title: Does the Use of a Decision Aid Improve Decision Making in Prosthetic Heart Valve Selection? A Multicenter Randomized Trial.
abstract: A Dutch online patient decision aid to support prosthetic heart valve selection was recently developed. A multicenter randomized controlled trial was conducted to assess whether use of the patient decision aid results in optimization of shared decision making in prosthetic heart valve selection.
  
  
  
  In a 5-center randomized controlled trial, patients were allocated to receive either standard preoperative care (control group) or additional access to the patient decision aid (intervention group). Legally capable adult patients accepted for elective isolated or combined aortic and mitral valve replacement were included. Primary outcome was preoperative decisional conflict (Decisional Conflict Scale); secondary outcomes included patient knowledge, involvement in valve selection, anxiety and depression, (valve-specific) quality of life, and regret. Out of 306 eligible patients, 155 were randomized (78 control and 77 intervention). Preoperative decisional conflict did not differ between the groups (34% versus 33%;P=0.834). Intervention patients felt better informed (median Decisional Conflict Scale informed subscore: 8 versus 17;P=0.046) and had a better knowledge of prosthetic valves (85% versus 68%;P=0.004). Intervention patients experienced less anxiety and depression (median Hospital Anxiety and Depression Scale score: 6 versus 9;P=0.015) and better mental well-being (mean Short Form Health Survey score: 54 versus 50;P=0.032). Three months postoperatively, valve-specific quality of life and regret did not differ between the groups.
  
  
  
  A patient decision aid to support shared decision making in prosthetic heart valve selection does not lower decisional conflict. It does result in more knowledgeable, better informed, and less anxious and depressed patients, with a better mental well-being.
  
  
  
  http://www.trialregister.nl. Unique identifier: NTR4350.
authors.affiliation: From the Department of Cardio-Thoracic Surgery (N.M.K., A.J.J.C.B., J.J.M.T.) and Department of Cardiology (J.W.R.-H.), Erasmus MC, Rotterdam, The Netherlands; Department of Cardio-Thoracic Surgery, Academic Medical Center, University of Amsterdam, The Netherlands (Y.A., D.R.K., F.d.H, J.K.); Department of Cardio-Thoracic Surgery, University Medical Center Utrecht, The Netherlands (M.B.); Department of Cardio-Thoracic Surgery (E.F.B., R.J.M.K.) and Department of Medical Decision Making (A.M.S.), Leiden University Medical Center, The Netherlands; Department of Cardiology, Diakonessenhuis, Utrecht, The Netherlands (J.J.J.B.); Department of Cardiology, St. Anna Hospital, Geldrop, The Netherlands (P.P.); Department of Cardio-Thoracic Surgery, Isala Klinieken, Zwolle, The Netherlands (T.M.); and Patient Organisation De Hart&Vaatgroep, The Hague, The Netherlands (I.v.d.B., R.L.).
authors.forename: Nelleke M
authors.initials: NM
authors.lastname: Korteland
authors.affiliation: From the Department of Cardio-Thoracic Surgery (N.M.K., A.J.J.C.B., J.J.M.T.) and Department of Cardiology (J.W.R.-H.), Erasmus MC, Rotterdam, The Netherlands; Department of Cardio-Thoracic Surgery, Academic Medical Center, University of Amsterdam, The Netherlands (Y.A., D.R.K., F.d.H, J.K.); Department of Cardio-Thoracic Surgery, University Medical Center Utrecht, The Netherlands (M.B.); Department of Cardio-Thoracic Surgery (E.F.B., R.J.M.K.) and Department of Medical Decision Making (A.M.S.), Leiden University Medical Center, The Netherlands; Department of Cardiology, Diakonessenhuis, Utrecht, The Netherlands (J.J.J.B.); Department of Cardiology, St. Anna Hospital, Geldrop, The Netherlands (P.P.); Department of Cardio-Thoracic Surgery, Isala Klinieken, Zwolle, The Netherlands (T.M.); and Patient Organisation De Hart&Vaatgroep, The Hague, The Netherlands (I.v.d.B., R.L.).
authors.forename: Yunus
authors.initials: Y
authors.lastname: Ahmed
authors.affiliation: From the Department of Cardio-Thoracic Surgery (N.M.K., A.J.J.C.B., J.J.M.T.) and Department of Cardiology (J.W.R.-H.), Erasmus MC, Rotterdam, The Netherlands; Department of Cardio-Thoracic Surgery, Academic Medical Center, University of Amsterdam, The Netherlands (Y.A., D.R.K., F.d.H, J.K.); Department of Cardio-Thoracic Surgery, University Medical Center Utrecht, The Netherlands (M.B.); Department of Cardio-Thoracic Surgery (E.F.B., R.J.M.K.) and Department of Medical Decision Making (A.M.S.), Leiden University Medical Center, The Netherlands; Department of Cardiology, Diakonessenhuis, Utrecht, The Netherlands (J.J.J.B.); Department of Cardiology, St. Anna Hospital, Geldrop, The Netherlands (P.P.); Department of Cardio-Thoracic Surgery, Isala Klinieken, Zwolle, The Netherlands (T.M.); and Patient Organisation De Hart&Vaatgroep, The Hague, The Netherlands (I.v.d.B., R.L.).
authors.forename: David R
authors.initials: DR
authors.lastname: Koolbergen
authors.affiliation: From the Department of Cardio-Thoracic Surgery (N.M.K., A.J.J.C.B., J.J.M.T.) and Department of Cardiology (J.W.R.-H.), Erasmus MC, Rotterdam, The Netherlands; Department of Cardio-Thoracic Surgery, Academic Medical Center, University of Amsterdam, The Netherlands (Y.A., D.R.K., F.d.H, J.K.); Department of Cardio-Thoracic Surgery, University Medical Center Utrecht, The Netherlands (M.B.); Department of Cardio-Thoracic Surgery (E.F.B., R.J.M.K.) and Department of Medical Decision Making (A.M.S.), Leiden University Medical Center, The Netherlands; Department of Cardiology, Diakonessenhuis, Utrecht, The Netherlands (J.J.J.B.); Department of Cardiology, St. Anna Hospital, Geldrop, The Netherlands (P.P.); Department of Cardio-Thoracic Surgery, Isala Klinieken, Zwolle, The Netherlands (T.M.); and Patient Organisation De Hart&Vaatgroep, The Hague, The Netherlands (I.v.d.B., R.L.).
authors.forename: Marjan
authors.initials: M
authors.lastname: Brouwer
authors.affiliation: From the Department of Cardio-Thoracic Surgery (N.M.K., A.J.J.C.B., J.J.M.T.) and Department of Cardiology (J.W.R.-H.), Erasmus MC, Rotterdam, The Netherlands; Department of Cardio-Thoracic Surgery, Academic Medical Center, University of Amsterdam, The Netherlands (Y.A., D.R.K., F.d.H, J.K.); Department of Cardio-Thoracic Surgery, University Medical Center Utrecht, The Netherlands (M.B.); Department of Cardio-Thoracic Surgery (E.F.B., R.J.M.K.) and Department of Medical Decision Making (A.M.S.), Leiden University Medical Center, The Netherlands; Department of Cardiology, Diakonessenhuis, Utrecht, The Netherlands (J.J.J.B.); Department of Cardiology, St. Anna Hospital, Geldrop, The Netherlands (P.P.); Department of Cardio-Thoracic Surgery, Isala Klinieken, Zwolle, The Netherlands (T.M.); and Patient Organisation De Hart&Vaatgroep, The Hague, The Netherlands (I.v.d.B., R.L.).
authors.forename: Frederiek
authors.initials: F
authors.lastname: de Heer
authors.affiliation: From the Department of Cardio-Thoracic Surgery (N.M.K., A.J.J.C.B., J.J.M.T.) and Department of Cardiology (J.W.R.-H.), Erasmus MC, Rotterdam, The Netherlands; Department of Cardio-Thoracic Surgery, Academic Medical Center, University of Amsterdam, The Netherlands (Y.A., D.R.K., F.d.H, J.K.); Department of Cardio-Thoracic Surgery, University Medical Center Utrecht, The Netherlands (M.B.); Department of Cardio-Thoracic Surgery (E.F.B., R.J.M.K.) and Department of Medical Decision Making (A.M.S.), Leiden University Medical Center, The Netherlands; Department of Cardiology, Diakonessenhuis, Utrecht, The Netherlands (J.J.J.B.); Department of Cardiology, St. Anna Hospital, Geldrop, The Netherlands (P.P.); Department of Cardio-Thoracic Surgery, Isala Klinieken, Zwolle, The Netherlands (T.M.); and Patient Organisation De Hart&Vaatgroep, The Hague, The Netherlands (I.v.d.B., R.L.).
authors.forename: Jolanda
authors.initials: J
authors.lastname: Kluin
authors.affiliation: From the Department of Cardio-Thoracic Surgery (N.M.K., A.J.J.C.B., J.J.M.T.) and Department of Cardiology (J.W.R.-H.), Erasmus MC, Rotterdam, The Netherlands; Department of Cardio-Thoracic Surgery, Academic Medical Center, University of Amsterdam, The Netherlands (Y.A., D.R.K., F.d.H, J.K.); Department of Cardio-Thoracic Surgery, University Medical Center Utrecht, The Netherlands (M.B.); Department of Cardio-Thoracic Surgery (E.F.B., R.J.M.K.) and Department of Medical Decision Making (A.M.S.), Leiden University Medical Center, The Netherlands; Department of Cardiology, Diakonessenhuis, Utrecht, The Netherlands (J.J.J.B.); Department of Cardiology, St. Anna Hospital, Geldrop, The Netherlands (P.P.); Department of Cardio-Thoracic Surgery, Isala Klinieken, Zwolle, The Netherlands (T.M.); and Patient Organisation De Hart&Vaatgroep, The Hague, The Netherlands (I.v.d.B., R.L.).
authors.forename: Eline F
authors.initials: EF
authors.lastname: Bruggemans
authors.affiliation: From the Department of Cardio-Thoracic Surgery (N.M.K., A.J.J.C.B., J.J.M.T.) and Department of Cardiology (J.W.R.-H.), Erasmus MC, Rotterdam, The Netherlands; Department of Cardio-Thoracic Surgery, Academic Medical Center, University of Amsterdam, The Netherlands (Y.A., D.R.K., F.d.H, J.K.); Department of Cardio-Thoracic Surgery, University Medical Center Utrecht, The Netherlands (M.B.); Department of Cardio-Thoracic Surgery (E.F.B., R.J.M.K.) and Department of Medical Decision Making (A.M.S.), Leiden University Medical Center, The Netherlands; Department of Cardiology, Diakonessenhuis, Utrecht, The Netherlands (J.J.J.B.); Department of Cardiology, St. Anna Hospital, Geldrop, The Netherlands (P.P.); Department of Cardio-Thoracic Surgery, Isala Klinieken, Zwolle, The Netherlands (T.M.); and Patient Organisation De Hart&Vaatgroep, The Hague, The Netherlands (I.v.d.B., R.L.).
authors.forename: Robert J M
authors.initials: RJ
authors.lastname: Klautz
authors.affiliation: From the Department of Cardio-Thoracic Surgery (N.M.K., A.J.J.C.B., J.J.M.T.) and Department of Cardiology (J.W.R.-H.), Erasmus MC, Rotterdam, The Netherlands; Department of Cardio-Thoracic Surgery, Academic Medical Center, University of Amsterdam, The Netherlands (Y.A., D.R.K., F.d.H, J.K.); Department of Cardio-Thoracic Surgery, University Medical Center Utrecht, The Netherlands (M.B.); Department of Cardio-Thoracic Surgery (E.F.B., R.J.M.K.) and Department of Medical Decision Making (A.M.S.), Leiden University Medical Center, The Netherlands; Department of Cardiology, Diakonessenhuis, Utrecht, The Netherlands (J.J.J.B.); Department of Cardiology, St. Anna Hospital, Geldrop, The Netherlands (P.P.); Department of Cardio-Thoracic Surgery, Isala Klinieken, Zwolle, The Netherlands (T.M.); and Patient Organisation De Hart&Vaatgroep, The Hague, The Netherlands (I.v.d.B., R.L.).
authors.forename: Anne M
authors.initials: AM
authors.lastname: Stiggelbout
authors.affiliation: From the Department of Cardio-Thoracic Surgery (N.M.K., A.J.J.C.B., J.J.M.T.) and Department of Cardiology (J.W.R.-H.), Erasmus MC, Rotterdam, The Netherlands; Department of Cardio-Thoracic Surgery, Academic Medical Center, University of Amsterdam, The Netherlands (Y.A., D.R.K., F.d.H, J.K.); Department of Cardio-Thoracic Surgery, University Medical Center Utrecht, The Netherlands (M.B.); Department of Cardio-Thoracic Surgery (E.F.B., R.J.M.K.) and Department of Medical Decision Making (A.M.S.), Leiden University Medical Center, The Netherlands; Department of Cardiology, Diakonessenhuis, Utrecht, The Netherlands (J.J.J.B.); Department of Cardiology, St. Anna Hospital, Geldrop, The Netherlands (P.P.); Department of Cardio-Thoracic Surgery, Isala Klinieken, Zwolle, The Netherlands (T.M.); and Patient Organisation De Hart&Vaatgroep, The Hague, The Netherlands (I.v.d.B., R.L.).
authors.forename: Jeroen J J
authors.initials: JJ
authors.lastname: Bucx
authors.affiliation: From the Department of Cardio-Thoracic Surgery (N.M.K., A.J.J.C.B., J.J.M.T.) and Department of Cardiology (J.W.R.-H.), Erasmus MC, Rotterdam, The Netherlands; Department of Cardio-Thoracic Surgery, Academic Medical Center, University of Amsterdam, The Netherlands (Y.A., D.R.K., F.d.H, J.K.); Department of Cardio-Thoracic Surgery, University Medical Center Utrecht, The Netherlands (M.B.); Department of Cardio-Thoracic Surgery (E.F.B., R.J.M.K.) and Department of Medical Decision Making (A.M.S.), Leiden University Medical Center, The Netherlands; Department of Cardiology, Diakonessenhuis, Utrecht, The Netherlands (J.J.J.B.); Department of Cardiology, St. Anna Hospital, Geldrop, The Netherlands (P.P.); Department of Cardio-Thoracic Surgery, Isala Klinieken, Zwolle, The Netherlands (T.M.); and Patient Organisation De Hart&Vaatgroep, The Hague, The Netherlands (I.v.d.B., R.L.).
authors.forename: Jolien W
authors.initials: JW
authors.lastname: Roos-Hesselink
authors.affiliation: From the Department of Cardio-Thoracic Surgery (N.M.K., A.J.J.C.B., J.J.M.T.) and Department of Cardiology (J.W.R.-H.), Erasmus MC, Rotterdam, The Netherlands; Department of Cardio-Thoracic Surgery, Academic Medical Center, University of Amsterdam, The Netherlands (Y.A., D.R.K., F.d.H, J.K.); Department of Cardio-Thoracic Surgery, University Medical Center Utrecht, The Netherlands (M.B.); Department of Cardio-Thoracic Surgery (E.F.B., R.J.M.K.) and Department of Medical Decision Making (A.M.S.), Leiden University Medical Center, The Netherlands; Department of Cardiology, Diakonessenhuis, Utrecht, The Netherlands (J.J.J.B.); Department of Cardiology, St. Anna Hospital, Geldrop, The Netherlands (P.P.); Department of Cardio-Thoracic Surgery, Isala Klinieken, Zwolle, The Netherlands (T.M.); and Patient Organisation De Hart&Vaatgroep, The Hague, The Netherlands (I.v.d.B., R.L.).
authors.forename: Peter
authors.initials: P
authors.lastname: Polak
authors.affiliation: From the Department of Cardio-Thoracic Surgery (N.M.K., A.J.J.C.B., J.J.M.T.) and Department of Cardiology (J.W.R.-H.), Erasmus MC, Rotterdam, The Netherlands; Department of Cardio-Thoracic Surgery, Academic Medical Center, University of Amsterdam, The Netherlands (Y.A., D.R.K., F.d.H, J.K.); Department of Cardio-Thoracic Surgery, University Medical Center Utrecht, The Netherlands (M.B.); Department of Cardio-Thoracic Surgery (E.F.B., R.J.M.K.) and Department of Medical Decision Making (A.M.S.), Leiden University Medical Center, The Netherlands; Department of Cardiology, Diakonessenhuis, Utrecht, The Netherlands (J.J.J.B.); Department of Cardiology, St. Anna Hospital, Geldrop, The Netherlands (P.P.); Department of Cardio-Thoracic Surgery, Isala Klinieken, Zwolle, The Netherlands (T.M.); and Patient Organisation De Hart&Vaatgroep, The Hague, The Netherlands (I.v.d.B., R.L.).
authors.forename: Thanasie
authors.initials: T
authors.lastname: Markou
authors.affiliation: From the Department of Cardio-Thoracic Surgery (N.M.K., A.J.J.C.B., J.J.M.T.) and Department of Cardiology (J.W.R.-H.), Erasmus MC, Rotterdam, The Netherlands; Department of Cardio-Thoracic Surgery, Academic Medical Center, University of Amsterdam, The Netherlands (Y.A., D.R.K., F.d.H, J.K.); Department of Cardio-Thoracic Surgery, University Medical Center Utrecht, The Netherlands (M.B.); Department of Cardio-Thoracic Surgery (E.F.B., R.J.M.K.) and Department of Medical Decision Making (A.M.S.), Leiden University Medical Center, The Netherlands; Department of Cardiology, Diakonessenhuis, Utrecht, The Netherlands (J.J.J.B.); Department of Cardiology, St. Anna Hospital, Geldrop, The Netherlands (P.P.); Department of Cardio-Thoracic Surgery, Isala Klinieken, Zwolle, The Netherlands (T.M.); and Patient Organisation De Hart&Vaatgroep, The Hague, The Netherlands (I.v.d.B., R.L.).
authors.forename: Inge
authors.initials: I
authors.lastname: van den Broek
authors.affiliation: From the Department of Cardio-Thoracic Surgery (N.M.K., A.J.J.C.B., J.J.M.T.) and Department of Cardiology (J.W.R.-H.), Erasmus MC, Rotterdam, The Netherlands; Department of Cardio-Thoracic Surgery, Academic Medical Center, University of Amsterdam, The Netherlands (Y.A., D.R.K., F.d.H, J.K.); Department of Cardio-Thoracic Surgery, University Medical Center Utrecht, The Netherlands (M.B.); Department of Cardio-Thoracic Surgery (E.F.B., R.J.M.K.) and Department of Medical Decision Making (A.M.S.), Leiden University Medical Center, The Netherlands; Department of Cardiology, Diakonessenhuis, Utrecht, The Netherlands (J.J.J.B.); Department of Cardiology, St. Anna Hospital, Geldrop, The Netherlands (P.P.); Department of Cardio-Thoracic Surgery, Isala Klinieken, Zwolle, The Netherlands (T.M.); and Patient Organisation De Hart&Vaatgroep, The Hague, The Netherlands (I.v.d.B., R.L.).
authors.forename: Rene
authors.initials: R
authors.lastname: Ligthart
authors.affiliation: From the Department of Cardio-Thoracic Surgery (N.M.K., A.J.J.C.B., J.J.M.T.) and Department of Cardiology (J.W.R.-H.), Erasmus MC, Rotterdam, The Netherlands; Department of Cardio-Thoracic Surgery, Academic Medical Center, University of Amsterdam, The Netherlands (Y.A., D.R.K., F.d.H, J.K.); Department of Cardio-Thoracic Surgery, University Medical Center Utrecht, The Netherlands (M.B.); Department of Cardio-Thoracic Surgery (E.F.B., R.J.M.K.) and Department of Medical Decision Making (A.M.S.), Leiden University Medical Center, The Netherlands; Department of Cardiology, Diakonessenhuis, Utrecht, The Netherlands (J.J.J.B.); Department of Cardiology, St. Anna Hospital, Geldrop, The Netherlands (P.P.); Department of Cardio-Thoracic Surgery, Isala Klinieken, Zwolle, The Netherlands (T.M.); and Patient Organisation De Hart&Vaatgroep, The Hague, The Netherlands (I.v.d.B., R.L.).
authors.forename: Ad J J C
authors.initials: AJ
authors.lastname: Bogers
authors.affiliation: From the Department of Cardio-Thoracic Surgery (N.M.K., A.J.J.C.B., J.J.M.T.) and Department of Cardiology (J.W.R.-H.), Erasmus MC, Rotterdam, The Netherlands; Department of Cardio-Thoracic Surgery, Academic Medical Center, University of Amsterdam, The Netherlands (Y.A., D.R.K., F.d.H, J.K.); Department of Cardio-Thoracic Surgery, University Medical Center Utrecht, The Netherlands (M.B.); Department of Cardio-Thoracic Surgery (E.F.B., R.J.M.K.) and Department of Medical Decision Making (A.M.S.), Leiden University Medical Center, The Netherlands; Department of Cardiology, Diakonessenhuis, Utrecht, The Netherlands (J.J.J.B.); Department of Cardiology, St. Anna Hospital, Geldrop, The Netherlands (P.P.); Department of Cardio-Thoracic Surgery, Isala Klinieken, Zwolle, The Netherlands (T.M.); and Patient Organisation De Hart&Vaatgroep, The Hague, The Netherlands (I.v.d.B., R.L.). j.j.m.takkenberg@erasmusmc.nl.
authors.forename: Johanna J M
authors.initials: JJ
authors.lastname: Takkenberg
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001007:Anxiety / Q000209:etiology / Q000517:prevention & control; D001021:Aortic Valve / Q000503:physiopathology / Q000601:surgery*; D000066491:Clinical Decision-Making; D003661:Decision Support Techniques; D003863:Depression / Q000209:etiology / Q000517:prevention & control; D005260:Female; D006349:Heart Valve Diseases / Q000175:diagnosis / Q000503:physiopathology / Q000601:surgery*; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation*; D006801:Humans; D020407:Internet; D008297:Male; D008603:Mental Health; D008875:Middle Aged; D008943:Mitral Valve / Q000503:physiopathology / Q000601:surgery*; D009426:Netherlands; D010353:Patient Education as Topic; D017060:Patient Satisfaction; D018579:Patient Selection; D011237:Predictive Value of Tests; D011446:Prospective Studies; D011474:Prosthesis Design; D011788:Quality of Life; D018570:Risk Assessment; D012307:Risk Factors; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
keywords: anxiety; cardiovascular diseases; decision making; heart valves; randomized controlled trial