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Methodology
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Background: There has been little research to investigate whether the appearance of paper Patient Information Leaflets (PILs) used to describe research studies to potential participants influences their decision to take part. Embedding a Study Within a Trial (SWAT) is an efficient way of answering this type of methodological question. We included a randomised SWAT within a large cohort study, Outcome monitoring After Cardiac Surgery (OMACS), to address this question. Methods: Potential participants for the OMACS study were randomised to receive one of three PILs, identical in content but with varying formatting and use of colour: PIL A (enhanced format), PIL B (hybrid format) and PIL C (standard format). Consent to OMACS was the primary outcome. Consent rates using the three different PIL formats were collected and compared. Qualitative feedback on the different formats was obtained from a Public and Patient Involvement (PPI) group. Results: For the SWAT, 1517 PILs were sent to potential participants and 640 (42%) consented to take part in OMACS. PIL B had the highest recruitment rate, with 45% of patients consenting to participation; 40% and 41% of patients consented to participation with PIL A and C respectively. Compared to PIL C, the consent rate was 4% higher with PIL B (45% versus 41%, 95% Confidence Interval (CI) -2% to +10%, p=0.16) and 1% lower with PIL A (40% versus 41%, 95% CI -7% to +5%, p=0.72). Conclusions: Consent rates were similar for all 3 PIL formats. PIL B is being used for the remainder of the host study and will be used to inform the design of PILs for other research studies as it was the preferred format of the PPI group.
Keywords
Patient Information Leaflet, randomised, study within a study, recruitment, consent
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CURRENT STATUS: Published
View the published article at Trials.
Version 3
Posted 19 Nov, 2019
No community comments so far
Editorial decision: Accept
On 04 Dec, 2019
Review #1 received
Received 28 Nov, 2019
Reviewer #2 agreed
On 19 Nov, 2019
Review #2 received
Received 19 Nov, 2019
Reviewer #1 agreed
On 15 Nov, 2019
Editor assigned
On 14 Nov, 2019
Reviewers invited
Invitations sent on 14 Nov, 2019
Submission checks complete
On 13 Nov, 2019
No comments provided
Editorial decision: Major revision
On 27 Sep, 2019
Review #2 received
Received 24 Sep, 2019
Reviewer #1 agreed
On 13 Sep, 2019
Reviewer #2 agreed
On 13 Sep, 2019
Review #1 received
Received 13 Sep, 2019
Editor assigned
On 12 Sep, 2019
Reviewers invited
Invitations sent on 12 Sep, 2019
Submission checks complete
On 11 Sep, 2019
No comments provided
Editorial decision: Major revision
On 05 Jul, 2019
Review #2 received
Received 02 Jul, 2019
Review #1 received
Received 20 Jun, 2019
Reviewer #2 agreed
On 14 Jun, 2019
Reviewer #1 agreed
On 11 Jun, 2019
Reviewers invited
Invitations sent on 03 Jun, 2019
Editor assigned
On 24 May, 2019
First submitted
On 30 Apr, 2019
Submission checks complete
On 30 Apr, 2019
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
Subject Areas
General Medicine
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A new preprint design is coming!
We have improved readability, clarity, accessibility, and opportunities for engagement.
See the published version of this preprint at Trials.
This is a preprint, a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Methodology
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Published
View the published article at Trials.
Version 3
Posted 19 Nov, 2019
No community comments so far
Editorial decision: Accept
On 04 Dec, 2019
Review #1 received
Received 28 Nov, 2019
Reviewer #2 agreed
On 19 Nov, 2019
Review #2 received
Received 19 Nov, 2019
Reviewer #1 agreed
On 15 Nov, 2019
Editor assigned
On 14 Nov, 2019
Reviewers invited
Invitations sent on 14 Nov, 2019
Submission checks complete
On 13 Nov, 2019
No comments provided
Editorial decision: Major revision
On 27 Sep, 2019
Review #2 received
Received 24 Sep, 2019
Reviewer #1 agreed
On 13 Sep, 2019
Reviewer #2 agreed
On 13 Sep, 2019
Review #1 received
Received 13 Sep, 2019
Editor assigned
On 12 Sep, 2019
Reviewers invited
Invitations sent on 12 Sep, 2019
Submission checks complete
On 11 Sep, 2019
No comments provided
Editorial decision: Major revision
On 05 Jul, 2019
Review #2 received
Received 02 Jul, 2019
Review #1 received
Received 20 Jun, 2019
Reviewer #2 agreed
On 14 Jun, 2019
Reviewer #1 agreed
On 11 Jun, 2019
Reviewers invited
Invitations sent on 03 Jun, 2019
Editor assigned
On 24 May, 2019
First submitted
On 30 Apr, 2019
Submission checks complete
On 30 Apr, 2019
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
Subject Areas
General Medicine
License:
This work is licensed under a CC BY 4.0 License. Read Full License
View the published article at Trials.
Background: There has been little research to investigate whether the appearance of paper Patient Information Leaflets (PILs) used to describe research studies to potential participants influences their decision to take part. Embedding a Study Within a Trial (SWAT) is an efficient way of answering this type of methodological question. We included a randomised SWAT within a large cohort study, Outcome monitoring After Cardiac Surgery (OMACS), to address this question. Methods: Potential participants for the OMACS study were randomised to receive one of three PILs, identical in content but with varying formatting and use of colour: PIL A (enhanced format), PIL B (hybrid format) and PIL C (standard format). Consent to OMACS was the primary outcome. Consent rates using the three different PIL formats were collected and compared. Qualitative feedback on the different formats was obtained from a Public and Patient Involvement (PPI) group. Results: For the SWAT, 1517 PILs were sent to potential participants and 640 (42%) consented to take part in OMACS. PIL B had the highest recruitment rate, with 45% of patients consenting to participation; 40% and 41% of patients consented to participation with PIL A and C respectively. Compared to PIL C, the consent rate was 4% higher with PIL B (45% versus 41%, 95% Confidence Interval (CI) -2% to +10%, p=0.16) and 1% lower with PIL A (40% versus 41%, 95% CI -7% to +5%, p=0.72). Conclusions: Consent rates were similar for all 3 PIL formats. PIL B is being used for the remainder of the host study and will be used to inform the design of PILs for other research studies as it was the preferred format of the PPI group.
Figure 1
Figure 2
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