Randomised control trial
L. Dalla Palma, F. Stacul, M. Bazzocchi, L. Pagnan, G. Festini, D. MaregaUltrasonography and plain film versus intravenous urography in ureteric colic
Clinical Radiology
1993;47:333-336
- 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?
no. there is no aim/objectives section in the abstract or before the method section.
2
Design
2.1
Is the study design suitable for the objectives
yes. The group of patients underwent both US and IVU hence a comparison between the 2 could be made.
2.2
Who / what was studied?
180 patients presenting to the ED
2.3
Was this the right sample to answer the objectives?
yes. all the patients had symptoms suggestive of colic
2.4
Is the study large enough to achieve its objectives? Have sample size estimates been performed?
120 patients out of the 180 had both US and IVU, this is a large number compared to some similar studies however, no sample size estimates were performed.
2.5
Were all subjects accounted for?
yes
2.6
Were all appropriate outcomes considered?
15 patients passed a stone before IVU could be performed.
2.7
Has ethical approval been obtained if appropriate?
n/a
2.8
Were the patients randomised between treatments?
all patients underwent US and IVU. there was no spliting of the patients into groups asigned to one 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. tables 1-4 summarise the results to accompany the text
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
4
Presentation of results
4.1
Are the basic data adequately described?
yes. tables 1-4 summarise the findings clearly.
4.2
Were groups comparable at baseline?
it does not mention how many of the patients were male and how many were female. we also do not know the ages of the patients. however all the 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. relevent findings are simplified into tables to accompany the text.
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 presented as percentage figures
5.2
Are the methods appropriate to the data?
yes
5.3
Are any statistics correctly performed and interpreted?
no additional statistical tests performed
6
Discussion
6.1
Are the results discussed in relation to existing knowledge on the subject and study objectives?
yes. other relevant studies are cited and compared with the current findings
6.2
Is the discussion biased?
no. results from other studies are discussed as well as study weaknesses which may have affected the results of this current 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 has given me a better idea of which imaging modality is best used to detect calculi
8
Implementation
8.1
Can any necessary change be implemented in practice?
US may be used in the future in combination with KUB as an initial investigation for a patient presenting with loin pain, perhaps one day replacing IVU.
8.2
What aids to implementation exist?
US is cheaper and easier to use than IVU. it also avoides contrast material and saves time.
8.3
What barriers to implementation exist?
better training in ultrasonic interpretation for radiologists is needed to ensure its accuracy.