Randomised control trial
T. Ripolles, M. Agramunt, J. Errando, M.J. Martinez, B. Coronel, M. Moralessuspected ureteral colic: plain film and sonography vs unenhanced helical CT. A prospective study in 66 patients.
European Radiology
2004;14:129-136
- 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. the first sentence of the abstract states the aim of the study.
2
Design
2.1
Is the study design suitable for the objectives
yes. A RCT is the best way to compare the 2 modes of imaging
2.2
Who / what was studied?
66 patients with acute flank pain presenting to the ED over a 4 month period
2.3
Was this the right sample to answer the objectives?
yes. all the patients had presenting symptoms suggestive of ureteral calculi.
2.4
Is the study large enough to achieve its objectives? Have sample size estimates been performed?
sample size estimates are not mentioned.
2.5
Were all subjects accounted for?
yes. 10 patients out of the 66 had no evidence of ureteral stone so were excluded leaving 56 patients in the study. no patients were lost to follow up
2.6
Were all appropriate outcomes considered?
yes
2.7
Has ethical approval been obtained if appropriate?
not stated
2.8
Were the patients randomised between treatments?
all patients underwent US and CT, there was no grouping of the patients into 1 modality or the other
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. the data analysis and results are clearly laid out and described
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 results were calculated by the observers separately and the interobserver agreement was calculated.
4
Presentation of results
4.1
Are the basic data adequately described?
yes. the basic findings are tabulated to accompany the description in text.
4.2
Were groups comparable at baseline?
yes. there were 46 men compared to 20 women. the age range of the group was 18-97 years. however, all patients presented with the same symptoms and underwent the same investigations.
4.3
Are the results presented clearly, objectively and in sufficient detail to enable readers to make their own judgement?
yes. the results are clear and easy to understand.
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?
yes. the results are given in the form of percenatge figures with related P values
5.2
Are the methods appropriate to the data?
yes
5.3
Are any statistics correctly performed and interpreted?
statistical analysis was performed using SPSS 9.0. the Chi-Squared test was done. K values are also given for interobserver agreement and intertechnique agreement.
6
Discussion
6.1
Are the results discussed in relation to existing knowledge on the subject and study objectives?
yes. findings of other studies are discussed in relation to the results found in this current study.
6.2
Is the discussion biased?
no. the authors accept the limitaions of their study.
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 had given me information which will help me decide which technique- US ot CT scan is better at detecting calculi.
8
Implementation
8.1
Can any necessary change be implemented in practice?
similar results are found using US+KUB than CT so CT could be reserved for patients with major colic or negative US.
8.2
What aids to implementation exist?
8.3
What barriers to implementation exist?
the availability of US and the experience of the radiologist on call.