References
Biomedical statistics & clinical epidemiology
SPIRIT Statement
published in November - December 2014 - in Il Fisioterapista - issue n.6
There are no translations available.
Bibliografia
- 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.
- World Medical Association. World Medical Association Declaration of Helsinki. Ethical principles for medical research involving human subjects. Nurs Ethics 2002; 9(1): 105-9.
- 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.
- 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.
- 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.
- Getz KA, Zuckerman R, Cropp AB, et al. Measuring the incidence, causes, and repercussions of protocol amendments. Drug Inf J 2011; 45: 265-75.
- Chan AW, Tetzlaff JM, Gøtzsche PC, et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ 2013; 346: e7586.