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. 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
- 3. Skip Introduction Skip Abstract METHODS and RESULTS
- 4. 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
- 6. Study Setting 13 multicenter Eligible Nonop 6wks Participants
- 7. Study Setting 13 multicenter Eligible Nonop 6wks Participants
- 8. Study Setting 13 multicenter Eligible Nonop 6wks Participants Exclusion
- 9. Study Setting 13 multicenter Eligible Nonop 6wks Participants Research nurse gave an option ! 501
- 10. E CExposure (Intervention) group Comparison (Control) group USUAL CARE ! Not controlled ! Major Flaw ! But real life situation
- 14. 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)
- 15. 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 ?
- 19. T P Randomisation Maintenance RAMBOMAN Compliance Crossover to Surgery Crossover to Nonoperative
- 20. 40% Nonop 45% surgery How much cross over is too much ?
- 21. 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
- 23. T P Randomisation Analyses RAMBOMAN 1) EG and CG same at Baseline ?
- 25. Analyses RAMBOMAN 2) Was Intention to treat analysis used ? Patients with radiculopat hy Assigned to Surgery Assigned to Nonop Surgery Nonop Surgery Nonop
- 26. Analyses RAMBOMAN Also as treated analyses is presented Patients with radiculopat hy Assigned to Surgery Assigned to Nonop Nonop Surgery Surgery Nonop
- 28. Analyses RAMBOMAN 3) 95% confidence limits ?
- 29. Analyses RAMBOMAN 3) 95% confidence limits ?
- 30. Analyses RAMBOMAN 3) 95% confidence limits ?
- 32. Not blinded Lot of crossover Potential Level 1 Downgraded to Level 2 Inherent problems in RCT
- 33. Intent to treat ? As treated ? No difference Surgery better
- 34. 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.
Notes de l'éditeur
- Start with PECOT using the GATE frame We are going to use the GATE frame for critical appraisal. It is a graphical approach to Epidemiology. Developed by Rod Jackson from New Zealand. I strongly urge you to look this up on Google.
- Nothing unusual !
- Nothing unusual !
- Risk taker Worse off patients tended to choose the observational cohort Did patients with more pain or severe neurological deficit choose to be in the observational cohort?
- Every time you do this same study there is a 95% chance that the treatment effect is going to be in this range. Now the values straddle 0. Means not significant
- Yes representative -
- All good here
- Loss to FU (Attrition) 20% (sort of acceptable) spans 80% Meaningful duration of FU Similar rates of FU in EG and CG
- Equivalent in both groups. The characteristics were similar to those without missing data except
- Expect this from an RCT
- Is there anything else that comes to your mind that they have not covered. None in my mind at least So were are okay here, and move ahead
- intent to treat analysis was used.
- intent to treat analysis was used.
- A priori power calculation done. Meaningful assumption made (10 point difference). So all good here too.
- 95% confidence limits On the sciatica bothersome index is on one side of zero. It is the only outcome measure favoring surgery
- Primary outcome measures. Notice the handle bars. They overlaps. So not significant difference at all time points
- Secondary outcome measure- only sciatica bothersome index the error bars don’t overlap. Significant difference here in spite of intention to treat analysis. Crossover will tend to reduce the benefit of surgery, thus in spite of high cross over rate the sciatica bothersome index favors surgery.
- As treated analyses Strong advantages for surgery at all times points. But as treated analyses will have bias. But point to note is that in spite the surgery group starting off with worse pain, they had better results to nonoperative care in the as treated analysis.
- Highlights the inherent problems of performing a RCT in surgical interventions. Not level 1 evidence but the study is still very important and valuable.
- IN conclusion - what to believe - intention to treat or as treated analysis.