SOW.pdf

Statement of Work

Collaboration to Develop ME/CFS Educational Materials Based on IOM Report

Background and Need

The primary message of the Institute of Medicine (IOM) report on myaglic encephalomyelitis/chronic fatigue syndrome (ME/CFS)1, commissioned by the US Health and Human Services (HHS), is that “ME/CFS is a serious, chronic, complex, and system disease that frequently and dramatically limits the activities of affected patients”.

The report recommends new diagnostic criteria that, compared with existing ME/CFS diagnostic criteria, are more focused on the central symptoms of ME/CFS and easier for clinicians to use to recognize and diagnose patients in a timely manner.

CDC’s existing web pages2, toolkit, and continuing education courses are highly visible and important resources on disease and its diagnosis that need to be revised to incorporate the IOM recommendations. While treatment/management recommendations were beyond the scope of the IOM report, CDC’s materials eventually need to incorporate the best evidence about these issues because diagnosis without further guidance on therapy/management is unlikely to improve the well-being of ME/CFS patients. An approach toward the development of such guidance would be a GRADE analysis or some other systematic review of the literature on

CFS treatment and management. In addition, the IOM report recommends that the name of the disease be changed from ME/CFS to systemic exertion intolerance disease (SEID).

These technical and educational materials need to be evidence-based and include information in form and content that is understandable and useful to all stakeholders (healthcare professionals, patients and advocates, CFS Advisory Committee (CFSAC)3, and federal agencies). This will only be achieved through collaboration of all stakeholders.

Project Identification and Purpose

The purpose of this contract is to provide the Centers for Disease Control and Prevention (CDC) an ”as needed” mechanism to obtain required services related to ME/CFS health education activities through facilitating meetings and teleconference calls for stakeholder engagement, conducting needs assessments, preparing reports for meetings and needs assessments, consultation and technical assistance, medical/scientific writing assistance and related support activities. The contractor will assist in document review and revision for CDC clearance.

Specific Objectives/Expected Outcomes

• Evidence-based web pages for CDC that will be made available to other HHS agencies to promulgate criteria for disease diagnosis in a way that is consistent with the IOM report recommendations and useful for the intended audiences.

• Additional educational materials – Continuing Medical Educational courses (CMEs), medical student curricula to be promoted by medical professional societies

• Preliminary planning regarding GRADE analysis (or similar systematic review) of treatment and management literature, with an eventual goal of producing evidence-based recommendations in this area.

Scope of Work

Independently and not as an agent of the Government, the contractor shall provide all personnel, facilities, equipment, materials, and supplies, to provide required services to the CDC CFS research program to support and organize collaboration with all stakeholders (healthcare professionals, patients and advocates, CFS Advisory

Committee (CFSAC), and federal agencies) to develop web page, toolkit, and continuing education materials incorporating IOM recommendations on ME/CFS diagnosis. The contractor shall also support planning activities regarding GRADE analysis (or similar systematic review) of the literature.

Tasks to be performed

The contractor shall perform the following specific tasks:

Task 1. The contractor shall coordinate a kick-off meeting with CDC and provide the minutes to the Contracting

Officers Representative (COR).

Task 2. Engage stakeholders in the development process of ME/CFS education materials

Form a Steering Committee (SC) and a Technical Development Workgroup (TDW) through formal invitations describing objectives and responsibilities of each.

• The Steering Committee will include representatives of HHS and CDC [Office of the Associate

Director for Science (OADS), National Center for Emerging and Zoonotic Infectious Diseases

(NCEZID), Division of High-Consequence Pathogens and Pathology (DHCPP), and CFS Program].

Representatives from other HHS agencies participating in CFSAC will be invited. The steering committee will further define the scope of work and the specific processes for the Technical

Development Workgroup to utilize.

• The Technical Development Workgroup will formed as a separate entity from the Steering

Committee and will include representatives from the following:

o CDC CFS program o CFSAC representatives (e.g. chair/co-chair, patient advocate) o Medical professional societies (e.g., American College of Physicians, American Academy of

Family Practice, American Academy of General Physicians, American Academy of Pediatrics, American Association of Nurse Practitioners, American Academy of Physician Assistants) o Medical education organizations (e.g., Association of American Medical Colleges, American

Association of Colleges of Nursing, Association for Prevention Teaching and Research, Association of Schools and Programs of Public Health) o ME/CFS medical specialists (2 from IOM committee and 2 not on IOM committee) o Representatives of ME/CFS Advocacy community (such as New Jersey Chronic Fatigue

Association, Massachusetts ME/CFS Association, International Association for Chronic Fatigue

Syndrome/ Myalgic Encephalomyelitis (IACFS/ME, and active individuals) (Based on discussions with CDC, several representatives from patient advocacy groups shall be selected for their potential role in ME/CFS education material development)

Task 3. Facilitate meetings/teleconferences with Steering Committee to develop a plan for needs assessment

A. Meet with Steering Committee to determine information that should be gathered from Technical

Development Workgroup to identify needs of each group

B. Develop needs assessment tools (e.g. interview guide or a short survey) to include the following areas:

• Need for revising existing web pages versus developing new web pages

• Areas of emphasis, including:

o Diagnosis, based on IOM report recommendations o Name for illness

• Types of materials most needed and target audiences o Web page (required – first priority of contract) o Brochure o Toolkit o Fact Sheet o CME

C. Review needs assessment tools with Steering Committee and revise based on Steering Committee feedback

Task 4. Conduct needs assessment and prioritize topics/areas for the development of ME/CFS education materials based on IOM report and assist SC in disseminating this information and developing subgroups of the

TDW

A. Use tools developed from Task 3 to assess needs in ME/CFS education materials; e.g. administer phone interviews or a survey to members of the TDW

B. Provide summary of findings to Steering Committee

C. Assist in using information from needs assessment interviews to prioritize topics/areas and develop subgroups of TDW to address specific issues or sections of the website and educational materials.

D. Develop summary of findings, rationale for work plan, and TDW subgroup assignments for SC to distribute to TDW

E. Organize in-person meeting of Steering Committee and TDW with goal of defining a work plan for each subgroup of the TDW

F. Expected deliverables and timelines

• Manage invitations and travel

• Organize agenda

• Take notes and provide summary

• Provide work plans for each section of the ME/CFS website

• Other logistic issues related to conducting needs assessment

Task 5. Facilitate the meetings and provide technical support to the Steering Committee and subgroups of the

Technical Development Work Group

A. Support subgroup conference calls and facilitate adherence to timelines

• Provide outline and rough draft of each web section to Steering Committee and assist subgroups in addressing any comments and producing final subgroup reports

• Provide final sub group materials to Steering Committee

B. Develop draft of complete website to Steering Committee and assist in clearance process

• CDC, other HHS as needed

• Make revisions as needed for clearance

Task 6. Develop and execute work plan for other types of education materials based on the needs assessment from Task 4

A. Develop work plan for other educational materials

• Priority of educational products to be determined by Steering Committee

• All brochures, toolkits, fact sheets and other materials should be based on information contained on the final website for consistency

B. Prepare final materials for Technical Development Work Group comment and Steering Committee review

C. Assist in clearance

Comment: Whenever possible, in order to reduce costs, CDC conference lines and meeting spaces should be utilized.

Reporting Requirements

(I) Progress Reports:

The progress report shall contain, at a minimum, the following information: a brief description of requirements, accomplishments during the reporting period and significant events regarding the task order, deliverables submitted, progress on deliverable products, any current and anticipated problems and solutions, stakeholder participation and issues, communications with persons, groups, organizations, and agencies and the nature of those communications, activities scheduled for the next reporting period, and key personnel changes and a brief summary of activity planned for the next reporting period.

(II) Final Project Report:

The contractor shall submit a draft Final Project Report to the Technical Monitor 30 days before the end of the project which summarizes the project and its findings in narrative and figurative format. The Technical Monitor will respond with comments on the draft final report within two weeks of its receipt. The contractor shall deliver a final report 2 weeks prior to the end of the contract.

General Information

Place of Performance: The work to be performed under this contract will be performed at the Contractor’s facility. Any education material products can be printed at CDC’s facility based on availability. The contractor is responsible for providing all necessary equipment. If CDC’s facility is not available for in person meetings, the contract will identify an appropriate location.

Section 508

Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d) helps to ensure that federal employees with disabilities have access to, and use of, the information and data they need to do their jobs. Furthermore, this law ensures that members of the public with disabilities have the ability to access government information and services.

Regardless of format, all Web content or communications materials produced for publication on or delivery via

CDC Web sites - including text, audio or video - must conform to applicable Section 508 standards to allow federal employees and members of the public with disabilities to access information that is comparable to information provided to persons without disabilities. All contractors (including subcontractors1) or consultants responsible for preparing or posting content intended for use on a CDC-funded or CDC-managed Web site must comply with applicable Section 508 accessibility standards, and where applicable, those set forth in the referenced policy or standards documents below. Remediation of any materials that do not comply with the applicable provisions of 36 CFR Part 1194 as set forth in the SOW or Performance Work Statement (PWS), shall be the responsibility of the contractor or consultant retained to produce the Web-suitable content or communications material. Checklists for various file formats are available at http://www.hhs.gov/web/508/index.html.

The following Section 508 provisions apply to the content or communications material identified in this SOW or

PWS:

36 CFR 1194.21 (for software and programmatic elements in websites), 36 CFR 1194.22 (for documents and websites), and 36 CFR 1194.24 (for video and multimedia content)

References:

HHS Policy for Section 508 Electronic and Information Technology (E&IT) (January 2005):

http://www.hhs.gov/od/Final_Section_508_Policy.html

HHS Section 508 Web site: http://508.hhs.gov/

HHS ASPA Web Communications Division Web site: http://www.hhs.gov/web/policies/index.html

US General Services Administration (GSA) Section 508 Web site: http://www.section508.gov/index.cfm

Prime contractors may enter into subcontracts in the performance of a Federal contract, but the prime remains obligated to deliver what is called for under the contract.

Deliverables

Task /

Deliverable

Description for

Deliverable Format Quantity Delivery Date Deliver To

Minutes from

Kick-Off Meeting

Teleconference call and one electronic copy in MS Word for the meeting minutes

Two weeks after contract award

Technical

Monitor and COR

Form Steering

Committee (SC) and Technical

Development

Work Group

(TDWG)

One electronic copy in

MS Word: member list and invitation for

SC and TDWG

1 month after contract award

Technical

Monitor and COR

3.1

Initial Plan for

Needs

Assessment

One electronic copy in

MS Word

2 month after contract award

Technical

Monitor and COR

3.2

Refined Plan with SC and

TDWG for Needs

Assessment

One electronic copy in

MS Word

3 months after contract award

Technical

Monitor and COR

Report for needs assessment

One electronic copy in

MS Word

4 months after contract award

Technical

Monitor and COR

5.1

Minutes from meetings for facilitating SC and TDWG in drafting the web sections of the

CFS website

In person or teleconference call and one electronic copy in MS Word for the meeting minutes

5 months after contract award

Technical

Monitor and COR

5.2

Initial draft/outline for the web sections

One electronic copy in

MS Word

7 months after contract award

Technical

Monitor and COR

5.3 Revised draft for

the web sections

One electronic copy in

MS Word

9 months after contract award

Technical

Monitor and COR

5.4

Final draft/outline for the web sections

One electronic copy in

MS Word

10 months after contract award

Technical

Monitor and COR

6.1

Plan for other types of education materials

One electronic copy in

MS Word for the plan;

minutes for teleconference calls with SC and TDWG representatives

11 months after contract award

Technical

Monitor and COR

6.2

Initial draft/outline for the selected types of education

One electronic copy in

MS Word

12 months after contract award

Technical

Monitor and COR

6.3

Revised draft for the selected types of education

One electronic copy in

MS Word

14 months after contract award

Technical

Monitor and COR

6.4

Final draft for the selected types of education

One electronic copy in

MS Word

15 months after contract award

Technical

Monitor and COR

Reporting

Requirements (I)

Teleconference

Call/Progress

Report

One electronic copy in

MS Word

Monthly after the contract award start date

Technical

Monitor and COR

Reporting

Requirements

(II)

Final Report One electronic copy in

MS Word

1) Draft within

30 days before the end of the contract award;

2) Final report

2-weeks before the end of the contract award.

Technical

Monitor and COR

Reference Materials

1. The IOM report on myaglic encephalomyelitis/chronic fatigue syndrome (ME/CFS), http://www.iom.edu/Reports/2015/ME-CFS.aspx

2. The CDC CFS website, http://www.cdc.gov/cfs/

3. The CFSAC website, http://www.hhs.gov/advcomcfs/