Rheumatology 2005;44:1267–1276 doi:10.

1093/rheumatology/keh605
Advance Access publication 29 March 2005

Development and preliminary validation of a systemic

lupus erythematosus-specific quality-of-life instrument
(SLEQOL)
K. P. Leong, K. O. Kong, B. Y. H. Thong, E. T. Koh, T. Y. Lian,
C. L. Teh, Y. K. Cheng, H. H. Chng, H. Badsha, W. G. Law, T. C. Lau,
L. C. Chew, H. J. Ho, L. Y. Pong, L. S. Hoi, N. Sangeetha, S. P. Chan1
and H. S. Howe

Objectives. Systemic lupus erythematosus (SLE), a chronic illness with an unpredictable and variable course, profoundly
affects the quality of life (QOL). General health questionnaires are used to assess QOL in SLE, but a disease-specific
instrument could offer enhanced responsiveness and content validity. We detail the steps we took to develop and validate a new

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SLE-specific QOL instrument, SLEQOL.
Methods. Rheumatology professionals nominated items that they felt were important determinants of QOL of SLE patients.
One hundred SLE patients were asked to assess the importance and frequency of occurrence of these items and to suggest
those that had not been listed. Item reduction was performed using Rasch model and factor analyses to create a new
questionnaire in English. This final questionnaire was administered to a cohort of 275 patients to study its psychometric
properties.
Results. Fifty-one items covering a wide range of QOL concerns were identified. The patients’ responses led to the elimination
of 11. The new questionnaire of 40 items was found to have Cronbach’s alpha of 0.95 and to consist of eight domains covering
physical, mental and social QOL issues. It has good test–retest reliability, poor to fair cross-sectional correlation with the
SF-36, with poor correlation with lupus activity or damage indices. The SLEQOL was more responsive to change than
the SF-36.
Conclusions. We have developed a new 40-item SLEQOL in English and showed that it is valid for use in SLE patients
in Singapore. It offers better content validity and responsiveness to change than the SF-36.
KEY WORDS: Quality of life, Systemic lupus erythematosus, Helplessness, Activity index, Rasch model analysis, Factor analysis.

Systemic lupus erythematosus (SLE), a chronic autoimmune
illness that usually begins in early adulthood, affects multiple
organ systems and may be associated with considerable
morbidity and mortality. In addition, SLE is incurable and
runs a variable course over the patient’s remaining years. The
response and complication of drug treatment are generally
unpredictable. These characteristics of the disease impact the
quality of life (QOL) in unique ways, thus measuring the
objective outcomes of morbidity and mortality only does not
fully reflect the burden of disease borne by the sufferers [1]. The
assessment of QOL has become an important facet of manage-
ment of chronic diseases such as this and is considered to
be very relevant for clinical practice, interventional trials and
outcome monitoring [2, 3].
General health instruments have been shown to be valid for
measuring QOL in SLE patients. They possess construct validity
and responsiveness and they allow the comparison of QOL
between different rheumatic diseases [4]. Criticisms levelled at
their use include the argument that they are not sufficiently
comprehensive for SLE, especially those that cater to the physical
and neglect the mental dimension [5].
The QOL domains of importance to lupus patients include
health, work and income, identity and independence, and social
and family life, which can be measured with a variety of general
health instruments [4–7]. Qualitative research has yielded as
many as 12 concepts: uncertainty/unpredictability of lupus,
fatigue, pain/symptoms, social support, misunderstood by others,
fear, dependence/feelings of inadequacy/loss of self, limitations/
restricted activities, personal self-management, medical treatment,
emotional stress and financial issues [8]. The unpredictability of
SLE in terms of the course of disease, extent of organ involve-
ment and response to treatment is a significant component of
the patient’s QOL that is not well represented by general health
instruments even though it may be indirectly assessed with a
helplessness index [9, 10].
There are recognized advantages to using a disease-specific QOL
instrument rather than a general health one [11]. Disease-specific
instruments respond to smaller changes in the QOL (improved
responsiveness). One benefit of this is that smaller number of
patients will be needed in clinical trials. Disease-specific instru-
ments also cover a wider range of QOL (superior face and
content validity) issues arising from that illness.

Department of Rheumatology, Allergy and Immunology, Tan Tock Seng Hospital, Singapore and 1Health Promotion Board, Singapore.

Received 28 July 2004; revised version accepted 15 February 2005.

Correspondence to: K. P. Leong, Department of Rheumatology, Allergy and Immunology, Tan Tock Seng Hospital, 11 Jalan Tan Tock Seng,
Singapore 308433. E-mail: khai_pang_leong@ttsh.com.sg
1267
ß The Author 2005. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For Permissions, please email: journals.permissions@oupjournals.org
1268 K. P. Leong et al.
As a part of a wide-ranging SLE study in our institution, we
recently developed a SLE-specific QOL scale (SLEQOL) using
an established methodology [12, 13]. In this paper, we describe
the steps we took to develop and validate the SLEQOL in our
patient population. We also compared our work with an
independent QOL instrument for SLE that has been published
recently [14].
Patients and method
Patients
All the patients fulfilled the 1982 American Rheumatism
Association (ARA) classification criteria for SLE or the 1997
American College of Rheumatology (ACR) revision [15, 16]. They
were recruited from our out-patient Rheumatology Clinic and
from the hospital wards in a single institution. The study was
approved by the Hospital’s Ethics Committee. The patients had
to be fluent in written and spoken English. Informed consent was
obtained according to the Declaration of Helsinki.
Development of the QOL instrument
Because there was no SLE-specific QOL instrument for compari-
son, we built one from first principles. A team of rheumatologists
and nurse clinicians, cognisant of the QOL issues in the literature
and experienced in managing SLE patients, generated the initial
list of QOL items in English. The items were assembled into a
questionnaire and administered to 100 SLE patients. They were
invited to suggest items not in the list that may be important to
them. They were also asked to rate the items with regard to their
frequency of occurrence and importance in the past month. Based
on these responses, factor analysis, Rasch model analysis and
expert review were used for item reduction. The reduced number
of items was finally composed into a questionnaire and its
psychometric properties were studied. The time frame for item
recollection was now changed to 1 week in order to optimize
responsiveness.
Data collection
Data were captured systematically during every study visit.
In addition to clinical data and SLEQOL, the SLE Disease
Activity Index (SLEDAI) [17], Systemic Lupus Activity Measure
(SLAM) [18], Rheumatology Attitudes Index (RAI) [9, 10, 19],
MOS 36-Item Short-Form Health Survey (SF-36) [20–22] and
the Systemic Lupus International Collaborating Clinic/American
College of Rheumatology damage index (SLICC/ACR-DI) [23, 24]
were recorded. Patients with disease duration shorter than 3 yr
were interviewed every 3 months.
The SLEDAI is a 24-item instrument for assessing SLE activ-
ity in nine organ systems. Clinical and laboratory data are
required to complete the questionnaire. The score ranges from
0 to 105 points, with higher values signifying disease activity.
SLAM assesses SLE activity from data on nine organ systems
and seven laboratory values. The RAI, known as the Arthritis
Helplessness Index before 1988, is a 15-item scale that is internally
consistent and correlates significantly with the independent indices
of control, self-esteem, anxiety and depression [19]. The items
resolve into two factors, one depicting the subjects’ belief in their
own ability to control their arthritis and the other, consisting
of five items, the concept of helplessness. Initially designed for
patients with rheumatoid arthritis, the RAI has been validated for
use in lupus patients [9, 10]. The SF-36 is a 36-item QOL
questionnaire. The items are summarized into eight domain scores,
each derived from a summation and transformation of items
scores. Each domain score ranges from 0 to 100, higher values
representing better self-perceived QOL. The physical health
domains are physical functioning, role physical, bodily pain and
general health. The mental health domains are vitality, social
functioning, role emotional and mental health. In this paper,
we did not further collapse the scores into the physical and mental
component summaries. SLICC/ACR-DI tracks irreversible organ
dysfunction across 12 systems. The dysfunction must be present
for 6 consecutive months in order to register as damage. The
organs systems of interest are ocular (0–2 points), neuropsychi-
atric (0–6 points), renal (0–3 points), pulmonary (0–5 points),
cardiovascular (0–6 points), peripheral vascular (0–5 points),
gastrointestinal (0–6 points), musculoskeletal (0–6 points), derma-
tological (0–3 points), gonadal (0–1 point), diabetes (0–1 point)
and malignancy (0–2 points). The score ranges from 0 to 46,
higher scores signifying more damage.
Statistical analysis
Factor structure was studied by factor extraction with principal
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components analysis followed by varimax rotation. We deter-
mined the minimal clinically important difference (MCID) of the
SLEQOL according to the method of Juniper et al. [25]. Test–
retest reliability was evaluated with the intraclass correlation
coefficient. We constructed a correlation matrix to compare the
items in the SLEQOL with the SF-36, RAI and its helplessness
subscale, the lupus activity scores and the damage score SLICC/
ACR-DI using the Pearson correlation coefficient. As there is
no single best responsiveness statistic for assessing HRQL (health-
related quality of life) instruments [26], we used four of them
to assess the evaluative property of SLEQOL and SF-36 with
regard to SLE: Liang’s relative efficacy (RE) [27], Liang’s stan-
dardized response mean (SRM) [28], Kazis’ effect size [29]
and Guyatt’s coefficient [30]. We analysed the data with the
SPSS Professional Statistics 8.0 (SPSS, Chicago, IL, USA). We
performed Rasch model analysis [31] with BIGSTEPS, a program
available at www.winsteps.com. All statistical tests were conducted
at the 5% level of significance.
Results
Item generation
In May 2002, we asked a group of rheumatologists and nurse
clinicians to nominate items that they believe were relevant to SLE
patients. By 13 June 2002, 51 items had been identified (Table 1).
As a gauge of their comprehensiveness, we noted that these items
cover Wiginton’s 12 concepts very well [8]. A draft questionnaire
consisting of these items was administered to 100 patients in
October 2002.
This group of 100 SLE patients comprises 11 males and
89 females. There were 84 Chinese, four Indians, 11 Malays
and one whose ethnicity was not specified. The mean age was
39.4
13.7 yr. Patient input was sought by encouraging these 100
patients to suggest activities in their lives that had been affected
by their illness that had been omitted in the questionnaire. We
also asked patients to score the importance and the frequency
of occurrence of every item using a seven-point Likert scale.
A seven-point scale was chosen over a five-point one because
this allowed a finer assessment of his or her QOL and provided a
better approximation to continuous data required for factor
analysis.
Item reduction and creation of SLEQOL
We analysed the input from the 100 patients to produce the
final questionnaire. The patients did not add any items to the
list. The data on the importance of the items were subjected
 Developing an SLE quality-of-life instrument 1269

TABLE 1. Rasch analysis of 51 initial items based on data provided by 100 SLE patients

Item INFIT INFIT OUTFIT OUTFIT

No. Item measure mean square Zstd mean square Zstd
1 Difficulty in taking part in social activities 1.01 2.02 2.5 1.63 1.3
2 Getting in and out of bed 0.78 1.34 1.2 0.75 0.7
3 Walking outdoors on level ground 0.77 0.95 0.2 0.48 1.8
4 Picking things from the floor 0.76 1.04 0.2 0.80 0.6
5 Turning taps on and off 0.71 0.91 0.4 0.76 0.7
6 Wishing others did not know that I have SLE 0.57 1.34 1.4 0.79 0.7
7 Inconvenience of daily medications 0.52 1.54 2.2 0.97 0.1
8 Getting in and out of car 0.51 0.75 1.3 0.62 1.4
9 Lifting glass 0.50 1.20 0.9 0.95 0.2
10 Shopping 0.48 0.74 1.4 0.65 1.3
11 Dressing 0.46 1.09 0.4 0.84 0.6
12 Bathing and drying 0.45 1.17 0.8 1.09 0.3
13 Low self esteem 0.29 0.92 0.5 0.86 0.5
14 Work and school performance affected 0.29 1.30 1.5 1.01 0.1
15 Consuming more alcohol or tobacco 0.23 0.92 0.5 0.74 1.1
16 Marketing 0.11 1.06 0.4 1.01 0.1
17 Fears bad news from doctor 0.08 1.64 3.5 2.02 3.3

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18 Side-effects of medicines 0.08 0.97 0.2 1.16 0.7
19 Walking 3 km 0.05 1.01 0.1 0.81 0.9
20 Sex 0.04 1.09 0.6 1.08 0.4
21 Itchy skin 0.01 1.00 0.0 0.83 0.8
22 Career or education interference 0.00 1.06 0.4 0.89 0.5
23 Inability to go for long holidays 0.03 1.06 0.4 0.86 0.6
24 Fear of painful procedures 0.03 0.95 0.3 0.94 0.3
25 Inability to go out under the sun 0.04 1.60 3.6 2.03 3.7
26 Loss of income 0.06 1.32 2.1 1.56 2.2
27 Difficult relationship with friends and relations 0.10 0.86 1.0 1.02 0.1
28 Joint pain and swelling 0.12 1.26 1.7 1.24 1.1
29 Poor concentration 0.15 0.95 0.4 0.78 1.2
30 Embarrassment 0.17 0.91 0.7 0.78 1.2
31 Dietary restrictions 0.21 1.02 0.1 1.07 0.4
32 Inconvenience of frequent clinic visits 0.22 1.36 2.4 1.59 2.6
33 Fatigue 0.22 1.17 1.2 1.61 2.6
34 Difficulties dealing with stress 0.23 0.85 1.1 0.97 0.2
35 Missed work or school 0.26 1.20 1.4 1.02 0.1
36 Fear of needles 0.30 1.37 2.5 1.30 1.5
37 Anxiety 0.31 0.85 1.2 0.98 0.1
38 Loss of appetite 0.33 0.78 1.8 0.71 1.7
39 Sore, painful or stinging skin 0.33 0.61 3.4 0.64 2.2
40 Friends and colleagues made fun of me 0.34 1.20 1.4 1.13 0.7
41 Self-consciousness 0.37 0.70 2.5 0.68 2.0
42 Depression 0.38 0.91 0.7 0.83 0.9
43 Poor memory 0.38 0.66 2.9 0.59 2.6
44 Slow in thinking 0.45 0.92 0.6 0.92 0.5
45 Lack of a good night’s sleep 0.48 0.72 2.3 0.82 1.0
46 Sports 0.50 0.91 0.6 0.97 0.1
47 Feeling low 0.51 0.83 1.3 0.80 1.2
48 Sore mouth 0.51 1.02 0.1 0.97 0.2
49 Concern that medicines do not work 0.54 1.13 0.9 1.12 0.6
50 Worry 0.54 1.11 0.8 1.52 2.5
51 Concern about being financial burden to the family 0.59 1.21 1.4 1.06 0.3

The items are ranked by the degree of difficulty, with the easiest at the top of the table.

to Rasch model analysis and factor analysis, followed by expert
review, for item elimination.
In Rasch model analysis, the probability of the respondent
successfully performing a certain task is a function of the ability
of the person and the difficulty of the task. It places data (both
person ability and item difficulty) on some reasonable hierarchy
on a single continuum of interest [31]. In this case, Rasch model
analysis was used to locate the level of difficulty of each of the
51 items on a linear logit scale. The item of mean difficulty
is assigned the value of zero. Negative measures denote that the
items are more difficult. The INFIT and OUTFIT values (reported
as mean squares) indicate the closeness of fit of the data to the
stochastic Rasch model. Values less than 1.0 indicate observations
are too predictable while those above 1.0 indicate unpredictability
(model underfit). Zstd values are t-tests of the observed data
against model-predicted values. Zstd values below zero indicate
that the fit is too predictable and values above zero indicate lack
of predictability. If the INFIT or OUTFIT values are between
0.6 and 1.4, Zstd can usually be ignored [32].
The most difficult item for our cohort of lupus patients is
concern about being a financial burden to her or her family,
followed by worry and concern that medicines do not work. The
items with which our patients experience the least difficulty are
social activities, getting in and out of bed and walking outdoors
(Table 1).
The items resolved into 11 components on factor analysis. The
first two components account for almost half of the variance
and all the items for about three-quarters (Table 2). Using the
1270 K. P. Leong et al.

TABLE 2. Factor analysis of the 51 initial items based on data provided by 100 SLE patients (values below 0.4 are suppressed)

Item/factor 1 2 3 4 5 6 7 8 9 10 11
Fatigue 0.40
Joint pain and swelling 0.67
Missed work or school 0.78
Interference with career or education 0.75
Difficult relationship 0.60
Difficult social activities 0.71
More alcohol or tobacco 0.73
Embarrassment 0.43 0.46 0.47
Self-consciousness 0.55
Feeling low 0.67
Lack of a good night’s sleep 0.46
Worry 0.78
Cannot go out under the sun 0.60
Wishing others did not know that I have SLE 0.74
Made fun of 0.41 0.45
Loss of income 0.47 0.45
Itchy skin 0.64
Sore, painful or stinging skin 0.69

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Difficulties dealing with stress 0.64
Anxiety 0.79
Depression 0.82
Concern medicines don’t work 0.59 0.46
Concern about side-effects of medicines 0.46 0.47
Loss of appetite 0.45
Slow in thinking 0.75
Poor memory 0.74
Poor concentration 0.48 0.61
Low self-esteem 0.51 0.41
Sore mouth 0.58
Concern about financial burden 0.55
Fear of receiving bad news from doctors 0.40 0.61
Fear of needles 0.89
Fear of painful procedures 0.78
Dietary restrictions 0.43 0.42
Inconvenience of frequent clinic visits 0.42 0.47
Inability to go for long holidays 0.54
Inconvenience of daily medication 0.46
Dressing 0.66 0.42
Getting in and out of bed 0.69 0.41
Lifting a glass of water 0.83
Walking outdoors on level ground 0.75
Bathing and drying yourself 0.90
Picking things from the floor 0.75
Turning taps on and off 0.86
Getting in and out of a car 0.86
Shopping 0.76
Marketing 0.78
Walking 3 km 0.52 0.49
Work and school performance 0.41 0.43
Sex 0.55
Sports 0.65
% of variance 40.02 9.10 4.68 4.05 3.18 3.019 2.66 2.46 2.17 2.04 2.01
Cumulative % 40.02 49.12 53.79 57.84 61.02 64.04 66.70 69.15 71.33 73.37 75.38

The factors were extracted by principal components analysis and varimax-rotated with Kaiser normalization.

results from these two analyses, we shortened the questionnaire
according to a few principles, in the following order of importance.
First, we ensured that there was a good distribution of questions
across the different factors and difficulty levels. Second, items
that have similar difficulty level and factor resolution were candi-
dates for elimination. Third, items with INFIT or OUTFIT values
below 0.6 or above 1.4 were also considered for removal [32].
Accordingly, the 11 items which were eliminated were: ‘lack
of a good night’s sleep’, ‘worry’, ‘slow in thinking’, fear of painful
procedures’, ‘inability to go for long holidays’, ‘difficulty with
dressing’, ‘difficulty with getting in and out of bed’, ‘difficulty with
lifting a glass of water’, ‘difficulty with picking things from the
floor’ and ‘difficulty with getting in and out of a car’. Wiginton’s
12 concepts are still well represented by the remaining items.
A new questionnaire with 40 questions was devised in
November 2002 (Appendix 1). The Flesch–Kincaid Grade
Reading Level was 6.0 and Flesch Reading Ease was 70.2. The
questions were grouped into six convenient subsections that
were guided by the outcome of factor analysis. Later, we shall
show that most of the subsections are internally correlated and
correspond to QOL domains of relevance in SLE.
Preliminary validation of the SLEQOL
We proceeded to study the performance of the SLEQOL on SLE
patients. We made use of our ongoing prospective study on
SLE outcomes. Data from 275 patients were available at the time
of analysis. In this group of patients, there were 249 females and
 Developing an SLE quality-of-life instrument 1271

26 males, with a mean age of 40.1
13.4 yr. The mean age at
diagnosis was 31.6
15.2 yr. There were 213 Chinese, 14 Indians,
41 Malays and seven of other races. Prospective data at 3-month
intervals were available for 95 patients and repeat data collection
in 2 weeks for 51 patients.
The SLEQOL has 40 items scored from 1 to 7, with higher
values corresponding to worse QOL. Therefore the minimum
score was 40 and the maximum 280, with a range that spanned
240 units. We took the summary score as the raw sum of these
responses. It is also possible to derive the summary score from
the sum of the mean of each of the six subsections, but this
may place undue emphasis on those subsections with a greater
number of items. This study was not designed to determine if
and how of the items should be weighted. These issues have to be
addressed in future analyses.
Face and content validity
These are subjective properties of QOL instruments. Face validity
is satisfied when a group of informed individuals (health-care
suggests no or negligible correlation, r ranging from 0.20 to
0.29 suggests weak negative correlation, r ranging from 0.30
to 0.39 suggests moderate negative correlation, r ranging from
0.40 to 0.69 suggests strong negative correlation and 0.70
or lower suggests very strong negative correlation. There was
little correlation between SLEQOL and SLEDAI, and between
SLAM and SLICC/ACR-DI. Generally, the summary score
of the SLEQOL correlated better with the SF-36 than do
its individual subsections. As support of the construct validity of
SLEQOL, subsection 1 (questions on physical ability) correlated
somewhat with the Physical Functional domain of the SF-36 and
subsection 6 (questions regarding self-esteem, embarrassment and
unpredictability) showed some correlation with the helplessness
subscale of the RAI.
Rasch analysis of SLEQOL
Rasch model analysis of SLEQOL is shown in Table 4. The
outcomes are generally the same though not identical to those
in the previous investigation. Rasch model analysis is designed

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providers and patients) judges that an instrument measures part
or all the experience of an illness. Content validity refers to the
comprehensiveness of coverage of the instrument based on some
existing theory or criteria. For example, the 40 items in SLEQOL
adequately cover the 12 concepts in Wiginton’s study [8]. By
inviting 16 rheumatologists and rheumatology nurses and 100
patients to contribute to the items, we have ensured reasonable
face and content validities. In a later section, where we present
the factor analysis, we shall show that the QOL domains covered
by SLEQOL include social and occupational activities, mood
and self-image, physical functioning, physical symptoms, self-
esteem and the unpredictability of the illness and its response
to treatment.
Using cross-sectional data from 275 patients, we constructed
a correlation matrix of the SLEQOL against the SF-36, RAI
and its helplessness subscale, the lupus activity scores and the
damage index SLICC/ACR-DI (Table 3). SLICC/ACR-DI was
not computed for 29 patients because of incomplete data. The
SLAM ranged from 0 to 52 (mean 3.52
5.66), SLEDAI ranged
from 0 to 39 (mean 2.74
4.82) and SLICC/ACR-DI ranged
from 0 to 6 (mean 0.67
1.12).
Conventionally, Pearson’s r>0.7 is regarded as showing very
strong positive correlation; r ranging from 0.4 to 0.69 suggests
strong positive correlation, r ranging from 0.30 to 0.39 suggests
moderate positive correlation, r ranging from 0.20 to 0.29
suggests weak positive correlation, r ranging from 0.19 to 0.19
to produce person-free and instrument-free information on item
difficulty. We believe that the slight differences may have resulted
from the change of time frame of item recall from 1 month to
1 week. Ten of the 40 items were non-fitting (taken as INFIT or
OUTFIT above 1.4 or below 0.6), namely items 2, 4, 5, 10, 13, 18,
19, 23, 31 and 39. We retained them to maintain the construct
validity of the questionnaire.
Floor and ceiling effect
The ceiling or floor effect occurs when patients perceive that
their condition has improved or deteriorated, respectively, beyond
what a QOL questionnaire can measure. This is an inadequacy
that is often difficult to eradicate. Table 5 shows the proportion
of patients whose responses reached the maximum and minimum
scores in the main sections of the SLEQOL and SF-36. The SF-36
and SLEQOL are scored from opposite directions but we have
made the scoring consistent in this table. In this case, the floor
values consistently represent good perceived QOL and ceiling
values poor QOL.
The floor effect was more substantial than the ceiling effect in
SLEQOL, consistent with the Rasch model analysis that many
of the items were too easy for the patients. On the other hand,
the ceiling effect was more obvious in the SF-36. While values
above 20% are considered high [22], this does not invalidate
the SLEQOL as the items contribute to the content validity.

TABLE 3. The cross-sectional correlation between the SLEQOL (and its subsections) and SF-36, Rheumatology Attitudes Index (and its helplessness
index) the two SLE activity indices SLEDAI and SLAM, and the damage index SLICC/ACR-DI

SLEQOL

Subsection 1:
Summary Physical Subsection 2: Subsection 3: Subsection 4: Subsection 5: Subsection 6:
score functioning Activities Symptoms Treatment Mood Self-image
SF-36
Physical functioning 0.112 0.234 0.069 0.066 0.066 0.055 0.042
Role physical 0.140 0.139 0.106 0.129 0.087 0.067 0.044
Bodily pain 0.171 0.171 0.098 0.159 0.084 0.090 0.084
General health 0.127 0.090 0.058 0.112 0.063 0.102 0.080
Vitality 0.140 0.059 0.087 0.134 0.043 0.127 0.082
Social functioning 0.107 0.069 0.087 0.059 0.042 0.108 0.055
Role emotional 0.061 0.056 0.029 0.045 0.030 0.076 0.030
Mental health 0.125 0.034 0.071 0.096 0.045 0.171 0.082
Rheumatology Attitudes Index 0.081 0.042 0.016 0.068 0.041 0.053 0.110
Helplessness subscale 0.115 0.053 0.048 0.078 0.046 0.099 0.119
SLEDAI 0.022 0.003 0.018 0.025 0.013 0.010 0.011
SLAM 0.018 0.016 0.010 0.010 0.029 0.007 0.009
SLICC 0.054 0.081 0.022 0.019 0.047 0.000 0.091
1272 K. P. Leong et al.

TABLE 4. Rasch analysis of the 40-item SLEQOL based on data provided by 275 SLE patients

Item INFIT INFIT OUTFIT OUTFIT

No. Item measure mean squares Zstd mean squares Zstd
2 Shopping 1.01 1.66 2.4 0.74 0.9
4 Marketing 0.92 1.40 1.6 0.76 0.9
39 Fears bad news from doctor 0.71 1.59 2.7 1.61 2.0
40 Consuming more alcohol or tobacco 0.51 1.04 0.3 0.78 1.0
3 Turning taps on and off 0.46 1.17 1.1 1.31 1.3
1 Walking outdoors on level ground 0.41 1.06 0.4 0.86 0.7
32 Wishing others did not know that I have SLE 0.36 1.18 1.2 0.87 0.6
20 Itchy skin 0.30 1.24 1.6 1.12 0.6
11 Sports 0.25 1.01 0.0 0.79 1.1
34 Low self-esteem 0.24 1.04 0.3 0.88 0.6
24 Fear of needles 0.15 0.89 1.0 0.96 0.2
16 Poor memory 0.14 0.74 2.4 0.74 1.5
21 Sore mouth 0.12 1.10 0.9 0.88 0.7
25 Dietary restrictions 0.12 1.11 1.0 1.14 0.7
23 Joint pain and swelling 0.08 1.64 4.8 2.40 5.7
33 Friends and colleagues made fun of me 0.05 0.91 0.9 0.73 1.7
12 Sex 0.00 0.86 1.4 0.72 1.8

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31 Anxiety 0.01 1.39 3.3 1.77 3.7
9 Missed work or school 0.03 1.11 1.0 0.84 1.0
27 Inconvenience of frequent clinic visits 0.04 0.74 2.8 0.63 2.6
8 Career or education interference 0.06 1.09 0.9 0.91 0.5
7 Work and school performance affected 0.08 0.90 1.0 0.79 1.4
6 Walking 3 km 0.10 1.00 0.0 0.96 0.2
19 Concentration 0.10 1.14 1.4 1.40 2.2
26 Inconvenience of daily medications 0.11 1.05 0.5 1.24 1.4
10 Difficult relationship with friends and relations 0.11 0.98 0.2 1.72 3.7
30 Depression 0.13 0.67 3.9 0.63 2.7
29 Feeling low 0.18 0.67 4.0 0.71 2.1
5 Bathing and drying 0.18 1.29 2.8 2.23 6.0
28 Self-consciousness 0.23 0.66 4.3 0.63 2.9
36 Concern about being financial burden to the family 0.28 1.22 2.3 1.09 0.6
18 Fatigue 0.31 0.58 5.7 0.60 3.4
15 Loss of income 0.31 0.78 2.7 0.83 1.3
22 Sore, painful or stinging skin 0.32 1.03 0.4 0.93 0.5
14 Sun 0.38 1.14 1.5 1.19 1.3
17 Loss appetite 0.46 0.66 4.6 0.85 1.2
13 Social activities 0.57 1.42 4.5 1.81 5.3
38 Side-effects of medicines 0.58 1.39 4.2 1.33 2.4
37 Medicines don’t work 0.60 1.24 2.7 1.28 2.1
35 Embarrassment 0.65 1.20 2.2 1.10 0.8

The items are ranked by the degree of difficulty, with the easiest at the top of the table.

TABLE 5. Number of patients whose responses were at floor and ceiling values of the subsections of the SLEQOL and SF-36

Number (%) who responded with the Number (%) who responded with the
floor value (good QOL) ceiling value (poor QOL)
SLEQOL
Subsection 1: Physical functioning 121 (44%) 0 (0%)
Subsection 2: Activities 49 (17.8%) 0 (0%)
Subsection 3: Symptoms 41 (14.9%) 0 (0%)
Subsection 4: Treatment 112 (40.7%) 1 (0.4%)
Subsection 5: Mood 107 (38.9%) 7 (2.6%)
Subsection 6: Self-image 46 (16.7%) 1 (0.4%)
SF-36
Physical functioning 2 (0.7%) 40 (14.6%)
Role physical 52 (18.9%) 143 (52.0%)
Bodily pain 1 (0.4%) 77 (28.0%)
General health 0 (0%) 1 (0.4%)
Vitality 0 (0%) 3 (1.1%)
Social functioning 3 (1.1%) 115 (41.8%)
Role emotional 62 (22.6%) 162 (58.9%)
Mental health 0 (0%) 7 (2.6%)

The SF-36 and SLEQOL are scored from opposite directions but we have made the scoring consistent in this table. For both instruments, the floor
values represent good perceived QOL and ceiling values poor QOL.
 Developing an SLE quality-of-life instrument 1273

The finding that SLEQOL has a more significant floor effect and
the SF-36 a ceiling effect suggests that they could compensate
for each other’s deficiency and they should be used together.
Test–retest reliability
Fifty-one patients with stable disease were asked to repeat the
questionnaire after 2 weeks to determine the test–retest reliability.
The intraclass correlation coefficient was 0.83 for the summary
score. For subsections 1–6, the intraclass correlations were 0.59,
0.57, 0.72, 0.52, 0.60 and 0.80, respectively.
Internal consistency
For the entire SLEQOL, Cronbach’s alpha was 0.95. For
subsection 1 (questions 1–6), Cronbach’s alpha was 0.85, for
subsection 2 (questions 7–15) it was 0.90, for subsection 3
(questions 16–23) it was 0.89, for subsection 4 (questions 24–27)
it was 0.76, for subsection 5 (questions 28–31) it was 0.93 and for
entire subsection 2); they are the social and occupational activities.
The second factor consisted of questions 16, 17, 19 and 28–31
(parts of subsections 3 and 5); they appear to be the mood-related
and self-image questions. The third factor was made up of
questions 1–6 (exclusively subsection 1), all regarding physical
functioning. The fourth factor contained questions 16–23 (exclu-
sively subsection 3), concerning physical symptoms. The fifth
factor consisted of items 36–39 (part of subsection 6), concerned
unpredictability of the response to treatment. Factor 6 was
made up of items 32–35 (another part of subsection 6), regarding
self-esteem. Factor 7 consisted of items 24–27 (exclusively sub-
section 4), all unpleasant aspects of the treatment of lupus.
Factor 8, of very low eigenvalue, consisted of items 6, 14 and 15,
regarding the ability to walk 3 km, ability to go out under the
sun and making money.
Responsiveness of SLEQOL and SF-36 to
changes in QOL

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subsection 6 (questions 32–40) it was 0.86. From the second interview onwards, patients were asked to
The 40 items of the SLEQOL resolved into eight factors rate their global change in QOL using a scale of integers from
(Table 6). The first factor consisted of questions 7–13 (almost the 7 to þ7. A score of 7 indicates ‘a very great deal worse’,

TABLE 6. Factor analysis of the 40 items of the SLEQOL (values below 0.4 are suppressed)

No. Item/factor 1 2 3 4 5 6 7 8
1 Walking outdoors on level ground 0.812
2 Shopping 0.778
3 Turning taps on and off 0.663
4 Going to the market 0.828
5 Bathing and drying yourself 0.791
6 Walking 3 km 0.563 0.442
7 Work and school performance 0.836
8 Interference with career or education 0.851
9 Missed work or school 0.799
10 Difficult relationship 0.709
11 Sports 0.483
12 Sex 0.490
13 Difficult social activities 0.594
14 Cannot go out under the sun 0.659
15 Making less money 0.500
16 Poor memory 0.437 0.470
17 Loss of appetite 0.421 0.503
18 Fatigue 0.488
19 Poor concentration 0.481 0.493
20 Itchy skin 0.654
21 Sore mouth 0.781
22 Sore skin 0.780
23 Joint pain 0.498
24 Fear of needles 0.659
25 Dietary restrictions 0.621
26 Inconvenience of daily medication 0.686
27 Inconvenience of clinic visits 0.581
28 Self-consciousness 0.540
29 Feeling low 0.818
30 Depression 0.838
31 Anxiety 0.782
32 Wishing others did not know that I have SLE 0.644
33 Made fun of 0.572
34 Low self-esteem 0.631
35 Embarrassment 0.760
36 Concern about financial burden 0.662
37 Concern medicines don’t work 0.783
38 Concern about side-effects of medicines 0.785
39 Fear of receiving bad news from doctors 0.808
40 More alcohol or tobacco 0.449
Eigenvalues 15.11 3.02 2.23 1.92 1.71 1.38 1.27 1.10
% of variance 37.76 7.56 5.57 4.81 4.26 3.46 3.17 2.76
Cumulative % 37.76 45.32 50.89 55.69 59.96 63.42 66.59 69.34

The factors were extracted by principal components analysis and varimax-rotated with Kaiser normalization.
1274 K. P. Leong et al.

Mental
Functioning Physical Pain Health Vitality Functioning Emotional Health

0.01

0.01

0.01
0.12

0.12

0.12

0.01

0.01
6 ‘a great deal worse’, 5 ‘a good deal worse’, 4 ‘moderately
worse’, 3 ‘somewhat worse’, 2 ‘a little worse’, 1 ‘almost the
same, hardly any worse at all’, 0 ‘no change’, þ1 ‘almost the
same, hardly any better at all’, þ2 ‘a little better’, þ3 ‘somewhat

Role

0.13
0.02

0.14
0.02

0.15
0.02
0.06

0.06
better’, þ4 ‘moderately better’, þ5 ‘a good deal better’, þ6
‘a great deal better’, and þ7 ‘a very great deal better’. Patients
who rated the change as 1, 0 or þ1 were regarded as having
no difference in QOL, while those who rated it as þ2, þ3, 2 or

Social

0.21
0.02

0.20
0.01

0.18
0.01
0.06

0.06
3 were felt to have a small but important change. Scores of
þ4, þ5, 4 and 5 suggested moderate change and scores of
þ6, þ7, 6 and 7 suggested large change [25].
We used a variety of responsiveness statistics to analyse the

0.11
0.01

0.11
0.01

0.11
0.01
0.03

0.03
data. Liang’s relative efficacy (RE) is formed by squaring the

SF-36
ratio of the appropriate t statistics of each instrument to be

Role Bodily General

compared [27]. SRM is taken as mean change in score divided

0.31
0.10

0.26
0.09

0.26
0.09
0.32

0.31
by the standard deviation of the change in scores [28]. Effect size
is calculated as mean change divided by the standard deviation
of the baseline scores [29]. Guyatt’s coefficient is equal to the

0.13
0.08

0.12
0.07

0.12
0.07
0.12

0.11
mean of change in scores divided by the between-subject variability
or the within-person change in stable subjects [30].

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0.11
0.08

0.11
0.08

0.12
0.08
0.03

0.03
In all, 119 data pairs from 95 patients were available for
analysis. Other investigators have also used more than one pair
of QOL data from one patient when available [33]. There were
12 data sets in which a decreased global QOL was reported, 50

Summary Subsection Subsection Subsection Subsection Subsection Subsection Physical

in which it was unchanged and 57 that improved. Because there

0.00
0.29

0.00
0.20

0.00
0.20
0.04

0.03
were only 12 in which the QOL worsened, we used the data from
the unchanged and improved patients to generate the responsive-
ness statistics (Table 7). All the four responsiveness statistics
show that the SLEQOL is more sensitive than any of the eight

0.23
0.16

0.19
0.17

0.22
0.17

0.24
6

–
domains of the SF-36. However, in the patients whose QOL
was unchanged, the SLEQOL scores varied to a greater degree
than those of the SF-36. Therefore, it is reasonable to state that
the SLEQOL was more sensitive but less specific to change than
0.37
0.07

0.33
0.07

0.35
0.07

0.54
5

–
the SF-36.
However, it is also clear from Table 7 that subsections 3, 4
and 5 of the SLEQOL were the best indicators of change of QOL,
superior to the summary score and all the domains of the SF-36.
0.23
0.05

0.25
0.04

0.22
0.04

0.20
They were both very sensitive and specific to the changes in
4

–
the QOL.
SLEQOL

0.59
0.00

0.48
0.00

0.57
0.00

1.00
3

–
Minimal clinically important difference
The MCID is a valued property of a QOL instrument because
0.51
0.27

0.39
0.19

0.43
0.19

0.73

it defines the quantum of change that warrants an intervention

2

by the physician. However, there are many ways of defining the

MCID. The methods to determine the MCID can be classified as
The four responsiveness statistics showed similar results.

the distributional, opinion-based and predictive approaches [34].

We derived the MCID for the summary score of SLEQOL
0.31
0.13

0.29
0.12

0.31
0.12

0.17
TABLE 7. Responsiveness of the SLEQOL and SF-36

by anchoring it to the patient’s opinion of what constitutes mini-

mal change of the global QOL, which constitutes the distributional
approach.
score

0.44
0.21

0.33
0.15

0.37
0.15
1.00

0.97

The change of SLEQOL was 98 in one patient who

assessed her global QOL change as large (deterioration), 30.4
in five patients who assessed it as moderate (deterioration),
Liang’s standardized response mean

Liang’s relative efficacy (excluding

25.33 in six patients who assessed it as small (deterioration),

þ5.48 in 50 patients who assessed as unchanged, þ10.13 in 31
the SLEQOL subsections)

who assessed it as small (improvement), þ32.75 who assessed

Overall QOL unchanged

Overall QOL unchanged

Overall QOL unchanged

Overall QOL improved

Overall QOL improved

Overall QOL improved

it as moderate (improvement), and þ13.8 in 10 patients who

Liang’s relative efficacy
Responsiveness statistic

assessed it as large (improvement). That the summary score of the

Guyatt’s coefficient

SLEQOL generally varies in the same direction and proportion as

Kazis’ effect size

the self-perceived change in global QOL supports the construct

validity of SLEQOL.
By taking the mean of the absolute difference of SLEQOL
in the group of 37 patients who rated their global QOL change
as þ2, þ3, 2 or 3, the MCID was calculated as 24.76, which
may be rounded off to 25 for use.
 Developing an SLE quality-of-life instrument
Discussion
We have described how we developed a new instrument for
measuring the QOL of SLE patients. We assembled the ques-
tionnaire from information from patients and health-care
workers using a rigorous methodology. Subsequently, we showed
that SLEQOL is valid for SLE because it possesses construct
validity, face and content validity, internal consistency, test–retest
reliability and responsiveness.
Though health-care professionals chose the items initially, the
involvement of lupus patients followed immediately. Patients
were asked to gauge the importance and frequency of the items.
Crucially, they were asked to suggest additional items if they felt
important areas were omitted. Qualitative interviews were not
performed for two reasons. First, as physicians and rheumatology
nurse educators, we are not experienced with qualitative research.
Second, a good report on the qualitative experience in lupus
is available [8]. Though not directly applicable across cultures,
we felt that most of the domains described in that paper reflect
our patients’ concerns. An analysis of the 51 items shows that they
cover Wiginton’s 12 concepts adequately.
Our instrument may be compared with the 38-item SLE
Symptom Checklist (SSC) [14]. The SSC was developed in
Dutch and translated to English whereas the SLEQOL was
developed entirely in English. The SLEQOL used a seven-point
scale whereas the SSC employed a five-point one. The SSC and
SLEQOL were elaborated upon different philosophies. Only six
items are common to both: arthritis, fatigue, itch, sensitivity to
sunlight, loss of concentration, and memory. The SSC consists
entirely of queries on the physical symptoms related to lupus,
while the SLEQOL seeks to encompass all the areas of QOL that
may be affected.
That the SLEQOL only correlated weakly with the SLE
activity indices is consistent with previous reports. For example,
there was poor correlation of the SF-20 with SLEDAI [35, 36]
and the SF-36 with BILAG [7]. On the other hand, other
investigators have found that the SF-36 correlated with SLEDAI
[37], the global disease activity measured by BILAG [38] and
SLAM [39]. This suggests that lupus activity and damage do
not consistently perturb the QOL. One possible explanation is
that local factors and personality have more a direct effect on
the subjective perception of QOL than life circumstances or
disease [40].
We feel that the poor correlation between SF-36 and SLEQOL
is due to the fact that they assay non-overlapping domains of
the QOL. The SF-36 asks questions about QOL in general health
while SLEQOL is specific about areas of concern in lupus.
The Rasch model analysis and distribution of the floor and
ceiling responses suggest that the SLEQOL was rather easy for
our patient cohort. Most of our patients were recruited from
the out-patient clinic and were not in hospital wards, so they
have either milder disease or controlled disease. More studies on
other patient populations are needed. This may not be a large
disadvantage because the instrument is likely to be employed
to study the QOL of the worse-affected or deteriorating patients
than the healthier patients. On the other hand, SF-36 suffered
from ceiling effect and it will have limited ability to track patients
as their QOL deteriorates.
At this moment, it is prudent to use SLEQOL together with
a generic QOL instrument such as SF-36. First, though the
SLEQOL is sufficiently comprehensive in its coverage of
SLE-related QOL issues, but it ignores other aspects of health-
related QOL. The employment of two instruments is relevant in
SLE patients with concurrent conditions, for example, Sjögren’s
syndrome, osteoporosis or atherosclerosis. Second, the fortuitous
discovery that SLEQOL has a significant floor effect while
SF-36 has a ceiling effect means that each can offset the other’s
limitation. Third, data collected with a generic questionnaire
enables the comparison of QOL in SLE with that in other diseases.
1275
SLEQOL is unique because it comprehensively covers the
physical and psychological aspects of QOL in SLE. The concept
of unpredictability of the disease course and the outcome of
treatment is well represented in SLEQOL and is absent in general
health instruments.
We have documented the steps we have undertaken to construct
a SLE-specific QOL instrument, and we showed that it possesses
construct validity, face and content validity, internal consistency,
test–retest reliability and responsiveness. Thus, the validity of the
SLEQOL has been established. Full validation is awaited; work
that remains to be done include resolving its role in clinical trials
and routine practice and confirming its applicability in different
populations.
Key messages
Rheumatology
 A new systemic lupus erythematosus-
specific quality-of-life instrument,
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SLEQOL, has been shown to be valid
and to have better content validity
and responsiveness than general health
instruments.
Acknowledgements
This study was supported by a grant from the Biomedical
Research Council of Singapore (01/1/28/18/016). We thank the
Medical Outcomes Trust for permission to use the SF-36TM
Health Survey. We also thank Mr Soo Yuen Chong for
excellent support in data analysis.
The authors have declared no conflicts of interest.
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