EULAR points to consider for conducting clinical trials in systemic lupus erythematosus: literature based evidence for the selection of endpoints: Table 1

2008 ◽  
Vol 68 (4) ◽  
pp. 477-483 ◽  
Author(s):  
G K Bertsias ◽  
J P A Ioannidis ◽  
J Boletis ◽  
S Bombardieri ◽  
R Cervera ◽  
...  
Keyword(s):  
Systemic Lupus Erythematosus ◽  
Clinical Trials ◽  
Literature Review ◽  
Outcome Measures ◽  
Lupus Erythematosus ◽  
Task Force ◽  
Evidence Base ◽  
Cochrane Library ◽  
Systemic Lupus ◽  
End Points

Objective:To assess available evidence on the use of end-points (outcome measures) in clinical trials in systemic lupus erythematosus (SLE), as a part of the development of evidence-based recommendations for points to consider in clinical trials in SLE.Methods:The European League Against Rheumatism (EULAR) Task Force on SLE comprised 19 specialists, a clinical epidemiologist and a research fellow. Key questions addressing the evidence for clinical trial end-points in SLE were compiled using the Delphi technique. A systematic search of the PubMed and Cochrane Library databases was performed using McMaster/Hedges clinical query strategies and an array of relevant terms. Evidence was categorised based on sample size and type of design, and the categories of available evidence were identified for each recommendation. The strength of recommendation was assessed based on the category of available evidence and agreement on the statements was measured across the 19 specialists.Results:Eight questions were generated regarding end-points for clinical trials. The evidence to support each proposition was evaluated. The literature review revealed that most outcome measures used in phase 2/3 trials in SLE have not been formally validated in clinical trials, although some indirect validation has been undertaken.Conclusion:This systematic literature review forms the evidence base considered in the development of the EULAR recommendations for end-points in clinical trials in SLE.

EULAR points to consider for conducting clinical trials in systemic lupus erythematosus

2008 ◽  
Vol 68 (4) ◽  
pp. 470-476 ◽  
Author(s):  
C Gordon ◽  
G Bertsias ◽  
J P A Ioannidis ◽  
J Boletis ◽  
S Bombardieri ◽  
...  
Keyword(s):  
Systemic Lupus Erythematosus ◽  
Clinical Trials ◽  
Outcome Measures ◽  
Lupus Erythematosus ◽  
Task Force ◽  
Controlled Trial ◽  
Evidence Based ◽  
Systemic Lupus ◽  
Eligibility Criteria ◽  
Evidenced Based

Objective:Systemic lupus erythematosus (SLE) is a complex multi-organ disease, characterised by relapses and remissions. Designing a high-quality randomised controlled trial poses many challenges. We have developed evidenced-based recommendations for points to consider in conducting clinical trials in patients with SLE.Methods:The EULAR Task Force on SLE comprised 19 specialists and a clinical epidemiologist. Initially, the evidence for clinical trial end-points in SLE was evaluated and this has been reported separately. A consensus approach was developed by the SLE Task Force in formulating recommendations for points to consider when conducting clinical trials in SLE.Results:The literature review revealed that most outcome measures used in phase 2/3 trials in SLE have not actually been validated in clinical trials, although other forms of validation have been undertaken. The final recommendations for points to consider for conducting clinical trials in SLE address the following areas: study design, eligibility criteria, outcome measures including adverse events, concomitant therapies for SLE and its complications.Conclusions:Recommendations for points to consider when conducting clinical trials in SLE were developed using an evidence-based approach followed by expert consensus. The recommendations should be disseminated, implemented and then reviewed in detail and revised using an evidence-based approach in about 5 years, by which time there will be further evidence to consider from current clinical trials.

scholarly journals Monitoring of Systemic Lupus Erythematosus Pregnancies: A Systematic Literature Review

2018 ◽  
Vol 45 (10) ◽  
pp. 1477-1490 ◽  
Author(s):  
Emily G. McDonald ◽  
Lyne Bissonette ◽  
Stephanie Ensworth ◽  
Natalie Dayan ◽  
Ann E. Clarke ◽  
...  
Keyword(s):  
Systemic Lupus Erythematosus ◽  
Literature Review ◽  
Systematic Literature Review ◽  
Lupus Erythematosus ◽  
Umbilical Artery ◽  
Grey Literature ◽  
Cochrane Library ◽  
Doppler Studies ◽  
Systemic Lupus ◽  
Umbilical Artery Doppler

Objective.Few data exist to guide the frequency and type of monitoring in systemic lupus erythematosus (SLE) pregnancies. A systematic literature review was performed to address this gap in the literature.Methods.A systematic review of original articles (1975–2015) was performed using Medline, Embase, and Cochrane Library. We included search terms for SLE, pregnancy, and monitoring. We also hand-searched reference lists, review articles, and grey literature for additional relevant articles.Results.The search yielded a total of 1106 articles. After removing 117 duplicates, 929 articles that were evidently unrelated to our topic based on title and/or abstract, and 7 that were in a language other than English or French, 53 articles were included for full-text review. Following a more in-depth review, 15 were excluded: 6 did not use any measure of SLE activity and 6 did not specifically address SLE monitoring in pregnancy; 1 case series, 1 review, and 1 metaanalysis were removed. Among the 38 included studies, presence of active disease, antiphospholipid (aPL) antibodies positivity, and abnormal uterine and umbilical artery Doppler studies predicted poor pregnancy outcomes. No studies evaluated an evidence-based approach to the frequency of monitoring.Conclusion.Few existing studies address monitoring for optimal care during SLE pregnancies. The available data imply roles for aPL antibodies measurement (prior to pregnancy and/or during the first trimester), uterine and umbilical artery Doppler studies in the second trimester, and following disease activity. Optimal frequency of monitoring is not addressed in the existing literature.

Clinical trials in children and adolescents with systemic lupus erythematosus: methodological aspects, regulatory landscape and future opportunities

2018 ◽  
Vol 78 (2) ◽  
pp. 162-170 ◽  
Author(s):  
Hermine I Brunner ◽  
Alberto Martini ◽  
Daniel J Lovell ◽  
Nicolino Ruperto
Keyword(s):  
Systemic Lupus Erythematosus ◽  
Clinical Trials ◽  
Outcome Measures ◽  
Lupus Erythematosus ◽  
Collaborative Study ◽  
New Drugs ◽  
Systemic Lupus ◽  
Double Blind ◽  
Collaborative Study Group ◽  
Study Designs

Childhood-onset systemic lupus erythematosus (cSLE) is rare in many regions of the world, including Europe. Access to approved medications for cSLE is currently limited, among others, due to a lack of high-quality evidence from clinical trials. The objectives of the study were to evaluate the current regulatory framework regarding medication approvals, delineate barriers to clinical trial conduct, and strategies to improve access to new medications for cSLE. Relevant methodological and regulatory aspects, epidemiological data, study designs and outcome measures are reviewed, and the results of a survey among Paediatric Rheumatology International Trials Organisation/Pediatric Rheumatology Collaborative Study Group investigators are presented. Laws and regulations in the USA and Europe necessitate that novel medicines are studied in paediatric populations, if similar or the same diseases in adults have been found to benefit from them. Regulatory agencies consider cSLE the paediatric form of SLE in adults. For medicines that have been found safe and effective in adult SLE, paediatric extrapolation strategies can limit the number and complexity of studies needed to support the labelling of these medicines for use in cSLE. In this setting, specialised research networks, validated outcome measures, stakeholder input, study designs as well as statistical methods successfully used in other uncommon diseases will help improve study efficiency in an effort to enhance the speed with which new drugs for cSLE can be studied. Open-label pharmacokinetic-pharmacodynamic studies are preferred by paediatric rheumatologists over double-blind parallel designs for cSLE trials. Appropriate infrastructure, outcome measures and sufficient numbers of patients are available for the testing of new medicines for children with cSLE.

Musculoskeletal Ultrasound in Systemic Lupus Erythematosus: Systematic Literature Review by the Lupus Task Force of the OMERACT Ultrasound Working Group

2019 ◽  
Vol 46 (10) ◽  
pp. 1379-1387 ◽  
Author(s):  
Priscilla C. Wong ◽  
Gavin Lee ◽  
Andrea Delle Sedie ◽  
Petra Hanova ◽  
Nevsun Inanc ◽  
...  
Keyword(s):  
Systemic Lupus Erythematosus ◽  
Literature Review ◽  
Lupus Erythematosus ◽  
Bone Erosion ◽  
Outcome Measurement ◽  
Interobserver Reliability ◽  
Joint Effusion ◽  
Measurement Properties ◽  
Cochrane Library ◽  
Systemic Lupus

Objective.To identify and synthesize the best available evidence on the application of musculoskeletal (MSK) ultrasound (US) in patients with systemic lupus erythematosus (SLE) and to present the measurement properties of US in different elementary lesions and pathologies.Methods.A systematic literature search of PubMed, Embase, and the Cochrane Library was performed. Original articles were included that were published in English between August 1, 2014, and December 31, 2018, reporting US, Doppler, synovitis, joint effusion, bone erosion, tenosynovitis, and enthesitis in patients with SLE. Data extraction focused on the definition and quantification of US-detected synovitis, joint effusion, bone erosion, tenosynovitis, enthesitis, and the measurement properties of US according to the OMERACT Filter 2.1 instruments selection.Results.Of the 143 identified articles, 15 were included. Most articles were cross-sectional studies (14/15, 93%). The majority of the studies used the OMERACT definitions for ultrasonographic pathology. Regarding the measurement properties of US in different elementary lesions and pathologies, all studies dealt with face validity, content validity, and feasibility. Most studies achieved construct validity. Concerning the reliability of image reading, 1 study (1/15, 7%) assessed both intraobserver and interobserver reliability. For image acquisition, 4 studies (4/15, 27%) evaluated interobserver reliability and none had evaluated intraobserver reliability. Criterion validity was assessed in 1 study (1/15, 7%). Responsiveness was not considered in any of the studies.Conclusion.This literature review demonstrates the need for further research and validation work to define the involvement of US as an outcome measurement instrument for the MSK manifestations in patients with SLE.

scholarly journals Association between depression and sleep quality in patients with systemic lupus erythematosus: a systematic review and meta-analysis

2021 ◽  
Author(s):  
Rulan Yin ◽  
Lin Li ◽  
Lan Xu ◽  
Wenjie Sui ◽  
Mei’e Niu ◽  
...  
Keyword(s):  
Systemic Lupus Erythematosus ◽  
Sleep Quality ◽  
Lupus Erythematosus ◽  
Sleep Disturbances ◽  
Cochrane Library ◽  
Poor Sleep ◽  
Moderate Correlation ◽  
Systemic Lupus ◽  
Poor Sleep Quality ◽  
Subjective Sleep Quality

Abstract Background Currently, there is no consistent understanding of the relationship between depression and sleep quality in patients with systemic lupus erythematosus (SLE). This study aimed to explore the correlation between depression and sleep quality in SLE patients. Methods Five English (PubMed, Web of Science, EMBASE, Cochrane Library, and CINAHL) databases were systematically searched from inception to January 12, 2021. Two authors independently screened publications and extracted data according to set inclusion and exclusion criteria. Statistical analyses were performed with STATA 16.0. Data were pooled using a random-effects model. Results A total of 9 identified studies matched the inclusion criteria, reporting on 514 patients with SLE in the analysis. A moderate correlation of depression with sleep quality was found (pooled r = 0.580 [0.473, 0.670]). Compared to good sleepers, patients with SLE and poor sleep quality had higher levels of depression (standardized mean difference =  − 1.28 [− 1.87, − 0.69]). Depression was associated with subjective sleep quality (r = 0.332 [0.009, 0.592]), sleep latency (r = 0.412 [0.101, 0.649]), sleep disturbances (r = 0.405 [0.094, 0.645]), daytime dysfunction (r = 0.503 [0.214, 0.711]), the four dimensions of Pittsburgh Sleep Quality Index (PSQI), while no significant correlation was found in the other three PSQI dimensions. Conclusion Depression had a moderate correlation with sleep quality in patients with SLE. Patients with poor sleep quality tended to have higher level of depression than that of good sleepers. Awareness of the correlation may help rheumatology physicians and nurses to assess and prevent depression and improve sleep quality in patients with SLE.

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