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To evaluate whether the quality of reporting harms improved after the publication of the Extension of the Consolidated Standards of Reporting Trials (CONSORT) statement and predictors that influence the safety reporting in randomized controlled trials (RCTs).
69 The standardised way of reporting harms was published only in 2004.
In addition, they identified no studies reporting harms resulting from screening, and judged the potential for harms to be small.
There was no difference in proportions of papers reporting harms (19), limitations (20), generalizability (21) and interpretation (22) before and after 2010 (Table 2).
A randomized control trial investigating the effectiveness of routine inquiry for intimate partner violence showed that screened women are not reporting harms because of screening [ 34].
In the future PRISMA Harms extension, we will limit these to the minimum set of essential items for reporting harms in a systematic review.
Similar(49)
The top reasons that people gave for not reporting harm were that they didn't think it was serious enough, they didn't feel they needed assistance and they worried about being blamed.
Those reporting harm or pain from chiropractic were less willing to try this therapy again.
Main endpoint: 1) Proportion of articles reporting harm in the abstract; and 2) Proportion of articles that reported harm in the abstract when harm was reported in the main body of the article.
Only reporting statistically significant harm in the text was related to the probability of reporting harm in the abstract [cPR = 1.25 (CI95% 1.12 to 1.38)].
The remaining factors did not show a statistically significant relationship with the probability of reporting harm in the abstract.
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com