Heart Function Assessment Registry Trial in Saudi Arabia
Project Description
(Introduction)
Heart failure (HF) is a complex clinical syndrome that can result from any structural or functional cardiac disorder that impairs the ability of the ventricle to fill with or eject blood. The cardinal manifestations of HF are dyspnea and fatigue, which may limit exercise tolerance, and fluid retention, which may lead to pulmonary congestion and peripheral edema. It represents a major and growing public health problem. Since there are no data documenting the national impact of this disease in Saudi Arabia, the following figures are related to the United States and have been used as an example to reflect the serious impact of this syndrome on the health care of cardiac patients. Approximately 5 million patients in the United States have HF, and over 550 000 patients are diagnosed with HF for the first time each year (1). The disorder is the primary reason for 12 to 15 million office visits and 6.5 million hospital days each year (2). From 1990 to 1999, the annual number of hospitalizations has increased from approximately 810 000 to over 1 million for HF as a primary diagnosis and from 2.4 to 3.6 million for HF as a primary or secondary diagnosis (3). In 2001, nearly 53 000 patients died of HF as a primary cause. The number of HF deaths has increased steadily despite advances in treatment, in part because of increasing numbers of patients with HF due to better treatment and "salvage" of patients with acute myocardial infarctions (MIs) earlier in life (1). Heart failure is primarily a condition of the elderly (4), and thus the widely recognized "aging of the population" also contributes to the increasing incidence of HF. The incidence of HF approaches 10 per 1000 population after age 65 (1), and approximately 80% of patients hospitalized with HF are more than 65 years old (5). Heart failure is the most common Medicare diagnosis-related group (i.e., hospital discharge diagnosis), and more Medicare dollars are spent for the diagnosis and treatment of HF than for any other diagnosis (6). It has been estimated that in 2005, the total direct and indirect cost of HF in the US will be equal to $27.9 billion (1).
Health Care Report Cards
The modern era of "scorecard cardiovascular medicine" began in the early 1990s (7). A well-known example, initiated in 1991, involved the publication of hospital and surgeon-specific report cards on in-hospital mortality after coronary artery bypass graft (CABG) surgery in New York State. The publication of this information stimulated quality improvement initiatives in several New York hospitals, and was associated with a 41% decline in the risk-adjusted in-hospital mortality rate after CABG surgery (from 4.14% to 2.45%) (8). Critics have charged that the mortality rate decline was, in part, the result of avoidance of high-risk patients and "gaming" of the data by involved physicians (9,10). Other researchers have noted that CABG mortality rates were also declining in jurisdictions that had not instituted public reporting systems (11). However, subsequent studies by Duke University researchers documented that mortality rates after CABG surgery declined fastest in New York State with its public reporting system and Northern New England with its confidential data feedback program (12). There are conflicting studies as to whether patients preferentially migrated to low-mortality hospitals and surgeons in New York State (13, 14). Report cards on hospital-specific AMI mortality rates have been developed in several jurisdictions including the United States (California, Pennsylvania), Scotland and Sweden (15-18). These report cards have all been generated using routinely collected hospital discharge administrative data. Critics have questioned the accuracy of these administrative data, the quality of the risk-adjustment methods, the lack of associated process of care data, the timeliness of the data, and the level of disclosure (which has been physician-specific in some jurisdictions). (18-20) The impact of these report cards on quality improvement activities appears to be limited, although few evaluative studies have been done. (21, 22) Most AMI report cards have reported solely on AMI outcomes, rather than on the processes of care that contribute to the outcomes. In spite of these controversies, report cards are gaining increasing favor in Canada and elsewhere as a method to respond to the strong demand for public accountability and improved quality of care by stakeholders, including the public, the media and policymakers. The Romanow Commission has called for the addition of accountability as a new pillar of the Canada Health Act and for regular reporting on the quality and performance of the health care system. (23)
Critical Pathways
These are management plans that display goals for patients & provide the corresponding ideal sequence & timing of staff actions to achieve optimal efficiency under a specific medical condition (24). Critical pathways have grown in use initially as a means of reducing hospital length of stay. However, they offer a unique opportunity to raise the standard of care at institutions, while at the same time to include all the appropriate tests and treatments for patients. In this fashion, they serve as a readily available guide to the clinician when treating the patient. They also may serve as a means of improving compliance with current guidelines for treating patients. The evolution of such pathways is just beginning and evidence is not yet available regarding their usefulness, but research is ongoing to evaluate the patient outcomes.
Disease-Management Programs
Heart failure (HF) is a complex clinical syndrome that can result from any structural or functional cardiac disorder that impairs the ability of the ventricle to fill with or eject blood. The cardinal manifestations of HF are dyspnea and fatigue, which may limit exercise tolerance, and fluid retention, which may lead to pulmonary congestion and peripheral edema. It represents a major and growing public health problem. Since there are no data documenting the national impact of this disease in Saudi Arabia, the following figures are related to the United States and have been used as an example to reflect the serious impact of this syndrome on the health care of cardiac patients. Approximately 5 million patients in the United States have HF, and over 550 000 patients are diagnosed with HF for the first time each year (1). The disorder is the primary reason for 12 to 15 million office visits and 6.5 million hospital days each year (2). From 1990 to 1999, the annual number of hospitalizations has increased from approximately 810 000 to over 1 million for HF as a primary diagnosis and from 2.4 to 3.6 million for HF as a primary or secondary diagnosis (3). In 2001, nearly 53 000 patients died of HF as a primary cause. The number of HF deaths has increased steadily despite advances in treatment, in part because of increasing numbers of patients with HF due to better treatment and "salvage" of patients with acute myocardial infarctions (MIs) earlier in life (1). Heart failure is primarily a condition of the elderly (4), and thus the widely recognized "aging of the population" also contributes to the increasing incidence of HF. The incidence of HF approaches 10 per 1000 population after age 65 (1), and approximately 80% of patients hospitalized with HF are more than 65 years old (5). Heart failure is the most common Medicare diagnosis-related group (i.e., hospital discharge diagnosis), and more Medicare dollars are spent for the diagnosis and treatment of HF than for any other diagnosis (6). It has been estimated that in 2005, the total direct and indirect cost of HF in the US will be equal to $27.9 billion (1).
Health Care Report Cards
The modern era of "scorecard cardiovascular medicine" began in the early 1990s (7). A well-known example, initiated in 1991, involved the publication of hospital and surgeon-specific report cards on in-hospital mortality after coronary artery bypass graft (CABG) surgery in New York State. The publication of this information stimulated quality improvement initiatives in several New York hospitals, and was associated with a 41% decline in the risk-adjusted in-hospital mortality rate after CABG surgery (from 4.14% to 2.45%) (8). Critics have charged that the mortality rate decline was, in part, the result of avoidance of high-risk patients and "gaming" of the data by involved physicians (9,10). Other researchers have noted that CABG mortality rates were also declining in jurisdictions that had not instituted public reporting systems (11). However, subsequent studies by Duke University researchers documented that mortality rates after CABG surgery declined fastest in New York State with its public reporting system and Northern New England with its confidential data feedback program (12). There are conflicting studies as to whether patients preferentially migrated to low-mortality hospitals and surgeons in New York State (13, 14). Report cards on hospital-specific AMI mortality rates have been developed in several jurisdictions including the United States (California, Pennsylvania), Scotland and Sweden (15-18). These report cards have all been generated using routinely collected hospital discharge administrative data. Critics have questioned the accuracy of these administrative data, the quality of the risk-adjustment methods, the lack of associated process of care data, the timeliness of the data, and the level of disclosure (which has been physician-specific in some jurisdictions). (18-20) The impact of these report cards on quality improvement activities appears to be limited, although few evaluative studies have been done. (21, 22) Most AMI report cards have reported solely on AMI outcomes, rather than on the processes of care that contribute to the outcomes. In spite of these controversies, report cards are gaining increasing favor in Canada and elsewhere as a method to respond to the strong demand for public accountability and improved quality of care by stakeholders, including the public, the media and policymakers. The Romanow Commission has called for the addition of accountability as a new pillar of the Canada Health Act and for regular reporting on the quality and performance of the health care system. (23)
Critical Pathways
These are management plans that display goals for patients & provide the corresponding ideal sequence & timing of staff actions to achieve optimal efficiency under a specific medical condition (24). Critical pathways have grown in use initially as a means of reducing hospital length of stay. However, they offer a unique opportunity to raise the standard of care at institutions, while at the same time to include all the appropriate tests and treatments for patients. In this fashion, they serve as a readily available guide to the clinician when treating the patient. They also may serve as a means of improving compliance with current guidelines for treating patients. The evolution of such pathways is just beginning and evidence is not yet available regarding their usefulness, but research is ongoing to evaluate the patient outcomes.
Disease-Management Programs
The disease-management approach views HF as a chronic illness that spans the home as well as outpatient and inpatient settings. Most patients have multiple medical, social, and behavioral challenges, and effective care requires a multidisciplinary systems approach that addresses these various difficulties. Heart failure disease-management programs vary in their content, but in general, they include intensive patient education, encouragement of patients to be more aggressive participants in their care, close monitoring of patients through telephone follow-up or home nursing, careful review of medications to improve adherence to evidence-based guidelines, and multidisciplinary care with nurse case management directed by a physician. High-risk patients have usually been chosen for such programs. Observational studies and randomized controlled trials have shown that disease-management programs can reduce the frequency of hospitalization and can improve quality of life and functional status (25, 26). Patients at high risk for clinical deterioration or hospitalization are likely to benefit from disease-management programs and represent those for whom such interventions are most likely to be cost-effective (27). The largest successful randomized controlled trial of disease management targeted elderly patients who had been hospitalized for HF, had a prior history of HF, had 4 or more hospitalizations within 5 years, or had an HF exacerbation caused by an acute MI or uncontrolled hypertension (28). Patients randomized to the disease-management program had significantly fewer hospitalizations and a reduced cost of care compared with patients in the control group. However, it is not clear which elements of disease-management programs are crucial for success. In addition, it is not known whether such interventions are feasible in settings with limited resources and personnel and among diverse patient populations. The European Society of Cardiology (ESC) guidelines recommended that the disease management program for HF patients includes the following elements (29):
█ Team approach
█ In-hospital and out-hospital care
█ Discharge planning
█ Education and counseling strategies, which focus on promoting self-care & teaching behavioral strategies
█ Optimizing medical therapy
█ Prescribing flexible diuretic regimen
█ Directing close attentions to clinical deterioration
█ Providing vigilant follow-up, and enhancing access to health care
The Heart Ejection Assessment Registry Trial in Saudi Arabia (HEARTS) is a registry database that is aimed to assist in reducing the gap between research and practice and to hence improving the quality of cardiac care for all patients with heart failure in Saudi Arabia.