Reliability and Validity of the Modified Korean Version of the Chalder Fatigue Scale (mKCFQ11).
ABSTRACT: Fatigue can accompany various diseases; however, fatigue itself is a key symptom for patients with chronic fatigue syndrome (CFS). Due to the absence of biological parameters for the diagnosis and severity of CFS, the assessment tool for the degree of fatigue is very important. This study aims to verify the reliability and validity of the modified Korean version of the Chalder Fatigue Scale (mKCFQ11). This study was performed using data from 97 participants (Male: 37, Female: 60) enrolled in a clinical trial for an intervention of CFS. The analyses of the coefficient between the mKCFQ11 score and the Fatigue Severity Scale (FSS), the Visual Analogue Scale (VAS) or the 36-item Short-Form Health Survey (SF-36) at two time points (baseline and 12 weeks) as well as their changed values were conducted. The mKCFQ11 showed strong reliability, as evidenced by the Cronbach's alpha coefficient of 0.967 for the whole item and two subclasses (0.963 for physical and 0.958 for mental fatigue) along with the suitable validity of the mKCFQ11 structure shown by the principal component analysis. The mKCFQ11 scores also strongly correlated (higher than 0.7) with the VAS, FSS and SF-36 on all data from baseline and 12 weeks and changed values. This study demonstrated the clinical usefulness of the mKCFQ11 instrument, particularly in assessing the severity of fatigue and the evaluation of treatments for patients suffering from CFS.
Project description:Background: There is a strong demand for therapeutics to treat chronic fatigue syndrome (CFS), although there are limitations. Myelophil, which is a combination of extracts from Astragali Radix and Salviae Miltiorrhizae Radix, has been clinically used to treat fatigue-related disorders in South Korea. We conducted a randomized controlled clinical trial of Myelophil in patients with CFS and evaluated its efficacy and safety in two hospitals. Methods: We enrolled 98 participants (M: 38, F: 60) with CFS in a phase 2 trial of oral Myelophil (2 g daily) or placebo for 12 weeks. The primary end point was a change in the Chalder fatigue scale, as scored by a numeric rating scale (NRS). The secondary end points included changes in the visual analogue scale, fatigue severity scale (FSS), and 36-item short-form health survey (SF-36). Biomarkers of oxidative stress and cytokines were evaluated by blood tests. Results: Ninety-seven participants (48 in the Myelophil group and 49 in the placebo group) completed the trial. An analysis of all participants showed that Myelophil slightly improved fatigue symptoms compared with those of the placebo, but this effect was not statistically significant (p > 0.05 for the NRS, VAS, FSS, and SF-36). By contrast, an analysis of the subpopulation (53 participants, M: 24, F: 29) with severe symptoms (?63, median NRS value of total participants) showed a statistically significant improvement in fatigue symptoms in the Myelophil group compared with the placebo (p < 0.05 for NRS, FSS, and SF-36). There were no significant changes in the biomarkers for oxidative stress and cytokines before or after the treatment. No Myelophil-related adverse response was observed during the trial. Conclusion: These results support the hypothesis that Myelophil can be a therapeutic candidate to manage CFS and provide the rationale for its progression to a phase 3 clinical trial. Clinical Trial Registration: www.ClinicalTrials.gov, identifier KCT0002317.
Project description:OBJECTIVES:To develop and test the psychometric properties of an Arabic version of Fatigue Severity Scale (FSS-Ar) that can be used to measure fatigue in Arabic patients with disorders where fatigue is a major symptom. METHODS:Forward and backward translations of FSS were undertaken to develop an Arabic version. The validity and reliability of the FSS-Ar was then tested on 28 patients with systemic lupus erythematosus (SLE), 24 patients with multiple sclerosis (MS), and 31 healthy subjects. Exploratory factor analysis and hypothesis testing methods were used to examine construct validity. The correlation between FSS-Ar and the vitality domain of the RAND 36-Item Health was examined to test construct validity. The study was conducted at the King Khalid University Hospital, Riyadh, Kingdom of Saudi Arabia between February and June 2012. RESULTS:Using a score of ?4.05 to define fatigue, 39 of 52 (75%) participants were fatigued compared with 10 out of 31 (32%) healthy participants. The correlation between the FSS-Ar and the vitality domain of the RAND-36 was acceptable (r = -0.46). Factor analysis showed that items of the FSS-Ar measured one underlying construct, namely, fatigue. Test-retest reliability and internal consistency of the FSS-Ar was acceptable (intraclass correlation coefficient model 2,1 = 0.80; Cronbach's alpha = 0.84). CONCLUSION:The Arabic version of the FSS demonstrated acceptable psychometric properties and was able to differentiate between patients with SLE or MS, and healthy subjects.
Project description:Although anti-myelin-associated glycoprotein (MAG) antibody neuropathy is reported as a slowly progressive disease, it can lead to significant disability and impairment of health-related quality of life (HR-QoL) and social participation. The aim of this cross-sectional study was to evaluate the functioning and HR-QoL determinants in 67 patients with anti-MAG neuropathy in terms of the International Classification of Functioning, Disability, and Health (ICF). Evaluations included: Medical Research Council (MRC) sum score, Sensory Modality Sum score (SMS), Berg balance scale (BBS), Fatigue Severity Scale (FSS), Visual Analogue Scale (VAS) for pain, 9-Hole Peg Test (9-HPT), 6-min Walk Distance (6MWD), Impact on Participation and Autonomy (IPA) and the physical component score (PCS) and mental component score (MCS) of the short-form-36 health status scale (SF-36) HR-QoL measure. In the regression models, 6MWD was the most reliable predictor of PCS, explaining the 52% of its variance, while the strongest determinants of 6MWD were BBS and FSS, explaining the 41% of its variance. Consistently, VAS and BBS were good predictor of PCS, explaining together 54% of its variance. FSS was the most reliable determinant of MCS, explaining 25% of its variance. SMS and MRC were not QoL determinants. The results of our study suggest that 6MWD and FSS might be considered as potential meaningful outcome measures in future clinical trials. Furthermore, neurorehabilitation interventions aimed at improving balance and walking performance, fatigue management, and specific pain relief therapy should be considered to ameliorate participation in social life and HR-QoL in anti-MAG neuropathy patients.
Project description:<h4>Background</h4>The Multidimensional Fatigue Inventory (MFI-20) was developed in 1995. Since then, it has been widely used in cancer research and cancer-related illnesses but has never been validated in fatiguing illnesses or in a large US population-selected sample. In this study, we sought to examine the reliability and validity of the MFI-20 in the population of the state of Georgia, USA. Further, we assessed whether the MFI-20 could serve as a complementary diagnostic tool in chronically fatigued and unwell populations.<h4>Methods</h4>The data derive from a cross-sectional population-based study investigating the prevalence of chronic fatigue syndrome (CFS) in Georgia. The study sample was comprised of three diagnostic groups: CFS-like (292), chronically unwell (269), and well (222). Participants completed the MFI-20 along with several other measures of psychosocial functioning, including the Medical Outcomes Survey Short Form-36 (SF-36), the Zung Self-Rating Depression Scale (SDS), and the Spielberger State-Trait Anxiety Inventory (STAI). We assessed the five MFI-20 subscales using several criteria: inter-item correlations, corrected item-total correlations, internal consistency reliability (Cronbach's alpha coefficients), construct validity, discriminant (known-group) validity, floor/ceiling effects, and convergent validity through correlations with the SF-36, SDS, and STAI instruments.<h4>Results</h4>Averaged inter-item correlations ranged from 0.38 to 0.61, indicating no item redundancy. Corrected item-total correlations for all MFI-20 subscales were greater than 0.30, and Cronbach's alpha coefficients achieved an acceptable level of 0.70. No significant floor/ceiling effect was observed. Factor analysis demonstrated factorial complexity. The MFI-20 also distinguished clearly between three diagnostic groups on all subscales. Furthermore, correlations with depression (SDS), anxiety (STAI), and functional impairment (SF-36) demonstrated strong convergent validity.<h4>Conclusions</h4>This study provides support for the MFI-20 as a valuable tool when used in chronically unwell and well populations. It also suggests that the MFI-20 could serve as a complementary diagnostic tool in fatiguing illnesses, such as CFS.
Project description:Systemic lupus erythematosus (SLE) is a chronic autoimmune disease that affects a large number of people throughout the world. Anxiety, depression and fatigue are common symptoms of SLE that substantially contribute to decreased quality of life. This study investigates the interplay between physical and psychiatric manifestations of lupus. To this end, an SLE patient cohort was examined for correlations between clinical presentation, laboratory tests, and psychological indicators.Seventy-two lupus patients were evaluated for psychological status using a battery of instruments, including assessments for fatigue (CFS & FSS), depression (HADS), anxiety (HADS), overall health (SF-36 & PSQI) and intimate relationship satisfaction (RAS & CSI). Scores from these assessments were correlated with lupus clinical profiles and laboratory test values.The prevalence of depression in the SLE patient cohort was 41.7%, as measured by the hospital depression and anxiety scale. The study identified that pain (p = 0.001), body mass index (p = 0.026), Chalder's fatigue scale (p < 0.001), fatigue severity scale (p < 0.001), and anxiety (p = 0.001) are all positively correlated with depression in SLE patients. Total complement (CH50) (p = 0.032), and SF-36 physical and mental characteristic assessments are negatively correlated with depression. Longitudinal analysis indicated that the disease related complaint alopecia (p = 0.008) and relationship assessment scale scores (p = 0.004) may also be correlated to depression in SLE patients. Multivariant scrutiny of the clinical and psychosocial characteristics identified the fatigue severity scale (p = 0.026), SF-36 physical function (p = 0.040), physical role function (0.030), and mental health (p = 0.002) as the best indicators directly correlated with depression for the SLE cohort.These results reveal the influence of physical manifestations of lupus including fatigue, pain, body mass index and anxiety, as well as decreased physical and mental function, on depression. Fatigue is the strongest factor correlated with depression in SLE patients in the cohort. Both physical and social/psychological aspects likely contribute to the depression and anxiety in lupus.
Project description:BACKGROUND:Late-onset Pompe disease (LOPD) is a rare, metabolic disease primarily affecting the musculoskeletal and respiratory systems. Forced vital capacity (FVC) is commonly used to measure pulmonary function; however, associations between FVC and other LOPD outcomes remain unclear. METHODS:A systematic literature review was conducted on November 2015, updated September 2016 and supplemented with clinical trial data from the sponsor. Outcomes included: 6-min walk test distance (6MWT), FVC, maximal inspiratory/expiratory pressure (MIP/MEP), Medical Research Council-skeletal muscle strength score (MRC), 36-item short-form survey-physical component score (SF-36), Rotterdam Handicap Scale (RHS), Fatigue Severity Scale (FSS) and survival. Individual patient data meta-analysis was used for cross-sectional analyses and longitudinal analyses to determine associations between percent of predicted FVC and LOPD measures and outcomes. RESULTS:Fifteen studies were selected. From cross-sectional analyses, FVC and MRC were most strongly associated. Specifically, patients with 10% higher FVC (a round number for illustrative purposes only) were associated with a 4.72% (95% confidence interval [CI]: 3.37, 6.07) higher MRC score, indicating a positive association. Similarly, slopes for the 6MWT and SF-36 relative to a 10% higher FVC were estimated at 33.2 meters (95% CI 24.0, 42.4) and 1.2% (95% CI 0.24, 2.16%), respectively. From longitudinal analyses, a 10% incremental increase in predicted FVC was associated with an average increase of 4.12% in MRC score (95% CI 1.29, 6.95), 35.6 m in the 6MWT (95% CI 19.9, 51.6), and 1.34% in SF-36 (95% CI 0.08, 2.60). There was insufficient data to conduct analyses for RHS, FSS and survival. CONCLUSIONS:FVC is positively associated with LOPD measures and outcomes across multiple domains. Additionally, longitudinal changes in FVC are positively associated with changes in the 6MWT, MRC and SF-36.
Project description:BACKGROUND: Fatigue is a common complaint in multiple sclerosis (MS) and often interferes with daily functioning. Both clinicians and researchers may need to detect high levels of fatigue impact using a time and effort efficient tool. This study evaluates the psychometric properties of a rapid screening instrument for fatigue impact in multiple sclerosis. METHODS: Three visual analogue scales (VAS) for assessing the impact of fatigue were developed. Sixty two subjects with definite MS (mean age 52 +/- 10.5 years; 29 women) and 24 healthy controls (mean age 52 +/- 14 years; 13 women) completed all VAS scales (range 0-100), the Fatigue Severity Scale (FSS) (range 7-63), the Modified Fatigue Impact Scale (MFIS) (range 0-84) and the Guy's Neurological Disability Scale (GNDS) (range 0-5). All tests were repeated with an interval of maximum three days. To evaluate the reproducibility, intraclass correlations (ICC) were calculated, based on one-way analysis of variance for repeated measurements. Validity was considered by means of correlation coefficients. ROC analysis was used to determine the accuracy of the VAS scales. RESULTS: The ICC of the VAS scales ranged from 0.68 to 0.69. VAS scales showed low to moderate correlation with FSS, MFIS and GNDS (Kendall's tau 0.23-0.45) and were not related with physical or cognitive performance, or with depression. All VAS scales were able to discriminate between subjects with MS and controls. Twenty five subjects with MS had a Fatigue Severity Scale score of 36 or more and were classified into the "fatigue" group. ROC analysis showed that VAS_1 is most useful to classify subjects in the "fatigue" group. A cut-off value of VAS_1 of 59 displayed 76% sensitivity and 72% specificity. When using the MFIS score of 40 or more to classify the groups, VAS_1 remained the strongest tool, with 81% sensitivity and 77% specificity at a cut-off value of 59. CONCLUSION: The VAS for the impact of fatigue on daily life (VAS_1) is a moderately reliable, though valid and useful tool to screen rapidly for fatigue impact in multiple sclerosis. A cut-off value of 59 satisfactorily classifies individuals having severe fatigue with a high impact on daily life. In clinical practice, a more comprehensive assessment of fatigue and the impact on daily life is recommended.
Project description:Objective:The aim was to evaluate the quality and acceptability of patient-reported outcome measures used to assess fatigue in patients with axial spondyloarthritis. Methods:A two-stage systematic review of major electronic databases (1980-2017) was carried out to: (i) identify measures; and (ii) identify evaluative studies. Study and measurement quality were evaluated following international standards. Measurement content was appraised against a conceptual model of RA-fatigue. Results:From 387 reviewed abstracts, 23 articles provided evidence for nine fatigue-specific measures: 6 multi-item and 3 single-item. No axial spondyloarthritis-fatigue-specific measure was identified. Evidence of reliability was limited, but acceptable for the Multi-dimensional Fatigue Inventory (internal consistency, test-retest) and Short Form 36-item Health Survey Vitality subscale (SF-36 VT; internal consistency). Evidence of construct validity was moderate for the Functional Assessment of Chronic Illness Therapy-Fatigue and 10 cm visual analog scale, limited for the SF-36 VT and not available for the remaining measures. Responsiveness was rarely evaluated. Evidence of measurement error, content validity or structural validity was not identified. Most measures provide a limited reflection of fatigue; the most comprehensive were the Multi-dimensional Assessment of Fatigue, Multi-dimensional Fatigue Inventory-20, Functional Assessment of Chronic Illness Therapy-fatigue and Fatigue Severity Scale. Conclusion:The limited content and often poor quality of the reviewed measures limit any clear recommendation for fatigue assessment in this population; assessments should be applied with caution until further robust evidence is established. Well-developed, patient-derived measures can provide essential evidence of the patient's perspective to inform clinical research and drive tailored health care. The collaborative engagement of key stakeholders must seek to ensure that future fatigue assessment is relevant, acceptable and of high quality.
Project description:BACKGROUND:Chronic fatigue syndrome (CFS) has a major impact on functioning. However, no validated measures of functioning for this population exist. AIMS:We aimed to establish the psychometric properties of the 5-item School and Social Adjustment Scale (SSAS) and the 10-item Physical Functioning Subscale of the SF-36 in adolescents with CFS. METHOD:Measures were completed by adolescents with CFS (n = 121). RESULTS:For the Physical Functioning Subscale, a 2-factor solution provided a close fit to the data. Internal consistency was satisfactory. For the SSAS, a 1-factor solution provided an adequate fit to the data. The internal consistency was satisfactory. Inter-item and item-total correlations did not indicate any problematic items and functioning scores were moderately correlated with other measures of disability, providing evidence of construct validity. CONCLUSION:Both measures were found to be reliable and valid and provide brief measures for assessing these important outcomes. The Physical Functioning Subscale can be used as two subscales in adolescents with CFS.
Project description:STUDY DESIGN: A prospective study. PURPOSE: To evaluate the reliability and validity of the adapted Korean version of the Neck Pain and Disability Scale (NPDS). OVERVIEW OF LITERATURE: The validity of Korean version of NPDS has not been completely demonstrated yet. METHODS: Translation/retranslation of the English version of NPDS was conducted, and all steps of the cross-cultural adaptation process were performed. The Korean version of the visual analog scale (VAS) measure of pain, NPDS and the previously validated Short Form-36 (SF-36) were mailed to 91 patients, who had been surgically treated for degenerative cervical disease. Eighty-one patients responded to the first mailing of questionnaires and 69 of the first time responder returned their second survey. Factor analysis and reliability assessment by kappa statistics of agreement for each item, the intraclass correlation coefficient and Cronbach's ? were conducted. Concurrent and construct validity were also evaluated by comparing the responses of NPDS with the results of VAS and responses of SF-36. RESULTS: Factor analysis extracted 3 factors. All items had a kappa statistics of agreement greater than 0.6. The NPDS showed excellent test/re-test reliability. Internal consistency of Cronbach's ? was found to be very good. The NPDS was correlated with the VAS. The Korean version of NPDS showed good significant correlation with SF-36 total score and with single SF-36 domains scores. CONCLUSIONS: The adapted Korean version of the NPDS was successfully translated and is considered suitable for outcome assessments in the Korean-speaking patients with neck pain.