title: Effectiveness and safety as outcome measures in reproductive medicine.
abstract: The aim of reproductive medicine is to help couples with an unfulfilled child wish to have a child by offering them the best treatment option. The choice of treatment reflects effectiveness and safety. While effectiveness refers to the extent to which a treatment increases the chance of a couple in having a baby, safety relates to adverse effects associated with such a treatment. In an attempt to integrate effectiveness and safety, healthy singleton live birth (at term) has been suggested as the ideal outcome measure for evaluative research in reproductive medicine. Although intuitively desirable, this proposal overlooks the fact that assessment of effectiveness and safety in this context cannot be measured as a single outcome. In this paper, we explain why effectiveness and safety outcomes in reproductive medicine should be assessed independently, and later synthesized to inform clinical decision-making.
authors.affiliation: Centre for Reproductive Medicine, Room Q3-119, Academic Medical Centre, University of Amsterdam, Meibergdreef 9, 1105 AZ Amsterdam, The Netherlands m.w.braakhekke@amc.nl.
authors.forename: M
authors.initials: M
authors.lastname: Braakhekke
authors.affiliation: Centre for Reproductive Medicine, Room Q3-119, Academic Medical Centre, University of Amsterdam, Meibergdreef 9, 1105 AZ Amsterdam, The Netherlands.
authors.forename: E I
authors.initials: EI
authors.lastname: Kamphuis
authors.affiliation: Centre for Reproductive Medicine, Room Q3-119, Academic Medical Centre, University of Amsterdam, Meibergdreef 9, 1105 AZ Amsterdam, The Netherlands.
authors.forename: F
authors.initials: F
authors.lastname: Mol
authors.affiliation: Robinson Research Institute, School of Paediatrics and Reproductive Health, University of Adelaide, Adelaide, Australia.
authors.forename: R J
authors.initials: RJ
authors.lastname: Norman
authors.affiliation: Reproductive Medicine, Division of Applied Health Sciences, University of Aberdeen, Aberdeen, UK.
authors.forename: S
authors.initials: S
authors.lastname: Bhattacharya
authors.affiliation: Centre for Reproductive Medicine, Room Q3-119, Academic Medical Centre, University of Amsterdam, Meibergdreef 9, 1105 AZ Amsterdam, The Netherlands.
authors.forename: F
authors.initials: F
authors.lastname: van der Veen
authors.affiliation: Robinson Research Institute, School of Paediatrics and Reproductive Health, University of Adelaide, Adelaide, Australia.
authors.forename: B W J
authors.initials: BW
authors.lastname: Mol
mesh_terms: D020000:Decision Support Systems, Clinical; D005260:Female; D006801:Humans; D007231:Infant, Newborn; D007246:Infertility / Q000628:therapy*; D050498:Live Birth; D018803:Models, Economic; D017063:Outcome Assessment, Health Care; D061214:Patient Safety; D011247:Pregnancy; D011256:Pregnancy Outcome; D018456:Reproductive Medicine / Q000379:methods* / Q000592:standards*; D027724:Reproductive Techniques, Assisted / Q000592:standards
keywords: effectiveness; outcome measures; reproductive medicine; safety