Best Evidence Topics

Randomised control trial

Reunala T, Lappalainen P, Brummer-Korvenkontio H, Coulie P, Palosuo, T.
Cutaneous reactivity to mosquito bites: effect of cetirizine and development of anti-mosquito antibodies.
Clinical and Experimental Allergy
1991; 21: 617-622.
  • Submitted by:sahdia choudry - 4th year medical student
  • Institution:mri
  • Date submitted:13th July 2005
Before CA, i rated this paper: 7/10
1 Objectives and hypotheses
1.1 Are the objectives of the study clearly stated?
  there is a sentence within the abstract stating what was done in the study and why but it is not clearly stated under a specific heading or section.
2 Design
2.1 Is the study design suitable for the objectives
  yes. a RCT is the best way to compare the 2 imaging techniques
2.2 Who / what was studied?
  98 patients presenting to the ED with colic and haematuria over an 8 month period
2.3 Was this the right sample to answer the objectives?
  yes. all the patients had symptoms suggestive of calculi
2.4 Is the study large enough to achieve its objectives? Have sample size estimates been performed?
  yes. there was sufficient data gathered form the sample of patients used however sample size estimates were not performed.
2.5 Were all subjects accounted for?
2.6 Were all appropriate outcomes considered?
2.7 Has ethical approval been obtained if appropriate?
  all patients gave informed consent.
2.8 Were the patients randomised between treatments?
  all patients underwent US and IVU in that order. there was no spliting of the patients into groups assigned to one modality or the other.
2.9 How was randomisation carried out?
2.10 Are the outcomes clinically relevant?
3 Measurement and observation
3.1 Is it clear what was measured, how it was measured and what the outcomes were?
  yes. there is detail of the investigations performed and how the results were interpreted.
3.2 Are the measurements valid?
3.3 Are the measurements reliable?
3.4 Are the measurements reproducible?
3.5 Were the patients and the investigators blinded?
  yes. the radiologists were blinded to the result of the other examination and the patient outcome.
4 Presentation of results
4.1 Are the basic data adequately described?
  yes. the results are described in text form as well as in clear tables.
4.2 Were groups comparable at baseline?
  there were 56 males and 29 females in the study with ages ranging from 18 to 77 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 clearly tabulated and described in the text which is easy to read and understand.
4.4 Are the results internally consistent, i.e. do the numbers add up properly?
4.5 Were side effects reported?
5 Analysis
5.1 Are the data suitable for analysis?
  yes. the findings are given in the form of percentages with P values stated and statistical significance stated.
5.2 Are the methods appropriate to the data?
5.3 Are any statistics correctly performed and interpreted?
  yes. Chi-Squared test was used on the data. also intra and inter observer error was calculated with a K value given
6 Discussion
6.1 Are the results discussed in relation to existing knowledge on the subject and study objectives?
  yes. the findings of similar studies are discussed in relation to the results found for this current study.
6.2 Is the discussion biased?
  no. the author accepted the limitaions of the study and the results from other studies that challenged their findings.
7 Interpretation
7.1 Are the authors' conclusions justified by the data?
7.2 What level of evidence has this paper presented? (using CEBM levels)
7.3 Does this paper help me answer my problem?
  yes. the results allowed me to get a better idea of which method of imaging was better; US or IVU.
After CA, i rated this paper: 7/10
8 Implementation
8.1 Can any necessary change be implemented in practice?
  US may be used more in the ED which may one day replace IVU as the primary investigation in a patient with ureteric colic
8.2 What aids to implementation exist?
  training courses for ED doctors in US technique and interpretation.
8.3 What barriers to implementation exist?
  the accessibiltiy of US and variable degree of physician training in ultrasonic diagnosis.