the Study Focus on no Specific Condition Clinical Trial
— SPIINOfficial title:
Impact of "Spin" on the Interpretation of Results of Randomized Trials in the Field of Cancer
NCT number | NCT01848704 |
Other study ID # | RAV 007 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 2013 |
Est. completion date | June 2013 |
Verified date | April 2013 |
Source | Assistance Publique - Hôpitaux de Paris |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Randomized controlled trials (RCT) are the gold standard for therapeutic evaluation. Rapid dissemination of trial results and their translation into clinical practice is particularly important. Abstracts published or presented in conferences are a large, rapid and free method to disseminate these results. However, this mode of dissemination may have serious consequences for patients if abstracts are not an accurate and unbiased reflection of the trial results. Investigators have great freedom when writing their abstracts and articles: they can choose the data and decide how to present it. Consequently, they have many opportunities to shape readers' impressions of their results, that is, to add "spin" (ie, spin is a specific way of reporting to convince readers that the beneficial effect of the experimental treatment is higher than shown by the results). Objective: To assess the impact of spin on the interpretation of results in abstracts of randomized controlled trials with non-statistically significant results in the field of cancer.
Status | Completed |
Enrollment | 300 |
Est. completion date | June 2013 |
Est. primary completion date | June 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion criteria The evaluators participating in this study were as follows: The "corresponding authors" of published RCTs in the field of cancer Experts of a French national grant in the field of cancer -investigator of trials registered in clinicaltrials.gov |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Interpretation of the Beneficial Effect of the Experimental Treatment | The primary endpoint was the interpretation of abstract results by the participants. All readers participating in the study evaluated the abstracts of randomized trials and answered the following questions: based on this abstract, do you think treatment A would be beneficial to patients? (answer: numerical scale from 0 not at all likely tp 10 very likely) | 1 month | |
Secondary | Overall Rigor of the Study Methodology | For each abstract, the participants answered the following: Rate the overall rigor of the study methodology(scale 0-10) Rate the importance of the study (scale 0-10) Are you interested in reading the full text article for the study described in this abstract? (scale 0-10) Do you think it would be interesting to run another trial evaluating this treatment? (scale 0-10) (Numerical scale from 0 not at all likely tp 10 very likely) |
1 month | |
Secondary | Importance of the Study | For each abstract, the participants answered the following: •Rate the importance of the study (scale from 0 not at all likely tp 10 very likely) |
1 month | |
Secondary | Interest in Reading Full Text | For each abstract, the participants answered the following: •Are you interested in reading the full text article for the study described in this abstract? (scale from 0 not at all likely tp 10 very likely) |
1 month | |
Secondary | Need for More Evidence (Run a New Trial) | For each abstract, the participants answered the following: •do you think it would be interesting to run another trial evaluating this treatment? (scale 0-10) (answer: numerical scale from 0 not at all likely tp 10 very likely |
1 month |
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