Core Outcome Measures in Effectiveness Trials

Core Outcome Set for Studies on Obesity in Pregnant Patients (COSSOPP)

General Information

Summary:
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

Contributors:
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

Further Study Information

Current Stage:
Ongoing
Date:
November 2017 - December 2019
Funding source(s):
None at present

Health Area

Disease Category
Pregnancy & childbirth

Disease Name
Obesity

Target Population

Age Range
16 - 50

Sex
Female


Nature / type of Intervention
Any

Method(s)

Consensus meeting
Delphi process
Focus group(s)
Interview
Literature review
Systematic review

Stakeholders Involved

Clinical experts
Conference participants
Consumers (caregivers)
Consumers (patients)
Epidemiologists
Families
Guideline developers
Policy makers
Researchers
Service providers
Service users
Statisticians
Trialists

Study Type

COS for clinical trials or clinical research
COS for practice
Definition
Patient perspectives

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