1. DEVELOPMENT AND PRELIMINARY
TESTING OF AN OFFICIAL FIVE-
LEVEL VERSION OF EQ-5D
Herdman M1, Gudex C2, Lloyd A3, Janssen B4,
Kind P5, Parkin D6, Bonsel G7, Badia X8
1
Insight
Insight Consulting & Research, Mataró, Spain. IMIM-Hospital del Mar, Barcelona, Spain
Mataró IMIM-
2
Odense University Hospital, Odense, Denmark. 3Oxford Outcomes Ltd, Oxford, UK.
4
EuroQol Group Executive Office, Rotterdam, The Netherlands. 5University of York, York,
UK. 6NHS South East Coast, UK. 7Erasmus Medical Centre, Rotterdam, The Netherlands.
8
IMS Health, Barcelona, Spain

2. Background
Mobility (MOB)
I have no problems in walking about
I have some problems in walking about
I am confined to bed
Self-care (SC)
I have no problems with self-care.
I have some problems washing or dressing myself
I am unable to wash or dress myself
Usual activities (e.g. work, study, housework, etc) (UA)
I have no problems with performing my usual activities
I have some problems with performing my usual activities.
I am unable to perform my usual activities
Pain / discomfort (PD)
I have no pain or discomfort…
I have moderate pain / discomfort
I have extreme pain / discomfort
Anxiety / depression (AD)
I am not anxious or depressed
I am moderately anxious or depressed
I am extremely anxious or depressed

3. Background
EQ-5D robust, well-validated, but….
– Substantial ceiling effects in some populations
– (Perceived as) insensitive to small changes in
health status or between-group differences,
particularly in milder disease
EuroQol Group research programme to explore
issues in developing a new and improved EQ-5D
Literature and prior research suggest advantages
with a 5 level version of the EQ-5D (with the same
number of dimensions)

4. Objectives
To develop official 5 level versions of
EQ-5D for UK and Spain and test their
face and content validity

5. METHODS
Two-stage approach:
i) response scaling in UK and Spain to
select severity labels for 5L version
ii) focus groups to assess face and
content validity of new versions in each
country

6. METHODS, PHASE 1:
LABEL SELECTION
Candidate labels for new severity levels selected from:
– review of existing PRO instruments
– literature
– searches in dictionaries and thesauruses
– informal questioning of lay people
Tested in face-to-face interviews in convenience samples of
lay people in Spain and UK
Label severity assessed using response scaling
≈ 40 respondents per country

7. METHODS, PHASE 1:
LABEL SELECTION
Respondents asked to assign a numerical value (0 – 100) to
each candidate label, individually
40 cm vertical, hash-marked visual analogue scale (VAS)
used as a visual aid
Anchors = (No problems, no pain, no anx/dep) and (unable
to, worst pain or anx/dep I can imagine)
Labels then ranked by numerical value to confirm
respondent ratings
MOB, SC, UA always separated by PD or AD

8. METHODS, PHASE 1: LABEL
SELECTION - ANALYSIS
Medians (IQRs) calculated for each
label
Labels selected according to:
– 25th, 50th and 75th centiles
– Consistency across dimensions
– Avoid possible translation problems

9. METHODS, PHASE 2: FACE
AND CONTENT VALIDITY
TWO alternative 5L versions tested in focus groups to
assess face and content validity
FOUR hypothetical 5L generated health states also tested
for face validity, interpretability, plausibility
EIGHT focus groups each in UK and Spain: 4 with
‘healthy’ participants, 4 with patients (primarily asthma,
diabetes, arthritis)
Range of socio-demographic characteristics
Groups led by experienced moderator using structured
script

10. METHODS, PHASE 2: FACE
AND CONTENT VALIDITY
Complete ALT 1 individually
Complete EQ-5D VAS
Discussion on ALT 1: acceptability, ease of
completion, overall impression
Collect socio-demographic data
Complete ALT 2 individually
Discussion on ALT 2: acceptability, ease of
completion, overall impression
Preferences for ALT 1 or ALT 2
Discussion of hypothetical health states
generated from ALT 1 and ALT 2

11. METHODS, PHASE 2: FACE AND
CONTENT VALIDITY- ANALYSIS
Transcripts reviewed by two researchers in each
country
Thematic analysis of overall impression, preferences
between alternative 5 level versions, and health state
descriptions
Selection of final version based on comments
regarding acceptability, comprehension of alternative
versions and stated preferences

12. RESULTS: PHASE 1, SAMPLE
CHARACTERISTICS
UK Spain
(n=40) (n=37)
Sex Male 18 (45%) 16 (43%)
Age <= 40 17 (43%) 19 (51%)
> 40 15 (57%) 18 (49%)
Educational Low (no
4 (10%) 7 (19%)
level qualifications)
Middle (left
21 (53%) 8 (22%)
school 16-18 yrs)
High (university
13 (33%) 22 (59%)
or equivalent)

13. RESULTS: PHASE 1, LABEL RATINGS
(functional dimensions; median, IQR)
Slight Minor A few Some Moderate Many A lot Major Severe Very Extreme
Moderados Bastantes
Leves Menores Algunos unos Muchos Mayores Graves severe Extremos
cuantos Muy
graves
Mobility
UK 15 17 20 30 43 60 70 85 82 90 90
(10-25) (10-25) (11-30) (20-40) (35-50) (51-75) (59- 80) (80-90) (76-90) (85-95) (90-95)
Spain 15 17 25 35 47 70 75 70 85 95 95
(8-28) (10-28) (15-46) (25-42) (28-50) (58-75) (69-80) (60-80) (80-90) (87-99) (90-98)
Self-care
UK 15 20 20 30 45 65 70 80 85 95 90
(10-29) (10-29) (15-30) (20-39) (40-50) (60-79) (60-75) (75-90) (80-90) (90-97) (90-95)
Spain 20 20 25 35 42 65 79 70 88 95 95
(10-27) (12-30) (14-31) (20-50) (30-50) (60-75) (70-88) (60-80) (80-90) (90-98) (90-99)
Usual activity
UK 15 15 25 30 50 70 70 80 85 90 90
(10-25) (10-25) (16-40) (20-40) (35-50) (60-75) (55-75) (75-90) (80-90) (86-95) (90-95)
Spain 15 15 20 30 40 69 70 75 85 90 95
(9-25) (9-22) (10-30) (20-45) (30-50) (47-75) (60-85) (65-80) (80-92) (88-98) (90-99)

14. RESULTS: PHASE 1, LABEL RATINGS
(PD, AD; median, IQR)
Pain/discomfort
A little Slight Mild Some Moderate A lot Severe Very Extreme
(un poco) (igero) (Leve) (algo de) (moderado) (mucho) (fuerte) severe (extremo)
(muy fuerte)
UK 10 10 15 20 45 70 80 90 90
(10-20) (10-20) (10-25) (10-30) (35-50) (60-75) (70-85) (85-93) (85-95)
Spain 18 -- 18 20 45 75 75 85 95
(10-26) (10-26) (10-30) (30-50) (69-80) (65-82) (75-90) (90-99)
Anxiety/depression
A little Slightly Mildly Some Moderately Quite Very Severely Very Extremely
(un poco) (ligera- (leve- (moderadamente) (Bastante) (muy) (severa) severely (extrema-
-what
mente) mente) (muy severa) damente)
(algo)
UK 16 20 25 30 40 43 78 85 90 90
(10-25) (10-30) (11-35) (16-40) (30-50) (30-59) (70- (80-90) (85-95) (85-95)
80)
Spain 20 15 15 20 40 65 75 85 85 95
(10-30) (10-25) (10-25) (10-38) (30-50) (50-70) (70- (78-90) (75-90) (90- 99)
80)

15. RESULTS: PHASE 1, ALTERNATIVE
VERSIONS FOR FURTHER TESTING
ALTERNATIVE A ALTERNATIVE B
Mobility (self-care, usual activities) Mobility (self-care, usual activities)
I have no problems walking about I have no problems walking about
I have slight problems walking about I have minor problems walking about
I have moderate problems walking about I have moderate problems walking about
I have severe problems walking about I have major problems walking about
I am unable to walk about I am unable to walk about
Pain / discomfort Pain / discomfort
I have no pain / discomfort I have no pain / discomfort
I have slight pain /discomfort I have mild pain /discomfort
I have moderate pain / discomfort I have moderate pain / discomfort
I have severe pain / discomfort. I have severe pain / discomfort
I have extreme pain / discomfort I have extreme pain / discomfort
Anxiety / depression Anxiety / depression
I am not anxious or depressed I am not anxious or depressed
I am slightly anxious or depressed I am mildly anxious or depressed
I am moderately anxious or depressed I am moderately anxious or depressed
I am severely anxious or depressed I am severely anxious or depressed
I am extremely anxious or depressed I am extremely anxious or depressed

16. RESULTS: PHASE 2
SOCIODEMOGRAPHIC
CHARACTERISTICS FOCUS GROUPS
UK Spain
Healthy Patients Healthy Patients
Sex N=15 N=15 N=18 N=19
Women, N (%) 8 (53) 5 (33.3) 12 (66.6) 11 (57.8)
Age
Years, mean (SD) 42.5 43.1 45.7 63.3
Educational level, N (%)
Further education after
leaving school
14 (93.3) 19 (66.7) 6 (33.3) 4 (21)
Main activity, N (%)
Employed 8 (53.3) 6 (40.0) 12 (66.6) 11 (57.8)
Seeking work 3 (20.0) 4 (26.6) 3 (16.6) 1 (5.2)
Student 3 (20.0) 1 (6.7) - -
Retired 1 (6.7) 3 (20.0) 3 (16.6) 7 (36.8)
Missing 0 (0.0) 1 (6.7) - -

17. RESULTS: PHASE 2,
PARTICIPANT COMMENTS
Overall impression: Participants generally found both versions easy to
complete and acceptably phrased:
“They are very clear points, and there is no doubt that you go from less to
more”. “All different levels seem to be covered.”
“I found it hard to choose between ‘leve’ and ‘moderado’ to describe my
problems in the first 3 dimensions”.
Preferences for ALT 1, ALT 2: Participants in UK and Spain generally
preferred Alternative A (‘slight’, ‘severe’ over ‘minor’ ‘major’)
“I think ‘slight’ and ‘severe’ reflects better the way we talk about health problems.
People don’t really say ‘minor’ and ‘major’ in relation to health problems.”

18. RESULTS: PHASE 2,
PARTICIPANT COMMENTS
Health states: participants understood the hypothetical health states
without significant problems, but insisted that health states need to be
internally consistent, e.g.
• “I almost done away with ‘unable to do my usual activities’ because there’s
only mild pain, minor problems, not anxious, no problems, so basically I
chucked that one [unable to do my usual activities] out the way, forgot about
it”

19. RESULTS: FINAL VERSIONS
FOR FURTHER TESTING
Mobility (self-care / usual activities) Movilidad (cuidado-personal / actividades
I have no problems walking about habituales)
I have slight problems walking about No tengo problemas para caminar
I have moderate problems walking about Tengo problemas leves para caminar
I have severe problems walking about Tengo problemas moderados para caminar
I am unable to walk about Tengo problemas graves para caminar
No puedo caminar
Pain / discomfort
I have no pain / discomfort Dolor / malestar
I have slight pain /discomfort No tengo dolor ni malestar
I have moderate pain / discomfort Tengo dolor o malestar leve
I have severe pain / discomfort Tengo dolor o malestar moderado
I have extreme pain / discomfort Tengo dolor o malestar fuerte
Tengo dolor o malestar extremo
Anxiety / depression
I am not anxious or depressed Ansiedad / depresión
I am slightly anxious or depressed No estoy ansioso ni deprimido
I am moderately anxious or depressed Estoy levemente ansioso o deprimido
I am severely anxious or depressed Estoy moderadamente ansioso o deprimido
I am extremely anxious or depressed Estoy muy ansioso o deprimido
Estoy extremadamente ansioso o deprimido

20. CONCLUSIONS
• Official 5L version of EQ-5D now available (UK,
Spain + a further 29 language versions developed or
underway)
• Good face validity
• Health states generated by 5L version apparently
well understood, but care required to ensure internal
coherence
• High levels of education of respondents in some
exercises
• Convenience samples, so not generalizable
• Psychometric properties of new version need to be
tested (against the 3L version)
• Are ceiling effects and sensitivity improved?
• Need to develop value sets for new 5L versions

21. FUTURE RESEARCH
• Psychometric properties of new version need to be
tested (against the 3L version)
• Are ceiling effects and sensitivity improved?
• Need to develop value sets for new 5L versions

22. ACKNOWLEDGEMENTS
Research project funded by the EuroQol
Group Foundation