CClinicalTrials.gg
WithdrawnNCT03071627Updated Feb 12, 2021

Interpretation of Health News Items Reporting Results of Pre-clinical Studies With or Without Spin By French-speaking Population

An interventional study of New items with spin and New items without spin in The Study Focus on no Specific Condition, sponsored by Assistance Publique - Hôpitaux de Paris. Withdrawn at 1 site in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-02-12.

Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Other

Why this study was withdrawn
Lack of funds
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The main objective of this study is to compare the interpretation of health news items reporting results of pre-clinical studies with or without spin (i.e., distortion of research results). The news items which reported those studies evaluating the treatment effect either in cell culture studies or animal studies, have high number of spin in the headline and text and received high online public attention will be selected. Spin will be deleted and will rewrite the news items without spin. This sample of news items reporting results of pre-clinical studies with and without spin will be interpreted by French-speaking population.

Read the detailed description

Health news is an important way to communicate updated medical research to the public. News items reporting the results of medical research attract a large audience. However, the quality of reporting in health news is questionable. The merits of a wide range of treatments and tests are overplayed and harms are underplayed. Several studies have shown the presence of spin (i.e., distorted presentation of study results) in health news. Distorted facts can be misleading and can affect the behaviour of physicians, healthcare providers and patients. However, little research has assessed whether spin can affect readers' interpretation of health news items.

Objective: To compare the interpretation of health news items reported with or without spin. News items reporting pre-clinical studies evaluating the effect of a pharmacological treatment that received high online public attention will be focused. "Spin" is defined as a misrepresentation of study results whatever the motive (intentionally or unintentionally) to highlight that the beneficial effect of the intervention in terms of efficacy and safety is greater than that shown by the results.

Hypothesis: The hypothesis of this study is that the spin can influence the reader's interpretation of health news items reporting results of pre-clinical studies.

Design: A randomized controlled trial

  1. Interventions: Health news items reporting results of pre-clinical studies with and without spin will be compared. A sample of health news items reporting the results of pre-clinical studies evaluating the effect of pharmacologic treatment and containing spin in the headline and text will be selected. Spin will be deleted in the selected news items and will be rewritten the news without spin.
  2. Participants: The participants will include French-speaking healthy population from Nutrinet santé.
  3. Sample size: For this RCT, the sample size will be 300 participants.
  4. Main outcome measures: The primary outcome will be participants' interpretation of the benefit of treatment after reading the news (What do you think is the probability that treatment X would be beneficial to patients? (scale, 0 [very unlikely] to 10 [very likely]).
  5. Expected results: This study will evaluate the impact of spin on the interpretation of news items reporting results of pre-clinical studies by French-speaking population.
  6. This study is approved by ethics review regulations by INSERM (CEEI-IRB): IRB00003888
02

Conditions studied

  • The Study Focus on no Specific Condition

Keywords

  • Spin
  • Misleading reporting
  • Misleading interpretation
  • Misleading extrapolation
  • Animal studies
  • Cell culture studies
  • Pre-clinical studies
03

In context

Lead sponsor

Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Native French speakers who can read the news

Exclusion criteria

Exclusion Criteria:

-

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
0 participants (actual)

Study arms

  • Active comparator
    News with Spin

    News items reporting results of animal studies with spin.

    Other: New items with spin

  • Experimental
    News without spin

    News items reporting results of animal studies without spin.

    Other: New items without spin

Interventions

  • OtherNew items with spin

    Interpretation of news items with spin

  • OtherNew items without spin

    Interpretation of news items without spin

06

What researchers measure

Primary outcomes

  1. Perception of beneficial effect of the treatment X. We ask participants, What do you think is the probability that treatment X would be beneficial to patients?

    With the choices of answers on a 10 points Likert scale, (scale, 0 \[very unlikely\] to 10 \[very likely\])

    Time frame: As the intervention is assigned (reading the news item) i.e., 1-2 hours

Secondary outcomes

  1. Perception of efficacy, safety, availability and clinical utility in existing clinical practice for the treatment X. We will ask the participants: What do you think is the size of the potential benefit for patients?

    With the choice of answers on a 5 points scale, (scale, \[none, small, moderate or large\]) -- analysis none, small vs moderate, large

    Time frame: As the intervention is assigned (reading the news item) i.e., 1-2 hours

  2. How safe do you think that treatment X would be for patients?

    With the choices of answers on a 10 points Likert scale, (scale, 0 \[very unsafe\] to 10 \[very safe\])

    Time frame: As the intervention is assigned (reading the news item) i.e., 1-2 hours

  3. Do you think this treatment should be offered to patients in the short term?

    With the choices of answers on a 10 points Likert scale, (scale, 0 \[absolutely no\] to 10 \[absolutely yes\])

    Time frame: As the intervention is assigned (reading the news item) i.e., 1-2 hours

  4. Do you think this treatment will make a difference in the existing clinical practice?

    With the choices of answers on a 10 points Likert scale, (scale, 0 \[absolutely no\] to 10 \[absolutely yes\])

    Time frame: As the intervention is assigned (reading the news item) i.e., 1-2 hours

07

Study locations

1 site
  • Assistance Publique - Hôpitaux de Paris
    Paris, Ile-de-france 75004, France
08

References and documents

Related links

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 12, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03071627
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Responsible party
Isabelle BOUTRON (Professor, Assistance Publique - Hôpitaux de Paris) — Principal investigator
First posted
Mar 7, 2017
Start date
Jun 2019 (estimated)
Primary completion
Dec 2019 (estimated)
Completion
Dec 2019 (estimated)
Last update
Feb 12, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is withdrawn, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.

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