Development of the Individual Participant Data Integrity Tool for Assessing the Integrity of Randomised Trials Using Individual Participant Data
Saved in:
| Title: | Development of the Individual Participant Data Integrity Tool for Assessing the Integrity of Randomised Trials Using Individual Participant Data |
|---|---|
| Language: | English |
| Authors: | Kylie E. Hunter (ORCID |
| Source: | Research Synthesis Methods. 2024 15(6):940-949. |
| Availability: | Wiley. Available from: John Wiley & Sons, Inc. 111 River Street, Hoboken, NJ 07030. Tel: 800-835-6770; e-mail: cs-journals@wiley.com; Web site: https://www.wiley.com/en-us |
| Peer Reviewed: | Y |
| Page Count: | 10 |
| Publication Date: | 2024 |
| Document Type: | Journal Articles Reports - Research |
| Descriptors: | Integrity, Randomized Controlled Trials, Data Use, Individual Characteristics, Credibility, Research and Development, Medical Research |
| DOI: | 10.1002/jrsm.1739 |
| ISSN: | 1759-2879 1759-2887 |
| Abstract: | Increasing integrity concerns in medical research have prompted the development of tools to detect untrustworthy studies. Existing tools primarily assess published aggregate data (AD), though scrutiny of individual participant data (IPD) is often required to detect trustworthiness issues. Thus, we developed the IPD Integrity Tool for detecting integrity issues in randomised trials with IPD available. This manuscript describes the development of this tool. We conducted a literature review to collate and map existing integrity items. These were discussed with an expert advisory group; agreed items were included in a standardised tool and automated where possible. We piloted this tool in two IPD meta-analyses (including 116 trials) and conducted preliminary validation checks on 13 datasets with and without known integrity issues. We identified 120 integrity items: 54 could be conducted using AD, 48 required IPD, and 18 were possible with AD, but more comprehensive with IPD. An initial reduced tool was developed through consensus involving 13 advisors, featuring 11 AD items across four domains, and 12 IPD items across eight domains. The tool was iteratively refined throughout piloting and validation. All studies with known integrity issues were accurately identified during validation. The final tool includes seven AD domains with 13 items and eight IPD domains with 18 items. The quality of evidence informing healthcare relies on trustworthy data. We describe the development of a tool to enable researchers, editors, and others to detect integrity issues using IPD. Detailed instructions for its application are published as a complementary manuscript in this issue. |
| Abstractor: | As Provided |
| Entry Date: | 2024 |
| Accession Number: | EJ1447268 |
| Database: | ERIC |
|
Full text is not displayed to guests.
Login for full access.
|
|
| Abstract: | Increasing integrity concerns in medical research have prompted the development of tools to detect untrustworthy studies. Existing tools primarily assess published aggregate data (AD), though scrutiny of individual participant data (IPD) is often required to detect trustworthiness issues. Thus, we developed the IPD Integrity Tool for detecting integrity issues in randomised trials with IPD available. This manuscript describes the development of this tool. We conducted a literature review to collate and map existing integrity items. These were discussed with an expert advisory group; agreed items were included in a standardised tool and automated where possible. We piloted this tool in two IPD meta-analyses (including 116 trials) and conducted preliminary validation checks on 13 datasets with and without known integrity issues. We identified 120 integrity items: 54 could be conducted using AD, 48 required IPD, and 18 were possible with AD, but more comprehensive with IPD. An initial reduced tool was developed through consensus involving 13 advisors, featuring 11 AD items across four domains, and 12 IPD items across eight domains. The tool was iteratively refined throughout piloting and validation. All studies with known integrity issues were accurately identified during validation. The final tool includes seven AD domains with 13 items and eight IPD domains with 18 items. The quality of evidence informing healthcare relies on trustworthy data. We describe the development of a tool to enable researchers, editors, and others to detect integrity issues using IPD. Detailed instructions for its application are published as a complementary manuscript in this issue. |
|---|---|
| ISSN: | 1759-2879 1759-2887 |
| DOI: | 10.1002/jrsm.1739 |
