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Eur J Cardiothorac Surg 2000;18:557-564
© 2000 Elsevier Science NL

Assessment of changes in general health status using the short-form 36 questionnaire 1 year following coronary artery bypass grafting

Grace M. Lindsaya, Phillip Hanlonb, Lorraine N. Smitha, David J. Wheatleyc

a Nursing & Midwifery School, 68 Oakfield Avenue, University of Glasgow, Glasgow G12 8LS, Scotland, UK
b Department of Public Health, 1 Lilybank Gardens, University of Glasgow, Glasgow G12 8LS, Scotland, UK
c University Department of Cardiac Surgery, North Glasgow University NHS Trust, 10 Alexandra Parade, Glasgow G4 0SF, Scotland, UK

Received 21 February 2000; received in revised form 5 July 2000; accepted 18 July 2000.

Corresponding author. Tel.: +44-141-330-6876; fax: +44-141-330-3539
e-mail: gl1z{at}clinmed.gla.ac.uk


   Abstract
Top
 Abstract
1. Introduction
 2. Methods
 3. Results
 4. Discussion
 5. Limitations
 6. Conclusions
 References
 
Objective: The problem addressed in the study was to gain a greater understanding of the health benefits of coronary artery bypass grafting (CABG). The purpose of the study was to assess general health status, using the short-form (SF)-36 questionnaire, approximately 12 months following CABG, and to document any associations between pre-operative health status, level of social support, coronary artery disease (CAD) risk factors, CAD symptom severity and post-operative health status. Methods: The study was prospective and observational in design and included assessments at two time points, namely pre-operatively in a hospital outpatient department (1995–1996) and post-operatively at home (1996–1997). Two hundred and fourteen patients awaiting elective CABG were recruited a month before the expected date of operation. Pre-operative assessment included: (1), severity of symptoms; (2), CAD risk factors; (3), SF-36 questionnaire; and (4), social activities questionnaire. Post-operative assessment measured health status using the SF-36 instrument (mean, 16.4 months). Correlation and multiple linear regression analyses were used to identify factors associated with improved health status following CABG. Results: Two hundred and fourteen patients were assessed pre-operatively and underwent CABG. There was a 4.8% 30-day mortality rate, and 183 patients were followed for a mean of 16.4 months after CABG. SF-36 scores following CABG were improved across all of the eight domains (P<0.001). A higher social network score and higher pre-operative health status were associated with improved health status. Patients with lower health levels (SF-36 scores) prior to CABG were less likely to gain improvement in health (SF-36 scores) following CABG. Lower SF-36 scores following operation were influenced by the presence of diabetes mellitus, cigarette smoking, younger age, a high socio-economic deprivation category and higher alcohol intake. Many patients had uncorrected CAD risk factors at pre-operative assessment. Conclusions: The SF-36 instrument was shown to be a useful and sensitive tool to assess differences and changes in the general health status of patients before and following CABG. High levels of social support were associated with improved health status post-operatively. Lower pre-operative general health status, the presence of diabetes mellitus and cigarette smoking were associated with poorer post-operative general health status.

Key Words: Health status indicator • Coronary artery bypass • Risk factors • Social support


   1. Introduction
Top
 Abstract
 1. Introduction
2. Methods
 3. Results
 4. Discussion
 5. Limitations
 6. Conclusions
 References
 
Coronary artery bypass grafting (CABG) has been an accepted treatment for angina pectoris for more than 25 years [1]. Early reports of the benefit of operation have focused on survival rates, cardiac events and other biomedical markers of disease[2]. More recently, outcome assessment has examined the ability of individuals to perform a variety of activities of daily life as a means of evaluating operative success. These have included assessments of exercise capacity [3] and return to employment [4]. Although such studies have been informative in terms of providing a greater understanding of the impact of CABG on broader aspects of daily life, as outcome measures, they may have limited use given the diversity of factors that influence them.

Several studies have been undertaken to evaluate patients’ assessment of their general health status following CABG, all reporting an improvement [5,6]. In these studies, health status was measured using the Nottingham Health Profile, a health assessment questionnaire which has recognized insensitivity when used in healthy populations. However, this may be of limited value as an outcome measurement tool to monitor change in health status before and after CABG where large improvements in health status may occur. In addition, the determinants of changes to health status in these studies have been based on a limited number of clinical variables or have utilized a small selected patient group, e.g. males younger than 60 years

The short-form (SF)-36 questionnaire [7], is a single 36 item scale that allows calculation of numerical scores for eight dimensions of health. As a measure of general health status, it has been reported as valid and reliable in evaluating the impact of changes in symptoms following angioplasty [8], and in normal populations [9]. In particular, low scores in the physical function domain of the instrument have been shown to be independently predictive of mortality 6 months following CABG [10]. It would therefore appear to be a suitable instrument to evaluate changes in health status following CABG and the main determinant factor in these changes.

As part of a larger study designed to examine factors influencing outcome following CABG, we assessed patients’ views of their general health status before and approximately 1 year following their operation using the SF-36 questionnaire [7]. To date, although the SF-36 questionnaire has been used extensively in a diverse range of groups, it has not been used as a tool to evaluate health outcome following CABG using pre- and post-operative scores.

In this paper, we report on the profile of changes in general health status as measured by the SF-36 instrument and the contribution of a range of pre-operative variables, including patient rated symptom severity, coronary artery disease (CAD) risk factors and social networks on post-operative health status.


   2. Methods
Top
 Abstract
 1. Introduction
 2. Methods
3. Results
 4. Discussion
 5. Limitations
 6. Conclusions
 References
 
2.1. Sample and size
A consecutive sample of patients (n=214) was recruited over a 6 month period from the surgical waiting list for CABG at one cardiac surgical centre according to the following inclusion criteria: isolated CABG procedure; elective operation; residence within approximately 50 miles of the hospital; and the expected date for operation was estimated to be approximately 4 weeks after pre-operative assessment for the study.

The total number of patients undergoing elective CABG surgery at Glasgow Royal Infirmary as a first and single procedure was 748 during the 9 month period (April 1995–January 1996) that the study was undertaken. The study patients represented a consecutive sample of all patients who underwent CABG surgery meeting the above criteria. All patients who were invited to participate in the study agreed to take part and written informed consent was provided. Ethical approval was obtained from the Research Ethics Committee of Glasgow Royal Infirmary NHS University Trust.

A sample size of approximately 175 patients would be sufficient to give 90% power to detect an increase of 10% in the mean score in any subscale of the SF-36 (e.g. from 40 to 44) at the 5% significance level. The sample size was increased from this level to allow for dropouts and attrition.

2.2. Setting
An acute teaching hospital in the west of Scotland.

2.3. Assessment instruments
2.3.1. SF-36 questionnaire
The SF-36 questionnaire (UK standard version) [7] is a 36 item scale that generates scores for eight dimensions of health, namely, physical functioning, role limitation due to physical health problems, bodily pain, general health, energy and vitality, social functioning, mental health and role limitations due to mental health problems. The scores for each domain range from 0 to 100, with 0 being the worst and 100 the best possible health status.

2.3.2. Symptom severity
Patients were asked to rate the severity of angina and breathlessness using two visual analogue rating scales (seven point scale)[11]. The rating scale used was a horizontal line anchored at each end by terms that represent the extremes of symptoms experienced as a result of angina pain and breathlessness. The two symptoms assessed were those of chest pain and breathlessness on self-rating scales based on a 0–7 range, where 0 represented ‘no effect on your overall well-being and health’ and 7 represented ‘complete disability, discomfort and restriction to life’. Respondents were asked to indicate the intensity of the sensation at that moment in time by placing a point across the scale.

2.3.3. Social networks
The social networks questionnaire [12] has 11 items in the scale, covering social contacts, group participation, social activities and subjective evaluation of the quality of relationships. Response categories were converted into scale scores for each item and an overall summary index of social support was generated. Higher scores are associated with greater levels of social support.

2.4. Data collection process
Patients were first assessed approximately 4 weeks prior to the operation in the outpatient department, and then approximately 16 months after the operation in the patient's home. The self-completion questionnaire was posted to the participants before both assessment appointments. All data were collected by the same researcher. At the post-operative assessment, as part of a more comprehensive follow-up review, the SF-36 questionnaire was administered.

2.5. Clinical assessment
Demographic details (age, sex, postcode) were used to estimate the socio-economic status using an updated version of Carstairs and Morris deprivation scores [13]. The habit of tobacco smoking was also recorded.

Blood pressure was measured in accordance with the British Hypertension Society guideline [14]. Korotkov phase I was taken as the systolic blood pressure and Korotkov phase V as the diastolic blood pressure, and each were measured to the nearest 2 mmHg. An average of the two recordings was used in the analysis.

A 10 ml venous blood sample was collected into a sample tube containing the anticoagulant, EDTA. Plasma cholesterol levels were measured at the Institute of Biochemistry, Glasgow Royal Infirmary NHS Trust using standardized protocols and internationally agreed quality assurance procedures.

Patients were weighed in light clothes without shoes to the nearest 0.1 kg, and height was measured in cm. The body mass index (BMI; kg/m2) was derived from these measurements. Waist measurement with a flexible tape was taken as the smallest circumference between the rib cage and the iliac crest and recorded to the nearest 0.1 cm [15].

2.6. Statistical methods
Summary statistics (mean and SD for continuous variables, median and interquartile range for non-normal data) were calculated for the variables recorded in both pre- and post-operative assessments. Differences in SF-36 scores obtained from the pre- and post-operative assessments were compared by paired t-tests or Wilcoxon tests for non-normal data. The percentage of patients who smoked cigarettes, had diabetes mellitus, and had levels of blood pressure, plasma cholesterol, alcohol intake and BMI exceeding target levels were calculated. Regression analysis was performed to derive Pearson product–moment correlation coefficients between normally distributed variables. Based on this, multiple linear regression analysis using nine normally distributed variables was carried out and the best subset regressions were calculated. For non-normal data Kendall's rank correlation was used to reflect the strength of the dependence, but obviously no multiple regression analysis was attempted. Data sets were also split on the basis of categorical variables, such as diabetes or current smoking, and compared using unpaired t-tests or Mann–Whitney tests for non-normal data.


   3. Results
Top
 Abstract
 1. Introduction
 2. Methods
 3. Results
4. Discussion
 5. Limitations
 6. Conclusions
 References
 
Two hundred and fourteen patients were reviewed pre-operatively and the demographic variables are presented in Table 1. The treatment for six patients was changed and therefore they did not undergo CABG and were not followed-up. Ten patients died in the 30-day period following operation (mortality rate, 4.8%) and a further three patients died during the follow-up period. Of the 195 patients contacted approximately 16 months after surgery (mean, 16.4 months), 183 patients (93.8%) agreed to post-operative assessment.


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  		Table 1. Demographic characteristics of study patients

 
The means and SDs for angina and breathlessness self-rated severity scores, collected using the visual analogue scale, were 4.07±1.82 and 3.78±1.93, respectively. The results from the assessment of CAD risk factors are presented in Table 2. In addition, the mean and SD of reported alcohol intake was 7.0±11.8 units/week.


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  		Table 2. Mean values of major CAD risk factors with percentage of patients exceeding target levelsa at pre-operative assessment

 
3.1. Changes in SF-36 scores between pre- and post-operative assessments
As there was a smaller number of patients to be assessed post-operatively, it was not possible to have complete paired data when comparing the mean pre- and post-operative SF-36 scores for each domain. Therefore, some data were inevitably lost at this stage of analysis. The results are presented in Table 3.


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  		Table 3. Comparison of pre-and post-operative SF-36 scores

 
3.2. Trend of changes in SF-36 scores
The percentage and mean changes in the direction of the SF-36 scores between pre- and post-operative assessment have been calculated and are presented in Table 4. The majority of the SF-36 scores either improved or deteriorated, with the exception of physical and emotional role limitation where approximately half of the cohort showed no change in their score. There were large improvements in all post-operative SF-36 domains, ranging from approximately 35% in physical role limitation to over 70% in physical function. However, for all the post-operative SF-36 domains except physical role limitation, approximately 20–36% of the cohort (dependent on the domain) decreased their scores, indicating a deterioration in their health status for that domain.


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  		Table 4. Percentage of patients (number) with decreased, no change and increased mean SF-36 scores with mean difference, between pre-operative and post-operative assessment

 
3.3. Association between pre-operative variables and post-operative SF-36 scores
Pre-operative variables were each correlated against post-operative SF-36 scores. Each pre-operative SF-36 domain correlated well with its post-operative counterpart. The other pre-operative variables assessed were also correlated with the SF-36 post-operative scores and the results are presented in Tables 5 and 6. Where data were normally distributed, linear regression was used. For non-normal data, Kendall's rank correlation results are presented. Older patients generally have higher post-operative SF-36 scores, with statistically significant higher scores for the domains of energy/vitality, general health and social function (it should be noted that the term older applies to the range of ages within this study group, which does not represent all ages of patients undergoing CABG). All post-operative SF-36 scores had significant positive correlations with the pre-operative social network score. Conversely, deprivation category, alcohol consumption and count of CAD risk factors were all negatively correlated with SF-36 post-operative scores to varying degrees. Pre-operative angina and breathlessness severity ratings, plasma cholesterol, BMI, waist, diastolic and systolic blood pressures were not significantly correlated with post-operative SF-36 scores, and therefore, have not been included in Table 5. The influence of diabetes was examined by splitting the data sets into diabetic versus non-diabetic. These data are presented in Table 6. Diabetes was associated with significantly poorer post-operative general health scores and also poorer physical function, physical role limitation and emotional role limitation scores. The data was next split to examine smokers versus non-smokers. For smokers, the only variables that showed statistically significant poorer values were energy–vitality, physical role limitation and emotional role limitation scores.


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  		Table 5. Linear (simple) correlations between pre-operative variables and post-operative SF-36 scores

 

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  		Table 6. Comparison of post-operative SF-36 domains with groups split by smoking habit or presence of diabetes

 
3.4. Multiple linear regression analysis
Normally distributed post-operative SF-36 domains (bodily pain, energy–vitality, general health and mental health) were correlated with normally distributed pre-operative variables. These were run against age, deprivation category, cigarettes smoked/day, alcohol consumption and the pre-operative scores for the domain in question. The effects of categorical variables have been dealt with in Table 6. The final multiple regression was derived from the best subset of variables subjected to the initial multiple regression. The extent to which the regression equation explained the variability of the predicted value of the data about the mean value of the dependent variable (r2) was also provided. The results are presented in Table 7. Social networks, alcohol, deprivation category and pre-operative SF-36 domain scores were important factors contributing to the post-operative SF-36 scores.


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  		Table 7. Summary of the statistically significant pre-operative variables contributing to each post-operative SF-36 score and direction of influencea

 

   4. Discussion
Top
 Abstract
 1. Introduction
 2. Methods
 3. Results
 4. Discussion
5. Limitations
 6. Conclusions
 References
 
The SF-36 health measure was used as the main health outcome measure following CABG surgery and demonstrated a significant improvement in general health status following operation, in agreement with other studies [5,6]. The scores generated showed that the measure was able to differentiate between levels of health in individuals at a single time point and in the same individuals over time, thereby satisfying an important feature for a useful health status measure in health outcome assessment [16]. The pre-operative SF-36 scores ranged from a minimum of 14.7 in the domain of role limitation due to physical factors to 61.1 in mental health, which were generally low scores (Table 3). This is perhaps not unexpected for patients with symptomatic CAD awaiting CABG. However, the identification of particularly poor health status pre-operatively may be an important factor in the overall assessment of operative risk, as another study has shown that low SF-36 physical function scores have been associated with increased mortality at 6 months following CABG [10].

A comparison of the mean SF-36 scores at baseline and follow-up are presented in Table 3, and show highly significant improvements in all SF-36 domains. However, the individual pattern of change in the SF-36 scores varied across the health domains shown in Table 4. Increases of between 60 and 74% were documented in bodily pain, energy and vitality, social function and physical function. This may reflect improvement in dimensions of health directly related to the reduction or removal of angina chest pain. A relationship between perceived improvements in quality of life and reduction in angina has been documented by other investigators [17]. However, the overall improvement in mean health scores conceals the fact that many individuals actually have scores that are lower than those recorded at pre-operative assessment (Table 4). The largest reductions in scores were between 23 and 36% compared with improvements which were of the order of 40–75%. So, even when deterioration in general health status was noted following operation, it was of a smaller magnitude than the degree of improvements observed. The mental health domain showed the greatest reduction in score that may be related to the trauma and long recovery that was evident for some patients.

More than half of the patients did not change their scores in the role limitation due to physical or emotional factor domains. This pattern of change was different from that reported in a large study monitoring health-related quality of life changes in patients with angina following the introduction of additional nitrate therapy [17]. The pattern of change over the 6 month time period was that of a consistent increase over time, correlating with a decrease in angina attacks, but of less magnitude (20–30%) than that observed in this work. By contrast to the results of this study, some of the largest increases were noted in the role limitation for both physical and emotional functions. Role limitation due to physical and emotional factors changed least as a result of surgical intervention.

The SF-36 scores obtained following operation were lower than normative data for adults (n=9332) of working age (18–64 years) [9]. Our values ranged between 39 and 85% of those recorded by Jenkinson [9]. As we had no access to the original data, we were therefore unable to ascribe significance values to these findings. We also do not know how comparable the groups were in terms of social class and presence of other illness, although they were drawn from a younger population than that of the study patients. However, if the lower health scores in our study patients reflects reality and is experienced more widely, then it is important that such information on likely health outcome be incorporated in clinical decision-making to avoid an over-optimistic expectation of health status after surgery.

The correlation analysis of pre-operative variables with general health status following CABG has highlighted some interesting associations (Tables 5 and 6). Patients from higher socio-economic deprivation groups had significantly lower scores for five of the eight post-operative health domains, confirming the previously documented relationship between high levels of socio-economic deprivation and ill-health [18]. Other smaller associations of interest include the negative correlations with increased alcohol intake, deprivation category and positive correlations of age with post-operative SF-36 scores in most domains (Table 5). The positive relationship with increasing age may reflect a less aggressive underlying disease process in patients who have symptomatic CHD at an older age. Other studies have reported adverse outcome following CABG for both older and younger ages [19]. Although these did not reach statistical significance for the number of patients within this study, a consistent trend was evident that these factors were related to health after CABG operation in either a detrimental or positive manner. Interestingly, the severity of angina and breathlessness pre-operatively was not associated with the level of general health post-operatively. Smoking, diabetes mellitus and a high social network score were clearly influencing general health status following CABG. There were too few females in this study group to examine any relationship between female sex and health outcome in this study.

The general consensus arising from the regression analyses was that the social network score was the most important non-SF-36 factor contributing to general health status post-operatively (Tables 5 and 7). It was a significant contributing factor to all SF-36 health domains, except for role limitation due to emotional factors, a domain that was relatively unchanged in almost half of the patients. This may be related to the insensitivity of this domain to different levels of health. The results of this study strongly endorse the importance of high levels of social support to general health and well-being following CABG surgery. The importance and positive consequences of social support have been documented in epidemiological studies [20] in relation to reduced mortality from a range of diseases, and to a reduced risk of cardiovascular mortality [21]. Factors that were found to be helpful in the recovery from surgery were related to ‘lay support’ which is a form of social support. Social support was lower in this patient group than reported in other population groups using the social network scale [12]. Low levels of social support may contribute to the decreased general health scores (SF-36) in these patients, which were lower than those reported in other individuals with CHD [8] and those of a general population group [9].

The second most important pre-operative variable was diabetes mellitus, which contributed negatively to four of the post-operative SF-36 domains. No significant sex differences were detected in the presence of diabetes mellitus in the study patients. The long-term mortality in patients with diabetes mellitus following CABG surgery has been shown to be higher than in a non-diabetic patient group [22].

The third most important variable was current smoking status, which made a significant contribution to one SF-36 domain and approached significance in a further two domains post-operatively. The current smoking levels were 22.9%. This level of smoking was more than double that noted in other studies [23] that have demonstrated an increased mortality in smokers compared to non-smokers at 5 years following surgery. Therefore, in the longer term, the study patients, who by comparison, reported higher levels of smoking, may be at increased risk of dying in the longer term following CABG.

Many patients had uncorrected CAD risk factors pre-operatively (Table 2) which have been shown to be related to the progression of atherosclerosis, particularly in vein grafts [24]. The finding is disappointing, given the publication of the EUROASPIRE study in 1996 [25] highlighting the problem of uncorrected CAD risk factors in patients with CAD, including CABG patients and the deleterious effects that such factors have on further cardiac events.


   5. Limitations
Top
 Abstract
 1. Introduction
 2. Methods
 3. Results
 4. Discussion
 5. Limitations
6. Conclusions
 References
 
The SF-36 questionnaire directed patients to select responses relating to different aspects of their general health status over a fixed time period, e.g. 4 weeks. This proved difficult in some cases because patients reported that the way they felt varied on a day-to-day basis. Nevertheless, an overall estimate of their health over a longer time period did not reflect this variability. Underpinning the whole study was the assumption that changes from baseline assessment, both positive and negative, resulted from the intervening CABG. Obviously, other major life events may have taken place in the months between assessments, for example, death of a spouse or major concomitant illness. Similarly, no account was taken of the details of the CABG surgical procedure undertaken or angiographic documentation of disease severity that may vary considerably and have a significant effect on outcome. Therefore, in the interpretation of the results of this study, it should be acknowledged that a range of other factors beyond the scope of this study could have an impact on health outcome.


   6. Conclusions
Top
 Abstract
 1. Introduction
 2. Methods
 3. Results
 4. Discussion
 5. Limitations
 6. Conclusions
References
 
General health status, as measured by the SF-36 questionnaire, improved significantly after CABG, although this overall trend did conceal the fact that many individuals had lower health scores after operation. The SF-36 tool was shown to be a useful measure of general health status, demonstrating sufficient sensitivity to discriminate between different patients at the same stage and in the same patients over time following operation. A strong positive association between high levels of social networks and improved health outcome was demonstrated, and this has not been reported previously for patients undergoing this procedure. This finding provides an important new opportunity for identification of patients who may be less likely to achieve maximum benefit from CABG. In addition, interventions designed to improve a patient's social context prior to CABG may help to improve the health outcome post-operatively. Factors previously documented as affecting adverse outcome following CABG, such as smoking and diabetes mellitus, similarly affected health outcome as measured by the SF-36 domains.


   Acknowledgments
 
The authors wish to thank Mr P.R. Belcher FRCS, Department of Cardiac Surgery, and Mr Harper Gilmour, Department of Public Health, University of Glasgow for their help and statistical advice. Funding: this study was undertaken as a research training fellowship funded by the Chief Scientist Office, Scottish Office, Department of Health.


   References
Top
 Abstract
 1. Introduction
 2. Methods
 3. Results
 4. Discussion
 5. Limitations
 6. Conclusions
 References
 

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E. W. Thornton, C. Groom, B. M. Fabri, M. A. Fox, C. Hallas, and M. Jackson
Quality of life outcomes after coronary artery bypass graft surgery: Relationship to neuropsychologic deficit
J. Thorac. Cardiovasc. Surg., October 1, 2005; 130(4): 1022 - 1027.
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 Eur. J. Cardiothorac. Surg.Home page
O. Jarvinen, T. Saarinen, J. Julkunen, H. Huhtala, and M. R. Tarkka
Changes in health-related quality of life and functional capacity following coronary artery bypass graft surgery
Eur. J. Cardiothorac. Surg., November 1, 2003; 24(5): 750 - 756.
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 Ann. Thorac. Surg.Home page
K. F. Welke, J. P. Stevens, W. C. Schults, E. C. Nelson, V. L. Beggs, and W. C. Nugent
Patient characteristics can predict improvement in functional health after elective coronary artery bypass grafting
Ann. Thorac. Surg., June 1, 2003; 75(6): 1849 - 1855.
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