Project Retrosight. Understanding the returns from cardiovascular and stroke research: Case Studies

Copyright @ 2011 RAND Europe. All rights reserved. The full text article is available via the link below.This project explores the impacts arising from cardiovascular and stroke research funded 15-20 years ago and attempts to draw out aspects of the research, researcher or environment that are associated with high or low impact. The project is a case study-based review of 29 cardiovascular and stroke research grants, funded in Australia, Canada and UK between 1989 and 1993. The case studies focused on the individual grants but considered the development of the investigators and ideas involved in the research projects from initiation to the present day. Grants were selected through a stratified random selection approach that aimed to include both high- and low-impact grants. The key messages are as follows: 1) The cases reveal that a large and diverse range of impacts arose from the 29 grants studied. 2) There are variations between the impacts derived from basic biomedical and clinical research. 3) There is no correlation between knowledge production and wider impacts 4) The majority of economic impacts identified come from a minority of projects. 5) We identified factors that appear to be associated with high and low impact. This report presents the key observations of the study and an overview of the methods involved. It has been written for funders of biomedical and health research and health services, health researchers, and policy makers in those fields. It will also be of interest to those involved in research and impact evaluation.This study was initiated with internal funding from RAND Europe and HERG, with continuing funding from the UK National Institute for Health Research, the Canadian Institutes of Health Research, the Heart and Stroke Foundation of Canada and the National Heart Foundation of Australia. The UK Stroke Association and the British Heart Foundation provided support in kind through access to their archives

Protocol for the 'e-Nudge trial' : a randomised controlled trial of electronic feedback to reduce the cardiovascular risk of individuals in general practice [ISRCTN64828380]

Background: Cardiovascular disease (including coronary heart disease and stroke) is a major cause of death and disability in the United Kingdom, and is to a large extent preventable, by lifestyle modification and drug therapy. The recent standardisation of electronic codes for cardiovascular risk variables through the United Kingdom's new General Practice contract provides an opportunity for the application of risk algorithms to identify high risk individuals. This randomised controlled trial will test the benefits of an automated system of alert messages and practice searches to identify those at highest risk of cardiovascular disease in primary care databases. Design: Patients over 50 years old in practice databases will be randomised to the intervention group that will receive the alert messages and searches, and a control group who will continue to receive usual care. In addition to those at high estimated risk, potentially high risk patients will be identified who have insufficient data to allow a risk estimate to be made. Further groups identified will be those with possible undiagnosed diabetes, based either on elevated past recorded blood glucose measurements, or an absence of recent blood glucose measurement in those with established cardiovascular disease. Outcome measures: The intervention will be applied for two years, and outcome data will be collected for a further year. The primary outcome measure will be the annual rate of cardiovascular events in the intervention and control arms of the study. Secondary measures include the proportion of patients at high estimated cardiovascular risk, the proportion of patients with missing data for a risk estimate, and the proportion with undefined diabetes status at the end of the trial

Comparison of a prototype for indications-based prescribing with 2 commercial prescribing systems

Importance: The indication (reason for use) for a medication is rarely included on prescriptions despite repeated recommendations to do so. One barrier has been the way existing electronic prescribing systems have been designed. Objective: To evaluate, in comparison with the prescribing modules of 2 leading electronic health record prescribing systems, the efficiency, error rate, and satisfaction with a new computerized provider order entry prototype for the outpatient setting that allows clinicians to initiate prescribing using the indication. Design, Setting, and Participants: This quality improvement study used usability tests requiring internal medicine physicians, residents, and physician assistants to enter prescriptions electronically, including indication, for 8 clinical scenarios. The tool order assignments were randomized and prescribers were asked to use the prototype for 4 of the scenarios and their usual system for the other 4. Time on task, number of clicks, and order details were captured. User satisfaction was measured using posttask ratings and a validated system usability scale. The study participants practiced in 2 health systems\u27 outpatient practices. Usability tests were conducted between April and October of 2017. Main Outcomes and Measures: Usability (efficiency, error rate, and satisfaction) of indications-based computerized provider order entry prototype vs the electronic prescribing interface of 2 electronic health record vendors. Results: Thirty-two participants (17 attending physicians, 13 residents, and 2 physician assistants) used the prototype to complete 256 usability test scenarios. The mean (SD) time on task was 1.78 (1.17) minutes. For the 20 participants who used vendor 1\u27s system, it took a mean (SD) of 3.37 (1.90) minutes to complete a prescription, and for the 12 participants using vendor 2\u27s system, it took a mean (SD) of 2.93 (1.52) minutes. Across all scenarios, when comparing number of clicks, for those participants using the prototype and vendor 1, there was a statistically significant difference from the mean (SD) number of clicks needed (18.39 [12.62] vs 46.50 [27.29]; difference, 28.11; 95% CI, 21.47-34.75; P \u3c .001). For those using the prototype and vendor 2, there was also a statistically significant difference in number of clicks (20.10 [11.52] vs 38.25 [19.77]; difference, 18.14; 95% CI, 11.59-24.70; P \u3c .001). A blinded review of the order details revealed medication errors (eg, drug-allergy interactions) in 38 of 128 prescribing sessions using a vendor system vs 7 of 128 with the prototype. Conclusions and Relevance: Reengineering prescribing to start with the drug indication allowed indications to be captured in an easy and useful way, which may be associated with saved time and effort, reduced medication errors, and increased clinician satisfaction

Association of inferior vena cava filter placement for venous thromboembolic disease and a contraindication to anticoagulation with 30-day mortality

Importance: Despite the absence of data from randomized clinical trials, professional societies recommend inferior vena cava (IVC) filters for patients with venous thromboembolic disease (VTE) and a contraindication to anticoagulation therapy. Prior observational studies of IVC filters have suggested a mortality benefit associated with IVC filter insertion but have often failed to adjust for immortal time bias, which is the time before IVC filter insertion, during which death can only occur in the control group. Objective: To determine the association of IVC filter placement with 30-day mortality after adjustment for immortal time bias. Design, Setting, and Participants: This comparative effectiveness, retrospective cohort study used a population-based sample of hospitalized patients with VTE and a contraindication to anticoagulation using the State Inpatient Database and the State Emergency Department Database, part of the Healthcare Cost and Utilization Project of the Agency for Healthcare Research and Quality, from hospitals in California (January 1, 2005, to December 31, 2011), Florida (January 1, 2005, to December 31, 2013), and New York (January 1, 2005, to December 31, 2012). Data analysis was conducted from September 15, 2015, to March 14, 2018. Exposure: Inferior vena cava filter placement. Main Outcomes and Measures: Multivariable Cox proportional hazard models were constructed with IVC filters as a time-dependent variable that adjusts for immortal time bias. The Cox model was further adjusted using the propensity score as an adjustment variable. Results: Of 126 030 patients with VTE, 61 281 (48.6%) were male and the mean (SD) age was 66.9 (16.6) years. In this cohort, 45 771 (36.3%) were treated with an IVC filter, whereas 80 259 (63.7%) did not receive a filter. In the Cox model with IVC filter status analyzed as a time-dependent variable to account for immortal time bias, IVC filter placement was associated with a significantly increased hazard ratio of 30-day mortality (1.18; 95% CI, 1.13-1.22; P \u3c .001). When the propensity score was included in the Cox model, IVC filter placement remained associated with an increased hazard ratio of 30-day mortality (1.18; 95% CI, 1.13-1.22; P \u3c .001). Conclusions and Relevance: After adjustment for immortal time bias, IVC filter placement was associated with increased 30-day mortality in patients with VTE and a contraindication to anticoagulation. Randomized clinical trials are needed to determine the efficacy of IVC filter placement in patients with VTE and a contraindication to anticoagulation

Comparison of a prototype for indications-based prescribing with 2 commercial prescribing systems

Importance: The indication (reason for use) for a medication is rarely included on prescriptions despite repeated recommendations to do so. One barrier has been the way existing electronic prescribing systems have been designed. Objective: To evaluate, in comparison with the prescribing modules of 2 leading electronic health record prescribing systems, the efficiency, error rate, and satisfaction with a new computerized provider order entry prototype for the outpatient setting that allows clinicians to initiate prescribing using the indication. Design, Setting, and Participants: This quality improvement study used usability tests requiring internal medicine physicians, residents, and physician assistants to enter prescriptions electronically, including indication, for 8 clinical scenarios. The tool order assignments were randomized and prescribers were asked to use the prototype for 4 of the scenarios and their usual system for the other 4. Time on task, number of clicks, and order details were captured. User satisfaction was measured using posttask ratings and a validated system usability scale. The study participants practiced in 2 health systems\u27 outpatient practices. Usability tests were conducted between April and October of 2017. Main Outcomes and Measures: Usability (efficiency, error rate, and satisfaction) of indications-based computerized provider order entry prototype vs the electronic prescribing interface of 2 electronic health record vendors. Results: Thirty-two participants (17 attending physicians, 13 residents, and 2 physician assistants) used the prototype to complete 256 usability test scenarios. The mean (SD) time on task was 1.78 (1.17) minutes. For the 20 participants who used vendor 1\u27s system, it took a mean (SD) of 3.37 (1.90) minutes to complete a prescription, and for the 12 participants using vendor 2\u27s system, it took a mean (SD) of 2.93 (1.52) minutes. Across all scenarios, when comparing number of clicks, for those participants using the prototype and vendor 1, there was a statistically significant difference from the mean (SD) number of clicks needed (18.39 [12.62] vs 46.50 [27.29]; difference, 28.11; 95% CI, 21.47-34.75; P \u3c .001). For those using the prototype and vendor 2, there was also a statistically significant difference in number of clicks (20.10 [11.52] vs 38.25 [19.77]; difference, 18.14; 95% CI, 11.59-24.70; P \u3c .001). A blinded review of the order details revealed medication errors (eg, drug-allergy interactions) in 38 of 128 prescribing sessions using a vendor system vs 7 of 128 with the prototype. Conclusions and Relevance: Reengineering prescribing to start with the drug indication allowed indications to be captured in an easy and useful way, which may be associated with saved time and effort, reduced medication errors, and increased clinician satisfaction

Outcome of very elderly (octogenarians) patients with coronary artery disease, all diagnosed by coronary angiography

Background: Women with ischemic heart disease (IHD) typically present less severe coronary artery atherosclerosis. Despite that, as compared with men, women maintain a worse outcome. This female susceptibility seems to be mainly related to older age of clinical presentation and heavier risk factors burden. Purpose: To investigate whether sex differences exist in the real-world management and clinical outcome of elderly patients with suspected IHD. Methods: Retrospective analysis of IHD elderly (≥ 80 years) patients undergoing coronary angiography for acute coronary syndrome (ACS) or stable angina (SA). Management strategy, including invasive revascularization or a conservative medical approach, and outcome were evaluated. Results: A total of 1420 (41% women; mean age: 83.1 ± 2.8) IHD patients referring for ACS (43%) and SA (57%) were analyzed. Men more likely accessed for SA (59.6% vs 52.5%, p<0.001) whereas ACS was the most frequent reason for angiography in women (28.8% vs 21.5%, p<0.001). No significant sex differences in the burden of obstructive epicardial disease were observed in both ACS and SA patients. No sex disparities in antiplatelet therapy, specifically clopidogrel, were detected. Compared with SA men patients, female ones received more likely a conservative therapy (p=0.049). After a median (IQR) follow-up time of 39.0 (16-71) months, a total of 514 (36%) patients died. No sex differences in cardiac death (p=0.139) was observed. Nevertheless, the Kaplan Meier curves showed a trend in lower all-cause mortality in female group(p=0.093). Conclusions: In the very elderly population, an invasive strategy is superior to a conservative one in terms of survival rate. However, a dilution of the efficacy occurs with increasing age and comorbidities, and for male patients the benefit of the invasive strategy is not clear. Prospective studies are warranted to evaluate the net benefit of an invasive or a conservative approach in older population

Motivational Interviewing Impact on Cardiovascular Disease

abstract: Harm reduction in cardiovascular disease is a significant problem worldwide. Providers, families, and healthcare agencies are feeling the burdens imparted by these diseases. Not to mention missed days of work and caregiver strain, the losses are insurmountable. Motivational interviewing (MI) is gaining momentum as a method of stimulating change through intrinsic motivation by resolving ambivalence toward change (Ma, Zhou, Zhou, & Huang, 2014). If practitioners can find methods of educating the public in a culturally-appropriate and sensitive manner, and if they can work with community stakeholders to organize our resources to make them more accessible to the people, we may find that simple lifestyle changes can lead to risk reduction of cardiovascular diseases. By working with our community leaders and identifying barriers unique to each population, we can make positive impacts on a wide range of issues that markedly impact our healthcare systems

An examination of factors influencing the choice of therapy for patients with coronary artery disease

Background A diverse range of factors influence clinicians' decisions regarding the allocation of patients to different treatments for coronary artery disease in routine cardiology clinics. These include demographic measures, risk factors, co-morbidities, measures of objective cardiac disease, symptom reports and functional limitations. This study examined which of these factors differentiated patients receiving angioplasty from medication; bypass surgery from medication; and bypass surgery from angioplasty. Methods Univariate and multivariate logistic regression analyses were conducted on patient data from 214 coronary artery disease patients who at the time of recruitment had been received a clinical assessment and were reviewed by their cardiologist in order to determine the form of treatment they were to undergo: 70 would receive/continue medication, 71 were to undergo angioplasty and 73 were to undergo bypass surgery. Results Analyses differentiating patients receiving angioplasty from medication produced 9 significant univariate predictors, of which 5 were also multivariately significant (left anterior descending artery disease, previous coronary interventions, age, hypertension and frequency of angina). The analyses differentiating patients receiving surgery from angioplasty produced 12 significant univariate predictors, of which 4 were multivariately significant (limitations in mobility range, circumflex artery disease, previous coronary interventions and educational level). The analyses differentiating patients receiving surgery from medication produced 14 significant univariate predictors, of which 4 were multivariately significant (left anterior descending artery disease, previous cerebral events, limitations in mobility range and circumflex artery disease). Conclusion Variables emphasised in clinical guidelines are clearly involved in coronary artery disease treatment decisions. However, variables beyond these may also be important factors when therapy decisions are undertaken thus their roles require further investigation

The systematic guideline review: method, rationale, and test on chronic heart failure

Background: Evidence-based guidelines have the potential to improve healthcare. However, their de-novo-development requires substantial resources-especially for complex conditions, and adaptation may be biased by contextually influenced recommendations in source guidelines. In this paper we describe a new approach to guideline development-the systematic guideline review method (SGR), and its application in the development of an evidence-based guideline for family physicians on chronic heart failure (CHF). Methods: A systematic search for guidelines was carried out. Evidence-based guidelines on CHF management in adults in ambulatory care published in English or German between the years 2000 and 2004 were included. Guidelines on acute or right heart failure were excluded. Eligibility was assessed by two reviewers, methodological quality of selected guidelines was appraised using the AGREE instrument, and a framework of relevant clinical questions for diagnostics and treatment was derived. Data were extracted into evidence tables, systematically compared by means of a consistency analysis and synthesized in a preliminary draft. Most relevant primary sources were re-assessed to verify the cited evidence. Evidence and recommendations were summarized in a draft guideline. Results: Of 16 included guidelines five were of good quality. A total of 35 recommendations were systematically compared: 25/35 were consistent, 9/35 inconsistent, and 1/35 un-rateable (derived from a single guideline). Of the 25 consistencies, 14 were based on consensus, seven on evidence and four differed in grading. Major inconsistencies were found in 3/9 of the inconsistent recommendations. We re-evaluated the evidence for 17 recommendations (evidence-based, differing evidence levels and minor inconsistencies) - the majority was congruent. Incongruity was found where the stated evidence could not be verified in the cited primary sources, or where the evaluation in the source guidelines focused on treatment benefits and underestimated the risks. The draft guideline was completed in 8.5 man-months. The main limitation to this study was the lack of a second reviewer. Conclusion: The systematic guideline review including framework development, consistency analysis and validation is an effective, valid, and resource saving-approach to the development of evidence-based guidelines