Identification and mitigation of a systematic analysis error in a multicenter dual-energy x-ray absorptiometry study

Area of Science:

• Clinical Research
• Data Integrity
• Quality Assurance

Background:

• Multicenter and longitudinal studies require robust data integrity measures.
• Sharing results with participants necessitates accurate and reproducible data.
• A quality assurance plan is crucial for monitoring and mitigating errors.

Purpose of the Study:

• To report a systematic error in bone mineral density (BMD) hip scan analysis.
• To describe the mitigation and communication plan implemented to ensure participant safety.
• To highlight the importance of quality assurance in multicenter clinical studies.

Main Methods:

• Ancillary bone mineral density study across 27 sites using dual x-ray absorptiometry scanners.
• Identified a systematic error in hip scan readings from one scanner type.
• Implemented a mitigation plan involving scan reanalysis and participant communication.

Main Results:

• An error in hip scan analysis led to lower BMD scores, misclassifying osteoporosis.
• Fourteen scans initially indicating osteoporosis or low BMD were reanalyzed, with reclassifications occurring in 10 scans.
• A broader review identified additional scans requiring reanalysis, with 12 reclassifications.

Conclusions:

• Analysis errors can impact participant safety, potentially leading to unnecessary treatment.
• A coordinated communication and mitigation plan is essential for accurate results and participant care.
• This study provides a framework for managing data integrity issues in clinical research.