The aim of this audit was to investigate process, personnel and anaesthetic factors in relation to mortality among patients with proximal femoral fractures. A questionnaire was used to record standardised data about 1195 patients with proximal femoral fracture admitted to 22 hospitals contributing to the Hip Fracture Anaesthesia Network over a 2-month winter period. Patients were demographically similar between hospitals (mean age 81 years, 73% female, median ASA grade 3). However, there was wide variation in time from admission to operation (24-108 h) and 30-day postoperative mortality (2-25%). Fifty percent of hospitals had a mean admission to operation time < 48 h. Forty-two percent of operations were delayed: 51% for organisational; 44% for medical; and 4% for 'anaesthetic' reasons. Regional anaesthesia was administered to 49% of patients (by hospital, range = 0-82%), 51% received general anaesthesia and 19% of patients received peripheral nerve blockade. Consultants administered 61% of anaesthetics (17-100%). Wide national variations in current management of patients sustaining proximal femoral fracture reflect a lack of research evidence on which to base best practice guidance. Collaborative audits such as this provide a robust method of collecting such evidence.
Summary 1. There should be protocol‐driven, fast‐track admission of patients with hip fractures through the emergency department. 2. Patients with hip fractures require multidisciplinary care, led by orthogeriatricians. 3. Surgery is the best analgesic for hip fractures. 4. Surgical repair of hip fractures should occur within 48 hours of hospital admission. 5. Surgery and anaesthesia must be undertaken by appropriately experienced surgeons and anaesthetists. 6. There must be high‐quality communication between clinicians and allied health professionals. 7. Early mobilisation is a key part of the management of patients with hip fractures. 8. Pre‐operative management should include consideration of planning for discharge from hospital. 9. Measures should be taken to prevent secondary falls. 10. Continuous audit and targeted research is required in order to inform and improve the management of patients with hip fracture.
Early clinical trials of therapies to treat Duchenne muscular dystrophy (DMD), a fatal genetic X-linked pediatric disease, have been designed based on the limited understanding of natural disease progression and variability in clinical measures over different stages of the continuum of the disease. The objective was to inform the design of DMD clinical trials by developing a disease progression modelbased clinical trial simulation (CTS) platform based on measures commonly used in DMD trials. Data were integrated from past studies through the Duchenne Regulatory Science Consortium founded by the Critical Path Institute (15 clinical trials and studies, 1505 subjects, 27,252 observations). Using a nonlinear mixedeffects modeling approach, longitudinal dynamics of five measures were modeled (NorthStar Ambulatory Assessment, forced vital capacity, and the velocities of the following three timed functional tests: time to stand from supine, time to climb 4 stairs, and 10 meter walk-run time). The models were validated on external data sets and captured longitudinal changes in the five measures well, including both early disease when function improves as a result of growth and development and the decline in function in later stages. The models can be used in the CTS platform to perform trial simulations to optimize the selection of inclusion/ exclusion criteria, selection of measures, and other trial parameters. The data sets and models have been reviewed by the US Food and Drug Administration and the European Medicines Agency; have been accepted into the Fit-for-Purpose and Qualification for Novel Methodologies pathways, respectively; and will be submitted for potential endorsement by both agencies.
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