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Abstract
Objective To externally evaluate the QFracture-2012 risk prediction tool for predicting the risk of major osteoporotic fracture and hip fracture.
Design External validation cohort study.
Setting UK primary care population. Linked general practice (Clinical Practice Research Datalink (CPRD) Gold), mortality registration (Office of National Statistics), and hospital inpatient (Hospital Episode Statistics) data, from 1 January 2004 to 31 March 2016.
Participants 2 747 409 women and 2 684 730 men, aged 30-99 years, with up-to-standard linked data that had passed CPRD checks for at least one year.
Main outcome measures Two outcomes were modelled based on those predicted by QFracture: major osteoporotic fracture and hip fracture. Major osteoporotic fracture was defined as any hip, distal forearm, proximal humerus, or vertebral crush fracture, from general practice, hospital discharge, and mortality data. The QFracture-2012 10 year predicted risk of major osteoporotic fracture and hip fracture was calculated, and performance evaluated versus observed 10 year risk of fracture in the whole population, and in subgroups based on age and comorbidity. QFracture-2012 calibration was examined accounting for, and not accounting for, competing risk of mortality from causes other than the major osteoporotic fracture.
Results 2 747 409 women with 95 598 major osteoporotic fractures and 36 400 hip fractures, and 2 684 730 men with 34 321 major osteoporotic fractures and 13 379 hip fractures were included in the analysis. The incidence of all fractures was higher than in the QFracture-2012 internal derivation. Competing risk of mortality was more common than fracture from middle age onwards. QFracture-2012 discrimination in the whole population was excellent or good for major osteoporotic fracture and hip fracture (Harrell’s C statistic in women 0.813 and 0.918, and 0.738 and 0.888 in men, respectively), but was poor to moderate in age subgroups (eg, Harrell’s C statistic in women and men aged 85-99 years was 0.576 and 0.624 for major osteoporotic fractures, and 0.601 and 0.637 for hip fractures, respectively). Without accounting for competing risks, QFracture-2012 systematically under-predicted the risk of fracture in all models, and more so for major osteoporotic fracture than for hip fracture, and more so in older people. Accounting for competing risks, QFracture-2012 still under-predicted the risk of fracture in the whole population, but over-prediction was considerable in older age groups and in people with high comorbidities at high risk of fracture.
Conclusions The QFracture-2012 risk prediction tool systematically under-predicted the risk of fracture (because of incomplete determination of fracture rates) and over-predicted the risk in older people and in those with more comorbidities (because of competing mortality). The current version of QFracture-2016 that is used by the UK's health service needs to be externally validated, particularly in people at high risk of death from other causes.
- Primary health care
- Rheumatology
- Musculoskeletal diseases
- Risk management
- Preventive medicine
Data availability statement
Data may be obtained from a third party and are not publicly available. The data controller is the Clinical Practice Research Datalink (CPRD), and under the data licence granted, the authors are not allowed to share data. Researchers can apply to CPRD directly for access to the raw data.
This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.
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Data availability statement
Data may be obtained from a third party and are not publicly available. The data controller is the Clinical Practice Research Datalink (CPRD), and under the data licence granted, the authors are not allowed to share data. Researchers can apply to CPRD directly for access to the raw data.
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Footnotes
Correction notice This article has been corrected since it first published. See full Correction notice for details.
Contributors The study was conceived of and designed by BG, DRM, and PD who obtained the funding. All authors contributed to study design and interpretation. SJL, CE, and MM led the data management and SJL led the analysis, supported in both by BG, DRM, and PD. SJL and BG drafted the paper, which all authors reviewed and edited. SJL, BG, MM, and DRM verified the underlying data. BG is the guarantor. The corresponding author attests that all listed authors meet authorship criteria and that no others meeting the criteria have been omitted. Transparency: BG (the guarantor) affirms that the manuscript is an honest, accurate, and transparent account of the study being reported; that no important aspects of the study have been omitted; and that any discrepancies from the study as planned (and, if relevant, registered) have been explained.
Funding This study and project is funded by the National Institute for Health Research (NIHR) Health Services and Delivery Research Programme (project reference 15/12/22). The views expressed are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care. The study funder had no role in study design, data collection, data analysis, data interpretation, or writing of the report. The corresponding author had full access to all of the data and the final responsibility to submit for publication.
Competing interests All authors have completed the ICMJE uniform disclosure form at www.icmje.org/disclosure-of-interest/ and declare: support from the National Institute for Health Research (NIHR) Health Services and Delivery Research Programme for the submitted work; BG reports funding from NIHR, Legal and General, Medical Research Council, and Chief Scientist Office unrelated to this study; CE is supported by a research grant from Legal and General (Advanced Care Research Centre) unrelated to this study; DRM is supported by a Wellcome Trust Clinical Research Development Fellowship (grant 214588/Z/18/Z) and reports funding from NIHR, Chief Scientist Office, and Tenovus, unrelated to this study; PTD reports funding from EU Health FP7 and Chief Scientist Office unrelated to this study; no financial relationships with any organisations that might have an interest in the submitted work in the previous three years; no other relationships or activities that could appear to have influenced the submitted work.
Provenance and peer review Not commissioned; externally peer reviewed.
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