This cross-sectional study was conducted from February 2019 to March 2020 at Shahid Kazemi Pharmacy in the city of Tehran Iran, as a national pharmacy providing specialized pharmaceutical care to patients with MS. This study was also approved by the Ethics Committee of Shahid Beheshti University of Medical Sciences, Tehran, Iran, with the registry code of IR.SBMU.PHARMACY.REC.1398.240.
The patients affected with MS referring to the pharmacy concerned were invited to participate in this study. After scrutinizing their prescriptions, additional questions were further raised to make sure that the patients had been diagnosed with MS. To be included in the study, the cases needed to be older than 18 years and with at least six months of MS diagnosis. A written informed consent was also given to the patients prior to their inclusion, and they were allowed to withdraw from the study whenever they desired.
The sample size was calculated using the Cochran’s formula. According to the statistics released by the Iranian MS Society, the number of patients with MS in Iran was 68,192 cases. In this formula, the confidence interval (CI) of 1.96 Z-score was defined as 95% and the p-value, as the ratio of the attribute in the society, was equal to 0.5. In addition, the margin of error (D) in this study was 0.05. The sample size was further estimated to be 382 individuals.
The validated Persian version of the MSQoL-54 questionnaire was applied to collect the required data, whose acceptable reliability and construct validity had been already confirmed . Notably, the MSQoL-54 is known as a health-related self-report questionnaire containing 54 items, categorized into 12 sub-scales: physical health (10 items), role limitations-physical (4 items), emotional well-being (8 items), pain (3 items), energy (5 items), health perceptions (5 items), social function (3 items), cognitive function (4 items), health distress (4 items), sexual function (5 items), change in health (1 item), and overall QoL (2 items). There was also one item under the theme of overall QoL, related to patients’ views about overall assessment of their own QoL, labeled as “self-score” in this study.
Additionally, there are two composite scores, namely, physical health composite (PHC) and mental health composite (MHC), measured by adding some sub-scales accordingly. The PHC includes eight sub-scales of physical function, health perceptions, energy/fatigue, role limitations-physical, pain, sexual function, social function, and health distress and the MHC is made up of five sub-scales: health distress, overall QoL, emotional well-being, role limitations-emotional, and cognitive function. More specifically, the composite scores can be calculated by transforming the item scores to zero to 100 scales, with zero representing the worst health status and 100 indicating the best health status.
With respect to demographic data, characteristics such as age, gender, levels of education, marital status, occupation, level of income, disease duration, and comorbidity are shown in Table 1. As well, the patients’ use of dietary supplements and levels of physical activity were recorded.
Alongside the implementation of the MSQoL-54 questionnaire, the participants were asked to complete two types of questions related to consumption patterns of dietary and herbal supplements and the Short Questionnaire to Assess Health-Enhancing Physical Activity (SQUASH). The structured questionnaire about the consumption patterns of dietary and herbal supplements included detailed questions to assess the use of supplements such as multivitamins and individual vitamins as well as minerals directly. The participants were accordingly instructed to write any products they were using. This questionnaire contained a total number of seven items on specific supplements used, dosage form, frequency of use, onset date, prescribing physician’s specialty, and reason for use.
The SQUASH was also comprised of items on commuting activities, leisure-time and sports activities, household activities, and activities at work and school. Based on the reported efforts in the SQUASH questionnaire, this tool could classify individuals into three different intensity scores, i.e., light, moderate, or vigorous .