Effect of Ginkgo biloba (EGb 761) and aspirin on platelet aggregation and platelet function analysis among older adults at risk of cardiovascular disease: a randomized clinical trial.

Several case reports have implicated Ginkgo biloba in clinically adverse bleeding disorders. Ginkgo biloba has been reported to increase pain-free walking distance among patients with peripheral artery disease (PAD). Standard PAD therapy includes 325 mg/day aspirin. The objective of this study was to examine potential adverse effects of concomitant aspirin and Ginkgo biloba on platelet function. Ginkgo biloba (EGb 761, 300 mg/day) was compared with placebo for effects on measures of platelet aggregation among adults consuming 325 mg/day aspirin in a randomized, double-blind, placebo-controlled, parallel design trial of 4-week duration. Participants were adults, age 69 +/- 10 years, with PAD or risk factors for cardiovascular disease. Outcome measures included platelet function analysis (PFA-100 analyzer) using ADP as an agonist (n = 26 placebo; n = 29 ginkgo), and platelet aggregation using ADP, epinephrine, collagen and ristocetin as agonists (n = 21 placebo; n = 23 ginkgo). Participants kept daily logs of bleeding or bruising episodes. There were no clinically or statistically significant differences between treatment groups for any agonists, for either PFA-100 analysis or platelet aggregation. Reports of bleeding or bruising were infrequent and similar for both study groups. In conclusion, in older adults with PAD or cardiovascular disease risk, a relatively high dose of Ginkgo biloba combined with 325 mg/day daily aspirin did not have a clinically or statistically detectable impact on indices of coagulation examined over 4 weeks, compared with the effect of aspirin alone. No adverse bleeding events were observed, although the trial was limited to a small sample size.     

Three-dimensional modeling system for unilateral mandibular bone distraction: a clinical case.

Facial hemiatrophies are anomalies of the first branchial arch and affect one in 4000-5000 newborns. Bone distraction is the technique of choice for the treatment of these dysmorphoses. Mandibular osteodistraction requires prior determination of the characteristics of the distraction vector whose three components will serve to activate the distractor. The patient, aged 5 years, presented with a right facial hemiatrophy, Grade IB according to the classification of Pruzansky. Tomodensitometric acquisition was obtained with a CT scanner. Software specifically designed for this application allows segmentation of the anatomical elements by a region-growing algorithm. The 3D representation of each element is added to a 3D scene, in which are placed the built-up landmarks necessary for the surgical simulation after 3D cephalometric analysis. The surgical cleavage plane is oriented according to the surgeon's requirements while preserving the predominant anatomical elements. The software allows performance of rotations and translations of the bone segments rendered independently from the cleavage plane. The distances and angles covered during the virtual movement are measured at its conclusion. The aim of moving the bone segments is to render the mandibular occlusion plane parallel to the reference occlusion plane. The vertical growth of the maxilla is realized by secondary recuperation. The distractor used was of an external multidirectional type allowing elongation of the mandibular ramus and mandibular corpus, closure of the goniac angle, and lateralization or medialization of the ramus. On the 15th day, the mandibular angle was reduced by 10 degrees, which allowed closure of the anterior gap and recentering of the incisive areas by a half-cuspid. The patient presented with a complex bone deficit in the three spatial directions, which allowed the development of software for modeling the distraction. Other clinical cases will be necessary to validate this 3D imaging-based technique.     

BS15PFACILITATING NATIONAL CONSISTENCY IN BREAST CANCER DATA COLLECTION

In Australia there is currently no consistent approach to collecting breast cancer specific data. The National Health Data Dictionary (NHDD) recommends a core set of generic data items for clinical cancer registration. However this list does not include the more detailed items required by specific tumour streams. The NBCC has developed a supplementary set of Breast Specific Data Items and definitions to serve as a guide for specialist breast cancer data collection in Australia. A multidisciplinary Working Group comprising clinical and consumer representation, including three breast surgeons, identified 16 breast specific data items for collection. The items are designed to align with items collected through the RACS National Breast Cancer Audit and leading cancer centres. A range of items from patient data (menopausal status), diagnostic data (HER2 status, sentinel lymph node), treatment (surgical margin clearance and involvement), and breast reconstruction are included. The data items are recommended as best practice for breast cancer specific data collection and aim to facilitate national consistency in defining, recording, and monitoring information about patients with breast cancer. This national approach will contribute to improved patient outcomes by informing planning, quality improvement and evaluation strategies for cancer services. The items are currently being piloted in two sites in NSW and will be available nationally in late 2007.     

Understanding the minimum clinically important difference: a review of concepts and methods.

BACKGROUND CONTEXT: The effectiveness of spinal surgery as a treatment option is currently evaluated through the assessment of patient-reported outcomes (PROs). The minimum clinically important difference (MCID) represents the smallest improvement considered worthwhile by a patient. The concept of an MCID is offered as the new standard for determining effectiveness of a given treatment and describing patient satisfaction in reference to that treatment. PURPOSE: Our goal is to review the various definitions of MCID and the methods available to determine MCID. STUDY DESIGN: The primary means of determining the MCID for a specific treatment are divided into anchor-based and distribution-based methods. Each method is further subdivided and examined in detail. METHODS: The overall limitations of the MCID concept are first identified. The basic assumptions, statistical biases, and shortcomings of each method are examined in detail. RESULTS: Each method of determining the MCID has specific shortcomings. Three general limitations in the accurate determination of an MCID have been identified: the multiplicity of MCID determinations, the loss of the patient's perspective, and the relationship between pretreatment baseline and posttreatment change scores. CONCLUSIONS: An ideal means of determining the MCID for a given intervention is yet to be determined. It is possible to develop a useful method provided that the assumptions and methodology are initially declared. Our efforts toward the establishment of a MCID will rely on the establishment of specific external criteria based on the symptoms of the patient and treatment intervention being evaluated.     

Clinical risk management in anaesthesia

Contin Educ Anaesth Crit