How might GRADE work for ILCOR? Summary of specific components of - - PowerPoint PPT Presentation

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How might GRADE work for ILCOR? Summary of specific components of - - PowerPoint PPT Presentation

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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

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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

1

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2 Vienna 2012

Worksheet identifier: TBA Author: Peter Morley Affiliation: ANZCOR Taskforce: ALS/BLS Other Worksheet Authors: TBA

In adult cardiac arrest (prehospital [OHCA], in- hospital [IHCA]), does the use of an ITD (I) compared with no ITD (C), improve any

  • utcomes (e.g. survival) (O)?
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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)

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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 Excluded unpublished studies, studies only published in abstract form, unless accepted for publication.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
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5 Vienna 2012

Risk of Bias in studies table(s)

Impedance Threshold Device + Standard CPR (I) vs Standard CPR (C)

Study Random

  • ization

Allocation concealment Blinding Loss to follow-up, Intention to Treat (IT) analysis Any other risks Outcomes to which these assessments apply Overall risk

  • f bias for
  • utcome(s)

for study** Aufderheide 2005, 734

ITD+SCPR vs ShamITD+SCPR

Low Low Low Low Discontinued early. Indirectness: 2000 guidelines. All Low Pirallo 2005, 13

ITD+SCPR vs ShamITD+SCPR

Low Unclear Low Low Changed device halfway into

  • study. Equipment problems

Indirectness: 2000 guidelines. All Low Aufderheide 2011, 798

ITD+SCPR vs ShamITD+SCPR

Low Low Low Low Indirectness: 2005 guidelines All Low

Impedance Threshold Device + Active Compression Decompression CPR (I) vs Active Compression Decompression CPR (C)

Study Random

  • ization

Allocation concealment Blinding Loss to follow-up, IT principle

  • bserved or per

protocol analysis Any other risks Outcomes to which these assessments apply Overall risk

  • f bias for
  • utcome(s)

for study** Plaisance 2000, 989

ITD+ACD vs ACD

Low Low Low Low No description primary

  • utcome/power. Indirectness:

1992 guidelines All Low Plaisance 2004, 265

ITD+ACD vs ShamITD+ACD

Low Low Low Low Automatic ventilator. Indirectness: 2000 guidelines. All Low Plaisance 2005, 990

ITD+ACD vs ShamITD+ACD

Low (order of use) Low Low Low Crossover trial. Indirectness: 2000 guidelines All Moderate

Impedance Threshold Device + Active Compression Decompression CPR (I) vs Standard CPR (C)

Study Random

  • ization

Allocation concealment Blinding Loss to follow-up, IT principle

  • bserved or per

protocol analysis Any other risks Outcomes to which these assessments apply Overall risk

  • f bias for
  • utcome(s)

for study** Wolcke 2003, 2201

ITD+ACD vs SCPR

Low High High Low Indirectness: ?1992/2000 guidelines All High Aufderheide 2011, 301

ITD+ACD vs SCPR

Low Unclear High (only

  • utcome

assessor) Unclear, some exclusions based on difficultly with airway border on deviation from IT analysis. High: Significant differences in real time feedback about CPR

  • quality. Increase enrollment

numbers then stop early. All High

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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

  • ization

Allocation concealment Blinding Loss to follow-up, IT principle

  • bserved or per

protocol analysis Any other risks Outcomes to which these assessments apply Overall risk

  • f bias for
  • utcome(s)

for study** Wolcke 2003, 2201

ITD+ACD vs SCPR

Low High High Low Indirectness: ?1992/2000 guidelines All High Aufderheide 2011, 301

ITD+ACD vs SCPR

Low Unclear High (only

  • utcome

assessor) Unclear, some exclusions based on difficultly with airway border on deviation from IT analysis. High: Significant differences in real time feedback about CPR

  • quality. Increase enrollment

numbers then stop early. All High

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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 Author Year 1

st page

Study Design Risk of bias* Inconsistency* Indirectness* Imprecision* Other (including publication bias)** Quality of evidence for

  • utcome***

Outcome 1 Neurologically intact survival (survival to hospital discharge with modified Rankin ≤ 3) Critical (9) 1 Aufderheide 2011 301 RCT Very serious limitations (blinding, feedback about CPR quality, exclusions/ IT analysis) No serious limitations No serious limitations Serious limitations (ARR CI

  • verlap 1%)

Undetected (sponsor involvement). More pulmonary

  • edema I

94/840 (11%) vs C 62/813 (7%) 0.015. Low (rated down for risk of bias and imprecision) Outcome 2 Survival to hospital discharge Critical (8) 2 Aufderheide 2011 301 Wolcke 2003 2201 RCT Very serious limitations (blinding, feedback about CPR quality, exclusions/ IT analysis) No serious limitations Serious limitations (Wolcke 2003 2210: 1992/2000 guidelines) Serious limitations (ARR CI

  • verlap 1%)

Undetected (sponsor involvement) More pulmonary

  • edema I

94/840 (11%) vs C 62/813 (7%) 0.015. Low (rated down for risk of bias, indirectness and imprecision)

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8 Vienna 2012

Summary of findings table(s)

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9 Vienna 2012

Summary of findings table: 1

Topic title: Impedance Threshold Device + Active Compression Decompression CPR (I) vs Standard CPR (C)

Patient

  • r

population: Patients in cardiac arrest Settings: OOHCA Intervention: Use

  • f

Impedance Threshold Device in addition to Active Compression Decompression CPR Comparison: Use

  • f

Standard CPR Outcomes Illustrative comparative risks*

  • (95%

CI) Relative effectOR (95% CI) No

  • f

Participants (studies) Quality

  • f

the evidence (GRADE) Comments Assumed risk Comparison Corresponding risk Intervention 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)** Low

1

Unblinded study with unbalanced control for quality

  • f

CPR.

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10 Vienna 2012

Summary of findings table: 2

Topic title: Impedance Threshold Device + Active Compression Decompression CPR (I) vs Standard CPR (C)

Patient

  • r

population: Patients in cardiac arrest Settings: OOHCA Intervention: Use

  • f

Impedance Threshold Device in addition to Active Compression Decompression CPR Comparison: Use

  • f

Standard CPR Outcomes Illustrative comparative risks*

  • (95%

CI) Relative effectOR (95% CI) No

  • f

Participants (studies) Quality

  • f

the evidence (GRADE) Comments Assumed risk Comparison Corresponding risk Intervention 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)*** Low

1

Unblinded studies with unbalanced control for quality

  • f

CPR.

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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.

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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).