Development of a core outcome set for venous leg ulceration (CoreVen) research evaluations (protocol)

BackgroundA venous leg ulcer is a chronic leg wound caused by poor venous blood circulation in the lower limbs. It is a recurring condition causing pain, malodour, reduced mobility, and depression. Randomised controlled trials evaluating treatments for venous leg ulcers provide important evidence to inform clinical decision-making. However, for findings to be useful, outcomes need to be clinically meaningful, consistently reported across trials, and fully reported. Research has identified the large number of outcomes reported in venous leg ulcer trials, impacting both synthesis of results, and clinical decision-making. To address this, a core outcome set will be developed. A core outcome set is an agreed standardised set of outcomes which should be, as a minimum, measured and reported in all trials which evaluate treatment effectiveness for a given indication. A core outcome set has the potential to reduce research waste, improve the utility of RCTs, reduce reporting bias, facilitate treatment comparisons across different sources of evidence and expedite the production of systematic reviews, meta-analyses and evidence-based clinical guidelines.AimThe aim of this project is to develop a core outcome set for research evaluating the effectiveness of interventions for treating venous leg ulceration.MethodsThrough a scoping review of the literature on venous leg ulceration, we will firstly identify a list of candidate outcome domains (broad categories in relation to what is being measured) from randomised controlled trials and qualitative research, and outcomes (specific methods in relation to what is being measured). In two further stages, we will use the resulting lists of outcome domains and outcomes to design two online surveys. A range of stakeholders will be invited to participate in the surveys and they will be asked to indicate which outcome domains and outcomes are most important and should be considered as core in future research reports.     

Development of a Simulation-Based Mastery Learning Curriculum for Breaking Bad News

Introduction

Physician communication impacts patient outcomes. However, communication skills, especially around difficult conversations, remain suboptimal, and there is no clear way to determine the validity of entrustment decisions. The aims of this study were to 1) describe the development of a simulation-based mastery learning (SBML) curriculum for breaking bad news (BBN) conversation skills and 2) set a defensible minimum passing standard (MPS) to ensure uniform skill acquisition among learners.

Cognition in breast cancer survivors: A pilot study of interval and continuous exercise

Objectives

The current study investigated the effects of two exercise interventions on cognitive function amongst breast cancer survivors.

Color Stability of Dry Earth Pigmented Maxillofacial Silicone A-2186 Subjected to Microwave Energy Exposure

PURPOSE: The purpose of this study was to measure spectrophotometrically the color stability of pigmented A-2186 silicone maxillofacial elastomer with 10% by volume of titanium white dry earth opacifier before and after exposure to microwave energy over a simulated 1.5-year period of microwave sterilization. Materials AND METHODS: A-2186 silicone elastomer opacified with titanium white dry earth pigment, pigmented with 5 cosmetic dry earth pigment colors [no pigment (control) group (Pc), red (Pr), yellow ochre (Py), burnt sienna (Po), and a mixture of Pr + Py + Po color group (P3)], was used in this study. Each of the 5 experimental groups consisted of 5 specimens. All specimens were placed in a 250 ml glass beaker filled with 150 ml of water (replenished for each microwave exposure). An exposure of 6 minutes was used 18 times (simulating 1.5 years of microwave sterilization with one 6 minute exposure monthly). Reflectance values were measured by spectrophotometer. Three- and two-way analyses of variance with repeated measures were performed for the color difference (DeltaE*) with the factors of group/color/months, and group/months, respectively. Means were compared by Tukey Honest Significant Difference (HSD) multiple range test calculated at the 0.05 level of significance using SPSS. RESULTS: The trained human eye can detect color changes (DeltaE*) greater than 1.0. Most DeltaE* values of the red pigment group at all intervals and the mixed pigment group at 15- and 18- month intervals increased significantly greater than 1.0 (p < 0.001) compared with the control group. Yellow and burnt sienna groups remained the most color stable over time with DeltaE* values below 0.35. CONCLUSIONS: Lack of color stability of red dry earth pigmented A-2186 silicone maxillofacial elastomers was clinically significant after 12-month exposure to microwave energy as compared with yellow, burnt sienna, and opacified A-2186 dry earth pigments.     

血管介入仿真模拟器在心血管医生冠状动脉介入技术规范化培训中的作用

目的明确Angiomemor（美国Simbionix公司生产）血管介入仿真模拟器是否有助于冠状动脉造影技术的掌握和提高。方法选取16名无血管放射介入经验的心血管医生，接受相同课时的冠状动脉介入造影理论培训后，按随机表编码随机分为模拟器培训组与非培训组各8名，模拟器培训组8名医生接受Angiomemor血管介入仿真模拟器培训，模拟冠状动脉造影操作，非培训组8名心血管医生未接受仿真模拟器培训。在随后的真实临床环境中操作冠状动脉造影时，评价2组医生冠状动脉造影操作过程中错误的频数、平均造影时间、造影剂使用量及术中放射线剂量。结果相对于非培训组，模拟器培训组医生在冠状动脉造影操作中错误频数减少62．5％、平均造影时间减少44．0％、造影剂使用量减少44．0％，术中平均放射线曝光时间减少了57．7％，平均X线累计曝光剂量减少51．6％，单位面积X线累计曝光剂量减少了52．4％。结论Angiomemor血管介入仿真模拟器有助于医生较快地熟练掌握冠状动脉造影技术，是冠状动脉介入规范化培训的重要辅助手段之一。     

AdEasy1／Cbfa1诱导间充质干细胞向成骨细胞分化的实验研究

目的：观察核心结合因子a1（Cbfa1）对兔骨髓间充质干细胞（MSCs）向成骨细胞分化的诱导作用。方法：体外分离培养兔骨髓MSCs，用AdEasy1／Cbfa1。转染MSCs，在转染后3d,1、2、3和4周时，组织化学和免疫组化等方法检测成骨标志碱性磷酸酶和骨钙素的表达。结果：AdEasy1／Cbfa1转染后的兔骨髓MSCs表现出与成骨细胞相似的形态，并且表达碱性磷酸酶和骨钙素。结论：Cbfa1可诱导兔骨髓MSCs向成骨细胞分化。     

Guidelines for Trials of Behavioral Treatments for Recurrent Headache, First Edition: American Headache Society Behavioral Clinical Trials Workgroup

Guidelines for design of clinical trials evaluating behavioral headache treatments were developed to facilitate production of quality research evaluating behavioral therapies for management of primary headache disorders. These guidelines were produced by a Workgroup of headache researchers under auspices of the American Headache Society. The guidelines are complementary to and modeled after guidelines for pharmacological trials published by the International Headache Society, but they address methodologic considerations unique to behavioral and other nonpharmacological treatments. Explicit guidelines for evaluating behavioral headache therapies are needed as the optimal methodology for behavioral (and other nonpharmacologic) trials necessarily differs from the preferred methodology for drug trials. In addition, trials comparing and integrating drug and behavioral therapies present methodological challenges not addressed by guidelines for pharmacologic research. These guidelines address patient selection, trial design for behavioral treatments and for comparisons across multiple treatment modalities (eg, behavioral vs pharmacologic), evaluation of results, and research ethics. Although developed specifically for behavioral therapies, the guidelines may apply to the design of clinical trials evaluating many forms of nonpharmacologic therapies for headache.     

Atrial Synchronous Ventricular Pacing with a Single Lead: Reliability of Atrial Sensing During Physical Activities, and Long-term Stability of Atrial Sensing

A VDD pacing system with bipolar single-pass leads, were implanted in 36 consecutive patients (average age 72 ± 2years) with high degree atrioventricular block and normal sinus node function. At implant the atrial signal amplitude was 2.6 ± 0.2mV measured by a pacing system analyser (PSA), 1.8 ± 0.1mV measured peak-to-peak from the telemetered calibrated electrogram, and 1.3 ± 0.1mV measured from the sensing threshold. At one month follow-up the peak-to-peak amplitudes (mV) of the telemetered atrial electrograms were not significantly different measured continuously during resting supine with quiet breathing (1.4 ± 0.1), sitting (1.6 ± 0.2). standing (1.5 ± 0.1), arm swinging (1.4 ± 0.2), hyperventilation (1.3 ± 0.1), Vaisalva manoeuvre (1.4 ± 0.1), and treadmill exercise (1.9 ± 0.6). The telemetered atrial electrogram amplitude and the atrial sensing threshold varied between 1.2 ± 0.09mV and 1.8 ± 0.1mV, and between 0.95 ± 0.07mV and 1.3 ± 0.01mV, respectively at 0.5, 1, 3, 6 and 12 months follow-up, but the changes were statistically nonsignificant. The Event Summary showed sensing of 98% to 99% of the atrial events at the different follow-up periods.     

丝裂霉素C化学稳定性的研究

在广泛ＰＨ范围内对丝裂霉素Ｃ的化学稳定性进行了研究，测定不同温度下不同ｐＨ时的速率常数，得到不同ｐＨ时的分解活化能及不同温度下的稳定ｐＨ值。活化能数据在ｐＨ５．５及７．８时出现极大值，而不同温度下的两上最稳定（ｐＨ）ｍ恰恰位于两个ｐＨ范围内。     

The effects of training, immobilization and remobilization on musculoskeletal tissue

Compared with the knowledge on immobilization, the effects of remobilization on musculoskeletal tissues have not been well established. What is sure is that remobilization and rehabilitation of any component of the musculoskeletal tissues require much more time than the time needed to cause the immobilization atrophy. With intensive rehabilitation, the functional properties of skeletal muscles can be improved significantly even years after the injury and following immobilization, but no study has shown whether full recovery is possible and whether these rehabilitated muscles are able to respond normally to further training. Experimental studies have given evidence that slow-twitch muscle fibres have better capacity for recovery than fast-twitch fibres, most likely due to better circulation and higher protein turnover. Also evidence has been given that fibre regeneration is possible through satellite cell activation and myotube formation. Very little is known, however, about the effects of age, gender or the level of preimmobilization muscle performance on the restoration capacity. Also the fate of the marked structural changes (for example, connective tissue accumulation) induced by immobilization is unknown. Tendon and ligament tissues are likely to respond appropriately to remobilization, resulting in acceleration of collagen synthesis and fibril neoformation. However, there is a strong suspicion that remobilized tendons and ligaments will not achieve all the biochemical and biomechanical properties of their healthy counterparts. Specifically, the amount of weak type III collagen has been shown to be overrepresented in these tissues instead of mature, strong type I collagen. It is not known whether this is an important risk factor for ruptures during later activity. The effects of remobilization on muscle-tendon junction and proprioceptive organs are not known. It would not be surprising if the serious structural changes induced by immobilization were unrestorable. In the literature dealing with immobilization and remobilization, cartilage degeneration is always a major concern, because not only too strenuous training or immobilization, but also unskilful remobilization may activate this process leading finally to osteoarthrosis. Bone may be one of the best components of musculoskeletal tissues to respond to remobilization, probably because the immobilization atrophy of bone is largely quantitative (osteoporosis) only. The prerequisites for bony recovery are that the follow-up time is long enough (months) and that immobilization has not exceeded about 6 months, the time limit between active and inactive (irreversible) osteoporosis. Prevention of the atrophying effects of immobilization can be very successful if performed properly. According to present knowledge, there are many methods for the purpose, including preimmobilization training early, controlled mobilization; optimal positioning of the immobilized joint; muscular training during immobilization; early weightbearing; exercise with the nonimmobilized extremity; and electrical stimulation. Lots of education and information will be needed, however, before these methods are deeply rooted in the daily routines of the attending physicians, physical therapists, athletic trainers and other persons involved in the treatment of musculoskeletal problems.