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

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1065

Phase

  • 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

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
Intervention / Treatment
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

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

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

The BMJ

Investigators

  • 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

January 1, 2016

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

September 8, 2015

First Submitted That Met QC Criteria

September 10, 2015

First Posted (Estimate)

September 14, 2015

Study Record Updates

Last Update Posted (Actual)

June 12, 2019

Last Update Submitted That Met QC Criteria

June 11, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID 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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