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Contacting Authors to Retrieve Individual Patient Data

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ClinicalTrials.gov Identifier: NCT02569411
Recruitment Status : Completed
First Posted : October 6, 2015
Results First Posted : July 1, 2020
Last Update Posted : July 1, 2020
Sponsor:
Information provided by (Responsible Party):
Andrea Tricco, St. Michael's Hospital, Toronto

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

Condition or disease Intervention/treatment Phase
Response Rates Other: Financial Incentive Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 129 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Other
Official Title: Contacting Authors to Retrieve Individual Patient Data: Protocol for a Randomized Controlled Trial
Actual Study Start Date : June 10, 2016
Actual Primary Completion Date : February 28, 2018
Actual Study Completion Date : February 28, 2018

Arm Intervention/treatment
No Intervention: No Incentive
Those allocated to the control group will be contacted by email, mail, and phone, but will not receive a financial incentive
Experimental: Incentive
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
money




Primary Outcome Measures :
  1. Proportion of Authors Who Provided Complete IPD [ Time Frame: June 2016 - October 2016 ]
    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.


Secondary Outcome Measures :
  1. Time Taken to Obtain the IPD Between Initial Request and Authors' Provision [ Time Frame: June 2016 - October 2016 ]
    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.

  2. The Completeness of the IPD Received [ Time Frame: June 2016 - October 2016 ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  Study Documents (Full-Text)

Documents provided by Andrea Tricco, St. Michael's Hospital, Toronto:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Andrea Tricco, Dr., St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier: NCT02569411    
Other Study ID Numbers: 15-240c
First Posted: October 6, 2015    Key Record Dates
Results First Posted: July 1, 2020
Last Update Posted: July 1, 2020
Last Verified: June 2020