Citations

The success of vascularized bone grafts from the medial femoral condyle in various clinical applications has sparked renewed interest in the microvascular anatomy of this region. This study describes the arterial supply of the distal medial femoral condyle and its implications in harvesting vascularized bone grafts. The location, branching pattern, internal diameter, and distribution of perforators of the descending genicular artery and superior medial genicular artery in 19 fresh cadaveric lower limbs were recorded. The descending genicular artery was present in 89% and the superior medial genicular artery was present in 100% of specimens with average distances proximal to the articular surface of 13.7 cm and 5.2 cm, respectively. The average number of perforating vessels was greatest in the posterior distal quadrant of the condyle. The blood supply of the medial femoral condyle is plentiful and consistent making it a useful source for free vascularized bone grafts.

Following the death of a youth hockey coach in a fight with a parent in 2000, the Mayo Clinic Sports Medicine Center and Minnesota Hockey collaborated to implement a three-component Hockey Education Program (HEP). HEP was initiated in 2003 to ensure youth players develop sportsmanship, skills, and a Fair Play approach to the game. Another goal was to decrease attrition of players, coaches, and officials. Coaching Excellence, a component of HEP, is based on 25 years of youth sport research. The HEP manuals Coaches Who Never Lose and Sports and Your Child contain the philosophy, objectives, and guidelines to ensure implementation of HEP components across players, coaches, and parents. The Skill Development component emphasizes learning age-appropriate hockey skills though skill progression. Increasing the practice-to-game ratio to 3–4 practices per game greatly increases the maximum time players skate with the puck during developmental years. Pre- and post-season Skills Challenges allow coaches, players, and parents to gauge improvement, and structure practices to address identified skill deficits. The Fair Play (FP) component emphasizes sportsmanship. Teams earn a FP point each game if they incur less than a preset number of penalty minutes. A coach receiving a game misconduct or a parent∕spectator asked to leave the game will cause the team to forfeit their FP point. FP points are factored into league standings across the state. This past season, 17 678 records of game data were obtained and 25 % (4420) were randomly selected for analysis. The data analysis permits comparison across seasons and changes are made accordingly. Based on four years of data, most Minnesota youth hockey games are played in a sportsmanlike manner. Checking from behind and head contact penalties have decreased since the penalty minutes for these dangerous infractions were increased.

Abstract Mortality in National Heart, Lung and Blood Institute–sponsored clinical trials of treatments for acute lung injury (ALI) has decreased dramatically during the past two decades. As a consequence, design of such trials based on a mortality outcome requires ever-increasing numbers of patients. Recognizing that advances in clinical trial design might be applicable to these trials and might allow trials with fewer patients, the National Heart, Lung and Blood Institute convened a workshop of extramural experts from several disciplines. The workshop assessed the current state of clinical research addressing ALI, identified research needs, and recommended: (1) continued performance of trials evaluating treatments of patients with ALI; (2) development of strategies to perform ALI prevention trials; (3) observational studies of patients without ALI undergoing prolonged mechanical ventilation; and (4) development of a standardized format for reporting methods, endpoints, and results of ALI trials.

Abstract The intensity of bone remodeling is a critical determinant of the decay of cortical and trabecular microstructure after menopause. Denosumab suppresses remodeling more than alendronate, leading to greater gains in areal bone mineral density (aBMD). These greater gains may reflect differing effects of each drug on bone microarchitecture and strength. In a phase 2 double-blind pilot study, 247 postmenopausal women were randomized to denosumab (60 mg subcutaneous 6 monthly), alendronate (70 mg oral weekly), or placebo for 12 months. All received daily calcium and vitamin D. Morphologic changes were assessed using high-resolution peripheral quantitative computed tomography (HR-pQCT) at the distal radius and distal tibia and QCT at the distal radius. Denosumab decreased serum C-telopeptide more rapidly and markedly than alendronate. In the placebo arm, total, cortical, and trabecular BMD and cortical thickness decreased (−2.1% to −0.8%) at the distal radius after 12 months. Alendronate prevented the decline (−0.6% to 2.4%, p = .051 to <.001 versus placebo), whereas denosumab prevented the decline or improved these variables (0.3% to 3.4%, p < .001 versus placebo). Changes in total and cortical BMD were greater with denosumab than with alendronate (p ≤ .024). Similar changes in these parameters were observed at the tibia. The polar moment of inertia also increased more in the denosumab than alendronate or placebo groups (p < .001). Adverse events did not differ by group. These data suggest that structural decay owing to bone remodeling and progression of bone fragility may be prevented more effectively with denosumab. © 2010 American Society for Bone and Mineral Research

Abstract The optimal design of phase II studies continues to be the subject of vigorous debate, especially studies of newer molecularly targeted agents. The observations that many new therapeutics “fail” in definitive phase III studies, coupled with the numbers of new agents to be tested as well as the increasing costs and complexity of clinical trials, further emphasize the critical importance of robust and efficient phase II design. The Clinical Trial Design Task Force (CTD-TF) of the National Cancer Institute (NCI) Investigational Drug Steering Committee (IDSC) has published a series of discussion papers on phase II trial design in Clinical Cancer Research. The IDSC has developed formal recommendations about aspects of phase II trial design that are the subject of frequent debate, such as endpoints (response versus progression-free survival), randomization (single-arm designs versus randomization), inclusion of biomarkers, biomarker-based patient enrichment strategies, and statistical design (e.g., two-stage designs versus multiple-group adaptive designs). Although these recommendations in general encourage the use of progression-free survival as the primary endpoint, randomization, inclusion of biomarkers, and incorporation of newer designs, we acknowledge that objective response as an endpoint and single-arm designs remain relevant in certain situations. The design of any clinical trial should always be carefully evaluated and justified based on characteristic specific to the situation. Clin Cancer Res; 16(6); 1764–9

BackgroundResearch involving incapacitated persons with dementia entails complex scientific, legal, and ethical issues, making traditional surveys of layperson views on the ethics of such research challenging. We therefore assessed the impact of democratic deliberation (DD), involving balanced, detailed education and peer deliberation, on the views of those responsible for persons with dementia.MethodsOne hundred and seventy‐eight community‐recruited caregivers or primary decision‐makers for persons with dementia were randomly assigned to either an all‐day DD session group or a control group. Educational materials used for the DD session were vetted for balance and accuracy by an interdisciplinary advisory panel. We assessed the acceptability of family‐surrogate consent for dementia research (“surrogate‐based research”) from a societal policy perspective as well as from the more personal perspectives of deciding for a loved one or for oneself (surrogate and self‐perspectives), assessed at baseline, immediately post‐DD session, and 1 month after DD date, for four research scenarios of varying risk‐benefit profiles.ResultsAt baseline, a majority in both the DD and control groups supported a policy of family consent for dementia research in all research scenarios. The support for a policy of family consent for surrogate‐based research increased in the DD group, but not in the control group. The change in the DD group was maintained 1 month later. In the DD group, there were transient changes in attitudes from surrogate or self‐perspectives. In the control group, there were no changes from baseline in attitude toward surrogate consent from any perspective.ConclusionsIntensive, balanced, and accurate education, along with peer deliberation provided by democratic deliberation, led to a sustained increase in support for a societal policy of family consent in dementia research among those responsible for dementia patients.