Funding Opportunity Announcement

Transcription

1 Funding Opportunity Announcement Confirmed Flu Near You: A Pilot Project to Assess Influenza Testing among the Flu Near You Community Issuing Organization Council of State and Territorial Epidemiologists (CSTE) at Participating Organizations Centers for Disease Control and Prevention (CDC), at Skoll Global Threats Fund (SGTF), at The Computational Epidemiology Lab (HealthMap) at Boston Children s Hospital, at Components of Participating Organizations Influenza Division, National Center for Immunization and Respiratory Diseases (NCIRD/CDC), at 1

2 Table of Contents Part I. Overview Information Part II. Full Text of Announcement Section I. Funding Opportunity Description 1. Background 2. Objectives 3. Methods Section II. Award Information 1.Mechanism of Support 2.Funds Available Section III. Eligibility Information 1. Eligible Applicants 2. Cost Sharing or Matching Section IV. Application and Submission Information 1. Content and Form of Application Submission 2. Submission Dates and Times Section V. Application Review Information 1.Criteria 2.Review and Selection Process Section VI. Award Administration Information 1. Award Notices 2. Recipient Responsibilities 3. CSTE Responsibilities 4. CDC Responsibilities 5. FNY Responsibilities Section VII. Appendices 1. Data Use Agreement 2. Data Dictionary 2

3 Part I. Overview Information The Council of State and Territorial Epidemiologists (CSTE) and the Centers for Disease Control and Prevention (CDC) Influenza Division support the enhancement of influenza surveillance at state and local health departments by promoting initiatives to maximize the utilization of existing surveillance systems and leveraging novel data sources to inform influenza disease burden estimation. CSTE seeks proposals that will leverage Flu Near You as a mechanism for obtaining respiratory specimens and laboratory testing results for ill members of the community. The pilot initiative described will improve the understanding of etiology of non-medically attended respiratory illness, will inform the feasibility of implementing similar community surveillance mechanisms in the event of unusual influenza or respiratory virus event, and will evaluate the utility of these data to enhance surveillance for influenza at state and local health departments. 3

4 Part II. Full Text of Announcement Section I: Funding Opportunity Description Background Currently, the CDC Influenza Division collaborates with state, local, and territorial health departments to conduct influenza surveillance, which relies primarily on reports of 1) outpatient visits made by primarycare providers and emergency departments and 2) influenza-associated hospitalizations and deaths. While this type of surveillance is important for monitoring trends in influenza activity and understanding the characteristics associated with severe influenza outcomes, it only captures illness among individuals who seek medical care and therefore underestimates the burden of influenza. Surveillance for influenza conducted at the community level overcomes this limitation by capturing illness among persons who did and did not seek medical care, allowing for more accurate and near real-time estimates of the disease burden, the case-hospitalization and fatality ratios, and the determinants of seeking care. Flu Near You (FNY) is an Internet-based community cohort that was created in 2011 through a collaboration between the American Public Health Association (APHA), the Computational Epidemiology Lab (HealthMap) at Boston Children s Hospital, and the Skoll Global Threats Fund (SGTF). Each week, FNY collects symptom data (including information on common influenza symptoms) among its users, and FNY influenza-like illness (ILI) reports have demonstrated a strong correlation with CDC s ILINet surveillance system. FNY just completed its fifth season of surveillance during the influenza season. Over 30,000 users reported their symptom status at least once during the season, and more than 4,000 users reported at least one episode of influenza-like illness (ILI, defined as fever with cough or sore throat). Limited pilots of respiratory testing among ill FNY participants have been successfully conducted, though the pilots were not done in collaboration with federal, state, and local health department staff and did not consider how the resulting surveillance information could be used by public health officials. For the season, CSTE seeks proposals from state or large local health department jurisdictions to enhance community surveillance by enrolling FNY participants in a self-swabbing pilot surveillance project and developing a mechanism to enable the testing and linkage of participant specimens with public health laboratory results. This pilot will improve the understanding of etiology of non-medically attended respiratory illness, will inform the feasibility of deployments of self-swabbing kits among FNY participants in the event of unusual influenza or respiratory virus event, and will evaluate the utility of these data to enhance surveillance for influenza at state and local health departments. This funding opportunity is open to any state or local health department which meets the eligibility requirements. 4

5 Funding awards are dependent on commitment and compliance with core activities, as outlined in the guidance of the current FOA. Objectives The overarching objective of the pilot is to assess Flu Near You as a mechanism for obtaining respiratory specimens among ill members of the FNY community. The specific objectives of this pilot project are to: 1. Recruit new or existing users of FNY to participate in an enhanced surveillance pilot project for collection of self-swab specimens for influenza testing. 2. Develop a system to link the following data from FNY participants: symptoms, self-collected respiratory specimens, and public health laboratory results to determine the proportion of illness among project participants. 3. Assess the utility of the FNY pilot for situational awareness and pandemic preparedness among state and local health departments. Jurisdictions are encouraged to create a project proposal that addresses all the above objectives to best fit jurisdictional surveillance needs. Methods Applicants should propose methods that accomplish the outlined objectives; however, to maximize the comparability of data across awarded sites, some detailed methods are outlined in the following section. Alternatives to the outlined methods are permitted, but should maintain compatible data. Multi-jurisdictional applications will be considered in order to expand surveillance population. Methods should clearly outline the specific role and responsibilities of each collaborating agency. Awards will be made to one coordinating agency (or agency s fiscal agent). The applicant should be the coordinating agency. 1. Data available from Flu Near You for the purposes of this pilot The Flu Near You dashboard provides a resource for public health jurisdictions to access aggregated Flu Near You data down to the zip code level. Data users can download data in CSV format or view charts and graphs embedded in the dashboard. New data users can request access via the following link: For the purposes of this pilot project, individual level data, including a unique FNY identifier for each participant, will be made available at the jurisdiction s request, with a signed Data Use Agreement between the jurisdiction and FNY. The FNY data use 5

6 agreement is provided in Appendix I, and the data dictionary for variables available in the FNY individual-level data are found in Appendix II. A sample of the data export can be made available to applicants from CSTE upon request. 2. Project Period The funding period is from January 8, 2018 June 30, Surveillance activities should be completed by May 30, 2018, to allow for data collection, data submission, and project evaluation by June 30, Project plans should ensure participant enrollment begins early enough to meet sample size assumptions. 3. Participant recruitment and characteristics Any existing and prospectively registered FNY members residing within jurisdictions of participating sites are eligible for this pilot project. Grantee state and/or local health departments ( sites ) are responsible for recruiting FNY participants to participate in this pilot. Sites may choose to enroll new participants into FNY and this pilot simultaneously, though recruitment of existing FNY participants is encouraged to allow for the evaluation of reporting history and compliance. Methods to recruit participants may include outreach to existing FNY users, or if enrolled prospectively, outreach at pre-existing public events or among local companies or organizations may be conducted. Additional methods of recruitment are permitted. FNY pilot participants can include household members in their weekly FNY reporting and in the self-swab project. If requested by the site, FNY can notify registered users in the site s jurisdiction about the pilot and can provide further site contact information to FNY users interested in participating. If requested by the site, FNY can host an enrollment portal where interested FNY users can provide their relevant contact info (including home address and telephone number) and/or consent to participate in the study. Contact information and notice of consent will be forwarded by FNY to site-specific contacts. The recruitment of specific demographic groups are not required for this pilot, but may be identified by sites for targeted enrollment if desired. The sole recruitment of groups that may be easy to enroll but not reflective of the community (e.g. employees of public health agencies) is discouraged. 4. Sample size Sites should plan to enroll enough participants to receive at least 30 respiratory swabs for testing during the funding period. If sites only provide one specimen collection kit per household, then around 500 participants will need to be enrolled in 6

7 the pilot per site (assuming that 15% of users will report an ILI episode and 40% of users with an illness will return their specimen kit). The estimated number of enrolled participants needed to meet the 30 specimens minimum will vary depending on the intensity of the influenza season, participant attrition, the propensity of ill participants to return swabs, and the number of swab kits provided to each enrolled household since households may have more than one illness episode during the project period. Sites may choose to enroll fewer than 500 participants provided they can justify their assumptions. 5. Symptom reporting and case definition FNY participants automatically receive a symptom survey via or app alert every Monday. A qualifying illness for which a swab should be collected is defined as self-reported fever AND cough. If requested by the site, participants reporting a qualifying illness will receive a follow-up prompt and message from FNY instructing the household member(s) with the qualifying illness(es) to self-collect a nasal swab sample for laboratory testing. A pre-identified public health and laboratory contact will also receive a notification when participants report a qualifying illness. 6. Specimen collection and shipping At enrollment, sites should provide participants a swab kit and instructions about how to collect nasal swabs from themselves or children (i.e., self-swab ). Sites should outline means by which staff will provide the swab kit at enrollment. The swab kit may be delivered to the enrolled participant in person or by mail. Swab kits should consist of swabs, shelf-stable viral transport media tubes, packaging and shipping materials, infection control supplies (e.g. masks/gloves), and infection control information regarding handling infectious materials. Sites should outline means by which staff will instruct participants about how to collect a nasal swab from themselves or their child if they experience a qualifying illness while participating in the pilot project. Proposals should include plans for providing written training and instruction materials, as well as a link to a web-based video demonstrating the procedure (e.g., Once collected, the swab will be placed in the provided tube of viral transport media in the swab kit and shipped to the site s public health laboratory at ambient 7

8 temperature using the packaging materials provided at enrollment. Specimens do not need to be overnighted to the testing laboratory. The sample should be collected and shipped as soon as possible from the time when the qualifying illness was detected and in accordance with collection protocol included for the test. One sample will be obtained per person per illness episode. Unless the site provides multiple swab kits to an enrolled household, one swab will be collected from one of the ill participants per household upon first illness episode. Sites are responsible for procuring specimen collection and shipping materials, and may freely choose these materials as long as the collection and transportation requirements of these kits is consistent with the required methods outlined Sites are not required to have unused swab kits returned at the end of the study. 7. Specimen linkage and testing Sites should ensure the swab-kits contain an identifier (e.g. the unique FNY identifier) that allow for the linkage of specimen receipt and results with FNY illness reports. The state or local public health laboratory should process and test specimens by PCR and record the date the specimen was received at the health department. Reagents and qualifying ancillary reagents for influenza testing is provided by CDC at no cost to validated PHL through the International Reagent Resource (IRR). Influenza testing should be conducted using the CDC Flu rrt-pcr Dx Panel in vitro diagnostic kit including influenza A (subtypes 2009 H1N1, H3) and influenza B (genotypes Yamagata and Victoria). Specimens do not need to be retained by the public health laboratory. Specimens collected from this pilot may be included as part of the site s pool of surveillance specimens submitted biweekly to the National Influenza Reference Centers (NIRCs) and CDC for detailed antigenic characterization and genetic characterization. 8. Data Collection (frequency, method) As a reminder, individual level data, including a FNY identifier, can be made available at the jurisdiction s request, with a signed Data Use Agreement between the site and FNY. An Excel file containing the unique participant identifier for all enrolled participants, symptom reports from FNY during the pilot period, date of receipt of specimen and testing results for returned swabs, and any non-personally identifiable demographic data elements collected by FNY or the site should be submitted to the CDC Influenza Division within 1 month of the conclusion of the project period. 8

9 9. Participant Evaluation Sites should describe methods to provide pilot participants a follow-up assessment to evaluate the compliance and acceptability of the self-swabbing pilot. 10. Grantee Evaluation At the conclusion of the study, CSTE/CDC will conduct a brief evaluation to understand the feasibility and acceptability of FNY as a source of respiratory specimens among nonmedically attended cases. Evaluation methods will include a brief quantitative assessment by the site of the number of eligible illnesses reported during the study period, the number of specimens received, how quickly specimens were shipped from illness onset, and participant attribution. Qualitative assessments of the feasibility of implementation of pilot project methods, including site successes, challenges, and lessons learned will be conducted during an end-of-study conference call. Successful applicants should demonstrate the capacity to participate in this evaluation. Section II: Award Information Mechanism of support CSTE will manage matters related to financial support for this project. CSTE will distribute funds to states in accordance with a fixed-funding type contract. In all cases, funds will only be reimbursed upon receipt of invoice from the applicant as well as sufficient progress as determined by CSTE made toward the activities of the project as outlined in this FOA and contract agreement with CSTE. Recipients are responsible for allocating appropriate amounts to support activities. Funds available Funding for this project will be firm fixed. CSTE intends to commit up to $33,500/jurisdiction for up to three jurisdictions. Although the financial plans provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the number of applications received. CSTE receives funding for this project through the Centers for Disease Control and Prevention (CDC) cooperative agreement number: 5U38OT Funds awarded under this announcement are subject to the laws, regulations and policies governing the U.S. Public Health Service grant awards. 9

10 Section III: Eligibility Information Eligible Applicants State, territorial, large local* public health agencies. *A large local public health agency is defined as a city or county health department serving a population of 500,000 residents or greater. Cost Sharing or Matching Cost sharing, matching, or cost participation is required only for activities that overlap with other CDC funded programs to avoid duplicate funding. For example, if personnel is fully funded by the Epidemiology and Laboratory Capacity Grant, the same individual cannot receive extra salary through this funding mechanism. Section IV: Application and Submission Information Applicants should submit an application addressing the objectives, components, and eligibility requirements stated in Section 1 and Section 3, respectively. Content and form of application submission The application should be written using a 12-point, Times New Roman font, on 8.5x11 inch paged paper with one-inch margins. Applications should include the following headings in the order listed and should address the issues included under each heading. Components of the application that exceed the page limit might not be reviewed. Contact information: Primary health department coordinator and primary laboratory contact, plus any additional contributors. Information should include , mailing address (no PO boxes) and phone number. All correspondence will be sent to the primary public health coordinator listed. 1 page limit Surveillance Experience: Applicants should describe their surveillance experience and that of any additional participating institutions that demonstrates their ability to successfully participate in this project and achieve the goals outlined. 1 page limit. Methods: Applicants should describe their proposed methods according to those described in the objectives and methods outlined in Section I. Applications should include at least the following: o Describe methods that will be used to identify/recruit participant cohort and any subpopulations targeted. o Describe methods that will be used to distribute self-swabbing kits and train on their proper use o Describe the methods by which specimens will be transferred or shipped to the PHL for testing 10

11 o o o Describe the methods that will link specimen receipt and results with individual FNY illness reports Describe data that will be collected and reported by the health department to CDC Describe capacity to participate in CDC/CSTE-led evaluation of pilot project, including willingness to participate in follow-up among participants and health department stakeholders. 4 page limit Laboratory test methods: Applicants should also describe the expected frequency of specimen testing and result reporting from the laboratory to project coordinators. 2 page limit Timeline: Please include a timeline for key activities and milestones, which should conclude before June 30, IRB: Human subject review process for the applicant if necessary. ½ page limit Letters of Support: A letter of support from the participating public health laboratory addressing commitment to participate and ability to integrate protocol. 1 page limit per letter Budget: Detailed budget and justification. Proposed budget should be reasonable and include the amount of funding needed and how it will be appropriated. No limit For further assistance, technical questions, or inquiries about the application, contact the Council of State and Territorial Epidemiologists (CSTE) at mschroeder@cste.org or Representatives from CSTE will be available to speak to potential applicants to discuss technical or administrative questions. All such questions and answers will be made available to all potential applicants upon request. Submission, review, and anticipated start dates Application submission receipt date: December 22, 2017 Anticipated award notification date: January 5, 2018 Anticipated award disbursement: After January 5, 2018 Submitting an application Please the completed application to the Council of State and Territorial Epidemiologists (CSTE) at mschroeder@cste.org. Applications must be received by 11:59 pm ET on December 22,

12 Section V: Application Review Information All applications will be reviewed against these criteria Background/Experience: 30% Applicant s understanding of the project and deliverables. Demonstrated expertise and/or prior experience of applicant (and project staff, if applicable). Adequate FNY participation in applicant jurisdiction or demonstrated capacity to enroll adequate participants during the project period. Project Plan and Methods: 50% Detailed deliverables specific to the proposed pilot project. Detailed workplan, methods, and timeline for completing the pilot project. Feasibility of proposed workplan. Technical merit of the proposed project as determined by peer review. Budget and Justifications: 15% Timeliness and completeness of applications: 5% Review and selection process Eligible applications that are complete will be evaluated for technical merit by CDC, SGTF, HealthMap, and CSTE in accordance with the review criteria. Funding awards will be made based upon the quality of the submitted proposal and the ability of the applicant to meet the objectives stated above. Section VI: Award Administration Information Award notices Applicants will be notified via no later than January 5, Any delays to this timeline will be communicated to all applicants. Recipient responsibilities The award recipient will have primary responsibility for the following: Accomplish the objectives and deliverables as listed in this announcement. Manage the overall project including responsibility for logistics planning. Participate in regularly scheduled and ad hoc conference calls with pilot sites, CSTE, and other project partners. Provide written summary reports and invoices to CSTE as required in the contract agreement. Actively engage partners and stakeholders, as necessary. CSTE responsibilities CSTE will have the primary responsibility for the following: Serve as the applicant s principal point of contact and provide avenues for communication between awardee and stakeholders. 12

13 Monitor the terms of the agreement. Fund according to the terms of the agreement. Provide information about the progress of the program to the CDC, CSTE Executive Board, and other stakeholders. Review all reports and distribute the final report to CDC and stakeholders. CDC responsibilities CDC will have the primary responsibility for the following: If IRB review is deemed necessary at the state or local level, CDC will assist the recipient in the development of a protocol that will be acceptable for local site IRB review and approval. Provide technical assistance in developing project plans and materials. Maintain a database for all project related data. Provide technical expertise during project period. FNY responsibilities FNY will have the primary responsibility for the following: Provide access to the FNY dashboard, which provides aggregated Flu Near You data down to the zip code level. Provide access to FNY individual level data, including a unique FNY identifier for each participant, with a signed Data Use Agreement between the jurisdiction and FNY. Notify registered users in the site s jurisdiction about the pilot and provide further site contact information to FNY users interested in participating (if requested by the site). Host an enrollment portal where interested FNY users can provide their relevant contact info and/or consent to participate in the study (if requested by the site). Send an automated alert to participants reporting a qualifying illness to self-collect a nasal swab sample for laboratory testing (if requested by the site). Send an automated alert to a designated public health and/or laboratory contact when a participant reports a qualifying illness (if requested by the site). For more information, contact: Monica Schroeder, MPH, CPH Council of State and Territorial Epidemiologists 2872 Woodcock Blvd., Suite 250 Atlanta, GA (phone) (fax) mschroeder@cste.org 13

14 Attachment I DATA USE AGREEMENT FOR RESEARCH This Data Use Agreement ( AGREEMENT ) is entered into by and between Children s Hospital Corporation d/b/a Boston Children s Hospital, a charitable corporation duly organized and existing under the laws of the Commonwealth of Massachusetts and having a place of business located at 300 Longwood Avenue, Boston, MA ( BCH ), and [ ] ( SITE ) and effective as of the date of the last signature ( EFFECTIVE DATE ). WHEREAS, SITE is interested in obtaining certain anonymized data collected under the IRB approved protocol # IRB-P entitled ( Using existing Flu Near You and Salud Boricua online, surveybased, participatory syndromic surveillance data for research ) by BCH ( DATA ). WHEREAS, SITE agrees to use the Data for [ ] and as further defined in Appendix A ( PURPOSE ) and under the direction of Dr(s) ( SITE INVESTIGATOR ) WHEREAS, BCH agrees to grant SITE access to DATA under this AGREEMENT. NOW, THEREFORE, BCH and SITE agree as follows: 1. Use of Data. The SITE warrants that it shall use DATA exclusively and only for PURPOSE and any subsequently amended and mutually agreed purposes. The SITE use of the DATA shall be used in accordance with all applicable laws and regulations, including, but not limited to the Health Insurance Portability and Accountability Act of 1996 ( HIPAA ), as codified at 45 CFR Parts 160 and Permitted Users. The SITE agrees to use and allow access to DATA only to SITE INVESTIGATOR and SITE personnel who are so authorized for such access by the SITE s Institutional Review Board (IRB) ( PERMITTED USERS ), as applicable. 3. Other Use, Transfer or Disclosure. SITE agrees that it will not disclose, transfer or allow access to DATA to anyone other than SITE INVESTIGATOR and PERMITTED USERS except as required by law. 4. BCH s Access to Results: Upon the request of BCH, SITE agrees to share any of the results of the information generated from the use of the DATA for BCH s own internal research, teaching and academic purposes. 5. Safeguards. SITE agrees to and shall ensure that SITE INVESTIGATOR and the PERMITTED USERS use appropriate safeguards to prevent use, access to or disclosure of DATA to anyone other than as provided by this AGREEMENT. 6. Reporting. SITE agrees to report in writing to BCH, and if applicable SITE s IRB, any unauthorized use or disclosure of DATA that it becomes aware of within five (5) business days of its discovery. Should disclosure or access other than SITE INVESTIGATOR and PERMITTED USERS be required by law, SITE shall notify BCH promptly of any request, warrant or order or of any access or disclosure. 1

15 7. Liability and Indemnification. Except to the extent permitted by law, SITE assumes all liability from and against any and all claims, losses, liabilities, costs and other expenses to the extent resulting from its use of DATA, except when caused by the gross negligence or willful misconduct of BCH. To the extent allowable by law, SITE assumes responsibility for, and agrees to indemnify and hold harmless BCH and BCH s trustees, officers, agents, students, and employees from any liability, loss, or damage they may suffer as a result of, any claims, demands, costs, or judgments against them arising out of the use, handling, storage, or disposal of the DATA by SITE and/or SITE INVESTIGATOR, except as such claims, demands, costs, or judgments may arise from BCH s gross negligence or willful misconduct. 8. Term. This AGREEMENT shall become effective on the EFFECTIVE DATE of the AGREEMENT and shall continue in effect for the duration of [one (1) year] from the EFFECTIVE DATE. Upon completion of the AGREEMENT, DATA shall be either destroyed or returned to SITE. 9. Termination. Either party may terminate this AGREEMENT in writing upon thirty (30) days notice to the other. Upon the termination of this Agreement, SITE shall immediately terminate its use of the DATA. Upon request by BCH, SITE shall return the DATA and copies thereof to BCH. Termination of this Agreement shall not relieve either party of the obligations arising hereunder. 10. Publication. SITE INVESTIGATOR shall have the right to publish, present, share, or use DATA in accordance with the highest academic and publication standards and for its own instruction, and agrees to provide appropriate acknowledgement of BCH or co-authorship by BCH where so specified, or if not so specified then as per the most recently released version of Uniform Requirements for Manuscripts Submitted to Biomedical Journals guidelines produced by the International Committee of Medical Journal Editors. 11. Publicity. Neither party will use the name of the other party in any publicity, advertising, or news release without the prior written approval of the authorized representative of the other party. 12. Disclaimer of Warranty. BCH makes no warranties, expressed or implied, regarding the quality of any product produced under this Agreement. 13. Governing Law. This Agreement will be governed by and construed exclusively in accordance with the laws of the Commonwealth of Massachusetts without regard to conflict of law principles. 2

16 SIGNATURE PAGE Boston Children s Hospital By: Title: Signature: Date: SITE AGREED AND ACCEPTED: By SITE: Title: ACKNOWLEDGED AND ACCEPTED: By SITE INVESTIGATOR: Title: Signature: _ Signature: Date: Date: 3

17 Appendix A (Briefly describe the overall purpose and goal of Project) 4

18 Attachment II FluNearYou Data Set Descriptions Variables in Data Sets: Variable Format Description user_id Numeric Unique ID for each participant (combination of user_entry.user_id and user_entry.user_household_id, calculated by adding user_id and the user_household_id/ ) user_entry_id Numeric Unique entry ID for each participant symptom report user_household_id Numeric Numeric: unique ID for each household member (0 for users) zip Alphanumeric Zip code provided by user at registration gender M=males Gender of participant F=females dob Date: Month/Year of birth of participant Y-m-d reg_date Date: Registration date of user Y-m-d h:m:s active Y = yes User enrolled in weekly reminders N = no week_of Date: Date of reporting week (Monday) Y-m-d entry_date Date: Date symptom report was submitted Y-m-d h:m:s platform ios, web, Type of platform used to report android no_symptoms 1=yes Participant did not have symptoms listed fever fever_f Numeric Recorded if participant responded yes to fever (recorded as <=99.9 if no fever) running_nose diarrhea chills nausea cough sorethroat bodyache headache fatigue breath

19 FluNearYou Data Set Descriptions rash ill_date medical_attention_no medical_attention_doctors_office medical_attention_urgent medical_attention_clinic medical_attention_emergency medical_attention_hospital medical_attention_other flu_vaccine 1=yes Date: Y-m-d Y = Yes N = No Y = Yes N = No Y = Yes N = No Y = Yes N = No Y = Yes N = No Y = Yes N = No Y = Yes N = No Y = Yes N = No Symptom Date of illness self-reported by user Did the participant seek medical attention for their symptoms? Yes, the participant sought medical attention for their symptoms at the doctor s office Yes, the participant sought medical attention for their symptoms at urgent care Yes, the participant sought medical attention for their symptoms at an in-store clinic (eg. CVS Minute Clinic) Yes, the participant sought medical attention for their symptoms at an Emergency Room Yes, the participant sought medical attention for their symptoms and was hospitalized overnight Yes, the participant sought medical attention for their symptoms at a facility that is not listed Denotes whether the user received their flu vaccine this season