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Decision aids for people considering taking part in clinical trials

Overview of attention for article published in Cochrane database of systematic reviews, November 2015
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About this Attention Score

  • In the top 5% of all research outputs scored by Altmetric
  • High Attention Score compared to outputs of the same age (94th percentile)
  • Good Attention Score compared to outputs of the same age and source (71st percentile)

Mentioned by

policy
1 policy source
twitter
42 tweeters
facebook
1 Facebook page

Citations

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22 Dimensions

Readers on

mendeley
170 Mendeley
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Title
Decision aids for people considering taking part in clinical trials
Published in
Cochrane database of systematic reviews, November 2015
DOI 10.1002/14651858.cd009736.pub2
Pubmed ID
Authors

Katie Gillies, Seonaidh C Cotton, Jamie C Brehaut, Mary C Politi, Zoe Skea

Abstract

Several interventions have been developed to promote informed consent for participants in clinical trials. However, many of these interventions focus on the content and structure of information (e.g. enhanced information or changes to the presentation format) rather than the process of decision making. Patient decision aids support a decision making process about medical options. Decision aids support the decision process by providing information about available options and their associated outcomes, alongside information that enables patients to consider what value they place on particular outcomes, and provide structured guidance on steps of decision making. They have been shown to be effective for treatment and screening decisions but evidence on their effectiveness in the context of informed consent for clinical trials has not been synthesised. To assess the effectiveness of decision aids for clinical trial informed consent compared to no intervention, standard information (i.e. usual practice) or an alternative intervention on the decision making process. We searched the following databases and to March 2015: Cochrane Central Register of Controlled Trials (CENTRAL), The Cochrane Library; MEDLINE (OvidSP) (from 1950); EMBASE (OvidSP) (from 1980); PsycINFO (OvidSP) (from 1806); ASSIA (ProQuest) (from 1987); WHO International Clinical Trials Registry Platform (ICTRP) (http://apps.who.int/trialsearch/); ClinicalTrials.gov; ISRCTN Register (http://www.controlled-trials.com/isrctn/). We also searched reference lists of included studies and relevant reviews. We contacted study authors and other experts. There were no language restrictions. We included randomised and quasi-randomised controlled trials comparing decision aids in the informed consent process for clinical trials alone, or in conjunction with standard information (such as written or verbal) or alongside alternative interventions (e.g. paper-based versus web-based decision aids). Included trials involved potential trial participants, or their guardians, being asked to consider participating in a real or hypothetical clinical trial. At least two authors independently assessed studies for inclusion, extracted reported data and assessed risk of bias. Findings were pooled where appropriate. We used GRADE to assess the quality of the evidence for each outcome. We identified one study (290 randomised participants) that investigated the effectiveness of decision aids compared to standard information in the informed consent process for clinical trials. This study reported two separate decision aid randomised controlled trials (RCTs). The decision aid trials were nested within two different parent trials focusing on breast cancer in postmenopausal women. One trial focused on informed consent for treatment in women who had previously had surgery for ductal carcinoma in situ (DCIS), the other on informed consent for prevention in women at high risk for breast cancer. Two different decision aids were used in these RCTs, and were compared with standard information.The pooled findings highlight the uncertainty surrounding most reported outcomes, including knowledge, decisional conflict, anxiety, trial participation and attrition. There was very low quality evidence that decision aids lower levels of decisional regret to a small degree (MD -5.53, 95% CI -10.29 to -0.76). No data were identified on several prespecified primary outcomes, including accurate risk perception, values-based decision, or whether potential participants recognised that a decision needed to be made, were able to identify features of options that matter most to individuals, or were involved in the decision. There was insufficient evidence to determine whether decision aids to support the informed consent process for clinical trials are more effective than standard information. Additional well designed, adequately powered clinical trials in more diverse clinical and social populations are needed to strengthen the results of this review. More generally, future research on which outcomes are most relevant for assessment in this context would be helpful.

Twitter Demographics

The data shown below were collected from the profiles of 42 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 170 Mendeley readers of this research output. Click here to see the associated Mendeley record.

Geographical breakdown

Country Count As %
United Kingdom 1 <1%
United States 1 <1%
South Africa 1 <1%
Canada 1 <1%
Unknown 166 98%

Demographic breakdown

Readers by professional status Count As %
Student > Master 26 15%
Researcher 26 15%
Student > Ph. D. Student 22 13%
Student > Bachelor 17 10%
Other 12 7%
Other 40 24%
Unknown 27 16%
Readers by discipline Count As %
Medicine and Dentistry 54 32%
Nursing and Health Professions 27 16%
Psychology 16 9%
Social Sciences 10 6%
Economics, Econometrics and Finance 5 3%
Other 17 10%
Unknown 41 24%

Attention Score in Context

This research output has an Altmetric Attention Score of 28. 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 30 May 2018.
All research outputs
#663,553
of 14,521,746 outputs
Outputs from Cochrane database of systematic reviews
#1,973
of 10,986 outputs
Outputs of similar age
#20,256
of 361,274 outputs
Outputs of similar age from Cochrane database of systematic reviews
#62
of 214 outputs
Altmetric has tracked 14,521,746 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 10,986 research outputs from this source. They typically receive a lot more attention than average, with a mean Attention Score of 22.1. This one has done well, scoring higher than 82% 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 361,274 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 94% of its contemporaries.
We're also able to compare this research output to 214 others from the same source and published within six weeks on either side of this one. This one has gotten more attention than average, scoring higher than 71% of its contemporaries.