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References

Biomedical statistics & clinical epidemiology
SPIRIT Statement

published in November - December 2014 - in Il Fisioterapista - issue n.6

There are no translations available.

Bibliografia

  1. Chan AW, Tetzlaff JM, Altman DG, et al. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med 2013; 158(3): 200-7.
  2. World Medical Association. World Medical Association Declaration of Helsinki. Ethical principles for medical research involving human subjects. Nurs Ethics 2002; 9(1): 105-9.
  3. Dwan K, Altman DG, Cresswell L, et al. Comparison of protocols and registry entries to published reports for randomised controlled trials. Cochrane Database Syst Rev 2011 Jan 19; (1): MR000031.
  4. Chan AW, Hróbjartsson A, Haahr MT, Gøtzsche PC, Altman DG. Empirical evidence for selective reporting of outcomes in randomized trials: comparison of protocols to published articles. JAMA 2004; 291(20): 2457-65.
  5. Scharf O, Colevas AD. Adverse event reporting in publications compared with sponsor database for cancer clinical trials. J Clin Oncol 2006; 24(24): 3933-8.
  6. Getz KA, Zuckerman R, Cropp AB, et al. Measuring the incidence, causes, and repercussions of protocol amendments. Drug Inf J 2011; 45: 265-75.
  7. Chan AW, Tetzlaff JM, Gøtzsche PC, et al. SPIRIT 2013 explanation and ela­boration: guidance for protocols of clinical trials. BMJ 2013; 346: e7586.

 
There are no translations available.