Randomised control trial
Reunala T, Brummer-Korvenkontio H, Petman L, Palosuo T, Sarna, S.Effect of ebastine on mosquito bites.
Acta Derm. Venereol.
1997; 77: 315-316.
- 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. a sentence is included before the method section.
2
Design
2.1
Is the study design suitable for the objectives
yes. patients underwent US and IVU to enable a comparison to be made. an RCT is the best method for this study
2.2
Who / what was studied?
20 patients presenting to the Emergency Department during a 24 month period.
2.3
Was this the right sample to answer the objectives?
yes, all patients presented with acute flank pain and haematuria.
2.4
Is the study large enough to achieve its objectives? Have sample size estimates been performed?
20 is a small number of patients compared to the number used in other similar studies. no mention of sample size estimates being made
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?
not mentioned
2.8
Were the patients randomised between treatments?
all patients underwent US prior to IVU.
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 are clear sections of text explaining the findings for each possible outcome i.e. obstructing calculi, hydronephrosis, intrarenal calcification and forniceal rupture. the number of calculi found using US and IVU are clearly compared.
3.2
Are the measurements valid?
yes
3.3
Are the measurements reliable?
yes, although it would be useful to compare the results with the findings of a similar study in which the patient group is larger.
3.4
Are the measurements reproducible?
yes
3.5
Were the patients and the investigators blinded?
yes. the radiologists interpreting the films were not aware of the results of the other examination.
4
Presentation of results
4.1
Are the basic data adequately described?
findings presented in text only- there are no tabulated form of results.
4.2
Were groups comparable at baseline?
there were 17 men and only 3 women. their ages ranged form 22 to 49 years. however they all presented with the same initial symptoms and underwent the same examinations.
4.3
Are the results presented clearly, objectively and in sufficient detail to enable readers to make their own judgement?
there is no tabulated summary of the results however the text is clear and comprehensive to the reader
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 given as a percentage figure
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. knowledge of the subject has been referenced from other sources as well as the findings of the current study.
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 given me more evidence to help me decide which mode of imaging is best in depicting calculi in the ED
8
Implementation
8.1
Can any necessary change be implemented in practice?
patients should be well hydrated before US is carried out to fully assess the whole of the ureter for calculi.
8.2
What aids to implementation exist?
patient instructions before coming to the Emergency Department
8.3
What barriers to implementation exist?
the emergency nature of the US may not allow the patient to be fully prepared for any investigation.