Heart failure (HF) is one the major challenges of health care, with an estimated prevalence of 26 million worldwide and 5.7 million in the United States^[1]. It is predicted that the overall prevalence of the disease in the US will approximately be 8 million by 2030. The annual incidence of HF reaches 10 per 1000 populations after 65 years of age. The number of Spanish speaking people in the US is 53 million, 17% of the total US population. It is estimated that the incidence rate of HF in Hispanicsis 3.5 per 1000 person-years which is higher than in Caucasians (2.4 per 1000 person-years), but lower than in African-Americans (4.6 per 1000 person-years)^[2,3].

HF causes a variety of physical and emotional symptoms, impacting patients’ quality of life (QoL)^[4]. Hence, assessing QoL is an essential step in the overall evaluation of HF patients. Traditionally New York Heart Association (NYHA) classification has been used to assess HF severity. However it is only an approximate expression of a physician’s opinion. Therefore, the merit of its use as a valid single outcome measure in clinical trials is questionable. In order to address this issue, patient-reported questionnaires were developed and have been broadly used in order to acquire information on patients’ perception of their own state of well-being^[5]. These questionnaires should be valid, reliable, and sensitive to clinical changes. The questionnaires should be adapted cross-culturally to maintain the content and validity of the original version and to prevent language and cultural biases^[6].

The Minnesota Living with HF Questionnaire (MLHFQ) has been used as a key outcome measure in studies and evaluations of patients with symptomatic HF and has been translated into different languages. Although it has been translated into Spanish in the past, there appears to be scarcity invalidation and achieving equivalence in every aspect of translation into a new culture^[7]. This necessitates further exploration into designing a valid translation tool consistent with the culture of the Spanish population in the US. This study aims to translate and validate a new version of the questionnaire to achieve this goal.

Methods

The minnesota living with heart failure questionnaire

The MLHFQ is a self-administered disease-specific questionnaire for patients with HF^[8], containing 21 items rated on the six-point Likert scale, representing important physical, emotional and socioeconomic ways HF can adversely affect a patient’s quality of life, from 0 (none) to 5 (very much) to indicate how much each specified adverse of HF has prevented the patient from living as he or she wanted to live during the past 4 weeks. The questionnaire is scored by the total of all 21 responses. It provides a total score range from 0 to 105, with lower scores indicating better health status and quality of life. It also provides scores for two dimensions, physical (8 items, range 0-40) and emotional (5 items, range 0-25) (Table 1). The other eight items (of the total of 21) are only considered for the calculation of the total score.

Process of translation into Spanish

We followed the recommended protocol of the Mapi Research Trust^[9] as well as the principles ordered by the Translation and Cultural Adaptation working group^[10]. The standard forward-backward translation (Linguistic validation) was done by three professional translators that did the forward translation from English to Spanish independently. After receiving forward translations, expert committee meetings with the three forward translators: An independent cardiologist and an independent professional translator were arranged to resolve the discrepancies among translations. These sessions were civil agreements about the existing differences among translation of each of the three translators. The team reached on an agreement regarding the most suitable word for each case. Finally, a single matched and revised questionnaire in Spanish was achieved.

Afterwards, the process of backward translation from Spanish to English was done by three different translators. For the next step, in a meeting in the presence of all translators, independent cardiologists, and independent professional translators, the original questionnaire of MLHFQ was reviewed and the backward translated questionnaire was compared with the original one. The discovered differences between the backward translated questionnaire and the original MLHFQ questionnaire were sent to another independent translator along with the backward translators’ explanations for each difference. In the end, the pre-final Spanish version of MLHFQ was established.

Pilot study

After the translation process, the Spanish version of the MLHFQ was tested in a pilot study by administering the questionnaire to 30 inpatient Spanish communicatory adults who were admitted for HF exacerbation for “cognitive debriefing”, and to two independent cardiologists for “clinician’s review.” According to the results of the pilot study and feedbacks from independent cardiologists and translators, the questionnaire was edited for the last time, and the final Spanish version of the MLHFQ was produced.

Study design

A total of 430 Spanish-speaking patients with HF, confirmed by echocardiography and laboratory tests were included in the study. Informed consent was obtained from all the participants in the study. Patients were admitted because of HF exacerbation at four hospitals in the states of New York and California from October 2016 to December 2017. Exclusion criteria included unwillingness to participate, cognitive disorders, loss to follow up and death. A total of 86 patients were excluded: 16 patients did not agree to participate in the study, 25 patients died and 45 patients did not participate in follow up visits. In the end, 344 patients were included in the study. All patients filled out Spanish versions of MLHFQ and the short form health survey (SF-12) once when they were admitted at the hospital and a second time during the outpatient follow up, four weeks post-discharge in the clinic. Only fully completed questionnaires were used for the analysis.

During the follow up encounter, each patient was visited by an independent cardiologist, who was then asked to designate the patient to a specific NYHA class, blinded to the patient’s NYHA functional class MLHFQ records during admission at the hospital.

SF-12 questionnaire

The SF-12 is a generic questionnaire for assessing Health-related quality of life^[11], comprising 12 items and two summary scales: the physical and mental component summary (PCS and MCS). The scores for these components range from 0 to 100, with higher scores indicating better health status.

Statistical analysis

Statistical analyses for patients’ characteristics, and their QoL scores, were performed using parametric or non-parametric tests depending on the distribution of the variables. Reliability was assessed by evaluating internal consistency and test-retest reliability. Internal consistency demonstrates to what extent the items of the questionnaire are inter-correlated or whether the measurement of the same construct is consistent, using Cronbach’s alpha coefficient, and test-retest reliability estimated by the mean of intra class correlation coefficient (ICC). After analyzing the reliability, Spearman correlation coefficient of the MLHFQ and SF-12 was used to assess construct validity of the questionnaire. Correlation coefficient > 0.5 was considered as strong correlation, indicating convergent validity, while divergent validity was defined as weak correlation coefficient (<0.4). IBM SPSS Statistics Version 25 was used for statistical analyses.

Results

The Spanish version of MLHFQ was completed by 344 patients. Mean age of the participants was 74.7 ± 9.1 years, and 52.9% were females. No patient was in NYHA I, while a total of 88% were in NYHA grade III and IV. 9 patients, who were in class IV during admission, ended up in class III on follow up visit. Table 1 represents demographic features and QoL scores during inpatient and outpatient evaluations.

Table 1: Demographic characteristics and health-related quality of life scores

No specific question was consistently left unanswered. No items had more than 6% missing data. The reliability coefficients for Spanish version of MLHFQ in the different domains ranged between 0.73 and 0.94, showing the satisfactory internal consistency of the questionnaire, as Cronbach’s alpha was 0.93 for the total scale, and its overall score demonstrated high reproducibility (ICC, 0.91, P < 0.001).

Data analysis shows a significant difference among mean MLHFQ scores in each NYHA functional class, demonstrating that the MLHFQ score in each NYHA class is significantly different than the others. The results of the analysis illustrate that as the NYHA class goes up, the MLHFQ scores in all dimensions increase, while SF-12 scores decrease (Table 2). There was no significant correlation between patients’ age and their MLHFQ scores.

Table 2: Relationship between MLHFQ scores and NYHA functional class

Analysis shows a significant positive correlation between NYHA functional class and MLHFQ. The construct validity of MLHFQ dimensions was assessed by multi-trait-multi-method approach, using Campbell and Fiske. Data shows high correlations between similar dimensions in both MLHFQ and SF-12. Table 3 shows the result of the multi-trait–multi-method matrices, constructed to illustrate the high correlation coefficients between physical and mental components of SF-12 with total MLHFQ, supporting the convergent validity of the measuring scale (negative correlation coefficients indicates the reverse scales).

Table 3: Correlation between total MLHFQ score, and NYHA functional class and SF-12 dimensions

All Correlationswere significant at the 0.01 level (2-tailed).

Discussion

Chest pain, shortness of breath and fatigue are associated with a lower QoL and consequently lower satisfaction with life among patients suffering from HF. It is expected that the number of Hispanics people living in the US to increase to over 120 million by 2060, estimating almost 1 of 3 US residents to be Hispanic^[12]. In most Hispanic patients, Spanish is the first language and sometimes the only language. HF has been shown to be a disorder that significantly affects patients QoL. In a study on 257 elderly Hispanics in a long-term facility, 67 (26%) developed HF at 43-month follow-up^[13].

With the NYHA classification using subjective measures of patient activity in classification of heart disease, it is relevant to discuss the validity of its use in patients with communication barriers including language and health literacy. A study by Sarkar et al. analyzed the use of questionnaires for patient and physicians attending cardiology clinic to assess the patients’ functional status, barriers in disease management, diagnosis of heart disease and treatment with the patient population consisting of a diverse cultural group. The study revealed that in 50% of the cases, physicians underestimated the NYHA class of the patient^[14]. As well, there were significant discrepancies in physician awareness of patient medication and also patient barriers in treatment adherence. This underlies a key determinant in health care and outcome. Analysis of differences in the health status of patients when comparing ethnicity, sex, and socio-economic status underlie personal health understanding as a key factor in adherence. Though standardized surveys exist, they do not account for differences in culture, language, and socio-economic status which determine the patient’s understanding of their disease. Use of calibrated questionnaires designed for a specific population outline a solution to the physician-patient relationship to further improve communication and healthcare literacy so the barriers of understanding and adherence can be overcome^[15].

The MLHFQ is one the most commonly used questionnaires to evaluate QoL in patients with HF. The validity of the questionnaire has been evaluated, using other QoL questionnaires such as short form 36 (SF-36)[5]. The presented Spanish version of MLHFQ showed excellent characteristics comparable to the original version in terms of internal consistency, reproducibility and convergent validity. The high reliability and excellent correlation coefficients support the merits of its use in assessments of QoL in the Spanish population of patients with HF in the US.

The majority of studies, which evaluated QoL in patients with HF among Spanish populations, using MLHFQ have been performed in inpatient settings, while in the current study the trend of changes in patients’ QoL was also followed in outpatient visits, and the patients’ scores in both settings were compared^[16-18]. Only a small percentage of questionnaire items were remained unfilled, indicating its good acceptability. The lack of floor and ceiling effects (percentage of patients with worst and best scores respectively) shows that the content of translation better reflects patients concerns, and it is a reliable indicator of patients’ improvements or deterioration. This result is in contrast to some other studies that found both ceiling and floor effects^[19].

Internal consistency in every dimensions has been shown by high Cronbach alpha coefficients above 0.9, which provides excellent support for reliability of the questionnaire, similar to reported findings in studies involving the Greek, Chinese and Portuguese versions of the questionnaire^[20-22], while it is different from the Brazilian and Dutch studies that reported Cronbach’s alphas of 0.80 and 0.85 respectively^[23,24].

The validation of the previous version of the Spanish translation of MLHFQ in primary care settings showed Cronbach’s alpha ranged from 0.79 to 0.94 for the various MLHFQ dimensions, which is similar to our range, although the study setting was different^[5]. While because of cultural variations in different countries, we expected to see discrepancies in study findings, the actual results of the above mentioned studies show relative similarities. This could be related to the high consistency of the questionnaire items themselves, and similar methodological approach that was taken by each team.

NYHA functional classification has long been used as a measure of severity in patients with HF, and MLHFQ has been expected to be beneficial in assessment of the severity of disease in HF patients[23]. Our study shows that MLHFQ can efficiently differentiate NYHA classes in both inpatient and outpatient evaluations, and the patients’ MLHFQ scores are strongly correlated with their NYHA functional class, confirming the hypothesis. This result is consistent with the findings of Spanish and Portuguese studies that showed a similar pattern of correlations^[16,22].

With regard to the construct validity, analyzed data reveals that the MLHFQ scores has strong correlation coefficients with either dimensions of SF-12, providing a satisfactory evidence of its construct validity. As the MLHFQ score increases, indicating the patient has a poorer QoL, the patient’s SF-12 score on both dimensions decreases. This result is consistent with the findings of the Italian version, which used the same scale for the construct validity^[25,26].

Conclusion

Our study has shown that the new Spanish version of MLHFQ has excellent reliability and validity in assessment of QoL in patients with HF. Considering its cross-cultural characteristics, it provides a useful instrument in studies involving Spanish population of the U.S, while its validity to be used in HF patients in other Spanish-speaking countries requires further investigations.

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