Examining the validity and reliability of the Persian version of the MiND‐B questionnaire in ALS patients

Abstract Background In addition to affecting the nerves and muscles, amyotrophic lateral sclerosis (ALS) disease also affects the behavior and cognition of patients. In this study, we examine the validity and reliability of the Persian version of Motor Neuron Disease Behavioral instrument (MiND‐B) questionnaire to investigate behavioral changes in Persian‐speaking ALS patients. Methods Forty‐six Persian‐speaking patients with ALS filled out the MiND‐B questionnaire. Then, the overall scores and each of the domains of this questionnaire were statistically analyzed. Results Cronbach's alpha coefficient was calculated .70 for the whole questionnaire. To check the validity of the questionnaire, the correlation of its scores with the Edinburgh Cognitive and Behavioral ALS screen (ECAS‐A) questionnaire was taken, and this correlation was significant (p = .038). Conclusion The findings of this study show that the Persian version of the MiND‐B questionnaire has the necessary validity and reliability to investigate behavioral changes in Persian‐speaking patients with ALS.


INTRODUCTION
Amyotrophic lateral sclerosis (ALS) is motor neuron disease (MND) with lesions in both upper and lower motor neurons and can affect either of the facial or limb muscles, presenting with muscle weakness and wasting (Brown & Al-Chalabi, 2017). Wordwide ALS prevalence is estimated to be 4.1-8.4 per 100,000 people (Andersen et al., 2012;Castro-Rodríguez et al., 2021) with a median survival of 3-5 years after symptom onset according to different studies (Paulukonis et al., 2015;Zhou et al., 2018). Having no definite cure, ALS patients have to receive palliative care on average 3-5 year course

Instrument
The MiND-B questionnaire was developed by Mioshi and colleagues to be a simple yet sensitive tool for both identifying and measuring behavioral changes in ALS patients. It is designed to be filled by the caregiver of the patients and consists of nine questions rating patient's behavioral changes on a Likert scale ranging from 0 to 4 and evaluates behavioral changes in three main domains including apathy (three questions, scoring 0-12), disinhibition (four questions, scoring 0-16), and stereotypical behavior (two questions, scoring 0-8) with a total score between 0 and 36 (Mioshi et al., 2014).
ECAS-A is another questionnaire which was especially designed to screen for cognitive and behavioral impairment in ALS patients and is supposed to be filled by the physician according to the answers of the patients. It evaluates cognitive impairment in domains of lan-guage, fluency, executive function, memory, and visuospatial and has a total score of 136. Moreover ECAS-A involves a part which screens for behavioral changes by which we search for signs of frontotemporal dementia according to checklist (Mojtabavi et al., 2021;Niven et al., 2015;Rascovsky et al., 2011;Snowden et al., 2012).

Questionnaire cross-cultural adaption
The questionnaire was developed by using the method of Beaton's six-step cross-cultural adaption and backward translation to Persian of a previously validated English version of the questionnaire (Beaton et al., 2000).

Statistical analysis
At first, the data were cleaned and the missing data were managed

Demographic information
Forty-six Persian-speaking patients with ALS diagnosed by a neurologist were included in the study to complete the MiND-B questionnaire.

Reliability and internal consistency
The other statistic indices for the patient's MiND-B questionnaire is given in Table 2

Validity
To evaluate the validity of the MiND-B questionnaire, the correlation was calculated between the scores of this questionnaire and the scores  Table 3.

DISCUSSION
Due to the high prevalence of behavioral changes in patients with ALS, the study of these changes in patients and their management can increase the quality of life of the patients and their caregivers, in addition to helping the healthcare providers to facilitate the treatment process.
Previous studies have examined the validity and reliability of the English version of MiND-B. In addition to an original study, two systematic review studies which examined various behavioral impairment measuring tools showed that the MiND-B questionnaire has the required validity and reliability to assess behavioral changes in ALS patients (Gosselt et al., 2020;Mioshi et al., 2014;Simon & Goldstein, 2019). In this study, we examined the validity and reliability of the demonstrate that the first part of the questionnaire, including the first five questions, has a larger Cronbach's alpha coefficient than the later four questions. An explanation to this difference between the two parts can be that in the first part the questions address changes that happen more simultaneously while in the second part the questions address more discrete behaviors. Furthermore, the corrected item-total correlation indicates that this value is high for most questions which shows that the majority of questions are well-discriminated and that the only question with a low value is question number 8 (Table 2).
To evaluate the validity of the MiND-B questionnaire, in this study, we measured the correlation between the MiND-B scores and the scores of the Persian version of the ECAS-A questionnaire. The ECAS-A questionnaire is used to assess cognitive changes in ALS patients and has different cognitive domains including memory, language, and executive function. Our statistical findings show that there is a negative correlation between the scores of these two questionnaires with a coefficient of −.435 while this correlation is significant (p = .038).
The negative correlation is due to the fact that either a lower ECAS-A score or a higher MiND-B score both are related to a more severe impairment. Therefore, the negative correlation indicates the direction of changes in the scores of these two instruments. So this result demonstrates that this questionnaire can be used to monitor the behavioral changes of ALS patients. In addition, to examine the degree of correlation by cognitive domains, there is a significant correlation between MiND-B scores as an indication of behavioral changes with the language and executive function domains addressed in ECAS-A (Table 3).
Of course, it should be noted that the overall correlation of ECAS-A with MiND-B is significant and indicates the alignment of changes and validity of MiND-B for research uses in ALS patients.
The findings of other studies also confirm the results of our study.
Two systematic reviews were performed on the subject of validity and reliability of various behavioral disorders questionnaires showed the MiND-B questionnaire has good validity and reliability, and this questionnaire can be used to assess behavioral changes in patients with ALS (Gosselt et al., 2020;Simon & Goldstein, 2019).
Our team also had limitations in conducting this study. The most important of these limitations was the inability of a wide range of patients to speak and communicate with family and the study team which challenged the interview process with the patient and his companions. Another limitation was our lack of access to many other behavioral and cognitive tests, the reason being that very few studies have been conducted on ALS in our country, and many of these tests have not been validated in Persian. Also, we did not have access to the genetic data of the patients. And an important limitation was that we lost the patients who are in the lower stages of ALS due to the lack of proper diagnosis in other centers and their lack of referral to our referral center. Considering all these limitations, we did our best to reduce the effects of these limitations on the results of our study.
As mentioned, the Persian version of the MiND-B questionnaire is suitable and acceptable for measuring behavioral changes in ALS patients with validity, reliability, and, internal consistency and this questionnaire can be used for research affairs to assess the behavioral changes of Persian-speaking patients with ALS.

DATA AVAILABILITY STATEMENT
The data that support the findings of this study are available from the corresponding author upon reasonable request.