Validation of the French Version of Lupus Patient Reported Outcome (LupusPRO), a Disease-Specific Patient Reported Outcome for Lupus Patients

Hervé Devilliers¹, Meenakshi Jolly², Maxime Samson³, Bernard Bonnotte⁴, Francois Maurier⁵, Pascal Sève⁶, Nadine Magy-Bertrand⁷, Denis Wahl⁸, Jean-Loup Pennaforte⁹, Thierry Martin¹⁰, Olivier Aumaître¹¹, Gilles Blaison¹², Philip Bielefeld¹³, Alexis Mathian¹⁴, Christine Binquet¹⁵ and Zahir Amoura¹⁴, ¹Department of Internal Medicine and Systemic Diseases, Hôpital François Mitterrand, CHU de Dijon, Dijon, France, ²Department of Medicine, Section of Rheumatology, Rush University Medical Center, Chicago, IL, ³Dijon University Hospital, Dijon, France, ⁴Department of Internal Medicine and Clinical Immunology, Hôpital François Mitterrand, CHU de Dijon, Dijon, France, ⁵Department of Internal Medicine, HP Metz Belle Isle Hospital, Metz, France, ⁶Internal medicine, Internal medicine department, Hôpital de la Croix-Rousse, Hospices Civils de Lyon, Lyon, France, ⁷CHU Jean-Minjoz, Service de médecine interne et immunologie clinique, Besançon, France, ⁸CHU de Nancy, Vascular Medicine Division and Regional Competence Centre For Rare Vascular And Systemic Autoimmune Diseases; and UMR_S U1116 Research Unit, France, Nancy, France, ⁹Internal Medicine, Internal medicine departement, CHU de Reims, Reims, France, ¹⁰Internal medicine and clinical immunology departement, Strasbourg University Hospital, Strasbourg, France, ¹¹Division of internal Medicine, Centre Hospitalier Universitaire, Hôpital Gabriel Montpied, Clermont–Ferrand, Clermont–Ferrand, France, ¹²Internal medicine departement, Colmar Hospital, Colmar, France, ¹³Internal medicine and systemic disease unit, Dijon University Hospital, Dijon, France, ¹⁴Department of Internal Medicine 2. Referal center for SLE/APS, Hôpital Pitié-Salpêtrière, AP-HP, UPMC Univ Paris 06 & French National Reference Center For Systemic Lupus and Antiphospholipid Syndrome, Paris, France, ¹⁵INSERM, CIC 1432, Clinical Epidemiology Unit, Hôpital François Mitterrand, CHU de Dijon, Dijon, France

Meeting: 2016 ACR/ARHP Annual Meeting

Date of first publication: September 28, 2016

Keywords: Epidemiologic methods, Quality of life and systemic lupus erythematosus (SLE)

Session Information

Date: Monday, November 14, 2016

Title: Quality Measures and Quality of Care - Poster II

Session Type: ACR Poster Session B

Session Time: 9:00AM-11:00AM

Background/Purpose:

To assess validity and reliability of French LupusPRO in France.

Methods:

After cross-cultural adaptation and harmonization for France, the LupusPRO was administered along with a generic PRO tool (the Short Form health survey 36 [SF-36]) in a prospective, multicenter study in France. SLE patients (ACR 1997 criteria) filled the questionnaires at baseline, and 3 months later. Demographics, disease activity and damage where recorded by the physicians at baseline. We performed a confirmatory factory analysis of the French LupusPRO and evaluated test-rest reliability and internal consistency. External validity was then explored as the correlation between LupusPRO scores and SF-36 scores or disease activity. Test-retest reliability was assessed by the mean of intra-class correlation between baseline and M3 scores among patients who did not report change in their quality of life during this period.

Results:

Among 269 patients participating to the study, 90% were women, with a mean age (SD) of 42 (12) years. Mean baseline activity was low, median (range) SELENA-SLEDAI (SS) score was 2 (0-19), 26% of patients having a moderate or severe flare at baseline according to SELENA-SLEDAI flare index revised (SFI-R). The fit of the data to the conceptual model of LupusPRO was acceptable: RMSEA, CFI, chi-square/degrees of freedom were 0.073, 0.97 and 2.6 respectively (with desirable values of <0.08, >0.95 and <3). Factor loading was over 0.7 for all items in their own dimension except for 3 out of 43 : 0.45 for item #1 (“Loss of hair” in “Lupus Symptoms” dimension), 0.36 for item #38 (“I learned to live with my lupus”) , and 0.35 for item #39 (“I received comfort/strength from my religious or spiritual beliefs”) , both in “coping” dimension. Cronbach’s alpha (Table 1) exceeded 0.7 except for “Lupus symptoms” (alpha=0.6) and “coping” dimensions (alpha=0.4). Test retest reliability -ICC ranged from 0.4 to 0.9 between baseline and M3. External validity was supported by a significant lower score in PRO among patients reporting a low health status according to SF-36 first question (p<0.0001 except for “procreation”, “coping”, and “satisfaction with care”), a high correlation with corresponding SF-36 domains and a low but significant correlation with disease activity.

Conclusion:

The French version of the LupusPRO is valid and reliable. Further study is needed to investigate whether the low fit of the items of “coping” domain is due to cultural difference between French and US patients.

Table 1. Reliability and external validity of French LupusPRO
LupusPRO HRQOL Domains	Correlation	p-value	ICC*	Cronbach’s alpha
1.Lupus Symptoms			0.7	0.6
PGA	-0.24	<.0001
SFI-R Flare	-0.28	<.0001
SFI-R Skin Flare	-0.13	0.032
SFI-R Articular Flare	-0.21	0.001
Total SLEDAI	-0.06	0.334
2.Cognition			0.8	0.9
3. Lupus Medication			0.6	0.7
PGA			0.6	0.7
4.Physical function, role physical			0.7	0.9
SF-36 PF	0.63	<.0001
SF-36 RP	0.69	<.0001
SLICC/DI	-0.13	0.041
SFI-R Articular Flare	-0.26	<.0001
Pain vitality			0.8	0.9
SF-36 BP	0.84	<.0001
SF-36 VT	0.76	<.0001
SFI-R Articular Flare	-0.33	<.0001
Emotional function, Role emotional			0.8	0.9
SF-36 MH	0.69	<.0001
SF-36 RE	0.58	<.0001
Body Image			0.8	0.9
SFI-R Flare	-0.14	0.020
SF-36 SF	0.61	<.0001
Non-HRQOL Domains
Desires, Goals, Plans			0.6	0.9
Procreation			0.7	0.9
Social Support			0.5	0.8
Coping			0.4	0.4
Satisfaction with Care			0.5	0.9
* Intraclass correlation to assess test-retest reliability

Disclosure: H. Devilliers, None; M. Jolly, Pfizer Inc, 9; M. Samson, None; B. Bonnotte, None; F. Maurier, Novartis Pharmaceutical Corporation, 3; P. Sève, None; N. Magy-Bertrand, None; D. Wahl, None; J. L. Pennaforte, None; T. Martin, None; O. Aumaître, None; G. Blaison, None; P. Bielefeld, None; A. Mathian, None; C. Binquet, None; Z. Amoura, None.

To cite this abstract in AMA style:

Devilliers H, Jolly M, Samson M, Bonnotte B, Maurier F, Sève P, Magy-Bertrand N, Wahl D, Pennaforte JL, Martin T, Aumaître O, Blaison G, Bielefeld P, Mathian A, Binquet C, Amoura Z. Validation of the French Version of Lupus Patient Reported Outcome (LupusPRO), a Disease-Specific Patient Reported Outcome for Lupus Patients [abstract]. Arthritis Rheumatol. 2016; 68 (suppl 10). https://acrabstracts.org/abstract/validation-of-the-french-version-of-lupus-patient-reported-outcome-lupuspro-a-disease-specific-patient-reported-outcome-for-lupus-patients/. Accessed .

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