Arthritis & Rheumatism (Arthritis Care & Research)

Vol. 57, No. 6, August 15, 2007, pp 972–979

DOI 10.1002/art.22881
© 2007, American College of Rheumatology
ORIGINAL ARTICLE

Development and Validation of a Disease-Specific

Health-Related Quality of Life Measure, the
LupusQoL, for Adults With Systemic Lupus
Erythematosus
KATHLEEN MCELHONE,1 JANICE ABBOTT,2 JOANNA SHELMERDINE,3 IAN N. BRUCE,3
YASMEEN AHMAD,3 CAROLINE GORDON,4 KATE PEERS,4 DAVID ISENBERG,5
ADA FERENKEH-KOROMA,5 BRIDGET GRIFFITHS,6 MOHAMED AKIL,7 PETER MADDISON,8 AND
LEE-SUAN TEH1

Objective. To develop and validate a disease-specific health-related quality of life (HRQOL) instrument for adults with
systemic lupus erythematosus (SLE).
Methods. The work consisted of 6 stages. Stage 1 included item generation for questionnaire content from semistructured
interviews with SLE patients. In stage 2 item selection for the draft questionnaire was performed by thematic analysis of
the patient interview transcripts and expert panel agreement. In stage 3 the content validity of the draft questionnaire was
assessed by patients completing the questionnaire and providing critical feedback. In stages 4 and 5 construct validity and
internal reliability of the 3 versions of the LupusQoL were evaluated using principal component analysis with varimax
rotation and Cronbach’s alpha coefficients, respectively. In stage 6 discriminatory validity, concurrent validity, and
test–retest reliability were evaluated.
Results. Stages 1, 2, and 3 resulted in a preliminary instrument containing 63 items. In stage 4, 8 domains were identified.
This factor structure, accounting for 82% of the variance, was confirmed in stage 5. The domains and Cronbach’s alpha
coefficients were physical health (0.94), emotional health (0.94), body image (0.89), pain (0.92), planning (0.93), fatigue
(0.88), intimate relationships (0.96), and burden to others (0.94). Discriminant validity was demonstrated for different
levels of disease activity (British Isles Lupus Assessment Group Index) and damage (Systemic Lupus International
Collaborating Clinics/American College of Rheumatology Damage Index). High correlations (r ⴝ 0.71– 0.79) between
comparable domains of the Short Form 36 and the LupusQoL assured acceptable concurrent validity. Good test–retest
reliability (r ⴝ 0.72– 0.93) was demonstrated.
Conclusion. The LupusQoL is a validated SLE-specific HRQOL instrument with 34 items across 8 domains defined by
patients as being important.

KEY WORDS. Quality of life; Systemic lupus erythematosus.

INTRODUCTION women during the childbearing years and is particularly

Systemic lupus erythematosus (SLE) is an autoimmune common in Chinese, Asian, and African American/Carib-
rheumatic disease of varying severity found mainly in bean individuals (1,2). The course of the disease is variable

Supported by Lupus UK and the former North West NHS

Executive Research and Development Directorate. Lupus
UK and the Arthritis Research Campaign support the Bir-
mingham, UK lupus cohort.
1
Kathleen McElhone, BSc, Lee-Suan Teh, MD, FRCP:
Royal Blackburn Hospital, Blackburn, UK; 2Janice Abbott,
PhD: University of Central Lancashire, Preston, UK; 3Joanna
Shelmerdine, RN, Ian N. Bruce, MD, FRCP, Yasmeen Ah-
mad, PhD, MRCP: Rheumatism Research Centre, Central
Manchester and Manchester Children’s University Hospital
Trust, Manchester, UK; 4Caroline Gordon, MD, FRCP, Kate
Peers, MSc: University of Birmingham, Birmingham, UK;
5
David Isenberg, MD, FRCP, Ada Ferenkeh-Koroma, BSc:
Middlesex Hospital, London, UK; 6Bridget Griffiths, MD,
FRCP: Freeman Hospital, Newcastle, UK; 7Mohamed Akil,
MD, FRCP: Hallamshire Hospital, Sheffield, UK; 8Peter
Maddison, MD, FRCP: Ysbyty Gwynedd, Bangor, UK.
Dr. Bruce has received consulting fees and/or honoraria
(less than $10,000 each) from Genelabs, Wyeth, and
Aspreva. Dr. Teh has received speaker’s fees (less than
$10,000) from GlaxoSmithKline.
Address correspondence to Lee-Suan Teh, MD, FRCP, De-
partment of Rheumatology, Level 1 Room S1615, Royal
Blackburn Hospital, Haslingden Road, Blackburn BB2 3HH,
UK. E-mail: lsteh@btinternet.com.
Submitted for publication July 11, 2006; accepted in re-
vised form January 8, 2007.

972
Development and Validation of the Revised LupusQoL 973

and unpredictable. The survival of patients with SLE has

improved over the last 40 years (3). As a consequence,
outcome measures other than death are gaining promi-
nence. A comprehensive assessment of patients with SLE
should include disease activity, accumulated damage, and
health-related quality of life (HRQOL) (4).
SLE-specific measures exist for the assessment of dis-
ease activity and damage (5– 8). At present, the Medical
Outcomes Survey Short Form 36 (SF-36) (9) is the most
widely used generic HRQOL measure in SLE studies
(10,11). Other generic measures that have been used in-
clude the Health Assessment Questionnaire (12), the Gen-
eral Health Questionnaire (13), the Quality of Life Scale
(14), the Arthritis Impact Measurement Scale, and the
Sickness Impact Profile (15). Because none of these were
designed for an SLE population, they may contain irrele-
vant items and/or lack items that are deemed important to
these patients, and may be less sensitive than a disease-
specific measure. For this reason, attention has turned
toward developing disease-specific questionnaires. In this
report, we describe the development and validation of a
self-report, lupus-specific measure, the LupusQoL. This
measure is patient derived, contains unique items, and
provides a profile of patients’ HRQOL, all of which distin-
guish it from existing lupus-specific measures.

PATIENTS AND METHODS

The study was approved by the Multi-centre Research
Ethics Committee and all participants gave written in-
formed consent. All patients fulfilled ⱖ4 of the revised
American College of Rheumatology (ACR) criteria for
SLE (16,17).
The study was cross-sectional apart from the assessment
of test–retest reliability. The work consisted of 6 stages
(Figure 1): 1) the derivation of items for questionnaire
content; 2) the selection of items for the draft question-
naire; 3) the assessment of the draft questionnaire for con-
tent validity; 4) testing the construct validity and internal
reliability of the first version of the LupusQoL; 5) testing
and confirming the construct validity and internal reliabil-
ity of the second and final versions of the LupusQoL; and
6) evaluating discriminatory validity, concurrent validity,
and test–retest reliability.
Stage 1: derivation of items for questionnaire content.
Items were derived from patients with SLE. Purposive
sampling was used to guarantee representation in terms of
age, clinical characteristics, disease duration, and ethnic-
ity. Patients received written information during their out-
patient visit to the Rheumatology Department at the Black-
burn Royal Infirmary.
Semistructured face-to-face interviews were carried out
by a single researcher (KM). The interview topics were
informed by 1) review of the existing SLE and HRQOL
literature, 2) review of other HRQOL measures, and 3)
discussions with members of the SLE multidisciplinary
team. The patients were asked for their perspective on the
ways in which the disease and treatment impacted their
life. The interviews were audiotaped to preclude recall
Figure 1. Stages in the development and validation of the Lu-
pusQoL.
bias and field notes were taken (18). An interpreter was
present when the patient did not have good command of
the English language. Interviews continued until no new
issues emerged. A clinical psychologist had volunteered to
see any patients who were distressed following the inter-
view, but this was never required.
Stage 2: selection of items for the draft questionnaire.
Item selection for the draft questionnaire was conducted
manually. The interview transcripts were analyzed the-
matically and a rigorous method of working through them
was devised (18). The transcripts were read and re-read
and aspects relating to the impact of SLE on the patients’
lives were identified and extracted. These aspects were
organized (separated or clustered together) into groups,
from which the themes emerged. The emerging themes
were verified by continual reference to the transcripts.
Furthermore, the transcripts were independently analyzed
by a second researcher. Any existing discrepancies were
discussed until a consensus was reached.
Based on the themes, a draft questionnaire was con-
structed. Each item was carefully worded to ensure that it
related specifically to SLE, and where possible the pa-
tients’ terminology was used. A panel of discussants (a
rheumatologist [L-ST] who specializes in SLE, a specialist
nurse [KM], and a psychologist [JA]) met to consider each
974
potential item. Items were included if they 1) were asso-
ciated with the respondent’s SLE, 2) were general enough
to apply to the majority of potential respondents, and 3)
expressed 1 idea only. Discussions were held until agree-
ment was reached for each item.
The questionnaire instructions and a 6-point Likert re-
sponse format (19) were devised. The responses were “all
of the time,” “most of the time,” “a good bit of the time,”
“sometimes,” “occasionally,” and “never.” A 4-week time
frame was chosen to correspond to that of the disease
activity measure, the British Isles Lupus Assessment
Group (BILAG) index (7).
Stage 3: assessment of the draft questionnaire for con-
tent validity. Testing the face or content validity of a
questionnaire determines whether the questionnaire ap-
pears to measure what it is meant to measure and ensures
that it is meaningful to patients with SLE. Patients com-
pleted the draft questionnaire and criticized/made com-
ments about the design, content, structure, and response
scale, either in the written comments section or at the
debriefing session during their outpatient visit to the
Rheumatology Department at the Blackburn Royal Infir-
mary. An opened-ended discussion between the patient
and researcher ensured that any issues not included in the
questionnaire were considered. This feedback was used to
refine the questionnaire. Purposive sampling was used,
excluding patients interviewed in stage 1.
Stage 4: psychometric testing of the LupusQoL (version
1). Psychometric validation of the LupusQoL (stages 4 and
5) necessitated multicenter collaboration. The collaborat-
ing rheumatology units were UK centers with an interest
in SLE as part of the BILAG (Bangor, Birmingham, Black-
burn, University College London, Manchester, Newcastle,
and Sheffield).
Patients were approached during their outpatient atten-
dance. They completed the LupusQoL and SF-36 in the
clinic or at home and returned them via the mail. A sub-
group of patients were invited to complete a repeat Lu-
pusQoL after 4 weeks. Demographic and clinical informa-
tion of those who consented was recorded. Disease activity
was measured using the BILAG index (7,20,21) and dam-
age was measured using the Systemic Lupus International
Collaborating Clinics/ACR Damage Index (SDI) (8).
At this stage, psychometric testing of the LupusQoL
consisted of determining the construct validity and inter-
nal reliability of the measure. Construct validity evaluates
the robustness of the structure and determines the sub-
scales of the questionnaire. Principal component analysis
(PCA) with varimax rotation was conducted for the 63
items. The generation of factors was exploratory, so no
restriction was placed on the number extracted. The ana-
lysis was used as a hypothesis-generating procedure to
enable the most appropriate questionnaire structure from
psychometric, psychosocial, and clinical perspectives. In-
ternal reliability measures the extent to which items
within a subscale are conceptually related and was as-
sessed using Cronbach’s alpha coefficients. SPSS software,
version 13 was used to conduct the statistical analysis
(SPSS, Chicago, IL).
McElhone et al
Stage 5: psychometric testing of the second and third
(final) versions of the LupusQoL. A postal survey was
administered for version 2 of the LupusQoL, and a combi-
nation of postal and clinic administration of the question-
naire was used for the final version. Information on age
and sex was also collected. The construct validity and
internal reliability of the revised measures were evaluated
as described in stage 4.
Stage 6: testing of discriminant validity, concurrent va-
lidity, and test–retest reliability. Based on the final 34
items, discriminant validity, concurrent validity, and test–
retest reliability were assessed.
Discriminant validity. It is important to evaluate
whether an instrument can differentiate between patients
with varying degrees of disease severity. In patients with
SLE, disease severity can be captured by either disease
activity using the BILAG index (20) or damage using the
SDI (8). For disease activity (BILAG), LupusQoL scores for
each domain were determined for the following 4 groups
of patients: group 1 included patients with no current
disease activity and those with mild disease (Es, Ds, or
Cs only in all systems), group 2 included patients with
moderate activity in only 1 system (1 B only), group 3
included patients with moderate activity in ⱖ2 systems
(ⱖ2 Bs), and group 4 included patients with severe active
disease in ⱖ1 system (any As). One-way analyses of vari-
ance with post hoc analysis using Tukey’s honestly signif-
icant difference were used to compare the LupusQoL do-
main scores between the 4 groups. For damage, patients
were divided into 2 groups: those with damage (scores ⱖ1)
and those without damage (scores ⫽ 0). Independent t-
tests were used to compare the 2 groups for all domains of
the LupusQoL.
Concurrent validity. It is typical to assess the concur-
rent validity of a new instrument by comparing it with an
established questionnaire. The SF-36 was used as a com-
parator instrument. Spearman’s correlations were com-
puted between the comparable domains of the SF-36 and
the LupusQoL.
Test–retest reliability. The test–retest procedure mea-
sures the stability of a questionnaire. If a repeat admin-
istration of the LupusQoL is conducted while the pa-
tient’s health status is stable, similar scores should be
obtained for each domain at both time points. A sub-
group of patients completed a repeat questionnaire after
4 weeks. Using a scale of integers from ⫺7 (worsening
health) to 7 (better health), patients were asked to rate
any changes over the 4 weeks for each LupusQoL do-
main (7 ⫽ a very great deal, 6 ⫽ a great deal, 5 ⫽ a good
deal, 4 ⫽ moderately, 3 ⫽ somewhat, 2 ⫽ a little, 1 ⫽
almost the same, and 0 ⫽ no change) (22). For patients
whose health had remained stable, test–retest reliability
was assessed by computing intraclass correlation coeffi-
cients (ICCs).
Development and Validation of the Revised LupusQoL
RESULTS
Derivation of items for questionnaire content (stage 1).
Thirty women with SLE consisting of 22 whites and 8
Asian Indians (4 were not fluent in English) with a re-
presentative range of clinical features were interviewed.
The mean ⫾ SD age was 48.1 ⫾ 13.1 years, disease du-
ration was 9.2 ⫾ 8.4 years, and education years was
12.7 ⫾ 4.5.
Selection of items for the draft questionnaire (stage 2).
The dominant themes expressed by patients are presented
in Table 1. A potential pool of 98 items/questions was
generated from these themes. From the panel’s discus-
sions, it was agreed that 67 items should form the draft
LupusQoL questionnaire.
Assessment of the draft questionnaire for content valid-
ity (stage 3). Twenty women with SLE (18 whites, 1 Afri-
can Caribbean, 1 Asian Indian) completed the draft ques-
tionnaire. The mean ⫾ SD age was 52 ⫾ 15.2 years, disease
duration was 11.2 ⫾ 6.1 years, and education years was
12.9 ⫾ 3.3.
Refinement of the draft LupusQoL questionnaire. Pa-
tients reported that the majority of the items were rele-
vant, easy to understand, easy to answer, and adequately
measured their HRQOL. No new items were suggested.
Four items regarding career were removed because pa-
tients found these irrelevant within the time frame. The
revised LupusQoL (version 1) contained 63 items.
Psychometric testing of version 1 of the LupusQoL
(stage 4). A total of 391 patients consented to the study
and 322 (79%) returned the LupusQoL questionnaire. The
mean ⫾ SD age and education years were 45.1 ⫾ 13.4
years and 13.8 ⫾ 3.1, respectively, and 93% were women.
A total of 75% were white, 9% were Asian Indian, 12%
were African Caribbean, 3% were Asian, and 1% were
other. Based on BILAG and SDI scores, 19% of patients
had no current disease activity and 61% had no damage,
respectively.
Construct validity and internal reliability. The solution
that emerged from the PCA highlighted 8 principal factors
with eigenvalues ⬎1, which accounted for 71% of the
overall variance within the data set. Internal reliability is
perceived as acceptable for factors/domains with a Cron-
bach’s alpha coefficient ⬎0.7 (23). The domains identified
were physical health (␣ ⫽ 0.95), emotional health (␣ ⫽
0.95), body image (␣ ⫽ 0.90), pain (␣ ⫽ 0.89), planning
(␣ ⫽ 0.93), fatigue (␣ ⫽ 0.94), intimate relationships (␣ ⫽
0.60), and burden to others (␣ ⫽ 0.86).
Item reduction and change of response scale. A revised
questionnaire was produced using information gained
from the PCA, patient feedback, and clinical decision.
Items that did not have a factor loading of at least 0.5
or loaded onto more than 1 factor were removed. Items
that did not significantly reduce the alpha coefficient of
975
Table 1. Major themes identified by the patients*
Concerns (themes) Patients
Prognosis and course of disease 25 (83)
Body image 25 (83)
Effects of treatment 23 (77)
Emotional difficulties 19 (63)
Inability to plan due to disease unpredictability 19 (63)
Fatigue 17 (57)
Pain 16 (53)
Career prospects and loss of income 14 (47)
Memory loss/concentration 14 (47)
Reliance on others to assist with everyday tasks 13 (43)
Pregnancy 11 (37)
* Values are the number (percentage).
the domain and the clinical value of the instrument when
removed were also deleted. Written comments were re-
ceived from 49% of patients and were carefully studied.
Three types of amendments were made: 5 questions
were rephrased because they were ambiguous; the re-
sponse scale was amended (“sometimes” was removed)
because the patients had difficulty in discriminating be-
tween sometimes and occasionally; and a “not applicable”
option was included for 8 questions (relating to intimate
relationships and body image) because they were not rel-
evant to patients without partners or these clinical fea-
tures. In total, 21 items were removed. The LupusQoL
(version 2) had 42 items and a 5-point Likert response
scale.
Psychometric testing of the second and third (final)
versions of the LupusQoL (stage 5). The second version of
the LupusQoL was mailed to 345 patients and 215 (64.6%)
patients returned the questionnaire. Of the respondents,
the mean ⫾ SD age was 46.2 ⫾ 13.3 years and 96% were
women. The third version was mailed to 115 patients and
administered in clinic to 93 patients. Of these patients,
77% responded. The mean ⫾ SD age was 45.3 ⫾ 13.9 years
and 95% were women.
Construct validity and internal reliability. For the sec-
ond version, again the PCA highlighted the original 8
principal factors. The domains had alpha coefficients rang-
ing from 0.79 to 0.94. Following the removal of another 8
items, testing of the final version of the LupusQoL with 34
items confirmed the 8 factors with eigenvalues ⬎1 and
accounted for 82% of the variance. All the factor loadings
and Cronbach’s alpha coefficients of the 8 domains of the
final LupusQoL are presented in Table 2. The final Lu-
pusQoL instrument is presented in Appendix A (available
at the Arthritis Care & Research Web site at http://www.
interscience.wiley.com/jpages/0004-3591:1/suppmat/index.
html). The physical health domain comprises item num-
bers 1– 8, pain comprises 9 –11, planning comprises 12–14,
intimate relationships comprises 15 and 16, burden to
others comprises 17–19, emotional health comprises 20 –
25, body image comprises 26 –30, and fatigue comprises
31–34. For each domain, final LupusQoL summary data,
floor and ceiling effects, and missing responses are given
in Table 3.
976 McElhone et al

Table 2. Factor loadings and Cronbach’s alpha coefficients for the 8 domains of the final LupusQoL

Component

1 2 3 4 5 6 7 8

Cronbach’s ␣ 0.94 0.94 0.89 0.92 0.93 0.88 0.96 0.94

Physical health 1 0.712* 0.226 0.189 0.041 0.111 0.173 0.311 ⫺0.074
Physical health 2 0.846* 0.225 0.120 0.111 0.154 0.160 0.168 0.007
Physical health 3 0.761* 0.133 0.174 0.154 0.127 0.118 0.100 0.291
Physical health 4 0.753* 0.151 0.091 0.285 0.249 0.259 0.133 0.033
Physical health 5 0.549* 0.189 0.218 0.255 0.259 0.104 0.407 0.034
Physical health 6 0.729* 0.173 0.112 0.365 0.325 0.072 ⫺0.008 0.140
Physical health 7 0.631* 0.192 0.129 0.426 0.337 0.221 0.139 0.022
Physical health 8 0.500* 0.287 0.242 0.512 0.255 0.170 0.128 ⫺0.004
Emotional health 1 0.189 0.754* 0.101 0.087 0.282 0.216 0.235 0.122
Emotional health 2 0.193 0.846* 0.160 0.114 0.231 0.122 0.055 0.126
Emotional health 3 0.244 0.790* 0.268 0.135 0.171 0.126 0.032 ⫺0.036
Emotional health 4 0.109 0.837* 0.129 0.220 0.139 0.138 0.225 0.050
Emotional health 5 0.184 0.751* 0.220 0.292 0.185 0.131 0.119 0.086
Emotional health 6 0.412 0.430* 0.470 0.113 0.276 0.037 0.142 0.190
Body image 1 0.298 0.410 0.560* 0.203 0.095 0.141 0.042 0.410
Body image 2 0.180 0.322 0.572* 0.192 0.195 0.181 0.187 0.452
Body image 3 0.151 0.373 0.765* 0.165 0.003 0.118 ⫺0.154 0.089
Body image 4 0.071 0.086 0.805* 0.073 0.277 0.028 0.226 ⫺0.176
Body image 5 0.184 0.085 0.700* 0.109 0.038 0.387 0.307 0.119
Pain 1 0.426 0.319 0.101 0.585* 0.225 0.206 0.338 0.124
Pain 2 0.302 0.261 0.172 0.688* 0.226 0.144 0.291 0.125
Pain 3 0.462 0.174 0.107 0.492* 0.295 0.141 0.334 0.296
Planning 1 0.353 0.295 0.237 0.298 0.527* 0.217 0.119 0.328
Planning 2 0.351 0.341 0.060 0.278 0.525* 0.273 0.223 0.329
Planning 3 0.244 0.304 0.085 0.310 0.514* 0.314 0.298 0.385
Fatigue 1 0.333 0.309 0.336 0.471 0.096 0.374* 0.197 0.121
Fatigue 2 0.277 0.303 0.266 0.325 0.190 0.621* 0.222 ⫺0.010
Fatigue 3 0.191 0.118 0.114 0.040 0.255 0.807* 0.067 0.142
Fatigue 4 0.254 0.381 0.220 0.327 0.096 0.657* 0.124 ⫺0.032
Intimate relationships 1 0.395 0.262 0.162 0.375 0.158 0.164 0.695* 0.081
Intimate relationships 2 0.334 0.247 0.221 0.257 0.142 0.178 0.731* 0.073
Burden to others 1 0.351 0.378 0.195 0.222 ⫺0.032 0.272 0.181 0.609*
Burden to others 2 0.383 0.369 0.260 0.205 ⫺0.097 0.207 0.076 0.626*
Burden to others 3 0.331 0.346 0.154 0.178 0.071 0.133 0.083 0.741*

* Factor loading relevant to domain.

Testing of discriminant validity, concurrent validity, for 269 patients who had completed the LupusQoL within
and test–retest reliability (stage 6). Discriminant validity. the same 4-week time frame. Significant main effects were
Disease activity data using the BILAG index were available observed for all LupusQoL domains except fatigue: phys-

Table 3. LupusQoL summary data, floor and ceiling effects, and missing responses

10% floor effects 10% ceiling effects Missing responses

LupusQoL domains Total scores, (% minimum (% maximum (% unable to
(no. of items in domain) mean ⴞ SD (range) score of 0) score of 100) score domain)

Physical health (8 items) 60.06 ⫾ 26.45 (3.13–100) 4.8 (0.0) 10.4 (4.1) 0.0
Emotional health (6 items) 72.79 ⫾ 20.70 (0–100) 2.5 (0.6) 20.4 (7.5) 1.3
Body image (5 items) 72.11 ⫾ 25.70 (0–100) 2.2 (1.3) 25.6 (15.7) 0.9*
Pain (3 items) 63.61 ⫾ 27.30 (0–100) 6.0 (2.2) 19.5 (10.1) 1.3
Planning (3 items) 66.26 ⫾ 29.21 (0–100) 5.6 (2.8) 28.2 (21.0) 1.0
Fatigue (4 items) 51.98 ⫾ 24.52 (0–100) 5.6 (1.9) 6.2 (4.00) 0.3
Intimate relationships (2 items) 61.05 ⫾ 33.06 (0–100) 10.8 (10.8) 19.3 (19.3) 1.0*
Burden to others (3 items) 59.19 ⫾ 28.02 (0–100) 8.6 (4.3) 14.3 (8.1) 0.0

* An additional 1.6% (body image) and 7.3% (intimate relationship) responses were missing because items were reported as not applicable by the
patient.
Development and Validation of the Revised LupusQoL 977

Table 4. Discriminatory ability of the LupusQoL: different levels of disease activity as assessed by the BILAG index and
damage as assessed by the SDI*

BILAG index

Group 1 SDI
Ds, Es, or Cs Group 2 Group 3 Group 4
only in all B in only B in >2 A in any
systems 1 system systems system SDI ⴝ 0 SDI > 1
(n ⴝ 120) (n ⴝ 95) (n ⴝ 47) (n ⴝ 19) (n ⴝ 166) (n ⴝ 108) P (95% CI)

Physical health 65.89 ⫾ 24.59 56.57 ⫾ 25.40 55.00 ⫾ 29.56 53.62 ⫾ 29.76 64.41 ⫾ 29.97 52.74 ⫾ 26.36 ⬍ 0.002
(4.43, 20.48)
Emotional health 76.96 ⫾ 19.67 69.06 ⫾ 21.73 72.25 ⫾ 19.02 66.01 ⫾ 22.10 73.54 ⫾ 20.93 72.35 ⫾ 20.31 NS
(⫺3.70, 9.06)
Body image 77.57 ⫾ 23.34 68.31 ⫾ 27.70 65.97 ⫾ 25.72 70.53 ⫾ 25.22 73.35 ⫾ 25.19 70.31 ⫾ 26.17 NS
(⫺5.69, 9.91)
Pain 68.43 ⫾ 26.53 61.26 ⫾ 25.13 59.33 ⫾ 30.67 55.70 ⫾ 30.81 67.55 ⫾ 26.18 56.83 ⫾ 28.44 ⬍ 0.02
(1.34, 17.81)
Planning 71.68 ⫾ 27.67 64.01 ⫾ 28.56 58.16 ⫾ 32.67 63.82 ⫾ 28.47 69.87 ⫾ 28.41 60.51 ⫾ 30.16 ⬍ 0.02
(1.64, 19.32)
Fatigue 55.64 ⫾ 24.45 49.31 ⫾ 24.48 47.30 ⫾ 23.26 53.62 ⫾ 26.46 53.83 ⫾ 23.85 49.09 ⫾ 25.26 NS
(⫺2.51, 12.40)
Intimate relationships 67.06 ⫾ 29.06 54.63 ⫾ 36.27 60.80 ⫾ 34.16 57.89 ⫾ 32.33 64.63 ⫾ 32.36 54.65 ⫾ 33.70 ⬍ 0.01
(2.96, 23.70)
Burden to others 64.72 ⫾ 27.02 57.80 ⫾ 28.35 52.48 ⫾ 25.65 47.81 ⫾ 32.26 62.04 ⫾ 27.65 55.78 ⫾ 27.82 ⬍ 0.04
(0.61, 17.59)

* Values are the mean ⫾ SD unless otherwise indicated. BILAG ⫽ British Isles Lupus Assessment Group; SDI ⫽ Systemic Lupus International
Collaborating Clinics/American College of Rheumatology Damage Index; 95% CI ⫽ 95% confidence interval; NS ⫽ not significant; A ⫽ severe disease
activity; B ⫽ moderate disease activity; C ⫽ mild disease activity; D ⫽ inactive disease; E ⫽ not involved.

ical health (F ⫽ 3.44, P ⬍ 0.01), emotional health (F ⫽ Scoring. The final LupusQoL has a 5-point Likert re-
3.38, P ⬍ 0.02), body image (F ⫽ 3.39, P ⬍ 0.01), pain (F ⫽ sponse format, where 0 ⫽ all of the time, 1 ⫽ most of the
2.63, P ⬍ 0.05), planning (F ⫽ 2.85, P ⬍ 0.02), intimate time, 2 ⫽ a good bit of the time, 3 ⫽ occasionally, and 4 ⫽
relationships (F ⫽ 3.16, P ⬍ 0.01), and burden to others never. Item response scores are totaled for each domain
(F ⫽ 3.68, P ⬍ 0.02) (Table 4). Post hoc analysis estab- and the mean raw domain score is obtained by dividing
lished that the LupusQoL discriminated between different the total score by the number of items in that domain. The
levels of severity. For all domains except fatigue, patients mean raw domain score is transformed to scores ranging
with no current activity and/or only mild activity in any from 0 (worst HRQOL) to 100 (best HRQOL) by dividing by
systems reported a better HRQOL (groups 1 and 2) than 4 (the number of Likert responses [5 responses] minus 1)
those with moderate activity in any systems (group 3) and and then multiplying by 100, as below:
those with severe active disease in any systems (group 4).
mean raw domain score
SDI data were completed for 262 patients who had com- ⫻ 100
pleted the LupusQoL. Patients with no damage reported a 4
better HRQOL than those with damage for physical health ⫽ transformed score for domain
(t ⫽ 3.58, P ⬍ 0.002), pain (t ⫽ 3.14, P ⬍ 0.02), planning
(t ⫽ 2.58, P ⬍ 0.02), intimate relationships (t ⫽ 2.33, P ⬍ Transformed domain scores are obtainable when at least
0.01), and burden to others (t ⫽ 1.87, P ⬍ 0.04) (Table 4). 50% of the items are answered. The mean raw domain
Concurrent validity. A total of 314 patients completed
Table 5. Test–retest reliability of the LupusQoL*
both the LupusQoL and the SF-36 at the same time. For the
4 comparable domains, the 2 measures correlated well (r ⫽ No. of patients who
0.71 for physical health/physical functioning, r ⫽ 0.79 for Domain remained stable ICC (95% CI)
emotional health/mental health, r ⫽ 0.76 for pain/bodily
pain, r ⫽ 0.72 for fatigue/vitality), indicating that the Lu- Physical health 36 0.93 (0.87, 0.97)
Emotional health 40 0.85 (0.74, 0.92)
pusQoL has good concurrent validity.
Body image 42 0.80 (0.65, 0.89)
Test–retest reliability. A total of 83 of 105 patients com- Pain 74 0.85 (0.77, 0.90)
pleted a repeat LupusQoL (79% response rate). The num- Planning 49 0.86 (0.77, 0.92)
ber who reported that their health had remained stable Fatigue 33 0.72 (0.50, 0.85)
(scores of ⫺1, 0, and 1) over the 4 weeks varied with the Intimate relationships 26 0.87 (0.73, 0.94)
domain of the scale. The number of patients who reported Burden to others 60 0.76 (0.64, 0.85)
stable health for each domain, the ICC, and the 95% con-
* QoL ⫽ quality of life; ICC ⫽ intraclass correlation coefficient; 95%
fidence interval are presented in Table 5. Good test–retest CI ⫽ 95% confidence interval.
reliability was observed for each domain of the LupusQoL.
978
score is then calculated by totaling the item response
scores of the answered items and dividing by the number
of answered items. A nonapplicable response is treated
as unanswered and the domain score is calculated as
above.
Patients typically completed the LupusQoL in ⬍10 min-
utes. The scoring and the transformation of the scores took
⬃5 minutes.
DISCUSSION
We have described the development and validation of a
new HRQOL instrument for adults with SLE. The evalua-
tion of the LupusQoL indicates that it is a valid and reli-
able disease-specific measure. The content was derived
from semistructured interviews with patients with SLE
and psychometric testing with patient feedback through-
out. Therefore, the items and response scale have been
generated by the patients as the primary source, which is
essential because this ensures the instrument is relevant
and acceptable to patients (24). In our opinion, item gen-
eration by patients is preferable to item generation based
on the literature, experts, and other second-hand sources.
The final LupusQoL consists of 34 items, making it short
and practical to use in research studies and clinical prac-
tice. The LupusQoL demonstrates good concurrent va-
lidity with the comparable domains of the SF-36. The
advantage of the LupusQoL is that it contains disease-
specific items and domains, which will provide SLE-
specific information regarding patients’ perceived health
status. The patients have anecdotally reported that the
LupusQoL is more meaningful and relevant than the
SF-36, and therefore it may be more sensitive to measuring
change. No unusual response patterns were identified
with the final 5-point Likert scale in terms of end aver-
sion or midpoint responding. Although 2 patients scored
100 for each domain, this may have resulted from their
considered response rather than response bias. Even with
a generous estimate of floor and ceiling effects, ceiling
effects were acceptable whereas floor effects were mini-
mal. Missing responses were low, suggesting that the
LupusQoL is acceptable.
Currently there are no LupusQoL data regarding sensi-
tivity to change over time, therefore it is not possible to
estimate clinically relevant changes. However, the results
of the test–retest reliability analysis demonstrate the sta-
bility of the instrument, which provides the foundation for
the evaluation of responsiveness to change.
Measurement of true construct validity is complex be-
cause it is an ongoing process of assessing whether the
LupusQoL performs consistently with theoretical expecta-
tions. The measure would be expected to discriminate
between levels of disease activity and damage, and indeed
the LupusQoL was able to discriminate between most
groups based on BILAG and SDI scores. Patients with more
active disease reported a poorer quality of life across all
domains except fatigue, whereas some domains (emo-
tional health, body image, and fatigue) were not able to
discriminate between patients with or without damage.
This does not make the measure/domains invalid. Rather,
McElhone et al
lack of discrimination may sometimes be desirable be-
cause HRQOL is typically conceptualized as being inde-
pendent of clinical status. Furthermore, it may be possible
to provide a clinical explanation for this result. Some
damage is amenable to treatment (e.g., cataracts), whereas
some damage is longstanding and the patient may have
adjusted psychologically. Fatigue is a major concern for
adults with SLE, so scores on the fatigue domain tended
to be poor regardless of levels of disease activity and/or
damage.
Men were not involved in the early stages of question-
naire development (item generation/pretesting) but oppor-
tunity was provided for comments from both men and
women during later stages, and these comments were
given due consideration. In stages 1 and 3, a qualitative
methodology was used and emphasis was placed on ob-
taining a comprehensive range of individual patients’ ex-
periences of living with SLE. This purposive sampling
may have coincidentally led to a higher mean age than
would be expected for this disease group. These patients
were also recruited from a nonteaching center, which may
have a different case mix from study populations in the
literature that are mainly derived from teaching centers. In
the subsequent stages, the majority of participating pa-
tients were from teaching centers. Therefore, the sum total
of all the study participants in the LupusQoL develop-
ment/validation is potentially more representative of the
overall British SLE population.
Difficulty with memory/concentration was reported by
nearly half (47%) of the patients during the interviews and
was predominantly related to the coordination of activities
(e.g., remembering tasks to do or items to buy). Patients did
not appear to experience problems when recalling how
SLE impacted on their lives generally and in the last 4
weeks. When patients expressed difficulty with certain
items, this was reflective of the deficiency of the question-
naire design rather than their ability to understand. There-
fore, it is unlikely that memory problems affected the
patients’ reporting during the development/validation of
the instrument.
There are currently 2 other SLE-specific scales pub-
lished in the literature: the SLE Symptom Checklist (SSC)
(25) and the SLE-specific Quality of Life instrument
(SLEQOL) (26). The SSC is a useful list of 38 symptoms
and their perceived burden to the patients. Because the
SSC is purely a symptom scale, the authors concede that it
does not evaluate HRQOL in a comprehensive manner.
The SLEQOL is an SLE HRQOL measure and its items
were derived from health professionals and were subse-
quently verified by patients who may have been reluctant
to challenge the health professionals’ ideas. Some of the
domains (physical function, pain, burden) are less com-
prehensively assessed in the SLEQOL than the LupusQoL.
The former contains no items related to body image, which
is an important aspect for patients (27). The SLEQOL pro-
vides a global score and the LupusQoL provides a profile
of domain scores. Both instruments are validated for En-
glish-speaking patients in different cultures: the SLEQOL
in a Singaporean Chinese population, and the LupusQoL
in a predominantly British white population. Currently,
the use of both instruments is limited to these populations
Development and Validation of the Revised LupusQoL
until further cultural adaptation and validation is under-
taken. Adaptations and application of the LupusQoL in
other languages and cultural settings are currently under-
way. In the US, other adult and pediatric lupus-specific
scales are currently under development (28,29). The most
appropriate HRQOL measure for use in a study will de-
pend on the research question and the study population.
ACKNOWLEDGMENTS
We would like to acknowledge the assistance of Julie Gray
with the transcripts, Janet Walker with database manage-
ment, and John Goodacre for helpful comments and en-
couragement during the development of the proposed
work.
AUTHOR CONTRIBUTIONS
Dr. Teh had full access to all of the data in the study and takes
responsibility for the integrity of the data and the accuracy of the
data analysis.
Study design. Abbott, Teh.
Acquisition of data. McElhone, Shelmerdine, Bruce, Ahmad, Gor-
don, Peers, Isenberg, Ferenkeh-Koroma, Griffiths, Akil, Maddison,
Teh.
Analysis and interpretation of data. McElhone, Abbott, Teh.
Manuscript preparation. McElhone, Abbott, Bruce, Ahmad, Gor-
don, Peers, Isenberg, Akil, Maddison, Teh.
Statistical analysis. McElhone, Abbott, Teh.
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 Appendix A. LupusQoL Questionnaire
The following questionnaire is designed to find out how SLE affects your life. Read each statement and then circle the
response, which is closest to how you feel. Please try to answer all the questions as honestly as you can.

How often over the last 4 weeks

1. Because of my Lupus I need help to do heavy physical jobs such as digging the garden, painting and/or decorating, moving
furniture
All of the time most of the time a good bit of the time occasionally never
2. Because of my Lupus I need help to do moderate physical jobs such as vacuuming, ironing, shopping, cleaning the
bathroom
All of the time most of the time a good bit of the time occasionally never
3. Because of my Lupus I need help to do light physical jobs such as cooking/preparing meals, opening jars, dusting, combing
my hair or attending to personal hygiene
All of the time most of the time a good bit of the time occasionally never
4. Because of my Lupus I am unable to perform everyday tasks such as my job, childcare, housework as well as
I would like to
All of the time most of the time a good bit of the time occasionally never
5. Because of my Lupus I have difficulty climbing stairs
All of the time most of the time a good bit of the time occasionally never
6. Because of my Lupus I have lost some independence and am reliant on others
All of the time most of the time a good bit of the time occasionally never
7. I have to do things at a slower pace because of my Lupus
All of the time most of the time a good bit of the time occasionally never
8. Because of my Lupus my sleep pattern is disturbed
All of the time most of the time a good bit of the time occasionally never
How often over the last 4 weeks
9. I am prevented from performing activities the way I would like to because of pain due to Lupus
All of the time most of the time a good bit of the time occasionally never
10. Because of my Lupus, the pain I experience interferes with the quality of my sleep
All of the time most of the time a good bit of the time occasionally never
11. The pain due to my Lupus is so severe that it limits my mobility
All of the time most of the time a good bit of the time occasionally never
12. Because of my Lupus I avoid planning to attend events in the future
All of the time most of the time a good bit of the time occasionally never
13. Because of the unpredictability of my Lupus I am unable to organise my life efficiently
All of the time most of the time a good bit of the time occasionally never
14. My Lupus varies from day to day which makes it difficult for me to commit myself to social arrangements
All of the time most of the time a good bit of the time occasionally never
15. Because of the pain I experience due to Lupus I am less interested in a sexual relationship
All of the time most of the time a good bit of the time occasionally never not applicable
16. Because of my Lupus I am not interested in sex
All of the time most of the time a good bit of the time occasionally never not applicable
17. I am concerned that my Lupus is stressful for those who are close to me
All of the time most of the time a good bit of the time occasionally never
18. Because of my Lupus I am concerned that I cause worry to those who are close to me
All of the time most of the time a good bit of the time occasionally never
19. Because of my Lupus I feel that I am a burden to my friends and/or family
All of the time most of the time a good bit of the time occasionally never
Over the past 4 weeks I have found my Lupus makes me
20. Resentful
All of the time most of the time a good bit of the time occasionally never
21. So fed up nothing can cheer me up
All of the time most of the time a good bit of the time occasionally never
22. Sad
All of the time most of the time a good bit of the time occasionally never
23. Anxious
All of the time most of the time a good bit of the time occasionally never
24. Worried
All of the time most of the time a good bit of the time occasionally never
25. Lacking in self-confidence
All of the time most of the time a good bit of the time occasionally never
How often over the past 4 weeks
26. My physical appearance due to Lupus interferes with my enjoyment of life
All of the time most of the time a good bit of the time occasionally never
(continued)
e2
 e3

Appendix A LupusQoL Questionnaire (Continued)

The following questionnaire is designed to find out how SLE affects your life. Read each statement and then circle the response,
which is closest to how you feel. Please try to answer all the questions as honestly as you can.

27. Because of my Lupus, my appearance (e.g. rash, weight gain/loss) makes me avoid social situations
All of the time most of the time a good bit of the time occasionally never not applicable
28. Lupus related skin rashes make me feel less attractive
All of the time most of the time a good bit of the time occasionally never not applicable
How often over the past 4 weeks
29. The hair loss I have experienced because of my Lupus makes me feel less attractive
All of the time most of the time a good bit of the time occasionally never not applicable
30. The weight gain I have experienced because of my Lupus treatment makes me feel less attractive
All of the time most of the time a good bit of the time occasionally never not applicable
31. Because of my Lupus I cannot concentrate for long periods of time
All of the time most of the time a good bit of the time occasionally never
32. Because of my Lupus I feel worn out and sluggish
All of the time most of the time a good bit of the time occasionally never
33. Because of my Lupus I need to have early nights
All of the time most of the time a good bit of the time occasionally never
34. Because of my Lupus I am often exhausted in the morning
All of the time most of the time a good bit of the time occasionally never
Please feel free to make any additional comments.

Please check that you have answered each question

Thank you, for completing this questionnaire
©2006. University of Central Lancashire & East Lancashire Hospitals NHS Trust. All rights reserved. Not to be reproduced in
whole or in part without the permission of the copyright holder.