HealthyNCT02548312
The Effect of Different Financial Competing Interest Statements on Readers' Perceptions of Clinical Educational Articles
A study testing Variations of financial competing interest statements in people with Healthy, run by The BMJ.
Trial summary
Financial ties with industry are common among doctors, academics and institutions. This trial aims to investigate the influence of different types of industry-linked activities on readers' perceptions of clinical reviews. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Variations of financial competing interest statements
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,065 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to May 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Practising doctors in the UK who are members of the British Medical Association (BMA) and receive The BMJ will be included.
Who cannot join
- BMA members who have opted out of receiving a free copy of The BMJ, public health doctors, consultant oral/dental surgeons, consultants in private practice, retired doctors and student members will be excluded.
About this study
Official title: Randomised Controlled Trial to Measure the Effect of Different Financial Competing Interest Statements on Readers' Perceptions of Clinical Educational Articles
Financial ties with industry are common among doctors, academics and institutions. This trial aims to investigate the influence of different types of industry-linked activities on readers' perceptions of clinical reviews. Two clinical reviews have been selected on medical topics and study participants (practicing doctors) will be sent one review each. The reviews will be identical except for the inclusion of one of four different permutations of competing interest statements. Participants will be asked to rate the one review they are sent based on the study outcomes (confidence, interest, importance and likeliness to change practice). The study focus is on educational articles as these are intended to guide patient care and convey the authors' interpretation of selected data.
- Conditions
- Healthy
- Being tested
- Variations of financial competing interest statements
- Keywords
- Readers' perceptions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Variations of financial competing interest statementsOther
Participants will be randomised to receive 1 of 2 review articles on different topics. For each review there will be 4 groups. Each of the 4 groups will receive an identical version of the review article with the exception of the competing interest statement which will vary depending on group assignment.
| Study group | Role | What they receive |
|---|---|---|
| Review 1- competing interest statement 1 | Experimental | Variations of financial competing interest statements. There will be a statement that the authors have no competing interests. Receives: Other: Variations of financial competing interest statements |
| Review 1- competing interest statement 2 | Experimental | Variations of financial competing interest statements. Receives: Other: Variations of financial competing interest statements |
| Review 1- competing interest statement 3 | Experimental | Variations of financial competing interest statements. Receives: Other: Variations of financial competing interest statements |
| Review 1- competing interest statement 4 | Experimental | Variations of financial competing interest statements. Receives: Other: Variations of financial competing interest statements |
| Review 2- competing interest statement 1 | Experimental | Variations of financial competing interest statements. There will be a statement that the authors have no competing interests. Receives: Other: Variations of financial competing interest statements |
| Review 2- competing interest statement 2 | Experimental | Variations of financial competing interest statements. Receives: Other: Variations of financial competing interest statements |
| Review 2- competing interest statement 3 | Experimental | Variations of financial competing interest statements. Receives: Other: Variations of financial competing interest statements |
| Review 2- competing interest statement 4 | Experimental | Variations of financial competing interest statements. Receives: Other: Variations of financial competing interest statements |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Readers' Level of Confidence in the Conclusions Drawn in the Article.
Measured on a single-item 10-point Likert scale from (1) "not at all confident" to (10) "extremely confident". Higher scores indicate more confidence. Min score = 0, max score =10.
Measured: Outcome measure will be assessed only at the time of the intervention (0 weeks). Readers will be asked to complete the study questionnaire immediately after reading the review article.
Secondary outcomes (3)
Importance of the Article.
Measured on a single-item 10-point Likert scale from (1) "not at all important" to (10) "extremely important". Higher scores indicate more importance. Min score = 0, max score =10.
Readers will be asked to complete the study questionnaire immediately after reading the review article.
Measured: Outcome measure will be assessed only at the time of the intervention (0 weeks)
Interest in the Article.
Measured on a single-item 10-point Likert scale from (1) "not at all interesting" to (10) "extremely interesting". Higher scores indicate more interest. Min score = 0, max score =10.
Readers will be asked to complete the study questionnaire immediately after reading the review article.
Measured: Outcome measure will be assessed only at the time of the intervention (0 weeks)
Number of Participants Who Are Extremely Likely to Change Practice on the Basis of the Article (Scored a "10"), for Those Currently Treating the Relevant Condition
Measured on a single-item 10-point Likert scale from (1) "not at all likely" to (10) "extremely likely". Higher scores indicate more likely to change practice. Min score = 1, max score =10.
Readers asked to complete the study questionnaire immediately after reading the review article.
Measured: Outcome measure will be assessed only at the time of the intervention (0 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2015 (estimated)
- Study startJan 2016
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 1,065 participants (actual)
Sponsor and investigators
- Lead sponsor
- The BMJ
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sara Schroter, PhD, Principal investigator, The BMJ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02548312
- Sponsor's protocol ID
- COI-RCT
- Status last verified
- Jun 2019
- First submitted
- 8 Sep 2015
- Last updated
- 12 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Schroter S, Pakpoor J, Morris J, Chew M, Godlee F. Effect of different financial competing interest statements on readers' perceptions of clinical educational articles: a randomised controlled trial. BMJ Open. 2019 Feb 19;9(2):e025029. doi: 10.1136/bmjopen-2018-025029.
PubMed 30782923Schroter S, Pakpoor J, Morris J, Chew M, Godlee F. Effect of different financial competing interest statements on readers' perceptions of clinical educational articles: study protocol for a randomised controlled trial. BMJ Open. 2016 Jun 10;6(6):e012677. doi: 10.1136/bmjopen-2016-012677.
PubMed 27288389
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Controlled Trial to Measure the Effect of Different Financial Competing Interest Statements on Readers' Perceptions of Clinical Educational Articles
- ClinicalTrials.gov ID
- NCT02548312
- Acronym / sponsor ID
- COI-RCT
- Conditions
- Healthy
- Keywords
- Readers' perceptions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,065 participants (actual)
- Lead sponsor
- The BMJUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 14 Sep 2015 (estimated)
- Results
- Posted 12 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Financial ties with industry are common among doctors, academics and institutions. This trial aims to investigate the influence of different types of industry-linked activities on readers' perceptions of clinical reviews. Two clinical reviews have been selected on medical topics and study participants (practicing doctors) will be sent one review each. The reviews will be identical except for the inclusion of one of four different permutations of competing interest statements. Participants will be asked to rate the one review they are sent based on the study outcomes (confidence, interest, importance and likeliness to change practice). The study focus is on educational articles as these are intended to guide patient care and convey the authors' interpretation of selected data.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Review 1- competing interest statement 1 | Experimental | Other: Variations of financial competing interest statementsVariations of financial competing interest statements. There will be a statement that the authors have no competing interests. |
| Review 1- competing interest statement 2 | Experimental | Other: Variations of financial competing interest statementsVariations of financial competing interest statements. |
| Review 1- competing interest statement 3 | Experimental | Other: Variations of financial competing interest statementsVariations of financial competing interest statements. |
| Review 1- competing interest statement 4 | Experimental | Other: Variations of financial competing interest statementsVariations of financial competing interest statements. |
| Review 2- competing interest statement 1 | Experimental | Other: Variations of financial competing interest statementsVariations of financial competing interest statements. There will be a statement that the authors have no competing interests. |
| Review 2- competing interest statement 2 | Experimental | Other: Variations of financial competing interest statementsVariations of financial competing interest statements. |
| Review 2- competing interest statement 3 | Experimental | Other: Variations of financial competing interest statementsVariations of financial competing interest statements. |
| Review 2- competing interest statement 4 | Experimental | Other: Variations of financial competing interest statementsVariations of financial competing interest statements. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Practising doctors in the UK who are members of the British Medical Association (BMA) and receive The BMJ will be included.
Key exclusion criteria (1 listed)
- BMA members who have opted out of receiving a free copy of The BMJ, public health doctors, consultant oral/dental surgeons, consultants in private practice, retired doctors and student members will be excluded.
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 |
|---|---|---|
| Variations of financial competing interest statementsParticipants will be randomised to receive 1 of 2 review articles on different topics. For each review there will be 4 groups. Each of the 4 groups will receive an identical version of the review article with the exception of the competing interest statement which will vary depending on group assignment. | Other | Review 1- competing interest statement 1, Review 1- competing interest statement 2, Review 1- competing interest statement 3, Review 1- competing interest statement 4, Review 2- competing interest statement 1, Review 2- competing interest statement 2, Review 2- competing interest statement 3, Review 2- competing interest statement 4 |
Primary outcome
The Readers' Level of Confidence in the Conclusions Drawn in the Article.
Time frame: Outcome measure will be assessed only at the time of the intervention (0 weeks). Readers will be asked to complete the study questionnaire immediately after reading the review article.
Measured on a single-item 10-point Likert scale from (1) "not at all confident" to (10) "extremely confident". Higher scores indicate more confidence. Min score = 0, max score =10.
3 secondary outcomes
Importance of the Article.
Time frame: Outcome measure will be assessed only at the time of the intervention (0 weeks)
Interest in the Article.
Time frame: Outcome measure will be assessed only at the time of the intervention (0 weeks)
Number of Participants Who Are Extremely Likely to Change Practice on the Basis of the Article (Scored a "10"), for Those Currently Treating the Relevant Condition
Time frame: Outcome measure will be assessed only at the time of the intervention (0 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30782923Schroter S, Pakpoor J, Morris J, Chew M, Godlee F. Effect of different financial competing interest statements on readers' perceptions of clinical educational articles: a randomised controlled trial. BMJ Open. 2019 Feb 19;9(2):e025029. doi: 10.1136/bmjopen-2018-025029.
- Derived from this study: PubMed 27288389Schroter S, Pakpoor J, Morris J, Chew M, Godlee F. Effect of different financial competing interest statements on readers' perceptions of clinical educational articles: study protocol for a randomised controlled trial. BMJ Open. 2016 Jun 10;6(6):e012677. doi: 10.1136/bmjopen-2016-012677.
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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.
Sara Schroter, PhD principal investigator
The BMJ
Questions about this trial
What is this clinical trial studying?
A study testing Variations of financial competing interest statements in people with Healthy, run by The BMJ.
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: finished, as of the sponsor's last update on 12 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 12 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Readers' Level of Confidence in the Conclusions Drawn in the Article. (time frame: Outcome measure will be assessed only at the time of the intervention (0 weeks). Readers will be asked to complete the study questionnaire immediately after reading the review article.). 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 NCT02548312, which also lists 2 linked publications.
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 Jun 2019; AzTrials last refreshed its copy on 7 Nov 2026.