10-year Risk Prediction Models of Complications and Mortality of DM in Hong Kong

The University of Hong Kong (HKU)

Status: Completed

Conditions: Mortality; Diabetes Mellitus; Cardiovascular Diseases; Primary Health Care

Study type: Observational

Funder types: Other

Identifiers

NCT03299010

HKUCTR-2232

Details and patient eligibility

About

Diabetes Mellitus (DM) is a well-recognized public health issue worldwide. DM can lead to many complications resulting in morbidity and mortality, approximately 70% of DM related deaths were attributed to cardiovascular diseases (CVD).

Objectives:

To develop 10-year risk prediction models for CVD, end stage renal disease (ESRD) and all-cause mortality among Chinese patients with DM in primary care.

Hypotheses:

1. Patient socio-demographic, clinical parameters, disease characteristics and treatment modalities are predictive of 10-year risk of CVD, ESRD and all-cause mortality.
2. Risk prediction models developed from this study should have over 70% of discriminating power.

Design and Subjects:

10-year retrospective cohort study. All Chinese patients who were clinically diagnosed to have DM and were receiving care in the public (Hospital Authority) primary care clinics on or before 1 July 2006 will be followed up until 31 December 2016.

Main outcomes measures:

For total CVD, CHD, stroke, heart failure, ESRD, all-cause mortality

1. 10-year incidence;
2. Predictive factors

Data analysis:

Two thirds of subjects will be randomly selected as the training sample for model development. Cox regressions will be used to develop sex-specific 10-year risk prediction models for each outcome. The validity of models will be tested on the remaining one third of subjects by Harrell C statistics and ROC

Expected results:

Risk prediction models will enable accurate risk stratification and cost-effective interventions for Chinese DM patients in primary care.

Full description

This study aims to develop 10-year risk prediction models for total CVD and all-cause mortality among Chinese diabetic patients in primary care. Risk prediction models for individual DM complications including CHD, heart failure, stroke and ESRD will also be developed.

The objectives are to:

1. Calculate the 10 years incidence of total CVD, all-cause mortality and each major DM complication in Chinese DM patients in primary care.
2. Determine the risk factors that significantly predict total CVD, all-cause mortality and each major DM complication for Chinese DM patients in primary care.
3. Develop and validate risk prediction models for total CVD, all-cause mortality and each major DM complication for Chinese DM patients in primary care.
4. Develop a risk prediction nomogram and chart for the risk of total CVD, all-cause mortality for Chinese DM patients in primary care

Hypotheses:

1. Patient socio-demographic, clinical parameters, disease characteristics, and treatment modalities are predictive of 10-year risk of total CVD, all-cause mortality and individual DM complication as a dependent variable.
2. The risk prediction models for total CVD, all-cause mortality and individual DM complication developed in this study can have over 70% of discriminating power.

Enrollment: 141,516 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. At least 1 GOPC/FMC attendance on or within 1 year before 1 July 2006
2. Had a CMS (Clinical Management System) record in the Hospital Authority (HA) of the coding of ICPC-2 of T89 (Diabetes insulin dependent) or T90 (Diabetes non-insulin dependent) on or before 1 July 2006

Exclusion criteria

1. Patients who had a diagnosis of any DM complications defined by the relevant ICPC-2 or ICD-9-CM on or before 1 July 2006
2. Patients exclusively managed by Specialist Out-Patient Clinic (SOPC) on or before 1 July 2006.

Trial design

141,516 participants in 1 patient group

DM patient

Description:

Patients with a documented clinical diagnosis of DM and were receiving care in the Hospital Authority (HA) primary care General Out-Patient Clinics (GOPC) and Family Medicine Clinics (FMC) on or before 1 July 2006 identified from the HA clinical management system (CMS) database.