How should we review the resuscitation science? The ... › download › 2009_spark_of_life_conference_-_ho… · 2005 Consensus on CPR Science 281 experts completed 403 systematic

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How should we review the resuscitation science?

The International Process

Peter Morley

Royal Melbourne Hospital

University of Melbourne

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Conflict of interest disclosure

Commercial/industry

Evidence Evaluation Expert (ILCOR/AHA)

Potential intellectual conflicts

Deputy Chair Australian Resuscitation Council (ARC)

Chair ALS Committee ARC

ARC rep on International Liaison Committee on Resuscitation (ILCOR)

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Plan of attack

Background of need for consensus on science

The systematic review (worksheet)

Why we need different levels of evidence

Threshold to change

Where to from now

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The Tony Smith modification of LOEsLevel one – randomised trials that support my own opinion

Level two – expert opinions that support my own opinion

Level three – all other forms of evidence that support my own opinion

Level four – any form of evidence that does not support my own opinion

Level five – uninformed opinion of morons

Level six – media reports of the uninformed opinion of morons

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Plan of attack




Threshold to change

Where to from now

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Many published Recommendations/Guidelines

National Research Council of the National Academy of Science (1966)

American Heart Association

1974, 1980, 1986, 1992

various resuscitation councils

European Resuscitation Council

Australian Resuscitation Council

others

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International Liaison Committee On Resuscitation (ILCOR)Advisory Statements(April 1997)

Resuscitation 1997; 34(2):99-150

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Guidelines 2000 for Cardiopulmonary Resuscitation & Emergency Cardiovascular Care

International Consensus on Science

Circulation 2000; 102(suppl I):1-384

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2005 Consensus on CPR Science

281 experts

completed 403

systematic reviews

on 276 topics

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Consensus?

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Consensus!

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So why develop an international consensus on science?

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Review the World Literature: >20,000!5,000?

per day

1,400

per day55

/day

Centre for Evidence-Based Medicine

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Seven alternatives to evidence based medicine

David Isaacs, Dominic Fitzgerald BMJ 1999;319:1618

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Purpose of C2010 process:Summary of science.

Building blocks for councils to develop resuscitation guidelines

Worksheets

= publishable systematic reviews

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Plan of attack




Threshold to change

Where to from now

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Quality items for meta-analyses

Were specific objectives of the review stated (based on a specific clinical question in which patient, intervention, comparator, outcome (PICO)

Was study design defined?

Were selection criteria for stated for studies to be included (based on trial design and methodological quality)?

Were inclusive searches undertaken (using appropriately crafted search strategies)?

Were characteristics and methodological quality of each trial identified?

Were selection criteria applied and a log of excluded studies with reasons for exclusion reported?

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Worksheet: 9 separate sectionsBasic demographics

Clinical Question

Declaration regarding conflict of interest

Search strategy and results

Summary of the evidence

Reviewer’s final comments

Conclusion

Acknowledgements

Citation list

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Clinical Question





Conclusion

Acknowledgements

Citation list

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Demographics

Name, contact addresses, resuscitation council will be obtained as part of the electronic submission process

Minimal data is recorded on worksheet

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Clinical Question





Conclusion

Acknowledgements

Citation list

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Process

Straightforward

Transparent

systematic,

but flexible

Every question vs priorities only

Depends on thoughts regarding final product

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Sources

Worksheets

COSTR

GAPS document (= lack of evidence)

Specific topics from

ILCOR taskforces

Individual councils

With rationale, and source?

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Evidence mapping as a stimulus for questions!

Systematically works through sequence of decision making steps

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Best signs to identifyNumber of initial breaths?

CV ratio, rate?Signs of life?

Energy levels

& waveforms?Duration of CPR?Which airway?RR and Vt?Vasopressors? Timing!!Which signs?Alter management?

Antiarrhythmics?

Etc, etc?

Ensure not omit Qs:

major/contentious

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Need to prioritise some topics

Anticipate contentious areas!

defibrillation, compression:ventilation ratios (including infinity), vasopressors, adjuncts for compression

Stimuli for advisory statements

Set earlier timelines for completion

Eg. completion of worksheets by Ghent or Fall 2008 (and update plan)

Allocate to selected worksheet authors

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Question to be answeredQuestions will be converted into a standardized (PICO) format

Patient/population

Intervention

± Comparison

Outcome

Clarifies purpose and facilitates searching

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PICO

In (P)atients does the (I)ntervention, when compared with (C)omparator, improve (O)utcome.

In Patients does the Intervention, when compared with Comparator, improve the diagnosis/prediction of the Outcome (or clinical state etc).

Default hypothesis=(I) has positive effect!

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Patient/population

Broad versus narrow

Usually better broad initially, as question probably important in related patients

Cardiac arrest vs OOHCA vs OOHCAVF

Can summarize within worksheet

Clarifies purpose and facilitates searching

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Intervention/Comparison

Most important components of search strategy

Comparison may be

usual care

Other specific intervention

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Outcome

Ultimate outcome for an intervention during cardiac arrests is survival (ideally long term and neurologically intact)

In some settings (eg. manikins), only accurate performance or haemodynamics

Searches do not need to specify, but can soon identify appropriate endpoints

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Types of study

Will determine

Specific wording of question

Levels of evidence to be used

Quality scales to be used

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New versus updated worksheet

Will be determined by task-force

Requirements for searching will be different

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Clinical Question





Conclusion

Acknowledgements

Citation list

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Conflict of interest

Registration: specific conflict of interest form will need to be completed electronically, and updated on a regular basis

In addition, a brief declaration regarding any relevant conflicts is required for each worksheet on behalf of all authors.

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Clinical Question





Conclusion

Acknowledgements

Citation list

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Search strategyTwo of the most important factors that are related to the final quality of a systematic literature review are:

a clearly stated search strategy

a clearly defined inclusion and exclusion criteria for the final evaluation phase

= “methodology section” of the worksheet based systematic review

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Databases to be searched

the Cochrane Library

Systematic Reviews

Central register of Controlled Trials

Database of Abstracts of Reviews of Effects

Medline (eg. PubMed, OVID or Scopus)

Embase

AHA Endnote database (EndNote X provided)

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Additional strategies to help identify articles

Review of references of relevant articles (or reviews)

Use of forward searching

eg. “cited by” in Scopus, Google Scholar and Web of Science

Hand searching (manual reviewing) of specific journals (eg. Resuscitation)

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Retrieving relevant articles

Identify with review of the title & abstract

Most of the articles that you find will be accessible in an electronic format

individual journal or institutional subscription

requested from your institution

not able to obtain identified article, let us know and we will assist whenever possible

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Inclusion and exclusion criteria

Clearly stated

study design (eg. RCTs, animal studies age ranges, review articles etc.)

no abstract only studies

Specific (eg do not relate directly to the question)

excluded or “Level 5” evidence

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Results of search

Summary of studies meeting criteria meeting further review

(including subsequent LOE allocation)

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Clinical Question





Conclusion

Acknowledgements

Citation list

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Individual study review

Level of Evidence

Relevance to the question asked

Methodological quality

Outcome(s) assessed

Magnitude of any observed effect

Direction of support or otherwise for the (+ve) hypothesis, according to the specific outcomes that have been assessed

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Summary of studies in tables

Supporting/Neutral/Opposing for hypothesis

LOE (according to question type)

Quality of study

Outcomes assessed

Other

Overlapping patients

Animal studies

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Plan of attack




Threshold to change

Where to from now

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Levels of evidence

Hierarchy of study design in order of minimization of bias

RCTs

Studies with concurrent controls

Studies without concurrent controls

Indirect/Animal/bench/modelling

Judged from high to very low, but with overlap dependent on quality

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C2005: surely our default

BUT

1 & 2 definitions include size of effect

7 was poorly used, and really overlaps with 6!

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We had an opportunity to revise our approach

review what’s out here

Use the best for us, and/or

Adopt those features we like, and

Publish our approach

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What’s out there? 2 reviews already

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Grade

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GRADE

Allows downgrading of quality estimate if involve “indirect evidence”

Population groups

? Animals etc!

Prognostic or aetiologic studies only useful if their use modifies outcomes!

Very good approach to making recommendations

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SIGN

Scottish Intercollegiate GuideliNes

To develop evidence based guidelines

Revised methodology from 2000

Widely used in UK

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SIGN LOEs

From 1 to 4 (expert opinion)

From ++ to + to -

Includes meta-analyses (including those of non-RCTs)

No retrospective control subset

Nil below case series (eg animals etc)

Not for non-therapy studies

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(A)NH&MRC

Australian National Medical Heath and Research Council

Revised in 2005-6

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(A)NH&MRC

LOEs from I to IV

Separates study types (intervention, diagnosis, prognosis, aetiology, screening)

Definitions and quality assessment tools for each

Input from McMaster, Oxford and GRADE

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(A)NH&MRC

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(O)CEBM

Oxford Centre for Evidence Based Medicine

Widely known, comprehensive system

10 levels of evidence (with definitions)

Covers therapy/aetiology, Prognosis, Diagnosis, Economic analysis

Simplistic compression into 4 grades of recommendations (1=A, 2-3=B, C=3, D=4)

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(O)CEBM May 2001

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ACCP

American College of Chest Physicians

Limited to 3 LOEs (A-C)

A=RCTs, B=RCTs of lesser quality, C+=extrapolated from RCTs, C=observational

Limited to 2 Grades of recommendation based on LOE and clarity of risk/benefit

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ACCP

Table 1: Current Approach to Grades of Recommendations

Grade of

recommendation

Clarity of

risk/benefit

Methodologic strength

of supporting evidence

Implications

Example of

recommendation

1A

Risk/benefit

clear

Randomized controlled trials (RCTs) without important limitations

Strong

recommen dation,

can apply to most

patients in most

circumstances

without reservation

We recommend warfa rin

therapy in patients with

atrial fibrillation at high

risk for stroke

1 B

Risk/benefit

clear

RCTs with important

limitations (inconsistent

results, methodological

flaws*)

Strong

recommen dations,

likely to apply to

most patients

We recommend that

pentoxifylline should not

be used in patients with

intermittent claudication

1 C+

Risk/benefit

clear

No RCTs but RCT

results can be

unequivocally

extrapolated, or

overwhelming evidence

from observational

studies

Strong

recommen dation,

can apply to most

patients in most

circumstances

We recommend long-term

warfarin therapy for

patients with atrial

fibrillation and rheumatic

mitral valve disease

1 C

Risk/benefit

clear

Observational studies

Intermediate

strength

recommen dation;

may change when

stronger evidence

available

We recommend

surveillance and

postpartum

anticoagulation for

pregnant patients with

prior venous

thromboembolism

associated with a transient

risk factor

2A

Risk/benefit

unclear

RCTs without important

limitations

Intermediate

strength

recommen dation,

best action may

differ depending on

circumstances or

patientsÕ or societal

values

We do not recommend

aspirin as sole therapy in

patients after hip fracture

surgery to prevent venous

thromboembolism

2 B

Risk/benefit

unclear

RCTs with important

limitations (inconsistent

results, methodological

flaws)

Weak

recommen dation,

alternative

approaches likely to

be better for some

patients under some

circumstances

We recommend early

anticoagulation in patients

with acute cardioembolic

large-artery ischemic

stroke who are ineligible

for thrombolysis

2 C

Risk/benefit

unclear

Observational studies

Very weak

recommen dations;

other alternatives

may be equally

reasonable

We recommend long term

aspirin therapy in patients

with bioprosthetic heart

valves who are in normal

sinus rhythm

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Others (less applicable)

US Preventative Services Taskforce

US Task Force on Community Preventative Services

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Comparisons and proposal

GRADE approach closest to our needs

Not numerical

Needs additional “non-therapy” LOEs

OCEBM or NH&MRC

Study type/Approach C2005 Grade SIGN NH&MRC OCEBM

Meta-analyses 1 n/a 1++ to 2++ I 1a or 2a

RCTs 1 or 2 High/Mod/Low 1/1+/1++ II 1b or 2b

Concurrent controls 3 High/Mod/Low 2- to 2++ III-1 or III-2 2b to 4

Retrospective controls 4 Low n/a III-3 ?1c!

No controls 5 Very low 3 IV 4

Animal/Mechanical/Model 6 ? As for extrap n/a n/a n/a

Extrapolations 7 Downgraded n/a n/a n/a

Covers "non-therapy" studies ?1to7 Irrelevant! No Detailed Detailed

C2010

12

34

55

YES

1 or 2

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Levels of Evidence for Therapeutic Interventions

LOE 1: Randomised Controlled Trials (or meta-analyses of RCTs)

LOE 2: Studies using concurrent controls without true randomisation (eg. ÒpseudoÓ-randomised)

LOE 3: Studies using retrospective controls

LOE 4: Studies without a control group (eg. case series)

LOE 5: Studies not directly related to the specific patient/population (eg. different

patient/population, animal models, mechanical models etc.)

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Flow chart for all LOEs

Does the study directly address the question asked?

Yes No

LOE = 5LOE = 1 to 4

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Flow chart for intervention LOEs

Does the study have its own control group?

Yes No

LOE = 4LOE = 1 to 3

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Does the study use concurrent controls?

Yes No

LOE = 3LOE = 1 or 2

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Does the study use true randomisation?

Yes No

LOE = 2LOE = 1

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In post-cardiac arrest patients with ROSC (P), does therapeutic

hypothermia (I) compared with usual care (C), improve morbidity or

mortality (O)?

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LOE 5

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LOE 4“The clinical use of hypothermia following cardiac arrest”Williams GR, Spencer FC. Ann Surg 1958;148:462-8.

Case report of 4 cases of good neurological outcome after in-hospital cardiac arrest.

All had open cardiac massage, 3/4 had fixed dilated pupils, all cooled after ROSC to 30-34°C with water cooled mattress for 24-72 hours.

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22 adults (historical controls)

surface cooled to 33C (ice packs, vecuronium) for 12 hrs, then warmed over 6 hrs

no adverse effects (bleeding [4 thrombolytics], sepsis)

more with good neurologic outcome 11/22 v 3/22

(17/22 had unreactive pupils in ED, 18/22 no response to pain)

Bernard SA, Jones BM, Horne MK (1997) Clinical trial of induced hypothermia in comatose survivors of out-of-hospital arrest.

Ann Emerg Med 30:146-153.

LOE 3

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• Multicentre study of OOH cardiac arrest in Melbourne

Australia.

• VF at arrival of ambulance, ROSC and persistent coma, but not

age < 18 (men) or <50 (women, as ? pregnant), hypotension (SBP

< 90 despite epinephrine infusion), or other causes of coma.

• Allocated according to day of month (ie. pseudo-randomised,

not blinded; but ? authors "not aware of eligible patients who were

not included in the outcome analysis”)

LOE 2

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Randomised controlled multicentre European study with

blinded assessment of outcome.

• Consecutive cases if initial VF/pulseless VT with , witnessed,

presumed cardiac cause, collapse-EMS resuscitation attempt time

5-15 min, ROSC within 60 min of collapse, no subsequent

prolonged hypotension or hypoxia before cooling, temperature not

<30°C on admission, or pre-existing

malignancy/pregnancy/coma/CNS depression with drugs/known

coagulopathy.

• Family informed about trial, but no withdrawals.

• Random numbers, blocks of 10, stratified by centre, sealed

envelope. Treating personnel not blinded, neurologic assessors

"unaware".

LOE 1

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What about meta-analyses???

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Plan of attack




Threshold to change

Where to from now

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Levels of Evidence for Therapeutic Interventions

LOE 1: Randomised Controlled Trials (or meta-analyses of RCTs)

LOE 2: Studies using concurrent controls without true randomisation (eg. ÒpseudoÓ-randomised)

LOE 3: Studies using retrospective controls

LOE 4: Studies without a control group (eg. case series)

LOE 5: Studies not directly related to the specific patient/population (eg. different

patient/population, animal models, mechanical models etc.)

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Assessing quality of individual studies

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Quality for RCTs

Many checklists available

None found perfect, some conflict

Demonstrated to influence outcome

True random allocation

Allocation concealment

Blinding

Funding or sponsorship

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Quality (summary)

There is no uniformly agreed to way of defining methodological quality

A number of numerical systems have been proposed but all have their limitations.

Instead of a strict criterion based assessment, we ask the worksheet reviewer to allocate the quality of each study into Good, Fair and Poor.

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Quality items for RCTs

Was the assignment of patients to treatment randomised?

Was the randomisation list concealed?

Were all patients who entered the trial accounted for at its conclusion?

Were the patients analysed in the groups to which they were randomised?

Were patients and clinicians "blinded" to which treatment was being received?

Aside from the experimental treatment, were the groups treated equally?

Were the groups similar at the start of the trial?

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Clinical Question





Conclusion

Acknowledgements

Citation list

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“Discussion section” of evidence based review

very important part of worksheet

succinctly describe the results of their review

including reference to individual studies whenever specific statements are made

start to synthesize the information.

tease out contradictions, make observations, and propose solutions.

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Clinical Question





Conclusion

Acknowledgements

Citation list

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Consensus on science

In this section the author should try and create a summary statement that encompasses the body of evidence, using generic format

WITH REFERENCING TO CITATIONS

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Output from worksheet

Statements on consensus on science

EPICOT (used in C2005)• Evidence, Population, Intervention, Comparison,

Outcome and Time stamp (assumed Nov 22 06)

• http://bmj.bmjjournals.com/cgi/content/full/333/7572/804

Treatment recommendations

Consider GRADE/ATS suggestion

http://bmj.bmjjournals.com/cgi/content/full/333/7572/804

http://bmj.bmjjournals.com/cgi/content/full/333/7572/804

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Generic statements

Evidence from X# type of study in adults {{insert study design and highest quality design}} [refs] and additional studies {{insert range of LOE}} [refs] document consistent improvement in {{insert relevant clinical outcome}} when {{insert treatment}} is administered by {{insert provider}} to patients with {{insert clinical condition}} in the {{insert prehospital, hospital, etc}} setting.

Therefore, administration of {{therapy}} for patients with {{condition, setting by personnel}} is recommended/should be considered.

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Treatment recommendation.

Consider

magnitude of the effect

outcome affected

generalizability from population studied

potential barriers to implementation (including cost, education, logistics etc).

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Clinical Question





Conclusion

Acknowledgements

Citation list

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Acknowledgements

As with any publication that undergoes peer review, the worksheet author(s) are required to acknowledge any significant contributions to their work

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Clinical Question





Conclusion

Acknowledgements

Citation list

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Citation list

Pasted from EndNote

Citation

Abstract

Comments• LOE,

• Quality,

• Supportive/Neutral/Opposing, and

• Brief summary statement(s), including comment about industry funding.

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C2010 Worksheet Flow Draft

Author submits WS online

Preliminary review by office

Complete Incomplete

Worksheet Expert Review

C2010 Conference

Review/Sign off by Task Force Chairs

Revise

CoSTR Review by Editorial Board

CoSTR

Publication

Revise

Revise

WS Posted to

the ExtraNet

WS Posted to

Internet

CoSTR Writing

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mc.manuscriptcentral.com/ilcor

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Studies of diagnostic tests

“Test” = examination finding/investigation

Gives “result”

Starting point is initial “test” on patients

Compare “test” result with known outcome (“gold standard”)

Develop threshold result (to alter Mx) = Clinical Decision Rule (CDR)

Better = confirm result in multiple centers

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C2010 LOEs for Diagnostic StudiesLOE D1: Validating cohort studies (or meta-analyses), or validation of Clinical Decision Rule (CDR)

LOE D2: Exploratory cohort study (or meta-analyses), or derivation of CDR, or split-sample validation only

LOE D3: Diagnostic case control study

LOE D4: Study of diagnostic yield (no reference standard)

LOE D5: Studies not directly related to the specific patient/population (eg. different patient/population, animal models, mechanical models etc.)

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Diagnosis outcomes

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Positive

Predictive

Value = 100%

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�Diagnostic cohort (studies of test

accuracy) or case-control studies (D1, D2, or D3)

Was the diagnostic test evaluated in an appropriate spectrum of patients (like in those in whom it would be used in practice; spectrum bias”)?

Was there an independent, blind comparison (review bias) with a reference ("gold") standard of diagnosis?

Was the reference standard applied regardlessof the test result (verification bias)?

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Studies related to prognosis

All “prognosis” questions share 3 elements

a qualitative aspect (which outcomes could happen?)

a quantitative aspect (how likely are they to happen?), and

a temporal aspect (over what time period?)

(EBM Sackett 2000)

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C2010 LOEs for Prognostic StudiesLOE P1: Inception (prospective) cohort studies (or meta-analyses of inception cohort studies), or validation of Clinical Decision Rule (CDR)

LOE P2: Follow up of untreated control groups in RCTs (or meta-analyses of followup studies), or derivation of CDR, or validated on split-sample only

LOE P3: Retrospective cohort studies

LOE P4: Case series

LOE P5: Studies not directly related to the specific patient/population (eg. different patient/population, animal models, mechanical models etc.)

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“Prognostic” studies using controls (LOE P1, P2 or P3)

Were comparison groups clearly defined?

Were outcomes measured in the same (preferably blinded), objective way in both groups?

Were known confounders identified and appropriately controlled for?

Was follow-up of patients sufficiently long and complete (eg. >80%)?

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Worksheets

Over 500 planned

Education resources


Templates and explanatory documents

Plan for additional video support

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What will it look like?

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2005 Consensus on CPR Science

281 experts

completed 403

systematic reviews

on 276 topics

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Plan of attack




Threshold to change

Where to from now

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Evidence behind the guidelines

some recommendations based on RCTs

many recommendations based on extrapolations from other RCTs

most recommendations are “consensus opinion” based on lesser levels of evidence

epidemiological

case series/experience

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Hobart 20099/17/2009 Slide 157

Outcome threshold for change

difficult to set

Variable

hospital discharge neurologically intact

survival to hospital, ROSC

Portfolio:

totality of evidence

pressure/desire to change

Ease of training/implementation

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What rhythm is our process in?

Hobart 20099/17/2009 Slide 161

Threshold for practice change

“Portfolio”Totality of evidence

• Quality & level

Magnitude of effect

• NNT

• Population at risk

Simplicity of training & implementation

Necessity of change

Bretylium

Monophasic

Pauses in compressions

Problems with training & implementation

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B

(Code

Blue)

30:2

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& don’t

push

hard

enough!

Europeans

interrupt

compressions

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Americans

blow

too fast

& interrupt compressions

Hobart 2009Circulation. 2004;109: 1960-1965

!

Hobart 2009 Circulation. 2004;109: 1960-1965.)

Not a CO2

effect!

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COSTR: ratio!

There is insufficient evidence that any specific

compression:ventilation ratio is associated with

improved outcome in patients with cardiac arrest.

To increase the number of compressions given,

minimize interruptions of chest compressions,

and simplify instruction for teaching and skills

retention, a single compression-ventilation ratio

of 30:2 for the lone rescuer of an infant, child, or

adult victim is recommended.

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Plan of attack




Threshold to change

Where to from now

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Where to nowMarch 2009: Osaka, Japan

Nov 2009: Orlando, Florida, USA

Feb 2010: Dallas, Texas, USA

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“Any attempt at resuscitation is better than

no attempt”

Australian Resuscitation Council

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Safeguards

Clear process based on methodology for systematic review

Detailed conflict of interest process

Multiple layers of independent review

Participants from wide backgrounds

Profession, country, continent

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Plan of attack




Threshold to change

Where to from now

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Documents

How should we review the resuscitation science? The ... › download › 2009_spark_of_life_conference_-_ho… · 2005 Consensus on CPR Science 281 experts completed 403 systematic