Background Systemic lupus erythematosus (SLE) is a chronic, fluctuating autoimmune disease associated with considerable morbidity resulting from accumulating damage to different organ systems over time.1 Although randomised controlled trials (RCTs) are the gold standard for clinical evidence, they may not adequately answer some questions; as a result, data from observational cohorts and registries are important
Objectives This systematic review aimed to identify and appraise large prospective cohort studies and registries of patients with SLE, and to assess the relevance of data collected and the quality of the registries.
Methods PubMed, Embase, and EconLit were searched using appropriate MeSH terms related to SLE and restricted to cohorts and registries. The review included prospective cohorts and registries with ≥12 months' follow-up and ≥100 patients aged ≥18 years. Also four major international conferences proceedings from the past 2 years were hand-searched for presentations and abstracts related to SLE. Data were extracted and evaluated for content (demography, disease history and activity, outcomes and drug use) and form (methodology and design) using a quality evaluation tool created with guidance from the Agency for Healthcare Research and Quality.2
Results From the 459 reports and conference abstracts initially identified, only 147 cohorts and registries were suitable for inclusion. The number of patients included varied hugely from one registry to another, as well as the follow up period. As an example of this, the 5 largest cohorts and registries ranked by number of patients and period of follow up are shown in Table 1. Results so far suggest that the relevance of the data collected is improving and adding to a better understanding of SLE. However, they also highlight evidence gaps in outcomes measurement and follow up. Few registries included data on health-related quality of life and more than a half of them lacked data on steroid and immunosuppressive agent utilisation Analysis of methodological quality suggested that only 20% of registries scored ≥80% on our quality evaluation tool which was developed using weighted scale for assessing targeted population, outcomes, follow up and other relevant components reported.
Conclusions Initial assessment highlights the important contribution made by some cohorts and registries, but also suggests that gaps and limitations remain, particularly for patient follow up, disease flare, treatment management, and quality of life.
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Gliklich R, Dreyer N, eds. Registries for evaluating patient outcomes: a user's guide. 2nd ed. Rockville, MD: Agency for Healthcare Research and Quality (US): 2010.
Disclosure of Interest Y. Chalabi Employee of: Eli Lilly, S. Al Sawah Employee of: Eli Lilly, S. Mettam Consultant for: Eli Lilly, C. Bushe Employee of: Eli Lilly