title: Risk and uncertainty: shifting decision making for aneuploidy screening to the first trimester of pregnancy.
abstract: OBJECTIVE
  The clinical introduction of first trimester aneuploidy screening uniquely challenges the informed consent process for both patients and providers. This study investigated key aspects of the decision-making process for this new form of prenatal genetic screening.
  
  
  METHODS
  Qualitative data were collected by nine focus groups that comprised women of different reproductive histories (N = 46 participants). Discussions explored themes regarding patient decision making for first trimester aneuploidy screening. Sessions were audio recorded, transcribed, coded, and analyzed to identify themes.
  
  
  RESULTS
  Multiple levels of uncertainty characterize the decision-making process for first trimester aneuploidy screening. Baseline levels of uncertainty existed for participants in the context of an early pregnancy and the debate about the benefit of fetal genetic testing in general. Additional sources of uncertainty during the decision-making process were generated from weighing the advantages and disadvantages of initiating screening in the first trimester as opposed to waiting until the second. Questions of the quality and quantity of information and the perceived benefit of earlier access to fetal information were leading themes. Barriers to access prenatal care in early pregnancy presented participants with additional concerns about the ability to make informed decisions about prenatal genetic testing.
  
  
  CONCLUSIONS
  The option of the first trimester aneuploidy screening test in early pregnancy generates decision-making uncertainty that can interfere with the informed consent process. Mechanisms must be developed to facilitate informed decision making for this new form of prenatal genetic screening.
authors.affiliation: Department of Bioethics and Obstetrics and Gynecology, Cleveland Clinic, Case Western Reserve University, Cleveland Clinic Lerner College of Medicine, Cleveland, Ohio 44195, USA. farrelr@ccf.org
authors.forename: Ruth M
authors.initials: RM
authors.lastname: Farrell
authors.forename: Natasha
authors.initials: N
authors.lastname: Dolgin
authors.forename: Susan A
authors.initials: SA
authors.lastname: Flocke
authors.forename: Victoria
authors.initials: V
authors.lastname: Winbush
authors.forename: Mary Beth
authors.initials: MB
authors.lastname: Mercer
authors.forename: Christian
authors.initials: C
authors.lastname: Simon
mesh_terms: D000293:Adolescent; D000328:Adult; D000782:Aneuploidy; D003657:Decision Making; D003663:Decision Trees; D005260:Female; D017144:Focus Groups; D005820:Genetic Testing; D006801:Humans; D007258:Informed Consent; D008875:Middle Aged; D011247:Pregnancy; D011261:Pregnancy Trimester, First; D011296:Prenatal Diagnosis; D036301:Qualitative Research; D012306:Risk; D035501:Uncertainty; D055815:Young Adult