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From protocol to published report: a study of consistency in the reporting of academic drug trials

Overview of attention for article published in Trials, February 2016
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About this Attention Score

  • In the top 5% of all research outputs scored by Altmetric
  • Among the highest-scoring outputs from this source (#49 of 3,825)
  • High Attention Score compared to outputs of the same age (96th percentile)

Mentioned by

news
3 news outlets
blogs
1 blog
twitter
62 tweeters
facebook
1 Facebook page
reddit
3 Redditors

Citations

dimensions_citation
8 Dimensions

Readers on

mendeley
26 Mendeley
citeulike
1 CiteULike
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Title
From protocol to published report: a study of consistency in the reporting of academic drug trials
Published in
Trials, February 2016
DOI 10.1186/s13063-016-1189-4
Pubmed ID
Authors

Louise Berendt, Torbjörn Callréus, Lene Grejs Petersen, Karin Friis Bach, Henrik Enghusen Poulsen, Kim Dalhoff

Abstract

Unacknowledged inconsistencies in the reporting of clinical trials undermine the validity of the results of the trials. Little is known about inconsistency in the reporting of academic clinical drug trials. Therefore, we investigated the prevalence of consistency between protocols and published reports of academic clinical drug trials. A comparison was made between study protocols and their corresponding published reports. We assessed the overall consistency, which was defined as the absence of discrepancy regarding study type (categorized as either exploratory or confirmatory), primary objective, primary endpoint, and - for confirmatory trials only - hypothesis and sample size calculation. We used logistic regression, χ(2), and Fisher's exact test. A total of 282 applications of academic clinical drug trials were submitted to the Danish Health and Medicines Authority in 1999, 2001, and 2003, 95 of which fulfilled the eligibility criteria and had at least one corresponding published report reporting data on trial subjects. Overall consistency was observed in 39 % of the trials (95 % CI: 29 to 49 %). Randomized controlled trials (RCTs) constituted 72 % (95 % CI: 63 to 81 %) of the sample, and 87 % (95 % CI: 80 to 94 %) of the trials were hospital based. Overall consistency between protocols and their corresponding published reports was low. Motivators for the inconsistencies are unknown but do not seem restricted to economic incentives.

Twitter Demographics

The data shown below were collected from the profiles of 62 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 26 Mendeley readers of this research output. Click here to see the associated Mendeley record.

Geographical breakdown

Country Count As %
Netherlands 1 4%
Unknown 25 96%

Demographic breakdown

Readers by professional status Count As %
Student > Master 6 23%
Researcher 6 23%
Student > Ph. D. Student 3 12%
Student > Bachelor 2 8%
Professor 2 8%
Other 3 12%
Unknown 4 15%
Readers by discipline Count As %
Medicine and Dentistry 7 27%
Biochemistry, Genetics and Molecular Biology 3 12%
Nursing and Health Professions 2 8%
Physics and Astronomy 2 8%
Economics, Econometrics and Finance 2 8%
Other 5 19%
Unknown 5 19%

Attention Score in Context

This research output has an Altmetric Attention Score of 68. 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 04 June 2017.
All research outputs
#290,264
of 14,557,298 outputs
Outputs from Trials
#49
of 3,825 outputs
Outputs of similar age
#8,684
of 265,367 outputs
Outputs of similar age from Trials
#1
of 1 outputs
Altmetric has tracked 14,557,298 research outputs across all sources so far. Compared to these this one has done particularly well and is in the 98th percentile: it's in the top 5% of all research outputs ever tracked by Altmetric.
So far Altmetric has tracked 3,825 research outputs from this source. They typically receive more attention than average, with a mean Attention Score of 7.5. 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 265,367 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