Psychometric evaluation of the Sinhalese version of MacNew Heart Disease Health Related Quality of Life Questionnaire in patients with stable angina.

BACKGROUND: A Sinhalese version of a validated, disease-specific patient-reported heart disease health related quality of life instrument is lacking. The purpose of this study was to validate the interviewer-administered Sinhalese version of the MacNew Heart Disease Health-related Quality of Life Questionnaire (MacNew) in patients with clinically diagnosed stable angina. METHODS: The Sinhalese translation of the MacNew was carried using standard forward- backward translation technique. In this validation study, the MacNew was administered to 200 patients with stable angina. Reliability was assessed by internal consistency and test-retest reliability. Construct validity was explored by exploratory factor analysis using principal component analysis and confirmed by confirmatory factor analysis using the robust maximum likelihood method and known group comparison. The correlation between compatible domain scores of MacNew and the World Health Organization's quality of life -brief questionnaire was used to assess concurrent validity. RESULTS: The original 3-factor model (Physical, Emotional and Social) of the MacNew with cross-loadings was confirmed: principal component analysis with 53.42 % of the explained variance and confirmatory factor analysis with adequate fit for each of the three model fit criteria considered [root mean square error of approximation = 0.044 (90 % CI = 0.031 to 0.056); comparative fit index = 0.99; χ(2)/df = 1.39]. Internal consistency of the MacNew was acceptable with Cronbach's α of 0.92 on the Global scale and on the domain scales ranging from 0.85-0.91. Test-retest reliability was also found to be satisfactory with intraclass correlation coefficients of >0.9 for total and domain scores. A satisfactory level of concurrent validity was demonstrated with statistically significant correlations between compatible domain scores of MacNew and the World Health Organization's quality of life questionnaire (Pearson correlation ranging from 0.36-0.79). CONCLUSIONS: The interviewer-administered Sinhalese MacNew is a valid and reliable patient-reported outcome measure to assess disease specific health-related quality of life among Sinhalese patients with stable angina.

Translation and validation of two Chinese health-related quality of life instruments in patients with coronary heart disease.

1. The Chinese version of the 27-item MacNew health-related quality of life (HRQL) questionnaire is a valid, reliable and responsive core coronary heart disease (CHD)-specific HRQL measure. It can be used to compare the health outcomes, burdens of illness, and treatment effectiveness in pure or mixed populations of patients with myocardial infarction, angina, or heart failure in clinical trials and in routine clinical practice. 2. The Chinese version of the 35-item Myocardial Infarction Dimensional Assessment Scale (MIDAS) did not perform as well. Although four of the seven subscales, which cover the physical and psychosocial aspects of HRQL, are psychometrically sound when used to evaluate HRQL among CHD patients with different cardiac diagnostic categories, the remaining three subscales covering treatment-related aspects are not. The latter had only weak validity and responsiveness, which may be due to cultural differences. 3. To improve the overall performance of the Chinese version of the MIDAS, further effort is required to clarify the treatment-related impact of CHD on well-being from the patient's perspective.

Economic burden of physical inactivity: healthcare costs associated with cardiovascular disease

Increasingly important objectives for developed and especially for developing countries include increasing the numbers of individuals who do not smoke, who eat healthy diets and who are physically active at levels that are health enhancing. In developing countries, deaths from chronic disease are projected to increase from 56% of all deaths in 2005 to 65% by 2030 (driven largely driven by deaths due to cardiovascular and coronary heart disease); in developed countries, however, the increase is only from 87.5 to 88.5%. The data on physical inactivity presented in this review were derived primarily from World Health Organization (WHO) publications and data warehouses. The prevalence of physical inactivity at less than the levels recommended for enhancing health is high; from 17 to 91% in developing countries and from 4 to 84% in developed countries. In developed countries, physical inactivity is associated with considerable economic burden, with 1.5–3.0% of total direct healthcare costs being accounted for by physical inactivity. Other than on some exciting work in Brazil, there is little information on the effectiveness and cost-effectiveness of physical activity-enhancement strategies in developing countries. The WHO has signaled a shift from the treatment of illness to promotion of health, with an emphasis on changing modifiable health-risk factors, including smoking, unhealthy diets and physical inactivity: the real question, especially for developing countries, is ‘what is the future healthcare cost of not encouraging healthier lifestyles today?’.

Health-related quality of life in patients with coronary artery disease treated for angina: validity and reliability of German translations of two specific questionnaires.

The German versions of two patient-perceived heart disease specific health-related quality of life (HRQL) questionnaires, the Seattle Angina Questionnaire (SAQ) and the MacNew Heart Disease questionnaire, were examined for their psychometric properties in patients with angiographically documented coronary artery disease and angina who were treated either medically or invasively and followed up for 1 year. Both HRQL questionnaires and the modified Canadian Cardiovascular Society (CCS) angina-associated disability scale were completed by 158 patients at baseline and 12 months later when they also completed a generic health status questionnaire, the SF-36. Both specific HRQL questionnaires were acceptable to patients. Three of the four MacNew scales, but none of the SAQ scales, discriminated between patients by baseline CCS disability levels I and IV. Internal consistency ranged from 0.75 to 0.94 for the SAQ and from 0.86 to 0.97 for the MacNew scales. Test-retest reliability over a 4-week period of time ranged from 0.45 to 0.81 for the SAQ scales and 0.61 to 0.68 for the MacNew scales. Over 12 months, HRQL improved (p < 0.001) on three of the five SAQ and on all four of the MacNew scales with the responsiveness statistic ranging from 0.59 to 1.55 for the SAQ and 0.86 to 1.12 for the MacNew. The 12 month scores on all SAQ and MacNew scales were significantly higher in patients who improved than those who deteriorated on the SF-36 reported health transition question. We conclude that the SAQ and the MacNew are both valid, reliable, and responsive in German, that the MacNew discriminates better between angina grades at baseline, that HRQL improves over 12 months with both measures, that the SAQ angina frequency and disease perception scales have the largest effect sizes, and that the 12-month change in HRQL with both instruments was associated with change in SF-36 reported health transition status.

Prevalence and outcomes of comorbid metabolic and cardiovascular conditions in middle- and older-age adults.

UNLABELLED: To estimate age group differences in the prevalence and outcomes of three common and often comorbid metabolic conditions (i.e., obesity, hypertension, and diabetes) and heart disease. DESIGN: Nationally representative prospective cohort study. SETTING: PARTICIPANTS' homes. PARTICIPANTS: 9825 adults aged 51 to 61 years (middle-age) in 1992, and 7370 adults aged 70 years and over (older-age) in 1993. MEASUREMENTS: Two-year dichotomous outcomes included: doctor visits, hospitalization, mobility difficulty, activity of daily living limitation, poor perceived health, and mortality. Odds ratios (OR) were adjusted for sociodemographic characteristics and history of cancer or lung disease. RESULTS: Those with one condition represented 80% and 70% of the middle- and older-age groups, respectively, while just 1-2% of each age group reported all three metabolic conditions. Thirteen percent and 32%, respectively, reported heart disease with or without metabolic conditions. Diabetes comorbid with other metabolic conditions, and particularly with heart disease, substantially elevated the risk of adverse outcomes such as health-related quality of life deficits, health services use, and mortality in both middle- and older-age adults. In the middle-age group, the OR was 6.81 for mortality in patients with a combination of obesity and diabetes and 6.10 in those with a combination of heart disease and diabetes. There also were significant ORs for mortality in middle-aged patients with heart disease (OR = 2.40), diabetes (OR = 2.63) and for those with a combination of obesity, hypertension, and diabetes (OR = 3.26). CONCLUSION: The impact of these often comorbid conditions underscores the importance of targeted and aggressive prevention, particularly among middle-age adults.

Determinants of exercise tolerance after acute myocardial infarction in older persons.

OBJECTIVES: Exercise tolerance is reduced with advancing age. Identification of potentially reversible determinants of the age-related decrement in exercise tolerance, which remain largely unexplored in older subjects and in patients recovering from a recent myocardial infarction (MI), may have useful therapeutic implications. The objective of this study was to identify the independent determinants of exercise tolerance in older patients with a recent MI. DESIGN, SETTING, AND PARTICIPANTS: Data is from baseline assessment of 265 post-MI patients (age range 45-85 years) enrolled in the Cardiac Rehabilitation in Advanced Age randomized, controlled trial. Patients with major comorbidities or severe MI complications were excluded from the trial. Exercise tolerance was determined from symptom-limited exercise testing and expressed as total work capacity (TWC, kg.m) or peak oxygen consumption (VO2peak, mL/kg/min). The associations between both TWC and VO2peak and baseline demographic, social, clinical, and neuropsychological variables and an index of health-related quality of life were determined with univariate and multivariate analysis. RESULTS: With univariate analysis, TWC decreased by 1285 kg.m per decade of increasing age between 45 and 85 years of age. With multivariate analysis, TWC decreased by 922 kg.m per decade. Increasing age (P < .001), female gender (P < .001), a small body surface area (P < .001), a low level of usual physical exercise before MI (P < .002), and the presence of post-MI depressive symptoms (P < .024) were independently associated with a lower TWC. The same factors, in addition to a small arm muscle area (P < .002), were also independently associated with a lower VO2peak. CONCLUSIONS: Age per se accounts for approximately 70% of the age-related decay in TWC or VO2peak. However, the inclusion of modifiable factors such as physical exercise and depression in the prediction model reinforces the importance of a multidimensional approach to the evaluation and treatment of older patients with a recent MI.

[Adaptation of the MacNew QLMI quality of life questionnaire after myocardial infarction to be used in the Spanish population]. / Adaptación del cuestionario de calidad de vida postinfarto MacNew QLMI para su uso en la población española.

BACKGROUND: The advantage of specific quality of life instruments is its ability to evaluate specific issues related to the illness of interest. The aim of the present study is to develope a Spanish version of the self-administered questionnaire MacNew QLMI, specific for patients after myocardial infarction (MI). MATERIAL AND METHOD: Forward and back-translation method by bilinguals was performed; once the test for feasibility and comprehension was carried out. 143 patients with a first MI completed the Spanish version of the MacNew QLMI and principal components factor analysis was performed. Reliability was assessed in 50 patients with stable MI that completed twice the questionnaire (with an interval of two weeks), measuring reproducibility and internal consistency with Student t test, intraclass correlation and Cronbach's alpha. RESULTS: Factor analysis showed a similar three dimensional structure as the original version. Intraclass correlation coeficient were 0.83, 0.87 and 0.83, and Cronbach's alpha coeficients were 0.85, 0.88 and 0.83 for the emotional, physical and social dimensions respectively. CONCLUSIONS: The Spanish version of the MacNew QLMI questionnaire has a good equivalence with the original version, a good internal consistency and a good reproducibility; it can be used in the Spanish population to study its validity.

Comprehensive cardiac rehabilitation: is it cost-effective?

A major challenge for all health care systems is to identify the most efficient use of limited and finite resources available for health care. Economic evaluation provides a balance sheet of the benefits, harms and costs for making choices between alternative health care services and is one strategy to assist decision-makers to make rational choices about effective and efficient health care. Cost and outcomes data collected on two or more alternatives form the basis for economic evaluations and calculating a cost-effectiveness ratio. While comprehensive cardiac rehabilitation has been shown to be an effective intervention for patients with documented heart disease, the economic evaluation data from which to determine the efficiency of cardiac rehabilitation are limited. Available economic evaluations of comprehensive cardiac rehabilitation suggest that it is a cost-effective intervention following an acute coronary event that can be economically justified. Although the majority of data from studies with less rigorous designs suggest either savings or a decrease in health care utilization, there were increased costs per quality-adjusted life year gained in the only randomized controlled trial with a cost-effectiveness analysis of cardiac rehabilitation. As the traditional delivery of cardiac rehabilitation services is undergoing re-examination, there is a need for considerably more research on the cost-effectiveness of cardiac rehabilitation before any definitive statement about reimbursement is made.

Cardiac rehabilitation and risk factor management after myocardial infarction. Clinical and economic evaluation.

The increasing scarcity of available, and finite, health care resources, and the increased demands for health care, have made consideration of effectiveness and cost-effectiveness of health care services, such as the secondary prevention of heart disease, an imperative. There is considerable evidence that modification of cigarette smoking, hyperlipidemia, hypertension, and lack of physical activity, either singly or in combination, are effective in reducing the number of clinical events in the secondary prevention of heart disease. Economic evaluation is the comparative analysis of alternative courses of action in terms of both costs and consequences. Data generated in economic evaluations of health care services, such as risk factor modification in the secondary prevention of heart disease, are useful in developing clinical practice guidelines and health policies. Smoking cessation is the most cost-effective intervention for patients with documented heart disease while treatment of hyperlipidemia and referral to cardiac rehabilitation are highly cost-effective per quality-adjusted life year and relatively cost-effective per year of life saved. Risk factor management, provided by a team including cardiovascular specialists and other physicians together with appropriately trained allied health professionals, is the cornerstone of optimal care in both the primary and secondary prevention of heart disease.

Anxiety and depression after acute myocardial infarction.

OBJECTIVES: To assess the following: (1) symptoms of anxiety and depression in hospitalized patients who had acute myocardial infarction (AMI); (2) the association between sex, infarct severity, history of previous AMI, and symptoms of anxiety and depression in hospitalized patients; (3) symptoms of anxiety and depression during the first year after AMI in a select group of patients; and (4) the association between educational and occupational status and symptoms of anxiety and depression at the time of hospitalization in a select group of patients. DESIGN: Cross-sectional survey (objectives 1 and 2) and prospective trial with random assignment (objectives 3 and 4). SETTING: Six university-affiliated hospitals in a Canadian city. PATIENTS: Seven hundred eighty-five hospitalized patients with AMI, with 1-year follow-up of 201 selected patients from this sample. INSTRUMENTS: State-Trait Anxiety Inventory and the short form of the Beck Depression Inventory. INTERVENTION: Data collection was initiated in the hospital 3 days after AMI, and patients were followed-up 14, 24, 41, and 56 weeks after AMI. RESULTS: Student t tests, analysis of variance, and descriptive statistics were used. When the patients were in the hospital the mean state (S-anxiety) and trait (T-anxiety) scores were 43 and 44, respectively. Ten percent had S-anxiety scores and 14% had T-anxiety scores that were higher than the mean scores reported for psychiatric patients. During the 1-year follow-up in the select group of subjects, the mean S-anxiety and T-anxiety scores were both 48 in-hospital, and decreased to 42 and 46, respectively, by 14 weeks and remained at these levels for the remainder of the year. During the course of the year, 16% of the patients had State-Trait Anxiety Inventory scores consistent with psychiatric conditions. The in-hospital Beck Depression Inventory mean score was 3, and 9% of the patients had scores consistent with moderate to severe depression. During the first 24 weeks, symptoms of moderate to severe depression were reported by 10% of the select group of patients. No associations were found between anxiety and depression and sex, creatine phosphokinase level, previous AMI, education, or occupational status. CONCLUSIONS: Symptoms of anxiety were prevalent among hospitalized patients who had an AMI, whereas depressive symptoms were rare. There was no association between anxiety and depression and sex, infarct severity, history of previous AMI, or educational or occupational status.

Outcomes measurement: health-related quality of life.

Outcomes research is rapidly expanding and evolving in the assessment of medical treatment and has significant potential contributions to the assistive technology field. Over the past two decades, numerous instruments have been developed and are widely used to collect data for evaluating the efficacy and effectiveness of traditional medical interventions. Although this methodology may not transfer seamlessly to assistive technology, the basis of its instrumentation and many of its concepts are highly relevant. Many current and emerging medical and assistive technology interventions are vigorously advocated but have inadequately demonstrated their positive impact on outcome. A key concept used in medical technology outcomes measurement is health-related quality of life, which represents the functional effect of an illness and its consequent therapy as perceived by the individual receiving treatment. People tend to make decisions about alternative health care services by estimating the effects of an intervention on outcomes important to themselves, by comparing intervention benefits and harms and by deciding whether the outcomes are worth the costs. Numerous valid, reliable, and responsive health-related quality of life instruments are available and are designed to discriminate between individuals, to evaluate change over time, or to predict outcome. Many are worth examining for potential use or adaptation in assistive technology outcomes measurement. Some of these instruments are generic, some specific, and others deal with health state preference. Generic health-related quality of life instruments are broadly applicable across various diseases, conditions, or populations. Specific instruments focus on a given disease, condition, or population. Health state preference instruments assess an individual's desirability for a given health state or outcome. Assistive technology practitioners claim that they improve the quality of life for the individuals they serve. Health-related quality of life must then be considered an integral component of the evaluation of service effectiveness. This paper reviews the concepts and instrumentation used in medical technology assessment for consideration and potential application in assistive technology measurement.

Outcomes measurement: health state preferences and economic evaluation.

A major health care policy issue in this era of accountability is controlling the introduction and utilization of increasingly sophisticated and expensive health care technologies. Data are needed about both the effectiveness and the costs of assistive technologies before making decisions without relying on "that's what we did last time," "gut feelings," or even "educated guesses." Services, such as assistive technology, fall in the category where rigorous scientific evidence about cost-effectiveness is virtually nonexistent. The field of medical technology assessment has been studying cost-effectiveness for decades and offers many methodological ideas to related fields such as assistive technology. Based on the experiences of medical technology assessment, the measurement of health state preferences and its use to estimate quality-adjusted life years is discussed in this paper. Economic evaluation can be defined as the comparative analysis of alternative courses of action in terms of both costs and consequences. Information from economic evaluation studies, including the use of quality-adjusted life years as an outcome measure, helps us to determine which health care services we can afford to incorporate into routine clinical practice. The major forms of economic evaluation for health care described in this paper are cost-benefit, cost-effectiveness, and a special form of cost-effectiveness, cost-utility. Important national and state health care policies are being considered and implemented on the basis of economic evaluation data and these are bound to have major implications for assistive technology. The assistive technology field needs to be aware of these methods both to understand how large scale health-related policy decisions are impacted by economic evaluations and to become participants in and contributors to this process.

Time course of recovery during cardiac rehabilitation.

PURPOSE: Exercise-based rehabilitation programs improve effort tolerance in patients with cardiovascular disease. Little is known regarding the time course of recovery of objective and subjective indices of exercise tolerance. METHODS: Twenty-six patients were studied at 0, 4, 8, and 12 weeks following early entry into rehabilitation following acute myocardial infarction (AMI), coronary artery bypass graft surgery (CABGS), or valve surgery. Exercise tolerance was assessed objectively by percent predicted cycle power output (%PO), and subjectively by a self-efficacy questionnaire for ambulatory (ASE) and muscular (MSE) items and by a disease-specific, health-related, quality-of-life questionnaire (HRQL). RESULTS: With the exception of percent predicted cycle power output, all exercise tolerance measures improved throughout the rehabilitation program. Extrapolation of recovery curves suggest that recovery to 85% predicted can be achieved in 10, 11, 18, and 21 weeks for a disease-specific, health-related, quality-of-life questionnaire, self-efficacy questionnaire for ambulatory items, muscular items, and power output, respectively. CONCLUSIONS: The data demonstrate that evaluation of both objective and subjective indices of exercise tolerance may be important in documenting outcomes of participation in structured rehabilitation programs. The time course of recovery of objective and subjective indices of exercise tolerance may not be highly correlated.

Lumbar spine surgery and mortality among Medicare beneficiaries, 1986.

OBJECTIVES: The purpose of this study was to compare lumbar spine surgical procedures by age, gender, and number of comorbidities with respect to mortality in patients 65 years of age and older in the United States. METHODS: A 100% sample of the 1986 Medicare inpatient Health Care Financing Administration claims files databases involving lumbar spine surgical procedures was analyzed. RESULTS: Lumbar spine surgery in 34,418 patients (median age = 71 years) was associated with a significant increase in in-hospital and 1-year cumulative mortality only beyond 80 years of age. When adjusted for age, in-hospital and 1-year cumulative mortality with both decompression and excision procedures were significantly higher in men than in women. When adjusted for both age and gender, mortality increased significantly as the number of comorbidities increased. CONCLUSIONS: With lumbar spine surgery in elderly patients, mortality did not significantly increase until 80 years of age and was consistently associated with decompression and excision, with male gender, and with an increase in number of comorbidities.

Cardiac rehabilitation services: what are they and are they worth it?

The objectives of cardiac rehabilitation include lowering mortality but, more importantly, increasing functional capacity so reducing disability and potentially improving quality of life. The data suggest that cardiac rehabilitation services are worth the patient's costs and efforts and as such, they should be considered an integral component of comprehensive cardiovascular care by cardiologists and primary care physicians. While there is considerable agreement on the roles of exercise testing and training in the three position stands, there are also substantiated, and important, differences in their recommendations on other cardiac rehabilitation services, such as counseling and risk factor management. The challenge for the 1990's is not only to continue to better define the effectiveness of cardiac rehabilitation services, but more urgently, how to deliver effective services most efficiently. This will help physicians provide optimum care for their patients, will improve the patient's likelihood of regaining for themselves an active and productive life, and should generate a more equitable and accountable reimbursement system for quality health care.

The health belief model: predicting compliance and dropout in cardiac rehabilitation.

We investigated the health belief model and the health locus of control constructs as predictors of group membership (compliers or dropouts) with cardiac rehabilitation and whether they added predictive utility to routinely assessed patient demographics and health behaviors. Questionnaires were completed on entry into the study by 120 patients with coronary artery disease, and by the end of the 6 month program there were 58 compliers and 62 dropouts. Discriminant function analyses were carried out to determine prediction of group membership. The health belief model predicted group membership 64.6% of the time, explaining 5.2% of the variance. Demographics, health behaviors, and health belief model factors accounted for 21.1% of the variance between compliers and total dropouts with group membership correctly predicted 74.4% of the time; avoidable and unavoidable dropout was correctly predicted 84.2% of the time with 56.9% of the variance explained. Health locus of control did not distinguish between compliers and dropouts. The addition of the health belief model provided additional information about compliance with cardiac rehabilitation beyond that explained by demographic and health behavior variables alone, particularly when predicting avoidable/unavoidable dropout.