Submited on: 22 Sep 2010 01:34:04 PM GMT
Published on: 22 Sep 2010 04:38:52 PM GMT
 
Critical appraisal of RCT protocol
Posted by Dr. William Kent on 16 Jun 2011 07:13:13 PM GMT

1 Is the subject of the article within the scope of the subject category? Yes
2 Are the interpretations / conclusions sound and justified by the data? No
3 Is this a new and original contribution? Yes
4 Does this paper exemplify an awareness of other research on the topic? Yes
5 Are structure and length satisfactory? Yes
6 Can you suggest brief additions or amendments or an introductory statement that will increase the value of this paper for an international audience? Yes
7 Can you suggest any reductions in the paper, or deletions of parts? No
8 Is the quality of the diction satisfactory? Yes
9 Are the illustrations and tables necessary and acceptable? No
10 Are the references adequate and are they all necessary? Yes
11 Are the keywords and abstract or summary informative? Yes
  • Other Comments:

    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.

     

  • Competing interests:
    No competing interests.
  • Invited by the author to review this article? :
    No
  • Have you previously published on this or a similar topic?:
    No
  • References:
    None
  • Experience and credentials in the specific area of science:

    Orthopaedic foundation trainee

  • How to cite:  Kent W .Critical appraisal of RCT protocol[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;2(6):WMCRW00825
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1 Is the subject of the article within the scope of the subject category? Yes
2 Are the interpretations / conclusions sound and justified by the data? Yes
3 Is this a new and original contribution? Yes
4 Does this paper exemplify an awareness of other research on the topic? Yes
5 Are structure and length satisfactory? Yes
6 Can you suggest brief additions or amendments or an introductory statement that will increase the value of this paper for an international audience? No
7 Can you suggest any reductions in the paper, or deletions of parts? No
8 Is the quality of the diction satisfactory? Yes
9 Are the illustrations and tables necessary and acceptable? Yes
10 Are the references adequate and are they all necessary? Yes
11 Are the keywords and abstract or summary informative? Yes
  • Other Comments: Good structure and flow of processes
  • Competing interests:
    None
  • 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:
    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
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  • 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.
  • Competing interests:
    Nil financial
  • 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
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