INSPECT-SR: a tool for assessing trustworthiness of randomised controlled trials

Area of Science:

• Clinical Research Methodology
• Evidence Synthesis
• Research Integrity

Background:

• Problematic randomized controlled trials (RCTs) pose a significant threat to the integrity of evidence synthesis.
• Concerns regarding data trustworthiness, including research misconduct or critical errors, can compromise RCT findings.
• Undetected problematic RCTs may be included in systematic reviews and guidelines, leading to distorted results.

Purpose of the Study:

• To develop a tool for assessing the trustworthiness of RCTs.
• To enable the identification and exclusion of problematic RCTs from systematic reviews.
• To present the INSPECT-SR tool and its accompanying guidance document.

Main Methods:

• Development of the INSPECT-SR (INveStigating ProblEmatic Clinical Trials in Systematic Reviews) tool.
• Creation of an associated guidance document to support the tool's application.
• Focus on assessing the trustworthiness of RCT data and findings.

Main Results:

• The INSPECT-SR tool has been developed.
• A guidance document has been created to accompany the tool.
• The tool facilitates the identification of problematic RCTs.

Conclusions:

• The INSPECT-SR tool addresses the critical issue of problematic RCTs in evidence synthesis.
• By identifying untrustworthy RCTs, the tool enhances the reliability of systematic reviews.
• The tool and guidance aim to improve the overall quality of clinical evidence used in guidelines.