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Pergamon
International Journal for Quality in Health Care
VoL 8 , No. 4 , pp . 401-40 7,1996
Copyright © 1996 Av tdii D ona bedi ui, Published by Eljevier Science Ltd. All righti reserved
Printed in Great Britain
1353-4505/96 15 .00+0.00
The Effectiveness of Quality Assurance
AVEDIS DONABEDIAN
The organizers of this conference intended,
from the very first, to adopt as its theme: "The
Impact of Quality Interventions in Health Ca re"
and, indeed, we have heard the strains of this
theme in its many variations, like the enticing
notes of a magic flute, all these many d ays.
What more appropriate ending to the con-
ference I thought, when asked to be your fare-
well speaker, than a few parting words about
"The Effectiveness of Quahty Assuran ce". W hat
easier, I went on to th ink, since this is a subject I
have studied and written about during the more
than thirty years of my professional life
[1,2].
How hasty I was How reckless How foolish
Soon you shall see why.
As the enormity of my task sank in, I stripped
it to its bare essentials. I shall speak, I decided,
only about one form of quality assurance: that
which consists of obtaining information about
performance and, based on an analysis of
performance in any given situation, leads to
modification in behavior: directly, through edu-
cational and motivational activities, and indir-
ectly, through adjustments in system design.
Furthermore, I would have in mind, I decided,
only clinical care, lopping off all othe r aspects of
organizational performance less central to the
patient-practitioner transaction.
But even when so restricted, the subject
presents some serious difficulties: in definition,
in conceptualization, in documentation, and in
presentation.
"Effectiveness"
is
itself no simple
concept.
It is
to be visualized as a process in a series of steps:
introduction; implantation; implementation;
modification in behavior; and finally, conse-
quent progress toward health and health-related
objectives. It is likely that many of the factors
that influence the effectiveness of quahty assur-
ance act continuously throughout this progres-
sion. It is also likely that at each stage some
factors are more influential than others, and that
at some points new factors emerge to become
critical. For example, early in the progression,
the nature of the intervention and the receptivity
to it are dominant factors. A t the transition from
behaviors to outcomes, the ability to harness
most effectively the technology of health care is
the more critical variable. Yet, what comes
before prefigures what is to come later; and
anticipation of what is to come influences what
happens at preceding steps.
A similar pattern of modulation and rever-
beration runs through the many layers of the
health care system. At the most general level,
there are the societal factors that surround,
shape, and profoundly influence the functioning
of the health care enterprise. That enterprise is
itself differentiated into layers and segments:
layers such as the institution, the department,
the work group, and the individual, and seg-
ments such as the professional and administra-
tive. At each of these levels and in each of these
segments, distinctive forces may influence
whether or not quahty assurance will be
adopted, the form it will take, and how effec-
tively it will be implem ented.
The large number of quality assurance inter-
ventions, separately and in combination, add
another set of complexities to the task at hand.
So does the imperfect state of our knowledge
about the effects of these interventions. True
enough, there is an extensive literature to draw
upon. But much of it is anecdotal; it merely
describes what was done, and what seemed to
have been accomplished, only in specific loca-
tions, during short periods of time. There are
very few controlled studies. For example, of the
more than
6 000
reports on continuing educa-
tion gathered by Davis and associates, only 99
Presented on May 30th, 1996, at the Closing Ceremony of the 13th International Conference of the IntcrnationaJ Society for
Quality in Health Care, Jerusalem. The author reserves copyright.
401
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4
A. Donabcdian
were deemed worthy of further analysis. Of
these, only two thirds reported a change in
behavior, and even fewer spoke of changes in
outcomes. Furthermore, the changes observed
were often limited to a few of the process and
outcome variables studied, they were small,
difficult to quantify, and of indeterminate clin-
ical significance [3].
Even rare r t han well-designed studies of single
interventions are assessments of variants of such
methods. Rarer still, to the point of non-
existence, are studies that set out to test compet-
ing, theory-based strategies of quality assurance.
To present this empirical material, even after
rigorous pru ning, w ould be impossible in a talk
such as this and if presented, it would lead to the
almost foregone conclusion that: every reason-
ably established method in the armamentarium
of quality assurance has been shown to work in
some situations. Precertification and second-
opinions work. Reminders, feedback, profiling,
benchm arking, guidelines, protocols, indicators,
detailing, continuing education in its various
forms—they all work. Quality circles, quality
improvement teams and similar group efforts
work. Financial incentives work; professional
incentives too. So do regulatory interventions,
administrative controls and professional inter-
ventions. They all work. Yet no one method is
demonstrably superior in every situation, or in
most.
One response to this uncertainty is to use a
combination of methods, hoping that a cumu-
lative effect, or even a synergy, may emerge.
Fortunately, the methods at hand do fall into
reasonable constellations or sequences that
promise mutual reinforcement. Guidelines,
feedback, professional persuasion and continu-
ing education form one such sequence. There
could also be an interaction between external
regulatory requirements and internal adminis-
trative or professional initiatives—an interac-
tion that is mutually supportive rather than
antagonistic.
Another response to the current uncertainty
in choosing what method is best is to postulate
that effectiveness depends not on the method
alone, but on an interaction between the
method and the situation in which it is to be
implemented. One looks, therefore, for a kind
of fit between method and situation. The study
of effectiveness becomes, then, a study of
contexts, and the interventions appropriate to
each of these.
In such a study a theory of effectiveness would
help, but I know of no such theory. There are,
rather, many theories and many competing
perspectives. The health care enterprise may be
seen as
a
culture, or a set of cultures, to which the
quality assurance effort must adapt, or which
may have to
be
modified if quality assurance
is
to
flourish. Or the health care enterprise may be
seen, in a somewhat related fash ion, as a system
of social interactions in which the example,
approval and support of significant others
govern behavior. Therefore, it is to this network
of social exchanges that quality assurance must
be linked [4]. Alternatively, the health care
enterprise is endowed with a considerable
degree of rationality, so that information and
knowledge rule and it is through these that
quality assurance must act [5]. Or, perhaps,
behavior in the health care system is rational in
still another w ay, tha t of self-seeking calc ulation,
the advantages sought being econom ic, social, or
professional. Quality assurance must, therefore,
aim to contribute to these interests or, at least,
not to harm them. Contrariwise, behavior in the
health care system may not be as rational as one
would like to believe. R ather , it may be governed
in part by a variety of psychological and
emotional needs, aspirations, and fears [6]. Or,
possibly, the health care system is a network of
communications, vertical and horizontal; or it is
a system of power relationships, or superordina-
tion and subordination; or it is all of the
aforementioned and other things besides.
In the absence of
a
unifying theory, one takes
refuge in eclectic formulations that draw on
several perspectives. The most dominant of
these formulations today goes under the name
of "total quality management" or some variant
of it.
I have before me two reports. One is of an
effort to reduce mortality from coronary artery
bypass surgery in several States in Northern
New England. It flies the banner of "TQM",
uses its concepts and methods, speaks its
language—and it succeeds. In this case, as in
many others, TQM w orks [7].
The second enterprise, this one in not too-far-
away New York State, has the same objectives,
but it is conceived and operated by a govern-
mental agency with awsome powers of retribu-
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The effectiveness of quality as surance
4 3
tion, held in check, but unmistakable. It is
traditional, pragmatic. TQM is beyond its ken.
Yet, it also works—at least as well, perhaps
better
[8].
Can one make sense of all this? Do you see,
now, the problem I have faced?
Fortunately, despite all the uncertainties I
have portrayed, there are certain themes that
run constantly throughout the literature on
"effectiveness", themes partly founded on
empirical evidence, partly on theory-based
expectations, and partly on informed specula-
tion. It is to these themes that I now turn.
To introduce a t least a semblance of order into
my presentation, I shall divide these themes,
rather arbitrarily, into "Contextual" and
"Operational".
The context subsumes the general properties
of the situation into which quality assurance is
to be introduced and in which it is to operate.
These properties may support or handicap
quality assurance, or they may only support it
in some forms, under restricted conditions.
Among the contextual factors, one encounters
at the onset, the notion of "culture", which
includes what one believes and values, how
reality is seen and interpreted, how one is to
behave and how things are to be done. All
these are manifested in how important quality
is regarded to be, how it is defined, who is to
be responsible for it, and through what
mechanisms. The role of government is critical
to these matters, as is the role of the health
professions, of the organizations that finance
and provide care and of consumers, in associa-
tion or individually.
In a step down from the more general to the
more particular, one often speaks of the culture
within an organization—the microcosm where
the issues I have just mentioned come into play.
It is often said that some forms of quality
assurance amount to a "thought revolution",
one that requires a corresponding cultural
change. Some features of that change appear in
the clear assum ption of responsibility for quality
in the highest reaches of an organization, the
diffusion of that responsibility throu gho ut all its
parts and layers, a corresponding empowerment
of personnel and a less authoritarian form of
governance. Furthermore, organizations are
distinguished into some that resist change and
others that seek to learn, are ready to strike out
in new directions, willing to take justifiable
risks
[9].
What is not clear is how the appropriate
cultural change is to be achieved. Perhaps it
occurs, partly, through the play of external
forces: such as governmental pressure, profes-
sional aspirations, consumer demand, the play
of market forces, and so on. All these imply a
manifest or subtle threat to the organization; it
must a dapt o r possibly perish.
Perhaps the factor most often mentioned as a
feature of
a
culture, as well as a m odifier of
it
is
leadership: leadership in every sphere of a society
and every level of an organization. The chief
executive is a leader; so is the head of a clinical
unit; so is a manager; so m ust be som eone in the
quality improvement team.
Leadership is often associated with positions
of authority; the ability to exercise authority, to
influence careers, to reward or censure, is an
important adjunct to it, even if kept in the
background. Power relationships are a factor
not to be ignored in the adoption and c onduct of
quality assurance. But other attributes of leader-
ship matter equally, if not more: the ability to
persuade, to motivate, to inspire trust, to set a
personal example of commitment to and perso-
nal participation in the quality assurance enter-
prise. Furtherm ore, mo st clinicians would like to
see in charge of the quality assurance a pparatu s
one of their own; a clinician senior
in
rank and of
unquestioned competence.
In part, this preference is related to still
another contextual factor, that of sponsorship.
In clinical practice, sponsorship by the relevant
professional association (of physicians, nurses,
and so on) confers legitimacy on the quality
assurance effort as a whole, and more so on the
particular guidelines and criteria that pertain to
the details of clinical work. It is a resource
assiduously to be sought.
Both leadership and sponsorship imply an
underlying structure of socially organized rela-
tionships. In addition to these, formal organiza-
tion of the health care enterprise is an almost
necessary requirement for the institution and
operation of quality assurance activities. Formal
organizations provide the arena within which
cultural change takes place and where leadership
is exercised. They have the m eans to set the goals
of performance, to investigate success or failure,
to identify causative factors and to take appro-
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4 4
A. Donabedian
priate action. Within organizations, the
networks of informal communication and inter-
personal influence are concentrated and poten-
tiated, offering thereby a ready vehicle for the
processes of quality assurance. When the orga-
nizational nexus is underdeveloped, or virtually
absent, as in the private practice of ambulatory
care, some new organizational structure, formal
or informal, is usually needed to allow physi-
cians to recruit resources, develop expertise, and
offer mutual support in the effort to improve
performance [10].
Let me now turn to my second category:
namely, the "ope rati ona l" factors that influence
effectiveness. To help me present these in some
order, I shall assume, guided by more general
models of health behavior, a rather crude
progress ion of steps, as follows [11].
(1) There is a demonstrable, consequential,
legitimate need.
(2) Something can be done to meet the need.
(3) Tha t w hich will be done, or is done, is the
right thing, done in the right way.
(4) There are demonstrable, useful results,
free of unforeseen, harmful consequences.
I shall go through these steps in order.
1. There
is a
demonstrable, consequential
legitimate need
The awareness of need may derive, as I have
already im plied, from the play of external forces,
or it may be self-generated, or the two may
interact. But, no ma tter how prom pted, the need
must be regarded as important and clinically
relevant. Often, a reasonable first step is an
organized effort, through group discussion, to
identify needs, and set them in an agreed-upon
order of priority. In general, trivialization is
deadly, but sometimes one must seize upon
something relatively unim portant that a clinical
unit wishes to have done, hoping in that way to
demonstrate the potential of the quality assur-
ance enterprise to help and to succeed.
In order to be demonstrable and credible,
what
is
needful m ust be documented w ith data—
data of unimpeachable provenance and quality.
Moreover, the inference to be drawn from the
data must, themselves, be persuasive and com-
pelling. Compariso ns m ay be made with norma-
tive standards of acceptable legitimacy, either
professionally approved or self-generated. Parti-
cipation in the formulation of such guidelines
and standards is said to enhance compliance. It
is said, moreover, that comparison with the
actual performance of peers or of similar
institutions tends to be more compelling, and
some believe that setting precise, measurable
goals in advance, especially concerning out-
comes of care, is powerfully motivating, if the
goals fail to be achieved [12,13].
The manner of presenting data is also im por-
tant. More effective than written transmittal is
the opportunity to explain and discuss the
findings and their interpretation, and even more
so if individual performance is discussed in
private with a trusted and respected senior
colleague [14].
A genuine conviction that performance needs
to be improved is the indispensable first step in
the process of quality assurance.
2.
Something can be done to meet the need
What should follow upon a conviction that
something needs to be improved is at least a
reasonable expectation tha t improvement can be
made. Loosely, this falls under the now pop ular,
even alluring, rubric of "e mpo werm ent".
Empowerment applies at all levels in an
organization: executive, managerial and opera-
tional. It applies, in particular, to the quality
assurance directorate. This is empowered by the
appointment of a chief of considerable stature
and authority, who belongs in the highest
reaches of an organization, where one can
participate in and influence, all decisions that
significantly impinge on quality. The directorate
is also empowered by having at its disposal the
necessary resources: human and material. These
include the requisite varieties and levels of
expertise. They also include time. Nothing
vitiates a quality assurance enterprise, revealing
its marginality in an organization, m ore than its
being delegated to persons of relatively little
authority, or conducted as an add-on to existing
responsibilities, in one's own free time.
These observations apply, as well, to groups
or teams that undertake, or are asked to under-
take, quality improvement tasks. Quality
flourishes if everyone is alert to op portunities to
improve it, can communicate these, can suggest
how improvements are to be made, and can
expect serious consideration, leading to action,
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The
effectiveness of quality assurance
405
where appropriate. T hus, one fosters a sense of
optimism, even of adventure,
in an
organization.
If
not
one can expect cynicism
at
first,
and
later
an apathetic resignation
in
those
who
remain,
while the best depart.
The necessary next step, therefore,
is
that
action
be
taken
but not any
action, only actions
that
are
reasonable
and
approved.
3.
That which will be done,
or is
done,
is the
right
thing, done
in the
right
way
Expectations of what interventions, what
disturbances
in the
accustomed life
of an
organization, quality assurance
is
likely
to
make,
are
perhaps
the
major determinant
of
how warmly
it is
likely
to be
received when
proposed,
or how
obstinately opposed. Later,
the very first actions taken can justify what
was
hoped for or either confirm or begin to allay the
fears that almost
any
change
in the
established
order
is
certain
to
arouse.
At
every step, there-
after, with each
new
undertaking,
the
need
to
gain approval recurs, except that past events,
one hopes, have gradually built
up
trust,
and
fostered
an
inclination
to
cooperate.
Much of what makes qu ality assurance inter-
ventions acceptable can be m ade to fall under the
rubric of "congruence" , which
is
the degree
of fit
between the interventions envisaged, and what I
earlier called "culture":
the
culture
of the
organization
as a
whole
or of the
subcultures
of its parts—amon g
the
latter, that of the health
care professions being the m ost compelling.
At
the
very least, one aim s
for a
compatibility
with professional ideals, or better still, a
reinforcem ent of these.
A
clear commitment
to
quality,
as
professionals understand
the
term,
rather than cost-saving mainly,
is a
necessary
bond. So is the resolve to advance the welfare of
patients,
to
reinforce professional responsibility,
and
to
serve
the
need
for
professionals
to
know,
and continue to learn. It helps if what is
proposed
is
familiar
in
rationale
and
method.
It
is less disturbing
if the
concepts
and
methods
of
quality assurance
are
seen
to
resemble those
of
the scientific method, which professionals
respect, or
of
clinical problem -solving,
in
which
they
are
daily engaged. If could
be
disturbing
to
ask professionals to adopt concepts and meth-
ods ostensibly borrowed from
the
industrial
sector.
And it is
unnecessary
to do so
since
service
to
patients
is a
compelling professional
goal, the model of governance proposed is an
established feature
of
professional life,
and the
methods
to
be em ployed
are
largely ep idem iolo-
gical, with some compatible extensions [15].
In most cases,
it is
best,
it
seems
to me to
emphasize continuities rathe r than disjunctions,
where possible extending quality assurance
activities already present
in
many health care
institutions.
But
that principle does
not
hold
if
what already exists is, itself externally imposed,
discordant, discredited,
and
demonstrably
inef-
fective. It
is
better, then,
to
offer
as
a replacement
not another unfamiliar incursion, but rather, a
return
to the
purer, more authentic traditions
of
the health care professions.
Much of what seems new
in
quality assurance
is,
in fact, eminently traditional. Professionals
wish
to
monitor their
own
work,
led by one of
their
own
whom they trust
and
respect. They
prefer
to
study patterns
of
performance rather
than to search for individual miscreants. They
would much rather look
for
causes
of
failure
in
underlying processes
and
structure, than
in
professional malfeasance. If
there
are failures in
knowledge, judgme nt,
or
skill, they would want
these
to be
corrected
by
education
and
retrain-
ing,
not
punishment. Furthermore, education
would be more effective if specifically directed at
discrete, verified needs, cond ucted
in
person
by
respected colleagues,
and
reinforced, where
possible, by individual consultation and advice.
All this is persuant to congruence with
professional norms.
But it
also serves
a
second
principle, that
of
"ownership". Professional
sponsorship and leadership are one prerequisite
to ownership. And so
is
personal participation in
the quality assurance enterprise:
in
setting
its
goals, in
constructing
its
criteria
and
standards,
in carrying out its processes and, w here possible,
implementing
the
changes that
it
prescribes.
Through "ownership", two other related
principles
are
also served. These are "relev ance"
and " utility". The purposes and consequences
of
quality assurance m ust be
relevant o
the life
and
work of those who engage in it or are to be
consumers,
so to
speak,
of its
findings
and
consequences.
It
operates
in the
domains these
consumers recognize as their own where they
work, where they exercise responsibility, where
they can bring about change. Ideally,
the
quality
assurance enterprise will
do
what
its
consumers
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406
A. Donabedian
would want to see done in the first place,
generate information they would like to have,
aim for effects they would want to
see realized.
In
short, it is useful.
Sometimes, quality assurance is useful in
solving discrete problems that have troubled a
clinical unit. At other times, it serves individual
aspirations, for example by revealing and
rewarding meritorious performance, otherwise
unnoticed. Sometimes, an entire profession,
nursing for example, is offered new opportu-
nities for person al self-expression and g rowth, as
well as an avenue to professional recognition—
even power. Whenever such utilities are man-
ifest, participation in quality assurance is not
only welcomed, it is avidly sought.
To summarize, the quality assurance enter-
prise, if it is to flourish, should conform to the
cultural imperatives of those it wishes to
influence. But quality assurance is also a force
capable, of itself to bring about a gradual
change in that c ulture, so that, in time, a greater
congruence can emerge. Therefore, the quality
assurance enterprise must
be
in for the long haul.
It must be persistent, consistent, meticulously
fair, and it must show results.
4. There are
demonstrable,
u seful results, free o f
unforeseen, harmful consequences
The credibility of the quality assurance enter-
prise hinges on one thing above all else; that
something is done as a consequence of its
activities, and tha t this something is demonstra-
bly useful. L et me call this, somew hat fancifully,
the principle of "fruition".
What could be more persuasive than to
experience, first hand, the benefits of quality
assurance? What could more demonstrably
confirm an organization's commitment to it?
On the contra ry, wh at could be more destructive
to the entire effort than to observe that quality
assurance is a tissue of ostentatious pronounce-
ments, or merely busy-work: onerous, boring,
unrewarding and useless.
Even worse, would be to experience the
undesirable consequences that one has feared
from the start, among them: dilution of profes-
sional responsibility, distortion of professional
judgment, stereotyping of practice, discourage-
ment of innovation, legal hazard and an ambi-
ence of fearfulness that leads to resistance,
evasion, concealment and ultimate demoraliza-
tion.
These dire prognostications are most often, of
course, only the hobgoblins summoned forth by
the timid, or the merely manipulative, to justify
opposition to legitimate quality assurance initia-
tives. But, sad experience has also shown that,
under perverse forms of intervention, such fears
can materialize. Therefore, at every step, they
are assiduously to be guarded against.
It is now time to end, but on a more hopeful
note.
To my mind, the most important single
condition for success in quality assurance is the
determination to make it work. If we are truly
committed to quality, almost any reasonable
method will work. If we are not, the most
elegantly constructed of mechanisms will fail.
We shall leave this place, I know, determined
to hold the stewardship of quality as a sacred
trust. Once again, we dedicate ourselves to that
high calling.
It is also fitting that, as we leave this city, we
offer thanks for its hospitality, and pray earn-
estly for peace to reign within it. Permit me,
therefore, to do so now , in the words of the sweet
psalmist himself first as he spoke, and then in
translation [16]:
tofia,
ftec
Pray for the peace of Jeru-
salem they shall prosper that
love thee.
Peace be w ithin th y wa lls ,
and prosperi ty within thy
palaces.
For my bre thren and com-
panions ' sakes, I wil l now say,
Peace
be
wi thin thee .
Because of the house of the
LORD OUT God I will seek th y
good.
And now, dear friends, farewell—and God
bless u s all.
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The effectiveness of quality assurance 4 7
Acknowledgements:
I wish to thank Dr. Richard
Baker who no t only helped m e locate references but,
also,
by sharing his own ideas, shaped some of my
thinking as well.
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16. Psalm 122, verses 6-9.
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iHlmatiomUoumalfor Qm iXj f Htetth Cart VoL 9, No. 4, pp. 311-312,199
O 1997 Hjevfer Sconce Ltd. All
righu
naencd
Printed in Gnat Briuin
ERRATA
B.
Ottosson I. R. HaDberg K. Axebson and L. Loven: Patients Satisfaction with Surgical Care Impaired by Cuts in
Expenditure and After Interventions to Improve Nursing Care at a Surgical Clinic. Int J Qual Health Care :43-53.
It is regretted that errors were made in Table 3 of the- above article. The corrected table is as follows:
TABLE 3. Respondents experience of tbelr personal contact with nursing staff. Comparisons between 1993 (n -131) and
1994 n - 1 2 8 ) as measured by the Mum-Whitney U-test
( )
Often Quite often Seldom No t at all p-value
99 993 993 993
994 994 994 994
Anxiety before examination/treatm.
Experience of em barrassment
Anxiety regarding professional secrecy
Needing someone to talk to without finding anyone
There is someone to talk to abo ut the examin./treatm.
There is someone to talk to about their personal
situation •
10.2
10.3
1.6
0.9
1.6
1.7
0.8
0.9
60.9
54.3
41.6
38.1
15.0
22.2 '
1.7
0.8
2.5
2.4
3.4
25.2
29.3
17.6
17.7
29.1
32.5
11.2
11.3
4.7
5.9
18.1
23.9
12.2
12.9
3.2
6.2
45.7
35.0
87.2
86.1
92.9
89.8
78.7
71.8
1.6
3.5
4.0
3.5
0.1
0.8
0.4
0.2
0.3
0.9
D not applicable
993
= 33.6%;
994
=
34.5%
Internal drop-out 1-10 respondents
11-15 respondents
311
8/19/2019 La Eficacia de La Garantía de Calidad
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312 Errata
ERRATUM
A. Donabedian: The Effectiveness of Quality Assurance.
Int J Qual Health are
8:401-407.
It is regretted that in publishing the above article, a passage of text was inadvertently printed upside-
down. The publishers would Uke to apologise for any embarrassment this error may have caused to
Professor D onab edian , and for any inconvenience to readers of the Journal. The correct version of the
text is given below:
The English translation is as follows:
Pray for the peace of Jeru-
salem.
:
they shall prosper that
love thee.
Peace be within thy walls ,
and prosperity within thy
For my brethren and com-
panions sakes, I will now say,
Peace be within thee.
Because of the house of the
L O R D our God I will seek th y
good.