National systemic lupus erythematosus prospective cohort in Saudi Arabia: A study protocol.
Journal
Medicine
ISSN: 1536-5964
Titre abrégé: Medicine (Baltimore)
Pays: United States
ID NLM: 2985248R
Informations de publication
Date de publication:
30 07 2021
30 07 2021
Historique:
received:
04
01
2021
accepted:
19
06
2021
entrez:
16
8
2021
pubmed:
17
8
2021
medline:
25
8
2021
Statut:
ppublish
Résumé
Systemic Lupus erythematosus (SLE) is a chronic multisystem, multifactorial inflammatory autoimmune disease. The SLE patients have 3 times increased risk of mortality based on international data with ethnicity playing an important impact on patients' morbidity and mortality. Descriptive studies from Saudi Arabia showed variation in clinical features from one region to another. Moreover, reliable inference from these studies is limited by study methodology and lack of translational data using biological samples to understand clinical phenotypes of Saudi SLE patients.The aim of this report is to describe the prospective study protocol of the National Systemic Lupus Erythematosus Cohort in Saudi Arabia. The purpose of this cohort study is multifold: first, to examine clinical characteristics and molecular phenotypes of Saudi SLE patients in relation to local environment and practices/lifestyles; second, to assess long-term outcomes of SLE in Saudi population and factors that influence favorable outcomes; third, to compare the effectiveness of various treatment regimens in Saudi SLE population.This study is a longitudinal prospective cohort study of adult, Saudi SLE patients using open cohort study design. Primary outcomes include disease-related outcomes (activity, improvement, and organ damage) and patient-reported outcomes (quality of life). Secondary outcomes include physiological and molecular modifications associated with changes in disease activity states.Results and analysis are in on-going study.This study provides a source of reliable data for clinical and translational research. This will allow us to have a holistic approach to SLE pathogenesis especially in Saudi population and may take us a step further toward much more personalized medicine.This protocol has been registered in NIH ClinicalTrial.gov (ClinicalTrial.gov identifier: NCT04604990) on October 27, 2020.
Identifiants
pubmed: 34397699
doi: 10.1097/MD.0000000000026704
pii: 00005792-202107300-00020
pmc: PMC8322486
doi:
Banques de données
ClinicalTrials.gov
['NCT04604990']
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
e26704Subventions
Organisme : College of Medicine Research Center, King Saud University, Riyadh (SA)
ID : CMRC-20-02
Commentaires et corrections
Type : ErratumIn
Informations de copyright
Copyright © 2021 the Author(s). Published by Wolters Kluwer Health, Inc.
Déclaration de conflit d'intérêts
The study received a start-up fund from College of Medicine Research Centre (College of Medicine Research Centre-20-02), King Saud University, Riyadh, Saudi Arabia on July 5, 2020. Support did not play any role in the design of the study and did not pose any conflict of interest. The authors have no conflicts of interest to disclose.
Références
Tsokos GC. Systemic lupus erythematosus. N Engl J Med 2011;365:2110–21.
Pons-Estel GJ, Alarcón GS, Scofield L, Reinlib L, Cooper GS. Understanding the epidemiology and progression of systemic lupus erythematosus. Semin Arthritis Rheum 2010;39:257–68.
Al Dhanhani AM, Agarwal M, Othman YS, Bakoush O. Incidence and prevalence of systemic lupus erythematosus among the native Arab population in UAE. Lupus 2017;26:664–9.
Al-Arfaj AS, Al-Balla SR, Al-Dalaan AN, et al. Prevalence of systemic lupus erythematosus in central Saudi Arabia. Saudi Med J 2002;23:87–9.
Fletcher RH, Fletcher SW, Fletcher GS. Clinical epidemiology: the essentials. 5th ed. 2014;Philadelphia, PA: Wolters Kluwer/Lippincott Williams & Wilkins Health, pp. 253.
Grimes DA, Schulz KF. Bias and causal associations in observational research. Lancet 2002;359:248–52.
Relton C, Torgerson D, O’Cathain A, Nicholl J. Rethinking pragmatic randomised controlled trials: introducing the “cohort multiple randomised controlled trial” design. BMJ 2010;340:c1066.
Chan AW, Tetzlaff JM, Altman DG, et al. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med 2013;158:200–7.
Chan AW, Tetzlaff JM, Gotzsche PC, et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ 2013;346:e7586 Published 2013 Jan 8.
Hochberg MC. Updating the American College of Rheumatology revised criteria for the classification of systemic lupus erythematosus. Arthritis Rheum 1997;40:1725.
Petri M, Orbai AM, Alarcón GS, et al. Derivation and validation of the Systemic Lupus International Collaborating Clinics classification criteria for systemic lupus erythematosus. Arthritis Rheum 2012;64:2677–86.
Aringer M, Costenbader K, Daikh D, et al. 2019 European League Against Rheumatism/American College of Rheumatology Classification Criteria for Systemic Lupus Erythematosus. Arthritis Rheumatol 2019;71:1400–12.
Bombardier C, Gladman DD, Urowitz MB, Caron D, Chang CH. Derivation of the SLEDAI. A disease activity index for lupus patients. The Committee on Prognosis Studies in SLE. Arthritis Rheum 1992;35:630–40.
Gladman DD, Ibañez D, Urowitz MB. Systemic lupus erythematosus disease activity index 2000. J Rheumatol 2002;29:288–91.
Touma Z, Gladman DD, Ibañez D, Urowitz MB. SLEDAI-2K responder index 50 captures 50% improvement in disease activity over 10 years. Lupus 2012;21:1305–11.
Gladman D, Ginzler E, Goldsmith C, et al. The development and initial validation of the Systemic Lupus International Collaborating Clinics/American College of Rheumatology damage index for systemic lupus erythematosus. Arthritis Rheum 1996;39:363–9.
McElhone K, Abbott J, Shelmerdine J, et al. Development and validation of a disease-specific health-related quality of life measure, the LupusQol, for adults with systemic lupus erythematosus. Arthritis Rheum 2007;57:972–9.
El Miedany Y, El Gaafary M, Sayed S, Ahmed I. THU0037 validation of a disease-specific patient-reported outcome measure for Arabic patients with systemic lupus erythematosus. Ann Rheum Dis 2014;73:189.
Bonilla-Martinez ZL, Albrecht J, Troxel AB, et al. The cutaneous lupus erythematosus disease area and severity index: a responsive instrument to measure activity and damage in patients with cutaneous lupus erythematosus. Arch Dermatol 2008;144:173–80.
Paez-Venegas N, Jordan-Estrada B, Chavarria-Avila E, et al. The montreal cognitive assessment test: a useful tool in screening of cognitive impairment in patients with systemic lupus erythematosus. J Clin Rheumatol 2019;25:325–8.
Wells G, Becker JC, Teng J, et al. Validation of the 28-joint Disease Activity Score (DAS28) and European League Against Rheumatism response criteria based on C-reactive protein against disease progression in patients with rheumatoid arthritis, and comparison with the DAS28 based on erythrocyte sedimentation rate. Ann Rheum Dis 2009;68:954–60.
Ceccarelli F, Perricone C, Massaro L, et al. The role of disease activity score 28 in the evaluation of articular involvement in systemic lupus erythematosus. ScientificWorldJournal 2014;2014:236842.
Kanis JA on behalf of the World Health Organization Scientific Group. Assessment of osteoporosis at the primary health-care level. Technical Report. World Health Organization Collaborating Centre for Metabolic Bone Diseases, University of Sheffield. London (UK): 2007. Available at: http://www.shef.ac.uk/FRAX . Accessed December 1, 2019.
Watts NG, Leslie WD, Foldes AJ, et al. 2013 International Society of Clinical Densitometry Position Development Conference: task force on normative database. J Clin Denitom 2013;16:472–81.
Alberti KG, Eckel RH, Grundy SM, et al. Harmonizing the metabolic syndrome: a joint interim statement of the International Diabetes Federation Task Force on Epidemiology and Prevention; National Heart, Lung, and Blood Institute; American Heart Association; World Heart Federation; International Atherosclerosis Society; and International Association for the Study of Obesity. Circulation 2009;120:1640–5.
Thompson K, Kulkarni J, Sergejew AA. Reliability and validity of a new Medication Adherence Rating Scale (MARS) for the psychoses. Schizophr Res 2000;42:241–7.
Hassen LM, Almaghlouth IA, Hassen IM, et al. Impact of COVID-19 outbreak on rheumatic patients’ perceptions and behaviors: a cross-sectional study. Int J Rheum Dis 2020;23:1541–9.
Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)—a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform 2009;42:377–81.
Fangtham M, Petri M. 2013 update: Hopkins lupus cohort. Curr Rheumatol Rep 2013;15:360.
Urowitz MB, Gladman DD. Contributions of observational cohort studies in systemic lupus erythematosus: the university of toronto lupus clinic experience. Rheum Dis Clin North Am 2005;31:211–21.
Legge A, Kirkland S, Rockwood K, et al. Construction of a frailty index as a novel health measure in systemic lupus erythematosus. J Rheumatol 2020;47:72–81.
Baechler EC, Batliwalla FM, Karypis G, et al. Interferon-inducible gene expression signature in peripheral blood cells of patients with severe lupus. Proc Natl Acad Sci U S A 2003;100:2610–5.
al Husain M, al Bunyan M. Consanguineous marriages in a Saudi population and the effect of inbreeding on prenatal and postnatal mortality. Ann Trop Paediatr 1997;17:155–60.
Delgado-Rodríguez M, Llorca J. Bias. J Epidemiol Community Health 2004;58:635–41.
Bosco JL, Silliman RA, Thwin SS, et al. A most stubborn bias: no adjustment method fully resolves confounding by indication in observational studies. J Clin Epidemiol 2010;63:64–74.