Plain English Summary
Background and study aims
We all need to make decisions about our health and treatments, and health and health research are often in the news. Information about treatments is sometimes confusing or hard to understand. To make it easier to understand for people making a decision about a treatment, we would like members of the public to test some different ways health research information can be presented. The DECIDE project is working to find ways to present information about treatments to all the people involved in making healthcare decisions, including patients and their families, healthcare managers, doctors, nurses and other health professionals. This is an important part of providing high quality healthcare.
Who can participate?
People aged over 18 who are on the SHARE online database of people in Scotland who are interested in participating in trials.
What does the study involve?
We have prepared some information on using the following treatments: antibiotics for middle ear infection; aspirin for primary prevention of cardiovascular disease; warfarin for atrial fibrillation. This information is based on the best research about treatment options for these health problems. We have prepared different ways of presenting this information. Participants are randomly allocated to be shown one of three ways of presenting information about one of these topics so that we can get their opinion on how helpful the information is. Completing the study takes around 15 minutes.
What are the possible benefits and risks of participating?
We aim to ask thousands of people to give their opinion, which will give a good idea of what works and what doesn’t. Taking part in the study won’t lead to an immediate benefit for participants personally. However, it will help organisations that produce health information improve the way they do this. This may be help people in the future when making real decisions about treatments.
Where is the study run from?
1. Health Services Research Unit at the University of Aberdeen (UK)
2. Norwegian Knowledge Centre for the Health Services (Norway)
When is the study starting and how long is it expected to run for?
November 2014 to January 2016
Who is funding the study?
The European Union (Belgium)
Who is the main contact?
Prof. Shaun Treweek
DECIDE_iSoF@icloud.com
Trial website
Contact information
Type
Public
Primary contact
Prof Shaun Treweek
ORCID ID
Contact details
Health Services Research Unit
University of Aberdeen
3rd Floor
Health Sciences Building
Foresterhill
Aberdeen
AB25 2ZD
United Kingdom
+44 775 614 4998
DECIDE_iSoF@icloud.com
Type
Scientific
Additional contact
Dr Jenny Moberg
ORCID ID
http://orcid.org/0000-0003-4931-2438
Contact details
Norwegian Knowledge Centre for the Health Services
Oslo
N-0130
Norway
+47 97 97 95 34
jmoberg@doctors.org.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Does an interactive "Summary of Findings table", compared with standard evidence-based patient information and with a static Summary of Findings table, improve members of the public's understanding of and satisfaction with information about the benefits and harms of treatments?
Acronym
Study hypothesis
1. An interactive Summary of Findings (iSoF) table compared to evidence-based patient information, and to static SoF tables will improve participants’ understanding of, and satisfaction with, information about the benefits and harms of treatments when making a hypothetical decision
2. The initial iSoF table presentation will have an effect on understanding of, and satisfaction with, information about the benefits and harms of treatments when making a decision; and that participants will prefer interactive presentations, and certain initial presentations over the other presentations
Ethics approval
The University of Aberdeen Life Sciences and Medicine College Research Ethics Board has prepared a checklist, which classes this work as very low risk and it therefore does not need formal review by their committee. The work will be conducted in accordance with the Ethical Review and Governance Framework of the University of Aberdeen.
Study design
Internet-based parallel randomized trial
Primary study design
Interventional
Secondary study design
Randomised parallel trial
Trial setting
Internet
Trial type
Other
Patient information sheet
https://s3.amazonaws.com/isof_pdf/Participant+Information+sheet+2015+09+21.pdf
Condition
Understanding and satisfaction with evidence-based information about the harms and benefits of treatments
Intervention
Members of the public are recruited to participate in the trial via the internet. Participants will consent and complete the trial on-line., before being randomly allocated to one six groups. Each group will see a scenario for one of two baseline risk levels for one of three different topics, and involve making a hypothetical decision about whether or not to use a treatment. The three topics are antibiotics for acute otitis media, aspirin for primary prevention of coronary heart disease, and warfarin for atrial fibrillation. For each of these six groups we will then randomly allocate participants to see either evidence-based patient information, one of six initial presentations of an interactive SoF, or of a static SoF. Using an online questionnaire participants will be asked to make a hypothetical decision whether or not to use the treatment, questions about their understanding of the balance between the benefits and harms, the sizes of effects, the certainty of the evidence; and whether they are satisfied that they have been adequately informed about the benefits and harms of the treatment. Participants will then be shown the alternative presentations for the same scenario and risk level, and ask whether they prefer the standard patient information, an interactive SoF, a static SoF, a combination of standard patient information with an interactive SoF or with a static SoF, and the reasons for their preferences.They will also be asked which initial presentation of the iSoF table they prefer and the reasons for their preferences. There is no follow up for participants after they have completed the online trial questionnaire
Intervention type
Other
Phase
Drug names
Primary outcome measure
1. Participants’ understanding of, and satisfaction with, information about the benefits and harms of treatments when making a decision is measured using a specially designed online questionnaire that they are given at the time of randomisation
2. Which presentations participants prefer is measured using a specially designed online questionnaire that they are given at the time of randomisation
Secondary outcome measures
1. The reasons for participants’ preferences, their understanding of the balance of the benefits and harms, and their hypothetical decisions is measured using a specially designed online questionnaire that they are given at the time of randomisation (baseline) and after the presentation
2. The primary outcomes in people who would like their doctor or somebody else to make a decision for them are excluded from the comparisons is measured using a specially designed online questionnaire that they are given at the time of randomisation (baseline) and after the presentation
3. Whether the primary outcomes vary across the six decision-making scenarios is measured using a specially designed online questionnaire that they are given at the time of randomisation (baseline) and after the presentation
Overall trial start date
25/11/2014
Overall trial end date
01/01/2016
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Members of the public aged 18 or over
2. Registered on the SHARE online database of people in Scotland who are interested in participating in trials (www.registerforshare.org)
Participant type
Mixed
Age group
Adult
Gender
Both
Target number of participants
3200
Participant exclusion criteria
1. Familiar with GRADE SoF tables (assessed by asking participants)
2. Those who have previously participated in the trial
3. Those who have research training or experience equivalent to an MSc or PhD
Recruitment start date
14/12/2015
Recruitment end date
31/12/2015
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Aberdeen
Health Services Research Unit
3rd Floor, Health Sciences Building
Foresterhill
Aberdeen
AB25 2ZD
United Kingdom
Trial participating centre
Norwegian Knowledge Centre for the Health Services
Pilestredet Park 7
Oslo
N-0130
Norway
Sponsor information
Organisation
Health Services Research Unit at the University of Aberdeen (UK)
Sponsor details
3rd Floor
Health Sciences Building
Foresterhill
Aberdeen
AB25 2ZD
United Kingdom
+44 (0)775 614 4998
DECIDE_iSoF@icloud.com
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
Seventh Framework Programme
Alternative name(s)
EC Seventh Framework Programme, European Commission Seventh Framework Programme, EU Seventh Framework Programme, European Union Seventh Framework Programme, FP7
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
Results and Publications
Publication and dissemination plan
Current publication and dissemination plan as of 29/10/2018:
Although 2290 people completed the online trial, the quantitative primary analysis was not possible. Unfortunately there was a fatal flaw in the web-based software that was not picked up during testing. This error meant that the iSoF did not work for some participants. We know this because some people commented on this. However, some participants appear to have completed the study even though the iSoF did not work for them and did not comment on this. Epistemonikos (the company that developed the software) cannot tell which participants had problems and which did not, so we can identify some, but not all of the participants for whom the iSoF did not work. This means that any quantitative analysis would be erroneous because it is not clear who actually received the iSoF intervention or not.
There are some qualitative data, which should still provide useful information. Changes in study staff circumstances have delayed the analysis of these data but the intention is that there will be a report describing these data.
Previous publication and dissemination plan:
The results will be published on the SHARE website. They will also be presented to guideline organisations and others through scientific documents, presentations and meetings. The results will be used to guide the way health information is presented in the future.
Intention to publish date
31/10/2016
Participant level data
Available on request
Basic results (scientific)
Publication list