- Describe your topic.
- What are the effectiveness and harms of pharmacological interventions (antipsychotics, benzodiazepines, lithium, anticonvulsants, mood stabilizers, antidepressants, stimulants, opioid use disorder pharmacotherapies, alcohol use disorder pharmacotherapies) compared to each other, to non-pharmacologic interventions, and to placebo/no treatment for treating women with a mental health disorder who are planning to become pregnant, are pregnant, postpartum, or breastfeeding? Non-pharmacological treatments would include psychotherapy, psychoeducation and other psychosocial interventions, including multi-component programs. It would also include non-pharmacological somatic therapies such as electroconvulsive therapy or transcranial magnetic stimulation, if relevant studies have been conducted. Outcomes related to efficacy/ effectiveness and harms may differ somewhat with the condition being treated and the specific therapeutic approach being used, but may include some or all of the following: • Maternal Outcomes: o Death (including suicide, all-cause mortality and cause-specific [e.g., cardiac] death) o Danger to self (suicidal and nonsuicidal behaviors) o Danger to infant (infanticidal behavior, abuse, or neglect) o Symptomatology as determined using validated scales Response Remission Speed and duration of response/remission Relapse Recurrence Change in core symptoms of illness o Functioning including capacity to care for self, infant and family o Quality of life using validated scales (e.g., Medical Outcomes Survey 36-item Short Form) o Interpersonal interactions including mother-father dyad and mother-infant dyad o Delivery and postpartum parameters o Breastfeeding status o Pregnancy weight gain o Social services utilization including use of child protective services o Maternal health system resource utilization including emergency department use, hospitalizations, and office visits o Adherence or persistence with treatment regimen o Treatment related harms Specific adverse effects or withdrawals due to specific adverse events related to treatment (e.g., hyponatremia, activation of mania/hypomania, seizures, suicidal ideation, hepatoxicity, weight gain, metabolic syndrome, gastrointestinal symptoms, and loss of libido) Overall adverse-event reports Withdrawals from study and discontinuation of treatment due to adverse events Adverse events associated with discontinuation of treatment Serious adverse events reported including in observational studies (e.g., maternal hemorrhage) • Fetus, Infant, Child Outcomes: o Preterm birth (e.g., < 32 weeks, < 37 weeks) o Size relative to gestational age (normalized for race/ethnicity) o Birth hospitalization length of stay o Parameters at birth and up to 12 months of age (normalized by age and sex) to assess appropriate growth (height, weight, head circumference, body mass index percentile) o Growth and development after 1 year of age: o Infant attachment o Developmental screening results and diagnoses o Learning (e.g., linguistic, cognitive, and social-emotional skills) and educational achievement Standardized testing outcomes Individualized education plans/use of specialized school services School failure/dropout rate High school graduation rate Missed school days o Social and emotional development o Health care utilization (well-baby visits, primary care, emergency department, hospitalization) o Social services utilization (Women, Infants, and Children Program [WIC], community health nurse, social worker, State Department of Health and Human Services, free and reduced lunch, and food stamps) o Contact with juvenile justice system. o Community resource utilization (community engagement measures) o Quality of life o Harms All-cause mortality Congenital anomalies (any) stratified into major and minor with further grouping by organ system or type of anomaly Other specific adverse events (e.g., low APGAR scores, withdrawal symptoms [neonatal abstinence symptoms], pulmonary hypertension, respiratory distress, neonatal convulsions, heart defects)
- Describe why this topic is important.
- For women who are pregnant or planning to become pregnant and for women who are post-partum, decisions about treatment for psychiatric conditions can be challenging. Women and their treating clinicians need to consider the potential risks of untreated illness to mother and fetus/infant as well as the comparative effectiveness and potential harms of available therapies. When medications are used at the time of conception, during pregnancy, or after delivery, decisions need to consider the risks to the fetus/infant from exposure in utero or via breast milk. Both the benefits and harms of treatment choices can have short- and long-term implications for the patient as well as for her child. A significant fraction of women of child-bearing age will experience a psychiatric illness in a given year (Kessler RC et al. Arch Gen Psychiatry. 2005 Jun;62(6):617-27). In addition to the negative effects of untreated psychiatric illness on the patient, it is increasingly clear that untreated illness can also be detrimental to the fetus/infant (Jarde A et al. JAMA Psychiatry. 2016 Aug 1;73(8):826-37; Gentile S. Neuroscience. 2017 Feb 7;342:154-166). There are also concerns that inadequate treatment of psychiatric symptoms may reduce adherence with prenatal care, decrease nutrient intake, increase alcohol or tobacco use, and produce disruptions within the family environment or in mother-infant bonding (ACOG Committee on Practice Bulletins—Obstetrics. Obstet Gynecol. 2008 Apr;111(4):1001-20). Furthermore, an estimated 5-15% of women will be taking a psychotropic medication during pregnancy and the use of psychotropic medications during pregnancy, including use of multiple concomitant medications, has been increasing in recent years (Hanley GE, Mintzes B. BMC Pregnancy Childbirth. 2014 Jul 22;14:242; Epstein RA et al. Pharmacoepidemiol Drug Saf. 2013 Jul;22(7):794-801; Leong C et al. Can J Psychiatry. 2017 Aug;62(8):543-550; Park Y et al. Psychiatr Serv. 2017 Nov 1;68(11):1112-1119; McAllister-Williams RH et al. J Psychopharmacol. 2017 May;31(5):519-552). Psychotropic medications cross the placenta and enter breast milk to varying degrees. Effects on the fetus/infant also vary depending upon the medication class, the specific drug and the stage of development at which exposure occurred. Some medications do not appear to have untoward effects, others have mild self-limited effects and still others appear to be associated with relatively rare but serious risks including significant congenital malformations (McAllister-Williams RH et al. J Psychopharmacol. 2017 May;31(5):519-552; Larsen ER et al. Acta Psychiatr Scand Suppl. 2015;(445):1-28; Petersen I et al. Health Technol Assess. 2016 Mar;20(23):1-176; Kronenfeld N et al. Birth Defects Res. 2017 Jul 17;109(12):957-997; Ornoy A et al. Birth Defects Res. 2017 Jul 17;109(12):933-956). As a result of these risks associated with taking psychotropic medications in pregnancy and during breastfeeding, many women choose to discontinue these medications during pregnancy or while breastfeeding (Larsen ER et al. Acta Psychiatr Scand Suppl. 2015;(445):1-28; Margulis AV et al. Matern Child Health J. 2014 Sep;18(7):1742-52; Petersen I et al. Schizophr Res. 2014 Oct;159(1):218-25); however, there are also risks with stopping medications including an increased likelihood of relapse with worsened outcomes for the patient and the fetus/infant (Wesseloo R et al. Am J Psychiatry. 2016 Feb 1;173(2):117-27). Consequently, it is essential for women and their treating clinicians to have needed information to be able to make informed, well-educated decisions that will be optimal for her and her baby whether that is to opt for no treatment, use non-pharmacological treatments only, begin pharmacotherapy, or continue current pharmacotherapy as is or with indicated adjustments in the number, type or dose of medications.
- Tell us why you are suggesting this topic.
- An up-to-date and comprehensive evidence report would be valuable to treating clinicians of all specialties -- mental health, primary care, addiction, and obstetrics-gynecology – particularly given the rapidly evolving literature on mental health interventions. Furthermore, the available literature is complex and can be difficult to interpret without substantial methodological expertise. Confounding factors are common because the vast majority of studies are based on observational, electronic record or registry data. Studies sometimes reach differing conclusions, which makes it difficult for clinicians and patients to understand the benefits and harms of specific treatment options. A well-done systematic review that synthesizes the best available evidence on this topic would be of major benefit. We do not have a target date but the system will not let me submit without one.
- Target Date.
- 2016-03-01
- Describe what you are doing currently and what you are hoping will change because of a new evidence report.
- We do not currently have any general guidance for members or the public on women with a mental health or substance use disorder and pregnancy. We have only addressed the issue in specific disorder-based guidelines, as appropriate, with a recommendation or suggestion statement. We are hoping to be able to provide more comprehensive information covering pregnancy planning, pregnancy, and the post-partum period including breastfeeding considerations. We also wish to include information on all psychotropic medications regardless of the diagnosis that is being treated, because many psychotropic medications and psychotherapies are used in more than one mental health condition.
- How will you or your group use the information from a new evidence report?
- The results of the effectiveness and harms review will be used to inform development of a practice guideline on treating women with a mental health and/or substance use disorder who are planning to become pregnant, are pregnant, postpartum, or breastfeeding. The APA has never produced a guideline on this topic. The American College of Obstetrics and Gynecology produced a guideline in 2008 with an update in 2012. There is a recent consensus document from the British Association for Psychopharmacology completed in 2017, but it did not include a complete systematic review of the recent evidence and focused on somatic treatments rather than psychotherapeutic interventions.
- How would you or your group plan to disseminate information from the report? Who would you plan to disseminate it to?
- Our guidelines are publicly available at no cost on our web site, as well as being available for sale in hard copy. We also provide derivative products on the guideline page and would consider materials such as a CME program, patient guide, training slides, and others. Additional dissemination could involve other specialty organizations that we identify in our development process, payers, or participants in registries such as the American Psychiatric Association's PsychPRO registry.
- Do you know of organizations that could use an evidence report to change clinical practice? Are you a part of, or have you been in contact with, any organizations that might implement the research findings of an evidence report?
- We have not been in contact with any other organizations about implementing findings of the report; however, multiple other specialty organizations would benefit including other mental health professional groups, specialists in obstetrics and gynecology, as well as primary care clinicians. Specific organizations to consider contacting may include the American Psychological Association, the American Society of Addiction Medicine, the American Academy of Addiction Psychiatry, the American College of Obstetricians and Gynecologists, the American College of Physicians, and the American Academy of Family Physicians.
- Information About You: (optional)
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- Provide a description of your role or perspective.
- Professional society
- If you are you making a suggestion on behalf of an organization, please state the name of the organization.
- American Psychiatric Association
- Please tell us how you heard about the Effective Health Care Program.
- I have worked with the AHRQ and EHCP before.
