Real World Evidence Study to Support Project Obesity: Determine co-diseases scenarios among Overweight and Obese patients. Assessment of metabolic profiles and economic burden of these different scenarios

Study type
Protocol
Date of Approval
Study reference ID
18_098
Lay Summary

Overweight and obesity have been found to be related to several diseases such as preventive diseases and established diseases as an example Diabetes, cardiovascular diseases, or certain types of cancer. This study seeks to examine the different scenarios of co-diseases in obese and overweight patients and the impact of these profiles on the use of the health care system such as more frequent hospital admission, higher number of contacts to the general practitioner (GP) and a higher number of prescriptions.
All adult patients in the CPRD are followed in 1 year period where hospital admission, contacts to general practitioners and number of prescriptions are registered. Each patient will be categorized based on their body mass index (BMI) in Obese or in Overweight group. The associated co-diseases will be assessed using the previous medical history of 1 year before the status of BMI. The findings of this study can provide valuable insight into the co-diseases profile in obesity and their impact on the economic burden.

Technical Summary

Objectives: The aim of this study is to use data from the Clinical Practice Research Datalink to identify and characterise overweight and obese patients by assessing scenarios of comorbidities and their impact on disease burden (using the metabolic profiles*) and on the economic burden using Health care resource utilization.

Methods: Retrospective overweight and obese cohorts will be derived. Cohorts will be defined using BMI values and diagnosis codes occurred between January 2014 and December 2015. Patients will be defined as Obese if BMI >/=30 kg/m2 as Overweight if BMI inside the range 25-29.9 kg/m2. Index date will be defined as the first status of Obese or overweight recorded during this period. Baseline period will be defined by 12-month pre-index date and follow-up period by 12 months after index date. Continuous enrolment of 1 year over baseline and follow-up will be required to be eligible for inclusion as a selected index date. Women with at least one record of pregnancy over baseline or follow-up will be excluded.

Analysis: Descriptive analysis will be conducted. Scenarios of comorbidities, Demographics, Treatment patterns, metabolic profiles will be described at baseline. Health care utilizations will be described during the follow-up period. All these parameters will be described in overweight and obese classes and in different scenarios of comorbidities considerate as interest for the research.

Health Outcomes to be Measured

Comorbidities
- Treatment patterns
- Primary and secondary care utilisation
- Metabolic profiles through LAB
- Primary and secondary care costs

Collaborators

Caroline Amand - Chief Investigator - Sanofi Winthrop Industrie (France)
Caroline Amand - Corresponding Applicant - Sanofi Winthrop Industrie (France)
Alexandre Civet - Collaborator - Quinten S.A.S.
Lilia Ben-Debba - Collaborator - SANOFI
Nicola Clavel - Collaborator - Quinten S.A.S.
Sébastien Tourlet - Collaborator - Quinten S.A.S.

Linkages

HES Accident and Emergency;HES Admitted Patient Care;HES Outpatient;ONS Death Registration Data