Randomised control trial
Liow RYL; Creagn A; Nanda R; Montgomery RJEarly mobilisation for minimally displaced radial head fractures is desirable: A prospective randomised study of two protocols
Injury
2002; 33: 801-806
- Submitted by:Craig Ferguson - SPR
- Institution:Salford Royal Foundation Trust
- Date submitted:22nd May 2006
1
Objectives and hypotheses
1.1
Are the objectives of the study clearly stated?
Yes. To compare outcomes of immediate movement exercises vs. a delay of 5 days.
2
Design
2.1
Is the study design suitable for the objectives
The patients are the correct group, i.e. those presenting to the ED with a radial head fracture. The review was blinded to treatment and extensive. The problem with the design was the randomisation process.
2.2
Who / what was studied?
Patients presenting to the ED with Mason type I or II fractures of the radial head.
2.3
Was this the right sample to answer the objectives?
Yes
2.4
Is the study large enough to achieve its objectives? Have sample size estimates been performed?
States that pilot study done suggesting around 30 pts in each group. Also states that power calculations done but no figures supplied at this point.
2.5
Were all subjects accounted for?
30 patients in each group at the start. No figures given after this, only mean results so not sure what the follow up rates were.
2.6
Were all appropriate outcomes considered?
Yes, checked for union, strength, range of movement, function.
2.7
Has ethical approval been obtained if appropriate?
No mention of ethical approval or consenting patients.
2.8
Were the patients randomised between treatments?
No. Patients were assigned to different orthopaedic consultants who advocated different treatments by the ED doctor. The ED doctor was presumably aware of which treatment was being assigned to each patient. Although not statistically significant, the majority of patients asssigned to early mobilisation had Type I fractures and the the majority of patients assigned to sling had Type II fractures which may have been more painful.
2.9
How was randomisation carried out?
As above. It is also convenient that 60 consecutive patients were equally distributed into the 2 groups. Is it possible that when one group had reached 30 patients the subsequent patients were sent to the other group?
2.10
Are the outcomes clinically relevant?
Yes. Pain and function are both appropriate outcomes to measure.
3
Measurement and observation
3.1
Is it clear what was measured, how it was measured and what the outcomes were?
Yes.
3.2
Are the measurements valid?
Yes, as far as I know.
3.3
Are the measurements reliable?
Presumably.
3.4
Are the measurements reproducible?
Presumably.
3.5
Were the patients and the investigators blinded?
The ED doctor was not blinded. The patient was not blinded. The orthopaedic doctor in the clinic was not blinded. The supervisor for the exercise program was not blinded. The assessor of function was blinded.
4
Presentation of results
4.1
Are the basic data adequately described?
Yes limited data provided in table 1. Would mechanism of injury have been useful?
4.2
Were groups comparable at baseline?
Yes. Difference in Type I vs. Type II fracture rates (19/30 in group A and 11/30 in group B) but not statistically significant.
4.3
Are the results presented clearly, objectively and in sufficient detail to enable readers to make their own judgement?
Yes. But numbers only provided as means, not able to check follow up rates.
4.4
Are the results internally consistent, i.e. do the numbers add up properly?
As above.
4.5
Were side effects reported?
No mention of any adverse events.
5
Analysis
5.1
Are the data suitable for analysis?
Yes.
5.2
Are the methods appropriate to the data?
Yes.
5.3
Are any statistics correctly performed and interpreted?
Unable to check as raw data not provided.
6
Discussion
6.1
Are the results discussed in relation to existing knowledge on the subject and study objectives?
Yes.
6.2
Is the discussion biased?
No. Good discussion of various methods of management of radial head fractures. Explains that both early mobilisation and a short delay in mobilisation both provide good outcomes in patients with this form of injury.
7
Interpretation
7.1
Are the authors' conclusions justified by the data?
Appears reasonable.
7.2
What level of evidence has this paper presented? (using CEBM levels)
2b
7.3
Does this paper help me answer my problem?
Yes. Early mobilisation appears safe and appropriate. If the patient appears very uncomfortable then unlikely to be any long term difference in outcome from few days immobilisation.
8
Implementation
8.1
Can any necessary change be implemented in practice?
Yes. Local protocols may need to be discussed with orthopaedic teams who take on the management of these patients from the ED. Management of these injuries may be by Emergency Nurse Practioners who may have their own protocols for management of these injuries.
8.2
What aids to implementation exist?
As above.
8.3
What barriers to implementation exist?
As above.