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Critical Appraisal of
SPORT RCT
Surgery versus nonoperative treatment
for lumbar disc herniation
Dr. Kshitij Chaudhary
MS ...
Skip Introduction
Skip Abstract
METHODS and RESULTS
Participants
Exposure
Group
Comparison
Group
Outcomes
Time
P
E C
O
T
PECOT
Rod Jackson
EPIQ group
University of Auckland
N...
Study Setting
13 multicenter
Participants
Study Setting
13 multicenter
Eligible
Nonop 6wks
Participants
Study Setting
13 multicenter
Eligible
Nonop 6wks
Participants
Study Setting
13 multicenter
Eligible
Nonop 6wks
Participants
Exclusion
Study Setting
13 multicenter
Eligible
Nonop 6wks
Participants
Research nurse gave
an option !
501
E CExposure (Intervention)
group
Comparison (Control)
group
USUAL CARE !
Not controlled !
Major Flaw !
But real life situa...
O
Primary
Secondary
T
Longitudinal study
P
E C
OT
Patients with
Lumbar disc herniation
Discectomy
Nonoperative
treatment
ODI (SE)
Randomised
186 187
501
-31.4(1.7)...
Recruitment
RAMBOMAN
Who are the findings applicable to?
Are the participants representative
of the target population ?
St...
T
P
Randomisation
Allocation
Concealed
allocation?
How was
random sequence
generated?
RAMBOMAN
T
P
Randomisation
Maintenance
RAMBOMAN
Completeness of followup
T
P
Randomisation
Maintenance
RAMBOMAN
Completeness of followup
T
P
Randomisation
Maintenance
RAMBOMAN
Compliance
Crossover to
Surgery
Crossover to
Nonoperative
40% Nonop 45% surgery
How much cross over is too
much ?
T
P
Randomisation
Blinding
RAMBOMAN
Not possible
Discectomy versus Sham Surgery ?
Ethical issues
No appropriate with super...
T
P
Randomisation
Objective measurement
RAMBOMAN
All good !!
T
P
Randomisation
Analyses
RAMBOMAN
1) EG and CG same at Baseline ?
Analyses
RAMBOMAN
2) Was Intention to treat analysis used ?
Patients
with
radiculopat
hy
Assigned to Surgery Assigned to N...
Analyses
RAMBOMAN
Also as treated analyses is presented
Patients
with
radiculopat
hy
Assigned to Surgery Assigned to Nonop...
T
P
Randomisation
Analyses
RAMBOMAN
3) Power ?
Assumption
Analyses
RAMBOMAN
3) 95% confidence limits ?
Analyses
RAMBOMAN
3) 95% confidence limits ?
Analyses
RAMBOMAN
3) 95% confidence limits ?
Not blinded
Lot of crossover
Potential Level 1
Downgraded to Level 2
Inherent problems in RCT
Intent to treat ?
As treated ?
No difference
Surgery better
Conclusion
• Surgery works better in patient with severe pain that
is not controlled with usual nonoperative care
• Don't ...
Critical Appraisal of an RCT using GATE - SPORT Trial
Critical Appraisal of an RCT using GATE - SPORT Trial
Critical Appraisal of an RCT using GATE - SPORT Trial
Critical Appraisal of an RCT using GATE - SPORT Trial
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Critical Appraisal of an RCT using GATE - SPORT Trial

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This is a presentation given at the research methodology workshop at IOACON 2016, Kochi, India. Critical appraisal of the SPORT RCT study is presented using the GATE framework developed by Prof Rod Jackson. SPORT was a large multicenter trial conducted in the USA that compared surgery versus nonoperative treatment for lumbar disc herniation

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Critical Appraisal of an RCT using GATE - SPORT Trial

  1. 1. Critical Appraisal of SPORT RCT Surgery versus nonoperative treatment for lumbar disc herniation Dr. Kshitij Chaudhary MS Orth, DNB Orth Consultant Spine Surgeon Sir HN Reliance Foundation Hospital Mumbai, India Presented at the Research Methodology Workshop at IOACON Kochi 2016
  2. 2. Skip Introduction Skip Abstract METHODS and RESULTS
  3. 3. Participants Exposure Group Comparison Group Outcomes Time P E C O T PECOT Rod Jackson EPIQ group University of Auckland New Zealand Graphic Approach To Epidemiology
  4. 4. Study Setting 13 multicenter Participants
  5. 5. Study Setting 13 multicenter Eligible Nonop 6wks Participants
  6. 6. Study Setting 13 multicenter Eligible Nonop 6wks Participants
  7. 7. Study Setting 13 multicenter Eligible Nonop 6wks Participants Exclusion
  8. 8. Study Setting 13 multicenter Eligible Nonop 6wks Participants Research nurse gave an option ! 501
  9. 9. E CExposure (Intervention) group Comparison (Control) group USUAL CARE ! Not controlled ! Major Flaw ! But real life situation
  10. 10. O Primary Secondary
  11. 11. T Longitudinal study
  12. 12. P E C OT Patients with Lumbar disc herniation Discectomy Nonoperative treatment ODI (SE) Randomised 186 187 501 -31.4(1.7) -28.7(1.7)2 years 245 256 Treatment effect = (-31.4) minus (-28.7) = -2.7 (-7.4 to 1.9)
  13. 13. Recruitment RAMBOMAN Who are the findings applicable to? Are the participants representative of the target population ? Study Setting 13 multicenter Eligible Nonop 6wks 501 Risk takers ?
  14. 14. T P Randomisation Allocation Concealed allocation? How was random sequence generated? RAMBOMAN
  15. 15. T P Randomisation Maintenance RAMBOMAN Completeness of followup
  16. 16. T P Randomisation Maintenance RAMBOMAN Completeness of followup
  17. 17. T P Randomisation Maintenance RAMBOMAN Compliance Crossover to Surgery Crossover to Nonoperative
  18. 18. 40% Nonop 45% surgery How much cross over is too much ?
  19. 19. T P Randomisation Blinding RAMBOMAN Not possible Discectomy versus Sham Surgery ? Ethical issues No appropriate with superiority of treatment is the primary endpoint in SPORT
  20. 20. T P Randomisation Objective measurement RAMBOMAN All good !!
  21. 21. T P Randomisation Analyses RAMBOMAN 1) EG and CG same at Baseline ?
  22. 22. Analyses RAMBOMAN 2) Was Intention to treat analysis used ? Patients with radiculopat hy Assigned to Surgery Assigned to Nonop Surgery Nonop Surgery Nonop
  23. 23. Analyses RAMBOMAN Also as treated analyses is presented Patients with radiculopat hy Assigned to Surgery Assigned to Nonop Nonop Surgery Surgery Nonop
  24. 24. T P Randomisation Analyses RAMBOMAN 3) Power ? Assumption
  25. 25. Analyses RAMBOMAN 3) 95% confidence limits ?
  26. 26. Analyses RAMBOMAN 3) 95% confidence limits ?
  27. 27. Analyses RAMBOMAN 3) 95% confidence limits ?
  28. 28. Not blinded Lot of crossover Potential Level 1 Downgraded to Level 2 Inherent problems in RCT
  29. 29. Intent to treat ? As treated ? No difference Surgery better
  30. 30. Conclusion • Surgery works better in patient with severe pain that is not controlled with usual nonoperative care • Don't disregard the Sciatica bothersome index. It was the only outcome measure that was specific to leg pain in this study.

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