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Agreement between self-reported fractures in a clinical trial with New Zealand Accident Compensation Corporation
Mark J Bolland1, Zaynah Nisa2, Anna Mellar2
1Bone and Joint Research Group, Department of Medicine, The University of Auckland, Auckland, New Zealand.
Aim:
The aim of this article was to assess agreement between verified self-reported fractures in a clinical trial with Accident Compensation Corporation (ACC) claim data.
Methods:
In a 10-year randomised controlled trial of 1,054 women aged 50-60 years, participants self-reported fractures as they occurred or on routine 6-monthly questionnaires. Radiology imaging and reports were used to verify fractures, which were then compared with ACC claims data (ACC is the New Zealand no-fault accident claims organisation funded through levies). Initially, fracture claim data only were obtained, followed by all ACC claims for each participant for the study period.
Results:
Three hundred and fifty-six self-reported fractures in 248 women were verified in the trial, whereas there were 328 ACC fracture claims from 238 women for the study period. Out of 356 trial fractures, 211 (59%) had a matching ACC fracture claim, and out of 328 ACC fracture claims 211 (64%) had a matching trial fracture. After obtaining all ACC claims, we identified a matching ACC claim for 340/356 (96%) trial fractures: 59% were fracture claims and 31% soft-tissue injury claims.
Conclusions:
Repurposing ACC fracture claims data for clinical trials has significant limitations and is likely to introduce false negative and false positive events. When tolerance for misclassification is higher (e.g., large non-randomised studies), ACC claims data may be useful because 60% of claims had a verified fracture, with higher proportions for major fracture types.
