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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE September 8, 2015
First Posted Date  ICMJE September 14, 2015
Results First Submitted Date  ICMJE November 2, 2018
Results First Posted Date  ICMJE June 12, 2019
Last Update Posted Date June 12, 2019
Study Start Date  ICMJE January 2016
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 11, 2019)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 10, 2015)
The readers' level of confidence in the conclusions drawn in the article, measured on a 10-point Likert scale from "not at all confident" to "extremely confident". [ 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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 11, 2019)
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 10, 2015)
  • Importance of the article, measured on a 10-point Likert scale from "not at all important" to "extremely important". [ 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
  • Interest in the article, measured on a 10-point Likert scale from "not at all interesting" to "extremely interesting". [ 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
  • Likeliness to change practice on the basis of the article, measured on a 10-point Likert scale from "not at all likely" to "extremely likely". [ 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Different Financial Competing Interest Statements on Readers' Perceptions of Clinical Educational Articles
Official Title  ICMJE Randomised Controlled Trial to Measure the Effect of Different Financial Competing Interest Statements on Readers' Perceptions of Clinical Educational Articles
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Other
Condition  ICMJE Healthy
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Other: Variations of financial competing interest statements
  • Experimental: Review 1- competing interest statement 2
    Variations of financial competing interest statements.
    Intervention: Other: Variations of financial competing interest statements
  • Experimental: Review 1- competing interest statement 3
    Variations of financial competing interest statements.
    Intervention: Other: Variations of financial competing interest statements
  • Experimental: Review 1- competing interest statement 4
    Variations of financial competing interest statements.
    Intervention: Other: Variations of financial competing interest statements
  • 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.
    Intervention: Other: Variations of financial competing interest statements
  • Experimental: Review 2- competing interest statement 2
    Variations of financial competing interest statements.
    Intervention: Other: Variations of financial competing interest statements
  • Experimental: Review 2- competing interest statement 3
    Variations of financial competing interest statements.
    Intervention: Other: Variations of financial competing interest statements
  • Experimental: Review 2- competing interest statement 4
    Variations of financial competing interest statements.
    Intervention: Other: Variations of financial competing interest statements
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 14, 2017)
1065
Original Estimated Enrollment  ICMJE
 (submitted: September 10, 2015)
1020
Actual Study Completion Date  ICMJE May 2016
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02548312
Other Study ID Numbers  ICMJE COI-RCT
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party The BMJ
Study Sponsor  ICMJE The BMJ
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sara Schroter, PhD The BMJ
PRS Account The BMJ
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP