AB1600 TIME TO PUBLICATION AND TIME-LAG PUBLICATION BIAS FOR RANDOMIZED TRIALS ON CONNECTIVE TISSUE DISEASES

Background Connective tissue diseases (CTDs) are systemic autoimmune diseases, some of which rare, characterized by a dysregulated immune response and heterogeneous clinical picture. Similarly to nonpublication, long time from completion publication randomized controlled trials (RCTs) results can indirectly harm patients allowing inefficacious or dangerous intervention being prescribed [1] , delaying the prescription useful treatment. We have recently shown that one-third CTDs-RCTs registered after 2000 never reached [2] but we did not estimate extent time-lag bias, neither analyzed factors associated with delayed publication. Objectives To assess on connective (CTDs), investigate with, explore influence significance study (time-lag bias). Methods included interventional, phase 2/3, 3 4 RCTs CTDs in Clinicaltrials.gov 2016, whose had been published peer-review journal less than 5 years their completion. Two reviewers selected studies according pre-specified criteria. Main trial features including primary outcome were collected. Time was earliest online date. Multivariable linear regression used identify association between results, adjusted for variables previously impact this outcome, e.g. funder, size trial, international status, year factor journal. Results 62 studies, mostly (62%) pharmacologic treatments (94%), recruiting lupus (55%) sclerosis (23%), planning enroll median 131 [IQR 61-288] patients. Twenty-two (35%) reported at least statistically significant outcome. Median 28 months 17-36], more half (n = 34, 55%) 2 (see Table 1). In multivariable analysis, progressively improved over (faster recent years, begin 1.3 [0.3, 2.4] shorter every year), influenced journal, number countries Figure Conclusion A high proportion is beyond find evidence time. References Awasthi S, Peto R, Read Richards SM, Pande V, Bundy D, DEVTA (Deworming Enhanced Vitamin A) team. Population deworming 6 albendazole 1 million pre-school children North India: DEVTA, cluster-randomised trial. Lancet . 2013;381(9876):1478-1486. Brigante A, Russo B, Mongin Lauper K, Allali Courvoisier DS, Iudici M. Extent reasons discontinuation nonpublication interventional diseases: an observational study. Arthritis Care & Research Published January 22, 2022. 1. Factors multivariate analysis. Factor Coefficient (95% CI) P value (Intercept) 41.3 (30.1; 52.4) <0.001 Positive (reference no) -1.5 (-8.6; 5.7) 0.69 Industry-funded (ref industry funded) -0.2 (-9.5; 9.1) 0.97 International international) 3.3 (-8.0; 14.5) 0.57 Impact 0.1 (-0.1; 0.3) 0.47 Number (per 100 patients) -1.2 (-2.6; 0.2) 0.09 Completion (counting 2000) -1.3 (-2.3; -0.3) 0.01 evolution considered present Area points proportional enrolment size. Acknowledgements: NIL. Disclosure Interests None Declared.