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5. A Prediction Model for Successful Increase of Adalimumab Dose Intervals in Patients with Crohn’s Disease: Secondary Analysis of the Pragmatic Open-Label Randomised Controlled Non-inferiority LADI Trial

Author

van Linschoten, Reinier C. A., Jansen, Fenna M., Pauwels, Renske W. M., Smits, Lisa J. T., Atsma, Femke, Kievit, Wietske, de Jong, Dirk J., de Vries, Annemarie C., Boekema, Paul J., West, Rachel L., Bodelier, Alexander G. L., Gisbertz, Ingrid A. M., Wolfhagen, Frank H. J., Römkens, Tessa E. H., Lutgens, Maurice W. M. D., van Bodegraven, Adriaan A., Oldenburg, Bas, Pierik, Marieke J., Russel, Maurice G. V. M., de Boer, Nanne K., Mallant-Hent, Rosalie C., ter Borg, Pieter C. J., van der Meulen-de Jong, Andrea E., Jansen, Jeroen M., Jansen, Sita V., Tan, Adrianus C. I. T. L., van der Woude, C. Janneke, and Hoentjen, Frank

Published
2024
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7. CAPITAL: Optimal subgroup identification via constrained policy tree search

Author

Cai, Hengrui, Lu, Wenbin, West, Rachel Marceau, Mehrotra, Devan V, and Huang, Lingkang

Subjects
Epidemiology, Statistics, Health Sciences, Mathematical Sciences, Prevention, Good Health and Well Being, Algorithms, Humans, Policy, Precision Medicine, Research Design, constrained policy tree search, optimal subgroup identification, personalized medicine, Public Health and Health Services, Statistics & Probability
Abstract

Personalized medicine, a paradigm of medicine tailored to a patient's characteristics, is an increasingly attractive field in health care. An important goal of personalized medicine is to identify a subgroup of patients, based on baseline covariates, that benefits more from the targeted treatment than other comparative treatments. Most of the current subgroup identification methods only focus on obtaining a subgroup with an enhanced treatment effect without paying attention to subgroup size. Yet, a clinically meaningful subgroup learning approach should identify the maximum number of patients who can benefit from the better treatment. In this article, we present an optimal subgroup selection rule (SSR) that maximizes the number of selected patients, and in the meantime, achieves the pre-specified clinically meaningful mean outcome, such as the average treatment effect. We derive two equivalent theoretical forms of the optimal SSR based on the contrast function that describes the treatment-covariates interaction in the outcome. We further propose a constrained policy tree search algorithm (CAPITAL) to find the optimal SSR within the interpretable decision tree class. The proposed method is flexible to handle multiple constraints that penalize the inclusion of patients with negative treatment effects, and to address time to event data using the restricted mean survival time as the clinically interesting mean outcome. Extensive simulations, comparison studies, and real data applications are conducted to demonstrate the validity and utility of our method.

Published
2022

8. CAPITAL: Optimal Subgroup Identification via Constrained Policy Tree Search

Author

Cai, Hengrui, Lu, Wenbin, West, Rachel Marceau, Mehrotra, Devan V., and Huang, Lingkang

Subjects
Statistics - Machine Learning, Computer Science - Machine Learning, Statistics - Applications, Statistics - Methodology
Abstract

Personalized medicine, a paradigm of medicine tailored to a patient's characteristics, is an increasingly attractive field in health care. An important goal of personalized medicine is to identify a subgroup of patients, based on baseline covariates, that benefits more from the targeted treatment than other comparative treatments. Most of the current subgroup identification methods only focus on obtaining a subgroup with an enhanced treatment effect without paying attention to subgroup size. Yet, a clinically meaningful subgroup learning approach should identify the maximum number of patients who can benefit from the better treatment. In this paper, we present an optimal subgroup selection rule (SSR) that maximizes the number of selected patients, and in the meantime, achieves the pre-specified clinically meaningful mean outcome, such as the average treatment effect. We derive two equivalent theoretical forms of the optimal SSR based on the contrast function that describes the treatment-covariates interaction in the outcome. We further propose a ConstrAined PolIcy Tree seArch aLgorithm (CAPITAL) to find the optimal SSR within the interpretable decision tree class. The proposed method is flexible to handle multiple constraints that penalize the inclusion of patients with negative treatment effects, and to address time to event data using the restricted mean survival time as the clinically interesting mean outcome. Extensive simulations, comparison studies, and real data applications are conducted to demonstrate the validity and utility of our method.

Published
2021

10. Preoperative screening and prehabilitation strategies prior to ileocolic resection in patients with Crohn’s disease are not incorporated in routine care

Author

Bak, Michiel Thomas Jan, van Ruler, Oddeke, Stassen, Laurents, Ruiterkamp, Marit, Arkenbosch, Jeanine Hubertina Catharina, Dijkstra, Gerard, Campmans-Kuijpers, Maria Johanna Elisabeth, van Meeteren, Nico Leonard Ulrich, Bongers, Bart Chateau, Romberg-Camps, Mariëlle, van der Marel, Sander, Hoentjen, Frank, van Dongen, Koen Willem, West, Rachel, van der Woude, Janneke, and de Vries, Annemarie Charlotte

Published
2023
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11. Interobserver agreement of current and new proposed endoscopic scores for postoperative recurrence in Crohn’s disease

Author

Bak, Michiel T.J., Hammoudi, Nassim, Allez, Matthieu, Silverberg, Mark S., Schellekens, Isa M., Erler, Nicole S., Dijkstra, Gerard, Romberg-Camps, Mariëlle, de Boer, Nanne K.H., Jansen, Sita V., van der Marel, Sander, Horjus, Carmen S., Visschedijk, Marijn C., Goetgebuer, Rogier L., van Dop, Willemijn A., Hoekstra, Jildou, Bodelier, Alexander G.L., Molendijk, Ilse, Derikx, Lauranne A.A.P., van Schaik, Fiona D.M., West, Rachel L., Duijvestein, Marjolijn, Janneke van der Woude, C., van Ruler, Oddeke, and de Vries, Annemarie C.

Published
2024
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12. Survival Analysis Using a 5-Step Stratified Testing and Amalgamation Routine in Randomized Clinical Trials

Author

Mehrotra, Devan V. and West, Rachel Marceau

Subjects
Statistics - Methodology, Statistics - Applications, Statistics - Machine Learning
Abstract

Randomized clinical trials are often designed to assess whether a test treatment prolongs survival relative to a control treatment. Increased patient heterogeneity, while desirable for generalizability of results, can weaken the ability of common statistical approaches to detect treatment differences, potentially hampering the regulatory approval of safe and efficacious therapies. A novel solution to this problem is proposed. A list of baseline covariates that have the potential to be prognostic for survival under either treatment is pre-specified in the analysis plan. At the analysis stage, using all observed survival times but blinded to patient-level treatment assignment, 'noise' covariates are removed with elastic net Cox regression. The shortened covariate list is used by a conditional inference tree algorithm to segment the heterogeneous trial population into subpopulations of prognostically homogeneous patients (risk strata). After patient-level treatment unblinding, a treatment comparison is done within each formed risk stratum and stratum-level results are combined for overall statistical inference. The impressive power-boosting performance of our proposed 5-step stratified testing and amalgamation routine (5-STAR), relative to that of the logrank test and other common approaches that do not leverage inherently structured patient heterogeneity, is illustrated using a hypothetical and two real datasets along with simulation results. Furthermore, the importance of reporting stratum-level comparative treatment effects (time ratios from accelerated failure time model fits in conjunction with model averaging and, as needed, hazard ratios from Cox proportional hazard model fits) is highlighted as a potential enabler of personalized medicine. A fiveSTAR R package is available at https://github.com/rmarceauwest/fiveSTAR., Comment: 40 pages; 9 figures, 2 tables

Published
2020

14. Increased versus conventional adalimumab dose interval for patients with Crohn's disease in stable remission (LADI): a pragmatic, open-label, non-inferiority, randomised controlled trial

Author

van Noord, Desirée, Hoekstra, Jildou, Kamphuis, Johannes T., Gorter, Moniek H.P., van Esch, Aura A.J., van Linschoten, Reinier C A, Jansen, Fenna M, Pauwels, Renske W M, Smits, Lisa J T, Atsma, Femke, Kievit, Wietske, de Jong, Dirk J, de Vries, Annemarie C, Boekema, Paul J, West, Rachel L, Bodelier, Alexander G L, Gisbertz, Ingrid A M, Wolfhagen, Frank H J, Römkens, Tessa E H, Lutgens, Maurice W M D, van Bodegraven, Adriaan A, Oldenburg, Bas, Pierik, Marieke J, Russel, Maurice G V M, de Boer, Nanne K, Mallant-Hent, Rosalie C, ter Borg, Pieter C J, van der Meulen-de Jong, Andrea E, Jansen, Jeroen M, Jansen, Sita V, Tan, Adrianus C I T L, van der Woude, C Janneke, and Hoentjen, Frank

Published
2023
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16. Superior Effectiveness of Tofacitinib Compared to Vedolizumab in Anti-TNF-experienced Ulcerative Colitis Patients: A Nationwide Dutch Registry Study

Author

Schlotter, Malena, van Workum, Martine, de Jong, Dirk, van Dop, Willemijn, van der Marel, S., El Ghabzouri, Hayat, Talhaoui, Kamila, Oldenburg, Bas, Boontje, Nynke, Fidder, Herma, Hirdes, Meike, Creemers, Rob H., Hoekstra, J., Smid, Jael, Mujagic, Zlatan, François-Verweij, Marthe, Schakel- van den Berge, Toos, Maljaars, Jeroen, Theeuwen, Rosaline, van den Berg, Denise, Gerretsen, Suzanne, Yocarini, Xenia, D’Haens, Geert, Lowenberg, Mark, Grootjans, Joep, Gecse, Krisztina, Bouma, Gerd, Waaijenberg, Petra, Muskens, Bart, Straatmijer, Tessa, Biemans, Vince B.C., Visschedijk, Marijn, Hoentjen, Frank, de Vries, Annemarie, van Bodegraven, Adriaan A., Bodelier, Alexander, de Boer, Nanne K.H., Dijkstra, Gerard, Festen, Noortje, Horjus, Carmen, Jansen, Jeroen M., Jharap, Bindia, Mares, Wout, van Schaik, Fiona D.M., Ponsioen, Cyriel, Romkens, Tessa, Srivastava, Nidhi, van der Voorn, Michael M.P. J.A., West, Rachel, van der Woude, Janneke, Wolvers, Marije D.J., Pierik, Marieke, van der Meulen-de Jong, Andrea E., and Duijvestein, Marjolijn

Published
2023
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17. A phase 1/2 study of favezelimab in combination with pembrolizumab for heavily pretreated anti–PD-1–refractory classical Hodgkin lymphoma (cHL): An updated analysis.

Author

Timmerman, John, primary, Lavie, David, additional, Johnson, Nathalie A., additional, Avigdor, Abraham, additional, Peter, Borchmann, additional, Andreadis, Charalambos, additional, Bazargan, Ali, additional, Gregory, Gareth P., additional, Keane, Colm, additional, Torzan, Inna, additional, Vucinic, Vladan, additional, Zinzani, Pier Luigi, additional, West, Rachel Marceau, additional, Pillai, Pallavi, additional, Marinello, Patricia, additional, and Herrera, Alex Francisco, additional

Published
2024
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20. Exploratory subgroup identification in the heterogeneous Cox model: A relatively simple procedure.

Author

León, Larry F., Jemielita, Thomas, Guo, Zifang, Marceau West, Rachel, and Anderson, Keaven M.

Subjects
RANDOM forest algorithms, NUMERICAL integration, SURVIVAL analysis (Biometry), CLINICAL trials, CENSORSHIP
Abstract

For survival analysis applications we propose a novel procedure for identifying subgroups with large treatment effects, with focus on subgroups where treatment is potentially detrimental. The approach, termed forest search, is relatively simple and flexible. All‐possible subgroups are screened and selected based on hazard ratio thresholds indicative of harm with assessment according to the standard Cox model. By reversing the role of treatment one can seek to identify substantial benefit. We apply a splitting consistency criteria to identify a subgroup considered "maximally consistent with harm." The type‐1 error and power for subgroup identification can be quickly approximated by numerical integration. To aid inference we describe a bootstrap bias‐corrected Cox model estimator with variance estimated by a Jacknife approximation. We provide a detailed evaluation of operating characteristics in simulations and compare to virtual twins and generalized random forests where we find the proposal to have favorable performance. In particular, in our simulation setting, we find the proposed approach favorably controls the type‐1 error for falsely identifying heterogeneity with higher power and classification accuracy for substantial heterogeneous effects. Two real data applications are provided for publicly available datasets from a clinical trial in oncology, and HIV. [ABSTRACT FROM AUTHOR]

Published
2024
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21. Clinical Trial: A Pragmatic Randomised Controlled Study to Assess the Effectiveness of Two Patient Management Strategies in Mild to Moderate Ulcerative Colitis—The OPTIMISE Study.

Author

Danese, Silvio, Fiorino, Gionata, Vicaut, Eric, Paridaens, Kristine, Ugur, Asiya, Clark, Brian, Vanasek, Tomas, Stepek, David, D'Amico, Ferdinando, West, Rachel, Gilissen, Lennard P. L., Wisniewska Jarosinka, Maria, Drobinski, Piotr, Fronik, Grzegorz, Fic, Mirosław, Walczak, Michał, Kowalski, Maciej, Korczowski, Bartosz, Wiatr, Michal, and Peyrin-Biroulet, Laurent

Subjects
INFLAMMATORY bowel diseases, ULCERATIVE colitis, BIOMARKERS, RANDOMIZED controlled trials, MISSING data (Statistics)
Abstract

Background: Current management of mild-to-moderate ulcerative colitis (UC) involves monitoring clinical markers of disease activity, such as stool frequency (SF) and rectal bleeding (RB), and adjusting treatment accordingly. Our aim was to assess whether targeting treatment based on faecal calprotectin (FC) levels (treat-to-target; T2T) provides greater UC disease control versus a symptom-based approach. Methods: This was a pragmatic, randomised (1:1) controlled study of patients with mild-to-moderate UC (global Mayo score 2–6) treated with ≤2.4 g/day 5-aminosalicylic acid that compared the effectiveness of two management strategies with (interventional arm) and without (reference arm) FC home monitoring over 12 months of follow-up. Treatment was optimised in the interventional arm using FC values and clinical symptoms (PRO-2), while the reference arm used only PRO-2. Results: 193 patients completed the study. No significant difference was found for the primary endpoint (Mayo Endoscopic Subscore [MES] = 0 at 12 months). A numerical advantage for the interventional arm over the reference arm for the primary endpoint (37.0% vs. 33.4%, respectively) and for MES ≤ 1, RB = 0, and SF ≤ 1 at 12 months was found following imputation for missing data. The composite endpoint of MES = 0, RB = 0, and SF ≤ 1 at 12 months was achieved at a significantly higher rate in the interventional arm than the reference arm (effect size [ES]: 0.17, 95% CI 0.02–0.32; p < 0.05). A similar result was obtained for MES ≤ 1, RB = 0 and SF ≤ 1 (ES: 0.22; 95% CI 0.07–0.37; p < 0.05). Conclusions: T2T using FC monitoring was effective in patients with mild-to-moderate UC at 12 months. Further longer-term studies are required to confirm the results. [ABSTRACT FROM AUTHOR]

Published
2024
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22. Variation Between Hospitals in Outcomes and Costs of IBD Care: Results From the IBD Value Study

Author

van Linschoten, Reinier C A, primary, van der Woude, C Janneke, additional, Visser, Elyke, additional, van Leeuwen, Nikki, additional, Bodelier, Alexander G L, additional, Fitzpatrick, Claire, additional, de Jonge, Vincent, additional, Vermeulen, Hestia, additional, Verweij, K Evelyne, additional, van der Wiel, Sanne, additional, Nieboer, Daan, additional, Birnie, Erwin, additional, van der Horst, Daniëlle, additional, Hazelzet, Jan A, additional, van Noord, Desirée, additional, and West, Rachel L, additional

Published
2024
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24. High-Dose Vitamin D Does Not Prevent Postoperative Recurrence of Crohn’s Disease in a Randomized Placebo-Controlled Trial

Author

Bemelman, W., Buskens, C., Clasquin, E., De Bruyn, J., D’Haens, G., Duijvestein, M., Van der Bilt, J., Ferreira, B., Mulder, S., West, R., Dijkstra, G., Engelsman, A., Lange, J., Homans, L., Witteman, B., Eroglu-Berger, A., Russel, M., Jansen, J., Schakel–van den Berge, T., Cuppen, S., Hoentjen, F., Van Esch, A., De Jong, D.J., Mahmmod, N., Hove.P. De Lange, W. Ten, Mallant, R., Houben, P., Ferrante, M., Vermeire, S., Outtier, A., Hermans, T., Lefrère, J., D’Hoore, A., Asnong, K., Bossuyt, P., Van de Schoot, I., Claerbout, B., Lambrecht, G., Boutaffala, L., Guebelle, C., Louis, E., Franchimont, D., Wambacq, V., Colard, A., Deflandre, A., de Bruyn, Jessica R., Bossuyt, Peter, Ferrante, Marc, West, Rachel L., Dijkstra, Gerard, Witteman, Ben J., Wildenberg, Manon, Hoentjen, Frank, Franchimont, Denis, Clasquin, Esmé, van der Bilt, Jarmila D., Tollens, Tim, Bemelman, Willem A., D’Hoore, Andre, Duijvestein, Marjolijn, and D’Haens, Geert R.

Published
2021
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25. Retreatment with anti-tumor necrosis factor therapy in combination with an immunomodulator for recurrence of Crohn’s disease after ileocecal resection results in prolonged continuation as compared to anti-tumor necrosis factor monotherapy

Author

ten Bokkel Huinink, Sebastiaan., Beelen, Evelien M.J., ten Bokkel Huinink, Thomas, Hoentjen, Frank, G. L. Bodelier, Alexander, Dijkstra, Gerard, Romberg-Camps, Marielle, de Boer, Nanne K., Stassen, Laurents P.S., van der Meulen, Andrea E., West, Rachel, van Ruler, Oddeke, van der Woude, C. Janneke, and de Vries, Annemarie C.

Published
2023
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29. Prognostic Value of the Modified Rutgeerts Score for Long-Term Outcomes After Primary Ileocecal Resection in Crohn’s Disease

Author

Bak, Michiel T.J., Bokkel Huinink, Sebastiaan ten, Erler, Nicole S., Bodelier, Alexander G.L., Dijkstra, Gerard, Romberg-Camps, Mariëlle, de Boer, Nanne K.H., Hoentjen, Frank, Stassen, Laurents P.S., van der Meulen–de Jong, Andrea E., West, Rachel L., van Ruler, Oddeke, van der Woude, C. Janneke, de Vries, Annemarie C., Bak, Michiel T.J., Bokkel Huinink, Sebastiaan ten, Erler, Nicole S., Bodelier, Alexander G.L., Dijkstra, Gerard, Romberg-Camps, Mariëlle, de Boer, Nanne K.H., Hoentjen, Frank, Stassen, Laurents P.S., van der Meulen–de Jong, Andrea E., West, Rachel L., van Ruler, Oddeke, van der Woude, C. Janneke, and de Vries, Annemarie C.

Abstract

IntroductionThe prognostic value of the modified Rutgeerts score (mRS) in patients with Crohn's disease (CD) needs to be further elucidated. This study assessed the prognostic value of the mRS for long-term outcomes after primary ileocecal resection in patients with CD.METHODS: Patients with CD after primary ileocecal resection with an available mRS at first postoperative ileocolonoscopy (index mRS) were retrospectively included. The primary outcome was surgical recurrence. Secondary outcomes were clinical recurrence and progression to severe endoscopic recurrence (‡i3). Cox proportional hazard models were used to assess the association between index mRS and outcomes. RESULTS: Six hundred fifty-two patients were included (mean follow-up: 6.4 years, SD: 4.6). Surgical recurrence rates were 7.7%, 5.3%, 12.9%, 19.1%, 28.8%, 47.8% for index mRS i0, i1, i2a, i2b, i3, and i4, respectively. Clinical recurrence occurred in 42.2% (i0), 53.7% (i1), 58.5% (i2a), 80.2% (i2b), 79.4% (i3), and 95.3% (i4) of patients. Progression to severe endoscopic recurrence occurred in 21.1% (i0), 33.9% (i1), 26.8% (i2a), and 33.3% (i2b) of patients. An index mRS of i2b (adjusted hazard ratio [aHR] 3.0; 1.5–5.6), i3 (aHR 4.0; 2.0–7.9) and i4 (aHR 8.0; 4.0–16.0) were associated with surgical recurrence. An index mRS of i1 (aHR 1.7; 1.2–2.4), i2a (aHR 1.7; 1.2–2.4), i2b (aHR 4.4; 3.2–6.0), i3 (aHR 3.6; 2.5–5.2), and i4 (aHR 7.3; 4.8–10.9) were associated with clinical recurrence. An index mRS of i1 (aHR 2.0; 1.1–3.7) or i2b (aHR 2.5; 1.4–4.6) was associated with progression to severe endoscopic recurrence.DISCUSSION: The increasing mRS corresponds closely with the risk of surgical and clinical recurrence.

Published
2024

30. Validation and update of a prediction model for risk of relapse after cessation of anti-TNF treatment in Crohn’s disease

Author

ten Bokkel Huinink, Sebastiaan, de Jong, Djuna C., Nieboer, Daan, Thomassen, Doranne, Steyerberg, Ewout W., Dijkgraaf, Marcel G.W., Bodelier, Alexander G.L., West, Rachel L., Römkens, Tessa E.H., Hoentjen, Frank, Mallant, Rosalie C., van Tuyl, Bas A.C., Mares, Wout G.N., Wolfhagen, Frank H.J., Dijkstra, Gerard, Reijnders, Jurriën G.P., de Boer, Nanne K., Tan, Adriaan C.I.T.L., van Boeckel, Petra G.A., Tack, Greetje J., van Asseldonk, Dirk P., D’Haens, Geert R.A.M., van der Woude, C Janneke, Duijvestein, Marjolijn, and de Vries, Annemarie C

Published
2022
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32. Laparoscopic ileocaecal resection versus infliximab for terminal ileitis in Crohn's disease: retrospective long-term follow-up of the LIR!C trial

Author

Hart, Ailsa, Warusavitarne, Janindra, Van Bodegraven, Ad A., Brink, Menno A., Consten, Esther C.J., Van Wagensveld, Bart A., Rijk, Marno C.M., Crolla, Rogier M.P.H., Noomen, Casper G., Houdijk, Alexander P.J., Mallant, Rosalie C., Boom, Maarten, Marsman, Willem A., Stockmann, Hein B., De Groof, A. Jeroen, Bruin, Karlien, Maring, John, van Ditzhuijsen, Theo, Prins, Hubert, van den Brande, Jan, Kingma, Paul, van Geloven, Anna, de Boer, Nanne, van der Peet, Donald, Jansen, Jeroen, Gerhards, Michael, van der Woude, Janneke, Schouten, Ruud, Oldenburg, Bas, van Hillegersberg, Richard, West, Rachel, Mannaerts, Guido, Spanier, Marcel, Spillenaar Bilgen, Ernst Jan, Lieverse, Rob, van der Zaag, Edwin, Depla, Annekatrien, van de Laar, Arnold, Bolwerk, Clemens, Brouwer, Hans, Mahmmod, Nofel, Hazebroek, Eric, Vecht, Juda, Pierik, Robert, Dijkstra, Gerard, Hofker, Sijbrand, Uiterwaal, Tessa, Eijsbouts, Quirijn, Oostenbrug, Liekele, Sosef, Meindert, Cahen, Djuna, van der Werff, Sjoerd, Marinelli, Andreas, Peters, Job, Cense, Huib, Talstra, Nynke, Morar, Pritesh, Stevens, Toer W, Haasnoot, Maria L, D'Haens, Geert R, Buskens, Christianne J, de Groof, E Joline, Eshuis, Emma J, Gardenbroek, Tjibbe J, Mol, Bregje, Stokkers, Pieter C F, Bemelman, Willem A, and Ponsioen, Cyriel Y

Published
2020
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34. The Effects of Minimum Wages on Food Stamp Enrollment and Expenditures

Author

Reich, Michael and West, Rachel

Abstract

We provide the first analysis of how minimum wage policy affect s enrollments and expenditures i n the Supplemental Nutrition Assistance Program (SNAP). Exploiting state and federal - level variation in minimum - wage policy between 1990 and 2012, and incorporating local controls in our specifications, we find that a 10 percent minimum wage increase reduces SNAP enrollment between 2.4 and 3.2 percent, and reduces program expenditures an estimated 1.9 percent. If the federal minimum wage were increased from $7.25 to $10.10, enrollment would fall between 7 .5 and 8.7 percent (3. 1 to 3. 6 million persons) relative to 2012 levels, and annual expenditures would decrease 6 percent ($4.6 billion).

Published
2015

36. Ten Dollars or Thirteen Dollars? Comparing the Effects of State Minimum Wage Increases in California

Author

Allegretto, Sylvia, Reich, Michael, and West, Rachel

Subjects
minimum wage, living wage, AB10, SB935
Abstract

In September of 2013, California Governor Jerry Brown signed Assembly Bill 10 into law. AB10 increases California’s minimum wage—which has stood at $8 per hour since 2008—to $9 on July 1, 2014, and to $10 on January 1, 2016. Some policymakers regard the modest increase provided by AB10 and the absence of annual adjustments for price increases as insufficient for the wellbeing of the Golden State’s lowest-paid workers. Indeed, for the first time in the state’s history a new minimum wage proposal—Senate Bill 935 sponsored by Senator Mark Leno—has been introduced in the legislature before the implementation of the already-legislated minimum wage increase (AB10). Senator Leno’s bill would increase California’s wage floor in several steps to reach $13 in January 2017, and annual cost of living adjustments would begin in 2018.California is not alone in implementing or considering minimum wage increases this year. Thus far in 2014 thirty eight states have considered minimum wage bills and eight states and Washington, DC have enacted new increases (NCSL 2014). Some states and cities have already enacted minimum wage standards that exceed $10. A number of California cities are currently contemplating citywide increases: $15 in San Francisco, $13 in Richmond, $12.53 in Berkeley, $12.50 in Oakland, and $11.50 in San Diego.While minimum wages of $10 to $15 are appearing for the first time in the U.S., when adjusted for inflation or compared to median wages they are not outside of previous experience (Dube 2014). The $10 minimum wage of AB10 represents just under 50 percent of the median full-time wage in California— less than the 55 percent ratio that held in the U.S. as a whole in the late 1960s, and about the same percentage as in European countries with a statutory minimum wage today. A fully implemented SB935 would be only modestly higher than the federal minimum wage in 1968. Its ratio to the median wage would be 58 percent, less than the ratio in many U.S. states in the 1960s and well below the equivalent percentage in the Nordic countries today. Nonetheless, it is important to ask: What are the implications of such double-digit minimum wages in California today?In this report we compare the effects of $10 (AB10) and $13 (SB935) minimum wage levels in California. We show that AB10 restores some of the ground lost by low-paid workers in recent years, but it maintains the inflation-adjusted minimum wage at about the same level as in 1988. The Leno bill, SB935, goes much further, raising the real minimum wage to just above the peak value obtained in 1968. Between 2014 and 2017, the aggregate increase in earnings accrued by affected workers will total about $8.2 billion for the $10 minimum wage bill and $22.5 billion for the $13 minimum wage proposal. We also analyze the effects of each minimum wage scenario on California’s businesses and on California’s state budget.We find that California’s businesses are likely to absorb the increased labor costs of either minimum wage largely with offsets from increased worker productivity, from declines in recruitment and retention costs, and with small price increases in the restaurant industry (the industry most affected by minimum wage increases).Unlike previous minimum wage impact studies, we pay particular attention to the effects of each minimum wage proposal on the state’s budget. Increased wage income will generate substantial income andsales tax revenue for California during 2014-17: approximately $444 million under AB10 and $2.62 billion under SB935. On the spending side, Medi-Cal costs will fall by about $562 million under AB10 and $1.54 billion under SB935, while increased wage costs for state-supported home care workers and developmentally disabled service workers will total about $400 million (AB10) and $2.04 billion (SB935). Increased revenues less increased outlays will total about $585 million (AB10) and $2.15 billion (SB935).The report proceeds as follows. In Section 1 we document trends in the distribution of wages in California since 1979, present the history of the state’s minimum wage, and illustrate its importance to the state’s lowest-paid workers. In Section 2 we discuss the effects of AB10 and the proposed SB935 on workers in the state, and analyze each proposal’s impact by demographic group and family status. Section 3 examines the cost impacts on businesses and discusses how businesses are likely to absorb these costs. Section 4 discusses how each of the two minimum wage paths will affect the state’s economy and the state’s budget. Here we address state tax revenue increases, savings in state Medicaid costs, and increased wage costs to California for developmentally disabled and in-home care support service workers. Section 5 concludes.

Published
2014

37. Prognostic Value of the Modified Rutgeerts Score for Long-Term Outcomes After Primary Ileocecal Resection in Crohn's Disease.

Author

Bak, Michiel T. J., ten Bokkel Huinink, Sebastiaan, Erler, Nicole S., Bodelier, Alexander G. L., Dijkstra, Gerard, Romberg-Camps, Mariëelle, de Boer, Nanne K. H., Hoentjen, Frank, Stassen, Laurents P. S., van der Meulen-de Jong, Andrea E., West, Rachel L., van Ruler, Oddeke, van der Woude, C. Janneke, and de Vries, Annemarie C.

Published
2024
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38. Impact of timing of primary ileocecal resection on prognosis in patients with Crohn’s disease

Author

Beelen, Evelien M J, primary, Arkenbosch, Jeanine H C, additional, Erler, Nicole S, additional, Sleutjes, Jasmijn A M, additional, Hoentjen, Frank, additional, Bodelier, Alexander G L, additional, Dijkstra, Gerard, additional, Romberg-Camps, Marielle, additional, de Boer, Nanne K, additional, Stassen, Laurents P S, additional, van der Meulen, Andrea E, additional, West, Rachel, additional, van Ruler, Oddeke, additional, van der Woude, C Janneke, additional, and de Vries, Annemarie C, additional

Published
2023
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39. P1068: UPDATED RESULTS FROM AN OPEN-LABEL PHASE 1/2 STUDY OF FAVEZELIMAB IN COMBINATION WITH PEMBROLIZUMAB IN PATIENTS WITH RELAPSED OR REFRACTORY CLASSICAL HODGKIN LYMPHOMA AFTER ANTI–PD-1 TREATMENT

Author

Timmerman, John, primary, Lavie, David, additional, Johnson, Nathalie, additional, Avigdor, Abraham, additional, Borchmann, Peter, additional, Andreadis, Charalambos, additional, Bazargan, Ali, additional, Gregory, Gareth, additional, Keane, Colm, additional, Tzoran, Inna, additional, Vucinic, Vladan, additional, Luigi Zinzani, Pier, additional, Marceau West, Rachel, additional, Pillai, Pallavi, additional, Marinello, Patricia, additional, and Herrera, Alex F., additional

Published
2023
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40. P1065: UPDATED RESULTS FROM AN OPEN-LABEL PHASE 1/2 STUDY OF FAVEZELIMAB IN COMBINATION WITH PEMBROLIZUMAB IN PATIENTS WITH ANTI–PD-1–NAIVE RELAPSED OR REFRACTORY CLASSICAL HODGKIN LYMPHOMA

Author

Johnson, Nathalie, primary, Lavie, David, additional, Borchmann, Peter, additional, Gregory, Gareth, additional, Herrera, Alex F., additional, Minuk, Leonard, additional, Vucinic, Vladan, additional, Armand, Philippe, additional, Avigdor, Abraham, additional, Gasiorowski, Robin, additional, Herishanu, Yair, additional, Keane, Colm, additional, Kuruvilla, John, additional, Marceau West, Rachel, additional, Pillai, Pallavi, additional, Marinello, Patricia, additional, and Timmerman, John, additional

Published
2023
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41. Laparoscopic ileocaecal resection versus infliximab for terminal ileitis in Crohn's disease: a randomised controlled, open-label, multicentre trial

Author

Bruin, Karlien, Maring, John, van Ditzhuijsen, Theo, Prins, Hubert, van den Brande, Jan, Kingma, Paul, van Geloven, Anna, de Boer, Nanne, van der Peet, Donald, Jansen, Jeroen, Gerhards, Michael, van der Woude, Janneke, Schouten, Ruud, Oldenburg, Bas, van Hillegersberg, Richard, West, Rachel, Mannaerts, Guido, Spanier, Marcel, Spillenaar Bilgen, Ernst Jan, Lieverse, Rob, van der Zaag, Edwin, Depla, Annekatrien, van de Laar, Arnold, Bolwerk, Clemens, Brouwer, Hans, Mahmmod, Nofel, Hazebroek, Eric, Vecht, Juda, Pierik, Robert, Dijkstra, Gerard, Hofker, Sijbrand, Uiterwaal, Tessa, Eijsbouts, Quirijn, Oostenbrug, Liekele, Sosef, Meindert, Cahen, Djuna, van der Werff, Sjoerd, Marinelli, Andreas, Peters, Job, Cense, Huib, Talstra, Nynke, Morar, Pritesh, Ponsioen, Cyriel Y, de Groof, E Joline, Eshuis, Emma J, Gardenbroek, Tjibbe J, Bossuyt, Patrick M M, Hart, Ailsa, Warusavitarne, Janindra, Buskens, Christianne J, van Bodegraven, Ad A, Brink, Menno A, Consten, Esther C J, van Wagensveld, Bart A, Rijk, Marno C M, Crolla, Rogier M P H, Noomen, Casper G, Houdijk, Alexander P J, Mallant, Rosalie C, Boom, Maarten, Marsman, Willem A, Stockmann, Hein B, Mol, Bregje, de Groof, A Jeroen, Stokkers, Pieter C, D'Haens, Geert R, and Bemelman, Willem A

Published
2017
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42. Social and economic policy interventions to address household food insecurity in high-income countries (HIC) and the developing nations of Brazil, Russia, India, China and South Africa (BRICS)

Author

Lindberg, Rebecca, additional, Wingrove, Kate, additional, Bastian, Amber, additional, West, Rachel, additional, Caraher, Martin, additional, Mchiza, Zandile JR, additional, Furey, Sinead, additional, Owen, Patrick J, additional, and McNaughton, Sarah, additional

Published
2023
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43. Cost-Effectiveness Analysis of Increased Adalimumab Dose Intervals in Crohn’s Disease Patients in Stable Remission: The Randomized Controlled LADI Trial

Author

Jansen, Fenna M, primary, van Linschoten, Reinier C A, additional, Kievit, Wietske, additional, Smits, Lisa J T, additional, Pauwels, Renske W M, additional, de Jong, Dirk J, additional, de Vries, Annemarie C, additional, Boekema, Paul J, additional, West, Rachel L, additional, Bodelier, Alexander G L, additional, Gisbertz, Ingrid A M, additional, Wolfhagen, Frank H J, additional, Römkens, Tessa E H, additional, Lutgens, Maurice W M D, additional, van Bodegraven, Adriaan A, additional, Oldenburg, Bas, additional, Pierik, Marieke J, additional, Russel, Maurice G V M, additional, de Boer, Nanne K, additional, Mallant-Hent, Rosalie C, additional, ter Borg, Pieter C J, additional, van der Meulen-de Jong, Andrea E, additional, Jansen, Jeroen M, additional, Jansen, Sita V, additional, Tan, Adrianus C I T L, additional, Hoentjen, Frank, additional, and van der Woude, C Janneke, additional

Published
2023
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46. Mercaptopurine for the treatment of ulcerative colitis - a randomised placebo-controlled trial

Author

Löwenberg, Mark, primary, Volkers, Adriaan, additional, van Gennep, Sara, additional, Mookhoek, Aart, additional, Montazeri, Nahid, additional, Clasquin, Esmé, additional, Duijvestein, Marjolijn, additional, van Bodegraven, Adriaan, additional, Rietdijk, Svend, additional, Jansen, Jeroen, additional, van Asseldonk, Dirk, additional, van der Zanden, Esmerij, additional, Dijkgraaf, Marcel, additional, West, Rachel, additional, de Boer, Nanne, additional, and D’Haens, Geert, additional

Published
2023
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48. CastorEDC API:A Python Package for Managing Real World Data in Castor Electronic Data Capture

Author

Van Linschoten, Reinier Cornelis Anthonius, Knijnenburg, Sebastiaan Laurens, West, Rachel Louise, Noord, Desirée Van, Van Linschoten, Reinier Cornelis Anthonius, Knijnenburg, Sebastiaan Laurens, West, Rachel Louise, and Noord, Desirée Van

Abstract

Real world data is being used increasingly in medical research. Castor Electronic Data Capture is a secure and user-friendly platform for managing study data. Integrating data from several databases into a single Castor database is complex. We developed CastorEDC API, a free and open source Python package which can be used to interact with the API of Castor, and through which data can be imported from multiple sources into a Castor database. The importer reads, cleans, validates and imports data while accounting for differences in column structure and variable coding between databases.

Published
2023

49. Cost-Effectiveness Analysis of Increased Adalimumab Dose Intervals in Crohn's Disease Patients in Stable Remission:The Randomized Controlled LADI Trial

Author

Jansen, Fenna M., Van Linschoten, Reinier C.A., Kievit, Wietske, Smits, Lisa J.T., Pauwels, Renske W.M., De Jong, Dirk J., De Vries, Annemarie C., Boekema, Paul J., West, Rachel L., Bodelier, Alexander G.L., Gisbertz, Ingrid A.M., Wolfhagen, Frank H.J., Römkens, Tessa E.H., Lutgens, Maurice W.M.D., Van Bodegraven, Adriaan A., Oldenburg, Bas, Pierik, Marieke J., Russel, Maurice G.V.M., De Boer, Nanne K., Mallant-Hent, Rosalie C., Ter Borg, Pieter C.J., Van Der Meulen-De Jong, Andrea E., Jansen, Jeroen M., Jansen, Sita V., Tan, Adrianus C.I.T.L., Hoentjen, Frank, Van Der Woude, C. Janneke, Van Noord, Desirée, Hoekstra, Jildou, Kamphuis, Johannes T., Gorter, Moniek H.P., Van Esch, Aura A.J., Jansen, Fenna M., Van Linschoten, Reinier C.A., Kievit, Wietske, Smits, Lisa J.T., Pauwels, Renske W.M., De Jong, Dirk J., De Vries, Annemarie C., Boekema, Paul J., West, Rachel L., Bodelier, Alexander G.L., Gisbertz, Ingrid A.M., Wolfhagen, Frank H.J., Römkens, Tessa E.H., Lutgens, Maurice W.M.D., Van Bodegraven, Adriaan A., Oldenburg, Bas, Pierik, Marieke J., Russel, Maurice G.V.M., De Boer, Nanne K., Mallant-Hent, Rosalie C., Ter Borg, Pieter C.J., Van Der Meulen-De Jong, Andrea E., Jansen, Jeroen M., Jansen, Sita V., Tan, Adrianus C.I.T.L., Hoentjen, Frank, Van Der Woude, C. Janneke, Van Noord, Desirée, Hoekstra, Jildou, Kamphuis, Johannes T., Gorter, Moniek H.P., and Van Esch, Aura A.J.

Abstract

Background and Aims: We aimed to assess cost-effectiveness of increasing adalimumab dose intervals compared to the conventional dosing interval in patients with Crohn's disease [CD] in stable clinical and biochemical remission. Design: We conducted a pragmatic, open-label, randomized controlled non-inferiority trial, comparing increased adalimumab intervals with the 2-weekly interval in adult CD patients in clinical remission. Quality of life was measured with the EQ-5D-5L. Costs were measured from a societal perspective. Results are shown as differences and incremental net monetary benefit [iNMB] at relevant willingness to accept [WTA] levels. Results: We randomized 174 patients to the intervention [n=113] and control [n=61] groups. No difference was found in utility (difference: -0.017, 95% confidence interval [-0.044; 0.004]) and total costs (-€943, [-€2226; €1367]) over the 48-week study period between the two groups. Medication costs per patient were lower (-€2545, [-€2780; -€2192]) in the intervention group, but non-medication healthcare (+€474, [+€149; +€952]) and patient costs (+€365 [+€92; €1058]) were higher. Cost-utility analysis showed that the iNMB was €594 [-€2099; €2050], €69 [-€2908; €1965] and -€455 [-€4,096; €1984] at WTA levels of €20 000, €50 000 and €80 000, respectively. Increasing adalimumab dose intervals was more likely to be cost-effective at WTA levels below €53 960 per quality-adjusted life year. Above €53 960 continuing the conventional dose interval was more likely to be cost-effective. Conclusion: When the loss of a quality-adjusted life year is valued at less than €53 960, increasing the adalimumab dose interval is a cost-effective strategy in CD patients in stable clinical and biochemical remission. Clinical Trial Registration Number: ClinicalTrials.gov, number NCT03172377.

Published
2023

50. Impact of timing of primary ileocecal resection on prognosis in patients with Crohn's disease

Author

Beelen, Evelien M.J., Arkenbosch, Jeanine H.C., Erler, Nicole S., Sleutjes, Jasmijn A.M., Hoentjen, Frank, Bodelier, Alexander G.L., Dijkstra, Gerard, Romberg-Camps, Marielle, de Boer, Nanne K., Stassen, Laurents P.S., van der Meulen, Andrea E., West, Rachel, van Ruler, Oddeke, van der Woude, C. Janneke, de Vries, Annemarie C., Beelen, Evelien M.J., Arkenbosch, Jeanine H.C., Erler, Nicole S., Sleutjes, Jasmijn A.M., Hoentjen, Frank, Bodelier, Alexander G.L., Dijkstra, Gerard, Romberg-Camps, Marielle, de Boer, Nanne K., Stassen, Laurents P.S., van der Meulen, Andrea E., West, Rachel, van Ruler, Oddeke, van der Woude, C. Janneke, and de Vries, Annemarie C.

Abstract

BACKGROUND: The advantage of early ileocecal resection after Crohn's disease diagnosis is a matter of debate. This study aims to assess the timing of ileocecal resection on prognosis, after correction for possible confounders. METHODS: Patients with Crohn's disease with primary ileocecal resection between 2000 and 2019 were included in a retrospective multicentre cohort. The primary endpoint was endoscopic recurrence (Rutgeerts score ≥i2b) within 18 months. Secondary endpoints were escalation of inflammatory bowel disease medication within 18 months and re-resection during follow-up. The association between timing of ileocecal resection and these endpoints was investigated using multivariable proportional hazard models, corrected for covariates including Montreal classification, postoperative prophylaxis, smoking, indication for surgery, medication before ileocecal resection, perianal fistulas, surgical approach, histology, length of resected segment and calendar year. RESULTS:In 822 patients ileocecal resection was performed after a median of 3.1 years (i.q.r. 0.7-8.0) after Crohn's disease diagnosis. The lowest incidence of endoscopic recurrence, escalation of inflammatory bowel disease medication and re-resection was observed for patients undergoing ileocecal resection shortly after diagnosis (0-1 months). After correction for covariates, patients with ileocecal resection at 0, 4 and 12 months after diagnosis had a cumulative incidence of 35 per cent, 48 per cent and 39 per cent for endoscopic recurrence, 20 per cent, 29 per cent and 28 per cent for escalation of inflammatory bowel disease medication and 20 per cent, 30 per cent and 34 per cent for re-resection, respectively. In the multivariable model ileocolonic disease (HR 1.39 (95 per cent c.i. 1.05 to 1.86)), microscopic inflammation of proximal and distal resection margins (HR 2.20 (95 per cent c.i. 1.21 to 3.87)) and postoperative prophylactic biol

Published
2023

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