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Quality of life assessment after acute coronary syndrome: systematic review

Acute coronary syndrome; quality of life; sickness impact profile; review

REVIEW ARTICLE

IEscola Nacional de Saúde Pública - ENSP - Fiocruz, Rio de Janeiro - RJ, Brazil

IIPROCEP Centro de Ensino e Pesquisa, Rio de Janeiro - RJ, Brazil

IIIHospital do Coração - IEP - Hcor, Rio de Janeiro - RJ, Brazil

IVInstituto de Pesquisa Clínica Evandro Chagas - IPEC - Fiocruz, Rio de Janeiro - RJ, Brazil

VSecretaria Municipal de Saúde e Defesa Civil - SMSDC-RJV, Rio de Janeiro - RJ, Brazil

Mailing Address

Keywords: Acute coronary syndrome, quality of life, sickness impact profile, review.

Introduction

The Acute Myocardial Infarction (AMI) has been known worldwide since the beginning of the twentieth century as an almost always fatal disease. The physical and psycho-emotional impact caused by the disease and the high prevalence of depression have been described as the major factors that contribute to the impairment of quality of life (QOL) of patients in the medium and long-term1-3.

A systematic review of studies evaluating QOL after acute myocardial infarction demonstrated that the effects of infarction on the QOL dissipate in the long term, but specific evaluation of patients who develop left ventricular function impairment in the acute phase of the event, does not seem to have been investigated4. In addition, two studies indicate that the consequences of both chronic ischemic heart disease and heart failure are not temporary, and their effects on QOL assessment worsen soon after diagnosis with no improvement in patient follow-up, differently from what has been observed after an acute event4,5.

Although health systems always focus on morbidity and mortality control, recent concerns have also encouraged the evaluation of the impact of health hazards on patients' daily life. These assessments are usually carried out using questionnaires developed and validated through a specific methodology, which involves replication in other populations rather than the original population for which they were developed.

There are several instruments to assess QOL in patients with ischemic heart disease and specific methodologies have been developed for the translation, cultural adaptation and interpretation of instruments when used in other languages. This systematic review aims at analyzing which instruments translated into Portuguese were used to assess quality of life in patients with acute coronary syndrome (ACS) and the interpretation of their results according to their psychometric properties.

Methods

Search strategy

The literature search was performed by a librarian specialized in the medical science field and saved using reference management software (Endnote, release 13.0). The search was not restricted to language or periods. The gateways, their respective databases and syntax used are described in Table 1. We performed a manual search of relevant cross-references.

Criteria for reference selection and data extraction

Reference selection and data collection were performed according to Prisma guideline6, by pairs of trained independent researchers.

Reference selection was carried out by reading the abstracts of the available literature (Table 1) and data extraction was performed by reading the full texts of selected references for the variables of interest.

The analysis included all studies that evaluated the quality of life of patients with acute coronary syndrome or myocardial infarction, using instruments translated into Portuguese.

The studies were included in the analysis regardless of the design and follow-up extent. Studies with results that were out of scale variation range were excluded.

Selected variables and outcomes of interest

We analyzed the quality of life (QOL) outcomes defined as the total and summarized scores of each instrument, according to the time elapsed between the diagnosis of acute coronary syndrome and the instrument application, as well as according to the clinical characteristics and socio-demographic profile of the population included in analysis. The validity results, including criterion (sensitivity, specificity, likelihood ratio) and construct validity (Pearson's, Spearman's or Kendall's correlation coeficient), reliability, including internal consistency (Cronbach's alpha test) and reproducibility (Intraclass coefficient of correlation or weighted kappa) and sensitivity, responsiveness, and interpretability were investigated and only the results found were described.

Statistical Analysis

The selected references and data collected were entered into an ACCESS database, release 2007, built specifically for this purpose.

Quantitative variables were summarized by means and standard deviations as measurement of quality of life scores and psychometric properties of the evaluated instruments. Heterogeneity between studies was assessed based on Cochrane's Q2 Test with a significance level of 10%7. The I2 test was also used to quantify the heterogeneity among studies on a scale from 0 to 100%. Studies with I2> 75% were considered highly heterogeneous. Weighted means and standard deviations of quality of life scores were pooled together according to the methodology standardized by Cochrane8.

Data from the longitudinal studies were consolidated by a random-effect model that considered the Inverse of Variance as a weight measure to compare results before and after in relation to the time of questionnaire application. This moment was defined in relation to the ACS diagnosis and stratified as: < 2 months and > 2 months and compared between them. For the cross-sectional studies, the comparison between the two moments was made considering the data imputed from the weighted mean of the other studies in that period (before or after). Statistical tests were performed using the RevMan 5 (Cochrane) program, considering a significance level of 5%. All tests were two-tailed.

Results

Reference selection and characteristics of studies included in the review

The search strategy results and reference selection are depicted in Figure 1 and the characteristics of the selected studies are shown in Table 1. We found four reviews9-12 that were used as basis for cross-reference search.


Of 2,990 reviewed abstracts, eighteen full texts were included in the qualitative synthesis, of which: three cohort studies13-15, two case-control studies16,17, eleven sectional studies18-28, one non-randomized clinical trial29 and one randomized clinical trial30. Three abstracts of which full texts were not published31-33 and two duplicated publications34,35 were excluded. Significant loss to follow up was observed in seven of the eighteen studies that were included. Three studies used different instruments that could not be included in the quantitative synthesis: one used the Seattle questionnaire15, one used the IPQ (Illness Perception Questionnaire)28 and one the NHP (Nottingham Health Profile)16. Four studies contributed to the meta-analysis (Figure 1).

Post-ACS quality of life was evaluated in selected populations from the south and southeast regions of Brazil, as well as the districts of Porto and Coimbra in Portugal; the vast majority of the patients were treated at cardiology outpatient clinics and rehabilitation programs of universitarian hospitals (Table 2).

Patient selection in these studies was carried out by searching the medical or hospital records and the sample size was defined by convenience. The time elapsed from ACS diagnosis to the questionnaire application varied among studies and was unclear in two of them. In seven studies the time from diagnosis was less than two months and in nine it ranged from two months to twelve years. The questionnaire application method, whether by interview, telephone contact or self-application was described in only six studies, was unclear in two studies and was not reported in the others (Table 2).

Most studies did not report on the previous history, habits, except for smoking, and socio-demographic characteristics of the studied populations (Table 3). None of the selected studies adjusted their results for any of these characteristics. Family income was less than four minimum wages19,25,26,28 and the level of schooling was less than four years in more than 50% of the studied population, except for the study by Dias et al13, which excluded patients with low educational level. Only two studies described the percentage of patients that returned to work after the coronary event, ranging from 26%19 to 52%28.

Quality of Life Questionnaires

The most widely used QOL questionnaires were: SF-36 in nine studies; MacNew in six studies; WHOQOL in three of them and Seattle, IPQ and NPH in one study each. The summarized and overall scores obtained in the periods before and after two months, and the mean of the difference between the two points are shown for the SF-36 and MacNew questionnaires in Figures 2 and 3, respectively, for both cross-sectional and longitudinal studies.



The two meta-analysis performed for the longitudinal studies suggest QOL improvement in the late follow-up of 0.55 (95%CI: 0.34 to 0.76) for the MacNew questionnaire and 5.87 (95%CI: 3.42 to 8.31) for the SF-36 questionnaire compared with the initial follow-up of up to two months after the ACS diagnosis.

The weighted means of the SF36, MacNew and WHOQOL36 and the Seattle results observed in the study by Souza et al15 were similar to those observed in patients with acute coronary syndrome in other countries (Table 4)37-40, and lower than the scores observed in the general population of the United States and other countries (Table 4)41, except for the summarized measurements, which had a behavior more similar to that of the general population in other countries than with the ACS population42.

Psychometric Properties

The psychometric properties of the MacNew, SF36 and WHOQOL questionnaires were evaluated in four of the eighteen analyzed studies. Convergent validity (a type of construct validity) was analyzed using Pearson's correlation between the MacNew, disease-specific, and SF-36, general, questionnaires (Alcântara25, Leal et al14 and Nakajima et al19), and between the WHOQOL-brief and SF-36 questionnaires, both general (Cruz et al26).

Correlations between MacNew and SF-36 scores were > 0.6 for mental health, vitality and functional capacity scores 19.The emotional score of MacNew questionnaire showed correlation values > 0,6 with only two domains of SF-36: mental health (r = 0,78) and vitality (r = 0,69) 19,25.The correlations between the physical component of the SF-36 and MacNew overall and physical scores were 0.70 and 0.72, respectively, and between the mental component of SF-36 and the emotional score of MacNew was 0.78 (Leal et al14).

The correlation between the emotional score of the two questionnaires ranged from -0.15 (Alcantara et al25) to 0.45 (Nakajima et al19) and between the social scores, it ranged from 0.49 to 0.58 between the studies14,19,25. Leal et al14 observed significant correlations (r > 0.70) between the overall and summarized scores of both questionnaires in the same dimensions (physical component of SF-36 vs. overall score and physical score of MacNew and mental component of SF -36 vs. MacNew emotional score). Cruz et al26 found significant Pearson's correlation (r > 0.55) between the physical score of the WHOQOL and all scores of SF-36 (except for the physical impairment and emotional state scores) and between the WHOQOL psychological score and the mental health and vitality scores of SF-36. The vitality (r = 0.58) and mental health scores of SF-36 (r = 0.68) and all WHOQOL scores (r> 0.55) moderately correlated with Beck's depression questionnaire26.

Discriminant validity (another type of construct validity) was investigated in the studies by Nakajima et al19 and Leal et al14. Patients with severe ventricular dysfunction had significantly lower QOL scores compared to those with mild or moderate ventricular dysfunction19. The MacNew questionnaire was able to significantly discriminate patients with severe LV dysfunction from the others, as well as patients with progressive worsening in SF-36 scores from those with improvement or no change in these scores. The MacNew questionnaire was also able to differentiate patients with and without depression or anxiety using the hospital scale for anxiety and depressão14.

Internal consistency (Cronbach-α) of SF-36 and WHOQOL, evaluated by Cruz et al26 was > 0.7 for all dimensions except for the social score. In the studies by Nakajima et al19 and Leal et al14, which evaluated the MacNew questionnaire, internal consistency was > 0.8 for all dimensions. These results are similar to what was observed in other countries (Table 5)43-46.

Reproducibility was assessed exclusively by Leal et al14 using the test-retest intraclass correlation for the MacNew questionnaire, with results ranging from 0.77 to 0.93, also showing results that were similar to those observed in other countries (Table 5)44.

The floor-ceiling effect, present when > 10%47, was observed in the "emotional state" and "physical impairment" scores of SF-36 evaluated in the study by Cruz et al26. This effect was not present in the MacNew questionnaire evaluated in the study by Leal et al14.

Heterogeneity

The longitudinal studies included in the meta-analysis showed moderate heterogeneity. Meta-regression analysis to evaluate the causes of heterogeneity was not performed due to the absence or inconsistency of information in most studies. Possible causes of heterogeneity may be related to different study designs included in the analysis and methods used for the selection of research subjects and questionnaire application. Another possible source of heterogeneity was the time elapsed between the ACS and questionnaire application, mainly in the group classified as evaluation "> two months," which ranged from three months to six years from the diagnosis. In addition, for the cross-sectional studies, other studies included in the analysis within the same category imputed based on the weighted mean of other studies included in the analysis within the same category, so that the comparison of means before and after could be performed for the studies that were found. The clinical and socio-demographic characteristics, when reported, also varied widely between studies and seem to be homogeneous only for age range and sex (Table 3).

Discussion

This systematic review is a survey of what was produced in Brazil and Portugal in relation to the subject "quality of life" in acute coronary disease, taking into account the results of quality of life scores measured by different instruments, according to time of disease and their psychometric properties.

The psychometric properties of the instruments were assessed in only four of eighteen studies analyzed, three of which evaluated the association of a general questionnaire (SF-36) to a specific questionnaire (MacNew) and are discussed below.

Construct validity

Construct validity was assessed according to previously established methods48,49 and showed: 1) high convergence between the items of the MacNew and SF-36 questionnaires, considering the same construct, except for the emotional scores, probably because they measure different quality of life aspects. While the MacNew questionnaire deals with the patient's perception, SF-36 is concerned with the impact of the emotional state on their daily activities, 2) high convergence was observed among all dimensions of the WHOQOL-brief and only the mental health score of SF -36, but not between the other scores of this instrument, probably as a consequence of the fact that the two questionnaires have very different scopes. While the SF-36 was designed to assess health status, the WHOQOL was designed to assess the patient's perception regarding the different aspects of his/her life, in an overall manner, 3) low discriminating capacity of the general questionnaires in opposition to the good discriminating capacity of the MacNew specific questionnaire for changes in quality of life related to heart failure or depression symptoms, and 4) moderate discriminating capacity of the WHOQOL questionnaire for the presence of depression.

The analyses of construct validity of the discriminant type were restricted to the MacNew questionnaire, which showed good discriminating capacity between patients with and without severe ventricular dysfunction, depression and anxiety compared to longitudinal observations with the SF-36. Functional classes of angina or heart failure were not evaluated, but previous studies have suggested that these questionnaires have low discriminant power for these items3.

Criterion validity was not assessed in any of the studies included in this review and its importance would relate primarily to determine performance, mainly of specific instruments to define the presence or absence of clinical conditions of interest, such as re-obstruction of coronary vessels or heart failure during the clinical follow-up of these patients.

Reliability

The internal consistency assessed by Cronbach's α was low for the social score of the general questionnaires, both SF-36 and WHOQOL, whereas the specific questionnaires Seattle and MacNew behaved differently from the general questionnaires and had high internal consistency in all their dimensions.

Reproducibility, considered satisfactory when > 0.50 for comparison between groups and > 0.90 when comparing the individual with him or herself44,47, was evaluated only for the MacNew questionnaire in 1 study, demonstrating that this questionnaire showed high reliability in the studied population14.

Sensitivity

The SF-36 dimensions that address the emotional state and social function showed a high floor-ceiling effect, which was also moderately present in the dimensions of body pain and physical impairment, consistent with what was seen in previous studies45,46. The propensity to the floor-ceiling effect was low for both specific questionnaires, MacNew and Seattle. Although the floor-ceiling effect has been described as a good parameter to infer the sensitivity of QOL instruments, as it demonstrates whether the instrument is able to detect variations between individuals rather than the extremes of the measurement, it is a method considered by many authors as insufficient to assess whether the instrument is capable of detecting small differences50. The method that has been proposed for the assessment of this property is that of the magnitude of the effect between groups through specific statistical tests, such as Cohen's size effect, Guyatt responsiveness index and the standardized mean difference, which was not was performed in any of the analyzed studies50,51.

Responsiveness

The interpretation of changes in QOL scores over time is another question of great importance when following patients with ischemic heart disease52. The floor-ceiling effect has also been used as a useful indicator of instrument responsiveness50, but the most widely used concept in the literature is the "minimal important difference" (MID), which represents the smallest difference in score of the domain of interest that is perceived by the patient and would determine, in the absence of clinical or financial limitations, the change in therapeutic conduct53,54. Norman et al54, based on a systematic review of QOL studies, showed that the MID can be estimated based on half of the standard deviation of the mean scores resulting from the initial instrument application in that population54. It has been shown that a change of at least 0.5 and 3.5 are useful indicators for MID in the scores of the MacNew and Seattle questionnaires, respectively55,56.

For the SF-36 questionnaire, a variation of around 10 points for the individual scores represented a marked change in the perception of the patients' health, whereas a change of about 5 points represented a moderate change57. In this review, only four of eighteen studies allowed this analysis, with values of 0.55 found for MacNew and 5.78 points for the SF-36, consistent with what has been established as the MID for these instruments. A change of approximately fifteen points was observed in the only study that evaluated the Seattle questionnaire15. This large variation may be related to the time of the first application of the instrument carried out at hospital admission, when the patient presented acute symptoms15. With the exception of the Seattle questionnaire, these findings corroborate the results of the systematic review by Simpson, which suggests a modest QOL recovery after an acute coronary event58.

The results of a previous systematic review, performed by Dempster et al59 suggest that the general questionnaires such as SF-36 and Nottingham Health Profile have low responsiveness and therefore their results should be interpreted with caution, as these instruments are little sensitive to the observation of small evolution variations in QOL of patients with ischemic heart disease. In addition to Dempster, other authors have suggested that a specific questionnaire should always be associated with a general questionnaire to assess the quality of life in patients with ischemic heart disease3,59.

Transcultural validation

Although the general instruments such as WHOQOL and SF-36, which were the most widely used in the assessed studies, in the vast majority as isolated instruments, have been validated in Portuguese in patients with clinical features that are completely different from those presented by patients with coronary disease60,61, preliminary assessments suggest that at least SF-36 has high reliability in different cultures and in different clinical conditions, and in Brazil, it showed adequate reproducibility in a population of patients with stable angina62. The other instruments (Seattle, MacNew and NHP), which are disease-specific, have been validated in the population of interest. Although there are records of translation and validation of the Seattle questionnaire for Brazilian patients with stable angina, details of the transcultural translation process have not been described62.

It is noteworthy the fact that no specific instrument for heart failure has been used in the evaluated studies. It is known that a significant proportion of patients develops heart failure after an acute coronary event and that quality of life information in patients who develop severe ventricular dysfunction in the initial period after the acute coronary event are scarce and when available, restricted to the general questionnaires.

Limitations

The studies included in the meta-analysis showed moderate heterogeneity. The scarcity of available information prevented the inclusion of only prospective cohort studies, which would clearly demonstrate the evolution of quality of life in the early and late periods after an acute coronary event, also preventing a meta-regression to identify other causes of heterogeneity.

The quality of life assessments were not adjusted for any of the clinical or socio-demographic variables studied, which are known to influence the outcome of scores. Patients enrolled in the studies were not homogeneous regarding disease time and severity, as well as the cultural variations between Brazil and Portugal. Moreover, the cross-sectional studies included in the analysis were categorized into early or late evaluation, and the missing information was imputed based on the weighted mean of the other studies within the same category. Therefore, the before and after comparison was based on study comparison and not on paired groups shown in the figures, except for the summarized scores of SF-36. Variations in mean scores may also be related to the proposed interventions for the treatment of patients, which have not been evaluated in this analysis.

These factors together prevent an accurate interpretation of the quality of life behavior in Brazilian and Portuguese patients suffering from acute coronary events and the differences between early and late assessment must be viewed with caution.

Such information, however, may be useful in formulating hypotheses and selecting the most appropriate instrument for the assessment of these populations.

Conclusion

In spite of the limitations, this review summarizes the studies carried out with instruments to evaluate quality of life, which have been translated into Portuguese, demonstrating flaws in the methods of validation and showing that information on the evolution of the QOL in Brazilian or Portuguese patients that have suffered an acute coronary event are still necessary. There has been a significant increase in the quality of life scores of 0.55 points for the MacNew questionnaire and of 5.8 points for SF-36 questionnaire. This review can be useful to create, design and carry out further studies in this area.

Acknowledgements

We thank Prof. Thomas M. Sakae for the prompt response to our contact and collaboration in providing non-published data that were important for this analysis and to librarian Maria Eduarda Puga for her invaluable help in creating the search strategy.

Co-Investigators

Andrea Ferreira Haddad, Fabio Antonio Abrantes Tuche, Monica Amorim de Oliveira (Health and Civil Defense Secretary/SMSDC-RJ), Paola Martins Presta, Raphael Kasuo Osugue, Renato Correa Alves Moreira, Rodrigo Mousinho (Pró-Cardíaco Hospital), Rodrigo de Carvalho Moreira, Karla Menezes, Sabrina Bernardez (PROCEP Teaching and Research Center).

Potential Conflict of Interest

No potential conflict of interest relevant to this article was reported.

Sources of Funding

There were no external funding sources for this study.

Study Association

This article is part of the thesis of doctoral submitted by Suzana Alves da Silva, from Escola Nacional de Saúde Pública Sérgio Arouca / Fiocruz.

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  • Quality of life assessment after acute coronary syndrome: systematic review

    Suzana Alves da SilvaI,II,III; Sonia Regina Lambert PassosIV; Mariana Teixeira CarballoIII; Mabel FigueiróIII; InvestigadoresII,V
  • Publication Dates

    • Publication in this collection
      16 Jan 2012
    • Date of issue
      Dec 2011

    History

    • Received
      11 Jan 2011
    • Reviewed
      11 Jan 2011
    • Accepted
      04 Mar 2011
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