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We did not observe improvement of reporting after the release of the CONSORT statement extension for NI trials.
The overall low adherence to the statement might be due to unfamiliarity of the authors, referees, and editors of all of the journals with the statement extension.
In general, no difference was seen in the quality of reporting before and after the release of the CONSORT statement extension 2006 or between the high-impact and low-impact journals.
(draft FDA guideline on NI trial 2010) should be specified in publication (CONSORT statement extension, 2006) Use of the full analysis set is generally not conservative and its role should be considered very careful (ICH E9) Both ITT and PP have equal importance (CPMP/EMEA 2000) Important to conduct both ITT and as-treated analyses.
To evaluate the quality of reporting, we compared the requirements from the extension of the CONSORT statement for NI and equivalence trials[10] between articles published before and after 2006 to evaluate the impact of the CONSORT statement extension on the reporting of NI trials.
We realized that it might be too early to see full adherence of the CONSORT statement extension after 3 years, but due to the reputation of the CONSORT statement itself, we considered it reasonable to expect a certain degree of improvement.
Similar(36)
It is intended that the STRICTOM can be used in conjunction with the main CONSORT Statement, extensions for nonpharmacologic treatment and pragmatic trials, and thereby raise the quality of reporting of clinical trials of moxibustion.
Reporting of the results of the study will be in accordance with the CONSORT statement 2010 (extension cluster randomised trials).
In this article, we follow the Consolidated Standard of Reporting Trials (CONSORT) 2010 statement on extension of the standard to cluster trials [ 48].
For the description of the design of the Opti-Med intervention, the Consolidated Standards of Reporting Trials (CONSORT) statement with extension to cluster randomised trials is followed [ 30].
It is intended that the revised STRICTA checklist, in conjunction with both the main CONSORT statement and extension for non-pharmacological treatment, will raise the quality of reporting of clinical trials of acupuncture.
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