Anti-cholinergic load, health care utilization, and survival in people with advanced cancer: a pilot study.

INTRODUCTION: Anti-cholinergic medications have been associated with increased risks of cognitive impairment, premature mortality and increased risk of hospitalisation. Anti-cholinergic load associated with medication increases as death approaches in those with advanced cancer, yet little is known about associated adverse outcomes in this setting. METHODS: A substudy of 112 participants in a randomised control trial who had cancer and an Australia modified Karnofsky Performance Scale (AKPS) score (AKPS) of 60 or above, explored survival and health service utilisation; with anti-cholinergic load calculated using the Clinician Rated Anti-cholinergic Scale (modified version) longitudinally to death. A standardised starting point for prospectively calculating survival was an AKPS of 60 or above. RESULTS: Baseline entry to the sub-study was a mean 62 +/- 81 days (median 37, range 1-588) days before death (survival), with mean of 4.8 (median 3, SD 4.18, range 1 - 24) study assessments in this time period. Participants spent 22% of time as an inpatient. There was no significant association between anti-cholinergic score and time spent as an inpatient (adjusted for survival time) (p = 0.94); or survival time. DISCUSSION: No association between anti-cholinergic load and survival or time spent as an inpatient was seen. Future studies need to include cognitively impaired populations where the risks of symptomatic deterioration may be more substantial.

The lung cancer exercise training study: a randomized trial of aerobic training, resistance training, or both in postsurgical lung cancer patients: rationale and design.

BACKGROUND: The Lung Cancer Exercise Training Study (LUNGEVITY) is a randomized trial to investigate the efficacy of different types of exercise training on cardiorespiratory fitness (VO2peak), patient-reported outcomes, and the organ components that govern VO2peak in post-operative non-small cell lung cancer (NSCLC) patients. METHODS/DESIGN: Using a single-center, randomized design, 160 subjects (40 patients/study arm) with histologically confirmed stage I-IIIA NSCLC following curative-intent complete surgical resection at Duke University Medical Center (DUMC) will be potentially eligible for this trial. Following baseline assessments, eligible participants will be randomly assigned to one of four conditions: (1) aerobic training alone, (2) resistance training alone, (3) the combination of aerobic and resistance training, or (4) attention-control (progressive stretching). The ultimate goal for all exercise training groups will be 3 supervised exercise sessions per week an intensity above 70% of the individually determined VO2peak for aerobic training and an intensity between 60 and 80% of one-repetition maximum for resistance training, for 30-45 minutes/session. Progressive stretching will be matched to the exercise groups in terms of program length (i.e., 16 weeks), social interaction (participants will receive one-on-one instruction), and duration (30-45 mins/session). The primary study endpoint is VO2peak. Secondary endpoints include: patient-reported outcomes (PROs) (e.g., quality of life, fatigue, depression, etc.) and organ components of the oxygen cascade (i.e., pulmonary function, cardiac function, skeletal muscle function). All endpoints will be assessed at baseline and postintervention (16 weeks). Substudies will include genetic studies regarding individual responses to an exercise stimulus, theoretical determinants of exercise adherence, examination of the psychological mediators of the exercise - PRO relationship, and exercise-induced changes in gene expression. DISCUSSION: VO2peak is becoming increasingly recognized as an outcome of major importance in NSCLC. LUNGEVITY will identify the optimal form of exercise training for NSCLC survivors as well as provide insight into the physiological mechanisms underlying this effect. Overall, this study will contribute to the establishment of clinical exercise therapy rehabilitation guidelines for patients across the entire NSCLC continuum. TRIAL REGISTRATION: NCT00018255.

Rationale and design of the Exercise Intensity Trial (EXCITE): A randomized trial comparing the effects of moderate versus moderate to high-intensity aerobic training in women with operable breast cancer.

BACKGROUND: The Exercise Intensity Trial (EXcITe) is a randomized trial to compare the efficacy of supervised moderate-intensity aerobic training to moderate to high-intensity aerobic training, relative to attention control, on aerobic capacity, physiologic mechanisms, patient-reported outcomes, and biomarkers in women with operable breast cancer following the completion of definitive adjuvant therapy. METHODS/DESIGN: Using a single-center, randomized design, 174 postmenopausal women (58 patients/study arm) with histologically confirmed, operable breast cancer presenting to Duke University Medical Center (DUMC) will be enrolled in this trial following completion of primary therapy (including surgery, radiation therapy, and chemotherapy). After baseline assessments, eligible participants will be randomized to one of two supervised aerobic training interventions (moderate-intensity or moderate/high-intensity aerobic training) or an attention-control group (progressive stretching). The aerobic training interventions will include 150 mins.wk⁻¹ of supervised treadmill walking per week at an intensity of 60%-70% (moderate-intensity) or 60% to 100% (moderate to high-intensity) of the individually determined peak oxygen consumption (VO₂peak) between 20-45 minutes/session for 16 weeks. The progressive stretching program will be consistent with the exercise interventions in terms of program length (16 weeks), social interaction (participants will receive one-on-one instruction), and duration (20-45 mins/session). The primary study endpoint is VO₂peak, as measured by an incremental cardiopulmonary exercise test. Secondary endpoints include physiologic determinants that govern VO₂peak, patient-reported outcomes, and biomarkers associated with breast cancer recurrence/mortality. All endpoints will be assessed at baseline and after the intervention (16 weeks). DISCUSSION: EXCITE is designed to investigate the intensity of aerobic training required to induce optimal improvements in VO₂peak and other pertinent outcomes in women who have completed definitive adjuvant therapy for operable breast cancer. Overall, this trial will inform and refine exercise guidelines to optimize recovery in breast and other cancer survivors following the completion of primary cytotoxic therapy. TRIAL REGISTRATION: NCT01186367.

WriteSim TCExam--an open source text simulation environment for training novice researchers in scientific writing.

BACKGROUND: The ability to write clearly and effectively is of central importance to the scientific enterprise. Encouraged by the success of simulation environments in other biomedical sciences, we developed WriteSim TCExam, an open-source, Web-based, textual simulation environment for teaching effective writing techniques to novice researchers. We shortlisted and modified an existing open source application - TCExam to serve as a textual simulation environment. After testing usability internally in our team, we conducted formal field usability studies with novice researchers. These were followed by formal surveys with researchers fitting the role of administrators and users (novice researchers) RESULTS: The development process was guided by feedback from usability tests within our research team. Online surveys and formal studies, involving members of the Research on Research group and selected novice researchers, show that the application is user-friendly. Additionally it has been used to train 25 novice researchers in scientific writing to date and has generated encouraging results. CONCLUSION: WriteSim TCExam is the first Web-based, open-source textual simulation environment designed to complement traditional scientific writing instruction. While initial reviews by students and educators have been positive, a formal study is needed to measure its benefits in comparison to standard instructional methods.

Research Question, Study Design and Continuous Research Education and Training Exercises (CREATE) Program.

The clinical research project starts with identifying the optimal research question, one that is ethical, impactful, feasible, scientifically sound, novel, relevant, and interesting. The project continues with the design of the study to answer the research question. Such design should be consistent with ethical and methodological principles, and make optimal use of resources in order to have the best chances of identifying a meaningful answer to the research question. Physicians and other healthcare providers are optimally positioned to identify meaningful research questions the answer to which could make significant impact on healthcare delivery. The typical medical education curriculum, however, lacks solid training in clinical research. We propose CREATE (Continuous Research Education And Training Exercises) as a peer- and group-based, interactive, analytical, customized, and accrediting program with didactic, training, mentoring, administrative, and professional support to enhance clinical research knowledge and skills among healthcare professionals, promote the generation of original research projects, increase the chances of their successful completion and potential for meaningful impact. The key features of the program are successive intra- and inter-group discussions and confrontational thematic challenges among participating peers aimed at capitalizing on the groups' collective knowledge, experience and skills, and combined intellectual processing capabilities to optimize choice of research project elements and stakeholder decision-making.

Cognitive training: the effects of working memory training

Gemstone Team Cognitive Training

Quality of Life and Neurocognitive Functioning in Children with Sickle Cell Disease: Investigating the Feasibility of a Computerized Cognitive Training Program

Children with sickle cell disease (SCD) have a high risk of neurocognitive impairment. No known research, however, has examined the impact of neurocognitive functioning on quality of life in this pediatric population. In addition, limited research has examined neurocognitive interventions for these children. In light of these gaps, two studies were undertaken to (a) examine the relationship between cognitive functioning and quality of life in a sample of children with SCD and (b) investigate the feasibility and preliminary efficacy of a computerized working memory training program in this population. Forty-five youth (ages 8-16) with SCD and a caregiver were recruited for the first study. Participants completed measures of cognitive ability, quality of life, and psychosocial functioning. Results indicated that cognitive ability significantly predicted child- and parent-reported quality of life among youth with SCD. In turn, a randomized-controlled trial of a computerized working memory program was undertaken. Eighteen youth with SCD and a caregiver enrolled in this study, and were randomized to a waitlist control or the working memory training condition. Data pertaining to cognitive functioning, psychosocial functioning, and disease characteristics were obtained from participants. The results of this study indicated a high degree of acceptance for this intervention but poor feasibility in practice. Factors related to feasibility were identified. Implications and future directions are discussed.

Suppression of the Hepatitis C viral load by Phyllanthus niruri extracts

Gemstone Team ANTIDOTE

Alternate lower extremity resistance training to increase stability in young and elderly adults

Gemstone Team BALANCE

Multi-touch and keyboard/mouse devices comparison in an information search task: influence on cognitive load and task engagement

Nowadays multi-touch devices (MTD) can be found in all kind of contexts. In the learning context, MTD availability leads many teachers to use them in their class room, to support the use of the devices by students, or to assume that it will enhance the learning processes. Despite the raising interest for MTD, few researches studying the impact in term of performance or the suitability of the technology for the learning context exist. However, even if the use of touch-sensitive screens rather than a mouse and keyboard seems to be the easiest and fastest way to realize common learning tasks (as for instance web surfing behaviour), we notice that the use of MTD may lead to a less favourable outcome. The complexity to generate an accurate fingers gesture and the split attention it requires (multi-tasking effect) make the use of gestures to interact with a touch-sensitive screen more difficult compared to the traditional laptop use. More precisely, it is hypothesized that efficacy and efficiency decreases, as well as the available cognitive resources making the users’ task engagement more difficult. Furthermore, the presented study takes into account the moderator effect of previous experiences with MTD. Two key factors of technology adoption theories were included in the study: familiarity and self-efficacy with the technology.Sixty university students, invited to a usability lab, are asked to perform information search tasks on an online encyclopaedia. The different tasks were created in order to execute the most commonly used mouse actions (e.g. right click, left click, scrolling, zooming, key words encoding…). Two different conditions were created: (1) MTD use and (2) laptop use (with keyboard and mouse). The cognitive load, self-efficacy, familiarity and task engagement scales were adapted to the MTD context. Furthermore, the eye-tracking measurement would offer additional information about user behaviours and their cognitive load.Our study aims to clarify some important aspects towards the usage of MTD and the added value compared to a laptop in a student learning context. More precisely, the outcomes will enhance the suitability of MTD with the processes at stakes, the role of previous knowledge in the adoption process, as well as some interesting insights into the user experience with such devices.

Elementary Principals' Perceptions of a Leadership Development Training Program

Research indicates that school leaders are crucial to improving instruction and raising student achievement (Council of Chief State School Officers, 2008). As such, educational reforms such as the No Child Left Behind Act (2001) and Race to the Top (2009) have sparked an accountability movement where principals are being held accountable for students' academic achievement and educational outcomes. The shift towards greater accountability has placed new attention on the ways principals are trained. Researchers have noted that organized professional development programs have not adequately prepared school principals to meet the priority demands of the 21st century (Hale & Moorman, 2003; Murphy, 1994). Murphy (1994) stated, "Traditional preparation programs - usually pre-service programs based in colleges or universities, that awarded certification and advanced degrees - rarely concentrated on the leadership challenges that principals actually face in real schools" (p. 4). As a result, many school districts are seeking ways to develop leadership development training programs that will prepare principals for their job responsibilities as a school leader. In spite of the additional training principals receive, researchers suggests that there is an obvious gap between the readiness of administrators to be instructional leaders and the demands for accountability that school administrators face (Hale & Moorman, 2003). This quantitative study examined elementary school principals' perceptions of their leadership development training program. Guided by four research questions, the study examined principals' perceptions of their overall training and how well their training prepared them to deal with school and classroom practices that contribute to student achievement; to work with teachers and others to design and implement a system for continuous student achievement; and to provide necessary support to carry out sound school, curriculum, and instructional practices. Data for this study was collected by way of survey responses from a total of 46 elementary school principals. The results from the study revealed that more than half (58.7%) of participants perceived their training as excellent. While principals' perceived that their training adequately prepared them to work collaboratively in teams, set clear visions and goals, and to use data to improve students achievement, many respondents reported a lack of training in being informed and focused on student achievement. Principals also suggested that they were not effectively trained in finding effective ways to obtain support from central office or community members.