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EPS Focus Report Date
[Title]
Evidence-based medical
practice in the 21st century
An
Focus Report
January 2006
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Contents
Executive Summary ........................ 2
www.epsltd.com
Introduction................................... 5
Drivers for change .......................... 6
Early adopter case studies ............. 15
• Partners Healthcare
• Adventist Health System
The commercial landscape ............. 18
Expert
•
•
•
•
Interviews
Clin-eguide ........................
Dr J A Muir Gray .................
Theradoc ...........................
Zynx.................................
35
39
40
42
Previous EPS Focus Reports ........... 44
“Publishers will undoubtedly
move into the area of clinical
decision support, integrating
their content into the
workflow of the clinician.
The value of reference-based
content from the clinician’s
perspective is falling because
of the clear value-add
offered by clinical decision
support services.”
Scott Weingarten, CEO, Zynx
David Bousfield
Ganesha Associates
Kate Worlock
Director, EPS
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EPS Focus Report January 2006
Evidence-based medical practice
in the 21st century
Executive Summary
Introduction
This EPS Focus Report describes how knowledge, data
and information technology are being fused together to
make the process of practicing medicine simpler, more
transparent and above all, more effective.
The scope will include both:
o the process of gathering information and
identifying best practice (Evidence Based
Medicine, EBM, in its strictest sense);
o the methods used to present this knowledge to
support decisions made by the clinician and
patient (Clinical Decision Support - CDS).
Drivers for change
The increasing complexity of healthcare and cost of the
underlying technologies needed to deliver these
benefits, coupled to a prejudice that ‘latest means
best’, has become the major driving force.
Medical errors are now one of the leading causes of
death. Based on the findings cited by a study from the
US Institute of Medicine (IOM), medical errors kill some
44,000 people in US hospitals each year.
The IOM emphasized that most medical errors are
systems-related and not necessarily attributable to
individual negligence or misconduct.
The key to
reducing medical errors then is to focus on improving
the systems of delivering information - healthcare
professionals are simply human and, like everyone
else, they make mistakes – and repeated research
studies have shown that system improvements can
reduce the error rates and improve the quality of
healthcare.
Today, the sheer volume and complexity of new
medical information greatly exceeds the capability of
the human brain to assimilate it – either by writing
about or memorizing it. This means that the gap
between what doctors might do (based on an evidencebased consensus informed by best clinical practice
guidelines, costs and patient outcomes) and what they
actually do is wide, variable and growing.
Even if information is available at the point-of-care, its
usefulness and relevance is conditional on an
increasingly complex data stream from the individual
patient, e.g. gender, weight, age, co-morbidities, comedications, allergies and pre-operative history, plus a
host of genetic and environmental factors.
The replacement of healthcare systems reliant on
paper-based medical records or generally localized
clinical information systems by very large scale health
information infrastructures centred on interoperable
electronic patient record systems is now underway in
many western countries. These national programs, all
established within the last few years, are so extensive
that they will precipitate a healthcare revolution in each
country where they have been announced.
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EPS Focus Report January 2006
Evidence-based medical practice
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The Electronic Health Record (EHR) seems to be the
ideal point-of-care solution for most clinicians to
simultaneously
improve
quality
and
enhance
operational efficiency. However, for various reasons,
EHR adoption has been slow in the US and in the UK,
particularly for physicians in small practices.
Early adopter case studies
Partners Healthcare
Partners’ information systems budget was $92.3m in
2002, monies that have been used to develop a
number of knowledge assets, such as a suite of
medication decision support systems which include
expert systems for tailoring drug dosage regimens to
specific patient groups such as the aged or cases of
renal insufficiency, order sets for radiology, and
outpatient decision support.
Partners sees its current challenges as largely being
driven by interoperability, knowledge management and
performance issues.
To combat these problems, Partners is investing in the
development of a knowledge management system.
Adventist Health System (AHS)
AHS’ motivation for undertaking its ‘evidence-based
practice’ program has been the improvement in quality
of outcome and reduction of costs.
Using Cochrane Library material, speciality medical
Society consensus views and data from the national
guideline clearing house (Agency for Healthcare
Research ad Quality - AHRQ) as a starting point,
medical literature surveys are carried out in-house to
identify best practice, but the resource intensive work
of structuring this information into clinical pathway
guidelines and order sets has been outsourced to Zynx.
The commercial landscape
Publishers and software developers have reacted to the
opportunities presented by healthcare informatics by
developing a range of products that provide support
across a range of applications:
o Simple tools for linking and aggregating
existing reference materials (e.g. Thomson’s
InfoButton provides a simple link from an
electronic health record to reference material
stored in its MicroMedex database system);
o Sources of reference to evidence-based medical
practices (e.g. PatientKeeper, Infotriever,
ClinicalResource@Ovid);
o Adaptation of EBM sources to specific point-ofcare applications (e.g. the Cochrane Library,
Clinical Evidence, InfoPOEMS, Bazian, Zynx,
Clin-eguide, TheraDoc);
o Adaptation of EBM sources, outcome and cost
information to create higher level management
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EPS Focus Report January 2006
Evidence-based medical practice
in the 21st century
tools (e.g. Thomson’s
Logic Modules (MLMs).
Micromedex
Medical
The changing shape of the marketplace
Healthcare should be an information-driven business,
but until now this has not been the case.
As
articulated by J A Muir Gray, founder of the Centre for
Evidence-based Medicine (CEBM) in Oxford, ‘The
application of what we know will have a bigger impact
on disease than any drug’. And yet there can a 20year gap between scientific discovery and the routine
application of those discoveries in clinical practice
(AHRQ, 2001).
The investment in networked healthcare systems is
now a national priority in many countries of the world.
This alone will bring about significant reductions in the
cost and improvements to quality. But the force for
transformational change will be the large-scale
implementation of the evidence-based practice of
medicine.
Drug information and order sets will commoditise most
rapidly. Most of the core information is within the
public domain already and as formularies and clinical
best practice become determined by efficacy and cost
rather than habit, there will be little scope for
differentiation other than on speed of update,
comprehensiveness and functionality.
The creation of national networks of linked EHR
repositories (the US National Health Information
Network, NHIN) and the UK’s NPfIT Connecting for
Health Spine) will create an enormous opportunity for
further commercial development when integrated with
the prescription and payer information.
Expert interviews
Clin-eguide: Carol Leighton, Director, Editorial &
Product Manager
Dr J A Muir Gray, Programme Director of the NHS
National Electronic Library for Health (NeLH) and
founder of the Centre for Evidence-Based Medicine
Theradoc: Stan Pestotnik, CEO
Zynx Health: Scott Weingarten, President and CEO
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EPS Focus Report January 2006
Evidence-based medical practice
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Introduction: what is evidence-based medicine and
why is it important?
“Medicine used to be simple, ineffective yet relatively safe.
Now it is complex, effective and potentially dangerous”1. It has
also become increasingly expensive and threatens to gobble up
an increasingly large fraction of GDP in many develop
countries. In the closing years of the last century several
governments sought to tackle these emerging problems by
investing heavily in IT development programs designed to
rationalize the healthcare process and make it more
accountable to the taxpayer and the consumer.
This EPS Focus Report describes how knowledge, data and
information technology are being fused together to make the
process of practicing medicine simpler, more transparent and,
above all, more effective.
Key to the success of these
initiatives will be the consolidation of evidence-based medical
processes and guidelines, and the structuring of this
information so that it can be easily integrated into workflow to
provide automated clinical decision support.
The report takes a broad view of the definition of evidencebased medicine – the scope will include both the process of
gathering information and identifying best practice (EBM in its
strictest sense) and the methods used to present this
knowledge to support decisions made by the clinician and
patient (CDS). The overlap is clear from popular definitions of
the two terms:
‘Evidence-based medicine (EBM) is a medical
movement based upon the application of the
scientific method to medical practice, including longestablished existing medical traditions not yet
subjected to adequate scientific scrutiny. According
to the Centre for Evidence-Based Medicine,
“evidence-based medicine is the conscientious,
explicit and judicious use of current best evidence in
making decisions about the care of individual
patients.”’
‘Clinical decision support (CDS) refers broadly to
providing clinicians or patients with clinical
knowledge
and
patient-related
information,
intelligently filtered, or presented at appropriate
times, to enhance patient care. Clinical knowledge of
interest could be simple facts and relationships for
managing patients with specific disease states, new
medical knowledge from clinical research and many
other types of information.’
Implicit in our interpretation of these definitions is the fact that
both EBM and CDS systems are created within a healthcare
system that is run to a budget – which will influence the choice
of drugs, procedures and care available to an individual patient
– and that choices will in future be driven by the consumer. In
other words, these definitions are still evolving in response to a
number of market forces. The purpose of this report is to
highlight and describe the changes that have had and will in
future have a bearing on commercial opportunities (and
threats) for STM publishers.
1
From Sir Cyril Chantler’s Hollister Lecture at Northwestern University, Illinois in 1999
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EPS Focus Report January 2006
Evidence-based medical practice
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Drivers for change
Background
All is not well with many western healthcare systems. The
most visible symptom, as observed through the lens of
newspaper headlines, is that costs are increasing much faster
than inflation. For example, by 2010 it has been projected that
healthcare costs will account for over 18% of US national
income, and yet over 50m citizens (about 16% of the
population) will still remain uninsured.
Figure 1: Per capita health expenditure and GDP
As Figure 1 shows, the per capita expenditure is lower for most
OECD countries than it is in the US, but other statistics show
that the rates of increase in health spending, as a percentage
of GDP, are comparable to the US. Why is this happening at a
time when medical knowledge and technological know-how are
at an all-time high?
Costs, errors and information overload
It is true that cost increases are in part caused by the
successes of modern medicine in extending our longevity and
consequently the length of time for which we shall each require
healthcare. However, it is the increasing complexity of
healthcare and cost of the underlying technologies needed to
deliver these benefits, coupled to a prejudice that ‘latest means
best’, that has become the major driving force.
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EPS Focus Report January 2006
Evidence-based medical practice
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Figure 2: US health costs by source
Source: Centers for Medicare and Medicaid Services
More disconcerting perhaps, and certainly less well ‘advertised’
by the news media, is the impact of this complexity on
clinicians’ performance. A report published by the US Institute
of Medicine (IOM) in 1999 found that medical errors were one
of the leading causes of death. Based on the findings cited by
this study, medical errors kill some 44,000 people in US
hospitals each year. Other surveys reviewed by IOM put the
number much higher at 98,000.
Even using the lower
estimate, more people die from medical mistakes each year
than from road accidents, breast cancer, or AIDS. Subsequent
reports have confirmed that neither is the problem getting
smaller, nor is it restricted to North America.
Not surprisingly, the customers are revolting. For example, a
new international survey supported by The Commonwealth
Fund found that one-third of US patients with health problems
reported experiencing medical mistakes, medication errors, or
inaccurate or delayed lab results – the highest rate of any of
the six nations surveyed. While sicker patients in all countries
reported safety risks, poor care coordination, and inadequate
chronic care treatment, with no country deemed best or worst
overall, the US stood out for high error rates, inefficient
coordination of care, and high out-of-pocket costs resulting in
forgone care.
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Evidence-based medical practice
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Rising costs and falling quality – is informatics part of the
solution?
At the dawning of the scientific method Sir Francis Bacon was
able to declare that, ‘Reading maketh a full man; conference a
ready man; and writing an exact man. And therefore, if a man
write little, he had need have a great memory.’ Today, the
sheer volume and complexity of new medical information
greatly exceeds the capability of the human brain to assimilate
it – either by writing about or memorizing it. This means that
the gap between what doctors might do (based on an
evidence-based consensus informed by best clinical practice
guidelines, costs and patient outcomes) and what they actually
do is wide, variable and growing.
Many factors contribute to this situation.
Doctors are
inundated with new, often poorly evidence-based and
sometimes conflicting clinical information. This is particularly
serious for a generalist working in primary care, with over
400,000 articles added to the biomedical literature each year.
Indeed, a recent medical study has shown that on average it
takes as many as twenty years for new medical knowledge to
be incorporated into clinical practice2.
Figure 3: Translational medicine – from bench to bedside in 20 years
Source: Balas and Boren (see footnote)
2
E. A. Balas & S. A. Boren. Managing Clinical Knowledge for Healthcare Improvement. Yearbook of
Medical Informatics 2000, 65-70
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Evidence-based medical practice
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Another study warns that many claimed research findings
amount simply to accurate measures of the prevailing bias or
are otherwise incorrect3.
Even if this information were available at the point-of-care, its
usefulness and relevance is conditional on an increasingly
complex data stream from the individual patient, e.g. gender,
weight, age, co-morbidities, co-medications, allergies and preoperative history, plus a host of genetic and environmental
factors. The availability of laboratory tests, drugs and clinical
procedures will be limited by a hospital’s formulary, or by the
patient’s level of health insurance.
The main drivers for healthcare reform are costs, the quality of
medical care and the patient or consumer’s perception of
value. Stated more simply, there is currently no basis for the
patient, physician, healthcare provider or payer to make
informed choices based on knowledge of outcomes,
performance or cost.
In other words, ‘evidence-based
medicine’ must currently be regarded as something of an
oxymoron. That said, this is precisely why governments across
the world are investing in the transformation of healthcare
financing and installation of national infrastructures for
informatics support.
We all want the best healthcare, but can we afford it?
The world’s healthcare systems can be categorized on their
financial basis into four main groups4. National health schemes
such as those found in Britain or Sweden cover everybody and
have a single payer who pays for the care at a salaried or
capitated5 rate. In The Netherlands, Australia, Canada, and
France, national schemes cover everybody and there is a single
payer but payment is in the form of a fee for each service
provided. Mandatory insurance (as in Germany, Brazil, Japan,
Malaysia, and Singapore) again covers everybody but has
multiple sickness funds or insurance carriers and provides care
through a mixture of salaried public providers and private
providers paid a fee for each service. Voluntary insurance (as
in the United States or South Africa) does not offer cover to
everybody and has many payers and providers and different
systems of payment and delivery.
Even the best of these systems are essentially ‘open loop’, in
that payers receive little feedback about the quality of care
they are purchasing and consequently allow consumer demand
and technological innovation to drive spiraling costs. Few
schemes manage to aligned physician payment incentives in a
way that effectively delivers a consumer-driven healthcare
system. However, there are strong signs that this will happen
over the next 5-10 years.
‘Managed care’ was introduced in the US in the early 1900s as
an alternative to indemnity insurance, and was one of the first
attempts to build a more balanced business model. Managed
care is a broad term and encompasses many different types of
organizations, payment mechanisms, review mechanisms and
3
Ioannidis JPA (2005) Why Most Published Research Findings Are False. PLoS Med 2(8): e124
Richard Smith, BMJ 1997;314:1495
5
The method of payment in which the provider is paid a fixed amount for each person served no
matter what the actual number or nature of services delivered.
4
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Evidence-based medical practice
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collaborations, but in essence it provides a gatekeeper function
between payers, providers and patients by creating tools with
which to review medical necessity, create incentives to use
cost-effective providers, and manage individual cases over time
so that outcome/cost benefits can be used more effectively to
shape future best practice.
In its initial form, managed care struggled to achieve
significant market share, but during the presidency of Ronald
Reagan government support enabled managed care to become,
albeit briefly, a means to control Medicare payouts. Indeed,
the new approach spread fairly quickly to the health insurance
industry in the private sector.
The rise of managed care has been credited with the lessened
rate of medical inflation seen between 1993 and 2000 in the
US, which during these years was little more than inflation.
However, this effect has ended and US medical inflation is once
again two or three times the rate of overall inflation. ‘Disease
management programs’ and ‘consumer-directed health plans’
are just two of the new strategies being used in the US and in
some European countries to combat increasing costs and to
insert some rules of economics between supply and demand.
Managed care plus - more management and more care
Disease management is a strategy for healthcare service
delivery employing interdisciplinary clinical teams, real-time
data analysis, and well-defined, cost-effective technological
procedures to improve the health outcomes in patients with
specific
diseases.
Unsurprisingly,
the
successful
implementation of disease management programs requires
sophisticated decision-support systems which can encapsulate
precise guidelines reflecting current clinical best practice, and
which can adapt to patient-specific needs such as the existence
of co-morbidities whilst simultaneously capturing the detailed
cost information needed for reimbursement purposes. Even
this still doesn’t completely close the feedback loop – the
consumer needs to become more aware of the costs of medical
treatment.
Consumer-directed health plans are currently an experiment in
the US, but provide a clear signpost to government thinking
about the consumer’s future financial responsibility and
involvement in healthcare choices. These health plans can
take the form of a two-part health insurance program
consisting of a high-deductible health insurance policy and a
tax-free medical savings investment account (MSA) set up to
fund medical costs not covered by the policy. MSAs benefit
individuals with low healthcare costs, who can take advantage
of the low-premium, high-deductible insurance policies, but
other multi-tiered schemes are emerging to meet a wider
variety of needs. In addition to creating financial incentives to
encourage patients to make cost-conscious choices, new
information tools are emerging to provide consumers with
comparative quality information about hospitals and physicians
and outcome statistics associated with specific diseases and
conditions6.
6
See http://www.hospitalcare.hhs.gov and http://www.chooseandbook.nhs.uk/
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Evidence-based medical practice
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Together with disease management, consumer-directed health
plans create an environment where cost and performance can
and will drive the rapid evolution of healthcare practices over
the course of the next decade. In particular it is likely that
insurers will increasingly move away from the old capitated
schemes in which the healthcare provider was paid a flat fee
per member per month, to these that capture more of the
individual patient’s circumstances and pay for performance.
This stratification of consumers will eventually result in the
demise of mutual insurance schemes for healthcare funding
and place a strong onus on the customer to keep fit and
knowledgeable about their health.
Investment in IT infrastructure – a cure for all ?
Since the original IOM study in 1999, there has been much
analysis of the failings of health systems and the need for
reform. From a US perspective, Blackford Middleton, Director
of Clinical Informatics R&D at Partners Healthcare in Boston
MA, has summarized some of the main issues arising:
Medical error, patient safety, quality and cost issues
1 in 4 prescriptions taken by a patient are not known
to the treating physician;
1
in
7
admissions
result
from
missing
ambulatory/outpatient information;
1 in 5 lab and x-ray tests are ordered because
originals can not be found;
40% of outpatient prescriptions are unnecessary;
Patients receive only half of recommended care.
Providers have incomplete knowledge of their patients
Patient data was unavailable in 81% of cases in one
clinic, with an average of 4 missing items per case.
18% of medical errors are estimated to be due to
inadequate availability of patient information.
Figure 4: Where adverse events originate
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Evidence-based medical practice
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In the UK, an analysis of the NHS has shown that during 200304, 885,832 adverse incidents and near misses were recorded.
A later follow-up survey found that for 2004-05 there were
around 974,000 reported adverse incidents and near misses.
The IOM emphasized that most medical errors are systemsrelated and not necessarily attributable to individual negligence
or misconduct. The key to reducing medical errors then is to
focus on improving the systems of delivering information healthcare professionals are only human and, like everyone
else, they make mistakes – and repeated research studies
have shown that system improvements can reduce the error
rates and improve the quality of healthcare. A common focus
for these studies is the point at which a clinician makes a
decision to prescribe a drug, or order a diagnostic test,
increasingly via some form of PDA. The collective acronym for
this activity is ACPOE (ambulatory computerised physician
order entry) and the results of one such study are shown in
Figure 5.
Figure 5: Cost savings estimated for Ambulatory
Computerized Physician Order Entry
The replacement of healthcare systems reliant on paper-based
medical records or generally localized clinical information
systems by very large scale health information infrastructures
centred on interoperable electronic patient record (electronic
health records, EHRs) systems is now underway in many
western countries. Some countries are well-advanced in the
implementation of electronic patient records and national
network infra-structures - particularly in Denmark, Finland,
Norway and Sweden,but most are just getting off the ground.
Governments in France, Canada, Australia, England, New
Zealand and the USA have only recently committed to deliver
national electronic networks and medical record systems to
support healthcare delivery for their populations, typically by
the end of the current decade.
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Evidence-based medical practice
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Figure 6: Healthcare informatics technology networks
Source: McKesson’s electronic health record roadmap whitepaper
Impact of national programs
These national programs, all established within the last few
years, are so extensive that they will precipitate a healthcare
revolution in each country where they have been announced.
In 2004, the European Commission took a lead in publishing an
action plan for a European e-Health Area. The plan specifies a
sequential set of actions to be taken by EU member states over
the period 2004-2010. The investment committed in at least
one case (the NHS in England on its wholly publicly-funded
Connecting for Health program) is unprecedented. Some other
countries, including France, are also funding their programs
exclusively with public money. Other governments, including
Australia and Canada, are promoting collaborations between
the private and public sectors. Finland's FinnWell program,
whose principal goal is to improve healthcare, is also designed
to promote healthcare technology development and create
opportunities for Finnish business and research especially in
the telemedicine sector.
The Electronic Health Record (EHR) seems to be the ideal
point-of-care solution for most clinicians to simultaneously
improve quality and enhance operational efficiency. However,
for various reasons, EHR adoption has been slow in the US and
in the UK, particularly for physicians in small practices (see
Figure 7).
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Figure 7: EHR adoption rates across the US healthcare system
The reasons behind this slow adoption include
cost;
immature technology;
difficulty with assessing product quality and
appropriateness for a particular practice;
incomplete interoperability with other necessary
systems;
a misalignment of incentives (providers bear the
costs and others reap the benefits).
However, within the past year, the rate of adoption has begun
to increase.
Figure 8: International EHR adoption rates
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Evidence-based medical practice
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Early adopter case studies – Partners Healthcare
and Adventist Health
Partners HealthCare
Partners HealthCare was founded in 1994 by Brigham and
Women's Hospital and Massachusetts General Hospital in
Boston. A not-for-profit organization, Partners is an integrated
healthcare system that offers patients a continuum of
coordinated high-quality care. The system includes primary
care and specialty physicians, community hospitals, the two
founding academic medical centres (Harvard Medical School
and the Dona Faber Cancer Institute), specialty facilities,
community health centres, and other health-related entities.
Partners has 3,200 beds, 135,000 admissions and 2.3m
outpatient visits per year.
It is one of the most active
organizations in the innovative use of informatics in healthcare
in the world.
Partners’ information systems budget was $92.3m in 2002,
monies that have been used to develop a number of knowledge
assets, such as a suite of medication decision support systems
which include expert systems for tailoring drug dosage
regimens to specific patient groups such as the aged or cases
of renal insufficiency, order sets for radiology, and outpatient
decision support. Partners also hosts the Research Patient
Data Registry, comprising over two million health records
collected since the mid-1990s which incorporates not only
stored data from lab tests, but also details of medicines
prescribed (IDX billing records) and precise definitions of the
illnesses diagnosed (ICH-9 disease classification codes).
Partners sees its current challenges as largely being driven by
interoperability, knowledge management and performance
issues.
It has seven home-grown and two commercial
ambulatory computerized physician order entry (ACPOE)
systems. Clinical knowledge capture is limited, and coding of
these data is often of a proprietary, non-scaleable nature.
Updating and maintenance processes are poorly developed and
resource-constrained.
Figure 9: Partners knowledge asset management strategy
Source: Partners
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EPS Focus Report January 2006
Evidence-based medical practice
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To combat these problems, Partners is investing in the
development of a knowledge management system.
This
system will:
facilitate organisational control and improvement as
judged by a series of quality and safety metrics;
support the analysis of clinical performance data in
order to understand where knowledge deficits are
preventing the achievement of performance goals;
provide support for asynchronous authoring and links
to key internal as well as commercial and academic
reference sources;
support the collection and integration of clinical data
sets both from a patient-centric and populationcentric (epidemiological) perspective;
incorporate the full gamut of gene diagnostic data
which is rapidly becoming the norm and which will
enrich the clinical understanding of inter-patient
variability considerably.
Adventist Health System
Adventist Health System (AHS) is the largest Protestant
healthcare organization in the US and has hospitals in 13
states, 42,000 employees and a total revenue of $4.1 billion
(2005). With its 6,234 inpatient beds and 6,634 physicians,
AHS sees four million patients annually. AHS’ motivation for
undertaking its ‘evidence-based practice’ program has been the
improvement in quality of outcome and reduction of costs.
Like Partners, the program focuses heavily on physician
involvement from the start. Using Cochrane Library material,
speciality medical society consensus views and data from the
national guideline clearing house (AHRQ) as a starting point,
medical literature surveys are carried out in-house to identify
best practice, but the resource intensive work of structuring
this information into clinical pathway guidelines and order sets
has been outsourced to Zynx (Zynx was interviewed for this
Focus Report – see page 42).
Adventist Health took great care to involve staff from the
outset in developing the systems and incorporating the
implementation process into key management practices.
Beginning in 2000, each hospital CEO had specific clinical
accountabilities associated with the scheme included as a
component of their overall corporate performance-related
objectives. For 2000-2004 this component amounted to 10%
of total and in 2005 this had increased to 25%. Throughout
the implementation period there was a commitment to collect
and measure severity-adjusted outcomes and share this data
with physicians on a regular basis.
It is claimed that this approach has been crucial in winning
over the physicians and dispelling the ‘cookbook’ stigma often
associated with evidence-based practice. The improvements in
care and outcome have been well documented – see Figure 10.
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EPS Focus Report January 2006
Evidence-based medical practice
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Figure 10: Improvement in outcomes for pneumonia patients using
proprietary pathway guidance tools as compared to controls
Source: Ann. Epidemiol (Elsevier). 2004, 14, 669-675
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Evidence-based medical practice
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The commercial landscape
The concepts of evidence-based medicine and clinical decision
support are brought together in the graphic below created by
Tonya Hongsermeier, Corporate Manager of Clinical Decision
Support and Knowledge Management, at Partners HealthCare.
This spectrum can be used to distinguish between different
vendors and their products on the basis of where their products
are embedded into the healthcare workflow and the types of
functionality they support.
Figure 11: Levels of complexity and function in
evidence-based medical practice
The left of the spectrum is dominated by companies that
acquire, aggregate and initiate the consolidation of knowledge.
The middle ground is dominated by companies that take
evidence of best practice and structure it into order sets,
clinical guidelines and care pathways using a fairly rigid rule set
to shape and confine decision-making.
Finally come the
developers of expert systems which combine evidence, real
time patient data and flexible logic to create diagnostic support
systems.
Some specific examples of these different
approaches are reviewed later in the report.
Blackford Middleton, also from Partners and source of much of
the evidence for cost savings derived from healthcare
informatics, has shown how these cost savings increase
dramatically as the complexity and sophistication of clinical
decision support for prescribing and diagnostic performance is
increased – see Figure 12.
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Evidence-based medical practice
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Figure 12: Savings derived from basic, intermediate (INT) and advanced (ADV)
support for prescribing (Rx) and diagnosis (Dx). ADE = adverse drug event
reduction
Source: Blackford Middleton
A growing hierarchy of increasingly sophisticated EBM/CDS tools
Publishers and software developers have reacted to the
opportunities presented by healthcare informatics by
developing a range of products that provide support across the
spectrum of applications described by Hongersmeier and
Middleton. This product range includes:
Simple tools for linking and aggregating existing
reference materials;
Sources of reference to EBM practices;
Adaptation of EBM sources to specific point-of-care
applications, such as:
o Order sets7 used in ambulatory computerized
physician order entry;
o e-prescribing;8
o Clinical guidelines used to assist diagnosis and
the management of a specific condition.9
Adaptation of EBM sources, outcome and cost
information to create higher level management
tools, such as:
o Clinical, careflow or workflow pathways;10
o Disease management support;11
7
Definition: An order set is a predefined list of actions that has been utilized in the standard care of
hospitals for many years typically on admission or after diagnosis.
8
Covered in the recent EPS Focus Report on Drug Informatics
9
Definition: Clinical guidelines briefly identify, summarize and evaluate the best evidence and most
current data about prevention, diagnosis, prognosis, therapy, risk/benefit and cost/effectiveness. Then
they define the most important questions related to clinical practice and identify all possible decision
options and their outcomes. Thus, they integrate the identified decision points and respective courses
of action to the clinical judgment and experience of practitioners. Many guidelines place the treatment
alternatives into classes to help providers in deciding which treatment to use.
10
Clinical Pathways (aka Careflow or Workflow Pathways) are structured, multidisciplinary plans of
care designed to support the implementation of clinical guidelines and protocols. They are designed to
support clinical management, clinical and non-clinical resource management, clinical audit and also
financial management. They provide detailed guidance for each stage in the management of a patient
(treatments, interventions etc) with a specific condition over a given time period, and include progress
and outcomes details. Clinical Pathways aim to improve, in particular, the continuity and co-ordination
of care across different disciplines and sectors.
11
Disease Management is a system of coordinated healthcare interventions and communications for
populations with conditions in which patient self-care efforts are significant. Disease management
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Evidence-based medical practice
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o
Predictive tools and disease.
What follows is a brief description of a series of products
arranged along this scale of increasing sophistication and
complexity.
Some specific examples
Linking
InfoButtons (a generic term) take the context of a clinician’s
user session in a clinical information system (e.g. the task
context such as review of lab results) and link this to the main
concept of interest (medications, problems, lab tests), placing
this in the patient context which includes factors such as age or
gender to identify a textual answer within a content reference
resource of some sort.
Figure 13: Thomson InfoButton linking an EHR to MicroMedex
Source: Thomson
For example, Thomson’s InfoButton provides a simple link from
an electronic health record to reference material stored in its
MicroMedex database system.
Elsevier uses a similar
functionality in its iConsult product linking with MDConsult, as
emphasizes prevention of exacerbations and complications utilizing evidence-based practice guidelines
and patient empowerment strategies, and evaluates clinical and economic outcomes on an ongoing
basis with the goal of improving overall health.
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Evidence-based medical practice
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does Wolters Kluwer for Skolar. HL7, an organization charged
with the development of informatics-driven process standards
across healthcare, is now chairing negotiations between
healthcare
providers
including
Partners
HealthCare,
Intermountain Health, Cedars Sinai and Columbia, software
vendors including IDX, Epic and Eclipsys, and publishers
including Thomson, Elsevier, Wolters Kluwer and Hearst, aimed
at creating a common programming interface so that content
from each of these sources can be integrated into a single
display when linking out from an electronic health record.
Aggregators
You don’t need to create content to be a player. Several
content aggregators play a prominent role in the EBM/CDS
market place. Access to clinical references, such as drug
guides, dictionaries, drug interaction guides, evidence-based
medicine modules, clinical guidelines, and calculators, can all
help physicians make more informed clinical decisions. Much
of the value in having access to such sources can be generated
by providing seamless interoperability between the different
content sources.
An example of this is PatientKeeper which has developed a
suite of products which combine patient information with the
wealth of clinical knowledge available in medical reference
material from a wide variety of third party sources, and
delivers the search results to a PDA.
Figure 14: PatientKeeper’s basic architecture
Source: PatientKeeper
A second example, recently purchased by Wiley, is Infotriever.
This service also offers a mix of proprietary and third party
content sources, but includes its own current awareness
service, InfoPoems. Claiming to be the only database system
of filtered, synopsized, evidence-based information, the
Infotriever search engine allows the user to simultaneously
search, via keyword, the following databases and reference
sources:
InfoPOEMs, synopses of recent research;
Cochrane Database abstracts;
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Evidence-based medical practice
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Evidence-based Practice Guideline summaries;
Clinical Decision Rules;
Diagnostic test calculators (unique combinations of
symptom -> disease -> test);
H&PE (Haematocrit & Partial Exchange Volume)
calculators (unique combinations of symptom ->
disease -> test);
The complete 5-Minute Clinical Consult Summaries;
The complete 5-Minute Clinical Consult Photos;
ICD-9 lookup tool, most commonly used disease
classification codes.
ClinicalResource@Ovid is another aggregated resource which
provides one-click access to important clinical resources
‘recommended by physicians for physicians’.
Assessable
knowledge resources include:
Clin-eguide (evidence-based diagnosis and treatment
guidelines);
5-Minute Consult Database;
Ovid MEDLINE;
Drug Facts and Comparisons;
A to Z Drug Facts;
Review of Natural Products;
MedFacts (English and Spanish patient handouts);
National Guideline Clearinghouse;
McKesson Patient Handouts.
From these three examples it is clear that, from the
perspective of the end-user, there is still much that can be
done to facilitate the broader integration of sources beyond the
normal proprietary boundaries. Given that there is also much
redundancy across the reference products cited here, a process
of selection-of-the-fittest will occur – the evidence-based
approach leaves little opportunity for the survival of diversity.
User interface design will also be a key factor in making sense
of search results channelled from so many different sources. It
will be interesting to watch development of InfoButton
technologies alongside these more traditional aggregator
services. Thomson has perhaps the strongest links with the US
standards bodies, but Wolters Kluwer has a wider range of
assets in this area.
Strong alliances with EHR vendors (to secure sales channels)
and the development of consumer branding will also be factors
that will influence the distribution of market share between the
major players in this field: Thomson, Wolters Kluwer and
Hearst.
Tertiary content providers:
No one can keep up-to-date with the relevant evidence in their
field of interest. The major bibliographic databases cover less
than half the world's literature and are biased towards English
language publications. Of the evidence available in the major
databases, only a fraction can be found by the average
searcher – incidentally providing a niche for specialist search
technologies and services, such as Bazian.
Textbooks, editorials and reviews which have not been
prepared systematically may be unreliable. Much evidence is
unpublished, but unpublished evidence may be important.
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Evidence-based medical practice
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More easily accessible research reports tend to exaggerate the
benefits of interventions12.
There is therefore an important role to be played by publishers
expert in distilling and publishing evidence-based consensus
reviews of medical practice and progress.
Figure 15: Reviews and protocols published by the Cochrane Database of
Systematic Review
Source: Cochrane
The Cochrane Library, now published by Wiley, is probably the
leading brand in this field - though there are still many
contenders who will vie for this position in the coming years.
Published on a quarterly basis and made available both on CDROM and online, it is the most comprehensive source of reliable
evidence about the effects of health care and is frequently cited
as the major component for many derivative products such as
BMJ’s Clinical Evidence, also available via NHS Direct branded
as Best Treatments13.
The five steps involved in creating EBM reviews are:
convert information need into answerable questions;
track down the best evidence to answer the
question;
critically appraise the evidence for its validity and
usefulness14;
integrate appraisal results with clinical expertise and
patient values;
evaluate outcomes.
Those who prepare the reviews are mostly healthcare
professionals who volunteer to work in one of Cochrane’s many
Collaborative Review Groups, with editorial teams overseeing
the preparation and maintenance of the reviews, as well as the
application of the quality standards.
12
See for example, Ioannidis JPA (2005) Why Most Published Research Findings Are False. PLoS Med
2(8): e124
13
http://www.besttreatments.co.uk/btuk/home.html, see also http://www.nelh.nhs.uk/
14
See http://www.cebm.net/levels_of_evidence.asp#levels for details as the methods used to assess
evidence.
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Evidence-based medical practice
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Other players in this field15 include Clinical Evidence (BMJ), the
journal Bandolier (CEBM), InfoPOEMS (Wiley), FirstConsult and
Bazian.
Figure 16: The Bazian product pipeline
Source: Bazian
Clinical Evidence and Bandolier aim to cover common or
important clinical conditions seen in primary and hospital care.
To decide which conditions to cover they review national data
on consultation rates, morbidity and mortality, take account of
national priorities for healthcare such as those outlined in the
UK National Service Frameworks and in the US Institute of
Medicine reports, and take advice from generalist clinicians and
patient groups.
InfoPOEMs (Patient Oriented Evidence that Matters) point out
valid, relevant research via daily e-mail synopses each working
day.
InfoPOEMS editors review more than 1,200 studies
monthly from 100+ medical journals, presenting only the best
as InfoPOEMs - only about 1 in 40 studies qualifies.
Bazian is also a leading global provider of evidence-based
healthcare solutions. Their branding is based on quality – they
claim to assess, analyse and synthesize clinical research from
around the world to reveal what works and what doesn’t with
an accuracy and clarity previously unavailable thus enabling
their clients do ‘what was previously almost impossible’.
There is the emergence of an industry here which is generating
evidence-based reviews, but the reality is that access (or
rather lack of it) to the primary content is what prevents the
group from consolidating to a single high quality supplier. The
editorial process is highly skilled (but not irreproducible) and
the volume required for reasonably comprehensive coverage
(say 10-20k core articles) not hugely onerous to maintain
provided the content can be re-used in a variety of spin-off
products.
Access via vendors to the major distribution channels will again
be an important variable in the equation for survival. Equally
important will be investment in metadata standards which
enable evidence-based content to be re-used in a wide variety
of applications, such as order sets and clinical guidelines. The
point about evidence-based practice is that there is only needs
to be one version of the text. This is not the case at present,
but the future will be about function as content value per se
becomes commoditized.
The principal user of EBM/CDS products need not be a clinician
– and consumer branding of evidence-based products is a new
frontier to watch. For example, when patients, caregivers and
15
See http://www.openclinical.org/ebm.html for a full list of alternative sources
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Evidence-based medical practice
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providers face critical treatment choices, NexCura, a recent
Thomson acquisition, can deliver the timely, targeted,
evidence-based and personally relevant knowledge they need.
This individualized information is made available through the
NexProfiles treatment option tools. These tools are available
for over 30 specific conditions, including various types of
cancer as well as cardiovascular and pulmonary conditions. As
hospitals increasingly market themselves in terms that address
consumers’ concerns about treatment quality, Intel Inside
branding may become a marketing tactic used by leading EHR
vendors and EBM publishers.
Order sets, clinical guidelines and care pathways
Order sets provide a highly structured set of decision points to
be completed by a nurse or physician on admission, during the
process of diagnosis and treatment of a particular disease, and
on discharge. In essence, order sets distil a well-characterized
set of actions and considerations that apply to a well-defined
patient population.
Order sets usually take the form of a simple list with links back
to
supporting
evidence
and
details
of
exceptional
circumstances. They can be easily customized to allow a
healthcare provider to choose common orders for a particular
disease state or circumstance according to best practice or
other local criteria. The EHR itself may recommend order sets
using a simple set of rule-based conditions or as the result of
other clinical information being entered into the EHR.
Alternatively, the order sets may simply be available for use as
a passive check list by the ordering physician or nurse.
Zynx, recently purchased by Hearst from Cerner, is a leader in
this field. Zynx begins by developing clinical summaries and
distil best practices based on rigorous reviews of the peerreviewed literature much in the same way as described earlier
in this section.
Within each order set module, evidence
synopses cover a range of topics from performance
improvement, to treatment, to discharge planning.
Each
synopsis includes a clinical recommendation, rationale
statements, and complete references with links to abstracts
and full-text articles (when available) for more comprehensive
literature reviews.
In some cases, clinical evidence may satisfy topic inclusion
criteria but cannot be directly translated into order items, so a
reminder item is embedded into the order set, and a hyperlink
to the evidence page is provided.
For example, a topic
regarding the use of a prediction rule to guide triage decisions
for patients with community-acquired pneumonia cannot be
translated into an order item, but an order set reminder item
can serve as a timely evidence-based reminder to the physician
at the point of care. Reminder items are created only for
topics that are presented in the evidence.
Order set section names are internally standardized healthcare
concepts that are used to group order items into the following
top-level organization: Condition, Vital Signs, Activity, Nursing
Orders, Diet, IV Fluids, Medications, Laboratory, Diagnostic
Tests, Specialty, Consults, and so on. Sections are often
divided into subsections for the purpose of grouping similar
concepts. The ontology of sections, order items, and reminder
items within Zynx default order sets can be rearranged and
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Evidence-based medical practice
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renamed during customization in the Zynx AuthorSpace editing
environment.
Wolters Kluwer’s Clin-eguide Clinical Knowledge System is a
similar clinical decision-support system designed to fit neatly
into the clinician’s workflow.
The Clin-eguide Clinical
Knowledge Base of structured diagnostic, management and
treatment recommendations, referenced to the primary
literature, is the cornerstone of the system. The two products
generated from this database, Clin-eguide Clinical Reference
and Clin-eguide Order Sets, are accessed via a web browser or
integrate with a clinical application such as Skolar MD – see
interview on page 36.
TheraDoc's products (see interview on page 40) take this
theme and develop it around very specific applications such as
the administration of antibiotics, painkillers and infection
control. For example, Antibiotic Assistant augments clinical
decision-making by providing the decision-maker with enriched
disease-specific recommendations for antibiotic treatments,
tests and referrals based on individual patient profiles.
This particular module integrates patient data with coded
clinical data, global medical knowledge, institutional protocols
and epidemiological factors, so that the software can be used
to assess all possible ways in which an infectious disease could
be managed, eliminating those options that are contraindicated due to factors such as allergies or neutropenia as well
as patient attributes such as height, weight, and age.
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Evidence-based medical practice
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Prediction and disease management
Clinical guidelines and pathways take this process further by
introducing decision points within the process.
Clinical
pathways are structured, multidisciplinary plans of care
designed to support the implementation of clinical guidelines
and protocols. They are designed to support clinical
management, clinical and non-clinical resource management,
clinical audit and also financial management. They provide
detailed guidance for each stage in the management of a
patient (treatments, interventions etc) with a specific condition
over a given time period, and include progress and outcomes
details.
Figure 17. A schematic of Isabel’s algorithm for the management of
meningococcal disease
Source: Isabel Healthcare
Clinical pathways aim to improve, in particular, the continuity
and co-ordination of care across different disciplines and
sectors. They can be viewed as algorithms in as much as they
offer a flowchart format of the decisions to be made and the
care to be provided for a given patient or patient group for a
certain condition in a step-wise sequence. See guideline logical
overview for the management of meningococcal disease taken
from Isabel Healthcare above.
In a similar vein, Thomson’s Micromedex Medical Logic Modules
(MLMs) integrate data into a clinical information system ‘rules
engine’ to support advanced clinical decision making. MLMs
are written using a standard rule-based system, Arden Syntax.
For example, the hypertension MLM is designed to remind the
clinician of appropriate treatment recommendations for
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Evidence-based medical practice
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patients with hypertension, thereby reducing the risk of serious
complications from uncontrolled hypertension, i.e., stroke,
heart attack, etc. To achieve this, the rules engine event
monitor detects the entry of a patient’s blood pressure made
during an office visit, prompting the physician to gather other
data from the patient’s record. These data would include risk
factors such as smoking, diabetes, age greater than 60 years,
etc. The MLM then calculates the patient’s blood pressure
stage and risk group based on, in this instance, the US national
guidelines, and returns a treatment recommendation based on
all of these factors.
Using software to add more value – prediction and disease
management
Predictive tools can take this process of sophistication one
stage further. For example, Advanced Biological Laboratory’s
TherapyEdge uses abstracted clinical knowledge and diagnostic
feedback data to assess the effectiveness of a cocktail of antiretroviral drugs being used to treat an HIV-positive patient.
At the heart of TherapyEdge is an algorithm called ViroScore
which was developed by and licensed from Stanford University.
This calculates the drug resistance indication and all other
relevant mutation information, enabling the clinician to
prescribe the most appropriate HIV anti-retroviral drugs and to
design a new optimized cocktail which can anticipate the
developing resistance as new viral strains emerge.
Some vendors are beginning to offer solutions that integrate
several of the types of product described so far, but centred on
providing overall support around a specific disease.
For
example, Delphi Diabetes Manager is a point-of-care system
that applies best practice knowledge to automate, manage,
and deliver patient care from the early identification and
intervention for patients at risk, to methodologies that help to
prevent or defer the progression to chronic disease and the
expensive medical complications. Not only is the functionality
much broader than the earlier products described, so is the
customer base.
For example, Delphi software provides
documentation for all major Pay-For-Performance quality
improvement initiatives for physicians, insurers, employers and
governments. These products are well liked, especially by
patients because of their emphasis on follow-up and monitoring
of disease progress.
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Evidence-based medical practice
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Figure 18. An overview of the Delphi disease management module
Source: Delphi
TheraSim has developed a range of clinical simulation
technologies to support the training of physicians, nurses,
medical students and pharmacists in the diagnosis and
treatment of chronic and infectious diseases. At the core of
TheraSim products is a Therapy Simulation Engine (TSE) that
analyzes a patient treatment path against an extensive
knowledgebase of best practices and pharmacokinetic data.
Figure 19: TheraSim knowledgebase organization
Source: Therasim
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This knowledgebase is distilled from various information
sources such as:
clinical best practices for various diseases;
clinical information on patient metabolics;
pharmacokinetic databases;
drug prescribing information;
published, peer-reviewed clinical research;
expert advice and review from the TheraSim Clinical
Advisory Panel.
The clinical data in the system is rigorously validated and
reviewed by a panel of medical experts prior to publication of
new TheraSim Simulations.
Most simulation products on the market cope with the nearly
unlimited clinical choices for diagnosis and treatment that face
a clinician in any patient encounter by limiting those choices to
just a few. This ‘multiple-choice’ approach severely limits the
clinical relevance of these products as the clinician user is
always presented with the correct answer, but the TSE
technology can be extended beyond education into clinical
decision support systems.
Entelos, for example, has developed a number of large-scale
computer models of human disease. Called PhysioLabs, each
provides a framework for integrating data (including genomic,
proteomic, physiologic, and environmental) in the context of a
disease, with a focus on understanding and determining clinical
responses to potential treatment. PhysioLab systems are built
and customized using thousands of peer-reviewed papers, the
expertise of world-class advisory boards, and the proprietary
information from industry collaborators.
Within the virtual research environment of a PhysioLab,
clinicians can simulate experiments in silico (in computer) that
could take months or years to do in the lab or clinic. In silico
R&D can be used to:
Identify and characterize novel pathways and genes;
Prioritize and evaluate new drug targets and
candidates;
Plan and optimize clinical trials and experiments;
Assess the clinical impact of therapeutic approaches
on different patient populations;
Relate genomic, proteomic, and in vitro data to
clinical outcomes.
But isn’t this beginning to blur the boundary between
informatics for health and informatics for drug development?
Precisely, and it is a major part of the NIH’s recently
announced Roadmap initiative in translational biology and
medicine – scientific research programs design to accelerated
the integration of bench findings into clinical practice.
i2b2 (Informatics for Integrating Biology and the Bedside) is an
NIH-funded National Center for Biomedical Computing based at
Partners HealthCare. The i2b2 Center is developing a scalable
informatics framework that will bridge clinical research data
and the vast data banks arising from basic science research in
order to better understand the mechanistic bases of complex
diseases such as hypertension, diabetes and Huntington’s
chorea. The expectation is that this knowledge will facilitate
the design of targeted therapies for individual patients with
many common diseases having complex genetic origins.
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“Providing high quality and efficient health care isn’t possible
anymore without a sophisticated marriage of information
technology and state-of-the-art science,” says John Glaser, CIO
at Partners Healthcare. “But bringing them together to inform
patient care is a tremendous undertaking.
i2b2 is about
harnessing all the possibilities afforded by the full array of new
information provided by genomic research – and making it real
for doctors and patients.” And, according to Isaac Kohane,
Director of Informatics at Harvard Medical School – Partners
Healthcare Center for Genetics and Genomics, the distillation
and publishing of this information will be managed internally –
a possible clue to the future branding strategy of leading-edge
healthcare consortia such as Partners.
Figure 20: i2d2’s project data model
Source: i2d2
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Through a glass, brightly - the changing shape (and size) of the
marketplace
Globally, healthcare is a multi-trillion dollar business. Yet,
challenged by error and care quality issues that result in
thousands of injury and deaths each year, it is one of the most
dangerous and inefficient industries in the world. Healthcare
should be an information-driven business, but until now this
has not been the case. As articulated by J A Muir Gray (see
interview p.39), founder of the Centre for Evidence-based
Medicine (CEBM) in Oxford, ‘The application of what we know
will have a bigger impact on disease than any drug’. And yet
there can a 20-year gap between scientific discovery and the
routine application of those discoveries in clinical practice
(AHRQ, 2001).
“I conclude that though the individual physician is not perfectible, the system of care is,
and that the computer will play a major part in the perfection of future care systems.”
Clem McDonald, MD NEJM 295:1355, 1976
“Current practice depends upon the clinical decision making capacity and reliability of
autonomous individual practitioners, for classes of problems that routinely exceed the
bounds of unaided human cognition”
Dan Masys, MD IOM Annual Meeting (2001)
The investment in networked healthcare systems is now a
national priority in many countries of the world. This alone will
bring about significant reductions in the cost and
improvements to quality. But the force for transformational
change will be the large-scale implementation of the evidencebased practice of medicine.
There are currently over 40,000 hospitals of a significant size
worldwide. These units will increasingly become grouped as
consortia or similar collaborations in order to better leverage
purchasing decisions.
Software (EHR) vendors such as
Cerner, EPIC, GE Healthcare and McKesson will play a
dominant role in shaping market access for publishers such as
Hearst, Thomson and Wolters Kluwer and vendors of
specialised knowledge-based systems such as Delphi and
TheraSim. Some vendors such as Cerner may chose to play in
both fields but they will be in the minority. It seems likely that
close alliances will form between publishers and vendors as the
pecking order amongst the vendors becomes clearer.
The geographical and political heterogeneity of the global
market will ensure that there will be space for perhaps half a
dozen software vendors for the foreseeable future, but there
will be far greater pressure to differentiate and add value
within both the traditional and the new entrant publishers. The
formation of alliances between the vendors and the publishers
will be key to ensuring sales and will influence product
specification (interoperability), marketing (software/content
value perception) and pricing (subscription/maintenance
revenue split).
An excellent example of this is Hearst’s
negotiation of a letter of understanding with vendors in the
UK’s National Program for Health IT, (NPfIT) to be sole supplier
of drug information. Where now is Haymarket’s MIMS, once
the desk-top bible of all of the UK’s GPs?
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Drug information and order sets will commoditise most rapidly.
Most of the core information is within the public domain
already and as formularies and clinical best practice become
determined by efficacy and cost rather than habit, there will be
little scope for differentiation other than on speed of update,
comprehensiveness and functionality. The winner in this sector
will be the player who manages to integrate drug information
into a richer selection of linked services such as guidelines,
pathways and predictive tools. However, initially, in terms of
the development of market access, the advantage may go to
companies such as Hearst (First Data Bank and Zynx) who
focus only on these areas – simply because they are generic.
Currently each physician practises medicine differently. These
differences stem from multiple sources, such as source and
recency of education, marketing influence of pharma
companies, the availability of new technologies and so forth.
Evidence-based medicine and clinical decision support will
reduce this variability to focus on known facts and measured
outcomes, a language the consumer and the physician can
both understand.
The branding of trustworthy sources of
information will be key to the survival for the suppliers (such
as Bazian) of what will otherwise be largely undifferentiated
content.
Software vendors are today’s pioneers, but what of tomorrow?
In the future, the main variable in the practice of medicine will
be the patient and, based around a variety of preventative
options, ability to pay, pharmacogenetics and individual
differences in the molecular pathology of disease. This will
place increasing pressure on content providers to structure
their offerings so that they can react to patient-specific details
embedded in their health record.
GE Healthcare’s purchase of IDX, one of the leading software
vendors, provides it with a solid foundation in the EHR
marketplace. The earlier acquisition of GeneticXchange and its
discoveryHub information management technology plus its
already dominant position in imaging and diagnostic systems
provide it with a clear opportunity to play in the more
sophisticated knowledge management market as this matures.
The prescription of a drug will be based upon its efficacy, not
the amount of money spent on its promotion. The treatment
of a disease will be based on a knowledge of measured
outcomes, tempered by a knowledge of genetic and
environmental variables peculiar to the patient. Where will this
leave direct-to-customer (DTC) advertising, direct-to-physician
(e-detailing), and pharma marketing strategies generally in the
future?
Finally, the creation of national networks of linked EHR
repositories (the US National Health Information Network,
NHIN, and the UK’s NPfIT Connecting for Health Spine) will
create an enormous opportunity for further commercial
development when integrated with the prescription and payer
information - currently a market very much dominated by IMS.
Amongst many benefits, these databases will provide
government, payers and providers with a resource which can
be used retrospectively to conduct virtual clinical trials, judge
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outcomes from a cost perspective and manage in real time the
implementation
of
evidence-based
medical
practice.
Thomson’s MedStat is well positioned to take advantage of this
opportunity, but Wolters Kluwer’s acquisition of NDC provides it
with some of the data-handling skill sets needed in this area.
EBM and Open Access
The National Institutes of Health (NIH) is the largest funder of
medical research in the world, and the largest funder of nonclassified research in the U.S. federal government. Its budget
for fiscal year 2005 was $28 billion. To date, its open access
policy has been to provide free online access to full-text, peerreviewed journal articles arising from taxpayer-funded
research. Currently the NIH asks every scientist who receives
an NIH research grant, and who publishes the results in a peerreviewed journal, to deposit voluntarily a copy of the article in
PubMed Central (PMC). PMC will then provide free online
access to its copy some time after the article is published in a
journal – until recently the length of the delay was a matter of
debate.
Introduced on December 14th 2005 by Senators Joe Lieberman
and Thad Cochran, the bipartisan Cures Bill is intended to
expedite development of new therapies and cures for lifethreatening diseases. Among the requirements of this bill is
the establishment of free public access to articles stemming
from research funded by agencies of the Department of Health
and Human Services (DHHS), including NIH, the Centers for
Disease Control and Prevention (CDC), and the Agency for
Healthcare Research and Quality (AHRQ).
“The Cures Bill is exactly the medicine that’s needed,” says
Heather Joseph, Executive Director of the Scholarly Publishing
and Academic Resources Coalition (SPARC) and a leader of the
Alliance for Taxpayer Access. “It goes right to the heart of the
case for unfettered access to publicly funded research.
Senators Lieberman and Cochran took a close look at how best
to speed development of treatments for diseases. Among their
conclusions is that it’s time we ensure the research we’re
already conducting is available to all potential users.”
Pat Furlong, executive director of Parent Project Muscular
Dystrophy comments, “It recognizes how important the sharing
of information is to speeding research and translating new
knowledge into cures. In the age of the Internet, it makes no
sense for the results of taxpayer-funded research to be hidden
away.”
The bill calls for DHHS-funded research to be made available
on PMC within four months of publication in a peer-reviewed
journal. NIH estimates that less than five percent of eligible
research is currently making its way into PubMed Central under
its current policy. The Cures Bill would require deposit of
refereed articles and reach beyond the NIH. It would also
provide access sooner than the current NIH policy.
Making evidence publicly available will be a boon to EBM
publishers such as Bazian, but a threat to larger content
providers such as Elsevier. The future of this marketplace will
depend very much on how players respond to the
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commoditisation of base content and to the need to retain
access to EHR software vendor distribution channels and to
create knowledge-based software products which are
interoperable and easily updated. This will require investment
and strong alliances with the software vendors and the major
agencies driving standards such as ONCHIT, HL7, HIMSS. This
view would favour Thomson, Hearst and Wolters Kluwer as
future market leaders in evidence-based medical publishing.
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Evidence-based medical practice
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Expert Interview
Clin-eguide
Carol Leighton, Director, Editorial & Product Manager, Clin-eguide,
Wolters Kluwer Health
Carol Leighton is Director of the Clin-eguide product from Wolters Kluwer Health.
Clin-eguide Clinical Reference and Clin-eguide Order Sets provide evidence-based
knowledge to the point of care and can be integrated with vendor or hospital clinical
systems.
The reference product can also be accessed through the Clinical
Resource@Ovid platform.
How do you define evidence-based medicine?
We started looking at evidence-based medicine (EBM) around five years ago, at a
time when it was not as well accepted as it is now. We evaluated how we could
provide evidence-based content that would be consistent across all medical
specialties, and developed a methodology that provides the user with the best
possible evidence and grades it according to the strength of the evidence. A
systematic review would be graded A1 to indicate that it is very strong evidence,
and other types of evidence such as case studies would be graded lower,
according to a sliding scale, down to expert opinion. We evaluate evidence from
a wide spectrum of resources to ensure we can answer clinical questions
encountered during practice. The important thing is to provide transparency, so
that when a statement is made it is clear to the user what the evidence is behind
it.
We developed our methodology after attending a course at MacMaster University
in Canada, and now have 450 topics that are evidence-based. At the beginning,
we received quite a few sceptical comments from users, (for example calling it
‘cookbook medicine’), but there were some who understood it and liked it. The
sceptics have become far fewer over the years and the majority of physicians now
find evidence-based content useful, especially in areas of controversy or outside
their fields of expertise. The feedback we have received from users is that where
there isn’t a definitive answer to their question the best approach is to provide
what evidence there is and label it clearly.
Who do you see as the key players in the marketplace?
There are a number of different companies that provide evidence that compete
with Clin-eguide. These include FirstConsult, part of Elsevier’s MDConsult, The
American College of Physicians Journal Club, PIER and InfoPOEMs, recently
acquired by John Wiley & Sons. Clin-eguide users also perceive UpToDate as a
competitor, even though it provides expert-based guidelines rather than
evidence-based content.
A lot of evidence-based content is still stuck in the library and getting it to the
point of care, and into the workflow where a physician needs it most, is a
challenge. We have partnered with Electronic Medical Record (EMR) providers
such as Cerner and Eclipsys, so that Clin-eguide is now integrated into their
systems and available from within the patient’s EMR. For example, one way we
have done this is through our new Clin-eguide order sets. When physicians do
their rounds, they have to order certain medications, laboratory and diagnostic
tests etc depending on the working diagnosis of the patient. The order sets
provide evidence-based lists of these orderables. If the physician has a patient
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EPS Focus Report January 2006
Evidence-based medical practice
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with a heart attack for example, the physician will now be able to retrieve a list of
orders for this condition that can be accessed from within the patient’s EMR. This
is intended to prevent clinical errors, provide consistent medical care and allows
us to provide content right at the point of care. There are also links from the
order set lists to our evidence-based guidelines. The order sets also contain
alerts and rules that serve to remind the physician of any medications that may
have been missed or tests that are outstanding. This is an excellent way to
improve and measure key performance indicators within an institution. Nearly all
the large EMR vendors are looking to provide order sets that link to evidencebased guidelines.
What role do publishers currently play?
It is important to provide robust and synthesized material, and the onus is on us
to make it practical, remove the barriers to access and make it easy to use. At
Clin-eguide we have physicians and pharmacists writing all the material to ensure
we get it presented in the right format. Unless we do it well customers will
simply choose to leave EBM out of their workflow. Integrating evidence-based
content into workflow is the biggest challenge publishers face – and yet its utility
is radically limited when in the library. Our strategy at WKH is to provide evidence
plus best practice with input from physicians, and then partner with EMR vendors
in order to get this content to the point of care.
How do you see this role changing over the next few years?
We will look at the breadth of our content across a number of different clinical
specialties, because EBM can be used across a range of disciplines, not only
physicians. The content will need to be consistent between clinical specialties, so
that nurses, physicians and pharmacists are all receiving consistent guidance.
We will also provide increasing levels of assistance with documentation and
provide what customers need in their workflow. Publishing for this market is now
about three things, the content, the technology and the services to help customer
implementation. Working within the EMR environment will be crucial - 13% of US
hospitals currently have an EMR, but this number will increase by 2008 to 3040%. This will mean a big culture change for physicians and we need to ask how
we can best assist them with this. Allowing customisation of our content will be
very important, because it makes it more applicable to a specific institution and
more acceptable to physician end users.
What are the key trends evident in the launch of new products and
services for this market?
Acceptance of EBM is growing. Customers increasingly want content based on
evidence-based methodology, and more integrated content that they can use as
templates. We are therefore more involved with hospital informaticists and
working with CIOs, CTOs, and CMOs.
What are the drivers of change in this market?
The incidence of medical errors is a key driver. The US is very litigious
and there is a need for physicians to be able to point to the content they
used to make a decision.
There is so much information available today that physicians need to
know how to navigate it. Evidence-based content can be useful even for
a senior physician operating outside their area of expertise.
Physicians are increasingly saying ‘I need to know more than my patient’.
Patients can now go on search engines such as Google and find
information about medical conditions.
There are a number of government initiatives on what types of content
physicians should have access to and also incentives to utilize EMRs.
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Hospitals are also finding that their own content (guidelines and order
sets) is difficult to maintain and to update. A lot of this content is paperbased and not consistent across different departments within the same
institution. As a result institutions are turning to publishers and asking
them to provide and update these guidelines and deliver them in
electronic form.
What do you believe are the future trends in evidence-based medicine?
We will see a lot more evidence integrated into workflow, particularly as by 2010
we will have a large proportion of institutions with EMRs. There will be features
such as information buttons for particular diseases integrated within the EMR, and
semantic networks between different content sets. Technology will allow us to link
co-morbidities and infer best treatment strategies for example, first-line
treatment for a pregnant patient with diabetes mellitus and heart disease. We
are starting to turn content into real knowledge and will see a bi-directional flow
of knowledge between the EMR and the physician. A physician will have access to
very granular information that is clinically relevant for the patient they have in
front of them. Rules and reminders are here today and will increase over the
years as the technology allows us to provide more focused content. However it is
very important to say that we know we can never replace physicians. We are not
trying to challenge their role as the decision makers, rather to provide evidence
to help the process along, because ultimately they are the ones with the patient
knowledge.
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EPS Focus Report January 2006
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Expert Interview
Dr J A Muir Grey
Dr Muir Gray is Programme Director of the NHS National Electronic Library for Health
(NeLH) and has been in the vanguard of the UK’s evidence-based health movement,
establishing the Centre for Evidence-Based Medicine at Oxford.
He runs a web and wireless service about health knowledge – www.soundshealthy.org
Who do you see as the key players in the marketplace?
All the major publishers now have offerings in this area, as it has become a key
area of growth for them. However key evidence-based medicine players include
Bazian, Zynx, EMed Group, and UpToDate.
What role do publishers currently play?
Publishers have been active in this market so far without adding a great deal of
value to the information available to medical professionals. This is because it is
the quality of the content published in their journals that is the real issue and one
that has yet to be solved. The peer review process is hopeless as a means of
providing sufficient quality, so most journals are too inaccurate for clinicians and
patients to use. The answer to this problem lies in the increased use of
systematic reviews by bodies such as the Cochrane Collaboration who can provide
a check on the validity of the content published. Journals also need to use
standards, such as CONSORT, to improve how they report research.
How do you see this role changing over the next couple of years?
I would hope that publishers would worry less about evidence-based medicine
and concentrate more on the quality of the books and journals they produce.
What are the key trends evident in the launch of new products and
services for this market?
We will see increasingly rigorous scrutiny of the quality of published content in
scholarly journals and a growing need to be explicit in what the updating
procedures for these are. It is clear that peer review is flawed and pressure will
grow for ways of improving the system.
What are the drivers of change in this market?
A key problem is that there is too much information of too low quality available to
clinicians, and there is a need to look for ways to both improve its quality and
help doctors navigate it effectively. Meanwhile the limits of finance, as hospitals
and surgeries struggle to balance and make the most of limited budgets, are
driving a need to increase the value derived from resources. Bound up with both
these trends is a growing awareness of the need to improve patient safety by
reducing medical errors, which is a very strong driver of developments both in the
US and here in the UK. Alongside these factors there has been a growth in
consumerism amongst patients, who are increasingly arriving at consultations
having already used the web to research their health conditions. Doctors must
be on top of all the latest evidence to deal effectively with well-informed patients.
What do you believe are the future trends in evidence-based medicine?
We will see the growth of better knowledge management, to address the issues
stemming from the mass of information available to medical professionals, and
better systems of care that will look to reduce medical errors. We can also expect
increasing levels of patient involvement.
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EPS Focus Report January 2006
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Expert Interview
TheraDoc
Stan Pestotnik, Chief Executive Officer and co-founder
TheraDoc was founded in 1999 and is based in Salt Lake City, Utah. It is a medical
informatics company that creates and markets software designed to help physicians
deliver evidence-based care.
How do you define evidence-based medicine?
We define it based on the Cochrane Collaboration standards; we grade the
evidence and we analyse control trials or observational trials.
How is this being developed at the moment?
We have an in-house editorial staff of physicians and pharmacists who collate the
literature and then, using the template for grading, grade it and build our
knowledge bases. But we let people know what the rules, guidelines and the
evidence behind this knowledge base is.
Is there any scepticism with regards to EBM?
Well, I think it depends - there can be. The way you get around that is how the
technology marries that evidence base with individual patient data. If you are
able to take the evidence base, and bring that into the context of patient care and
patient data, then I think you get away from that criticism because I think what
you are doing is taking that evidence base and turning into actionable knowledge
at both the time and the point of care.
Who do you see as the key players in the marketplace?
In my opinion, the current leader in the evidence-based space is going to be
Zynx, a division of Hearst Corporation. In the whole content arena there are
other legitimate players – Clin-eguide being one, another being UpToDate, Skolar
and Healthgate.
The larger players are going to have to take a more pro-active in healthcare
information technology and workflow solutions. Their content – their evidence
base – is quickly becoming a commodity and eventually will just become a
commodity.
What role do publishers currently play?
The role they play right now is – and I think this will continue to be a major role –
is that they act as collators or aggregators of this knowledge. They are the ones
who are the repositories, and they need to be able to take that knowledge and
get it into the context of patient care workflow – that’s where they are struggling
right now. We are seeing this with the recent announcement that Wolters Kluwer
just bought a company at the end of the year (a documentation company). What
remains uncertain in my mind is whether or not they are going to be able to
execute on their vision. Giving a selfish reason, I think companies like TheraDoc
are going to be the ones that are going to do that. The EMR vendors and the HIT
vendors talk a good story about this, but they haven’t been successful in doing
this either and I think it’s too specialised a niche for them. They have too much
more to try to accomplish in creating the electronic health record or electronic
medical record as well as refining the transaction base. Trying to get into the
knowledge space is a difficult proposition for them.
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How have you approached this issue?
One of the things we have been able to do with our technology is that we have a
platform that the knowledge integrates with and that platform is designed to
create the interoperability and connectivity with the patient data. It also provides
interoperability connectivity with the knowledge or evidence base so it is within
that platform that the technology (which is proprietary) draws on the strength of
expert systems technology and on the knowledge bases that contain the
evidence. It is this expert system platform where this happens. That’s how we
are unlike the publishers. What we are working diligently on is establishing
relationships with publishers like Zynx, Clin-eguide, and the Micromedex because
I think what we bring to the table is the ability to take that rich content and
integrate it into workflow which they have not been able to do to date.
Do you think the growth of EBM is largely pegged to the growth of
electronic medical records?
The next wave you are going to see is when we empower the consumer of
healthcare to use these technologies to be able to get access to the evidence
base in conjunction with whatever their particular issue is. Where we are going
with this in the industrialised nations is shared medical decisioning. One of the
only viable answers in addressing escalating healthcare costs is to make the
patient part of the decision-making on the best treatments. The way to do that is
to give them proper information that is graded and in a format that they can
understand and they can discuss with their physicians. We are years away from
that, but I think it will be one of the great flatteners.
WebMD has something like this too, but it will end up with the healthcare
providers like the NHS in Britain or some of the larger carers in the United States.
The movement is evident within some of the large insurance carriers in the US,
which are trying to create these so-called portals that will connect patients with
their doctors and their hospitals - they are now trying to figure out how to bring
the evidence base into the whole mix.
What growth rate are we likely to see with regards to hospitals using
EMRs? One figure we have is 30-40% of US hospitals using EMR by
2008.
I think that’s pretty accurate. It’s going to continue to grow because of the many
national initiatives – whether it be in the UK or the US or other places – for this.
I think it is now a political issue, at least in the US. It is also now the lay-person
who is talking more about this because they are exposed to it. With the
presidential elections in 2008, health records, shared medical decision-making
and escalating healthcare costs are all going to be major political issues. I see
the healthcare, IT and EBM sectors continuing to grow.
What are the drivers of change in this market?
The number one drivers at the moment are regulatory requirements, at least in
the US, to do with quality and safety. You are also seeing, at least in my view,
the explosion of medical knowledge. It is impossible for an individual to keep
abreast of the information they need to be competent in their area of expertise,
and then you couple that with the manpower shortages that are uniformly seen
with physicians, pharmacists and nurses. All of these things couple and will push
for EBM and IT adoption.
What I keep trying to tell publishers is that their content is a commodity and it is
going to continue to be a commodity unless they change.
Can old-world
publishers, to use a worn-out phrase, change their stripes and move into the
digital age? It’s all about workflow. They are going to have to have workflow
solutions. To just sit the content in a library is not going to help anyone. It has
to be at the point of care.
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EPS Focus Report January 2006
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Expert Interviews
Zynx Health
Scott Weingarten, President, Chief Executive Officer, and cofounder
Zynx Health was founded in 1996 as part of the Cedars-Sinai Medical Center Division
of Health Services Research. It became a subsidiary of the Hearst Business Media
division of The Hearst Corporation in 2004. The company delivers its services to
almost 1000 hospitals, largely in the US. Zynx creates clinical decision support content
using peer-reviewed scientific literature.
How do you/your organisation define evidence-based medicine?
Zynx defines evidence-based medicine as the process by which scientific evidence
from peer-reviewed scientific literature is used to inform clinical decisions. The
goal of evidence-based medicine is to ensure that clinicians are informed of all of
the relevant scientific evidence to enable them to take better patient care
decisions.
Who do you see as the key players in the marketplace?
Lots of different organisations are involved in this sector, although Zynx believes
that it has little direct competition with evidence-based clinical information that
can be integrated with clinical information systems. Other organisations involved
in evidence-based medicine include the Cochrane Collaboration, an international
not-for-profit organisation, providing up-to-date information about the effects of
healthcare. Its major product is the Cochrane Database of Systematic Reviews
which is published quarterly – this therefore is a very different model to that
employed by Zynx which delivers continuously updated information to the
clinician at the point-of-care. The Health Information Research Unit at McMaster
University has also done a lot of work in this area.
Zynx has found that some healthcare institutions believe that they can use staff
members to develop their own evidence-based medicine clinical information.
What role do publishers currently play?
At present, the role played by publishers in developing evidence-based clinical
information that can be integrated with clinical information systems is still in its
fairly early stages. Some publish evidence-based medicine journals and books,
but there is less activity in the area of integrating evidence-based medicine into
healthcare information technology to improve clinical decision makings at the
point of care. These technologies allow rapid access to context-specific evidencebased medicine information very quickly.
How do you see this role changing over the next few years?
Publishers will undoubtedly move into the area of clinical decision support,
integrating their content into the workflow of the clinician.
The value of
reference-based content from the clinician’s perspective is falling because of the
clear value-add offered by clinical decision support services.
What are the key trends evident in the launch of new products and
services for this market?
Clinical decision support tools are driving the recognition that referential sources
are difficult for time-pressured clinicians to use consistently and effectively
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What are the drivers of change in this market?
In addition to this recognition, healthcare organisations are moving down the
road of adopting much more healthcare information technology which evidencebased medicine services will be able to feed into. Examples of these types of
technology include electronic health records, computerised physician order entry
systems, and handheld devices.
What do you believe are the future trends in evidence-based medicine?
Evidence-based medicine is intended to improve levels of patient care, but it is
challenging to practice evidence-based medicine without clinical information
systems. The development of these products and services however will enable
them to be used by clinicians to practice medicine on a daily basis.
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Tel: 020 7837 3345 · Fax: 020 7837 8901 · [email protected] · www.epsltd.com
43
EPS Focus Report January 2006
Evidence-based medical practice
in the 21st century
Previous EPS Focus Reports
2005
December
November
October
September
August
July
June
April/May
February/March
January
20 to watch in 2006
STM Publishing in Asia
The future of reference publishing
Drug informatics – where are the opportunities for STM
publishers?
The Mobile Content Market: Drivers, trends and technologies
Business Publishing in China
Online Corporate Recruitment Activities: How is the
recruitment landscape changing?
Google and Publishers: assessing the impact of the
Googlesphere
Outsourcing and offshoring: Can it work for publishers?
Innovation in e-learning: Expanding the realm of the possible
2004
November/December:
October:
September:
July/August:
June:
April/May:
March:
February
January:
ELT content: What does the future hold for this market?
Humanities and social sciences publishing: attitudes,
challenges and innovations
Business models for online content: balancing the bucks
The Transformation of Healthcare in the US
Digital Rights Management: gaining real value from
implementation
STM Book Publishing: A Sector in Crisis?
The road ahead for digital and online newspapers
Classifieds Online: Where Now? Where Next?
DOI in 2004: Where are the tipping points?
2003
November/December:
October:
September:
July/August:
June:
May:
April:
March:
February:
January:
Publishing and the Investment Community
Future-gazing: projects and technologies for the content
industry to watch
E-Textbooks: their place in the undergraduate content mix
Healthcare Publishing: a model for other markets
Aggregating Content for the Corporate User
Integrating Content With Workflow: Learning from the pioneers
E-learning 2003: lessons from the marketplace
Profitable Publishing Architectures
Digital publishing in the UK schools market
Open Archives Initiative: Market revolution or hot air?
All EPS Focus Reports are available in HTML and PDF to EPS Market Intelligence and
Advisory Service clients at www.epsltd.com. We are happy to e-mail PDF versions to
clients on request.
Executive summaries of EPS Focus Reports are free of charge to guests, and are available
at www.epsltd.com.
Electronic Publishing Services Ltd, 7-15 Rosebery Avenue, London EC1R 4SP
Tel: 020 7837 3345 · Fax: 020 7837 8901 · [email protected] · www.epsltd.com
44