Healthy
Conditions
Keywords
Readers' perceptions
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.
Interventions
OTHERVariations 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.
Sponsors
The BMJ
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Readers' Level of Confidence in the Conclusions Drawn in the Article. | 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
| Measure | Time frame | Description |
|---|---|---|
| Importance of the Article. | 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. | 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 | 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 100 |
| 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. | 90 |
| 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 | 96 |
| 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. | 87 |
| 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. | 99 |
| 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. | 93 |
| 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.. | 93 |
| 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. | 91 |
| Total | 749 |
Baseline characteristics
| Characteristic | Total | Gout Review- Competing Interest Statement 4 | Dyspepsia Review- Competing Interest Statement 1 | Gout Review- Competing Interest Statement 3 | Dyapepsia Review- Competing Interest Statement 2 | Gout Review- Competing Interest Statement 1 | Dyspepsia Review- Competing Interest Statement 4 | Dyspepsia Review- Competing Interest Statement 3 | Gout Review- Competing Interest Statement 2 |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 44 years | 42.9 years | 43.5 years | 42.8 years | 42.9 years | 44.9 years | 42.8 years | 44.7 years | 45.5 years |
| Region of Enrollment United Kingdom | 749 participants | 91 participants | 100 participants | 93 participants | 93 participants | 99 participants | 87 participants | 96 participants | 90 participants |
| Sex: Female, Male Female | 404 Participants | 51 Participants | 52 Participants | 51 Participants | 51 Participants | 53 Participants | 45 Participants | 55 Participants | 46 Participants |
| Sex: Female, Male Male | 345 Participants | 40 Participants | 48 Participants | 42 Participants | 42 Participants | 46 Participants | 42 Participants | 41 Participants | 44 Participants |
| Type of doctor Consultant | 264 Participants | 30 Participants | 31 Participants | 34 Participants | 31 Participants | 37 Participants | 33 Participants | 35 Participants | 33 Participants |
| Type of doctor General practice | 263 Participants | 29 Participants | 36 Participants | 33 Participants | 34 Participants | 33 Participants | 29 Participants | 35 Participants | 34 Participants |
| Type of doctor Junior doctor | 222 Participants | 32 Participants | 33 Participants | 26 Participants | 28 Participants | 29 Participants | 25 Participants | 26 Participants | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 100 | 0 / 90 | 0 / 96 | 0 / 87 | 0 / 99 | 0 / 93 | 0 / 93 | 0 / 91 |
| serious Total, serious adverse events | 0 / 100 | 0 / 90 | 0 / 96 | 0 / 87 | 0 / 99 | 0 / 93 | 0 / 93 | 0 / 91 |
Outcome results
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.
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.
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Dyspepsia Review- Competing Interest Statement 1 | The Readers' Level of Confidence in the Conclusions Drawn in the Article. | 6.2 score on a scale |
| Gout Review- Competing Interest Statement 2 | The Readers' Level of Confidence in the Conclusions Drawn in the Article. | 7.0 score on a scale |
| Dyspepsia Review- Competing Interest Statement 3 | The Readers' Level of Confidence in the Conclusions Drawn in the Article. | 6.1 score on a scale |
| Dyspepsia Review- Competing Interest Statement 4 | The Readers' Level of Confidence in the Conclusions Drawn in the Article. | 6.4 score on a scale |
| Gout Review- Competing Interest Statement 1 | The Readers' Level of Confidence in the Conclusions Drawn in the Article. | 7.1 score on a scale |
| Dyspepsia Review- Competing Interest Statement 2 | The Readers' Level of Confidence in the Conclusions Drawn in the Article. | 6.2 score on a scale |
| Gout Review- Competing Interest Statement 3 | The Readers' Level of Confidence in the Conclusions Drawn in the Article. | 7.4 score on a scale |
| Gout Review- Competing Interest Statement 4 | The Readers' Level of Confidence in the Conclusions Drawn in the Article. | 7.4 score on a scale |
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.
Time frame: Outcome measure will be assessed only at the time of the intervention (0 weeks)
Population: 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).
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Dyspepsia Review- Competing Interest Statement 1 | Importance of the Article. | 6.3 score on a scale |
| Gout Review- Competing Interest Statement 2 | Importance of the Article. | 6.4 score on a scale |
| Dyspepsia Review- Competing Interest Statement 3 | Importance of the Article. | 6.3 score on a scale |
| Dyspepsia Review- Competing Interest Statement 4 | Importance of the Article. | 6.3 score on a scale |
| Gout Review- Competing Interest Statement 1 | Importance of the Article. | 6.9 score on a scale |
| Dyspepsia Review- Competing Interest Statement 2 | Importance of the Article. | 6.5 score on a scale |
| Gout Review- Competing Interest Statement 3 | Importance of the Article. | 6.7 score on a scale |
| Gout Review- Competing Interest Statement 4 | Importance of the Article. | 7.0 score on a scale |
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.
Time frame: Outcome measure will be assessed only at the time of the intervention (0 weeks)
Population: 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).
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Dyspepsia Review- Competing Interest Statement 1 | Interest in the Article. | 5.9 score on a scale |
| Gout Review- Competing Interest Statement 2 | Interest in the Article. | 6.2 score on a scale |
| Dyspepsia Review- Competing Interest Statement 3 | Interest in the Article. | 5.8 score on a scale |
| Dyspepsia Review- Competing Interest Statement 4 | Interest in the Article. | 5.8 score on a scale |
| Gout Review- Competing Interest Statement 1 | Interest in the Article. | 6.7 score on a scale |
| Dyspepsia Review- Competing Interest Statement 2 | Interest in the Article. | 6.0 score on a scale |
| Gout Review- Competing Interest Statement 3 | Interest in the Article. | 6.5 score on a scale |
| Gout Review- Competing Interest Statement 4 | Interest in the Article. | 7.0 score on a scale |
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.
Time frame: Outcome measure will be assessed only at the time of the intervention (0 weeks)
Population: Analysis only includes subset that indicated they currently treat gout/dyspepsia and own practice differed from recommendations given in the review.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Dyspepsia Review- Competing Interest Statement 1 | 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 | 0 Participants |
| Gout Review- Competing Interest Statement 2 | 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 | 4 Participants |
| Dyspepsia Review- Competing Interest Statement 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 | 2 Participants |
| Dyspepsia Review- Competing Interest Statement 4 | 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 | 1 Participants |
| Gout Review- Competing Interest Statement 1 | 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 | 1 Participants |
| Dyspepsia Review- Competing Interest Statement 2 | 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 | 2 Participants |
| Gout Review- Competing Interest Statement 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 | 2 Participants |
| Gout Review- Competing Interest Statement 4 | 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 | 3 Participants |