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

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ClinicalTrials.gov Identifier: NCT02548312
Recruitment Status : Completed
First Posted : September 14, 2015
Results First Posted : June 12, 2019
Last Update Posted : June 12, 2019
Sponsor:
Information provided by (Responsible Party):
The BMJ

Study Description
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Brief 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. 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.

Condition or disease Intervention/treatment Phase
Healthy Other: Variations of financial competing interest statements Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1065 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Other
Official Title: Randomised Controlled Trial to Measure the Effect of Different Financial Competing Interest Statements on Readers' Perceptions of Clinical Educational Articles
Study Start Date : January 2016
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016
Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


  2. 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.


  3. 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.



Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02548312


Sponsors and Collaborators
The BMJ
Investigators
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Principal Investigator: Sara Schroter, PhD The BMJ
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: The BMJ
ClinicalTrials.gov Identifier: NCT02548312    
Other Study ID Numbers: COI-RCT
First Posted: September 14, 2015    Key Record Dates
Results First Posted: June 12, 2019
Last Update Posted: June 12, 2019
Last Verified: June 2019
Keywords provided by The BMJ:
Readers' perceptions