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2. Assessing Performance and Clinical Usefulness in Prediction Models With Survival Outcomes: Practical Guidance for Cox Proportional Hazards Models

Author

Mclernon, D, Giardiello, D, Van Calster, B, Wynants, L, van Geloven, N, van Smeden, M, Therneau, T, Steyerberg, E, McLernon D. J., Giardiello D., Van Calster B., Wynants L., van Geloven N., van Smeden M., Therneau T., Steyerberg E. W., Mclernon, D, Giardiello, D, Van Calster, B, Wynants, L, van Geloven, N, van Smeden, M, Therneau, T, Steyerberg, E, McLernon D. J., Giardiello D., Van Calster B., Wynants L., van Geloven N., van Smeden M., Therneau T., and Steyerberg E. W.

Abstract

Risk prediction models need thorough validation to assess their performance. Validation of models for survival outcomes poses challenges due to the censoring of observations and the varying time horizon at which predictions can be made. This article describes measures to evaluate predictions and the potential improvement in decision making from survival models based on Cox proportional hazards regression. As a motivating case study, the authors consider the prediction of the composite outcome of recurrence or death (the “event”) in patients with breast cancer after surgery. They developed a simple Cox regression model with 3 predictors, as in the Nottingham Prognostic Index, in 2982 women (1275 events over 5 years of follow-up) and externally validated this model in 686 women (285 events over 5 years). Improvement in performance was assessed after the addition of progesterone receptor as a prognostic biomarker. The model predictions can be evaluated across the full range of observed follow-up times or for the event occurring by the end of a fixed time horizon of interest. The authors first discuss recommended statistical measures that evaluate model performance in terms of discrimination, calibration, or overall performance. Further, they evaluate the potential clinical utility of the model to support clinical decision making according to a net benefit measure. They provide SAS and R code to illustrate internal and external validation. The authors recommend the proposed set of performance measures for transparent reporting of the validity of predictions from survival models.

Published
2023

4. Seasonal variation of serotonin turnover in human cerebrospinal fluid, depressive symptoms and the role of the 5-HTTLPR.

Author

Luykx, JJ, Bakker, SC, van Geloven, N, Eijkemans, MJC, Horvath, S, Lentjes, E, Boks, MPM, Strengman, E, DeYoung, J, Buizer-Voskamp, JE, Cantor, RM, Lu, A, van Dongen, EPA, Borgdorff, P, Bruins, P, Kahn, RS, and Ophoff, RA

Subjects
Humans, Serotonin, Homovanillic Acid, Hydroxyindoleacetic Acid, Regression Analysis, Longitudinal Studies, Depression, Seasons, Polymorphism, Genetic, Alleles, Adult, Middle Aged, Female, Male, Serotonin Plasma Membrane Transport Proteins, cerebrospinal fluid, depression, 5-HTTLPR, monoamine, season, serotonin, Polymorphism, Genetic, Clinical Sciences, Public Health and Health Services, Psychology
Abstract

Studying monoaminergic seasonality is likely to improve our understanding of neurobiological mechanisms underlying season-associated physiological and pathophysiological behavior. Studies of monoaminergic seasonality and the influence of the serotonin-transporter-linked polymorphic region (5-HTTLPR) on serotonin seasonality have yielded conflicting results, possibly due to lack of power and absence of multi-year analyses. We aimed to assess the extent of seasonal monoamine turnover and examined the possible involvement of the 5-HTTLPR. To determine the influence of seasonality on monoamine turnover, 5-hydroxyindoleacetic acid (5-HIAA) and homovanillic acid (HVA) were measured in the cerebrospinal fluid of 479 human subjects collected during a 3-year period. Cosine and non-parametric seasonal modeling were applied to both metabolites. We computed serotonin (5-HT) seasonality values and performed an association analysis with the s/l alleles of the 5-HTTLPR. Depressive symptomatology was assessed using the Beck Depression Inventory-II. Circannual variation in 5-HIAA fitted a spring-peak cosine model that was significantly associated with sampling month (P=0.0074). Season of sampling explained 5.4% (P=1.57 × 10(-7)) of the variance in 5-HIAA concentrations. The 5-HTTLPR s-allele was associated with increased 5-HIAA seasonality (standardized regression coefficient=0.12, P=0.020, N=393). 5-HIAA seasonality correlated with depressive symptoms (Spearman's rho=0.13, P=0.018, N=345). In conclusion, we highlight a dose-dependent association of the 5-HTTLPR with 5-HIAA seasonality and a positive correlation between 5-HIAA seasonality and depressive symptomatology. The presented data set the stage for follow-up in clinical populations with a role for seasonality, such as affective disorders.

Published
2013

6. Validation of prediction models in the presence of competing risks: a guide through modern methods

Author

Van Geloven, N, Giardiello, D, Bonneville, E, Teece, L, Ramspek, C, Van Smeden, M, Snell, K, Van Calster, B, Pohar-Perme, M, Riley, R, Putter, H, Steyerberg, E, Van Geloven N., Giardiello D., Bonneville E. F., Teece L., Ramspek C. L., Van Smeden M., Snell K. I. E., Van Calster B., Pohar-Perme M., Riley R. D., Putter H., Steyerberg E., Van Geloven, N, Giardiello, D, Bonneville, E, Teece, L, Ramspek, C, Van Smeden, M, Snell, K, Van Calster, B, Pohar-Perme, M, Riley, R, Putter, H, Steyerberg, E, Van Geloven N., Giardiello D., Bonneville E. F., Teece L., Ramspek C. L., Van Smeden M., Snell K. I. E., Van Calster B., Pohar-Perme M., Riley R. D., Putter H., and Steyerberg E.

Abstract

Thorough validation is pivotal for any prediction model before it can be advocated for use in medical practice. For time-to-event outcomes such as breast cancer recurrence, death from other causes is a competing risk. Model performance measures must account for such competing events. In this article, we present a comprehensive yet accessible overview of performance measures for this competing event setting, including the calculation and interpretation of statistical measures for calibration, discrimination, overall prediction error, and clinical usefulness by decision curve analysis. All methods are illustrated for patients with breast cancer, with publicly available data and R code.

Published
2022

10. External validation of a frequently used prediction model for ongoing pregnancy in couples with unexplained recurrent pregnancy loss

Author

Geboortecentrum voorzitterschap, Child Health, Youssef, A., van der Hoorn, M. L.P., Dongen, M., Visser, J., Bloemenkamp, K., van Lith, J., van Geloven, N., Lashley, E. E.L.O., Geboortecentrum voorzitterschap, Child Health, Youssef, A., van der Hoorn, M. L.P., Dongen, M., Visser, J., Bloemenkamp, K., van Lith, J., van Geloven, N., and Lashley, E. E.L.O.

Published
2022

13. A new perspective on the BO06 trial in osteosarcoma: short- and long-term prognostic value of histologic response and intensified chemotherapy

Author

Anninga J, Marta Fiocco, van Geloven N, Hans Gelderblom, and Eni Musta

Subjects
Oncology, medicine.medical_specialty, Chemotherapy, business.industry, Proportional hazards model, Poor responder, medicine.medical_treatment, Histological response, medicine.disease, Logistic regression, Regimen, Internal medicine, Short term survival, medicine, Osteosarcoma, business
Abstract

PurposeCure rate models accounting for cured and uncured patients, provide additional insights into long and short term survival. We aim to better understand the prognostic value of histologic response and chemotherapy intensification on cure fraction and progression-free survival (PFS) for the uncured patients.MethodsA logistic model is assumed for the effect of histologic response and intensified chemotherapy on the cure status, while a Cox regression model is estimated only for the uncured patients on PFS. The mixture cure model is used to simultaneously study these two effects.ResultsHistologic response is a strong prognostic factor for the cure status (OR: 3.00 [1.75-5.17]), but it has no clear effect on PFS for the uncured patients (HR: 0.78 [0.53-1.16]). The cure fractions are 55% [46%-63%] and 29% [22%-35%] among patients with good histologic response (GR) and poor responders (PR) respectively. The intensified regimen was associated with higher cure fraction among PR (OR: 1.90 [0.93 – 3.89]), with no evidence of effect for GR (OR: 0.78 [0.38 – 1.59]).ConclusionsAccounting for cured patients is valuable in distinguishing the covariate effects on cure and PFS. Estimating cure chances based on these prognostic factors is relevant for counseling patients and can affect treatment decisions.

Published
2021
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15. Comparison of laparoscopic versus robot-assisted versus transanal total mesorectal excision surgery for rectal cancer: a retrospective propensity score-matched cohort study of short-term outcomes

Author

Hol, J C, primary, Burghgraef, T A, additional, Rutgers, M L W, additional, Crolla, R M P H, additional, van Geloven, N A W, additional, Hompes, R, additional, Leijtens, J W A, additional, Polat, F, additional, Pronk, A, additional, Smits, A B, additional, Tuynman, J B, additional, Verdaasdonk, E G G, additional, Consten, E C J, additional, and Sietses, C, additional

Published
2021
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21. Chlamydia antibody testing and diagnosing tubal pathology in subfertile women: an individual patient data meta-analysis

Author

Broeze, K.A., Opmeer, B.C., Coppus, S.F.P.J., Van Geloven, N., Alves, M.F.C., Ånestad, G., Bhattacharya, S., Allan, J., Guerra-Infante, M.F., Den Hartog, J.E., Land, J.A., Idahl, A., Van der Linden, P.J.Q., Mouton, J.W., Ng, E.H.Y., Van der Steeg, J.W., Steures, P., Svenstrup, H.F., Tiitinen, A., Toye, B., Van der Veen, F., and Mol, B.W.

Published
2011
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26. Predictors for Anastomotic Leak, Postoperative Complications, and Mortality After Right Colectomy for Cancer: Results From an International Snapshot Audit

Author

Gallo, G., Pata, F., Vennix, S., Laurberg, S., Morton, D., Rubbini, M., Vaizey, C., Magill, L., Perry, R., Sheward, N., Hervas, D., Cillo, M., Estefania, D., Uriburu, J.P., Ruiz, H., Solomon, M., Makhmudov, A., Selnyahina, L., Varabei, A., Vizhynis, Y., Claeys, D., Defoort, B., Muysoms, F., Pletinckx, P., Vergucht, V., Debergh, I., Feryn, T., Reusens, H., Nachtergaele, M., Francart, D., Jehaes, C., Markiewicz, S., Monami, B., Weerts, J., Houben, B., Haeck, L., Lange, C., Sommeling, C., Vindevoghel, K., Castro, S., De Bruyn, H., Huyghe, M., De Wolf, E., Reynders, D., D'Hoore, A., De Buck Van Overstraeten, A., Wolthuis, A., Delibegovic, S., Christiani, A., Marchiori, M., Jr., De Moraes, C.R., Tercioti, V., Jr., Arabadjieva, E., Bulanov, D., Dardanov, D., Stoyanov, V., Yonkov, A., Angelov, K., Maslyankov, S., Sokolov, M., Todorov, G., Toshev, S., Georgiev, Y., Karashmalakov, A., Zafirov, G., Wang, X., Condic, D., Kraljik, D., Mrkovic, H., Pavkovic, V., Raguž, K., Bencurik, V., Holášková, E., Skrovina, M., Farkašová, M., Grolich, T., Kala, Z., Antos, F., Pruchova, V., Sotona, O., Chobola, M., Dusek, T., Ferko, A., Örhalmi, J., Hoch, J., Kocian, P., Martinek, L., Bernstein, I., Sunesen, K.G., Leunbach, J., Thorlacius-Ussing, O., Oveson, A.U., Christensen, P., Chirstensen, S.D., Gamez, V., Oeting, M., Loeve, U.S., Ugianskis, A., Jessen, M., Krarup, P., Linde, K., Mirza, Q., Stovring, J.O., Erritzøe, L., Jakobsen, H.L., Lykke, J., Colov, E.P., Madsen, A.H., Friis, T.L., Funder, J.A., Dich, R., Kjar, S., Rasmussen, S., Schlesinger, N., Kjaer, M.D., Qvist, N., Khalid, A., Ali, G., El-Hussuna, A., Hadi, S., Walker, L.R., Kivelä, A., Lehtonen, T., Lepistö, A., Scheinin, T., Siironen, P., Kössi, J., Kuusanmäki, P., Tomminen, T., Turunen, A., Rautio, T., Vierimaa, M., Huhtinen, H., Karvonen, J., Lavonius, M., Rantala, A., Varpe, P., Cotte, E., Francois, Y., Glehen, O., Kepenekian, V., Passot, G., Maggiori, L., Manceau, G., Panis, Y., Gout, M., Rullier, E., Van Geluwe, B., Chafai, N., Lefevre, J., Parc, Y., Tire, E., Couette, C., Duchalais, E., Agha, A., Hornberger, M., Hungbauer, A., Iesalnieks, I., Weindl, I., Crescenti, F., Keller, M., Kolodziejski, N., Scherer, R., Sterzing, D., Bock, B., Boehm, G., El-Magd, M., Krones, C., Niewiera, M., Buhr, J., Cordesmeyer, S., Hoffmann, M., Krückemeier, K., Vogel, T., Schön, M., Baral, J., Lukoschek, T., Münch, S., Pullig, F., Horisberger, K., Kienle, P., Magdeburg, J., Post, S., Batzalexis, K., Germanos, S., Agalianos, C., Dervenis, C., Gouvas, N., Kanavidis, P., Kottikias, A., Katsoulis, I., Korkolis, D., Plataniotis, G., Sakorafas, G., Akrida, I., Argentou, M., Kollatos, C., Lampropoulos, C., Tsochatzis, S., Besznyák, I., Bursics, A., Egyed, T., Papp, G., Svastics, I., Atladottir, J., Möller, P., Sigurdsson, H., Stefánsson, T., Valsdottir, E., Andrews, E., Foley, N., Hechtl, D., Majeed, M., McCourt, M., Hanly, A., Hyland, J., Martin, S., O'Connell, R., Winter, D., Connelly, T., Joyce, W., Wrafter, P., Berkovitz, R., Avital, S., Yahia, I.H., Herman, N., Shpitz, B., White, I., Lishtzinsky, Y., Tsherniak, A., Wasserberg, N., Horesh, N., Keler, U., Pery, R., Shapiro, R., Zmora, O., Tulchinsky, H., Badran, B., Dayan, K., Iskhakov, A., Lecaros, J., Nabih, N., Angrima, I., Bardini, R., Pizzolato, E., Tonello, M., Arces, F., Balestri, R., Ceccarelli, C., Prosperi, V., Rossi, E., Giannini, I., Vincenti, L., Di Candido, F., Di Iena, M., Guglielmi, A., Iambrenghi, O., Marsanic, P., Mellano, A., Muratore, A., Annecchiarico, M., Bencini, L., Bonapasta, S., Coratti, A., Guerra, F., Asteria, C., Boccia, L., Gerard, L., Pascariello, A., Manca, G., Marino, F., Casaril, A., Inama, M., Moretto, G., Bacchelli, C., Carvello, M., Mariani, N., Montorsi, M., Spinelli, A., Romairone, E., Scabini, S., Belli, A., Bianco, F., De Franciscis, S., Romano, G.M., Delrio, P., Pace, U., Rega, D., Sassaroli, C., Scala, D., De Luca, R., Ruggieri, E., Elbetti, C., Garzi, A., Romoli, L., Scatizzi, M., Vannucchi, A., Curletti, G., Durante, V., Galleano, R., Mariani, F., Reggiani, L., Bellomo, R., Infantino, A., Franceschilli, L., Sileri, P., Clementi, I., Coletta, D., La Torre, F., Mingoli, A., Velluti, F., Di Giacomo, A., Fiorot, A., Massani, M., Padoan, L., Ruffolo, C., Caruso, S., Franceschini, F., Laessig, R., Monaci, I., Rontini, M., De Nardi, P., Lemma, M., Rosati, R., Tamburini, A., De Luca, M., Sartori, A., Benevento, A., Bottini, C., Ferrari, C., Tessera, G., Pellino, G., Selvaggi, F., Lanzani, A., Romano, F., Sgroi, G., Steccanella, F., Turati, L., Yamamoto, T., Ancans, G., Gerkis, S., Leja, M., Pcolkins, A., Sivins, A., Latkauskas, T., Lizdenis, P., Saladžinskas, Ž., Švagždys, S., Tamelis, A., Razbadauskas, A., Sokolovas, M., Dulskas, A., Samalavicius, N., Jotautas, V., Mikalauskas, S., Poskus, E., Poskus, T., Strupas, K., Camenzuli, C., Cini, C., Predrag, A., Psaila, J., Spiteri, N., Bemelman, W., Buskens, C., De Groof, J., Gooszen, J., Tanis, P., Belgers, E., Davids, P., Furnee, E., Postma, E., Pronk, A., Smakman, N., Clermonts, S., Zimmerman, D., Omloo, J., Van Der Zaag, E., Van Duijvendijk, P., Wassenaar, E., Bruijninckx, M., De Graff, E., Doornebosch, P., Tetteroo, G., Vermaas, M., Iordens, G., Knops, S., Toorenvliet, B., Van Westereenen, E., Boerma, E., Coene, P., Van Der Harst, E., Van Der Pool, A., Raber, M., Melenhorst, J., De Castro, S., Gerhards, M., Arron, M., Bremers, A., De Wilt, H., Ferenschild, F., Yauw, S., Cense, H., Demirkiran, A., Hunfeld, M., Mulder, I., Nonner, J., Swank, H., Van Wagensveld, B., Bolmers, M., Briel, J., Van Geloven, N., Van Rossem, C., Klemann, V., Konsten, J., Leenders, B., Schok, T., Bleeker, W., Gidwani, A., Lawther, R., Loughlin, P., Skelly, B., Spence, R., Brun, M., Helgeland, M., Ignjatovic, D., Øresland, T., Peyman, Y., Backe, I.F., Sjo, O.H., Nesbakken, A., Tandberg-Eriksen, M., Cais, A., Traland, J.H., Herikstad, R., Kørner, H., Lauvland, N., Jajtner, D., Kabiesz, W., Rak, M., Gmerek, L., Horbacka, K., Horst, N., Krokowicz, P., Kwiatkowski, A., Pasnik, K., Karcz, P., Romaniszyn, M., Rusek, T., Walega, P., Czarencki, R., Obuszko, Z., Sitarska, M., Wojciech, W., Zawadzki, M., Amado, S., Clara, P., Couceiro, A., Malaquias, R., Rama, N., Almeida, A., Barbosa, E., Cernadas, E., Duarte, A., Silva, P., Costa, S., Insua, C.M., Pereira, J., Pereira, C., Sacchetti, M., Ferreira, R.A.M., Pinto, B.C., Sousa, P.J.V., Oliveira, A., Cardoso, R., Carlos, S., Corte-Real, J., Pereira, P.M., Souto, R., Carneiro, C., Marinho, R., Nunes, V., Rocha, R., Sousa, M., Leite, J., Melo, F., Pimentel, J., Ventura, L., Nova, C.V., Copǎescu, C., Bintintan, V., Ciuce, C., Dindelegan, G., Scurtu, R., Seicean, R., Domansky, N., Karachun, A., Moiseenko, A., Pelipas, Y., Petrov, A., Pravosudov, I., Aiupov, R., Akmalov, Y., Parfenov, A., Suleymanov, N., Tarasov, N., Jumabaev, H., Mamedli, Z., Rasulov, A., Aliev, I., Chernikovskiy, I., Kochnev, V., Komyak, K., Smirnov, A., Achkasov, S., Bolikhov, K., Shelygin, Y., Sushkov, O., Zapolskiy, A., Gvozdenovic, M., Jovanovic, D., Lausevic, Z., Cvetković, D., Maravić, M., Milovanovic, B., Stojakovic, N., Tripković, I., Mihajlovic, D., Nestorovic, M., Pecic, V., Petrovic, D., Stanojevic, G., Barisic, G., Dimitrijevic, I., Krivokapic, Z., Markovic, V., Popovic, M., Aleksic, A., Dabic, D., Kostic, I., Milojkovic, A., Perunicic, V., Dragana, R., Lukic, D., Petrovic, T., Radovanovic, Z., Cuk, V., Kenic, M., Kovacevic, B., Krdzic, I., Korcek, J., Rems, M., Toplak, J., Escarrâ, J., Barrionuevo, M.G., Golda, T., Moreno, E.K., Martin, C.Z., Laso, C.A., Cumplido, P., Padin, H., Fons, J.B., Hernández-Lizoain, J., Martinez-Ortega, P., Molina-Fernández, M., Sánchez-Justicia, C., Solanas, J.A.G., De Laspra, E.C.D., Elia-Guedea, M., Gallego, E., Ramirez, J., Chaves, J.A., González, P.D., Elosua, T., Sahagún, J., Frade, A.T., Conde, J.A., Castrillo, E., Maag, R.D., Maderuelo, V., Saldarriaga, L., Cao, I.A., Varela, X.F., Fernández, S.N., Calvo, A.P., Álvarez, S.V., Sierra, I.B., Lozano, R., Márquez, M., Porcel, O., Menendez, P., Hevia, M.F., Sigüenzo, L.F., Toscano, M.J., Fortuny, A.L., Trujillo, J.O., Espi, A., Garcia-Botello, S., Martín-Arévalo, J., Moro-Valdezate, D., Pla-Martí, V., Blanco-Antona, F., Abrisqueta, J., Canovas, N.I., Mompean, J.L., Ripoll, D.E., Gonzalez, S.M., Parodi, J., López, A.F., Fernández, M.R., Valls, J.C., De Zarate, L.O., Ribas, R., Sabia, D., Viso, L., Gonçalves, S.A., Egea, M.J.G., Damieta, M.P., Pera, M., Ruiz, S.S., Bernal, J., Landete, F., Ais, G., Alonso, E., Lucia, J.A., Boscá, A., Deusa, S., Del Caño, J.G., Viciano, V., García-Armengol, J., Roig, J., Blas, J., Escartin, J., Fatás, J., Fernando, J., Ferrer, R., Pacheco, R.A., Flórez, L.G., Gijón, M.M., Díez, J.O., Garcia, L.S., Teixido, F.A., Ojo, C.B., Berzosa, J.B., Moure, S.L., Sierra, J.E., Fermiñán, A., Herrerias, F., Rufas, M., Viñas, J., Codina-Cazador, A., Farrés, R., Gómez, N., Julià, D., Planellas, P., López, J., Luna, A., Maristany, C., Duyos, A.M., Puértolas, N., Moral, M.A., Serra-Aracil, X., Coello, P.C., Gómez, D., Carton, C., Miguel, A., Pascual, F.R., Cerrato, X.V., Muñoz, R.Z., Cervera-Aldama, J., González, J.G., Ramos-Prada, J., Santamaría-Olabarrieta, M., Urigüen-Echeverría, A., Alcover, R.C., Soria, J.E., Rodriguez, E.F., Hernandis, J., Ibañez, V.M., De La Torre Gonzalez, F., Huerga, D., Viejo, E.P., Rivera, A., Ucar, E.R., Garcia-Septiem, J., Jiménez, V., Miramón, J.J., Rodriquez, J.R., Alvarez, V.R., Garcea, A., Ponchietti, L., Borda, N., Enriquez-Navascues, J., Saralegui, Y., Molina, G.F., Nogues, E., Méndez, A.R., Castellano, C.R., Quesada, Y.S., Gallego, M., Pascual, I., Perez, I., San Andrés, B., Villanueva, F., Alonso, J., Cagigas, C., Castillo, J., Gómez, M., Martín-Parra, J., Ballester, M.M., Franco, E.P., Aledo, V.S., Navarro, G.V., Rodriquez, E.C., De Chaves, P.G., Hernandez, G., Alvarez, A.P., Sanchez, A.S., Garcia, F.C.B., Roque, J.G.A., Aria, F.L.R., Del Valle Ruiz, S.R., De La Villa, G.S., Compañ, A., Marín, A.G., Nofuentes, C., Micó, F.O., Auladell, V.P., Carrasco, M., Perez, C.D., Gálvez-Pastor, S., Garcia, I.N., Perez, A.S., Enjuto, D., Bujalance, F.M., Marcelin, N., Pérez, M., García, R.S., Cabrera, A., De La Portilla, F., Diaz-Pavon, J., Jimenez-Rodriguez, R., Vazquez-Monchul, J., González, J.D., Pérez, R.G., Castellano, J.R., De La Rua, J.R., Toral, B.C., Alustiza, J.E., Fernández, L., Ramirez, J.R., Ramos, J.S., Alias, D., Garcia-Olmo, D., Guadalajara, H., Herreros, M., Pacheco, P., Del Castillo Díez, F., Pinto, F.L., Alegre, J.M., Ortega, I., Antonio, A.P.N., Caro, A., Escuder, J., Feliu, F., Millan, M., Company, R.A., Caregnato, A.F., Trujillo, R.L., Carrillo, R.R., Carmona, M.R., Alonso, N., Zafra, D.A., Candia, B.A.A., Pascual, J.B., Flores, C.P., Montero, J.A., Clavijo, M.A., Garcia, J., Tocino, J.S., Alcazar, C., Navarro, D.C., Romero, J.F., Riveiro, M.R., Romero, M., Arencibia, B., Esclapez, P., Frasson, M., García-Granero, E., Granero, P., Herrera, A.B.G., Diaz, L., Tordera, E.M.T., Fernandez, F.M., Rodriguez, E.N., Arenal, J., Citores, M., Marcos, J., Sánchez, J., Tinoco, C., Espin, E., Granero, A.G., Gomez, L.J., Garcia, J.S., Vallribera, F., Folkesson, J., Sköldberg, F., Bergman, K., Borgström, E., Frey, J., Silfverberg, A., Söderholm, M., Nygren, J., Segelman, J., Gustafsson, D., Lagerqvist, A., Papp, A., Pelczar, M., Abraham-Nordling, M., Ahlberg, M., Sjovall, A., Tengstrom, J., Hagman, K., Chabok, A., Ezra, E., Nikberg, M., Smedh, K., Tiselius, C., Al-Naimi, N., Dao Duc, M., Meyer, J., Mormont, M., Ris, F., Prevost, G., Villiger, P., Hoffmann, H., Kettelhack, C., Kirchhoff, P., Oertli, D., Weixler, B., Aytac, B., Leventoglu, S., Mentes, B., Yuksel, O., Demirbas, S., Ozkan, B.B., Özbalci, G.S., Sungurtekin, Uğur, Gülcü, B., Ozturk, E., Yilmazlar, T., Challand, C., Fearnhead, N., Hubbard, R., Kumar, S., Arthur, J., Barben, C., Skaife, P., Slawik, S., Williams, M., Zammit, M., Barker, J., French, J., Sarantitis, I., Slawinski, C., Clifford, R., Eardley, N., Johnson, M., McFaul, C., Vimalachandran, D., Allan, S., Bell, A., Oates, E., Shanmugam, V., Brigic, A., Halls, M., Pucher, P., Stubbs, B., Agarwal, T., Chopada, A., Mallappa, S., Pathmarajah, M., Sugden, C., Brown, C., Macdonald, E., Mckay, A., Richards, J., Robertson, A., Kaushal, M., Patel, P., Tezas, S., Touqan, N., Ayaani, S., Marimuthu, K., Piramanayagam, B., Vourvachis, M., Iqbal, N., Korsgen, S., Seretis, C., Shariff, U., Arnold, S., Battersby, N.J., Chan, H., Clark, E., Fernandes, R., Moran, S., Bajwa, A., McArthur, D., Cao, K., Cunha, P., Pardoe, H., Quddus, A., Theodoropoulou, K., Bolln, C., Denys, G., Gillespie, M., Manimaran, N., Reidy, J., Malik, A., Pitt, J., Aryal, K., El-Hadi, A., Lal, R., Pal, A., Velchuru, V., Chaudhri, S., Cunha, M.O., Singh, B., Thomas, M., Bains, S., Boyle, K., Miller, A., Norwood, M., Yeung, J., Goian, L., Gurjar, S., Saghir, W., Sengupta, N., Stewart-Parker, E., Bailey, S., Khalil, T., Lawes, D., Nikolaou, S., Omar, G., Church, R., Muthiah, B., Garrett, W., Marsh, P., Obeid, N., Chandler, S., Coyne, P., Evans, M., Hunt, L., Lim, J., Oliphant, Z., Papworth, E., Weaver, H., Leon, K.C., Williams, G., Hernon, J., Kapur, S., Moosvi, R., Shaikh, I., Swafe, L., Aslam, M., Evans, J., Ihedioha, U., Kang, P., Merchant, J., Hompes, R., Middleton, R., Broomfield, A., Crutten-Wood, D., Foster, J., Nash, G., Akhtar, M., Boshnaq, M., Eldesouky, S., Mangam, S., Rabie, M., Ahmed, J., Khan, J., Goh, N.M., Shamali, A., Stefan, S., Nepogodiev, D., Pinkney, T.D., Thompson, C., Amin, A., Docherty, J., Lim, M., Walker, K., Watson, A., Hossack, M., Mackenzie, N., Paraoan, M., Alam, N., Daniels, I., Narang, S., Pathak, S., Smart, N., Al-Qaddo, A., Codd, R., Rutka, O., Bronder, C., Crighton, I., Davies, E., Raymond, T., Bookless, L., Griffiths, B., Plusa, S., Carlson, G., Harrison, R., Lees, N., Mason, C., Quayle, J., Branagan, G., Broadhurst, J., Chave, H., Sleight, S., Awad, F., Bhangu, A., Cruickshank, N., Joy, H., Boereboom, C., Daliya, P., Dhillon, A., Watson, N., Watson, R., Artioukh, D., Gokul, K., Javed, M., Kong, R., Sutton, J., Faiz, O., Jenkins, I., Leo, C., Samaranayake, F., Warusavitarne, J., Arya, S., Bhan, C., Mukhtar, H., Oshowo, A., Wilson, J., Duff, S., Fatayer, T., Mbuvi, J., Sharma, A., Cornish, J., Davies, L., Harries, R., Morris, C., Torkington, J., Knight, J., Lai, C., Shihab, O., Tzivanakis, A., Hussain, A., Luke, D., Padwick, R., Torrance, A., Tsiamis, A., Dawson, P., Balfour, A., Brady, R., Mander, J., Paterson, H., Chandratreya, N., Chu, H., Cutting, J., Vernon, S., Ho, C.W., Andreani, S., Patel, H., Warner, M., Tan, J.Y.Q., Iqbal, A., Khan, A., Perrin, K., Raza, A., Tan, S., European Society of Coloproctology Collaborating Group Collaborators, Group, ESCP Cohort Studies Sub-Committee, ESCP Research Committee, Logistical Support and Data Collection, Analysis, Investigators, Radiology and nuclear medicine, RS: GROW - R3 - Innovative Cancer Diagnostics & Therapy, Surgery, MUMC+: MA Heelkunde (9), Graduate School, AGEM - Amsterdam Gastroenterology Endocrinology Metabolism, CCA - Cancer Treatment and Quality of Life, Neurology, and Center for Evidence Based Education

Subjects
Male, Leak, Conference Paper, adverse event, ileostomy, non-smoker, 0302 clinical medicine, middle aged, antibiotic therapy, 80 and over, antibiotic agent, postoperative complication, emergency surgery, Colectomy, cecum, Aged, 80 and over, OUTCOMES, adult, COLON-CANCER, Gastroenterology, operation duration, clinical trial, General Medicine, cohort analysis, laparoscopic surgery, ureter injury, Survival Rate, aged, risk factor, 030220 oncology & carcinogenesis, Cohort, kidney injury, 030211 gastroenterology & hepatology, Colonic Neoplasms/mortality, anastomosis leakage, liver injury, prospective study, medicine.medical_specialty, SURGICAL STRESS, ELECTIVE RIGHT, surgical infection, 03 medical and health sciences, Humans, human, Aged, clinical audit, sex ratio, major clinical study, mortality, hemicolectomy, multicenter study, RISK-FACTORS, observational study, Complication, Anastomotic leak, Colon cancer, Postoperative outcome, Right colectomy, general surgery, surgical mortality, SURGERY, very elderly, morbidity, Anastomotic Leak, mortality rate, open surgery, Cohort Studies, Postoperative Complications, gallbladder disease, LAPAROSCOPY, Risk Factors, Neoplasms, cancer mortality, Laparoscopy, Prospective cohort study, colon resection, Medical Audit, medicine.diagnostic_test, Mortality rate, colon tumor, Middle Aged, female, colon cancer, Right Colectomy, Colonic Neoplasms, ileum, surgical stapling, Female, cancer surgery, Colectomy/adverse effects, duodenum injury, small intestine resection, RESECTION, reoperation, Anastomosis, NO, MORBIDITY, medicine, operative blood loss, LS7_4, percutaneous drainage, business.industry, suture technique, Surgery, blood vessel injury, peroperative complication, elective surgery, Anastomotic Leak/epidemiology, pathology, business
Abstract

A right hemicolectomy is among the most commonly performed operations for colon cancer, but modern high-quality, multination data addressing the morbidity and mortality rates are lacking.This study reports the morbidity and mortality rates for right-sided colon cancer and identifies predictors for unfavorable short-term outcome after right hemicolectomy.This was a snapshot observational prospective study.The study was conducted as a multicenter international study.The 2015 European Society of Coloproctology snapshot study was a prospective multicenter international series that included all patients undergoing elective or emergency right hemicolectomy or ileocecal resection over a 2-month period in early 2015. This is a subanalysis of the colon cancer cohort of patients.Predictors for anastomotic leak and 30-day postoperative morbidity and mortality were assessed using multivariable mixed-effect logistic regression models after variables selection with the Lasso method.Of the 2515 included patients, an anastomosis was performed in 97.2% (n = 2444), handsewn in 38.5% (n = 940) and stapled in 61.5% (n = 1504) cases. The overall anastomotic leak rate was 7.4% (180/2444), 30-day morbidity was 38.0% (n = 956), and mortality was 2.6% (n = 66). Patients with anastomotic leak had a significantly increased mortality rate (10.6% vs 1.6% no-leak patients; p0.001). At multivariable analysis the following variables were associated with anastomotic leak: longer duration of surgery (OR = 1.007 per min; p = 0.0037), open approach (OR = 1.9; p = 0.0037), and stapled anastomosis (OR = 1.5; p = 0.041).This is an observational study, and therefore selection bias could be present. For this reason, a multivariable logistic regression model was performed, trying to correct possible confounding factors.Anastomotic leak after oncologic right hemicolectomy is a frequent complication, and it is associated with increased mortality. The key contributing surgical factors for anastomotic leak were anastomotic technique, surgical approach, and duration of surgery. See Video Abstract at http://links.lww.com/DCR/B165. PREDICTORES DE FUGA ANASTOMóTICA, COMPLICACIONES POSTOPERATORIAS Y MORTALIDAD DESPUéS DE LA COLECTOMíA DERECHA POR CáNCER: RESULTADOS DE UNA AUDITORíA INTERNACIONAL DE CORTO PLAZO: La hemicolectomía derecha se encuentra entre las operaciones más frecuentemente realizadas para cáncer de colon, pero faltan datos modernos multinacionales de alta calidad, que aborden las tasas de morbilidad y mortalidad.Reportar la tasa de morbilidad y mortalidad para cáncer de colon del lado derecho, e identificar predictores de resultados desfavorables a corto plazo, después de la hemicolectomía derecha.Estudio prospectivo observacional de corto plazo.Estudio multicéntrico internacional.El estudio de corto plazo de la Sociedad Europea de Coloproctología de 2015, fue una serie prospectiva multicéntrica internacional, que incluyó a todos los pacientes sometidos a hemicolectomía derecha electiva, de emergencia o resección ileocecal, por un período de dos meses y a principios de 2015. Este es un subanálisis, cohorte de pacientes con cáncer de colon.Los predictores de fuga anastomótica, morbilidad y mortalidad postoperatorias a los 30 días, se evaluaron usando modelos de regresión logística de efectos multivariables mixtos, después de la selección de variables con el método Lasso.De los 2,515 pacientes incluidos, se realizó una anastomosis en el 97,2% (n = 2,444); sutura manual en 38.5% (n = 940) y por engrapadora en 61.5% (n = 1504) casos. La tasa global de fuga anastomótica fue del 7,4% (180/2,444), morbilidad a los 30 días fue del 38,0% (n = 956) y la mortalidad fue del 2,6% (n = 66). Los pacientes con fuga anastomótica tuvieron una tasa de mortalidad significativamente mayor (10,6% frente al 1,6% de pacientes sin fuga, p0,001). En el análisis multivariable, las siguientes variables se asociaron con la fuga anastomótica: mayor duración de la cirugía (OR 1.007 por minuto, p = 0.0037), abordaje abierto (OR 1.9, p = 0.0037) y anastomosis por engrapadora (OR 1.5, p = 0.041).Este es un estudio observacional y por lo tanto podría estar presente el sesgo de selección. Por esta razón, se realizó un modelo de regresión logística multivariable, tratando de corregir posibles factores de confusión.La fuga anastomótica después de la hemicolectomía derecha oncológica, es una complicación frecuente y asociada a mayor mortalidad. Los factores quirúrgicos clave que contribuyeron a la fuga anastomótica, fueron la técnica anastomótica, abordaje quirúrgico y duración de la cirugía. Consulte Video Resumen en http://links.lww.com/DCR/B165. (Traducción-Dr. Fidel Ruiz Healy).

Published
2020
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29. Does the effectiveness of IUI in couples with unexplained subfertility depend on their prognosis of natural conception?: A replication of the H2Oil study

Author

Biostatistiek Onderzoek, Child Health, Circulatory Health, Infection & Immunity, JC onderzoeksprogramma Infectieziekten, JC onderzoeksprogramma Methodologie, van Eekelen, R, Rosielle, K, van Welie, N, Dreyer, K, van Wely, M, Mol, B W, Eijkemans, M J, Mijatovic, V, van Geloven, N, Biostatistiek Onderzoek, Child Health, Circulatory Health, Infection & Immunity, JC onderzoeksprogramma Infectieziekten, JC onderzoeksprogramma Methodologie, van Eekelen, R, Rosielle, K, van Welie, N, Dreyer, K, van Wely, M, Mol, B W, Eijkemans, M J, Mijatovic, V, and van Geloven, N

Published
2020

30. External validation of a frequently used prediction model for ongoing pregnancy in couples with unexplained recurrent pregnancy loss.

Author

Youssef, A, Hoorn, M L P van der, Dongen, M, Visser, J, Bloemenkamp, K, Lith, J van, Geloven, N van, Lashley, E E L O, van der Hoorn, M L P, van Lith, J, and van Geloven, N

Subjects
RECURRENT miscarriage, PREDICTION models, PREGNANCY outcomes, MISCARRIAGE, PREGNANCY, PROGNOSTIC models, BIRTH rate, RETROSPECTIVE studies, MATERNAL age
Abstract

Study Question: What is the predictive performance of a currently recommended prediction model in an external Dutch cohort of couples with unexplained recurrent pregnancy loss (RPL)?Summary Answer: The model shows poor predictive performance on a new population; it overestimates, predicts too extremely and has a poor discriminative ability.What Is Known Already: In 50-75% of couples with RPL, no risk factor or cause can be determined and RPL remains unexplained. Clinical management in RPL is primarily focused on providing supportive care, in which counselling on prognosis is a main pillar. A frequently used prediction model for unexplained RPL, developed by Brigham et al. in 1999, estimates the chance of a successful pregnancy based on number of previous pregnancy losses and maternal age. This prediction model has never been externally validated.Study Design, Size, Duration: This retrospective cohort study consisted of 739 couples with unexplained RPL who visited the RPL clinic of the Leiden University Medical Centre between 2004 and 2019.Participants/materials, Setting, Methods: Unexplained RPL was defined as the loss of two or more pregnancies before 24 weeks, without the presence of an identifiable cause for the pregnancy losses, according to the ESHRE guideline. Obstetrical history and maternal age were noted at intake at the RPL clinic. The outcome of the first pregnancy after intake was documented. The performance of Brigham's model was evaluated through calibration and discrimination, in which the predicted pregnancy rates were compared to the observed pregnancy rates.Main Results and the Role Of Chance: The cohort included 739 women with a mean age of 33.1 years (±4.7 years) and with a median of three pregnancy losses at intake (range 2-10). The mean predicted pregnancy success rate was 9.8 percentage points higher in the Brigham model than the observed pregnancy success rate in the dataset (73.9% vs 64.0% (95% CI for the 9.8% difference 6.3-13.3%)). Calibration showed overestimation of the model and too extreme predictions, with a negative calibration intercept of -0.46 (95% CI -0.62 to -0.31) and a calibration slope of 0.42 (95% CI 0.11-0.73). The discriminative ability of the model was very low with a concordance statistic of 0.55 (95% CI 0.51-0.59). Recalibration of the Brigham model hardly improved the c-statistic (0.57; 95% CI 0.53-0.62).Limitations, Reasons For Caution: This is a retrospective study in which only the first pregnancy after intake was registered. There was no time frame as inclusion criterium, which is of importance in the counselling of couples with unexplained RPL. Only cases with a known pregnancy outcome were included.Wider Implications Of the Findings: This is the first study externally validating the Brigham prognostic model that estimates the chance of a successful pregnancy in couples with unexplained RPL. The results show that the frequently used model overestimates the chances of a successful pregnancy, that predictions are too extreme on both the high and low ends and that they are not much more discriminative than random luck. There is a need for revising the prediction model to estimate the chance of a successful pregnancy in couples with unexplained RPL more accurately.Study Funding/competing Interest(s): No external funding was used and no competing interests were declared.Trial Registration Number: N/A. [ABSTRACT FROM AUTHOR]

Published
2022
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33. Predicting the chances of having a baby with or without treatment at different time points in couples with unexplained subfertility

Author

McLernon, D J, primary, Lee, A J, additional, Maheshwari, A, additional, van Eekelen, R, additional, van Geloven, N, additional, Putter, H, additional, Eijkemans, M J, additional, van der Steeg, J W, additional, van der Veen, F, additional, Steyerberg, E W, additional, Mol, B W, additional, and Bhattacharya, S, additional

Published
2019
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34. The therapeutic effect of hysterosalpingography in couples with unexplained subfertility : a post-hoc analysis of a prospective multi-centre cohort study

Author

Dreyer, K., van Eekelen, R., Tjon-Kon-Fat, R. I., van der Steeg, J. W., Steures, P., Eijkemans, M. J.C., van der Veen, F., Hompes, P. G.A., Mol, B. W.J., van Geloven, N., Dreyer, K., van Eekelen, R., Tjon-Kon-Fat, R. I., van der Steeg, J. W., Steures, P., Eijkemans, M. J.C., van der Veen, F., Hompes, P. G.A., Mol, B. W.J., and van Geloven, N.

Published
2019

35. Is IUI with ovarian stimulation effective in couples with unexplained subfertility?

Author

van Eekelen, R, van Geloven, N, van Wely, M, McLernon, D J, Mol, F, Custers, I M, Steures, P, Bhattacharya, S, Mol, B W, van der Veen, F, Eijkemans, M J, van Eekelen, R, van Geloven, N, van Wely, M, McLernon, D J, Mol, F, Custers, I M, Steures, P, Bhattacharya, S, Mol, B W, van der Veen, F, and Eijkemans, M J

Published
2019

36. Predicting the chances of having a baby with or without treatment at different time points in couples with unexplained subfertility

Author

McLernon, D. J., Lee, A. J., Maheshwari, A., Van Eekelen, R., Van Geloven, N., Putter, H., Eijkemans, M. J., Van Der Steeg, J. W., Van Der Veen, F., Steyerberg, E. W., Mol, B. W., Bhattacharya, S., McLernon, D. J., Lee, A. J., Maheshwari, A., Van Eekelen, R., Van Geloven, N., Putter, H., Eijkemans, M. J., Van Der Steeg, J. W., Van Der Veen, F., Steyerberg, E. W., Mol, B. W., and Bhattacharya, S.

Published
2019

37. IVF for unexplained subfertility; Whom should we treat?

Author

Van Eekelen, R., Van Geloven, N., Van Wely, M., Bhattacharya, S., Van Der Veen, F., Eijkemans, M. J., McLernon, D. J., Van Eekelen, R., Van Geloven, N., Van Wely, M., Bhattacharya, S., Van Der Veen, F., Eijkemans, M. J., and McLernon, D. J.

Published
2019

38. Immediate versus delayed removal of urinary catheter after laparoscopic hysterectomy: A randomised controlled trial

Author

Sandberg, E. M. (author), Twijnstra, A.R.H. (author), van Meir, C. A. (author), Kok, H. S. (author), van Geloven, N. (author), Gludovacz, K. (author), Kolkman, W. (author), Nagel, H.T.C. (author), Haans, L.C.F. (author), Kapiteijn, K. (author), Jansen, F.W. (author), Sandberg, E. M. (author), Twijnstra, A.R.H. (author), van Meir, C. A. (author), Kok, H. S. (author), van Geloven, N. (author), Gludovacz, K. (author), Kolkman, W. (author), Nagel, H.T.C. (author), Haans, L.C.F. (author), Kapiteijn, K. (author), and Jansen, F.W. (author)

Abstract

Objective: To evaluate if immediate catheter removal (ICR) after laparoscopic hysterectomy is associated with similar retention outcomes compared with delayed removal (DCR). Study design: Non-inferiority randomised controlled trial. Population: Women undergoing laparoscopic hysterectomy in six hospitals in the Netherlands. Methods: Women were randomised to ICR or DCR (between 18 and 24 hours after surgery). Primary outcome: The inability to void within 6 hours after catheter removal. Results: One hundred and fifty-five women were randomised to ICR (n = 74) and DCR (n = 81). The intention-to-treat and per-protocol analysis could not demonstrate the non-inferiority of ICR: ten women with ICR could not urinate spontaneously within 6 hours compared with none in the delayed group (risk difference 13.5%, 5.6–24.8, P = 0.88). However, seven of these women could void spontaneously within 9 hours without additional intervention. Regarding the secondary outcomes, eight women from the delayed group requested earlier catheter removal because of complaints (9.9%). Three women with ICR (4.1%) had a urinary tract infection postoperatively versus eight with DCR (9.9%, risk difference −5.8%, −15.1 to 3.5, P = 0.215). Women with ICR mobilised significantly earlier (5.7 hours, 0.8–23.3 versus 21.0 hours, 1.4–29.9; P ≤ 0.001). Conclusion: The non-inferiority of ICR could not be demonstrated in terms of urinary retention 6 hours after procedure. However, 70% of the women with voiding difficulties could void spontaneously within 9 hours after laparoscopic hysterectomy. It is therefore questionable if all observed urinary retention cases were clinically relevant. As a result, the clinical advantages of ICR may still outweigh the risk of bladder retention and it should therefore be considered after uncomplicated laparoscopic hysterectomy. Tweetable abstract: The advantages of immediate catheter removal after laparoscopic hysterectomy seem to outweigh the risk of bladder retention., Medical Instruments & Bio-Inspired Technology

Published
2019
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39. Efficacy and safety of IVIG in CIDP: Combined data of the PRIMA and PATH studies

Author

Merkies, ISJ, van Schaik, IN, Leger, J-M, Bril, V, van Geloven, N, Hartung, H-P, Lewis, RA, Sobue, G, Lawo, J-P, Durn, BL, Cornblath, DR, De Bleecker, JL, Sommer, C, Robberecht, W, Saarela, M, Kamienowski, J, Stelmasiak, Z, Tackenberg, B, Mielke, O, Sabet, A, George, K, Roberts, L, Carne, R, Blum, S, Henderson, R, Van Damme, P, Demeestere, J, Larue, S, D'Amour, C, Kunc, P, Valis, M, Sussova, J, Kalous, T, Talab, R, Bednar, M, Toomsoo, T, Rubanovits, I, Gross-Paju, K, Sorro, U, Auranen, M, Pouget, J, Attarian, S, Le Masson, G, Wielanek-Bachelet, A, Desnuelle, C, Delmont, E, Clavelou, P, Aufauvre, D, Schmidt, J, Zschuentzsch, J, Kramer, D, Hoffmann, O, Goerlitz, C, Haas, J, Chatzopoulos, M, Yoon, R, Gold, R, Berlit, P, Jaspert-Grehl, A, Liebetanz, D, Kutschenko, A, Stangel, M, Trebst, C, Baum, P, Bergh, F, Klehmet, J, Meisel, A, Klostermann, F, Oechtering, J, Lehmann, H, Schroeter, M, Hagenacker, T, Mueller, D, Sperfeld, A, Bethke, F, Drory, V, Algom, A, Yarnitsky, D, Murinson, B, Di Muzio, A, Ciccocioppo, F, Sorbi, S, Mata, S, Schenone, A, Grandis, M, Lauria, G, Cazzato, D, Antonini, G, Morino, S, Cocito, D, Zibetti, M, Yokota, T, Ohkubo, T, Kanda, T, Kawai, M, Kaida, K, Onoue, H, Kuwabara, S, Mori, M, Iijima, M, Ohyama, K, Baba, M, Tomiyama, M, Nishiyama, K, Akutsu, T, Yokoyama, K, Kanai, K, Eftimov, F, Notermans, NC, Visser, N, Faber, C, Hoeijmakers, J, Rejdak, K, Chyrchel-Paszkiewicz, U, Casanovas Pons, C, Antonia, M, Gamez, J, Salvado, M, Marquez Infante, C, Benitez, S, Lunn, M, Morrow, J, Gosal, D, Lavin, T, Melamed, I, Testori, A, Ajroud-Driss, S, Menichella, D, Simpson, Lai, EC-H, Dimachkie, M, Barohn, RJ, Beydoun, S, Johl, H, Lange, D, Shtilbans, A, Muley, S, Ladha, S, Freimer, M, Kissel, J, Latov, N, Chin, R, Ubogu, E, Mumfrey, S, Rao, T, MacDonald, P, Sharma, K, Gonzalez, G, Allen, J, Walk, D, Hobson-Webb, L, Gable, K, Franques, J, Morales, RJ, Nguento, A, Schrey, C, Zwolinska, G, Merkies, ISJ, van Schaik, IN, Leger, J-M, Bril, V, van Geloven, N, Hartung, H-P, Lewis, RA, Sobue, G, Lawo, J-P, Durn, BL, Cornblath, DR, De Bleecker, JL, Sommer, C, Robberecht, W, Saarela, M, Kamienowski, J, Stelmasiak, Z, Tackenberg, B, Mielke, O, Sabet, A, George, K, Roberts, L, Carne, R, Blum, S, Henderson, R, Van Damme, P, Demeestere, J, Larue, S, D'Amour, C, Kunc, P, Valis, M, Sussova, J, Kalous, T, Talab, R, Bednar, M, Toomsoo, T, Rubanovits, I, Gross-Paju, K, Sorro, U, Auranen, M, Pouget, J, Attarian, S, Le Masson, G, Wielanek-Bachelet, A, Desnuelle, C, Delmont, E, Clavelou, P, Aufauvre, D, Schmidt, J, Zschuentzsch, J, Kramer, D, Hoffmann, O, Goerlitz, C, Haas, J, Chatzopoulos, M, Yoon, R, Gold, R, Berlit, P, Jaspert-Grehl, A, Liebetanz, D, Kutschenko, A, Stangel, M, Trebst, C, Baum, P, Bergh, F, Klehmet, J, Meisel, A, Klostermann, F, Oechtering, J, Lehmann, H, Schroeter, M, Hagenacker, T, Mueller, D, Sperfeld, A, Bethke, F, Drory, V, Algom, A, Yarnitsky, D, Murinson, B, Di Muzio, A, Ciccocioppo, F, Sorbi, S, Mata, S, Schenone, A, Grandis, M, Lauria, G, Cazzato, D, Antonini, G, Morino, S, Cocito, D, Zibetti, M, Yokota, T, Ohkubo, T, Kanda, T, Kawai, M, Kaida, K, Onoue, H, Kuwabara, S, Mori, M, Iijima, M, Ohyama, K, Baba, M, Tomiyama, M, Nishiyama, K, Akutsu, T, Yokoyama, K, Kanai, K, Eftimov, F, Notermans, NC, Visser, N, Faber, C, Hoeijmakers, J, Rejdak, K, Chyrchel-Paszkiewicz, U, Casanovas Pons, C, Antonia, M, Gamez, J, Salvado, M, Marquez Infante, C, Benitez, S, Lunn, M, Morrow, J, Gosal, D, Lavin, T, Melamed, I, Testori, A, Ajroud-Driss, S, Menichella, D, Simpson, Lai, EC-H, Dimachkie, M, Barohn, RJ, Beydoun, S, Johl, H, Lange, D, Shtilbans, A, Muley, S, Ladha, S, Freimer, M, Kissel, J, Latov, N, Chin, R, Ubogu, E, Mumfrey, S, Rao, T, MacDonald, P, Sharma, K, Gonzalez, G, Allen, J, Walk, D, Hobson-Webb, L, Gable, K, Franques, J, Morales, RJ, Nguento, A, Schrey, C, and Zwolinska, G

Abstract

Intravenous immunoglobulin (IVIG) is a potential therapy for chronic inflammatory demyelinating polyneuropathy (CIDP). To investigate the efficacy and safety of the IVIG IgPro10 (Privigen) for treatment of CIDP, results from Privigen Impact on Mobility and Autonomy (PRIMA), a prospective, open-label, single-arm study of IVIG in immunoglobulin (Ig)-naïve or IVIG pre-treated subjects (NCT01184846, n = 28) and Polyneuropathy And Treatment with Hizentra (PATH), a double-blind, randomized study including an open-label, single-arm IVIG phase in IVIG pre-treated subjects (NCT01545076, IVIG restabilization phase n = 207) were analyzed separately and together (n = 235). Efficacy assessments included change in adjusted inflammatory neuropathy cause and treatment (INCAT) score, grip strength and Medical Research Council (MRC) sum score. Adverse drug reactions (ADRs) and ADRs/infusion were recorded. Adjusted INCAT response rate was 60.7% in all PRIMA subjects at Week 25 (76.9% in IVIG pre-treated subjects) and 72.9% in PATH. In the pooled cohort (n = 235), INCAT response rate was 71.5%; median time to INCAT improvement was 4.3 weeks. No clear demographic differences were noticed between early (responding before Week 7, n = 148) and late responders (n = 21). In the pooled cohort, median change from baseline to last observation was -1.0 (interquartile range -2.0; 0.0) point for INCAT score; +8.0 (0.0; 20.0) kPa for maximum grip strength; +3.0 (1.0; 7.0) points for MRC sum score. In the pooled cohort, 271 ADRs were reported in 105 subjects (44.7%), a rate of 0.144 ADRs per infusion. This analysis confirms the efficacy and safety of IgPro10, a recently FDA-approved IVIG for CIDP, in a population of mainly pre-treated subjects with CIDP [Correction added on 14 March 2019 after first online publication: the INCAT response rate has been corrected.].

Published
2019

40. Restabilization treatment after intravenous immunoglobulin withdrawal in chronic inflammatory demyelinating polyneuropathy: Results from the pre-randomization phase of the Polyneuropathy And Treatment with Hizentra study

Author

Mielke, O, Bril, V, Cornblath, DR, Lawo, J-P, van Geloven, N, Hartung, H-P, Lewis, RA, Merkies, ISJ, Sobue, G, Durn, B, Shebl, A, van Schaik, IN, Sabet, A, George, K, Roberts, L, Carne, R, Blum, S, Henderson, R, Van Damme, P, Demeestere, J, Larue, S, D'Amour, C, Kunc, P, Valis, M, Sussova, J, Kalous, T, Talab, R, Bednar, M, Toomsoo, T, Rubanovits, I, Gross-Paju, K, Sorro, U, Saarela, M, Auranen, M, Pouget, J, Attarian, S, Le Masson, G, Wielanek-Bachelet, A, Desnuelle, C, Delmont, E, Clavelou, P, Aufauvre, D, Schmidt, J, Zschuentzsch, J, Sommer, C, Kramer, D, Hoffmann, O, Goerlitz, C, Haas, J, Chatzopoulos, M, Yoon, R, Gold, R, Berlit, P, Jaspert-Grehl, A, Liebetanz, D, Kutschenko, A, Stangel, M, Trebst, C, Baum, P, Bergh, F, Klehmet, J, Meisel, A, Klostermann, F, Oechtering, J, Lehmann, H, Schroeter, M, Hagenacker, T, Mueller, D, Sperfeld, A, Bethke, F, Drory, V, Algom, A, Yarnitsky, D, Murinson, B, Di Muzio, A, Ciccocioppo, F, Sorbi, S, Mata, S, Schenone, A, Grandis, M, Lauria, G, Cazzato, D, Antonini, G, Morino, S, Cocito, D, Zibetti, M, Yokota, T, Ohkubo, T, Kanda, T, Kawai, M, Kaida, K, Onoue, H, Kuwabara, S, Mori, M, Iijima, M, Ohyama, K, Baba, M, Tomiyama, M, Nishiyama, K, Akutsu, T, Yokoyama, K, Kanai, K, Eftimov, F, Notermans, NC, Visser, N, Faber, C, Hoeijmakers, J, Rejdak, K, Chyrchel-Paszkiewicz, U, Casanovas Pons, C, Antonia, M, Gamez, J, Salvado, M, Marquez Infante, C, Benitez, S, Lunn, M, Morrow, J, Gosal, D, Lavin, T, Melamed, I, Testori, A, Ajroud-Driss, S, Menichella, D, Simpson, E, Lai, EC-H, Dimachkie, M, Barohn, RJ, Beydoun, S, Johl, H, Lange, D, Shtilbans, A, Muley, S, Ladha, S, Freimer, M, Kissel, J, Latov, N, Chin, R, Ubogu, E, Mumfrey, S, Rao, T, MacDonald, P, Sharma, K, Gonzalez, G, Allen, J, Walk, D, Hobson-Webb, L, Gable, K, Mielke, O, Bril, V, Cornblath, DR, Lawo, J-P, van Geloven, N, Hartung, H-P, Lewis, RA, Merkies, ISJ, Sobue, G, Durn, B, Shebl, A, van Schaik, IN, Sabet, A, George, K, Roberts, L, Carne, R, Blum, S, Henderson, R, Van Damme, P, Demeestere, J, Larue, S, D'Amour, C, Kunc, P, Valis, M, Sussova, J, Kalous, T, Talab, R, Bednar, M, Toomsoo, T, Rubanovits, I, Gross-Paju, K, Sorro, U, Saarela, M, Auranen, M, Pouget, J, Attarian, S, Le Masson, G, Wielanek-Bachelet, A, Desnuelle, C, Delmont, E, Clavelou, P, Aufauvre, D, Schmidt, J, Zschuentzsch, J, Sommer, C, Kramer, D, Hoffmann, O, Goerlitz, C, Haas, J, Chatzopoulos, M, Yoon, R, Gold, R, Berlit, P, Jaspert-Grehl, A, Liebetanz, D, Kutschenko, A, Stangel, M, Trebst, C, Baum, P, Bergh, F, Klehmet, J, Meisel, A, Klostermann, F, Oechtering, J, Lehmann, H, Schroeter, M, Hagenacker, T, Mueller, D, Sperfeld, A, Bethke, F, Drory, V, Algom, A, Yarnitsky, D, Murinson, B, Di Muzio, A, Ciccocioppo, F, Sorbi, S, Mata, S, Schenone, A, Grandis, M, Lauria, G, Cazzato, D, Antonini, G, Morino, S, Cocito, D, Zibetti, M, Yokota, T, Ohkubo, T, Kanda, T, Kawai, M, Kaida, K, Onoue, H, Kuwabara, S, Mori, M, Iijima, M, Ohyama, K, Baba, M, Tomiyama, M, Nishiyama, K, Akutsu, T, Yokoyama, K, Kanai, K, Eftimov, F, Notermans, NC, Visser, N, Faber, C, Hoeijmakers, J, Rejdak, K, Chyrchel-Paszkiewicz, U, Casanovas Pons, C, Antonia, M, Gamez, J, Salvado, M, Marquez Infante, C, Benitez, S, Lunn, M, Morrow, J, Gosal, D, Lavin, T, Melamed, I, Testori, A, Ajroud-Driss, S, Menichella, D, Simpson, E, Lai, EC-H, Dimachkie, M, Barohn, RJ, Beydoun, S, Johl, H, Lange, D, Shtilbans, A, Muley, S, Ladha, S, Freimer, M, Kissel, J, Latov, N, Chin, R, Ubogu, E, Mumfrey, S, Rao, T, MacDonald, P, Sharma, K, Gonzalez, G, Allen, J, Walk, D, Hobson-Webb, L, and Gable, K

Abstract

In patients with chronic inflammatory demyelinating polyneuropathy (CIDP), intravenous immunoglobulin (IVIG) is recommended to be periodically reduced to assess the need for ongoing therapy. However, little is known about the effectiveness of restabilization with IVIG in patients who worsen after IVIG withdrawal. In the Polyneuropathy And Treatment with Hizentra (PATH) study, the pre-randomization period included sudden stopping of IVIG followed by 12 weeks of observation. Those deteriorating were then restabilized with IVIG. Of 245 subjects who stopped IVIG, 28 did not show signs of clinical deterioration within 12 weeks. Two hundred and seven received IVIG restabilization with an induction dose of 2 g/kg bodyweight (bw) IgPro10 (Privigen, CSL Behring, King of Prussia, Pennsylvania) and maintenance doses of 1 g/kg bw every 3 weeks for up to 13 weeks. Signs of clinical improvement were seen in almost all (n = 188; 91%) subjects. During IVIG restabilization, 35 subjects either did not show CIDP stability (n = 21, analyzed as n = 22 as an additional subject was randomized in error) or withdrew for other reasons (n = 14). Of the 22 subjects who did not achieve clinical stability, follow-up information in 16 subjects after an additional 4 weeks was obtained. Nine subjects were reported to have improved, leaving a maximum of 27 subjects (13%) who either showed no signs of clinical improvement during the restabilization phase and 4 weeks post-study or withdrew for other reasons. In conclusion, sudden IVIG withdrawal was effective in detecting ongoing immunoglobulin G dependency with a small risk for subjects not returning to their baseline 17 weeks after withdrawal.

Published
2019

41. The therapeutic effect of hysterosalpingography in couples with unexplained subfertility: a post-hoc analysis of a prospective multi-centre cohort study

Author

Biostatistiek Onderwijs, MS VPG/Gynaecologie, Biostatistiek Onderzoek, Infection & Immunity, Circulatory Health, Child Health, JC onderzoeksprogramma Infectieziekten, JC onderzoeksprogramma Methodologie, Dreyer, K., van Eekelen, R., Tjon-Kon-Fat, R. I., van der Steeg, J. W., Steures, P., Eijkemans, M. J.C., van der Veen, F., Hompes, P. G.A., Mol, B. W.J., van Geloven, N., Biostatistiek Onderwijs, MS VPG/Gynaecologie, Biostatistiek Onderzoek, Infection & Immunity, Circulatory Health, Child Health, JC onderzoeksprogramma Infectieziekten, JC onderzoeksprogramma Methodologie, Dreyer, K., van Eekelen, R., Tjon-Kon-Fat, R. I., van der Steeg, J. W., Steures, P., Eijkemans, M. J.C., van der Veen, F., Hompes, P. G.A., Mol, B. W.J., and van Geloven, N.

Published
2019

42. Predicting the chances of having a baby with or without treatment at different time points in couples with unexplained subfertility

Author

Biostatistiek Onderwijs, Biostatistiek Onderzoek, Infection & Immunity, Circulatory Health, JC onderzoeksprogramma Infectieziekten, JC onderzoeksprogramma Methodologie, McLernon, D. J., Lee, A. J., Maheshwari, A., Van Eekelen, R., Van Geloven, N., Putter, H., Eijkemans, M. J., Van Der Steeg, J. W., Van Der Veen, F., Steyerberg, E. W., Mol, B. W., Bhattacharya, S., Biostatistiek Onderwijs, Biostatistiek Onderzoek, Infection & Immunity, Circulatory Health, JC onderzoeksprogramma Infectieziekten, JC onderzoeksprogramma Methodologie, McLernon, D. J., Lee, A. J., Maheshwari, A., Van Eekelen, R., Van Geloven, N., Putter, H., Eijkemans, M. J., Van Der Steeg, J. W., Van Der Veen, F., Steyerberg, E. W., Mol, B. W., and Bhattacharya, S.

Published
2019

43. IVF for unexplained subfertility; Whom should we treat?

Author

Biostatistiek Onderwijs, Biostatistiek Onderzoek, Infection & Immunity, Circulatory Health, JC onderzoeksprogramma Infectieziekten, JC onderzoeksprogramma Methodologie, Van Eekelen, R., Van Geloven, N., Van Wely, M., Bhattacharya, S., Van Der Veen, F., Eijkemans, M. J., McLernon, D. J., Biostatistiek Onderwijs, Biostatistiek Onderzoek, Infection & Immunity, Circulatory Health, JC onderzoeksprogramma Infectieziekten, JC onderzoeksprogramma Methodologie, Van Eekelen, R., Van Geloven, N., Van Wely, M., Bhattacharya, S., Van Der Veen, F., Eijkemans, M. J., and McLernon, D. J.

Published
2019

44. Is IUI with ovarian stimulation effective in couples with unexplained subfertility?

Author

Biostatistiek Onderwijs, JC onderzoeksprogramma Methodologie, MS VPG/Gynaecologie, Biostatistiek Onderzoek, Infection & Immunity, van Eekelen, R, van Geloven, N, van Wely, M, McLernon, D J, Mol, F, Custers, I M, Steures, P, Bhattacharya, S, Mol, B W, van der Veen, F, Eijkemans, M J, Biostatistiek Onderwijs, JC onderzoeksprogramma Methodologie, MS VPG/Gynaecologie, Biostatistiek Onderzoek, Infection & Immunity, van Eekelen, R, van Geloven, N, van Wely, M, McLernon, D J, Mol, F, Custers, I M, Steures, P, Bhattacharya, S, Mol, B W, van der Veen, F, and Eijkemans, M J

Published
2019

45. Feasibility of switching from intravenous to subcutaneous immunoglobulin in CIDP: PATH trial and clinical experience

Author

Cocito, D., primary, Peci, E., additional, Lauria Pinter, G., additional, Dacci, P., additional, Di Muzio, A., additional, Telese, R., additional, Schenone, A., additional, Benedetti, L., additional, Antonini, G., additional, Morino, S., additional, Sorbi, S., additional, Matà, S., additional, Bril, V., additional, van Geloven, N., additional, Hartung, H-P., additional, Lewis, R.A., additional, Sobue, G., additional, Lawo, J.-P., additional, Mielke, O., additional, Durn, B.L., additional, Cornblath, D.R., additional, Merkies, I.S.J., additional, and van Schaik, I.N., additional

Published
2019
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46. Subcutaneous immunoglobulin (SCIG) for maintenance treatment in chronic inflammatory demyelinating polyneuropathy (CIDP), a multicenter randomized double-blind placebo-controlled trial: The PATH Study

Author

Cocito, D., primary, Peci, E., additional, Lauria Pinter, G., additional, Dacci, P., additional, Di Muzio, A., additional, Telese, R., additional, Schenone, A., additional, Benedetti, L., additional, Antonini, G., additional, Morino, S., additional, Sorbi, S., additional, Matà, S., additional, Bril, V., additional, van Geloven, N., additional, Hartung, H.-P., additional, Lewis, R.A., additional, Sobue, G., additional, Lawo, J.-P., additional, Mielke, O., additional, Durn, B.L., additional, Cornblath, D.R., additional, Merkies, I.S.J., additional, and van Schaik, I.N., additional

Published
2019
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