An Electronic Health Record Compatible Model to Predict Personalized Treatment Effects from the Diabetes Prevention Program: A Cross-Evidence Synthesis Approach Using Clinical Trial and Real World Data

Background: An intensive lifestyle modification program or metformin pharmacotherapy reduced the risk of developing diabetes in patients at high risk, but are not widely used in the 88 million American adults with prediabetes. Objective: Develop an electronic health record (EHR) based risk tool that provides point-of-care estimates of diabetes risk to support targeting interventions to patients most likely to benefit. Design: Cross-design synthesis: risk prediction model developed and validated in large observational database, treatment effect estimates from risk-based reanalysis of clinical trial data. Setting: Outpatient clinics in US. Patients: Risk model development cohort: 1.1 million patients with prediabetes from the OptumLabs Data Warehouse (OLDW); validation cohort: distinct sample of 1.1 million patients in OLDW. Randomized clinical trial cohort: 3081 people from the Diabetes Prevention Program (DPP) study. Interventions: Randomization in the DPP: 1) an intensive program of lifestyle modification; 2) standard lifestyle recommendations plus 850 mg metformin twice daily; or 3) standard lifestyle recommendations plus placebo twice daily. Results: Eleven variables reliably obtainable from the EHR were used to predict diabetes risk. This model validated well in the OLDW (c-statistic = 0.76; observed 3-year diabetes rate was 1.8% in lowest-risk quarter and 19.6% in highest-risk quarter). In the DPP, the hazard ratio for lifestyle modification was constant across all levels of risk (HR = 0.43, 95% CI 0.35 to 0.53); while the HR for metformin was highly risk-dependent (HR HR = 1.1 [95% CI: 0.61 to 2.0] in the lowest risk quarter vs. HR=0.45 [95% CI: 0.35 to 0.59] in the highest risk quarter). Fifty-three percent of the benefits of population wide dissemination of the DPP lifestyle modification, and 76% of the benefits of population wide metformin therapy can be obtained targeting the highest risk quarter of patients. Limitations: Differences in variable definitions and in missingness across observational and trial settings may introduce estimation error in risk based treatment effects. Conclusion: An EHR compatible risk model might support targeted diabetes prevention to more efficiently realize the benefits of the DPP interventions.

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An Electronic Health Record–Compatible Model to Predict Personalized Treatment Effects From the Diabetes Prevention Program: A Cross-Evidence Synthesis Approach Using Clinical Trial and Real-World Data

Mayo Clinic Proceedings ◽

10.1016/j.mayocp.2021.09.012 ◽

2021 ◽

Author(s):

David M. Kent ◽

Jason Nelson ◽

Anastassios Pittas ◽

Francis Colangelo ◽

Carolyn Koenig ◽

...

Keyword(s):

Clinical Trial ◽

Electronic Health Record ◽

Real World ◽

Prevention Program ◽

Diabetes Prevention ◽

Evidence Synthesis ◽

Diabetes Prevention Program ◽

Health Record ◽

Real World Data ◽

Synthesis Approach

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Integrating data from an online diabetes prevention program into an electronic health record and clinical workflow, a design phase usability study

BMC Medical Informatics and Decision Making ◽

10.1186/s12911-016-0328-x ◽

2016 ◽

Vol 16 (1) ◽

Cited By ~ 17

Author(s):

Rebecca Grochow Mishuris ◽

Jordan Yoder ◽

Dan Wilson ◽

Devin Mann

Keyword(s):

Electronic Health Record ◽

Prevention Program ◽

Diabetes Prevention ◽

Diabetes Prevention Program ◽

Health Record ◽

Design Phase ◽

Usability Study ◽

Clinical Workflow ◽

Electronic Health

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3385 TARGETING DIABETES PREVENTION PROGRAMS: INDIVIDUAL RISK-BASED HEALTH ECONOMIC ANALYSIS

Journal of Clinical and Translational Science ◽

10.1017/cts.2019.356 ◽

2019 ◽

Vol 3 (s1) ◽

pp. 155-156

Author(s):

Natalia Olchanski ◽

David van Klaveren ◽

Joshua T Cohen ◽

John B Wong ◽

Robin Ruthazer ◽

...

Keyword(s):

Prevention Program ◽

Diabetes Prevention ◽

Proportional Hazards Model ◽

Risk Model ◽

Lifestyle Modification ◽

Diabetes Prevention Program ◽

Cox Proportional Hazards Model ◽

Individual Risk ◽

Diabetes Diagnosis ◽

Diabetes Research

OBJECTIVES/SPECIFIC AIMS: Objective: Approximately 86 million people in the US have prediabetes, but only a fraction of them receive proven effective therapies to prevent diabetes. Further, the effectiveness of these therapies varies with individual risk of progression to diabetes. We estimated the value of targeting those individuals at highest diabetes risk for treatment, compared to treating all individuals meeting inclusion criteria for the Diabetes Prevention Program (DPP). METHODS/STUDY POPULATION: METHODS: Using a micro-simulation model, we estimated total lifetime costs and quality-adjusted life expectancy (QALE) for individuals receiving: (1) lifestyle intervention involving an intensive program focused on healthy diet and exercise, (2) metformin administration, or (3) no intervention. The model combines several components. First a Cox proportional hazards model predicted onset of diabetes from baseline characteristics for each pre-diabetic individual and yielded a probability distribution for each alternative. We derived this risk model from the Diabetes Prevention Program (DPP) clinical trial data and the follow-up study DPP-OS. The Michigan Diabetes Research Center Model for Diabetes then estimated costs and outcomes for individuals after diabetes diagnosis using standard of care diabetes treatment. Based on individual costs and QALE, we evaluated NMB of the two interventions at population and individual levels, stratified by risk quintiles for diabetes onset at 3 years. RESULTS/ANTICIPATED RESULTS: Results: Compared to usual care, lifestyle modification conferred positive benefits for all eligible individuals. Metformin’s NMB was negative for the lowest population risk quintile. By avoiding use among individuals who would not benefit, targeted administration of metformin conferred a benefit of $500-$800 per person, depending on duration of treatment effect. When treating only 20% of the population (e.g., due to capacity constraints), targeting conferred a NMB of $14,000-$18,000 per person for lifestyle modification and $16,000-$20,000 for metformin. DISCUSSION/SIGNIFICANCE OF IMPACT: Conclusions: Metformin confers value only among higher risk individuals, so targeting its use is worthwhile. While lifestyle modification confers value for all eligible individuals, prioritizing the intervention to high risk patients when capacity is constrained substantially increases societal benefits.

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Implementing electronic health record‐based National Diabetes Prevention Program referrals in a rural county

Public Health Nursing ◽

10.1111/phn.12860 ◽

2020 ◽

Author(s):

Jeanette Olsen ◽

Samantha Peterson ◽

Alisyn Stevens

Keyword(s):

Electronic Health Record ◽

Prevention Program ◽

Diabetes Prevention ◽

Diabetes Prevention Program ◽

Health Record ◽

Rural County ◽

Electronic Health

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Health Behavior Change Following Stroke: Recommendations for Adapting the Diabetes Prevention Program–Group Lifestyle Balance Program

American Journal of Lifestyle Medicine ◽

10.1177/1559827619897252 ◽

2020 ◽

pp. 155982761989725

Author(s):

Ryan R. Bailey ◽

Jennifer L. Stevenson ◽

Simon Driver ◽

Evan McShan

Keyword(s):

Focus Groups ◽

Prevention Program ◽

Diabetes Prevention ◽

Lifestyle Modification ◽

Recurrent Stroke ◽

Diabetes Prevention Program ◽

Health Behavior Change ◽

Community Dwelling ◽

Dietary Recommendations ◽

Care Partners

Objective. History of stroke increases risk for recurrent stroke, which is a significant issue faced by survivors. The Diabetes Prevention Program–Group Lifestyle Balance (DPP-GLB) program is an effective lifestyle modification intervention for ameliorating cardiovascular risk factors but has not been adapted to account for common stroke-related deficits. The purpose of this study was to determine appropriate adaptations to the DPP-GLB for adults with stroke. Design and Methods. In this phenomenological qualitative study, a total of 15 community-dwelling adults with stroke and 10 care-partners participated in 4 focus groups to review DPP-GLB curriculum materials and provide recommendations for adaptation. Focus groups were recorded and transcribed. Inductive content analysis was used to identify key themes. Results. Three themes were identified. First, physical, cognitive, sensory, and psychosocial stroke-related deficits could affect DPP-GLB participation. Second, existing DPP-GLB characteristics could facilitate participation by adults with stroke. Third, stroke-specific adaptations were recommended, including modified session content and format, adapted physical activity and dietary recommendations, and inclusion of care-partners. Conclusion. Current DPP-GLB content and structure may be insufficient to meet the unique needs of adults with stroke. The suggested adaptations should be incorporated into a stroke-specific curriculum and tested for preliminary efficacy for reducing recurrent stroke risk.

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