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Background <p>Healthcare Systems Data (HSD) are increasingly used in RCTs to supplement data required for clinical trial outcomes; however, the true quality and utility of this data remain unclear. In clinical trials when data discrepancies are present, rules of data integration must be in place to handle the differences; however, there is little evidence as to the best approach for how these principles are set. The purpose of this study is to conduct a comprehensive data utility comparison of HSD mortality data and trial-specific mortality data collected in the BOSS trial.</p> Methods <p>Trial-specific and HSD mortality data collected in the BOSS trial were compared to assess levels of agreement between death status, death dates, and causes of death. Potential sources of data inconsistencies were examined to determine underlying patterns between HSD and trial-specific data discrepancies. HSD and trial-specific data were combined through five data integration approaches to assess their impact on the primary outcome of overall survival.</p> Results <p>Death status and death dates were similar between trial-specific and HSD data (Cohen’s Kappa statistic 0.866, 95% CI 0.842 to 0.889); however, more than 100 participants were recorded with inconsistent death statuses, and the median difference between different death dates was almost a year (340&#xa0;days, IQR: 11 to 865&#xa0;days). All data integration approaches contributed to similar treatment effect estimates, and none changed the results of the trial. The treatment effect estimations from either source exclusively were comparable (HSD Hazard Ratio 1.01, 95% CI 0.85 to 1.20; trial-specific Hazard Ratio 0.89, 95% CI 0.75 to 1.06), and when both sources were integrated to produce hazard ratio estimates, the results were almost identical regardless of the approach taken.</p> Conclusions <p>In a direct comparison of mortality data between HSD and trial-specific data for the BOSS trial, both sources were mostly accurate and complete. Trial results were not impacted by different approaches of data integration and were generally strengthened by combining all data sources. This should be always encouraged when trial data and HSD are both collected.</p> Trial registration <p>ISRCTN54190466. Registered on 8 January 2008.</p>

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Agreement and utility between registry and trial mortality data - a data utility comparison in the BOSS trial

  • 期刊论文

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  • 发表日期：

    2026年3月17日

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  • Alex Zimmermann,
  • Oliver Old,
  • Hugh Barr,
  • Sharon B. Love,
  • M. Sofia Massa,
  • George Abouda,
  • Khurshid Akhtar,
  • David Aldulaimi,
  • Haythem Ali,
  • Miles Allison,
  • Max Almond,
  • Yeng Ang,
  • Stephen Attwood,
  • Mariann Baulf,
  • Ian Beales,
  • Conrad Beckett,
  • Abduljail Benhamida,
  • Pradeep Bhandari,
  • Phil Boger,
  • Nicholas Bosanko,
  • Abbi Botting,
  • Graham Butcher,
  • Jayne Butcher,
  • Guy Chung-Faye,
  • Carole Collins,
  • Ben Collypriest,
  • Howard Curtis,
  • Gareth Davies,
  • John De Caestecker,
  • Anjan Dhar,
  • Alan Desmond,
  • John Dillon,
  • Andrew Dixon,
  • Samuel Dresner,
  • Cathryn Edwards,
  • David Elphick,
  • Adam Farmer,
  • Mark Farrant,
  • Stephen Foley,
  • Mark Fullard,
  • Thukalan Paulose George,
  • Ian Gooding,
  • Stephen Gore,
  • John Green,
  • Susi Green,
  • Charles Grimley,
  • Chris Haigh,
  • Richard Hammonds,
  • Peter Hanson,
  • Jamal Hayat,
  • Andrew Higham,
  • Gavin Hill,
  • David Hobday,
  • Tracey Hodgkiss,
  • Alan Ireland,
  • Tariq Iqbal,
  • Peter Isaacs,
  • Matthew Johnson,
  • Sudarshan Kadri,
  • Jin-Yong Kang,
  • Prashant Kant,
  • Kapil C. Kapur,
  • Carrie Kelly,
  • Mark Kelly,
  • Iqbal Khan,
  • Konrad Koss,
  • Ian London,
  • Laurence Lovat,
  • Karen Low,
  • Christopher MacDonald,
  • Ravi Madhotra,
  • Inder Mainie,
  • Philip Mairs,
  • James M. Manson,
  • Hugh McMurtry,
  • Mike Mendall,
  • Andrew D. Millar,
  • Faiyaz Mohammed,
  • Andrew Moore,
  • Danielle Morris,
  • Frank Murphy,
  • Ian Murray,
  • Mark Narain,
  • John O’Donohue,
  • Stuart Paterson,
  • Vinod Patel,
  • Mike Perry,
  • Karen Phillips,
  • Perminder Phull,
  • Puroshothaman Premchand,
  • Sean Preston,
  • Roger Prudham,
  • Johan Rademaker,
  • Krish Ragunath,
  • John Ramage,
  • Bashir Rameh,
  • Ashraf Rasheed,
  • Colin Rees,
  • Bjorn Rembacken,
  • Joanne Rothwell,
  • Michael Roberts,
  • Matt Rutter,
  • Ian Sargeant,
  • Vishal Saxena,
  • Syed Shah,
  • Amanullah Shams,
  • Achuth Shenoy,
  • James Shutt,
  • Salil Singh,
  • Ganesh Sivaji,
  • Simon Smales,
  • Howard Smart,
  • Katie Smith,
  • Mark Smith,
  • Ashraf Soliman,
  • Shelly Soo,
  • Michael Sprakes,
  • Ali Taha,
  • Nigel Trudgill,
  • Olga Tucker,
  • Bernhard Usselmann,
  • Kishor Vaidya,
  • Andrew Veitch,
  • Martin Wadley,
  • Saj Wajed,
  • David Watmough,
  • Peter Watson,
  • Mark Whitehead,
  • Robert P. Willert,
  • Jessica Williams,
  • Joy Worthington,
  • Kevin Yoong,
  • Mohamed Yousif

摘要

Background

Healthcare Systems Data (HSD) are increasingly used in RCTs to supplement data required for clinical trial outcomes; however, the true quality and utility of this data remain unclear. In clinical trials when data discrepancies are present, rules of data integration must be in place to handle the differences; however, there is little evidence as to the best approach for how these principles are set. The purpose of this study is to conduct a comprehensive data utility comparison of HSD mortality data and trial-specific mortality data collected in the BOSS trial.

Methods

Trial-specific and HSD mortality data collected in the BOSS trial were compared to assess levels of agreement between death status, death dates, and causes of death. Potential sources of data inconsistencies were examined to determine underlying patterns between HSD and trial-specific data discrepancies. HSD and trial-specific data were combined through five data integration approaches to assess their impact on the primary outcome of overall survival.

Results

Death status and death dates were similar between trial-specific and HSD data (Cohen’s Kappa statistic 0.866, 95% CI 0.842 to 0.889); however, more than 100 participants were recorded with inconsistent death statuses, and the median difference between different death dates was almost a year (340 days, IQR: 11 to 865 days). All data integration approaches contributed to similar treatment effect estimates, and none changed the results of the trial. The treatment effect estimations from either source exclusively were comparable (HSD Hazard Ratio 1.01, 95% CI 0.85 to 1.20; trial-specific Hazard Ratio 0.89, 95% CI 0.75 to 1.06), and when both sources were integrated to produce hazard ratio estimates, the results were almost identical regardless of the approach taken.

Conclusions

In a direct comparison of mortality data between HSD and trial-specific data for the BOSS trial, both sources were mostly accurate and complete. Trial results were not impacted by different approaches of data integration and were generally strengthened by combining all data sources. This should be always encouraged when trial data and HSD are both collected.

Trial registration

ISRCTN54190466. Registered on 8 January 2008.