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Development of standard definitions and grading for Maternal and Fetal Adverse Event Terminology

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Development of standard definitions and grading for Maternal and Fetal Adverse Event Terminology. / Spencer, Rebecca N; Hecher, Kurt; Norman, Gill; Marsal, Karel; Deprest, Jan; Flake, Alan; Figueras, Francesc; Lees, Christoph; Thornton, Steve; Beach, Kathleen; Powell, Marcy; Crispi, Fatima; Diemert, Anke; Marlow, Neil; Peebles, Donald M; Westgren, Magnus; Gardiner, Helena; Gratacos, Eduard; Brodszki, Jana; Batista, Albert; Turier, Helen; Patel, Mehali; Power, Beverley; Power, James; Yaz, Gillian; David, Anna L.

in: PRENATAL DIAG, Jahrgang 42, Nr. 1, 01.2022, S. 15-26.

Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung

Harvard

Spencer, RN, Hecher, K, Norman, G, Marsal, K, Deprest, J, Flake, A, Figueras, F, Lees, C, Thornton, S, Beach, K, Powell, M, Crispi, F, Diemert, A, Marlow, N, Peebles, DM, Westgren, M, Gardiner, H, Gratacos, E, Brodszki, J, Batista, A, Turier, H, Patel, M, Power, B, Power, J, Yaz, G & David, AL 2022, 'Development of standard definitions and grading for Maternal and Fetal Adverse Event Terminology', PRENATAL DIAG, Jg. 42, Nr. 1, S. 15-26. https://doi.org/10.1002/pd.6047

APA

Spencer, R. N., Hecher, K., Norman, G., Marsal, K., Deprest, J., Flake, A., Figueras, F., Lees, C., Thornton, S., Beach, K., Powell, M., Crispi, F., Diemert, A., Marlow, N., Peebles, D. M., Westgren, M., Gardiner, H., Gratacos, E., Brodszki, J., ... David, A. L. (2022). Development of standard definitions and grading for Maternal and Fetal Adverse Event Terminology. PRENATAL DIAG, 42(1), 15-26. https://doi.org/10.1002/pd.6047

Vancouver

Spencer RN, Hecher K, Norman G, Marsal K, Deprest J, Flake A et al. Development of standard definitions and grading for Maternal and Fetal Adverse Event Terminology. PRENATAL DIAG. 2022 Jan;42(1):15-26. https://doi.org/10.1002/pd.6047

Bibtex

@article{a7982c5417e640c3840ac82bc0ff0884,
title = "Development of standard definitions and grading for Maternal and Fetal Adverse Event Terminology",
abstract = "OBJECTIVE: Adverse event (AE) monitoring is central to assessing therapeutic safety. The lack of a comprehensive framework to define and grade maternal and fetal AEs in pregnancy trials severely limits understanding risks in pregnant women. We created AE terminology to improve safety monitoring for developing pregnancy drugs, devices and interventions.METHOD: Existing severity grading for pregnant AEs and definitions/indicators of 'severe' and 'life-threatening' conditions relevant to maternal and fetal clinical trials were identified through a literature search. An international multidisciplinary group identified and filled gaps in definitions and severity grading using Medical Dictionary for Regulatory Activities (MedDRA) terms and severity grading criteria based on Common Terminology Criteria for Adverse Event (CTCAE) generic structure. The draft criteria underwent two rounds of a modified Delphi process with international fetal therapy, obstetric, neonatal, industry experts, patients and patient representatives.RESULTS: Fetal AEs were defined as being diagnosable in utero with potential to harm the fetus, and were integrated into MedDRA. AE severity was graded independently for the pregnant woman and her fetus. Maternal (n = 12) and fetal (n = 19) AE definitions and severity grading criteria were developed and ratified by consensus.CONCLUSIONS: This Maternal and Fetal AE Terminology version 1.0 allows systematic consistent AE assessment in pregnancy trials to improve safety.",
author = "Spencer, {Rebecca N} and Kurt Hecher and Gill Norman and Karel Marsal and Jan Deprest and Alan Flake and Francesc Figueras and Christoph Lees and Steve Thornton and Kathleen Beach and Marcy Powell and Fatima Crispi and Anke Diemert and Neil Marlow and Peebles, {Donald M} and Magnus Westgren and Helena Gardiner and Eduard Gratacos and Jana Brodszki and Albert Batista and Helen Turier and Mehali Patel and Beverley Power and James Power and Gillian Yaz and David, {Anna L}",
note = "{\textcopyright} 2021 The Authors. Prenatal Diagnosis published by John Wiley & Sons Ltd.",
year = "2022",
month = jan,
doi = "10.1002/pd.6047",
language = "English",
volume = "42",
pages = "15--26",
journal = "PRENATAL DIAG",
issn = "0197-3851",
publisher = "John Wiley and Sons Ltd",
number = "1",

}

RIS

TY - JOUR

T1 - Development of standard definitions and grading for Maternal and Fetal Adverse Event Terminology

AU - Spencer, Rebecca N

AU - Hecher, Kurt

AU - Norman, Gill

AU - Marsal, Karel

AU - Deprest, Jan

AU - Flake, Alan

AU - Figueras, Francesc

AU - Lees, Christoph

AU - Thornton, Steve

AU - Beach, Kathleen

AU - Powell, Marcy

AU - Crispi, Fatima

AU - Diemert, Anke

AU - Marlow, Neil

AU - Peebles, Donald M

AU - Westgren, Magnus

AU - Gardiner, Helena

AU - Gratacos, Eduard

AU - Brodszki, Jana

AU - Batista, Albert

AU - Turier, Helen

AU - Patel, Mehali

AU - Power, Beverley

AU - Power, James

AU - Yaz, Gillian

AU - David, Anna L

N1 - © 2021 The Authors. Prenatal Diagnosis published by John Wiley & Sons Ltd.

PY - 2022/1

Y1 - 2022/1

N2 - OBJECTIVE: Adverse event (AE) monitoring is central to assessing therapeutic safety. The lack of a comprehensive framework to define and grade maternal and fetal AEs in pregnancy trials severely limits understanding risks in pregnant women. We created AE terminology to improve safety monitoring for developing pregnancy drugs, devices and interventions.METHOD: Existing severity grading for pregnant AEs and definitions/indicators of 'severe' and 'life-threatening' conditions relevant to maternal and fetal clinical trials were identified through a literature search. An international multidisciplinary group identified and filled gaps in definitions and severity grading using Medical Dictionary for Regulatory Activities (MedDRA) terms and severity grading criteria based on Common Terminology Criteria for Adverse Event (CTCAE) generic structure. The draft criteria underwent two rounds of a modified Delphi process with international fetal therapy, obstetric, neonatal, industry experts, patients and patient representatives.RESULTS: Fetal AEs were defined as being diagnosable in utero with potential to harm the fetus, and were integrated into MedDRA. AE severity was graded independently for the pregnant woman and her fetus. Maternal (n = 12) and fetal (n = 19) AE definitions and severity grading criteria were developed and ratified by consensus.CONCLUSIONS: This Maternal and Fetal AE Terminology version 1.0 allows systematic consistent AE assessment in pregnancy trials to improve safety.

AB - OBJECTIVE: Adverse event (AE) monitoring is central to assessing therapeutic safety. The lack of a comprehensive framework to define and grade maternal and fetal AEs in pregnancy trials severely limits understanding risks in pregnant women. We created AE terminology to improve safety monitoring for developing pregnancy drugs, devices and interventions.METHOD: Existing severity grading for pregnant AEs and definitions/indicators of 'severe' and 'life-threatening' conditions relevant to maternal and fetal clinical trials were identified through a literature search. An international multidisciplinary group identified and filled gaps in definitions and severity grading using Medical Dictionary for Regulatory Activities (MedDRA) terms and severity grading criteria based on Common Terminology Criteria for Adverse Event (CTCAE) generic structure. The draft criteria underwent two rounds of a modified Delphi process with international fetal therapy, obstetric, neonatal, industry experts, patients and patient representatives.RESULTS: Fetal AEs were defined as being diagnosable in utero with potential to harm the fetus, and were integrated into MedDRA. AE severity was graded independently for the pregnant woman and her fetus. Maternal (n = 12) and fetal (n = 19) AE definitions and severity grading criteria were developed and ratified by consensus.CONCLUSIONS: This Maternal and Fetal AE Terminology version 1.0 allows systematic consistent AE assessment in pregnancy trials to improve safety.

U2 - 10.1002/pd.6047

DO - 10.1002/pd.6047

M3 - SCORING: Journal article

C2 - 34550624

VL - 42

SP - 15

EP - 26

JO - PRENATAL DIAG

JF - PRENATAL DIAG

SN - 0197-3851

IS - 1

ER -