(PS2-B26) Developing a Core Outcome Set for Perinatal Women with Generalized Anxiety Disorder (GAD): Standardizing Reported Outcomes in Clinical Research

Background: Anxiety disorders during the perinatal period (pregnancy and the first year postpartum) affect between 15-24% of women, with generalized anxiety disorder (GAD) occurring most frequently. Untreated GAD during the perinatal period is associated with poor emotional, behavioural, and functional outcomes for both mother and infant, illuminating the importance to identify and evaluate safe and effective treatments. Currently, treatment studies that assess the effectiveness of interventions for GAD during the perinatal period (e.g., Cognitive Behavioural Therapy; CBT) measure a variety of different outcomes which are subjectively chosen to determine if the treatment is effective. This variability of outcome selection impedes the ability to compare and contrast treatments for this population and impedes the systematic reviews and meta-analyses synthesis process. To prevent this variability in outcome selection and measurement, a standardized core outcome set can be developed and implemented.

Methods: The aim of this study is to develop a core outcome set (COS) for GAD during the perinatal period. A COS is a standardized list of outcomes to be measured and reported in all clinical studies of a specific health condition. A COS does not restrict researchers to measure only the outcomes in the COS, rather, it is a list of outcomes that researchers should measure at minimum to determine if a treatment for a particular condition is effective. Developing a COS for GAD during the perinatal period would minimize the variability in outcomes reported across clinical research studies for GAD in perinatal women, improve the evidence synthesis process and translation to care through systematic reviews and meta-analyses, and ensure that reported outcomes in trials are relevant to stakeholders such as researchers, clinical service providers, and most importantly, patients.

Results: This multi-phase project is currently underway. The first phase of the project is complete where researchers conducted a scoping review to identify the outcomes and measures that are currently used in treatment studies aiming to assess the effectiveness of interventions for GAD during the perinatal period. The authors found that although 75% of the studies assessed the effectiveness of same type of therapy (i.e., CBT) and heterogeneity existed in the outcomes and measures that were used across these treatment studies, halting the ability to synthesize the results of these studies into systematic reviews or meta-analyses. The next step of this project is in progress namely, to conduct focus groups with patients with lived experience of GAD during the perinatal period to identify the treatment outcomes that matter the most to them. As thematic analysis will take place and results will be reported.

Conclusions: As clinicians and researchers continue to establish best practice guidelines for GAD during the perinatal period, developing a COS for this population would significantly improve the method development of CBT approaches and inform future clinical trials.