The effect of question order on the outcomes in the core outcome set for brief alcohol interventions among online help-seekers
| ISRCTN | ISRCTN17954645 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17954645 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Dnr 2020-01799 |
| Sponsor | Linköping University |
| Funder | Investigator initiated and funded |
- Submission date
- 26/07/2020
- Registration date
- 05/08/2020
- Last edited
- 17/09/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Alcohol Brief Interventions (ABI) have been researched and disseminated in a variety of contexts over the past 60 years, in both face-to-face and digital settings. Defined by the World Health Organization (WHO) as “practices that aim to identify a real or potential alcohol problem and motivate an individual to do something about it”, ABI encompass a broad range of actions which aim to help individuals change their drinking behaviour. At their core, ABI assess and provide feedback on alcohol use, and can be used once or over time.
However, the variety of outcome measures used in trials to evaluate ABIs effectiveness and efficacy is a limiting factor in providing evidence about these interventions. Comparisons across trials is sometimes impossible despite interventions being similar. The Outcome Measures in Brief Intervention Trials: Alcohol (ORBITAL) project quantified this problem when they identified 2641 different outcomes, measured in approximately 1560 different ways, in 405 trials of ABIs. Through a systematic review of all trials of brief interventions and two e-Delphi rounds, the ORBITAL project established a consensus on a core outcome set (COS) for ABIs. The COS outcomes are:
1. Frequency of drinking
2. Typical number of drinks consumed on a drinking day
3. Frequency of heavy episodic drinking
4. Combined consumption measure
5. Hazardous or harmful drinking
6. Standard drinks consumed in the past week
7. Alcohol related problems or consequences
8. Alcohol related injury
9. Use of emergency healthcare services
10. Quality of life
The current study aims to assess if there is a concern for question order bias among the outcomes of the COS. Question order bias occurs when an individual’s response to a question is affected by previously asked questions, and is a well-known phenomenon which has been studied, and perhaps abused, in marketing and political science for some time. Recently, it was discovered that question order bias may affect measures of alcohol consumption, as individuals who were asked to first report weekly alcohol consumption were then less likely to be screened as risky drinkers, in comparison to individuals who were first screened and then asked about weekly alcohol consumption.
This trial aims to estimate order effects among the questions within the COS for ABIs, and to investigate patterns of abandonment of the questionnaire. In particular, the trial findings will apply in the context of self-completion of the COS using digital questionnaires among online help-seeking individuals.
Who can participate?
Anyone can participate who is 18 years or older.
What does the study involve?
Responding to a questionnaire about alcohol consumption which is estimated to take 10 minutes.
What are the possible benefits and risks of participating?
There are no anticipated risks from participating. Responding to questions about one's alcohol consumption has been found to help some decide to reduce their consumption. There will also be links to further help available at the end of the questionnaire.
Where is the study run from?
Linköping University (Sweden) but is accessed by participants via the internet in all countries where Google is accessible.
When is the study starting and how long is it expected to run for?
October 2019 to October 2022
Who is funding the study?
The study is funded investigator initiated and funded.
Who is the main contact?
Dr Marcus Bendtsen
marcus.bendtsen@liu.se
Contact information
Scientific
Linköping University
Linköping
58183
Sweden
 ORCID ID |
0000-0002-8678-1164 |
|---|---|
| Phone | +46 (0)13-28 10 00 |
| marcus.bendtsen@liu.se |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | A double-blind randomized factorial design trial to investigate question order bias among the outcomes of the core outcome set for brief alcohol interventions |
| Secondary study design | Factorial design |
| Participant information sheet | ISRCTN17954645_PIS.pdf |
| Scientific title | The effect of question order on the outcomes in the core outcome set for brief alcohol interventions among online help-seekers: a double-blind randomized factorial design trial |
| Study acronym | QOBCOS-1 |
| Study objectives | 1. The order in which the questions of the core outcome set for alcohol brief interventions is asked effects the way individuals respond 2. There are patterns with respect to both particular questions, and the order of the questions, which are associated with abandonment of the questionnaire |
| Ethics approval(s) | Approved 03/07/2020, the Swedish Ethical Review Authority (Etikprövningsmyndigheten, Box 2110, 750 02 Uppsala; +46 (0)10-475 08 00; registrator@etikprovning.se), ref: Dnr 2020-01799 |
| Health condition(s) or problem(s) studied | Prevention of harmful and hazardous alcohol consumption |
| Intervention | The ten COS outcomes will be divided into four clusters of questions: 1. Cluster 1: frequency of drinking, the typical number of drinks consumed on a drinking day, frequency of heavy episodic drinking, combined summary consumption measure, hazardous or harmful drinking 2. Cluster 2: standard drinks consumed in the past week 3. Cluster 3: alcohol-related problems or consequences, alcohol-related injury, and use of emergency healthcare services 3. Cluster 4: quality of life The order of these clusters will be permuted to create 24 order combinations. Block randomization (random block sizes of 24 and 48) will be used to achieve equal allocation among arms. The randomization sequence and allocation will be fully automated and computerized. Since no identifiers are collected for individuals, we will use web browser cookies and HTML5 storage to store allocation information on the participants’ web-browsers. Participants who have not completed the questionnaire and return to the trial website will be presented with the cluster order according to their assignment. Participants who have completed the questionnaire and return to the trial website will be thanked for their participation, but not offered an opportunity to answer the questions again. Participants will be aware that they are taking part in a research study, however, the true nature of the study will not be revealed to them, since this would interfere with the effect being studied. Therefore, participants will not be aware of which arm they are in, and hence will be blinded to allocation. Research personnel will also be blind to participant allocation. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
1. The ten outcomes of the COS as follows: |
| Key secondary outcome measure(s) |
1. Proportion visiting provided links at the end of the questionnaire, measured using data collected by the survey platform |
| Completion date | 01/10/2022 |
Eligibility
| Participant type(s) | All |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 5000 |
| Total final enrolment | 7334 |
| Key inclusion criteria | Aged ≥18 years |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 01/10/2020 |
| Date of final enrolment | 01/10/2022 |
Locations
Countries of recruitment
- United Kingdom
- Australia
- Canada
- India
- New Zealand
- South Africa
- Sweden
- United States of America
Study participating centre
58183
Sweden
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Other |
| IPD sharing plan | The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 12/02/2023 | 20/02/2023 | Yes | No | |
| Protocol article | protocol | 26/11/2020 | 27/11/2020 | Yes | No |
| Participant information sheet | Informed consent materials | 17/09/2024 | No | Yes | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Additional files
- ISRCTN17954645_PIS.pdf
- Informed consent materials
Editorial Notes
17/09/2024: Patient information sheet added.
20/02/2023: Publication reference and total final enrolment added.
27/11/2020: Publication reference added.
30/07/2020: Trial’s existence confirmed by the Swedish Ethical Review Authority.
