Effectiveness of information presentation in drug fact boxes
| ISRCTN | ISRCTN17033137 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17033137 |
| Secondary identifying numbers | 1 |
- Submission date
- 06/04/2020
- Registration date
- 24/04/2020
- Last edited
- 15/02/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
Fact boxes are evidence-based health information. They have been developed to represent the indispensable and understandable benefits and harms of drugs. They are offered as one-sided tabular representations of benefits and harms with or without additional texts. Risk information in fact boxes can be presented in different formats: natural frequencies, percentages or graphically. Few previous studies have shown that natural frequencies and percentages are comparable regarding enhancing knowledge and risk perception of health information. In addition, subgroup analyses indicate that people with lower educational levels might benefit from graphical presentations. The aim of this study is to compare three fact boxes (natural frequencies vs percentages vs bar graphs) with regard to knowledge and risk perception, using "antibiotics for acute bronchitis" as an example.
Who can participate?
Adults aged over 18 living in Germany
What does the study involve?
The study involves the provision of fact boxes. Participants are randomly allocated to one of three groups. Each group is provided with a different presentation format (natural frequencies, percentages or graphics). After reading the fact boxes, participants are asked to answer questions that survey the outcomes.
What are the possible benefits and risks of participating?
The researchers do not anticipate any risk for the participants. However, the study may enable the participants to become familiar with the fact box format. It is possible that the participants are sensitized to the way health information can be presented. They will receive detailed information on the risks and benefits of antibiotic therapy for acute bronchitis.
Where is the study run from?
Martin Luther University Halle-Wittenberg (Germany)
When is the study starting and how long is it expected to run for?
August 2019 to January 2021 (updated 30/03/2021, previously: June 2020)
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Prof. Dr Anke Steckelberg
anke.steckelberg@medizin.uni-halle.de
Contact information
Scientific
Martin Luther University Halle-Wittenberg
Medical Faculty
Center for Health Sciences
Institute of Health and Nursing Science
Magdeburgerstraße 8
Halle (Saale)
06112
Germany
| Phone | +49 (0)345 557 4106 |
|---|---|
| anke.steckelberg@medizin.uni-halle.de |
Study information
| Study design | Randomized controlled pilot study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Other |
| Participant information sheet | Not available in web format and only available in German language on request |
| Scientific title | Drug fact boxes: efficacy of presentation formats - natural frequencies, percentages and bar graphs: a pilot study |
| Study objectives | It is expected that the presentation formats natural frequencies, percentage and bar graphs are comparable with regard to knowledge and risk perception. Participants with low educational level might benefit from bar graph presentation. |
| Ethics approval(s) | Approved 05/04/2020, ethics committee, Martin Luther University Halle-Wittenberg (Magdeburgerstraße 16, 06112 Halle, Germany; +49 (0)345 557-4476; ethik-kommission@uk-halle.de); ref: 2019-044 |
| Health condition(s) or problem(s) studied | Drug information presentation |
| Intervention | Randomisation: each time a participant agreed to participate a random number is generated and the participant is allocated to the presentation format according to that number. The study involves the provision of fact boxes. Each study arm is provided with a different presentation format about antibiotics in acute bronchitis, presenting risk information on the benefit and harm of antibiotic therapy in three different formats: natural frequencies, percentages and bar graphs. After reading the fact boxes, participants are asked to answer the questions that survey the outcomes. The outcomes are surveyed immediately after the intervention. There will be no follow-up. |
| Intervention type | Other |
| Primary outcome measure | Verbatim knowledge/risk perception, which is surveyed by 9 items coded 1 (correct answer) or 0 (incorrect answer), measured immediately after the intervention |
| Secondary outcome measures | Measured immediately after the intervention: 1. Readability/comprehensibility is measured by four questions using a four-point Likert scale 2. Acceptance is measured by three questions using a four-stage interval scale 3. Relevance refers to the importance of the information. This endpoint is measured with one question |
| Overall study start date | 04/08/2019 |
| Completion date | 25/01/2021 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Pilot study: 300; 100 in each group |
| Total final enrolment | 227 |
| Key inclusion criteria | Adults > 18 years who have their primary residence in Germany and belong to the panel |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 04/05/2020 |
| Date of final enrolment | 30/05/2020 |
Locations
Countries of recruitment
- Germany
Study participating centre
Center for Health Sciences
Institute of Health and Nursing Science
Magdeburgerstraße 8
Halle (Saale)
06112
Germany
Sponsor information
University/education
Medical Faculty
Center for Health Sciences
Institute of Health and Nursing Science
Magdeburgerstraße 8
Halle
06112
Germany
| Phone | +49 (0)345 557 4106 |
|---|---|
| anke.steckelberg@medizin.uni-halle.de | |
| Website | http://www.uni-halle.de/ |
"ROR" |
https://ror.org/05gqaka33 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 30/09/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | The study protocol is available in German on request. All the results of the study (including negative results) will be published in international and open-access journals and presented at meetings and congresses. According to the recommendations of the International Committee of Medical Journal Editors (ICMJE), only persons directly involved in the study will be designated as authors. |
| IPD sharing plan | The data of the panel are collected and stored at the Institute for Medical Epidemiology, Biometry and Computer Science at Martin Luther University. The study center will coordinate the data sharing process for all the principal investigators. Public sharing of the data is not intended. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Dataset | The submitted dataset contains data for the comparison of different representations of frequencies in fact boxes | 03/09/2022 | 15/02/2023 | No | No |
| Results article | primary and secondary outcome results | 25/01/2023 | 15/02/2023 | Yes | No |
Editorial Notes
15/02/2023: Publication reference added and link to dataset.
28/06/2022: The intention to publish date has been changed from 05/12/2021 to 30/09/2022.
15/11/2021: The intention to publish date was changed from 31/10/2021 to 05/12/2021.
27/09/2021: The intention to publish date was changed from 30/09/2021 to 31/10/2021.
20/08/2021: The intention to publish date was changed from 31/08/2021 to 30/09/2021.
30/03/2021: The following changes were made to the trial record:
1. The overall end date was changed from 30/06/2020 to 25/01/2021.
2. The intention to publish date was changed from 31/08/2020 to 31/08/2021.
3. The plain English summary was updated to reflect these changes.
4. The total final enrolment was added.
24/04/2020: Trial's existence confirmed by the ethics committee of the Martin-Luther-University Halle-Wittenberg.
