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Factors Important for the Selection of Key
Patient Management Issues and Related
Research Activities
Before discussing high priority patient management issues in AMI, the
committee briefly reviewed its understanding of the major reasons that AMI
had been selected for the Effectiveness Initiative research program.
Coronary artery disease is very prevalent among elderly women and men,
and AMI is the leading cause of death in the United States for all age groups
above 40. However, the individual outcome for those who survive the acute
event is less predictable; that is, an AMI can lead to chronic disability in
some patients but to little chronic problem in others. New diagnostic and
therapeutic interventions have developed rapidly in recent years, and much
data from clinical trials of these interventions are accumulating. The multi-
ple patterns of treatment for young and elderly AMI patients include many
high-cost and high-risk procedures, with little clear relation between specif-
ic therapies and long-term outcome, particularly functional health status and
psychological aspects.
SELECTING PATIENT MANAGEMENT ISSUES
Several factors affect the selection of key patient management issues for
AMI in elderly patients. These factors are not equally well documented in
the clinical, research, or health policy literature. The IOM committee
believed, however, Mat all of them were sufficiently important to be consid-
ered as the panel identified specific study topics. These factors include:
· Epidemiologic aspects of AMI among the elderly (e.g., higher or
lower prevalence of more advanced coronary disease in particular sub-
groups)
25
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26
EFFECTWENESS INITIATWE
· Important health status and quality-of-life burdens of the illness for
elderly patients
· Different treatment options for the elderly, characterized, for instance,
by whether different therapies have different likelihoods of prolonging sur-
vival, producing major impairment and disability, or improving the patient's
physical functioning, emotional well-being, and independence
· High degree of professional and clinical uncertainty about some alter-
native strategies for managing the care of AMI patients, especially the very
elderly
· Substantial variation across geographic areas in the per-person use of
services for AMI, including those related to prevention and management of
risk factors; that is, variation beyond that explained by differences in patient
characteristics or health resources in the areas
· Substantial variation across geographic areas or institutions in the out-
comes of care for AMI; that is, variation beyond that explained by the dif-
ferences in the severity or stage of illness (i.e., case mix) or sociodemo-
graphic characteristics of patients
· Relatively high costs to the Medicare program of reimbursing for the
services provided to patients to prevent, diagnose, and treat AMI and to
manage postmyocardial infarction care
· Relatively high out-of-pocket costs to the Medicare beneficiary for
services to prevent, diagnose, and treat AMI and to manage posonfarction
care that are not covered or are only incompletely covered by the Medicare
program.
SELECTING RESEARCH TOPICS AND ACTIVITIES
Content, Conduct, and Use of Research
In specifying research activities focused on high-priority AMI topics, the
committee raised three additional points concerning the content, conduct,
and use of this research. First, it endorsed four generic areas of concern
identified at the 1988 clinical workshop to set priorities for the Effectiveness
Initiative: (1) clarification of the implications of the difference between
efficacy and effectiveness for the overall purposes of the research program;
(2) screening and prevention of the illness; (3) generation and use of reliable
and valid outcome measures that relate to functional status and quality of
life; and (4) mental and emotional dimensions (cognitive functioning;
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ACUTE MYOCARDIAL INFARCTION
27
anxiety and depression). With respect to the last two, the committee noted
that several good measures of health-related quality of life (relating to func-
tioning, emotional well-being, and so forth) are currently available or could
be adapted for effectiveness research.
Second, in principle, several approaches can be used to this research ini-
tiative, either sequentially or simultaneously. They fall into the following
basic categories (in increasing order of complexity, rigor, and expense):
cost, utilization, and outcome monitoring through analysis of administrative
data; observational (cross-sectional, case-control, or longitudinal-cohort)
studies with a richer data set than that afforded by routinely collected
administrative data; quasi-experimental studies and demonstrations; and,
potentially, RCTs.
In addition, projects based on newer, or nonexperimental techniques,
such as meta-analysis, decision analysis, and cost-effectiveness analysis,
should be included among the research options. In short, the committee
concluded that all these approaches should be considered potential investi-
gational methods for effectiveness research. The committee also empha-
sized the importance of evaluating beforehand the trade-offs implicit in
selecting one approach over another and in pursuing combined approaches.
Third, studies on specific illnesses serve as prototypes for examining
other, similar conditions. For instance, studies of primary and secondary
prevention, early diagnosis and treatment, staging of acute disease in rela-
tion to outcome, treatment options, and quality-of-life outcome measures
related to AMI provide opportunities to address conceptual and method-
ologic issues for other illnesses that are prevalent in the Medicare popula-
tion, that have both acute and chronic aspects, or that affect the cardiovascu-
lar system.
Data Issues
The 1988 clinical workshop had questioned the availability and quality of
data for effectiveness research in HCFA's existing (or anticipated) a~ninis-
trative files. This remained a critical issue, as evidenced by appreciable dis-
cussion of the topic by the AMI workshop committee.
The committee underlined the importance of HCFA's ability to acquire
additional data through special studies, surveys, and patient follow-up aciiv-
ities, for several reasons. Data available on pre- and posthospital events,
particularly those in physician office records, must be expanded, and prob-
lems (e.g., missing data or un~nterpretable information) with office records
must be addressed. The relative lack of documentation of deaths that occur
before hospitalization or at some time after hospital discharge for AMI
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EFFECTIVENESS INTTIATIVE
needs to be taken into account. Two substantial problems in coding cod-
ing rules for the diagnosis of AMI in hospital records and the lack of flexi-
bility and responsiveness in creating new codes for new tests and treatments
must be confronted. Considerable effort should be made to enhance the
collection of outcome information that is pertinent to elderly AMI patients.
For example, return to work or ability to drive a car, outcomes that might be
relevant at age 50, may be less important at age 75.
The development of the Uniform Clinical Data Set (UCDS) (see the
appendix) and the use of the Medicare Peer Review Organizations (PROs)
to abstract this information from clinical records were considered. Some
committee members raised concern about the accuracy of such records, the
value of retrospective abstracting rather than concurrent analysis, and the
lack of clinical peer review of both the data set itself and the PRO method-
ology. These difficulties were particularly emphasized with regard to risk
stratification methodologies and identification of the sequence of diagnostic
and therapeutic events.
Notwithstanding these concerns, current data sets were considered useful
for monitoring variations and trends in the use of tests and treatments and
for assessing the relation of certain services to simple short-term outcomes,
particularly survival, some complications, and reinfarction. These data
would be useful, for example, in looking at differences by geographic region
or size and type of hospital. Moreover, claims data may be valuable as a
source for generating hypotheses, building a convincing case for more
detailed data collection, and constructing decision models that could be test-
ed win rigorous study designs.
Representative terms from entire chapter:
patient management
