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| Name | Class |
|---|---|
| London School of Hygiene and Tropical Medicine | OTHER |
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To examine the effects of using decision support tools during the online Delphi process.
The purpose of this exploratory work is to develop improved methods for building a protocol for a participatory randomized controlled trial. An online Delphi will be combined with an embedded trial testing the effectiveness of a decision support tool. This method provides for consensus building and collaborative problem-solving which is informed, and participatory. The online Delphi offers involvement and confidentiality thus sidestepping the complications of power imbalances and undue influence as respondents contribute anonymously.
The embedded trial was considered after the building of a database of existing online trials and conducting a descriptive analysis" Creating a database of Internet-based clinical trials to support a public-led research programme: A descriptive analysis, followed by the completion of a systematic overview of systematic overviews, "Patient and Public Involvement in Clinical Trials Design: An Overview of Systematic Reviews" and followed this with an analysis of "Self-Management Open Online Trials in Health"(In review). The results included a lack of standardization, insufficient guidance for implementation and significant research reporting weaknesses. Decision-making support tools may improve decision quality.
This embedded trial will be implemented in an online Delphi to come to the consensus about what declarations and methods to include when building a participatory online trials protocol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Online MCDA | Experimental |
| |
| Online Delphi | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MCDA | Behavioral | Experimental decision support |
| |
| Delphi |
| Measure | Description | Time Frame |
|---|---|---|
| My Decision Quality (MDQ) | MDQ is a patient reported outcome measure that combines a set of importance weights for multiple criteria (options, effect, importance, chance, trust, support ,control and commitment) with performance ratings for each option on these criteria and calculates the overall score as the expected value of these components. | Up to 20 weeks or study completion |
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| Measure | Description | Time Frame |
|---|---|---|
| Time to consensus | Aggregated group time to reach consensus | Up to 20 weeks or study completion |
Inclusion Criteria:
Protocol lab online trialsl Delphi (PLOT-D) Participant
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amy I Price, PhD | University of Oxford | Principal Investigator |
| Mike J Clarke, DPhil | Queen's University, Belfast | Principal Investigator |
| Mette Kjer Kaltoft, PhD | Syddansk Universitet | Study Director |
| Jack Dowie, PhD | The London School of Hygiene & Tropical Medicine | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Oxford | Oxford | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29076631 | Background | Price 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. | |
| 29942546 | Background | 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. |
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Individual participant data is not available due to data protection rules. De-identified aggregated data may be available by contacting the Principal Investigator
following publication
contact PI
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| Behavioral |
Standard support |
|
| 23910715 | Background | Dowie J, Kjer Kaltoft M, Salkeld G, Cunich M. Towards generic online multicriteria decision support in patient-centred health care. Health Expect. 2015 Oct;18(5):689-702. doi: 10.1111/hex.12111. Epub 2013 Aug 2. |
| Background | Kaltoft MK, Dowie J, Turner R, et al. Decisional equipoise is not decisional conflict: avoiding the false clarity bias in the evaluation of decision aids and Shared Decision Making processes. F1000Research 2015;4. doi:10.7490/F1000RESEARCH.1110671.1 |
| 24335587 | Background | Kaltoft M, Cunich M, Salkeld G, Dowie J. Assessing decision quality in patient-centred care requires a preference-sensitive measure. J Health Serv Res Policy. 2014 Apr;19(2):110-7. doi: 10.1177/1355819613511076. Epub 2013 Dec 12. |