Feasibility study on dengue infection requiring general practice and hospital care

Study type
Feasibility Study
Date of Approval
Study reference ID
FS_002795
Lay Summary

Dengue is a mosquito-borne infection which is carried to humans by mosquito bites in certain parts of Asia, Africa, South America and Southern Europe. Many travellers returning from these regions to the United Kingdom (UK) have been infected with Dengue. Some develop severe symptoms, such as high-grade fever and bleeding, which require admission to hospital for treatment. There is limited information about dengue patients utilising the healthcare services in the UK. This feasibility study seek to understand if the Clinical Practice Research DataLink data sources called AURUM and GOLD and the Hospital Episodes Statistics datasets can be utilised to assess how many people present with dengue in the UK and what types of symptoms that they suffer from as well as how they are cared for while in hospital, including their cost. Therefore, this feasibility study will check what potential outcomes they may have in terms of symptoms and utilisation of healthcare resources as well as mortality; the quality and completeness of this data will be assessed. All this information will inform whether it will be possible to conduct a study with good quality on dengue using CPRD and HES data sources and the findings will be used to inform health professionals and providers about the impact of dengue on patients and the health care system, especially developing preventative measures and the planning of adequate care for dengue in the UK.

Technical Summary

Dengue is transmitted to humans through mosquito bites in endemic regions of Asia, Africa, South America and Southern Europe. Many travellers returning from these regions to the United Kingdom (UK) have been infected with Dengue. Some develop severe symptoms, such as high-grade fever and haemorrhages, requiring admission to hospital. Diagnosis codes and general practice codes (ICD 10 in Hospital Episodes Statistics (HES) and medcodes or READ codes in Clinical Practice Research DataLink (CPRD) AURUM or GOLD) for dengue will be used to identify patients. HES datasets will be required because they contain admitted, outpatient and emergency care data for potentially severe dengue. The sample sizes for dengue patients (in primary and secondary care) will be obtained, including for subgroups of interest, which would be potential inclusion criteria (e.g. elderly) for future research on dengue. Historical data on dengue is important as recurrent infection can be more severe. Therefore, data from the earliest possible time on CPRD and HES datasets will therefore be required, as well as for assessing the distribution of risk factors (e.g. comorbidities or symptoms) on outcomes (e.g. mortality). Data quality and completeness for key variables will be assessed. The possibility to define cause-specific hospitalisation, outpatient visits and general practice consultations will also be assessed. Basic summary statistics (including counts, proportions, mean and, standard deviations, medians and interquartile ranges, etc) will be obtained. Rates in person-time will be calculated wherever appropriate. This feasibility study will use this data to assess the potential of conducting good quality research on dengue using CPRD and HES data sources, which will be planned to generate evidence to inform health professionals and providers about the impact of dengue on patients and the healthcare system, with an aim to developing preventative measures and for the planning of adequate care for dengue in the UK.

Health Outcomes to be Measured

This feasibility study will assess the possibility of identifying several demographic and clinical characteristics (described below in section D, which will assist with the planning of studies). In addition, the following outcome measures will be determined as part of the feasibility study:
• Mortality (cause-specific, overall; number, and proportions)
• Survival (feasibility of defining and estimating disease-free or progression-free, overall)
• Hospitalisation, outpatient visits and general practice consultation (cause-specific and overall)
• Pregnancy and birth among dengue patients

Collaborators

Indraraj Umesh Doobaree - Chief Investigator - Takeda UK Limited
Indraraj Umesh Doobaree - Corresponding Applicant - Takeda UK Limited
Ananya Roy Chowdhury - Collaborator - Takeda Development Center Americas, Inc.
Ning (Julia) Zhu - Collaborator - Takeda Development Center Americas, Inc.
SUDHAKAR MANNE - Collaborator - Takeda Development Center Americas, Inc.

Linkages

CPRD Aurum Pregnancy Register;CPRD GOLD Pregnancy Register;CPRD GOLD Mother-Baby Link;HES Accident and Emergency;HES Admitted Patient Care;HES Outpatient;ONS Death Registration Data;Patient Level Index of Multiple Deprivation;CPRD Aurum Mother-Baby Link;Practice Level Index of Multiple Deprivation (Standard)