda exists as yet to improve this situation. The existence of major local differences in processing time and documentation required has been reported previously but little is known about the costs incurred and whether or not specific certifications and research contracts are mandatory. The current study evaluated these aspects of local procedures for obtaining approval of two oncological multicentre RCTs. DESIGN: Retrospective, descriptive. METHOD: All local procedures for obtaining approval of two randomised clinical trials were evaluated: the CAIRO5 and CHARISMA trials initiated by the Dutch Colorectal Cancer Group (DCCG). We objectified time between approval by the Medical Ethics Review Committee (METC) and final approval by the Board of Directors (RvB), the type and number of documents needed, and costs charged. RESULTS: The median time interval between the approval by the Medical Ethics Review Committee and the approval by the Board of Directors was 90 days (range 4-312). The number of documents required per centre ranged from 6-20. The costs charged ranged from € 0-€ 1750, and amounted to € 8575 for all procedures combined. No costs were charged by the majority of the centres. CONCLUSION: The approval procedures for multicentre clinical trials in the Netherlands demonstrate major differences. Processing times, documentation required and costs are unpredictable; greater uniformity is highly desirable in this context.

Effectiveness of a Multidisciplinary Clinical Pathway for Elderly Patients With Hip Fracture: A Multicenter Comparative Cohort Study.

INTRODUCTION: The use of a multidisciplinary clinical pathway (MCP) for patients with hip fracture tends to be more effective than usual care (UC). The aim of this study was to evaluate the effects of an MCP approach on time to surgery, length of stay, postoperative complications, and 30-day mortality, compared to UC. MATERIALS AND METHODS: This multicenter retrospective cohort study included patients aged 50 years or older with a proximal hip fracture who underwent surgery in one of the 6 hospitals in the Limburg trauma region of the Netherlands in 2012. Data such as demographics, process outcome measures, and clinical outcome were collected. RESULTS: This study included a total of 1193 patients (665 and 528 patients in the MCP and UC groups, respectively). There were no differences in patient demographics present. Time to surgery was significantly shorter in the MCP compared to the UC group (19.2 vs 24.4 hours, P < .01). The mean length of stay was 10 versus 12 days (P < .01). In the MCP group, significantly lower rates of postoperative complications were observed and significantly more patients were institutionalized than in the UC group. Mortality within 30 days after admission was comparable between the groups (overall mortality 6%). CONCLUSION: An MCP approach is associated with reduced time to surgery, postoperative complications, and length of stay, without a significant difference in 30-day mortality. The institutionalization rate was significantly higher in the MCP group.

How does lateral tilting affect the internal strains in the sacral region of bed ridden patients? - A contribution to pressure ulcer prevention.

BACKGROUND: Repositioning of individuals with reduced mobility and at risk of pressure ulcers is an essential preventive step. Manual or automatic lateral tilting is a way of doing this and the international guidelines propose a 30° to 40° side lying position. The goal of the present study was to determine the internal strains in individuals lying in a supine position and during tilting. METHODS: Based on magnetic resonance imaging (MRI) of the sacral area of human volunteers, subject specific finite element models were developed. By comparing calculated contours of the skin, fat and muscle with MRI measurements on a flat surface the models were validated. A parameter study was performed to assess the sensitivity of the model for changes in material properties. Simulations were performed at tilting angles of volunteers between 0° and 45°. FINDINGS: Subjects in a supine position or tilted have the highest strains in the muscle and fat. Tilting does affect the strain distribution, taking away the highest peak strains. There seems to exist an optimal tilting angle between 20° and 30°, which may vary depending on factors such as BMI of the subject and is in the current paper investigated only for the sacrum. INTERPRETATION: The study shows that tilting indeed has a significant, positive influence on internal strains, which is important for the prevention of deep tissue injury. Additional studies are needed to draw conclusions about the greater trochanter area and the tissues around the shoulder.

A numerical study to analyse the risk for pressure ulcer development on a spine board.

BACKGROUND: Spine boards are used to immobilise accident victims suspected of having spinal injury. Guidelines about the maximum time patients remain on the board are often exceeded and on occasions may lead to pressure ulcers. Etiological research has shown that two processes ultimately lead to pressure ulcers:"Ischemic damage" which takes several hours to initiate and "deformation damage" at high strains. The latter process is very quick and the first signs of cell damage are already evident within minutes. Thus in order to minimise the risk of pressure ulcer development during prolonged loading, a new soft-layered long spine board has been designed. METHODS: A subject specific numerical approach has been adopted to evaluate the prototype spine board in comparison to a conventional spine board, with reference to the estimated strains in the soft tissues adjacent to the sacrum in the supine position. The model geometry is derived from magnetic resonance images of three human volunteers in an unloaded situation. The loaded images are used to "tune" the material parameters of skin, fat and muscle. The prediction of the deformed contours on the soft-layered board is used to validate the model. FINDINGS: Comparison of the internal strains in muscle tissue near the spine showed that internal strains on the soft-layered board are reduced and maximum strains are considerably less than the threshold at which deformation damage is possible. By contrast, on the rigid spine board this threshold is exceeded in all cases. INTERPRETATION: The prototype comfort board is able to reduce the risk for deformation damage and thus reduces the risk of developing pressure ulcers.

Prehospital care in patients with severe traumatic brain injury: does the level of prehospital care influence mortality?

INTRODUCTION AND PURPOSE: The controversy between the "scoop and run" versus the "stay and play" approach in severely injured trauma patients has been an ongoing issue for decades. The present study was undertaken to investigate whether changes in prehospital care for patients with severe traumatic brain injury in the Netherlands have improved outcome. METHODS: In this retrospective study, files (n = 60) were analyzed from a prospectively collected database including all patients admitted to one of six hospitals in the Limburg region in the Netherlands with a Glasgow Coma Scale (GCS) score ≤8 on admittance over the period from January 2006 to December 2008. All patients had traumatic brain damage proven on computed tomography (CT) or magnetic resonance imaging (MRI). Relevant prehospital and clinical data from the present cohort were compared to data from a similar study (n = 30) conducted 20 years ago. The primary outcome assessed was mortality. RESULTS: The two study groups had similar characteristics with regard to the GCS score. In the historic cohort, Basic Life Support (BLS) and the "scoop and run" approach in patients with major traumatic brain injury was common, with an average time on scene of 7.5 min. Currently, prehospital care is performed mainly on the level of prehospital Advanced Life Support (ALS), with the average time on scene being about four times as long as in the historic cohort. However, the overall mortality rate for the current cohort compared to the historic cohort has not changed. CONCLUSION: Despite more on-site ALS in severely head injured patients nowadays compared to the historic cohort, there was no reduction in mortality.