The Study Focus on no Specific ConditionNCT03094117
Interpretation of Health News Items Reporting Results of Phase I/II (Non-randomized) Trials With or Without Spin by French-speaking Patients
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 (nonrandomized) trials with or without spin (i.e., distortion of research results). Read more about this study
- Who is it for?
- Ages 18 years and older
- 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
- 0 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2019to Dec 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Native French speakers
- Have at least one chronic disease
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
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 French-speaking Patients
The main objective of this study is to compare the interpretation of health news items reporting results of phase I/II (nonrandomized) 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 French-speaking patients.
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 French-speaking patients from an e-cohort COMPARE.
- 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) studies by French-speaking patients.
- This study is approved by ethics review regulations by INSERM (CEEI-IRB):IRB00003888
- 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]); analysis none, small vs 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 startJun 2019 (estimated)
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Why it stopped: Lack of funds
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 0 participants (actual)
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
- NCT03094117
- Sponsor's protocol ID
- ISB-007
- Status last verified
- Feb 2021
- First submitted
- 22 Mar 2017
- Last updated
- 12 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2021. 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 French-speaking Patients
- ClinicalTrials.gov ID
- NCT03094117
- Acronym / sponsor ID
- ISB-007
- 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
- WithdrawnReason stopped: Lack of funds
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Jun 2019 (estimated)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 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 (nonrandomized) 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 French-speaking patients.
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 French-speaking patients from an e-cohort COMPARE.
- 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) studies by French-speaking patients.
- This study is approved by ethics review regulations by INSERM (CEEI-IRB):IRB00003888
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
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Native French speakers
- Have at least one chronic disease
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
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2021.
- Related InfoLink provided by the sponsor.
- 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 2 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: withdrawn, as of the sponsor's last update on 12 Feb 2021. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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?
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 12 Feb 2021.