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No improvement in the reporting of clinical trial subgroup effects in high-impact general medical journals

Overview of attention for article published in Trials, July 2016
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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 (93rd percentile)

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2 blogs
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31 tweeters

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25 Dimensions

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40 Mendeley
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Title
No improvement in the reporting of clinical trial subgroup effects in high-impact general medical journals
Published in
Trials, July 2016
DOI 10.1186/s13063-016-1447-5
Pubmed ID
Authors

Nicole B. Gabler, Naihua Duan, Eli Raneses, Leah Suttner, Michael Ciarametaro, Elizabeth Cooney, Robert W. Dubois, Scott D. Halpern, Richard L. Kravitz

Abstract

When subgroup analyses are not correctly analyzed and reported, incorrect conclusions may be drawn, and inappropriate treatments provided. Despite the increased recognition of the importance of subgroup analysis, little information exists regarding the prevalence, appropriateness, and study characteristics that influence subgroup analysis. The objective of this study is to determine (1) if the use of subgroup analyses and multivariable risk indices has increased, (2) whether statistical methodology has improved over time, and (3) which study characteristics predict subgroup analysis. We randomly selected randomized controlled trials (RCTs) from five high-impact general medical journals during three time periods. Data from these articles were abstracted in duplicate using standard forms and a standard protocol. Subgroup analysis was defined as reporting any subgroup effect. Appropriate methods for subgroup analysis included a formal test for heterogeneity or interaction across treatment-by-covariate groups. We used logistic regression to determine the variables significantly associated with any subgroup analysis or, among RCTs reporting subgroup analyses, using appropriate methodology. The final sample of 416 articles reported 437 RCTs, of which 270 (62 %) reported subgroup analysis. Among these, 185 (69 %) used appropriate methods to conduct such analyses. Subgroup analysis was reported in 62, 55, and 67 % of the articles from 2007, 2010, and 2013, respectively. The percentage using appropriate methods decreased over the three time points from 77 % in 2007 to 63 % in 2013 (p < 0.05). Significant predictors of reporting subgroup analysis included industry funding (OR 1.94 (95 % CI 1.17, 3.21)), sample size (OR 1.98 per quintile (1.64, 2.40), and a significant primary outcome (OR 0.55 (0.33, 0.92)). The use of appropriate methods to conduct subgroup analysis decreased by year (OR 0.88 (0.76, 1.00)) and was less common with industry funding (OR 0.35 (0.18, 0.70)). Only 33 (18 %) of the RCTs examined subgroup effects using a multivariable risk index. While we found no significant increase in the reporting of subgroup analysis over time, our results show a significant decrease in the reporting of subgroup analyses using appropriate methods during recent years. Industry-sponsored trials may more commonly report subgroup analyses, but without utilizing appropriate methods. Suboptimal reporting of subgroup effects may impact optimal physician-patient decision-making.

Twitter Demographics

The data shown below were collected from the profiles of 31 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 40 Mendeley readers of this research output. Click here to see the associated Mendeley record.

Geographical breakdown

Country Count As %
United Kingdom 1 3%
Unknown 39 98%

Demographic breakdown

Readers by professional status Count As %
Researcher 9 23%
Student > Bachelor 6 15%
Student > Master 5 13%
Student > Doctoral Student 4 10%
Other 4 10%
Other 8 20%
Unknown 4 10%
Readers by discipline Count As %
Medicine and Dentistry 17 43%
Pharmacology, Toxicology and Pharmaceutical Science 3 8%
Mathematics 2 5%
Engineering 2 5%
Social Sciences 2 5%
Other 5 13%
Unknown 9 23%

Attention Score in Context

This research output has an Altmetric Attention Score of 35. 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 27 April 2017.
All research outputs
#875,013
of 20,975,194 outputs
Outputs from Trials
#175
of 5,359 outputs
Outputs of similar age
#14,108
of 219,055 outputs
Outputs of similar age from Trials
#1
of 1 outputs
Altmetric has tracked 20,975,194 research outputs across all sources so far. Compared to these this one has done particularly well and is in the 95th percentile: it's in the top 5% of all research outputs ever tracked by Altmetric.
So far Altmetric has tracked 5,359 research outputs from this source. They typically receive more attention than average, with a mean Attention Score of 7.8. This one has done particularly well, scoring higher than 96% 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 219,055 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 93% 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