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Adherence to the International Committee of Medical Journal Editors’ (ICMJE) prospective registration policy and implications for outcome integrity: a cross-sectional analysis of trials published in…

Overview of attention for article published in Trials, August 2018
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  • In the top 5% of all research outputs scored by Altmetric
  • High Attention Score compared to outputs of the same age (96th percentile)

Mentioned by

news
1 news outlet
blogs
4 blogs
twitter
77 tweeters

Citations

dimensions_citation
36 Dimensions

Readers on

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41 Mendeley
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Title
Adherence to the International Committee of Medical Journal Editors’ (ICMJE) prospective registration policy and implications for outcome integrity: a cross-sectional analysis of trials published in high-impact specialty society journals
Published in
Trials, August 2018
DOI 10.1186/s13063-018-2825-y
Pubmed ID
Authors

Anand D. Gopal, Joshua D. Wallach, Jenerius A. Aminawung, Gregg Gonsalves, Rafael Dal-Ré, Jennifer E. Miller, Joseph S. Ross

Abstract

Registration of clinical trials is critical for promoting transparency and integrity in medical research; however, trials must be registered in a prospective fashion to deter unaccounted protocol modifications or selection of alternate outcomes that may enhance favorability of reported findings. We assessed adherence to the International Committee of Medical Journal Editors' (ICMJE) prospective registration policy and identified the frequency of registrations occurring after potential observation of primary outcome data among trials published in the highest-impact journals associated with US professional medical societies. Additionally, we examined whether trials that are unregistered or registered after potential observation of primary outcome data were more likely to report favorable findings. We conducted a retrospective, cross-sectional analysis of the 50 most recently published clinical trials that reported primary results in each of the ten highest-impact US medical specialty society journals between 1 January 2010 and 31 December 2015. We used descriptive statistics to characterize the proportions of trials that were: registered; registered retrospectively; registered retrospectively potentially after initial ascertainment of primary outcomes; and reporting favorable findings, overall and stratified by journal and trial characteristics. Chi-squared analyses were performed to assess differences in registration by journal and trial characteristics. We reviewed 6869 original research reports published between 1 January 2010 and 31 December 2015 to identify a total of 486 trials across 472 publications. Of these 486 trials, 47 (10%) were unregistered. Among 439 registered trials, 340 (77%) were registered prospectively and 99 (23%) retrospectively. Sixty-seven (68%) of these 99 retrospectively registered trials, or 15% of all 439 registered trials, were registered after potential observation of primary outcome data ascertained among participants enrolled at inception. Industry-funded trials, those with enrollment sites in the US, as well as those assessing FDA-regulated interventions each had lower rates of retrospective registration. Unregistered trials were more likely to report favorable findings than were registered trials (89% vs. 64%; relative risk (RR) = 1.38, 95% confidence interval (CI) = 1.20-1.58; p = 0.004), irrespective of registration timing. Adherence to the ICMJE's prospective registration policy remains sub-standard, even in the highest-impact journals associated with US professional medical societies. These journals frequently published unregistered trials and trials registered after potential observation of primary outcome data.

Twitter Demographics

The data shown below were collected from the profiles of 77 tweeters who shared this research output. Click here to find out more about how the information was compiled.

Mendeley readers

The data shown below were compiled from readership statistics for 41 Mendeley readers of this research output. Click here to see the associated Mendeley record.

Geographical breakdown

Country Count As %
Unknown 41 100%

Demographic breakdown

Readers by professional status Count As %
Student > Master 9 22%
Student > Bachelor 5 12%
Researcher 5 12%
Student > Ph. D. Student 5 12%
Student > Postgraduate 3 7%
Other 7 17%
Unknown 7 17%
Readers by discipline Count As %
Medicine and Dentistry 10 24%
Psychology 5 12%
Nursing and Health Professions 3 7%
Pharmacology, Toxicology and Pharmaceutical Science 3 7%
Biochemistry, Genetics and Molecular Biology 2 5%
Other 9 22%
Unknown 9 22%

Attention Score in Context

This research output has an Altmetric Attention Score of 71. This is our high-level measure of the quality and quantity of online attention that it has received. This Attention Score, as well as the ranking and number of research outputs shown below, was calculated when the research output was last mentioned on 10 January 2022.
All research outputs
#465,493
of 21,542,809 outputs
Outputs from Trials
#71
of 5,434 outputs
Outputs of similar age
#11,295
of 298,168 outputs
Outputs of similar age from Trials
#1
of 1 outputs
Altmetric has tracked 21,542,809 research outputs across all sources so far. Compared to these this one has done particularly well and is in the 97th percentile: it's in the top 5% of all research outputs ever tracked by Altmetric.
So far Altmetric has tracked 5,434 research outputs from this source. They typically receive more attention than average, with a mean Attention Score of 8.0. This one has done particularly well, scoring higher than 98% of its peers.
Older research outputs will score higher simply because they've had more time to accumulate mentions. To account for age we can compare this Altmetric Attention Score to the 298,168 tracked outputs that were published within six weeks on either side of this one in any source. This one has done particularly well, scoring higher than 96% of its contemporaries.
We're also able to compare this research output to 1 others from the same source and published within six weeks on either side of this one. This one has scored higher than all of them