New methods for RWE collection and synthesis

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Research papers

  • Makady A, Kalf RRJ, Ryll B, Spurrier G, de Boer A, Hillege H, Klungel OH, Goettsch W. Social media as a tool for assessing patient perspectives on quality of life in metastatic melanoma: a feasibility study. Health Qual Life Outcomes. 2018 Nov 29. doi: 10.1186/s12955-018-1047-z. Abstract and full-text available through https://www.ncbi.nlm.nih.gov/pubmed/30497502
  • Martina R, Jenkins D, Bujkiewicz S, Dequen P, Abrams K. The inclusion of real world evidence in clinical development planning. Trials. 2018 August 29. doi: 10.1186/s13063-018-2769-2. Abstract and full-text available through https://www.ncbi.nlm.nih.gov/pubmed/30157904
  • Didden EM, Ruffieux Y, Hummel N, Efthimiou O, Reichenbach S, Gsteiger S, Finckh A, Flecther C, Salanti G, Egger M. Prediction of Real-World Drug Effectiveness Prelaunch: Case Study in Rheumatoid Arthritis. Medical Decision Making. 2018 August 3. doi: 10.1177/0272989X18775975. Abstract and full-text available through https://www.ncbi.nlm.nih.gov/pubmed/30074882
  • Karcher H, Fu S, Meng J, Ankarfeldt MZ, Efthimiou O, Belger M, Haro JM, Abenhaim L, Nordon C. The "RCT augmentation": a novel simulation method to add patient heterogeneity into phase III trials. BMC Medical Research Methodology. 2018 July 6. doi: 10.1186/s12874-018-0534-6. Abstract and full-text available through https://www.ncbi.nlm.nih.gov/pubmed/29980181#
  • Kalf RR, Makady A, Ten Ham RM, Meijboom K, Goettsch WG. Use of Social Media in the Assessment of Relative Effectiveness: Explorative Review With Examples From Oncology. JMIR Cancer. 2018 June 8. doi: 10.2196/cancer.7952. Abstract and full-text available through https://www.ncbi.nlm.nih.gov/pubmed/29884607
  • Nordon C, Constance B, Verdoux H, Haro JM, Belger M, Abenhaim L, Van Staa, T. The use of random-effects models to identify health care center-related characteristics modifying the effect of antipsychotic drugs. Clinical Epidemiology. 2017 November 14. Abstract and full-text available here.
  • Kilcher G, Hummel N, Didden EM, Egger M, Reichenbach S. Rheumatoid arthritis patients treated in trial and real world settings: comparison of randomized trials with registries. Rheumatology. 2017 November 14. doi: 10.1093/rheumatology/kex394. [Epub ahead of print]. Abstract and full-text available through https://www.ncbi.nlm.nih.gov/pubmed/29149289
  • Makady A, Stegenga H, Antonio C, Debray TPA, Lees M, Happich M, Ryll B, Abrams K, Thwaites R, Garner S, Jonsson P, Goettsch W. Practical Implications of Using Real-World Evidence (RWE) in Comparative Effectiveness Research: Learnings from IMI-GetReal. Future Medicine. 2017 September 6. doi: 10.2217/cer-2017-0044. Abstract and full-text available through https://www.ncbi.nlm.nih.gov/pubmed/28857631
  • Makady A, de Boer A, Hillege H, Klungel O, Goettsch W. What is Real-World Data? A Review of Definitions Basedon Literature and Stakeholder Interviews. Value in Health. 2017 July-August. 10.1016/j.jval.2017.03.008. Abstract and full-text available through https://www.ncbi.nlm.nih.gov/pubmed/28712614
  • Meinecke AK, Welsing P, Kafatos G, Burke D, Trelle S, Kubin M, Nachbaur G, Egger M, Zuidgeest M. Data collection in pragmatic trials. Journal of Clinical Epidemiology. 2017 July 14 [Epub ahead of print]. 10.1016/j.jclinepi.2017.07.003. Abstract and full-text available through https://www.ncbi.nlm.nih.gov/pubmed/28716504
  • Nordon C, Bovagnet T, Belger M, Jimenez J, Olivares R. Chevrou-Severac H, Verdoux H, Haro JM, Abenhaim L, Karcher H. Trial exclusion criteria and their impact on the estimation of antipsychotic drugs effect: A case study using the SOHO database. Schizophrenia Research. 2017 July 13 [Epub ahead of print]. doi: 10.1016/j.schres.2017.07.031. Abstract and full-text available through https://www.ncbi.nlm.nih.gov/pubmed/28712965
  • Zuidgeest M, Welsing PMJ, van Thiel GJMW, Ciaglia A, Alfonso-Cristancho R, Eckert L, Eijkemans MJC, Egger M. Pragmatic trials: defining questions, choosing comparators, allocating treatments. Journal of Clinical Epidemiology. 2017 July 8 [Epub ahead of print]. doi: 10.1016/j.jclinepi.2017.07.001. Abstract and full-text available through https://www.ncbi.nlm.nih.gov/pubmed/28694123
  • Zuidgeest M, Goetz I, Groenwold R, Irving E, van Thiel G, Grobbee DE. Pragmatic trials and real world evidence - an introduction to the series. Journal of Clinical Epidemiology. 2017 May 24 [Epub ahead of print]. doi: 10.1016/j.jclinepi.2016.12.023. Abstract and full-text available through https://www.ncbi.nlm.nih.gov/pubmed/28549929
  • Worsley SD, Oude Rengerink K, Irving E, Lejeune S, Mol K, Collier S, Groenwold RHH, Enters-Weijnen C, Egger M, Rhodes T. Challenges in Pragmatic Trials: Selection and Inclusion of Usual Care Sites. Journal of Clinical Epidemiology. 2017 May 11 [Epub ahead of print]. doi: 10.1016/j.jclinepi.2017.05.003. Abstract and full-text available through https://www.ncbi.nlm.nih.gov/pubmed/28502811
  • Oude Rengerink K, Kalkman S, Collier S, Ciaglia A, Worsley SD, Lightbourne A, Eckert L, Groenwold RHH, Grobbee DE, Irving EA. Participant eligibility, recruitment and retention in pragmatic trials. Journal of Clinical Epidemiology. 2017 May 11 [Epub ahead of print]. doi: 10.1016/j.jclinepi.2016.12.021. Abstract and full-text available through https://www.ncbi.nlm.nih.gov/pubmed/28502808
  • Kalkman S, van Thiel GJMW, Zuidgeest MGP, Goetz I, Pfeiffer BM, Grobbbee DE, van Delden JM. Challenges of informed consent for pragmatic trials. Journal of Clinical Epidemiology. 2017 May 11 [Epub ahead of print]. doi: 10.1016/j.jclinepi.2017.03.019 Abstract and full-text available through https://www.ncbi.nlm.nih.gov/pubmed/28502809
  • Welsing P, Oude Rengerink K, Collier S, Eckert L, van Smeden M, Ciaglia A, Nachbaur G, Trelle S, Taylor A, Egger M, Goetz I. Outcome Selection and Measurement in Pragmatic Trials. Journal of Clinical Epidemiology. 2017 May 11 [Epub ahead of print]. doi: 10.1016/j.jclinepi.2016.12.022. Abstract and full-text available through https://www.ncbi.nlm.nih.gov/pubmed/28502810
  • Irving E, van den Bor R, Welsing P, Walsh V, Alfonso-Cristancho R, Harvey C, Garman N, Grobbee DE. Collecting and Reporting Safety Data and Monitoring Trial Conduct In Pragmatic Trials. Journal of Clinical Epidemiology. 2017 May 11 [Epub ahead of print]. doi: 10.1016/j.jclinepi.2017.05.004. Abstract and full-text available through https://www.ncbi.nlm.nih.gov/pubmed/28502812
  • Makady A, Ham RT, de Boer A, Hillege H, Klungel O, Goettsch W. Policies for Use of Real-World Data in Health Technology Assessment (HTA): A Comparative Study of Six HTA Agencies. Value in Health. 2017 April. doi: 10.1016/j.jval.2016.12.003. Abstract and full-text available through https://www.ncbi.nlm.nih.gov/pubmed/28407993
  • Kalkman S, van Thiel G, van der Graaf R, Zuidgeest M, Goetz I, Grobbee D, van Delden J. The Social Value of Pragmatic Trials. Bioethics. 2017 February. doi: 10.1111/bioe.12315. Abstract and full-text available through https://www.ncbi.nlm.nih.gov/pubmed/28060433
  • Candlish J, Pate A, Sperrin M, van Staa T. Evaluation of biases present in the cohort multiple randomized controlled trial design: a simulation study. BMC Medical Research Methodology. 2017 January 31. doi: 10.1186/s12874-017-0295-7. Abstract and full-text available through https://www.ncbi.nlm.nih.gov/pubmed/28143408
  • Ankarfeldt MZ, Adalsteinsson E, Groenwold RHH, Ali MS, Klungel OH. A systematic literature review on the efficacy–effectiveness gap: comparison of randomized controlled trials and observational studies of glucose-lowering drugs. Clinical Epidemiology. 2017 January 23. doi: 10.2147/CLEP.S121991. Abstract and full-text available through https://www.ncbi.nlm.nih.gov/pubmed/28176959
  • Ankarfeldt MZ, Thorsted BL, Groenwold RHH, Adalsteinsson E, Ali MS, Klungel OH. Assessment of channeling bias among initiators of glucose-lowering drugs: A UK cohort study. Clinical Epidemiology. 2017 January 18. doi: 10.2147/CLEP.S124054. Abstract and full-text available through https://www.ncbi.nlm.nih.gov/pubmed/28176886
  • Efthimiou O, Mavridis D, Debray TP, Samara M, Belger M, Siontis GC, Leucht S, Salanti G. Combining randomized and non-randomized evidence in network meta-analysis. Statistics in Medicine. 2017 January 12. doi: 10.1002/sim.7223. Abstract and full-text available through https://www.ncbi.nlm.nih.gov/pubmed/28083901
  • Efthimiou O, Welton N, Samara M, Leucht S, Salanti G. A Markov model for longitudinal studies with incomplete dichotomous outcomes. Pharmaceutical Statistics. 2016 December 5. doi: 10.1002/pst.1794. Abstract and full-text available through https://www.ncbi.nlm.nih.gov/pubmed/27917593
  • Pate A, Candlish J, Sperrin M, Van Staa TP. Cohort Multiple Randomised Controlled Trials (cmRCT) design: efficient but biased? A simulation study to evaluate the feasibility of the Cluster cmRCT design. BMC Medical Research Methodology. 2016 August 26. doi: 10.1186/s12874-016-0208-1. Abstract and full-text available through  http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5000409/
  • Kalkman S, van Thiel GJ, Grobbee DE, Meinecke AK, Zuidgeest MG, van Delden JJ. Stakeholders' views on the ethical challenges of pragmatic trials investigating pharmaceutical drugs. Trials. 2016 August 22. doi: 10.1186/s13063-016-1546-3. Abstract and full-text available through http://www.ncbi.nlm.nih.gov/pubmed/27550379.
  • Panayidou K, Gsteiger S, Egger M, Kilcher G, Carreras M, Efthimiou O, Debray TP, Trelle S, Hummel N. GetReal in mathematical modelling: a review of studies predicting drug effectiveness in the real world. Research Synthesis Methods. 2016 August 16. doi: 10.1002/jrsm.1202. Abstract and full-text available through http://www.ncbi.nlm.nih.gov/pubmed/27529762
  • Debray TPA, Schuit E, Efthimiou O, Reitsma JB, Ioannidis JP, Salanti G, Moons KGM. An overview of methods for network meta-analysis using individual participant data: when do benefits arise? Statistical Methods in Medical Research. 2016 August 2. doi: 10.1177/0962280216660741. Abstract and full-text available through http://www.ncbi.nlm.nih.gov/pubmed/27487843.
  • Egger M, Moons KGM, Fletcher C. GetReal: from efficacy in clinical trials to relative effectiveness in the real world. Research Synthesis Methods. 2016 July 7. doi: 10.1002/jrsm.1207. Abstract and full-text available through https://www.ncbi.nlm.nih.gov/pubmed/27390256
  • Nieuwenhuis JB, Irving E, Oude Rengerink K, Lloyd E, Goetz I, Grobbee DE, Stolk P, Groenworld RH, Zuidgeest MG. Pragmatic trial design elements showed a different impact on trial interpretation and feasability than explanatory elements. Journal of Clinical Epidemiology. 2016 May 7. doi: 10.1016/j.jclinepi.2016.04.010. Abstract and full-text available through http://www.ncbi.nlm.nih.gov/pubmed/27164273.
  • Zuidgeest MG, Goetz I, Grobbee DE. PRECIS-2 in perspective: what's next for pragmatic trials? Journal of Clinical Epidemiology. 2016 Feb 29. doi.org/10.1016/j.jclinepi.2016.02.027. Full-text available through https://www.ncbi.nlm.nih.gov/pubmed/26960164

  • Efthimiou O, Debray TPA, Van Valkenhoef G, Trelle S, Panayidou K, Moons KGM, Reitsma JB, Shang A, Salanti G. GetReal in network meta-analysis: a review of the methodology. Research Synthesis Methods. 2016 Jan 11. doi: 10.1002/jrsm.1195. Abstract and full-text available through http://www.ncbi.nlm.nih.gov/pubmed/26754852.
  • Nordon C, Karcher H, Groenwold RHH, Ankarfeldt MZ, Pichler F, Chevrou-Severac H, Rossignol M, Abbe A, Abenhaim L. The “Efficacy-Effectiveness Gap”: Historical Background and Current Conceptualization. Value in Health. 2015 Nov 19. doi: 10.1016/j.jval.2015.09.2938. Abstract and full-text available through https://www.ncbi.nlm.nih.gov/pubmed/27201991.
  • Schmidt AF, Klungel OH, Groenwold RHH. Adjusting for Confounding in Early Postlaunch Settings: Going Beyond Logistic Regression Models. Epidemiology. 2015 Oct 1. doi: 10.1097/EDE.0000000000000388. Abstract and full-text available through http://www.ncbi.nlm.nih.gov/pubmed/26436519.

  • Debray TPA, Moons KGM, van Valkenhoef G, Efthimiou O, Hummel N, Groenwold RHH, Reitsma JB. Get real in individual participant data (IPD) meta-analysis: a review of the methodology. Research Synthesis Methods. 2015 Aug 19. doi: 10.1002/jrsm.1160. Abstract and full-text available through http://www.ncbi.nlm.nih.gov/pubmed/26287812.
  • Kalkman S, van Thiel GJ, Grobbee DE, van Delden JJ. Pragmatic randomized trials in drug development pose new ethical questions: a systematic review. Drug Discovery Today. 2015 Mar 17. pii: S1359-6446(15)00113-0. doi: 10.1016/j.drudis.2015.03.005. Abstract and full-text available through http://www.ncbi.nlm.nih.gov/pubmed/25794600.