Date of ISAC Approval:
Gastroparesis, paralysis of the muscles of the stomach, usually results in delayed emptying of food from the stomach into the small intestine which causes symptoms such as nausea and vomiting. As of today, there are only two publications that studied the percentage of the population affected by this condition. The only studies that looked at the condition were conducted in a small population in the United States (US) from Olmstead County, Minnesota. The number of patient affected by gastroparesis has not not been studied in the United Kingdom (UK). We propose to use the Clinical Practice Research Datalink (CPRD) to generate real world evidence about gastroparesis. The proportion of people who have gastroparesis, newly diagnosed with the condition, and how does the disease progress in the general UK population will be studied. Additionally, we will describe the characteristics of patients and the general medical practice with gastroparesis in the UK. Patients with gastroparesis will be selected from health records in the database and adjusted based on national census data for national estimation. This generated data will be important and useful to improve the knowledge of gastroparesis in the UK and help healthcare practitioners, policy makers, and researchers to better understand the condition.
We aim to evaluate gastroparesis epidemiology including both prevalence and incidence and natural history within the UK CPRD using a retrospective cohort study. The study population will include all patients who were registered at any time during 2000 to 2016 with a "up to research standard" general practice (GP) in the CPRD linkage subset. Incident cases of gastroparesis are defined as newly diagnosed gastroparesis, while prevalent cases include both previously and newly diagnosed patients. At least 1 year of gastroparesis free enrolment is required to distinguish prevalent and incident cases. Prevalence and incidence will be assessed annually. The crude prevalence and incidence will be stratified based on age group and sex and standardized using the age and/or sex-specific UK population estimate in mid-2016 as the reference population. Descriptive statistics for demographics and clinical characteristics as well as the medical practice to manage gastroparesis will be summarized and described for gastroparesis patients.
Health Outcomes to be Measured:
- Prevalence - Incidence - disease management
Dr Paul Dolin - Chief Investigator - Takeda Europe Ltd
Dimitri Bennett - Collaborator - Takeda TGRD - USA
Sudhakar Manne - Collaborator - Takeda TGRD - USA
Yizhou (James) Ye - Corresponding Applicant - Takeda Pharmaceuticals Company Ltd