MS is a neurological disease that primarily affects young adults. Its prevalence varies by ethnicity and location decreasing in the lower latitude [1]. According to recent data from the World Health Organization (WHO), the estimated number of people with MS worldwide increased from 2.1 million in 2008 to 2.3 million in 2013 [2]. Although its etiology remains uncertain, evidence suggests that MS is an immune-mediated attack on myelin with secondary destruction of axons causing progressive disability [3]. The disease’s symptoms include weakness, fatigue, sensory loss, dizziness, lack of coordination, sexual dysfunction, urinary incontinence, optic atrophy, dysarthria, and mental problems. The longevity of patients with MS is about eight years less than that of a healthy person. Longevity is bimodally distributed with many patients having normal longevity and some dying at a significantly younger age depending on disease aggressiveness, disability severity, infection, or suicide [4,5]. One third of patients with MS will need to use a wheelchair. About two-thirds will have disabilities that prevent them from working [6]. It is important to incorporate a quality of life (QoL) evaluation from the beginning, during patient monitoring, and when evaluating the effects of the treatment used [1].

In 1995, Vickrey et al. [5] at the University of California in Los Angeles (UCLA) developed a specific instrument for the MS population with 12 sub-scales; all showed good internal consistency with Cronbach's alphas, 0.75–0.96 and good reliability, with test-retest intraclass correlation coefficients in ranging from 0.66–0.96. This instrument, the MSQoL-54, was translated into multiple languages [4,7-14] and has since been one of the most utilized questionnaires in the scientific community.

The objective of this study was to translate and transculturally adapt the MSQoL-54 to Brazilian Portuguese. Then, its reliability will be evaluated, making it available for use in the Brazilian scientific community.

Permission to use the MSQoL-54 instrument was requested from the original author of this questionnaire who approved the translation into Brazilian Portuguese.

In general, there are four main steps involved in a linguistic validation of an instrument: translation (from the original to the intended language), back-translation (quality control), comprehension testing, and international harmonization. The function of each step is to improve the translation’s quality for conceptual equivalence between the original and translated instruments enabling easy patient understanding [1]. The Free and Informed Consent Form was signed by the participants in the pre-test phase. They received all research information, including that data would be kept confidential and that they could leave the study at any time.

Instruments

The MSQoL-54 has 54 items, 36 of which belong to the generic Short Form 36 Health Survey (SF-36). It then added 18 additional specific items related to MS. It is a structured self-report questionnaire that the patient can usually complete with little or no assistance, except for those with disease-related clinical deficiencies. Of the 54 items that comprise the instrument, 52 measure 12 health-related QoL scales, evaluating two major components: physical health and mental health (Table 1). There are also two additional measurements; one is part of the SF-36, “change in health,” and the other is from the 18 specific items, “satisfaction with sexual function.”

Table 1: Schema representing the 2 components, 12 domains and 54 items of the MSQoL-54 Translation of 18 specific items.

This article describes the translation into Portuguese (Brazil) of 18 specific items for evaluating QoL in MS patients translated, a process similar to what occurred in other languages where the SF-36 had also already been validated [4,7,8,13]. The SF-36 was previously translated, adapted, validated, and published in Brazilian Portuguese [15] and is widely used. The translation of the MSQoL-54 instrument to Brazilian Portuguese was completed per international recommendations [16] and other articles that used equivalent methodology [7,13] (Table 2).

Table 2: Description of the phases of the study of translation.

All the patients who participated in the last phase were mostly women (70%) with a mean age of 42 ± 9.67 years (26–59 years), diagnosed with MS for a mean of 7.67 ± 4.36 years. Of them, 70% had completed secondary school. All were in MS treatment, eight with glatiramer acetate (80%) and two with beta interferon. The mean response time for the 18 items was five minutes.

The MSQoL-54 was well accepted and easily administered to the study population. None of the items was identified by the patient sample as being embarrassing.

Four (40%) of the participants marked the option “not applicable,” which had been added to evaluate comprehension of the question. They said that they did not know how to proceed. They understood the items, but since they had not had sexual relations in the last four weeks, they had no way to mark any of the alternatives. Thus, there was no need to revise version 2, as described in the results.

Of the patients who participated in the pre-test, four marked the option “not applicable.” This was not an interpretation, embarrassment, or misunderstanding problem, but rather because they had not had sexual intercourse in the last four weeks. This can also be observed in other studies on translations of the MSQoL-54 [10-14], including the original [4]. Among these, some also observed that the highest percentage of items with no response on sexual function and satisfaction with sexual function come from female patients [10,12,14]. This differs from our results where the proportion was 1:1, but in a smaller sample than that of the validation. To explain these results, the study conducted in Turkey suggested that this was due to the fact that people with MS may find sex-related items distressing, difficult to understand, or too private [12]. Solari et al. also found this in the Italian validation study and they attributed this result to the social and cultural characteristics of Italian society [14].

The fact that the MSQoL-54 was well accepted and that there was no embarrassment about answering the items was also observed in other studies. However, these results are presented primarily in the validation phase. The Turkish version presented a similar result, but the women said that they only found the sexual satisfaction and sexual function domain-related items to be embarrassing [12].

It was not possible to discuss linguistics, which deals with tool translation into a language different from both the original and the other languages in which articles on the transcultural translation of the MSQoL-54 have been published [7-9]. Therefore, the researchers conducted a conceptual review on the idiomatic, semantic, and conceptual equivalence of item content of the final Portuguese version.

We wanted to understand the specific items and alternatives that presented discrepancies in translation, as well as the committee’s work to improve the semantics prior to the final version. Below we individually describe the items they addressed to improve understanding (Table 3).

Table 3: Result of translation of the MSQoL-54 instrument to Brazilian Portuguese.

To better follow the translation of items from 38 through 45, it is important to present the English instruction to which they refer. “How much of the time during the past four weeks...” is translated into Portuguese as “Quanto tempo, nas últimas 4 semanas.” To understand this phrase in Portuguese, it is not necessary to maintain the word “durante” as in the original (“during”). This title is used in two domains: “Health Distress,” which comprises items 38 through 41, and “Cognitive Function,” formed by items 42–45. In Portuguese, these are “Função Cognitiva” and “Preocupação com a Saúde,” respectively, discussed below.

The patients judged the questionnaire to be quick and easy to understand, but we must consider that this sample responded only to the 18 items evaluated [7] out of the 54 that comprise the tool. Considering that they took an average of five minutes to answer, the 54 items would thus take 15 minutes, which is consistent with what the instrument’s author suggests [4]. The most debated items were also cited by Acquadro in the French Canadian version [7]; the problems occurred mainly due to semantics. For the Portuguese questionnaire to have the same result when it is used, it should follow the patterns of the study’s circumstances. It is well known that it is an instrument that can be completed in an environment with other patients, i.e., in waiting rooms. It is also well known that the result will only be reliable if the patient does not receive any support from their family on the best response. This does not prevent the patient from receiving help to read or complete the items due to any clinical difficulties, despite being a self-assessment questionnaire. If the respondent has trouble understanding it, they should read it as many times as necessary, but may not receive any help with interpreting it.

The results of this study were positive and the Portuguese-language MSQoL-54 instrument is in the process of being validated.

The authors would like to thank the translator Jonathan Hutchins who worked on the back-translation, the Dr. Mariana Socal who worked on the translation (from the original to the Brazilian Portuguese), the Dr. Patrícia Picon for the support to the methodology, the study participants, the neurology ambulatory-HCPA, the FIPE, and Dr. Barbara Vickrey for her authorization and support.

The research project followed the Declaration of Helsinki approved by the Brazil Plataform (CAAE 17172313.5.0000.5327). All patients received clarification regarding the research process and signed the informed consent form. Legal guardians signed the forms for minors and patients with severe illness.

The authors declare no potential conflict of interest with respect to the research, authorship and/or publication of this article.

This work was supported by FIPE-HCPA (Research and Events Support Fund at Hospital de Clínicas de Porto Alegre) grant number 110155.

1. Brønnum-Hansen H, Koch-Henriksen N, Stenager E (2011) The Danish multiple sclerosis registry. Scand J Public Health 39: 62-64.
2. Federation MSI (2014) What is multiple sclerosis? London.
3. Pereira T, Lineu A, Ruffino A (2012) Aspectos epidemiológicos da tuberculose em crianças e adolescentes no Rio de Janeiro. J Pediatr 88: 335-340.
4. Yamamoto T, Ogata K, Katagishi M, Shimizu H, Ogawa M, et al. (2004) Validation of the Japanese-translated version multiple sclerosis Quality of Life-54 instrument. Rinsho Shinkeigaku 44: 417-421.
5. Vickrey BG, Hays RD, Harooni R, Myers LW, Ellison GW (1995) A health-related quality of life measure for multiple sclerosis. Qual Life Res 4: 187-206.
6. Fragoso YD, Adoni T, Anacleto A, da Gama PD, Goncalves MV, et al. (2014) Recommendations on diagnosis and treatment of depression in patients with multiple sclerosis. Pract Neurol 14: 206-209.
7. Acquadro C, Lafortune L, Mear I (2003) Quality of life in multiple sclerosis: Translation in French Canadian of the MSQoL-54. Health Qual Life Outcomes 1: 70.
8. Fernández O, Fernández V, Baumstarck-Barrau K, Muñoz L, Alvarez MDMG, et al. (2011) Spanish adaptation of the disease-specific questionnaire MSQOL-54 in multiple sclerosis patients. Neurologia 21: 181-187.
9. Bonniaud V, Parratte B (2006) Cross-cultural adaptation of health-related quality of life questionnaire: English version of Qualiveen abstract. Ann Readapt Med Phys 49: 92-99.
10. Füvesi J, Bencsik K, Benedek K, Mátyás K, Mészáros E, et al. (2008) Cross-cultural adaptation and validation of the 'Multiple Sclerosis Quality of Life Instrument' in Hungarian. Mult Scler 14: 391-398.
11. Ghaem H, Borhani Haghighi A, Jafari P, Nikseresht AR (2007) Validity and reliability of the Persian version of the multiple sclerosis quality of life questionnaire. Neurol India 55: 369-375.
12. Idiman E, Uzunel F, Ozakbas S, Yozbatiran N, Oguz M, et al. (2006) Cross-cultural adaptation and validation of multiple sclerosis quality of life questionnaire (MSQOL-54) in a Turkish multiple sclerosis sample. J Neurol Sci 240: 77-80.
13. Pekmezovic T, Kisic Tepavcevic D, Kostic J, Drulovic J (2007) Validation and cross-cultural adaptation of the disease-specific questionnaire MSQOL-54 in Serbian multiple sclerosis patients sample. Qual Life Res 16: 1383-1387.
14. Solari A, Filippini G, Mendozzi L, Ghezzi A, Cifani S, et al. (1999) Validation of Italian multiple sclerosis quality of life 54 questionnaire. J Neurol Neurosurg Psychiatry 67: 158-162.
15. Ciconelli R (1999) Brasilian-Portuguese version of the SF-36. A reliable and valid quality of life outcome measure. Brazilian J of Rheumatology 39: 143-150.
16. Mear I (2002) Difficulties of international clinical trials: cultural adaptation of quality of the life questionnaires, in Health-related quality of life and patient-reported outcomes: Scientific and useful outcome criteria. Springer Verlag Publishers, Paris.