Dataset Information

Informing potential participants about research: observational study with an embedded randomized controlled trial.

ABSTRACT:

Objectives

To assess: 1) the feasibility of electronic information provision; 2) gather evidence on the topics and level of detail of information potential research participant's accessed; 3) to assess satisfaction and understanding.

Design

Observational study with an embedded randomised controlled trial.

Setting

Low risk intervention study based in primary care.

Participants

White British & Irish, South Asian and African-Caribbean subjects aged between 40-74 years eligible for a blood pressure monitoring study.

Interventions

PDF copy of the standard paper participant information sheet (PDF-PIS) and an electronic Interactive Information Sheet (IIS) where participants could choose both the type and level of detail accessed.

Main outcome measures

1) Proportion of participants providing an email address and accessing electronic information 2) Willingness to participate in a recruitment clinic. 3) Type and depth of information accessed on the IIS. 4) Participant satisfaction and understanding.

Results

1160 participants were eligible for the study. Of these, 276 (24%) provided an active email address, of whom 84 did not respond to the email. 106 responded to the email but chose not to access any electronic information and were therefore ineligible for randomisation. 42 were randomised to receive the PDF-PIS and 44 to receive the IIS (with consent rates of 48% and 36%, respectively; odds ratio 0.6, 95% confidence interval 0.25 to 1.4). Electronic observation of information accessed by potential participants showed 41% chose to access no information and only 9% accessed the detail presented on the Research Ethics Committee approved participant information sheet before booking to attend a recruitment clinic for the intervention study. 63 of the 106 participants (59%) who chose not to access any electronic information also booked an appointment.

Conclusions

Current written information about research may not be read, emphasising the importance of the consent interview and consideration of new ways of presenting complex information.

SUBMITTER: Kirkby HM

PROVIDER: S-EPMC3789820 | biostudies-literature | 2013

REPOSITORIES: biostudies-literature

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Publications

Informing potential participants about research: observational study with an embedded randomized controlled trial.

Kirkby Helen M HM Calvert Melanie M McManus Richard J RJ Draper Heather H

PloS one 20131003 10

<h4>Objectives</h4>To assess: 1) the feasibility of electronic information provision; 2) gather evidence on the topics and level of detail of information potential research participant's accessed; 3) to assess satisfaction and understanding.<h4>Design</h4>Observational study with an embedded randomised controlled trial.<h4>Setting</h4>Low risk intervention study based in primary care.<h4>Participants</h4>White British & Irish, South Asian and African-Caribbean subjects aged between 40-74 years e ...[more]

PMID: 24098499

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Project description:BackgroundPlacebo effects and their underpinning mechanisms are increasingly well understood. However, this is poorly communicated to participants in placebo-controlled trials. For valid informed consent, participants should be informed about the potential benefits and risks of participating in placebo-controlled trials. Existing information leaflets often fail to describe the potential benefits and adverse effects associated with placebo allocation. This study tested the effects of a new website designed to inform patients about placebo effects (The Power of Placebos, PoP). PoP was designed using qualitative methods in combination with theory- and evidence-based approaches to ensure it was engaging, informative, and addressed patients' concerns.ObjectiveThis study aimed to test the effects of PoP, compared with a control website, on people's knowledge about placebo and the ability to make an informed choice about taking part in a placebo-controlled trial.MethodsA total of 350 adults with back pain recruited from 26 general practices in Southern England participated in this Web-based study. Participants were randomly assigned to PoP (which presented scientifically accurate information about placebo effects in an engaging way) or a control website (based on existing information leaflets from UK trials). Participants self-completed Web-based pre- and postintervention questionnaire measures of knowledge about placebo effects and preintervention questionnaire measures of attitudes toward and intentions to participate in a placebo-controlled trial. The 2 primary outcomes were (1) knowledge and (2) informed choice to take part in a placebo-controlled trial (computed from knowledge, attitudes, and intentions).ResultsAfter viewing PoP, participants had significantly greater knowledge about placebos (mean 8.28 [SD 1.76]; n=158) than participants who viewed the control (mean 5.60 [SD 2.24]; n=174; F1,329=173.821; P<.001; η2=.346). Participants who viewed PoP were 3.16 times more likely than those who viewed the control to make an informed choice about placebos (χ21=36.5; P<.001).ConclusionsIn a sample of adults with back pain, PoP increased knowledge and rates of informed choice about placebos compared with a control website. PoP could be used to improve knowledge about placebo effects in back pain. After essential further development and testing in clinical trial settings, it could support informed consent in placebo-controlled trials.

Dataset Information

Informing potential participants about research: observational study with an embedded randomized controlled trial.

Objectives

Design

Setting

Participants

Interventions

Main outcome measures

Results

Conclusions

Publications

Informing potential participants about research: observational study with an embedded randomized controlled trial.

Similar Datasets

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