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Michael Herdman

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  • 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