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Efficacy gap between phase II and subsequent phase III studies in oncology.

Vreman RA, Belitser SV, Mota ATM, Hövels AM, Goettsch WG, Roes KCB, Leufkens HGM, Mantel-Teeuwisse AK.

Br J Clin Pharmacol. 2020 Feb 7. doi: 10.1111/bcp.14237. [Epub ahead of print]


Benefits and harms of high-dose haemodiafiltration versus high-flux haemodialysis: the comparison of high-dose haemodiafiltration with high-flux haemodialysis (CONVINCE) trial protocol.

Blankestijn PJ, Fischer KI, Barth C, Cromm K, Canaud B, Davenport A, Grobbee DE, Hegbrant J, Roes KC, Rose M, Strippoli GF, Vernooij RW, Woodward M, de Wit GA de, Bots ML.

BMJ Open. 2020 Feb 5;10(2):e033228. doi: 10.1136/bmjopen-2019-033228.


Recall and Outcome of Screen-detected Microcalcifications during 2 Decades of Mammography Screening in the Netherlands National Breast Screening Program.

Luiten JD, Voogd AC, Luiten EJT, Broeders MJM, Roes KCB, Tjan-Heijnen VCG, Duijm LEM.

Radiology. 2020 Mar;294(3):528-537. doi: 10.1148/radiol.2020191266. Epub 2020 Jan 28.


Safety of switching from vitamin K antagonist to non-vitamin K antagonist oral anticoagulant in frail elderly with atrial fibrillation: rationale and design of the FRAIL-AF randomised controlled trial.

Joosten LPT, van Doorn S, Hoes AW, Nierman MC, Wiersma NM, Koek HL, Hemels MEW, Huisman MV, Roes KC, van den Bor RM, Buding WF, Rutten FH, Geersing GJ.

BMJ Open. 2019 Dec 29;9(12):e032488. doi: 10.1136/bmjopen-2019-032488.


Beyond "Intent-to-treat" and "Per protocol": Improving assessment of treatment effects in clinical trials through the specification of an estimand.

Pétavy F, Guizzaro L, Dos Reis IA, Teerenstra S, Roes KCB.

Br J Clin Pharmacol. 2019 Dec 27. doi: 10.1111/bcp.14195. [Epub ahead of print]


Pragmatic rules for comparability of biological medicinal products.

van der Plas RM, Hoefnagel MHN, Hillege HL, Roes KCB.

Biologicals. 2020 Jan;63:97-100. doi: 10.1016/j.biologicals.2019.11.002. Epub 2019 Dec 11.


Goal attainment scaling as an outcome measure in rare disease trials: a conceptual proposal for validation.

Gaasterland CMW, van der Weide MCJ, Roes KCB, van der Lee JH.

BMC Med Res Methodol. 2019 Dec 4;19(1):227. doi: 10.1186/s12874-019-0866-x.


Study methodology in trauma care: towards question-based study designs.

Houwert RM, Beks RB, Dijkgraaf MGW, Roes KCB, Öner FC, Hietbrink F, Leenen LPH, Groenwold RHH.

Eur J Trauma Emerg Surg. 2019 Oct 29. doi: 10.1007/s00068-019-01248-5. [Epub ahead of print]


Critical design considerations for time-to-event endpoints in amyotrophic lateral sclerosis clinical trials.

van Eijk RPA, Nikolakopoulos S, Roes KCB, Middelkoop BM, Ferguson TA, Shaw PJ, Leigh PN, Al-Chalabi A, Eijkemans MJC, van den Berg LH.

J Neurol Neurosurg Psychiatry. 2019 Dec;90(12):1331-1337. doi: 10.1136/jnnp-2019-320998. Epub 2019 Jul 10.


Level of evidence for promising subgroup findings: The case of trends and multiple subgroups.

Tanniou J, Smid SC, van der Tweel I, Teerenstra S, Roes KCB.

Stat Med. 2019 Jun 30;38(14):2561-2572. doi: 10.1002/sim.8133. Epub 2019 Mar 13.


Randomized All-Comers Evaluation of a Permanent Polymer Zotarolimus-Eluting Stent Versus a Polymer-Free Amphilimus-Eluting Stent.

Rozemeijer R, Stein M, Voskuil M, van den Bor R, Frambach P, Pereira B, Koudstaal S, Leenders GE, Timmers L, Rittersma SZ, Kraaijeveld AO, Agostoni P, Roes KC, Doevendans PA, Stella PR; ReCre8 Study Investigators.

Circulation. 2019 Jan 2;139(1):67-77. doi: 10.1161/CIRCULATIONAHA.118.037707.


Applicability and added value of novel methods to improve drug development in rare diseases.

Mitroiu M, Oude Rengerink K, Pontes C, Sancho A, Vives R, Pesiou S, Fontanet JM, Torres F, Nikolakopoulos S, Pateras K, Rosenkranz G, Posch M, Urach S, Ristl R, Koch A, Loukia S, van der Lee JH, Roes KCB.

Orphanet J Rare Dis. 2018 Nov 12;13(1):200. doi: 10.1186/s13023-018-0925-0.


Recommendations for the design of small population clinical trials.

Day S, Jonker AH, Lau LPL, Hilgers RD, Irony I, Larsson K, Roes KC, Stallard N.

Orphanet J Rare Dis. 2018 Nov 6;13(1):195. doi: 10.1186/s13023-018-0931-2.


Multimodal nocturnal seizure detection in a residential care setting: A long-term prospective trial.

Arends J, Thijs RD, Gutter T, Ungureanu C, Cluitmans P, Van Dijk J, van Andel J, Tan F, de Weerd A, Vledder B, Hofstra W, Lazeron R, van Thiel G, Roes KCB, Leijten F; the Dutch Tele-Epilepsy Consortium.

Neurology. 2018 Nov 20;91(21):e2010-e2019. doi: 10.1212/WNL.0000000000006545. Epub 2018 Oct 24.


The POWER-tool: Recommendations for involving patient representatives in choosing relevant outcome measures during rare disease clinical trial design.

Gaasterland CMW, Jansen-van der Weide MC, Vroom E, Leeson-Beevers K, Kaatee M, Kaczmarek R, Bartels B, van der Pol WL, Roes KCB, van der Lee JH.

Health Policy. 2018 Dec;122(12):1287-1294. doi: 10.1016/j.healthpol.2018.09.011. Epub 2018 Sep 21.


Ethics in musculoskeletal regenerative medicine; guidance in choosing the appropriate comparator in clinical trials.

de Windt TS, Niemansburg SL, Vonk LA, van Delden JM, Roes KCB, Dhert WJA, Saris DBF, Bredenoord AL.

Osteoarthritis Cartilage. 2019 Jan;27(1):34-40. doi: 10.1016/j.joca.2018.08.022. Epub 2018 Sep 20.


Rare disease registries: potential applications towards impact on development of new drug treatments.

Jansen-van der Weide MC, Gaasterland CMW, Roes KCB, Pontes C, Vives R, Sancho A, Nikolakopoulos S, Vermeulen E, van der Lee JH.

Orphanet J Rare Dis. 2018 Sep 5;13(1):154. doi: 10.1186/s13023-018-0836-0.


Outlier classification performance of risk adjustment methods when profiling multiple providers.

Brakenhoff TB, Roes KCB, Moons KGM, Groenwold RHH.

BMC Med Res Methodol. 2018 Jun 15;18(1):54. doi: 10.1186/s12874-018-0510-1.


Interval estimation of the overall treatment effect in a meta-analysis of a few small studies with zero events.

Pateras K, Nikolakopoulos S, Mavridis D, Roes KCB.

Contemp Clin Trials Commun. 2018 Jan 9;9:98-107. doi: 10.1016/j.conctc.2017.11.012. eCollection 2018 Mar.


Predicting enrollment performance of investigational centers in phase III multi-center clinical trials.

van den Bor RM, Grobbee DE, Oosterman BJ, Vaessen PWJ, Roes KCB.

Contemp Clin Trials Commun. 2017 Jul 20;7:208-216. doi: 10.1016/j.conctc.2017.07.004. eCollection 2017 Sep.


Why was this transfusion given? Identifying clinical indications for blood transfusion in health care data.

van Hoeven LR, Kreuger AL, Roes KC, Kemper PF, Koffijberg H, Kranenburg FJ, Rondeel JM, Janssen MP.

Clin Epidemiol. 2018 Mar 29;10:353-362. doi: 10.2147/CLEP.S147142. eCollection 2018.


Towards an appropriate framework to facilitate responsible inclusion of pregnant women in drug development programs.

Roes KCB, van der Zande ISE, van Smeden M, van der Graaf R.

Trials. 2018 Feb 20;19(1):123. doi: 10.1186/s13063-018-2495-9.


Dynamic borrowing through empirical power priors that control type I error.

Nikolakopoulos S, van der Tweel I, Roes KCB.

Biometrics. 2018 Sep;74(3):874-880. doi: 10.1111/biom.12835. Epub 2017 Dec 11.


European regulatory use and impact of subgroup evaluation in marketing authorisation applications.

Tanniou J, Teerenstra S, Hassan S, Elferink A, van der Tweel I, Gispen-de Wied C, Roes KCB.

Drug Discov Today. 2017 Dec;22(12):1760-1764. doi: 10.1016/j.drudis.2017.09.012. Epub 2017 Sep 21.


Validation of multisource electronic health record data: an application to blood transfusion data.

Hoeven LRV, Bruijne MC, Kemper PF, Koopman MMW, Rondeel JMM, Leyte A, Koffijberg H, Janssen MP, Roes KCB.

BMC Med Inform Decis Mak. 2017 Jul 14;17(1):107. doi: 10.1186/s12911-017-0504-7.


Estimates of subgroup treatment effects in overall nonsignificant trials: To what extent should we believe in them?

Tanniou J, van der Tweel I, Teerenstra S, Roes KCB.

Pharm Stat. 2017 Jul;16(4):280-295. doi: 10.1002/pst.1810. Epub 2017 May 15.


A computationally simple central monitoring procedure, effectively applied to empirical trial data with known fraud.

van den Bor RM, Vaessen PWJ, Oosterman BJ, Zuithoff NPA, Grobbee DE, Roes KCB.

J Clin Epidemiol. 2017 Jul;87:59-69. doi: 10.1016/j.jclinepi.2017.03.018. Epub 2017 Apr 12.


Meta-analysis approach as a gene selection method in class prediction: does it improve model performance? A case study in acute myeloid leukemia.

Novianti PW, Jong VL, Roes KC, Eijkemans MJ.

BMC Bioinformatics. 2017 Apr 11;18(1):210. doi: 10.1186/s12859-017-1619-7.


Level of Digitization in Dutch Hospitals and the Lengths of Stay of Patients with Colorectal Cancer.

van Poelgeest R, van Groningen JT, Daniels JH, Roes KC, Wiggers T, Wouters MW, Schrijvers G.

J Med Syst. 2017 May;41(5):84. doi: 10.1007/s10916-017-0734-3. Epub 2017 Apr 8.


Use of quality indicators by obstetric caregivers in the Netherlands: A descriptive study.

Cellissen E, Franx A, Roes KCB.

Eur J Obstet Gynecol Reprod Biol. 2017 Apr;211:177-181. doi: 10.1016/j.ejogrb.2017.02.016. Epub 2017 Feb 28.


Sequential designs with small samples: Evaluation and recommendations for normal responses.

Nikolakopoulos S, Roes KC, van der Tweel I.

Stat Methods Med Res. 2018 Apr;27(4):1115-1127. doi: 10.1177/0962280216653778. Epub 2016 Jun 24.


Methods to control for unmeasured confounding in pharmacoepidemiology: an overview.

Uddin MJ, Groenwold RH, Ali MS, de Boer A, Roes KC, Chowdhury MA, Klungel OH.

Int J Clin Pharm. 2016 Jun;38(3):714-23. doi: 10.1007/s11096-016-0299-0. Epub 2016 Apr 18. Review.


Evaluating different physician's prescribing preference based instrumental variables in two primary care databases: a study of inhaled long-acting beta2-agonist use and the risk of myocardial infarction.

Uddin MJ, Groenwold RH, de Boer A, Afonso AS, Primatesta P, Becker C, Belitser SV, Hoes AW, Roes KC, Klungel OH.

Pharmacoepidemiol Drug Saf. 2016 Mar;25 Suppl 1:132-41. doi: 10.1002/pds.3860.


Instrumental variables analysis using multiple databases: an example of antidepressant use and risk of hip fracture.

Uddin MJ, Groenwold RH, de Boer A, Gardarsdottir H, Martin E, Candore G, Belitser SV, Hoes AW, Roes KC, Klungel OH.

Pharmacoepidemiol Drug Saf. 2016 Mar;25 Suppl 1:122-31. doi: 10.1002/pds.3863.


Methodological comparison of marginal structural model, time-varying Cox regression, and propensity score methods: the example of antidepressant use and the risk of hip fracture.

Ali MS, Groenwold RH, Belitser SV, Souverein PC, Martín E, Gatto NM, Huerta C, Gardarsdottir H, Roes KC, Hoes AW, de Boer A, Klungel OH.

Pharmacoepidemiol Drug Saf. 2016 Mar;25 Suppl 1:114-21. doi: 10.1002/pds.3864.


Case-only designs for studying the association of antidepressants and hip or femur fracture.

de Groot MC, Candore G, Uddin MJ, Souverein PC, Ali MS, Belitser SV, Huerta C, Groenwold RH, Alvarez Y, Slattery J, Korevaar J, Hoes AW, Roes KC, de Boer A, Douglas IJ, Schlienger RG, Reynolds R, Klungel OH, Gardarsdottir H.

Pharmacoepidemiol Drug Saf. 2016 Mar;25 Suppl 1:103-13. doi: 10.1002/pds.3850.


Subgroup analyses in confirmatory clinical trials: time to be specific about their purposes.

Tanniou J, van der Tweel I, Teerenstra S, Roes KC.

BMC Med Res Methodol. 2016 Feb 18;16:20. doi: 10.1186/s12874-016-0122-6. Review.


Selecting a classification function for class prediction with gene expression data.

Jong VL, Novianti PW, Roes KC, Eijkemans MJ.

Bioinformatics. 2016 Jun 15;32(12):1814-22. doi: 10.1093/bioinformatics/btw034. Epub 2016 Feb 11.


Efficient Source Data Verification Using Statistical Acceptance Sampling: A Simulation Study.

van den Bor RM, Oosterman BJ, Oostendorp MB, Grobbee DE, Roes KCB.

Ther Innov Regul Sci. 2016 Jan;50(1):82-90. doi: 10.1177/2168479015602042.


Aiming for a representative sample: Simulating random versus purposive strategies for hospital selection.

van Hoeven LR, Janssen MP, Roes KC, Koffijberg H.

BMC Med Res Methodol. 2015 Oct 23;15:90. doi: 10.1186/s12874-015-0089-8.


An Application of Sequential Meta-Analysis to Gene Expression Studies.

Novianti PW, van der Tweel I, Jong VL, Roes KC, Eijkemans MJ.

Cancer Inform. 2015 Sep 10;14(Suppl 5):1-10. doi: 10.4137/CIN.S27718. eCollection 2015.


Long-term Follow-up Assessing Renal Angiomyolipoma Treatment Patterns, Morbidity, and Mortality: An Observational Study in Tuberous Sclerosis Complex Patients in the Netherlands.

Eijkemans MJ, van der Wal W, Reijnders LJ, Roes KC, van Waalwijk van Doorn-Khosrovani SB, Pelletier C, Magestro M, Zonnenberg B.

Am J Kidney Dis. 2015 Oct;66(4):638-45. doi: 10.1053/j.ajkd.2015.05.016. Epub 2015 Jul 10.


Factors affecting the accuracy of a class prediction model in gene expression data.

Novianti PW, Jong VL, Roes KC, Eijkemans MJ.

BMC Bioinformatics. 2015 Jun 21;16:199. doi: 10.1186/s12859-015-0610-4.


MEDUCATE trial: effectiveness of an intensive EDUCATional intervention for IT-mediated MEDication management in the outpatient clinic - study protocol for a cluster randomized controlled trial.

van Stiphout F, Zwart-van Rijkom JE, Aarts JE, Koffijberg H, Klarenbeek-deJonge E, Krulder M, Roes KC, Egberts AC, ter Braak EW.

Trials. 2015 May 22;16:223. doi: 10.1186/s13063-015-0744-8.


Meta-analyses triggered by previous (false-)significant findings: problems and solutions.

Schuit E, Roes KC, Mol BW, Kwee A, Moons KG, Groenwold RH.

Syst Rev. 2015 Apr 25;4:57. doi: 10.1186/s13643-015-0048-9.


Exploring homogeneity of correlation structures of gene expression datasets within and between etiological disease categories.

Jong VL, Novianti PW, Roes KC, Eijkemans MJ.

Stat Appl Genet Mol Biol. 2014 Dec;13(6):717-32. doi: 10.1515/sagmb-2014-0003.


Reporting of covariate selection and balance assessment in propensity score analysis is suboptimal: a systematic review.

Ali MS, Groenwold RH, Belitser SV, Pestman WR, Hoes AW, Roes KC, Boer Ad, Klungel OH.

J Clin Epidemiol. 2015 Feb;68(2):112-21. doi: 10.1016/j.jclinepi.2014.08.011. Epub 2014 Nov 26. Review.


Performance of prior event rate ratio adjustment method in pharmacoepidemiology: a simulation study.

Uddin MJ, Groenwold RH, van Staa TP, de Boer A, Belitser SV, Hoes AW, Roes KC, Klungel OH.

Pharmacoepidemiol Drug Saf. 2015 May;24(5):468-77. doi: 10.1002/pds.3724. Epub 2014 Nov 20.


Quantitative falsification of instrumental variables assumption using balance measures.

Ali MS, Uddin MJ, Groenwold RH, Pestman WR, Belitser SV, Hoes AW, de Boer A, Roes KC, Klungel OH.

Epidemiology. 2014 Sep;25(5):770-2. doi: 10.1097/EDE.0000000000000152. No abstract available.


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