Practical Considerations and Challenges When Conducting an Individual Participant Data (IPD) Meta-Analysis

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Meta-Research

Part of the book series: Methods in Molecular Biology ((MIMB,volume 2345))

Abstract

This chapter provides a broad overview of the use of individual participant (sometimes referred to as patient) data (IPD ) within meta-analyses, the associated advantages of using IPD in meta-analysis compared to aggregate data, and when IPD should be used in meta-analysis.

This chapter also outlines the steps of conducting an IPD meta-analysis, with practical guidance relating to requesting and obtaining IPD for meta-analysis. Challenges that can be associated with conducting an IPD meta-analysis are also discussed, including consideration of availability bias, when a subset of the relevant IPD is not available for meta-analysis.

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References

  1. Lyman GH, Kuderer NM (2005) The strengths and limitations of meta-analyses based on aggregate data. BMC Med Res Methodol 5:14. https://doi.org/10.1186/1471-2288-5-14

    Article  PubMed  PubMed Central  Google Scholar 

  2. Jefferson T, Doshi P, Boutron I, Golder S, Heneghan C, Hodkinson A, Jones M, Lefebvre C, Stewart LA (2018) When to include clinical study reports and regulatory documents in systematic reviews. BMJ Evid Based Med 23(6):210–217. https://doi.org/10.1136/bmjebm-2018-110963

    Article  PubMed  Google Scholar 

  3. Ferran JM, Nevitt SJ (2019) European medicines agency policy 0070: an exploratory review of data utility in clinical study reports for academic research. BMC Med Res Methodol 19(1):204. https://doi.org/10.1186/s12874-019-0836-3

    Article  PubMed  PubMed Central  Google Scholar 

  4. Riley RD, Lambert PC, Abo-Zaid G (2010) Meta-analysis of individual participant data: rationale, conduct, and reporting. BMJ 340:c221. https://doi.org/10.1136/bmj.c221

    Article  PubMed  Google Scholar 

  5. Debray TP, Riley RD, Rovers MM, Reitsma JB, Moons KG (2015) Individual participant data (IPD) meta-analyses of diagnostic and prognostic modeling studies: guidance on their use. PLoS Med 12(10):e1001886. https://doi.org/10.1371/journal.pmed.1001886

    Article  PubMed  PubMed Central  Google Scholar 

  6. Simmonds MC, Higgins JP, Stewart LA, Tierney JF, Clarke MJ, Thompson SG (2005) Meta-analysis of individual patient data from randomized trials: a review of methods used in practice. Clin Trials 2(3):209–217. https://doi.org/10.1191/1740774505cn087oa

    Article  PubMed  Google Scholar 

  7. Stewart LA, Clarke MJ (1995) Practical methodology of meta-analyses (overviews) using updated individual patient data. Cochrane working group. Stat Med 14(19):2057–2079. https://doi.org/10.1002/sim.4780141902

    Article  CAS  PubMed  Google Scholar 

  8. Simmonds M, Stewart G, Stewart L (2015) A decade of individual participant data meta-analyses: A review of current practice. Contemp Clin Trials 45(Pt A):76–83. https://doi.org/10.1016/j.cct.2015.06.012

    Article  PubMed  Google Scholar 

  9. Stewart LA, Parmar MK (1993) Meta-analysis of the literature or of individual patient data: is there a difference? Lancet 341(8842):418–422. https://doi.org/10.1016/0140-6736(93)93004-k

    Article  CAS  PubMed  Google Scholar 

  10. Stewart LA, Tierney JF (2002) To IPD or not to IPD? Advantages and disadvantages of systematic reviews using individual patient data. Eval Health Prof 25(1):76–97. https://doi.org/10.1177/0163278702025001006

    Article  PubMed  Google Scholar 

  11. Altman DG, De Stavola BL, Love SB, Stepniewska KA (1995) Review of survival analyses published in cancer journals. Br J Cancer 72(2):511–518. https://doi.org/10.1038/bjc.1995.364

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  12. Parmar MK, Torri V, Stewart L (1998) Extracting summary statistics to perform meta-analyses of the published literature for survival endpoints. Stat Med 17(24):2815–2834. https://doi.org/10.1002/(sici)1097-0258(19981230)17:24<2815::aid-sim110>3.0.co;2-8

    Article  CAS  PubMed  Google Scholar 

  13. Stewart LA, Clarke M, Rovers M, Riley RD, Simmonds M, Stewart G, Tierney JF (2015) Preferred reporting items for systematic review and meta-analyses of individual participant data: the PRISMA-IPD statement. JAMA 313(16):1657–1665. https://doi.org/10.1001/jama.2015.3656

  14. Cochrane Methods IPD Meta-Analysis (2019) Frequently Asked Questions: How long does it take to do an IPD review? https://methods.cochrane.org/ipdma/frequently-asked-questions#9. Accessed 29 Jan 2020

  15. Tudur Smith C, Marcucci M, Nolan SJ, Iorio A, Sudell M, Riley R, Rovers MM, Williamson PR (2016) Individual participant data meta-analyses compared with meta-analyses based on aggregate data. Cochrane Database Syst Rev 9:Mr000007. https://doi.org/10.1002/14651858.MR000007.pub3

    Article  PubMed  Google Scholar 

  16. Oxford Clinical Trial Service Unit and Epidemiological Studies Unit (2019) EBCTCG: Early Breast Cancer Trialists’ Collaborative Group. https://www.ctsu.ox.ac.uk/research/ebctcg. Accessed 29 Jan 2020

  17. Nevitt SJ, Marson AG, Davie B, Reynolds S, Williams L, Smith CT (2017) Exploring changes over time and characteristics associated with data retrieval across individual participant data meta-analyses: systematic review. BMJ 357:j1390. https://doi.org/10.1136/bmj.j1390

    Article  PubMed  PubMed Central  Google Scholar 

  18. International Committee of Medical Journal Editors (2019) Recommendations for the conduct, Reporting, Editing and Publication of Scholarly Work in Medical Journals. http://www.ICMJE.org. Accessed 29 Jan 2020

  19. Taichman DB, Backus J, Baethge C, Bauchner H, de Leeuw PW, Drazen JM, Fletcher J, Frizelle FA, Groves T, Haileamlak A, James A, Laine C, Peiperl L, Pinborg A, Sahni P, Wu S (2016) Sharing clinical trial data: a proposal from the International Committee of Medical Journal Editors. JAMA 315(5):467–468. https://doi.org/10.1001/jama.2015.18164

    Article  CAS  PubMed  Google Scholar 

  20. Taichman DB, Sahni P, Pinborg A, Peiperl L, Laine C, James A, Hong ST, Haileamlak A, Gollogly L, Godlee F, Frizelle FA, Florenzano F, Drazen JM, Bauchner H, Baethge C, Backus J (2017) Data sharing statements for clinical trials: a requirement of the International Committee of Medical Journal Editors. JAMA 317(24):2491–2492. https://doi.org/10.1001/jama.2017.6514

    Article  PubMed  Google Scholar 

  21. Polanin JR, Terzian M (2019) A data-sharing agreement helps to increase researchers' willingness to share primary data: results from a randomized controlled trial. J Clin Epidemiol 106:60–69. https://doi.org/10.1016/j.jclinepi.2018.10.006

    Article  PubMed  Google Scholar 

  22. Nevitt SJ, Sudell M, Weston J, Tudur Smith C, Marson AG (2017) Antiepileptic drug monotherapy for epilepsy: a network meta-analysis of individual participant data. Cochrane Database Syst Rev 12:Cd011412. https://doi.org/10.1002/14651858.CD011412.pub3

    Article  PubMed  Google Scholar 

  23. Rathi V, Dzara K, Gross CP, Hrynaszkiewicz I, Joffe S, Krumholz HM, Strait KM, Ross JS (2012) Sharing of clinical trial data among trialists: a cross sectional survey. BMJ 345:e7570. https://doi.org/10.1136/bmj.e7570

    Article  PubMed  PubMed Central  Google Scholar 

  24. Rathi VK, Strait KM, Gross CP, Hrynaszkiewicz I, Joffe S, Krumholz HM, Dzara K, Ross JS (2014) Predictors of clinical trial data sharing: exploratory analysis of a cross-sectional survey. Trials 15:384. https://doi.org/10.1186/1745-6215-15-384

    Article  PubMed  PubMed Central  Google Scholar 

  25. Savage CJ, Vickers AJ (2009) Empirical study of data sharing by authors publishing in PLoS journals. PLoS One 4(9):e7078. https://doi.org/10.1371/journal.pone.0007078

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  26. Lo B (2015) Sharing clinical trial data: maximizing benefits, minimizing risk. JAMA 313(8):793–794. https://doi.org/10.1001/jama.2015.292

    Article  CAS  PubMed  Google Scholar 

  27. European Medicines Agency (2014) European medicines agency policy on publication of clinical data for medicinal products for human use (POLICY/0070). http://www.ema.europa.eu/docs/en_GB/document_library/Other/2014/10/WC500174796.pdf. Accessed 30 Jan 2020

  28. Zarin DA (2013) Participant-level data and the new frontier in trial transparency. N Engl J Med 369(5):468–469. https://doi.org/10.1056/NEJMe1307268

    Article  CAS  PubMed  Google Scholar 

  29. Ross JS, Lehman R, Gross CP (2012) The importance of clinical trial data sharing: toward more open science. Circ Cardiovasc Qual Outcomes 5(2):238–240. https://doi.org/10.1161/circoutcomes.112.965798

    Article  PubMed  PubMed Central  Google Scholar 

  30. Krumholz HM, Peterson ED (2014) Open access to clinical trials data. JAMA 312(10):1002–1003. https://doi.org/10.1001/jama.2014.9647

    Article  CAS  PubMed  Google Scholar 

  31. Tudur Smith C, Nevitt S, Appelbe D, Appleton R, Dixon P, Harrison J, Marson A, Williamson P, Tremain E (2017) Resource implications of preparing individual participant data from a clinical trial to share with external researchers. Trials 18(1):319. https://doi.org/10.1186/s13063-017-2067-4

    Article  PubMed  PubMed Central  Google Scholar 

  32. Nevitt SJ (2017) Data sharing and transparency: the impact on evidence synthesis. University of Liverpool, Liverpool

    Google Scholar 

  33. Veroniki AA, Ashoor HM, Le SPC, Rios P, Stewart LA, Clarke M, Mavridis D, Straus SE, Tricco AC (2019) Retrieval of individual patient data depended on study characteristics: a randomized controlled trial. J Clin Epidemiol 113:176–188. https://doi.org/10.1016/j.jclinepi.2019.05.031

    Article  PubMed  Google Scholar 

  34. Kovalchik SA (2012) Survey finds that most meta-analysts do not attempt to collect individual patient data. J Clin Epidemiol 65(12):1296–1299. https://doi.org/10.1016/j.jclinepi.2012.07.010

    Article  PubMed  PubMed Central  Google Scholar 

  35. Jaspers GJ, Degraeuwe PL (2014) A failed attempt to conduct an individual patient data meta-analysis. Syst Rev 3:97. https://doi.org/10.1186/2046-4053-3-97

    Article  PubMed  PubMed Central  Google Scholar 

  36. Vickers AJ (2006) Whose data set is it anyway? Sharing raw data from randomized trials. Trials 7:15. https://doi.org/10.1186/1745-6215-7-15

    Article  PubMed  PubMed Central  Google Scholar 

  37. Hrobjartsson A (2013) Why did it take 19 months to retrieve clinical trial data from a non-profit organisation? BMJ 347:f6927. https://doi.org/10.1136/bmj.f6927

    Article  PubMed  Google Scholar 

  38. Riley RD, Simmonds MC, Look MP (2007) Evidence synthesis combining individual patient data and aggregate data: a systematic review identified current practice and possible methods. J Clin Epidemiol 60(5):431–439. https://doi.org/10.1016/j.jclinepi.2006.09.009

    Article  PubMed  Google Scholar 

  39. Huang Y, Mao C, Yuan J, Yang Z, Di M, Tam WW, Tang J (2014) Distribution and epidemiological characteristics of published individual patient data meta-analyses. PLoS One 9(6):e100151. https://doi.org/10.1371/journal.pone.0100151

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  40. Ahmed I, Sutton AJ, Riley RD (2012) Assessment of publication bias, selection bias, and unavailable data in meta-analyses using individual participant data: a database survey. BMJ 344:d7762. https://doi.org/10.1136/bmj.d7762

    Article  PubMed  Google Scholar 

  41. Tsujimoto Y, Fujii T, Onishi A, Omae K, Luo Y, Imai H, Takahashi S, Itaya T, Pinson C, Nevitt SJ, Furukawa TA (2019) No consistent evidence of data availability bias existed in recent individual participant data meta-analyses: a meta-epidemiological study. J Clin Epidemiol 118:107–114.e5. https://doi.org/10.1016/j.jclinepi.2019.10.004

    Article  PubMed  Google Scholar 

  42. Riley RD, Lambert PC, Staessen JA, Wang J, Gueyffier F, Thijs L, Boutitie F (2008) Meta-analysis of continuous outcomes combining individual patient data and aggregate data. Stat Med 27(11):1870–1893. https://doi.org/10.1002/sim.3165

    Article  PubMed  Google Scholar 

  43. Riley RD, Steyerberg EW (2010) Meta-analysis of a binary outcome using individual participant data and aggregate data. Res Synth Methods 1(1):2–19. https://doi.org/10.1002/jrsm.4

    Article  PubMed  Google Scholar 

  44. Sutton AJ, Kendrick D, Coupland CA (2008) Meta-analysis of individual- and aggregate-level data. Stat Med 27(5):651–669. https://doi.org/10.1002/sim.2916

    Article  CAS  PubMed  Google Scholar 

  45. Egger M, Davey Smith G, Schneider M, Minder C (1997) Bias in meta-analysis detected by a simple, graphical test. BMJ 315(7109):629–634. https://doi.org/10.1136/bmj.315.7109.629

    Article  CAS  PubMed  PubMed Central  Google Scholar 

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Correspondence to Sarah J. Nevitt .

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Nevitt, S.J., Tudur Smith, C. (2022). Practical Considerations and Challenges When Conducting an Individual Participant Data (IPD) Meta-Analysis. In: Evangelou, E., Veroniki, A.A. (eds) Meta-Research. Methods in Molecular Biology, vol 2345. Humana, New York, NY. https://doi.org/10.1007/978-1-0716-1566-9_16

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  • DOI: https://doi.org/10.1007/978-1-0716-1566-9_16

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