A Systematic Review of Clinical Trial Designs and Outcome Measures in Sjögren Disease Randomized Controlled Trials
Bibliographic record
Abstract
OBJECTIVE: To systematically review all existing Sjögren disease (SjD)-related instruments reported in clinical trials for SjD. METHODS: We systematically searched Medline (PubMed) and EMBASE between January 2002 and March 2023 to identify all randomized controlled trials (RCTs) using both a manual approach and artificial intelligence software (Bibliography BOT). We extracted all the instruments used as primary or secondary outcomes and assessed whether the study succeeded in improving the outcome. We also classified the instruments according to the recently defined preliminary outcome domains. RESULTS: Among 5420 references, 60 RCTs were included, focusing either on overall disease manifestations (53%) or on a single organ/symptom (eg, dry eyes [17%], xerostomia [15%], fatigue [12%], or pulmonary function [3%]). Primary outcomes included measures of oral or ocular dryness, patient-reported outcomes (PROs), systemic activity, and other outcomes. Common instruments used were European Alliance of Associations for Rheumatology (EULAR) Sjögren Syndrome Disease Activity Index (ESSDAI), EULAR Sjögren Syndrome Patient-Reported Index, Schirmer-I test for unstimulated salivary flow, and IgG levels. ESSDAI was a primary outcome in 11 studies, with 45% of studies reaching significance, whereas none of the 16 studies with ESSDAI as a secondary outcome reached significance. PROs were the primary outcome in 34 studies. Glandular function measurements varied, with unstimulated salivary flow as the most commonly measured outcome. Life impact was assessed more frequently as a secondary outcome. Only 2 studies focused on biological activity. CONCLUSION: Our review highlighted the heterogeneity of SjD RCTs in both the study designs and outcomes. The use of PROs and composite outcomes has increased in recent years, highlighting a shift from objective dryness measures to more holistic patient-centered outcomes.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.090 | 0.299 |
| Meta-epidemiology (narrow) | 0.004 | 0.002 |
| Meta-epidemiology (broad) | 0.026 | 0.013 |
| Bibliometrics | 0.017 | 0.014 |
| Science and technology studies | 0.002 | 0.003 |
| Scholarly communication | 0.006 | 0.005 |
| Open science | 0.004 | 0.003 |
| Research integrity | 0.005 | 0.003 |
| Insufficient payload (model declined to judge) | 0.008 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".