NCT02569411

Brief Summary

The objective of this study is to examine the impact of incentivizing authors of RCTs that are eligible for a systematic review and meta-analysis, versus usual contact strategies to obtain original IPD

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
129

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 30, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 6, 2015

Completed
8 months until next milestone

Study Start

First participant enrolled

June 10, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2018

Completed
2.3 years until next milestone

Results Posted

Study results publicly available

July 1, 2020

Completed
Last Updated

July 1, 2020

Status Verified

June 1, 2020

Enrollment Period

1.7 years

First QC Date

September 30, 2015

Results QC Date

May 6, 2020

Last Update Submit

June 16, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Proportion of Authors Who Provided Complete IPD

    We contacted authors of eligible studies from June 2016 to October 2016. Authors were first contacted in June 2016, where we sent: a) an email requesting their IPD, b) email reminders (4 in total) at 2, 6, 10, and 14-week intervals after the initial email, c) reminders by post in week 7, and d) reminders via telephone in week 15.

    June 2016 - October 2016

Secondary Outcomes (2)

  • Time Taken to Obtain the IPD Between Initial Request and Authors' Provision

    June 2016 - October 2016

  • The Completeness of the IPD Received

    June 2016 - October 2016

Study Arms (2)

No Incentive

NO INTERVENTION

Those allocated to the control group will be contacted by email, mail, and phone, but will not receive a financial incentive

Incentive

EXPERIMENTAL

Those allocated to the intervention group will be contacted by email, mail, and phone, and will be asked to provide the IPD from their RCT and they will be given a financial incentive.

Other: Financial Incentive

Interventions

money

Incentive

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Corresponding authors of RCTs included in our previous and updated systematic reviews

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Veroniki AA, Ashoor HM, Le SPC, Rios P, Stewart LA, Clarke M, Mavridis D, Straus SE, Tricco AC. Retrieval of individual patient data depended on study characteristics: a randomized controlled trial. J Clin Epidemiol. 2019 Sep;113:176-188. doi: 10.1016/j.jclinepi.2019.05.031. Epub 2019 May 30.

  • Veroniki AA, Straus SE, Ashoor H, Stewart LA, Clarke M, Tricco AC. Contacting authors to retrieve individual patient data: study protocol for a randomized controlled trial. Trials. 2016 Mar 15;17(1):138. doi: 10.1186/s13063-016-1238-z.

Results Point of Contact

Title
Dr. Areti Angeliki Veroniki
Organization
St. Michael's Hospital

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

September 30, 2015

First Posted

October 6, 2015

Study Start

June 10, 2016

Primary Completion

February 28, 2018

Study Completion

February 28, 2018

Last Updated

July 1, 2020

Results First Posted

July 1, 2020

Record last verified: 2020-06