Performance Measures Using Electronic Health Records: Five Case Studies

Presents the experiences of five provider organizations in developing, testing, and implementing four types of electronic quality-of-care indicators based on EHR data. Discusses challenges, and compares results with those from traditional indicators

An evidence-based review of edoxaban and its role in stroke prevention in patients with nonvalvular atrial fibrillation.

Atrial fibrillation is the most common arrhythmia in the elderly. It is responsible for significant morbidity and mortality from cardioembolic complications like stroke. As a result, atrial fibrillation patients are risk-stratified using the CHADS2 or CHA2DS2-VASc scoring systems. Those at intermediate-to-high risk have traditionally been treated with therapeutic anticoagulation with warfarin for stroke prevention. Although effective, warfarin use is fraught with multiple concerns, such as a narrow therapeutic window, drug-drug and drug-food interactions, and excessive bleeding. Novel oral anticoagulant agents have recently become available as viable alternatives for warfarin therapy. Direct thrombin inhibitor dabigatran and factor Xa inhibitors like rivaroxaban and apixaban have already been approved by the US Food and Drug Administration (FDA) for stroke prevention in patients with nonvalvular atrial fibrillation. Edoxaban is the latest oral direct factor Xa inhibitor studied in the largest novel oral anticoagulant trial so far: ENGAGE AF-TIMI 48. Treatment with a 30 mg or 60 mg daily dose of edoxaban was found to be noninferior to dose-adjusted warfarin in reducing the rate of stroke and systemic embolism in patients with nonvalvular atrial fibrillation, with a lower incidence of bleeding complications and cardiovascular deaths. Edoxaban was recently reviewed by an FDA advisory committee and recommended as a stroke-prophylaxis agent. Once approved, it promises to provide another useful alternative to warfarin therapy

How Can We Move Clinical Genomics Beyond the Hype?

Examines the debate over increased use of genetic testing, due in part to lax regulation, and its consequences: wasteful spending, patient harm, and health system challenges. Makes recommendations for implementation of and data on promising technologies

Hypertension and atrial fibrillation: diagnostic approach, prevention and treatment. Position paper of the Working Group 'Hypertension Arrhythmias and Thrombosis' of the European Society of Hypertension.

Hypertension is the most common cardiovascular disorder and atrial fibrillation is the most common clinically significant arrhythmia. Both these conditions frequently coexist and their prevalence increases rapidly with aging. There are different risk factors and clinical conditions predisposing to the development of atrial fibrillation, but due its high prevalence, hypertension is still the main risk factor for the development of atrial fibrillation. Several pathophysiologic mechanisms (such as structural changes, neurohormonal activation, fibrosis, atherosclerosis, etc.) have been advocated to explain the onset of atrial fibrillation. The presence of atrial fibrillation per se increases the risk of stroke but its coexistence with high blood pressure leads to an abrupt increase of cardiovascular complications. Different risk models are available for the risk stratification and the prevention of thromboembolism in patients with atrial fibrillation. In all of them hypertension is present and is an important risk factor. Antihypertensive treatment may contribute to reduce this risk, and it seems some classes are superior to others in the prevention of new-onset atrial fibrillation and prevention of stroke. Antithrombotic treatment with warfarin is effective in the prevention of thromboembolic events, although quite recently, new classes of anticoagulants that do not require international normalized ratio monitoring have been introduced with promising results

Cost-effectiveness of dabigatran etexilate for the prevention of stroke and systemic embolism in UK patients with atrial fibrillation

Objective To assess the cost-effectiveness of dabigatran etexilate, a new oral anticoagulant, versus warfarin and other alternatives for the prevention of stroke and systemic embolism in UK patients with atrial fibrillation (AF). Methods A Markov model estimated the cost-effectiveness of dabigatran etexilate versus warfarin, aspirin or no therapy. Two patient cohorts with AF (starting age of <80 and ≥80 years) were considered separately, in line with the UK labelled indication. Modelled outcomes over a lifetime horizon included clinical events, quality-adjusted life years (QALYs), total costs and incremental cost-effectiveness ratios (ICERs). Results Patients treated with dabigatran etexilate experienced fewer ischaemic strokes (3.74 dabigatran etexilate vs 3.97 warfarin) and fewer combined intracranial haemorrhages and haemorrhagic strokes (0.43 dabigatran etexilate vs 0.99 warfarin) per 100 patient-years. Larger differences were observed comparing dabigatran etexilate with aspirin or no therapy. For patients initiating treatment at ages <80 and ≥80 years, the ICERs for dabigatran etexilate were £4831 and £7090/QALY gained versus warfarin with a probability of cost-effectiveness at £20 000/QALY gained of 98% and 63%, respectively. For the patient cohort starting treatment at ages <80 years, the ICER versus aspirin was £3457/QALY gained and dabigatran etexilate was dominant (ie, was less costly and more effective) compared with no therapy. These results were robust in sensitivity analyses. Conclusions This economic evaluation suggests that the use of dabigatran etexilate as a first-line treatment for the prevention of stroke and systemic embolism is likely to be cost-effective in eligible UK patients with AF

Investigating prescribers' experiences of direct-acting oral anticoagulants for the management of nonvalvular atrial fibrillation.

Direct-acting oral anticoagulants (DOACs) have relatively recently been licensed for stroke and systemic embolism prevention in patients with non-valvular atrial fibrillation (AF) and have replaced warfarin as the first line agent of choice. The aim of this research was to determine prescribers' views and experiences of the use of DOACs for the management of non-valvular AF. The first phase was a PROSPERO-registered systematic review of clinicians' views and experiences of DOACs for the management of non-valvular atrial fibrillation. Ten studies were identified. In those studies reporting clinician preference, DOACs were first choice over warfarin in naïve patients, based on perceptions of evidence that DOACs had effectiveness equivalent or superior to warfarin and were also superior in safety. Other advantageous factors were in those with an unstable International Normalized Ratio and who were likely to miss appointments. There were, however, concerns relating to management of over-anticoagulation and experiences of observed bleeding rates. In addition to the lack of studies, none of the studies had used theory in the development of the data collection tools or analysis, indicating a gap in the literature. The second phase was a cross-sectional survey of prescriber's views, behaviours and experiences related to prescribing DOACs for the management of non-valvular AF. The survey was conducted in NHS Highland, inviting all medical and non-medical prescribers to participate. Items on potential influences on DOAC prescribing were based on the Theoretical Domains Framework (TDF). Principal component analysis (PCA) of the TDF items gave four components. Component scores were positive for (i) role of professionals, their knowledge and skills and (ii) influences on prescribing. There did, however, appear to be issues in switching from warfarin to DOACs or from one DOAC to another. Scores were more neutral for (iii) consequences of prescribing and (iv) monitoring for safety and effectiveness. There were low levels of agreement for statements relating to DOACs being more effective, safer and cost-effective than warfarin. There were similar responses around the complexity of bleeding management and detection of over and under-anticoagulation. Less experienced prescribers were statistically significantly more positive than more experienced prescribers in terms of the consequences of prescribing (p < 0.05). Content analysis of the responses to the open questions identified that the overwhelming perceived benefit was the absence of need for INR monitoring, with the main limitations being the lack of a suitable reversal agent and ability to monitor anticoagulation status.Given the updated recommendations of Healthcare Improvement Scotland (HIS) to use edoxaban first line, the final phase was a cross-sectional survey of prescriber's views, behaviours and experiences related to prescribing edoxaban for the management of non-valvular AF. Responses were received from 103 prescribers in NHS Highland. While almost all respondents had been encouraged to implement this recommendation of prescribing edoxaban, less than one third had either switched patients from warfarin or other DOACs to edoxaban. The following three PCA components identified in the previous survey were applied to the TDF determinants: the role of professionals, their knowledge and skills; influences on prescribing; and consequences of prescribing. While component scores for the first two components were positive, the scores for consequences of prescribing were more neutral. Although a number of respondents described edoxaban (and other DOAC) related adverse drug reactions (ADRs), very few had submitted a Yellow Card report to the Medicines and Healthcare products Regulatory Agency (MHRA). Content analysis of the responses to the open questions identified benefits and limitations similar to the previous survey. This doctoral research has generated original findings in terms of DOACs views, experiences and behaviours related to management of non-valvular AF. There is merit in reviewing the local and national guidelines, particularly in relation to switching and awareness of the evidence base. Attention should be paid to the literature on guideline implementation

Oral anticoagulant use in cardiovascular disorders: a perspective on present and potential indications for rivaroxaban.

BACKGROUND: Four nonvitamin K antagonist oral anticoagulants (NOACs) have been approved for use in various cardiovascular indications. The direct thrombin inhibitor dabigatran and the direct factor Xa inhibitors apixaban, edoxaban, and rivaroxaban are now increasingly used in clinical practice. For some of these agents, available data from real-world studies support the efficacy and safety data in phase III clinical trials. OBJECTIVES: This review aims to summarize the current status of trials and observational studies of oral anticoagulant use over the spectrum of cardiovascular disorders (excluding venous thrombosis), provide a reference source beyond stroke prevention for atrial fibrillation (AF) and examine the potential for novel applications in the cardiovascular field. METHODS: We searched the recent literature for data on completed and upcoming trials of oral anticoagulants with a particular focus on rivaroxaban. RESULTS: Recent data in specific patient subgroups, such as patients with AF undergoing catheter ablation or cardioversion, have led to an extended approval for rivaroxaban, whereas the other NOACs have ongoing or recently completed trials in this setting. However, there are unmet medical needs for several arterial thromboembolic-related conditions, including patients with: AF and acute coronary syndrome, AF and coronary artery disease undergoing elective percutaneous coronary intervention, coronary artery disease and peripheral artery disease, implanted cardiac devices, and embolic stroke of unknown source. CONCLUSION: NOACs may provide alternative treatment options in areas of unmet need, and numerous studies are underway to assess their benefit-risk profiles in these settings

Development and preliminary evaluation of a clinical guidance programme for the decision about prophylactic oophorectomy in women undergoing a hysterectomy

Objectives: To develop a decision analysis based and computerised clinical guidance programme (CGP) that provides patient specific guidance on the decision whether or not to undergo a prophylactic oophorectomy to reduce the risk of subsequent ovarian cancer and to undertake a preliminary pilot and evaluation. Subjects: Women who had already agreed to have a hysterectomy who otherwise had no ovarian pathology. Setting: Oophorectomy decision consultation at the outpatient or pre-admission clinic. Methods: A CGP was developed with advice from gynaecologists and patient groups, incorporating a set of Markov models within a decision analytical framework to evaluate the benefits of undergoing a prophylactic oophorectomy or not on the basis of quality adjusted life expectancy, life expectancy, and for varying durations of hormone replacement therapy. Sensitivity analysis and preliminary testing of the CGP were undertaken to compare its overall performance with established guidelines and practice. A small convenience sample of women invited to use the CGP were interviewed, the interviews were taped and transcribed, and a thematic analysis was undertaken. Results: The run time of the programme was 20 minutes, depending on the use of opt outs to default values. The CGP functioned well in preliminary testing. Women were able to use the programme and expressed overall satisfaction with it. Some had reservations about the computerised format and some were surprised at the specificity of the guidance given. Conclusions: A CGP can be developed for a complex healthcare decision. It can give evidence-based health guidance which can be adjusted to account for individual risk factors and reflects a patient’s own values and preferences concerning health outcomes. Future decision aids and support systems need to be developed and evaluated in a way which takes account of the variation in patients’ preferences for inclusion in the decision making process

Development of an international standard set of outcome measures for patients with atrial fibrillation: a report of the International Consortium for Health Outcomes Measurement (ICHOM) atrial fibrillation working group.

AIMS: As health systems around the world increasingly look to measure and improve the value of care that they provide to patients, being able to measure the outcomes that matter most to patients is vital. To support the shift towards value-based health care in atrial fibrillation (AF), the International Consortium for Health Outcomes Measurement (ICHOM) assembled an international Working Group (WG) of 30 volunteers, including health professionals and patient representatives to develop a standardized minimum set of outcomes for benchmarking care delivery in clinical settings. METHODS AND RESULTS: Using an online-modified Delphi process, outcomes important to patients and health professionals were selected and categorized into (i) long-term consequences of disease outcomes, (ii) complications of treatment outcomes, and (iii) patient-reported outcomes. The WG identified demographic and clinical variables for use as case-mix risk adjusters. These included baseline demographics, comorbidities, cognitive function, date of diagnosis, disease duration, medications prescribed and AF procedures, as well as smoking, body mass index (BMI), alcohol intake, and physical activity. Where appropriate, and for ease of implementation, standardization of outcomes and case-mix variables was achieved using ICD codes. The standard set underwent an open review process in which over 80% of patients surveyed agreed with the outcomes captured by the standard set. CONCLUSION: Implementation of these consensus recommendations could help institutions to monitor, compare and improve the quality and delivery of chronic AF care. Their consistent definition and collection, using ICD codes where applicable, could also broaden the implementation of more patient-centric clinical outcomes research in AF

Cost-Utility Analysis of Venous Thromboembolism Prophylaxis Strategies for People Undergoing Elective Total Hip and Total Knee Replacement Surgeries in the English National Health Service

Background: Major orthopedic surgery, such as elective total hip replacement (eTHR) and elective total knee replacement (eTKR), are associated with a higher risk of venous thromboembolism (VTE) than other surgical procedures. Little is known, however, about the cost-effectiveness of VTE prophylaxis strategies in people undergoing these procedures. Aim: The aim of this work was to assess the cost-effectiveness of these strategies from the English National Health Service perspective to inform NICE guideline (NG89) recommendations. Materials and Methods: Cost-utility analysis, using decision modeling, was undertaken to compare 15 VTE prophylaxis strategies for eTHR and 12 for eTKR, in addition to “no prophylaxis” strategy. The analysis complied with the NICE Reference Case. Structure and assumptions were agreed with the guideline committee. Incremental net monetary benefit (INMB) was calculated, vs. the model comparator (LMWH+ antiembolism stockings), at a threshold of £20,000/quality-adjusted life-year (QALY) gained. The model was run probabilistically. Deterministic sensitivity analyses (SAs) were undertaken to assess the robustness of the results. Results: The most cost-effective strategies were LMWH for 10 days followed by aspirin for 28 days (INMB = £530 [95% CI: -£784 to £1,103], probability of being most cost-effective = 72%) for eTHR, and foot pump (INMB = £353 [95% CI: -£101 to £665]; probability of being most cost-effective = 18%) for eTKR. There was considerable uncertainty regarding the cost-effectiveness ranking in the eTKR analysis. The results were robust to change in all SAs. Conclusions: For eTHR, LMWH (standard dose) for 10 days followed by aspirin for 28 days is the most cost-effective VTE prophylaxis strategy. For eTKR, the results are highly uncertain but foot pump appeared to be the most cost-effective strategy, followed closely by aspirin (low dose). Future research should focus on assessing cost-effectiveness of VTE prophylaxis in the eTKR population.Peer reviewe