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Development and Validation of Fear of Relapse Scale for Relapsing-Remitting Multiple Sclerosis: Understanding Stressors in Patients.

ABSTRACT: Chronic diseases are associated with patients' long-term stress and development of fear to things related to the source of stress. Better management of a patients' condition requires investigation of the underlying mechanisms that contribute to the process of development of chronic stress. Multiple Sclerosis (MS) is a debilitating chronic disease in most cases diagnosed after a relapse and characterized by the periodic occurrence of relapses in most patients. Due to the unpredictable course of the disease and relapses, patients with Relapsing-Remitting MS (RRMS) may deal with the stress of anticipation of relapse and its unpredictable consequences. The role of relapses and related stress on patients' quality of life has not been previously investigated. This study is the first effort to develop a self-report measure of Fear of Relapse (FoR) in patients with RRMS. Thirty-one items were extracted from in-depth clinical interviews with 33 RRMS patients to develop the preliminary version of the scale. Subsequently, 168 RRMS patients completed the questionnaire, the Intolerance of Uncertainty Scale (IUS) and Depression, Anxiety, and Stress Scale (DASS). Fifty-one patients completed the scale one more time a month later. Factor analysis revealed three components, and five items failed to load on any of them. To test the FoR's independence from similar measures, responses to 26 items were pooled once with DASS items and once with IUS items, and each time were subjected to confirmatory factor analysis (two-component solution). Despite significant correlations between FoR, DASS, and IUS Independent loadings of items belonging to FoR and DASS, and FoR and IUS revealed independence and unique contribution of FoR to the evaluation of patients. Cronbach's alpha for the 26-item version was 0.92. Test-retest reliability for total score was equal to 0.74. These findings provide preliminary evidence of the validity and reliability of the measure. This scale can help researchers and clinicians to have a more comprehensive understanding of patients' experience with the uncertain nature of MS, which is necessary for future efforts to address this stressor by targeting the underlying mechanism.

SUBMITTER: Khatibi A

PROVIDER: S-EPMC7100001 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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Development and Validation of Fear of Relapse Scale for Relapsing-Remitting Multiple Sclerosis: Understanding Stressors in Patients.

Khatibi Ali A Moradi Nahid N Rahbari Naghmeh N Salehi Taranom T Dehghani Mohsen M

Frontiers in psychiatry 20200320

Chronic diseases are associated with patients' long-term stress and development of fear to things related to the source of stress. Better management of a patients' condition requires investigation of the underlying mechanisms that contribute to the process of development of chronic stress. Multiple Sclerosis (MS) is a debilitating chronic disease in most cases diagnosed after a relapse and characterized by the periodic occurrence of relapses in most patients. Due to the unpredictable course of t ...[more]

PMID: 32265764

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Project description:Multiple sclerosis (MS) is a chronic demyelinating disease of the central nervous system and mainly affects young adults. Its natural history has changed in recent years with the advent of disease-modifying drugs, which have been available since the early 1990s. The increasing number of first-line and second-line treatment options, together with the variable course of the disease and patient lifestyles and expectations, makes the therapeutic decision a real challenge. The aim of this review is to give a comprehensive overview of the main present and some future drugs for relapsing-remitting MS, including risk-benefit considerations, to enable readers to draw their own conclusions regarding the risk-benefit assessment of personalized treatment strategies, taking into account not only treatment-related but also disease-related risks. We performed a Medline literature search to identify studies on the treatment of MS with risk stratification and risk-benefit considerations. We focused our attention on studies of disease-modifying, immunomodulating, and immunosuppressive drugs, including monoclonal antibodies. Here we offer personal considerations, stemming from long-term experience in the treatment of MS and thorough discussions with other neurologists closely involved in the care of patients with the disease. MS specialists need to know not only the specific risks and benefits of single drugs, but also about drug interactions, either in simultaneous or serial combination therapy, and patient comorbidities, preferences, and fears. This has to be put into perspective, considering also the risks of untreated disease in patients with different clinical and radiological characteristics. There is no single best treatment strategy, but therapy has to be tailored to the patient. This is a time-consuming task, rich in complexity, and influenced by the attitude towards risk on the parts of both the patient and the clinical team. The broader the MS drug market becomes, the harder it will be for the clinician to help the patient decide which therapeutic strategy to opt for.

Project description:BACKGROUND: Numerous cytokines are implicated in the immunopathogenesis of multiple sclerosis (MS), but studies are often limited to whole blood (WB) or peripheral blood mononuclear cells (PBMCs), thereby omitting important information about the cellular origin of the cytokines. Knowledge about the relation between blood and cerebrospinal fluid (CSF) cell expression of cytokines and the cellular source of CSF cytokines is even more scarce. METHODS: We studied gene expression of a broad panel of cytokines in WB from relapsing-remitting multiple sclerosis (RRMS) patients in remission and healthy controls (HCs). Subsequently we determined the gene expression of the dysregulated cytokines in isolated PBMC subsets (CD4+, CD8+T-cells, NK-cells, B-cells, monocytes and dendritic cells) from RRMS patients and HCs and in CSF-cells from RRMS patients in clinical relapse and non-inflammatory neurological controls (NIND). RESULTS: RRMS patients had increased expression of IFN-gamma (IFNG), interleukin (IL) 1-beta (IL1B), IL7, IL10, IL12A, IL15, IL23, IL27, lymphotoxin-alpha (LTA) and lymphotoxin-beta (LTB) in WB. In PBMC subsets the main sources of pro-inflammatory cytokines were T- and B-cells, whereas monocytes were the most prominent source of immunoregulatory cytokines. In CSF-cells, RRMS patients had increased expression of IFNG and CD19 and decreased expression of IL10 and CD14 compared to NINDs. CD19 expression correlated with expression of IFNG, IL7, IL12A, IL15 and LTA whereas CD14 expression correlated with IL10 expression. CONCLUSIONS: Using a systematic approach, we show that expression of pro-inflammatory cytokines in peripheral blood primarily originates from T- and B-cells, with an important exception of IFNG which is most strongly expressed by NK-cells. In CSF-cell studies, B-cells appear to be enriched in RRMS and associated with expression of pro-inflammatory cytokines; contrarily, monocytes are relatively scarce in CSF from RRMS patients and are associated with IL10 expression. Thus, our findings suggest a pathogenetic role of B-cells and an immunoregulatory role of monocytes in RRMS.

Project description:BACKGROUND:Recent data from animal models of multiple sclerosis (MS) and from a pilot study indicated a possible beneficial impact of statins on MS. METHODOLOGY/PRINCIPAL FINDINGS:Safety, tolerability and effects on disease activity of atorvastatin given alone or in combination with interferon-beta (IFN-beta) were assessed in a phase II open-label baseline-to-treatment trial in relapsing-remitting MS (RRMS). Patients with at least one gadolinium-enhancing lesion (CEL) at screening by magnetic resonance imaging (MRI) were eligible for the study. After a baseline period of 3 monthly MRI scans (months -2 to 0), patients followed a 9-month treatment period on 80 mg atorvastatin daily. The number of CEL in treatment months 6 to 9 compared to baseline served as the primary endpoint. Other MRI-based parameters as well as changes in clinical scores and immune responses served as secondary endpoints. Of 80 RRMS patients screened, 41 were included, among them 16 with IFN-beta comedication. The high dose of 80 mg atorvastatin was well tolerated in the majority of patients, regardless of IFN-beta comedication. Atorvastatin treatment led to a substantial reduction in the number and volume of CEL in two-sided multivariate analysis (p = 0.003 and p = 0.008). A trend towards a significant decrease in number and volume of CEL was also detected in patients with IFN-beta comedication (p = 0.060 and p = 0.062), in contrast to patients without IFN-beta comedication (p = 0.170 and p = 0.140). Immunological investigations showed no suppression in T cell response but a significant increase in IL-10 production. CONCLUSIONS/SIGNIFICANCE:Our data suggest that high-dose atorvastatin treatment in RRMS is safe and well tolerated. Moreover, MRI analysis indicates a possible beneficial effect of atorvastatin, alone or in combination with IFN-beta, on the development of new CEL. Thus, our findings provide a rationale for phase II/III trials, including combination of atorvastatin with already approved immunomodulatory therapy regimens. TRIAL REGISTRATION:ClinicalTrials.gov NCT00616187.

Dataset Information

Development and Validation of Fear of Relapse Scale for Relapsing-Remitting Multiple Sclerosis: Understanding Stressors in Patients.

Publications

Development and Validation of Fear of Relapse Scale for Relapsing-Remitting Multiple Sclerosis: Understanding Stressors in Patients.

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