Anxiety disorders (AD) experienced during pregnancy or the postpartum period are known as perinatal anxiety disorders. ADs during the perinatal period affect between 15-24% of pregnant and postpartum women, with generalized anxiety disorder (GAD) occurring most frequently. Untreated perinatal GAD 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 for GAD in perinatal women through clinical trials. Currently, clinical research for perinatal GAD measures a variety of different outcomes which are subjectively chosen to determine if the treatment under study is effective in reducing anxiety symptoms. This variability of outcome selection impedes the ability to compare and contrast studies and synthesize results through systematic reviews and meta-analyses. To prevent this variability in outcome selection and measurement, a standardized core outcome set can be developed and implemented.
A core outcome set (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, a COS 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 perinatal GAD 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.
PI: Sheryl Green, PhD, C.Psych
Collaborators: Benicio Frey, MD, PhD, Dr. Randi McCabe, PhD, C.Psych, Nancy Butcher, PhD, Emma Stallwood, BHSc, BA
Disease Category: Mental health
Disease Name: Perinatal Generalized Anxiety Disorder
Age Range: 18 - 45
Nature of Intervention: Drug, Psychological & behavioural
- Clinical experts
- Conference participants
- Consumers (caregivers)
- Consumers (patients)
- Governmental agencies
- Patient/ support group representatives
- Pharmaceutical industry representatives
- Regulatory agency representatives
- Service providers
- Service users
- COS for clinical trials or clinical research
- COS for practice
- Consensus meeting
- Delphi process
- Focus group(s)
- Literature review
- Semi structured discussion
- Systematic review
This project will use the Core Outcome Measures in Effectiveness Trials Initiative (COMET) and Core Outcome Set-STAndards for Development (COS-STAD) guidelines for developing this COS. Step 1: Identify all reported outcomes in perinatal GAD clinical research studies through a systematic scoping review. Step 2: Conduct focus groups with patients with lived experience of perinatal GAD and other significant family members (e.g., partner) to generate a list of treatment outcomes that are most important to these patients. Step 3: Outcomes generated from step 1 and step 2 will be prioritized through a Delphi survey, which is an iterative multi-stage process that allows group consensus decisions to be made. Two to three rounds of international Delphi surveys will be sent out to perinatal stakeholders (including patients) to prioritize the list of outcomes generated from step 1 and step 2. The results of the Delphi survey will determine a consensus on which outcomes should be prioritized in the COS. Step 4: After completion of the Delphi surveys, a consensus meeting will be held with healthcare professionals who work in the perinatal anxiety field as well as patients with lived experience. The goal of this meeting will be to establish a final COS. Step 5: Dissemination of findings through publication, conference presentations, and social media posts.