1 1 Vienna 2012 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 Vienna 2012 In adult cardiac arrest (prehospital [OHCA], in- hospital [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 Vienna 2012 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 Vienna 2012 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 Excluded unpublished studies, studies only published in abstract form, unless accepted for publication.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 Vienna 2012 Risk of Bias in studies table(s) Impedance Threshold Device + Standard CPR (I) vs Standard CPR (C) Study Random Allocation Blinding Loss to follow-up, Any other risks Outcomes to Overall risk -ization concealment Intention to Treat which these of bias for (IT) analysis assessments apply outcome(s) for study** Aufderheide 2005, 734 Low Low Low Low Discontinued early. All Low ITD+SCPR vs ShamITD+SCPR Indirectness: 2000 guidelines. Pirallo 2005, 13 Low Unclear Low Low Changed device halfway into All Low ITD+SCPR vs ShamITD+SCPR study. Equipment problems Indirectness: 2000 guidelines. Aufderheide 2011, 798 Low Low Low Low Indirectness: 2005 guidelines All Low ITD+SCPR vs ShamITD+SCPR Impedance Threshold Device + Active Compression Decompression CPR (I) vs Active Compression Decompression CPR (C) Study Random Allocation Blinding Loss to follow-up, Any other risks Outcomes to Overall risk -ization concealment IT principle which these of bias for observed or per assessments apply outcome(s) protocol analysis for study** Plaisance 2000, 989 Low Low Low Low No description primary All Low ITD+ACD vs ACD outcome/power. Indirectness: 1992 guidelines Plaisance 2004, 265 Low Low Low Low Automatic ventilator. All Low ITD+ACD vs ShamITD+ACD Indirectness: 2000 guidelines. Plaisance 2005, 990 Low Low Low Low Crossover trial. All Moderate ITD+ACD vs ShamITD+ACD (order of Indirectness: 2000 guidelines use) Impedance Threshold Device + Active Compression Decompression CPR (I) vs Standard CPR (C) Study Random Allocation Blinding Loss to follow-up, Any other risks Outcomes to Overall risk -ization concealment IT principle which these of bias for observed or per assessments apply outcome(s) protocol analysis for study** Wolcke 2003, 2201 Low High High Low Indirectness: ?1992/2000 All High ITD+ACD vs SCPR guidelines Aufderheide 2011, 301 Low Unclear High Unclear, some High: Significant differences in All High ITD+ACD vs SCPR (only exclusions based on real time feedback about CPR outcome difficultly with quality. Increase enrollment assessor) airway border on numbers then stop early. deviation from IT analysis.
6 Vienna 2012 Risk of Bias in studies table: ITD+ACDCPR vs Standard CPR Impedance Threshold Device + Active Compression Decompression CPR (I) vs Standard CPR (C) Study Random Allocation Blinding Loss to follow-up, Any other risks Outcomes to Overall risk -ization concealment IT principle which these of bias for observed or per assessments apply outcome(s) protocol analysis for study** Wolcke 2003, 2201 Low High High Low Indirectness: ?1992/2000 All High ITD+ACD vs SCPR guidelines Aufderheide 2011, 301 Low Unclear High Unclear, some High: Significant differences in All High ITD+ACD vs SCPR (only exclusions based on real time feedback about CPR outcome difficultly with quality. Increase enrollment assessor) airway border on numbers then stop early. deviation from IT analysis.
7 Vienna 2012 Evidence profile table: 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 No of studies Study Risk of Inconsistency* Indirectness* Imprecision* Other (including Quality of st page Author Year 1 Design bias* publication evidence for bias)** outcome*** Outcome 1 1 RCT Very No serious No serious Serious Undetected Low (rated Neurologically intact Aufderheide 2011 serious limitations limitations limitations (sponsor down for survival 301 limitations (ARR CI involvement). risk of bias (survival to hospital (blinding, overlap 1%) More and discharge with feedback pulmonary imprecision) modified Rankin ≤ 3) about CPR oedema I Critical (9) quality, 94/840 (11%) vs exclusions/ C 62/813 (7%) IT 0.015. analysis) Outcome 2 2 RCT Very No serious Serious Serious Undetected Low (rated Survival to hospital Aufderheide 2011 serious limitations limitations limitations (sponsor down for discharge 301 limitations (Wolcke 2003 (ARR CI involvement) risk of bias, Critical (8) Wolcke 2003 2201 (blinding, 2210: overlap 1%) More indirectness feedback 1992/2000 pulmonary and about CPR guidelines) oedema I imprecision) quality, 94/840 (11%) vs exclusions/ C 62/813 (7%) IT 0.015. analysis)
8 Vienna 2012 Summary of findings table(s)
9 Vienna 2012 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*� � Relative� No� of� Quality� of� Comments � (95%� CI) � effectOR� Participants� the� (95%� CI) � (studies) � evidence� (GRADE) � Assumed� risk� Corresponding� risk� Comparison � Intervention � OR� 1.60� Outcome� 1 � 1 � 47/813� (5.8%)� 75/840� (8.9%)� 2470� (1)**� � Low Unblinded� study� with� (1.09� to� 2.33)� Neurologically� intact� Difference� 3.15%� (0.64� to� unbalanced� control� for� survival� 5.66)� quality� of� CPR.� (survival� to� hospital� NNT� 31.8� discharge� with� modified� Rankin� ≤ � 3)� Critical� (9)�
10 Vienna 2012 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*� � Relative� No� of� Quality� of� Comments � (95%� CI) � effectOR� Participants� the� (95%� CI) � (studies) � evidence� (GRADE) � Assumed� risk� Corresponding� risk� Comparison � Intervention � OR� 1.32� 1 � Outcome� 2 � 94/920� (10.2%)� 123/943� (13%)� 2680� (2)***� � Low Unblinded� studies� with� (0.99� to� 1.75)� Survival� to� hospital� Difference� 2.83%� (-0.08� to� unbalanced� control� for� discharge� 5.73)� quality� of� CPR.� Critical� (8)� NNT� 35.4�
11 Vienna 2012 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 Vienna 2012 2015 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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