The Study Focus on no Specific ConditionNCT03094104
Interpretation of Health News Items Reporting Results of Phase I/II (Non-randomized) Trials With or Without Spin by English-speaking Population
A study testing News items with spin and News items without spin in people with The Study Focus on no Specific Condition, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The main objective of this study is to compare the interpretation of health news items reporting results of phase I/II (non-randomized) trials with or without spin (i.e., distortion of research results). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- The Study Focus on no Specific Condition
- What is being tested?
- News items with spin and News items without spin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2019to Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Native English speakers or have a very good level in reading and understanding of English language
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
France1 site
Assistance Publique - Hôpitaux de Paris
Paris, Île-de-France Region, 75004
Isabelle BOUTRON, Prof., +33 (0)1.42.34.78.33, isabelle.boutron@aphp.fr
Audrey Conjaud, +33 (0)1.42.34.89.87, secretariat.epidemiologie.htd@aphp.fr
About this study
Official title: Interpretation of Health News Items Reporting Results of Phase I/II (Non-randomized) Trials With or Without Spin: A Randomized Controlled Trial Among English-speaking Population
The main objective of this study is to compare the interpretation of health news items reporting results of phase I/II (non-randomized) trials with or without spin (i.e., distortion of research results). The news items which reported studies evaluating the treatment effect, having highest 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 phase I/II (non-randomized) trials with and without spin will be interpreted by English-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: "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. To compare the interpretation of health news items reporting phase I/II (non-randomized) trials with or without spin. News items evaluating the effect of a pharmacological treatment that received high online public attention will be focused.
Hypothesis: The hypothesis of this study is that the spin can influence the reader's interpretation of health news items reporting results of phase I/II (non-randomized) trials.
Design: A randomized controlled trial
- Interventions: Health news items reporting results of phase I/II (non-randomized) studies with and without spin will be compared. A sample of health news items reporting the results of phase I/II (non-randomized) 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.
- Participants: The participants will include English-speaking population from FindParticipants (https://www.findparticipants.com/).
- Sample size: For this RCT, the sample size will be 300 participants.
- The primary outcome will be perception of beneficial effect of the treatment X. We will ask participants, what do you think is the probability that treatment X would be beneficial to patients? (scale, 0 [very unlikely] to 10 [very likely]). Perception of safety and beneficial effects of treatment in clinical studies is considered as a surrogate marker of health outcome as it may have an impact on the future development of the drug, and then the potential use of the drug for patients.
- Expected results: This study will evaluate the impact of spin on the interpretation of news items reporting results of phase I/II (non-randomized) trials by English-speaking population.
- Conditions
- The Study Focus on no Specific Condition
- Being tested
- News items with spin, News items without spin
- Keywords
- Spin, Misleading reporting, Misleading interpretation, Misleading extrapolation, phase I/II trials, non-randomized trials, Patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
News items with spinOther
Interpretation of news items with spin
News items without spinOther
Interpretation of news items without spin
| Study group | Role | What they receive |
|---|---|---|
| News with Spin | Active comparator | News items reporting results of phase I/II (non-randomized) trials with spin Receives: Other: News items with spin |
| News without spin | Experimental | News items reporting results of phase I/II (non-randomized) trials without spin Receives: Other: News items without spin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perception of beneficial effect of the treatment X
We will 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 point Likert scale, (scale, 0 [very unlikely] to 10 [very likely])
Measured: As the intervention is assigned (reading the news item) i.e., 1-2 hours
Secondary outcomes (4)
Perception of efficacy, safety, availability and clinical utility of the treatment X in existing clinical practice
We will ask participants, what do you think is the size of the potential benefit for patients? With the choices of answers on a 5 point scale (scale, [none, small, moderate or large])
Measured: As the intervention is assigned (reading the news item) i.e., 1-2 hours
How safe do you think that treatment X would be for patients?
With the choices of answers on a 10 point Likert scale, (scale, 0 [very unsafe] to 10 [very safe])
Measured: As the intervention is assigned (reading the news item) i.e., 1-2 hours
Do you think this treatment should be offered to patients in the short term?
With the choices of answers on a 10 point Likert scale, (scale, 0 [absolutely no] to 10 [absolutely yes])
Measured: As the intervention is assigned (reading the news item) i.e., 1-2 hours
Do you think this treatment will make a difference in the existing clinical practice?
With the choices of answers on a 10 point Likert scale, (scale, 0 [absolutely no] to 10 [absolutely yes])
Measured: As the intervention is assigned (reading the news item) i.e., 1-2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2017
- Study startJan 2019 (estimated)
- Primary completionJun 2019 (estimated)
- Study completionJun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for The Study Focus on no Specific ConditionStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two arms, parallel group, randomized controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Isabelle BOUTRON, Assistance Publique - Hôpitaux de Paris
- Investigators
- Isabelle BOUTRON, Prof., Principal investigator, INSERM U1153, University of Paris-DescartesRomana HANEEF, PhD researcher, Principal investigator, Institut National de la Santé Et de la Recherche Médicale, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03094104
- Sponsor's protocol ID
- ISB-006
- Status last verified
- Sep 2018
- First submitted
- 22 Mar 2017
- Last updated
- 11 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Boutron I, Haneef R, Yavchitz A, Baron G, Novack J, Oransky I, Schwitzer G, Ravaud P. Three randomized controlled trials evaluating the impact of "spin" in health news stories reporting studies of pharmacologic treatments on patients'/caregivers' interpretation of treatment benefit. BMC Med. 2019 Jun 4;17(1):105. doi: 10.1186/s12916-019-1330-9.
PubMed 31159786
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interpretation of Health News Items Reporting Results of Phase I/II (Non-randomized) Trials With or Without Spin: A Randomized Controlled Trial Among English-speaking Population
- ClinicalTrials.gov ID
- NCT03094104
- Acronym / sponsor ID
- ISB-006
- Conditions
- The Study Focus on no Specific Condition
- Keywords
- Spin, Misleading reporting, Misleading interpretation, Misleading extrapolation, phase I/II trials, non-randomized trials, Patients
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Jan 2019 (estimated)
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 29 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objective of this study is to compare the interpretation of health news items reporting results of phase I/II (non-randomized) trials with or without spin (i.e., distortion of research results). The news items which reported studies evaluating the treatment effect, having highest 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 phase I/II (non-randomized) trials with and without spin will be interpreted by English-speaking population.
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: "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. To compare the interpretation of health news items reporting phase I/II (non-randomized) trials with or without spin. News items evaluating the effect of a pharmacological treatment that received high online public attention will be focused.
Hypothesis: The hypothesis of this study is that the spin can influence the reader's interpretation of health news items reporting results of phase I/II (non-randomized) trials.
Design: A randomized controlled trial
- Interventions: Health news items reporting results of phase I/II (non-randomized) studies with and without spin will be compared. A sample of health news items reporting the results of phase I/II (non-randomized) 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.
- Participants: The participants will include English-speaking population from FindParticipants (https://www.findparticipants.com/).
- Sample size: For this RCT, the sample size will be 300 participants.
- The primary outcome will be perception of beneficial effect of the treatment X. We will ask participants, what do you think is the probability that treatment X would be beneficial to patients? (scale, 0 [very unlikely] to 10 [very likely]). Perception of safety and beneficial effects of treatment in clinical studies is considered as a surrogate marker of health outcome as it may have an impact on the future development of the drug, and then the potential use of the drug for patients.
- Expected results: This study will evaluate the impact of spin on the interpretation of news items reporting results of phase I/II (non-randomized) trials by English-speaking population.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Two arms, parallel group, randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| News with Spin | Active comparator | Other: News items with spinNews items reporting results of phase I/II (non-randomized) trials with spin |
| News without spin | Experimental | Other: News items without spinNews items reporting results of phase I/II (non-randomized) trials without spin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Native English speakers or have a very good level in reading and understanding of English language
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| News items with spinInterpretation of news items with spin | Other | News with Spin |
| News items without spinInterpretation of news items without spin | Other | News without spin |
Primary outcome
Perception of beneficial effect of the treatment X
Time frame: As the intervention is assigned (reading the news item) i.e., 1-2 hours
We will 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 point Likert scale, (scale, 0 [very unlikely] to 10 [very likely])
4 secondary outcomes
Perception of efficacy, safety, availability and clinical utility of the treatment X in existing clinical practice
Time frame: As the intervention is assigned (reading the news item) i.e., 1-2 hours
How safe do you think that treatment X would be for patients?
Time frame: As the intervention is assigned (reading the news item) i.e., 1-2 hours
Do you think this treatment should be offered to patients in the short term?
Time frame: As the intervention is assigned (reading the news item) i.e., 1-2 hours
Do you think this treatment will make a difference in the existing clinical practice?
Time frame: As the intervention is assigned (reading the news item) i.e., 1-2 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2018.
- Derived from this study: PubMed 31159786Boutron I, Haneef R, Yavchitz A, Baron G, Novack J, Oransky I, Schwitzer G, Ravaud P. Three randomized controlled trials evaluating the impact of "spin" in health news stories reporting studies of pharmacologic treatments on patients'/caregivers' interpretation of treatment benefit. BMC Med. 2019 Jun 4;17(1):105. doi: 10.1186/s12916-019-1330-9.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Isabelle BOUTRON, Prof. principal investigator
INSERM U1153, University of Paris-Descartes
Romana HANEEF, PhD researcher principal investigator
Institut National de la Santé Et de la Recherche Médicale, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing News items with spin and News items without spin in people with The Study Focus on no Specific Condition, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Isabelle BOUTRON, Prof. (+33 (0)1.42.34.78.33, isabelle.boutron@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perception of beneficial effect of the treatment X (time frame: As the intervention is assigned (reading the news item) i.e., 1-2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03094104, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2018; AzTrials last refreshed its copy on 8 Nov 2026.