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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Financial Incentive | Other | money |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31153977 | Derived | 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. | |
| 26975720 | Derived |
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Authors whose contact information was unidentifiable were excluded.
Authors identified in randomized controlled trials that were eligible for inclusion in two systematic review and network meta-analysis papers.
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| ID | Title | Description |
|---|---|---|
| FG000 | No Incentive (Control) | Those allocated to the control group will be contacted using the same approaches as the intervention arm for their participation to share individual patient data of their study. No financial incentive is provided. |
| FG001 | Financial Incentive (Intervention) | Those allocated to the intervention group will be contacted by email, mail, and phone to share individual patient data from their study. They will be given a financial incentive (an offer of a $100 CAD gift card at first contact (or equivalent amount in the author's relevant currency) for their participation to share individual patient data of their study). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Baseline data not collected on any participants
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| ID | Title | Description |
|---|---|---|
| BG000 | No Incentive | Those allocated to the control group will be contacted by email, mail, and phone, but will not receive a financial incentive |
| BG001 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | None of the authors in either arm shared individual patient data from their study. | Posted | Count of Participants | Participants | June 2016 - October 2016 |
|
Not applicable. This study is non-clinical and so adverse event data was not collected.
Not applicable. This study is non-clinical and so adverse event data was not collected.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | No Incentive (Control) | Those allocated to the control group will be contacted using the same approaches as the intervention arm for their participation to share individual patient data of their study. No financial incentive is provided. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Areti Angeliki Veroniki | St. Michael's Hospital | 416-360-4000 | averonik@cc.uoi.gr |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 15, 2016 | Jun 16, 2020 | Prot_SAP_000.pdf |
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| June 2016 - October 2016 |
| 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. | June 2016 - October 2016 |
| 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. |
| BG002 | Total | Total of all reporting groups |
|
| Sex/Gender, Customized |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. |
| OG001 |
| Financial Incentive (Intervention) |
Those allocated to the intervention group will be contacted by email, mail, and phone to share individual patient data from their study. They will be given a financial incentive (an offer of a $100 CAD gift card at first contact (or equivalent amount in the author's relevant currency) for their participation to share individual patient data of their study). |
|
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| 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. | None of the authors in either arm shared individual patient data from their study therefore no data collected for this Outcome Measure. | Posted | June 2016 - October 2016 |
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|
| 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. | None of the authors in either arm shared individual patient data from their study therefore no data collected for this Outcome Measure | Posted | June 2016 - October 2016 |
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|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Financial Incentive (Intervention) | Those allocated to the intervention group will be contacted by email, mail, and phone to share individual patient data from their study. They will be given a financial incentive (an offer of a $100 CAD gift card at first contact (or equivalent amount in the author's relevant currency) for their participation to share individual patient data of their study). | 0 | 0 | 0 | 0 | 0 | 0 |
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