.I Chron Dis Vol. 34, pp. 585 to 597. 1981 0021.9681:8,:,20585-13SO2.

00~0
Prmfed in Great Britam Pergamonpress I.uI

MEASURING THE QUALITY OF LIFE

OF CANCER PATIENTS

A CONCISE QL-INDEX FOR USE BY PHYSICIANS

WALTER 0. SPITZER, ANNETTE J. DOBSON, JANE HALL, ESTHER CHESTERMAN,

JOHN LEVI, RICHARD SHEPHERD,RENALDO N. BATTISTA and BARRY R. CATCHL~VE
From the Royal North Shore Hospital of Sydney, The Commonwealth Institute of Health
of Australia at Sydney University, The University of Newcastle and the McGill Cancer Centre.
Montreal, Canada

(Recri~rd 1 Nocemher. 1980)

Abstract- To complement the hard variables generally used in the assessment of different treat-
ments for cancer and other chronic diseases we developed a hardened. succinct quantitative
index to measure the quality of life (QL-Index) of survivors. It was designed for use by physicians.
It has five items and its range of scores is O-10. It was used in pretests and validation tests by
more than 150 physicians to rate 879 patients; median completion time was one minute. Fifty-
nine percent of physicians reported that they were at least very confident of the accuracy of their
scores. We established predetermined criteria for validity before field work commenced and
evaluated the index using convergent and discriminant approaches of construct validity, as well
as content validity. The QL-Index has convergent discriminant and content validity among
cancer patients and patients with other chronic physical diseases. Assessment of internal consist-
ency demonstrated a high coefficient (Cronbachs tl = 0.775) and the interrater Spearman rank
correlation was high and statistically significant (rho = 0.81, P < 0.001) when independent scores
of two physicians were compared, or doctors ratings were compared to self-ratings of patients
(rho = 0.61, P < 0.001) Our aim has been to provide a new measure that can help physicians
assess the relative benefits and risks of various treatments for serious illness and of supportive
programs such as palliative care or hospice service. The QL-Index is not, however. suitable for
measuring or classifying the quality of life of ostensibly healthy people.

Key words: quality of life, measurement, cancer, chronic disease. validation

INTRODUCTION
THE EFFECTIVENESS
of cancer treatment on individual patients in relation to a defined
population is generally measured using objective or hard
such as mortality, criteria
recurrence of disease, or clinical and paraclinical indication of spread of disease. Useful
though such criteria are, excessive concern for their precise measurement may lead to
neglect of pertinent but softer subjective data. Measures like mortality and morbidity
may be insensitive to important differences in the estimations of the effectiveness of
treatments. In a review of 16 studies assessing end results of surgery for cancer McPeek
ef af. [1] commented that almost all reported only the rates of recurrence and survival
among the patients. Most of the studies did not demonstrate striking differences in the
effectiveness of the various treatments as assessed by such hard variables. It would have
been fruitful to report reliably on contrasts in the effects of treatments on the quality of
life, or on the dying process experienced by the patients. They pointed out that evalu-
ation with such variables would be particularly relevant because of the difference in
impact on patients of such varied therapies as castration, irradiation, chemotherapy,
surgery or symptomatic treatment.
Supported by grants from the Commonwealth Department of Health of Australia. Canberra, and the M&III
Cancer Centre. Senior Investigator supported in part by the W. K. Kellogg Foundation and by Health and
Welfare Canada. Reprint requests to Dr W. 0. Spitzer, 1650 Cedar Ave. Montrtal. Canada H3G lA4.
586 WALTER 0. SPITZER et al.

Measures of sociopersonal or quality of life variables should include physical, social

and emotional function, attitudes to illness, personal features or patients daily lives,
including family interactions, and the cost of illness [2]. In research projects involving
patients it is important that such data-gathering instruments be accepted and used by
physicians or clinical investigators responsible for the care of those patients. We report
here the development of a new instrument which we call the Quality of Life Index
(QL-Index). It is concise, quantitative and easily used; it has been designed primarily for
use by physicians; it was based on advice from various sections of the community rather
than on our preconceived notions. We also report our methods and results to assess the
validity and reliability of the QL-Index.

EXISTING INDEXES AND THEIR LIMITATIONS

FOR USE BY PHYSICIANS

Indexes somewhat similar to the QL-Index exist but they are either based on very
general definitions of health that equate health with quality of life or they focus narrowly
on some form of physical illness. Defining health operationally is difficult, given its
multidimensional nature.
Several workers have attempted to assess the quality of life of chronically ill patients.
In 1948, Karnovsky [3] published an index designed for use in cancer research based on
an interpretation of quality of life in terms of physical ability. This index has been used
primarily to assess therapy for patients with inoperable cancer. Grogono and Woodgate
[4] developed a scale with 10 items focussing mainly on physical function. Izsak and
Medalies Ability Index [S] integrates 21 items covering physical, emotional, social and
economic factors to produce a single score. It is modified for each type of cancer. Several
other workers have endeavoured to measure lifes quality using only one or a few aspects
considered most relevant to the condition of primary interest to the investigator. Hoch-
berg [6] determined physical function of patients with glioblastoma. Worden and Weis-
man [7] assessed postmastectomy depression and loss of self-esteem using several instru-
ments restricted to emotional factors. Westaby [8] focussed on symptoms, drug use and
work capability in patients treated surgically for coronary artery disease. Priestman and
Baum [9] measured subjective effects of treatment for advanced cancer of the breast by
summing 10 single-dimensional scales, McNeil [lo] studied the risks patients would take
rather than tolerate morbidity in an increased life span. Anthony [ll] compared two
treatment programs for bronchial cancer using physical activity and pain as indicators.
In contrast to some of the preceding measuring instruments, the Katz ADL Index (Ac-
tivities of Daily Living) [12] is probably the best example of a scale created for a variety
of diagnoses. It measures the basic sociobiological functions of bathing, dressing, tiolet-
ing, transfer, continence and feeding. The Health Index from McMaster University [13]
measures social, emotional and physical function of persons with a wide range of health
problems.)
Several indexes deal with social function or conformity with expected social norms.
Kaplan [14] created a health index with two components: level of well-being and prog-
nosis, the latter being the probability of attaining a level of well-being by a certain time.
Patrick [lS] measured the perceived social values of defined functional levels of health.
The sickness Impact Profile (SIP) [16], based on the concept of health-related dysfunc-
tion, is an outcome measure derived from quantitative estimates of changes in the behav-
ior of respondents. It has 312 items in 14 categories. The self-administered questionnaire
of the Alameda County Human Population Laboratory [17-183 yields three separate
scores for physical, mental and social health. It has been used successfuly in representa-
tive samples of general populations.
The examples cited show that existing instruments for assessing global health or the
quality of life:
(a) are usually lengthy;
 Quality of Life of Cancer Patients 587

(b) require specially-trained research personnel to administrater, code and store the
information;
(c) were generally developed by experts on the basis of their own views of the appro-
priate dimensions to be included;
(d) are frequently oriented to physical function with insufficient attention to social and
emotional aspects of quality of life;
(e) have often been applied in only one disease or one health problem;
(f) have limited use outside the original research setting because physicians find them
too long or complicated for routine, periodic assessment of patients; and
(g) have not always been validated, this is especially true for the shorter ones.
Having reviewed the current state of relevant methods, we concluded that for practical
clinical and investigative purposes, the type of quality of life index that we would develop
should include these 10 attributes:
(1) It should be simple, which means it should be short, easy to understand, to
remember, to administer and to record.
(2) It should be comprehensive, covering an adequate range of the different dimen-
sions of quality of life.
(3) Its content should be compatible with views of the community and the dimensions
should be identified empirically from patients, healthy people, physicians, and
other health providers.
(4) It should be quantitative.
(5) It should be applicable in many situations with as few restrictions as possible
related to factors such as age, sex, occupation and category of chronic disease.
(6) It should be formally validated before being recommended for wide or general
use.
(7) It must be acceptable to those measuring (particularly clinicians) and to those
measured.
(8) It should be sensitive to changes in the health status of persons measured.
(9) It should discriminate well among groups of people with demonstrably different
levels of quality of life.
(10) The new index should be plausible; the resulting scores should be consistent with
other measures of health status, clinical status or life stage. In developing our new
measure we used the Apgar Scale [20] as a model and decided to create an index
that would give ordinal scores.
DEVELOPMENT OF THE QL-INDEX
Content validity
Phase l-Identijkation of the content and development of two draft QL-Indexes. Our first
task was to design the proposed index in a way that would make demonstrable validity
readily demonstrable. Our first step was to identify the overall domain encompassing the
attribute or construct of interest, quality of life. To ensure that the content of the index
reflected community opinion, we formed three closely similar advisory panels with 43
matched triplets of people from the Sydney metropolitain area in Australia. Each panel
of 43 people created by random assignment within triplets consisted of 4 cancer
patients, 4 relatives of cancer patients, 4 with other chronic diseases, 4 relatives of such
people, 4 healthy people 20-59 yr of age, 4 healthy people over 60,4 physicians, 4 nurses,
4 social workers, 3 other health professionals, and 4 clergy. One panel received a loosely
structured open-ended questionnaire designed to elicit spontaneous opinions about
factors that could enhance or decrease the quality of life. The second panel received a
more structured questionnaire seeking views on many specific aspects of quality of life.
The third panel assessed the results from the first two, to confirm or reject the prelimi-
nary conclusions and to give us a further indication of the relative importance of the
main factors. The factors that emerged as most important, in the opinion of the three
panels, were incorporated into two developmental drafts of the QL-Index.
588 WALTER 0. SPITZER et al.

One draft, the D-QL(A) index had the following seven items: PRESENCE OF SYMP-
TOMS, PHYSICAL INDEPENDENCE, FINANCIAL INDEPENDENCE, COM-
MUNICATION WITH OTHERS, OUTLOOK ON LIFE, INVOLVEMENT IN
OCCUPATION, and PARTICIPATION IN LEISURE ACTIVITIES. For each item we
formulated three optional statements to be scored 0, 1 and 2 respectively. In deriving a
composite score, we used an equal weighting scheme, since we had no evidence that any
of the items deserved more weight than others.
The second draft index, D-QL(B) was based on seven items that were frequently
nominated by the advisory panels and that either gave a different perspective on items in
D-QL(A) or were important factors not included in D-QL(A). D-QL(B) contained the
following items: ACTIVITIES OF DAILY LIVING, WORK PERFORMED (paid, run-
ning a household or voluntary), PAIN AND DISCOMPORT, PERCEPTION OF
OWN PHYSICAL HEALTH, MENTAL ALERTNESS, MOOD, SUPPORT OF
FAMILY AND FRIENDS. Each item in D-QL(B) had four optional statements scored
0, 1, 2 or 3 respectively, giving a composite score in the range &21.
We created a linear analogue scale that we refer to as UNISCALE (Fig. 1). It simply
required raters to make a mark on an open bar. We then derived scores from it in an
ordinal scale compatible with the drafts A and B of the QL-Index. UNISCALE was
coded on a scale between O-14 by measuring the distance of the mark from the left end of
the bar. The purpose of this unidimensional measure was to permit a completely different
way of measuring the same global attribute. Thus we had a check on the performance of
the other two drafts.
Phase 2-Pretesting of the draft indexes and development of the QL-index. D-QL(A) and
D-QL(B) questionnaires and UNISCALE were tested on 339 subjects aged 20-70yr
(mean age 51.7 f 13.9) from clinics in major Sydney teaching hospitals, general practices
in the cities of Sydney and Newcastle, and a terminal care hospice. The subjects com-
prised 217 cancer patients, 71 patients with other chronic diseases, 30 individuals aged
20-50 who were healthy or with self-limiting minor illness, and 21 healthy people aged
51-70. Each subject was assessed by a rater using two of the instruments, generally
D-QL(A) and either D-QL(B) or UNISCALE. When UNISCALE was used it was ad-
ministered before D-QL(A) or D-QL(B). The raters for the pretest included 8 general
practitioners, 7 oncologists, 9 internists, 6 nurses and 5 social workers. The time needed
to complete the draft QL-Indexes was recorded.
UNISCALE, the simplest of the three instruments, was used for 216 subjects; the
median score was 8 (mean = 7.2 + 4.3). D-QL(A) which also allowed scores in the range
O-14 was used for 322 subjects giving a median score of 10 (mean = 9.3 + 3.6). D-QL(B)
with scores in the range O-21 was used for 105 subjects whose median score was 14
(mean 14.8 + 4.0). When subjects were assessed by both UNISCALE and D-QL(A) the
scores were highly correlated (Spearmans rank correlation rho = 0.87 for n = 205)
although UNISCALE scores were usually about 2 units below DQL(A) scores. For 101
subjects assessed by D-QL(A) and D-QL(B) the two sets of scores were also strongly
correlated (rho = 0.86).
Correlations between individual items and combinations of items from both D-QL(A)
and D-QL(B) provided a clearer picture of the dimensions of the quality of life. FINAN-
CIAL INDEPENDENCE (in D-QL(A)) and MENTAL ALERTNESS in D-QL(B)) were
very insensitive and were discarded. The remaining items appeared to be grouped into
clinically and socially meaningful clusters characterized by high intra-group correlations
and lower inter-group correlations. For example INVOLVEMENT IN OCCUPATION
and PARTICIPATION IN LEISURE ACTIVITIES from D-QL(A) are closely related
to each other (rho = 0.80, n = 205) and to WORK PERFORMED from D-QL(B)
(rho = 0.73, and rho = 0.71 respectively with n = 91). This suggested that these three
items describe aspects of a single dimension of quality of life. Similarly, PHYSICAL
INDEPENDENCE from D-QL(A) and ACTIVITIES OF DAILY LIVING from
D-QL(B) correlated well (rho = 0.51, n = 91) indicating a second dimension of quality
of life. Items PERCEPTION OF OWN PHYSICAL HEALTH and PAIN AND DIS-
 Sndv No. .__._./ ~~ _~____
QUALITY OF LIFE UNISCALE
Prdamtan/oCCupdim . .. . .._.................._..... 000
RATING WEST

0
E
8
-I

Fig. 1. The actual material used by the raters in concurrent validation.

590 WALTER0. SPITZERet al.

COMFORT FROM D-QL(B) and PRESENCE OF SYMPTOMS from D-QL(A) were

also highly correlated (all correlation coefficients greater than 0.55 for n = 91). Likewise
MOOD and OUTLOOK ON LIFE seemed to describe a single dimension (rho = 0.70,
n = 91) and SUPPORT OF FAMILY AND FRIENDS and COMMUNICATION
WITH OTHERS (rho = 0.72, it = 91) yet another.
To create the definitive QL-Index we chose one item within each of five plausibly
distinct item groupings or dimensions that emerged from the analysis. In selecting items
we took into account simplicity and our field experience. Thus, although LEISURE
ACTIVITIES was a statistically sound choice, it caused considerable scoring difficulties
for many raters. After assessing comments by all raters about each item in the draft
indexes and analyzing the distributions of scores of each item, we included the following
items (with abbreviated designations) in the definitive QL-Index:
(1) ACTJVITY+INVOLVEMENT IN OWN OCCUPATION, from D-QL(A) but
with a more general title);
(2) DAILY LIVING--(ACTIVITIES OF DAILY LIVING from D-QL(B), but on a
reduced scale);
(3) HEALTH-(PERCEPTION OF OWN HEALTH, from D-QL(B), on a reduced
scale);
(4) SUPPORT-(SUPPORT OF FAMILY AND FRIENDS, from D-QL(B), on a
reduced scale);
(5) OUTLOOK ON LIFE, from D-QL(B)).
The five items were all acceptable to the raters. They encompassed physical, social and
emotional aspects of life. Each item exhibited distributions reflecting sensitivity to vari-
ations in the attributes measured. The correlation matrix of the items in the QL-Index
are displayed in Table 1. Correlations near zero would have been implausible considering
the overlap of concepts and perceptions contributing to all items; correlations near one
would have suggested that such items were measuring the same attribute.
Since D-QL(B), in which items were scored on a O-3 scale, had taken more time for
raters to use (median 3 min) but had given similar results to D-QL(A) (median time
1 min), we decided to adopt the O-2 scale of D-QL(A) for all items on the QL-Index. We
have no evidence that any of the items are more important than the others. Accordingly,
we consider equal weighting of the items to be justifiable at present and added the item
scores to give a total score in the range of c-10. The format of the definitive QL-Index is
given in Fig. 2.
From the pool of remaining acceptable items pretested we used ten to create MUL-
TISCALE, a longer questionnaire to measure quality of life. Each item had four options
and was scored O-3 so that its cumulated score was in the range O-30.
Phase _&_eriJicution of content ualidity. In this third phase of content validation, the
definitive version of the QL-Index as well as MULTISCALE and UNISCALE were
assessed by two independent panels with a view to a verification of the content we had
adopted. (The verification was carried out after we had preliminary evidence of content
validity.) The first panel was composed of 34 lay persons including healthy people,
patients with cancer and other chronic diseases and patients relatives. The second panel,
an expert panel, included 34 health professionals and methodologists. We questioned
respondents from one half of each panel about the QL-Index first and then about

TABLE 1. PRETESTCORRELATIONSBETWEENITEMSUSED IN QL INDEX

Activity Daily living Health support

Activity
Daily living 0.71
Health 0.45 0.40
Support 0.28 0.21 0.24
Outlook 0.38 0.34 0.51 0.57

Spearman rank correlation coefficients for n = 91 subjects.

 Study No p/
QUALITY OF LIFE INDEX
A9e __________ -_ 00
Sex M, F2 IRmg appropriate letter) __ __~__._~~ Cl
Primaty Problem or Diignos~s __-_
SCORING FORM -____ __~~~_ .- DOD
Secondary Problem or Dregnosis. or compbcadon iti appropnatel 000
Scorers Specialty ___ -___. ._ _ 000

ACTIVITY During the last week, the padent

. has been workmg in unpaid
... o( studving full-time. or nearly so, I usual occupation: or managr19 own household; or partq~tmg
or vduntsrv acuvmes. whether rewed or not ........................................................... ................ 2
has been working or studying in usual occupalion or managing own household or panicipetmg an unpaid or voluntary ectwit#es: but
requirmg major aswtance of e significanl reduction in hours worked or a sheltered situation or was on sick leave ............ 1
. hasnotbeenworkingorrfudyinginanycapacihlandnotmaMgingownhourehold ................. ...... ............... ::.:O
DAILY LIVING Ourinn the test wwk. the patkmt
. has been selfveliinf in eating. washing, toifetting and dressing; using public transport or driving own car ............................ 2
. has been requiring asristence lenother pereon or special equipment) for daily activities and fransport but performing lhghttests. 1
has not been managing pmsonal care nor fight tests end/of not leaving own home or insfitution ef all. ............................... 0
HEALTH Owing the last week. the patient
has been appearing to feef well or reporting feeling great most of the *mm .................................................... .
has been lacking energy or not feefing entirely up 1o par more lhan just ...........................................
occattonally 1
has been feeling very ill or ..lousy ... seeming weak and washed out most of the time or was unconscious. ............. ........... 0
SUPPORT Owing the last wash
the patie? has been having good relationships with ofhers and receiving strong support from et Ieeet one family member
and/o,fr*nd ................................................................................................. 2
. suppot~ recewed or perceived has been limited from family and friends and/w by the pelients .........
condmon .............. 1 0
. supwn from family end friends occurred infrequently or only when absolutely neceesary or petaenl was unconscious ................ 0
OUTLOOK Ouring th8 pest wmh the patient
has uyalb been appearing cairn and positwe in wdook, accepting and in control of personal c~rcumslences.
includ~ngsurramdmgs...............................................~............ .,.....,,............ 2
her urmetfmes hen mu&d because not fully m contrd of personal c#rcum%tencesor has been hawng permds of obvious anxier/
ordepressmn...................................... .,....,._..............,......... ,..,...... 1 0
has been seriously confused or very frightened or consislendy anxious and depressed or unconscious ,. 0

QL INDEX TOTAL 00
___--- _ __~~
How confident are you that your scoring of the preceding dimensions is accurate? Please ring the approprlafe Category. cl
Absolutely Confident Duite Crfident No, Very Confident Not at all Conf,dem
4 6
1

Fig. 2. The format of the final version adopted.

592 WALTER 0. SPITZER et al.

MULTISCALE and UNISCALE. The remaining respondents in each panel were asked
about MULTISCALE first and then about the QL-Index and UNISCALE. None of the
68 respondents in either panel had previously been involved in the project,
For the QL-Index and the MULTISCALE, the a priori criterion for establishing
content validity was that a majority of each panel (51%) should respond affirmatively to
all of five questions about each scale: Is the group of items appropriate? Are there
sufficient items? Is each item important? Would it discriminate among individuals?
Among groups? Failure to answer any one question in the affirmative was regarded as a
negative response by that person.
The QL-Index and MULTISCALE met the criterion we had set for content validity.
Indeed, when submitted to the lay panel, 13 out of 18 subjects gave affirmative responses
to all questions about the QL-Index and 10 of 16 did so for MULTISCALE. When
submitted to the expert panel 11 out of 16 subjects gave affirmative answers to all
questions for the QL-Index and 12 out of 18 subjects responded positively about
MULTISCALE. The more comprehensive MULTISCALE with 10 items and 4 choices
per item, was preferred by a majority of both panels. This was so whether the respon-
dents were questioned first about the QL-Index and then MULTISCALE or vice versa.
The simplest rating scale, UNISCALE was least preferred, but rather surprisingly, 16 of
the 34 experts considered it an appropriate method of assessing quality of life. Only 11 of
the 34 in the panel of lay persons assessed UNISCALE favourably.

Construct validity
For validation of the QL-Index we then had a very simple unidimensional scale and a
comprehensive multidimensional questionnaire that permitted independent simultaneous
tests on all subjects. We also created and pretested self-administered versions of the
QL-Index and UNISCALE.
1. Comergent approach. The protocol of the study specified the extent of convergent
agreement we required to conclude that validity was demonstrated. For the interrater
comparisons, before field work began, we specified that a weighted kappa of 0.3 would be
our minimum criterion. Thus, in addition to Spearman rank correlation coefficients in
the convergent approach we calculated weighted kappa. For the evaluation approach,
five instruments were used: The QL-Index (Fig. 2), UNISCALE (Fig. l), a self-adminis-
tered form of the QL-Index (SAQL), a self-administered version of UNISCALE
(SAUNI), and MULTISCALE. Participants in the validation exercise were drawn from
most socioeconomic groups residing in the Sydney metropolitan area (population
approximately 3,500,000), the Hunter Valley (population approximately 400,000 includ-
ing the industrial city of Newcastle with a population of 250,000) situated 140 km from
Sydney and many smaller towns and rural farming areas. Five panels of subjects aged
2&70yr were assembled. Two panels consisted of Healthy Subjects from Sydney and
the Hunter Valley. Healthy Subjects were defined as persons visiting general practi-
tioners for minor or self-limiting illnesses and women with uncomplicated pregnancy.
The third panel was composed of people with chronic diseases (irreversible or disabling
disease such as rheumatoid arthritis, advanced diabetes, spinal injury or chronic obstruc-
tive lung disease). The fourth panel included patients with the more common cancers.
Moreover, within each cancer, early, stable, rapidly evolving and advanced stages of
cancer were included. Seriously ill patients made up the fifth panel which was used to
assess the performance of the QL-Index for patients in critical and even terminal phases
of illness. In summary, the panels were:

1. Sydney healthy people a4

2. Hunter Valley healthy people 101
3. Chronically diseased patients 108
4. Cancer patients 105
5. Seriously ill patients 78
Total 476
 Quality of Life of Cancer Patients 593

Each subject was rated on the QL-Index by an attending physician who knew the
subject well, had seen the subject within the last seven days and felt able to assess the
subjects current level of quality of life. More than 70 physicians used the QL-Index at
this stage. Subjects (except those in panel 5) rated themselves first using UNISCALE and
then self-administered QL. Subjects were also assessed independently by up to 4 other
raters using UNISCALE first and then MULTISCALE. Two of these 4 raters were
health professionals, usually another doctor plus a nurse or a social worker, an occupa-
tional therapist, a physiotherapist or a pharmacist. The other two independent raters
were lay people, typically one relative and one unrelated friend. All raters had to know
the subject well and must have seen the subject during the preceding 7 days. Up to 11
ratings were done for each subject; the array of data for each subject was as follows:

1. QL-Index by attending physician

2. Self-Administered by subject unless seriously ill
UNISCALE (SAUNI)
3. Self-Administered by subject unless seriously ill
QL-Index (SAQL)
4. UNISCALE by another physician or an allied
health professional
5. UNISCALE by a health professional
6. UNISCALE by a close relative or friend
7. UNISCALE by a second lay person
8. MULTISCALE by a physician or other health
professional
9. MULTISCALE by a health professional
10. MULTISCALE by a close friend or relative
11. MULTISCALE by a second lay person

Methods had to be modified slightly for the panel of seriously ill subjects because of
the poor condition of the patients. The self-administered instruments (SAQL and
SAUNI) were excluded and only two independent professional raters were used in ad-
dition to the physicians using the QL-Index.
Rank correlations were computed between QL-Index scores and scores obtained by
the simultaneous and independent use of MULTISCALE and UNISCALE in all five
panels. They are reported in Table 2. The agreements are strong, consistent and statisti-
cally significant at the 0.005 or 0.001 levels but only for the panels 3, 4 and 5 of

TABLE2. CORRELATIONS
BETWEEN
QL-INDEXANDOTHERMEASURES

Panel number 1 2 3 4 5

Healthy Healthy Chronically Cancer Seriously

Panel name Sydney Hunter diseased patients ill

SAQL 0.4S 0.25 0.57** 0.63**

UNISCALE Hi 0.39** 0.28* 0.48** 0.61** 0.34*t
HZ 0.17 0.34** 0.51** 0.46** 0.49**t
RI 0.24 0.13 0.44** 0.49**
R2 0.24 0.31* 0.42** 0.54**
SAUNI 0.23 0.14 0.43** 0.46**
MULTISCALE Hl 0.29 0.42** 0.54** 0.71** 0.38*
H2 0.49** 0.34** 0.55** 0.61** 0.53**
Rl 0.30 0.31* 0.60** 0.72**
R2 0.33* 0.36** 0.58** 0.61**
Sminimum number of subjects 72 91 93 68 63

*Significant at less than 0.005 level.

**Significant at less than 0.001 level.
tSample size n = 77.
$Not all measures were available on all subjects
594 WALTER0. SPITZERet al.

TABLE3. SUMMARY
STATISTICS FOR CONCURRENT
VALIDATION

1 2 3 4 5

Frequencies of QL Healthy Healthy Chronically Cancer Seriously

scores Sydney Hunter diseased patients ill

0 1 1
1 7
2 1 1 16
3 2 3 7 20
4 8 14 19
5 14 7 9
6 4 4 13 9 4
7 6 7 10 11 2
8 14 15 21 24
9 17 17 19 8
10 40 58 19 24
Number of subjects n 84 101 108 105 78
Mean QL score 8.80 9.17 7.31 7.11 3.31
Standard deviation 1.67 1.16 2.10 2.39 1.48

chronically diseased patients, of cancer patients and of seriously ill patients. For the two
panels of healthy people the relationships are poor and erratic. Thus we can say that
convergent validity of the QL-Index was evident when it was used for definitely diseased
subjects. The correlations were higher for cancer patients than for patients with other
chronic diseases.
2. Discriminant approach. The distribution of QL-Index scores assigned by physicians
to each subject are given in Table 3. There is a gradient of diminishing mean QL scores
as one progresses from the panels 1 and 2 of healthy subjects to those with definite
disease (panels 3 and 4) and then to the seriously ill in panel 5. The close clustering of
high scores among healthy subjects, the spread of score in those definitely ill and the
clustering of low scores in the seriously ill make clinical sense and common sense,
buttressing evidence of discriminant construct validity.

RELIABILITY
We evaluated the reliability of the QL-Index with two approaches: internal
consistency and interrater agreements.

Internal consistency
Determination of internal consistency was done by calculating Cronbachs standard-
ized item alpha [21] also known as the general form of the Spearman-Brown prophecy
formula [22]. Cronbachs c( tests whether the items in a questionnaire have a homo-
geneous content with respect to the construct of interest. If the internal consistency
coefficient were close to zero, it can be concluded that the items bear only a chance
relationship to one another and that not more than one of the items actually measures
the general attribute of interest. If CIwere equal to 1, very high homogeneity could be
deduced but few of the items would be likely to add a distinctive dimension to the global
measure. From the correlation matrix of Table 1, we calculated Cronbachs CI= 0.775
which is a clearly adequate reliability coefficient for a five-item instrument.

Interrater agreements
1. Comparison of two physicians. In one Canadian panel, two physicians assessed
patients independently, within 7 days, using the QL-Index. For 64 patients the interrater
correlation coefficient was 0.81 (P < 0.001, Spearman rank correlations). When the
English version of the QL-Index was used the correlation coefficient was 0.84, P < 0.001;
the French version used by French-speaking doctors with 24 francophone patients was
0.74, P < 0.005.
 Quality of Life of Cancer Patients 595

2. Comparison of physicians and patients. From data elicited in Australian and Cana-
dian panels of patients we were able to compare the QL scores of attending physicians
with those the patients assigned themselves using a self-administered format of the index.
For 161 Australian patients, Spearmans rho = 0.61 (P < 0.001). For 51 Canadian
patients rho = 0.69 (P < 0.001). The correlations were high. Interestingly, we observed a
systematic trend of patients rating themselves one or two points higher (out of ten) than
the rates given by their doctors.

RESULTS IN RELATION TO A PRIORI CRITERIA

Calculation of weighted kappas for the panels used in the validation process revealed
that the level of 0.3 had been exceeded in panels 3, 4 and 5 which included only patients
with definite disease. The content validity panels gave appreciably higher verdicts than
the 519i criterion. The two requirements for validity we had stipulated in advance were
met.

DISCUSSION

The QL-Index we have developed in this calibrational project to serve as a global

measure of quality of life is valid for patients with definite physical disease. The reliability
of the instrument in the hands of physicians has been demonstrated for different types
and stages of chronic diseases most particularly cancer. Our experience during pretesting
and validation with 879 Australian and Canadian subjects suggests that it will be
accepted and used by physicians conducting or collaborating in clinical or epidemiologic
research. The ready acceptance of the QL-Index by more than 150 clinicians in both
countries may be partly explained by the median completion time of 1 min; physicians
who had used it on ten or more patients could measure accurately and consistently with
it in less than 1 min. Moreover, more than 59% of doctors participating in the validation
reported that they were absolutely confident or very confident of their scores. A further
36% were quite confident.
When we obtained clusters of four independent ratings of one subject by physicians or
health professionals and lay persons, the agreement among all observers was generally
high but only for definitely diseased patients. High correlations occurred regardless of the
pairings of professional and non-professional raters, of the type of instrument used and of
rural or urban settings. The comparable consensus among doctors, other professionals
and lay people will help us and other workers to plan simpler methods of convergent
validation for similar instruments in the future.
The QL-Index discriminates between healthy subjects and diseased patients. It also
discriminates between persons with early or moderate presentations of their disease and
patients who are seriously ill. The gradient of means and the distributions of scores of the
various panels displayed in Table 3 suggests that the new measure can distinguish groups
of people with excellent quality of life from groups who can be expected to have pro-
gressive limitations. The QL-Index may well achieve the objective of helping physicians
to assess relative benefits and risks of various treatments in diseased subjects.
The evidence on reliability from three sources is particularly reassuring. They contrib-
ute favourably to a performance profile of the QL-Index which is consistent with a
verdict of accuracy and precision. We do not pretend, however, that the QL-Index is as
accurate or as discriminating as it might have been with many more dimensions or finer
scales. But we have provided evidence that it correlates highly with independent ratings
derived from MULTISCALE, a more comprehensive questionnaire with higher content
validity. The QL-Index also correlates very well with self-assessments of subjects,
although patients give themselves somewhat higher scores than do their doctors, their
relatives, their friends and other health professionals. This succinct quantitative scale can
now be used to measure the quality of life among people treated for cancer and patients
with other serious chronic disease. We believe it can be used in clinical controlled trials
and possibly in follow-up for clinical practice. It is expected to be particularly useful in
trials of effectiveness of palliative care or hospice services. The QL-Index is not a satisfac-
596 WALTER 0. SPITZER et al.

tory tool to measure or classify the quality of life of ostensibly healthy people in unse-
lected general populations. It does not discriminate adequately among well people. It
would seem that there are no shortcuts to the long, comprehensive questionnaires such
as the SIP and the Alameda County instruments to assess the physical, social and
emotional functions of people living freely in the community.
Few subjects had very low scores (0, 1, 2, 3). We wished to demonstrate the capability
of arriving at very low scores with the new index. Our difficulty in finding patients with
very low scores was due in part to the design of the study; patients with relatives, friends
and professionals willing to help in a validation study of an instrument of this kind
seemed destined to score higher on the QL-Index. Another field problem that became
apparent after several hundred measurements had been made was the wording of the
instructions to physician raters and the statements in some dimensions which cause a
tendency to score higher. Minor changes to correct the bias have now been made and
have been incorporated in Fig. 2. However, infrequent low scores might also have
occurred because of properties of the measurers or of those measured. We cannot dis-
count the possibility that the QL-Index has unrecognized defects which make it some-
what insensitive at the extremes of possible scores. On the other hand, we may be
underestimating the ability of the human mind and spirit to compensate for major
infirmity. Finally, since this calibrational research was done largely in Australia, scores
slightly higher than expected, especially on self-assessment, could reflect a cultural trait
which often causes the Australian in adversity not to complain but say calmly Shell be
right, mate. As good methodological practice dictates, the study has been replicated in
the two main cultures of Canada. Further work on construct validity and assessment of
reliability of the QL-Index continues, The process of validation of any measuring tool,
for research or for clinical practice, seldom ends.

Acknowlrdgements~The authors acknowledge the contribution of our research assistants, Mrs Glen Rose, Mrs
Margaret Breden and Mr Daniel Vezina whose diligence and attention to detail permitted completion of all the
field work, including several thousand measurements in standard conditions, in record time.

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