Perceived changes and minimum clinically important difference of the Neurological Fatigue Index for multiple sclerosis (NFI-MS)

2012 ◽  
Vol 19 (4) ◽  
pp. 502-505 ◽  
Author(s):  
RJ Mills ◽  
M Calabresi ◽  
A Tennant ◽  
CA Young

The determination of the minimum clinically important difference (MCID) is an important aspect of scale development. The Neurological Fatigue Index for multiple sclerosis (NFI-MS) was administered before and after expected change or stability in fatigue in 208 multiple sclerosis (MS) patients. The overall change scores of the NFI-MS accorded with perceived direction of change; importantly, no change was seen when none was perceived. Using the interval level NFI-MS scores, the largest MCID equated to 2.49 points on the Summary scale, 2.36 points on the Physical scale, 0.84 points on the Cognitive scale, 0.97 on the Diurnal Sleep scale and 1.95 on the Nocturnal Sleep scale. Our conclusion is that the NFI-MS responds as expected to changes in fatigue and has desirably small MCID scores.

2013 ◽  
Vol 20 (5) ◽  
pp. 577-587 ◽  
Author(s):  
H Hegen ◽  
A Millonig ◽  
A Bertolotto ◽  
M Comabella ◽  
G Giovanonni ◽  
...  

Background: Neutralizing antibodies (NAb) affect efficacy of interferon-beta (IFN-b) treatment in multiple sclerosis (MS) patients. NAbs evolve in up to 44% of treated patients, usually between 6–18 months on therapy. Objectives: To investigate whether early binding antibody (BAb) titers or different IFN-b biomarkers predict NAb evolution. Methods: We included patients with MS or clinically isolated syndrome (CIS) receiving de novo IFN-b treatment in this prospective European multicenter study. Blood samples were collected at baseline, before and after the first IFN-b administration, and again after 3, 12 and 24 months on that therapy; for determination of NAbs, BAbs, gene expression of MxA and protein concentrations of MMP-9, TIMP-1, sTRAIL, CXCL-10 and CCL-2. Results: We found that 22 of 164 (13.4%) patients developed NAbs during a median time of 23.8 months on IFN-b treatment. Of these patients, 78.9% were BAb-positive after 3 months. BAb titers ≥ 1:2400 predicted NAb evolution with a sensitivity of 74.7% and a specificity of 98.5%. Cross-sectionally, MxA levels were significantly diminished in the BAb/NAb-positive samples; similarly, CXCL-10 and sTRAIL concentrations in BAb/NAb-positive and BAb-positive/NAb-negative samples, respectively, were also diminished compared to BAb/NAb-negative samples. Conclusions: BAb titers reliably predict NAbs. CXCL-10 is a promising sensitive biomarker for IFN-b response and its abrogation by anti-IFN-b antibodies.


2019 ◽  
Vol 54 (3) ◽  
pp. 1900281 ◽  
Author(s):  
Claire M. Nolan ◽  
Surinder S. Birring ◽  
Matthew Maddocks ◽  
Toby M. Maher ◽  
Suhani Patel ◽  
...  

Health status is increasingly used in clinical practice to quantify symptom burden and as a clinical trial end-point in patients with interstitial lung disease (ILD). The King's Brief Interstitial Lung Disease (KBILD) questionnaire is a brief, validated 15-item, disease-specific, health-related quality of life questionnaire that is increasingly used in clinical trials, but little data exist regarding the minimum clinically important difference (MCID). Using pulmonary rehabilitation as a model, we aimed to determine the responsiveness of KBILD and provide estimates of the MCID.KBILD scores, Chronic Respiratory Questionnaire (CRQ) scores, Medical Research Council (MRC) Dyspnoea score and incremental shuttle walk test (ISWT) distance were measured in 209 patients with ILD (105 with idiopathic pulmonary fibrosis (IPF)) before and after an outpatient pulmonary rehabilitation programme. Changes with intervention and Cohen's effect size were calculated. Anchor-based (linear regression and receiver operating characteristic plots) or distribution-based approaches (0.5 sd and standard error of measurement) were used to estimate the MCID of KBILD domain and total scores.KBILD, CRQ, MRC Dyspnoea and ISWT improved with intervention, and the effect sizes of KBILD domain and total scores ranged from 0.28 to 0.38. Using anchor-based estimates, the MCID estimates for KBILD-Psychological, KBILD-Breathlessness and activities, and KBILD-Total were 5.4, 4.4 and 3.9 points, respectively. Using distribution-based methods, the MCID estimate for KBILD-Chest symptoms was 9.8 points. The MCID estimates for KBILD in IPF patients were similar.In patients with ILD and IPF, KBILD is responsive to intervention with an estimated MCID of 3.9 points for the total score.


2012 ◽  
Vol 12 (12) ◽  
pp. 1122-1128 ◽  
Author(s):  
Scott L. Parker ◽  
Owoicho Adogwa ◽  
Stephen K. Mendenhall ◽  
David N. Shau ◽  
William N. Anderson ◽  
...  

Thorax ◽  
2017 ◽  
Vol 73 (7) ◽  
pp. 680-682 ◽  
Author(s):  
Claire M Nolan ◽  
Veronica Delogu ◽  
Matthew Maddocks ◽  
Suhani Patel ◽  
Ruth E Barker ◽  
...  

The incremental shuttle walk (ISW) is well validated in COPD but limited psychometric data restrict its use in idiopathic pulmonary fibrosis (IPF). Study 1: 50 patients performed the ISW and 6 min walk test (6MWT). Study 2: 72 patients completed the ISW before and after pulmonary rehabilitation (PR). The ISW correlated strongly with 6MWT distance (r=0.81,p<0.0001). Mean (95% confidence interval) improvement in ISW with PR was 54 (38 to 70) m with an effect size of 0.29. Distribution-based and anchor-based minimum clinically important difference (MCID) estimates ranged from 31 to 46 m. The ISW is valid and responsive in IPF, with an anchor-based MCID estimate similar to that observed in chronic obstructive pulmonary disease.Trial registration numberPre-results; NCT02530736, NCT02436278.


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