How might GRADE work for ILCOR? Summary of specific components of GRADE using example worksheet
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1 1 How might GRADE work for ILCOR? Summary of specific components of GRADE using example worksheet Associate Professor Peter Morley Director Medical Education Royal Melbourne Hospital University of Melbourne 10 min
2 2 In adult cardiac arrest (prehospital [OHCA], inhospital [IHCA]), does the use of an ITD (I) compared with no ITD (C), improve any outcomes (e.g. survival) (O)? Worksheet identifier: TBA Author: Peter Morley Affiliation: ANZCOR Taskforce: ALS/BLS Other Worksheet Authors: TBA
3 3 C2015 PICO Population: adult cardiac arrest (prehospital [OHCA], in-hospital [IHCA]) Intervention: the use of an ITD Comparison: compared with no ITD Outcomes Neurologically intact survival (critical 9) Discharge from hospital alive (critical 8) Return of spontaneous circulation (important 6)
4 4 Inclusion/Exclusion/Articles Found Included all studies with concurrent controls. Excluded review articles, studies with historical controls, animal studies, and studies that did not specifically answer the question. Excluded unpublished studies, studies only published in abstract form, unless accepted for publication. 8 Articles Finally Evaluated
5 5 Risk of Bias in studies table(s) Impedance Threshold Device + Standard CPR (I) vs Standard CPR (C) Study Random -ization ocation concealment Blinding Loss to follow-up, Intention to Treat (IT) analysis Aufderheide 2005, 734 ITD+SCPR vs ShamITD+SCPR Pirallo 2005, 13 ITD+SCPR vs ShamITD+SCPR Aufderheide 2011, 798 ITD+SCPR vs ShamITD+SCPR Any other risks Outcomes to which these assessments apply Low Low Low Low Discontinued early. Indirectness: 2000 guidelines. Low Unclear Low Low Changed device halfway into Low study. Equipment problems Indirectness: 2000 guidelines. Low Low Low Low Indirectness: 2005 guidelines Low Overall risk of bias for outcome(s) for study** Low Impedance Threshold Device + Active Compression Decompression CPR (I) vs Active Compression Decompression CPR (C) Study Random -ization ocation concealment Blinding Any other risks Plaisance 2000, 989 ITD+ACD vs ACD Plaisance 2004, 265 ITD+ACD vs ShamITD+ACD Plaisance 2005, 990 ITD+ACD vs ShamITD+ACD Loss to follow-up, IT principle observed or per protocol analysis Low Low Low Low No description primary outcome/power. Indirectness: 1992 guidelines Low Low Low Low Automatic ventilator. Indirectness: 2000 guidelines. Low (order of use) Low Low Low Crossover trial. Indirectness: 2000 guidelines Outcomes to which these assessments apply Overall risk of bias for outcome(s) for study** Low Low Moderate Impedance Threshold Device + Active Compression Decompression CPR (I) vs Standard CPR (C) Study Random -ization ocation concealment Blinding Loss to follow-up, IT principle observed or per Any other risks Wolcke 2003, 2201 ITD+ACD vs SCPR Aufderheide 2011, 301 ITD+ACD vs SCPR protocol analysis Low High High Low Indirectness:?1992/2000 guidelines Low Unclear High High: Significant differences in (only real time feedback about CPR outcome quality. Increase enrollment assessor) numbers then stop early. Unclear, some exclusions based on difficultly with airway border on deviation from IT analysis. Outcomes to which these assessments apply Overall risk of bias for outcome(s) for study** High High
6 6 Risk of Bias in studies table: ITD+ACDCPR vs Standard CPR Impedance Threshold Device + Active Compression Decompression CPR (I) vs Standard CPR (C) Study Wolcke 2003, 2201 ITD+ACD vs SCPR Aufderheide 2011, 301 ITD+ACD vs SCPR Random -ization ocation concealment Blinding Loss to follow-up, IT principle observed or per protocol analysis Any other risks Low High High Low Indirectness:?1992/2000 guidelines Low Unclear High High: Significant differences in (only real time feedback about CPR outcome quality. Increase enrollment assessor) numbers then stop early. Unclear, some exclusions based on difficultly with airway border on deviation from IT analysis. Outcomes to which these assessments apply Overall risk of bias for outcome(s) for study** High High
7 Evidence profile table: 7 ITD+ACDCPR vs Standard CPR Impedance Threshold Device + Active Compression Decompression CPR (I) vs Standard CPR (C) Population: Patients in cardiac arrest Settings: OOHCA Intervention: Impedance Threshold Device + Active Compression Decompression CPR Comparison: Standard CPR Outcome Outcome 1 Neurologically intact survival (survival to hospital discharge with modified Rankin 3) Critical (9) Outcome 2 Survival to hospital discharge Critical (8) No of studies Author Year 1 st page 1 Aufderheide Aufderheide Wolcke Study Design RCT RCT Risk of bias* Very serious (blinding, feedback about CPR quality, exclusions/ IT analysis) Very serious (blinding, feedback about CPR quality, exclusions/ IT analysis) Inconsistency* Indirectness* Imprecision* Other (including publication bias)** No serious No serious No serious Serious (Wolcke : 1992/2000 guidelines) Serious (ARR CI overlap 1%) Serious (ARR CI overlap 1%) Undetected (sponsor involvement). More pulmonary oedema I 94/840 (11%) vs C 62/813 (7%) Undetected (sponsor involvement) More pulmonary oedema I 94/840 (11%) vs C 62/813 (7%) Quality of evidence for outcome*** Low (rated down for risk of bias and imprecision) Low (rated down for risk of bias, indirectness and imprecision)
8 8 Summary of findings table(s)
9 9 Summary of findings table: 1 Topic title: Impedance Threshold Device + Active Compression Decompression CPR (I) vs Standard CPR (C) Patient or population: Patients in cardiac arrest Settings: OOHCA Intervention: Use of Impedance Threshold Device in addition to Active Compression Decompression CPR Comparison: Use of Standard CPR Outcomes Illustrative comparative risks* (95% CI) Assumed risk Comparison Corresponding risk Intervention Relative effector (95% CI) No of Participants (studies) Quality of the evidence (GRADE) Comments Outcome 1 Neurologically intact survival (survival to hospital discharge with modified Rankin 3) Critical (9) 47/813 (5.8%) 75/840 (8.9%) Difference 3.15% (0.64 to 5.66) NNT 31.8 OR 1.60 (1.09 to 2.33) 2470 (1)** Low1 Unblinded study with unbalanced control for quality of CPR.
10 10 Summary of findings table: 2 Topic title: Impedance Threshold Device + Active Compression Decompression CPR (I) vs Standard CPR (C) Patient or population: Patients in cardiac arrest Settings: OOHCA Intervention: Use of Impedance Threshold Device in addition to Active Compression Decompression CPR Comparison: Use of Standard CPR Outcomes Illustrative comparative risks* (95% CI) Assumed risk Comparison Corresponding risk Intervention Relative effector (95% CI) No of Participants (studies) Quality of the evidence (GRADE) Comments Outcome 2 Survival to hospital discharge Critical (8) 94/920 (10.2%) 123/943 (13%) Difference 2.83% (-0.08 to 5.73) NNT 35.4 OR 1.32 (0.99 to 1.75) 2680 (2)*** Low1 Unblinded studies with unbalanced control for quality of CPR.
11 11 Consensus on Science statements Impedance Threshold Device + Active Compression Decompression CPR (I) vs Standard CPR (C) One RCT enrolling over 2000 OOHCAs [Aufderheide 2011, 301]reported improved neurologically intact survival when the unblinded use of an Impedance Threshold Device and Active Compression Decompression CPR was compared with manual standard CPR. Two RCTs enrolling over 2000 OOHCAs [Aufderheide 2011, 301; Wolcke 2003, 2201] were unable to demonstrate any improvements in survival to hospital discharge when the unblinded use of an Impedance Threshold Device and Active Compression Decompression CPR was compared with manual standard CPR.
12 Draft Treatment Recommendations Impedance Threshold Device + Active Compression Decompression CPR (I) vs Standard CPR (C) There is insufficient evidence to recommend the routine use of the combination of an Impedance Threshold Device and manual active compression decompression cardiopulmonary resuscitation instead of standard CPR (weak recommendation, low quality of evidence).
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