Kaiser
Permanente Southern California Regional Technology Management Process:
Evidence-Based Medicine Operationalized |
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By
Joanne
Schottinger, MD; Richard M Odell
Presented
as Kanter M, Schottinger J, Odell R. "New technologies in health
care: an evidence-based approach to evaluating new technologies,"
at the Kaiser Permanente Care Management Institute and The Permanente
Journal Evidence-Based Medicine Symposium, Costa Mesa, California,
December 3-4, 2004.
Introduction
Kaiser
Permanente (KP) has a robust process for evaluating, deploying, and
monitoring new types of medical technology, including devices, equipment,
diagnostics, and procedures. This process provides guidance and management
of new and existing medical technology to ensure that physicians of
the Southern California Permanente Medical Group (SCPMG) can provide
state-of-the art care. The success of the process depends on participation
of a variety of internal professional and physician experts as well
as other internal groups, such as the Interregional New Technologies
Committee, Laboratory Committees, and Pharmacy Committees.
The process
of managing medical technology uses three teams of physicians and
support staff: the Medical Technology Assessment Team (MTAT), the
Medical Technology Deployment Strategy Team (MTDST), and the Regional
Product Council (RPC). The medical technology management process seeks
to evaluate medical technology in a timely manner, using principles
of evidence-based medicine and focusing on efficacy, safety, and expected
improvement in health outcomes. The evaluation process also provides
analytical and tactical support to SCPMG physicians by assisting them
with systematic, well-thought-out deployment of medical technology.
The final component of the process considers benchmark standards to
coordinate purchase of the technology while ensuring that KP leverages
its collective purchasing power, and provides appropriate vendor support.
Over
the past two decades, the process of managing new technology in the
KP Southern California Region has evolved continuously. Initially,
in 1983, a Medical Technology Committee was formed to evaluate requests
of local medical centers for regional approval to purchase capital
medical equipment. At that time, much focus was directed on new types
of imaging technology, such as computed tomography (CT) or magnetic
resonance imaging (MRI).
In 1995,
the Technology Assessment and Guidelines (TAG) Unit was developed
to support the committee by providing evidence-based evaluation of
new technology. In 1998, the California legislature enacted the Friedman-Knowles
Act, which set the stage for independent medical review of coverage
decisions for individual health plan enrollees. The Medical Technology
Inquiry Line was created in the KP Southern California Region as a
one-stop location for giving clinicians prompt access to objective,
evidence-based medical information on new technology. With the support
of the Permanente Federation, this service was expanded to include
support for KP regions outside California.
In 2000,
a process called the Medical Technology Management Process was implemented
to connect the discipline of evidence-based evaluation of medical
technology with a strategy for planned equipment purchase and deployment.
Figure 1 shows the groups currently participating in this process,
the components of which include assessing and deploying medical technology
as well as responding to inquiries about it.
Technology
Assessment
The Medical
Technology Assessment Team (MTAT) performs critical analysis of published,
peer-reviewed medical literature to evaluate the evidence supporting
use (or avoidance) of specific types of technology for medical diagnosis
or treatment. Assessment of new technology includes describing the
specific health problem, the population of concern, the new technology,
any alternative interventions, and the desired health outcomes. The
medical problem of interest is described precisely and systematically
with input from clinicians practicing in specialties relevant to the
specified condition.
One of
the analytical staff uses PubMed (an online bibliographic resource)
to search the medical literature. The published medical literature
is searched also to identify any previous assessments that may have
been conducted by other organizations that use evidence-based methodology
(for example, the Emergency Care Research Institute, Blue Cross/Blue
Shield, or Hayes, Inc, an independent assessor of health technology).
Information is sought also from government agencies, such as the US
Food and Drug Administration (FDA), National Institutes of Health
(NIH), National Cancer Institute (NCI), Centers for Disease Control
and Prevention (CDC), and from medical specialty societies.
The MTAT
carefully evaluates the quality of available evidence by thoughtfully
considering such factors as number of studies and subjects, quality
of investigation (Figure 2),1 consistency of study results,
certainty and magnitude of possible benefits and harms, and number
of potential candidates for a specified intervention. Stating the
rationale for its conclusion, the MTAT develops and forwards to interested
specialty groups a recommendation based on the sufficiency of the
evidence.
Technology
Deployment
Technology
whose use is supported by available evidence is also recommended by
MTAT to the Medical Technology Deployment Strategy Team (MTDST), which
considers the logistics of deployment, including forecasting the need
and uses for the technology, developing a business case for its use,
determining requirements for training and credentialing staff who
will use the technology, and defining processes for monitoring the
quality of the technology's outcomes. The Regional Product Council
(RPC) is responsible for acquiring, standardizing, and budgeting for
medical equipment. The RPC communicates with KP's geographic service
areas in Southern California.
This
process of evaluating, recommending, planning, acquiring, and monitoring
use of new medical technology is tied together and is administratively
coordinated by the Joint Chairs Committee (a group which includes
the Chair and Cochairs of the MTAT, MTDST, and RPC). The Joint Chairs
Committee ultimately makes regionwide recommendations about new technology
after carefully consulting with KP internal experts, chiefs groups,
regional clinical committees, and clinical technology committees.
At their meetings, the medical directors and medical group administrators
receive regular updates on new technology, including capital requirements
as well as implications for future space planning.
Responding
to Inquiries about Technology
Physicians
or Member Services Representatives with a specific patient case question
or leaders with questions about new technologies can easily access
informational resources on new technology by contacting the KP Southern
California Region Technology Inquiry Line at 626-405-5138 or by sending
an electronic inquiry to Med-Technology-AGU, Scal (KP e-mail) or scal.med-technology-agu@kp.org
(Internet access). Questions can range widely--from the newest technology
for targeted cancer therapy or drugs still in clinical trials to the
oldest technologies--and ask, for example, "What is the role
of leeches in medical therapy?" and "How can we acquire
leeches appropriate for medical use?"
In response
to the inquiry, the technology assessment group sends an electronic
file containing several components:
-
a summary and analysis of published information
-
a reference list with published abstracts obtained from MEDLINE
-
assessments obtained from other evidence-based organizations, if
available; and
-
information on FDA/Medicare coverage.
Figure
1. Diagram illustrates the KP Southern California
Region technology management process.
The inquiry line receives about 700 inquiries per year, about a third
of which originate from outside California. Maintaining assessments
and responses in a database enables most inquiries to be answered
within 24 hours.
The KP Interregional
New Technologies Committee
Technology
that may have programwide application is also assessed by an interregional
KP group, the Interregional New Technologies Committee. This group,
chaired by the Permanente Federation Associate Executive Director
for Quality and Program Improvement, includes physician-representatives
from each KP region, Program Offices, the Care Management Institute
(CMI), and from Kaiser Foundation Hospitals benefits and regulatory
services, legal counsel, public affairs departments, and ethics advisors.
The INTC tracks emerging technology as it is developed for entry into
the marketplace.
On the
basis of the published literature reviewed, the INTC can issue any
of three types of recommendation:
-
Sufficient evidence shows that use of the technology is medically
appropriate for select patients
-
Insufficient evidence exists for the committee to determine whether
use of the technology is medically appropriate for any patient;
or
-
Sufficient evidence shows that use of the technology is generally
not medically appropriate for any patient.
Recommendations
and discussion of the rationale for new technology discussed by the
INTC are available on the clinical library Intranet site, http://cl.kp.org/.
These materials are filed under Clinical Practice Guidelines as the
last item (New Clinical Technologies) and can be searched either chronologically
or alphabetically. Table 1 lists some recent examples of technology
reviewed by the INTC along with its recommendations.
Evaluation
of New Drugs
Assisted
by monographs prepared by KP National Drug Information Services, the
KP Pharmacy and Therapeutic Committees use an evidence-based approach
to assess the safety and efficacy of new medications. Individual clinicians
can obtain literature searches and information about new medications
from the Drug Info line (available by phone in the KP Southern California
Region), electronically at Drug-Info-Inquiry (available through KP
e-mail), or Drug-Info-Inquiry@kp.org (accessed over the Internet).
The KP
Biotechnology and Emerging Pharmaceuticals Technology Advisory Committee
(BEPTAC) was formed in response to the exploding growth of new types
of medication, including human proteins, monoclonal antibodies, growth
factors, immunomodulatory drugs, and chemotherapeutic agents. Although
expensive, these drugs often represent major advances in treating
the diseases for which the new medications are approved. Monitoring
these medications is challenging also because they may have more widespread
potential applications that have not yet been well studied; and that
neither the safety of these medications, often approved after review
of very limited clinical trials, nor the adverse reactions they cause,
may not yet be completely understood. This concern is illustrated
by the recent withdrawal of natalizumab from the market after progressive
multifocal leukoencephalopathy developed in some patients who had
received the drug as treatment for multiple sclerosis or Crohn's disease.2-4
Challenges
to Use of New Medical Technology
Tension
in evidence-based technology management is presented mostly by the
statement that "there is insufficient evidence showing that this
intervention is medically appropriate for patients." Because
the process tries to "stay ahead of the curve," many assessments
of medical technology initially include this statement, often reflecting
existence of lag time between data collection, its presentation at
specialty society meetings, and publication of the evidence in peer-reviewed
medical journals. In some cases, the technology that appears in a
publication is already outdated and has been replaced by newer methods.
Frequently, assessments must be updated and the medical literature
monitored until the technology "matures" or until high-quality
investigational trials are completed.
|
Figure
2. Diagram shows pyramidal hierarchy of evidence used by clinicians,
researchers, and administrative decisionmakers to evaluate medical
technology for possible use in the KP Southern California Region.
(Reproduced
by permission of the publisher from: SUNY Downstate Medical
Center, Medical Research Library of Brooklyn. SUNY Downstate
Medical Center evidence based medicine tutorial [home page on
the Internet]. [Brooklyn (NY): SUNY Downstate Medical Center];
2005 [updated 2004 Jan 6; cited 2005 Nov 14]. Available from:
http://library.downstate.edu/EBM2/contents.htm.
1
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A good
current example of this sequence of events is presented by virtual
colonoscopy as used for detecting polyps and colorectal cancer. The
medical community eagerly awaits the results of ongoing large randomized
controlled trials to determine the utility of this technology compared
with standard visual colonoscopy.5
Another
reason for concluding that a recommendation is supported by insufficient
evidence may be that different studies present conflicting evidence.
In addition, other reasons may be found for recommending against use
of medical technology: existing published studies may be methodologically
weak or include too small a study cohort; the magnitude of the benefit
may be small; or no comparison has been made with existing technologies
and therefore no evidence has been presented showing that the newer
technology improves upon the older technology. In these instances,
one possible solution is to deploy the new technology at KP as part
of a research protocol or as a quality pilot project designed to collect
data for responding to unanswered questions about whether the technology
deployed within KP has improved treatment outcomes. If the technology
is thus deployed as part of a research protocol, we can contribute
to the health of our communities also by contributing to the peer-reviewed
medical literature or by publishing our own results. With our organization's
size, the interests of our clinicians, the strength of our research
departments, and especially the power of an electronic medical record,
the future holds much promise for us to lead in the most effective
use of new medical technology.
References
- SUNY
Downstate Medical Center, Medical Research Library of Brooklyn.
SUNY Downstate Medical Center evidence based medicine tutorial [home
page on the Internet]. [Brooklyn (NY): SUNY Downstate Medical Center];
2005 [updated 2004 Jan 6; cited 2005 Nov 14]. Available from: http://library.downstate.edu/EBM2/contents.htm.
- Kleinschmidt-DeMasters
BK, Tyler KL. Progressive multifocal leukoencephalopathy complicating
treatment with natalizumab and interferon beta-1a for multiple sclerosis.
N Engl J Med 2005 Jul 28;353(4):369-74. Epub 2005 Jun 9.
- Langer-Gould
A, Atlas SW, Green AJ, Bollen AW, Pelletier D. Progressive multifocal
leukoencephalopathy in a patient treated with natalizumab. N Engl
J Med 2005 Jul 28;353(4):375-81. Epub 2005 Jun 9.
- Van
Assche G, Van Ranst M, Sciot R, et al. Progressive multifocal leukoencephalopathy
after natalizumab therapy for Crohn's disease. N Engl J Med 2005
Jul 28;353(4):362-8. Epub 2005 Jun 9.
- Mulhall
BP, Veerappan GR, Jackson JL. Meta-analysis: computed tomographic
colonography. Ann Intern Med 2005 Apr 19;142(8):635-50.
