Insert Long Worksheet Title

New Orleans Nov 2008 #1

ILCOR resuscitation science review process: update

New Orleans Nov 5th 2008

Peter Morley


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)


Purpose of C2010 process:

Summary of science

Worksheets

= publishable systematic reviews


Plan of attack

Summary (worksheet)

Worksheet flow

Identification of questions

Questions related to interventions

Questions related to diagnosis/prognosis

Worksheet examples



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?


Plan of attack

Summary

Worksheet flow




Worksheet examples


Internet site mc.manuscriptcentral.com/ilcor


Worksheet flow for authors (1):

Author notified of worksheet question

Author registers COI

Author accesses instructions on internet

Author submits initial search strategy*

Author continues with worksheet

Author submits subsequent revisions of worksheet


Revision flow for authors (2):

Feedback provided

Staff (Tanya)

Taskforce co-chair (or delegate)

Worksheet expert

Evidence Evaluation Expert

Incomplete (feedback provided)

Complete for interim (need 2009 update)

• Worksheet posted on intranet



Final 2009 worksheet submitted incorporating 2009 search data

Incorporating feedback

• task forces, WSE, E3


Complete

Worksheet posted on internet



Worksheet feedback from community:


Complete

Worksheet presentations (2008/9/10)

Worksheet information incorporated into

Consensus on Science document

C2010 Worksheet Flow Draft


WS Posted to the ExtraNet

WS Posted to

Internet

Author submits WS online

Preliminary review by office

Revise

Worksheet Expert Review

Complete Incomplete

Review/Sign off by Task Force Chairs

Revise

Revise

C2010 Conference

CoSTR Writing

CoSTR Review by Editorial Board

CoSTR

Publication


Plan of attack

Summary

Worksheet flow




Worksheet examples


Have we flagged all the questions that we need to answer for C2010???

Ongoing process!


Best signs to identify

Number 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


Plan of attack

Summary

Worksheet flow




Worksheet examples


Flow chart for all LOEs

Does the study directly address the question asked?

Yes No

LOE = 1 to 4 LOE = 5


Flow chart for intervention LOEs

Does the study have its own control group?

Yes No

LOE = 1 to 3 LOE = 4



Does the study use concurrent controls?

Yes No

LOE = 1 or 2 LOE = 3



Does the study use true randomisation?

Yes No

LOE = 1 LOE = 2


Plan of attack

Summary

Worksheet flow




Worksheet examples


C2010 LOEs for Diagnostic Studies

LOE 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.)


Quality for diagnostic studies

Consistent aim = minimize bias


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 regardless of the test result (verification bias)?


Diagnostic studies without reference standard (LOE D4)

(As for other LOEs with out controls)

Were outcomes measured in an objective way?

Were known confounders identified and appropriately controlled for?

Was follow-up of patients sufficiently long and complete?

Diagnosis outcomes




Sensitivity

= those with the disease who were identified by the +ve test / all with disease

Specificity

= those without the disease who were identified by the -ve test / all without disease



Likelihood ratio for a positive test

= probability +ve test in those with disease / probability +ve test in those without disease [= sens/(1-spec)]

Likelihood ratio for a negative test

= probability -ve test in those without disease / probability -ve test in those with disease [= (1-sens)/spec)]



C2010 LOEs for Prognostic Studies

LOE P1: Inception (prospective) cohort studies (or metaanalyses 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.)


Quality for prognostic studies

Consistent aim = minimize bias


New versus updated worksheet

Will be determined by task-force

Requirements for searching will be different (2004 onwards)

Need to refer to articles cited in previous worksheet

Summary from C2005 can be pasted and designated


Worksheet: 9 separate sections

Basic demographics

Clinical Question

Declaration regarding conflict of interest

Search strategy and results

Summary of the evidence

Reviewer’s final comments

Conclusion

Acknowledgements

Citation list


Search strategy

Two 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



Deciding Search Terms first select the most unique concept

Combining searches

In practice, often there is no C

(comparison), and you may be interested in all O (outcomes)

Starting with a simple combination of the Population and Intervention is often the best approach: P and I.


Combining searches

Use Boolean Operators

“AND” restricts searches: to be retrieved a reference must be indexed with every term searched. The more terms that are combined with ‘and’, the smaller the number of references retrieved.

“OR” extends searches: to be retrieved a reference just needs one of the terms searched. The more terms you ‘or’, the greater the number of references retrieved.


Medical Subject Headings (MeSH)

The National Library of Medicine uses a controlled vocabulary, referred to as Medical Subject Headings (MeSH) cross-reference every single abstract indexed on Medline.

The use of a controlled vocabulary provides a consistent way to retrieve information that may use different expressions to describe similar concepts

To ensure that this controlled vocabulary is reliably applied, when a paper is submitted for indexing on

Medline, a professional nosologist assesses the paper and indexes it using the appropriate MeSH terms.


Refining your search terms use the Details button to evaluate your search terms use the MeSH database to refine your

MeSH terms use the display citation feature to find

MeSH categories


“three step process” the generation of a series of focused clinical questions to identify potential search terms

The use of PubMed Clinical Query search filters

The use of:

Details feature

MeSH Database

Display Citation feature to select and refine appropriate MeSH terms.

Search strategies

1. exp Heart Arrest/

2. exp Death, Sudden/

3. cardiac arrest.tw.

4. heart arrest.tw.

5. cardiopulmonary arrest.tw.

6. sudden cardiac death$.tw.

7. sudden death$.tw.

8. or/1-7

9. exp Cardiopulmonary Resuscitation/

To 67 steps



Succinct example

"infusions, intravenous"[MeSH Terms] AND

("heart arrest"[MeSH Terms] OR

"cardiopulmonary resuscitation"[MeSH Terms])

("cardiac only" OR "compression only" OR

"compressions only" OR "hands only") AND

("heart arrest"[MeSH Terms] OR

"cardiopulmonary resuscitation"[MeSH Terms])









Cardiac arrest centres














Troubleshooting your (PubMed) search

Too many results (eg. >3000)

Use MeSH only, then combine with

(AND) text words, or limits

Too few results (eg. <100): broaden

Avoid limits and subheadings

Add text words to MeSH

Consider alternative words


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


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


Results of search

Summary of studies meeting criteria meeting further review

(including subsequent LOE allocation)


Problems with submitted searches

Scant detail list of words only

No clear way they are combined

Too simplistic

Too narrow (miss a lot)



Basic demographics

Clinical Question





Conclusion

Acknowledgements

Citation list


Problems with LOE/quality

1-4 vs 5

Not answer question

• Different population or disease

• Manikin not human

• Time frame wrong (before, during, late)

Good vs not include

Power, protocol changed, follow up



Basic demographics

Clinical Question





Conclusion

Acknowledgements

Citation list


Reviewer’s final comments

“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.



Problems with comments

Scant detail: not actually summary

No description of individual studies

Not referenced


Standardised reference

(citation) template

To facilitate accurate translation into

CoSTR: [Author Year, Pages]

We will circulate endnote style to you








You can format your favorite style



Basic demographics

Clinical Question





Conclusion

Acknowledgements

Citation list


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


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.


Treatment recommendation.

Consider magnitude of the effect outcome affected generalizability from population studied potential barriers to implementation

(including cost, education, logistics etc).


Problems with COS and TR

Often too detailed

Repeating what should be the summary

Needs succinct statements or will be overlooked!

TR needs to follow from COS

Therefore . . .



Basic demographics

Clinical Question





Conclusion

Acknowledgements

Citation list


Citation list

Pasted from EndNote

Citation

Abstract

Comments

• LOE,

• Quality,

• Supportive/Neutral/Opposing, and

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



Problems with citation list

No abstracts

No comments

Not alphabetical order reader cannot chase articles citations referred to many different ways

New Orleans Nov 2008 #92 mc.manuscriptcentral.com/ilcor


Where to now

Nov 2008: New Orleans, USA

“Spring” 2009: Osaka, Japan

Nov 2009: Chicago, USA

Feb 2010: Dallas


Essential slide.

Estimated presentation time 20 sec

Total of 9 (no studies) to 12 slides (maximum) using standard format.

Almost all information should be able to be cut and pasted from worksheet.

Please delete these text boxes when not needed anymore.

Insert Worksheet Question

Worksheet identifier: BLSXYZ

Author: Name

Affiliation: Name

Taskforce: Name

Other Worksheet Authors: Names

Essential slide. Estimated time <30 sec


Please paste from worksheet.

Worksheet Specific Conflict

Of Interest disclosure

Please paste from worksheet

Commercial/industry

List here

Potential intellectual conflicts

List here



Insert your proposed Treatment

Recommendations recommendation(s) from worksheet.

Proposed Treatment evaluate your presentation and decide if the data supports it or not.

Insert Treatment Recommendations from worksheet eg.

Parachutes should be used in all planned and unplanned jumps from altitude.

Handkerchiefs should not be used in jumps from altitude



Supporting evidence table

Select header, table, and footer from Worksheet and “Paste special” as picture.

Adjust pasted picture size if necessary. Paste key beside key article(s).

Summary of evidence

Evidence Supporting Clinical Question

Good

Fair

Poor

1 2 3

Level of evidence

4 5

A = Return of spontaneous circulation

B = Surviva l of event neurological surviva l

C = Survival to hospital discharge E = Other endpoint

Italics = Animal studies

D = Intact denotes key article(s)



Neutral evidence table



Evidence Neutral to Clinical question

Good

Fair

Poor

1 2 3


4 5








Opposing evidence table



Evidence Opposing Clinical Question

Good

Fair

Poor

1 2 3


4 5







Optional slide. Estimated time <60 sec

Key studies

One of up to 3 (maximum) summary slides (in standard format).

May refer to more than one citation per slide if necessary.

Present a key summary graph or table

Citation #1 [Author, Year, pages]



Key studies

One of up to 3 (maximum) summary slides (in standard format).

May refer to more than one citation per slide if necessary.

Present a key summary graph or table

Citation #2 [Author, Year, pages]



One of up to 3 (maximum) summary slides (an example of an alternative

Summary Outcomes (example)

Copy and Paste Summary Table from Worksheet

Patient group Numbers ROSC Long term survivors

K/x (m%) Adult c-surgery

Adult other

Total adult

Paed c-surgery

Paed other

Total paed x y

D/x (g%)

E/y (h%) x + y D+E/x+y (i%)

A

B

A + B etc etc etc etc


Essential slide (one slide only).

Estimated time <60 sec

Insert Summary statement(s) from worksheet.

Consensus on Science statements

Insert Summary statement(s) from worksheet

(eg. Evidence from 3 observational studies [Author, Year, pages] and 7 animal studies [Author, Year, pages] confirm consistent benefits for Parachutes over Handkerchiefs when assessing the following outcome variables: . . .)

Some harm was noticed when parachutes failed to open

(NNH= 1) [Author, Year, pages]


Essential slide (one slide only).

Estimated time <60 sec

Insert Treatment recommendations(s) from worksheet.

Draft Treatment Recommendations

Insert Treatment Recommendations from worksheet eg.

Parachutes should be used in all planned and unplanned jumps from altitude.

Handkerchiefs should not be used in jumps from altitude

Essential slide (one slide only). Estimated time <30 sec


Knowledge Gaps (eg. ETT vs BVM)

Other specific worksheets that would be helpful

Relationship with training to ETT success

Specific research required

Adult ETT vs BVM


Ongoing issues

Worksheet template issues

Hypothesis, LOEs D1-5 etc

Presentation template

Worksheet preparation process

Submission process

Combination of information

Overlapping areas of interest

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