D-Attachment SOW.pdf

Version 11-30-2016-1 FAR Part 11—Describing Agency Needs

STATEMENT OF WORK (SERVICES)

(SOW)

GENERAL INFORMATION

Title of Project:

Procurement of Services to Support Research into the association between climate change and autoimmune/age-related diseases

Statement of Need and Purpose:

To construct a comprehensive dataset from Korean public data sources, including National Health Insurance Service (NHIS) claims database, and analyze the short- and long-term effect of climate change on autoimmune and age-related diseases with consideration of climate change.

Background Information and Objective:

Climate change refers to the long-term variations in the Earth's climate, both on a global scale and regionally, caused by human emissions of greenhouse gases. It typically refers to the average changes in climate patterns from decades to millions of years. Global warming refers to the phenomenon of increasing average temperatures of the Earth's atmosphere and oceans, which is predicted to continue rising in the future. As a result of global warming, the Earth's surface temperature has increased by over 1°C since 1850-1900. The impacts of climate change on health include health risks associated with extreme temperatures such as heatwaves, increased mortality and morbidity due to rising temperatures, the emergence of diseases, and extreme weather events like floods, droughts, and hurricanes. These factors can directly harm human health and contribute to the spread of infectious diseases.

Climate change can impact the microbiome, potentially causing dysbiosis and contributing to the development of inflammatory, autoimmune, and neurological diseases. Extreme weather conditions (air pollution, extreme heat, flood/tornado, wildfire) may worsen autoimmune diseases due to their impact on altered immune states. Some studies have reported on the relationship between air pollution and the exacerbation of specific autoimmune diseases, but evidence for other climate change factors is relatively limited.

Autoimmune diseases are disorders in which an abnormal response to specific antigens, either self or foreign, triggers an immune reaction, leading to diseases such as type 1 diabetes, systemic lupus erythematosus, Sjögren's syndrome, and systemic sclerosis. Autoimmune diseases represent a major cause of mortality among young and middle-aged women in the United States. There are gender differences in the incidence of autoimmune diseases, with over 85% of patients with Hashimoto's thyroiditis, systemic sclerosis, Sjögren's syndrome, and systemic lupus erythematosus being female. While most diseases can occur across all age groups, some primarily affect children and adolescents (type 1 diabetes), middle-aged individuals (polymyositis, multiple sclerosis), or the elderly (rheumatoid arthritis, primary systemic vasculitis). Incidence rates vary depending on the specific autoimmune disease, ranging from less than 1 case of newly diagnosed systemic sclerosis per year to more than 20 cases of adult-onset rheumatoid arthritis per 100,000 person-years. Prevalence rates also vary from less than 5 cases per 100,000 individuals (chronic active hepatitis, pericarditis) to over 500 cases per 100,000 individuals (rheumatoid arthritis). Autoimmune diseases are regulated by both genetic and environmental factors, both of which influence susceptibility to autoimmunity at three levels: overall reactivity of the immune system, specific antigen recognition and presentation, and target issues.

The objective of this work is to explore the pattern of mortality and morbidity (new diagnoses, changes in medication, increased frequency of visits/disruption of visits, mental health, etc.)

both overall and among specific autoimmune and age-related conditions in different climate change settings. To accomplish this goal, the National Institute on Aging (NIA) will be required to develop novel ways to assess exposure and analyze the association as well as fully utilize existing methods.

Period of Performance:

36 months from the date of the award

SCOPE OF WORK

General Requirements:

Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities not otherwise provided by the Government as needed to perform the Statement of Work below:

Specific Requirements:

The contractor shall construct exposures and outcomes database to analyze the short- (up to 7 days) and long-term (at least 1 year) association between climate change and age-related and autoimmune diseases. Climate change will be assessed using various factors, including temperature, deviation of temperature, precipitation, composite index, etc. The contractor shall analyze the association of various climate change-related factors and explore the feasibility of a composite exposure index. The outcome will include morbidity and mortality from age-related and auto-immune diseases. The direct and indirect pathways via air pollution will be assessed by applying interaction and mediation analysis. Short-term association shall be assessed by utilizing time-series analysis or case-crossover analysis. The long-term association shall be assessed by using Cox proportional hazard model. New analytical methods may be explored.

TASK 1 – OBTAIN INSTITUTIONAL APPROVALS AND DATASETS

The Contractor shall obtain approvals from the relevant institutional review board (IRB) and other institutional officials, if required. The Contractor shall obtain approval, for extracting relevant data from computerized databases and preparing analytic files suitable for epidemiologic research. All data will be queried from the National Emergency Department

Information System (NEDIS) and National Health Insurance Service (NHIS) of Korea database.

These data include clinical diagnoses, procedures, medications, and other data elements. The Contractor shall be the sole party responsible for communications with any IRB or other institutional officials and shall regularly communicate the status of the approval process to the Government.

TASK 2 – ESTABLISH ANALYSIS DATA SETS

The Contractor shall collaborate with the NIA to select the analytical datasets. Short-term health effects shall be evaluated using time-series study, merged with the air quality monitoring data provided by AirKorea. Daily meteorological data including temperature, humidity, atmospheric pressure, sun radiation, wind speed, and precipitation will be extracted from Korea Meteorological Administration’s database and merged with the dataset as well.

Long-term health effects shall be examined in a retrospective cohort from the NHIS database, which offers randomly selected individual data (usually maximum of 5% of the population) of approximately 3 million. The same climate change exposure database and variables as the short-term study will be utilized.

TASK 3 – CONDUCT ANALYSIS

The Contractor shall collaborate with the NIA to conduct the statistical analysis following the plan proposed by the NIA program officer.

TASK 4 – PREPARE REPORT

The Contractor shall collaborate with the NIA program officer to interpret the results and prepare a scientific report containing the methodology as well the aggregated results. There is no page limit for the document.

LEVEL OF EFFORT:

Proposal application, data acquisition, construction and analysis

GOVERNMENT RESPONSIBILITIES

The contractor will not require access to any government facility.

DELIVERY OR DELIVERABLES

The contractor will deliver the electronic copy of results within 36 months from the date of award.

DELIVERABLE DELIVERABLE DESCRIPTION / FORMAT

REQUIREMENTS

DUE DATE

#1 (Task 1) Obtain IRB and institutional approvals required for this requirement. Contractor shall confirm approval via e-mail to the NIA

30 calendar days after award.

officer.

#2 (Task 2) Regularly communicate with NIA personnel to develop the datasets.

Weekly calls during the first two weeks after award

#3 (Task 3) Collaborate with the NIA to conduct the statistical analysis following the plan proposed by NIA investigators.

Monthly calls after award

#4 (Task 3) Provide summary tables (MS word or Excel format) for publication

60 days prior to expiration of the period of performance

#5 (Task 4) Provide draft report submitted in MS word format.

45 days prior to expiration of the period of performance.

#6 (Task 4) Provide final report submitted in MS word format.

15 calendar days prior to expiration of the period of performance.

REPORTING REQUIREMENTS

The contractor should report any problems encountered and progress on the resolution.

OTHER CONSIDERATIONS

Travel:

The NHIS database is only accessible at the data center, and the contractor shall be required to travel to the data center regularly. The contractor will be responsible for the travel reimbursement.

Key Personnel:

Contractor shall provide a dedicated Project Manager to the government as a contact point for the services. The contractor must have the ability to apply for access to the NHIS database and maintain access for the duration of this requirement.

Information System Security Plan:

No personal identifications will be accessed by the contractor.

Data Rights:

The government has the sole right regarding the use, production, and disclosure of the data generated.

Section 508—Electronic and Information Technology Standards:

The contractor is not required to develop, procure, maintain, or use Electronic and Information Technology in the performance of the SOW. However, all reports and deliverables shall be submitted electronically and, shall be compliant with Section 508 of the Rehabilitation Act of 1973. Additional information about testing documents for Section 508 compliance, including guidance and specific checklists, by application, can be found at:

https://www.hhs.gov/web/section-508/index.html and at:

https://www.section508.gov/create/documents,"Create Accessible Documents."

Publications and Publicity:

The contractor may participate as a co-author of the articles to be published as a result of the requirements of the SOW.

Confidentiality of Information:

No personal identifications will be accessed by the contractor. The data will be delivered via the NIH Box.