In 1995, the American Association of Cardiovascular and Pulmonary Rehabilitation (AACVPR) published its initial position statement on the value and rationale for measuring patient outcomes in cardiac and pulmonary rehabilitation programs.1 Subsequently, the AACVPR Outcomes Tools Resource Guide was published,2 with an updated AACVPR Web site revision produced in 2002.3 As outcome measurement has now become a standard in cardiac1–10 and pulmonary rehabilitation,5,11–15 a number of AACVPR affiliate societies16–23 have developed and implemented registries for the collection and analysis of outcome data. In 2007, the American Heart Association (AHA), American College of Cardiology (ACC), and AACVPR co-published evidence-based scientific statements stressing the importance of documenting patient outcomes and program performance measures within the core components of care reflecting progress toward patient goals.6,7
Outcome measurement is essential for optimal short- and long-term monitoring of patient progress, quality assurance, and overall program effectiveness. Standardization of measures is also critical for data comparisons across programs for benchmarking purposes. In 2004, the AACVPR published a consensus statement on outcomes4 with a specific focus on the Health, Clinical, Behavioral, and Service domains (Table 1) and processes to track these measures within the components of care of the Outcomes Matrix.5 Unfortunately, there continues to be variability in the definition, interpretation, and calculation of outcome parameters. The purpose of this statement is to define and give examples for measuring selected patient outcomes within 1 of these domains—the behavioral domain. This information is applicable to both cardiovascular and pulmonary rehabilitation programs and should assist program staff to better understand, define, and track various behavioral outcome measures. As we move toward consistency in measurement processes, the presentation of outcome data will become clearer and the interpretation more valued by physicians, healthcare administrators, and third-party payers.
THE BEHAVIORAL DOMAIN
Outcomes within this domain are individualized and reflect patient self-reported behaviors, self-efficacy, knowledge, adherence to medical and behavioral therapies, and lifestyle modifications. These outcomes are typically measured through the use of standardized questionnaires, surveys, patient logs and diaries, or by observations from the staff. Examples of Behavioral domain outcome measures are presented in Table 2. This statement addresses 5 behavioral outcome measures: smoking cessation, medication adherence, adherence to supplemental oxygen, exercise habits, and nutritional habits. These specific examples of behavioral outcomes were chosen because they are representative of behavioral changes that (1) are significant to health and well-being, (2) are universally addressed in cardiopulmonary rehabilitation programs, and (3) may be objectively measured. Although other behavioral outcomes can be used to describe behavioral changes, the authors believe that those defined here can be commonly used by program staff to demonstrate the level of achievement of both personal and program goals and thus define a level of success toward behavioral modification. In discussion of these measures, sample questions are presented for cardiac and pulmonary rehabilitation practitioners to use at program entry, program completion, and each follow-up evaluation. In addition, equations for calculation of these measures are also presented (Appendix). It should be noted that the suggested measurements, sample questions, Likert-type scales, and calculations provided in the appendix are only examples and should not be interpreted as mandatory measures for program adoption.
Participants who enter cardiac and pulmonary rehabilitation programs are frequently current smokers who have only recently stopped using tobacco as a result of a recent hospitalization. However, others may be former smokers who have abstained from tobacco for various lengths of time (eg, weeks, months, years). Regardless, similar to many behaviors, the decision-making process to abstain from tobacco and remain tobacco-free occurs within a continuum of stages. This continuum, “the transtheoretical model of change,” has shown that individuals move through a series of 5 stages of change (precontemplation, contemplation, preparation, action, and maintenance) in the adoption of healthy behaviors or cessation of unhealthy ones.24 Determining patient readiness to change is included as a recommendation in the 2007 Core Components of Cardiac Rehabilitation/Secondary Prevention 6 and the 2006 Guidelines for Secondary Prevention.8 A useful source of validated tools used in the clinical setting for smoking cessation is the Clinical Practice Guideline: Treating Tobacco Use and Dependence.25
Adapted from statements from the AACVPR, ACC, and AHA,6–8 the following classification scheme should aid the healthcare practitioner in describing the status of patient tobacco use:
- Never smoked: The patient has never used tobacco products.
- Former smoker: The patient has not used tobacco products within the past 12 months.
- Current smoker: The patient is currently using tobacco products or has used tobacco products within the past 12 months.
Those who are categorized as “former” or “current” tobacco users should be targeted for treatment strategies associated with continued tobacco avoidance or complete cessation at program discharge or by the next follow-up evaluation.8 Smoking recidivism is particularly high within the first year of quitting, hence, the importance of classifying both “former” and “current” smokers.7,9 Tobacco use status can also be determined through clinical measures such as blood or urinary cotinine levels and exhaled carbon monoxide, but these measures may not be available in many rehabilitation programs. Self-reported measures of tobacco use are more commonly used in rehabilitation programs (Appendix).
Ideally, tobacco use should be assessed at every program or office visit, advising the patient to quit if there is continued use, particularly during the first 2 weeks of cessation. During these visits, tobacco cessation follow-up, referral to special programs, or pharmacotherapy may be discussed.7–9,25 The success of tobacco avoidance strategies can be characterized by the percentage of former or current tobacco users identified at program entry who remain tobacco-free or who quit during cardiac or pulmonary rehabilitation intervention (Appendix).
Environmental exposure to tobacco smoke should also be assessed for every program participant. Environmental smoke exposure includes unintentional exposure to smoke generated from cigarettes, cigars, or pipes and is defined as follows:
- Current exposure: The patient is currently exposed to environmental tobacco smoke at home, at work, or in recreational settings or has been exposed within the past year.
- Former exposure: The patient has a history of significant exposure to environmental tobacco smoke at home, at work, or in recreational settings but not within the past year.
The goal for each participant is to have no exposure to environmental tobacco smoke in any instance.8,9
Cardiac and pulmonary rehabilitation practitioners should regularly and systematically assess patient medication adherence. Assessment of adherence to medication therapy is a frequent component of the evaluation process defined in the core components and performance measures of cardiac and pulmonary rehabilitation programs.6,7,9,14 There are several objective methods for evaluating adherence to medical therapy.26 Pill counts, electronic pharmacy monitoring, and measurement of serum levels of drugs can be used, although the latter may not be practical in cardiac and pulmonary rehabilitation settings. Standardized questionnaires such as the Medication Adherence Report Scale27,28 and the Drug Attitude Inventory29 are available, but these are valid only in specific clinical populations and have not been validated in cardiac or pulmonary rehabilitation patients.
Probably, the most practical method for assessing medication adherence is by patient self-report, whereby the patient is questioned directly.30 At the initial evaluation, each patient should provide a list of current medications (or the medication containers) and the purpose of each medication. Gaining assistance from the patient's spouse or family member can also be helpful for more accurate reporting of this behavioral outcome. Questions about adherence should be framed in a nonjudgmental way. For example, the staff may begin by saying: “People often have difficulty taking their pills for one reason or another.” They may then ask: “Have you missed any pills in the past week?”31 or “Have you had any difficulty in taking your pills as prescribed in the past week?” The outcome measure is the number of pills missed during the past week with the goal of 100% compliance. One or more missed doses signals possible decreased adherence and warrants interventions at improving medication compliance.
Because validated questionnaires are limited, a simple scale can be created that denotes the percentage of time medications are taken as prescribed, from 0% (“Not taking as prescribed at any time”) to 100% (“Taking as prescribed 100% of the time”). Another example would be a 5-point Likert-type scale where medication adherence is measured as follows: “0” = never, “1” 5 rarely, “2” 5 sometimes, “3” 5 often, and “4” 5 always. Patients are asked to describe how often they take their medications as prescribed by their doctors. To track improvement or decline over time, changes in medication adherence are calculated by dividing the difference in scores from 1 assessment to the next by the initial score expressed as a percentage (Appendix). Nonadherence is generally defined as following the prescription less than 80% of the time.32 Other techniques for monitoring medication adherence may exist, and the best method for monitoring this patient outcome should be determined by the program medical director and staff.
Adherence to Supplemental Oxygen Use
Supplemental oxygen usage is a behavioral outcome measure characterized by the degree of adherence to oxygen use as prescribed by the physician for patients who use oxygen during supervised cardiac and pulmonary rehabilitation exercise sessions. Patients prescribed oxygen should be frequently assessed for knowledge of its use, appropriate setup and delivery via mask or cannula, and appropriate flow rates at rest and during exercise. Determining changes in absolute oxygen usage expressed as liters per minute, flow rate, or percentage of oxygen delivered via a mask device such as a partial-or non-rebreather for a given cohort of patients is often difficult to quantify because oxygen requirements may vary throughout the course of cardiac or pulmonary rehabilitation. Moreover, patients with different types of restrictive and obstructive lung diseases, for example, cystic fibrosis and idiopathic pulmonary fibrosis, may have their own individual characteristics of oxygen use, making across the board comparisons in oxygen use increase or decrease difficult, if not impossible. Thus, it may be practical to track oxygen usage only across patient subgroups over time.
Nonetheless, there are methods to track patient adherence with supplemental oxygen usage. One example is by asking specific questions that focus on patient adherence at program entry and again at program discharge or follow-up, such as: “On a scale of 0–4, where “0” = never, “1” = rarely, “2” = sometimes, “3” = often, and “4” = always, how often do you use your oxygen as prescribed by your physician?” As with medication adherence, tracking change in supplemental oxygen adherence is calculated by dividing the difference between scores from one assessment to the next by the initial score and expressing as a percentage (Appendix).
Observations by program staff are particularly important in tracking this outcome properly. Examples of staff observations of oxygen usage are as follows:
- The patient uses supplemental oxygen properly at all times in the cardiac or pulmonary rehabilitation setting. (Yes/No)
If the answer is “No” to the above, the following 2 observations may be reported:
- The patient does not use supplemental oxygen properly upon arrival to the program.
- The patient does not use supplemental oxygen properly during or following exercise in the program.
Examples of improper oxygen use include failure to turn on the oxygen, failure to observe that the oxygen tank is near empty or empty, failure to appropriately adjust oxygen flow rate, improperly fitting the nasal cannula, and improperly filling the liquid oxygen dispenser from the reservoir. Overall program effectiveness in promoting individual proper oxygen usage can be determined by calculating the number of times a patient uses supplemental oxygen properly as prescribed divided by the number of attended exercise sessions. The resulting fraction is expressed as percentage of time that the patient adheres to oxygen use as prescribed by his or her physician (Appendix).
Adherence to proper exercise habits is defined as patient adherence to the prescribed level of daily or weekly exercise. To determine whether the patient is meeting the prescribed exercise goals for both the rehabilitation program and at home, program staff need to quantify exercise variables by using program data and patient home exercise logs. These logs should include the prescribed exercise duration (minutes/day), frequency (days/week), and intensity (low, moderate, or high exertion level indicated by the training exercise heart rate range, rating of perceived exertion, and/or rating of perceived dyspnea). The principles of overload, progression, and specificity must also be taken into account. Program practitioners are encouraged to use published guidelines as benchmarks to determine whether the patient is achieving prescribed daily or weekly exercise goals.33–36 Recommended levels of daily/weekly aerobic and resistive exercise for healthy adults, older adults, and cardiac and pulmonary rehabilitation populations are presented in Table 3.6–9,14,33–37
Exercise adherence may also be assessed through patient self-report, as provided by written surveys that include questions about home and/or fitness center exercise habits. There are a number of validated questionnaires that track physical activity such as the Dartmouth COOP Functional Health Assessment38 and the International Physical Activity Questionnaire.39 These surveys have been validated in older populations and may be applicable for use in cardiopulmonary rehabilitation programs. To track changes in physical activity habits from physical activity surveys such as these, scores from one recording time period may be compared with those from another to assess percentage improvement or decline in home exercise habits.
Two focus areas of exercise adherence that are particularly important include the number of days of exercise per week and the minutes of exercise per day. Example questions 1 and 2 in the Appendix are used at program entry, whereas questions 3 and 4 are used at program follow-up or at discharge. When tracking this outcome, it is important that program staff provide simple home exercise recording forms for ease of documentation by the patient. Examples and calculations for tracking exercise compliance for both individual patients and patients as a group are presented in the Appendix.
Nutritional assessment provides an estimation of food and nutrients eaten over a given period of time to determine patient nutritional habits, including present status and needs at program entry and periodically throughout program participation. Dietary patterns can be assessed through patient self-report or by using a standardized nutritional survey or dietary assessment tool. The goals of nutritional assessment are to (1) obtain estimates of total daily energy intake and dietary content of saturated fat, trans fat, cholesterol, sodium, and nutrients; (2) assess eating habits, including consumption of fruits and vegetables, whole grains, fish, and alcohol, number of meals/snacks, and frequency of dining out; and (3) determine target areas for nutrition intervention with regard to weight, hypertension, diabetes, heart failure, kidney disease, and other comorbidities.6,8 Expected outcomes include developing a dietary plan to reinforce adherence to a proper diet, education, and counseling on dietary goals. The patient should also understand basic dietary principles, including proper fat, energy, cholesterol, and nutrient intakes.6,8 Some commonly used tools to assess dietary status in cardiac rehabilitation are the Diet Habit Survey,40 the Northwest Fat Questionnaire,41 and the MEDFICTs Diet Survey.42,43 Three- and 7-day dietary recall and food records have also been used to estimate dietary nutrient intake. To our knowledge, a validated tool to assess nutritional habits in patients of pulmonary rehabilitation programs has not been published. However, given the detrimental effects of weight loss in pulmonary populations and the ever-increasing percentage of overweight and obese pulmonary patients, nutritional assessments are as valuable for this population as for those in cardiac rehabilitation or secondary prevention programs.14,44
In addition to assessing nutritional habits, it is also important to assess the degree of patient underweight, overweight, or obesity status to help with behavioral and weight management goal setting. Various clinical measures may be of value in this regard including height, weight, body mass index, and abdominal circumference. These can be measured at program entry and periodically throughout program participation for assessment of overall body composition changes and to help determine patient progress toward behavioral goals.6–8,14,45 Sample equations are presented in the Appendix by using the Diet Habit Survey39 scoring format to track individual and group improvements in dietary habits over time.
This AACVPR statement provides examples of various measures of the Behavioral domain within the Outcomes Matrix for cardiac and pulmonary rehabilitation clinicians. Example calculations for these measures should aid in the assessment of overall individual performance, program effectiveness, and quality improvement. Performance measurement and analysis of patient outcomes for program sustainability and quality requires consistent definitions within the Behavioral domain.
The authors thank Joy Reardon, RN, Denise Albert, RD, and members of the AACVPR Outcomes Committee for their helpful suggestions during the preparation of this article.
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Examples of Calculations for Behavioral Domain Outcome Measures
Tobacco use can be determined by asking patients if they are currently using tobacco products. If so, specific questions can be asked with regard to frequency and amounts. The percentage change in tobacco use is calculated as the difference in usage between pre- and post-assessments divided by the initial usage reported at the pre-assessment, and then expressed as a percentage. These calculations may be used for the individual patient or for patients as a group to gain an indication of the overall smoking success rate for a program during a particular time period.
A. Individual patient: Below are sample questions to assess the degree of tobacco use followed by a table showing the percentage decline from program entry to 12 and 24 weeks of program participation.
- How many days each week are you currently smoking or using smokeless tobacco?
- How many cigarettes, pipes of tobacco, cigars, or dips of smokeless tobacco do you currently smoke or use each day?
- How many times each week are you exposed to secondhand tobacco smoke at home, at work, or in your social settings?
B. Patient group: Twelve patients who smoked 7 days per week at program entry report that after 12 weeks in the rehabilitation program, they now smoke only an average of 4.6 days per week.
Assessment of the degree of readiness to quit using tobacco products (self-efficacy measure) may also be addressed and documented by asking the following sample question: “How willing are you to make a quit attempt?” Using a 5-point Likert-type scale, “0” could indicate “I am not ready to quit at this time” and “4” could indicate “I am ready to quit at this time.” For the former tobacco user, the following sample question could be asked: “How confident are you that you will remain tobacco free?” Using the same Likert-type scale format, “0” could indicate “I am not confident that I can remain tobacco-free at this time” to “4,” indicating “I am very confident that I can remain tobacco-free at this time.”
A. Individual patient (5-point Likert-type scale): When asked about medication adherence at program entry, a cardiac rehabilitation patient reports “3” (often) daily medication usage. After 16 weeks of program participation, the patient reports “4” (always) medication usage.
B. Patient group: Fifty-four of 60 patients in a cardiac rehabilitation program report “often” (“3” on the Likert-type scale) in taking their medications as prescribed at program entry. After 16-weeks of participation, 49 of these same 54 patients (the same cohort of patients must be used) report their medication adherence as “always” (“4” on the Likert-type scale).
Thus, after 16 weeks of cardiac rehabilitation intervention, 91% (49 of 54) of the patients followed showed an improvement of 33% in medication adherence. Six patients of the original 60 (10%) rated their medication adherence as “often” (“3” on the Likert-type scale) at follow-up and thus did not improve in medication usage from cardiac rehabilitation entry.
SUPPLEMENTAL OXYGEN USE
A. Individual patient (5-point Likert-type scale): When asked: “On a scale of 0–4, how often do you use your oxygen as prescribed by your physician?” a patient entering pulmonary rehabilitation reports “2” (sometimes). After 24 weeks of program participation, the patient reports “4” (always) to the same question.
B. Individual patient (exercise visits): A pulmonary rehabilitation patient attends 32 program sessions during the recording period of September 30 through December 31. During this period, supplemental oxygen was properly used on arrival into the program for 26 exercise sessions.
C. Patient group (exercise visits): Eighteen patients who routinely used supplemental oxygen during exercise attended a total of 606 pulmonary rehabilitation exercise sessions during the recording period of September 30 to December 31. During this time period, there were 502 sessions in which patients used supplemental oxygen properly during exercise.
A. Individual patient: Given below are sample questions followed by a table showing the exercise frequency and duration for a participant in a secondary prevention program entry and following 12 and 24 weeks of program participation:
- How many days per week were you exercising at home or in a fitness setting before having your cardiac or pulmonary event and entering the rehabilitation program (eg, walking, cycling, swimming)?
- How many minutes per day were you exercising, either at home or in a fitness setting, before having your cardiac or pulmonary event and entering the rehabilitation program (eg, walking, cycling, swimming)?
- How many days per week are you currently exercising at home or in a fitness setting such as the rehabilitation program (eg, walking, cycling, swimming)?
- How many minutes per day are you currently exercising at home or in a fitness setting such as the rehabilitation program (eg, walking, cycling, swimming)?
By 24 weeks of participation, this patient improved exercise adherence by 200% from the time of program entry.
B. Patient group: Thirty-six of 50 secondary prevention patients documented exercising at least 30 minutes each day at a moderate exercise intensity level (eg, within their prescribed training exercise heart rate and rating of perceived exertion levels) for at least 5 days per week during the recording period of April 1 to June 30.
Thus, 72% of patients met standards for exercise habits, eg, at least 30 minutes each day, at a moderate intensity level, for at least 5 days per week.
A Individual patient (Diet Habit Survey [DHS]) 40: A cardiac rehabilitation patient scored 148 on her entry DHS, indicating a 30% fat diet. After 12 weeks of rehabilitation intervention, she scored 206 on the follow-up survey, indicating a 25% fat diet.
Thus, this patient improved diet by 39% and decreased fat intake from 30% to 25% on the basis of DHS criteria.
B. Patient group: A total of 84 patients in cardiac rehabilitation completed the DHS at program entry and again after 16 weeks of program participation. The mean entry DHS score for the group was 111, indicating a 30% fat diet, whereas the mean 16-week DHS score was 200, indicating a 25% fat diet.
Thus, as a group, patients in the cardiac rehabilitation program improved DHS scores by 80%, improving from a 30% fat diet to a 25% fat diet following 16 weeks of the rehabilitation intervention.
Abbreviations: AACVPR, American Association of Cardiovascular and Pulmonary Rehabilitation; ACC, American College of Cardiology; ACSM, American College of Sports Medicine; AHA, American Heart Association; CCC, Council on Clinical Cardiology; CNPAM, Council on Nutrition, Physical Activity, and Metabolism; CR, cardiac rehabilitation; PR, pulmonary rehabilitation; reps, repetitions; USDA, United States Department of Agriculture; USDHHS, United States Department of Health and Human Services.