This study aims to describe the disease burden, characteristics and treatment patterns of gastroparesis patients in England. Gastroparesis is a chronic condition where the stomach cannot empty normally, meaning that food passes through slower than usual, likely due to a problem with the nerves and muscles controlling this process. Gastroparesis has few treatment options available. Treatment focuses on symptom management using several off-label medications and few select surgeries. Symptoms of gastroparesis include weight-loss, bloating, abdominal pain, nausea and vomiting. Gastroparesis is often associated with diabetes, both type 1 and type 2.
All Clinical Practice Research Datalink-Hospital Episode Statistics linked patients with a diagnosis of gastroparesis in their record will be included in the study and will be sub-divided into diabetes-related gastroparesis and idiopathic (unknown origin) gastroparesis. Patients with gastroparesis due to other causes will be excluded. The proportion of patients receiving medications and procedures to treat gastroparesis will be described, followed by the sequence and duration of treatments received. The study will compare the use of healthcare services by gastroparesis patients to patients without gastroparesis in terms of hospital stays, surgeries and outpatient visits – overall costs compared.
Gastroparesis likely affects a higher proportion of the population than estimated due to the broad nature of its symptoms, leading to underdiagnosis. The National Institute for Health and Care Excellence has produced guidelines for one procedure to treat gastroparesis. By describing the burden of this disease in England, this study may help inform more specific clinical guidelines for treatment in the future.
This is a retrospective cohort study using CPRD-HES linked data to describe the disease burden, characteristics and treatment patterns among gastroparesis patients in England. The study includes all prevalent patients with a diagnosis of gastroparesis (based on Read codes) in their CPRD record, who are eligible for linkage to Hospital Episode Statistics (HES) data and will be followed-up from the most recent of 1st April 2007 or date of first gastroparesis diagnosis until censoring, death or end of the study time period (most recently available data). Patients will be subdivided into diabetic gastroparesis (DG) and idiopathic gastroparesis (IG) dependent on the presence of a record of diabetes diagnosis or treatment in their CPRD record. Patients of other aetiologies will be excluded.
Clinical/demographic characteristics (e.g. age, sex, year of diagnosis/index), the proportion of patients who received medications and procedures to treat gastroparesis at any time during follow-up will be described. Treatment patterns among incident patients will be described using Sankey plots showing 1st, 2nd and 3rd lines of therapy, treatment duration and switches. All-cause HCRU and HCRU costs will be assessed and compared to a matched cohort of non-gastroparesis patients. HCRU will be described in terms of inpatient admissions, outpatient visits and A&E visits. Comparator cohorts will have the same inclusion/exclusion criteria as the study cohort, with the added requirement of no gastroparesis diagnosis. Comparators will be matched using either exact or propensity score matching depending on data availability and suitability. All analyses will be stratified by DG vs. IG.
Results will be described using mean (SD), median, minimum and maximum values for continuous variables and counts, percentages and 95% confidence intervals for categorical variables. Diagnoses, patient characteristics and medications will be captured using primary care data from CPRD, whilst medical procedures and HCRU analysis will use linked HES data.
Clinical and demographic characteristics (e.g. age, sex, year of diagnosis, comorbidities), pharmacological treatments for gastroparesis, surgical interventions for gastroparesis, line of therapy, treatment duration, all-cause HCRU costs: primary care visits, hospitalisations, medication prescriptions, procedures.
Christelle Elia - Chief Investigator - IQVIA Ltd ( UK )
Paul Berg - Corresponding Applicant - IQVIA Ltd ( UK )
Erik Landfeldt - Collaborator - IQVIA Solutions Sweden AB
Hafsa Mohamed - Collaborator - IQVIA Ltd ( UK )
Mustafa Dungarwalla - Collaborator - IQVIA World Publications Ltd.
Riho Klement - Collaborator - StatFinn Estonia OU
Sarah Lay-Flurrie - Collaborator - IQVIA Ltd ( UK )
Elizabeth Adamson - Collaborator - IQVIA Ltd ( UK )
Erik Landfeldt - Collaborator - IQVIA Solutions Sweden AB
Hafsa Mohamed - Collaborator - IQVIA Ltd ( UK )
Maria João Fonseca - Collaborator - IQVIA Ltd ( UK )
Peter McMahon - Collaborator - IQVIA Ltd ( UK )
Riho Klement - Collaborator - StatFinn Estonia OU
Sarah Lay-Flurrie - Collaborator - IQVIA Ltd ( UK )
HES Accident and Emergency;HES Admitted Patient Care;HES Outpatient