Prediction models and nomograms for 10-year risk of end-stage renal disease in Chinese type 2 diabetes mellitus patients in primary care.

AIMS: To develop and validate 10-year risk prediction models, nomograms and charts for end-stage renal disease (ESRD) in Chinese patients with type 2 diabetes mellitus (T2DM) in primary care, in order to guide individualized treatment. MATERIALS AND METHODS: This was a 10-year population-based observational cohort study. A total of 141 516 Chinese T2DM patients without history of cardiovascular disease or ESRD who were managed in public primary care clinics in 2008 were included and followed up until December 2017. Two-thirds of these patients were randomly selected to develop sex-specific ESRD risk prediction models using Cox regressions. The validity and accuracy of the models were tested on the remaining third of patients using Harrell's C-index. We selected variables based on their clinical and statistical importance to construct the nomograms and charts. RESULTS: The median follow-up period was 9.75 years. The cumulative incidence of ESRD was 6.0% (men: 6.1%, women: 5.9%). Age, diabetes duration, systolic blood pressure (SBP), SBP variability, diastolic blood pressure, triglycerides, glycated haemoglobin (HbA1c), HbA1c variability, urine albumin to creatinine ratio (UACR), and estimated glomerular filtration rate (eGFR) were significant predictors for both sexes. Smoking and total cholesterol to HDL cholesterol ratio were additional significant predictors for men and women, respectively. The models showed Harrell's C-statistics of 0.889/0.889 (women/men). Age, eGFR, UACR, SBP and HbA1c were selected for both sexes to develop nomograms and charts. CONCLUSIONS: Using routinely available variables, the 10-year ESRD risk of Chinese T2DM patients in primary care can be predicted with approximately 90% accuracy. We have developed different tools to facilitate routine ESRD risk prediction in primary care, so that individualized care can be provided to prevent or delay ESRD in T2DM patients.

Cost-effectiveness of a primary care multidisciplinary Risk Assessment and Management Program for patients with diabetes mellitus (RAMP-DM) over lifetime.

PURPOSE: The multidisciplinary Risk Assessment and Management Program for patients with diabetes mellitus (RAMP-DM) was found to be cost-saving in comparison with usual primary care over 5 years' follow-up. This study aimed to estimate the cost-effectiveness of RAMP-DM over lifetime. METHODS: We built a Discrete Event Simulation model to evaluate the cost-effectiveness of RAMP-DM over lifespan from public health service provider's perspective. Transition probabilities among disease states were extrapolated from a cohort of 17,140 propensity score matched participants in RAMP-DM and those under usual primary care over 5-year's follow-up. The mortality of patients with specific DM-related complications was estimated from a cohort of 206,238 patients with diabetes. Health preference and direct medical costs of DM patients referred to our previous studies among Chinese DM patients. RESULTS: RAMP-DM individuals gained 0.745 QALYs and cost US$1404 less than those under usual care. The probabilistic sensitivity analysis found that RAMP-DM had 86.0% chance of being cost-saving compared to usual care under the assumptions and estimates used in the model. The probability of RAMP-DM being cost-effective compared to usual care would be over 99%, when the willingness to pay threshold is HK$20,000 (US$ 2564) or higher. CONCLUSION: RAMP-DM added to usual primary care was cost-saving in managing people with diabetes over lifetime. These findings support the integration of RAMP-DM as part of routine primary care for all patients with diabetes.

Ten-year risk prediction models of complications and mortality of Chinese patients with diabetes mellitus in primary care in Hong Kong: a study protocol.

INTRODUCTION: Diabetes mellitus (DM) is a major disease burden worldwide because it is associated with disabling and lethal complications. DM complication risk assessment and stratification is key to cost-effective management and tertiary prevention for patients with diabetes in primary care. Existing risk prediction functions were found to be inaccurate in Chinese patients with diabetes in primary care. This study aims to develop 10-year risk prediction models for total cardiovascular diseases (CVD) and all-cause mortality among Chinese patients with DM in primary care. METHODS AND ANALYSIS: A 10-year cohort study on a population-based primary care cohort of Chinese patients with diabetes, who were receiving care in the Hospital Authority General Outpatient Clinic on or before 1 January 2008, were identified from the clinical management system database of the Hospital Authority. All patients with complete baseline risk factors will be included and followed from 1 January 2008 to 31 December 2017 for the development and validation of prediction models. The analyses will be carried out separately for men and women. Two-thirds of subjects will be randomly selected as the training sample for model development. Cox regressions will be used to develop 10-year risk prediction models of total CVD and all-cause mortality. The validity of models will be tested on the remaining one-third of subjects by Harrell's C-statistics and calibration plot. Risk prediction models for diabetic complications specific to Chinese patients in primary care will enable accurate risk stratification, prioritisation of resources and more cost-effective interventions for patients with DM in primary care. ETHICS AND DISSEMINATION: The study was approved by the Institutional Review Board of the University of Hong Kong-the Hospital Authority Hong Kong West Cluster (reference number: UW 15-258). TRIAL REGISTRATION NUMBER: NCT03299010; Pre-results.

Five-Year Cost-effectiveness of the Multidisciplinary Risk Assessment and Management Programme-Diabetes Mellitus (RAMP-DM).

OBJECTIVE: To estimate the cost-effectiveness of the multidisciplinary Risk Assessment and Management Programme-Diabetes Mellitus (RAMP-DM) in primary care patients with type 2 diabetes in comparison with usual primary care in a cohort with 5 years' follow-up. RESEARCH DESIGN AND METHODS: We conducted a prospective cohort study among 17,140 propensity score-matched participants in RAMP-DM and those under usual primary care. The effectiveness measures were cumulative incidences of complications and all-cause mortality over 5 years. In a bottom-up approach, we estimated the program costs of RAMP-DM and health service utilization from the public health service provider's perspective. The RAMP-DM program costs included the setup costs, ongoing intervention costs, and central administrative costs. We calculated the incremental cost-effectiveness ratio by dividing the incremental costs by the incremental effectiveness of the RAMP-DM group compared with those of the usual-care group. RESULTS: There were significantly lower cumulative incidences of individual on any complications (15.34% vs. 28.65%, P < 0.001) and all-cause mortality (7.96% vs. 21.35%, P < 0.001) in the RAMP-DM group compared with the usual-care group. The mean program cost of RAMP-DM was 157 U.S. dollars (range 66-209) per participant over 5 years. The costs of health service utilization among participants in RAMP-DM group was 7,451 USD less than that of the usual-care group, resulting in a net savings of 7,294 USD per individual. CONCLUSIONS: RAMP-DM added to usual primary care was a cost-saving intervention in managing diabetes in patients over 5 years. These findings support the integration of RAMP-DM as part of routine primary care for all patients with diabetes.

Five-Year Effectiveness of the Multidisciplinary Risk Assessment and Management Programme-Diabetes Mellitus (RAMP-DM) on Diabetes-Related Complications and Health Service Uses-A Population-Based and Propensity-Matched Cohort Study.

OBJECTIVE: To evaluate the 5-year effectiveness of a multidisciplinary Risk Assessment and Management Programme-Diabetes Mellitus (RAMP-DM) in primary care patients with type 2 diabetes. RESEARCH DESIGN AND METHODS: A 5-year prospective cohort study was conducted with 121,584 Chinese primary care patients with type 2 DM who were recruited between August 2009 and June 2011. Missing data were dealt with multiple imputations. After excluding patients with prior diabetes mellitus (DM)-related complications and one-to-one propensity score matching on all patient characteristics, 26,718 RAMP-DM participants and 26,718 matched usual care patients were followed up for a median time of 4.5 years. The effect of RAMP-DM on nine DM-related complications and all-cause mortality were evaluated using Cox regressions. The first incidence for each event was used for all models. Health service use was analyzed using negative binomial regressions. Subgroup analyses on different patient characteristics were performed. RESULTS: The cumulative incidence of all events (DM-related complications and all-cause mortality) was 23.2% in the RAMP-DM group and 43.6% in the usual care group. RAMP-DM led to significantly greater reductions in cardiovascular disease (CVD) risk by 56.6% (95% CI 54.5, 58.6), microvascular complications by 11.9% (95% CI 7.0, 16.6), mortality by 66.1% (95% CI 64.3, 67.9), specialist attendance by 35.0% (95% CI 33.6, 36.4), emergency attendance by 41.2% (95% CI 39.8, 42.5), and hospitalizations by 58.5% (95% CI 57.2, 59.7). Patients with low baseline CVD risks benefitted the most from RAMP-DM, which decreased CVD and mortality risk by 60.4% (95% CI 51.8, 67.5) and 83.6% (95% CI 79.3, 87.0), respectively. CONCLUSIONS: This naturalistic study highlighted the importance of early optimal DM control and risk factor management by risk stratification and multidisciplinary, protocol-driven, chronic disease model care to delay disease progression and prevent complications.

Evaluation of the quality of care of a multi-disciplinary Risk Factor Assessment and Management Programme for Hypertension (RAMP-HT).

BACKGROUND: There is some evidence to support a risk-stratified, multi-disciplinary approach to manage patients with hypertension in primary care. The aim of this study is to evaluate the quality of care (QOC) of a multi-disciplinary Risk Assessment and Management Programme for Hypertension (RAMP-HT) for hypertensive patients in busy government-funded primary care clinics in Hong Kong. The objectives are to develop an evidence-based, structured and comprehensive evaluation framework on quality of care, to enhance the QOC of the RAMP-HT through an audit spiral of two evaluation cycles and to determine the effectiveness of the programme in reducing cardiovascular disease (CVD) risk. METHOD/DESIGN: A longitudinal study is conducted using the Action Learning and Audit Spiral methodologies to measure whether pre-set target standards of care intended by the RAMP-HT are achieved. A structured evaluation framework on the quality of structure, process and outcomes of care has been developed based on the programme objectives and literature review in collaboration with the programme workgroup and health service providers. Each participating clinic is invited to complete a structure of care evaluation questionnaire in each evaluation cycle. The data of all patients who have enrolled into the RAMP-HT in the pre-defined evaluation periods are used for the evaluation of the process and outcomes of care in each evaluation cycle. For evaluation of the effectiveness of RAMP-HT, the primary outcomes including blood pressure (both systolic and diastolic), low-density lipoprotein cholesterol and estimated 10-year CVD risk of RAMP-HT participants are compared to those of hypertensive patients in usual care without RAMP-HT. DISCUSSION: The QOC and effectiveness of the RAMP-HT in improving clinical and patient-reported outcomes for patients with hypertension in normal primary care will be determined. Possible areas for quality enhancement and standards of good practice will be established to inform service planning and policy decision making.