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1. Electrodiagnosis of Guillain-Barre syndrome in the International GBS Outcome Study: Differences in methods and reference values

Author

Addington, J.M., Ajroud-Driss, S., Andersen, H., Antonini, G., Attarian, S., Badrising, U.A., Balloy, G., Barroso, F.A., Bateman, K., Bella, I.R., Benedetti, L., van den Bergh, P., Bertorini, T.E., Bhavaraju-Sanka, R., Bianco, M., Brannagan, T.H., Briani, C., Buerrmann, Busby, M., Butterworth, S., Casasnovas, C., Cavaletti, G., Chao, C.C., Chavada, G., Chen, S., Claeys, K.G., Conti, M.E., Cornblath, D.R., Cosgrove, J.S., Dalakas, M.C., van Damme, P., Dardiotis, E., Davidson, A., Derejko, M.A., van Dijk, G.W., Dimachkie, M.M., van Doorn, P.A., Dornonville de la Cour, C., Echaniz-Laguna, A., Eftimov, F., Faber, C.G., Fazio, R., Feasby, T.E., Fokke, C., Fujioka, T., Fulgenzi, E.A., Galassi, G., Garcia-Sobrino, T., Garssen, M.P.J., Gijsbers, C.J., Gilchrist, J.M., Gilhuis, H.J., Goldstein, J.M., Gorson, K.C., Goyal, N.A., Granit, V., Grisanti, S.T.E., Gutiérrez-Gutiérrez, Gutmann, L., Hadden, R.D.M., Harbo, T., Hartung, H.P., Holbech, J.V., Holt, J.K.L., Hsieh, S.T., Htut, M., Hughes, R.A.C., Illa, I., Islam, B., Islam, Z., Jacobs, B.C., Fehmi, J., Jellema, K., Jerico Pascual, I., Kaida, K., Karafiath, S., Katzberg, H.D., Khoshnoodi, M.A., Kiers, L., Kimpinski, K., Kleyweg, R.P., Kokubun, N., Kolb, N.A., van Koningsveld, R., van der Kooi, A.J., Kramers, J.C.H.M., Kuitwaard, K., Kusunoki, S., Kuwabara, S., Kwan, J.Y., Ladha, S.S., Landschoff Lassen, L., Lawson, V., Lehmann, H.C., Lee Pan, E., Lunn, M.P.T., Manji, H., Marfia, G.A., Márquez Infante, C., Martin-Aguilar, L., Martinez Hernandez, E., Mataluni, G., Mattiazi, M., McDermott, C.J., Meekins, G.D., Miller, J.A.L., Mohammad, Q.D., Monges, M.S., Moris de la Tassa, G., Nascimbene, C., Navacerrada-Barrero, F.J., Nobile-Orazio, E., Nowak, R.J., Orizaola, P.J., Osei-Bonsu, M., Pardal, A.M., Pardo, J., Pascuzzi, R.M., Péréon, Y., Pulley, M.T., Querol, L., Reddel, S.W., van der Ree, T., Reisin, R.C., Rinaldi, S., Roberts, R.C., Rojas-Marcos, I., Rudnicki, Sachs, G.M., Samijn, J.P.A., Santoro, L., Schenone, A., Sedano Tous, M.J., Shahrizaila, N., Sheikh, K.A., Silvestri, N.J., Sindrup, S.H., Sommer, C.L., Stein, B., Song, Y., Stino, A.M., Tankisi, H., Tannemaat, M.R., Twydell, P., Vélez-Santamaria, P.V., Varrato, J.D., Vermeij, F.H., Visser, L.H., Vytopil, M.V., Waheed, W., Walgaard, C., Wang, Y.Z., Willison, H.J., Wirtz, P.W., Yamagishi, Y., Zhou, L., Zivkovic, S.A., Arends, Samuel, Drenthen, Judith, van den Bergh, Peter, Franssen, Hessel, Hadden, Robert D.M., Islam, Badrul, Kuwabara, Satoshi, Reisin, Ricardo C., Shahrizaila, Nortina, Amino, Hiroshi, Antonini, Giovanni, Attarian, Shahram, Balducci, Claudia, Barroso, Fabio, Bertorini, Tulio, Binda, Davide, Brannagan, Thomas H., Buermann, Jan, Casasnovas, Carlos, Cavaletti, Guido, Chao, Chi-Chao, Dimachkie, Mazen M., Fulgenzi, Ernesto A., Galassi, Giuliana, Gutiérrez Gutiérrez, Gerardo, Harbo, Thomas, Hartung, Hans-Peter, Hsieh, Sung-Tsang, Kiers, Lynette, Lehmann, Helmar C., Manganelli, Fiore, Marfia, Girolama A., Mataluni, Giorgia, Pardo, Julio, Péréon, Yann, Rajabally, Yusuf A., Santoro, Lucio, Sekiguchi, Yukari, Stein, Beth, Stettner, Mark, Uncini, Antonino, Verboon, Christine, Verhamme, Camiel, Vytopil, Michal, Waheed, Waqar, Wang, Min, Zivkovic, Sasha, Jacobs, Bart C., and Cornblath, David R.

Published
2022
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2. Predicting Outcome in Guillain-Barre Syndrome International Validation of the Modified Erasmus GBS Outcome Score

Author

Doets, A.Y., Lingsma, H.F., Walgaard, C., Islam, B., Papri, N., Davidson, A., Yamagishi, Y., Kusunoki, S., Dimachkie, M.M., Waheed, W., Kolb, N., Islam, Z., Mohammad, Q.D., Harbo, T., Sindrup, S.H., Chavada, G., Willison, H.J., Casasnovas, C., Bateman, K., Miller, J.A.L., Berg, B. van den, Verboon, C., Roodbol, J., Leonhard, S.E., Benedetti, L., Kuwabara, S., Bergh, P. van den, Monges, S., Marfia, G.A., Shahrizaila, N., Galassi, G., Pereon, Y., Burmann, J., Kuitwaard, K., Kleyweg, R.P., Marchesoni, C., Tous, M.J.S., Querol, L., Illa, I., Wang, Y.Z., Nobile-Orazio, E., Rinaldi, S., Schenone, A., Pardo, J., Vermeij, F.H., Lehmann, H.C., Granit, V., Cavaletti, G., Gutierrez-Gutierrez, G., Barroso, F.A., Visser, L.H., Katzberg, H.D., Dardiotis, E., Attarian, S., Kooi, A.J. van der, Eftimov, F., Wirtz, P.W., Samijn, J.P.A., Gilhuis, H.J., Hadden, R.D.M., Holt, J.K.L., Sheikh, K.A., Karafiath, S., Vytopil, M., Antonini, G., Feasby, T.E., Faber, C.G., Gijsbers, C.J., Busby, M., Roberts, R.C., Silvestri, N.J., Fazio, R., Dijk, G.W. van, Garssen, M.P.J., Straathof, C.S.M., Gorson, K.C., Jacobs, B.C., IGOS Consortium, Neurology, ANS - Neuroinfection & -inflammation, EURO-NMD, Klinische Neurowetenschappen, MUMC+: MA Med Staf Spec Neurologie (9), RS: MHeNs - R1 - Cognitive Neuropsychiatry and Clinical Neuroscience, Doets, A, Lingsma, H, Walgaard, C, Islam, B, Papri, N, Davidson, A, Yamagishi, Y, Kusunoki, S, Dimachkie, M, Waheed, W, Kolb, N, Islam, Z, Mohammad, Q, Harbo, T, Sindrup, S, Chavada, G, Willison, H, Casasnovas, C, Bateman, K, Miller, J, van den Berg, B, Verboon, C, Roodbol, J, Leonhard, S, Benedetti, L, Kuwabara, S, Van den Bergh, P, Monges, S, Marfia, G, Shahrizaila, N, Galassi, G, Péréon, Y, Bürmann, J, Kuitwaard, K, Kleyweg, R, Marchesoni, C, Sedano Tous, M, Querol, L, Illa, I, Wang, Y, Nobile-Orazio, E, Rinaldi, S, Schenone, A, Pardo, J, Vermeij, F, Lehmann, H, Granit, V, Cavaletti, G, Gutiérrez-Gutiérrez, G, Barroso, F, Visser, L, Katzberg, H, Dardiotis, E, Attarian, S, van der Kooi, A, Eftimov, F, Wirtz, P, Samijn, J, Gilhuis, H, Hadden, R, Holt, J, Sheikh, K, Karafiath, S, Vytopil, M, Antonini, G, Feasby, T, Faber, C, Gijsbers, C, Busby, M, Roberts, R, Silvestri, N, Fazio, R, van Dijk, G, Garssen, M, Straathof, C, Gorson, K, Jacobs, B, Public Health, and Immunology

Subjects
Guillain-Barrè, predicting, outcome, IGOS, MODELS, Guillain-Barre Syndrome, Prognosis, Settore MED/26, Cohort Studies, POOR-PROGNOSIS, Outcome Assessment, Health Care, Humans, INTRAVENOUS IMMUNOGLOBULIN, Neurology (clinical), Prospective Studies, Child, Research Article
Abstract

Background and ObjectivesThe clinical course and outcome of the Guillain-Barré syndrome (GBS) are diverse and vary among regions. The modified Erasmus GBS Outcome Score (mEGOS), developed with data from Dutch patients, is a clinical model that predicts the risk of walking inability in patients with GBS. The study objective was to validate the mEGOS in the International GBS Outcome Study (IGOS) cohort and to improve its performance and region specificity.MethodsWe used prospective data from the first 1,500 patients included in IGOS, aged ≥6 years and unable to walk independently. We evaluated whether the mEGOS at entry and week 1 could predict the inability to walk unaided at 4 and 26 weeks in the full cohort and in regional subgroups, using 2 measures for model performance: (1) discrimination: area under the receiver operating characteristic curve (AUC) and (2) calibration: observed vs predicted probability of being unable to walk independently. To improve the model predictions, we recalibrated the model containing the overall mEGOS score, without changing the individual predictive factors. Finally, we assessed the predictive ability of the individual factors.ResultsFor validation of mEGOS at entry, 809 patients were eligible (Europe/North America [n = 677], Asia [n = 76], other [n = 56]), and 671 for validation of mEGOS at week 1 (Europe/North America [n = 563], Asia [n = 65], other [n = 43]). AUC values were >0.7 in all regional subgroups. In the Europe/North America subgroup, observed outcomes were worse than predicted; in Asia, observed outcomes were better than predicted. Recalibration improved model accuracy and enabled the development of a region-specific version for Europe/North America (mEGOS-Eu/NA). Similar to the original mEGOS, severe limb weakness and higher age were the predominant predictors of poor outcome in the IGOS cohort.DiscussionmEGOS is a validated tool to predict the inability to walk unaided at 4 and 26 weeks in patients with GBS, also in countries outside the Netherlands. We developed a region-specific version of mEGOS for patients from Europe/North America.Classification of EvidenceThis study provides Class II evidence that the mEGOS accurately predicts the inability to walk unaided at 4 and 26 weeks in patients with GBS.Trial Registration InformationNCT01582763.

Published
2022
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3. Second intravenous immunoglobulin dose in patients with Guillain-Barré syndrome with poor prognosis (SID-GBS): a double-blind, randomised, placebo-controlled trial

Author

Walgaard, C., Walgaard, C., Jacobs, B.C., Lingsma, H.F., Steyerberg, E.W., van den Berg, B., Doets, A.Y., Leonhard, S.E., Verboon, C., Huizinga, R., Drenthen, J., Arends, S., Budde, I.K., Kleyweg, R.P., Kuitwaard, K., van der Meulen, M.F.G., Samijn, J.P.A., Vermeij, F.H., Kuks, J.B.M., van Dijk, G.W., Wirtz, P.W., Eftimov, F., van der Kooi, A.J., Garssen, M.P.J., Gijsbers, C.J., de Rijk, M.C., Visser, L.H., Blom, R.J., Linssen, W.H.J.P., van der Kooi, E.L., Verschuuren, J.J.G.M., van Koningsveld, R., Dieks, R.J.G., Gilhuis, H.J., Jellema, K., van der Ree, T.C., Bienfait, H.M.E., Faber, C.G., Lovenich, H., van Engelen, B.G.M., Groen, R.J., Merkies, I.S.J., van Oosten, B.W., van der Pol, W.L., van der Meulen, W.D.M., Badrising, U.A., Stevens, M., Breukelman, A.J.J., Zwetsloot, C.P., van der Graaff, M.M., Wohlgemuth, M., Dutch GBS Study Grp, van Doorn, Pieter Antoon, Walgaard, C., Walgaard, C., Jacobs, B.C., Lingsma, H.F., Steyerberg, E.W., van den Berg, B., Doets, A.Y., Leonhard, S.E., Verboon, C., Huizinga, R., Drenthen, J., Arends, S., Budde, I.K., Kleyweg, R.P., Kuitwaard, K., van der Meulen, M.F.G., Samijn, J.P.A., Vermeij, F.H., Kuks, J.B.M., van Dijk, G.W., Wirtz, P.W., Eftimov, F., van der Kooi, A.J., Garssen, M.P.J., Gijsbers, C.J., de Rijk, M.C., Visser, L.H., Blom, R.J., Linssen, W.H.J.P., van der Kooi, E.L., Verschuuren, J.J.G.M., van Koningsveld, R., Dieks, R.J.G., Gilhuis, H.J., Jellema, K., van der Ree, T.C., Bienfait, H.M.E., Faber, C.G., Lovenich, H., van Engelen, B.G.M., Groen, R.J., Merkies, I.S.J., van Oosten, B.W., van der Pol, W.L., van der Meulen, W.D.M., Badrising, U.A., Stevens, M., Breukelman, A.J.J., Zwetsloot, C.P., van der Graaff, M.M., Wohlgemuth, M., Dutch GBS Study Grp, and van Doorn, Pieter Antoon

Abstract

Background Treatment with one standard dose (2 g/kg) of intravenous immunoglobulin is insufficient in a proportion of patients with severe Guillain-Barre syndrome. Worldwide, around 25% of patients severely affected with the syndrome are given a second intravenous immunoglobulin dose (SID), although it has not been proven effective. We aimed to investigate whether a SID is effective in patients with Guillain-Barre syndrome with a predicted poor outcome.Methods In this randomised, double-blind, placebo-controlled trial (SID-GBS), we included patients (>= 12 years) with Guillain-Barre syndrome admitted to one of 59 participating hospitals in the Netherlands. Patients were included on the first day of standard intravenous immunoglobulin treatment (2 g/kg over 5 days). Only patients with a poor prognosis (score of >= 6) according to the modified Erasmus Guillain-Barre syndrome Outcome Score were randomly assigned, via block randomisation stratified by centre, to SID (2 g/kg over 5 days) or to placebo, 7-9 days after inclusion. Patients, outcome adjudicators, monitors, and the steering committee were masked to treatment allocation. The primary outcome measure was the Guillain-Barre syndrome disability score 4 weeks after inclusion. All patients in whom allocated trial medication was started were included in the modified intention-to-treat analysis.Findings Between Feb 16, 2010, and June 5, 2018, 327 of 339 patients assessed for eligibility were included. 112 had a poor prognosis. Of those, 93 patients with a poor prognosis were included in the modified intention-to-treat analysis: 49 (53%) received SID and 44 (47%) received placebo. The adjusted common odds ratio for improvement on the Guillain-Barre syndrome disability score at 4 weeks was 1.4 (95% CI 0.6-3.3; p=0.45). Patients given SID had more serious adverse events (35% vs 16% in the first 30 days), including thromboembolic events, than those in the placebo group. Four patients died in the intervention group (

Published
2021

4. International Guillain-Barré Syndrome Outcome Study: protocol of a prospective observational cohort study on clinical and biological predictors of disease course and outcome in Guillain-Barré syndrome

Author

Jacobs, B.C. (Bart C.), Berg, B. (Bianca) van den, Verboon, C. (Christine), Chavada, G. (Govindsinh), Cornblath, D.R. (David), Gorson, K.C. (Kenneth), Harbo, T. (Thomas), Hartung, H.P., Hughes, R.A.C. (Richard A. C.), Kusunoki, S. (Susumu), Doorn, P.A. (Pieter) van, Willison, H.J. (Hugh J.), Jacobs, B.C. (Bart), Hughes, R.A.C. (Richard), Cornblath, D.R., Gorson, K.C., Kusunoki, S., Willison, H.J. (Hugh), van Woerkom, M., van den Berg, B., Verboon, C., Roodbol, J. (J.), Reisin, R. (R.), Reddel, S.W., Islam, Z. (Zhahirul), Islam, B., Mohammad, Q.D. (Quazi), Bergh, P.Y.K. (Paul) van den, Feasby, T.E., Wang, Y.Z., Harbo, T., Péréon, Y., Lehmann, H.C., Dardiotis, E., Nobile-Orazio, E. (Eduarde), Shahrizaila, N., Jacobs, B.C., Bateman, K., Illa, I. (Isabel), Querol, L. (Luis), Hsieh, S.T., Willison, H.J., Chavada, G., Davidson, A., Addington, J.M., Ajroud-Driss, S., Andersen, H., Antonini, G., Attarian, S., Badrising, U.A. (Umesh), Barroso, F.A., Benedetti, L., Beronio, A., Bianco, M., Binda, D., Briani, C., Bürmann, J., Bella, I.R., Bertorini, T.E., Bhavaraju-Sanka, R., Brannagan, T.H., Busby, M., Butterworth, S., Campagnolo, M., Casasnovas, C., Cavaletti, G., Chao, C.S., Chen, S., Chetty, S., Claeys, T. (Tine), Cohen, J.A., Conti, M.E., Cosgrove, J.S., Dalakas, M.C. (Marinos), Dimachkie, M.M., Dillmann, U., Domínguez González, C., Doppler, K., Dornonville de la Cour, C., Echaniz-Laguna, A., Eftimov, F. (Filip), Faber, C.G., Fazio, R. (R.), Fokke, M. (Maureen), Fujioka, T., Fulgenzi, E. (E.), Galassi, G., Garcia, T., Garnero, M., Garssen, M.P.J. (Marcel), Gijsbers, C.J., Gilchrist, J.M., Gilhuis, J. (Job), Goldstein, J.M., Goyal, N., Granit, V., Grapperon, A., Gutiérrez Gutiérrez, G., Gutmann, L., Hadden, R.D.M. (Rob), Holbech, J.V., Holt, J.K.L., Homedes Pedret, C., Htut, M., Jellema, K., Jericó Pascual, I., Kaida, K.I. (Ken Ichi), Karafiath, S., Katzberg, H. (Hans), Kiers, H.A.L. (Henk), Kieseier, B.C. (Bernd), Kimpinski, K., Kleyweg, R.P., Kokubun, N., Kolb, N.A., Kuitwaard, K. (Krista), Kuwabara, S., Kwan, J.Y., Ladha, S.S., Landschoff Lassen, L., Lawson, V., Ledingham, D., Léon Cejas, L., Luciano, C.A., Lucy, S.T., Lunn, M.P.T. (Michael P. T.), Magot, A., Manji, H., Marchesoni, A., Marfia, G.A.M., Márquez Infante, C., Martinez Hernandez, E., Mataluni, G., Mattiazi, M., McDermott, C.J., Meekins, G.D., Miller, J., Monges, M.S., Montero, M.C.J., Morís de la Tassa, G., Nascimbene, C., Neumann, C., Nowak, R.J., Orizaola Balaguer, P., Osei-Bonsu, M., Pan, E.B.L., Pardo Fernandez, J., Pasnoor, M., Pulley, M.T., Rajabally, Y.A., Rinaldi, S. (Sabina), Ritter, C., Roberts, R.C., Rojas-Marcos, I., Rudnicki, S.A., Sachs, G.M., Samijn, J.P. (Johnny), Santoro, L., Saperstein, D.S., Savransky, A., Schneider, H., Schenone, A. (Andrea), Sedano Tous, M.J., Sekiguchi, Y., Sheikh, K.A., Silvestri, N.J., Sindrup, S.H., Sommer, C., Stein, B., Stino, A.M., Spyropoulos, A., Srinivasan, J., Suzuki, H., Taylor, S.W., Tankisi, H., Tigner, D., Twydell, P.T., Valzania, F., van Damme, P., Kooj, A.J. (Anneke), Dijk, G.W. (Gert) van, van der Ree, T., Koningsveld, R. (Rinske) van, Varrato, J.D., Vermeij, F.H. (Frederique), Verschuuren, J.J. (Jan), Visser, L.H. (Leendert), Vytopil, M.V., Waheed, W., Wilken, M., Wilkerson, C., Wirtz, P.W., Yamagishi, Y., Yiu, E.M., Zhou, L., Zivkovic, S.A. (Sasa), Jacobs, B.C. (Bart C.), Berg, B. (Bianca) van den, Verboon, C. (Christine), Chavada, G. (Govindsinh), Cornblath, D.R. (David), Gorson, K.C. (Kenneth), Harbo, T. (Thomas), Hartung, H.P., Hughes, R.A.C. (Richard A. C.), Kusunoki, S. (Susumu), Doorn, P.A. (Pieter) van, Willison, H.J. (Hugh J.), Jacobs, B.C. (Bart), Hughes, R.A.C. (Richard), Cornblath, D.R., Gorson, K.C., Kusunoki, S., Willison, H.J. (Hugh), van Woerkom, M., van den Berg, B., Verboon, C., Roodbol, J. (J.), Reisin, R. (R.), Reddel, S.W., Islam, Z. (Zhahirul), Islam, B., Mohammad, Q.D. (Quazi), Bergh, P.Y.K. (Paul) van den, Feasby, T.E., Wang, Y.Z., Harbo, T., Péréon, Y., Lehmann, H.C., Dardiotis, E., Nobile-Orazio, E. (Eduarde), Shahrizaila, N., Jacobs, B.C., Bateman, K., Illa, I. (Isabel), Querol, L. (Luis), Hsieh, S.T., Willison, H.J., Chavada, G., Davidson, A., Addington, J.M., Ajroud-Driss, S., Andersen, H., Antonini, G., Attarian, S., Badrising, U.A. (Umesh), Barroso, F.A., Benedetti, L., Beronio, A., Bianco, M., Binda, D., Briani, C., Bürmann, J., Bella, I.R., Bertorini, T.E., Bhavaraju-Sanka, R., Brannagan, T.H., Busby, M., Butterworth, S., Campagnolo, M., Casasnovas, C., Cavaletti, G., Chao, C.S., Chen, S., Chetty, S., Claeys, T. (Tine), Cohen, J.A., Conti, M.E., Cosgrove, J.S., Dalakas, M.C. (Marinos), Dimachkie, M.M., Dillmann, U., Domínguez González, C., Doppler, K., Dornonville de la Cour, C., Echaniz-Laguna, A., Eftimov, F. (Filip), Faber, C.G., Fazio, R. (R.), Fokke, M. (Maureen), Fujioka, T., Fulgenzi, E. (E.), Galassi, G., Garcia, T., Garnero, M., Garssen, M.P.J. (Marcel), Gijsbers, C.J., Gilchrist, J.M., Gilhuis, J. (Job), Goldstein, J.M., Goyal, N., Granit, V., Grapperon, A., Gutiérrez Gutiérrez, G., Gutmann, L., Hadden, R.D.M. (Rob), Holbech, J.V., Holt, J.K.L., Homedes Pedret, C., Htut, M., Jellema, K., Jericó Pascual, I., Kaida, K.I. (Ken Ichi), Karafiath, S., Katzberg, H. (Hans), Kiers, H.A.L. (Henk), Kieseier, B.C. (Bernd), Kimpinski, K., Kleyweg, R.P., Kokubun, N., Kolb, N.A., Kuitwaard, K. (Krista), Kuwabara, S., Kwan, J.Y., Ladha, S.S., Landschoff Lassen, L., Lawson, V., Ledingham, D., Léon Cejas, L., Luciano, C.A., Lucy, S.T., Lunn, M.P.T. (Michael P. T.), Magot, A., Manji, H., Marchesoni, A., Marfia, G.A.M., Márquez Infante, C., Martinez Hernandez, E., Mataluni, G., Mattiazi, M., McDermott, C.J., Meekins, G.D., Miller, J., Monges, M.S., Montero, M.C.J., Morís de la Tassa, G., Nascimbene, C., Neumann, C., Nowak, R.J., Orizaola Balaguer, P., Osei-Bonsu, M., Pan, E.B.L., Pardo Fernandez, J., Pasnoor, M., Pulley, M.T., Rajabally, Y.A., Rinaldi, S. (Sabina), Ritter, C., Roberts, R.C., Rojas-Marcos, I., Rudnicki, S.A., Sachs, G.M., Samijn, J.P. (Johnny), Santoro, L., Saperstein, D.S., Savransky, A., Schneider, H., Schenone, A. (Andrea), Sedano Tous, M.J., Sekiguchi, Y., Sheikh, K.A., Silvestri, N.J., Sindrup, S.H., Sommer, C., Stein, B., Stino, A.M., Spyropoulos, A., Srinivasan, J., Suzuki, H., Taylor, S.W., Tankisi, H., Tigner, D., Twydell, P.T., Valzania, F., van Damme, P., Kooj, A.J. (Anneke), Dijk, G.W. (Gert) van, van der Ree, T., Koningsveld, R. (Rinske) van, Varrato, J.D., Vermeij, F.H. (Frederique), Verschuuren, J.J. (Jan), Visser, L.H. (Leendert), Vytopil, M.V., Waheed, W., Wilken, M., Wilkerson, C., Wirtz, P.W., Yamagishi, Y., Yiu, E.M., Zhou, L., and Zivkovic, S.A. (Sasa)

Abstract

Guillain-Barré syndrome (GBS) is an acute polyradiculoneuropathy with a highly variable clinical presentation, course, and outcome. The factors that determine the clinical variation of GBS are poorly understood which complicates the care and treatment of individual patients. The protocol of the ongoing International GBS Outcome Study (IGOS), a prospective, observational, multicenter cohort study that aims to identify the clinical and biological determinants and predictors of disease onset, subtype, course and outcome of GBS is presented here. Patients fulfilling the diagnostic criteria for GBS, regardless of age, disease severity, variant forms, or treatment, can participate if included within 2 weeks after onset of weakness. Information about demography, preceding infections, clinical features, diagnostic findings, treatment, course, and outcome is collected. In addition, cerebrospinal fluid and serial blood samples for serum and DNA is collected at standard time points. The original aim was to include at least 1,000 patients with a follow-up of 1–3 years. Data are collected via a web-based data entry system and stored anonymously. IGOS started in May 2012 and by January 2017 included more than 1,400 participants from 143 active centers in 19 countries across 5 continents. The IGOS data/biobank is available for research projects conducted by expertise groups focusing on specific topics including epidemiology, diagnostic criteria, clinimetrics, electrophysiology, antecedent events, antibodies, genetics, prognostic modeling, treatment effects, and long-term outcome of GBS. The IGOS will help to standardize the international collection of data and biosamples for future research of GBS.

Published
2017
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6. The Preventive Antibiotics in Stroke Study (PASS): a pragmatic randomised open-label masked endpoint clinical trial

Author

Westendorp, W.F., Vermeij, J.D., Zock, E., Hooijenga, I.J., Kruyt, N.D., Bosboom, H.J.L.W., Kwa, V.I.H., Weisfelt, M., Remmers, M.J.M., Houten, R. ten, Schreuder, A.H.C.M., Vermeer, S.E., Dijk, E.J. van, Dippel, D.W.J., Dijkgraaf, M.G.W., Spanjaard, L., Vermeulen, M., Poll, T. van der, Prins, J.M., Vermeij, F.H., Roos, Y.B.W.E.M., Kleyweg, R.P., Kerkhoff, H., Brouwer, M.C., Zwinderman, A.H., Beek, D. van de, Nederkoorn, P.J., PASS Investigators, Erasmus MC other, Neurology, Anesthesiology, Neurosciences, Graduate School, Other departments, Clinical Research Unit, AII - Amsterdam institute for Infection and Immunity, Medical Microbiology and Infection Prevention, ANS - Amsterdam Neuroscience, Infectious diseases, Center of Experimental and Molecular Medicine, ACS - Amsterdam Cardiovascular Sciences, APH - Amsterdam Public Health, and Epidemiology and Data Science

Subjects
Male, medicine.medical_specialty, THERAPY, Modified Rankin Scale, Internal medicine, INFECTION, Clinical endpoint, medicine, Humans, Prospective Studies, ACUTE ISCHEMIC-STROKE, Prospective cohort study, Stroke, Aged, Netherlands, Aged, 80 and over, OUTCOMES, Intention-to-treat analysis, business.industry, Standard treatment, Ceftriaxone, MINOCYCLINE, General Medicine, Pneumonia, Recovery of Function, Length of Stay, Middle Aged, CARE, medicine.disease, Disorders of movement Donders Center for Medical Neuroscience [Radboudumc 3], Anti-Bacterial Agents, Intention to Treat Analysis, Clinical trial, Treatment Outcome, Urinary Tract Infections, Physical therapy, UPDATE, Female, Quality-Adjusted Life Years, business, medicine.drug, Follow-Up Studies
Abstract

Item does not contain fulltext BACKGROUND: In adults with acute stroke, infections occur commonly and are associated with an unfavourable functional outcome. In the Preventive Antibiotics in Stroke Study (PASS) we aimed to establish whether or not preventive antimicrobial therapy with a third-generation cephalosporin, ceftriaxone, improves functional outcome in patients with acute stroke. METHODS: In this multicentre, randomised, open-label trial with masked endpoint assessment, patients with acute stroke were randomly assigned to intravenous ceftriaxone at a dose of 2 g, given every 24 h intravenously for 4 days, in addition to stroke unit care, or standard stroke unit care without preventive antimicrobial therapy; assignments were made within 24 h after symptom onset. The primary endpoint was functional outcome at 3 months, defined according to the modified Rankin Scale and analysed by intention to treat. The primary analysis was by ordinal regression of the primary outcome. Secondary outcomes included death, infection rates, antimicrobial use, and length of hospital stay. Participants and caregivers were aware of treatment allocation but assessors of outcome were masked to group assignment. This trial is registered with controlled-trials.com, number ISRCTN66140176. FINDINGS: Between July 6, 2010, and March 23, 2014, a total of 2550 patients from 30 sites in the Netherlands, including academic and non-academic medical centres, were randomly assigned to the two treatment groups: 1275 patients to ceftriaxone and 1275 patients to standard treatment (control group). 12 patients (seven in the ceftriaxone group and five in the control group) withdrew consent immediately after randomisation, leaving 2538 patients available for the intention-to-treat-analysis (1268 in the ceftriaxone group and 1270 in the control group). 2514 (99%) of 2538 patients (1257 in each group) completed 3-month follow-up. Preventive ceftriaxone did not affect the distribution of functional outcome scores on the modified Rankin Scale at 3 months (adjusted common odds ratio 0.95 [95% CI 0.82-1.09], p=0.46). Preventive ceftriaxone did not result in an increased occurrence of adverse events. Overgrowth infection with Clostridium difficile occurred in two patients (

Published
2015

8. Treatment of the Guillain-Barré syndrome

Author

Kleyweg, R.P. and Kleyweg, R.P.

Abstract

The Guillain-Barre syndrome (GBS) is an inflammatory polyneuropathy with an incidence of 1-1.8/100,000. It is characterised by an acute or subacute onset and a progressive phase of less than four weeks, followed by a plateau phase of variable duration [106, 111]. Improvement then starts spontaneously; about 80% of the patients revover completely [135]. During the disease, 10-23% of the patients require artificial ventilation and there is still a mortality of 3-5%. Ultimately, 10-22% of the patients remain disabled [106, 113, 135]. Since not all patients make an uneventful, complete recovery, the search for an effective treatment is going on continuously. The possible role of humoral components in the pathogenesis of GBS [30] prompted an open study with plasma exchange (PE) in a single patient with severe GBS. That was very successful [14]. After numerous case reports [28, 58, 109, 130, 141, 149, 172] and several clinical trials [50, 57, 61, 131] examining the effects of PE in GBS patients, PE is now generally accepted as a treatment for patients with severe GBS [26]. PE carries, however, certain risks [69, 159]. It is a cumbersome procedure and therefore not widely applicable. This prompted us to investigate an alternative treatment with immunoglobulins, given intravenously (Igiv), which forms the basis for this thesis. The aim of this study was to investigate a new, and relatively simple treatment for patients with Guillain-Barre syndrome (GBS).

Published
1990

12. Time to treatment and preventive antibiotics in stroke

Author

Zock, Elles, van de Beek, D., Kerkhoff, H., Kleyweg, R.P., Faculteit der Geneeskunde, van de Beek, Diederik, Kleyweg, R. P., Amsterdam Neuroscience - Neuroinfection & -inflammation, Graduate School, and Neurology

Abstract

Stroke is caused by cerebral ischaemia or intracerebral haemorrhage. Delay in stroke treatment after onset of symptoms and infections during the first days after stroke onset are associated with worse outcome. Haemorrhagic stroke in patients using vitamin K antagonists (VKA) has a poor outcome. Delay in antagonizing VKA in these patients is present in earlier studies. With a qualitative study, we explored patient-related factors causing delay in seeking help after stroke onset. About half of the patients undertook no action after onset of symptoms. Knowledge or recognition of stroke symptoms were not associated with shorter alarm-time. Many participants had no interest in gaining knowledge about stroke symptoms or treatment options. Many participants would like to resolve the problems by themselves, not wanting to bother somebody or complaining easily. Future stroke-campaigns should be changed with less emphasis on knowledge, but based on input from population-embedded focus groups. We studied whether a shorter in-hospital delay in treatment with prothrombin complex concentrate in VKA-related haemorrhagic stroke was associated with better functional outcome. We found, that a shorter delay was associated with a worse functional outcome, because severely affected patients were treated with less delay. We studied whether preventive use of ceftriaxone improves functional outcome after 3 months. Ceftriaxone did not result in a beneficial effect. The rate of urinary tract infections was reduced, but not the pneumonia-rate. Despite these results a cost-effectiveness study showed that the intervention seems cost-effective in at least 66% of patients.

Published
2020

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