Randomised control trial
S.O Henderson, R.J Hoffner, J.L Aragona, D.E Groth, V.I Esekogwu, D. Chanbedside emergency department ultrasonography plus radiography of the kidneys, ureter and bladder vs intravenous pyelography in the evaluation of suspected ureteral colic
Academic Emergeny Medicine
1998; 5:666-671
- Submitted by:sahdia choudry - 4th year medical student
- Institution:mri
- Date submitted:13th July 2005
1
Objectives and hypotheses
1.1
Are the objectives of the study clearly stated?
yes. there is a clear paragraph headed 'objective' in the abstract.
2
Design
2.1
Is the study design suitable for the objectives
yes. a RCT is the best study design to compare the 2 modes of imaging.
2.2
Who / what was studied?
all the consecutive patients presenting to the ED with unilateral flank pain and haematuria over a 8 month period.
2.3
Was this the right sample to answer the objectives?
yes. all the patients had presenting symptoms consistent with ureteric colic.
2.4
Is the study large enough to achieve its objectives? Have sample size estimates been performed?
out of 139 eligible patients, 108 were enrolled. this is a large number of patients and so a good sample size for the study. however, there is no mention of sample size estimated being done
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?
all patients gave informed consent prior to enrollment
2.8
Were the patients randomised between treatments?
all patients underwent US followed by IVU, there was no grouping of the patients to one modality or another.
2.9
How was randomisation carried out?
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. there is a clearly marked section headed 'measurements' describibg what was done and why.
3.2
Are the measurements valid?
yes
3.3
Are the measurements reliable?
yes
3.4
Are the measurements reproducible?
yes
3.5
Were the patients and the investigators blinded?
yes. the radiologists interpreting the films were blinded to the results found by the other modality.
4
Presentation of results
4.1
Are the basic data adequately described?
yes. the data is simplified and tabulated in table 1 as well as a text section
4.2
Were groups comparable at baseline?
yes. all patients in the study presented with the same symptoms and underwent the same imaging investigations.
4.3
Are the results presented clearly, objectively and in sufficient detail to enable readers to make their own judgement?
yes. the text is very clear with the relevent findings easy to read and to understand.
4.4
Are the results internally consistent, i.e. do the numbers add up properly?
yes
4.5
Were side effects reported?
non found
5
Analysis
5.1
Are the data suitable for analysis?
yes. results are presented as percentage figures with confidence intervals stated
5.2
Are the methods appropriate to the data?
yes
5.3
Are any statistics correctly performed and interpreted?
no additional statistical tests were done
6
Discussion
6.1
Are the results discussed in relation to existing knowledge on the subject and study objectives?
yes. findings and knowledge from other similar studies is discussed and compared with the findings of this current study.
6.2
Is the discussion biased?
no. the authors accept and discuss the limitations of the study and results from similar studies which challenge their fiindings.
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. it allows me to get a better idea of which modality, US or IVU is better at detecting calculi in the ED.
8
Implementation
8.1
Can any necessary change be implemented in practice?
US+KUB could well replace IVU for initial evaluation of patients with ureteral stones.
8.2
What aids to implementation exist?
an increasing number of emergency medicine training courses teaching necessary skills in ultrasonic performance and interpretation.
8.3
What barriers to implementation exist?
IVU is still considered the gold standard. Also US requires skill and time to perform