LupusPRO (Lupus Patient Reported Outcome Tool) v1.7
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1 LupusPRO (Lupus Patient Reported Outcome Tool) v1.7 Authors: Meenakshi Jolly and Simon Pickard For information on, or permission to use tool, please contact: Meenakshi Jolly, MD Assistant Professor of Medicine Rheumatology, Department of Medicine Rush University Medical Center 1611 W Harrison Street, Suite 510 Chicago, Il Phone: Fax: Meenakshi_Jolly@rush.edu Copyright: Rush University and University of Illinois at Chicago Conditions of use: With Author s written Permission Free for academic/non- profit research, with signature of an agreement With fees for commercial/pharmaceutical companies, with signature of an agreement: For rates, contact Matw Raymond at or matw_j_raymond@rush.edu
2 LupusPRO is a disease targeted patient reported outcome tool for patients with systemic lupus erymatosus (SLE). It was developed from ethnically diverse US patients with SLE (1-3). It has been validated for use in US. It has 43 items of which 30 items are for health related quality of life. It has two constructs Health Related Quality of Life and Non-health related quality of life. The HRQOL domains include Lupus Symptoms Lupus Medications Cognition, Procreation Physical health Emotional Health Pain & Vitality Body Image N-HRQOL domains include Desires & Goals Coping Social Support Satisfaction with medical Care Time to completion: 7-10 minutes Translations: Available in Spanish and French
3 LupusPRO (v 1.7) This questionnaire asks for your views about effect of lupus or its treatment on your health, quality of life, and medical care you receive related to your lupus. Answer each question by placing a cross mark (x) in response box that best describes you. If you are unsure about how to answer a question, please answer as best you can. There is no right or wrong answer. Please select only one response to each question. You may choose option for a question only if a box is provided in that column for that particular question. A. In past 4 weeks, how often did you experience following due to your lupus? 1. Loss of hair A little of Some of Most of skin rashes side effects. medications being received for lupus. affect ability to have a baby. pregnancy. 2. New or flare of previous lupus-related 3. Lupus flare 4. Poor memory 5. Lack of concentration 6. Lupus medication(s) related borsome 7. Concern about number of 8. Concern that lupus medication(s) will 9. Worry about ability to prevent unplanned B. How often were you limited in performing following daily activities because of your physical health due to your lupus over past 4 weeks? 10. Taking care of your personal needs Some of Most of (dress, comb hair, toilet, eat, ba) 11. Getting in and out of a bed or chair depend on me (family, pet). 12. Fulfilling family responsibilities 13. Taking care of those who directly
4 C. How often did you feel following due to your lupus during past 4 weeks? 14. I felt I was a burden to family or friends due to my inability to perform daily activities. 15. I woke up feeling worn out Some of Most of due to bodily pain 16. I felt pain and aching in my body 17. I was unable to do my usual activities 18. I was unable to perform usual activities for long periods of (e.g. around home or at work) because of pain or fatigue 19. I was limited in kinds of tasks or activities I could perform because of pain or fatigue D. During past 4 weeks, how often did you feel because of your lupus that you were: 20. Worried about lupus impact on my Some of Most of future may lead to more health problems 21. Worried about losing income 22. Anxious 23. Depressed 24. Concerned that lupus (or its treatment) 25. Concerned that lupus related health problems will last a long E. During past 4 weeks, how often did you feel following due to lupus? 26. I disliked my appearance Some of Most of appearance 27. I thought less of myself 28. I lacked control over my appearance 29. I was self conscious about my 30. I was embarrassed about how ors perceived me
5 F. During past 4 weeks, how often did lupus interfere with your: 31. Ability to plan activities and schedule Some of Most of events 32. Overall life satisfaction 33. Enjoyment of life 34. Fulfillment of career goals G. During past 4 weeks, how often would you say in regards to your lupus? Some of Most of H. During past 3 months, how often did you feel following about medical care for lupus you received? religious or spiritual beliefs. 35. I received support from my friends. 36. I received support from my family. 37. I focused on making my situation better. 38. I learned to live with my lupus. 39. I received comfort/strength from my Some of Most of 40. My doctor was accessible when I had a question regarding my lupus. 41. My doctor understood impact of lupus on my life. 42. My doctor provided me with information I need to understand my lupus. 43. My doctor discussed/ monitored side effects of lupus medicine/s. Thank you for completing this questionnaire. Please check to make sure all questions have been answered. 2007, Rush University Medical Center and Board of Trustees of University of Illinois at Chicago. All rights reserved
6 Table 1: Summary Scores and Reliability of LupusPRO domains Domain Mean (SD, Range) Internal Consistency Reliability Test Retest Reliability Lupus Symptoms 74.1 (24.1, 0-100) Cognition 73.1 (27.8, 0-100) Lupus Medication 77.9 (27.2, 0-100) Physical Health 78.1 (22.9, 0-100) Pain-Vitality 60.4 (28.4, 0-100) Emotional Health 60.4 (28.6, 0-100) Procreation 90.9 (21.3, 0-100) Body Image 72.8 (29.0,0-100) General Health 68.6 (24.9, 0-100) NA 0.91 Desires/Goals 68.1 (29.2,0-100) Coping 69.7 (27.2,0-100) Social support 70.6 (30.9, 0-100) Satisfaction with care 76.5 (30.2,0-100)
7 Table 2. Validity of LupusPRO against SF36, disease activity and disease damage. *n=68 for BILAG Disease Activity Domain Lupus Symptoms SF36 (r, p value) n=236 Disease Damage (r, p value) n=68 (r, p value) n=184* PGA (-0.37, 0.001) SLEDAI ( -0.23, 0.002) LFA (-0.44, 0.001) General BILAG (-0.31,0.01), Muco-cutaneous BILAG (-0.47,0.001) Musculo-skeletal BILAG (-0.13,0.29) Total BILAG (-0.43,0.001) Cognition LFA (-0.19, 0.04) -0.23, 0.06 SLEDAI (-0.17,0.02) Lupus Medication -0.37, LFA (-0.15, 0.08) PGA (-0.14, 0.05) PF (0.62, 0.001) Physical Health LFA (-0.25, 0.004) RP (0.57, 0.001) Total BILAG (-0.23,0.05) PGA (-0.14, 0.06) BP (0.75, 0.001) LFA (-0.21, 0.02) Pain-Vitality VT (0.74,0.001) Musculo-skeletal BILAG (-0.26,0.03) Total BILAG (-0.27,0.02) PGA (-0.19, 0.01) SLEDAI (-0.14, 0.05) LFA (-0.20, 0.02) MH (0.64,0.001) Emotional Health Muco-cutaneous BILAG (-0.25,0.04) RE (0.52, 0.001) Musculo-skeletal BILAG (-0.21,0.09) Vasculitis BILAG (-0.31, 0.01) Total BILAG (-0.34,0.01) PGA (-0.20, 0.007) Procreation -0.24,0.05 SLEDAI (-0.18, 0.01) PGA (-0.20, 0.005) SLEDAI (-0.16, 0.03) LFA (-0.23, 0.01) Body Image -0.28,0.03 Muco-cutaneous BILAG (-0.25, 0.04) Vasculitis BILAG (-0.26,0.04) Total BILAG (-0.24,0.05) LFA (-0.21, 0.03) General Health GH (0.58, 0.001) Musculo-skeletal BILAG (-0.26,0.03) Vasculitis BILAG (-0.24, 0.04) PGA (-0.18, 0.01) SLEDAI (-0.22, 0.003) LFA (-0.18, 0.04) Desires/Goals General BILAG (-0.30,0.01) Muco-cutaneous BILAG (-0.33, 0.01) Musculo-skeletal BILAG (-0.35,0.001) Total BILAG (-0.50,0.001) Coping Vasculitis BILAG (-0.25, 0.04) Social support SS (0.20, 0.002) Vasculitis BILAG (-0.23, 0.06) -0.26, 0.04 PGA (0.18, 0.01) Satisfaction with care Musculo-skeletal BILAG (-0.23,0.06) Cardio-Pulmonary BILAG (-0.35, 0.001) PGA (-0.30, 0.001) SLEDAI (-0.32, 0.001) PCS (0.54, 0.001) LFA (-0.29, 0.002) HRQOL MCS (0.64, 0.001) -0.32,0.01 Muco-cutaneous BILAG (-0.23, 0.06) SF6D (0.68, 0.001) Musculo-skeletal BILAG (-0.22,0.08) Vasculitis BILAG (-0.21, 0.09) PCS (0.30, 0.001) Non-HRQOL MCS (0.27, 0.001) Vasculitis BILAG (-0.28, 0.02) SF6D (0.36, 0.001)
8 Table 3. Criterion validity of LupusPRO Lupus Symptoms PGA mean (SD) (n=182) (19.4) > (23.6) > (28.2) (p=0.001) Cognition (25.5) > (27.9) Lupus Medication > (31.4) (p=0.18) (26.4) > (25.8) > (32.8) (p=0.04) Physical Health (21.5) > (24.2) > (22.7) (p=0.02) Pain-Vitality (28.9) > (27.6) Emotional Health > (31.9) (p=0.14) (28.6) > (29.8) > (31.7) (p=0.01) Procreation (18.1) > (24.8) > (30.5) (p=0.02) Body Image (23.4) > (28.9) > (32.7) (p=0.01) General Health (18.8) > (21.4) > (28.5) (p=0.07) Desires/Goals (27.4) > (27.7) > (34.7) (p=0.008) Coping (27.9) > (26.4) > (32.2) (p=0.56) Social support (32.5) > (29.7) Satisfaction with care > (31.3) (p=0.58) (29.2) > (32.0) > (12.7) (p=0.02) LFA Flare mean (SD) (n=128) Yes 80.5 (21.6) No 51.6 (26.6) (p=0.001) Yes 72.5 (27.6) No 59.3 (27.3) (p=0.03) Yes 80.7 (26.4) No 70 (31.8) (p= ) Yes 79.7 (24.6) No 63.8 (22.3) (p=0.003) Yes 60.4 (29.5) No 45 (24.9) (p=0. 01) Yes 65.4 (29.5) No 50.0 (31.3) (p=0. 02) Yes 93.8 (19.5) No 90.0 (27.9) (p=0.42) Yes 79.2 (26.3) No 63.2 (30.5) (p=0. 009) Yes 63.4 (30.4) No 49.5 (26.9) (p=0. 03) Yes 73.3 (28.1) No 60.0 (30.1) (p= ) Yes 73.0 (26.4) No 69.7 (31.3) (p=0. 59) Yes 72.5 (32.4) No 67.0 (32.0) (p=0.45) Yes 76.4 (32.0) No 78.0 (28.7) (p=0.82)
9 Scoring for LupusPRO v1.7 Items Construct Domain Description Reverse Coding 1-3 HRQOL Lupus Symptoms Lupus Symptoms Yes 4-5 HRQOL Cognition Cognition Yes 6-7 HRQOL Lupus Medications Lupus Medications Yes 8-9 HRQOL Procreation Procreation Yes HRQOL Physical Health Physical Function, Role Physical Yes HRQOL Pain Vitality Pain Vitality Yes HRQOL Emotional Health Emotional function, Role Emotional Yes HRQOL Body Image Body Image Yes N-HRQOL Desires-Goals Desires, Goals, Plans Yes N-HRQOL Social support Support system No N-HRQOL Coping Coping No N-HRQOL Satisfaction with care Satisfaction with Lupus Care No The LupusPRO has 5 point Likert response format, where 0= /not applicable, 1= A little of, 2= Some of, 3=Most of, 4=, 5= applicable (recode as 0 for scoring). Reverse scoring for some items is required (as above). There are 12 observed domains. Item scores are totaled for each domain item and mean domain score is obtained by dividing total score by number of items in that domain. The mean raw domain score is transformed to scores ranging from 0 (worst QOL) to 100 (best QOL) by dividing by 4 ( number of Likert responses {5 responses} minus 1) and n multiplying by 100, as below: (Mean raw domain score/4) x 100= Transformed score for domain. Transformed domain scores are obtainable when at least 50% of items are answered. Total HRQOL and N-HRQOL scores are obtained by averaging transformed domain scores within each construct. Reference List (1) Jolly M, Pickard AS, Wilke C, Lin HW, Khandelwal S, Rodby R et al. Development and Validation of a US Lupus Specific Patient Reported Outcome Measure. Arthritis & Rheum. 56[9s], S (2) Jolly M, Pickard AS, Fogg L, Wilke C, Lin H, Mikolaitis R et al. US Patient Derived Lupus-Specific Patient Reported Outcome Measure (Lupus-PRO ): Validity and Reliability. Arthritis & Rheumatism 2008; 58(9s):S805. (3) Cervera J, Cooray D, Jolly M, Katsaros EP, Moldovan I, Shinada S et al. Predictors of Patient Reported Health Outcomes in A New Lupus Cohort in Sourn California. Arthritis & Rheum 60[10s], S
10 Table 1: Summary Scores and Reliability of LupusPRO domains Domain Mean (SD, Range) Internal Consistency Reliability Test Retest Reliability Lupus Symptoms 74.1 (24.1, 0-100) Cognition 73.1 (27.8, 0-100) Lupus Medication 77.9 (27.2, 0-100) Physical Health 78.1 (22.9, 0-100) Pain-Vitality 60.4 (28.4, 0-100) Emotional Health 60.4 (28.6, 0-100) Procreation 90.9 (21.3, 0-100) Body Image 72.8 (29.0,0-100) General Health 68.6 (24.9, 0-100) NA 0.91 Desires/Goals 68.1 (29.2,0-100) Coping 69.7 (27.2,0-100) Social support 70.6 (30.9, 0-100) Satisfaction with care 76.5 (30.2,0-100)
11 Table 2. Validity of LupusPRO against SF36, disease activity and disease damage. *n=68 for BILAG Disease Activity Domain Lupus Symptoms SF36 (r, p value) n=236 Disease Damage (r, p value) n=68 (r, p value) n=184* PGA (-0.37, 0.001) SLEDAI ( -0.23, 0.002) LFA (-0.44, 0.001) General BILAG (-0.31,0.01), Muco-cutaneous BILAG (-0.47,0.001) Musculo-skeletal BILAG (-0.13,0.29) Total BILAG (-0.43,0.001) Cognition LFA (-0.19, 0.04) -0.23, 0.06 SLEDAI (-0.17,0.02) Lupus Medication -0.37, LFA (-0.15, 0.08) PGA (-0.14, 0.05) PF (0.62, 0.001) Physical Health LFA (-0.25, 0.004) RP (0.57, 0.001) Total BILAG (-0.23,0.05) PGA (-0.14, 0.06) BP (0.75, 0.001) LFA (-0.21, 0.02) Pain-Vitality VT (0.74,0.001) Musculo-skeletal BILAG (-0.26,0.03) Total BILAG (-0.27,0.02) PGA (-0.19, 0.01) SLEDAI (-0.14, 0.05) LFA (-0.20, 0.02) MH (0.64,0.001) Emotional Health Muco-cutaneous BILAG (-0.25,0.04) RE (0.52, 0.001) Musculo-skeletal BILAG (-0.21,0.09) Vasculitis BILAG (-0.31, 0.01) Total BILAG (-0.34,0.01) PGA (-0.20, 0.007) Procreation -0.24,0.05 SLEDAI (-0.18, 0.01) PGA (-0.20, 0.005) SLEDAI (-0.16, 0.03) LFA (-0.23, 0.01) Body Image -0.28,0.03 Muco-cutaneous BILAG (-0.25, 0.04) Vasculitis BILAG (-0.26,0.04) Total BILAG (-0.24,0.05) LFA (-0.21, 0.03) General Health GH (0.58, 0.001) Musculo-skeletal BILAG (-0.26,0.03) Vasculitis BILAG (-0.24, 0.04) PGA (-0.18, 0.01) SLEDAI (-0.22, 0.003) LFA (-0.18, 0.04) Desires/Goals General BILAG (-0.30,0.01) Muco-cutaneous BILAG (-0.33, 0.01) Musculo-skeletal BILAG (-0.35,0.001) Total BILAG (-0.50,0.001) Coping Vasculitis BILAG (-0.25, 0.04) Social support SS (0.20, 0.002) Vasculitis BILAG (-0.23, 0.06) -0.26, 0.04 PGA (0.18, 0.01) Satisfaction with care Musculo-skeletal BILAG (-0.23,0.06) Cardio-Pulmonary BILAG (-0.35, 0.001) PGA (-0.30, 0.001) SLEDAI (-0.32, 0.001) PCS (0.54, 0.001) LFA (-0.29, 0.002) HRQOL MCS (0.64, 0.001) -0.32,0.01 Muco-cutaneous BILAG (-0.23, 0.06) SF6D (0.68, 0.001) Musculo-skeletal BILAG (-0.22,0.08) Vasculitis BILAG (-0.21, 0.09) PCS (0.30, 0.001) Non-HRQOL MCS (0.27, 0.001) Vasculitis BILAG (-0.28, 0.02) SF6D (0.36, 0.001)
12 Table 3. Criterion validity of LupusPRO Lupus Symptoms PGA mean (SD) (n=182) (19.4) > (23.6) > (28.2) (p=0.001) Cognition (25.5) > (27.9) Lupus Medication > (31.4) (p=0.18) (26.4) > (25.8) > (32.8) (p=0.04) Physical Health (21.5) > (24.2) > (22.7) (p=0.02) Pain-Vitality (28.9) > (27.6) Emotional Health > (31.9) (p=0.14) (28.6) > (29.8) > (31.7) (p=0.01) Procreation (18.1) > (24.8) > (30.5) (p=0.02) Body Image (23.4) > (28.9) > (32.7) (p=0.01) General Health (18.8) > (21.4) > (28.5) (p=0.07) Desires/Goals (27.4) > (27.7) > (34.7) (p=0.008) Coping (27.9) > (26.4) > (32.2) (p=0.56) Social support (32.5) > (29.7) Satisfaction with care > (31.3) (p=0.58) (29.2) > (32.0) > (12.7) (p=0.02) LFA Flare mean (SD) (n=128) Yes 80.5 (21.6) No 51.6 (26.6) (p=0.001) Yes 72.5 (27.6) No 59.3 (27.3) (p=0.03) Yes 80.7 (26.4) No 70 (31.8) (p= ) Yes 79.7 (24.6) No 63.8 (22.3) (p=0.003) Yes 60.4 (29.5) No 45 (24.9) (p=0. 01) Yes 65.4 (29.5) No 50.0 (31.3) (p=0. 02) Yes 93.8 (19.5) No 90.0 (27.9) (p=0.42) Yes 79.2 (26.3) No 63.2 (30.5) (p=0. 009) Yes 63.4 (30.4) No 49.5 (26.9) (p=0. 03) Yes 73.3 (28.1) No 60.0 (30.1) (p= ) Yes 73.0 (26.4) No 69.7 (31.3) (p=0. 59) Yes 72.5 (32.4) No 67.0 (32.0) (p=0.45) Yes 76.4 (32.0) No 78.0 (28.7) (p=0.82)
13 Scoring for LupusPRO v1.7 Items Construct Domain Description Reverse Coding 1-3 HRQOL Lupus Symptoms Lupus Symptoms Yes 4-5 HRQOL Cognition Cognition Yes 6-7 HRQOL Lupus Medications Lupus Medications Yes 8-9 HRQOL Procreation Procreation Yes HRQOL Physical Health Physical Function, Role Physical Yes HRQOL Pain Vitality Pain Vitality Yes HRQOL Emotional Health Emotional function, Role Emotional Yes HRQOL Body Image Body Image Yes N-HRQOL Desires-Goals Desires, Goals, Plans Yes N-HRQOL Social support Support system No N-HRQOL Coping Coping No N-HRQOL Satisfaction with care Satisfaction with Lupus Care No The LupusPRO has 5 point Likert response format, where 0= /not applicable, 1= A little of, 2= Some of, 3=Most of, 4=, 5= applicable (recode as 0 for scoring). Reverse scoring for some items is required (as above). There are 12 observed domains. Item scores are totaled for each domain item and mean domain score is obtained by dividing total score by number of items in that domain. The mean raw domain score is transformed to scores ranging from 0 (worst QOL) to 100 (best QOL) by dividing by 4 ( number of Likert responses {5 responses} minus 1) and n multiplying by 100, as below: (Mean raw domain score/4) x 100= Transformed score for domain. Transformed domain scores are obtainable when at least 50% of items are answered. Total HRQOL and N-HRQOL scores are obtained by averaging transformed domain scores within each construct. Reference List (1) Jolly M, Pickard AS, Wilke C, Lin HW, Khandelwal S, Rodby R et al. Development and Validation of a US Lupus Specific Patient Reported Outcome Measure. Arthritis & Rheum. 56[9s], S (2) Jolly M, Pickard AS, Fogg L, Wilke C, Lin H, Mikolaitis R et al. US Patient Derived Lupus-Specific Patient Reported Outcome Measure (Lupus-PRO ): Validity and Reliability. Arthritis & Rheumatism 2008; 58(9s):S805. (3) Cervera J, Cooray D, Jolly M, Katsaros EP, Moldovan I, Shinada S et al. Predictors of Patient Reported Health Outcomes in A New Lupus Cohort in Sourn California. Arthritis & Rheum 60[10s], S
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