STATEMENT OF WORK.doc

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STATEMENT OF WORK

Title: Impact of changes of components of the risk score on future prevalence of diabetes C.1 Background and Need:

National surveys in the United States have documented more than a doubling of the prevalence of diagnosed diabetes over the past 3 decades, making diabetes one of the nation’s most concerning health threats. Moreover, nearly 40% of people with diabetes have chronic kidney disease, meaning that they are at increased risk for heart disease and stroke, two of the leading causes of death for Americans. This has stimulated diverse public health programs to prevent diabetes and its complications. However, the impact of changes in the distribution of risk factors, with or without these interventions, on the total number of people with diabetes is largely unknown, and is in part offset by the declines in mortality rates that have led the average American adult with diagnosed diabetes to live many more years with the disease than persons in prior decades. These dynamics in the epidemiology of diabetes have left open questions about the future burden of diabetes and its impact on complications. Understanding the drivers of diabetes prevalence might be the basis for predicting effects of population wide prevention programs or interventions and for predicting the prevalence of diabetes with late complications. The results from these analyses will provide a clearer assessment of the impact of existing prevention and treatment systems on expected health and economic burden of diabetes. These analyses will be used to develop publications for peer-reviewed reports and will be incorporated into the ongoing U.S. NDSS to serve as a baseline for future monitoring.

Researchers at The German Diabetes Center, University of Düsseldorf, led by Dr. Ralph Brinks (Ralph.Brinks@DDZ.uni-duesseldorf.de), have developed and validated mathematical compartment models that permit calculation of disease incidence when data on prevalence and mortality exist and conversely, to compute prevalence when data on incidence and mortality are available. To date, these approaches have been applied to chronic conditions in Germany and in validation studies using data from the U.S. Researchers at the German Diabetes Center are the only ones to have applied such models to the calculation of true incidence and the only known group to have the experience and expertise to apply these approaches to U.S. national survey data such as the National Health and Nutrition Examination Survey (NHANES) and the National Health Interview Survey (NHIS).

Specific objectives of this work are to:

1. Conduct mathematical projections of people with diabetes based on the prevalence and incidence data from NHANES and NHIS. Birth rates and life expectancy data are extracted from the population projections of the U.S. Census Bureau. Future prevalence will be calculated using the partial differential equation based on the illness-death model. Projections will be stratified by type of diabetes (type 1 and type 2), sex, and ethnicity.

2. Analyze how the future number of people with diabetes changes if modifiable components of the U.S. diabetes risk score are changed. To do this, the current incidence of diabetes based on NHIS needs to be calibrated to the current distribution of the diabetes risk score. Then, elasticity of the modifiable components of the risk score are calculated and reported. This way, the impact of changes of components of the risk score can be estimated on future prevalence of diabetes. This might be the basis for predicting effects of population wide prevention programs or interventions.

3. Using the extended illness-death model (four-state model), the effective rate method can be applied to estimate the future number of people with diabetes complications. For this, the elasticity of components of the diabetes risk score (see #2) are combined with the incidence of diabetic late complications (such as ESRD).

C.2 Project Objective:

The Contractor will apply the four-part compartment models to NHANES and NHIS to predict future cases of diabetes in the U.S. population.

C.3 Scope of Work:

The Contractor will:

1. Determine the future number of people with diabetes (type 1 and type 2) in the U.S.

2. Estimate analytically the prevalence of diabetes, i.e. without running lengthy simulations, if the distribution of a risk-factor in the population shifts.

3. Adapt the partial differential equation (PDE) about the prevalence of chronic conditions to take into account changes in the distribution of risk factors (effective rate method).

4. Prepare publication-ready tables and figures in support of publications for each of the analyses described above (#1, #2, #3).

C.4 Technical Requirements:

The contractor will:

Task A:

· Participate in teleconference calls with the Epidemiology and Statistics Branch (ESB) staff every 2 months to discuss progress and technical issues related to preparatory analyses.

· E-mail monthly progress report Task B:

· Conduct mathematical calculations using illness-death models to provide preliminary projections of type 1 and type 2 diabetes prevalence.

· Conduct mathematical calculations to construct dynamic presentations portraying trends in incidence, prevalence, mortality among people at risk for diabetes using national survey data.

· Check the analyses and data to exclude any mistakes, conduct tests of reliability and validity, and sensitivity analyses from the four-part compartment models.

· E-mail summary tables with preliminary findings

· Provide written descriptions of methods for each analysis to serve as the methods section and appendix of manuscripts for peer reviewed journals.

· Contribute to the editing and authorship of at least 2 manuscripts.

C.5. Government furnished materials:

CDC will coordinate accessibility to all key aggregate data (NHANES, NHIS, SEARCH) by the German Diabetes Center and, where appropriate, provide analytic codes to assist in variable construction and definition.

C.6 Period of performance:

The period of performance will be 12 months from September 1, 2021 through August 31, 2022.

C.7 Reporting Schedule (and deliverables):

Annual Technical Progress Reports shall be sent to CDC Project Officer, Dr. Meda Pavkov, with a copy to the CDC Contract Administrators.

*All deliverables are provided in English C.7 Special Considerations:

(Start of provision) HHSAR Provision, 352.239-73: Electronic and Information Technology Accessibility Notice

(a) Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended by the Workforce Investment Act of 1998 and the Architectural and Transportation Barriers Compliance Board Electronic and Information (EIT) Accessibility Standards (36 CFR part 1194), require that when Federal agencies develop, procure, maintain, or use electronic and information technology, Federal employees with disabilities have access to and use of information and data that is comparable to the access and use by Federal employees who are not individuals with disabilities, unless an undue burden would be imposed on the agency. Section 508 also requires that individuals with disabilities, who are members of the public seeking information or services from a Federal agency, have access to and use of information and data that is comparable to that provided to the public who are not individuals with disabilities, unless an undue burden would be imposed on the agency.

(b) Accordingly, any offeror responding to this solicitation must comply with established HHS EIT accessibility standards. Information about Section 508 is available at http://www.hhs.gov/web/508. The complete text of the Section 508 Final Provisions can be accessed at http://www.access-board.gov/sec508/standards.htm.

(c) The Section 508 accessibility standards applicable to this contract are: 1194.

205 WCAG 2.0 Level A & AA Success Criteria 302 Functional Performance Criteria 502 Inoperability with Assistive Technology 504 Authoring Tools 602 Support Documentation 603 Support Services

In order to facilitate the Government's determination whether proposed EIT supplies meet applicable Section 508 accessibility standards, offerors must submit an HHS Section 508 Product Assessment Template, in accordance with its completion instructions. The purpose of the template is to assist HHS acquisition and program officials in determining whether proposed EIT supplies conform to applicable Section 508 accessibility standards. The template allows offerors or developers to self-evaluate their supplies and documentation detail - whether they conform to a specific Section 508 accessibility standard, and any underway remediation efforts addressing conformance issues. Instructions for preparing the HHS Section 508 Evaluation Template are available under Section 508 policy on the HHS Web site http://hhs.gov/web/508.

In order to facilitate the Government's determination whether proposed EIT services meet applicable Section 508 accessibility standards, offerors must provide enough information to assist the Government in determining that the EIT services conform to Section 508 accessibility standards, including any underway remediation efforts addressing conformance issues.

(d) Respondents to this solicitation must identify any exception to Section 508 requirements. If a offeror claims its supplies or services meet applicable Section 508 accessibility standards, and it is later determined by the Government, i.e., after award of a contract or order, that supplies or services delivered do not conform to the accessibility standards, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the Contractor at its expense.

(e) Electronic content must be accessible to HHS acceptance criteria. Checklist for various formats are available at http://508.hhs.gov/, or from the Section 508 Coordinator listed at https://www.hhs.gov/web/section-508/additional-resources/section-508-contacts/index.html. Materials that are final items for delivery should be accompanied by the appropriate checklist, except upon approval of the Contracting Officer or Representative.

(End of provision) Task X Data Collection Data Analysis and Technical Support

The contractor shall provide ongoing support for quantitative and qualitative data analyses of data, including integrating other data sources such as program performance data from CDC-funded programs (e.g., CDC’s data).

The contractor shall continuously improve the development, organization, and maintenance of processes for data analysis and related data management activities.

The contractor shall support, coordinate, and collaborate with multidisciplinary staff at CDC to provide technical support for data analysis planning, design, methods, execution, and interpretation of findings.

Data Analysis All Data

a. Develop, implement, and maintain best-practice data analysis and related data management standards, protocols, processes, and procedures for both quantitative and qualitative data.

b. Prepare, as part of data management planning, a detailed data analysis plan.

c. Provide monthly, semi-annual, annual, and final data analyses in report form.

i. Deliver a monthly report that provides descriptive statistics for data.

ii. Deliver a semi-annual provider-specific report that contains descriptive and inferential statistics for data.

iii. Deliver a semi-annual provider-specific report that contains descriptive and inferential statistics for data sources that allow integration of program performance data.

iv. Deliver an annual interim report that provides descriptive and inferential statistics for available data.

v. Deliver an annual interim report that provides descriptive and inferential statistics for data sources that allow integration of program performance data.

vi. Deliver a 5-year summary report that provides descriptive and inferential statistics for data.

vii. Deliver 5-year summary report that provides descriptive and inferential statistics for data sources that allow integration of program performance data.

Quantitative Data

Contractor shall perform computer programming for quantitative data analysis using SPSS and other computer software languages, packages, and tools. Develop SPSS programming to generate analysis-ready datasets for baseline, composite, and computed variables. Automate data management processes by developing and using complex SPSS macros.

Statistical Support

The Contractor shall provide statistical analysis and technical support, including but not limited to the following activities.

1. Provide support for analysis planning. Evaluate, design, and develop project/study protocols; provide actionable recommendations to optimize study designs.

2. Provide support for execution of analyses. Assess the compatibility of existing and proposed statistical methods and analytical tools with project/study design and objectives. Provide actionable recommendations to resolve statistical/analytical issues.

3. Prepare written interpretations of data analysis findings for use in reports, scientific meetings, and scientific publications.

4. Provide statistical analysis and scientific writing to develop abstracts, manuscripts, presentations, etc.

5. Provide clear, organized, and detailed verbal and written summaries and descriptions of statistical/analysis methods and results.

Data and Information Dissemination

To support the preparation of project/study presentations, ad hoc reports, abstracts, manuscripts, and other types of data and information dissemination products, the contractor shall provide (1) summary data tables, figures, and other outputs, (2) descriptions and summaries of analytical methods, results, and interpretations, and (3) support for tracking and responding to data requests.

Information Dissemination

1. The contractor shall develop conference presentations that shall be co-authored with CDC designated staff (e.g. scientists, statisticians) to describe the program evaluation findings and the contractor shall provide the documents needed for the CDC clearance process and abstract submission.

2. The contractor shall develop draft and final one manuscript per year during Option Period 2 and Option Period 4. The manuscripts shall be co-authored with CDC designated staff (e.g. scientists, statisticians) to describe program evaluation findings.

3. The contractor shall routinely monitor and provide tracking and reports within CDC approved timeframes for:

a. Publication abstract and manuscript submission deadlines

b. Abstracts, presentations, and publications throughout the clearance and submission process.

Data Summaries and Tables

1. The contractor shall prepare data summaries including data tables, figures, graphs, presentations, narratives to supplement and support abstracts, manuscripts, and ad hoc reports. Prepare finalized data summaries that are suitable for CDC clearance and acceptance by journal, conference, etc.

2. The contractor shall provide data summaries in designated formats, e.g., Microsoft Word, Excel, PowerPoint, PDF, and HTML.

Project Coordination and Management

The contractor shall provide ongoing project coordination and management for the program evaluation tasks completed under this statement of work. The contractor shall perform project coordination and management that includes the following activities:

1. Schedule and provide support for bi-weekly (every two weeks) project management meeting, Base Year kickoff meeting, and annual option period project review meetings, including the following activities:

a. Prepare meeting materials (e.g. agenda).

b. Provide status updates for tasks and deliverables.

c. Prepare minutes, detailed meeting notes, site visit reports, and other summaries.

2. Coordinate closely with partners, both internal (scientists, program consultants, etc.) and external (19-1904 recipients, etc.) to:

a. Capture evolving data management requirements.

3. Resolve data quality issues in a timely manner.

4. Provide active and prompt resolution of data management issues and problems.

5. Ensure that contractor staff meet data confidentiality and security requirements.

6. Maintain access to CDC systems, applications, and facilities through completion of required credentialing processes (e.g. SmartCard) and required initial and annual IT security training.

7. The contractor shall submit a monthly written progress report which summarizes achievements and issues.

8. The contractor shall submit financial reports that describe the cumulative actual costs incurred and estimated costs to complete

C.8 Government Furnished Property: None C.9 References:

ADDIN EN.REFLIST C.10 COR Identity:

Meda Pavkov (gta3@cdc.gov )

The Centers for Disease Control and Prevention

National Center for Chronic Disease Prevention and Health Promotion

Division of Diabetes Translation

4770 Buford Highway, N.E., Mailstop S107-3

Atlanta, GA 30341

770-488-1160 C.11 Payment schedule upon the completion of task requirements under each task

C.12 Requirements of Proposal

(1) Technical Proposal Page Limit: 20 pages with double spacing (excluding any cover page, table of contents and appendices). The Contractor will provide a proposal based on the requirements under C.4 Technical Requirements in the Statement of Work by detailing their past experiences and providing a narrative that demonstrates a clear understanding of the technical requirement.