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Alhazzani et al. Neuroimmunol Neuroinflammation 2018;5:8  I  http://dx.doi.org/10.20517/2347-8659.2017.55           Page 3 of 10

               Data collection tool
               This study used a pretested, pre-coded, self-administered questionnaire that included sociodemographic
               patients’ characteristics and Patient Determined Disease Steps (PDDS) to quantify disability in MS patients
               as well as the Patient Health Questionnaire (PHQ) for quick assessment of depression score among MS
               patients.


               The severity of the illness was measured using the PDDS . It is a 9-item patient-administered measure of MS-
                                                              [15]
               related disability. Its content validity is indicated by the consistency of the items with the Expanded Disability
               Status Scale (EDSS) . The PDDS scores range from 0 to 8, and can be used to categorize participants into
                                [16]
               3 groups according to level of disability: a score of 0 to 2 indicates mild disability, represented by sensory
               symptoms but no limitations on walking; a score of 3 to 5 indicates moderate disability, represented by
               symptoms that interfere with daily activities, especially walking, and the need for a cane; and a score of 6 to
               8 indicates severe disability, represented by the need for bilateral support, the use of a wheelchair, or being
               bed-ridden .
                        [17]
               Learmonth et al.  reported that the PDDS had a strong correlation with the EDSS, supporting criterion
                              [15]
               aspects of validity. The magnitude and pattern of correlations between PDDS and EDSS scores were
               consistent between persons with mild and moderate-to-severe disability. Such results provide evidence for
               the validity of PDDS scores as a patient-reported outcome of disability in persons with MS.


               Kroenke et al.  stated that the PHQ is a reliable and valid measure of depression severity. It scores each of
                           [18]
               the 9 DSM-IV criteria as “0” (not at all) to “3” (nearly every day).

               Data collection method
               The questionnaire sheets were personally distributed by researchers to all participant MS patients.

               Data analysis
               Collected data were analyzed by using the Statistical Package for Social Sciences (SPSS version 22). We used
               Chi-square test to examine the association between demographic factors, depression severity and level of
               disability. P-values less than 0.05 were considered statistically significant.


               Ethical considerations
               The ethical approval for conducting this study was obtained from Head of Research Ethics Committee
               (HA-06-B-001) in King Khalid University (REC) # 2016-08-23.


               Prior to interviewing participants, the purpose of the study has been explained briefly and their consent
               has been obtained and they were informed that they have the full right to withdraw at any point of time.
               Participants’ confidentiality and anonymity were fully secured. Finally, participants have been reassured
               that they have the right to withdraw at any point of time.


               RESULTS
               Demographics of the studied subjects
               Participants’ socio-demographic characteristics are shown in Table 1. Our study included 598 patients with
               MS. Males constituted 35.8% of patients. Patients’ age ranged between 15 and 60 years with a mean age (±
               SD) of 32.4 ± 8.5 years. Most participants (87%) were Saudi. About two thirds (63.2%) had a Bachelor Degree,
               while 24.3% were secondary school educated. More than half of respondents (51.8%) were married and the
               monthly income of 43.5% was less than 3000 Saudi Riyals (SR).
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