Best Evidence Topics

Randomised control trial

Holdsworth BJ, Clements DA, Rothwell PN.
Fractures of the radial head - the benefit of aspiration: a prospective controlled trial.
  • Submitted by:Simon Carley - Consultant in Emergency Medicine
  • Institution:Manchester Royal Infirmary
  • Date submitted:29th November 2003
Before CA, i rated this paper: 3/10
1 Objectives and hypotheses
1.1 Are the objectives of the study clearly stated?
  Yes. To examine the effect of aspiration in radial head fractures.
Patients had aspiration performed the day after presentation in the fracture clinic.
2 Design
2.1 Is the study design suitable for the objectives
  Yes. But not in the way the authors have performed it.
2.2 Who / what was studied?
  98 patients had radial head fractures. 14 were excluded because of insufficient records.
Of the remaining 80 only 38 had aspirations. It is not clear how this group were selected.
2.3 Was this the right sample to answer the objectives?
  No They should have set clear inclusion criteria and ransomised on that.
2.4 Is the study large enough to achieve its objectives? Have sample size estimates been performed?
  No. No calculation performed but clearly too small.
2.5 Were all subjects accounted for?
2.6 Were all appropriate outcomes considered?
  Too some extent. Pain and function at discharge were the main outcomes
2.7 Has ethical approval been obtained if appropriate?
  Don't know
2.8 Were the patients randomised between treatments?
  Yes on their hospital number (whatever that means)
2.9 How was randomisation carried out?
  Don't know
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?
  No. I found it difficult to determine how the authors reached their conclusions and why they introduced a rather irrelevant control group in the results section without prior mention. The graphs presented are difficult to interpret and unclear.
3.2 Are the measurements valid?
  Range of movement - probably
Delay in mobilisation - unsure
Pain relief - No, as non standard scales used.
3.3 Are the measurements reliable?
  No - see 3.2
3.4 Are the measurements reproducible?
3.5 Were the patients and the investigators blinded?
4 Presentation of results
4.1 Are the basic data adequately described?
  No. this is very unclear
4.2 Were groups comparable at baseline?
  Don't know
4.3 Are the results presented clearly, objectively and in sufficient detail to enable readers to make their own judgement?
  Absolutely not
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?
  Probably, though they have not done it
5.2 Are the methods appropriate to the data?
  Not applicable
5.3 Are any statistics correctly performed and interpreted?
  Not applicable
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?
  Yes. It is not evidently based upon their findings. Since they found no difference in late outcome their conclusions are a little too strongly held (that aspiration is advocated)
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)
  Is there a 7?
7.3 Does this paper help me answer my problem?
  A little, but not enough on its own
After CA, i rated this paper: 1/10
8 Implementation
8.1 Can any necessary change be implemented in practice?
  Yes, minimal additional training
8.2 What aids to implementation exist?
8.3 What barriers to implementation exist?