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Introduction
EFFECTIVENESS INITIATIVE
In 1988, the Health Care Financing Administration (HCFA) of the
U.S. Department of Health and Human Services (DHHS) proposed an
Effectiveness Initiative, the purpose of which was to bring the resources of
Medicare to bear on the question of what works in the practice of medicine.
The objectives of the Effectiveness Initiative were, first, to assess the
overall merit of competing health care interventions and, second, to provide
information that would help clinicians in managing their patients, improve
the peer review process (e.g., of the Medicare Peer Review Organizations
[PROs]), and aid policymakers in allocating Medicare resources. HCFA
also identified four activities to support these objectives: (1) monitoring
time trends in the use of services by the Medicare population; (2) analyzing
geographic (population-based) variations in the use of services and in
outcomes of care; (3) assessing interventions by clinical demonstrations,
observational studies, and randomized controlled trials (RCTs); and (4)
feeding back information to clinicians in education programs.
Planning for effectiveness and outcomes research within DHHS in 1988
and 1989, and the recent transfer of effectiveness-research to the Public
Health Service, incorporates the above purposes and adds responsibility for
the development of practice guidelines. Although this monograph reports
on work conducted for the HCFA Effectiveness Initiative, it pertains to all
effectiveness research supported by DHHS.
THE IOM CLINICAL WORKSHOP
In 1988, HCFA consulted widely with individuals and organizations
in the medical, health financing, and health services and policy research
s
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6
EFFECTIVENESS IN1TLATIVE
communities for guidance on its program initiative. It then asked the
Institute of Medicine (IOM), National Academy of Sciences, to recommend
the clinical conditions that should receive priority attention. Conceptually,
this reflected a decision to choose the clinical condition as the unit of
analysis rather than specific procedures or technologies.
In October 1988, the IOM appointed a study committee and convened
a "clinical workshop." The clinical workshop committee recommended five
clinical priorities; stable and unstable angina, acute myocardial infarction,
breast cancer, congestive heart failure, and hip fracture.) These five condi-
tions met several selection criteria, including high prevalence, burden of the
illness on elderly people, appreciable variations in the use of services and
in outcomes, high costs, and controversy about alternative ways to manage
patients that reflects professional uncertainty.
Hip fracture was recommended for several other reasons. It is almost
exclusively a disease of elderly people, there is little clinical disagreement
about diagnosis, and the acute phase is universally treated in hospitals.
Disagreement exists about certain aspects of the treatment: length of
hospital stay, surgical options (pinning, replacing the femoral head, total hip
replacement), and timing of surgical interventions; and about etiology and
prevention. Issues of long term care and of long-run functional outcomes
are also very important.
CONDITION-SPECIFIC RESEARCH WORKSHOPS
Purpose
After the clinical workshop, HCFA asked the IOM to conduct condi-
tion-specific workshops for three high-priority clinical areas: breast cancer,
acute myocardial infarction, and hip fracture. These workshops had three
objectives: (1) to examine each clinical condition in detail; (2) to iden-
tify central topics within each condition deserving further investigation in
terms of "effectiveness" as contrasted with "efficacy"; and (3) to propose
appropriate research strategies and methods.
The distinction between effectiveness and efficacy is especially impor-
tant. Efficacy typically means the outcome of an intervention when it is
applied in "ideal," well-controlled circumstances, such as those inherent
in prospective randomized controlled trials. Outcomes of interest may
be quite technical and oriented to physiologic variables and survival. By
~ The 1988 clinical workshop committee also recommended a second tier of clinical conditions
that could receive later attention: cataracts, depressive disorders, prostatic hypertrophy, and
transient ischemic attacks with or without occlusion. The report of this study was published as
Effectiveness Initiative: Setting Priorities for Clinical Conditions in April 1989, it is available from
the Institute of Medicine (Report No. IOM-89-04~.
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HIP FRACTURE
7
contrast, effectiveness concerns the outcome of an intervention realized
when it is applied in "everyday" or "average" circumstances (such as the
daily practice of medicine); these situations may involve patient subgroups
that differ considerably from those studied in RCD. Outcomes, moreover,
may embrace broader quality-of-life concerns, such as physical and social
functioning and emotional well-being.
Research Workshop Committee
For the condition-specific research workshops, the IOM appointed a
"core committee" of clinicians and researchers in 1989; it was chaired
by Kenneth I. Shine, M.D., Dean of the School of Medicine, University
of California, Los Angeles.2 For each workshop, the core committee was
augmented with clinicians and researchers with recognized expertise in the
condition of interest.
Committee Charge
The hip fracture committee was charged with two responsibilities: (1)
to recommend to the HCFA administrator a small number of issues in hip
fracture patient management for the elderly population *at should receive
priority in the Effectiveness Initiative; and (2) to suggest specific research
strategies to be employed by HCFA and other public and private research
organizations that address these issues. Secondary questions were how
the present or proposed Medicare databases might be used to further this
research, what should be added to the current databases, and what studies
must be conducted independently of the HCFA databases.
This monograph reports on the hip fracture workshop, presents back-
ground information on clinical aspects of hip fracture, and summarizes the
committee's deliberations, findings, and recommendations. The appendix
documents the study and workshop activities.
Move members of the core committee had also been members of the clinical workshop commit-
tee (Drs. Shine, Murray, Nelson, Smith, and Sox), and three are new (Drs. Henderson, Keeler,
and Schwartz).
Representative terms from entire chapter:
clinical workshop
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