|Year : 2019 | Volume
| Issue : 1 | Page : 43-48
Reliability and validity of a disease-specific quality of life tool in Nigerian patients with heart failure
Iseko Iyoko Iseko1, Adewole A Adebiyi2, Ayodele O Falase2
1 Department of Clinical Sciences, Division of Internal Medicine, Limi Hospital Limited, Abuja-FCT, Ibadan, Oyo State, Nigeria
2 Department of Medicine, Division of Cardiology, University College Hospital, Ibadan, Oyo State, Nigeria
|Date of Submission||13-Apr-2019|
|Date of Acceptance||12-Jun-2019|
|Date of Web Publication||22-Oct-2019|
Dr. Iseko Iyoko Iseko
1487, LM Iseko Street, Off Constitution Avenue, Central Area, Abuja-FCT
Source of Support: None, Conflict of Interest: None
Background: Heart failure results in varying limitation in activities of daily living, and consequently on the individual's quality of life. There is a thus a need for a reliable and valid tool to assess HRQoL in Nigerian patients.
Aims and Objectives: To determine the health-related quality of life of Nigerian patients with heart failure using the Minnesota Living with Heart Failure Questionnaire (MLHFQ), its validity and reliability, and its relationship between to disease severity as defined by the NYHA class.
Materials and Methods: 106 consecutive stable participants diagnosed with HF were recruited and studied. The MLHFQ was self-administered by recruited participants and NYHA class was determined by clinical evaluation. Appropriate descriptive and inferential statistical analysis was subsequently carried out.
Results: The mean age (SD) of the subjects was 56.8 (13.4) years. 41.6% of HF subjects had suboptimal HRQoL in varying degrees with a median score of 19. The MLHFQ was found to be reliable exhibiting high internal consistency (Cronbach's alpha reliability coefficient - 0.928), similarly high for each of the subscale domains and there was a significant relationship between the MLHFQ and the NYHA class (rho: 0.7706; P < 0.001), a finding that also validates the MLHFQ.
Conclusion: HRQoL evaluation in Nigerian participants with HF using the MLHFQ should be considered in routine practice as it is a reliable and valid assessment with possible significant clinical utility.
Keywords: Heart failure, Minnesota Living with Heart Failure Questionnaire, New York Heart Association class, quality of life, reliability, validity
|How to cite this article:|
Iseko II, Adebiyi AA, Falase AO. Reliability and validity of a disease-specific quality of life tool in Nigerian patients with heart failure. Nig J Cardiol 2019;16:43-8
|How to cite this URL:|
Iseko II, Adebiyi AA, Falase AO. Reliability and validity of a disease-specific quality of life tool in Nigerian patients with heart failure. Nig J Cardiol [serial online] 2019 [cited 2020 Jul 15];16:43-8. Available from: http://www.nigjcardiol.org/text.asp?2019/16/1/43/269652
| Introduction and Background|| |
Despite advances in management and new treatment options for heart failure (HF), the mortality remains marked and it has a significant effect on activities of daily living through varying degrees of functional capacity limitation which affect the health-related quality of life (HRQoL), an important index of morbidity. Although reliable estimates are lacking in Nigeria and many other countries, HF is estimated to have a 2%–3% prevalence in the adult population, increasing with age. Health-related quality of life (HRQoL) is a major goal in the context of therapeutic and preventive cardiology, and in recent years, the HRQoL has emerged as a valid measurable endpoint and indeed one of the indices for evaluating efficacy of the treatment of HF. Its emergence is likely not unrelated to increasing longevity of populations and the consequent changing demographics, a trend that has seen general interest in how to achieve “goodness” of life.,
The HRQoL can be typically evaluated using either generic or disease-specific instruments. The generic instruments, being less specific to a particular disease, apply to a wide variety of patient groups with a broad spectrum of domains relevant to HRQoL while disease-specific tools focus on areas specific to primary interest as they affect the HRQoL, in this case, HF. Of the disease-specific tools, the Minnesota Living with Heart Failure Questionnaire (MLHFQ), a disease-specific questionnaire developed by Rector et al. in 1987, is considered as the tool most commonly used in clinical trials in which HRQoL is a primary or secondary end point and has documented positive appraisal.,, Although concerns have been raised about the MLHFQ in terms of the patients' ability to separate symptoms and impairments related to HF from other comorbidities, the measure has been found to be valid in comparison with other health outcome scales. It also has documented validity, reliability, and sensitivity to change (responsiveness) from various studies;,,, however, there is a dearth of studies among Nigerian patients with HF.
| Methodology|| |
Over a 12-month period, 106 consecutive stable participants diagnosed with HF (New York Heart Association [NYHA] Class I–III), based on the Framingham criteria (concurrent presence of either two major or one major and two minor criteria), for at least 1 month attending the Cardiology Outpatient Clinic of University College Hospital, Ibadan, were recruited and studied.
Participants with acute HF and acute decompensation of chronic HF or NYHA Class IV were excluded from the study. Similarly, nonconsenting participants and those with a psychiatric diagnosis, for example, schizophrenia and depression were also excluded from the study.
The MLHFQ was self-administered by recruited participants with the help of a trained research assistant where necessary. The degree of help given by the candidate or assistant depended on each patient's ability to read, write, and comprehend the questions. The participants answered the questions without being influenced by others such as their spouse or family members as much as possible. The MLHFQ which contains 21 items with 6-point response scales ranging from 0 to 5 was scored by summating the responses to all 21 questions to produce the total (global) HRQoL score. The possible range of the total HRQoL score is from 0 to 105, with a higher score indicating poorer HRQoL., In addition, three subscale scores (dimensions) which reflect the physical dimension (items 2, 3, 4, 5, 6, 7, 12, and 13), emotional dimension (items 17, 18, 19, 20, and 21), and the other items are related to financial and medication side effects, and lifestyle considerations (overall dimensions) were scored by simple summation to further characterize the effect of HF on a patient's life (43, 70).
Data generated from the study were entered into the Statistical Package for the Social Sciences (SPSS) version 20.0 (IBM Corp., NY, USA). Descriptive statistics were carried out for continuous variables to characterize the sample through means and standard deviations (SDs). HRQoL as measured by MLHFQ was further analyzed to assess the reliability of each of its items and domains by obtaining and examining the Cronbach's alpha reliability coefficient. Validity of the MLHFQ construct, in the absence of a gold standard for HRQoL, was assessed by correlations with NYHA class. The Kruskal–Wallis test was used to assess the MLHFQ scores of the three functional classes, followed by a post hoc Bonferroni test to establish the differences among them, if any.
Being a nonbiological variable, the HRQoL did not follow a normal distribution, and this was demonstrated by the Shapiro–Wilk test. Consequent on this, median scores which represent a better measure of central tendency in this case were predominantly used as opposed to mean scores. Behlouli et al.'s MLHFQ score cutoffs determined by neural network approach were adopted where a score of <24 on the MLHFQ represents a good HRQoL, a score between 24 and 45 represents a moderate HRQoL, and a score >45 represents a poor HRQoL.
| Results|| |
The mean age (SD) of the participants was 56.8 (13.4) years with age ranging between 21 and 85 years and the frequency of males with HF being about twice that of females.
About half of the participants had postprimary school education (secondary, tertiary, and posttertiary), and most participants finance their health-care out-of-pocket expenditure [See [Table 1]].
Health-related quality of life in participants with heart failure
[Table 2] shows the distribution of HRQoL and its domains. Using Behlouli et al.'s MLHFQ classification, 62 (58.5%, 95% confidence interval (CI): 47.0–69.0) participants were classified as having good quality of life, while 22 (20.8%, 95% CI: 11.9–30.0) of the participants had moderate and 22 (20.8%, 95% CI: 11.9–30.0) had poor quality of life irrespective of HF etiology.
|Table 2: Global and subscale quality of life dimensions in participants with heart failure|
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| Reliability of the Minnesota Living With Heart Failure Quality of Life Questionnaire|| |
The Cronbach's alpha reliability coefficient, which is used to estimate the reliability of psychometric tests, such as the MLHFQ, was used to assess reliability by determining the internal consistency. It determines how closely related a set of items are as a group and to know that the instrument used will always elicit a consistent and reliable response even if questions were replaced with other similar questions. It is a function of the number of items in the test, the average covariance between item pairs, and the variance of the total score.
The value of Cronbach's alpha varies from 0 to 1, with higher values being more desirable. A reliability of 0.70 or higher is generally regarded as an acceptable reliability coefficient.
The three domain scores of MLHFQ had an overall reliability coefficient (Cronbach's alpha) of 0.928 indicating high degree of internal consistency. The largest domain – global correlation coefficients – was noticed for physical domain (rho: 0.931), followed by overall domain (rho: 0.870) and emotional domain (rho: 0.801).
Reliability coefficient of individual domains showed that physical domain had the highest internal consistency (Cronbach's alpha: 0.927), followed by emotional domain (Cronbach's alpha: 0.814), while the overall domain had the least internal consistency (Cronbach's alpha: 0.767).
Validity of the Minnesota Living with Heart Failure Quality of Life Questionnaire
Global scores showed a significant difference between different NYHA classes with post hoc testing showing significant between all groups. Participants with different NYHA severity also differed in all domains of the MLHFQ.
NYHA class differences resulted in distinctive domain and global score profiles, as shown in [Figure 1]. These were significant after performing a MANOVA for domain scores across groups (Pillai T2 = 10.165, P < 0.001).
|Figure 1: Profile of the Minnesota Living with Heart Failure Questionnaire scores for the New York Heart Association classes|
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[Table 3] shows a statistically significant relationship between the NYHA class and the MLHFQ score (global score and subscale domain scores). The post hoc Bonferroni test done showed that the differences observed between the individual functional classes were similarly significant (i.e., between Classes I and II and between Classes II and III).
|Table 3: The Minnesota Living with Heart Failure Questionnaire scores across various NYHA classes (Kruskal–Wallis test)|
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| Discussion|| |
Growing in its relevance and application in chronic diseases, the HRQoL in HF plays an important role as a treatment endpoint for intervention studies and also as a prognostic tool in the routine management of HF participants. Compared to other chronic diseases, the HRQoL is affected relatively more in HF and is an important patient-reported goal of treatment compared to the duration of life.,
The HRQoL in participants as assessed by the MLHFQ with HF in this study was poor in 20.8% of participants while an additional 20.8% had moderate HRQoL, making a total of 41.6% of participants with suboptimal HRQoL in varying degrees. Quality of life has been reported to be affected significantly to varying degrees in participants with HF from other studies, and in some, it has also been shown to have prognostic value.,,,, In a study from Lagos, Mbakwem reported 27.36% of HF participants with suboptimal quality of life using the Kansas City Cardiomyopathy Questionnaire (KCCQ), a disease-specific questionnaire.
However, with a group mean of 23.8 and median of 19.0, the global HRQoL was relatively low, a finding which was similar to research from Spain which reported a median of 28. This may perhaps be the consequence of nondisclosure of sexual-related features and relative amelioration or alteration in perspective on emotional issues following religious and spiritual inclinations of the populace. This may possibly suggest that the questionnaire might need some adaptation to better represent the prevailing needs and values to the Nigerian context.
All the measured domains of quality of life in HF participants are affected with the physical domain (median: 8; interquartile range: 3–17) being affected more than emotional domain (median: 3; interquartile range: 0–3). While it is sometimes suggested that the emotional domain of quality of life may be less affected in Nigerians because of the extended family support systems that exist,, no statistically significant correlation or association was found between living alone or the number of caregivers and the emotional domain of the HRQoL in this study.
Literature documenting appraisal of the MLHFQ tool in Nigerian participants with HF is at a dearth, and this study documents the reliability using statistical tools and the validity by determining the relationship of the MLHFQ to existing traditional clinical outcome variables in routine use in Nigeria such as the NYHA classification and the distance covered during a standard 6-min walk test.
Reliability of the Minnesota Living with Heart Failure Questionnaire
The MLHFQ reliability coefficient was measured by examining the Cronbach's alpha, a reliability estimate for psychometric tests, for the global MLHFQ score and all its subscale domains. In this study, the global MLHFQ score had a Cronbach's alpha (reliability coefficient) of 0.928 indicating high internal consistency, and it was similarly high for each of the subscale domains (0.801–0.931). Having demonstrated a high internal consistency coefficient, the inter-item correlation of the MLHFQ indicated the absence of repetitive questions, i.e., questions on the MLHFQ that essentially tests the same thing. Such high internal consistency as seen in this study suggests that the total MLHFQ score measures a single construct, in this case presumed to be the effect of HF on a patient's quality of life. This finding is a similar finding of the reliability coefficient reported by several other authors in the appraisal of the MLHFQ,,, and the item-total correlation coefficients in the 21 items, and discriminative ability in all items and subscale were within acceptable limits as similarly reported by Heo et al. in a study examining the psychometric properties of the MLHFQ.
| Validity of the Minnesota Living With Heart Failure Questionnaire and Its Relationship to the New York Heart Association Class|| |
The validity of the MLHFQ as with other HRQoL tools refers to the assessment of whether the tool is measuring what it is supposed to measure. The absence of a gold standard for HRQoL means that the validity determination of the HRQoL tool necessitates the examination of the MLHFQ discriminant validity by determining whether the dimensions of the MLHFQ were able to distinguish between participants with different levels of HF severity as determined by other variables (in this study, NYHA)., The correlation between the MLHFQ score (global and subdomains) and the NYHA class in this study demonstrated statistical significance (P < 0.001) more so with the physical domain score as expected. This relationship is rather unsurprising as the NYHA classification is essentially a provider-derived classification scheme to categorize participants in terms of symptoms associated with daily activities. The trend toward higher MLHFQ scores with worsening NYHA functional class in participants with HF was demonstrated [Figure 2], and this finding was statistically significant. Such a trend is a characteristic finding in the MLHFQ validation studies and was demonstrated similarly by Parajón et al. and Morcillo et al. in studies from Spain.
|Figure 2: Box plot showing the Minnesota Living with Heart Failure Questionnaire scores for each New York Heart Association functional class|
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The relationship of NYHA class to HRQoL was not clearly demonstrated by Ola et al. although their study was carried out with a generic HRQoL questionnaire, and this may account for that finding. However, while using another disease-specific HRQoL measure (KCCQ), a statistically significant correlation between NYHA class and HRQoL was demonstrated by Mbakwem.
Although at the time of this study there has been no available published MLHFQ validity data from Nigeria, the validity of this tool has been demonstrated in previous studies carried out in other parts of the world.,,,,
| Conclusion|| |
Being a patient-reported outcome measure, HRQoL assessment in HF corroborates with the global trend towards patient-centered care as a goal of healthcare systems,, and its addition to the traditional approach to patient evaluation is therefore of increasing importance and value.
The evaluation of HRQoL in Nigerian participants with HF using the MLHFQ is a reliable and valid assessment with significant clinical utility, and thus, it should be considered in routine practice and research evaluations of participants with HF.
Informed consent was obtained from all individual participants included in the study.
Declaration of patient consent
The authors certify that they have obtained all appropriate patient consent forms. In the form, the patients have given their consent for their images and other clinical information to be reported in the journal. The patients understand that their names and initials will not be published and due efforts will be made to conceal their identity, but anonymity cannot be guaranteed.
Financial support and sponsorship
This was a self-funded study.
Conflicts of interest
There are no conflicts of interest.
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[Figure 1], [Figure 2]
[Table 1], [Table 2], [Table 3]