Quality Of Clinical Outcomes Research Articles

Specialized hereditary breast and ovarian cancer syndrome clinics: Are we achieving our desired outcomes?

Objective: To improve early detection and survival in women with Hereditary Breast and Ovarian Cancer (HBOC) syndromes, national organizations have advocated the development of specialized clinics. We evaluated clinical quality outcomes related to ovarian cancer screening and risk-reduction guidelines at our institutional high-risk Prevention Assessment and Tailored Health Screening (PATHS) clinic, compared to national guidelines.

Wednesday, September 26, 2018 7:35 AM–9:00 AM ePosters: P140. Registry outcomes of cement augmentation for osteoporotic vertebral compression fractures

BACKGROUND CONTEXT The BenchMarket Medical Vertebral Compression Fracture registry (BMM VCF Registry) is a stakeholder collaborative. BMM (authorized registry vendor), Noridian Healthcare Solutions (NHS, Medicare vendor, payer) and clinicians collaborated to gather outcomes evidence for cement augmentation treatments (CA) of patients with acute, painful, osteoporotic vertebral compression fractures (OVCFs). The VCF Registry was designed to provide an easy to use data collection platform, for clinicians performing CA procedures, in order to support their submissions of required clinical and outcomes data. Noridian used the data submissions for claims purposes. PURPOSE The BMM VCF Registry was designed to provide outcomes evidence to inform the payer's “coverage with evidence development” decision to authorize reimbursement for CA treatments. VCF Registry outcomes are also used for internal quality improvement and educational purposes. STUDY DESIGN/SETTING Prospective observational registry data were collected from community hospitals, ambulatory care and tertiary care centers. PATIENT SAMPLE Prospective observational registry data (patient characteristics, diagnosis, process of care, patient reported outcomes (PROs) for pain (NRS) and function (RM) were collected for 1,000 patients suffering acute, painful OVCFs. Thoracolumbar OVCFs (T4-L5) were included in this study. OUTCOME MEASURES Patient reported outcomes were collected at baseline, 1 month, 3 months and 6 months. Primary outcomes were pain (Numeric Rated Pain Scale, NRS 0–10, 0=no pain, 10=worst pain) and function (Rolland Morris Disability Questionnaire, RM 1–24, 1=minimal ADL Disability, 24=maximal disability). All treated patients were tracked for primary (PROs – pain and function) and secondary outcome variables, at the same time points (baseline, 1 month, 3 months and 6 months). Secondary outcomes were patient characteristics, steroids, diagnosis, cement leakage, new neurologic deficit, adverse events, readmit, new VCF, death. METHODS All patients in this study received CA treatments of acute, painful OVCFs. The type of CA treatment (balloon kyphoplasty, vertebroplasty, cavity creation) was at the discretion of the clinician. RESULTS The BMM VCF Registry delivered validated outcomes data to support Noridian's “coverage with evidence development” decision. Registry outcomes confirmed “real-world” evidence of significant pain relief (delta NRS −6) and function improvements (delta RM −10) for CA treated patients, at all time points. The BMM VCF Registry benefited clinicians by providing streamlined authorizations, facilitated required data submissions and avoided authorization denials while facilitating reimbursements. CONCLUSIONS Cement augmentation treatments of patients with acute painful OVCFs reliably results in significant benefit, pain relief and improved function for this vulnerable, elderly population. Vertebral Compression Fracture Registry data are used for clinical internal quality improvement, outcomes reporting and referral or health system education.

Quality of Clinical Outcomes and Effectiveness of Heart Failure Exacerbation Management in Emergency Room Observation Unit Versus Coronary Care Unit

Quality of Clinical Outcomes and Effectiveness of Heart Failure Exacerbation Management in Emergency Room Observation Unit Versus Coronary Care Unit

Using segmented regression analysis of interrupted time series data to assess colonoscopy quality outcomes of a web-enhanced implementation toolkit to support evidence-based practices for bowel preparation: a study protocol.

BackgroundWhile there is convincing evidence on interventions to improve bowel preparation for patients, the evidence on how to implement these evidence-based practices (EBPs) in outpatient colonoscopy settings is less certain. The Strategies to Improve Colonoscopy (STIC) study compares the effect of two implementation strategies, physician education alone versus physician education plus an implementation toolkit for staff, on adoption of three EBPs (split-dosing of bowel preparation, low-literacy education, teach-back) to improve pre-procedure and intra-procedure quality measures. The implementation toolkit contains a staff education module, website containing tools to support staff in delivering EBPs, tailored patient education materials, and brief consultation with staff to determine how the EBPs can be integrated into the existing workflow. Given adaptations to the implementation plan and intentional flexibility in the delivery of the EBPs, we utilize a pragmatic study to balance external validity with demonstrating effectiveness of the implementation strategies.Methods/DesignParticipants will include all outpatient colonoscopy physicians, staff, and patients from a convenience sample of six endoscopy settings. Aim #1 will explore the relative effect of two strategies to implement patient-level EBPs on adoption and clinical quality outcomes. We will assess the change in level and trends of clinical quality outcomes (i.e., adequacy of bowel preparation, adenoma detection) using segmented regression analysis of interrupted time series data with two groups (intervention and delayed start). Aim #2 will examine the influence of organizational readiness to change on EBP implementation. We use a PRECIS diagram to reflect the extent to which each indicator of the study was pragmatic versus explanatory, revealing a largely pragmatic study.DiscussionImplementation challenges have already motivated several adaptations to the original plan, reflecting the nature of implementation in real-world healthcare settings. The pragmatic study responds to the evolving needs of its healthcare partners and allows for flexibility in intervention delivery, thereby informing clinical decision-making in real-world settings. The current study will provide information about what works (intervention effectiveness), for whom it works (influence of Medicaid versus other insurance), in which contexts it works (setting characteristics that influence implementation), and how it works best (comparison of implementation strategies).Electronic supplementary materialThe online version of this article (doi:10.1186/s13012-015-0276-3) contains supplementary material, which is available to authorized users.

A Public-Private Partnership Improves Clinical Performance In A Hospital Network In Lesotho.

Health care public-private partnerships (PPPs) between a government and the private sector are based on a business model that aims to leverage private-sector expertise to improve clinical performance in hospitals and other health facilities. Although the financial implications of such partnerships have been analyzed, few studies have examined the partnerships' impact on clinical performance outcomes. Using quantitative measures that reflected capacity, utilization, clinical quality, and patient outcomes, we compared a government-managed hospital network in Lesotho, Africa, and the new PPP-managed hospital network that replaced it. In addition, we used key informant interviews to help explain differences in performance. We found that the PPP-managed network delivered more and higher-quality services and achieved significant gains in clinical outcomes, compared to the government-managed network. We conclude that health care public-private partnerships may improve hospital performance in developing countries and that changes in management and leadership practices might account for differences in clinical outcomes.

Transforming the Primary Care Training Clinic: New York State's Hospital Medical Home Demonstration Pilot.

Training in patient-centered medical home (PCMH) settings may prepare new physicians to measure quality of care, manage the health of populations, work in teams, and include cost information in decision making. Transforming resident clinics to PCMHs requires funding for additional staff, electronic health records, training, and other resources not typically available to residency programs. Describe how a 1115 Medicaid waiver was used to transform the majority of primary care training sites in New York State to the PCMH model and improve the quality of care provided. The 2013-2014 Hospital Medical Home Program provided awards to 60 hospitals and 118 affiliated residency programs (training more than 5000 residents) to transform outpatient sites into PCMHs and provide high-quality, coordinated care. Site visits, coaching calls, resident surveys, data reporting, and feedback were used to promote and monitor change in resident continuity and quality of care. Descriptive analyses measured improvements in these areas. A total of 156 participating outpatient sites (100%) received PCMH recognition. All sites enhanced resident education using PCMH principles through patient empanelment, development of quality dashboards, and transforming resident scheduling and training. Clinical quality outcomes showed improvement across the demonstration, including better performance on colorectal and breast cancer screening rates (rate increases of 13%, P≤.001, and 11%, P=.011, respectively). A 1115 Medicaid waiver is a viable mechanism for states to transform residency clinics to reflect new primary care models. The PCMH transformation of 156 sites led to improvements in resident continuity and clinical outcomes.

Cost-Quality Tradeoff in Healthcare: Does it Affect Patient Experience?

This study empirically investigates the effect of cost and average length of stay on experiential quality in healthcare. The author uses aggregate level data from 245 acute care hospitals operating in the state of California and performs ordinary least squares regression to test his hypotheses. Supporting the classic theory on cost-quality tradeoff, results show that hospitals do have a tradeoff between cost efficiency and experiential quality. Further, the author finds that hospitals with a higher average length of stay rate have, on average, lower experiential quality. In light of the recent move by Medicare to performance-based reimbursement, the author's results provide key insights to hospital administrators regarding cost-quality tradeoff and the tradeoff between achieving clinical quality and experiential quality outcomes.

I Brazilian Registry of Heart Failure - Clinical Aspects, Care Quality and Hospitalization Outcomes.

BackgroundHeart failure (HF) is one of the leading causes of hospitalization in adults in Brazil. However, most of the available data is limited to unicenter registries. The BREATHE registry is the first to include a large sample of hospitalized patients with decompensated HF from different regions in Brazil.ObjectiveDescribe the clinical characteristics, treatment and prognosis of hospitalized patients admitted with acute HF.MethodsObservational registry study with longitudinal follow-up. The eligibility criteria included patients older than 18 years with a definitive diagnosis of HF, admitted to public or private hospitals. Assessed outcomes included the causes of decompensation, use of medications, care quality indicators, hemodynamic profile and intrahospital events.ResultsA total of 1,263 patients (64±16 years, 60% women) were included from 51 centers from different regions in Brazil. The most common comorbidities were hypertension (70.8%), dyslipidemia (36.7%) and diabetes (34%). Around 40% of the patients had normal left ventricular systolic function and most were admitted with a wet-warm clinical-hemodynamic profile. Vasodilators and intravenous inotropes were used in less than 15% of the studied cohort. Care quality indicators based on hospital discharge recommendations were reached in less than 65% of the patients. Intrahospital mortality affected 12.6% of all patients included.ConclusionThe BREATHE study demonstrated the high intrahospital mortality of patients admitted with acute HF in Brazil, in addition to the low rate of prescription of drugs based on evidence.

An Evaluation of Time and Cost Variability in Hospice Interdisciplinary Group Meetings and Comparative Clinical Quality Outcomes

This study involved a community-based, multisite hospice program serving 7 distinct communities in the greater Washington, DC, metropolitan area. The objectives were to compare time and costs among hospice interdisciplinary group (IDG) meetings and resultant select clinical outcomes in order to esta

Consideration of a new definition of clinically relevant myocardial infarction after coronary revascularization: An expert consensus document from the society for cardiovascular angiography and interventions (SCAI)

Numerous definitions have been proposed for the diagnosis of myocardial infarction (MI) after coronary revascularization. The universal definition for MI designates post procedural biomarker thresholds for defining percutaneous coronary intervention (PCI)-related MI (type 4a) and coronary artery bypass grafting (CABG)-related MI (type 5) which are of uncertain prognostic importance. In addition, for both MI types cTn is recommended as the biomarker of choice, the prognostic significance of which is less well validated than CK-MB. Widespread adoption of a MI definition not clearly linked to subsequent adverse events such as mortality or heart failure may have serious consequences for the appropriate assessment of devices and therapies, may affect clinical care pathways, and may result in misinterpretation of physician competence. Rather than employing an MI definition sensitive for small degrees of myonecrosis (the occurrence of which, based on contemporary large-scale studies, are unlikely to have important clinical consequences), it is instead recommended that a threshold level of biomarker elevation which has been strongly linked to subsequent adverse events in clinical studies be used to define a "clinically relevant MI." The present document introduces a new definition for "clinically relevant MI" after coronary revascularization (PCI or CABG) which is applicable for use in clinical trials, patient care, and quality outcomes assessment.

Cancer therapy and heart failure: Successful management through collaborative interdisciplinary practice.

123 Background: Heart failure (HF) is a clinical problem of emerging importance in cancer care. The advances in cancer detection and complex treatment regimens have resulted in increased cancer treatment induced HF. The literature indicates that more than 50% of all patients exposed to anthracyclines will show some degree of cardiac dysfunction either acutely or 10 to 20 years after treatment, and 5% of those patients will develop overt HF. Successful management requires a collaborative, interdisciplinary approach. The purpose of this presentation is to discuss how the “Heart Success Program” (HSP) resulted in cost effective and clinical quality outcomes in patients with cancer and HF. Methods: The HSP was piloted in the emergency center and telemetry units with high volume admission of HF patients. The HSP includes comprehensive education of patients, families, and health care providers regarding HF management in cancer patients. HSP implementation includes a HF order set, patient education booklet, and educational videotape specific for patients with cancer and HF. Weekly interdisciplinary clinical rounds provide a forum for discussion of identified patient’s problems and formulation of solutions. Endpoint outcomes include compliance with the Center for Medicare and Medicaid Services (CMS) core measures for HF, as well as decreasing HF readmissions. Results: The pilot implementation of the HSP resulted in decreased hospital length of stay by 57%, and average hospital admission cost by 60%. Despite multiple co morbid conditions, patients were discharged with improved functional status and compliance with CMS HF core measures. Conclusions: The findings from this quality improvement project showed significant impact in clinical and cost outcomes for patients with cancer and HF. The multidisciplinary team approach that provided support to patients and their families and allowed for patients to continue their cancer treatment resulting in improved outcomes. As we move toward value-based purchasing, the HSP provides an example of how collaboration and standardized process improvement impacts cost and quality in the oncology population.

Better Medical Office Safety Culture Is Not Associated With Better Scores on Quality Measures

A strong safety culture is an essential element of safe medical practice. Few studies, however, have studied the link between safety culture and clinical quality outcomes. In this study, we examined the association between safety culture and quality measures in primary care offices. A total of 24 primary care offices in Cleveland, Ohio. The Medical Office Survey on Patient Safety was administered to clinicians and support staff to rate 12 dimensions of safety culture and a single overall patient safety rating. An average of the 12 safety culture dimension scores was calculated to produce an aggregated patient safety score. Using linear correlation, we calculated the association between the 2 summary safety measures (overall patient safety rating and aggregated patient safety score) and 2 composite quality measures, a chronic disease score, and a prevention score. The survey response rate was 79% (387/492). There was considerable variation in both safety culture scores and quality scores from office to office. There was no association between the chronic disease score and either summary measure of safety culture. There were small but statistically significant negative associations between the prevention score and the overall patient safety rating (β = -0.087, P = 0.002) as well as the aggregated patient safety score (β = -0.004, P = 0.007). Although safety theory predicts a positive association between safety culture and quality, we found no meaningful associations between safety culture and currently accepted measures of primary care clinical quality. Larger studies across several health care organizations are needed to determine whether these findings are reproducible. If so, it may be necessary to reconsider the dimensions of safety culture in primary care as well as the relationship between safety culture and primary care clinical quality.

Assessing the Value of the Diabetes Educator

The purpose of this study was to evaluate the effectiveness of diabetes self-management education or training provided by diabetes educators in reducing complications and improving quality of life. Commercial and Medicare payer-derived claims data were used to assess the relationship between DSME/T and cost. Unlike the prior study that examined diabetes education provided by all professionals, the current study focused on the value of interventions performed as part of formal accredited/recognized diabetes education programs provided by diabetes educators only. Specifically, the current study focused on diabetes education delivered in diabetes self-management training programs based on 2 codes (G0108 and G0109). Results of the study provide insights into the differences in trends between participants and nonparticipants in DSMT. People with diabetes who had DSMT encounters provided by diabetes educators in accredited/recognized programs are likely to show lower cost patterns when compared with a control group of people with diabetes without DSMT encounters. People with diabetes who have multiple episodes of DSMT are more likely to receive care in accordance with recommended guidelines and to comply with diabetes-related prescription regimens, resulting in lower costs and utilization trends. Conclusions and Policy Implications The collaboration between diabetes educators and patients continues to demonstrate positive clinical quality outcomes and cost savings. This analysis shows that repeated DSMT encounters over time result in a dose-response effect on positive outcomes.

Payment Changes: A Catalyst for Quality

QUALITY MEASUREMENT: THE PAST AS PROLOGUE Nothing changes behavior in healthcare faster than a change in reimbursement. The introduction of DRG reimbursement in the early 1980s and the subsequent rise of managed care and preauthorization of inpatient admissions effectively drove down inpatient utilization in hospitals throughout the country. The new payment mechanisms being piloted in healthcare reform legislation, such as bundled payments and accountable care organizations, are meant to further reduce utilization. Although these mechanisms and structures will affect physicians and other providers across the continuum of care, hospitals will be the first to feel the pressure on revenue. The new payment mechanisms shift payment from volume to value, or quality-based measures. As Rutledge, Huber, and Mathews point out, the Institute of Medicine's (IOM's) seminal 1999 report, To Err is Human, was a major catalyst for the emphasis on quality in our healthcare system. Amid a sea of statistics in the healthcare industry, the IOM statement that up to 98,000 people die in hospitals each year as a result of medical errors that could been prevented impelled many hospitals to work toward resolving the problem immediately. Pilot projects of early clinical performance improvement initiatives, such as those in which CaroMont Health participated, began to establish healthcare quality metrics. But in the 1990s, the paper-driven healthcare system lacked defined measures and the means to capture the necessary data. Gathering quality data was a labor-intensive effort that was inherently subject to error. Physicians, hospitals, and other healthcare providers pursued quality improvement as the right thing to do, but there was no systematic way to measure quality. As recently as 1998, The Joint Commission's ORYX initiative required only the reporting of nonstandardized data on performance measures. In 2002, accredited hospitals were required to collect and report performance data for just two core measure sets (from a total of four). Over the past decade, changes in quality measurement have been breathtaking, say Chassin and colleagues (2010) in a recent New England Journal of Medicine commentary that traces the history of the use of accountability measures to promote healthcare quality improvement. Today, hospitals provide data to The Joint Commission from a selection of 57 inpatient measures, of which 31 are publicly reported. And the National Quality Forum has endorsed more than 600 quality measures. Although this progress in data collection and reporting can and should be celebrated, it has yet to translate to significant improvements in clinical quality outcomes. In June 2010, the Commonwealth Fund released the latest in a succession of reports showing that the United States ranks last overall, compared with selected other industrialized countries, on measures of healthcare quality, efficiency, access to care, equity, and the ability to lead long, healthy, productive lives. That report comes on the heels of the Agency for Healthcare Research and Quality's 200C) National Healthcare Quality Report, which found that the median rate of improvement on 33 core measures of quality was just 2 percent per year. Ultimately, real change in healthcare is not achieved until providers' efforts are rewarded or penalized by the payment system. Links between quality and payment started when the Centers for Medicare & Medicaid Services (CMS) began to mandate reporting of its defined quality metrics and imposing payment penalties on hospitals that failed to provide these data. CMS progressed to publicly reporting the results, ushering in a new era of transparency (although relatively few patients understood the data) and allowing hospitals to compare their performance data with those of other organizations in a somewhat standardized way. However, until recently, payment was still tied only to the requirement to report - not to performance. …

312: Patient Satisfaction Is Associated With Clinical Quality and Hospital Outcomes in Acute Myocardial Infarction

312: Patient Satisfaction Is Associated With Clinical Quality and Hospital Outcomes in Acute Myocardial Infarction

Stimulus Law Directs Funds to Health Care Improvement

Stimulus Law Directs Funds to Health Care Improvement

Measuring the Quality of Inpatient Care for Asthma

Hospital Care| March 01 2009 Measuring the Quality of Inpatient Care for Asthma AAP Grand Rounds (2009) 21 (3): 30. https://doi.org/10.1542/gr.21-3-30 Views Icon Views Article contents Figures & tables Video Audio Supplementary Data Peer Review Share Icon Share Facebook Twitter LinkedIn MailTo Tools Icon Tools Get Permissions Cite Icon Cite Search Site Citation Measuring the Quality of Inpatient Care for Asthma. AAP Grand Rounds March 2009; 21 (3): 30. https://doi.org/10.1542/gr.21-3-30 Download citation file: Ris (Zotero) Reference Manager EasyBib Bookends Mendeley Papers EndNote RefWorks BibTex toolbar search toolbar search search input Search input auto suggest filter your search All PublicationsAll JournalsAAP Grand RoundsPediatricsHospital PediatricsPediatrics In ReviewNeoReviewsAAP NewsAll AAP Sites Search Advanced Search Topics: asthma, inpatients Source: Nkoy FL, Fassl BA, Simon TD, et al. Quality of care for children hospitalized with asthma. Pediatrics. 2008;122(5):1055–1063; doi:10.1542/peds.2007–2399 In this retrospective, observational study researchers from Primary Children’s Medical Center in Salt Lake City developed evidence-based measures of quality for the inpatient management of asthma, and evaluated rates of compliance with these measures at their institution. Utilizing systematic methodologies to review the literature and develop expert consensus, the research team identified 43 potential measures of quality. Of these, a consensus panel selected nine final measures that were evidence-based, feasible, and could be reliably assessed using chart review. The nine final quality measures evaluated specific medical decisions or attributes of the processes of care for asthma in the hospital. Clinical outcomes were not measured directly, but were assumed to be linked to the quality measures based on support from the medical literature. Compliance with the identified measures was rated utilizing retrospective chart review of children 2–17 years of age discharged from the hospital with a primary diagnosis of asthma exacerbation during 2005. The medical records of 252 patients were reviewed. Provider compliance with quality measures specific to acute inpatient management of asthma included: documentation of asthma severity at admission, 39%; use of systemic corticosteroid therapy, 98%; use of oral, not intravenous, corticosteroid, 87%; use of ipratropium bromide limited to the first 24 hours after admission, 71%; and use of metered-dose inhaler rather than nebulizer for children >5 years of age, 20%. Provider compliance with these measures was higher than compliance with the four measures related to preventing re-exacerbation and readmission: documentation of chronic asthma severity, 22%; parental participation in asthma education class, 33%; provision of a written asthma action plan, 5%; and scheduled follow-up with the primary care provider at discharge, 22%. This research team identified nine potential determinants of quality of care for children hospitalized with asthma. Variable and low compliance with these measures suggests that emphasizing and monitoring these measures may lead to improvements in the quality of inpatient care for these patients. Dr. Pate has disclosed no financial relationship relevant to this commentary. This commentary does not contain a discussion of an unapproved/investigative use of a commercial product/device. This study has important limitations, many of which are discussed comprehensively by the authors. Two deserve special attention. First, the study may have been subject to bias in the selection of patients, the selection of final quality measures, and the description of institutional compliance with the measures. Second, due to the chart review methodology, several important indicators of quality of asthma care were not included in the group of final measures. Taken together, these limitations weaken the implied association between the nine measures and overall quality of clinical outcomes in asthma care for hospitalized patients. Measuring specific medical decisions, documentation, and processes as determinants of quality is attractive because these endpoints may be easier to measure than clinical outcomes. However, in order to maximize the value of this intermediate focus, we must demonstrate a... You do not currently have access to this content.

Quality of radiosurgery for single brain metastases with respect to treatment technology: a matched-pair analysis

A comparison of treatment parameters and quality of clinical outcome in patients with single brain metastases treated with two different technologies for radiosurgery (Gamma Knife and CyberKnife). Treatment parameters were statistically analyzed. Clinical outcome was assessed by matched-pair analysis based on the treatment device, differences in dose prescription, and the date of the treatment. Patients were matched according to their tumor size, age, gender, primary cancer, and Radiation Therapy Oncology Group score. Survival post-radiosurgery, local and distant tumor control, and complications were analyzed. Predictive factors were investigated. 423 single brain metastases were treated with Gamma Knife and 73 with CyberKnife. Tumor volumes were similar. The parameters minimum tumor dose, maximum tumor dose, prescription isodose volume, conformality index, homogeneity index, volume of tissue receiving a dose of 10 Gy or more were significantly larger in Gamma Knife group. Sixty-three patients were good matches. These showed the same pattern in parameters. Concerning the outcome analysis, only overall survival differed significantly between groups, twice as long with CyberKnife (P < 0.03). According to pooled data, dose was predictive of local failure, whole brain radiation therapy and chemotherapy were predictive of toxicity, the Radiation Therapy Oncology Group score was predictive of survival after radiosurgery, and date of treatment was predictive of overall survival. No factor predicted new brain metastases, including whole brain radiation therapy. The most important result of this study was the finding that the obvious differences in treatment-related parameters between Gamma Knife and CyberKnife had no impact on the quality of the clinical outcome after radiosurgery. Survival time increased chronologically, presumably due to an intensified anti-cancer therapy in the more recent era of the CyberKnife treatments.

Quality measurement in oncology practices

The prolonged, ubiquitous use of practice management systems and the more recent use of electronic medical record systems in oncology have led to the accumulation of significant repositories of financial, operational, and clinical data. This article examines the use of these data to provide peer-to-peer benchmarking of operational and financial information and a series of data-driven national indices of clinical treatment patterns in oncology. Although not directly a measure of the presence or absence of managerial excellence or clinical quality outcomes, these benchmarks and indices do measure the degree to which processes in place may be beneficial to higher quality management of clinical, financial, and operational outcomes.

Discrepancies in the identification of major bleeding events in patients taking warfarin

Background The method by which major bleeding is defined influences the observed rate of bleeding complications. However, there is no standardized definition of major bleeding for patients taking warfarin. The lack of a consensus definition can influence safety data generated by clinical trials and quality outcomes in anticoagulation clinics. Methods A retrospective analysis of bleeding events in patients taking warfarin and managed by the University of Washington Medical Center Anticoagulation Clinic was performed. Events were evaluated against three definitions of major bleeding, including a subjective definition (‘‘bleeding requiring hospitalization’’) and two more objective definitions (ISCOAT and ISTH). Bleeding events that met at least one definition were included in the analysis. Level of agreement among the definitions was determined by the kappa statistic. Results Over a 5 year period, 2631 patients taking warfarin representing 3600 patients—years of therapy experienced 705 bleeding events. Of these, 138 events met at least one of the definitions of major bleeding. The level of agreement between the subjective definition and either of the objective definitions was poor, with kappa statistic value -0.134 (95% CI -0.196 to -0.071). The subjective definition underestimated major bleeding events by excluding events that were managed on an outpatient basis. Conclusions Use of a standard objective definition of major bleeding in clinical trials and in clinical practice is warranted to assess drug safety, quality of care, and total costs of care in patients treated with warfarin.