Behavior, ConsumerNCT03505450
Effects of Population Compared to Purposive Sampling for Consensus in an Online Delphi Study
An observational study of Behavior, Consumer, run by ThinkWell at 1 site in United Kingdom.
Trial summary
This study will be nested as a randomized controlled trial within an online Delphi and will assess the effects of the population sampling compared to purposive sampling for consensus in an online Delphi. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Behavior, Consumer
- What is being tested?
- Population Sample and Purposive sample
- How many people
- 385 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 29 May 2018to 29 Oct 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy adults from an online cohort who are invited to come to consensus in an online Delphi
Who may be able to join
- Protocol lab online trials Delphi (PLOT-D) Participant
Who cannot join
- None if meets inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
This study will be nested as a randomized controlled trial within an online Delphi and will assess the effects of the population sampling compared to purposive sampling for consensus in an online Delphi.
Read the detailed description
The Delphi method of engaging panels of experts from specific interest areas has been widely utilized in the for the development of research reporting guidelines, core outcome sets, clinical medicine, nursing practice, medical education and healthcare services. An assessment completed by Atkins and colleagues in 2005 report that a small panel of similarly trained experts can develop reliable criteria that inform judgment and support effective decision-making. Despite the wide applicability of the Delphi methodology, it is not known how the number of participants or their similarity as a stakeholder group influences results in an online Delphi.Purposeful sampling will be used with a randomized sample taken from each stakeholder group for analysis and this analysis will be presented alongside the full analysis and the results compared.
The Protocol Lab for Online Trials-Delphi (PLOT-D), which will use an online 3-round Delphi combined with participatory action research to inform the development of a multi-use protocol template for writing protocols for self-recruited online trials of interventional self-management. The Protocol lab will use the Delphi findings, along with earlier research to redesign a series of protocols for online randomized trials with the aim of providing support for citizens to work alongside researchers to build participatory health trials online.
- Conditions
- Behavior, Consumer
- Being tested
- Population Sample, Purposive sample
- Keywords
- decision support tools,
- Medical subject headings
- Consumer Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Population SampleOther
full sample of recruited participants
Purposive sampleOther
purposive sample of recruited participants
| Study group | Role | What they receive |
|---|---|---|
| Population sample | Not described Receives: Other: Population Sample | |
| Purposive Sample | Not described Receives: Other: Purposive sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delphi response rate differences as measured by % of completed questions between samples
Full Delphi sample compared to a 10% randomized stratified sample taken from of the 5 stakeholder groups
Measured: Up to 20 weeks or study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2018
- Study start29 May 2018
- Primary completion30 Sep 2018
- Study completion29 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Behavior, ConsumerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 385 participants (actual)
Sponsor and investigators
- Lead sponsor
- ThinkWell
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amy Price, PhD, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03505450
- Sponsor's protocol ID
- PLOT-D Sampling Type Effects
- Status last verified
- Mar 2021
- First submitted
- 1 Apr 2018
- Last updated
- 22 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Aggregated data available by request from the study investigator
Publications
Brookes ST, Chalmers KA, Avery KNL, Coulman K, Blazeby JM; ROMIO study group. Impact of question order on prioritisation of outcomes in the development of a core outcome set: a randomised controlled trial. Trials. 2018 Jan 25;19(1):66. doi: 10.1186/s13063-017-2405-6.
PubMed 29370827Sinha IP, Smyth RL, Williamson PR. Using the Delphi technique to determine which outcomes to measure in clinical trials: recommendations for the future based on a systematic review of existing studies. PLoS Med. 2011 Jan 25;8(1):e1000393. doi: 10.1371/journal.pmed.1000393.
PubMed 21283604Fletcher AJ, Marchildon GP. Using the Delphi Method for Qualitative, Participatory Action Research in Health Leadership. International Journal of Qualitative Methods 2014;13:1-18
Brice A, Price A, Burls A. Creating a database of internet-based clinical trials to support a public-led research programme: A descriptive analysis. Digit Health. 2015 Nov 20;1:2055207615617854. doi: 10.1177/2055207615617854. eCollection 2015 Jan-Dec.
PubMed 29942546Bagley HJ, Short H, Harman NL, Hickey HR, Gamble CL, Woolfall K, Young B, Williamson PR. A patient and public involvement (PPI) toolkit for meaningful and flexible involvement in clinical trials - a work in progress. Res Involv Engagem. 2016 Apr 27;2:15. doi: 10.1186/s40900-016-0029-8. eCollection 2016.
PubMed 29062516Price A, Albarqouni L, Kirkpatrick J, Clarke M, Liew SM, Roberts N, Burls A. Patient and public involvement in the design of clinical trials: An overview of systematic reviews. J Eval Clin Pract. 2018 Feb;24(1):240-253. doi: 10.1111/jep.12805. Epub 2017 Oct 27.
PubMed 29076631
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Population Compared to Purposive Sampling for Consensus in an Online Delphi Study
- ClinicalTrials.gov ID
- NCT03505450
- Acronym / sponsor ID
- PLOT-D Sampling Type Effects
- Conditions
- Behavior, Consumer
- Keywords
- decision support tools,
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 385 participants (actual)
- Lead sponsor
- ThinkWellUniversity, hospital or other
- Study start
- 29 May 2018 (actual)
- Primary completion
- 30 Sep 2018 (actual)
- Study completion
- 29 Oct 2018 (actual)
- First posted
- 23 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will be nested as a randomized controlled trial within an online Delphi and will assess the effects of the population sampling compared to purposive sampling for consensus in an online Delphi.
Detailed description
The Delphi method of engaging panels of experts from specific interest areas has been widely utilized in the for the development of research reporting guidelines, core outcome sets, clinical medicine, nursing practice, medical education and healthcare services. An assessment completed by Atkins and colleagues in 2005 report that a small panel of similarly trained experts can develop reliable criteria that inform judgment and support effective decision-making. Despite the wide applicability of the Delphi methodology, it is not known how the number of participants or their similarity as a stakeholder group influences results in an online Delphi.Purposeful sampling will be used with a randomized sample taken from each stakeholder group for analysis and this analysis will be presented alongside the full analysis and the results compared.
The Protocol Lab for Online Trials-Delphi (PLOT-D), which will use an online 3-round Delphi combined with participatory action research to inform the development of a multi-use protocol template for writing protocols for self-recruited online trials of interventional self-management. The Protocol lab will use the Delphi findings, along with earlier research to redesign a series of protocols for online randomized trials with the aim of providing support for citizens to work alongside researchers to build participatory health trials online.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Population sample | – | Other: Population Sample |
| Purposive Sample | – | Other: Purposive sample |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy adults from an online cohort who are invited to come to consensus in an online Delphi
Key inclusion criteria (1 listed)
- Protocol lab online trials Delphi (PLOT-D) Participant
Key exclusion criteria (1 listed)
- None if meets inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Population Samplefull sample of recruited participants | Other | Population sample |
| Purposive samplepurposive sample of recruited participants | Other | Purposive Sample |
Primary outcome
Delphi response rate differences as measured by % of completed questions between samples
Time frame: Up to 20 weeks or study completion
Full Delphi sample compared to a 10% randomized stratified sample taken from of the 5 stakeholder groups
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2021.
- Background: PubMed 29370827Brookes ST, Chalmers KA, Avery KNL, Coulman K, Blazeby JM; ROMIO study group. Impact of question order on prioritisation of outcomes in the development of a core outcome set: a randomised controlled trial. Trials. 2018 Jan 25;19(1):66. doi: 10.1186/s13063-017-2405-6.
- Background: PubMed 21283604Sinha IP, Smyth RL, Williamson PR. Using the Delphi technique to determine which outcomes to measure in clinical trials: recommendations for the future based on a systematic review of existing studies. PLoS Med. 2011 Jan 25;8(1):e1000393. doi: 10.1371/journal.pmed.1000393.
- BackgroundFletcher AJ, Marchildon GP. Using the Delphi Method for Qualitative, Participatory Action Research in Health Leadership. International Journal of Qualitative Methods 2014;13:1-18
- Background: PubMed 29942546Brice A, Price A, Burls A. Creating a database of internet-based clinical trials to support a public-led research programme: A descriptive analysis. Digit Health. 2015 Nov 20;1:2055207615617854. doi: 10.1177/2055207615617854. eCollection 2015 Jan-Dec.
- Background: PubMed 29062516Bagley HJ, Short H, Harman NL, Hickey HR, Gamble CL, Woolfall K, Young B, Williamson PR. A patient and public involvement (PPI) toolkit for meaningful and flexible involvement in clinical trials - a work in progress. Res Involv Engagem. 2016 Apr 27;2:15. doi: 10.1186/s40900-016-0029-8. eCollection 2016.
- Background: PubMed 29076631Price A, Albarqouni L, Kirkpatrick J, Clarke M, Liew SM, Roberts N, Burls A. Patient and public involvement in the design of clinical trials: An overview of systematic reviews. J Eval Clin Pract. 2018 Feb;24(1):240-253. doi: 10.1111/jep.12805. Epub 2017 Oct 27.
- Individual participant dataSharing planned: Yes. Aggregated data available by request from the study investigator
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amy Price, PhD principal investigator
University of Oxford
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Behavior, Consumer, run by ThinkWell at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delphi response rate differences as measured by % of completed questions between samples (time frame: Up to 20 weeks or study completion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03505450, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2021.