The Quality of Randomized Controlled Trials in High Impact Rheumatology Journals, 1998-2018.

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Well-designed randomized controlled trials (RCTs) mitigate bias and confounding, but prior evaluations of rheumatology trials found high rates of methodological flaws. Outside of rheumatoid arthritis, no studies in the modern era have assessed the quality of rheumatology RCTs over time or with respect to industry funding.We identified all RCTs published in three high impact rheumatology journals from the years 1998, 2008, and 2018. Quality metrics derived from a modified Jadad scale were analyzed by the year of publication and by funding source.Ninety-six publications met inclusion criteria; 82 of these described the primary analysis of an RCT. Over time (1998 - 2008 - 2018), trials were less likely to adequately report dropouts and withdrawals (100% vs. 82% vs. 60%, p < 0.01) or include an active comparator (44% vs. 12% vs. 13%, p = 0.01). Later trials were more likely to evaluate biologic therapy (11% vs. 38% vs. 83%, p < 0.01) and report adequate randomization procedures (39% vs. 29% vs. 60%, p = 0.04). Seventy nine percent of trials received industry funding. Industry funded trials were more likely to report double blinding (86% vs. 53%, p < 0.01), patient reported outcome measures (77% vs. 41%, p < 0.01), and intention to treat analyses (86% vs. 65%, p = 0.04).Industry funded trials comprise the majority of RCTs published in high impact rheumatology journals and more frequently report metrics associated with RCT quality. RCTs assessing active comparators and non-biologic therapies have become less common in high impact rheumatology journals.

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