Impact of "Spin" on the Interpretation of Results of Randomized Trials in the Field of Cancer (SPIIN)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01848704
First received: April 11, 2013
Last updated: July 26, 2013
Last verified: April 2013
  Purpose

1Randomized 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. Indeed, investigators have great freedom when writing their abstracts and articles. They can choose the data to present and decide how to present them. 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 (efficacy, safety) 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 nonstatistically significant results in the field of cancer.

Design: The investigators performed a RCT comparing the interpretation of results in abstracts a) with and b) without spin.

  1. Identification of abstracts of randomized trials with spin. The investigators selected a sample of negative published RCTs (i.e. non statistically significant results) with a spin in abstract conclusion identified in previous works. Inclusion criteria were 1) RCTs with non statistically significant primary outcome, 2) spin in the abstract conclusion.
  2. Abstracts' modification Selected abstracts were systematically rewritten to contain no "spin". All abstracts were presented in the same format without the names of authors, references, or the name of the journal in which it was published, and the names of treatments were masked by using generic terms (e.g., treatment A, comparator B). All abstracts had the same number of words +/-20
  3. Assessment Abstracts were assessed by corresponding authors of randomized trials, experts of specific grants and investigator of trials registered in clinicaltrials.gov. Experts were invited to participate in our study. They were not informed of the objectives of our study. Each clinician were randomized to evaluate 1 abstracts with or 1 abstracts without spin.
  4. The primary endpoint was the interpretation of abstract results by the participants. All readers participating in the study evaluated the abstract of randomized trial and answered the following question: Based on this abstract, do you think treatment A would be beneficial to patients? (answer: numerical scale from 0-10)

Condition Intervention
the Study Focus on no Specific Condition
Behavioral: interpretation of the abstract

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Official Title: Impact of "Spin" on the Interpretation of Results of Randomized Trials in the Field of Cancer

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • interpretation of the abstracts [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    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 0-10)


Secondary Outcome Measures:
  • assessment of the study quality [ Time Frame: 1 month ] [ Designated as safety issue: No ]

    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)


Enrollment: 300
Study Start Date: May 2013
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: abstract with spin
30 abstracts of 2 parallel arms negative RCTs (ie, non-statistically significant primary outcome) evaluating treatment in the field of cancer and having spin in the abstract conclusion according to a classification developed previously
Behavioral: interpretation of the abstract
Experimental: abstract without spin
The abstracts with spin were systematically rewritten without spin
Behavioral: interpretation of the abstract

  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 clinicaltrial.gov
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01848704

Locations
France
Paris, France
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: isabelle BOUTRON, PhD Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01848704     History of Changes
Other Study ID Numbers: RAV 007
Study First Received: April 11, 2013
Last Updated: July 26, 2013
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
spin
interpretation
bias

ClinicalTrials.gov processed this record on August 28, 2014