The development of a patient decision aid to reduce decisional conflict about antidepressant use in pregnancy.

BACKGROUND: People with moderate to severe depression in pregnancy must weigh potential risks of untreated or incompletely treated depression against the small, but uncertain risks of fetal antidepressant drug exposure. Clinical support alone appears insufficient for helping individuals with this complex decision. A patient decision aid (PDA) has the potential to be a useful tool for this population. The objective of our work was to use internationally recognized guidelines from the International Patient Decision Aids Standards Collaboration to develop an evidence-based PDA for antidepressant use in pregnancy. METHODS: A three-phased development process was used whereby, informed by patient and physician perspectives and evidence synthesis, a steering committee commissioned a web-based PDA for those deciding whether or not to start or continue antidepressant treatment for depression in pregnancy (Phase 1). A prototype was developed (Phase 2) and iteratively revised based on feedback during field testing based on a user-centred process (Phase 3). RESULTS: We developed a web-based PDA for people deciding whether to start or continue antidepressant use for depression in pregnancy. It has five interactive sections: (1) information on depression and treatment; (2) reasons to start/continue an antidepressant and to start/stop antidepressant medication; (3) user assessment of values regarding each issue; (4) opportunity to reflect on factors that contribute to decision making; and (5) a printable PDF that summarizes the user's journey through the PDA. CONCLUSIONS: This tool, which exclusively focuses on depression treatment with Selective Serotonin Reuptake Inhibitors and Serotonin-Norepinephrine Reuptake Inhibitors, can be used by individuals making decisions about antidepressant use to treat depression during pregnancy. Limitations of the PDA are that it is not for other conditions, nor other medications that can be used for depression, and in its pilot form cannot be used by women who do not speak English or who have a visual impairment. Pending further study, it has the potential to enhance quality of care and patient experience.

Decision-making about antidepressant medication use in pregnancy: a comparison between women making the decision in the preconception period versus in pregnancy.

BACKGROUND: Decisions about antidepressant use in pregnancy are complex. Little is known about how pregnancy-planning and already pregnant women making these decisions differ. METHODS: In 95 Canadian women having difficulty deciding whether to take antidepressants in pregnancy, we compared sociodemographic factors, clinical characteristics, and treatment intent between women planning pregnancy (preconception women) and currently-pregnant women. RESULTS: About 90% of preconception women (n = 55) were married or cohabitating and university-educated, and over 60% had an annual income of > 80,000 CAD/year; this was not different from currently-pregnant women (n = 40). Almost all women had previously used antidepressants, but preconception women were more likely to report current use (85.5% vs. 45.0%). They were more likely to have high decisional conflict (83.6% vs. 60.0%) and less likely to be under the care of a psychiatrist (29.1% vs. 52.5%). Preconception women were more likely than pregnant women to report the intent to use antidepressants (60% vs. 32.5%, odds ratio 3.11, 95% confidence interval 1.33-7.32); this was partially explained by between-group differences in current antidepressant use. CONCLUSIONS: Preconception women were more likely than pregnant women to intend to use antidepressants in pregnancy, in part because more of them were already using this treatment. Strategies to enhance support for decision-making about antidepressant medication use in pregnancy may need to be tailored differently for pregnancy-planning and already pregnant women.

A patient decision aid for antidepressant use in pregnancy: Pilot randomized controlled trial.

BACKGROUND: Decisions about antidepressant use in pregnancy are complex. We performed a pilot randomized controlled trial assessing the feasibility of a trial protocol for an online patient decision aid (PDA) for women deciding about antidepressant use in pregnancy. METHODS: 96 preconception and pregnant Canadian women recruited from specialist (n = 51) and non-specialist (n = 45) settings with Decisional Conflict Scale (DCS, range 0-100) score of ≥25 signifying moderate-to-high decisional conflict were randomly allocated to either the PDA or a control condition that guided participants to publicly available resources for advice around antidepressants and pregnancy. Follow-up data were collected at 4 weeks post-randomization. RESULTS: About 88.9% of eligible participants consented to participate. Women's views of the tool were positive; 88.7% of participants provided follow-up data. At follow-up, mean DCS score had decreased by 19.9 points in the PDA group vs. 13.3 in controls (adjusted mean difference, MD, 7.01, 95% CI -14.3 to 0.30). In the non-specialist setting, DCS scores decreased more for PDA users (25.5 points) than controls (10.5 points; adjusted MD -15.1, 95% CI -25.6 to -4.55); the MD was negligible in the specialist setting. LIMITATIONS: The main limitation is the highly educated, high-income nature of our sample. CONCLUSIONS: Evaluation of an online PDA for antidepressant use in pregnancy with national recruitment is feasible. Pilot results suggest that the tool is acceptable and reduces decisional conflict more than clinical care alone in a non-specialist setting. Evaluation of the PDA's impact on longer-term maternal and child clinical outcomes is a key next step.

A patient decision aid for antidepressant use in pregnancy: study protocol for a randomized controlled trial.

BACKGROUND: Many women with depression experience significant difficulty making a decision about whether or not to use antidepressant medication in pregnancy. Patient decision aids (PDAs) are tools that assist patients in making complex health decisions. PDAs can reduce decision-making difficulty and lead to better treatment outcomes. We describe the methods for a pilot randomized controlled trial of an interactive web-based PDA for women who are having difficulty deciding about antidepressant drug use in pregnancy. METHODS/DESIGN: This is a pilot randomized controlled trial that aims to assess the feasibility of a larger, multi-center efficacy study. The PDA aims to help a woman: (1) understand why an antidepressant is being recommended, (2) be knowledgeable about potential benefits and risks of treatment and non-treatment with antidepressants, and (3) be clear about which benefits and risks are most important to her, with the goal of improving confidence in her decision-making. We include women aged 18 years or older who are: (1) planning a pregnancy or are pregnant (gestational age less than 30 weeks), (2) diagnosed with major depressive disorder, (3) deciding whether or not to use a selective serotonin reuptake inhibitor (SSRI) or serotonin norepinephrine reuptake inhibitor (SNRI) antidepressant in pregnancy, and (4) having at least moderate decision-making difficulty as per a Decisional Conflict Scale (DCS) Score ≥25. Participants are randomized to receive the PDA or an informational resource sheet via a secure website, and have access to the stated allocation until their final study follow-up. The primary outcomes of the pilot study are feasibility of recruitment and retention, acceptability of the intervention, and adherence to the trial protocol. The primary efficacy outcome is DCS score at 4 weeks post randomization, with secondary outcomes including depressive and anxiety symptoms. DISCUSSION: Our PDA represents a key opportunity to optimize the decision-making process for women around antidepressants in pregnancy, leading to effective decision-making and optimizing improved maternal and child outcomes related to depression in pregnancy. The electronic nature of the PDA will facilitate keeping it up-to-date, and allow for widespread dissemination after efficacy is demonstrated. TRIAL REGISTRATION: This trial is registered on ClinicalTrials.Gov under the identifier NCT02308592 (first registered: 2 December 2014).

Atypical cystic fibrosis: identification in the primary care setting.

OBJECTIVE: To review the diagnosis of patients with atypical cystic fibrosis (CF). SOURCES OF INFORMATION: A comprehensive search of MEDLINE (1950 to the third week of May 2009), MEDLINE In-Process and Other Non-Indexed Citations and Cases (1950 to the third week of May 2009), and EMBASE (1980 to the fourth week of March 2009). The Cystic Fibrosis Canada website was also reviewed and the most recent patient data registry report was consulted. MAIN MESSAGE: Atypical CF is a milder form of the CF disorder, which is associated with mutations of the cystic fibrosis transmembrane receptor gene. Instead of having classic symptoms, individuals with atypical CF might only have mild dysfunction in 1 organ system and might or might not have elevated sweat chloride levels. Atypical CF is a very diverse disorder affecting different organ systems to varying degrees. The symptoms patients experience can also fluctuate over time; however, certain clinical signs and symptoms affecting the respiratory, gastrointestinal, endocrine and metabolic, and genitourinary systems should alert physicians to the possibility of CF. Patients with atypical CF often have fewer hospitalizations during childhood than those with classic CF do, and the disorder can remain undiagnosed for many years, at times into adulthood. CONCLUSION: Although patients diagnosed with atypical CF have longer life expectancies than individuals with classic CF, the long-term expected outcome for many individuals with atypical CF is unknown. It is important to counsel patients about the possibility of future illness. Education about CF can help patients understand their symptoms, modify their lifestyles to optimize health, reduce the incidence of complications, and receive family planning counseling when appropriate.