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1. Standardising definitions for the pre-eclampsia core outcome set: A consensus development study

Author

Duffy, J. M. N., Cairns, A. E., Magee, L. A., von Dadelszen, P., van 't Hooft, J., Gale, C., Brown, M., Chappell, L. C., Grobman, W. A., Fitzpatrick, R., Karumanchi, S. A., Lucas, D. N., Mol, B., Stark, M., Thangaratinam, S., Wilson, M. J., Williamson, P. R., Ziebland, S., Mcmanus, R. J., Abalos, E. J., Adamson, C. C. D., Akadri, A. A., Akturk, Z., Allegaert, K., Angel-Muller, E., Antretter, J., Ashdown, H. F., Audibert, F., Auger, N., Aygun, C., Babic, I., Bagga, R., Baker, J. M., Beebeejaun, Y., Bhakta, P., Bhandari, V., Bhattacharya, S., Blanker, M. H., Bloomfield, F. H., Bof, A., Brennan, S. M., Broekhuijsen, K., Broughton Pipkin, F., Browne, J. L., Browning, R. M., Bull, J. W., Butt, A., Button, D., Campbell, J. P., Campbell, D. M., Carbillon, L., Carthy, S., Casely, E., Cave, J. A., Cecatti, J. G., Chamillard, M. E., Chassard, D., Checheir, N. C., Chulkov, V. S., Cluver, C. A., Crawford, C. F., Daly, M. C., Darmochwal-Kolarz, D. A., Davies, R. E., Davies, M. W., Dawson, J. S., Dobson, N., Dodd, C. N., Donald, F., Duley, L., Epstein-Mares, J., Erez, O., Evans, E., Farlie, R. N., Ferris, A. V., Frankland, E. M., Freeman, D. J., Gainder, S., Ganzevoort, W., Gbinigie, O. A., Gerval, M. -O., Ghosh, S. K., Gingel, L. J., Glogowska, M., Goodlife, A., Gough, K. L., Green, J. R., Gul, F., Haggerty, L., Hall, D. R., Hallman, M., Hamilton, L. M., Hammond, S. J., Harlow, S. D., Hays, K. E., Hickey, S. C., Higgins, M., Hinton, L., Hobson, S. R., Hogg, M. J., Hollands, H. J., Homer, C. S. E., Hoodbhoy, Z., Howell, P., Huppertz, B., Husain, S., Jacoby, S. D., Jacqz-Aigrain, E., Jenkins, G., Jewel, D., Johnson, M. J., Johnston, C. L., Jones, P. M., Kantrowitz-Gordon, I., Khan, R. -U., Kirby, L. J., Kirk, C., Knight, M., Korey, M. T., Lee, G. J., Lee, V. W., Levene, L. S., Londero, A. P., Lust, K. M., Mackenzie, V., Malha, L., Mattone, M., Mccartney, D. E., Mcfadden, A., Mckinstry, B. H., Middleton, P. F., Mills, D. J., Mistry, H. D., Mitchell, C. A., Mockler, J. C., Molsher, S. -A., Monast, E. S., Moodley, J., Mooij, R., Moore, E. L., Morgan, L., Moulson, A., Mughal, F., Mundle, S. R., Munoz, M. A., Murray, E., Nagata, C., Nair, A. S., Nakimuli, A., Nath, G., Newport, R. S., Oakeshott, P., Ochoa-Ferraro, M. R., Odendaal, H., Ohkuchi, A., Oliveira, L., Ortiz-Panozo, E., Oudijk, M. A., Oygucu, S. E., Paech, M. J., Painter, R. C., Parry, C. L., Payne, B. A., Pearson, E. L., Phupong, V., Pickett, N., Pickles, K. A., Plumb, L. K., Prefumo, F., Preston, R., Ray, J. G., Rayment, J., Regan, L. V., Rey, E., Robson, E. J., Rubin, A. N., Rubio-Romero, J. A., Rull, K., Sass, N., Sauve, N., Savory, N. A., Scott, J. R., Seaton, S. E., Seed, P. T., Shakespeare, J. M., Shand, A. W., Sharma, S., Shaw, T. Y., Smedley, K. L., Smith, D., Smith Conk, A., Soward, D., Stepan, H., Stroumpoulis, K., Surendran, A., Takeda, S., Tan, L., Theriot, B. S., Thomas, H. F., Thompson, K., Thompson, P. I., Thompson, M. J., Toms, L., Torney, K. L. H. T., Treadwell, J. S., Tucker, K. L., Turrentine, M. A., Van Hecke, O., Van Oostwaard, M. F., Vasquez, D. N., Vaughan, D. J. A., Vinturache, A., Walker, J., Wardle, S. P., Wasim, T., Waters, J. H., Whitehead, C. L., Wolfson, A., Yeo, S., Zermansky, A. G., (iHOPE), International Collaboration to Harmonise Outcomes for Pre-eclampsia, Life Course Epidemiology (LCE), University of Oxford, University College London, King’s College London, Academic Medical Center, Imperial College London, St George Hospital and University of New South Wales, Northwestern University, Cedars-Sinai Medical Center, London North West University Healthcare NHS Trust, Monash University, University of Adelaide, Barts and The London School of Medicine and Dentistry, University of Sheffield, University of Liverpool, Centro Rosarino de Estudios Perinatales, Chelsea and Westminster Hospital NHS Foundation Trust, Babcock University, Ailem Academic Counselling, KU Leuven, Universidad Nacional de Colombia, Northwell Health, Université de Montréal, University of Montreal Hospital Centre, Ondokuz Mayıs University, Prince Sultan Military Medical City, Postgraduate Institute of Medical Education and Research, Fetal Medicine Research Institute, University Hospital Limerick, Drexel University, University of Aberdeen, University of Groningen, University of Auckland, Haaglanden Medisch Centrum, Nottingham University Medical School, Utrecht University, King Edward Memorial Hospital for Women, Imperial College Healthcare NHS Trust, Jean-Verdier Hospital, Downland Practice, Universidade Estadual de Campinas (UNICAMP), Université Lyon, University of North Carolina School of Medicine, South Ural State Medical University, Stellenbosch University, Irish Neonatal Health Alliance, University of Rzeszow, Royal Brisbane and Women’s Hospital, Nottingham University Hospitals NHS Trust, University Hospitals of Leicester, North Bristol NHS Trust, University of Nottingham, Soroka University Medical Center Ben Gurion University of the Negev, St George’s University Hospitals NHS Foundation Trust, Hospitalsenhed Midt, University of Glasgow, Amsterdam Universitair Medische Centra, All India Institute of Medical Sciences Patna, Luton and Dunstable University Hospital, Khyber Medical University Institution of Medical Sciences, Midwife Mid Essex Hospitals NHS Trust, University of Oulu, University of Michigan, Bastyr University, Irish Nurses and Midwives Organisation, University of Toronto, Barts Health NHS Trust, University Hospitals Plymouth NHS Trust, Burnet Institute, Aga Khan University, Medical University of Graz, Homerton University Hospital NHS Foundation Trust, Mount Royal University, Université de Paris, Royal Surrey County Hospital, University Hospital Southampton NHS Foundation Trust, University of Washington School of Nursing, Evelina London Children's Hospital Neonatal Unit, University of Sydney, University of Leicester, Academic Hospital of Udine, NHS Borders, Weill Cornell Medical College, University of Dundee, University of Edinburgh, South Australian Health and Medical Research Institute, Monash University and Monash Health, United Lincolnshire Hospitals NHS Trust, University of Kwa Zulu-Natal, Beatrix Hospital, Keele University, Government Medical College, Institut Catala de la Salut. IdiapJgol, National Center for Child Health and Development, Basavatarakam Indo-American Cancer Hospital and Research Institute, Axon Anaesthesia Associates, Pennine Acute Hospitals NHS Trust, University of London, Norfolk and Norwich University Hospital, Jichi Medical University School of Medicine, Universidade Estadual Paulista (UNESP), National Institute of Public Health, University of Kyrenia, King Edward Memorial Hospital, Amsterdam University Centres, University of British Columbia, Chulalongkorn University, University of Brescia, University Of British Columbia, University of Montreal, Women's Clinic of Tartu University Hospital, Universidade Federal de São Paulo (UNIFESP), Université de Sherbrooke, University Hospital of Wales, University of Iowa, King's College London, Westmead Hospital, Princess Royal Maternity, Leipzig University, Centre Hospitalier Public du Cotentin, Lewisham and Greenwich NHS Trust, Juntendo University Faculty of Medicine, Western Sydney University, National Institute of Health Research, University of Washington, Baylor College of Medicine, Capelle aan den Ijssel, Sanatorio Anchorena, Oxford University Hospitals NHS Foundation Trust, University of Leeds, Institute of Medical Sciences, UPMC Magee Womens Hospital, Penn Medicine Princeton Health, University of North Carolina at Chapel Hill, and Obstetrics and Gynaecology

Subjects
Adult, medicine.medical_specialty, Consensus, Delphi Technique, Standardization, Birth weight, Psychological intervention, Randomised controlled trials, 030204 cardiovascular system & hematology, Outcome (game theory), 03 medical and health sciences, Hypertension in pregnancy, Outcome measure, 0302 clinical medicine, Pre-Eclampsia, Pregnancy, Consensus development study, Internal Medicine, medicine, Humans, Set (psychology), 030219 obstetrics & reproductive medicine, Eclampsia, business.industry, Pregnancy Outcome, Obstetrics and Gynecology, Core outcome set, Reference Standards, medicine.disease, Pre-eclampsia, Pregnancy Complications, Core (game theory), Treatment Outcome, Systematic review, Family medicine, 1114 Paediatrics and Reproductive Medicine, Female, International Collaboration to Harmonise Outcomes for Pre-eclampsia (iHOPE), business
Abstract

Made available in DSpace on 2022-04-28T19:29:02Z (GMT). No. of bitstreams: 0 Previous issue date: 2020-07-01 Medical Research Council Canada National Institute for Health Research Objectives: To develop consensus definitions for the core outcome set for pre-eclampsia. Study design: Potential definitions for individual core outcomes were identified across four formal definition development initiatives, nine national and international guidelines, 12 Cochrane systematic reviews, and 79 randomised trials. Eighty-six definitions were entered into the consensus development meeting. Ten healthcare professionals and three researchers, including six participants who had experience of conducting research in low- and middle-income countries, participated in the consensus development process. The final core outcome set was approved by an international steering group. Results: Consensus definitions were developed for all core outcomes. When considering stroke, pulmonary oedema, acute kidney injury, raised liver enzymes, low platelets, birth weight, and neonatal seizures, consensus definitions were developed specifically for low- and middle-income countries because of the limited availability of diagnostic interventions including computerised tomography, chest x-ray, laboratory tests, equipment, and electroencephalogram monitoring. Conclusions: Consensus on measurements for the pre-eclampsia core outcome set will help to ensure consistency across future randomised trials and systematic reviews. Such standardization should make research evidence more accessible and facilitate the translation of research into clinical practice. Video abstract can be available at: www.dropbox.com/s/ftrgvrfu0u9glqd/6.%20Standardising%20definitions%20in%20teh%20pre-eclampsia%20core%20outcome%20set%3A%20a%20consensus%20development%20study.mp4?dl=0. Nuffield Department of Primary Care Health Sciences University of Oxford Institute for Women’s Health University College London Department of Women and Children’s Health School of Life Course Sciences King’s College London Department of Obstetrics and Gynecology Amsterdam UMC Academic Medical Center Academic Neonatal Medicine Imperial College London Department of Renal Medicine St George Hospital and University of New South Wales Department of Obstetrics and Gynaecology Feinberg School of Medicine Northwestern University Health Services Research Unit Nuffield Department of Population Health University of Oxford Cedars-Sinai Medical Center London North West University Healthcare NHS Trust Women’s Health Care Research Group Department of Obstetrics and Gynaecology Monash University Department of Obstetrics and Gynaecology University of Adelaide Women’s Health Research Unit Barts and The London School of Medicine and Dentistry School of Health and Related Research University of Sheffield MRC North West Hub for Trials Methodology Research Department of Biostatistics University of Liverpool Centro Rosarino de Estudios Perinatales Chelsea and Westminster Hospital NHS Foundation Trust Babcock University Ailem Academic Counselling KU Leuven Universidad Nacional de Colombia Northwell Health University of Oxford Université de Montréal University of Montreal Hospital Centre Ondokuz Mayıs University Prince Sultan Military Medical City Postgraduate Institute of Medical Education and Research King's Fertility Fetal Medicine Research Institute University Hospital Limerick Drexel University University of Aberdeen University of Groningen University of Auckland Haaglanden Medisch Centrum Nottingham University Medical School Utrecht University King Edward Memorial Hospital for Women Imperial College Healthcare NHS Trust Jean-Verdier Hospital Downland Practice University of Campinas Université Lyon University of North Carolina School of Medicine South Ural State Medical University Stellenbosch University Irish Neonatal Health Alliance University of Rzeszow Royal Brisbane and Women’s Hospital Nottingham University Hospitals NHS Trust University Hospitals of Leicester North Bristol NHS Trust University of Nottingham Soroka University Medical Center Ben Gurion University of the Negev St George’s University Hospitals NHS Foundation Trust Hospitalsenhed Midt University of Glasgow Amsterdam Universitair Medische Centra All India Institute of Medical Sciences Patna Luton and Dunstable University Hospital Khyber Medical University Institution of Medical Sciences Midwife Mid Essex Hospitals NHS Trust University of Oulu University of Michigan Bastyr University Irish Nurses and Midwives Organisation University of Toronto Barts Health NHS Trust University Hospitals Plymouth NHS Trust Burnet Institute Aga Khan University Medical University of Graz Homerton University Hospital NHS Foundation Trust Mount Royal University Université de Paris Royal Surrey County Hospital University Hospital Southampton NHS Foundation Trust University of Washington School of Nursing Evelina London Children's Hospital Neonatal Unit University of Sydney University of Leicester Academic Hospital of Udine NHS Borders Weill Cornell Medical College University of Dundee University of Edinburgh South Australian Health and Medical Research Institute University of Sheffield Monash University and Monash Health United Lincolnshire Hospitals NHS Trust University of Kwa Zulu-Natal Beatrix Hospital Keele University Government Medical College Institut Catala de la Salut. IdiapJgol University College London National Center for Child Health and Development Basavatarakam Indo-American Cancer Hospital and Research Institute Axon Anaesthesia Associates Pennine Acute Hospitals NHS Trust St George's University of London Norfolk and Norwich University Hospital Jichi Medical University School of Medicine São Paulo State University National Institute of Public Health University of Kyrenia King Edward Memorial Hospital Amsterdam University Centres University of British Columbia Chulalongkorn University University of Brescia University Of British Columbia University of Montreal Women's Clinic of Tartu University Hospital Universidade Federal de São Paulo Université de Sherbrooke University Hospital of Wales University of Iowa King's College London Westmead Hospital Princess Royal Maternity Leipzig University Centre Hospitalier Public du Cotentin Lewisham and Greenwich NHS Trust Juntendo University Faculty of Medicine Western Sydney University National Institute of Health Research University of Washington Baylor College of Medicine Capelle aan den Ijssel Sanatorio Anchorena Oxford University Hospitals NHS Foundation Trust University of Leeds Institute of Medical Sciences UPMC Magee Womens Hospital Penn Medicine Princeton Health University of North Carolina at Chapel Hill São Paulo State University

Published
2020

2. A core outcome set for pre-eclampsia research: an international consensus development study

Author

Duffy, J. M. N., Cairns, A. E., Richards-Doran, D., van 't Hooft, J., Gale, C., Brown, M., Chappell, L. C., Grobman, W. A., Fitzpatrick, R., Karumanchi, S. A., Khalil, A., Lucas, D. N., Magee, L. A., Mol, B. W., Stark, M., Thangaratinam, S., Wilson, M. J., von Dadelszen, P., Williamson, P. R., Ziebland, S., Mcmanus, R. J., Abalos, E. J., C. C. D., Da, Akadr, A. A., Akturk, Z., Allegaert, K., Angel-Muller, E., Antretter, J., Ashdown, H. F., Audibert, F., Auger, N., Aygun, C., Babic, I., Bagga, R., Baker, J. M., Bhakta, P., Bhandari, V., Bhattacharya, S., Blanker, M. H., Bloomfield, F. H., Bof, A., Brennan, S. M., Broekhuijsen, K., Pipkin, E. F. B., Browne, J. L., Browning, R. M., Bull, J. W., Butt, A., Button, D., Campbell, J. P., Campbell, D. M., Carbillon, L., Carthy, S., Casely, E., Cave, J. A., Cecatti, J. G., Chamillard, M. E., Chassard, D., Checheir, N. C., Chulkov, V. S., Cluver, C. A., Crawford, C. F., Daly, M. C., Darmochwal-Kolarz, D. A., Davies, R. E., Davies, M. W., Dawson, J. S., Dobson, N., Dodd, C. N., Donald, F., Duley, L., Epstein-Mares, J., Erez, O., Evans, E., Farlie, R. N., Ferris, A. V., Frankland, E. M., Freeman, D. J., Gainder, S., Ganzevoort, W., Gbinigie, O. A., Ghosh, S. K., Glogowska, M., Goodlife, A., Gough, K. L., Green, J. R., Gul, F., Haggerty, L., Hall, D. R., Hallman, M., Hamilton, L. M., Hammond, S. J., Harlow, S. D., Hays, K. E., Hickey, S. C., Higgins, M., Hinton, L., Hobson, S. R., Hogg, M. J., Hollands, H. J., C. S. E., Eh, Hoodbhoy, Z., Howell, P., Huppertz, B., Husain, S., Jacoby, S. D., Jacqz-Aigrain, E., Jenkins, G., Jewel, D., Johnson, M. J., Johnston, C. L., Jones, P. M., Kantrowitz-Gordon, I., Khan, R. -U., Kirby, L. J., Kirk, C., Knight, M., Korey, M. T., Lee, G. J., Lee, V. W., Levene, L. S., Londero, A. P., Lust, K. M., Mackenzie, V., Malha, L., Mattone, M., Mccartney, D. E., Mcfadden, A., Mckinstry, B. H., Middleton, P. F., Mistry, H. D., Mitchell, C. A., Mockler, J. C., Molsher, S. -A., Monast, E. S., Moodley, E. J., Mooij, R., Moore, E. L., Morgan, L., Moulson, A., Mughal, F., Mundle, S. R., Munoz, M. A., Murray, E., Nagata, C., Nair, A. S., Nakimuli, A., Nath, G., Newport, R. S., Oakeshott, P., Ochoa-Ferraro, M. R., Odendaal, H., Ohkuchi, A., Oliveira, L., Ortiz-Panozo, E., Oudijk, M. A., Oygucu, S. E., Paech, M. J., Painter, R. C., Parry, C. L., Payne, B. A., Pearson, E. L., Phupong, V., Pickett, N., Pickles, K. A., Plumb, L. K., Prefumo, F., Preston, R., Ray, J. G., Rayment, J., Regan, L. V., Rey, E., Robson, E. J., Rubin, A. N., Rubio-Romero, A. N., Rull, K., Sass, N., Sauve, N., Savory, N. A., Scott, J. R., Seaton, S. E., Seed, P. T., Shakespeare, J. M., Shand, A. W., Sharma, S., Shaw, T. Y., Smedley, K. L., Smith, D., Conk, A. S., Soward, D., Stepan, H., Stroumpoulis, K., Surendr, A., Takeda, S., Tan, L., Theriot, B. S., Thomas, H. F., Thompson, K., Thompson, P. I., Thompson, M. J., Toms, L., Torney, K. L. H. T., Treadwell, J. S., Tucker, K. L., Turrentine, M. A., Van Hecke, O., Van Oostwaard, M. F., Vasquez, D. N., D. J. A., Av, Vinturache, A., Walker, J., Wardle, S. P., Wasim, T., Waters, J. H., Whitehead, C. L., Wolfson, A., Yeo, S., Obstetrics and Gynaecology, Life Course Epidemiology (LCE), University of Oxford, University College London, Academic Medical Centre, Imperial College London, St George Hospital and University of New South Wales, King's College London, Northwestern University, Cedars-Sinai Medical Center, St George's University of London, London North West University Healthcare NHS Trust, Monash University, University of Adelaide, Barts and the London School of Medicine and Dentistry, University of Sheffield, University of Liverpool, Centro Rosarino de Estudios Perinatales, Chelsea and Westminster Hospital NHS Foundation Trust, Babcock University, Ailem Academic Counselling, KU Leuven, Universidad Nacional de Colombia, Northwell Health, Université de Montréal, University of Montreal Hospital Centre, Ondokuz Mayis University, Prince Sultan Military Medical City, Chandigarh, University Hospital Limerick, Drexel University, University of Aberdeen, University of Groningen, University of Auckland, Haaglanden Medisch Centrum, Nottingham University Medical School, Utrecht University, King Edward Memorial Hospital for Women, Imperial College Healthcare NHS Trust, Jean-Verdier Hospital, Downland Practice, Universidade Estadual de Campinas (UNICAMP), Université Lyon, University of North Carolina School of Medicine, South Ural State Medical University, Stellenbosch University, Irish Neonatal Health Alliance, University of Rzeszow, Royal Brisbane and Women's Hospital, Nottingham University Hospitals NHS Trust, University Hospitals of Leicester, North Bristol NHS Trust, University of Nottingham, Soroka University Medical Centre Ben Gurion University of the Negev, St George's University Hospitals NHS Foundation Trust, Hospitalsenhed Midt, University of Glasgow, Postgraduate Institute of Medical Education and Research, Amsterdam Universitair Medische Centra, All India Institute of Medical Sciences Patna, Luton and Dunstable University Hospital, Khyber Medical University Institution of Medical Sciences, Midwife Mid Essex Hospitals NHS Trust, University of Oulu, University of Michigan, Bastyr University, Irish Nurses and Midwives Organisation, University of Toronto, Barts Health NHS Trust, University Hospitals Plymouth NHS Trust, Burnet Institute, Aga Khan University, Medical University of Graz, Homerton University Hospital NHS Foundation Trust, Mount Royal University, Université de Paris, Royal Surrey County Hospital, University Hospital Southampton NHS Foundation Trust, University of Washington School of Nursing, Evelina London Children's Hospital Neonatal Unit, University of Sydney, University of Leicester, Academic Hospital of Udine, NHS Borders, Weill Cornell Medical College, University of Dundee, University of Edinburgh, South Australian Health and Medical Research Institute, Monash University and Monash Health, United Lincolnshire Hospitals NHS Trust, University of Kwa Zulu-Natal, Beatrix Hospital, Keele University, Nagpur, Institut Catala de la Salut. IdiapJgol, National Centre for Child Health and Development, Basavatarakam Indo-American Cancer Hospital and Research Institute, Axon Anaesthesia Associates, Pennine Acute Hospitals NHS Trust, University of London, Norfolk and Norwich University Hospital, Jichi Medical University School of Medicine, Universidade Estadual Paulista (UNESP), National Institute of Public Health, University of Kyrenia, King Edward Memorial Hospital, Amsterdam University Centres, University of British Columbia, Chulalongkorn University, University of Brescia, University of Montreal, Women's Clinic of Tartu University Hospital, Universidade Federal de São Paulo (UNIFESP), Université de Sherbrooke, University Hospital of Wales, University of Iowa, Westmead Hospital, Princess Royal Maternity, Leipzig University, Centre Hospitalier Public du Cotentin, Lewisham and Greenwich NHS Trust, Juntendo University Faculty of Medicine, Western Sydney University, National Institute of Health Research, University of Washington, Baylor College of Medicine, Capelle aan den Ijssel, Sanatorio Anchorena, Oxford University Hospitals NHS Foundation Trust, University of Leeds, Lahore, UPMC Magee Womens Hospital, and Penn Medicine Princeton Health

Subjects
PROTOCOL, medicine.medical_specialty, pre-eclampsia, Biomedical Research, Consensus development study, core outcome set, modified Delphi method, modified nominal group technique, outcome reporting bias, Female, Humans, International Cooperation, Pre-Eclampsia, Pregnancy, Pregnancy Outcome, Population, GUIDELINES, RECOMMENDATIONS, Obstetrics and gynaecology, Intensive care, Nominal group technique, medicine, Obstetrics & Reproductive Medicine, Intensive care medicine, education, 11 Medical and Health Sciences, reproductive and urinary physiology, education.field_of_study, Science & Technology, Eclampsia, business.industry, Obstetrics & Gynecology, Obstetrics and Gynecology, Gestational age, medicine.disease, TRIALS, Systematic review, International Collaboration to Harmonise Outcomes for Pre-eclampsia (iHOPE), Thematic analysis, business, Life Sciences & Biomedicine
Abstract

Made available in DSpace on 2022-04-28T19:28:54Z (GMT). No. of bitstreams: 0 Previous issue date: 2020-11-01 National Institute for Health Research Barts Charity Objective: To develop a core outcome set for pre-eclampsia. Design: Consensus development study. Setting: International. Population: Two hundred and eight-one healthcare professionals, 41 researchers and 110 patients, representing 56 countries, participated. Methods: Modified Delphi method and Modified Nominal Group Technique. Results: A long-list of 116 potential core outcomes was developed by combining the outcomes reported in 79 pre-eclampsia trials with those derived from thematic analysis of 30 in-depth interviews of women with lived experience of pre-eclampsia. Forty-seven consensus outcomes were identified from the Delphi process following which 14 maternal and eight offspring core outcomes were agreed at the consensus development meeting. Maternal core outcomes: death, eclampsia, stroke, cortical blindness, retinal detachment, pulmonary oedema, acute kidney injury, liver haematoma or rupture, abruption, postpartum haemorrhage, raised liver enzymes, low platelets, admission to intensive care required, and intubation and ventilation. Offspring core outcomes: stillbirth, gestational age at delivery, birthweight, small-for-gestational-age, neonatal mortality, seizures, admission to neonatal unit required and respiratory support. Conclusions: The core outcome set for pre-eclampsia should underpin future randomised trials and systematic reviews. Such implementation should ensure that future research holds the necessary reach and relevance to inform clinical practice, enhance women's care and improve the outcomes of pregnant women and their babies. Tweetable abstract: 281 healthcare professionals, 41 researchers and 110 women have developed #preeclampsia core outcomes @HOPEoutcomes @jamesmnduffy. [Correction added on 29 June 2020, after first online publication: the order has been corrected.]. Nuffield Department of Primary Care Health Sciences University of Oxford Institute for Women's Health University College London Department of Obstetrics and Gynaecology Amsterdam UMC Academic Medical Centre Academic Neonatal Medicine Imperial College London Department of Renal Medicine St George Hospital and University of New South Wales Department of Women and Children's Health School of Life Course Sciences King's College London Department of Obstetrics and Gynecology Feinberg School of Medicine Northwestern University Health Services Research Unit Nuffield Department of Population Health University of Oxford Cedars-Sinai Medical Center Vascular Biology Research Centre Molecular and Clinical Sciences Research Institute St George's University of London London North West University Healthcare NHS Trust Department of Obstetrics and Gynaecology Monash University Department of Obstetrics and Gynaecology University of Adelaide Women's Health Research Unit Barts and the London School of Medicine and Dentistry School of Health and Related Research University of Sheffield MRC North West Hub for Trials Methodology Research Department of Biostatistics University of Liverpool Centro Rosarino de Estudios Perinatales Chelsea and Westminster Hospital NHS Foundation Trust Babcock University Ailem Academic Counselling KU Leuven Universidad Nacional de Colombia Northwell Health University of Oxford Université de Montréal University of Montreal Hospital Centre Ondokuz Mayis University Prince Sultan Military Medical City Postgraduate Institute of Medical Education and Research Chandigarh University Hospital Limerick Drexel University University of Aberdeen University of Groningen University of Auckland Haaglanden Medisch Centrum Nottingham University Medical School Utrecht University King Edward Memorial Hospital for Women Imperial College Healthcare NHS Trust Jean-Verdier Hospital Downland Practice University of Campinas Université Lyon University of North Carolina School of Medicine South Ural State Medical University Stellenbosch University Irish Neonatal Health Alliance University of Rzeszow Royal Brisbane and Women's Hospital Nottingham University Hospitals NHS Trust University Hospitals of Leicester North Bristol NHS Trust University of Nottingham Soroka University Medical Centre Ben Gurion University of the Negev St George's University Hospitals NHS Foundation Trust Hospitalsenhed Midt University of Glasgow Postgraduate Institute of Medical Education and Research Amsterdam Universitair Medische Centra All India Institute of Medical Sciences Patna Luton and Dunstable University Hospital Khyber Medical University Institution of Medical Sciences Midwife Mid Essex Hospitals NHS Trust University of Oulu University of Michigan Bastyr University Irish Nurses and Midwives Organisation University of Toronto Barts Health NHS Trust University Hospitals Plymouth NHS Trust Burnet Institute Aga Khan University Medical University of Graz Homerton University Hospital NHS Foundation Trust Mount Royal University Université de Paris Royal Surrey County Hospital University Hospital Southampton NHS Foundation Trust University of Washington School of Nursing Evelina London Children's Hospital Neonatal Unit University of Sydney University of Leicester Academic Hospital of Udine NHS Borders Weill Cornell Medical College University of Dundee University of Edinburgh South Australian Health and Medical Research Institute University of Sheffield Monash University and Monash Health United Lincolnshire Hospitals NHS Trust University of Kwa Zulu-Natal Beatrix Hospital Keele University Government Medical College Nagpur Institut Catala de la Salut. IdiapJgol University College London National Centre for Child Health and Development Basavatarakam Indo-American Cancer Hospital and Research Institute Axon Anaesthesia Associates Pennine Acute Hospitals NHS Trust St George's University of London Norfolk and Norwich University Hospital Jichi Medical University School of Medicine São Paulo State University National Institute of Public Health University of Kyrenia King Edward Memorial Hospital Amsterdam University Centres University of British Columbia Chulalongkorn University University of Brescia University of Montreal Women's Clinic of Tartu University Hospital Universidade Federal de São Paulo Université de Sherbrooke University Hospital of Wales University of Iowa King's College London Westmead Hospital Princess Royal Maternity Leipzig University Centre Hospitalier Public du Cotentin Lewisham and Greenwich NHS Trust Juntendo University Faculty of Medicine Western Sydney University National Institute of Health Research University of Washington Baylor College of Medicine Capelle aan den Ijssel Sanatorio Anchorena Oxford University Hospitals NHS Foundation Trust University of Leeds Institute of Medical Sciences Lahore UPMC Magee Womens Hospital Penn Medicine Princeton Health University of North Carolina at Chapel Hill USA and Dr Arnold G. Zermansky University of Leeds São Paulo State University

Published
2020

3. Predicting Outcomes in Men With Metastatic Nonseminomatous Germ Cell Tumors (NSGCT): Results From the IGCCCG Update Consortium

Author

Christopher Sweeney, Eric Winquist, Darren R. Feldman, Ugo De Giorgi, Daniel Y.C. Heng, Silke Gillessen, Michal Chovanec, Jourik A. Gietema, Robert Huddart, Costantine Albany, Fay H. Cafferty, Peter Grimison, Aaron R. Hansen, Carsten Bokemeyer, Karim Fizazi, Jörg Beyer, Christian D. Fankhauser, Nicolas Sauvé, Alexey Tryakin, Torgrim Tandstad, Olof Ståhl, Helene F. S. Negaard, Ronald de Wit, Anja Lorch, Andrea Necchi, David J. Vaughn, Angelika Terbuch, Axel Heidenreich, Cora N. Sternberg, Marcus Hentrich, Xavier Garcia-del-Muro, Gedske Daugaard, Laurence Collette, Jonathan Shamash, Gillessen, S., Sauve, N., Collette, L., Daugaard, G., de Wit, R., Albany, C., Tryakin, A., Fizazi, K., Stahl, O., Gietema, J. A., de Giorgi, U., Cafferty, F. H., Hansen, A. R., Tandstad, T., Huddart, R. A., Necchi, A., Sweeney, C. J., Garcia-Del-Muro, X., Heng, D. Y. C., Lorch, A., Chovanec, M., Winquist, E., Grimison, P., Feldman, D. R., Terbuch, A., Hentrich, M., Bokemeyer, C., Negaard, H., Fankhauser, C., Shamash, J., Vaughn, D. J., Sternberg, C. N., Heidenreich, A., Beyer, J., Guided Treatment in Optimal Selected Cancer Patients (GUTS), and Damage and Repair in Cancer Development and Cancer Treatment (DARE)

Subjects
Male, 0301 basic medicine, Oncology, Cancer Research, Lung Neoplasms, International Cooperation, medicine.medical_treatment, Metastasis, chemistry.chemical_compound, PROGNOSTIC-FACTORS, 0302 clinical medicine, Antineoplastic Combined Chemotherapy Protocols, Young adult, Etoposide, Age Factors, BLEOMYCIN, Middle Aged, Neoplasms, Germ Cell and Embryonal, Prognosis, Cèl·lules germinals, ETOPOSIDE, 030220 oncology & carcinogenesis, SURVIVAL, TRIAL, medicine.drug, Adult, medicine.medical_specialty, Adolescent, 610 Medicine & health, Bleomycin, CLASSIFICATION, TESTICULAR CANCER, CISPLATIN, Young Adult, 03 medical and health sciences, Testicular Neoplasms, Metàstasi, Internal medicine, Germ cells, medicine, Humans, Testicular cancer, Aged, Tumors, BEP, Cisplatin, Chemotherapy, Errata, business.industry, medicine.disease, Clinical trial, 030104 developmental biology, MARKER DECLINE, chemistry, Germ cell tumors, 610 Medizin und Gesundheit, business
Abstract

PURPOSE The classification of the International Germ Cell Cancer Collaborative Group (IGCCCG) plays a pivotal role in the management of metastatic germ cell tumors but relies on data of patients treated between 1975 and 1990. MATERIALS AND METHODS Data on 9,728 men with metastatic nonseminomatous germ cell tumors treated with cisplatin- and etoposide-based first-line chemotherapy between 1990 and 2013 were collected from 30 institutions or collaborative groups in Europe, North America, and Australia. Clinical trial and registry data were included. Primary end points were progression-free survival (PFS) and overall survival (OS). The survival estimates were updated for the current era. Additionally, a novel prognostic model for PFS was developed in 3,542 patients with complete information on potentially relevant variables. The results were validated in an independent data set. RESULTS Compared with the original IGCCCG publication, 5-year PFS remained similar in patients with good prognosis with 89% (87%-91%) versus 90% (95% CI, 89 to 91), but the 5-year OS increased from 92% (90%-94%) to 96% (95%-96%). In patients with intermediate prognosis, PFS remained similar with 75% (71%-79%) versus 78% (76%-80%) and the OS increased from 80% (76%-84%) to 89% (88%-91%). In patients with poor prognosis, the PFS increased from 41% (95% CI, 35 to 47) to 54% (95% CI, 52 to 56) and the OS from 48% (95% CI, 42 to 54) to 67% (95% CI, 65 to 69). A more granular prognostic model was developed and independently validated. This model identified a new cutoff of lactate dehydrogenase at a 2.5 upper limit of normal and increasing age and presence of lung metastases as additional adverse prognostic factors. An online calculator is provided ( https://www.eortc.org/IGCCCG-Update ). CONCLUSION The IGCCCG Update model improves individual prognostication in metastatic nonseminomatous germ cell tumors. Increasing age and lung metastases add granularity to the original IGCCCG classification as adverse prognostic factors.

Published
2021

4. Survival and New Prognosticators in Metastatic Seminoma: Results From the IGCCCG-Update Consortium

Author

Eric Winquist, Darren R. Feldman, Ignacio Duran, Andrea Necchi, Silke Gillessen, Alexey Tryakin, David J. Vaughn, Angelika Terbuch, Axel Heidenreich, Christopher Sweeney, Enrique Gonzalez-Billalabeitia, Anna Patrikidou, Aaron R. Hansen, Daniel Y.C. Heng, Jonathan Shamash, Costantine Albany, Peter Grimison, Robert Huddart, Anja Lorch, Carsten Bokemeyer, Torgrim Tandstad, Cora N. Sternberg, Ugo De Giorgi, Marko Bebek, Jörg Beyer, Gedske Daugaard, Nicolas Sauvé, Richard Cathomas, Ronald de Wit, Laurence Collette, Christian D. Fankhauser, Helene F. S. Negaard, Olof Ståhl, Stéphane Culine, Ben Tran, Michal Chovanec, Samson Assele, Marcus Hentrich, Fay H. Cafferty, Dan Stark, Jourik A. Gietema, Guided Treatment in Optimal Selected Cancer Patients (GUTS), Damage and Repair in Cancer Development and Cancer Treatment (DARE), Beyer, J., Collette, L., Sauve, N., Daugaard, G., Feldman, D. R., Tandstad, T., Tryakin, A., Stahl, O., Gonzalez-Billalabeitia, E., de Giorgi, U., Culine, S., de Wit, R., Hansen, A. R., Bebek, M., Terbuch, A., Albany, C., Hentrich, M., Gietema, J. A., Negaard, H., Huddart, R. A., Lorch, A., Cafferty, F. H., Heng, D. Y. C., Sweeney, C. J., Winquist, E., Chovanec, M., Fankhauser, C., Stark, D., Grimison, P., Necchi, A., Tran, B., Heidenreich, A., Shamash, J., Sternberg, C. N., Vaughn, D. J., Duran, I., Bokemeyer, C., Patrikidou, A., Cathomas, R., Assele, S., and Gillessen, S.

Subjects
Male, 0301 basic medicine, Oncology, Cancer Research, medicine.medical_specialty, International Cooperation, medicine.medical_treatment, MEDLINE, 03 medical and health sciences, Collaborative group, CISPLATIN, 0302 clinical medicine, GERM-CELL CANCER, Testicular Neoplasms, Internal medicine, Antineoplastic Combined Chemotherapy Protocols, medicine, Humans, Neoplasm Metastasis, 610 Medicine & health, Cisplatin, Chemotherapy, L-Lactate Dehydrogenase, business.industry, Cancer, CHEMOTHERAPY, Prognosis, medicine.disease, Seminoma, 030104 developmental biology, Germ cell cancer, Multicenter study, 030220 oncology & carcinogenesis, Metastatic seminoma, business, medicine.drug
Abstract

PURPOSE The classification of the International Germ-Cell Cancer Collaborative Group (IGCCCG) has been a major advance in the management of germ-cell tumors, but relies on data of only 660 patients with seminoma treated between 1975 and 1990. We re-evaluated this classification in a database from a large international consortium. MATERIALS AND METHODS Data on 2,451 men with metastatic seminoma treated with cisplatin- and etoposide-based first-line chemotherapy between 1990 and 2013 were collected from 30 institutions or collaborative groups in Australia, Europe, and North America. Clinical trial and registry data were included. Primary end points were progression-free survival (PFS) and overall survival (OS) calculated from day 1 of treatment. Variables at initial presentation were evaluated for their prognostic impact. Results were validated in an independent validation set of 764 additional patients. RESULTS Compared with the initial IGCCCG classification, in our modern series, 5-year PFS improved from 82% to 89% (95% CI, 87 to 90) and 5-year OS from 86% to 95% (95% CI, 94 to 96) in good prognosis, and from 67% to 79% (95% CI, 70 to 85) and 72% to 88% (95% CI, 80 to 93) in intermediate prognosis patients. Lactate dehydrogenase (LDH) proved to be an additional adverse prognostic factor. Good prognosis patients with LDH above 2.5× upper limit of normal had a 3-year PFS of 80% (95% CI, 75 to 84) and a 3-year OS of 92% (95% CI, 88 to 95) versus 92% (95% CI, 90 to 94) and 97% (95% CI, 96 to 98) in the group with lower LDH. CONCLUSION PFS and OS in metastatic seminoma significantly improved in our modern series compared with the original data. The original IGCCCG classification retains its relevance, but can be further refined by adding LDH at a cutoff of 2.5× upper limit of normal as an additional adverse prognostic factor.

Published
2021

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