Protocol Lab for Online Trial Delphi and Question Effects

Behavior, Adaptive Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03498677
• Other study ID #: PLOT-D Question Effects
• Status: Completed
• Phase: N/A
• Start date: May 29, 2018
• Est. completion date: October 30, 2019

Study information

• Verified date: March 2021
• Source: ThinkWell
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 385
• Est. completion date: October 30, 2019
• Est. primary completion date: April 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• None if inclusion criteria are met

Related Conditions & MeSH terms

• Behavior, Adaptive
• Decision Analysis

Intervention

Behavioral:
• presentation order
section presentation one
• alternative presentation order
section presentation two

Locations

Country	Name	City	State
United Kingdom	ThinkWell	Oxford	Oxfordshire

Sponsors (1)

Lead Sponsor	Collaborator
ThinkWell

Country where clinical trial is conducted

United Kingdom, 

References & Publications (9)

Altman DG. Practical statistics for medical research. London: Chapman and Hall; 1991

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Context effects of question order	measure to what extent question section order changes context response between conditions	Up to 20 weeks or study completion
Secondary	Question section presentation order	response differences amongst stakeholder groups randomized to 1 of 2 presentation order conditions	Up to 20 weeks or study completion
Secondary	Retention	difference in number of items retained at the end of the first Delphi round by randomized assignment to condition	Up to 20 weeks or study completion