The Journal of Rheumatology Volume 38, no. 9
Systemic Lupus Erythematosus
Generic Versus Dia-specific Measures of Health-related Quality of Life in VIBEKE STRAND and ALVINA D. CHU
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Editorial
Generic Versus Dia-specific Measures of Health-related Quality of Life in Systemic Lupus Erythematosus
Systemic lupus erythematosus (SLE) is an autoimmune inflammatory dia that significantly affects health-relat-ed quality of life (HRQOL): physical, psychologic, mental, and social aspects of well-being that are influenced by dis-ea, in the context of life experiences and expectations spe-cific to each patient1. A relapsing, remitting chronic dia, SLE results in disability in 20%–40% of afflicted young and middle-aged women and men2. In patients with SLE, HRQOL is influenced by dia activity and symptoms of fatigue, depression, pain, sleep disturbances, and cognitive dysfunction3. Across 5 randomized controlled trials (RCT) in SLE, baline HRQOL scores were low and were similar to tho of subjects following myocardial infarction or with chronic congestive heart failure4. Lower scores were highly correlated with history of renal dia, prence of anti-dsDNA antibodies, higher dia activity scores by Systemic Lupus Erythematosus Dia Activity Index (
SLEDAI) and/or Safety of Estrogens in Lupus Erythema -tosus National Asssment (SELENA-SLEDAI), hypocom-plementemia, African American descent, and age. A variety of therapeutic interventions, including pharmacologic and biologic therapies, have been shown in RCT to improve HRQOL, including prasterone, mycophenolate mofetil, abetimus sodium, oral contraceptive, and hormone replace-ment therapy in the SELENA trials, as well as monoclonal antibodies epratuzumab and belimumab5,6,7,8.
In 1998, an international connsus conference on out-come measures in rheumatology (OMERACT 4) recom-mended that 4 core domains be assd in RCT and longi-tudinal obrvational studies (LOS) in SLE: dia activi-ty, HRQOL, adver events, and damage9. OMERACT has also recommended that both generic and dia-specific instruments be utilized to measure HRQOL. Ongoing efforts to develop promising therapies for SLE have demonstrated the importance of including patient-reported outcomes (PRO) to asss HRQOL in RCT.底线议论文
Measurement of HRQOL adds a unique dimension to the asssment of treatment respon. It has been shown that HRQOL may be influenced by, but does not correlate h ighly with, dia activity and damage measures, and thus offers a different domain of asssment10. A widely ud generic measure, the Medical Outcomes Survey Short-Form 36 (SF-36), has to date best revealed the effect
of SLE on HRQOL in RCT and LOS. SF-36 has been well validated in SLE, translated into many languages, and cross-culturally validated, and has frequently been utilized as the only PRO measure in RCT5,6,7,8,9. It compris 8 domains: physical functioning, role physical, bodily pain, general health perceptions, vitality (which includes fatigue, energy, and “pep”), social functioning, role emotional, and mental health effect; the are combined into physical and mental component summary scores (PCS and MCS, respec-tively). The summary scores are not fully independent of each other, and examining changes across all 8 domains reveals a more complete picture of the impact of dia as well as treatment-associated changes.
Several dia-specific instruments have been designed to asss HRQOL in SLE: LupusQoL, L-QoL, SLE-QoL, and Lupus-PRO. Derived from mistructured interviews with SLE patients, the LupusQoL questionnaire contains 34 items across 8 domains: Physical Health, Emotional Health, Body Image, Pain, Planning, Fatigue, Intimate Relation -ships, and Burden to Others11. It emphasizes areas such as sleep, body image, and xual health, which are not specif-ically queried in SF-36. LupusQoL has demonstrated good internal consistency, test-retest reliability, and concurrent validity with the generic SF-3612. Developed in the UK, it has now been adapted and validated for u in the US and Canada, and a Spanish version has been validated13,14. The L-QoL 什么是粗纤维食物
was developed from patient interviews and validat-ed in the UK, and is bad on the concept that improve-ments in HRQOL derive from the ability and capacity of individuals to satisfy their needs15.
The
Systemic Lupus Erythematosus specific Quality of Life (SLEQOL), devel-
See Is there an advantage over SF-36 with a QOL measure specific to SLE?, page 1898
oped in Singapore, contains 40 items lected by 100 patients from 51 items suggested by rheumatologists, but lacks a formal qualitative study involving patient input —an acknowledged limitation16,17. It has been validated in both English and Chine versions. The lupus-specific PRO measure Lupus-PRO, developed in the US, includes 10 domains of HRQOL as well as 4 that are considered to reflect “non-HRQOL” including desires/goals, coping, social support, and medical care18. The summary HRQOL score correlated well with health utility measures SF-6D, derived from SF-36, and EuroQol EQ-5D. Undergoing fur-ther validation, it is also being utilized to develop a patient-reported instrument for u in day-to-day practice: Lupus Tracker19,20. One challenge with the dia-specific instruments is that most are culturally and geographically distinct, validated in the UK, Singapore and the US, and do not readily lend themlves to u in multinational trials required in SLE. This is exemplified by a recent focus group study conducted by Thumboo and colleagues in Singapore among English-speaking Asian patients with SLE18. They identified 4 doma
ins not included in existing SLE-specific measures of HRQOL: dia impact upon family, relation-ships, freedom, and stigma and discrimination — where importance of the latter may be accentuated in the Asian sociocultural context.
In this issue of The Journal, Touma, et al compare the generic SF-36 to the dia-specific LupusQoL in a cohort of 41 patients, assd monthly for a total of 376 patient visits21. Forty-one were “baline” visits, 127 vis-its demonstrated remission in 23 patients, 14 demonstrated flare in 10 patients, 11 showed improvement in 8 patients, and 183 visits demonstrated no change in 34 patients. The objectives of this investigation were to determine whether the LupusQoL questionnaire contributed additional infor-mation not obtained using SF-36 in this SLE cohort and to evaluate its responsiveness to changes in dia activity. Scores across comparable and noncomparable domains of SF-36 and LupusQoL were assd by effect sizes and standardized respon means. Interestingly, the study demonstrated strong correlations between comparable domains of LupusQoL and SF-36. And for the 4 noncom-parable domains of LupusQoL, correlations existed between each domain and at least one component score of SF-36: Body Image and SF-36 MCS; Planning and SF-36 MCS; Intimate Relationships and SF-36 PCS; and Burden to Others and SF-36 MCS. Both SF-36 and LupusQoL were responsive to clinically significant changes in dia activity in this patient pop
ulation with relatively low dis-ea activity, with median SLEDAI-2K scores of 2. The authors conclude that the 2 instruments were equivalent in asssing HRQOL over time in SLE, and offered com-plementary information. LupusQol has been validated in US patients with higher dia activity with median SLEDAI-2K scores of 419. Work is under way to similarly compare the 2 instruments in patients with moderate to vere SLE dia activity22.
The challenges of conducting trials in SLE are well r ecognized, and published. HRQOL is an important domain for asssment in SLE. Dia activity, damage, and HRQOL are independent of one another, reflecting different domains affected by SLE, and all should be assd in a patient with SLE to clarify the complete clinical picture; moreover, they add discriminative power when asssing promising new therapies. U of different dia-specific instruments to asss HRQOL limits comparison across studies, hence the increasing u of SF-36 is encouraging. As HRQOL is a widely utilized generic measure validated in a variety of rheumatic dias (including rheumatoid arthri-tis, osteoarthritis, psoriatic arthritis, gout, fibromyalgia, and systemic sclerosis), its u enables comparisons between the dias as well as to normative data7,8. Further, HRQOL appears to discriminate between SLE dia activ-ity and fibromyalgia8. Recently it was demonstrated that changes in SF-36 summary and domain scores, in particular tho related to mental health, were str
ongly associated with clinical outcome of neuropsychiatric events in patients with SLE, underscoring its importance in this regard23.
SF-36 may also be utilized to derive health utility scores, such as the SF-6D, which permit economic analys of cost of dia and treatment and facilitate comparisons across dis-ea states8. This is important, as the frequently ud EQ-5D is less nsitive to change than SF-36 in many rheumatic dis-eas, summarizing health status using only 5 q uestions24.
Recent data demonstrate the value of utilizing not only a generic measure, such as SF-36, but also a dia-specific measure. Now that LupusQoL has been adapted and vali-dated for u in the US and Canada and a Spanish version validated, there is an opportunity to u a more broadly applicable dia-specific instrument to asss HRQOL. Another option, illustrated by Thumboo, et al, would be to adapt the PROMIS (Patient-Reported Outcomes Measure -ment Information System) item banks for u as dia-specific measures of HRQOL in SLE, which may better accommodate cross-cultural differences.
In summary, patient-reported HRQOL, an important domain to be assd in SLE studies, provides unique infor-mation that cannot be obtained from measures of d ia activity and/or damage. This is best measured by u of both generic and well validated dia-specific i nstruments.
VIBEKE STRAND,MD, FACP, FACR,
Clinical Professor, Adjunct,
Division of Immunology/Rheumatology,
Stanford University;
ALVINA D. CHU,MD,
Adjunct Clinical Instructor,
Division of Immunology/Rheumatology,
Stanford University School of Medicine,
Stanford, California, USA
Address correspondence to Dr. Strand; E-mail: vstrand@stanford.edu
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J Rheumatol 2011;38:1821–3; doi:10.3899/jrheum.110766
