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OCR for page 176
~' Effects of Clinical Evaluation on the
7 Diffusion of Medical Technology
Patterns of medical practice often di-
verge from recommendations based on
controlled clinical evaluations. This chap-
ter views such discrepancies in light of the
many forces in addition to clinical evalua-
tion that influence the adoption and aban-
donment of medical technology.
The central question for the chapter can
be stated simply: What effect does the
evaluation of medical technologies have on
their diffusion? The next two sections of
the chapter introduce some of the complex-
ities of this question and present an ap-
proach to assessing the literature that tries
to answer it. Following a review of litera-
ture about the effect of evaluation on the
diffusion of medical technology, the chap-
ter summarizes its principal conclusions
and offers a few recommendations.
The relation between evaluation and
diffusion is part of a larger issue of the con-
tribution of technology assessment to im-
proved health. This review emphasizes the
connection between evaluations and physi-
Harvey V. Fineberg prepared this chapter.
clan behavior, although recognizing that
health benefits in many medical situations
ultimately depend on the behavior of pa-
tients as much as or more than that of phy-
. .
slclans.
EVALUATION
In this review, the impact of two general
types of evaluation are considered: (l) pri-
mary assessments of the consequences of a
medical technology and (2) synthetic as-
sessments of the implications for clinical
practice of the available primary evidence.
Both primary and synthetic assessments
take a variety of forms. Primary assess-
ments range from judgments based on per-
sonal experience to multicenter random-
ized clinical trials. Synthetic activities
range from review articles to meetings of
experts for the purpose of reaching consen-
sus on a controversial issue.
This section deals with the effect of eval-
uation on medical care decisions, usually
the decisions of physicians. Relatively few
studies quantitatively assess the influence
of community-based epidemiological stud-
ies, data banks, or case studies on changes
176
OCR for page 177
EFFECTS OF CLINICAL EVALUATION
in physician practice. Many primary and
synthetic evaluations are used by regula-
tory bodies like the Food and Drug Admin-
istration or by third-party payers in reach-
ing their policy decisions; these evaluations
indirectly and powerfully impinge on clin-
ical practice and should be considered by
someone. In this chapter no attempt was
made to cover the effect of evaluations on
decisions about the organization, adminis-
tration, and support systems of health in-
stitutions, although these too have an indi-
rect bearing on medical practices. Nor has
an attempt been made to catalog the im-
pact of epidemiologic assessments on social
policy (as in the areas of toxicology and en-
vironmental health) or on public behavior
(as in the decline in cigarette smoking) re-
lated to health. The emphasis is on physi-
cian practices and on the influence of vari-
ous forms of clinical evaluation in
changing those practices.
Primary clinical evaluations could be ar-
ranged in a hierarchy according to their
freedom from bias, for instance, with the
randomized clinical trial (RCT) at the top
and then, moving downward, controlled
(nonrandomized) studies, series of patients
without controls, and personal recollection
unaided by systematic record keeping. If
even the weakest forms of evaluation count
in our lexicon of evaluation, then most
clinical practice is based on an evaluation.
To refine the question posed at the outset
of the chapter, we would like to know
whether (and, possibly, to what extent) the
more rigorous and powerful forms of pri-
mary clinical assessment are more influen-
tial than less rigorous forms in shaping
medical practice and the policy decisions
that affect the use of medical technology.
In some instances, of course, a particular
technology cannot be studied using the
stronger methods, for example, when an
RCT is not feasible because of sample size.
177
Diffusion refers to the spread of an inno-
vation over time in a social system (Rogers
and Shoemaker, 1971~. The concept in-
cludes new practices being adopted and
old practices being abandoned. Built into
the notion of diffusion is the expectation
that social change is not instantaneous and
that some difference in practice among
physicians at a moment in time is therefore
reasonable and likely. Many studies of dif-
fusion in the social sciences examine situa-
tions in which measurable expansion or
contraction in a practice occurs over the
duration of the study rather than where
patterns of practice (possibly including
marked variation across individuals, insti-
tutions, or geography) are relatively sta-
ble.
In many studies of diffusion, the correct-
ness of knowledge available to the poten-
tial adopter is taken for granted. An inno-
vation or practice is regarded as objectively
and knowably good or bad. The majority
of these studies do not relate the nature and
quality of evaluative evidence to the
spread of a practice over time. Instead, dif-
fusion studies tend to focus on characteris-
tics of the innovation, characteristics of the
potential adopters, communication chan-
nels (bringing information to the adopter),
the decision-making process, institutional
features, and environmental forces that
bear on the spread of a practice. Notions of
evaluation, if introduced at all, tend to en-
ter as attributes of the innovation (for ex-
ample, the ease with which it can be tried
on an interim basis) rather than as an inde-
pendent determinant of the rate or extent
of diffusion.
Investigators concerned with the impact
of scientific evidence on physician beliefs
and practices frequently examine the state
of practice at a single point in time rather
than as a diffusion process over time. The
prime interest in many of these studies has
been to assess the knowledge and judgment
OCR for page 178
178
of physicians rather than to judge critically
the effectiveness of a clinical trial in reach-
ing or convincing physicians. This discus-
sion is especially concerned with studies
that relate evaluation and specific evalua-
tion methods to changes in practice over
time.
Determinants of Diffusion
Many factors bear on the adoption and
abandonment of medical technology. The
following discussion identifies 10 sources of
influence. The first 4 (prevailing theory,
attributes of the innovation, features of the
clinical situation, and the presence of an
advocate) are relatively insensitive to
change by policymakers. The next 3 (prac-
tice setting, decision-making process, and
characteristics of the potential adopters)
may be subject over time to some policy in-
fluence. The remaining 3 (environmental
constraints and incentives, conduct and
methods of evaluation, and channels of
communication) are relatively susceptible
to influence by policymakers. Each factor
is discussed briefly, with the greatest atten-
tion given to the last group.
Prevailing Theory Prevailing theory
and accepted explanations for empirical
phenomena appear to have a strong influ-
ence on the acceptance of new ideas. Pre-
vailing theories may delay the acceptance
of ultimately proved innovations. Stern
(1927) cites a number of classic examples,
such as the resistance to smallpox vaccina-
tion by those who held that improved sani-
tation was the main cause of a decline in
the smallpox rate, disbelief in the manifold
consequences of syphilis by those who held
to the theory of duality of tuberculosis; and
refusal to recognize puerperal fever as a
contagious disease by those who subscribed
to atmospheric, cosmic, and telluric influ-
ences on health. Twentieth century exam-
ples include long-delayed acceptance of sa-
licylates in the treatment of rheumatoid
ASSESSING MEDICAL TECHNOLOGY
arthritis (Goodwin and Goodwin, 1982)
and a number of advances in cardiopulmo-
nary medicine and surgery (Comroe,
1976~. In other cases, appeals to prevailing
theory as a rational basis for belief about
etiology and treatment of disease appeared
to have hastened the acceptance of unsub-
stantiated practices that were ultimately
discarded. This occurred, for example, in
the case of gastric freezing for the treat-
ment of duodenal ulcers (Fineberg, 1979)
and the conduct of subsequently discarded
operations such as surgery for the endo-
crine glands and surgery for constipation
(Barnes, 1977~. Marks (Ideas as Social Re-
forms: The Legacies of Randomized Clini-
cal Trials, unpublished report, 1983) ar-
gues that relatively new methods of
evaluation (like RCTs) are themselves an
innovation whose acceptance is influenced
by prevailing theory about the nature of
clinical evaluation and its role in medical
decision making.
The Innovation Innovations vary in
the benefits and costs they offer the physi-
cian and in their compatibility with the
physician's experience and style of prac-
tice. Diffusion of new practices is presum-
ably enhanced by the extent to which they
are easy to use, require little effort to learn,
impose little change in practice style, are
highly remunerative and satisfying, and
have no clinically worthy competitors.
The Clinical Situation An innovation
that solves an important clinical problem
and is seen as highly pertinent to practice is
likely to be adopted more readily than an
otherwise equally attractive innovation
that addresses a less pressing or pertinent
situation.
Advocacy Successful diffusion of new
practices often has been attributed to an
authoritative advocate who promotes the
innovation (Globe et al., 1967; Barnes,
1977; Fineberg, 1979~. Forceful advocates
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EFFECTS OF CLINICAL EVALUATION
have wrongly encouraged practices that
were subsequently abandoned as ineffec-
tive as well as practices that were eventu-
ally proved effective. An authority figure
who is correct in strongly promoting or op-
posing one innovation may turn out to be
wrong about a later innovation (Stern,
1927; Comroe, 1976; Fineberg, 1979~.
The Potential Adopter
Many studies of
diffusion and of variation in medical prac-
tices seek to explain patterns of practice in
terms of physician attributes such as their
technical skills, demographic characteris-
tics, professional characteristics, socio-
metric status, and attitudes toward inno-
vation. In principle, changes in medical
school admissions policies and in access to
various types of specialty training could in
time alter attributes of the physician popu-
lation.
The Practice Setting Several features
of the setting and environment in which
physicians practice can influence their use
of medical technology. Physicians in group
practices appear to adopt innovations
more rapidly than physicians in solo prac-
tice (Williamson, 197S). The size and
teaching status of hospitals appear to influ-
ence hospital acquisition of equipment,
making possible new physician practices
(Russell, 1979~. The pattern of practice
among colleagues influences the way phy-
sicians use available medical technology
(Freeborn et al., 1972~.
The Decision-Making Process Some
medical practice decisions are wholly
within the domain of the individual practi-
tioner. Others are group decisions, and yet
others require a concomitant or prior insti-
tutional decision. A decision-making pro-
cess that involves more people is likely to
require a longer time to reach a conclusion.
In a study of three anesthetic practices, the
one that required a collective and institu-
tional decision (scavenging for waste anes-
179
thetic gases) entailed several years longer
delay between awareness and change in
practice than was the case for the other
two practices in which the physician could
take action as an individual (Fineberg et
al., 1978, 1980~.
Environmental Constraints and Incen-
tives Regulatory agencies and medical
care insurers exercise direct and indirect
control over the diffusion of many medical
practices. Examples may be cited at the
federal, state, and local levels. At the fed-
eral level, the Food and Drug Administra-
tion sets standards for the approval of new
drugs and medical devices; the Health
Care Financing Administration makes in-
surance coverage decisions for Medicare
patients that may prompt similar action by
other third-party payers; and the Centers
for Disease Control set the antigenic con-
tent and recommended usage of vaccines,
among other recommendations for prac-
tice. At the state level, certificate-of-need
programs, at least in principle, directly in-
fluence hospital equipment and services,
many of which impinge on clinicians' prac-
tices. Locally, institutional review bodies
and quality assurance efforts affect deci-
sions about medical practices. The climate
of malpractice litigation also may alter a
clinicians' reliance on certain medical pro-
cedures. All such environmental forces
shape the opportunities and incentives for
change in medical practice.
Evaluation and Methods of Evalua-
tion The factor that is of central concern
in this chapter is the role of formal evalua-
tion in shaping the behavior of physicians.
Evaluation may act directly on the percep-
tions of physicians; it may influence ex-
perts who in turn influence physicians
(through a channel of communication); or
it may influence the policy decisions of reg-
ulatory bodies (such as the Food and Drug
Administration), or of third-party payers
(such as the Health Care Financing Ad-
OCR for page 180
180
ministration), and hence alter the environ-
ment in which medical practice decisions
are made. In this chapter, all three possible
chains of influence on physician practices
are examined.
Many clinicians are not well prepared to
deal with quantitative methods in formal
evaluations (Berwick et al., 1981~. Debates
about the merits of particular evaluations
may be the expression of fundamental dis-
agreement about the nature and role of
controlled clinical trials in medicine (Fein-
stein, 1983; Bonchek, 1979; Marks, unpub-
lished report, 1983~.
Channels of Communication A sub-
stantial number of diffusion studies in
medicine have examined the ways in
which physicians learn about new prac-
tices. Investigators are interested in which
sources of information and which channels
of communication are most influential. Be-
cause different channels of communication
can to a degree be selected by clinical in-
vestigators and potentially enhanced by
policymakers, research in this area war-
rants elaboration.
A large body of early work on channels
of communication concerned the dissemi-
nation of drugs among medical practition-
ers, especially the influence of face-to-face
sales representatives and of social networks
among physicians (Sherrington, 1965~.
These early studies found that direct per-
son-to-person contacts by drug company
representatives were more influential than
other forms of advertising (Caplow, 1954~.
This finding has been reaffirmed in recent
studies showing that personal representa-
tion by pharmacists or, even more effec-
tively, by other physicians can influence
doctors to be more prudent drug prescrib-
ers (Avorn and Soumerai, 1983; Schaffner,
1983~.
Studies of how doctors learn about new
medical practices, based on physician sur-
veys, have found medical journals, discus-
sion with colleagues, and continuing edu-
ASSESSING MEDICAL TECHNOLOGY
cation each to be regarded as important
sources, with journals most consistently
cited as high (Fineberg et al., 1978; Man-
ning and Denson, 1979, 1980; Stross and
Harlan, 1981; Market Facts, 1982; Jordan
et al., 1983~. One study of physician
awareness of pertinent findings published
in a journal of a specialty different from
their own found that most of those who
were aware of the findings learned about
them from consultants or colleagues
(Stross, 1979~. In a study of three practices
in anesthesiology, the channels of commu-
nication (papers published in journals, col-
leagues, and continuing education) dif-
fered more in how many physicians they
reached than in their persuasiveness to
change practice (Fineberg et al., 1978~.
Persuasiveness depended more on the na-
ture of the clinical finding being communi-
cated than on the channel of communica-
tion. Whether formal medical training
appears relatively important in conveying
new knowledge (Jordan et al., 1983) or rel-
atively unimportant (Manning and Den-
son, 1979) may depend mainly on the re-
cency of the innovation and on the age of
the potential adopter. Other studies are be-
ginning to assess the influence of National
Institutes of Health (NIH) consensus con-
ferences on specific physician practices
(The Rand Corporation, 1983; Jacoby,
Biomedical Technology Information Dis-
semination and the NIH Consensus Devel-
opment Process, unpublished report,
19834.
In thinking about the implications of
these studies, several additional points
should be borne in mind. First, channels of
communication that are perceived to be
most effective may be specific to particular
types of innovation (e. g., different for
drugs than for surgical procedures) and the
particular physician audiences (specialists
or younger practitioners may be attuned to
different channels than generalists or older
physicians).
Second, what physicians say or believe
OCR for page 181
EFFECTS OF CLINICAL EVALUATION
influences them may differ from what ac-
tually influences them (Avorn et al., 1982~.
Third, investigators are unlikely to draw
favorable conclusions about the impor-
tance of channels of communication that
they omit from their survey instruments.
If, for example, a survey questionnaire lists
"journals, books, conferences, and contin-
uing education" as possible responses, then
"talking with colleagues" is unlikely to be
found important. If a study restricts itself
to the social network of physicians in the
transmission of information, then the role
of journals is not likely to appear very
prominent.
Fourth, if a channel of communication
has been less effective, it may be because
few physicians have been exposed to that
channel or because that channel is intrinsi-
cally unconvincing compared with other
sources of information. Continuing medi-
cal education, for example, appears to
have lesser perceived impact than medical
journals. The policy implications are quite
different if one believes that the weak
showing is because of low exposure to con-
tinuing education than if one believes that
physicians are not convinced by what they
see and hear at such educational programs.
Fifth, as time passes after the initial re-
lease of new information, different chan-
nels of communication may become rela-
tively more important as conveyors of
information to physicians. The initial re-
lease of new findings usually come in the
form of a publication or presentation at a
professional meeting. Soon after the re-
lease of new findings, then, journals (or
public news media) may be especially
prominent sources (Stross and Harlan,
1981; Market Facts, 1982~. Later, col-
leagues and medical teaching conferences
may become more prominent than they
were earlier (Fineberg et al., 1978; Stross
and Harlan, 1979; Jordan et al., 1983~.
Thus, in a study of the importance of cl~-
ferent channels of communication, find-
ings may depend in part on the timing of
181
the study relative to the time the innova-
tion was introduced.
All physicians are challenged to discern
what they need to know from the sea of
new medical information that surges
around them. Physicians do appear open to
the idea of receiving direct mail summaries
of new medical findings (Market Facts,
1982~. The success of the brief monthly,
The Medical Letter, has spawned a flock of
imitators, and at least one medical text-
book (Scientific American Medicine) pro-
vides monthly updates with short summar-
ies of key findings relevant to practice.
Channels of communication that convey
pertinent, concise information would seem
to have a comparative advantage. The ex-
panding availability of personal computers
in physician homes and offices offers a new
medium that can potentially convey evalu-
ative information on new and current
medical practices. Of course, the physi-
cians most resistant to changing their med-
ical practices may also be the last ones to
install a home computer.
Measures of Diffusion and
Sources of Data
Studies of diffusion and evaluation in-
volve a variety of dependent variables,
partly determined by the specific objec-
tives of the study, partly by the nature of
the medical practice being studied, and
partly by the data available to the investi-
gator.
Interest here is in evidence about the di-
rect and indirect effects of evaluation on
(1) physician beliefs, (2) expert opinion,
and (3) clinical practices. Measures of the
first typically rely on surveys or interviews
with practitioners and express results as a
proportion who adhere to certain beliefs at
a particular time or at different points in
time. Studies of expert opinion may also
use survey methods or rely on literature re-
views or on recommendations in textbooks,
review articles, or other guidelines written
OCR for page 182
182
by experts. Studies of medical practices
may draw upon many data sources: (1)
surveys of physicians or of institutions; (2)
information gathered from patients or
from the general public, as in the Health
Interview Survey of the National Center
for Health Statistics (NCEIS); (3) patient
medical records; (4) pharmaceutical rec-
ords; (5) information from manufacturers
of equipment or of medical devices; (6) na-
tional practice registries, such as the Na-
tional Disease and Therapeutic Index; (7)
insurance payment records; and (8) infor-
mation from state and national data files
on hospitalization and medical proce-
dures, such as the NCHS Hospital Dis-
charge Survey, reports of the Commission
on Professional Hospital Activities, and
several statewide data consortia.
While admiring the ingenuity of many
investigators in finding pertinent data, we
should bear in mind limitations and biases
lurking in these various measures. Surveys
are subject to selection and recall biases.
Manufacturer sales data may trace the dis-
semination of new equipment, although
that is not necessarily coincident with the
extent of its use. Records from selected in-
surers may be incomplete, and national
registries may fail to reflect changing pat-
terns of disease classification and new, im-
portant though less than major, changes in
patient management.
The dependent variable in a diffusion
study may be expressed as a count or as a
proportion. For example, a certain num-
ber of pills, number of prescriptions, or
number of devices is supplied each year; or
a certain fraction of physicians used a drug
or a fraction of hospitals have purchased a
new piece of equipment. Embedded in
each of these dependent variables is a pop-
ulation of potential adopters of the prac-
tice being studied. The potential target
population is explicitly the denominator in
a fraction and is left unspecified in the case
of counts. In either case, the interpretation
of a study depends on an appropriately de-
ASSESSING MEDICAL TECHNOLOGY
fined target population that is either stable
over time or is correctly adjusted over
time, as, for example, the target pool of pa-
tients varies or the number of trained clini-
cians changes.
Diffusion as Affected by Evaluation
Diffusion may be considered a process of
growth and decay over time. In an ideal-
ized case, unambiguous new findings of an
unequivocally superior innovation, or
clear-cut determination of a definitively
inferior current practice, would be instan-
taneously communicated to all pertinent
adopters who would promptly make the
appropriate change in practice without
any constraints or disincentives. The diffu-
sion pattern would be an extremely sharp
rise in the case of adoption and an ex-
tremely sharp fall in the case of abandon-
ment (Figure 4-1A and 4-1B).
Evaluations often are not clear-cut, and
any of the 10 factors that influence diffu-
sion can introduce friction into the system.
Empirically, a number of innovations have
been found to follow an S-shaped pattern
of diffusion (Figure 4-2A). A traditional so-
ciometric model accounting for such a pat-
tern postulates early adopters and opinion
leaders who influence increasing numbers
of other physicians to adopt a new prac-
tice, leaving some resisters in the end who
fail to adopt the innovation (Rogers and
Shoemaker, 1971~. Other models invoking
different determinants of diffusion (fea-
tures of the innovation itself, of the setting
for use, of the decision making process,
etc.) could also be constructed to account
for an observed S-shaped pattern of diffu-
sion. Thus, an observed pattern of diffu-
sion does not typically indicate the relative
contributions of the various possible deter-
minants of diffusion.
Several studies of the spread! of medical
equipment and institutional innovations
have shown approximately S-shaped pat-
terns of spread with slower initial rise fol-
OCR for page 183
EFFECTS OF CLINICAL EVALUATION
A. Vertical Adoption
— IIJ
z
LLJ ~
~ O
O ~
B. Vertical Abandonment
Unequivocally
Superior
Innovation
TIME .
Definitively
Inferior Current
Practice
TIME
FIGURE 4-1A and 4-1B Idealized diffusion pattern.
lowed by an accelerated phase (Fineberg et
al., 1977; Fineberg, 1979; Russell, 1979;
Office of Technology Assessment IOTA],
1981~. Some studies of the diffusion of new
drugs have found a pattern of spread that is
initially very rapid (Figure 4-2B) (Warner,
1975; Fineberg and Pearlman, 1981~.
Fewer empirical studies have examined the
phase of abandonment. Some cases show
gradual abandonment (Figure 4-2C)
(Fineberg et al., 1980~; others, involving
drugs found to be unsafe, show rapid de-
cline in usage shortly after release of the
findings (Figure 4-2D) (Finkelstein and
Gilbert, 1983~.
An assessment of the impact of evalua-
tion on practice requires a standard for
judging impact. Two standards seem plau-
sible, one that might be called rational be-
havior, and a second that might be called
expected behavior. With rational behavior
as the standard, emphasis is on the extent
to which practice conforms to the findings
of evaluation, meaning all adopt for posi-
tive evaluations and all abandon for nega-
tive evaluations. With expected behavior
183
as the standard, emphasis is on changes in
the pattern of diffusion that can be related
to evaluation.
A clinical evaluation might affect both
the rate of adoption or abandonment of a
practice and the extent of its ultimate use.
Since these changes may be in a direction
consistent with the findings of evaluation,
though falling short of full conformance,
the expected behavior standard is less de-
manding than the rational behavior stan-
dard. Investigators who base their conclu-
sions on a rational standard often intend to
judge the behavior of physicians, not the
credibility of an evaluation method. An ex-
pected behavior standard implicitly recog-
nizes that evaluation is only one of many
determinants of diffusion.
Seeking to establish a relation between
an evaluation and a change in diffusion
can take the form of answering five kinds
of questions:
1. What is the baseline pattern of diffu-
sion? In other words, what pattern of
adoption or abandonment of pertinent
OCR for page 184
184
ASSESSING MEDICAL TECHNOLOGY
A. S-Shaped Adoption
6
~ Lo
Z
LL ~
~ O
O
~ oh
6
~ 111
Z ~
111 Q
~ O
O ~
B. Convex Upward
Adoption
/
-
TIME ~
C. S-Shaped Abandonment
TIME -
/
TIME -
D. Concave Upward
Abandonment
TIME -
FIGURE 4-2A through 4-2D Empirical diffusion patterns.
clinical practices would be expected to oc-
cur over time if the evaluation in question
had not been carried out?
2. What do results of the evaluation,
when correctly interpreted, imply about
what constitutes appropriate medical
care? Do the implications require a change
in the use of a medical technology? In ef-
forts to discriminate among the effects of
different types of evaluation, are the impli-
cations from one type of evaluation differ-
ent from the implications of others?
3. Are there changes in physician
awareness and in the pattern of practice
that are consistent with the findings of
evaluation (or of one type of evaluation)?
4. What is the temporal relation be-
tween evaluation and changes, if any, in
the pattern of practice?
5. Is there additional evidence (such as
interviews, bibliographic citations, opin-
ion surveys, etc.) supporting a connection
between an evaluation and change in prac-
tice?
Answers. to these questions can provide
circumstantial evidence about the relation
between evaluation and practice, making
OCR for page 185
EFFECTS OF CLINICAL EVALUATION
a connection seem plausible or implausi-
ble, though not established in a rigorous
way. A controlled trial of the effectiveness
of controlled trials has not been done and is
hard to imagine.
EVIDENCE ABOUT THE EFFECTS OF
EVALUATION ON DIFFUSION
The principle body of work used in this
analysis consists of 48 papers, reports,
books, and other documents that assess the
relation between evaluation and medical
practice. This highly diverse literature cuts
across many medical specialty areas. (A
summary of the literature is appended.)
Though doubtless incomplete, this collec-
tion is sufficiently rich to provide a basis
for discussion. Several recent reviews con-
cerned with the effects of clinical trials on
medical practice aided the bibliographic
search (Controlled Clinical Trials, Sep-
tember 1982; OTA, 1983; Hawkins, Eval-
uating the Benefit of Clinical Trials to Pa-
tients, unpublished report, 1983~.
The terminology in referring to this lit-
erature can be confusing because it consists
of studies of the effects of other studies. In
the remainder of this chapter, the term
study will be reserved for an analysis of the
effects of one or more clinical trials, con-
sensus exercises, or other forms of clinical
evaluation on physician behavior in a par-
ticular clinical situation. We use the words
practice or clinical practice to mean physi-
cian behavior. When referring to a clinical
evaluation that is the subject of a study, we
will refer to it as a clinical trial or, when
appropriate, as a randomized clinical trial
(RCT).
The discussion is organized in two major
categories depending on the directly mea-
sured effect of evaluation: (1) effects cli-
rectly on physician behavior and (2) effects
directly on regulators or third-party pay-
ers.
185
Evaluation and Physician Behavior
All but two of the reviewed studies deal
at least in part with the relation between
clinical evaluation and the knowledge, be-
liefs, and decisions of physicians. The kinds
of evaluation whose effects are examined
in these studies fall into two broad groups:
primary evaluations, such as randomized
clinical trials, which acquire and present
new clinical findings; and synthetic evalu-
ations, such as consensus conferences,
which integrate and interpret available
primary evidence. Thirty-eight studies
deal at least in part with primary evalua-
tions.
The Impact of Primary Evaluations on
Physicians In attempting to organize evi-
dence about the relation between clinical
trials and physician decision making, it is
useful to distinguish two analytic strategies
that may be adopted in a study (Gamier et
al., 1982; OTA, 1983; Hawkins, unpub-
lished report, 1983~. The first strategy be-
gins with a clinical trial or trials and at-
tempts to trace its effects on physician
awareness or behavior. The second begins
with a set of practices or innovations and
traces back to the various kinds of evalua-
tion that contributed to its development,
dissemination, or abandonment. The next
two subsections discuss studies that follow
the first strategy and examine the effects of
clinical trials on physician awareness and
clinical decisions. The third subsection re-
views studies that follow the second strat-
egy and attempt to trace the origin of med-
ical opinion or practices.
Effects of Clinical Trials on Physician
Awareness Two studies are devoted
mainly to assessing physician awareness of
findings from RCTs (Stross and Harlan,
1979, 1981~. In the first, family physicians
and internists attending a continuing med-
ical education (CME) course (on an un-
specified subject) were asked whether they
OCR for page 186
186
were aware of findings about the treat-
ment of diabetic retinopathy that had been
published 18 months earlier in the Ameri-
can journal of Ophthalmology. Two-
thirds were not (72 percent of family prac-
titioners and 54 percent of internists). Of
the minority who did know about the
study, two-thirds said they learned about it
from an ophthalmologist or colleague. A1-
though 70 citations to the controlled trial
of treatment for diabetic retinopathy ap-
peared in the medical literature between
1976 and 1979, none before 1978 was pub-
lished in a general American medical jour-
nal unrestricted in geographical or subject
scope (Dunn, 1981~. In this case, numerous
citations did not ensure the effective com-
munication of a scientific finding. More-
over, physician awareness would turn out
to be no guarantee of improved medical
practice. A later evaluation found that 60
percent of internists could not properly di-
agnose proliferative diabetic retinopathy
and so would be unable to recognize pa-
tients to whom the initial RCT applies
(Sussman et al., 1982~.
In a second study of physician aware-
ness, Stross and Harlan (1981) surveyed
physicians attending CME courses about
their knowledge of results from the Hyper-
tension Detection and Follow-up Program
(HDFP). This time, 40 percent of family
physicians and 60 percent of internists, re-
spectively 2 months and 6 months follow-
ing publication of the RCT in the Journal
of the American Medical Association in
1979, said they were aware of the findings,
and most of those had learned about it
from the literature. These figures represent
awareness among physicians at single
points in time for each physician group.
Hence, the figures are not revealing about
the diffusion over time of knowledge about
this RCT, much less about its impact on
clinical practices. As in the case of diabetic
retinopathy, a later study would raise
questions about the translation of this RCT
into effective clinical practice, in part be-
ASSESSIN(7 MEDICAL TECHNOLOGY
cause of inappropriate medication pre-
scribed by physicians and in part because
of patient nonadherence to prescribed
medication regimens (Wagner, 1981~.
The management of hypertension illus-
trates some of the pitfalls in attempting to
draw conclusions about the effects of clini-
cal evaluations on physician awareness and
medical practice. In 1977, the Joint Na-
tional Committee on Detection, Evalua-
tion, and Treatment of High Blood Pres-
sure recommended an individualized
approach to treating patients with mild
hypertension. A 1978 survey of physicians
in New York City found that 92 percent
were routinely starting antIhypertensive
medication for patients with mild hyper-
tension, a far more aggressive treatment
strategy than recommended by the Na-
tional Committee (Thomson, 1981~. Re-
sults from the Hypertension Detection and
Follow-up Program subsequently lent sup-
port to the more aggressive treatment strat-
egy previously followed by more than nine
out of ten physicians in New York City. In
this case, a widespread practice that ap-
peared unjustified at one time was borne
out by a subsequent randomized trial;
thus, demonstration of efficacy by an RCT
may follow as well as precede prevailing
patterns of practice. The optimal strategy
for treatment of mild hypertension con-
tinues to be controversial, and value judg-
ments about the conformance of physician
practices to a particular management
strategy would seem more hazardous today
than perhaps they once appeared.
A set of surveys recently commissioned
by the National Heart, Lung, and Blood
Institute (NHLBI) investigated physician
awareness of findings from two specific
RCTs and their effects on practice (Market
Facts, 1982~. This study design is notewor-
thy in that it represents an exceptional ef-
fort to obtain data on physician knowledge
and attitudes both before and after release
of findings in 1980 from an RCT (the Aspi-
rin Mvocardial Infarction Study FAMISH
OCR for page 200
200
APPENDIX 4-A Continued
ASSESSING MEDICAL TECHNOLOGY
Reference
(Year)
Type of Evaluation Source of Data
Studied on Effects Findings
Studies of Patterns of Clinical Evaluation and of the Effect of Clinical Evaluations on the Opinions of Experts
Secondarypre- Marks, unpub- 7 RCTs Published articles, re- Views persistent controver-
vention of fished report views, editorials, sies as disputes over cri-
myocardial (1983) letters. teria for judging evi-
infarction dence, weights accorded
different types of evi-
dence (RCTs and other),
and convictions about
RCTs as the single,
proper standard for
judging merit of prac-
tices.
Antiplatelet Friedwald and 2 RCTs (aspirin Views of authors. Aspirin not demonstrably
agents to Schoenberger myocardial in- effective; methodologic
prevent re- (1982) farction study controversies dominate
current and anturane anturane trial.
myocardial reinfarction trial)
infarction
Cancer ther- UICC reports; Ar- RCTs and other Views of authors. RCTs have been more use-
apy mitage et al. controlled trials ful than non-RCTs in
(1978) developing cancer treat-
ments.
Treatment of Rockette et al. RCTs Views of authors. RCTs have strong effect on
breast can- (1982) shaping breast cancer
cer treatment.
Neurosurgical Haines (1983) 51 RCTs in the lit- Views of authors. Many trials have serious
procedures erasure published methodologicshortcom-
since 1944 ings and few if any have
resolved important clini-
cal questions.
Therapy for Gehan (1982) Published trials Review of literature. Nonrandomized (rather
acute leuke- than randomized) stud-
mia ies have been the pri-
mary means of establish-
ing effectiveness of new
therapies between 1948
and 1971.
Therapy for Gamier et al. Available literature Opinion of hospital In most cases where there
head and (1982) experts plus review is a consensus about
neck cancer of literature. treatment at the investi-
gators' hospital, it is the
result of nonrandomized
studies.
Innovations in Gilbert et al. Published evalua- Literature review. Of 107 papers assessing in-
surgery and (1977) tions of innova- novation, approximately
anesthesia tions in surgery one-third are RCTs.
and anesthesia Less well-controlled
studies are more positive
about innovation.
OCR for page 201
EFFECTS OF CLINICAL EVALUATION
201
Discharge of Berg and Salis- Comparison group (Blue Cross) Insur- 90% of low-birth-weight
low birth bury (1971) (concomitant) ance records. infants are kept in hospi-
weight nonrandomized tal longer than neces-
trial (plus absence sary; 2 years after publi-
of contradictory cation of initial study.
evidence in litera-
ture)
Oral hypogly- Chalmers (1974' RCT (University National Disease and No decline in use of all
comic agents Group Diabetes Therapeutic Index oral hypoglycemics 3
in diabetics Project) (NDTI). years after UGDP results
published in 1970.
Warner et al. Use of all hypoglycemics
(1978~; Finkel- drops by 50 % between
stein and Gil- third and seventh years
bert (1983) after UGDP results pub-
lished. Use of tolbu-
tamide shows prompt
and sharp decline soon
after publication of
UGDP results.
Stilbestrol in Chalmers (1974) 6 controlled trials, Reported marketing 50,000 women per year re-
pregnancy one randomized studies. ceived stilbestrol in late
to prevent between 1946 1960s.
abortion and 1955, show
no effect; uncon-
trolled studies re-
port positive
results
Bedrest in viral Chalmers (1974) 2 controlled trials Medical records of 10-15 years after the first
hepatitis (randomization hospitalized pa- definitive study 49% of
unspecified) show tients. university hospital pa-
no benefit to tients and 67 Coo of com-
bed rest munity hospital patients
still being kept at bed
rest.
Bland diet for Chalmers (1974) 8 studies (type un- Medical records of 35 of 38 physicians admit-
duodenal ul- specified) show hospitalized pa- tingpatientswith diag-
cer no benefit for ul- tients. nosis of ulcer order
cer healing from bland diets (a practice
bland diet not substantiated by
studies).
Tetracyclines Ray et al. (1977)
in children
Reports of drug tox- Insurance (Medicaid) 5 % of all prescriptions
icity in children records in Tennes- (7,000 prescriptions) for
see. children under 8 years
of age were for tetracy-
clines.
OCR for page 202
202
APPENDIX 4-A Continued
ASSESSING MEDICAL TECHNOLOGY
Reference
Topic (Year)
.Studi~..s of Patt~rn.s of Clinical Evaluation and of the Effect of Clinical Evaluations on the Opinions of Experts
Following publication of
VA RCT results in 1975,
there was a slight de-
cline in the proportion
of patients with 1-vessel
and 2-vessel disease re-
ferred for surgery (an ef-
fect consistent with find-
ings of the study):
1974- 1978-
1975
Type of Evaluation Source of Data
Studied on Effects Findings
Coronary ar- Fisher and Ken- 7 RCTs
tery bypass nedy (1982)
graft surgery
Prophylactic Wilson et al. RCTs
antimicrobials (1982)
in gastroin-
testinal sur-
gery
Three practices Fineberg et al.
on anesthesi- (1978)
ology
Referrals for
treatment of
senile macu-
lar degener-
ation
Internal mam-
mary artery
ligation
Combs (1982)
Barsamian (1977~; RCT
Fisher and Ken-
nedy (1982)
Gastric freez- Miao (1977) RCTs and other
ing studies
Fineberg (1979)
Referrals to surgery
for CASS Registry
within 4 years of
Veteran's Adminis-
tration (VA) RCT.
Survey of surgeons in
Scotland.
Epidemiologic sur-
veys; physiologic
findings; nonran-
domized con-
trolled trials
Mailed questionnaire
to anesthesiologists,
at least 5 years af-
ter publication of
evaluations.
RCT showing bene- Records of Witmer
fit of treatment Ophthalmological
Institute.
Views of authors.
Manufacturer
records.
1979
1-vessel 38 %
2-vessel 53 %
3-vessel 63.9 %
29.6%
46.7 To
64.3%
Most use prophylactic anti-
microbiotics in accor-
dance with RCTs; 25 %
believe definitive proof
lacking.
Proportion who had
adopted new practices
at time of survey ranged
from 65 to 85 % . Delay
between awareness and
change was longest for
the one practice requir-
ing institutional action
(scavenging waste
gases) .
In 6 months following an-
nouncement of study
results compared to 6
months previous, the
number of patient refer-
rals tripled and the
number of treatable
cases doubled.
RCT definitively showed
procedure to be ineffec-
tive. (No quantitative
data on utilization of the
procedure before defini-
tive studies.)
RCT definitively showed
procedure to be ineffec-
tive.
Sale of devices stopped sev-
eral years prior to ap-
pearance of definitive
study.
OCR for page 203
EFFECTS OF CLINICaL EVALUATION
CT scanning Creditor and Car- Availableliterature Hospital records.
rett (1979)
203
Acceptance of computed
tomographic (CT) scan-
ning preceded controlled
evaluation.
Extracorporeal Fineberg and RCT Views of authors. Early randomized trial
support for Hiatt (1979) said to prevent spread of
respiratory technology.
· rr. .
1nsuttlclency
Amniocentesis Omenn (1978) Multi-center con- Views of authors. Early multicenter trials
trolled trial said to promote wider
dissemination.
Hyperbaric O2 OTA (1978, 1983) RCT Views of authors. RCT finds procedure inef-
for cognitive fective and dampens
deficits in physician use.
the elderly
Treatment of McPherson and RCTs National rates of sur- Physicians persist in using
breast can- Fox (1977) gery cited in other radical mastectomy de-
cer works. spite evidence from
RCTs that simple mas-
tectomy plus irradiation
is at least as successful.
Treatment of OTA (1983) RCTs Survey of surgical Practice has changed in
breast can- patterns by Ameri- the direction, though
cer can College of Sur- not the degree, indi-
geons. cased by RCTs,
Percent of
breast cancer
patients
1972 1981
Radical
mastectomy 50 %
Modified
radical 30 % 70 %
Lumpectomy 3 % 8 %
(Remainder) presumably
represents simple mas-
tectomy and possibly
other treatments.
Beta-blockers OTA (1983); 41 RCTs Views of authors. Small RCTs all show trend
after Friedwald and favoring use of beta-
myocardial Schoenberger blockers. Widespread
infarction (1982) use probably preceded
evidence from RCTs.
Length of stay Chassin (1983) RCTs other con- NCHS Hospital Dis- LOS for myocardial in-
(LOS) for trolled studies charge Survey. farction (MI) in the
myocardial and non-RCTs United States declined
infarction by one-third between
1968 and 1980. Many
studies find shorter stays
as safe as longer, though
results are not conclu-
s~ve.
OCR for page 204
204
APPENDIX 4-A Continued
ASSESSING MEDICAL TECHNOLOGY
Reference
Topic (Year)
Studies of Patterns of Clinical Evaluation and of the Effect of Clinical Evaluations on the Opinions of Experts
Type of Evaluation Source of Data
Studied on Effects Findings
Treatment of
alcohol
withdrawal
Moskowitz et al. RCTs
(1981)
Drugs to lower Friedewald and
blood lipids Schoenberger
(CDP) (1982)
Hypertension Friedewald and
detection Schoenberger
and follow- (1982)
up
Drug to lower
blood lipids
(Coronary
Drug Proj-
ect)
Aspirin to re-
duce recur-
rence of
myocardial
infarction
(AMIS)
RCT (CDP) Views of authors.
RCT (HDFP) Views of authors.
Market Facts
(1982)
RCT
Market Facts RCT
(1982)
Modern medi- Lambert (1978) Varied
cat mistakes
Discarded sur- Barnes (1977)
gical proce-
dures
Drugs to lower
blood lipids
(Coronary
Drug Proj-
ect)
Survey of physicians. Physicians practice was
consistent with findings
in RCTs prior to ap-
pearance of review arti-
cles making same recom-
mendations.
Gradual reduction in use
of clofibrate consistent
with findings in study.
Study should have broad
Survey of physicians
4-5 years after trial
showing risks and
lack of benefit from
lipid-lowering
agents.
Survey of physicians
before and after
study showing no
benefit from aspi-
rin following
myocardial infarc-
tion.
Review of literature.
Evaluations in liter- Literature between
ature 1880 and 1942.
Friedman et al. RCT (COP)
(1983)
National Disease and
Therapeutic Index.
impact, leading to more
aggressive treatment of
hypertension.
Majority of physicians ei-
ther never prescribe
lipid-lowering drugs
(14 Coo ~ or use them only
as secondary therapy
(72 % ). 47 % said they
were using lipid-lower-
ing drugs less often than
in the past; 67 % use
these drugs more often.
Majority of physicians re-
mained unaffected by
AMIS findings, continu-
ing to prescribe aspirin
for patients following
myocardial infarction.
Many medical mistakes oc-
cur because of the ab-
sence of proper early
evaluation.
Eventually discarded oper-
ations were character-
ized by lack of control
. , .
experience ana In sev-
eral cases were sustained
in the literature over
decades.
Prescriptions for all lipid-
lowering drugs in the
United States rose from
1.5 million in 1970 to
2.3 million in 1975 then
fell to 1 million in 1980.
OCR for page 205
EFFECTS OF CLINICAL EVALUATION
205
Personal interviews
with 1,785 physi-
cians from 1979
through 1981 (see
Market Facts,
1982).
Percentage of physicians
prescribing lipid-lower-
ing drugs for post-MI
patients:
1979 1980 1981
Never
prescribe 10.2 17.2 18.0
TRY only as 2°
therapy 73.8 74.0 69.2
Sometimes
Rx as 1°
therapy 15.9 8.8 12.7
Number of
physicians 859 296 621
Studies of the Effect of Synthetic Assessment on Knowledge of Physicians
NIH consen- Jacoby, unpub- Consensus confer- Telephone surveys of 8-9 % of physicians were
sus confer- lished report ence 700 physicians in aware of the Consensus
ences on CT (1983) pertinent specialty Development Program
scanning areas 2 weeks prior at NIH. Two weeks be-
and total hip to conference and 6 fore each conference,
replacement weeks after publi- 16 °70 of physicians knew
cation of confer-
ence results in the
Journal of the
American Medical
Association.
about the upcoming
conference on CT; 7 %
knew about the confer-
ence on hip joint re-
placement.
Six weeks after publication
of results, 14 % were
aware of the conference
on CT and 4% aware of
the conclusions; 7 %
were aware of the con-
ference on hip joint re-
placement and 1%
aware of its conclusions.
Most of those aware of
study findings had read
about them in profes-
sional journals.
Studies of Effect of Synthetic Assessments on Clinical Practices
Guidelines Leff et al. (1979); Recommendation Mail survey of 28 mu- Greater conformity to
for tubercu- Leff and Bre- from Public nicipal tuberculosis guidelines on chemopro-
losis control win (1981) Health Service, control officers. L}IIV1~1L ~ .1.~1.1 Ad L11~1~ ~-
American Tho-
racic Society,
American Lung
Association
phylaxis than on diagno-
sis and treatment.
Medical neces- Blue Cross and Consensus on 42 Insurance claims in Number of claims paid for
sity, Blue Blue Shield As- outmoded prac- 1975 and 1978 for tested surgical proce-
Cross and sociation (1982) tices, announced Federal Employee cures declined 26%;
Blue Shield and disseminated Health Benefits claims paid for listed di-
in 1977 Program offered by agnostic procedures de-
Blue Cross and . clined 85 % .
Blue Shield.
OCR for page 206
206
APPENDIX 4-A Continued
ASSESSING MEDICAL TECHNOLOGY
Reference
Topic (Year)
Type of Evaluation Source of Data
Studied on Effects Findings
Studies of Effect of Synthetic Assessments on Clinical Practices
Approved uses
for cimeti-
dine
Fineberg and
Pearlman
(1981)
Schade and
Donaldson
<1981)
Cocco and Cocco
(1981)
NIH consensus Thomson et al.
conference (1981)
on high
blood pres-
sure, held in
1977
Treatment of
alcohol
withdrawal
FDA-approved uses NDTI data on drug Many uses of cimetidine in
use. practice are not ap-
proved by FDA.
Medical records. Many uses of cimetidine in
practice are not ap-
proved by FDA.
Consensus confer-
ence
Moskowitz et al.
(1981)
Survey of physicians
in ambulatory set-
tings in New York
City.
Review articles Survey of physicians.
Many uses of cimetidine in
practice are not ap-
proved by FDA.
90 % of respondents were
routinely treating pa-
tients with mild hyper-
tension in contrast to in-
dividualized approach
advocated by consensus
statement.
Physician use practices
that were found effec-
tive in RCTs and use
them before they are
recommended in review
articles.
Studies of the Effects of Clinical Evaluations and Synthetic Assessments on Regulation and Reimbursement
PHS adviso- Center for Analy- Review by PHS Estimates of authors. The PHS through National
ries to sis of Health Center for Health Care
HCFA Practices (1981) Technology made rec-
ommendations of non-
reimbursement for 21 of
50 procedures reviewed
during 1979-1980. All
recommendations were
accepted by HCFA,
though procedures at
HCFA did not necessar-
ily assure uniform appli-
cation throughout the
country. Decisions not
to reimburse four proce-
dures (dialysis for schiz-
ophrenia, hyperthermia
for cancer, radial kera-
totomy for myopia, and
endothelial cell photog-
raphy) are estimated to
produce savings of $312
million to the Medicare
program over a 10-year
period.
OCR for page 207
EFFECTS OF CLINICAL EVALUATION
Hyperbaric ox- OTA (1978, 1983) RCT
ygen for
cognitive
deficits in
the elderly
Drugs to lower Friedman et al.
blood lipids (1983)
207
Views of authors.
RCTs (CDP and
WHO clofibrate
trial)
RCT shows procedure in-
effective; facilitates deci-
sion by Medicare and
other insurers not to re-
imburse.
Review of FDA label- Changes in labeling, iden-
ing changes for clo-
fibrate (Atrom id- S)
between 1969 and
1982.
tifying more side effects
and progressively re-
stricting indications for
use, are believed due in
part to CDP (which as-
sessed use in patients
with previous MI;
results with clofibrate
published 1975) and to
WHO clofibrate trial
(which assessed primary
prevention of MI; results
published 1978 and
1980~. Major labeling
changes in 1979 are at-
tributed to both CDP
and WHO trial; further
restrictions in 1982 re-
flect most recent find-
ings from WHO trial,
with CDP results serving
as background.
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Representative terms from entire chapter:
medical technology
