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Submited on: 22 Sep 2010 01:34:04 PM GMT
Published on: 22 Sep 2010 04:38:52 PM GMT
- Other Comments: Good structure and flow of processes
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Competing interests:
None
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Invited by the author to review this article? :
Yes -
Have you previously published on this or a similar topic?:
No
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References:
None -
Experience and credentials in the specific area of science:
Surgical research registrar with experience setting up trials - How to cite: Siddiqui M R.Physical therapy or Platelet Rich Plasma injections in the treatment of tennis elbow: A randomised clinical trial.[Review of the article 'Physical therapy or Platelet Rich Plasma Injections in the Treatment of Tennis Elbow: A Randomised Clinical Trial ' by Jacobs L].WebmedCentral 2010;1(12):WMCRW00199
- Other Comments: This is a protocol for an intended randomised controlled trial examining the use of platelet rich plasma in the treatment for tennis elbow. The background is appropriately brief but may benefit from additional information such as statistics of failure rates of surgery and in what types of patients they fail in. It may also be useful to identify what the pitfalls of surgery are as opposed to consevative treatment. For example what are the complication rates? The literature review whilst informative lacks refernces and this should be addressed. I would avoid definitive statements such as incorrect as this implies that the authors are an authority on the subject. These definitions may differ from continent to continent. In the bioactive section it would be best to avoid adjectives such as extremely, and qualify that statement. It may be more appropriate also to comment on acceptability and efficacy of a modality. The rationale for the study is clearly documented. The statement "The patient will be made aware that the level of their care will not alter whether they consent to entering the trial or not and that they may freely exit the trial at any point." is not entirely accurate as they will be having 2 different treatment regimes. This should be highlighted. The technique of injection should be described in more detail and should ideally be referenced. As a note you will need to describe in more detail how the information is held and secured. Your inclusion criteria needs to show how coersion will not be implied. I.e is there a period over which consent is taken? The physiotherapy regime needs more detail. Although the sample size calculation is undoubtedly correct the method of calculation needs more description. Is your power too low? The ethical aspect needs to be restructured to display a more scientific approach to the issue at hand. The ethical section needs much more work to be acceptable at an ethics committee. There may also be a requirement to register the trial in an international database. Overall a good summary protocol however referencing needs to be much more detailed and further work would be required before a formal ethics committee would approve it. I look forward to the final results.
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Competing interests:
Nil financial
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Invited by the author to review this article? :
Yes -
Have you previously published on this or a similar topic?:
No
-
References:
None -
Experience and credentials in the specific area of science:
Surgery - How to cite: Siddiqui M R.Physical therapy or Platelet Rich Plasma injections in the treatment of tennis elbow: A randomised clinical trial.[Review of the article 'Physical therapy or Platelet Rich Plasma Injections in the Treatment of Tennis Elbow: A Randomised Clinical Trial ' by Jacobs L].WebmedCentral 2010;1(9):WMCRW0042
Critical appraisal
Criteria
Comment
Evaluation*
Research Question
Study design:
Trail Protocol for a RCT
CRD evidence level = N/A
Population:
N/A
Intervention/
Exposure:
1 PRP injection
Y
Comparison/
Control:
8 sessions Eccentric PT
Y
Outcome:
CGO
EGO
1
VAS
2
DASH
3
PRTEE
Y
Time of follow-up:
1/12; 3/12; 1 year
Y
Minimizing bias, confounding & chance
Recruitment
Randomization
Y
Inclusion criteria
>18y; Dx=LE;
Informed consent
Exclusion criteria
Other Rx
Bilateral Sx;
Other pathology or surgery;
PRP CI;
Pt refusal
Y
Allocation
Sealed envelops
?
Maintenance
N/A
Measurement
blinding
Single
objectivity
Subjective outcome measures
?
Statistical analysis
Sample size calc.
Y
ES
?
p or precision
?
Intention to Rx
?
N
Outcomes
Relative risk (RR) = EGO/CGO
N/A
Risk (Absolute) difference (RD) = EGO – CGO
N/A
NNT = 1/RD
N/A
* Y = adequate; N = inadequate; ? = unsure/not reported; n/a = not applicable
(Critical appraisal method adapted from:
Jackson R, et al. The GATE frame: critical appraisal with pictures. Evidence Based Medicine. 2006 Apr 1;11(2):35 -38.)
Evaluation, limitations & suggestions for improvements
The previous reviews are noted and the points raised are agreed with. In addition I would add:
The Background section shows good knowledge and awareness of previous research and a logical, valid and important research question is presented.
The Methods are generally well described and detailed enough to follow and replicate. The outcome measures are validated research tools used in other studies. However, the allocation method is open to easy corruption by well meaning physicians with their patients best interest at heart (see Kent, W. Why not just flip a coin? Randomization and blinding in clinical trials:Educational article [Internet]. Version 8. Open Journal of Medicine. 2011 Jun 13. Available from: http://knol.google.com/k/w-kent/why-not-just-flip-a-coin-randomisation/1blm6ty1i8a7z/4.). Also, the sample size calculation is well described but the statistical analysis is not described. How will the results be analyzed? & Presented? Will a measure of precision be provided to aid interpretations? And will an intention to treat analysis be used to prevent bias due to non-compliant participants?
Other questions for future research
Do the results generalize to other populations outside the age range? and with concomitant pathology? Is there a difference between the sample population and those who refused to participate? Was the randomization process robust enough to prevent subversion by the clinicians who felt certain subjects might benefit from a certain intervention?
An interesting randomized controlled trial protocol, with potentially practice changing implications. I look forward to the final trial results.
No competing interests.
No
No
None
Orthopaedic foundation trainee