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Contacting Authors to Retrieve Individual Patient Data

Contacting Authors to Retrieve Individual Patient Data: Protocol for a Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02569411
Enrollment
129
Registered
2015-10-06
Start date
2016-06-10
Completion date
2018-02-28
Last updated
2020-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Response Rates

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

Interventions

OTHERFinancial Incentive

money

Sponsors

Unity Health Toronto
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Proportion of Authors Who Provided Complete IPDJune 2016 - October 2016We 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

MeasureTime frameDescription
Time Taken to Obtain the IPD Between Initial Request and Authors' ProvisionJune 2016 - October 2016We 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.
The Completeness of the IPD ReceivedJune 2016 - October 2016We 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.

Participant flow

Recruitment details

Authors identified in randomized controlled trials that were eligible for inclusion in two systematic review and network meta-analysis papers.

Pre-assignment details

Authors whose contact information was unidentifiable were excluded.

Participants by arm

ArmCount
No Incentive
Those allocated to the control group will be contacted by email, mail, and phone, but will not receive a financial incentive
0
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. Financial Incentive: money
0
Total0

Baseline characteristics

Characteristic
Age, Customized
Authors who provided complete IPD
Sex/Gender, Customized
Authors who provided complete IPD

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 00 / 0
other
Total, other adverse events
0 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 0

Outcome results

Primary

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.

Time frame: June 2016 - October 2016

Population: None of the authors in either arm shared individual patient data from their study.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
No Incentive (Control)Proportion of Authors Who Provided Complete IPD0 Participants
Financial Incentive (Intervention)Proportion of Authors Who Provided Complete IPD0 Participants
Secondary

The Completeness of the IPD Received

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.

Time frame: June 2016 - October 2016

Population: None of the authors in either arm shared individual patient data from their study therefore no data collected for this Outcome Measure

Secondary

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

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.

Time frame: June 2016 - October 2016

Population: None of the authors in either arm shared individual patient data from their study therefore no data collected for this Outcome Measure.

Source: ClinicalTrials.gov · Data processed: Mar 13, 2026