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Protocol Lab for Online Trial Delphi and Question Effects

NCT03498677 — Not applicable, Completed, 385 participants, ThinkWell

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Effects of Question Section Order on Prioritization of Items by Stakeholder Groups in an Online Delphi Study

RegistryNCT03498677
StatusCompleted
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: none, other
Enrollment385 (Actual)
SponsorThinkWell (Other)
ConditionsBehavior, Adaptive, Decision Analysis
Interventionspresentation order, alternative presentation order (Behavioral)
Datesstart 2018-05-29, primary completion 2019-04-30, completion 2019-10-30, first posted 2018-04-17, last updated 2021-03-22
Locations1 site in United Kingdom

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-Summary

This study nested as a randomized controlled trial within an online Delphi and will assess the impact of using different question section groupings to provide aggregate feedback to participants in an online Delphi study.

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+Detailed description

A similar assessment has been done during the development of a core outcome for critical care trials set with a nested study examining the impact of question order on prioritization of outcomes. Research reports different stakeholders groups may differ in how they value or prioritize research questions and outcomes and it is recommended that each group should be adequately represented.

The Protocol Lab for Online Trials-Delphi (PLOT-D) study will use an online 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.

+Arms and interventions

ArmTypeInterventionsDescription
Method of presentation oneActive comparatorBehavioral: presentation order
Method of presentation twoActive comparatorBehavioral: alternative presentation order
  • presentation order (Behavioral): section presentation one
  • alternative presentation order (Behavioral): section presentation two

+Outcome measures

Primary outcomes

  • Context effects of question order [Up to 20 weeks or study completion]: measure to what extent question section order changes context response between conditions

Secondary outcomes

  • Question section presentation order [Up to 20 weeks or study completion]: response differences amongst stakeholder groups randomized to 1 of 2 presentation order conditions
  • Retention [Up to 20 weeks or study completion]: difference in number of items retained at the end of the first Delphi round by randomized assignment to condition

+Eligibility

Sex: All, ages: 18 Years to any, accepts healthy volunteers

Inclusion Criteria:

* Protocol lab for online trials Delphi (PLOT-D) participants

Exclusion Criteria:

* None if inclusion criteria are met

+Locations (1)

FacilityCityCountryStatus
ThinkWellOxford, OxfordshireUnited Kingdom

+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. PMID 29370827
  • Potter S, Brookes ST, Holcombe C, Ward JA, Blazeby JM. Exploring methods the for selection and integration of stakeholder views in the development of core outcome sets: a case study in reconstructive breast surgery. Trials. 2016 Sep 23;17(1):463. doi: 10.1186/s13063-016-1591-y. PMID 27664072
  • Snow R, Crocker JC, Crowe S. Missed opportunities for impact in patient and carer involvement: a mixed methods case study of research priority setting. Res Involv Engagem. 2015 Aug 4;1:7. doi: 10.1186/s40900-015-0007-6. eCollection 2015. PMID 29062496
  • Sinha 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. PMID 21283604
  • Fletcher 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. PMID 29942546
  • Bagley 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. PMID 29062516
  • 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. PMID 29076631
  • Altman DG. Practical statistics for medical research. London: Chapman and Hall; 1991

+Investigators

My Notes