External validation of prognostic models predicting pre-eclampsia: individual participant data meta-analysis.

Autor: Snell KIE; Centre for Prognosis Research, School of Primary, Community and Social Care, Keele University, Keele, UK. k.snell@keele.ac.uk., Allotey J; Barts Research Centre for Women's Health (BARC), Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.; Pragmatic Clinical Trials Unit, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK., Smuk M; Pragmatic Clinical Trials Unit, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK., Hooper R; Pragmatic Clinical Trials Unit, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK., Chan C; Pragmatic Clinical Trials Unit, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK., Ahmed A; MirZyme Therapeutics, Innovation Birmingham Campus, Birmingham, UK., Chappell LC; Department of Women and Children's Health, School of Life Course Sciences, King's College London, London, UK., Von Dadelszen P; Department of Women and Children's Health, School of Life Course Sciences, King's College London, London, UK., Green M; Action on Pre-eclampsia (APEC) Charity, Worcestershire, UK., Kenny L; Faculty Health & Life Sciences, University of Liverpool, Liverpool, UK., Khalil A; Fetal Medicine Unit, St George's University Hospitals NHS Foundation Trust and Molecular and Clinical Sciences Research Institute, St George's University of London, London, UK., Khan KS; Barts Research Centre for Women's Health (BARC), Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.; Pragmatic Clinical Trials Unit, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK., Mol BW; Department of Obstetrics and Gynaecology, Monash University, Monash Medical Centre, Clayton, Victoria, Australia., Myers J; Maternal and Fetal Health Research Centre, Manchester Academic Health Science Centre, University of Manchester, Central Manchester NHS Trust, Manchester, UK., Poston L; Department of Women and Children's Health, School of Life Course Sciences, King's College London, London, UK., Thilaganathan B; Fetal Medicine Unit, St George's University Hospitals NHS Foundation Trust and Molecular and Clinical Sciences Research Institute, St George's University of London, London, UK., Staff AC; Division of Obstetrics and Gynaecology, Oslo University Hospital, and Faculty of Medicine, University of Oslo, Oslo, Norway., Smith GCS; Department of Obstetrics and Gynaecology, NIHR Biomedical Research Centre, Cambridge University, Cambridge, UK., Ganzevoort W; Department of Obstetrics, Amsterdam UMC University of Amsterdam, Amsterdam, The Netherlands., Laivuori H; Department of Medical and Clinical Genetics, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.; Institute for Molecular Medicine Finland, Helsinki Institute of Life Science, University of Helsinki, Helsinki, Finland.; Department of Obstetrics and Gynecology, Faculty of Medicine and Health Technology, Tampere University Hospital and Tampere University, Tampere, Finland., Odibo AO; University of South Florida, Tampa, FL, USA., Arenas Ramírez J; Department of Obstetrics and Gynaecology, University Hospital de Cabueñes, Gijón, Spain., Kingdom J; Maternal-Fetal Medicine Division, Department OBGYN, Mount Sinai Hospital, University of Toronto, Toronto, Canada., Daskalakis G; Department of Obstetrics and Gynecology, National and Kapodistrian University of Athens, Alexandra Hospital, Athens, Greece., Farrar D; Bradford Institute for Health Research, Bradford Teaching Hospitals, Bradford, UK., Baschat AA; Johns Hopkins Center for Fetal Therapy, Department of Gynecology & Obstetrics, Johns Hopkins University School of Medicine, Baltimore, MD, USA., Seed PT; Department of Women and Children's Health, School of Life Course Sciences, King's College London, London, UK., Prefumo F; Department of Obstetrics and Gynaecology, University of Brescia, Brescia, Italy., da Silva Costa F; Department of Gynecology and Obstetrics, Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, São Paulo, Brazil., Groen H; Department of Epidemiology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands., Audibert F; Department of Obstetrics and Gynecology, CHU Ste Justine, Université de Montréal, Montreal, Canada., Masse J; Department of Molecular Biology, Medical Biochemistry and Pathology, Laval University, Quebec City, Canada., Skråstad RB; Department of Clinical and Molecular Medicine, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology - NTNU, Trondheim, Norway.; Department of Clinical Pharmacology, St. Olav University Hospital, Trondheim, Norway., Salvesen KÅ; Department of Obstetrics and Gynecology, Trondheim University Hospital, Trondheim, Norway.; Department of Laboratory Medicine, Children's and Women's Health, Norwegian University of Science and Technology, Trondheim, Norway., Haavaldsen C; Department of Obstetrics and Gynaecology, Akershus University Hospital, Lørenskog, Norway., Nagata C; Department of Education for Clinical Research, National Center for Child Health and Development, Tokyo, Japan., Rumbold AR; South Australian Health and Medical Research Institute and Robinson Research Institute, The University of Adelaide, Adelaide, Australia., Heinonen S; Department of Obstetrics and Gynaecology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland., Askie LM; NHMRC Clinical Trials Centre, University of Sydney, Sydney, Australia., Smits LJM; Care and Public Health Research Institute, Maastricht University Medical Centre, Maastricht, The Netherlands., Vinter CA; Department of Gynecology and Obstetrics, Odense University Hospital, University of Southern Denmark, Odense, Denmark., Magnus P; Centre for Fertility and Health, Norwegian Institute of Public Health, Oslo, Norway., Eero K; National Institute for Health and Welfare, Helsinki, Finland.; Children's Hospital, University of Helsinki and Helsinki University Hospital, Helsinki, Finland., Villa PM; Department of Obstetrics and Gynaecology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland., Jenum AK; General Practice Research Unit (AFE), Department of General Practice, Institute of Health and Society, Faculty of Medicine, University of Oslo, Oslo, Norway., Andersen LB; Institute for Clinical Research, University of Southern Denmark, Odense, Denmark.; Department of Obstetrics and Gynecology, Odense University Hospital, Odense, Denmark., Norman JE; MRC Centre for Reproductive Health, University of Edinburgh, Edinburgh, UK., Ohkuchi A; Department of Obstetrics and Gynecology, Jichi Medical University School of Medicine, Shimotsuke-shi, Tochigi, Japan., Eskild A; Department of Obstetrics and Gynaecology, Akershus University Hospital, Lørenskog, Norway.; Institute of Clinical Medicine, University of Oslo, Oslo, Norway., Bhattacharya S; Obstetrics & Gynaecology, Institute of Applied Health Sciences, School of Medicine, Medical Sciences and Nutrition, University of Aberdeen, Aberdeen, UK., McAuliffe FM; UCD Perinatal Research Centre, School of Medicine, University College Dublin, National Maternity Hospital, Dublin, Ireland., Galindo A; Fetal Medicine Unit, Maternal and Child Health and Development Network (SAMID), Department of Obstetrics and Gynaecology, Hospital Universitario, Instituto de Investigación Hospital, Universidad Complutense de Madrid, Madrid, Spain., Herraiz I; Fetal Medicine Unit, Maternal and Child Health and Development Network (SAMID), Department of Obstetrics and Gynaecology, Hospital Universitario, Instituto de Investigación Hospital, Universidad Complutense de Madrid, Madrid, Spain., Carbillon L; Department of Obstetrics and Gynecology, Assistance Publique-Hôpitaux de Paris Université Paris, Paris, France., Klipstein-Grobusch K; Julius Centre for Health Sciences and Primary Care, University Medical Centre Utrecht, Utrecht University, Utrecht, The Netherlands., Yeo SA; University of North Carolina at Chapel Hill, Chapel Hill, NC, USA., Browne JL; Julius Centre for Health Sciences and Primary Care, University Medical Centre Utrecht, Utrecht University, Utrecht, The Netherlands., Moons KGM; Julius Centre for Health Sciences and Primary Care, University Medical Centre Utrecht, Utrecht University, Utrecht, The Netherlands.; Cochrane Netherlands, Utrecht, The Netherlands., Riley RD; Centre for Prognosis Research, School of Primary, Community and Social Care, Keele University, Keele, UK., Thangaratinam S; Institute of Metabolism and Systems Research, WHO Collaborating Centre for Women's Health, University of Birmingham, Birmingham, UK.
Jazyk: angličtina
Zdroj: BMC medicine [BMC Med] 2020 Nov 02; Vol. 18 (1), pp. 302. Date of Electronic Publication: 2020 Nov 02.
DOI: 10.1186/s12916-020-01766-9
Abstrakt: Background: Pre-eclampsia is a leading cause of maternal and perinatal mortality and morbidity. Early identification of women at risk during pregnancy is required to plan management. Although there are many published prediction models for pre-eclampsia, few have been validated in external data. Our objective was to externally validate published prediction models for pre-eclampsia using individual participant data (IPD) from UK studies, to evaluate whether any of the models can accurately predict the condition when used within the UK healthcare setting.
Methods: IPD from 11 UK cohort studies (217,415 pregnant women) within the International Prediction of Pregnancy Complications (IPPIC) pre-eclampsia network contributed to external validation of published prediction models, identified by systematic review. Cohorts that measured all predictor variables in at least one of the identified models and reported pre-eclampsia as an outcome were included for validation. We reported the model predictive performance as discrimination (C-statistic), calibration (calibration plots, calibration slope, calibration-in-the-large), and net benefit. Performance measures were estimated separately in each available study and then, where possible, combined across studies in a random-effects meta-analysis.
Results: Of 131 published models, 67 provided the full model equation and 24 could be validated in 11 UK cohorts. Most of the models showed modest discrimination with summary C-statistics between 0.6 and 0.7. The calibration of the predicted compared to observed risk was generally poor for most models with observed calibration slopes less than 1, indicating that predictions were generally too extreme, although confidence intervals were wide. There was large between-study heterogeneity in each model's calibration-in-the-large, suggesting poor calibration of the predicted overall risk across populations. In a subset of models, the net benefit of using the models to inform clinical decisions appeared small and limited to probability thresholds between 5 and 7%.
Conclusions: The evaluated models had modest predictive performance, with key limitations such as poor calibration (likely due to overfitting in the original development datasets), substantial heterogeneity, and small net benefit across settings. The evidence to support the use of these prediction models for pre-eclampsia in clinical decision-making is limited. Any models that we could not validate should be examined in terms of their predictive performance, net benefit, and heterogeneity across multiple UK settings before consideration for use in practice.
Trial Registration: PROSPERO ID: CRD42015029349 .
Databáze: MEDLINE
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