38.3% of women in the U.S. between 20 and 39 years of age are obese (BMI > 30 kg/m2), congruent with the rising obesity trend globally. In addition to the adverse health risks already present for this population, women entering pregnancy and labour do so at an elevated risk of maternal and neonatal complications compared to women with a normal BMI. Numerous clinical trials exist to improve outcomes, however, these studies are limited in their translation to clinical care due to variable outcome reporting that omits the patient perspective. Outcome standardization addresses irrelevancy of outcomes, researcher bias and study incomparability, and can thus improve research quality and subsequent application to clinical practice. This may be achieved via the development of a Core Outcome Set for Studies in Obese Pregnant Patients (COSSOPP) that involves the relevant stakeholder groups, as per the following objectives:
I. To identify reported outcomes and definitions in the literature thus far;
II. To determine outcomes important to stakeholders, including patients;
III. To achieve consensus and arrive at a COS for future studies
Our methodology to arrive at the COS entails a systematic review of clinical trials and systematic reviews of all study types, a literature review of qualitative studies, a qualitative stage (focus groups and individual interviews) and finally, the Delphi methodology followed by a face-to-face consensus meeting. To arrive at the most appropriate measurements per outcome in the core set, we will evaluate using COSMIN and the Delphi methodology.
PROSPERO Registration of the Systematic Review: CRD42017080279
Protocol: https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-018-3029-1
Principal Investigator
Dr. Rohan D’Souza
Co-investigators
Dr. John Kingdom
Dr. Cynthia Maxwell
Dr. Janet Parsons
Dr. Rory Windrim
Graduate Student
Ms. Rachel Dadouch
Disease Category: Pregnancy & childbirth
Disease Name: Obesity
Age Range: 16 - 50
Sex: Female
Nature of Intervention: Any
- Clinical experts
- Consumers (caregivers)
- Consumers (patients)
- Epidemiologists
- Researchers
- Service providers
- Service users
- Statisticians
- Conference participants
- Families
- Guideline developers
- Policy makers
- Trialists
- COS for clinical trials or clinical research
- COS for practice
- Definition
- Patient perspectives
- Systematic review
- Consensus meeting
- Delphi process
- Focus group(s)
- Interview
- Literature review