Randomised control trial
M. Patalas, A. Farkas, D. Fisher, I. Zaghal, I. Hadas-HalpernUltrasound vs CT for the detection of ureteric stones in patients with renal colic
The British Institute of Radiology
2001;74:901-904
- 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 aim is stated in the first line of the abstract.
2
Design
2.1
Is the study design suitable for the objectives
yes. a RCT is the best way to compare the 2 imaging modalitites. the study method allows this comparison to be made.
2.2
Who / what was studied?
62 consecutive patients with flank pain
2.3
Was this the right sample to answer the objectives?
yes. all patients were examined with CT and US.
2.4
Is the study large enough to achieve its objectives? Have sample size estimates been performed?
sample size estimate performance is not mentioned
2.5
Were all subjects accounted for?
43 of the 62 patients had ureteral calculi.
2.6
Were all appropriate outcomes considered?
yes
2.7
Has ethical approval been obtained if appropriate?
there is no mention of consent taken
2.8
Were the patients randomised between treatments?
all patients underwent US and CT scan. the patients were not split into 2 groups and assigned an examination
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 method section clearly describes what was measured and how the examinations were carried out.
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 two sets of studies were reviewed by independent radiologists who were blinded to the patients identities.
4
Presentation of results
4.1
Are the basic data adequately described?
yes. the basic data is tabulated to accompany the text. CT and US film images are also included.
4.2
Were groups comparable at baseline?
there were 42 men compared to 20 women, age range 26-89 years. al patients however underwent the same investigations and presented with the same symptoms or flank pain.
4.3
Are the results presented clearly, objectively and in sufficient detail to enable readers to make their own judgement?
yes. the results are clearly shown 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 percentage figures.
5.2
Are the methods appropriate to the data?
yes
5.3
Are any statistics correctly performed and interpreted?
there is no statistical testing used.
6
Discussion
6.1
Are the results discussed in relation to existing knowledge on the subject and study objectives?
yes. results from other studies are also citied in the discussion
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. it has helped clarify whether CT is a better mode of imaging to detect calculi than US.
8
Implementation
8.1
Can any necessary change be implemented in practice?
US should be used first as an initial investigation for renal colic
8.2
What aids to implementation exist?
the increasing number of training courses for doctors to improve ulrasonic technique and interpretation skills
8.3
What barriers to implementation exist?
US requires skilled physicians and adequate patient preparation. CT is more precise and considered the gold standard