NCT02548312

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,065

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Jan 2016

Shorter than P25 for not_applicable healthy

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 8, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 14, 2015

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
3.1 years until next milestone

Results Posted

Study results publicly available

June 12, 2019

Completed
Last Updated

June 12, 2019

Status Verified

June 1, 2019

Enrollment Period

4 months

First QC Date

September 8, 2015

Results QC Date

November 2, 2018

Last Update Submit

June 11, 2019

Conditions

Keywords

Readers' perceptions

Outcome Measures

Primary Outcomes (1)

  • 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.

    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.

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

  • Interest in the 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

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

Study Arms (8)

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.

Other: Variations of financial competing interest statements

Review 1- competing interest statement 2

EXPERIMENTAL

Variations of financial competing interest statements.

Other: Variations of financial competing interest statements

Review 1- competing interest statement 3

EXPERIMENTAL

Variations of financial competing interest statements.

Other: Variations of financial competing interest statements

Review 1- competing interest statement 4

EXPERIMENTAL

Variations of financial competing interest statements.

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.

Other: Variations of financial competing interest statements

Review 2- competing interest statement 2

EXPERIMENTAL

Variations of financial competing interest statements.

Other: Variations of financial competing interest statements

Review 2- competing interest statement 3

EXPERIMENTAL

Variations of financial competing interest statements.

Other: Variations of financial competing interest statements

Review 2- competing interest statement 4

EXPERIMENTAL

Variations of financial competing interest statements.

Other: Variations of financial competing interest statements

Interventions

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.

Review 1- competing interest statement 1Review 1- competing interest statement 2Review 1- competing interest statement 3Review 1- competing interest statement 4Review 2- competing interest statement 1Review 2- competing interest statement 2Review 2- competing interest statement 3Review 2- competing interest statement 4

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

  • Schroter 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.

Results Point of Contact

Title
Dr Sara Schroter
Organization
BMJ

Study Officials

  • Sara Schroter, PhD

    The BMJ

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2015

First Posted

September 14, 2015

Study Start

January 1, 2016

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

June 12, 2019

Results First Posted

June 12, 2019

Record last verified: 2019-06