Introduction
Multiple Sclerosis (MS) is a neurodegenerative disease characterized by chronic inflammation, demyelination, and scarring of the central nervous system. Symptoms include weakness, fatigue, sensory loss, vertigo, lack of coordination, impotence or sexual dysfunction, urinary incontinence, optic atrophy, dysarthria, and mental problems [
1,
2]. The average age at onset of MS is 30 years, and the disease runs its course for the remainder of the patient's life frequently causing disability of varying degrees [
1]. The prevalence of MS varies with both geography and ethnic background with women twice as likely to be afflicted as men [
3]. With an estimated 35,000 sufferers, Canada is considered a high frequency area with an average of between 55 and 202 per 10,000 persons [
4].
While the effect of MS on life expectancy remains controversial, the disease's negative effect on health-related quality of life (HRQoL) is documented and a topic currently undergoing clinical study [
5‐
7]. Several studies have shown that HRQoL assessments provide unique information not measured by the Kurtzke's Expanded Disability Status Scale (EDSS), the commonly used outcome measure of impairment disability for MS patients [
8‐
10]. As an alternative indicators of the impact of the disease on a patient's life, self-reported HRQoL focuses more attention on MS patients as a whole, in addition to focusing on physical problems [
11,
12].
From the perspective of patients' organizations and regulatory agencies HRQOL assessments are increasingly seen as additional sources of information on the safety and efficacy of treatments, particularly important in chronic progressive, disabling diseases for which there is no cure [
13]. Although the main use of HRQoL instruments has been in the context of clinical trials, the observation that measures of patients' perception of their health do not overlap with clinician assessments of disability reinforces the importance of developing HRQoL instruments for use in routine clinical practice [
14,
15]. Rothwell
et al. have shown that physical disability may not always be the main determinant of overall health related quality of life. Furthermore, their study showed that patient with MS are less concerned than their clinicians about physical disability in their illness [
15]. Provinciali
et al. have shown that including HRQoL in their multidimensional assessment protocol provides a detailed and sensitive evaluation of patients' disability profile and perceived difficulties thereby allowing clinicians to develop a care program tailored to each individual's needs [
16]. HRQoL measures can also serve as screening instruments for patients reporting changes in symptom severity or functional ability. The quality of life data can be used to involve patients and family members in clinical decision-making [
17].
The MSQOL-54 questionnaire was developed to measure HRQoL in patients suffering from multiple sclerosis [
18]. Composed of the Short Form 36 Item Health survey (Short Form-36 or SF-36) [
19,
20] and 18 disease specific items, this 54-item self-report measure combines the strength of generic and disease specific approaches to HRQoL measurement. By complementing the SF-36 with questions focusing on the specific domains affected by MS it becomes possible to compare the HRQOL of a patient suffering from MS with the HRQoL of the general population and the HRQOL of patients with other diseases. In routine clinical practice the instrument could be used to evaluate the differences in HRQoL of individuals at various stages of MS.
The MSQOL-54 has been used in the United States and has proven a valuable instrument for measuring HRQoL in MS [
21‐
23]. The questionnaire has also been translated into both Italian [
24] and French [
25,
26].
The objective of this study was to translate the MSQOL-54 into French Canadian, and to make it available to the Canadian scientific community for clinical research and clinical practice.
Results
What follows is an overview of the problems encountered and the solving process. Minor changes made for typographical or grammatical reasons are not discussed.
As both gender populations will use these questionnaires both forms will be used in the translation wherever appropriate.
Title: "Multiple Sclerosis Quality of life (MSQOL-54)
It was suggested that "Questionnaire de Qualité de vie sur la sclérose en plaques" (Quality of Life Questionnaire on multiple sclerosis) was not satisfactory as the notion of "sur la sclérose en plaques" (on multiple sclerosis) was not idiomatic. As a result of the discussions between the French Canadian team and Mapi Research Institute it was decided that "Questionnaire de Qualité de vie dans la sclérose en plaques"(Quality of Life Questionnaire in multiple sclerosis) was more understandable and more accepted in spoken French Canadian.
Instructions
• First instruction sentence: "The survey asks you about your health and daily activities"
In French Canadian it is impossible to use a literal translation of the verb "to ask" in this context because in spoken French only a person can ask something of another person, a survey cannot. After discussion with the French Canadian consultant, it was decided to render "asks you about" as "porte sur" (concerns), a much more idiomatic verb in this sense.
• Second instruction sentence: "Answer every question by ticking the appropriate statement"
As it is not idiomatic to use the verb "tick" in French Canadian, it was decided to use "cocher" (cross), the usual way to mark answers in this language.
• Third instruction sentence: " If you are unsure how to answer a question, please give the best answer you can."
The notion "If you are unsure…" was initially translated as " En cas d'hésitation…" (In case of hesitation…). However, subsequent to review and recommendation, it was decided to change this to "En cas de doute…"(In case of doubt…), as the French Canadian population more readily understands it.
Item by Item Review
• Item 38: "Were you discouraged by you health problems?"
The item was originally translated as "Avez-vous été découragé(e)…" (Have you been discouraged…). After review, it was recommended to harmonize the structure of this item with the one used in items 39 and 41 respectively in order to maintain fluency in French Canadian. Thus "Have you been discouraged…" was changed to "Vous êtes-vous senti(e) découragé(e)… " (Have you felt discouraged…).
• Item 40: "Was your health a worry in your life?"
This item was originally translated as "Did your health worry you?" which is not equivalent to the original as the notion of "in your life" was not included. Following the backward translation step it was decided to reword the question to include "dans votre vie" (in your life) to maintain the original documents intent and include a notion of duration. As a result " Votre santé a-t-elle été un souci dans votre vie?" (Has your health been a worry in your life?) was adopted in French Canadian.
• Item 43: "Did you have trouble keeping attention on an activity for long"
The original expression "keeping attention" was initially translated to "se concentrer " (to concentrate). This form was determined to be too restrictive since to concentrate is an action with no notion of duration. After discussions with the French Canadian consultant following the backward translation step, it was decided to adopt "rester concentré(e) " (remain concentrated) to include the duration factor.
• Item 45: "Have others, such as family members or friends, noticed that you have trouble with your memory or problems with your concentration?"
The concept of "noticed" was initially translated as "pointed out to you". During the backward translation step it was determined that the original did not reflect the notion that the family pointed this out to the patient and was worded in such a way that the patient might have heard these things indirectly or by chance. "Faire remarquer" (to point out) refers explicitly to a verbal exchange between the patient and his/her family or friends, while "remarquer" (remark, notice) simply refers to the fact that the patient's friends or family noticed his/her problems with memory but did not necessarily mention them to the patient. It was therefore determined to replace the concept of "faire remarquer" (pointed out) with "remarqué" (noticed) following the backward translation step.
• Subtitle: "Sexual Function"
A literal translation was initially rendered but after Cognitive debriefing the translation was deemed too technical. As a result the French Canadian term "Vie Sexuelle" (Sexual life) was adopted.
• Item 49: "Ability to satisfy sexual Partner"
The French Canadian team initially suggested translating "ability" as "incapacity" given that items 46, 47, and 48 used negative wording to refer to sexual problems/dysfunctions. Item 46 refers to "lack of sexual interest", 47 to "difficulty getting or keeping an erection/inadequate lubrication, and 48 "difficulty having orgasm". Following discussion between The Project Manager and Mapi Research Institute, it was determined that use of the term "incapacité" (incapacity) would carry a distinctly negative connotation thereby discouraging the patients to rate ability even if the ability exists in a reduced form. "Incapacité" was replaced by "capacité" (capacity) to better reflect the original document and thus remain more neutral, and less influential on patient's judgment of self.
Cognitive Debriefing
The French Canadian version of the MSQOL-54 was tested on five French Canadian subjects with multiple sclerosis. The mean age of the subjects was 51 years. Completion of the questionnaire took an average of 19 minutes. (See Table
1 for the data summary.)
Table 1
Cognitive debriefing subject data
Subject 1
| F | 60 | 20 | Accounts Clerk | Multiple Sclerosis |
Subject 2
| M | 51 | 18 | Truck Driver | Multiple Sclerosis |
Subject 3
| F | 45 | 18 | Housewife | Multiple Sclerosis |
Subject 4
| F | 47 | 23 | Teacher | Multiple Sclerosis |
Subject 5
| M | 52 | 18 | Building Superintendent | Multiple Sclerosis |
Mean
| / | 51 | 19.4 | | |
The subjects report on the questionnaire was favorable. It was found to be clear, relevant, and appropriate to the condition. The length of the questionnaire was acceptable to the subjects with one exception who stated that the questionnaire should not exceed its current length as problems with concentration arose during the final phase of completion.
No suggestions were made for missing articles or topics in the questionnaire.The translated MSQOL-54 went through cognitive debriefing successfully.
Conclusion
Health-related Quality of Life (HRQoL) questionnaires are increasingly used in international clinical trials. The cultural adaptation of an HRQoL questionnaire is a rigorous and complex process [
31,
34]. The main objective is to obtain a conceptual equivalence between the original and translated versions, allowing, among other things, a poolingand comparison of international studies data. This incremental methodological approach has become essential as increasing amounts of data are collected about cultural differences in measuring quality of life as well as the different types of equivalence between cultures [
35].
The translation of the MSQOL-54 in French Canadian was carried out within the confines of internationally accepted methodologies under the supervision of experts in the field of cultural adaptation [
29,
30]. Instructions and Items 38, 43, 45 and 49 were the most debated. Problematic issues mainly resided in the field of semantics.
As suggested by Ware et al [
20], HRQoL questionnaires can form a practical tool for directly linking the norms from large population surveys with the results from more focused clinical trials, outcomes research studies, and monitoring efforts in everyday clinical practice. Patients have reported that information from assessments helped guide discussions about treatment options and care planning, thereby improving communication with health care providers [
36]. It has been suggested in the extent literature on doctor-patient relationships that the clinical application of HRQoL instruments helps to open the lines of communication between doctors and patients [
37]. It signals to the patient that his or her doctor is prepared to discuss a wide range of health related issues thereby allowing them to relay details surrounding their condition that might otherwise remain unspoken. In addition, these discussions help patients feel understood both physically and emotionally. Of course, the use of HRQOL questionnaires can never substitute for the natural dynamics of doctor-patient communication and interaction. It can, however, be viewed as a valuable tool for structuring the information gathering process. For these reasons, the French Canadian MSQOL-54 can be considered as a useful tool to help health-care providers to conduct formal HRQoL assessments of patients with MS as a routine part of clinical practice. Its proper use will necessitate the adherence to a few basic guidelines: 1) the average time of completion should not exceed 19 minutes, 2) the questionnaire may be administered directly in the waiting room, 3) the integrity of the instruments' wording should be maintained, 4) the patient's autonomy during completion process should be respected.
The next step in the cultural adaptation process of the MSQOL-54 in French Canadian will be field research to provide the empirical data necessary for its psychometric evaluation.