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We lead multidisciplinary applied research and training to rethink the way health care is delivered in general practice and across the community.
What Drives Responses to Willingness-to-pay Questions? A Methodological Inquiry in the Context of Hypertension Self-management.
Background: The use of economic evaluation to determine the cost-effectiveness of health interventions is recommended by decision-making bodies internationally. Understanding factors that explain variations in costs and benefits is important for policy makers. Objective: This work aimed to test a priori hypotheses defining the relationship between benefits of using self-management equipment (measured using the willingness-to-pay (WTP) approach) and a number of demographic and other patient factors. Methods: Data for this study were collected as part of the first major randomised controlled trial of self-monitoring combined with self-titration in hypertension (TASMINH2). A contingent valuation framework was used with patients asked to indicate how much they were willing to pay for equipment used for self-managing hypertension. Descriptive statistics, simple statistical tests of differences and multivariate regression were used to test six a priori hypotheses. Results: 393 hypertensive patients (204 in the intervention and 189 in the control) were willing to pay for self-management equipment and 85% of these (335) provided positive WTP values. Three hypotheses were accepted: higher WTP values were associated with being male, higher household incomes and satisfaction with the equipment. Prior experiences of using this equipment, age and changes in blood pressure were not significantly related to WTP. Conclusion: The majority of hypertensive patients who had taken part in a self-management study were prepared to purchase the self-monitoring equipment using their own funds, more so for men, those with higher incomes and those with greater satisfaction. Further research based on bigger and more diverse populations is recommended.
Choice of statistical model for cost-effectiveness analysis and covariate adjustment: empirical application of prominent models and assessment of their results
Context: Statistical models employed in analysing patient-level cost and effectiveness data need to be flexible enough to adjust for any imbalanced covariates, account for correlations between key parameters, and accommodate potential skewed distributions of costs and/or effects. We compare prominent statistical models for cost-effectiveness analysis alongside randomised controlled trials (RCTs) and covariate adjustment to assess their performance and accuracy using data from a large RCT. Method: Seemingly unrelated regressions, linear regression of net monetary benefits, and Bayesian generalized linear models with various distributional assumptions were used to analyse data from the TASMINH2 trial. Each model adjusted for covariates prognostic of costs and outcomes. Results: Cost-effectiveness results were notably sensitive to model choice. Models assuming normally distributed costs and effects provided a poor fit to the data, and potentially misleading inference. Allowing for a beta distribution captured the true incremental difference in effects and changed the decision as to which treatment is preferable. Conclusions: Our findings suggest that Bayesian generalized linear models which allow for non-normality in estimation offer an attractive tool for researchers undertaking cost-effectiveness analyses. The flexibility provided by such methods allows the researcher to analyse patient-level data which are not necessarily normally distributed, while at the same time it enables assessing the effect of various baseline covariates on cost-effectiveness results.
Results and lessons from the spironolactone to prevent cardiovascular events in early stage chronic kidney disease (STOP-CKD) randomised controlled trial
Objectives: To determine whether low-dose spironolactone can safely lower arterial stiffness in patients with chronic kidney disease stage 3 in the primary care setting. Design: A multicentre, prospective, randomised, placebo-controlled, double-blinded study. Setting: 11 primary care centres in South Birmingham, England. Participants: Adult patients with stage 3 chronic kidney disease. Main exclusion criteria were diagnosis of diabetes mellitus, chronic heart failure, atrial fibrillation, severe hypertension, systolic blood pressure <120 mm Hg or baseline serum potassium ≥5 mmol/L. Intervention: Eligible participants were randomised to receive either spironolactone 25 mg once daily, or matching placebo for an intended period of 40 weeks. Outcome measures: The primary end point was the change in arterial stiffness as measured by pulse wave velocity. Secondary outcome measures included the rate of hyperkalaemia, deterioration of renal function, barriers to participation and expected recruitment rates to a potential future hard end point study. Results: From the 11 practices serving a population of 112 462, there were 1598 (1.4%) patients identified as being eligible and were invited to participate. Of these, 134 (8.4%) attended the screening visit of which only 16 (1.0%) were eligible for randomisation. The main reasons for exclusion were low systolic blood pressure (<120 mm Hg: 40 patients) and high estimated glomerular filtration rate (≥60 mL/min/1.73 m2: 38 patients). The trial was considered unfeasible and was terminated early. Conclusions: We highlight some of the challenges in undertaking research in primary care including patient participation in trials. This study not only challenged our preconceptions, but also provided important learning for future research in this large and important group of patients. Trial registration number: ISRCTN80658312.
Routine failures in the process for blood testing and the communication of results to patients in primary care in the UK: a qualitative exploration of patient and provider perspectives
BACKGROUND: The testing and result communication process in primary care is complex. Its successful completion relies on the coordinated efforts of a range of staff in primary care and external settings working together with patients. Despite the importance of diagnostic testing in provision of care, this complexity renders the process vulnerable in the face of increasing demand, stretched resources and a lack of supporting guidance.
Test result communication in primary care: a survey of current practice
BACKGROUND: The number of blood tests ordered in primary care continues to increase and the timely and appropriate communication of results remains essential. However, the testing and result communication process includes a number of participants in a variety of settings and is both complicated to manage and vulnerable to human error. In the UK, guidelines for the process are absent and research in this area is surprisingly scarce; so before we can begin to address potential areas of weakness there is a need to more precisely understand the strengths and weaknesses of current systems used by general practices and testing facilities.
Digital interventions to promote self-management in adults with hypertension: Protocol for systematic review and meta-analysis
Background: Digital interventions, defined as any intervention accessed and taking input from patients in the form of a computer/Web-based program or mobile phoned-based app, can potentially help empower patients to self-manage long-term conditions such as hypertension. Importantly, digital interventions have the potential to provide patients with personalized information and support for active involvement in treatment as well as cost saving. Objective: The purpose of this systematic review is to synthesize the evidence for using digital interventions to support patient self-management of hypertension, and determine their impact on control and reduction of blood pressure, other clinical outcomes, quality of life, medication adherence, health service utilization, and economic benefits. Methods: A systematic search of bibliographic databases including Medline, Embase, CINAHL, and PsycINFO will be undertaken. Abstracts and citations will be independently screened by 2 researchers against predetermined inclusion criteria. Any disagreements will be resolved by discussion and further consideration of the inclusion criteria. Only randomized controlled trials which have been published in peer peer-reviewed journals with a diagnosis of hypertension will be considered. Inclusion criteria will be (1) adults (age ≥ 18 years) with hypertension (as defined by the primary authors); (2) an interactive digital intervention compared with usual care; and (3) outcomes of objectively measured change in blood pressure. Data extraction from identified articles will be undertaken by 2 independent reviewers using a uniform template. The main outcomes are systolic blood pressure (SBP) and diastolic blood pressure (DBP), and quality of life indicators. Secondary outcomes include cost- effectiveness, medication adherence, emotional well-being, and physical activity. Risk of bias of included studies will be assessed using the Cochrane tool. Results: Our research is currently ongoing. Data will be summarized narratively, and if possible, meta-analyses will be performed to assess the impact of the interventions on outcomes. Conclusions: By summarizing and synthesizing available data, this review will help inform policy on the use of digital interventions for self-management of hypertension and will clarify areas for further research.
Patients' views about taking a polypill to manage cardiovascular risk: A qualitative study in primary care
Background A 'polypill' containing a combination of antihypertensives and statins could prevent up to 80% of cardiovascular disease (CVD) events. Aim To investigate patients' opinions about the use of a polypill for CVD prevention. Design and setting Qualitative study of 17 patients from seven primary care practices in Birmingham, UK. Method Patients were recruited through purposive sampling to maximise variation of characteristics. Semi-structured interviews were conducted with responders. Results were analysed and reported using a qualitative description approach. Results Patients expressed concerns that polypill prescription for primary prevention simply on the basis of age was unnecessary and would lead to side effects, despite recognising potential benefits. For high-risk patients, or for secondary prevention, a polypill was deemed more acceptable, but was still felt to require regular monitoring of blood pressure and cholesterol. Conclusion Patients were sceptical about the role of a polypill as a 'blanket' approach. If a population strategy offering a polypill to all people over a certain age was to be implemented, it would need to be supported by patient education.
Patient perspectives on test result communication in primary care: A qualitative study
Background: Although the number of blood tests ordered in primary care continues to increase, efficient systems for the communication of blood test results to patients are lacking. This is a concern in terms of both patient safety and patient satisfaction. Aim: To gain an understanding of patient perspectives on organisational and technological aspects of current and prospective systems for communicating laboratory test results in primary care, and the influences that impact patients' preferred methods for receiving results. Design and setting: Qualitative study using patient focus groups in four primary care practices in Birmingham, UK. Method: The primary care practices were purposively selected to ensure they varied in size, socioeconomic environment, and the default pathways they used to communicate test results. A total of 26 patients from the four practices who had had a recent blood test were recruited. Over a 6 month period in 2011, six, 1-hour focus groups were conducted at the four practices involved in the study. Results: Patients expressed a preference for receiving results from the ordering GP or a clinically qualified member of staff. Suggestions for refining current systems included improved access to phlebotomy appointments, better management of patient telephone calls, and a clear, accessible protocol for the communication of results. Conclusion: Despite the testing and result communication process being a core activity in primary care, it was found that practices could improve their service in a number of areas. Patients described frequent delays and inconsistency in both the level of information and the method of communication, as well as dissatisfaction with non-clinical staff relaying results. Patient preferences for result communication based on their experience of current systems have produced practical suggestions to improve processes.
Use of anticoagulants and antiplatelet agents in stable outpatients with coronary artery disease and atrial fibrillation. International CLARIFY registry
Background Few data are available regarding the use of antithrombotic strategies in coronary artery disease patients with atrial fibrillation (AF) in everyday practice. We sought to describe the prevalence of AF and its antithrombotic management in a contemporary population of patients with stable coronary artery disease. Methods and Findings CLARIFY is an international, prospective, longitudinal registry of outpatients with stable coronary artery disease, defined as prior (≥12 months) myocardial infarction, revascularization procedure, coronary stenosis >50%, or chest pain associated with evidence of myocardial ischemia. Overall, 33,428 patients were screened, of whom 32,954 had data available for analysis at baseline; of these 2,229 (6.7%) had a history of AF. Median (interquartile range) CHA2DS2-VASc score was 4 (3, 5). Oral anticoagulation alone was used in 25.7%, antiplatelet therapy alone in 52.8% (single 41.8%, dual 11.0%), and both in 21.5%. OAC use was independently associated with permanent AF (p<0.001), CHA2DS2-VASc score (p=0.006), pacemaker (p<0.001), stroke (p=0.04), absence of angina (p=0.004), decreased left ventricular ejection fraction (p<0.001), increased waist circumference (p=0.005), and longer history of coronary artery disease (p=0.008). History of percutaneous coronary intervention (p=0.004) and no/partial reimbursement for cardiovascular medication (p=0.01, p<0.001, respectively) were associated with reduced oral anticoagulant use. Conclusions In this contemporary cohort of patients with stable coronary artery disease and AF, most of whom are theoretical candidates for anticoagulation, oral anticoagulants were used in only 47.2%. Half of the patients received antiplatelet therapy alone and one-fifth received both antiplatelets and oral anticoagulants. Efforts are needed to improve adherence to guidelines in these patients.