Evaluation of a Decision Aid for Women with Epilepsy Who Are Considering Pregnancy: A Randomized Controlled Trial

Abstract

Background. For many women with epilepsy (WWE), decision making about pregnancy is complicated by considerations such as the potential teratogenicity of antiepileptic drugs, offspring risk of epilepsy, seizure occurrence during pregnancy, and the challenges of parenting amidst poorly controlled seizures. Objective. This proof-of-concept, randomized controlled trial aimed to evaluate a decision aid (DA) developed to help WWE decide if they should start or enlarge their families. Methods. Seventy-nine WWE of childbearing age were recruited from Epilepsy Action Australia between October and November 2013 and randomized to receive the intervention (the DA) or not, and to complete a set of questionnaires pre- and post- intervention. The DA, delivered as a PDF booklet, provided balanced evidence-based information about options, risks and benefits, including probabilities; as well as steps for clarifying values and considering options within one’s personal situation. Results. Compared with the control group, the DA group had statistically significant improvements in knowledge about pregnancy and epilepsy (Cohen’s d = 1.24; 95%CI = 0.77 to 1.83) and reduced decisional conflict (Cohen’s d = 0.59; 95%CI = 0.21 to 0.99). Changes in decision self-efficacy, certainty of choice, patient-practitioner communication abilities and value congruence with choice were comparable between the DA and control group. Importantly, women’s decisions about motherhood were not biased towards either direction, and there were no adverse effects on depression or anxiety. All women who received the DA indicated they would recommend it to other WWE. Conclusions. The DA has the potential to serve as a useful support tool for WWE who are considering motherhood. Future research is needed to test the DA in clinical settings with guidance from a health professional. The trial was registered with the Australian New Zealand Clinical Trials Registry (ID ACTRN12613001082796).

Keywords

decision aid decision making epilepsy pregnancy motherhood

Get full access to this article

View all access options for this article.

References

Meador

Reynolds

Crean

Fahrbach

Probst

. Pregnancy outcomes in women with epilepsy: A systematic review and meta-analysis of published pregnancy registries and cohorts. Epilepsy Res. 2008;81:1–13.

Bromley

Weston

Adab

. Treatment for epilepsy in pregnancy: neurodevelopmental outcomes in the child. The Cochrane Library. 2014;10:CD010236.

National Institute for Health and Clinical Excellence. The epilepsies: The diagnosis and management of the epilepsies in adults and children in primary and secondary care (CG137). London: National Institute for Health and Clinical Excellence, 2012.

Harden

Hopp

Ting

. Practice parameter update: Management issues for women with epilepsy—Focus on pregnancy (an evidence-based review): Obstetrical complications and change in seizure frequency. Neurology. 2009;73:126–32.

Viinikainen

Heinonen

Eriksson

Kalviainen

. Community-based, prospective, controlled study of obstetric and neonatal outcome of 179 pregnancies in women with epilepsy. Epilepsia. 2006;47:186–92.

McAuley

Patankar

Lang

Prasad

. Evaluating the concerns of pregnant women with epilepsy: A focus group approach. Epilepsy Behav. 2012;24:246–8.

Annegers

Hauser

Elveback

. Seizure disorders in offspring of parents with a history of seizures: A maternal-paternal difference? Epilepsia. 1976;17:1–9.

Berkovic

Howell

Hay

Hopper

. Epilepsies in twins: Genetics of the major epilepsy syndromes. Ann Neurol. 1998;43:435–45.

Crawford

. Best practice guidelines for the management of women with epilepsy. Epilepsia. 2005;46(Suppl. 9):117–24.

10.

McGrath

Sharpe

Lah

Parratt

. Pregnancy-related knowledge and information needs of women with epilepsy: A systematic review. Epilepsy Behav. 2014;31:246–55.

11.

Helbig

Bernhardt

Conway

. Genetic risk perception and reproductive decision making among people with epilepsy. Epilepsia. 2010;51:1874–7.

12.

Wallace

Shorvon

Tallis

. Age-specific incidence and prevalence rates of treated epilepsy in an unselected population of 2,052,922 and age-specific fertility rates of women with epilepsy. Lancet. 1998;352:1970–3.

13.

Viinikainen

Heinonen

Eriksson

Kalviainen

. Fertility in women with active epilepsy. Neurology. 2007;69:2107–8.

14.

Elwyn

O’Connor

Stacey

. Developing a quality criteria framework for patient decision aids: Online international Delphi consensus process. BMJ. 2006;333:417.

15.

O’Connor

Legare

Stacey

. Risk communication in practice: The contribution of decision aids. BMJ. 2003;327:736–40.

16.

Stacey

Légaré

Col

. Decision aids for people facing health treatment or screening decisions. Cochrane Database Syst Rev. 2014:CD001431.

17.

Dugas

Shorten

Dube

. Decision aid tools to support women’s decision making in pregnancy and birth: A systematic review and meta-analysis. Soc Sci Med. 2012;74:1968–78.

18.

Meade

Sharpe

Hallab

Aspanell

Manolios

. Navigating motherhood choices in the context of rheumatoid arthritis: Women’s stories. Musculoskeletal Care. 2012;11:73–82.

19.

Prunty

Sharpe

Butow

Fulcher

. The motherhood choice: Themes arising in the decision-making process for women with multiple sclerosis. Mult Scler. 2008;14:701–4.

20.

Prunty

Sharpe

Butow

Fulcher

. The motherhood choice: A decision aid for women with multiple sclerosis. Patient Educ Couns. 2008;71:108–15.

21.

Meade

T DE

Manolios

Sharpe

. The motherhood choices decision aid for women with rheumatoid arthritis increases knowledge and reduces decisional conflict: a randomized controlled trial. BMC Musculoskelet Disord. 2015;16:1.

22.

O’Connor

. Validation of a Decisional Conflict Scale. Med Decis Making. 1995;15:25-30.

23.

O’Connor

. User manual – Decisional Conflict Scale Ottawa: Ottawa Hospital Research Institute; 1993 [updated 6 February 2014]. Available from: URL: http://decisionaid.ohri.ca/docs/develop/User_Manuals/UM_Decisional_Conflict.pdf.

24.

International Patient Decision Aid Standards (IPDAS) Collaboration. IPDAS Collaboration Background Document; 2005. Available from: URL: http://ipdas.ohri.ca/resources.html.

25.

Fraenkel

Rabidou

Wittink

Fried

. Improving informed decision-making for patients with knee pain. J Rheumatol. 2007;34:1894–8.

26.

Cranney

O’Connor

Jacobsen

. Development and pilot testing of a decision aid for postmenopausal women with osteoporosis. Patient Educ Counsel. 2002;47:245–55.

27.

O’Connor

. User manual – Decision Self-Efficacy Scale Ottawa: Ottawa Hospital Research Institute; 1995 [modified 2002] [updated 6 February 2014]. Available from: URL: https://decisionaid.ohri.ca/docs/develop/User_Manuals/UM_Decision_SelfEfficacy.pdf.

28.

Sepucha

Borkhoff

Lally

. Establishing the effectiveness of patient decision aids: Key constructs and measurement instruments. BMC Med Inform Decis Mak. 2013;13(Suppl. 2):S12.

29.

Radloff

. The CES-D Scale: A self-report depression scale for research in the general population. Appl Psych Meas. 1977;1:385–401.

30.

Myers

Weissman

. Use of a self-report symptom scale to detect depression in a community sample. Am J Psych. 1980;137:1081–4.

31.

Jones

Hermann

Woodard

. Screening for major depression in epilepsy with common self-report depression inventories. Epilepsia. 2005;46:731–5.

32.

Spitzer

Kroenke

Williams

JBW

Lowe

. A brief measure for assessing Generalized Anxiety Disorder: The GAD-7. Arch Intern Med. 2006;166:1092–7.

33.

Seo

J-G

Cho

Lee

S-J

. Validation of the Generalized Anxiety Disorder-7 in people with epilepsy: A MEPSY study. Epilepsy Behav. 2014;35:59–63.

34.

Harden

Meador

Pennell

. Practice parameter update: Management issues for women with epilepsy—Focus on pregnancy (an evidence-based review): Teratogenesis and perinatal outcomes. Neurology. 2009;73:133–41.

35.

Harden

Pennell

Koppel

. Practice parameter update: Management issues for women with epilepsy—Focus on pregnancy (an evidence-based review): Vitamin K, folic acid, blood levels, and breastfeeding. Neurology. 2009;73:142–9.

36.

McGrath

. Deciding on Motherhood: The Development and Evaluation of a Decision Aid for Women with Epilepsy. 2014. MSc thesis: University of Sydney. Available from: URL: http://hdl.handle.net/2123/11950.

37.

Drake

Engler-Todd

O’Connor

Surh

Hunter

. Development and evaluation of a decision aid about prenatal testing for women of advanced maternal age. J Genet Couns. 1999;8:217–33.

38.

Fiset

O’Connor

Evans

. Development and evaluation of a decision aid for patients with stage IV non-small cell lung cancer. Health Expect. 2000;3:125–36.

39.

O’Connor

A M

Cranney

. User manual – Acceptability. Ottawa Hospital Research Institute. Ottawa: Ottawa Hospital Research Institute; 1996 [modified 2002]. Available from: URL: http://decisionaid.ohri.ca/docs/develop/User_Manuals/UM_Acceptability.pdf.

40.

McLaughlin

. SMOG grading: A new readability formula. J Reading. 1969;12:639–46.

41.

Finkelsztejn

Brooks

JBB

Paschoal

Jr Fragoso

. What can we really tell women with multiple sclerosis regarding pregnancy? A systematic review and meta-analysis of the literature. BJOG. 2011;118:790–7.

42.

Pennell

. Pregnancy in women who have epilepsy. Neurol Clin. 2004;22:799–820.

43.

EURAP Study Group. Seizure control and treatment in pregnancy: Observations from the EURAP epilepsy pregnancy registry. Neurology. 2006;66:354–60.

44.

International Patient Decision Aid Standards (IPDAS) Collaboration. 2012 Update of the IPDAS Collaboration Background Document; 2012. Available from: URL: http://ipdas.ohri.ca/resources.html.

45.

Metcalfe

Roberts

Abdulla

. Patient knowledge about issues related to pregnancy in epilepsy: A cross-sectional study. Epilepsy Behav. 2012;24:65–9.

Supplementary Material

Please find the following supplemental material available below.

For Open Access articles published under a Creative Commons License, all supplemental material carries the same license as the article it is associated with.

For non-Open Access articles published, all supplemental material carries a non-exclusive license, and permission requests for re-use of supplemental material or any part of supplemental material shall be sent directly to the copyright owner as specified in the copyright notice associated with the article.

0.00 MB

3.01 MB

0.02 MB