Background: Hypertensive disorders of pregnancy (HDP) including preeclampsia confer a lifelong increased risk of cardiovascular disease after pregnancy. Recent calls to action outline a need to improve research and clinical care regarding the long-term management after HDP, but there is currently no clinical consensus on which clinical outcomes and outcome measures should be used to evaluate the impact of clinical interventions. This study aims to create a set of core outcomes to guide future research on cardiovascular disease (CVD) prevention after HDP.
Existing COS have assessed the health of birthing person and offspring immediately post delivery, and cardiac diseases during pregnancy, but none-to-date have assessed for long term cardiovascular disease outcomes in this patient population.
Determining a set of core outcomes has the potential to impact clinician and researchers’ ability to compare data, as this field of literature grows and evolves. Ultimately, a core data set can lead to clinical decisions that improve patient outcomes. The COS-CV-HDP aims to improve the quality of HDP literature with regards to CVD prevention.
Keywords: Hypertensive Disorders of Pregnancy, Preeclampsia, Core outcome set, Clinical interventions, health outcomes, prevention, cardiovascular diseases.
This study aims to create a set of core outcomes to guide future research on cardiovascular disease (CVD) prevention after HDP.Contributors
Kimberley Nix (PI)
Kara Nerenberg (Supervisor)
- COS for clinical trials or clinical research
- COS for practice
- Consensus meeting
- Delphi process
- Semi structured discussion
The COS-CV-HDP project was launched in 2022 and is in keeping with the standards of the Core Outcomes Measures in Effectiveness Trials (COMET) initiative and the Core Outcome Set Standards for Reporting (COS-STAR) statement.
Participants will include interested parties with personal or expert experience with CVD following HDP. These participants will aim to include patients, members of related health organizations, collaborative healthcare providers, and researchers. Participants will be recruited through email invitation and social media invitation. Email invitations will be sent to selected patients who have consented to receive information about research studies through the IMPROVE research clinic, members of the Canadian Post Pregnancy Network, the Heart and Stroke Foundation, and the journal editors of relevant academic publications such as Obstetric Medicine and JOGC. These participants have been identified as key interested parties who may benefit from the identification of outcomes pertaining to CVD following HDP.
The study will take place in 6 stages:
Stage 1: Systematic review, data extraction, synthesis and preliminary determination of relevant outcomes for CVD post HDP.
Stage 2: Investigators meeting will be conducted virtually using institutional Zoom, requiring a password. Meetings will be transcribed but not recorded. Informed consent will be required of all participants. Participants will review the outcomes and add any additional outcomes felt relevant.
Stage 3: 2 (two) rounds of electronic Delphi survey will be conducted to establish outcome hierarchy (to be completed online via Qualtrics by all individuals identified above as interested parties). Participants will need to provide implied consent. Participants will be able to both add and rank outcomes in the first round of the eDelphi survey. Participants will rank items from 1-9 (one being least and 9 being most important). After two rounds, consensus will be reached on outcome inclusion if >70% of survey respondents score the outcome as 7-9 on the scale, and <15% of participants score it 1-3. Outcomes will be dropped if >70% of participants rank the outcome 1-3, with less than 15% of the cohort ranking it 7-9. All other items will move forward to a consensus process.
Stage 4: Consensus meeting will be conducted virtually using institutional Zoom, requiring a password. Meetings will be transcribed but not recorded. Participants will need to provide informed consent.
Stage 5: Analysis of outcomes determined.
Stage 6: Dissemination of study findings.