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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Review 1- competing interest statement 2 | Experimental | Variations of financial competing interest statements. |
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| Review 1- competing interest statement 3 | Experimental | Variations of financial competing interest statements. |
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| Review 1- competing interest statement 4 | Experimental | Variations of financial competing interest statements. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Variations of financial competing interest statements | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Importance of the Article. | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sara Schroter, PhD | The BMJ | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30782923 | Derived | 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. | |
| 27288389 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Dyspepsia Review- Competing Interest Statement 1 | Honoraria & Travel: We have read and understood the BMJ policy on declaration of interests and declare the following: DF is funded by a NIH clinician scientist award; SN receives no specific funding; JB has received honoraria and travel expenses from Jenka Pharmaceuticals for lecturing at a conference. |
| FG001 | Gout Review- Competing Interest Statement 2 | Advisory board & consultancies: We have read and understood the BMJ policy on declaration of interests and declare the following: DF is funded by a NIH clinician scientist award; SN receives no specific funding; JB has received fees from Jenka Pharmaceuticals for consultancies and being an advisory board member. |
| FG002 | Dyspepsia Review- Competing Interest Statement 3 | Research funding: We have read and understood the BMJ policy on declaration of interests and declare the following: DF is funded by a NIH clinician scientist award; SN receives no specific funding; JB has received research funding from Jenka Pharmaceuticals |
| FG003 | Dyspepsia Review- Competing Interest Statement 4 | None: We have read and understood the BMJ policy on declaration of interests and declare the following: DF is funded by a NIH clinician scientist award; SN receives no specific funding; JB has no competing interests. |
| FG004 | Gout Review- Competing Interest Statement 1 | Honoraria & travel: We have read and understood the BMJ policy on declaration of interests and declare the following: DF is funded by a NIH clinician scientist award; SN receives no specific funding; JB has received honoraria and travel expenses from Jenka Pharmaceuticals for lecturing at a conference. |
| FG005 | Dyspepsia Review- Competing Interest Statement 2 | Advisory board & consultancies. We have read and understood the BMJ policy on declaration of interests and declare the following: DF is funded by a NIH clinician scientist award; SN receives no specific funding; JB has received fees from Jenka Pharmaceuticals for consultancies and being an advisory board member. |
| FG006 | Gout Review- Competing Interest Statement 3 | Research funding: We have read and understood the BMJ policy on declaration of interests and declare the following: DF is funded by a NIH clinician scientist award; SN receives no specific funding; JB has received research funding from Jenka Pharmaceuticals.. |
| FG007 | Gout Review- Competing Interest Statement 4 | None: We have read and understood the BMJ policy on declaration of interests and declare the following: DF is funded by a NIH clinician scientist award; SN receives no specific funding; JB has no competing interests. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Dyspepsia Review- Competing Interest Statement 1 | Honoraria & Travel: We have read and understood the BMJ policy on declaration of interests and declare the following: DF is funded by a NIH clinician scientist award; SN receives no specific funding; JB has received honoraria and travel expenses from Jenka Pharmaceuticals for lecturing at a conference. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | One participant in the Group 'Gout review- competing interest statement 2', one in 'Dyspepsia review- competing interest statement 2', one in 'Dyspepsia- statement 3', and one in 'Gout- statement 4' did not respond to the question related to the primary outcome. Hence, for this outcome the numbers analyzed= 89, 92, 95 and 90, respectively. | Posted | Mean | 95% Confidence Interval | score on a scale | 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. |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dyspepsia Review- Competing Interest Statement 1 | Honoraria & Travel: We have read and understood the BMJ policy on declaration of interests and declare the following: DF is funded by a NIH clinician scientist award; SN receives no specific funding; JB has received honoraria and travel expenses from Jenka Pharmaceuticals for lecturing at a conference. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Sara Schroter | BMJ | 02073836744 | sschroter@bmj.com |
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| Review 2- competing interest statement 2 | Experimental | Variations of financial competing interest statements. |
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| Review 2- competing interest statement 3 | Experimental | Variations of financial competing interest statements. |
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| Review 2- competing interest statement 4 | Experimental | Variations of financial competing interest statements. |
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| Interest in the Article. | 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 | 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) |
| BG001 |
| Gout Review- Competing Interest Statement 2 |
Advisory board & consultancies: We have read and understood the BMJ policy on declaration of interests and declare the following: DF is funded by a NIH clinician scientist award; SN receives no specific funding; JB has received fees from Jenka Pharmaceuticals for consultancies and being an advisory board member. |
| BG002 | Dyspepsia Review- Competing Interest Statement 3 | Research funding: We have read and understood the BMJ policy on declaration of interests and declare the following: DF is funded by a NIH clinician scientist award; SN receives no specific funding; JB has received research funding from Jenka Pharmaceuticals |
| BG003 | Dyspepsia Review- Competing Interest Statement 4 | None: We have read and understood the BMJ policy on declaration of interests and declare the following: DF is funded by a NIH clinician scientist award; SN receives no specific funding; JB has no competing interests. |
| BG004 | Gout Review- Competing Interest Statement 1 | Honoraria & travel: We have read and understood the BMJ policy on declaration of interests and declare the following: DF is funded by a NIH clinician scientist award; SN receives no specific funding; JB has received honoraria and travel expenses from Jenka Pharmaceuticals for lecturing at a conference. |
| BG005 | Dyapepsia Review- Competing Interest Statement 2 | Advisory board & consultancies. We have read and understood the BMJ policy on declaration of interests and declare the following: DF is funded by a NIH clinician scientist award; SN receives no specific funding; JB has received fees from Jenka Pharmaceuticals for consultancies and being an advisory board member. |
| BG006 | Gout Review- Competing Interest Statement 3 | Research funding: We have read and understood the BMJ policy on declaration of interests and declare the following: DF is funded by a NIH clinician scientist award; SN receives no specific funding; JB has received research funding from Jenka Pharmaceuticals.. |
| BG007 | Gout Review- Competing Interest Statement 4 | None: We have read and understood the BMJ policy on declaration of interests and declare the following: DF is funded by a NIH clinician scientist award; SN receives no specific funding; JB has no competing interests. |
| BG008 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type of doctor | Count of Participants | Participants |
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Honoraria & Travel:
We have read and understood the BMJ policy on declaration of interests and declare the following: DF is funded by a NIH clinician scientist award; SN receives no specific funding; JB has received honoraria and travel expenses from Jenka Pharmaceuticals for lecturing at a conference.
| OG001 | Gout Review- Competing Interest Statement 2 | Advisory board & consultancies: We have read and understood the BMJ policy on declaration of interests and declare the following: DF is funded by a NIH clinician scientist award; SN receives no specific funding; JB has received fees from Jenka Pharmaceuticals for consultancies and being an advisory board member. |
| OG002 | Dyspepsia Review- Competing Interest Statement 3 | Research funding: We have read and understood the BMJ policy on declaration of interests and declare the following: DF is funded by a NIH clinician scientist award; SN receives no specific funding; JB has received research funding from Jenka Pharmaceuticals |
| OG003 | Dyspepsia Review- Competing Interest Statement 4 | None: We have read and understood the BMJ policy on declaration of interests and declare the following: DF is funded by a NIH clinician scientist award; SN receives no specific funding; JB has no competing interests. |
| OG004 | Gout Review- Competing Interest Statement 1 | Honoraria & travel: We have read and understood the BMJ policy on declaration of interests and declare the following: DF is funded by a NIH clinician scientist award; SN receives no specific funding; JB has received honoraria and travel expenses from Jenka Pharmaceuticals for lecturing at a conference. |
| OG005 | Dyspepsia Review- Competing Interest Statement 2 | Advisory board & consultancies. We have read and understood the BMJ policy on declaration of interests and declare the following: DF is funded by a NIH clinician scientist award; SN receives no specific funding; JB has received fees from Jenka Pharmaceuticals for consultancies and being an advisory board member. |
| OG006 | Gout Review- Competing Interest Statement 3 | Research funding: We have read and understood the BMJ policy on declaration of interests and declare the following: DF is funded by a NIH clinician scientist award; SN receives no specific funding; JB has received research funding from Jenka Pharmaceuticals.. |
| OG007 | Gout Review- Competing Interest Statement 4 | None: We have read and understood the BMJ policy on declaration of interests and declare the following: DF is funded by a NIH clinician scientist award; SN receives no specific funding; JB has no competing interests. |
|
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| Secondary | Importance of the Article. | 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. | One participant in the Group 'Gout review- competing interest statement 4' and one participant in 'Dyspepasia review- competing interest statement 3' did not respond to the question related to this outcome. Hence, for this outcome the numbers analyzed= 90 and 95 respectively (n=91 and n=96 in the participant flow chart). | Posted | Mean | 95% Confidence Interval | score on a scale | Outcome measure will be assessed only at the time of the intervention (0 weeks) |
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|
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| Secondary | Interest in the Article. | 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. | One participant in the Group 'Dyspepsia review- competing interest statement 2', 'Dyspepsia review- statement 3', 'Gout review- statement 4' did not respond to the question related to this outcome. Hence, for this outcome the numbers analyzed= 92, 90 and 95 respectively (however n=93, 91 and 96 in participant flowchart). | Posted | Mean | 95% Confidence Interval | score on a scale | Outcome measure will be assessed only at the time of the intervention (0 weeks) |
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| Secondary | 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 | 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. | Analysis only includes subset that indicated they currently treat gout/dyspepsia and own practice differed from recommendations given in the review. | Posted | Count of Participants | Participants | Outcome measure will be assessed only at the time of the intervention (0 weeks) |
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| 0 |
| 100 |
| 0 |
| 100 |
| EG001 | Gout Review- Competing Interest Statement 2 | Advisory board & consultancies: We have read and understood the BMJ policy on declaration of interests and declare the following: DF is funded by a NIH clinician scientist award; SN receives no specific funding; JB has received fees from Jenka Pharmaceuticals for consultancies and being an advisory board member. | 0 | 90 | 0 | 90 |
| EG002 | Dyspepsia Review- Competing Interest Statement 3 | Research funding: We have read and understood the BMJ policy on declaration of interests and declare the following: DF is funded by a NIH clinician scientist award; SN receives no specific funding; JB has received research funding from Jenka Pharmaceuticals | 0 | 96 | 0 | 96 |
| EG003 | Dyspepsia Review- Competing Interest Statement 4 | None: We have read and understood the BMJ policy on declaration of interests and declare the following: DF is funded by a NIH clinician scientist award; SN receives no specific funding; JB has no competing interests. | 0 | 87 | 0 | 87 |
| EG004 | Gout Review- Competing Interest Statement 1 | Honoraria & travel: We have read and understood the BMJ policy on declaration of interests and declare the following: DF is funded by a NIH clinician scientist award; SN receives no specific funding; JB has received honoraria and travel expenses from Jenka Pharmaceuticals for lecturing at a conference. | 0 | 99 | 0 | 99 |
| EG005 | Dyspepsia Review- Competing Interest Statement 2 | Advisory board & consultancies. We have read and understood the BMJ policy on declaration of interests and declare the following: DF is funded by a NIH clinician scientist award; SN receives no specific funding; JB has received fees from Jenka Pharmaceuticals for consultancies and being an advisory board member. | 0 | 93 | 0 | 93 |
| EG006 | Gout Review- Competing Interest Statement 3 | Research funding: We have read and understood the BMJ policy on declaration of interests and declare the following: DF is funded by a NIH clinician scientist award; SN receives no specific funding; JB has received research funding from Jenka Pharmaceuticals.. | 0 | 93 | 0 | 93 |
| EG007 | Gout Review- Competing Interest Statement 4 | None: We have read and understood the BMJ policy on declaration of interests and declare the following: DF is funded by a NIH clinician scientist award; SN receives no specific funding; JB has no competing interests. | 0 | 91 | 0 | 91 |
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