The Effect of Different Financial Competing Interest Statements on Readers' Perceptions of Clinical Educational Articles

June 11, 2019 updated by: The BMJ

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1065

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Practising doctors in the UK who are members of the British Medical Association (BMA) and receive The BMJ will be included.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Review 1- competing interest statement 1
Variations of financial competing interest statements. There will be a statement that the authors have no competing interests.
Other: Variations of financial competing interest statements
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.
Experimental: Review 1- competing interest statement 2
Variations of financial competing interest statements.
Other: Variations of financial competing interest statements
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.
Experimental: Review 1- competing interest statement 3
Variations of financial competing interest statements.
Other: Variations of financial competing interest statements
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.
Experimental: Review 1- competing interest statement 4
Variations of financial competing interest statements.
Other: Variations of financial competing interest statements
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.
Experimental: Review 2- competing interest statement 1
Variations of financial competing interest statements. There will be a statement that the authors have no competing interests.
Other: Variations of financial competing interest statements
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.
Experimental: Review 2- competing interest statement 2
Variations of financial competing interest statements.
Other: Variations of financial competing interest statements
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.
Experimental: Review 2- competing interest statement 3
Variations of financial competing interest statements.
Other: Variations of financial competing interest statements
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.
Experimental: Review 2- competing interest statement 4
Variations of financial competing interest statements.
Other: Variations of financial competing interest statements
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Importance of the Article.
Time Frame: Outcome measure will be assessed only at the time of the intervention (0 weeks)

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.
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)

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.
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)

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.
Outcome measure will be assessed only at the time of the intervention (0 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The BMJ

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sara Schroter, PhD, The BMJ

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 8, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 10, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 14, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 12, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 11, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • COI-RCT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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