Evaluation of Randomised Controlled Trials

Evaluation Of Randomised Controlled Trials

M.J.McKeown, MD, FACOG, FACS

Objective and Ethics

Outcome Measures

Interventions

Study Population And Sample Size

Checklist For Appraising Randomized Trials

Objective and Ethics

Objective:

What is it that makes the purpose of this study relevant?

Ethics:

Has the study satisfied all review boards for ethics?

Outcome Measures

The primary outcome measures should be:

1. easy to diagnose or observe

2. free of measurement errors or ascertainment errors

3. capable of being observed independent of treatment assignment

4. clinically relevant

5. chosen before the start of data collection

Interventions

The test and control treatment must be:

1. distinguishable from one another

2. medically justifiable

3. compatible with the health care needs of the subjects

4. acceptable to the patients and their care providers

5. there must be reasonable doubt about the efficacy of the treatment

6. it should be thought the benefits of the treatment will outweigh the risks

Study Population And Sample Size

Define the exclusion and inclusion criteria and how the subjects should be sampled.

Decide how many subjects will be needed in the trial

Checklist For Appraising Randomized Trials

1. Was the objective of the trial appropriately described?

2. Was a satisfactory statement given of the entry criteria to the trial.

3. Were concurrent controls used?

4. Were the treatments well defined?

5. Was random allocation to treatments used?

6. Was the potential degree of blindness used?

7. Was there a satisfactory description of outcome criteria?

8. Were the outcomes measured appropriate?

9. Was a pre-study calculation of sample size needed reported?

10. Was the duration of the post-treatment follow-up stated?

11. Were the treatment and control groups comparable?

12. Were a high proportion of the subjects followed up?

13. Were the drop-outs described by treatment and control groups?

14. Were the side-effects of treatment reported?

15. How were the ethical issues dealt with?

16. Was there a statement adequately describing the statistical procedures used?

17. What tests were used to compare the outcome in test and control patients?

18. Were 95% confidence intervals given for the main result?

19. Were additional analyses done to see whether baseline prognostic factors influenced the outcomes observed?

20. Were the conclusions drawn from the statistical analyses justified?

Source: www.cancerlynx.com


Missing Covariate Data w/in Cancer Prognostic Studies: Review

Br J Cancer, 6/04

Contradicted & Initially Stronger Effects in Highly Cited Res

JAMA, 6/05


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