Randomised control trial
Das SK, Brow TD, Pepper J.Continuing controversy in the management of concomitant coronary and carotid disease: an overview.
Int J Cardiol
2000;74:47–65.
- Submitted by:shweta gidwani - clincal effectiveness fellow
- Institution:MRI
- Date submitted:23rd November 2004
1
Objectives and hypotheses
1.1
Are the objectives of the study clearly stated?
yes
2
Design
2.1
Is the study design suitable for the objectives
yes
2.2
Who / what was studied?
1)pain scores, 0-3 scale
2)time to best response
3)morphine dose per hour
2)time to best response
3)morphine dose per hour
2.3
Was this the right sample to answer the objectives?
yes
2.4
Is the study large enough to achieve its objectives? Have sample size estimates been performed?
power calculation was done to detect a 40% reduction in pain scores in those given a nerve block
2.5
Were all subjects accounted for?
yes
2.6
Were all appropriate outcomes considered?
yes
2.7
Has ethical approval been obtained if appropriate?
yes
2.8
Were the patients randomised between treatments?
yes
2.9
How was randomisation carried out?
method of randomization not mentioned
2.10
Are the outcomes clinically relevant?
yes
3
Measurement and observation
3.1
Is it clear what was measured, how it was measured and what the outcomes were?
yes
3.2
Are the measurements valid?
yes
3.3
Are the measurements reliable?
yes
3.4
Are the measurements reproducible?
no, assesment of pain is subjective
3.5
Were the patients and the investigators blinded?
patients - no
investigators - yes
investigators - yes
4
Presentation of results
4.1
Are the basic data adequately described?
no
4.2
Were groups comparable at baseline?
yes
4.3
Are the results presented clearly, objectively and in sufficient detail to enable readers to make their own judgement?
yes
4.4
Are the results internally consistent, i.e. do the numbers add up properly?
yes
4.5
Were side effects reported?
no
5
Analysis
5.1
Are the data suitable for analysis?
5.2
Are the methods appropriate to the data?
5.3
Are any statistics correctly performed and interpreted?
6
Discussion
6.1
Are the results discussed in relation to existing knowledge on the subject and study objectives?
yes
6.2
Is the discussion biased?
no
7
Interpretation
7.1
Are the authors' conclusions justified by the data?
yes
7.2
What level of evidence has this paper presented? (using CEBM levels)
7.3
Does this paper help me answer my problem?
yes
8
Implementation
8.1
Can any necessary change be implemented in practice?
femoral nerve blocks can be used instead of iv morphine in the ED setting
8.2
What aids to implementation exist?
easy technique
8.3
What barriers to implementation exist?
lack of training/ experience for junior doctors to carry out femoral nerve blocks