Best Evidence Topics

Randomised control trial

Bergvist D, Dahlgren S, Hessman Y
Local inhibition of the fibrinolytic system in patients with massive upper gastrointestinal haemorrhage
Up J Med Sci
1980; 85: 173-8
  • Submitted by:Anna Morgan - ST6 Emergency Medicine
  • Institution:Homerton Hospital
  • Date submitted:15th May 2011
Before CA, i rated this paper: 4/10
1 Objectives and hypotheses
1.1 Are the objectives of the study clearly stated?
  Yes: the effects of oral tranexamic acid on massive gastrointestinal haemorrhage (defined as haematemesis and / or melaena with circulatory involvement on arrival) in terms transfusion requirements, surgical intervention frequency and mortality.
2 Design
2.1 Is the study design suitable for the objectives
  Yes: randomised controlled study, double blinded
2.2 Who / what was studied?
  Patients presenting with haematemesis and / or melaena with circulatory involvement.
2.3 Was this the right sample to answer the objectives?
2.4 Is the study large enough to achieve its objectives? Have sample size estimates been performed?
  No sample size estimates have been performed
2.5 Were all subjects accounted for?
2.6 Were all appropriate outcomes considered?
2.7 Has ethical approval been obtained if appropriate?
  Not stated in the paper.
2.8 Were the patients randomised between treatments?
  Stated that they were.
2.9 How was randomisation carried out?
  Not stated in the paper.
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?
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?
  It is stated that they were.
4 Presentation of results
4.1 Are the basic data adequately described?
4.2 Were groups comparable at baseline?
  Yes, largely so.
4.3 Are the results presented clearly, objectively and in sufficient detail to enable readers to make their own judgement?
  No. Statistical significance of the results for transfusion requirements are not given. No statistical analysis of the mortality results data.
4.4 Are the results internally consistent, i.e. do the numbers add up properly?
  Yes, as far as they are reported.
4.5 Were side effects reported?
5 Analysis
5.1 Are the data suitable for analysis?
5.2 Are the methods appropriate to the data?
  There is no statistical analysis of the outcomes.
5.3 Are any statistics correctly performed and interpreted?
  Not performed.
6 Discussion
6.1 Are the results discussed in relation to existing knowledge on the subject and study objectives?
6.2 Is the discussion biased?
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?
After CA, i rated this paper: 3/10
8 Implementation
8.1 Can any necessary change be implemented in practice?
8.2 What aids to implementation exist?
  Not applicable
8.3 What barriers to implementation exist?
  Not applicable