Survival biases lead to flawed conclusions in observational treatment studies of influenza patients

Journal of Clinical Epidemiology

Volumn 84, Issue , 2017, Pages 121-129

  Wolkewitz, Martin ^a   Schumacher, Martin ^a  

^a UNIVERSITY OF FREIBURG   (Germany)

Author keywords

Competing risk bias; Length bias; Neuraminidase inhibitors; Oseltamivir; Tamiflu; Time dependent bias

Indexed keywords

OSELTAMIVIR; ANTIVIRUS AGENT;

2009 H1N1 INFLUENZA; ANTIVIRAL THERAPY; ARTICLE; DEATH; HOSPITAL ADMISSION; HOSPITAL DISCHARGE; HOSPITAL MORTALITY; HUMAN; LENGTH OF STAY; MAJOR CLINICAL STUDY; OBSERVATIONAL STUDY; PANDEMIC INFLUENZA; PRIORITY JOURNAL; STATISTICAL BIAS; SURVIVAL; SURVIVAL BIAS; DRUG EFFECTS; EPIDEMIOLOGY; INFLUENZA A VIRUS (H1N1); INFLUENZA, HUMAN; MORTALITY; PROPORTIONAL HAZARDS MODEL; REPRODUCIBILITY; STATISTICS AND NUMERICAL DATA; SURVIVAL ANALYSIS; UNITED KINGDOM;

ANTIVIRAL AGENTS; BIAS (EPIDEMIOLOGY); HOSPITAL MORTALITY; HUMANS; INFLUENZA A VIRUS, H1N1 SUBTYPE; INFLUENZA, HUMAN; LENGTH OF STAY; OBSERVATIONAL STUDIES AS TOPIC; OSELTAMIVIR; PROPORTIONAL HAZARDS MODELS; REPRODUCIBILITY OF RESULTS; SURVIVAL ANALYSIS; UNITED KINGDOM;

EID: 85014224818     PISSN: 08954356     EISSN: 18785921     Source Type: Journal    
DOI: 10.1016/j.jclinepi.2017.01.008     Document Type: Article

References (36)

1. Chavalarias, D., Ioannidis, J.P., Science mapping analysis characterizes 235 biases in biomedical research. J Clin Epidemiol 63 (2010), 1205–1215.
2. Horton, N.J., Switzer, S.S., Statistical methods in the journal. N Engl J Med 353 (2005), 1977–1979.
3. Saracci, R., Survival-related biases survive well. Int J Epidemiol 36 (2007), 244–246.
4. van Walraven, C., Davis, D., Forster, A.J., Wells, G.A., Time-dependent bias was common in survival analyses published in leading clinical journals. J Clin Epidemiol 57 (2004), 672–682.
5. Beyersmann, J., Gastmeier, P., Wolkewitz, M., Schumacher, M., An easy mathematical proof showed that time-dependent bias inevitably leads to biased effect estimation. J Clin Epidemiol 61 (2008), 1216–1221.
6. Cnaan, A., Ryan, L., Survival analysis in natural history studies of disease. Stat Med 8 (1989), 1255–1268.
7. Wolkewitz, M., Allignol, A., Harbarth, S., de Angelis, G., Schumacher, M., Beyers- mann, J., Time-dependent study entries and exposures in cohort studies can easily be sources of different and avoidable types of bias. J Clin Epidemiol 65 (2012), 1171–1180.
8. Wolkewitz, M., Cooper, B.S., Bonten, M.J., Barnett, A.G., Schumacher, M., Interpreting and comparing risks in the presence of competing events. BMJ, 349, 2014, g5060.
9. Andersen, P.K., Geskus, R.B., de Witte, T., Putter, H., Competing risks in epidemiology: possibilities and pitfalls. Int J Epidemiol 41 (2012), 861–870.
10. van Walraven, C., McAlister, F.A., Competing risk bias was common in Kaplan-Meier risk estimates published in prominent medical journals. J Clin Epidemiol 69 (2016), 170–173.
11. Schumacher, M., Ohneberg, K., Beyersmann, J., Competing risk bias was common in a prominent medical journal. J Clin Epidemiol 80 (2016), 135–136.
12. Schumacher, M., Allignol, A., Beyersmann, J., Binder, N., Wolkewitz, M., Hospital- acquired infections: appropriate statistical treatment is urgently needed. Int J Epidemiol 42 (2013), 1502–1508.
13. Muthuri, S.G., Venkatesan, S., Myles, P.R., Leonardi-Bee, J., Al Khuwaitir, T.S., Al Mamun, A., et al. Effectiveness of neuraminidase inhibitors in reducing mortality in patients admitted to hospital with influenza A H1N1pdm09 virus infection: a meta-analysis of individual participant data. Lancet Respir Med 2:5 (2014), 395–404.
14. Jones, M., Del Mar, C., Hama, R., Statistical and methodological concerns about the beneficial effect of neuraminidase inhibitors on mortality. Lancet Respir Med 2:7 (2014), e9–e10.
15. Wolkewitz, M., Schumacher, M., Statistical and methodological concerns about the beneficial effect of neuraminidase inhibitors on mortality. Lancet Respir Med 2:7 (2014), 8–9.
16. Wolkewitz, M., Schumacher, M., Neuraminidase inhibitors and hospital mortality in British patients with H1N1 influenza A: a re-analysis of observational data. PLoS One, 11, 2016, e0160430.
17. Myles, P.R., Semple, M.G., Lim, W.S., Openshaw, P.J., Gadd, E.M., Read, R.C., et al. Predictors of clinical outcome in a national hospitalised cohort across both waves of the influenza A/H1N1 pandemic 2009–2010 in the UK. Thorax 67:8 (2012), 709–717.
18. Beyersmann, J., Allignol, A., Schumacher, M., Competing risks and multistate models with R. 2011, Springer, New York.
19. van Houwelingen, H.C., Putter, H., Dynamic prediction in clinical survival analysis. 2011, CRC Press, Boca Raton.
20. van Houwelingen, H.C., Putter, H., Dynamic predicting by landmarking as an alternative for multi-state modeling: an application to acute lymphoid leukemia data. Lifetime Data Anal 14:4 (2008), 447–463.
21. Cortese, G., Andersen, P.K., Competing risks and time-dependent covariates. Biom J 52:1 (2010), 138–158.
22. Fine, J., Gray, R.J., A proportional hazards model for the subdistribution of a competing risk. J Am Stat Assoc 94 (1999), 496–509.
23. Beyersmann, J., Gerds, T., Schumacher, M., Letter to the editor: comment on ‘Illustrating the impact of a time-varying covariate with an extended Kaplan-Meier estimator’ by Steven Snapinn, Qi Jiang, and Boris Iglewicz in the November 2005 issue of the American Statistician. Am Stat 60:30 (2006), 295–296.
24. Latouche, A., Allignol, A., Beyersmann, J., Labopin, M., Fine, J.P., A competing risks analysis should report results on all cause-specific hazards and cumulative incidence functions. J Clin Epidemiol 66 (2013), 648–653.
25. Jones, M., Mark Jones's reply to Myles and Leonardi-Bee's response to his critique of their paper reported in the BMJ. BMJ, 348, 2014, g3001.
26. Beyersmann, J., Kneib, T., Schumacher, M., Gastmeier, P., Nosocomial infection, length of stay, and time-dependent bias. Infect Control Hosp Epidemiol 30 (2009), 273–276.
27. Freemantle, N., Shallcross, L.J., Kyte, D., Rader, T., Calvert, M.J., Oseltamivir: the real world data. BMJ, 348, 2014, g2371.
28. Adisasmito, W., Chan, P.K., Lee, N., Oner, A.F., Gasimov, V., Aghayev, F., et al. Effectiveness of antiviral treatment in human influenza A(H5N1) infections: analysis of a Global Patient Registry. J Infect Dis 202 (2010), 1154–1160.
29. McGeer, A., Green, K.A., Plevneshi, A., Shigayeva, A., Siddiqi, N., Raboud, J., et al. Antiviral therapy and outcomes of influenza requiring hospitalization in Ontario, Canada. Clin Infect Dis 45 (2007), 1568–1575.
30. Liem, N.T., Tung, C.V., Hien, N.D., Hien, T.T., Chau, N.Q., Long, H.T., et al. Clinical features of human influenza A (H5N1) infection in Vietnam: 2004-2006. Clin Infect Dis 48 (2009), 1639–1646.
31. Jefferson, T., Jones, M., Doshi, P., Spencer, E.A., Onakpoya, I., Heneghan, C.J., Os- eltamivir for influenza in adults and children: systematic review of clinical study reports and summary of regulatory comments. BMJ, 348, 2014, g2545.
32. Heneghan, C.J., Onakpoya, I., Thompson, M., Spencer, E.A., Jones, M., Jefferson, T., Zanamivir for influenza in adults and children: systematic review of clinical study reports and summary of regulatory comments. BMJ, 348, 2014, g2547.
33. Dobson, J., Whitley, R.J., Pocock, S., Monto, A.S., Oseltamivir treatment for influenza in adults: a meta-analysis of randomised controlled trials. Lancet 385 (2015), 1729–1737.
34. EditorialNeuraminidase inhibitors for influenza: a call for better research. Lancet, 386, 2015, 1510.
35. Dunn, A.G., Zhou, X., Hudgins, J., Arachi, D., Mandl, K.D., Coiera, E., et al. Financial competing interests were associated with favorable conclusions and greater author productivity in nonsystematic reviews of neuraminidase inhibitors. J Clin Epidemiol 80 (2016), 43–49.
36. Zhou, X., Wang, Y., Tsafnat, G., Coiera, E., Bourgeois, F.T., Dunn, A.G., Citations alone were enough to predict favorable conclusions in reviews of neuraminidase inhibitors. J Clin Epidemiol 68 (2015), 87–93.