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RESEARCH ARTICLE

Different Wording of the Patient Global Visual Analogue


Scale (PG-VAS) Affects Rheumatoid Arthritis Patients’
Scoring and the Overall Disease Activity Score (DAS28):
A Cross-Sectional Study
Tracy French1, Sarah Hewlett2, John Kirwan3 & Tessa Sanderson2*
1
Rheumatology Department, Bristol Royal Infirmary, Bristol, UK
2
University of West of England, Bristol, and Academic Rheumatology, Bristol Royal Infirmary, Bristol, UK
3
University of Bristol and Division of Medicine, Bristol Royal Infirmary, Bristol, UK

Abstract
Objective. The Disease Activity Score in 28 joints (DAS28) is a key measure in clinical practice and clinical trials.
There are at least five different versions of the ‘Patient Global’ Visual Analogue Scale (PG-VAS) being used in
the DAS28. The developers suggested that the PG-VAS can be an assessment of global health or disease activity,
but did not specify the wording of the question. There is no consensus on what the PG-VAS is intended to capture,
and the different words and phrases have not been evaluated. The aim of this study was to test if phrasing affects
PG-VAS scores and hence yields different results for the DAS28.
Methods. Fifty patients with rheumatoid arthritis taking biologic agents in a rheumatology outpatient department
completed a self-administered questionnaire containing five versions of the 100 mm PG-VAS.
Results. All PG-VAS versions correlated strongly with each other (rho = 0.67–0.87, p < 0.0001). However, individ-
ual scores for each PG-VAS, when compared with the comparator on a Bland–Altman chart had wide limits of
agreement—the largest being 42 mm to +45 mm. The five overall DAS28 scores were calculated for each patient
using the five different PG-VAS. The largest difference in DAS28 scores was 0.63.
Conclusion. Different phrasing of the PG-VAS gives different DAS28 results. As the DAS28 is a key outcome mea-
sure, such differences have the potential to influence clinical decisions relating to eligibility for biologic agents and
evaluation of new therapies. We urgently need to decide on the concept to be measured and the phrasing required
to capture this. The PG-VAS phrasing should then be standardized and validated. Copyright © 2013 John Wiley &
Sons, Ltd. Copyright © 2013 John Wiley & Sons, Ltd.
Keywords
Rheumatoid arthritis; outcomes research; patient perspective; DAS28

*Correspondence
Tessa Sanderson, Academic Rheumatology, Bristol Royal Infirmary, Lower Maudlin Street, Bristol, BS2 8HW, UK. Tel: +44 (0)117 342 2901;
Fax: +44 (0)117 342 3841 Email: Tessa2.Sanderson@uwe.ac.uk

Published online 4 February 2013 in Wiley Online Library (wileyonlinelibrary.com) DOI: 10.1002/msc.1046

Introduction the efficacy of these drugs in clinical practice is critical


to ensure that erosive damage to joints is prevented and
Rheumatoid arthritis (RA) is controlled using disease- to maintain quality of life for patients. The ultimate
modifying anti-rheumatic drugs (DMARDs) such as goal is to achieve remission. The cost of biologic thera-
methotrexate and glucocorticoids and/or biologic ther- pies is far higher than for traditional DMARDs so there
apies, depending on the severity of disease. Assessing is the extra consideration of financial implications

Musculoskelet. Care 11 (2013) 229–237 © 2013 John Wiley & Sons, Ltd. 229
Wording of the Patient Global Visual Analogue Scale French et al.

when assessing response to biologics. The British because it could capture non-inflammatory issues such
Society for Rheumatology Biologics Register (2009) as low back pain and functional limitations (Masri et al.,
and the European League Against Rheumatism 2012). The PG-VAS is also an important component of
(EULAR) (Smolen et al., 2010) recommend that the the RA core set (Felson et al., 1995), indices such as the
Disease Activity Score in 28 joints (DAS28) is used in Clinical Disease Activity Index (CDAI) (Aletaha et al.,
clinical practice to evaluate the response to therapies 2005) and may be used independently by clinicians to
by assessing clinical disease activity, and it is commonly assess patient status; whenever it is used, the same limita-
used in clinical trials and treat-to-target strategies. The tions apply. However, we focus here on the DAS28
DAS28 is a composite index of four process variables: because of its role to determine eligibility for biologic
28-tender joint count, 28-swollen joint count, a mea- agents.
sure of inflammatory markers [either C-reactive pro- There is no clarity about the concept that the DAS
tein (CRP) or erythrocyte sedimentation rate] and a PG-VAS should capture, or how it should be phrased
‘Patient Global’ Visual Analogue Scale (PG-VAS) (van in order to do so. The DAS28 algorithm uses a weighting
der Heijde et al., 1992). The DAS was developed based of 0.014 for the PG-VAS. Given this small weighting, it is
on the clinical judgement of six rheumatologists during possible that differences in phrasing would result in little
a prospective study, aiming to standardize the compar- difference to the overall DAS28 score but, alternatively,
ison of treatment efficacy across trials (van der Heijde the differences in scoring could be significant. The current
et al., 1992). However, there was no patient involve- study therefore aimed to test whether i) different phrasing
ment in developing the wording of the PG-VAS and affects how patients score the PG-VAS, and ii) if any
there is no ‘gold standard’ for the phrasing of the PG- differences in scores were large enough to alter their sub-
VAS. Publications on the development of the DAS do sequent calculated DAS28 score.
not specify the actual phrasing of the stem question
for the PG-VAS, or the timeframe (Prevoo et al., Methods
1995; van der Heijde, 1998; van der Heijde et al.,
1992, 1993; van Gestel et al., 1996). Patients
The DAS was validated using an unspecified ‘general Consecutive adult patients with RA attending nurse-led
health’ PG-VAS (van der Heijde et al., 1993), but the biologic clinics in one centre over a two-month period
DAS website (DAS Group, 2001) suggests that a were invited to participate. The questionnaires could be
‘disease activity’ PG-VAS can also be used, although completed at home or within the clinic, but no profes-
this has not been validated. Several authors have vari- sional assistance was given during completion to ensure
ously reported that the PG-VAS (unspecified phrasing) that no bias occurred. Patients were excluded if they
is presumed to capture ‘disease activity’, ‘general could not complete the questionnaire independently
health’ and ‘arthritis impact’ (Harrison et al., 2009; or if they were not fluent in English. Written consent
Kalyoncu et al., 2009; Smedstad et al., 1997). It is was obtained and ethics approval was granted by the
unlikely that one question can assess all these aspects Frenchay Research Ethics Committee (10/HO107/13).
of RA. The literature shows a disparity in the phrasing
of the PG-VAS (Meenan et al., 1980; Scott et al., 1993;
Outcome measures
van Gestel and van Riel, 1997; van Gestel et al., 1998).
Porter and colleagues (2011) have highlighted this issue Five published or commonly used versions of the PG-VAS
and suggested that a standardized approach should be were tested (Table 1). Four were taken from the literature
used when assessing the PG-VAS, although this was not (see Table 1) and one from a rheumatology nurse pilot
based on data. For the assessment of remission in RA, survey of current clinical practice (French, 2010, unpub-
the American College of Rheumatology (ACR)/EULAR lished), but which is not found in the literature. All of
have suggested that the patient global assessment uses the PG-VASs were presented in the same format, with a
the following phrasing: ‘Considering all of the ways your horizontal 100 mm scale without marks and with the
arthritis has affected you, how do you feel your arthritis same timeframe (previous seven days). Version 5 [Arthri-
is today?’ (Anchors: very well–very poor) (Felson et al., tis Impact Measurement Scales (AIMS) phrasing]
2011). This version of the question is very important for (Meenan et al., 1980) is used locally and does not specify
future clinical practice, but may affect remission rates a timeframe; it was decided not to change this, because it

230 Musculoskelet. Care 11 (2013) 229–237 © 2013 John Wiley & Sons, Ltd.
French et al. Wording of the Patient Global Visual Analogue Scale

Table 1. Versions of the PG-VAS used in the study

PG-VAS version Stem Instructions Anchors Source and changes

1. Feeling How do you feel concerning your Please place a mark on the Very well to Extremely (van Gestel et al., 1998: 1846)
arthritis over the last week? line below bad Timeframe added
2. Disease activity How active has your disease been Please place a mark on the Not active at all to (Scott et al., 1993: 27)
this week? line below Extremely active Statement turned into a
question
3. Well-being How has your overall well-being Please indicate on the scale Best imaginable health (British Society for
been this week? below state to Worst imaginable Rheumatology, 2009)
health state Timeframe added
4. Best/worst If 0 is the best you have ever been Please place a mark on the Best you have ever been to (French, 2010), unpublished
and 100 is the worst you have ever line below Worst you have ever been
been, where do you think you have
been over the last week?
5. AIMS Considering all the ways your . . .mark on the line below Very well to Very badly (Meenan et al., 1980)
arthritis affects you. . . how well you are doing.

AIMS, arthritis impact measurement scales; PG-VAS, ‘patient global’ visual analogue scale

would alter clinical practice for all patients attending the (DAS Group, 2001). Prior to any analysis of the data, a
centre. One of the PG-VAS versions that had originally one-way (repeated measure) analysis of variance test
been a statement was presented as a question to aid com- was conducted to identify any order effect there may
prehension and provide consistency. have been from the four differently ordered question-
PG-VAS versions 1–4 were embedded in a self- naires. Parametric or non-parametric analyses were
administered questionnaire, separated by a larger conducted as appropriate to the data distribution. The
set of standard questions and other VAS measures shared variance (r2) between all pairs of PG-VAS was
(detailed below) which served as ‘distracters’. The calculated and Bland–Altman plots were produced to
PG-VAS versions 1–4 were differently ordered in four illustrate the limits of agreement between individual
questionnaire packs, and these were given out in scores for the comparator PG-VAS version 5 and each
sequence, so that any order effect bias could be detected. of the other PG-VASs. Correlation coefficients were
Version 5, the locally used phrasing of the PG-VAS used also calculated to determine the strength and direction
as a comparator, was collected as part of routine assess- of the relationship between the five DAS28 scores,
ment during the consultation. Swollen and tender joint calculated with the five versions of PG-VAS. Each
counts, CRP and the Health Assessment Questionnaire PG-VAS was also correlated with the other clinical
(HAQ) Disability Index (Fries et al., 1980) were collected, variables collected, and with a three-variable DAS28
along with 100 mm VASs for fatigue (‘Please place a mark (swollen joint count, tender joint count and CRP,
on the line to show your level of fatigue over the last omitting the patient global question) to assess their
7 days’; anchors: ‘No fatigue’ and ‘Totally exhausted’), relationship with these disease activity measures.
emotional well-being (‘Considering all the ways your
arthritis affects you, please mark on the line below to
Results
show your sense of emotional well-being today’; anchors:
‘Little emotional well-being’ and ‘Great emotional well- Of 54 sequential patients approached, 53 were
being’) and pain (‘How much pain have you had over recruited and 50 completed the study. The sample
the last 24 hours?’; anchors: ‘No pain’ and ‘Severe pain’). characteristics are presented in Table 2, and show a
wide range in disease activity (DAS28 1.79–7.69).
The repeated measures one-way analysis of variance
Statistical methods
gave a Wilks’ l of 0.984 (p = 0.870), showing that
A sample size of 50 provides 90% power to detect a 0.1 there was no order effect of versions 1–4 of the PG-
unit effect on the DAS28 (based on a 7 mm difference VAS on patient scores. Scores for PG-VAS versions
in the PG-VAS score equalling a 0.1 change in 1–4 were normally distributed (0.073–0.112 Kolmo-
DAS28, using the DAS28 algorithm with four variables) gorov–Smirnov, p > 0.05, indicating normality) but the

Musculoskelet. Care 11 (2013) 229–237 © 2013 John Wiley & Sons, Ltd. 231
Wording of the Patient Global Visual Analogue Scale French et al.

Table 2. Sample characteristics (rho = 0.69) and HAQ (rho = 0.62), all p < 0.0001
(Table 5). The ‘Disease Activity’ PG-VAS correlated
Number (%) or mean
Variable (SD)
least well compared with the other versions: Disease
activity (DAS28 with three variables tender, swollen
Gender, female 39 (78%)
joint count and CRP) (rho = 0.64, p < 0.0001), HAQ-
Ethnicity, White British 46 (92%)
Age (years) 58.2 (13.9) DI (rho = 0.45, p < 0.001) and Fatigue VAS (rho = 0.48,
Disease duration (years) 16.4 (9.2) p < 0.0001). The effect of differences in PG-VAS scores
HAQ-DI (n = 49) 1.65 (0.9) on the overall DAS28 was assessed by calculating the
DAS28 (PG-VAS version 5), taken on day 4.31 (1.5)
five DAS28 scores for each patient using the different
recruited
PG-VAS scores. These correlated strongly and posi-
DAS28, disease activity score in 28 joints; HAQ-DI, Health Assess- tively—all better than 0.98 (96% variance, p < 0.001).
ment Questionnaire - Disability Index; PG-VAS, ‘patient global’ visual
The amount of agreement between individual
analogue scale; SD, standard deviation
participant scores for versions 1–4 of the PG-VAS and
the comparator [‘AIMS’ PG-VAS (version 5)] and for
PG-VAS version 5 was non-normally distributed (0.15 the DAS28 versions 1–4 and the comparator [‘AIMS’
Kolmogorov–Smirnov), so non-parametric tests were DAS (version 5)] are shown in Table 5. There were
used in the analysis. However, the DAS28 scores calculated wide 95% limits of agreement, the largest being be-
from the PG-VAS scores in the second part of the analysis tween the ‘Disease Activity’ PG-VAS (version 2) and
were normally distributed so they were analysed using the ‘AIMS’ PG-VAS (version 5) with a range of
parametric tests. The inter-quartile ranges for the five 41.86 mm to +45.26 mm from a maximum possible
PG-VASs are presented in Table 3, illustrating that the range of 100 mm to +100 mm. For the DAS28 values,
mean scores were very similar, but that all PG-VASs had the smallest limits of agreement were between the
a wide distribution of scores. ‘Feeling’ PG-VAS (version 1) and the ‘AIMS’ PG-VAS
All PG-VAS scores correlated strongly and positively (version 5) (0.43 to +0.42), and the largest between
(rho = 0.67–0.87, p < 0.0001) (Table 4), and the coeffi- the ‘Disease Activity’ PG-VAS (version 2) and the
cient can be interpreted as large if r ≥ 0.50 (Bland and ‘AIMS’ PG-VAS (version 5) (0.59 to +0.63).
Altman, 1986). Shared variance was calculated, show-
ing that the ‘Disease Activity’ PG-VAS (version 2) had
Discussion
the least shared variance with the three general
health/well-being PG-VASs (versions 3, 4 and 5). The The effect of phrasing on PG-VAS scores
‘Feeling’ and ‘Best/Worst’ PG-VASs (versions 1 and The current study showed that different words or
4) showed the highest amount of shared variance. Cor- phrasing of the Patient Global VAS change the scoring
relations between the PG-VAS and other clinical mea- of the PG-VAS and that this changes the value of the
sures are also shown in Table 4. The ‘Feeling’ PG- subsequently calculated DAS score. The strong and
VAS correlated strongly with most other measures: positive correlations found between the different ver-
Pain VAS (rho = 0.81), disease activity [DAS28 with sions of the PG-VAS are to be expected as they are
three variables (i.e. tender, swollen joint count and measuring a similar global variable which is broadly
CRP)] (rho = 0.74), Emotional Well-being PG-VAS determined by the overall state of the patient’s arthritis.
However, as Bland and Altman (1986) demonstrate, it
Table 3. Descriptive statistics for the five versions of the PG-VAS is the ‘limits of agreement’ which better describe the
(N = 50)
measurement accuracy of two measures of the same
PG-VAS version Mean (SD) Median Inter-quartile range construct. There were wide 95% limits of agreement
between the PG-VAS scores, indicating a clear lack
1. Feeling 43.22 (27.01) 41.00 19, 65
2. Disease activity 41.36 (28.41) 39.50 17, 65
of agreement between the different versions of the
3. Well-being 41.40 (24.61) 41.00 24, 62 PG-VAS. This is the case for other measures of disease
4. Best–worst 42.00 (25.40) 39.50 21, 61 activity when testing reliability (e.g. Uhlig et al., 2009).
5. AIMS 43.06 (24.29) 39.00 26, 62 In the Bland–Altman analysis, 50% or more patients
AIMS, arthritis impact measurement scales; PG-VAS, ‘patient global’ had a difference between PG-VAS versions 1–4 and
visual analogue scale the comparator ‘AIMS’ PG-VAS (version 5). This

232 Musculoskelet. Care 11 (2013) 229–237 © 2013 John Wiley & Sons, Ltd.
French et al.

Table 4. Correlations (rho) between the five versions of the PG-VAS and the five versions of the DAS calculated from them, and shared variance (%), and other measures (all p < 0.0001, except where
indicated) (N = 50)

PG-VAS scores Other measures

Emotional
2. Disease Fatigue VAS well-being VAS HAQ Pain VAS DAS28† Swollen joint Tender joint
activity 3. Well-being 4. Best/worst 5. AIMS (N = 50) (N = 49) (N = 49) (N = 49) (CRP) count count CRP

Musculoskelet. Care 11 (2013) 229–237 © 2013 John Wiley & Sons, Ltd.
1. Feeling 0.70 (49.0) 0.76 (57.8) 0.87 (75.7) 0.82 (67.2) 0.69 0.69 0.62 0.81 0.75 0.69 0.62 0.37*
2. Disease 0.67 (44.9) 0.74 (54.8) 0.67 (44.9) 0.48 0.67 0.45 0.71 0.69 0.70 0.65 0.00{
activity
3. Well-being 0.79 (62.4) 0.74 (54.8) 0.81 0.66 0.49 0.63 0.71 0.64 0.63 0.21{
4. Best/worst 0.70 (49.0) 0.67 0.67 0.51 0.76 0.76 0.72 0.66 0.22{
5. AIMS 0.64 0.65 0.54 0.80 0.80 0.74 0.71 0.34**

All p < 0.0001 except:


*p < 0.05
**p < 0.01
{
Not significant

Calculated without the PG-VAS (i.e. on three clinical variables only)
AIMS, arthritis impact measurement scales; CRP, C-reactive protein; DAS28, disease activity score in 28 joints; HAQ, health assessment questionnaire; VAS, visual analogue scale
Wording of the Patient Global Visual Analogue Scale

233
Wording of the Patient Global Visual Analogue Scale French et al.

strongly suggests that the different words and phrases and ‘Extremely bad’) be used for the PG-VAS for the
do capture different information. patient component of the DAS28. That is, if the VAS
The PG-VAS has a weighting of 0.014 within the is to capture the global patient experience, this phrasing
DAS28 calculation, so that the maximum difference is most effective. While this version of this PG-VAS has
that the PG-VAS can make to the overall DAS28 is similarities to that proposed by the ACR/EULAR
1.4 (shown by holding the other variables constant remission group (Felson et al., 2011), we recommend
and using first a PG-VAS score of 0 mm, then of that the ‘Feeling’ PG-VAS (version 1) phrasing is used
100 mm). The different scores for the PG-VAS ver- as it is based on data, whereas the ACR/EULAR remis-
sions, when translated into the DAS28, showed differ- sion group did not report the decision-making process
ences in the DAS28 scores. The largest DAS28 that led to their proposed version. Contrary to Masri
difference reported here was 0.63, which is easily large and colleagues’ (2012) contention that the PG-VAS is
enough to affect the assessment of suitability for, and problematic because it captures non-inflammatory
response to, biologic agents and DMARDs. Treatment factors, we argue that this broader measurement is
with anti-tumour necrosis factor (TNF) therapy should favourable.
only be continued in the National Health Service if Since the current study was undertaken, Dougados
there is an adequate response (an improvement in and colleagues (2011) have published a comparison of
DAS28 of 1.2 points or more) at six months following two PG-VASs: a general health status PG-VAS (‘In
initiation of therapy (National Institute for Health general, how would you rate your health over the last
and Clinical Excellence, 2007). However, physicians in- 2–3 weeks?’) and an RA disease activity PG-VAS
terpret DAS scores, and the differences shown in the (‘Please estimate your disease activity over the last
current study may not influence their interpretations 48 hours’). This was carried out in a larger sample of
and subsequent clinical decisions in other circum- 108 patients in a clinical trial of etanercept, from
stances. Nevertheless, tight control strategies (Bakker screening to 12 weeks after commencing therapy. They
et al., 2012) imply the use of outcome measures such used the intra-class correlation coefficient to compare
as the DAS. the results for the two techniques and found similar
Different phrasings of the PG-VAS correlate scores, but they concluded that the DAS28 was not
differently with specific clinical variables. The ‘Disease significantly affected by the different techniques used
Activity’ PG-VAS had the least amount of shared vari- to assess the PG-VAS. There are, however, differences
ance with three other PG-VAS and had the widest 95% between the studies which may limit direct comparison
limits of agreement on the Bland–Altman plot. It also of the results. First, the sample was in a clinical trial
correlated least well with other measures (DAS28 with rather than being ‘real life’ patients. Second, Dougados
three variables, HAQ-DI and Fatigue VAS), whereas and colleagues (2011) did not specify where the phras-
the ‘Feeling’ PG-VAS correlated well with these. There- ing of the two PG-VASs they tested originated. In spite
fore, based on these data it would be recommended of their results, they recommend that standardization
that the phrasing ‘How do you feel concerning your ar- of the phrasing is preferable, to reduce heterogeneity
thritis over the last week?’ (with anchors: ‘Very well’ in scoring of the DAS28, and recommend that further
analysis of this issue is needed.
Fries and Ramey (1997) compared a quality of life
Table 5. The 95% limits of agreement (mm) in Bland-Altman (EuroQoL) vertical feeling thermometer with a hori-
plots for the AIMS PG-VAS (version 5) compared to the PG-VAS zontal VAS using the AIMS phrasing (PG-VAS version
versions 1–4, and for the AIMS DAS28 (version 5) compared to
DAS versions 1–4
5) and concluded that the two scales produced similar
results. Their study was much larger (n = 663), with
AIMS PG-VAS AIMS DAS 43 patients being retested six months later. Their corre-
1. Feeling 30.34 to þ30.02 0.43 to þ0.42
lations were r = 0.68 (p < 0.0001) with strong retest
2. Disease activity 41.86 to þ45.26 0.59 to þ0.63 scores. They concluded that the small differences found
3. Well-being 32.27 to þ35.59 0.45 to þ0.50 were due to the differences in phrasing and presenta-
4. Best/Worst 35.39 to þ37.51 0.50 to þ0.53 tion of the two scales. However, they did not examine
AIMS, arthritis impact measurement scales; DAS, disease activity their data to look at variance or agreement between
score; PG-VAS, ‘patient global’ visual analogue scale the two scales. Further analysis of individual scores

234 Musculoskelet. Care 11 (2013) 229–237 © 2013 John Wiley & Sons, Ltd.
French et al. Wording of the Patient Global Visual Analogue Scale

(with a Bland–Altman plot), rather than groups of not currently explained (van Tuyl and Boers, 2012)
scores (with Pearson’s correlation), may have shown a and how to construct the ideal phrasing to capture
lack of agreement between the two scales, as was the those determinants.
case in the present study.
Harrison et al. (2009) compared responses to a
Strengths and limitations of the study
global health VAS, presented both as a 10 cm horizon-
tal VAS with no incremental markers, and a vertical A limitation of the study may be the decision not to
20 cm VAS with 1 cm markers. They concluded that change the comparator ‘AIMS’ phrasing (PG-VAS
different presentation of scales, order effect and incre- version 5) to include a timeframe, which may have
mental markers on VAS affect scoring. The present adversely influenced the study results. Also, the inter-
study addressed these possibilities for bias and showed pretation of the significance of the limits of agreement
that phrasing alone affects scoring. on the Bland–Altman plots is clinical rather than
Wolfe and Michaud (2009) studied over 20,000 RA 2statistical, due to the distribution of the data collected.
patients to assess whether treatment success as deter- However, the range of DAS28 scores is comparable with
mined by outcome measures (including the DAS28) those of Smith and colleagues (2007), who conducted
were also defined as successful by patients in terms of a study with 679 patients examining the necessity of
health satisfaction. They found a correlation of 0.46 be- pre-assessment for anti-TNF therapy. This indicates that
tween DAS28 and PG VAS (AIMS phrasing). From this the results are generalizable to other patients attending
lack of agreement they identified the importance to biologic clinics. Recruitment of patients from a nurse-
patients of not only having fewer tender and swollen led biologic clinic is unlikely to have consequences for
joints, but also of feeling better in themselves. This the representativity of the findings because care is shared
highlights the fact that the patient opinion is vital for with the rheumatologists. It was not possible to calculate
assessing the success of drug therapies as well as clinical test–retest reliability for the same measures in this study,
signs. It is therefore paramount that the small contri- and such calculations may indicate that a range of differ-
bution that patients make to the DAS is evaluated in ences within a measure are the result of natural variation.
an effective and standardized way. This should include
addressing variation in phrasing, presentation and Conclusion
timeframe. Prior to standardization of this outcome
The present study has shown that different phrasing of
measure, a consensus is required on what the PG-VAS
the PG-VASs gives different DAS28 results; therefore,
should capture. Those questions relating to overall health
this outcome measure should be standardized. In the
or general well-being may be assessing the impact of
UK, the DAS28 is used to assess eligibility for and
disease, which may be a composite of disease
response to biologic therapies. National disparity in
activity, the patient’s ability to self-manage and the
the implementation of the DAS28 could potentially af-
importance of consequences of their condition
fect patient access to these expensive and extremely ef-
(Sanderson et al., 2011).
fective treatments. Internationally, clinical trials use the
Recent qualitative research, primarily to define well-
EULAR response criteria (Smolen et al., 2010) and the
being and flare, shows that patients do not consider the
ACR core set of outcome measures (Felson et al.,
similarly phrased and commonly used PG-VAS version
1995), which both include a PG-VAS; thus, the results
5 (AIMS question) to capture disease activity, and
of the study are applicable in all research settings in
would favour a more direct question if that is the
which these response criteria are used. First, greater
intended target (Hewlett et al., 2012; Sanderson,
clarity is needed about the underlying construct being
2009). In an observational study, it was found that pain
assessed by patient global questions; then greater rigour
was the main determinant (75.6%) for the PG-VAS
should be used in the standardization and validation of
when phrased ‘How do you estimate your disease activ-
patient global measurement instruments.
ity today?’ (0 = no disease activity, 100 mm highly ac-
tive disease) (Studenic et al., 2012). Therefore, further
qualitative research with patients may be necessary to
Acknowledgements
allow researchers to determine the remaining 25% of We thank the patient research partners who advised on
variability in the perception of disease activity that is the study: Bev Davies and Val Lloyd; Rosemary

Musculoskelet. Care 11 (2013) 229–237 © 2013 John Wiley & Sons, Ltd. 235
Wording of the Patient Global Visual Analogue Scale French et al.

Greenwood for statistical advice; and Arthritis Research European League Against Rheumatology provisional defi-
UK for an educational bursary (TF). The study was nition of remission in rheumatoid arthritis for clinical
sponsored by Arthritis Research UK (educational trials. Arthritis and Rheumatism 63: 573–86.
bursary: grant no. 17974). Fries JF, Ramey DR (1997). ‘Arthritis specific’ global
health analog scales assess ‘generic’ health related
quality-of-life in patients with rheumatoid arthritis.
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