Evaluating The Quality of Medical Care

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Evaluating the Quality of Medical Care

Author(s): Avedis Donabedian


Source: The Milbank Memorial Fund Quarterly, Vol. 44, No. 3, Part 2: Health Services
Research I. A Series of Papers Commissioned by the Health Services Research Study Section
of the United States Public Health Service. Discussed at a Conference Held in Chicago,
October 15-16, 1965 (Jul., 1966), pp. 166-206
Published by: Wiley on behalf of Milbank Memorial Fund
Stable URL: http://www.jstor.org/stable/3348969
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EVALUATING THE QUALITY OF MEDICAL CARE

AVEDIS DONABEDIAN

INTRODUCTION

This paper is an attempt to describe and evaluate curr


for assessing the quality of medical care and to suggest som
for further study. It is concerned with methods rather th
and with an evaluation of methodology in general, rat
detailed critique of methods in specific studies.
This is not an exhaustive review of the pertinent lite
tain key studies, of course, have been included. Other
been selected only as illustrative examples. Those omit
for that reason, less worthy of note.
This paper deals almost exclusively with the evalu
medical care process at the level of physician-patient in
excludes, therefore, processes primarily related to the
livery of medical care at the community level. Moreove
is not concerned with the administrative aspects of qua
Many of the studies reviewed here have arisen out of
need to evaluate and control the quality of care in organize
of medical care. Nevertheless, these studies will be disc
terms of their contribution to methods of assessment and not in
terms of their broader social goals. The author has remained, by an
large, in the familiar territory of care provided by physicians and has
avoided incursions into other types of health care. Also, consideratio
of the difficult problem of economic efficiency as a measurable dimen-
sion of quality has been excluded.
Three general discussions of the evaluation of quality have been

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very helpful in preparing this review. The first is a classic paper
by Mindel Sheps which includes an excellent discussion of methods.'
A more recent paper by Peterson provides a valuable appraisal of the
field.2 The paper by Lerner and Riedel discusses one recent study
of quality and raises several questions of general importance.3

Definition of Quality
The assessment of quality must rest on a conceptual and opera-
tionalized definition of what the "quality of medical care" means.
Many problems are present at this fundamental level, for the quality
of care is a remarkably difficult notion to define. Perhaps the best-
known definition is that offered by Lee and Jones4 in the form of
eight "articles of faith," some stated as attributes or properties of
the process of care and others as goals or objectives of that process.
These "articles" convey vividly the impression that the criteria of
quality are nothing more than value judgments that are applied
to several aspects, properties, ingredients or dimensions of a process
called medical care. As such, the definition of quality may be almost
anything anyone wishes it to be, although it is, ordinarily, a reflection
of values and goals current in the medical care system and in the
larger society of which it is a part.
Few empirical studies delve into what the relevant dimensions
and values are at any given time in a given setting. Klein, et al.,
found that 24 "administrative officials," among them, gave 80 criteria
for evaluating "patient care." They conclude that patient care, like
morale, cannot be considered as a unitary concept and ". . . it seems
likely that there will never be a single comprehensive criterion by
which to measure the quality of patient care."
Which of a multitude of possible dimensions and criteria are
selected to define quality will, of course, have profound influence on
the approaches and methods one employs in the assessment of medical
care.

APPROACHES TO ASSESSMENT: WHAT TO ASSESS

The outcome of medical care, in terms of recover


function and of survival, has been frequently used
the quality of medical care. Examples are studies
tality,6'7 surgical fatality rates8 and social restor
discharged from psychiatric hospitals.9

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Many advantages are gained by using outcome as the criterion
of quality in medical care. The validity of outcome as a dimension
of quality is seldom questioned. Nor does any doubt exist as to the
stability and validity of the values of recovery, restoration and
survival in most situations and in most cultures, though perhaps not
in all. Moreover, outcomes tend to be fairly concrete and, as such,
seemingly amenable to more precise measurement.
However, a number of considerations limit the use of outcomes as
measures of the quality of care. The first of these is whether the
outcome of care is, in fact, the relevant measure. This is because
outcomes reflect both the power of medical science to achieve
certain results under any given set of conditions, and the degree to
which "scientific medicine," as currently conceived, has been applied
in the instances under study. But the object may be precisely to
separate these two effects. Sometimes a particular outcome may be
irrelevant, as when survival is chosen as a criterion of success in a
situation which is not fatal but is likely to produce suboptimal health
or crippling."
Even in situations where outcomes are relevant, and the relevant
outcome has been chosen as a criterion, limitations must be reckoned
with. Many factors other than medical care may influence outcome,
and precautions must be taken to hold all significant factors other
than medical care constant if valid conclusions are to be drawn. In
some cases long periods of time, perhaps decades, must elapse before
relevant outcomes are manifest. In such cases the results are not
available when they are needed for appraisal and the problems of
maintaining comparability are greatly magnified. Also, medic
technology is not fully effective and the measure of success that
can be expected in a particular situation is often not precisely know
For this reason comparative studies of outcome, under controlled
situations, must be used.
Although some outcomes are generally unmistakable and easy to
measure (death, for example) other outcomes, not so clearly define
can be difficult to measure. These include patient attitudes an
satisfactions, social restoration and physicial disability and rehabilit
tion.1" Even the face validity that outcomes generally have as criter
of success or failure, is not absolute. One may debate, for exampl
whether the prolongation of life under certain circumstances
evidence of good medical care. McDermott, et al., have shown that
although fixing a congenitally dislocated hip joint in a given positio

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is considered good medicine for the white man, it can prove crippling
for the Navajo Indian who spends much time seated on the floor
or in the saddle.12 Finally, although outcomes might indicate good
or bad care in the aggregate, they do not give an insight into the
nature and location of the deficiences or strengths to which the
outcome might be attributed.
All these limitations to the use of outcomes as criteria of medical
care are presented not to demonstrate that outcomes are inappropriate
indicators of quality but to emphasize that they must be used with
discrimination. Outcomes, by and large, remain the ultimate valida-
tors of the effectiveness and quality of medical care.
Another approach to assessment is to examine the process of care
itself rather than its outcomes. This is justified by the assumption
that one is interested not in the power of medical technology to
achieve results, but in whether what is now known to be "good"
medical care has been applied. Judgments are based on considera-
tions such as the appropriateness, completeness and redundancy of
information obtained through clincial history, physical examination
and diagnostic tests; justification of diagnosis and therapy; technical
competence in the performance of diagnostic and therapeutic pro-
cedures, including surgery; evidence of preventive management in
health and illness; coordination and continuity of care; acceptability
of care to the recipient and so on. This approach requires that a
great deal of attention be given to specifying the relevant dimensions,
values and standards to be used in assessment. The estimates of
quality that one obtains are less stable and less final than those th
derive from the measurement of outcomes. They may, however,
more relevant to the question at hand: whether medicine is prope
practiced.
This discussion of process and outcome may seem to imply a sim
separation between means and ends. Perhaps more correctly, one m
think of an unbroken chain of antecedent means followed by int
mediate ends which are themselves the means to still further ends.T8
Health itself may be a means to a further objective. Several authors
have pointed out that this formulation provides a useful approach to
evaluation.4'15 It may be designated as the measurement of pro-
cedural end points and included under the general heading of
"process" because it rests on similar considerations with respect to
values, standards and validation.
A third approach to assessment is to study not the process of care

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itself, but the settings in which it takes place and the instrumentalities
of which it is the product. This may be roughly designated as the
assessment of structure, although it may include administrative and
related processes that support and direct the provision of care. It is
concerned with such things as the adequacy of facilities and equip-
ment; the qualifications of medical staff and their organization; the
administrative structure and operations of programs and institutions
providing care; fiscal organization and the like.16'17 The assumption
is made that given the proper settings and instrumentalities, good
medical care will follow. This approach offers the advantage of
dealing, at least in part, with fairly concrete and accessible informa-
tion. It has the major limitation that the relationship between struc-
ture and process or structure and outcome, is often not well estab-
lished.

Sources and Methods of Obtaining Information


The approach adopted for the appraisal of quality determines, in
large measure, the methods used for collecting the requisite informa-
tion. Since these range the gamut of social science methods, no
attempt will be made to describe them all. Four, however, deserve
special attention.
Clinical records are the source documents for most studies of the
medical care process. In using them one must be aware of their
several limitations. Since the private office practice of most physicians
is not readily accessible to the researcher, and the records of such
practice are generally disappointingly sketchy, the use of records has
been restricted to the assessment of care in hospitals, outpatient de-
partments of hospitals and prepaid group practice. Both Petersonl8
and Clute'9 have reported the prevailing inadequacies of recording
in general practice. In addition, Clute has pointed out that, in gen-
eral practice, ". . . the lack of adequate records is not incompatible
with practice of a good, or even an excellent quality. .. ." On the
other hand, a recent study of the office practice of a sample of
members of the New York Society of Internal Medicine20 suggests
that abstracts of office records can be used to obtain reproducible
judgments concerning the quality of care. But to generalize from
this finding is difficult. It concerns a particular group of physicians
more likely to keep good records than the average. Moreover, for
one reason or another, the original sample drawn for this study
suffered a 61 per cent attrition rate.

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Assuming the record to be available and reasonably adequate, two
further issues to be settled are the veracity and the complete-
ness of the record. Lembcke'1 has questioned whether key statements
in the record can be accepted at face value. He has questioned not
only the statements of the physician about the patient and his
management, but also the validity of the reports of diagnostic ser-
vices. The first is verified by seeking in the record, including the
nurses' notes, what appears to be the most valid evidence of the true
state of affairs. The second is verified by having competent judges
re-examine the evidence (films, tracings, slides) upon which diagnostic
reports are made. Observer error tends to be a problem under the
best of circumstances.21 But nothing can remove the incredulity
from the finding by Lembcke, in one hospital, that the true incidence
of uterine hyperplasia was between five and eight per cent rather
than 60 to 65 per cent of uterine curettages, as reported by the
hospital pathologist. In any case, the implications of verification as
part of the assessment of quality must be carefully considered. Errors
in diagnostic reports no doubt reflect particularly on the quality
of diagnostic service and on the care provided by the hospital, in
general. But the physician may be judged to perform well irrespective
of whether the data he works with are or are not valid. This is so
when the object of interest is the logic that governs the physician's
activities rather than the absolute validity of these activities.
Much discussion has centered on the question of the completeness
of clinical records and whether, in assessing the quality of care based
on what appears in the record, one is rating the record or the care
provided. What confuses the issue is that recording is itself a separate
and legitimate dimension of the quality of practice, as well as the
medium of information for the evaluation of most other dimensions.
These two aspects can be separated when an alternative source of
information about the process of care is available, such as the direct
observation of practice.1819 In most instances, however, they are con-
founded. Rosenfeld22 handled the problem of separating recording
from care by examining the reasons for downrating the quality of care
in each patient record examined. He demonstrated that the quality
of care was rated down partly because of what could have been poor
recording ("presumptive" evidence) and partly for reasons that could
not have been a matter of recording ("substantial" evidence). He
also found that hospitals tended to rank high or low on both types
of errors, showing that these errors were correlated. Since routine

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recording is more likely to be complete in the wards, comparison of
ward and private services in each hospital by type of reason for down-
rating might have provided further information on this important
question. Other investigators have tried to allow for incompleteness
in the record by supplementing it with interviews with the attend-
ing physician and making appropriate amendments.23-25 Unfortunately,
only one of these studies (length of stay in Michigan hospitals) con-
tains a report of what difference this additional step made. In this
study "the additional medical information elicited by means of
personal interviews with attending physicians was of sufficient im-
portance in 12.6 per cent of the total number of cases studied to
warrant a reclassification of the evaluation of necessity for admis-
sion and/or the appropriateness of length of stay."3'25 When informa-
tion obtained by interview is used to amend or supplement the
patient record, the assumption may have to be made that this
additional information has equal or superior validity. Morehead, who
has had extensive experience with this method, said, "Many of the
surveyors engaged in the present study employed the technique of
physician interview in earlier studies without fruitful results ....
The surveyor was . . . left in the uncomfortable position of having
to choose between taking at face value statements that medical care
was indeed optimal, or concluding that statements presented were
untrue."26 Even in an earlier study, where supplementation by inter-
view is reported to have been used,24 verbal information was discarded
unless it was further corroborated by the course of action or by
concrete evidence.27
Another question of method is whether the entire record or ab-
stracted digests of it should be used as a basis for evaluation. The
question arises because summaries and abstracts can presumably be
prepared by less skilled persons allowing the hard-to-get expert to
concentrate on the actual task of evaluation. Abstracting, however,
seemingly involves the exercise of judgment as to relevance and
importance. For that reason, it has been used as a first step in the
evaluation of quality only in those studies that use very specific and
detailed standards.10 Even then, little information is available about
how reliable the process of abstracting is, or how valid when com-
pared with a more expert reading of the chart. The study of New
York internists, already referred to, demonstrated a high level of
agreement between physicians and highly trained non-physicians
abstracting the same office record.20

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While the controversy about the record as a source of information
continues, some have attempted to reduce dependence on the physi-
cian's recording habits by choosing for evaluation diagnostic cate-
gories which are likely to be supported by recorded evidence addi-
tional to the physician's own entries.28 This explains, in part, the
frequent use of surgical operations as material for studies of quality.
In general practice, patient records are too inadequate to serve
as a basis for evaluation. The alternative is direct observation of the
physician's activities by a well qualified colleague.'1819 The major
limitation of this method would seem to be the changes likely to
occur in the usual practice of the physician who knows he is being
observed. This has been countered by assurances that the physician
is often unaware of the true purpose of the study, becomes rapidly
accustomed to the presence of the observer, and is unable to change
confirmed habits of practice. Even if changes do occur, they would
tend to result in an overestimate of quality rather than the reverse.
These assurances notwithstanding, measuring the effect of observa-
tion on practice remains an unsolved problem.
Those who have used the method of direct observation have been
aware that the problem of completeness is not obviated. The practic-
ing physician often knows a great deal about the patient from previous
contacts with him. Hence the need to select for observation "new"
cases and situations that require a thorough examination irrespectiv
of the patient's previous experience. Moreover, not all of the manag
ing physician's activities are explicit. Some dimensions of care, no
subject to direct observation, must be excluded from the scheme of
assessment. Selective perception by the observer may be an addition
problem. The observer is not likely to be first a neutral recorder o
events and then a judge of these same events. His knowledge and
criteria are likely to influence what he perceives, and thus to intro
duce a certain distortion into perception.
An indirect method of obtaining information is to study behavior
and opinions from which inferences may be drawn concerning quality.
A sociometric approach has been reported by Maloney, et al., which
assumes that physicians, in seeking care for themselves and their
families, exhibit critical and valid judgments concerning the capacit
of their colleagues to provide care of high quality.29 Such choices were
shown to identify classes of physicians presumed to be more highl
qualified than others. But both sensitivity and specificity, using
criterion more rigorous estimates of the quality of care, lack valid

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tion. Georgopoulos and Mann30 used what might be called an auto-
reputational31 approach in assessing the quality of care in selected
community hospitals. This grew out of previous studies showing that
people are pretty shrewd judges of the "effectiveness" of the organiza-
tions in which they work.32 The hospitals were rated and ranked
using opinions concerning the quality of medical care, and other
characteristics, held by different categories of managerial, professional
and technical persons working in, or connected with, each hospital,
as well as by knowledgeable persons in the community. The responses
were sufficiently consistent and discriminating to permit the hospitals
to be ranked with an apparently satisfactory degree of reliability. This
in spite of the generally self-congratulatory nature of the responses
that classified the quality of medical care in the hospitals as "very
good," "excellent," or "outstanding" in 89 per cent of cases, and
"poor" in almost none. The authors provide much evidence that the
several opinions, severally held, were intercorrelated to a high degree.
But little evidence supports the validity of the judgments by using
truly external criteria of the quality of care.

SAMPLING AND SELECTION

The first issue in sampling is to specify precisely


be sampled, which, in turn, depends on the nature o
tions that one wishes to make. Studies of quality ar
cerned with one of three objects: 1. the actual care
specified category of providers of care; 2. the actual car
specified group of people and 3. the capacity of a s
of providers to provide care. In the first two instanc
samples of potential providers or recipients are req
representative samples of care provided or received
instance a representative sample of providers is
necessarily a representative sample of care. A more
is to select, uniformly of course, significant dimens
haps performance should be studied in certain clinic
are particularly stressful and therefore more reve
capacities or weaknesses in performance. Hypothetic
may even be set up to assess the capacity to perf
dimensions of care.33-35 The distinctions made abov
those between the assessment of actual care prov
capacity to provide care, are useful in evaluating th
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cedures used in the major studies of quality. By these criteria, some
studies belong in one category or another, but some seem to com-
bine features of several in such a way that generalization becomes
difficult. For example, in the first study of the quality of care received
by Teamster families, the findings are meant to apply only to the
management of specific categories of hospitalized illness in a specified
population group.28 In the second study of this series, somewhat
greater generalizability is achieved by obtaining a representative sample
(exclusive of seasonal variation) of all hospitalized illness in the
same population group.26 Neither study is meant to provide informa-
tion about all the care provided by a representative sample of physi-
cians.

The degree of homogeneity in the universe to be sampled is, of


course, a matter of great importance in any scheme of sampling or
selection. The question that must be asked is to what extent the
care provided by a physician maintains a consistent level. Do specific
diagnostic categories, levels of difficulty or dimensions of care exist
in which a physician performs better than in others? Can one find,
in fact, an "overall capacity for goodness in medical care,"18 or is he
dealing with a bundle of fairly disparate strands of performance?
One might, similarly, ask whether the care provided by all subdivisions
of an institution are at about the same level in absolute terms or in
relation to performance in comparable institutions. Makover, for
example, makes an explicit assumption of homogeneity when he writes,
"No attempt was made to relate the number of records to be studied
to the size of enrollment of the medical groups. The medical care
provided to one or another individual is valid evidence of quality
and there should be little or no chance variation which is affected
by adjusting the size of the sample."23 Rosenfeld began his study
with the hypothesis "that there is a correspondence in standards of
care in the several specialties and for various categories of illness in
an institution."22

The empirical evidence concerning homogeneity is not extensive.


Both the Peterson and Clute studies of general practice18'19 showed
a high degree of correlation between performance of physicians in
different components or dimensions of care (history, physical examina-
tion, treatment, etc.). Rosenfeld demonstrated that the differences
in quality ratings among several diagnoses selected within each area
of practice (medicine, surgery and obstetrics-gynecology) were not
large. Although the differences among hospitals by area of practice

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appeared by inspection to be larger, they were not large enough
to alter the rankings of the three hospitals studied.
The two studies of care received by Teamster families26 28 arrived
at almost identical proportions of optimal and less than optimal care
for the entire populations studied. This must have been coincidental,
since the percent of optimal care, in the second study, varied greatly
by diagnostic category from 31 per cent for medicine to 100 per
cent for ophthalmology (nine cases only). If such variability exists,
the "diagnostic mix" of the sample of care must be a matter of
considerable importance in assessment. In the two Teamster studies,
differences in "diagnostic mix" were thought to have resulted in
lower ratings for medicine and higher ratings for obstetrics-gynecology
in the second study than in the first. That the same factor may
produce effects in two opposite directions is an indication of the
complex interactions that the researcher must consider. "The most
probable explanation for the ratings in medicine being lower in the
present (second) study is the nature of the cases reviewed." The
factor responsible is less ability to handle illness "which did not fall
into a well recognized pattern." For obstetrics and gynecology the
finding of the second study ". . . differed in one major respect from
the earlier study where serious questions were raised about the manage-
ment of far more patients. The earlier study consisted primarily of
major abdominal surgery, whereas this randomly selected group
contained few such cases and had more patients with minor condi-
tions."26 In studies such as these, where the care received by total or
partial populations is under study, the variations noted stem partly
from differences in diagnostic content and partly from institutionalized
patterns of practice associated with diagnostic content. For example,
all nine cases of eye disease received optimal care because "this is a
highly specialized area, where physicians not trained in this field
rarely venture to perform procedures."26
Sampling and selection influence, and are influenced by, a number
of considerations in addition to generalization and homogeneity. The
specific dimensions of care that interest one (preventive management
or surgical technique, to mention two rather different examples)
may dictate the selection of medical care situations for evaluation.
The situations chosen are also related to the nature of the criteria and
standards used and of the rating and scoring system adopted. Attempts
to sample problem situations, rather than traditional diagnoses or
operations, can be very difficult, because of the manner in which
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clinical records are filed and indexed. This is unfortunate, because
a review of operations or established diagnoses gives an insight into
the bases upon which the diagnosis was made or the operation per-
formed. It leaves unexplored a complementary segment of practice,
namely the situations in which a similar diagnosis or treatment may
have been indicated but not made or performed.

Measurement Standards

Measurement depends on the development of standards. In the


assessment of quality standards derive from two sources.
Empirical standards are derived from actual practice and are
generally used to compare medical care in one setting with that in
another, or with statistical averages and ranges obtained from
larger number of similar settings. The Professional Activities Study
is based, in part, on this approach.36
Empirical standards rest on demonstrably attainable levels of care
and, for that reason, enjoy a certain degree of credibility and accept
ability. Moreover, without clear normative standards, empirical ob-
servations in selected settings must be made to serve the purpose.
An interesting example is provided by Furstenberg, et al., who used
patterns of prescribing in medical care clinics and outpatient hospitals
as the standard to judge private practice.37
In using empirical standards one needs some assurance that the
clinicial material in the settings being compared is similar. Th
Professional Activities Study makes some allowance for this by report-
ing patterns of care for hospitals grouped by size. The major short-
coming, however, is that care may appear to be adequate in com-
parison to that in other situations and yet fall short of what is attain-
able through the full application of current medical knowledge.
Normative standards derive, in principle, from the sources that
legitimately set the standards of knowledge and practice in the
dominant medical care system. In practice, they are set by standard
textbooks or publications,10 panels of physicians,25 highly qualified
practitioners who serve as judges26 or a research staff in consultation
with qualified practitioners.22 Normative standards can be put very
high and represent the "best" medical care that can be provided, o
they can be set at a more modest level signifying "acceptable" or
"adequate" care. In any event, their distinctive characteristic is that
they stem from a body of legitimate knowledge and values rather than
from specific examples of actual practice. As such, they depend for

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their validity on the extent of agreement concerning facts and values
within the profession or, at least, among its leadership. Where equally
legitimate sources differ in their views, judgments concerning quality
become correspondingly ambiguous.
The relevance of certain normative standards, developed by one
group, to the field of practice of another group, has been questioned.
For example, Peterson and Barsamian report that although spermatic
fluid examination of the husband should precede surgery for the
Stein-Leventhal syndrome, not one instance of such examination was
noted, and that this requirement was dropped from the criteria for
assessment.38 Dissatisfaction has also been voiced concerning the
application to general practice of standards and criteria elaborated by
specialists who practice in academic settings. The major studies of
general practice have made allowances for this. Little is known,
however, about the strategies of "good" general practice and the
extent to which they are similar to, or different from, the strategies
of specialized practice in academic settings.
Some researchers have used both types of standards, normative and
empirical, in the assessment of care. Rosenfeld used normative stand-
ards but included in his design a comparison between university
affiliated and community hospitals. "Use of the teaching hospital
as a control provides the element of flexibility needed to adjust to
the constantly changing scientific basis of the practice of medicine.
No written standards, no matter how carefully drawn, would be
adequate in five years."22 Lembcke used experience in the best hospitals
to derive a corrective factor that softens the excessive rigidity of his
normative standards. This factor, expressed in terms of an acceptable
percent of compliance with the standard, was designed to take account
of contingencies not foreseen in the standards themselves. It does,
however, have the effect of being more realistically permissive as well.
This is because the correction factor is likely to be made up partly
of acceptable departures from the norm and partly of deviations that
might be unacceptable.
Standards can also be differentiated by the extent of their specificity
and directiveness. At one extreme the assessing physician may be
very simply instructed as follows: "You will use as a yardstick in
relation to the quality of care rendered, whether you would have
treated this particular patient in this particular fashion during this
specific hospital admission."26 At the other extreme, a virtually water-
tight "logic system" may be constructed that specifies all the decision

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rules that are acceptable to justify diagnosis and treatment.38'39 Most
cases fall somewhere in between.
Highly precise and directive standards are associated with the selec-
tion of specific diagnostic categories for assessment. When a representa-
tive sample of all the care provided is to be assessed, little more than
general guides can be given to the assessor. Lembcke, who has
stressed the need for specific criteria, has had to develop a correspond-
ingly detailed diagnostic classification of pelvic surgery, for example.10
In addition to diagnostic specificity, highly directive standards are
associated with the preselection of specific dimensions of care for
evaluation. Certain diagnoses, such as surgical operations, lend them-
selves more readily to this approach. This is evident in Lembcke's
attempt to extend his system of audits to nonsurgical diagnoses.40
The clear, almost rule-of-thumb judgments of adequacy become
blurred. The data abstracted under each diagnostic rubric are more
like descriptions of patterns of management, with insufficient norma-
tive criteria for decisive evaluation. The alternative adopted is com-
parison with a criterion institution.
Obviously, the more general and nondirective the standards are,
the more one must depend on the interpretations and norms of the
person entrusted with the actual assessment of care. With greater
specificity, the research team is able, collectively, to exercise much
greater control over what dimensions of care require emphasis and
what the acceptable standards are. A great deal appears in common
between the standards used in structured and unstructured situations as
shown by the degree of agreement between "intuitive" ratings and di-
rected ratings in the Rosenfeld study,22 and between the "qualitative"
and "quantitative" ratings in the study by Peterson, et al.l Indeed,
these last two were so similar that they could be used interchangeably.
When standards are not very specific and the assessor must exercise
his own judgment in arriving at an evaluation, very expert and care-
ful judges must be used. Lembcke claims that a much more precise
and directive system such as his does not require expert judges. "It
is said that with a cookbook, anyone who can read can cook. The
same is true, and to about the same extent, of the medical audit using
objective criteria; anyone who knows enough medical terminology to
understand the definitions and criteria can prepare the case abstracts
and tables for the medical audit. However, the final acceptance,
interpretation and application of the findings must be the responsi-
bility of a physician or group of physicians."41 The "logic system"

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developed by Peterson and Barsamian appears well suited for rating
by computer, once the basic facts have been assembled, presumably
by a record abstractor.38 39
The dimensions of care and the values that one uses to judge them
are, of course, embodied in the criteria and standards used to assess
care.42 These standards can, therefore, be differentiated by their
selectivity and inclusiveness in the choice of dimensions to be assessed.
The dimensions selected and the value judgments attached to them
constitute the operationalized definition of quality in each study.
The preselection of dimensions makes possible, as already pointed
out, the development of precise procedures, standards and criteria.
Lembcke'1 has put much stress on the need for selecting a few specific
dimensions of care within specified diagnostic categories rather than
attempting general evaluations of unspecified dimensions which, he
feels, lack precision. He uses dimensions such as the following: con-
firmation of clinical diagnosis, justification of treatment (including
surgery) and completeness of the surgical procedure. Within each
dimension, and for each diagnostic category, one or more previously
defined activities are often used to characterize performance for that
dimension as a whole. Examples are the compatibility of the diagnosis
of pancreatitis with serum amylase levels or of liver cirrhosis with
biopsy findings, the performance of sensitivity tests prior to antibiotic
therapy in acute bronchitis, and the control of blood sugar levels in
diabetes.

In addition to the extent to which preselection of dimensions takes


place, assessments of quality differ with respect to the number of
dimensions used and the exhaustiveness with which performance in
each dimension is explored. For example, Peterson, et al.,l8 and
Rosenfeld22 use a large number of dimensions. Peterson and Barsam-
ian,38'39 on the other hand, concentrate on two basic dimensions,
justification of diagnosis and of therapy, but require complete proof
of justification. A much more simplified approach is illustrated by
Huntley, et al.,43 who evaluate outpatient care using two criteria
only: the percent of work-ups not including certain routine pro-
cedures, and the percent of abnormalities found that were not fol-
lowed up.
Judgments of quality are incomplete when only a few dimensions
are used and decisions about each dimension are made on the basis
of partial evidence. Some dimensions, such as preventive care or the

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psychological and social management of health and illness, are often
excluded from the definition of quality and the standards and criteria
that make it operational. Examples are the intentional exclusion of
psychiatric care from the Peterson study18 and the planned exclusion
of the patient-physician relationship and the attitudes of physicians
in studies of the quality of care in the Health Insurance Plan of
Greater New York.27 Rosenfeld22 made a special point of including
the performance of specified screening measures among the criteria
of superior care; but care was labeled good in the absence of these
measures. In the absence of specific instructions to the judges, the
study by Morehead, et al.,26 includes histories of cases, considered to
have received optimal care, in which failure of preventive manage-
ment could have resulted in serious consequences to the patient.
Another characteristic of measurement is the level at which the
standard is set. Standards can be so strict that none can comply with
them, or so permissive that all are rated "good." For example, in the
study of general practice reported by Clute,l9 blood pressure examina-
tions, measurement of body temperature, otoscopy and performance
of immunizations did not serve to categorize physicians because all
physicians performed them well.

Measurement Scales

The ability to discriminate different levels of performance depends


on the scale of measurement used. Many studies of quality use a
small number of divisions to classify care, seen as a whole, into
categories such as "excellent," "good," "fair" or "poor." A person's
relative position in a set can then be further specified by computing
the percent of cases in each scale category. Other studies assign scores
to performance of specified components of care and cumulate these
to obtain a numerical index usually ranging from 0-100. These prac-
tices raise questions relative to scales of measurement and legitimate
operations on these scales. Some of these are described below.
Those who adhere to the first practice point out that any greater
degree of precision is not possible with present methods. Some have
even reduced the categories to only two: optimal and less than
optimal. Clute19 uses three, of which the middle one is acknowledged
to be doubtful or indeterminate. Also, medical care has an all-or-none
aspect that the usual numerical scores do not reflect. Care can be
good in many of its parts and be disastrously inadequate in the

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aggregate due to a vital error in one component. This is, of course,
less often a problem if it is demonstrated that performance on dif-
ferent components of care is highly intercorrelated.
Those who have used numerical scores have pointed out much
loss of information in the use of overall judgments,38 and that numer-
ical scores, cumulated from specified subscores, give a picture not
only of the whole but also of the evaluation of individual parts.
Rosenfeld22 has handled this problem by using a system of assigning
qualitative scores to component parts of care and an overall qualitative
score based on arbitrary rules of combination that allow for the
all-or-none attribute of the quality of medical care. As already
pointed out, a high degree of agreement was found between intuitive
and structured ratings in the Rosenfeld study22 and between qualita-
tive and quantitative ratings in the study by Peterson, et al.18
A major problem, yet unsolved, in the construction of numercial
scores, is the manner in which the different components are to be
weighted in the process of arriving at the total. At present this is an
arbitrary matter. Peterson, et al.,18 for example, arrive at the follow-
ing scale: clinical history 30, physical examination 34, use of labora-
tory aids 26, therapy 9, preventive medicine 6, clinical records 2, total
107. Daily and Morehead24 assign different weights as follows: records
30, diagnostic work-up 40, treatment and follow-up 30, total 100.
Peterson, et al., say: "Greatest importance is attached to the process
of arriving at a diagnosis since, without a diagnosis, therapy cannot
be rational. Furthermore, therapy is in the process of constant change,
while the form of history and physical examination has changed
very little over the years.""' Daily and Morehead offer no justification
for their weightings, but equally persuasive arguments could prob-
ably be made on their behalf. The problem of seeking external con-
firmation remains.44

The problem of weights is related to the more general problem of


value of items of information or of procedures in the medical care
process. Rimoldi, et al.,34 used the frequency with which specified items
of information were used in the solution of a test problem as a
measure of the value of that item. Williamson had experts classify
specified procedures, in a specified diagnostic test setting, on a scale
ranging from "very helpful" to "very harmful." Individual per-
formance in the test was then rated using quantitative indices of
"efficiency," "proficiency" and overall "competence," depending on
the frequency and nature of the procedures used.85

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A problem in the interpretation of numerical scores is the meaning
of the numerical interval between points on the scale. Numerical
scores derived for the assessment of quality are not likely to have the
property of equal intervals. They should not be used as if they had.

Reliability
The reliability of assessments is a major consideration in studies
of quality, where so much depends on judgment even when the
directive types of standards are used. Several studies have given some
attention to agreement between judges. The impression gained is that
this is considered to be at an acceptable level. Peterson, et al.,18 on
the basis of 14 observer revisits, judged agreement to be sufficiently
high to permit all the observations to be pooled together after ad-
justment for observer bias in one of the six major divisions of care.
In the study by Daily and Morehead, "several cross-checks were made
between the two interviewing internists by having them interview the
same physicians. The differences in the scores of the family physicians
based on these separate ratings did not exceed 7 per cent."24 Rosen-
feld22 paid considerable attention to testing reliability, and devised
mathematical indices of "agreement" and "dispersion" to measure
it. These indicate a fair amount of agreement, but a precise evalua-
tion is difficult since no other investigator is known to have used
these same measures. Morehead, et al.,26 in the second study of
medical care received by Teamster families, report initial agree-
ment between two judges in assigning care to one of two classes
in 78 per cent of cases. This was raised to 92 per cent following
reevaluation of disagreements by the two judges.
By contrast to between-judge reliability, very little has been re-
ported about the reliability of repeated judgments of quality made
by the same person. To test within-observer variation, Peterson,
et al.,'8 asked each of two observers to revisit four of his own pre-
viously visited physicians. The level of agreement was lower within
observers than between observers, partly because revisits lasted a
shorter period of time and related, therefore, to a smaller sample of
practice.
The major mechanism for achieving higher levels of reliability
is the detailed specification of criteria, standards and procedures
used for the assessment of care. Striving for reproducibility was, in
fact, a major impetus in the development of the more rigorous
rating systems by Lembcke, and by Peterson and Barsamian. Un-

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fortunately, no comparative studies of reliability exist using highly
directive versus nondirective methods of assessment. Rosenfeld's raw
data might permit a comparison of reliability of "intuitive" judg-
ments and the reliability of structured judgments by the same two
assessors. Unreported data by Morehead, et al.,26 could be analyzed
in the same way as those of Rosenfeld22 to give useful information
about the relationship between degree of reliability and method of
assessment. The partial data that have been published suggest that
the post-review reliability achieved by Morehead, et al., using the
most non-directive of approaches, is quite comparable with that
achieved by Rosenfeld who used a much more directive technique.
Morehead, et al., raised the important question of whether the
reliability obtained through the detailed specification of standards
and criteria may not be gained at the cost of reduced validity.
"Frequently, such criteria force into a rigid framework similar actions
or factors which may not be appropriate in a given situation due to
the infinite variations in the reaction of the human body to illness ....
The study group rejects the assumption that such criteria are neces-
sary to evaluate the quality of medical care. It is their unanimous
opinion that it is as important for the surveyors to have flexibility in
the judgment of an individual case as it is for a competent physician
wlhen confronting a clinical problem in a given patient."26
The reasons for disagreement between judges throw some light
on the problems of evaluation and the prospects of achieving greater
reliability. Rosenfeld found that "almost half the differences were
attributable to situations not covered adequately by standards, or in
which the standards were ambiguous. In another quarter differences
developed around questions of fact, because one consultant missed a
significant item of information in the record. It would therefore
appear that with revised standards, and improved methods of orient-
ing consultants, a substantially higher degree of agreement could
be achieved."22 Less than a quarter of the disagreements contain
differences of opinion with regard to the requirements of manage-
ment. This is a function of ambiguity in the medical care system and
sets an upper limit of reproducibility. Morehead, et al., report that
in about half the cases of initial disagreement "there was agree-
ment on the most serious aspect of the patient's care, but one sur-
veyor later agreed that he had not taken into account corollary
aspects of patient care."26 Other reasons for disagreement were
difficulty in adhering to the rating categories or failure to note

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all the facts. Of the small number of unresolved disagreements
(eight per cent of all admissions and 36 per cent of initial dis-
agreements) more than half were due to honest differences of
opinion regarding the clinical handling of the problem. The re-
mainder arose out of differences in interpreting inadequate records,
or the technical problems of where to assess unsatisfactory care in a
series of admissions.27
A final aspect of reliability is the occasional breakdown in the
performance of an assessor, as so dramatically demonstrated in the
Rosenfeld study.22 The question of what the investigator does when
a well defined segment of his results are so completely aberrant will be
raised here without any attempt to provide an answer.

Bias

When several observers or judges describe and evaluate the process


of medical care, one of them may consistently employ more rigid
standards than another, or interpret predetermined standards more
strictly. Peterson, et al.,18 discovered that one of their observers gen-
erally awarded higher ratings than the other in the assessment of
performance of physical examination, but not in the other areas of
care. Rosenfeld22 showed that, of two assessors, one regularly awarded
lower ratings to the same cases assessed by both. An examination of
individual cases of disagreement in the study by Morehead, et al.,26
reveals that, in the medical category, the same assessor rated the care
at a lower level in 11 out of 12 instances of disagreement. For
surgical cases, one surveyor rated the care lower than the other in all
eight instances of disagreement. The impression is gained from examin-
ing reasons for disagreement on medical cases that one of the judges
had a special interest in cardiology and was more demanding of
clarity and certainty in the management of cardiac cases.
The clear indication of these findings is that bias must be accepted
as the rule rather than the exception, and that studies of quality
must be designed with this in mind. In the Rosenfeld study,22 for
example, either of the two raters used for each area of practice would
have ranked the several hospitals in the same order, even though one
was consistently more generous than the other. The Clute study of
general practice in Canada,19 on the other hand, has been criticized
for comparing the quality of care in two geographic areas even
though different observers examined the care in the two areas in
question.45 The author was aware of this problem and devised methods

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for comparing the performance of the observers in the two geographic
areas, but the basic weakness remains.
Predetermined order or regularity in the process of study may be
associated with bias. Therefore, some carefully planned procedures may
have to be introduced into the research design for randomization. The
study by Peterson, et al.,18 appears to be one of the few to have paid
attention to this factor. Another important source of bias is knowledge,
by the assessor, of the identity of the physician who provided the care
or of the hospital in which care was given. The question of removing
identifying features from charts under review has been raised,3 but
little is known about the feasibility of this procedure and its effects
on the ratings assigned. Still another type of bias may result from
parochial standards and criteria of practice that may develop in
and around certain institutions or "schools" of medical practice. To
the extent that this is true, or suspected to be true, appropriate
precautions need to be taken in the recruitment and allocation of
judges.

Validity
The effectiveness of care as has been stated, in achieving or produc-
ing health and satisfaction, as defined for its individual members
by a particular society or subculture, is the ultimate validator of the
quality of care. The validity of all other phenomena as indicators of
quality depends, ultimately, on the relationship between these phe-
nomena and the achievement of health and satisfaction. Neverthe-
less, conformity of practice to accepted standards has a kind of con-
ditional or interim validity which may be more relevant to the pur-
poses of assessment in specific instances.
The validation of the details of medical practice by their effect
on health is the particular concern of the clinical sciences. In the
clinical literature one seeks data on whether penicillin promotes re-
covery in certain types of pneumonia, anticoagulants in coronary
thrombosis, or corticosteroids in rheumatic carditis; what certain tests
indicate about the function of the liver; and whether simple or radical
mastectomy is the more life-prolonging procedure in given types of
breast cancer. From the general body of knowledge concerning such
relationships arise the standards of practice, more or less fully vali-
dated, by which the medical care process is ordinarily judged.
Intermediate, or procedural, end points often represent larger

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bundles of care. Their relationship to outcome has attracted the
attention of both the clinical investigator and the student of medical
care organization. Some examples of the latter are studies of relation-
ships between prenatal care and the health of mothers and infants46'47
and the relationship between multiple screening examinations and
subsequent health.48 An interesting example of the study of the
relationship between one procedural end point and another is the
attempt to demonstrate a positive relationship between the perform-
ance of rectal and vaginal examinations by the physician, and the
pathological confirmation of appendicitis in primary appendectomies,
as reported by the Professional Activities Study.49
Many studies reviewed8' 19'23'26'28 attempt to study the relation-
ship between structural properties and the assessment of the process
of care. Several of these studies have shown, for example, a relation-
ship between the training and qualifications of physicians and the
quality of care they provide. The relationship is, however, a complex
one, and is influenced by the type of training, it duration and the
type of hospital within which it was obtained. The two studies of
general practice18 19 have shown additional positive relationships
between quality and better office facilities for practice, the presence
or availabilty of laboratory equipment, and the institution of an ap-
pointment system. No realtionship was shown between quality and
membership of professional associations, the income of the physician
or the presence of x-ray equipment in the office. The two studies
do not agree fully on the nature of the relationship between quality
of practice and whether the physician obtained his training in a
teaching hospital or not, the number of hours worked or the nature
of the physician's hospital affiliation. Hospital accreditation, pre-
sumably a mark of quality conferred mainly for compliance with a
wide range of organizational standards, does not appear, in and of
itself, to be related to the quality of care, at least in New York City.26
Although structure and process are no doubt related, the few
examples cited above indicate clearly the complexity and ambiguity
of these relationships. This is the result partly of the many factors
involved, and partly of the poorly understood interactions among
these factors. For example, one could reasonably propose, based on
several findings26'38 that both hospital factors and physician factors
influence the quality of care rendered in the hospital, but that dif-
ferences between physicians are obliterated in the best and worst

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hospital and express themselves, in varying degrees, in hospitals of
intermediate quality.
An approach particularly favored by students of medical care
organization is to examine relations between structure and outcome
without reference to the complex processes that tie them together.
Some examples of such studies have been cited already.6"9 Others
include studies of the effects of reorganizing the outpatient clinic on
health status,50 the effects of intensive hospital care on recovery,51
the effects of home care on survival52 and the effect of a rehabilita-
tion program on the physical status of nursing home patients.53'54
The lack of relationship to outcome in the latter two studies suggests
that current opinions about how care should be set up are sometimes
less than well established.
This brief review indicates the kinds of evidence pertaining to the
validity of the various approaches to the evaluation of quality of
care. Clearly, the relationships between process and outcome, and
between structure and both process and outcome, are not fully under-
stood. With regard to this, the requirements of validation are best
expressed by the concept, already referred to, of a chain of events
in which each event is an end to the one that comes before it and a
necessary condition to the one that follows. This indicates that the
means-end relationship between each adjacent pair requires validation
in any chain of hypothetical or real events.55 This is, of course, a
laborious process. More commonly, as has been shown, the intervening
links are ignored. The result is that causal inferences become atten-
uated in proportion to the distance separating the two events on the
chain.
Unfortunately, very little information is available on actual assess-
ments of quality using more than one method of evaluation con-
currently. Makover has studied specifically the relationships between
multifactorial assessments of structure and of process in the same
medical groups. "It was found that the medical groups that achieved
higher quality ratings by the method used in this study were those
that, in general, adhered more closely to HIP's Minimum Medical
Standards. However, the exceptions were sufficiently marked, both in
number and degree, to induce one to question the reliability56 of
one or the other rating method when applied to any one medical
group. It would seem that further comparison of these two methods
of rating is clearly indicated."23

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INDICES OF MEDICAL CARE

Since a multidimensional assessment of medical care i


laborious undertaking, the search continues for discrete, r
able data that can provide information about the qualit
care. The data used may be about aspects of structure
outcome. The chief requirement is that they be easily
routinely, measurable and be reasonably valid. Among
quality using this approach are those of the Professio
Study,36 Ciocco, et al.,57 and Furstenberg, et al.37
Such indices have the advantage of convenience; but t
that are drawn from them may be of doubtful validi
pointed out the many limitations of the traditional in
quality of hospital care, including rates of total and p
mortality, complications, postoperative infection, Caes
consultation and removal of normal tissue at operation.58 T
and completeness of the basic information may be open
More important still, serious questions may be raised ab
index means since so many factors are involved in pro
phenomenon which it measures. Eislee has pointed out,
hand, that at least certain indices can be helpful, if use
The search for easy ways to measure a highly complex
such as medical care may be pursuing a will-o'-the-wis
simple indices in lieu of more complex measures may b
demonstrating high correlations among them.' But, in t
demonstrated causal links, this may be an unsure foun
which to build. On the other hand, each index can be
a dimension or ingredient of care. Judiciously selected
dices may, therefore, constitute the equivalent of borings
survey which yield sufficient information about the pa
reconstruction of the whole. The validity of inferenc
whole will depend, of course, on the extent of internal
in the individual or institutional practice of medicine.

Some Problems of Assessing Ambulatory Care


Some of the special difficulties in assessing the quality of
care have already been mentioned. These include th
recorded information, and the prior knowledge, by th
physician, of the patient's medical and social history.

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these problems has led to the use of trained observers and the second
to the observation of cases for which prior knowledge is not a factor
in current management. The degree of relevance to general practice
of standards and strategies of care developed by hospital centered and
academically oriented physicians has also been questioned.
Another problem is the difficulty of defining the segment of care
that may be properly the object of evaluation in ambulatory care.
For hospital care, a single admission is usually the appropriate unit.59
In office or clinic practice, a sequence of care may cover an indeter-
minate number of visits so that the identification of the appropriate
unit is open to question. Usually the answer has been to choose an
arbitrary time period to define the relevant episode of care. Ciocco,
et al.,57 defined this as the first visit plus 14 days of follow-up. Huntley,
et al.,43 use a four-week period after the initial work-up.

CONCLUSIONS AND PROPOSALS

This review has attempted to give an impression of the


approaches and methods that have been used for eval
quality of medical care, and to point out certain issues a
lems that these approaches and methods bring up for con
The methods used may easily be said to have been of dou
and more frequently lacking in rigor and precision. But h
do estimates of quality have to be? At least the better me
been adequate for the administrative and social policy
that have brought them into being. The search for perfec
not blind one to the fact that present techniques of evaluatin
crude as they are, have revealed a range of quality from
ing to deplorable. Tools are now available for making broad
of this kind with considerable assurance. This degree of a
supported by findings, already referred to, that suggest
levels of homogeneity in individual practice and of reprod
qualitative judgments based on a minimally structured ap
evaluation. This is not to say that a great deal does not r
be accomplished in developing the greater precision necessa
tain other purposes.
One might begin a catalogue of needed refinements by c
the nature of the information which is the basis for jud

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quality. More must be known about the effect of the observer on
the practice being observed, as well as about the process of observation
itself-its reliability and validity. Comparisons need to be made between
direct observation and recorded information both with and without
supplementation by interview with the managing physician. Recording
agreement or disagreement is not sufficient. More detailed study is
needed of the nature of, and reasons for, discrepancy in various settings.
Similarly, using abstracts of records needs to be tested against using
the records themselves.
The process of evaluation itself requires much further study. A
great deal of effort goes into the development of criteria and standards
which are presumed to lend stability and uniformity to judgments of
quality; and yet this presumed effect has not been empirically demon-
strated. How far explicit standardization must go before appreciable
gains in reliability are realized is not known. One must also consider
whether, with increasing standardization, so much loss of the ability
to account for unforeseen elements in the clinical situation occurs
that one obtains reliability at the cost of validity. Assessments of the
same set of records using progressively more structured standards and
criteria should yield valuable information on these points. The con-
tention that less well trained assessors using exhaustive criteria can
come up with reliable and valid judgments can also be tested in this
way.
Attention has already been drawn, in the body of the review, to
the little that is known about reliability and bias when two or more
judges are compared, and about the reliability of repeated judgments
of the same items of care by the same assessor. Similarly, very little
is known about the effects on reliability and validity, of certain
characteristics of judges including experience, areas of special interest
and personality factors. Much may be learned concerning these and
related matters by making explicit the process of judging and sub-
jecting it to careful study. This should reveal the dimensions and
values used by the various judges and show how differences are
resolved when two or more judges discuss their points of view. Some
doubt now exists about the validity of group reconciliations in which
one point of view may dominate, not necessarily because it is more
valid.1 The effect of masking the identity of the hospital or the
physician providing care can be studied in the same way. What is
proposed here is not only to demonstrate differences or similarities

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in overall judgments, but to attempt, by making explicit the thought
processes of the judges, to determine how the differences and similar-
ities arise, and how differences are resolved.
In addition to defects in method, most studies of quality suffer
from having adopted too narrow a definition of quality. In general,
they concern themselves with the technical management of illness and
pay little attention to prevention, rehabilitation, coordination and
continuity of care, or handling the patient-physician relationship.
Presumably, the reason for this is that the technical requirements of
management are more widely recognized and better standardized.
Therefore, more complete conceptual and empirical exploration of
the definition of quality is needed.
What is meant by "conceptual exploration" may be illustrated by
considering the dimension of efficiency which is often ignored in studies
of quality. Two types of efficiency might be distinguished: logical
and economic. Logical efficiency concerns the use of information to
arrive at decisions. Here the issue might be whether the information
obtained by the physician is relevant or irrelevant to the clinical
business to be transacted. If relevant, one might consider the degree
of replication or duplication in information obtained and the extent
to which it exceeds the requirements of decision making in a given
situation. If parsimony is a value in medical care, the identification
of redundancy becomes an element in the evaluation of care.
Economic efficiency deals with the relationships between inputs
and outputs and asks whether a given output is produced at least cost.
It is, of course, influenced by logical efficiency, since the accumulation
of unnecessary or unused information is a costly procedure which
yields no benefit. Typically it goes beyond the individual and is
concerned with the social product of medical care effort. It considers
the possibility that the "best" medical care for the individual may
not be the "best" for the community. Peterson, et al., cite an example
that epitomizes the issue. "Two physicians had delegated supervision
of routine prenatal visits to office nurses, and the doctor saw the
patient only if she had specific complaints."'8 In one sense, this may
have been less than the best care for each expectant mother. In
another sense, it may have been brilliant strategy in terms of making
available to the largest number of women the combined skills of a
medical care team. Cordero, in a thought provoking paper, has docu-
mented the thesis that, when resources are limited, optimal medical

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care for the community may require less than "the best" care for its
individual members.60
In addition to conceptual exploration of the meaning of quality,
in terms of dimensions of care and the values attached to them,
empirical studies are needed of what are the prevailing dimensions
and values in relevant population groups.5 Little is known, for example,
about how physicians define quality, nor is the relationship known
between the physician's practice and his own definition of quality.
This is an area of research significant to medical education as well
as quality. Empirical studies of the medical care process should also
contribute greatly to the identification of dimensions and values to
be incorporated into the definition of quality.
A review of the studies of quality shows a certain discouraging
repetitiousness in basic concepts, approaches and methods. Further
substantive progress, beyond refinements in methodology, is likely
to come from a program of research in the medical care process itself
rather than from frontal attacks on the problem of quality. This
is believed to be so because, before one can make judgments about
quality, one needs to understand how patients and physicians interact
and how physicians function in the process of providing care. Once
the elements of process and their interrelationships are understood,
one can attach value judgments to them in terms of their contributions
to intermediate and ultimate goals. Assume, for example, that author-
itarianism-permissiveness is one dimension of the patient-physician
relationship. An empirical study may show that physicians are in fact
differentiated by this attribute. One might then ask whether author-
itarianism or permissiveness should be the criterion of quality. The
answer could be derived from the general values of society that may
endorse one or the other as the more desirable attribute in social
interactions. This is one form of quality judgment, and is perfectly
valid, provided its rationale and bases are explicit. The study of
the medical care process itself may however offer an alternative, and
more pragmatic, approach. Assume, for the time being, that compliance
with the recommendations of the physician is a goal and value in the
medical care system. The value of authoritarianism or permissiveness
can be determined, in part, by its contribution to compliance. Com-
pliance is itself subject to validation by the higher order criterion of
health outcomes. The true state of affairs is likely to be more com-
plex than the hypothetical example given. The criterion of quality

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may prove to be congruence with patient expectations, or a more
complex adaptation to specific clinical and social situations, rather
than authoritarianism or permissiveness as a predominant mode.
Also, certain goals in the medical care process may not be compatible
with other goals, and one may not speak of quality in global terms
but of quality in specified dimensions and for specified purposes.
Assessments of quality will not, therefore, result in a summary judg-
ment but in a complex profile, as Sheps has suggested.'
A large portion of research in the medical care process will, of
course, deal with the manner in which physicians gather clinically
relevant information, and arrive at diagnostic and therapeutic deci-
sions. This is not the place to present a conceptual framework for
research in this portion of the medical care process. Certain specific
studies may, however, be mentioned and some directions for further
research indicated.
Research on information gathering includes studies of the percep-
tion and interpretation of physical signs.61'62 Evans and Bybee have
shown, for example, that in interpreting heart sounds errors of per-
ception (of rhythm and timing) occurred along with additional
errors of interpretation of what was perceived. Faulty diagnosis, as
judged by comparison with a criterion, was the result of these two
errors.62 This points to the need for including, in estimates of quality,
information about the reliability and validity of the sensory data
upon which management, in part, rests.
The work of Peterson and Barsamian38'39 represents the nearest
approach to a rigorous evaluation of diagnostic and therapeutic de-
cision making. As such, it is possibly the most significant recent ad-
vance in the methods of quality assessment. But this method is based
on record reviews and is almost exclusively preoccupied with the
justification of diagnosis and therapy. As a result, many important
dimensions of care are not included in the evaluation. Some of these
are considerations of efficiency, and of styles and strategies in prob-
lem solving.
Styles and strategies in problem solving can be studied through
actual observation of practice, as was done so effectively by Peterson,
et al., in their study of general practice.18 A great deal that remains
unobserved can be made explicit by asking the physician to say aloud
what he is doing and why. This method of reflexion parlee has been
used in studies of problem solving even though it may, in itself, alter
behavior.63 Another approach is to set up test situations, such as those

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used by Rimoldi, et al.,34 and by Williamson,35 to observe the decision
making process. Although such test situations have certain limitations
arising out of their artificiality,64 the greater simplicity and control
that they provide can be very helpful.
At first sight, the student of medical care might expect to be helped
by knowledge and skill developed in the general field of research in
problem solving. Unfortunately, no well developed theoretical base
is available which can be exploited readily in studies of medical care.
Some of the empirical studies in problem solving might however,
suggest methods and ideas applicable to medical care situations.63-67
Some of the studies of "troubleshooting" in electronic equipment, in
particular, show intriguing similarities to the process of medical diag-
nosis and treatment. These and similar studies have identified be-
havioral characteristics that might be used to categorize styles in
clinical management. They include amount of information collected,
rate of seeking information, value of items of information sought as
modified by place in a sequence and by interaction with other items of
information, several types of redundancy, stereotypy, search patterns
in relation to the part known to be defective, tendencies to act prior
to amassing sufficient information or to seek information beyond the
point of reasonable assurance about the solution, "error distance" and
degrees of success in achieving a solution, and so on.
Decision making theory may also offer conceptual tools of research
in the medical care process. Ledley and Lusted,68'69 among others,
have attempted to apply models based on conditional probabilities to
the process of diagnosis and therapy. Peterson and Barsamian38'39 de-
cided against using probabilities in their logic systems for the very
good reason that the necessary data (the independent probabilities
of diseases and of symptoms, and the probabilities of specified symptoms
in specified diseases) were not available. But Edwards, et al.,70 point
out that one can still test efficiency in decision making by substituting
subjective probabilities (those of the decision maker himself or of
selected experts) for the statistical data one would prefer to have.
A basic question that has arisen frequently in this review is the
degree to which performance in medical care is a homogeneous or
heterogeneous phenomenon. This was seen, for example, to be relevant
to sampling, the use of indices in place of multidimensional measure-
ments, and the construction of scales that purport to judge total
performance. When this question is raised with respect to individual
physicians, the object of study is the integration of various kinds of

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knowledge and of skills in the personality and behavior of the physician.
When it is raised with respect to institutions and social systems the
factors are completely different. Here one is concerned with the
formal and informal mechanisms for organizing, influencing and
directing human effort in general, and the practice of medicine in
particular. Research in all these areas is expected to contribute to
greater sophistication in the measurement of quality.
Some of the conventions accepted in this review are, in themselves,
obstacles to more meaningful study of quality. Physicians' services
are not, in the real world, separated from the services of other health
professionals, nor from the services of a variety of supportive personnel.
The separation of hospital and ambulatory care is also largely artificial.
The units of care which are the proper objects of study include the
contributions of many persons during a sequence which may include
care in a variety of settings. The manner in which these sequences are
defined and identified has implications for sampling, methods of
obtaining information, and standards and criteria of evaluation.
A final comment concerns the frame of mind with which studies
of quality are approached. The social imperatives that give rise to
assessments of quality have already been referred to. Often associated
with these are the zeal and values of the social reformer. Greater
neutrality and detachment are needed in studies of quality. More
often one needs to ask, "What goes on here?" rather than, "What
is wrong; and how can it be made better?" This does not mean
that the researcher disowns his own values or social objectives. It
does mean, however, that the distinction between values, and ele-
ments of structure, process or outcome, is recognized and main
tained; and that both are subjected to equally critical study. Partly
to achieve this kind of orientation emphasis must be shifted from
preoccupation with evaluating quality to concentration on understand
ing the medical care process itself.

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REFERENCES

1 Sheps, M. C., Approaches to the Quality of Hospital Care, Pub


Reports, 70, 877-886, September, 1955.
This paper represents an unusually successful crystallization of thi
cerning the evaluation of quality. It contains brief but remarkably
discussions of the purposes of evaluation, problems of definition, cr
standards, various approaches to measurement, the reliability of qual
ments and indices of quality. The bibliography is excellent.
2 Peterson, L., Evaluation of the Quality of Medical Care, New
Journal of Medicine, 269, 1238-1245, December 5, 1963.
3 Lerner, M. and Riedel, D. C., The Teamster Study and the Q
Medical Care, Inquiry, 1, 69-80, January, 1964.
The major value of this paper is that it raises questions concernin
of assessment including the sampling of populations and diagnostic
the use of records and the need for supplementation by interview
of detailed standards, the need for understanding the auditing p
definition of terms and concepts (of "unnecessary admission," fo
and the problems of defining the relevant episode of care.
4 Lee, R. I. and Jones, L. W., THE FUNDAMENTALS OF GOOD MEDICAL
CARE, Chicago, University of Chicago Press, 1933.
6 Klein, M. W., et al., Problems of Measuring Patient Care in the Out Pa-
tient Department, Journal of Health and Human Behavior, 2, 138-144,
Summer, 1961.
6 Kohl, S. G., PERINATAL MORTALITY IN NEW YORK CITY: RESPONSIBLE
FACTORS, Cambridge, Harvard University Press, 1955.
This study, sponsored by the New York Academy of Medicine, was an exam-
ination by an expert committee of records pertaining to a representative sample
of perinatal deaths in New York City. Preventable deaths were recognized and
"responsibility factors" identified, including errors in medical judgment and
technique. The incidence of both of these was further related to type of hospital
service, type of professional service and type of hospital, indicating relationships
between structure and outcome as modified by the characteristics of the popu-
lation served.

7 Shapiro, S., et al., Further Observations on Prematurity and Perinatal


Mortality in a General Population and in the Population of a Prepaid Group
Practice Medical Care Plan, American Journal of Public Health, 50, 1304-1317,
September, 1960.
8 Lipworth, L., Lee J. A. H. and Morris, J. N., Case Fatality in Teaching
and Nonteaching Hospitals, 1956-1959, Medical Care, 1, 71-76, April-June,
1963.

9 Rice, C. E., et al., Measuring Social Restoration Performance of Public


Psychiatric Hospitals, Public Health Reports, 76, 437-446, May, 1961.
10 Lembcke, P. A., Medical Auditing by Scientific Methods, Journal of the

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American Medical Association, 162, 646-655, October 13, 1956. (Appendices
A and B supplied by the author.)
This is perhaps the single best paper that describes the underlying concepts
as well as the methods of the highly structured approach developed by Lembcke
to audit hospital records. Also included is an example of the remarkable effect
that an "external audit" of this kind can have on surgical practice in a hospital.
11 Kelman, H. R. and Willner, A., Problems in Measurement and Evaluation
of Rehabilitation, Archives of Physical Medicine and Rehabilitation, 43, 172-
181, April, 1962.
12 McDermott, W., et al., Introducing Modern Medicine in a Navajo Com-
munity, Science, 131, 197-205 and 280-287, January 22 and 29, 1960.
13 Simon, H. A., ADMINISTRATIVE BEHAVIOR, New York, The Macmillan
Company, 1961, pp. 62-66.
14 Hutchinson, G. B., Evaluation of Preventive Services, Journal of Chronic
Diseases, 11, 497-508, May, 1960.
15 James, G., EVALUATION OF PUBLIC HEALTH, Report of the Second Na-
tional Conference on Evaluation in Public Health, Ann Arbor, The University
of Michigan, School of Public Health, 1960 pp. 7-17.
16 Weinerman, E. R., Appraisal of Medical Care Programs, American Jour-
nal of Public Health, 40, 1129-1134, September, 1950.
17 Goldmann, F. and Graham, E. A., THE QUALITY OF MEDICAL CARE PRO-
VIDED AT THE LABOR HEALTH INSTITUTE, ST. LOUIS, MISSOURI, St. Louis,
The Labor Health Institute, 1954.
This is a good example of an approach to evaluation based on structural
characteristics. In this instance, these included the layout and equipment of
physical facilities, the competence and stability of medical staff, provisions made
for continuity of service centering around a family physician, the scheduling
and duration of clinic visits, the content of the initial examination, the degree
of emphasis on preventive medicine and the adequacy of the medical records.
18 Peterson, O. L., et al., An Analytical Study of North Carolina General
Practice: 1953-1954, The Journal of Medical Education, 31, 1-165, Part 2,
December, 1956.
Already a classic, this study is distinguished by more than ordinary attention
to methods and rather exhaustive exploration of the relationship between quality
ratings and characteristics of physicians, including education training and
methods of practice. The findings of this study, and others that have used the
same method, raise basic questions about traditional general practice in this
and other countries.

19 Clute, K. F., THE GENERAL PRACTITIONER: A STUDY OF MEDICAL EDU-


CATION AND PRACTICE IN ONTARIO AND NOVA SCOTIA, Toronto, University of
Toronto Press, 1963, chapters 1, 2, 16, 17 and 18.
Since this study uses the method developed by Peterson, et al., it offers an
excellent opportunity to examine the generality of relationships between physi-
cian characteristics and quality ratings. In addition, the reader of this elegantly
written volume gets a richly detailed view of general practice in the two areas
studied.

20 Kroeger, H. H., et al., The Office Practice of Internists, I. The Feasibility


of Evaluating Quality of Care, The Journal of the American Medical Associa-
tion, 193, 371-376, August 2, 1965.
This is the first of a series of papers based on a study of the practice of mem-

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bers of the New York Society of Internal Medicine. This paper reports findings
concerning the completeness of office records, their suitability for judging quality
and the degree of agreement between abstracts of records prepared by physicians
and by highly trained non-physicians. Judgments concerning the quality of care
provided are not given. Other papers in this series currently appearing in the
Journal of the American Medical Association concern patient load (August 23),
characteristics of patients (September 13), professional activities other than
care of private patients (October 11), and background and form of practice
(November 1).
21 Kilpatrick, G. S., Observer Error in Medicine, Journal of Medical Educa-
tion, 38, 38-43, January, 1963. For a useful bibliography on observer error see
Witts, L. J. (Editor), MEDICAL SURVEYS AND CLINICAL TRIALS, London, Oxford
University Press, 1959, pp. 39-44.
22 Rosenfeld, L. S., Quality of Medical Care in Hospitals, American Journal
of Public Health, 47, 856-865, July, 1957.
This carefully designed comparative study of the quality of care in four
hospitals addresses itself to the problems of methods in the assessment of quality.
Here one finds important information about the use of normative and empirical
standards, reliability and bias in judgments based on chart review, the correla-
tion between defects in recording and defects in practice and homogeneity in
quality ratings within and between diagnostic categories.
23 Makover, H. B., The Quality of Medical Care: Methodological Survey of
the Medical Groups Associated with the Health Insurance Plan of New York,
American Journal of Public Health, 41, 824-832, July, 1951.
This is possibly the first published report concerning an administratively
instituted, but research oriented, program of studies of the quality of care in
medical groups contracting with the Health Insurance Plan of Greater New
York. Unfortunately much of this work remains unpublished. A particular fea-
ture of this paper is that it describes, and presents the findings of simultaneous
evaluation of structure (policies, organization, administration, finances and pro-
fessional activities) and process (evaluation of a sample of clinical records).
24 Daily, E. F. and Morehead, M. A., A Method of Evaluating and Improv-
ing the Quality of Medical Care, American Journal of Public Health, 46,
848-854, July, 1956.
25 Fitzpatrick, T. B., Riedel, D. C. and Payne, B. C., Character and Effec-
tiveness of Hospital Use, in McNerney, W. J., et al., HOSPITAL AND MEDICAL
ECONOMICS, Chicago, Hospital Research and Educational Trust, American
Hospital Association, 1962, pp. 495-509.
26 Morehead, M. A., et al., A STUDY OF THE QUALITY OF HOSPITAL CARE
SECURED BY A SAMPLE OF TEAMSTER FAMILY MEMBERS IN NEW YORK CITY,
New York, Columbia University, School of Public Health and Administrative
Medicine, 1964.
This study and its companion28 perform a very important social and admin-
istrative function by documenting how frequently the care received by members
of a union through traditional sources proves to be inadequate. These studies
also make a major contribution to understanding the relationships between hos-
pital and physician characteristics and the quality of care they provide. Con-
sidered are physician classifications by specialty status and admission privileges,
as well as hospital classifications by ownership, medical school affiliation, ap-
proval for residency training and accreditation status. The interactional effects
of some of these variables are also explored. In addition, the second of the two
studies26 pays considerable attention to questions of method, including repre-
sentative versus judgmental sampling of hospital admissions and the reliability
of record evaluations by different judges.

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27 Morehead, M. A., Personal communication.
28 Ehrlich, J., Morehead, M. A. and Trussell, R. E., THE QUANTITY, QUAL-
ITY AND COSTS OF MEDICAL AND HOSPITAL CARE SECURED BY A SAMPLE OF
TEAMSTER FAMILIES IN THE NEW YOR.K AREA, New York, Columbia Unive
School of Public Health and Administrative Medicine, 1962.
29 Maloney, M. C., Trussell, R. E. and Elinson, J., Physicians Choose M
cal Care: A Sociometric Approach to Quality Appraisal, American Journ
Public Health, 50, 1678-1686, November, 1960.
This study represents an ingenious approach to evaluation through the
of "peer judgments" in what is believed to be a particularly revealing situa
choice of care for the physician or members of his own family. Some of the c
acteristics of the physicians and surgeons selected included long-standing p
sonal and professional relationships, recognized specialist status, and me
school affiliation. An incidental pearl of information is that although nine out
ten physicians said everyone should have a personal physician, four out of
said they had someone whom they considered their personal physician, and
two out of ten had seen their personal physician in the past year!
30 Georgopoulos, B. S. and Mann, F. C., THE COMMUNITY GENERAL HOS
PITAL, New York, The Macmillan Company, 1962.
The study of quality reported in several chapters of this book is based o
the thesis that if one wishes to find out about the quality of care provided
one might need to do is to ask the persons directly or indirectly involved in
provision of such care. Although physicians may find this notion rather n
the stability and internal consistency of the findings reported in this study in
cate that this approach deserves further careful evaluation. A second study
nationwide sample of general hospitals will attempt to confirm the validit
respondent opinions by comparing them to selected indices of professional acti
ties in each hospital. The findings will be awaited with great interest.
31 One of the author's students, Mr. Arnold D. Kaluzny, helped the auth
to coin this word.

32 Georgopoulos, B. S. and Tannenbaum, A. S., A Study of Organizational


Effectiveness, American Sociological Review, 22, 534-540, October, 1957.
33 Evans, L. R. and Bybee, J. R., Evaluation of Student Skills in Physical
Diagnosis, Journal of Medical Education, 40, 199-204, February, 1965.
34 Rimoldi, H. J. A., Haley, J. V. and Fogliatto, H., THE TEST OF DIAG-
NOSTIC SKILLS, Loyola Psychometric Laboratory Publication Number 25, Chi-
cago, Loyola University Press, 1962.
This study is of interest because it uses a controlled test situation to study
the performance of medical students and physicians. Even more intriguing is
the attempt to approach the question of the value or utility of diagnostic actions
in a systematic and rigorous manner. While this particular study does not appear
to contribute greatly to understanding the quality of care, this general approach
appears to be worth pursuing.
35 Williamson, J. W., Assessing Clinical Judgment, Journal of Medical Edu-
cation, 40, 180-187, February, 1965.
This is another example of the assessment of clinical performance using an
artificial test situation. The noteworthy aspect of the work is the attachment of
certain values ("helpful" or "harmful") to a set of diagnostic and therapeutic
actions and the development of measures of "efficiency," "proficiency" and
"competence" based on which actions are selected by the subject in managing
the test case. Differences of performance between individual physicians were
detected using this method. An unexpected finding was the absence of system-
atic differences by age, training or type of practice in groups tested so far.

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36 Eislee, C. W., Slee, V. N. and Hoffmann, R. G., Can the Practice of
Internal Medicine Be Evaluated?, Annals of Internal Medicine, 44, 144-161,
January, 1956.
The authors discuss the use of indices from which inferences might be drawn
concerning the quality of surgical and medical management. The indices de-
scribed include tissue pathology reports in appendectomies, diabetes patients
without blood sugar determinations and without chest x-rays, and pneumonia
without chest x-rays. A striking finding reported in this paper, and others based
on the same approach, is the tremendous variation by physician and hospital
in the occurrence of such indices of "professional activity."
37 Furstenberg, F. F., et al., Prescribing as an Index to Quality of Medical
Care: A Study of the Baltimore City Medical Care Program, American Journal
of Public Health, 43, 1299-1309, October, 1953.
38 Peterson, O. L. and Barsamian, E. M., An Application of Logic to a Study
of Quality of Surgical Care, Paper read at the Fifth IBM Medical Symposium,
Endicott, New York, October 7-11, 1963.
This paper and its companion39 present a fairly complete description of the
"logic tree" approach to the evaluation of quality. Examples are given of the
logic systems for the Stein-Leventhal Syndrome and uterine fibromyoma. No
data are given on empirical findings using this method.
39 , Diagnostic Performance, in Jacquez, J. A. (Editor), THE DIAG-
NOSTIC PROCESS, Ann Arbor, The University of Michigan Press, April, 1964,
pp. 347-362.
40 Lembcke, P. A. and Johnson, O. G., A MEDICAL AUDIT REPORT, Los
Angeles, University of California, School of Public Health, 1963 (Mimeo-
graphed).
This is an extension of Lembcke's method of medical audit to medical diag-
nostic categories as well as a large number of surgical operations. Although this
volume is a compendium of fairly raw data, careful study can provide insights
and limitations of the method used by the author.
41 Lembcke, P. A., A Scientific Method for Medical Auditing, Hospitals,
33, 65-71, June 16 and 65-72, July 1, 1959.
42 The dimensionality of the set of variables incorporating these standards
remains to be determined.

43Huntley, R. R., et al., The Quality of Medical Care: Techniques and


Investigation in the Outpatient Clinic, Journal of Chronic Diseases, 14, 630-
642, December, 1961.
This study provides an example of the application of a routine chart review
procedure as a check on the quality of management in the outpatient depart-
ment of a teaching hospital. Fairly often routine procedures were not carried
out and abnormalities that were found were not followed up. A revised chart
review procedure seemed to make a significant reduction in the percent of
abnormalities not followed up.
44 Peterson, et al., loc. cit., attempted to get some confirmation of weightings
through the procedure of factor analysis. The mathematically sophisticated are
referred to their footnote on pp. 14-15.
45 Mainland, D., Calibration of the Human Instrument, Notes from a Lab-
oratory of Medical Statistics, Number 81, August 24, 1964 (Mimeographed).
46 Joint Committee of the Royal College of Obstetricians and Gynecologists
and the Population Investigation Committee, MATERNITY IN GREAT BRITAIN,
London, Oxford University Press, 1948.

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47Yankauer, A., Goss, K. G. and Romeo, S. M., An Evaluation of Prenatal
Care and its Relationship to Social Class and Social Disorganization, American
Journal of Public Health, 43, 1001-1010, August, 1953.
48 Wylie, C. M., Participation in a Multiple Screening Clinic with Five-Year
Follow-Up, Public Health Reports, 76, 596-602, July, 1961.
49 Commission on Professional and Hospital Activities, MEDICAL AUDIT
STUDY REPORT 5: PRIMARY APPENDICTOMIES, Ann Arbor, The Commission on
Professional and Hospital Activities, October, 1957.
50 Simon, A. J., Social Structure of Clinics and Patient Improvement, Ad-
ministrative Science Quarterly, 4, 197-206, September, 1959.
51Lockward, H. J., Lundberg, G. A. F. and Odoroff, M. E., Effect of Inten-
sive Care on Mortality Rate of Patients with Myocardial Infarcts, Public Health
Reports, 78, 655-661, August, 1963.
52 Bakst, J. N. and Marra, E. F., Experiences with Home Care for Cardiac
Patients, American Journal of Public Health, 45, 444-450, April, 1955.
53 Muller, J. N., Tobis, J. S. and Kelman, H. R., The Rehabilitation Poten-
tial of Nursing Home Residents, American Journal of Public Health, 53, 243-
247, February, 1963.
54These studies also include data on the relationships between structural
features and procedural end points. Examples are the effect of clinic structure
on the number of outpatient visits,50 and the effect of a home care program on
hospital admissions.52

55 Getting, V. A., et al., Research in Evaluation in Public Health Practices,


Paper presented at the 92nd Annual Meeting, American Public Health Associ-
ation, New York, October 5, 1964.
56 Assuming the direct evaluation of process to be the criterion, the issue
becomes one of the implications of reliability measures for validity.
57 Ciocco, A., Hunt, H. and Altman, I., Statistics on Clinical Services to
New Patients in Medical Groups, Public Health Reports, 65, 99-115, January
27, 1950.
This is an early application to group practice of the analysis of "professional
activities" now generally associated with the evaluation of hospital care. The
indices used included the recording of diagnosis and treatment, the performance
of rectal and vaginal examinations, the performance of certain laboratory exam-
inations and the use of sedatives, stimulants and other medications subject to
abuse. As is true of hospitals, the groups varied a great deal with respect to
these indicators.

58 Myers, R. S., Hospital Statistics Don't Tell the Truth, Modern Hospital,
83, 53-54, July, 1954.
69 Even for hospital care the appropriate unit may include care before and
after admission, as well as several hospital admissions.3
60 Cordero, A. L., The Determination of Medical Care Needs in Relation to
a Concept of Minimal Adequate Care: An Evaluation of the Curative Out-
patient Services in a Rural Health Center, Medical Care, 2, 95-103, April-
June, 1964.
61 Butterworth, J. S. and Reppert, E. H., Auscultatory Acumen in the
General Medical Population, Journal of the American Medical Association, 174,
32-34, September 3, 1960.

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62 Evans, L. R. and Bybee, J. R., Evaluation of Student Skills in Physical
Diagnosis, Journal of Medical Education, 40, 199-204, February, 1965.
63 Fattu, N. C., Experimental Studies of Problem Solving, Journal of Medical
Education, 39, 212-225, February, 1964.
64 John, E. R., Contributions to the Study of the Problem Solving Process,
Psychological Monographs, 71, 1957.
65 Duncan, C. P., Recent Research in Human Problem Solving, Psycho-
logical Bulletin, 56, 397-429, November, 1959.
66 Fattu, N. A., Mech, E. and Kapos, E., Some Statistical Relationships
between Selected Response Dimensions and Problem-Solving Proficiency, Psy-
chological Monographs, 68, 1954.
67 Stolurow, L. M., et al., The Efficient Course of Action in "Trouble Shoot-
ing" as a Joint Function of Probability and Cost, Educational and Psychological
Measurement, 15, 462-477, Winter, 1955.
68 Ledley, R. S. and Lusted, L. B., Reasoning Foundations of Medical Diag-
nosis, Science, 130, 9-21, July 3, 1959.
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sity of Michigan Press, 1964, pp. 157-174.
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325.

ACKNOWLEDGMENTS

Included among the reviewed authors who read the m


and made corrections or comments are Georgopoulos,
Morehead, Peterson, Riedel, Rosenstock, Rosenfeld,
Weinerman. The author is especially indebted to Dr. M
Morehead and to professors Basil S. Georgopoulos,
Klarman and Charles A. Metzner for taking time to mak
comments. The official critics, Mr. Sam Shapiro and Dr
Muller were helpful in sharpening some of the issues in
ment of quality. Since the author was unable to use all the
advice he received, he alone is responsible for defects in
This review has been supported, in part, by Grant C
from the Division of Community Health Services, Uni
Public Health Service.

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DISCUSSION

The feasibility of individual vs. population level st


this discussion concentrates on the choice of the aspe
forth in Dr. Donabedian's paper. While his focus on
individual patient-physician relationship was acknow
traditional concern, a research approach from the sta
target populations was advocated as a broader an
framework for studying quality in the future. In s
assessment of quality should include such factors as
tion, accessibility and use of medical services, re
other things, to the efficiency of providing and deliver
though no new facilities become available, the qu
care received by particular population groups may c
through a different pattern of use. While Dr. Dona
examples of how the best quality of care for the ind
be the best care for a community, unfortunately he
this concept further, but remains within the frame
havior of the individual patient and physician.
In reply Dr. Donabedian contends that if quality
defined to include the total medical care system an
tions, all research in health services involving value
research into "quality." The meaning of "quality"
little precision it has and would be even more difficu
it is already. Introducing utilization and other socioec
would greatly multiply the factors to be integrated
should be placed on studies at the individual patient
or on studies of the kinds of medical services offere
the more complex variables could be introduced in s
vestigations.
The most reputable findings in the social sciences appear to stem
from studies of groups rather than of individuals. Likewise, the na-
tural sciences deal with the interactions of large populations. Similarly,
while studies of the educational process at the individual pupil-teacher
relationship have not been revealing, they have succeeded with re-

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markable precision in replicating relationships between settings, ad-
ministrative structures and outcomes. Since the whole patient care
process cannot be brought into view and related even to a profile of
outcomes, the study of process at the level of individual interactions
would have to stop at immediate microcriteria and would not be
fruitful. While complex variables do enter into the study of both
the individual patient-physician relationship and populations at risk,
the research problem is more within the investigator's grasp if popula-
tions rather than individuals are the object of study.
The importance of medical care outcomes. Also disputed is Dr.
Donabedian's assumption that the more promising research strategy
lay in studying process rather than outcome. The overall social cir-
cumstances in which medical care is provided today requires concen-
tration on the issues and goals of the system and on outcomes rather
than process. While the discussion brought out the difficulties of
using the outcome approach, the obstacles are not considered insuper-
able. The difficulties cited by Dr. Donabedian reflected more on the
ability of the investigators to define criteria relevant to the populations
studied than on the power or desirability of the outcome approach.
Divorced from the issue of context, any branch of study could be
overwhelmed with methodological problems. Acceptance of a margin
of error is basic to all research and the real methodological issue
for investigation concerns the degree of interference that bias can
exert on conclusions concerning quality of care. Such determinations
of the significant methodological problems cannot be made in the
abstract, without discussion of the specific issues and goals of evaluating
quality of care. Had Dr. Donabedian concentrated more on the issues
and values of the medical care system he might have been led to a
less pessimistic view of the importance of the outcome approach and
to its more extensive treatment. In addition, he might have further
clarified the gaps in methodology currently deterring research progress,
the compromises that have to be accepted, and the priorities for
sharpening existing research tools. While Dr. Donabedian agrees to
the validity of introducing organizational changes, for example, and
then observing the outcome in terms of care, he feels that such studies
possess inherent limitations. The unknown variables involved prohibit
generalizations about the ways such outcomes occur. The relation-
ships between changes in settings and changes in outcomes can only be
validated through studies of process. Also, outcomes may reflect the

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effects of two different processes; one which furthers, the other which
detracts from good outcome. By themselves, outcome studies cannot
take account of such cancellation effects.
Since numerous variables other than medical care affect outcome,
much more research should be devoted to identifying the proportion
of outcome that is related to medical care variables. The study of
process at the individual level, aggregated to the population, is
proposed as a way to define the contribution that medical care makes
to outcome. Seen in this way, the study of process at the population
level would no longer be considered as an inferior substitute for the
study of outcome.
The need to separate values from the elements of the process. In
Dr. Donabedian's opinion, the issue is not one of process vs. outcome,
but of choosing in any particular situation what is the most productive
thing to do. While the ultimate concern in this field is indeed with
outcomes, from certain vantage points he advocates concentrating
on process and leaving the validation of the relationship between
process and outcome to different kinds of investigators, clinicians in
particular.
Furthermore, he avoids reference to content issues and to the goals
and values of medical care because he specifically argues for the need
to separate value judgments from descriptions of the elements of the
process. In Dr. Donabedian's opinion, the approach to quality which
maintains that, for example, continuity of care must constitute good
care, is a very naive approach. Research ought to transcend this
limited stance and develop methods to define operationally what con-
tinuity means and to study its natural history, how and when it
manifests itself. The study of the values and goals of the medical
care process needs to be approached from a completely different
and radically empirical point of view. Particularly important is the
need to discover to what extent values in the medical care system
agree or contradict each other. Whenever values conflict, medical care
cannot be described as simply either good or bad. It can only be
characterized as good in terms of certain specific dimensions and bad
in terms of other dimensions. The elements of the process must there-
fore be dissected and understood much more clearly before any value
judgments can be attached to them in terms of their contribution to
certain goals.

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