Bringing Evidence to Patient CareBringing Evidence to Patient Care

Is the Internet Helping Yet?

Barry Markovitz, MDDepartments of Anesthesiology and Pediatrics

Washington University School of MedicineSt. Louis Children’s Hospital

Case presentation

• A 12 yo white male sustains a crush injury to the chest during a MVA. He presents with signs and symptoms of frank respiratory failure and tracheal intubation is performed. Conventional mechanical ventilation is initiated.

• Over the course of the first 24 hours, his respiratory failure worsens. While on 100% oxygen and PEEP of 15 cm H2O, the arterial pO2 is 50. Chest radiograph demonstrates diffuse radiodensities throughout both lung fields, and the peak airway pressure to achieve a tidal volume of 10 cc/kg is 55 cm H2O.

• The new PL-2 asks if extracorporeal membrane oxygenation would be an appropriate therapy to employ at this point.

Approach: 1990

• The pathophysiologic approach: makes sense

• The expert/"how I trained" approach: I learned this didn't work

• The anecdotal approach: didn't work last time we tried

• The consult approach: may ask a few colleagues you work with

• The textbook approach: no strong support

• Or some combination of these...

Approach: 1998

• First instinct: same as 1990

• Go to bedside workstation: Medline search

Approach: 1998

• First instinct: same as 1990

• Go to bedside workstation: Medline search

– Unable to retrieve original paper(s)

– Not enough time anyway

• Go to Web browser on workstation

Approach: 1998

• First instinct: same as 1990

• Go to bedside workstation: Medline search

– Unable to retrieve original paper(s)

– Not enough time anyway

• Go to Web browser on workstation

– General searching non-specific

– “Metasite” searching too “textbook”

• “What if this is as good as it gets?”

Bringing Evidence to Patient CareIs the Internet Helping Yet?

• Clinical research evidence to practice

• Levels of evidence: original and “synthetic”

• Transmission of evidence

– The biomedical journal - gold standard in trouble?

– The Internet arrives

– E-Publishing - time for a new paradigm?

• Internet research?

• The future

Haynes et al. Br Med J 1998;317:273-276

Levels of Information and Evidence

• Traditional route

– training

– print original journals

– meetings and CME

– consultation

• Faltering now

– information overload

• small fraction truly appropriate for direct application

• ill equipped to digest and synthesize

– busier practices

– reimbursement pressures

Evidence-based Health Care

The aim of evidence based health care is to provide the means by which current best evidence from research can be judiciously and conscientiously applied in the prevention, detection, and care of health disorders. This aim is decidedly ambitious given how slowly important new treatments are disseminated into practice and how resistant practitioners are to withdrawing established treatments from practice even once their utility has been disproved. Haynes et al. Br Med J 1998;317:273-

276

Original Evidence: Translation into Practice

• Outcomes-oriented clinical research

• Practitioner-based EBM

– Generating focused clinical questions

• In pediatric patients with ARDS, does ECMO improve survival?

– Efficiently finding the evidence

• Database searching: tools and techniques

• Locating appropriately focused clinical study (ies)

– Determination of validity, results, applicability

• User's Guide to the Medical Literature

– Questions for articles on therapy, diagnostic tests, prognosis, harm, etc.

Information and Evidence: Translation into Practice

• New venues: Synthetic Research

– Journals that critically appraise primary studies

Information and Evidence: Translation into Practice

• New venues: Synthetic Research

– Journals that critically appraise primary studies

– Systematic reviews: Cochrane Collaboration

Systematic Reviews

• Clear statement of purpose and scope

• Comprehensive search and retrieval of the relevant research

• Explicit selection criteria

• Critical appraisal of the primary studies

• Reproducible decisions regarding relevance, selection, and methodologic rigor of the primary research

• When quantitative methodology applied -> meta-analysis

Information and Evidence: Translation into Practice

• New venues: Synthetic Research – Journals that critically appraise primary studies– Systematic reviews: Cochrane Collaboration

• Formulation of Evidence-Based Practice Guidelines– Critical analysis of primary evidence– Promise of consistency and optimal care– Source, methodology, accessibility

• User's Guide to interpret guidelines...

National Guideline Clearinghouse

• The NGC Web site will:

– contain standardized information for thousands of guidelines such as title, sponsoring organization, author(s), and methodology used;

– provide guideline abstracts, and where possible the full text of guidelines;

– compare and contrast the recommendations of guidelines on similar topics, with summaries covering major areas of agreement and disagreement;

– have topic-specific electronic mailing lists to enable registered users to communicate with one another on guideline development, dissemination, implementation, and use.

The Biomedical Journal

• History of the scientific journal

– 1655: Royal Society of London publishes first scientific journal

– steady growth over 300+ years

– 50 years: exponential growth of researchers, papers, journals

• Sponsored by societies; later commercial publishers

• Peer review process and journal hierarchy

"Professionally our methods of transmitting and receiving the results of research are generations old and now totally inadequate for their purpose"

Vannevark Bush1945

The Process Falters

• What's wrong with this picture now?

– Exponential increase in volume of information

– Economic "serials crisis”

– "Faustian bargain" even more untenable today

– Considering the alternatives now available...

Information Explosion

• Tremendous growth in scientific and biomedical publications

– Estimates: number of papers doubling every 10 years

– Increasing number of journals in a given field

– MEDLINE indexes ~4000 publications; a distinct minority

– Related to numbers of physicians and scientists

• volume of publications key to success

The “Serials Crisis”

• Since 1986, the 121 members of the Association of Research Libraries (ARL) have spent 124 percent more on serials to purchase 7 percent fewer titles (Case 1998).

• Appears to be a difference between society-sponsored and commercial journals

• Individual subscriptions prohibitive

Walker, 1998

Walker, 1998

The “Serials Crisis”

• Becker library: titles cancelled:– For the 1993 subscription period: 440– For the 1994 subscription period: 36– For the 1995 subscription period: 69– For the 1996 subscription period: 188– For the 1997 subscription period: 33

• Becker: 85 titles studied 1996-97: 14 to 69% price increase• SLCH library: one third of 61 titles to be dropped• Developing world: out of reach

The “Faustian Bargain”

• Clinical or basic research scientists must publish their results in peer reviewed journals

– basic goal is dissemination of knowledge

– also a prerequisite for academic recognition and promotion

• Must assign copyright to the publisher

• Why is this the case?

Copyright Conflicts in Scholarly Publishing

• Trade publications – author assigns copyright to publisher– no conflict of interests

• Scholarly publications– author assigns copyright to publisher– significant conflict of interests

• “Faustian bargain” revealed– authors sell their “soul” (copyright) for “immortality”

(distribution of work)

There is something inherently irrational about a model that has an intelligent person giving away ownership of the fruits of intellectual labor to a commercial profit-driven enterprise in which he or she has no proprietary interest. Indeed, in many disciplines an author must actually pay on a per-page basis to have his or her work published, and then must buy back, or expect libraries to buy back, their work (or, similarly, the work of others) with all the recompense going to the journal publishing industry (and it is an industry). In my opinion, this is not an act of charity; it is one of stupidity.

(Morton, 1997)

Print Biomedical Journal: The Case Against

• Expensive to produce, distribute, store

• Limited in scope

– Due to costs, limitations of articles and article size

– supporting data often missing

• Due to medium, limited to text and 2-dimensional graphics

• Inefficient to access

• Citations "cross-link" - but must manually retrieve

• Environmentally incorrect

– Limited natural resource as medium

– Limited and polluting distribution mechanisms

• As currently configured, inherent conflict of interests between authors and publishers

Enter the Internet

• Global high-speed computer "network of networks"

• Military and academic roots

• Explosive growth of late

• Platform-independent, graphical user interface and seamless hyperlinks:

– the World Wide Web

• Graphics, animation, interaction

• Near universal access

Biomedicine and the Net: Unresolved issues

• Quality

• Consistency of access

• Sponsorship and affiliation

• Copyright

– new legislation could limit access and raise costs dramatically

• Ethical issues

– confidentiality and more

• “Practicing” over the net

• Payment

The Case for Electronic Publishing on the Internet

• Eliminates print publishing delays

• (Potentially) nearly universal access

• Unlimited formatting and data inclusion

• True use of "cross-linking" between papers

• Reduction in costs/resources use of print, paper, and distribution

• Potential to bring evidence directly to the bedside

The Death of the Biomedical Journal?

• The physics model: http://xxx.lanl.gov/

– ongoing tradition of circulating "pre-prints"

– 1990, Paul Ginsparg organized a server to collect "e-prints"

– archives thousands of papers, both before and after "publication"

The Death of the Biomedical Journal?

• The physics model: http://xxx.lanl.gov/

– ongoing tradition of circulating "pre-prints"

– 1990, Paul Ginsparg organized a server to collect "e-prints"

– archives thousands of papers, both before and after "publication"

• The social science model: http://cogprints.soton.ac.uk/

– Harnad: subversive proposal, scholarly skywriting

The “Ingelfinger Rule”

“The understanding is that material submitted to the Journal has not been offered to any book, journal or newspaper.”

Franz J. Ingelfinger

JAMA 1997

NEJM 1969

“Electronic publishing (which includes the Internet) is publishing.”

International Committee of Medical Journal Editors

The “Value Added” Journal?

"We write the stuff for this journal. We peer review it. We edit the journal. We buy the journal. We read it. What exactly do you do?" The answer, scandalously, in the case of many publishers is "not much."

Richard Smith, editor British Medical Journal

“Medical journal editors have relationships of trust with many publics, beginning with the reader and the author, extending through the owner and the sources of financial support but, most especially, to patients. In medical information quality of content will continue to be king for the benefit of all of us as patients.”

George Lundberg, editorJAMA

BMJ 1997

Publishing on the Net: Economics 101

• Have seen the spiraling costs of print publications

• What is the cost of Internet publishing?

– estimates range from 30 to 70% less than print

– relate to the medium, e.g., printing, paper, distribution

• Online publications should be significantly less expensive

• Intellectual "labor" is still not compensated!

Time for a New Paradigm?Option 1

• Continue to let publishers set the rules

– maintain the trade model: pay-per-view, site licenses, subscriptions

– academic and wealthy insitutions may get the information, but at a high cost

– does nothing to level the playing field for less fortunate

– perpetuates author-publisher conflict of interest and the “Faustian bargain”

Time for a New Paradigm?Option 2

• A New Paradigm: Non-Commerical E-Publishing

– No need for publishing companies at all

– "University Press" model - centralized (NLM?) or regionalized

– Peer review can be maintained

– Modest page charges should more than cover costs of online production

– It is the editorial board that determines a journal's quality and "prestige" - the medium is not the message!

Time for a New Paradigm?Option 3

• Gradual shift from reader to author payment

– Authors who pay page charges - put the article online at no charge

– Others - wait a year

How Can We Help?

• Individual subversion– enough authors insisting on e-prints, web publication– vote with your feet - avoid journals with regressive

policies• Professional Societies

– lobby the AAP, SCCM, etc.• Academic/Health Care institutions

– consortia of major players• Academic recognition of peer-reviewed Internet publications

Bringing Evidence to Patient Care: Is the Internet Helping Yet?

• A qualified “maybe”– Learning how to use best evidence in patient care

• the resources are there– Getting primary evidence to the bedside

• gaps in service, and at a cost– Integrative/secondary/synthetic evidence

• to a large extent • The future...

– Can the Internet help collect the evidence?

InternetPeer-reviewed “journals”e-PreprintsEducational resourcesOnline databasesConferencing/telemedicinePICU 1PICU 3PICU 2Evidence-based guidelines

A Virtual PICU

An Agenda for Biomedical Informatics: BHAG’s(big hairy audacious goals)

• Virtual Health Care Databank

– Clinical Trials and Clinical Practice

• National Health Care Knowledge Base

– Static resources, EB Guidelines, Problem-specific integration

• Personal Clinical Health Record– Empowered clients (or ‘1984’ revisited)

Greenes et al. JAMIA 1998; 5: 395

Back to our case: Approach 2008

• Patient’s clinical data dowloaded to Internet database in real time

• Risk categories assigned and decision support available

– linked to primary evidence and evidence-based guidelines

– family preferences and values included

• No replacement for physician-patient/family relationship

Fellow revolutionaries: There are three types of people in the world.

Those who make things happen. Those who watch things happen. And those who ask - "What happened?"

John Peters President, Internet Free-Press

http://www.free-press.com/