itamar nitzan, md, francis mimouni, md, reuben...

Itamar Nitzan, MD, Francis Mimouni, MD, Reuben Bromiker, MD Department of Neonatology

The Shaare Zedek Medical Center The Hebrew University

Jerusalem, Israel

And where does it stand in terms of evidence-based medicine?

What is the quality of a consensus statement?

A general agreement about something : an idea or opinion that is shared by all the people in a group

Reference: http://www.merriam-webster.com/dictionary/consensus

Nobody knows its true definition, for the simple reason that there have been no attempts to identify what consensus actually is.

The lack of such a definition means that the use of consensus to determine whether a specific action should be performed is nearly worthless.

The word can mean so many things that it can often be used - and abused - in order for an entity to meet its ends.

Consensus is often confused for the attainment of a specific percentage of votes in support of something.

Consensus does not mean unanimity although unanimity or something near would be an ideal result.

Should not the rules be written in the methods section of the article?

EBM is about finding evidence and using that evidence to make clinical decisions.

A cornerstone of EBM is the hierarchical system of classifying evidence. This hierarchy is known as the levels of evidence.

Physicians are encouraged to find the highest level of evidence to answer clinical questions

The levels of evidence were originally described in a report by the Canadian Task Force on the Periodic Health Examination in 1979.

The report’s purpose was to develop recommendations on the periodic health exam and base those recommendations on evidence in the medical literature.

The authors developed a system of rating evidence when determining the effectiveness of a particular intervention.

Systematic reviews with meta-analyses of RCTs trials use the data from individual RCTs and statistically pool it.

This effectively increases the number of patients that the data were obtained from, thereby increasing the effective sample size.

Consensus statements can be located at the lowest level of evidence (expert opinions)

Consensus statements can be located at the highest level of evidence (systematic reviews performed by experts)

multisocieties report

J Allergy Clin Immunol 2015;136:258-61 PEDIATRICS Volume 2015; 136 (3):600-604

World Allergy Organ J. 2015 Aug 3;8(1):27

1. American Academy of Allergy, Asthma & Immunology 2. American Academy of Pediatrics 3. American College of Allergy, Asthma & Immunology 4. Australasian Society of Clinical Immunology and

Allergy 5. Canadian Society of Allergy and Clinical Immunology 6. European Academy of Allergy and Clinical Immunology 7. Israel Association of Allergy and Clinical Immunology 8. Japanese Society for Allergology 9. Society for Pediatric Dermatology 10. World Allergy Organization

Impossible to know from the article….

American Academy of Pediatrics report

PEDIATRICS 2010; 126: 597-615

How were the authors selected ? (self selected? Elected members of a society?)

o Mark E. Halstead, MD, Kevin D. Walter, MD, and the council on sports medicine and fitness

Where did they meet? What were the precise questions asked? How did they search for literature?

(systematic review or not?) How did they reach consensus?

NIH consensus

J Allergy Clin Immunol 2015;136:262-71

On March 19, 2013, the Division of Allergy, Immunology, and Transplantation of the National Institute of Allergy and Infectious Diseases (NIAID) convened a workshop on drug allergy (Bethesda, MD)

International experts in the field of drug allergy with backgrounds in allergy, immunology, infectious diseases, dermatology, clinical pharmacology, and pharmacogenomics.

These experts were joined by representatives from several National Institutes of Health institutes and the US Food and Drug Administration.

To identify important advances that make new research directions feasible

To make suggestions for research priorities and for development of infrastructure to advance our knowledge of the mechanisms, diagnosis, management, and prevention of drug allergy.

This is a report of a single-day workshop and therefore does not provide a comprehensive review of the field of immunologically mediated DRs.

Because of the limited duration of the workshop and the limited number of investigators who could be invited, it was not possible to do a comprehensive review of the field.

A quantitative approach to published consensus statements

Consensus statements were recorded in the Medline since 1976

To compare the trends in the yearly number of consensus publications in the pediatric and the adult literature.

Medline search engine was used to determine the yearly number of published consensus statements from 1976 to 2014.

We used the filters of "English" only, "Consensus Development conference" or "consensus development conference (NIH)", or "practice guidelines"

We also used the filter of "age" ( all ages, adults (19 years or more), child (birth to 18 years).

The Minitab statistical program version 16 (Minitab, State College, PA) was used for statistical analyses.

Linear and polynomial regression were used to determine trends.

A P-value of <0.05 was considered significant.

An analysis of the first and last 100 consensus articles of the study period revealed that many consensus articles were not age-classified, and their contents were more often applicable to adults than to pediatric patients.

100 first articles 100 last articles

Pediatric only 9(8) 12 (14)

Adult only 7(42) 8 (40)

Unclassified by PubMed 68 79

Classified as both by

PubMed

16 1

The first numbers are according to PubMed, the numbers in parentheses are after our own tagging.

All ages consensus statements increased in a cubic fashion (r2= 97.9%, P<0.0001 ) over time (nearly none since 1976 to late 1980's, and up to approximately 1400/year in the 2010's.

Pediatric ages consensus statements increased in a cubic fashion (r2= 94.1%, P<0.0001 ) (nearly none since 1976 to 1980's, up to approximately 200/year in the 2010's)

201520102005200019951990198519801975

200

150

100

50

0

Year

Pe

dia

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R-Sq 94.1%

Adult ages consensus statements increased in a cubic fashion (r2= 94.7%, P<0.0001 ) (nearly none since 1976 to 1980's, up to approximately 200/year in the 2010's)

201520102005200019951990198519801975

200

150

100

50

0

Year

Ad

ult

s c

on

se

nsu

s a

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R-Sq 94.7%

The yearly published consensus number has increased dramatically since the 1980's to nowadays.

In view of the cubic relationship, the rate of increase may have slowed down in the past few years.

Most consensus statements are not age-tagged and may be more applicable to adults than to children

Consensus of local versus global impact

Quality versus quantity Criteria for quality consensus statements must

be defined: ◦ Selection of experts ◦ Methods of review and analysis of the available

evidence ◦ Level of evidence of each statement made

CIP was founded “for the purpose of promoting and seeking optimal Global Pediatric Health Care by establishing academic debate platforms that stimulate Consensus and agreements on main child health pathologies, difficulties and controversies.”

We speculate that CIP, as an organization, will act over the next few years as the fertile grounds that will grow quality consensus statements that might impact on clinical care, as well as on the trends in consensus pediatric publications over time