Minimum Clinically Important Difference Analysis Confirms the Efficacy of IgPro10 in CIDP: the PRIMA Trial

Overview

Journal J Peripher Nerv Syst

Publisher Wiley

Specialty Neurology

Date 2017 Jun 9

PMID 28594116

Citations 3

Authors

Ingemar S J Merkies

John-Philip Lawo

Jonathan M Edelman

Jan L De Bleecker

Claudia Sommer

Wim Robberecht

Mika Saarela

Jerzy Kamienowski

Zbigniew Stelmasiak

Orell Mielke

Bjorn Tackenberg

Jean-Marc Leger

Affiliations

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Citing Articles

Minimal Clinically Important Difference (MCID) in Patient-Reported Outcome Measures for Neurological Conditions: Review of Concept and Methods.

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Prognostic value of neurofilament light chain in chronic inflammatory demyelinating polyneuropathy.

Godelaine J, De Schaepdryver M, Bossuyt X, Van Damme P, Claeys K, Poesen K Brain Commun. 2021; 3(1):fcab018.

PMID: 33796853 PMC: 7991223. DOI: 10.1093/braincomms/fcab018.

Efficacy and safety of IVIG in CIDP: Combined data of the PRIMA and PATH studies.

Merkies I, van Schaik I, Leger J, Bril V, van Geloven N, Hartung H J Peripher Nerv Syst. 2019; 24(1):48-55.

PMID: 30672091 PMC: 6594229. DOI: 10.1111/jns.12302.

References

Heesch K, Masse L, Dunn A . Using Rasch modeling to re-evaluate three scales related to physical activity: enjoyment, perceived benefits and perceived barriers. Health Educ Res. 2006; 21 Suppl 1:i58-72. DOI: 10.1093/her/cyl054. View

Leger J, De Bleecker J, Sommer C, Robberecht W, Saarela M, Kamienowski J . Efficacy and safety of Privigen(®) in patients with chronic inflammatory demyelinating polyneuropathy: results of a prospective, single-arm, open-label Phase III study (the PRIMA study). J Peripher Nerv Syst. 2013; 18(2):130-40. PMC: 3910165. DOI: 10.1111/jns5.12017. View

Vanhoutte E, Hermans M, Faber C, Gorson K, Merkies I, Thonnard J . Rasch-ionale for neurologists. J Peripher Nerv Syst. 2015; 20(3):260-8. DOI: 10.1111/jns.12122. View

Tennant A, Conaghan P . The Rasch measurement model in rheumatology: what is it and why use it? When should it be applied, and what should one look for in a Rasch paper?. Arthritis Rheum. 2007; 57(8):1358-62. DOI: 10.1002/art.23108. View

Hughes R, Bensa S, Willison H, Van den Bergh P, Comi G, Illa I . Randomized controlled trial of intravenous immunoglobulin versus oral prednisolone in chronic inflammatory demyelinating polyradiculoneuropathy. Ann Neurol. 2001; 50(2):195-201. DOI: 10.1002/ana.1088. View

Marais I, Andrich D . Formalizing dimension and response violations of local independence in the unidimensional Rasch model. J Appl Meas. 2008; 9(3):200-15. View

Hughes R, Donofrio P, Bril V, Dalakas M, Deng C, Hanna K . Intravenous immune globulin (10% caprylate-chromatography purified) for the treatment of chronic inflammatory demyelinating polyradiculoneuropathy (ICE study): a randomised placebo-controlled trial. Lancet Neurol. 2008; 7(2):136-44. DOI: 10.1016/S1474-4422(07)70329-0. View

Merkies I, Lauria G . 131st ENMC international workshop: selection of outcome measures for peripheral neuropathy clinical trials 10-12 December 2004, Naarden, The Netherlands. Neuromuscul Disord. 2006; 16(2):149-56. DOI: 10.1016/j.nmd.2005.12.003. View

Draak T, Vanhoutte E, van Nes S, Gorson K, van der Pol W, Notermans N . Comparing the NIS vs. MRC and INCAT sensory scale through Rasch analyses. J Peripher Nerv Syst. 2015; 20(3):277-88. DOI: 10.1111/jns.12127. View

10.

Hobart J, Cano S . Improving the evaluation of therapeutic interventions in multiple sclerosis: the role of new psychometric methods. Health Technol Assess. 2009; 13(12):iii, ix-x, 1-177. DOI: 10.3310/hta13120. View

11.

Jaeschke R, Singer J, Guyatt G . Measurement of health status. Ascertaining the minimal clinically important difference. Control Clin Trials. 1989; 10(4):407-15. DOI: 10.1016/0197-2456(89)90005-6. View

12.

Kleyweg R, van der Meche F, Schmitz P . Interobserver agreement in the assessment of muscle strength and functional abilities in Guillain-Barré syndrome. Muscle Nerve. 1991; 14(11):1103-9. DOI: 10.1002/mus.880141111. View

13.

Lunn M, Leger J, Merkies I, Van den Bergh P, van Schaik I . 151st ENMC international workshop: Inflammatory Neuropathy Consortium 13th-15th April 2007, Schiphol, The Netherlands. Neuromuscul Disord. 2007; 18(1):85-9. DOI: 10.1016/j.nmd.2007.08.004. View

14.

Draak T, Vanhoutte E, van Nes S, Gorson K, van der Pol W, Notermans N . Changing outcome in inflammatory neuropathies: Rasch-comparative responsiveness. Neurology. 2014; 83(23):2124-32. DOI: 10.1212/WNL.0000000000001044. View

15.

Merkies I, van Nes S, Hanna K, Hughes R, Deng C . Confirming the efficacy of intravenous immunoglobulin in CIDP through minimum clinically important differences: shifting from statistical significance to clinical relevance. J Neurol Neurosurg Psychiatry. 2010; 81(11):1194-9. DOI: 10.1136/jnnp.2009.194324. View

16.

Vanhoutte E, Faber C, Merkies I . 196th ENMC international workshop: Outcome measures in inflammatory peripheral neuropathies 8-10 February 2013, Naarden, The Netherlands. Neuromuscul Disord. 2013; 23(11):924-33. DOI: 10.1016/j.nmd.2013.06.006. View

17.

Vanhoutte E, Faber C, van Nes S, Jacobs B, van Doorn P, van Koningsveld R . Modifying the Medical Research Council grading system through Rasch analyses. Brain. 2011; 135(Pt 5):1639-49. PMC: 3338921. DOI: 10.1093/brain/awr318. View