Translation, Cross-Cultural Adaptation, and Psychometric Properties of the Revised Fibromyalgia Impact Questionnaire (FIQR) for Use in Arabic-Speaking Patients in Saudi Arabia.

Background/Aim: Fibromyalgia (FM) is a complex and debilitating condition that significantly impacts patients' daily lives. The continuous assessment of the impact and severity of FM is essential to manage the condition effectively. Assessment tools in Arabic are lacking for use in Saudi Arabia, which might lead to ineffective management. This study aimed to translate and cross-culturally adapt and validate the Arabic version of the Revised Fibromyalgia Impact Questionnaire (FIQR). Methods: Following translation guidelines, 2 Arabic translators and 2 English-certified translators performed forward and backward translations of the FIQR. In a cross-sectional study design, the questionnaire was piloted with 5 participants and then subjected to cognitive interviews and psychometric analysis. Participants were FM patients recruited from a University Hospital in Riyadh and FM support groups in Saudi Arabia. The internal consistency, and reliability using the Cronbach α and interclass correlation coefficient (ICC) of 2-week test-retest, and criterion validity were evaluated. Results: The results included a total of 42 participants with FM. Six minor modifications were made during the stepwise translation of the questionnaire. The Arabic version of the FIQR had good internal consistency and test-retest reliability, with a Cronbach α of 0.855 for the physical functioning domain, 0.663 for overall well-being, 0.803 for symptoms, and 0.895 for the total FIQR, and the Pearson correlation coefficient of the ICC for physical functioning was 0.769 (95% confidence interval (CI), 0.541-0.884) for the overall well-being domain, 0.555 (95% CI, 0.129-0.772) for the symptoms domain, and 0.720 (95% CI, 0.370-0.868) and 0.794 (95% CI, 0.579-0.899) for the total FIQR score (p < 0.001), respectively. Conclusion: The Arabic version of the FIQR is a valid, reliable, and practical tool for assessing the impact of FM on Arabic-speaking patients and potentially contributing to the improvement of FM outcomes.

Pharmacovigilance Practices by Healthcare Providers in Oncology: A Cross-Sectional Study.

Investigating pharmacovigilance (PV) practices among oncology healthcare providers (HCPs) is crucial for patient safety in oncology settings. This study aimed to assess the awareness, attitudes, and practices towards PV and identify barriers to effective adverse drug reaction (ADR) reporting for HCPs working in oncology-related settings. Employing a cross-sectional survey design, we collected data from 65 HCPs, focusing on their experiences with ADR reporting, education on ADR management, and familiarity with PV protocols. The results showed that about half of the responders were pharmacists. Around 58.9% of the respondents reported ADRs internally, and 76.9% had received some form of ADR-related education. However, only 38.5% were aware of formal ADR review procedures. Methotrexate and paclitaxel emerged as the drugs most frequently associated with ADRs. The complexity of cancer treatments was among the common reasons for the low reporting of ADRs by the study participants. The findings highlight the need for enhanced PV education and standardized reporting mechanisms to improve oncology care. We conclude that reinforcing PV training and streamlining ADR-reporting processes are critical to optimizing patient outcomes and safety in oncology, advocating for targeted educational interventions and the development of unified PV guidelines.

Fibromyalgia Rapid Screening Tool (FiRST): Arabic Translation and Cross-Cultural Adaptation and Validation.

Background: Fibromyalgia (FM), a complex neurological disorder, has multiple consequences for the patient. To diagnose patients, healthcare practitioners use multiple diagnostic questionnaires. However, Arabic translated or validated tools are lacking. This study aimed to translate and validate the Fibromyalgia Rapid Screening Tool (FiRST) into the Arabic language. Methods: Forward and backward translations of the FiRST were conducted by two Arabic translators and two English-certified translators. The survey was piloted (n = 5) and subjected to cognitive interviews and psychometric analysis. Patients were recruited from a university hospital in Riyadh and an FM support group in Saudi Arabia. The internal consistency, factor analysis, and test-retest correlations were evaluated. Results: This study included 46 patients. The stepwise translation process resulted in minor edits related to the use of synonyms to the survey items. The translated survey had a good internal consistency and test-retest correlation, with a Cronbach's alpha of 0.7 and Pearson's correlation coefficient of 0.79 (p-value < 0.001), respectively. The survey was factorable into two themes: generalized symptoms and more specific sensations. Conclusions: The Arabic FiRST is a simple, valid, and reliable tool to diagnose patients with FM in different settings.

Relationship between different anti-rheumatic drug therapies and complementary and alternative medicine in patients with rheumatoid arthritis: an interview based cross-sectional study.

OBJECTIVES: The use of complementary and alternative medicine (CAM) by patients with rheumatoid arthritis (RA) is highly prevalent. The relationship of these remedies with disease therapy are not fully studied. We aimed to explore the relationship between different anti-rheumatic drug therapy and CAM use in RA patients. METHODS: The study used an interview-based cross-sectional survey in two major referral centres in Riyadh, Saudi Arabia. Patients were adults with confirmed RA that attended rheumatology clinics. Information on the utilization of CAM, RA duration, drug therapy, and laboratory parameters were obtained. Descriptive statistics as well as adjusted odds ratio using bivariate logistic regression were used to explore the different factors related to CAM use, including drug therapy. RESULTS: A total of 438 adult patients with RA were included. The mean (±SD) age of the patients was 49 (±15.0) years. The majority were women 393 (89.7%). Two hundred and ninety-two patients (66.7%) had used CAM. The CAM users who had a longer disease duration (AOR 1.041 [95% CI: 1.011, 1.073]; p = 0.008) were more likely to be female (AOR 2.068 [95% CI: 1.098, 3.896]; p = 0.024), and use methotrexate (AOR 1.918 [95% CI: 1.249, 2.946]; p = 0.003) as opposed to celecoxib (AOR 0.509 [95% CI: 0.307, 0.844]; p = 0.009) and biologic monotherapy (AOR 0.443 [95% CI: 0.224, 0.876]; p = 0.019). Other factors related to CAM were meloxicam use (AOR 2.342 [95% CI: 1.341, 4.089]; p = 0.003) and traditional therapy (AOR 2.989 [95% CI: 1.647, 5.425]; p = 0.000). The remaining factors were not significant. CONCLUSION: CAM use is prevalent in patients with RA. Understanding patients and disease related factors associated with higher use of CAM is warranted to improve RA management and provide more rational use of these remedies.

Prevalence of Fibromyalgia in Pharmacy Professionals and Students: A Cross-Sectional Study.

BACKGROUND: The prevalence of fibromyalgia (FM) in pharmacy students and professionals is unknown. This study identifies the prevalence of FM in pharmacy students and professionals using three screening tools and factors associated with its development. Furthermore, this study assesses the level of agreement between the tools and the magnitude of the participants' responses to each item in the screening tools. METHODS: This was a cross-sectional survey conducted on members of the Saudi Pharmaceutical Society using an online questionnaire. The participants were asked to fill three questionnaires: the London Fibromyalgia Epidemiology Study Screening Questionnaire (LFESSQ), Fibromyalgia Rapid Screening Tool (FiRST) and Fibromyalgia Survey Questionnaire (FSQ). Demographic data and factors affecting FM in pharmacy students and professionals were collected and analysed. RESULTS: Two hundred ninety-three participants accessed the survey: most of them were Saudi (93.5%) and females (78.8%) with a mean (standard deviation) age of 29 (8) years. Furthermore, 52% of the participants had generalised body pain. The prevalence of FM using FiRST, LFESSQ Pain, LFESSQ with fatigue criteria and FSQ was 27.1%, 34.9%, 50.9% and 68.4%, respectively. Fleiss' kappa coefficient revealed fair agreement among all three screening tools (kappa = 0.350; p < 0.001). After adjusting for significant variables, the resulting adjusted odds ratio of developing FM was 4.86 in people working for 41-45 h weekly (95% confidence interval [CI], 1.32-17.84; p = 0.017), 5.16 in people who frequently wake up during sleep (95% CI, 1.85-14.40; p = 0.002) and 12.99 in people with sleep apnea or other sleeping disorders (95% CI, 2.07-81.68; p = 0.006). CONCLUSION: FM was prevalent among pharmacy students and professionals and was much more than data reported on the general population or other healthcare workers. Traditional factors along with higher working hours were identified as significant variables.

Incidence of hemorrhagic cystitis after cyclophosphamide therapy with or without mesna: A cohort study and comprehensive literature review.

BACKGROUND: Cyclophosphamide is an alkylating agent associated with significant toxicities, most importantly hemorrhagic cystitis. Many approaches including mesna use were established to reduce this toxicity. However, data on mesna efficacy are conflicting. OBJECTIVE: To investigate the incidence of hemorrhagic cystitis in patients receiving cyclophosphamide therapy with or without mesna. METHODS: A retrospective chart review was done on all adult patients receiving cyclophosphamide therapy with or without mesna at the King Saud University Medical City. The incidence of hemorrhagic cystitis was recorded. Patients receiving mesna were compared with those not receiving mesna. Data were reported as numbers and percentages, and appropriate statistical tests of association were used. This step was followed by a comprehensive literature review using appropriate keywords in PubMed from the inception of the database until August 2019. All studies of interest were reported. RESULTS: A total of 718 patients' medical records were reviewed. The majority of the patients received mesna (n = 433, 60%). The mesna group had a greater incidence of hemorrhagic cystitis (3.5% vs. 0.4%, p < 0.004) and received a significantly larger cumulative dose (3103 ± 1696 vs. 2465 ± 1528, p < 0.001) mg of cyclophosphamide therapy. Our literature review revealed large differences in the conclusions of published trials with highly diverse study designs and populations, emphasizing on the need of large prospective trials to address this topic.Conclusion and relevance: Our study results do not support the use of mesna in preventing hemorrhagic cystitis. We found that the only influential factor in the development of hemorrhagic cystitis was the dose of cyclophosphamide therapy.

Risk Factors Associated with Methotrexate Intolerance in Rheumatoid Arthritis Patients.

BACKGROUND: Methotrexate (MTX) Intolerance Severity Score (MISS) has been previously validated in the Arabic language and has helped to detect high levels of intolerance in rheumatoid arthritis (RA) patients. The aim of the current study was to evaluate patient and disease characteristics associated with a high risk of MTX intolerance. MATERIALS AND METHODS: A cross-sectional interview-based survey was conducted using adult RA patients as a study group, who were visiting a specialized rheumatology clinic at King Saud University Medical City. The Arabic MISS was used in this survey. Statistical analyses were performed to understand associations between MTX-intolerant and MTX-tolerant patients. RESULTS: A total of 117 patients were involved in this study. Of those, 101 (86.3%) were females with a mean (SD) disease duration of 6.6 (5.7) years. The median (interquartile range (IQR)) Disease Activity Score-28 (DAS28) was 3.6 (3.6-4.1). MTX intolerance was observed in 55 (47%) patients. The most predominant component in patients with a positive test was the behavioral component. Intolerant patients had a higher median of pain (47.3 vs. 50.0; P = 0.010) and patient global assessment (50.0 vs. 60.0; P = 0.004) scales compared to those in tolerant patients. Additionally, MTX intolerance was associated with the female gender (adjusted odds ratio (AOR) 6.724; 95% CI 1.420, 31.843, P = 0.016), marital status (AOR 2.549; 95% CI 1.037, 6.270, P = 0.042) and DAS28 (AOR 1.612; 95% CI 1.032, 2.517, P = 0.036). There was no significant difference between the two groups in the remaining disease activity parameters, background therapies, seropositivity, and smoking status (P > 0.05). CONCLUSION: Patient characteristics, rather than disease activity, significantly impact MTX intolerance. Behavioral component is the main driver of intolerance. Intolerant patients have higher patient-reported outcomes. Qualitative studies are needed to explore causes and potential solutions to MTX intolerance.

Polypharmacy and comorbidities among ambulatory cancer patients: A cross-sectional retrospective study.

INTRODUCTION: Polypharmacy is prevalent among cancer patients; however, its relationship with comorbidities as well as its other potential factors has not been well studied among this segment of the patient population. Although several studies have described the prevalence of polypharmacy in cancer patients, its prevalence among Middle Eastern cancer patients is largely unknown. Therefore, the aim of this study is to assess the prevalence of polypharmacy among ambulatory cancer patients as well as its association with comorbidities. METHODS: A cross-sectional study using patients' electronic health records was conducted among ambulatory cancer patients aged ≥ 18 years in a tertiary care hospital. Polypharmacy was defined as the cumulative use of five or more medications. The main outcome was to assess the factors related to polypharmacy among ambulatory cancer patients which was evaluated using a multivariable binary logistic regression model. RESULTS: A total of 383 ambulatory cancer patients were included. Of these, approximately 79% had polypharmacy. Polypharmacy was more likely among patients with hypertension (AOR = 3.24; 95% CI: 1.41-7.42), diabetes (AOR = 3.33; 95% CI: 1.39-7.98), asthma (AOR = 8.64; 95% CI: 1.64-45.54), and anxiety (AOR = 3.61; 95% CI: 1.72-7.57). CONCLUSIONS: Polypharmacy is highly prevalent in the Saudi Arabian oncology patients, especially in those with comorbidities like hypertension, diabetes, anxiety and asthma. Because polypharmacy mostly goes hand in hand with comorbidities, therefore, a multidisciplinary team approach of oncology pharmacist working with other healthcare providers to manage polypharmacy and simplify drug regimens for cancer patients is warranted to optimize the healthcare quality and improve drug safety.