3,090 research outputs found

    CARE CR - Cardiovascular and cardiorespiratory Adaptations to Routine Exercise-based Cardiac Rehabilitation; A study protocol for a community-based control study with criterion methods

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    Introduction: Cardiac rehabilitation (CR) reduces all-cause and cardiovascular mortality in patients with coronary heart disease (CHD). Much of the improvement has been attributed to the beneficial effects of structured exercise training. However, UK-based studies have not confirmed this. Improvements in survival and cardiovascular health are associated with concurrent improvements in cardiorespiratory fitness (CRF). It is therefore concerning that estimated CRF improvements resulting from UK-based CR are approximately one third of those reported in international literature. Modest improvements in CRF suggest that UK CR exercise training programmes may require optimisation if long-term survival is to be improved. However, contemporary UK studies lack control data or, use estimates of CRF change. CARE-CR is a longitudinal, observational, controlled study designed to assess the short and longer-term effect of CR on CRF, as well cardiovascular and cardiometabolic health. Methods and Analysis: Patients will be recruited following referral to their local CR programme and will either participate in a routine, low to moderate intensity, eight-week (16 sessions) exercise-based CR programme or freely abstain from supervised exercise. Initial assessment will be conducted prior to exercise training, or approximately two weeks after referral to CR if exercise training is declined. Reassessment will coincide with completion of exercise training, or 10 weeks after initial assessment for control participants. Participants will receive a final follow-up 12 months after recruitment. The primary outcome will be peak oxygen consumption determined using maximal cardiopulmonary exercise testing. Secondary outcomes will include changes in subclinical atherosclerosis (carotid intima-media thickness and plaque characteristics), body composition (dual Xray absorptiometry) and cardiometabolic biomarkers. Ethics and Dissemination: Ethical approval for this non-randomised controlled study has been obtained from the Humber Bridge NHS Research Ethics Committee - Yorkshire and the Humber on the 27th September 2013, (12/YH/0278). Results will be presented at national conferences and published in peer-reviewed journals

    The cardiorespiratory and vascular adaptations to a routine UK exercise based cardiac rehabilitation programme

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    Introduction: Recent data suggests that UK cardiac rehabilitation (CR) programmes do not substantially improve cardiorespiratory fitness (CRF) or patient survival. The exercise dose prescribed as part of a routine CR programme may be insufficient. The aims of the thesis were to (i) investigate whether a routine UK CR exercise training programme could improve peak oxygen consumption (VOā‚‚peak) and, (ii) reduce carotid intima-media thickness (CIMT) progression in patients with coronary heart disease (CHD) and, (iii) determine whether higher exercise training doses prescribed to patients with CHD through a tele-monitoring system elicit superior VOā‚‚peak improvements compared to routine CR alone.Study One: We recruited n=34 patients (85.3% male; age 62.1 Ā± 8.8 years; body mass index [BMI] 29.5 Ā± 4.5 KgĀ·mā»Ā²) who had recently been diagnosed with CHD. n=22 patients formed an exercise training group (TG) and undertook an eight week (16 session) low to moderate intensity (40-70% peak heart rate reserve), routine CR exercise training programme. n=12 patients declined routine CR and were assigned to a non- exercise control group (CG). Patients in the training group were followed up after completing their exercise training programme. Controls were followed up approximately 8 to 10 weeks after their initial visit (visit 2). Both groups were followed up 12 months later. VOā‚‚peak change was determined in all patients via ā€œgold standardā€ maximal cardiopulmonary exercise testing (CPET) using the modified Bruce treadmill protocol. C-IMT progression was also determined using B-mode ultrasound.In the UK, submaximal exercise tests such as cycle ergometry are typically used to assess CRF change following CR. Submaximal cycle ergometry (intensities up to 70% heart rate reserve) was used to estimate changes in CRF. Submaximal cycle ergometry showed a mean improvement of 1.64 METs (95% CI 1.20 to 2.09 METs; p<0.001). However, ā€œgold standardā€ maximal CPET showed that this equated to no significant change in VOā‚‚peak (Ī” change: 0.12 mlĀ·kgā»Ā¹Ā·min-1; 95% CI -1.00 to 1.24 mlĀ·kgā»Ā¹Ā·minā»Ā¹). No VOā‚‚peak improvement was detected in controls (Ī” change: 0.15mlĀ·kgā»Ā¹Ā·minā»Ā¹; 95% CI -1.37 to 1.66 mlĀ·kgā»Ā¹Ā·minā»Ā¹; p=0.978). VOā‚‚peak remained unchanged after 12 months amongst patients in the TG (Ī” -0.94 mlĀ·kgā»Ā¹Ā·minā»Ā¹; range -6.09 to 2.10 mlĀ·kgā»Ā¹Ā·minā»Ā¹; p=0.846). Controls experienced C-IMT progression in the right lateral aspect of their common carotid artery (CCA) at the end of the eight week CR period (Ī” change: 0.070 mm; range -0.060 to 0.200 mm; p=0.038). Patients in the TG experienced C-IMT reduction in the left lateral aspect of their CCA between CR programme completion and their 12 month follow-up (Ī” change: 0.054 mm; range -0.160 to 0.020 mm; p=0.015). Study Two: We recruited n=50 healthy volunteers (60% male; age 26.2 Ā± 5.0 years; BMI 24.6 kgĀ·mā»Ā² ) to examine the intra and inter-operator variability of automated c-IMT measurements when taken by novice operators. Two novice operators performed serial bilateral C-IMT ultrasound measurements using the CardioHealth Station (Panasonic Biomedical Sales Europe BV, Leicestershire, UK). Immediate inter-operator variability was determined by comparing operatorsā€™ initial measurements. Immediate retest variability was determined by comparing consecutive measurements (<10 minutes apart). Longer-term variability was determined by comparing operatorsā€™ initial measurements to a third set of measurements conducted one week later. Bland-Altman analysis and intraclass correlations were conducted. The limits of agreement (LoA) for immediate inter-operator variability were -0.063 to 0.056 mm (mean bias -0.003 mm). Operator 1ā€™s immediate retest intra-operator LoA were -0.057 to 0.046 mm (mean bias was -0.005 mm). Operator 1ā€™s intra-operator LoA at one week were -0.057 to 0.050 mm (mean bias -0.003 mm). Operator 2ā€™s LoA were similar to those of operator 1. Novice operators produce acceptable short-term and one week inter- and intra-operator C-IMT measurement variability in healthy, young to middle aged adults using the Panasonic CardioHealth Station.Study Three: We recruited n=27 patients with a diagnosis of CHD (88.9% male; age 59.5 Ā± 10.0 years; BMI 29.6 Ā± 3.8 kgĀ·mā»Ā²). VOā‚‚peak change was quantified in n=10 patients receiving routine CR plus personalised exercise training based on maximal CPET data delivered via a bespoke tele-monitoring device. VOā‚‚peak change was also determined in n=17 patients receiving routine CR only. CPET was performed using a 25W stepped cycle ergometry protocol. The combination of routine CR and a bespoke exercise training programme significantly increase VOā‚‚peak (Ī” change: 2.08 mlĀ·kgā»Ā¹Ā·minā»Ā¹; 95% CI 1.88 to 3.97 mlĀ·kgā»Ā¹Ā·minā»Ā¹; p=0.014) compared to routine CR alone (Ī” change: -0.29 mlĀ·kgā»Ā¹Ā·minā»Ā¹; 95% CI -1.75 to 1.16 mlĀ·kgā»Ā¹Ā·minā»Ā¹; p=0.841).Conclusions: An eight week (16 session) low to moderate intensity (40-70% peak heart rate reserve) CR exercise training programme, typical of many programmes in the UK, does not improve direct measurements of VOā‚‚peak on treadmill or cycle ergometer protocols. Current assessment methods utilising submaximal exercise testing may be overstating the effect of CR exercise interventions on CRF. Current UK recommendations for exercise training doses may also be inadequate. Data within study three indicates that a minimum of 13 sessions over a 12 week period may be required to improve VOā‚‚peak. Limited evidence indicates that routine CR with structured exercise training may attenuate C-IMT progression compared with usual care control participants. This anti-atherosclerotic effect may be related to lower coronary risk factors and better adherence to other secondary prevention measures. Overall, higher exercise training doses and personalised exercise prescription derived from maximal CPET data appeared necessary for attaining significant CRF improvements in patients with CHD

    Randomized controlled trial of a coordinated care intervention to improve risk factor control after stroke or transient ischemic attack in the safety net: Secondary stroke prevention by Uniting Community and Chronic care model teams Early to End Disparities (SUCCEED).

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    BackgroundRecurrent strokes are preventable through awareness and control of risk factors such as hypertension, and through lifestyle changes such as healthier diets, greater physical activity, and smoking cessation. However, vascular risk factor control is frequently poor among stroke survivors, particularly among socio-economically disadvantaged blacks, Latinos and other people of color. The Chronic Care Model (CCM) is an effective framework for multi-component interventions aimed at improving care processes and outcomes for individuals with chronic disease. In addition, community health workers (CHWs) have played an integral role in reducing health disparities; however, their effectiveness in reducing vascular risk among stroke survivors remains unknown. Our objectives are to develop, test, and assess the economic value of a CCM-based intervention using an Advanced Practice Clinician (APC)-CHW team to improve risk factor control after stroke in an under-resourced, racially/ethnically diverse population.Methods/designIn this single-blind randomized controlled trial, 516 adults (ā‰„40&nbsp;years) with an ischemic stroke, transient ischemic attack or intracerebral hemorrhage within the prior 90&nbsp;days are being enrolled at five sites within the Los Angeles County safety-net setting and randomized 1:1 to intervention vs usual care. Participants are excluded if they do not speak English, Spanish, Cantonese, Mandarin, or Korean or if they are unable to consent. The intervention includes a minimum of three clinic visits in the healthcare setting, three home visits, and Chronic Disease Self-Management Program group workshops in community venues. The primary outcome is blood pressure (BP) control (systolic BP &lt;130&nbsp;mmHg) at 1&nbsp;year. Secondary outcomes include: (1) mean change in systolic BP; (2) control of other vascular risk factors including lipids and hemoglobin A1c, (3) inflammation (C reactive protein [CRP]), (4) medication adherence, (5) lifestyle factors (smoking, diet, and physical activity), (6) estimated relative reduction in risk for recurrent stroke or myocardial infarction (MI), and (7) cost-effectiveness of the intervention versus usual care.DiscussionIf this multi-component interdisciplinary intervention is shown to be effective in improving risk factor control after stroke, it may serve as a model that can be used internationally to reduce race/ethnic and socioeconomic disparities in stroke in resource-constrained settings.Trial registrationClinicalTrials.gov Identifier NCT01763203

    The Quality and Variability of Cardiac Rehabilitation Delivery

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    Background: Cardiac care, including cardiac rehabilitation (CR), is most effective if it is high-quality. The aim of this study was to describe CR quality, using the recently-developed Canadian Cardiovascular Society CR quality indicators (QIs). As secondary and tertiary objectives, site differences in quality were measured, and the criterion validity of 4 of the QIs in comparison to self-report data were established. Methods: Secondary analysis was conducted on an observational, prospective, multi-site CR program evaluation cohort. A convenience sample of patients from one of 3 CR programs was approached at their first CR visit, and consenting participants completed a survey. Clinical data were extracted from charts pre and post-program. Of the 30 CR QIs, 21 (70.0%) were assessable: 10 process, 9 outcome and 2 structure QIs. Results: Of 411 consenting patients, 209 (53.0%) completed CR. The greatest quality was observed for assessment of blood pressure (98.1%), communication with primary healthcare at CR discharge (94.2%), and patient enrollment (93.7%). The lowest quality was observed for wait time from hospital discharge (9.2%), assessments of blood glucose (42.1%), and lipid control (53.0%). Of the 7 QIs that had an established benchmark, quality for 2 (28.6%) was above the benchmark (particularly assessment of blood pressure). Significant site differences were observed in 11 (64.7%) QIs. The magnitude of quality differences between sites was largest for assessment of lipid control (72.6%), assessment of blood glucose control (69.0%), and wait time in median days from referral to enrollment (30.6 days). Validity was fair for QIs 2a and 3. None to slight validity was found for QI-17, and 18 respectively. Conclusion: There is wide variability in CR program quality, both overall and between CR sites. Quality improvement in particular aspects of CR care is required

    Advancing Physician Performance Measurement: Using Administrative Data to Assess Physician Quality and Efficiency

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    Summarizes national initiatives to advance the practice of standardized measurement and outlines goals for developing a method for tracking efficiency and quality that will reward physicians and enable patients to make informed healthcare choices

    Creating Equity Reports: A Guide for Hospitals

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    Offers a framework for equity reporting -- identifying ethnic and racial disparities in hospitals and ways to reduce them -- including implementation, data collection, quality measures, and utilization. Reviews case studies and lessons learned

    Role of Causal Information in Patient Education: An Experimental and Clinical Approach

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    Abstract It is somewhat paradoxical that few patient education interventions actually consider the processes by which individuals best learn health-related information. The paucity of empirically validated teaching strategies impedes efforts to improve the delivery of care in cardiovascular rehabilitation and secondary prevention (CRSP) programs. The main goal of this dissertation was to examine whether explaining how illness pathophysiology, symptoms and health behaviour are interconnected (i.e., causal information) enhances the effectiveness of patient education materials. This question was first addressed in a laboratory setting (Study 1) in which younger and older adults read about a fictitious disease under two conditions. Younger participants who read about how health behaviours were causally linked to illness pathophysiology and symptom reduction were better able to apply their knowledge than those who read this information in a non-integrated manner. However, this effect was not observed in the older sample. These findings were followed up in a cluster randomized controlled trial, in which causal information about connections among endothelial pathophysiology, cardiac risk factors, symptoms and health behaviours were integrated into a group education session at a Cardiac Rehabilitation and Secondary Prevention (CRSP) program. Results from Study 2 indicated that the addition of causal information was associated with deeper levels of knowledge about cardiovascular management and enhanced efficacy beliefs about the CRSP program. Study 3, which focused on participantsā€™ behaviours, showed that the intervention did not impact patientsā€™ likelihood to enroll into CRSP nor their physical activity levels four months into the program. The intervention group was marginally faster at completing prerequisites for program entry, but baseline characteristics, including anxiety and male gender, were stronger predictors of this behavior. The present dissertation is the first to provide empirical support for the inclusion of causal information into patient education curricula. Findings indicate that patientsā€™ depth of understanding warrants more attention in patient education contexts. Taken together, results from this dissertation serve as a stepping-stone towards enhancing provider-patient collaboration by demonstrating that patients have a better understanding when they are told why they are being asked to follow the cardiovascular management recommendations rather than simply being told what to do

    Enabling late-stage translation of regenerative medicine based products

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    The primary aim of the thesis is to contribute to demonstrating how established and emerging science in the regenerative medicine (RM) domain can be translated into profitable commercial practice, and generate clinically- and cost-effective therapies. It achieves this by exploring and assessing underlying economics, including investment readiness and economic assessment, exploring regulatory and reimbursement frameworks, developing stem cell culture systems and assessing fit with clinical practice. The thesis is the first public domain wide-ranging analysis of business trends in the production, manufacturing and supply segments of the RM industry. It analyses the clinical potential of the domain as well as the translational and commercial challenges facing the industry. The industry is at a turning point as big pharmaceutical companies engage with RM in order to explore technologies as potential therapeutics and discovery tools. This unlocks the industry by confirming an exit path for RM based small- and medium-sized enterprises. Translation has come to be recognised as a core issue in the overall space and translation of regenerative therapies into the clinic is presently challenging, high-risk and expensive. This research addresses the question what are the mechanisms required to enable translation of emerging scientific knowledge into commercially viable clinical RM products? These mechanisms are particularly important as their creation involves and requires major investment decisions, which can determine the success or failure of RM developments and indeed of the companies concerned. The lack of well-established business models and the complexity of the domain suggested a conceptual approach drawing upon relevant literature from product and process development, applied business and revenue models, technological evolution and capital market ingenuity. The research was carried out in two phases. The first phase was concerned with identification of key challenges and mapping the overall industry emergence including emergence of related regulations to provide a context and framework for understanding the domain. Based on the emergence mapping a timeline of key parallel factors was identified, and their inherent connections explored to identify transforming events affecting and influencing multiple factors on the journey to clinical success within a business environment. This creates the reference model. The second phase was concerned with manufacturing a stem cell based therapeutic and applying health economic principles to determine available headroom for investment, cost of goods and return on investment, taking hearing disorders as a case exemplar, and exploring the behaviour of the net present value curve to identify key parameters affecting the economic positioning of this novel regime. A key output of the research is the investment readiness reference model. It integrates key RM business issues against reducing uncertainty and increasing value. The model argues that the complex nature of RM products means that the issues affecting industry emergence and development go well beyond the primarily scientific and technological concerns on which much current research focuses. The performance of RM firms ultimately hinges upon the successful clinical application of their developed products, the key step for creating and realising value, and their ability to deal with the fundamental business issues specific to the area. The framework deals with these business issues, which are investment & technology readiness, business models, organisational challenges, public policy and industry emergence. This thesis explores ideas that may bridge the chasm between the promise and reality of RM i.e. mechanisms to enable late stage translation of RM products. It links technological capability and business models for firms in the domain. Furthermore, it offers a unique perspective on the nature and characteristics of investment readiness and financial assessment, specifically identifying key parameters affecting economic positioning. The key contributions are therefore: New insights into the key challenges involved in realising the commercial potential of cell based therapeutics. Technology road mapping to link fundamental enabling technological capability for developing RM products with robust business plans integrating strategy, technology development and the regulatory and reimbursement framework. A generic investment readiness reference model generated from the enabling technology, value and supply chain structures to identify key indicators and characteristics of industry readiness. A novel experimental programme demonstrating expansion, maintenance and differentiation of human embryonic stem cells by manual and automated methods. New insights into economic positioning by mapping net present value, and economic analysis by estimating available headroom, cost of goods and return on investment for a putative hearing therapeutic
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