EBN Corner - tebna.org.tw

1 EBN Corner : : : : : : ( ) 2014; Volume 1, 103 9 2014; Volume 1 1 2 4 : CONSORT 2010- 5 / : - 14 : - 21 Cochrane 16 : 18 : 20 / : 28 : 31 34 35 2014; Volume 1 2 Taiwan Evidence-based Nursing Association, TEBNA 2011 9 24 JBI 2012 2012 98 2013 11 29 30 15 7 122 (Taiwan Joanna Briggs Institute Collaborating Center,TJBCC)

2 2011 11 7~9 12 2012 11 12~14 55 2013 10 21~23 JBI 14 (Taormina) (International Society for Evidence-Based Health Care, ISEHC) 6 2014; Volume 1 3 2014; Volume 1 4 1992 1996 2001 2 2014 8 58 2011 9 24 (RCT)

3 CONSORT 2010 2012 3 2014; Volume 1 5 CONSORT 2010- / (PICO) (Level of evidence, level 1) (meta-analyses) (Randomized Control Trial, RCT) (level 2) ( 1965~2013 ) 1965 2 2013 998 CONSORT 2010 RCT RCT 1965~2013 RCT RCT Schulz, Altman, Moher 2010 1996 (Consolidated Standards of Reporting Trials Statement) JAMA (Begg et al.)

4 , 1996) (CONSORT Statement updated guidelines for reporting parallel group randomised 2014; Volume 1 6 trials) 2001 (Moher, Schulz, & Altman, 2001) 2010 (Schulz, Altman, & Moher, 2010) RCT 2010 CONSORT Annals of Internal Medicine, BMC Medicine Journal of Clinical Epidemiology CONSORT 2010 RCT randomised control trial 4 CONSORT CEPS 1 RCT (J ni, Altman, & Egger, 2001) CONSORT 2010 CONSORT 2010 Moher (2010) (checklist) (flow diagram) 25 ( ) 2010 / 1a 1b 2a 2b 3a ( ) 3b 4a 4b 5 6a 6b 7a 7b 8a 8b ( (block) ) 9 10 2014.

5 Volume 1 7 11a 11b 12a 12b 13a 13b 14a 14b 15 16 ( ) ( ) 17a ( 95 % ) 17b 18 19 20 21 ( ) 22 23 24 25 ( ) 25 : 1. 2. 3. (1) (parallel) (factorial experiment) (2) (superiority trial) (equivalence trial) (non-inferiority trial) (3) (4) 2014; Volume 1 8 4.

6 (external validity) 5. 5W1H 6. (primary) (secondary) 7. (Sample size) (Type I error, ) (Type II error, ) (Effect size) (allocation ratio) (dropout proportion) G-power Epi Info WinPepi PS (power and sample size calculation) SSize 8. (bias) (allocation sequence generation) 9. (allocation concealment) (detection bias) 10. 11. (blinding) ( ) (measurement bias) 12.

7 13. 2010 ( ) (intention-to-treat analysis, ITT) CONSORT ( ) CONSORT ( 2012) 2014; Volume 1 9 2010 Moher, D., et al. (2010). CONSORT 2010 Explanation and Elaboration: updated guidelines for reporting parallel group randomised trials. BMJ, 340, c869. doi: Wilson, A., et al. (2011). The impact of enhanced cleaning within the intensive care unit on contamination of the near-patient environment with hospital pathogens: A randomized crossover study in critical care units in two hospitals. Critical Care Medicine, 39(4), 651-658. 2014; Volume 1 10 CONSORT 14. 15.

8 ( ) (stratified randomization) (homogeneous) 16.. (missing data) 17. RCT p effect size 95 % (relative risk) (relative risk reduction) (odds ratio) (absolute risk reduction) (number needed to treat, NNT) 18. ( 65 ) (false-positive findings) 19. (adverse effect) RCT 2004 CONSORT for harms 2014; Volume 1 11 CONSORT for harms (Hodkinson, Kirkham, Tudur-Smith, & Gamble, 2013) 20. 21.

9 ( ) (External Validity) 22. 23. ( 2014) 24. 25. ( 2014) ( ) ( ) CONSORT (International Committee of Medical Journal Editors) (Turner,Shamseer,Altman,Schulz,& Moher,2012) (patient-reported outcomes,PRO) (Enhancing the Quality and Transparency of Health Research, EQUATOR) CONSORT PRO (CONSORT PRO extension)(Calvert,Blazeby,Altman,Revick i, Moher,& Brundage,2013) CONSORT 2010 RCT 600 CONSORT 2010 CONSORT (Turner et al.)

10 ,2012) 2014; Volume 1 12 .. (2010) CONSORT Statement 2010 21 408-418 (2014) 2013 57(4) 54-57 (2012) ( ) Begg, C., Cho, M., Eastwood, S., Horton, R., Moher, D., Olkin, I., & .. Stroup, D. (1996). Improving the quality of reporting of randomized controlled trials. The CONSORT statement. The Journal of the American Medical Association, 276(8), 637-639. Calvert, M., Blazeby, J., Altman, D., Revicki, D., Moher, D., & Brundage, M. (2013). Reporting of patient-reported outcomes in randomized trials: the CONSORT PRO extension. JAMA: The Journal Of The American Medical Association, 309(8), 814-822. Hodkinson, A., Kirkham, J., Tudur-Smith, C., & Gamble, C. (2013). Reporting of harms data in RCTs: a systematic review of empirical assessments against the CONSORT harms extension.