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Intervention Research in Psychosis:
Issues Related to the Assessment of
Quality of Life1
by A. Qeorge Awad and Lakshmi N . P . Voruganti
significant currency as they get used in the political arena.
In 1964, President Johnson introduced the term "quality
of life" in his address on "the Great Society." As a broad,
general concept, quality of life has always included several domains related to health, but the concept also originally included many other non-health-related issues such
as work, family, prosperity, spirituality, and environment.
Such broad domains clearly complicate the usefulness of
quality of life as a health outcome.
Over the past 40 years, medicine has been going
through major changes as a result of scientific and technological advances. With enhanced life expectancy, the medical focus has shifted from merely prolonging life to
improving the quality of life. This has led to a narrower
concept of quality of life specifically related to health.
This narrower concept was quickly embraced for use in
particular medical illnesses such as cancer and arthritis.
Although interest in the concept of quality of life of the
chronically mentally ill has its roots in the early 1960s, as
an extension of the increasing'concerns about the unsatisfactory life conditions of chronic psychiatric patients in
the community, these interests were unfortunately not
adequately sustained over the next two decades, except
for some serious contributions by a few researchers
(Malm et al. 1981; Lehman et al. 1982; Lehman 1983).
Several reasons have contributed to the lack of interest in quality of life research in psychiatry. In a previous
review, we examined several such factors, which include
lack of agreement on a definition or what constitutes quality of life in schizophrenia, concerns and doubts about the
credibility of chronic psychiatric patients' self-reports,
lack of adequate appropriate conceptual models for the
particular population as well as the phase of the illness
Abstract
Quality of life has emerged as the ideal of modern
medicine viewed from a biopsychosocial perspective.
The concept has been increasingly used as an important attribute in patient care and clinical studies as
well as the basis in many health economic evaluations.
Although the concept has been extensively applied in a
number of other medical fields such as oncology, cardiovascular, and arthritis, it is only recently that quality of life has received serious attention in the study of
severe psychiatric disorders. For the concept to be
meaningfully applied in the study of these disorders,
several basic and methodological issues have to be adequately resolved. Five such issues are identified: definition of quality of life, the subjective/objective
dichotomy, significant determinants of quality of life,
how quality of life is measured, and the role of quality
of life in clinical management and health economics.
Unless these issues are adequately clarified and
resolved, the recent heightened interest in the concept
of quality of life may fade away, and that would be a
missed opportunity in the mental health field.
Keywords: Quality of life, psychosis, schizophrenia, antipsychotics, conceptual models, research issues.
Schizophrenia Bulletin, 26(3):557-564,2000.
Over the past 20 years, the concept of quality of life has
come to represent the new image of modern medicine as
viewed from biopsychosocial perspectives (Awad et al.
1997a). No one is sure how the general concept originated
except that it had its beginning in the post-World War II
period. Post-war economic prosperity and enhanced standards of living led to various life expectations such as satisfaction, well-being, and psychological fulfilment. These
broad notions were picked up by social scientists, who
advanced population-based quality of life research that
contributed significantly to social indicators. As frequently happens, such social science concepts gain more
1
Based on a presentation to the Workshop on Intervention in
Psychosis, Geriatric Psychiatry Intervention Research Center, San
Diego, California, October 1998.
Send reprint requests to Prof. A.G. Awad, Mental Health Program,
Humber River Regional Hospital, 2175 Keele St., Toronto, Ontario
M6M 4Z4, Canada; e-mail: [email protected].
557
Schizophrenia Bulletin, Vol. 26, No. 3, 2000
A.G. Awad and L.N.P. Voruganti
and subsequently, adequate methodology for measurement (Awad et al. 1997a). Fortunately, over the last few
years, there has been significant renewed interest in quality of life assessment in psychiatry. Although many might
have difficulty in articulating what quality of life is, the
concept in its popular usage in society has proved simple
for everyone to understand. The concept also appropriately captures what physicians, patients, and their families
aspire to accomplish in the treatment of any significant
chronic long-term illness. In other words, the concept has
come to represent the ultimate outcome of the interaction
between the patient and the illness, its treatment, its psychological impact, as well as social contributions and consequences. Other factors have also contributed to the
recent increased popularity of the concept. With economic
constraints and efforts to contain health care costs, more
attention has focused on quality of life as an outcome
measure for comparison of therapies and programs as well
as for resource allocation. The recent rise in consumerism
has increased pressure on clinicians for patients and their
families not only to participate in the clinical decisionmaking process but also to expect better therapies. Recent
accelerated developments in neuroscience, both in its
research and its technological aspects, have led to the
introduction of several new and expensive medical procedures and therapies. In addition, the high acquisition costs
of new psychiatric medications have led drug regulatory
agencies as well as formulary and drug benefit plans to
require data about quality of life and pharmacoeconomics.
The pharmaceutical industry, while promoting new products, has emphasized quality of life as a significant marketing tool to highlight differences between individual
medications and to project a favorable health economic
status.
5.
What Is Quality of Life?
A construct such as quality of life cannot be verified,
appropriately measured, and subjected to serious study
unless it is well-defined. More than three decades ago,
Campbell et al. (1976) anticipated the controversy that
continues until the present time about the lack of agreement on a definition of quality of life: "Quality of Life is a
vague and ethereal entity, something that many people
talk about but which nobody clearly knows what to do
about." Over the last 30 years, several definitions of quality of life were introduced; these definitions depended
mostly on theoretical orientation and ranged in scope to
focus on psychological issues such as feelings of wellbeing and satisfaction to issues related to standards of living such as housing, finances, and employment.
Several other definitions emerged reflecting the different theoretical frameworks of their authors. In an
attempt to circumvent the unresolved issue of absence of
a gold standard against which quality of life can be measured, Caiman (1984) defined quality of life as the gap
between the patients' expectations and achievements.
Wood-Dauphinee and Williams (1987) introduced the
concept of "reintegration to normal living" as equivalent
to quality of life. A broader definition by Ware (1984)
conceptualized quality of life as hierarchical concentric
circles, with the center representing the impact of the illness and the outer circles progressing from personal functioning, feelings of well-being, and psychological distress,
to overall general health perceptions, and ultimately to
social and role functioning. Such a definition broadens the
concept of quality of life from a personal individual perspective to a broader social and societal concept. Clearly,
there is no agreement on definitions, and it may be that
many definitions are needed depending on the population
under study, the stage of the illness and its treatment, as
well as societal expectations at a particular point of time.
With the state of the art as such, it is incumbent on
researchers to define what they mean by quality of life in
their publications and communications. In a 1994 report
examining the quality of quality of life research, using
standardized criteria, Gill and Feinstein reported that
quality of life was defined in only 15 percent of the
reports they reviewed. In our studies in schizophrenia, we
adopted a somewhat narrower and more specific definition reflecting our belief that quality of life in schizophrenia represents the functional effect of the illness itself and
its treatment upon a patient as perceived by the patient.
With all these factors converging to make the concept
of quality of life most popular in the psychiatric field,
such popularity and high expectations have also brought
in several concerns that can undermine the usefulness of
the concept. Clinicians, as well as the majority of
researchers, have become preoccupied with measurement
of quality of life without any clear understanding of what
they are measuring or what the factors are that contribute
to the concept itself. Much less research has been devoted
on how to integrate quality of life measurements into clinical psychiatric care. Based on our experience, over the
past 15 years, and the identified gaps in the literature, the
following represent some major issues that require concerted research attention:
1
2.
3.
4.
What role does quality of life have in clinical management and health economics?
How should quality of life be defined?
Whose measurement of quality of life is relevant?
What are the significant determinants of quality of
Me?
How should quality of life be measured?
558
Issues Related to the Assessment of Quality of Life
Schizophrenia Bulletin, Vol. 26, No. 3, 2000
Figure 1. Illness severity and consistency of SIP
The Subjective/Objective Debate:
Whose Measurement of Quality of Life
Is Relevant?
scores'
By definition, quality of life is a subjective construct that
needs to include patients' self-reports and their subjective
judgement. As such, it requires a degree of cognitive ability.
Traditionally, clinicians have been suspicious of subjective
assessment by patients of treatment outcomes. As patients
with schizophrenia frequently experience disturbed thinking
and communication, as well as a range of neurocognitive
deficits, their reports about their feelings, values, and levels
of satisfaction are frequently uncritically dismissed as unreliable. Paradoxically, clinicians do not feel reluctant to base
diagnostic formulations of their patients on unobservable or
non-objectively verifiable self-reports about their unique
psychotic experiences such as hallucinations and delusions,
without questioning the reliability of such information. Over
the past few years, a growing body of research has supported the notion that subjective self-reports can be both
measured and reliably quantified (Van Putten and May
1978; Hogan et al. 1983; Hogan and Awad 1992; Naber et
al. 1994; Awad et al. 1995; Voruganti et al. 1998). In a
recent report of the reliability of quality of life self-reports
(Voruganti et al. 1998), we confirmed that the reliability
coefficient of patients' self-reports measured weekly over a
4-week period were statistically significant (r = 0.80-0.87, p
> 0.0001). In addition, we also reported significant concordance between patients' subjective self-reports and objective
measures conducted by clinicians. Repeated ANOVA analysis of variance failed to detect any group by week interaction effects for the severity of symptoms, side effects, neurocognitive deficits, antipsychotic drug doses, or attitudes
toward medications (Voruganti et al. 1998). The lack of such
interactions confirms that subjective self-reported scores
remained consistent for all the subgroups over time (figure
1). Our data were obtained from clinically stable but moderately symptomatic patients with schizophrenia attending a
medication clinic.
— Minimal
-•-Mild
•*• Moderate
•*" Severe
Weeks
Note.—The higher the SIP score, the lower the quality of life is.
1
SIP = Sickness Impact Profile (Bergner et al. 1981, as modified
by Awad 1995).
life measures such as spirituality and feelings of wellbeing of patients with schizophrenia were unrelated to
objective measures of their standard of living such as
housing or financial and social support. Warner et al.
(1998), in their study comparing a sample of patients with
schizophrenia in Bologna, Italy, and Boulder, Colorado,
reported that objective quality of life variables using a factor analysis sorted separately from subjective satisfaction
scores, suggesting that they may be measuring different
underlying constructs. Although objective measures of
quality of life were rated as more favorable for schizophrenia patients in Bologna, as compared with Boulder, subjective satisfaction ratings were not different in both sites.
Interestingly enough, another study reported that subjective quality of life was rated higher in a sample of patients
with schizophrenia than in those with affective disorder,
although in objective measures, the reverse was true
(Atkinson et al. 1997). Such dichotomy was also demonstrated in our recent study of neurocognitive deficits and
quality of life in a sample of patients with schizophrenia.
We were unable to demonstrate significant correlation
between neurocognitive deficits and self-rated quality of
life (Heslegrave et al. 1997). Although patients in our sample have demonstrated significant neurocognitive deficits,
the correlation to their subjective self-reports of quality of
life was weak, at best. On the other hand, in a recent report
by Green (1996), a review of data from several studies
pointed to strong correlation between aspects of neurocognitive deficits and functional status as measured by objective criteria. The issue of subjective self-reports of quality
of life and the conquest for objectivity is clearly far from
being resolved. Most likely, both approaches are measuring different constructs. Where does this leave researchers
Obviously, one cannot be sure to what extent these
findings can be extended to other subgroups of patients,
such as those with severe psychotic disorganization or
marked cognitive impairment, who may also be markedly
compromised in insight and judgement. A striking finding
in our study is that the subgroup of patients with a higher
level of symptoms was as reliable in their self-reports as
the subgroup of patients with a lower level of symptoms.
This suggests that severity of illness in itself does not
undermine the ability of patients to report their experiences consistently. Other authors have advanced an opposite point of view. Skantze et al. (1992), in a comparative
study of persons with schizophrenia and a matched control
of college students, concluded that subjective quality of
559
A.G. Awad and L.N.P. Voruganti
Schizophrenia Bulletin, Vol. 26, No. 3, 2000
in the field for future directions? On one hand, one has to
accept the subjective nature of quality of life and the
importance of including patients' self-reports in any measurement of quality of life. On the other hand, how does
one reconcile this with the fact that, at least, a subgroup of
the schizophrenia population suffer from severe psychotic
symptoms and seriously impaired insight and judgment?
To minimize bias in subjective self-reports, our experience
has been that using multidimensional approaches rather
than a global self-report rating can yield more reliable
information. Using a global self-rating approach can be
misleading as it has been observed that psychiatric
patients, in general, tend to report higher scores as most of
the responses tend to gravitate toward the middle. It is
likely that patients tend to project themselves as somewhat
better. Such bias can be minimized by eliciting self-reports
on a number of specific domains and detailed dimensions.
Our data question the reliability of information from single
global self-rating as this information did not significantly
correlate with clinician-rated quality of life (Voruganti et
al. 1998; Awad and Voruganti 1999a, 1999c).
What Are the Significant Determinants
of Quality of Life?
To measure quality of life meaningfully, one has to define
its major determinants as well as the relative contribution
of such factors. Over the years, parallel to the diversity of
definitions that have been introduced for quality of life, a
number of conceptual constructs were proposed. Safety,
employment, financial support, and family and social relations were identified as primary determinants of quality of
life (Lehman et al. 1982; Lehman 1983). Another study
concluded that social relations and finances are the main
determinants of quality of life for chronic psychiatric
patients (Sullivan et al. 1991). Another study identified different dimensions such as the number of readmissions in
the previous year, frequency of family contacts, and satisfaction with social life as the best predictors of quality of
life (Levitt et al. 1990). Most of these conceptual constructs relied to a large extent on exploring patients' living
conditions and identifying objective indicators of quality
of life. Other constructs focused mostly on subjective psychological dimensions such as satisfaction derived through
hedonism, achievement, and conformity but not through
obtaining satisfaction with objective needs were proposed
as the major determinants of quality of life (Corten et al.
1994). These diverse conceptual approaches have lead to
different emphasis on measurement and suggest that the
primary dimension of quality of life in schizophrenia differs markedly depending on theoretical constructs as well
as whether objective or subjective criteria are used.
560
Since our research interests, over the years, have been
to explore the impact of the illness and its treatment on
quality of life in schizophrenia, we realized the need for
an integrative model that can reflect the multidimensional
aspects of the disorder. Of particular interest for us has
been the elucidation of the impact of antipsychotic medications, both positively and negatively, on quality of life
in schizophrenia. In our conceptual and integrative model
of quality of life of schizophrenia patients on medications,
we defined quality of life as the outcome of interaction
between three major determinants: psychotic symptoms
and their severity, medication side effects, and the level of
psychosocial performance (Awad et al. 1997ft). We also
identified other important second order issues, which can
modulate such dynamic interaction and eventually impact
on outcome. Such factors include personality characteristics, premorbid adjustment, values and attitudes toward
health and illness, and resources and the ability to make
use of them. We conceptualized these factors to be integrated in a circular model that emphasizes the multidimensional nature of the concept of quality of life as well
as underscores the interrelatedness of the factors. Since
these factors are affected to a greater or lesser degree by
various interventions, the balance will shift with any
change in the patients' regimen. These factors are not simply baseline conceptual factors for judging quality of life;
they are also factors that can influence therapeutic outcome. Details of our conceptual model have been published elsewhere (Awad 1992, 1995). Although our conceptual model was clinically intuitive in its development,
it allowed us to conduct a series of studies to experimentally test its validity. Based on multiple regression analysis of data from a sample of stable chronic schizophrenia
patients attending a medication clinic, psychotic symptoms and their severity as well as subjective distress
caused by specific side effects of medication—notably,
akathisia and neuroleptic dysphoria—have accounted for
nearly half of the variance in quality of life (Awad et al.
1997ft) (table 1).
These preliminary results can be interpreted as
broadly endorsing the key components of our conceptual
model and confirm its multidimensionality. In this
approach, we have been able to identify the significant
components that contribute to the quality of life profile of
patients on antipsychotic medications as well as their relative contribution. The development of such a model has
also provided us with a framework for measurement of
quality of life in our studies. We are convinced that there
have to be different conceptual models appropriate for the
population studied, as well as the phase of the illness and
the impact of its treatment in a recognized psychosocial
context. The field of quality of life in psychiatry urgently
requires more research attention to basic fundamental
Issues Related to the Assessment of Quality of Life
Schizophrenia Bulletin, Vol. 26, No. 3, 2000
Table 1. Clinical indices and self-rated global quality of life in schizophrenia, based on multiple
regression analysis
Variance
(partial R2)
Ftest
PANSS
DAI
0.24
12.38*
0.11
6.40*
0.01
Side effects
HAS
0.06
4.03*
0.05
Psychosocial functioning multidimensionality
SPS
0.01
0.81
0.37
Psychosocial functioning global
GAF
0.01
0.87
0.35
Predictor variable
Psychopathology
Patients' subjective responses and attitudes
Scale
0.001
Note.—DAI = Drug Attitude Inventory (Hogan et al. 1983; Awad et al. 1995); GAS = Global Assessment Scale (Endicott et al. 1976);
HAS = Hillside Akathisia Scale (Fleishhacker et al. 1989); PANSS = Positive and Negative Syndrome Scale (Kay et al. 1987); SPS =
Social Performance Scale (Wykes et al. 1986).
* Statistically significant.
issues such as the key factors that influence and contribute
to the concept of quality of life. Such understanding of
these issues can make it possible to translate data from
quality of life measurement into meaningful clinical management.
4.
How To Measure Quality of Life
5.
As the concept of quality of life in psychiatry has become
popular, there has been noticeable proliferation in the
development of scales for its measurement, in addition to
the well-established ones. A frequent request for us has
been, over the past few years, to recommend one of these
quality of life scales. As we oblige and try to assist in
these situations, we frequently discover that the researcher
or the clinician is unclear about why he or she needs to
employ a measure of quality of life. Frequently, the decision to include a quality of life measure in clinical trials
appears to be an afterthought. Similarly, we realized that
certain scales were used without having adequate information about their psychometric properties or without
their having been tested and validated for the particular
population or the particular clinical condition under study.
Similarly, many scales are used without understanding the
framework or the theoretical constructs behind them. Our
suggestions for choosing an appropriate quality of life
scale include the following:
6.
The scale has to be adapted to the life of psychotic
patients. Many scales include extensive numbers of
items that frequently tax the already compromised
cognitive ability of many patents with schizophrenia
and contribute to inadequate collection of information. Using two short scales that tap specific areas is
often preferable to using a multipurpose long scale.
The scale has to be consistent with the theoretical
framework that the researcher uses to understand and
define quality of life in the study.
The scale has to be sensitive to pick up relatively
small changes that are expected, even under optimum
conditions of response. Most clinical trials with medications are relatively short term, lasting from 8
weeks to 3-6 months. Under these conditions, the
scale needs to be sensitive enough to pick up small
differences. The ideal scale for pharmacological clinical trials is one that can also capture differences in
pharmacological effects as translated to feelings and
behaviors (Awad et al. 1997c). Certain scales are
more suited to measure quality of life after long-term
interventions, such as in rehabilitation programs, but
are not suited or sensitive enough to be used in shortterm pharmacological clinical trials.
What Role Does Quality of Life Have in
Health Economics and Clinical
Management?
1. The scale has to be appropriate, to the population
under study, the clinical condition, and the phase of
illness. Its psychometrics have to be known and documented.
2. Quality of life is a multidimensional construct, and
this has to be reflected in its measurement.
3. Quality of life is a subjective phenomena, and any
approach to its measurement has to include patients'
self-reports.
Schizophrenia, as a long-term illness without any known
cure, is costly both in terms of direct and indirect costs
(Davies and Drummond 1990). Over the past 50 years, biomedical and technological advances have significantly
reduced to society the risk of life-threatening illnesses, but
this risk has been replaced by the risk of chronic long-term
conditions. With the rising cost of management of such
561
Schizophrenia Bulletin, Vol. 26, No. 3, 2000
A.G. Awad and L.N.P. Voruganti
chronic illnesses, emphasis has shifted from merely prolonging life, to enhancing quality of life. In such a context,
quality of life measurement has become not only a new
paradigm for enhancing the life of chronic patients but also
a tool for comparing programs and various interventions,
and subsequently, for allocating resources. Pharmacoeconomic studies have received major impetus, in recent years,
by the introduction of second generation antipsychotic
medications. New antipsychotic medications are generally
better tolerated, with fewer side effects, yet their acquisition
cost is much higher compared with the old conventional
antipsychotics (Awad and Voruganti 1999a; Voruganti et
al., in press). Although the cost of medications represents
less than 5 percent of the total direct costs of management
of schizophrenia, historically low psychiatric budgets have
become stretched, which has led to increased interest in
demonstrating whether the increased benefits of such new
antipsychotics can justify their high acquisition costs.
Although health economics, and particularly pharmacoeconomics in schizophrenia, is in its early infancy, several
important contributions have already been published
(Rivicki and Luce 1995; Hargreaves and Shumway 1996;
Awad and Voruganti 19996). It is clear that the present state
of the art in methodology requires a good deal of refinement and adaptation to the unique clinical picture of the illness. Generally, quality of life measurements have been
used in two approaches: a direct health profile approach or
as part of cost utility evaluation. The central issue of any
health economic evaluation is to compare the dollar costs
and consequences of different interventions or health care
programs. Although there have been several attempts to
estimate the costs of schizophrenia, the issue still continues
to be, largely, unresolved. It is difficult to analyze costs of
management for schizophrenia because there are many cost
factors and several different perspectives on cost. The
major expense in direct costs generally relate to hospitalizations, but even comparing hospitalizations can be challenging, because of differences in procedures and efficiencies
from one hospital to another. A more recent and innovative
approach is cost utility analysis. This approach is grounded
on well-defined economic and decision theory and elicits
patients' preferences for a particular health state based on
quality of life. The measurement of scores for the utility of
health states is performed using a number of techniques
such as Standard Gamble or Time Trade-Off.' In the
Standard Gamble approach, the individual is offered a
choice between two alternative health states: living in the
present health state with a degree of certainty or taking a
gamble on the proposed treatment choice with uncertain
outcome. In the Time Trade-Off paradigm, the patient is
offered living for several years in perfect health or fewer or
longer years in some alternative health state that is less
desirable. Although the cost utility approach is interesting
562
and has proved useful in a number of other medical conditions, its usefulness in psychiatric illness, particularly schizophrenia, has not yet been adequately demonstrated. In a
recent study, we reported that the cost utility approach in
schizophrenia, although feasible, requires further research
to resolve several methodological difficulties (Awad and
Voruganti 19996). In clinical management, quality of life
measurements can serve a variety of important purposes.
They can serve as a needs assessment, and they can yield
valuable information for the clinician about gaps in management, which can lead to development of corrective measures. As an outcome, quality of life can demonstrate the
effectiveness of the various management approaches, and
conceptually, can change the focus of management from
just symptoms improvement to broader outcomes that
include function, satisfaction, and possibly the return to a
somewhat productive role. It is clear that raising the quality
of life for patients with schizophrenia may at first lead to
higher costs in the provision of psychiatric care related to
the cost of new medications, rehabilitation, social assistance, and support groups. However, one expects that the
higher the level of quality of life obtained by treatment, the
more likely the patient may, again, become a somewhat
productive member of society and not simply a source of
large medical expenditures and a recipient of social assistance. It is our contention that the most cost-effective treatment is the one that brings about the highest quality of life
through rehabilitation, even if it is more expensive in the
short term. Although interest in measurement of quality of
life, both in research and clinical management, has phenomenally increased over the past few years, unfortunately
there is no indication that such enhanced interest in measurement has been integrated in clinical management or
translated into better outcomes. A significant recent contribution has been the recommendations from the
Schizophrenia Patient Outcomes Research Team, which
provided an approach on how to translate research into
practice (Lehman et al. 1998).
Concluding Remarks
The concept of quality of life has emerged over the past two
decades as a popular concept in health sciences. It has been
used increasingly as an outcome of treatment in clinical management, as an outcome variable in clinical trials, as well as a
basis for various pharmacoeconomic evaluations of new
antipsychotic medications. However, such recent enhanced
interests in quality of life measurement have not been
equally matched by more research interests in exploring a
number of basic issues related to the concept itself, such as
its boundaries and determinants as well as its meaningful
application in clinical management and health economics.
Unless several methodological issues are adequately
Schizophrenia Bulletin, Vol. 26, No. 3, 2000
Issues Related to the Assessment of Quality of Life
resolved, interest in the quality of life concept may fade
away. If that is allowed to happen, it would constitute a
missed opportunity since the concept of quality of life has
provided a common language that seems to be relevant and
easily understood by clinicians, patients and their families,
health economists, health administrators, and policy makers.
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A. George Awad, M.B., B.Ch., Ph.D., is Professor Emeritis,
Department of Psychiatry, University of Toronto, Toronto,
Canada, and Chief of Psychiatry/Physician Director, Mental
Health Program, Humber River Regional Hospital, Toronto.
Lakshmi N.P. Voruganti, M.D., M . S c , is Assistant
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