Outcomes in cardiopulmonary rehabilitation.

Key Words: Cardiopulmonary, Management, Measurement, Outcomes.

A well-developed and well-implemented system of outcome assessment for cardiopulmonary rehabilitation can provide valuable information, which will identify the most effective and efficient methods of delivery of this intervention. This article begins with definitions and a discussion of the domains of outcome measures. Results of published outcome studies in cardiac and pulmonary rehabilitation are summarized, followed by a discussion of what outcome data should be assessed. Outcome management is then addressed, followed by suggestions of how these data, when analyzed, can be used to improve the long-term outcomes after cardiopulmonary rehabilitation.

The lack of evidence of decreased mortality or reversal of disease progression may have led to the underutilization of cardiac and pulmonary rehabilitation as an intervention.[1] Mortality and morbidity, although important, are no longer the only primary indicators of outcome. Quality of life (QOL) is also of importance because it represents the multifactorial, functional effect of an illness and the consequent therapy upon a patient, as perceived by that patient.[2] As more and more studies have been published, many of which have demonstrated a decrease in symptoms,[3,4] an improvement in disease management,[5,6] and an enhanced QOL,[7-9] the positive outcomes resulting from this intervention have become recognized.

One definition of outcomes is "those changes, either favorable or adverse, in the actual or potential health status of persons, groups, or communities that can be attributed to prior or concurrent care."[10] Health status, in this context, is a measure of overall functional status and well-being. Confounding the impact that can be attributed to cardiopulmonary rehabilitation intervention are numerous factors, which, in concert with the intervention, influence outcomes. This is illustrated in Figure 1, Iezzoni's model, the "Algebra of Effectiveness."[11]

To condense the myriad of outcomes that might be assessed, Green and colleagues[12] proposed a method that classifies outcomes as being in one of three domains: health, clinical, or behavioral. In this scheme, the health domain is a primary indicator of a health care intervention and includes variables such as morbidity, mortality, and QOL. These variables are affected by the secondary indicators, which comprise the clinical and behavioral domains. Physiological, psychosocial, and medical utilization indices, which clinicians routinely use, are within the clinical domain. The behavioral domain consists of patient behaviors that may need adapting, such as disease symptom management, diet, and smoking cessation. Although each domain has value, it is important to differentiate the health domain, a primary, global indicator of outcome that includes functional status, from the clinical and behavioral domains, which are secondary indicators of outcome that include traditional measurements of impairments.[13] The patient's beliefs, values, and judgments affect his or her perception of treatment. Figure 2[14] illustrates the complexity of these domains.

The Health Outcome Domain

Primary indicators of the health outcome domain are measures of morbidity, mortality, and QOL. Because morbidity and mortality occur with relative infrequency, their measurement requires large, multicenter, longitudinal designs, which are not feasible for most cardiopulmonary rehabilitation programs. Pooled data from randomized trials with patients participating in cardiac rehabilitation programs following myocardial infarction (MI) have documented a 20% decrease in cardiac and overall mortality over a 2- to 3-year follow-up period post-MI.[15] Additionally, a 37% decrease in sudden death has been reported in patients who participated in cardiac rehabilitation programs during the first year post-MI.[16] In 15 randomized controlled studies of patients in cardiac rehabilitation programs, there was no statistically significant reduction in morbidity related to nonfatal reinfarction.[1]

In a 10-year follow-up of a comprehensive pulmonary rehabilitation program for patients with severe chronic obstructive pulmonary disease, Sahn et al[17] found no improvement in mortality, but their study and other studies[18,19] have shown a decrease in frequency of hospitalization among patients enrolled in pulmonary rehabilitation programs, an important indicator of morbidity.

Quality of life, unlike morbidity and mortality, can be meaningfully assessed in most individual rehabilitation programs. This primary health indicator requires the patient's assessment of functional status, which the Report of the Society of General Internal Medicine Task Force on Health Assessment[20] conceptually defines as those everyday behaviors encompassing the areas of physical function, psychological well-being, and social functioning. The measure of physical function includes the patient's perception of abilities in self-care, mobility, physical activity, and communication. Self-esteem, thoughts of the future, feelings about personal relationships, and feelings about critical life events are important in measuring psychological well-being, and how the patient perceives his or her work and social performance, material welfare, and support from and participation with family and friends are indicators of social functioning. Measurement of QOL, a measure of disability rather than of impairment, has been proposed for physical therapists in both research and clinical practice.[13,21,22,]

Quality of life is among the most meaningful long-term benefits of pulmonary rehabilitation that have been reported.[3,8,17,18,23] Additionally, Oldridge and colleagues[7] reported improved QOL with comprehensive rehabilitation after acute MI. Although measures such as QOL are, by definition, very difficult to quantify, many valid and reliable tools, both general and disease-specific, that examine multiple areas of functional status are available. Descriptive information about a variety of tools for measuring QOL is listed in Table 1.[7,8,24-41]

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General QOL tools address issues related to the limitations in health status, whereas disease- or symptom-specific QOL tools address issues related to the clinical manifestations of a disorder. General QOL tools can be highly relevant to people with heart disease,[42,43(pp1-22)] although some disease-specific measures[7,24,34,35] have been designed to address selected changes unique to patients with cardiovascular disease, such as congestive heart failure or angina. A number of excellent pulmonary-specific QOL measures[8,36-39] have been developed that have the advantage of being directly applicable and responsive to patients in pulmonary rehabilitation programs. Dyspnea, because of its high incidence and impact on the QOL of people with pulmonary disease, has been a dimension measured by many of these tools.[44]

One tool that is used to assess one domain of QOL, physical functioning, is the New York Heart Association functional classification.45 This early, disease-specific scale continues to be used by clinicians to assess limitations of ability to perform physical activity applicable in a variety of cardiovascular diseases. The Specific Activity Scale' may be more precise and correlates well with measures of maximal oxygen uptake at exercise testing.[46] More recently, functional status evaluations have been developed,[47] some of which focus on specific patient groups such as elderly people[48] and people with chronic heart failure.[49,50]

Used alone, evaluations of one QOL domain do not address its multidimensional nature, and disease-specific measures do not allow comparison with patients who have other chronic diseases. Therefore, researchers and clinicians may desire to complement the use of uni-dimensional or single-perspective tools with a measure of general life quality.[42,51]

The Clinical Outcome Domain

Due to the influence of the medical model, rehabilitation programs have traditionally tended to focus on outcomes that are easily quantified, accurate, and easily statistically analyzed and interpreted,[52] such as the maximum work load achieved during a graded exercise test. For assessment of the patient's status, I contend that the clinician should also use physical, psychological, social, and medical utilization measures.

Physical Measures

Physiologic measures such as results of laboratory tests, angiographic studies, pulmonary function tests, and graded exercise tests, as well as functional capacity evaluations at home and at work, should be addressed in the assessment of the physical status of the patient because they affect the primary indicators of health status. In cardiac and pulmonary rehabilitation, the standard for evaluating functional capacity is the graded exercise test, as measured on the treadmill, on a cycle ergometer, or during a timed walk.[53-57] This test provides information for assessing the safety of exercise and for developing an exercise prescription.[53] Functional capacity is a clinical measure of impairment that contributes to, but should not be confused with, functional status, a more global and primary health outcome.

Because a conceptual barrier to evaluating functional capacity is the interrelationship between its physical, mental, social, and emotional components,[42,58] I contend that functional capacity is best evaluated in combination with a QOL tool that assesses the patient's perceptions of physical well-being.[13,24]

Benefits demonstrated in randomized, controlled clinical trials of patients in cardiac rehabilitation programs include improved work capacity,[59,60] with the best results reported, as might be expected, among the patients who are male, healthy, and young and have less myocardial damage.[61] In spite of the small changes in exercise capacity demonstrated in patients in cardiac rehabilitation programs who are severely limited or elderly, increases to four or five metabolic equivalents can provide this group with the ability to maintain independence and provide their self-care.[6]

Although it has been generally accepted that the improvement in exercise capacity is due to peripheral adaptations,[62] reports indicate that for some patients post-MI, a 1-year moderate- to high-intensity training program can elicit adaptations that may well be due to improved coronary blood flow,[63] improved left ventricular function,[64,65] or ventricular remodeling.66 Improved heart rate, blood pressure response, myocardial oxygen uptake, and maximum cardiac output also have been reported in participants of cardiac rehabilitation programs.[67]

Another clinical outcome of cardiac rehabilitation programs is secondary prevention and regression of atherosclerosis.[68-71] Hedback and associates[72] reported that improved coronary risk-factor profiles resulting from cardiac rehabilitation contributed to higher survival rates. In another study,[68] regression of atherosclerotic lesions was documented by angiography following intensive physical exercise in group training sessions, daily home exercise periods, and an aggressive low-fat, low-cholesterol diet.

Although positive changes have been seen on submaximal exercise tests in patients engaging in pulmonary rehabilitation,[3,18,19,23,73-81] no changes have been demonstrated on maximal exercise tests.3,23,74 These positive outcomes may be attributed to improved exercise ability, increased motivation, desensitization to dyspnea, and improved pacing,[5] the primary goals in most comprehensive pulmonary rehabilitation programs.

Findings of clinical outcome studies reported in the literature on patients in cardiac and pulmonary rehabilitation programs are summarized in Table 2.(*) Clinical outcomes that are important in secondary prevention should be monitored in patients with cardiac and pulmonary disease. Some examples include dyspnea, blood pressure, lipid levels, and exercise capacity.

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Psychological Measures

Because studies have shown that depression,91 low morale, and distress are predictors of mortality among patients post-MI[92-94] and that depression is so prevalent among patients with pulmonary disease,[95-98] in many cardiac rehabilitation programs these elements are monitored. Yet, although positive psychosocial effects have been reported in the literature for patients in programs of cardiac rehabilitation[7,99-101] and pulmonary rehabilitation,[3,9,17,18] this information is not routinely measured in rehabilitation programs.[1,102] In a recent study by Jette and Downing,[42] a strong relationship was found between psychological impairments and the health status of patients enrolled in cardiac rehabilitation programs. The report concluded that clinicians should identify both the psychological and physical impairments of their patients in order to comprehensively address the patients' health requirements.

Although there are good tests for measuring specific areas of distress, such as depression,[103,104] hostility,[105] or anxiety,[106] global tests of psychological functioning[107,108] may be preferred because a single test that measures multiple areas of distress may be easier on the respondent and the staff.

Table 3[40,43(pp170-183),103-115] describes some instruments for measuring psychological outcomes.

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In many rehabilitation programs, a licensed psychologist provides consultation in decisions regarding the selection and assessment of these measures of outcome and is available for supervision of psychological testing. Some psychological tests require a psychologist to administer, and many of these tests require a psychologist to interpret.

Social Measures

Social changes among patients in rehabilitation programs are common, with patients frequently experiencing changes in social relationships, sexual functioning, and vocational status.[56,116-120] Usually, the patients with cardiac and pulmonary disease must reevaluate roles and responsibilities in the home, in the workplace, and in interpersonal relationships. Marriage, in particular, plays an important role in psychosocial functioning in patients in rehabilitation programs.[121-123] The Marriage Adjustment Scale[124] and the Medical Outcome Study (MOS) Social Support Survey[125] are two instruments developed to measure change in social role functioning.

Medical Utilization Measures

Medical utilization indices provide an indirect measure of cost. Unlike a direct measure, such as the annual cost of providing the intervention, indirect measures of cost include time lost from work, decreased productivity while at work, or medical resources expended related to an intervention.

Decreased rehospitalization and total medical costs and an increased rate of return to work have been shown for those people who have participated in cardiac rehabilitation programs.[4,82-85,126-130] Few controlled studies have been published in this area for patients enrolled in pulmonary rehabilitation programs,[131,132] although improved disease and symptom management should be rewarded with fewer emergent-care visits and hospitalizations.[133,134]

The Behavioral Outcome Domain

Making and maintaining healthy lifestyle changes is a goal in cardiac and pulmonary rehabilitation programs. It is important, therefore, to assess behaviorally based interventions. These interventions include smoking cessation, diet management, stress management, and interventions aimed at improving compliance rates with medication use, exercise, and diet. Although research has shown the benefits of modifying a person's lifestyle,[70,135-139] most people find it difficult to discard lifelong habits and replace them with unfamiliar practices.[140]

Adherence to behavioral interventions is usually assessed by self-report. Many of the techniques known to chart adherence in one area may be used to monitor and assess patient success in other areas of needed behavioral change. These techniques may include having patients maintain diaries or daily or weekly logs or interviewing patients in person or by phone. The most sophisticated instruments for measuring behavioral change have been developed for assessing adherence to dietary interventions. These instruments include the Diet Habit Survey,[141] the Harvard-Willett Food Frequency Questionnaire,[142] and Block's Food Questionnaire.[143]

Selection of Outcome Data to Monitor

In selecting what outcome data to monitor, clinicians first determine for whom the data are needed. Many parties have a vested interest in the information. These parties include the patient, the family, the employer, the payer, clinicians, and managers, as well as groups of patients with a particular diagnosis, members of professions, insurers and managed care organizations, and the federal government.

The perspective of the interested parties should be considered when selecting the data that will provide them with meaningful information. Physical therapists have worked hard to establish norms for clinical documentation,[144-146] not only for risk management but also for communicating with physicians and other clinical associates. Additionally, monitoring patient satisfaction has long been accepted as essential to good practice management and has been expanded to include all interested parties.[147-150] Assessment of satisfaction has often been limited to evaluating service delivery, such as timeliness, courtesy, and comfort, rather than being a more comprehensive evaluation of the outcome of the service provided.[151] Patients in cardiac and pulmonary rehabilitation programs generally enjoy their program, the companionship of other patients, and the support of staff.[152,153] Even though endurance and work capacity generally improve with participation in exercise programs,[53] current health care providers and consumers demand further measures of outcome that will document the efficiency and effectiveness of the intervention.

Examples of outcome information frequently requested are cost, which is important to management, employers, payers, government, and patients; functional well-being, which is important to patients, family, employers, and clinicians; physiological response, which is important to clinicians, managers, and diagnostic groups; and return to work, which is important to patients, family, and employers.

Although many outcomes of cardiac and pulmonary rehabilitation have been discussed, it is the clinician's responsibility to determine what can be measured. By measuring and evaluating at least one variable in each domain (one health outcome domain variable, one clinical outcome domain variable, and one behavioral outcome domain variable), information on meaningful outcomes should, in my opinion, be available to all interested parties. An example of data required for the assessment of patient outcomes is presented in Table 4.57

Outcome Management

One definition of outcome management is "a way to help patients, payors, and providers make rational medical care-related choices based on better insight into the effect of these choices on the patient's life."[154(p1551)] Although outcomes cannot be managed directly, clinicians can influence outcomes by managing the process of care delivery, such as assessment, diagnosis, and treatment.[155] The challenge is to improve the "clinical value ... the clinical, functional, and satisfaction outcomes achieved in relationship to the costs incurred for care of a patient, or a population of patients, over a period of time."[155(p9)]

Ellwood[154] described four steps in outcome management: (1) development of standards and guidelines, (2) routine, widespread measurement of disease-specific clinical outcomes and patient functioning and well-being, (3) collection of clinical and outcome data on a massive scale, and (4) analysis and dissemination of findings from a continually expanding database.

With publication of the Guidelines for Cardiac Rehabilitation Programs in 1991,[156] followed by a second edition in 1995,[57] and the American Heart Association's Statement for Healthcare Professionals on Cardiac Rehabilitation Programs,157 the American Thoracic Society's Standards for the Diagnosis and Care of Patients With Chronic Obstructive Pulmonary Disease (COPD) and Asthma,[158] and the Guidelines for Pulmonary Rehabilitation Programs in 1993,[56] standards of care for these fields were established. These publications describe the important components of rehabilitation services and suggest methods for their implementation. Both the Guidelines for Cardiac Rehabilitation Programs and the Guidelines for Pulmonary Rehabilitation Programs address outcome measurement. Other than these publications, the primary standards available to practitioners have been in the form of exercise testing and training guidelines.[53,55 159,160]

In 1992, the Agency for Health Care Policy and Research contracted for the development of a clinical practice guideline on cardiac rehabilitation to define the scientific basis for recommendations for provision of cardiac rehabilitation services.[1] An expert multidisciplinary panel of health care providers and consumers were assembled to assist in developing the clinical practice guidelines. They represented a diversity of health care specialties, including clinical and academic cardiology, internal medicine, family practice, nursing, behavioral science, nutrition, physical therapy, and exercise physiology, as well as patients and family members. After an extensive literature search that included review and evaluation of the evidence and outcomes of cardiac rehabilitation, the guideline was published in October 1995. It is designed to guide clinical as well as administrative decision making regarding the provision of cardiac rehabilitation services.[1] Further, a companion piece[161] was developed to guide consumers in making choices related to their recovery from heart problems through cardiac rehabilitation. This type of nationally recognized clinical practice guideline has not yet been produced for pulmonary rehabilitation.

The American Association of Cardiovascular and Pulmonary Rehabilitation established a committee on outcomes, whose goal is to promote the use of standardized, valid, and reliable measures.[162] As chair of this committee, I have found that although interest has been widespread, application and use of outcome measures has not occurred. Although most cardiac and pulmonary rehabilitation programs have some of the needed data in records, few clinicians have taken the initiative or incurred the cost of compiling the information into a database for reporting the outcomes. Furthermore, there is no widespread collection of clinical and outcome data in cardiopulmonary rehabilitation.

In rehabilitation, a formal outcome measurement system has been used for a number of years--the Functional Independence Measure (FIM).[163] The Uniform Data System for Medical Rehabilitation collects FIM data, and these data allow subscribers to evaluate and compare their outcomes with those of other facilities. Although the FIM is the predominant measure used in physical rehabilitation in the United States and Canada, only occasional subscribers have reported outcomes of patients with cardiac or pulmonary diagnoses.[164]

Managers of cardiac and pulmonary rehabilitation programs who have access to analyzed findings from databases can find information for program evaluation, "benchmarking," quality improvement, cost-efficiency, and cost-effectiveness. The aggregated data collected can serve as information for program evaluation--the accountability system that qualitatively and quantitatively measures outcome achieved compared with outcome projected.

Through networking, rehabilitation programs that share aggregate data will be able to compare their own performance with that of their peers. As subgroups begin to utilize similar measurement tools, comparative outcome data can be collected for "benchmarking," a process of evaluating a similar organization's data in order to compare the data with one's own data and thereby improve one's own service. By analyzing the pooled outcome data, protocols can be changed or refined, alternative interventions can be developed, and standards for quality can be established. These steps are the key to quality improvement, but first the quality of the data must be assessed to determine whether the data meet minimal measurement standards.

Proactive program managers can examine outcomes achieved in relation to both outcomes expected and total resources expended. Resources expended can be defined as the true cost of the rehabilitation intervention and therefore include staff salaries, equipment, supplies, and facility overhead. Charges can be converted to true costs by utilization of the institutional cost/charge ratio. Where possible, I contend, data collection should include costs for the rehabilitation intervention, dropout rates, rehospitalization rates, return-to-work rates, and a QOL or functional status measure for determination of cost per effect, or cost-effectiveness. Cost-efficiency can be estimated by determining the cost per treatment unit.

This type of economic analysis enables comparison of the costs and benefits of cardiopulmonary rehabilitation with other means of treatment or with no treatment. Those who pay for services increasingly expect to have this information prior to approving referrals and setting reimbursement rates.

Outcome information should serve as the basis of strategic planning and market positioning and should be made available for use by management, clinicians, finance, marketing, payers, and patients--everyone with a vested interest in effective health care management.

Conclusion

Before a system for assessing cardiopulmonary outcomes is established, whether the measurements Will meet a minimal level of acceptance should be considered. The selection, measurement, and interpretation of data will then require ongoing scrutiny and discussion--to improve the svstem's procedures and their usefulness and to develop confidence that the available data truly reflect the outcomes.[144]

The results of this ongoing process can provide a primary means for evaluating the effectiveness and efficiency of this intervention for the individual, for subsets of patients within individual rehabilitation programs, and for large groups of patients. Resulting information can prove invaluable for the quality of care provided to the patients.

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