AHRQ-15-10001_Amendment_0001.pdf

Request for Proposal No. AHRQ-15-10001

PART I - THE SCHEDULE

SECTION A - SOLICITATION FORM

Date Issued: June 11, 2014 Date Questions Due: June 18, 2014 Please Note: All questions and inquires will be processed on a non-attribution basis.

Date Notice of Intent Due: July 2, 2014 Date and Time Proposals Due: July 11, 2014 at 11:00 AM, EDT

You are invited to submit a proposal to the Agency for Healthcare Research and Quality (AHRQ) for Request for Proposal (RFP) No. AHRQ-15-10001 entitled “Evidence-based Practice Centers (EPC) V”. Your proposal must be developed and submitted in accordance with the requirements and instructions of this RFP.

Solicitation Information: Please review the table of contents and refer to the appropriate section of this RFP for requirements, proposal instructions and evaluation information. The Government intends to award this contract without negotiations, so it is imperative that all questions are addressed during the solicitation phase, and that all proposals submitted include the required information and accept the terms and conditions as stated. Failure to comply with proposal instructions or submit required information may result in the removal of a proposal from consideration for award. Please review Section L carefully.

Proposal Intent: If you intend to submit a proposal in response to this solicitation, please inform the Contracting Officer of your intent by completing the Proposal Intent Response Form (See section L.12 and Attachment A) and send it to the Contracting Officer no later than July 2, 2014.

You may mail it to the address below, fax it to 301-427-1740, Attention: Scott Henderson, Contract Specialist or email it to scott.henderson@ahrq.hhs.gov.

Questions: All Questions regarding this solicitation shall be received in this office no later than the date shown above. All questions shall be submitted electronically by e-mail to Scott Henderson, Contract Specialist, at the following email address: scott.henderson@ahrq.hhs.gov.

Subject line shall read: Proposal Questions RFP No. AHRQ-15-10001. Answers to questions and all solicitation amendments will be posted to the Federal Business Opportunities web page: www.fbo.gov. It is your responsibility to monitor the web site.

Additional Information:

• An Indefinite Delivery, Indefinite Quantity, multiple -award, task order-type contract is contemplated for a period of five years.

IDIQ Request for Proposal v. May-14 AHRQ-15-10001 Evidence-based Practice Centers (EPC) V Page 1 of 97 http://www.fbo.gov/

• The Government anticipates awarding 12 contracts from this solicitation on or about November 12, 2014.

• Proposals submitted in response to this solicitation must state that they are valid for a period of at least 120 days (reference FAR clause 52.215-1 in Section L of this document.

• The NAICS code for this requirement is 541990 with a size standard of $14 million.

Proposal Submission: The proposal shall be signed by an authorized official to bind your organization and must be received in our Contracts Office by the due date specified above.

Your proposal must be mailed to the following address:

Agency for Healthcare Research and Quality Division of Contracts Management 540 Gaither Road Rockville, Maryland 20850 Attn: Scott Henderson, (301) 427-1764

Hand carried proposals may be dropped off at the above location. However, please allow ample time as proposals cannot be accepted until they have gone through security. We will not be held responsible for any delays that may be incurred getting your proposal through security.

NOTE: The U.S. Postal Service’s “Express Mail” does not deliver to our Rockville, Maryland address. Packages delivered via this service will be held at a local post office for pick-up. The Government will not be responsible for picking up any mail at a local post office. If a proposal is not received at the place, date, and time specified herein, it will be considered a “late proposal.”

System for Award Management: In accordance with Federal Acquisition Regulation, all contractors must be registered in the System for Award Management (SAM) database in order to conduct business with the government [See Section I - FAR clause 52.204-7 System for Award Management]. Access the System for Award Management (SAM) at http://www.sam.gov.

Reminder: The Procurement Integrity Act prohibits the unauthorized disclosure of, inquiry about, or acceptance of procurement information. Communications with any other individual outside the AHRQ contracting office may result in rejection of an offeror’s proposal. All requests for any information concerning this RFP should be referred to Scott Henderson, (301) 427-1764 or e-mail: scott.henderson@ahrq.hhs.gov. Please note e-mail requests should state subject as

RFP AHRQ-15-10001.

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Table of Contents

PART I - THE SCHEDULE

SECTION A - SOLICITATION FORM

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

SECTION C - DESCRIPTION/SPECIFICATION/WORK STATEMENT

SECTION D - PACKAGING AND MARKING

SECTION E - INSPECTION AND ACCEPTANCE

SECTION F - DELIVERIES OR PERFORMANCE

SECTION G - CONTRACT ADMINISTRATION DATA

SECTION H - SPECIAL CONTRACT REQUIREMENTS

PART II – CONTRACT CLAUSES

SECTION I CONTRACT CLAUSES

PART III- LIST OF DOCUMENTS, EXHIBITS AND ATTACHMENTS

SECTION J – SOLICITATION LIST OF ATTACHMENTS

PART IV– REPRESENTATIONS AND INSTRUCTIONS

SECTION K - REPRESENTATIONS, CERTIFICATIONS, AND OTHER STATEMENTS OF OFFERORS

SECTION L - INSTRUCTIONS, CONDITIONS AND NOTICES TO OFFERORS

SECTION M - EVALUATION FACTORS FOR AWARD

Attachments Attachments listed in Section J are appended at the end of this document.

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SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

B.1 BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

“Evidence-based Practice Centers (EPC) V”. See Section C for a complete description.

B.2 TASK ORDERS

This is a Multiple Award, Indefinite Delivery/Indefinite Quantity IDIQ contract. All services will be acquired on an as-needed basis through issuance of Task Orders. Under this IDIQ contract, the minimum is $60,000, while the total maximum amount of all task orders awarded to any IDIQ contractor shall not exceed $49,000,000. Once a single IDIQ contractor reaches this maximum, the fair opportunity for competition will be considered reached and no new task orders will be awarded to any IDIQ contractor. No costs shall be incurred or reimbursed on this contract unless the cost is associated with an approved, signed Task Order.

The contract items and associated Statement of Work (Section C) requirements and prices are shown below.

Item No. Tasks Technical Area Prices

1 Task D.1.1

Task D.1.1.2

Task D.2.3

Topic Development Topic Development with Input from a Prioritization group Participation in Derivative Products

FFP

2 Task D.2.1

Manuscript Preparation

Task D.1.2 Task D.1.2.2 Task D.1.3.2

Topic Refinement Systematic Review Surveillance Limited Update

4 Task D.1.2.1 Topic Refinement for USPSTF $

Task D.1.4 Task D.1.3 Task D.1.3.2 Task D.1.3.3 Task D.1.3.4

Technical Brief Limited Systematic Review Small Systematic Review Update Limited Technology Assessment Limited Systematic Review for USPSTF

FFP

6 Task D.1.3 Task D.1.3.2 Task D.1.3.3 Task D.1.3.4

Small Systematic Review Medium Systematic Review Update Small Technology Assessment Small Systematic Review for USPSTF

Task D.1.3.2

Medium Systematic Review Large Systematic Review Update

FFP

Evidence-based Practice Centers (EPC) V Page 4 of 97

Task D.1.3.4

Medium Technology Assessment Medium Systematic Review for USPSTF

Task D.1.3.4

Large Systematic Review Large Technology Assessment Large Systematic Review for USPSTF

FFP

9 Task D.1.5

Task D.1.6 Task D.5.

Decision-Analysis, Modeling and Clinical Economic studies Individual Patient Data Meta-analysis Rapid reviews or other related EPC activities

To Be Negotiated

Limited SR/updates – estimated 0-15 articles Small SR/updates – estimated 16-50 articles, or estimated less than 16 studies, but with a broad search that yields over 10,000 articles.

Medium SR/updates – estimated 51-180 studies, or estimated less than 50 studies, but with a broad search that yields over 10,000 articles.

Large SR/update – estimated >180 studies, or estimated less than 180 studies, but with a broad search that yields over 10,000 articles.

B. 3 PROVISIONS APPLICABLE TO DIRECT COSTS

a. Items Unallowable Unless Otherwise Provided

Notwithstanding the clauses, ALLOWABLE COST AND PAYMENT, and FIXED FEE, incorporated into this contract, unless authorized in writing by the Contracting Officer, the costs of the following items or activities shall be unallowable as direct costs:

(1) Acquisition, by purchase or lease, of any interest in real property;

(2) Rearrangement or alteration of facilities;

(3) Purchase or lease of any item of general purpose-office furniture or office equipment regardless of dollar value. (General purpose equipment is defined as any items of personal property which are usable for purposes other than research, such as office equipment and furnishings, pocket calculators, etc.);

(4) Accountable Government property;

(5) Travel to attend general scientific meetings;

(6) Foreign Travel;

(7) Any costs incurred prior to the contract's effective date;

(8) Rental of meeting rooms not otherwise expressly paid for by the contract;

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(9) Any formal subcontract arrangements not otherwise expressly provided for in the contract;

(10) Consultant fees;

(11) Information Technology hardware or software; and

(12) Food and Beverages.

(13) No funding or expenditures are authorized under this contract/task order for travel or meeting expenses of any person that is not an employee of the contractor or approved subcontractor in accordance with the terms of the contract. See 31 USC 1345 for appropriations restrictions.

Note: Food and Beverages are unallowable costs. Contracting Officer Authorization for Food and Beverages will be only made as specifically authorized by statute, which is extremely rare. The contractor shall not provide food or beverages of any type. The contractor shall not accept food or beverages, even if included in, or provided ‘free’ as part of a meeting/conference ‘package’.

b. Travel Costs

This contract is subject to the provisions of Public Law (P.L.) 99-234 which amends the

Office of Federal Procurement Policy Act to provide that contractor costs for travel, including lodging, other subsistence, and incidental expenses, shall be allowable only to the extent that they do not exceed the amount allowed for Federal employees. The Contractor, therefore, shall invoice and be reimbursed for all travel costs in accordance with Federal Acquisition Regulations (FAR) 31.205-46.

The following applies to Educational Institutions: The Contractor shall invoice and be reimbursed for all travel costs in accordance with OMB Circular A-21 - "Cost Principles for Educational Institutions."

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SECTION C - DESCRIPTION/SPECIFICATION/WORK STATEMENT

Independently and not as an agent of the Government, the Contractor shall be required to 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 as follows:

Statement of Work

A. Background Information

The Agency for Healthcare Research and Quality

The Agency for Healthcare Research and Quality (AHRQ) was established in 1989 as the Agency for Health Care Policy and Research. Its reauthorizing legislation (42 U.S.C. 299 et seq; “Healthcare Research and Quality Act of 1999”) renamed the Agency the Agency for Healthcare Research and Quality (AHRQ) and established it as the lead Federal agency for enhancing the quality, appropriateness, and effectiveness of health services and access to such services.

To achieve these goals, the Agency conducts and supports a broad base of scientific research and promotion of improvements in clinical and health systems practices, including the prevention of diseases and other health conditions. AHRQ sponsors and conducts research that develops and presents evidence-based information on healthcare outcomes, quality, patient safety, cost, use and access. Included in AHRQ’s mandate is support of synthesis and dissemination of available scientific evidence, including dissemination research and analytic methods or systems for rating the strength of scientific evidence. AHRQ sponsors and conducts research on existing as well as innovating technologies, and conducts research on methods for measuring quality and strategies for improving quality. AHRQ also recognizes that a number of populations experience persistent disparities in health status, access to care, quality of care, and poor health outcomes.

To address these disparities, AHRQ encourages research projects to include special populations such as low-income groups, racial and ethnic minority groups, women, children, the elderly, and individuals with disabilities and chronic health conditions.

Evidence-based Practice Centers Program

The EPCs were created in 1997 to synthesize existing scientific literature about important health care topics and promote evidence-based practice and decision-making.

The goal of EPC work is to present the “state of the science” on a given topic in a manner that can be directly applied to decisions made by users of health care information. EPCs produce various types of evidence reports, all based on the methodology of systematic review. A key feature of systematic reviews is that they systematically and critically appraise existing research and synthesize knowledge on a particular topic. Systematic review methods have been defined by EPCs in Methods Guide (www.effectivehealthcare.ahrq.gov/methodsguide.cfm) and other organizations, such as the IOM (IOM Standards, 2011). Technical briefs employ similar systematic review methods when applied to areas where there is less established evidence.

Users of EPC reports include clinicians, patients, policy-makers, and purchasers and payers of healthcare, and may be individuals or their related organizations. EPC work has been the scientific foundation for development and implementation of clinical practice guidelines, clinical pathways, review criteria, performance measures, and other clinical quality improvements tools, individual treatment decisions, coverage or reimbursement policies, and research agendas.

To advance the translation and synthesis of EPC reports, EPCs engage directly with stakeholders to determine the questions that patients, providers, and policy-makers ask though topic development and

Evidence-based Practice Centers (EPC) V Page 7 of 97 http://www.effectivehealthcare.ahrq.gov/methodsguide.cfm topic refinement phases prior to the actual systematic review process. EPCs continue to be involved in development of dissemination materials to ensure that key messages are accurately portrayed. In addition to various stakeholders, EPCs also continue to engage technical experts to provide input while developing the protocol in order to ensure that the review will be comprehensive and relevant.

To improve the scientific rigor, transparency, and consistency of reviews conducted under the Effective Health Care Program (described below), the EPC program has collaborated to improve the methods used by developing guidance to the program as well as instituting processes to uphold the quality of the methods of reports. The Methods Guide for Effectiveness and Comparative Effectiveness Reviews is an ongoing, collaborative process by the EPCs to provide guidance on how to handle the most difficult methodologic issues in conducting systematic reviews. The current guidance papers can be found at:

www.effectivehealthcare.ahrq.gov/methodsguide.cfm and http://www.effectivehealthcare.ahrq.gov/medtestsguide.cfm. Training modules are also provided which help new EPC investigators implement the methods guide and can be found as downloadable slides or CME at: http://www.effectivehealthcare.ahrq.gov/trainingmodules.cfm. In addition to reference and teaching materials, the EPC program has a rigorous editorial and peer review process to ensure the production of quality, unbiased reports. A panel of associate editors and peer reviewers are selected to provide unbiased expert feedback to authors (http://www.effectivehealthcare.ahrq.gov/index.cfm/who-is-involved-in-the-effective-health-care-program1/about-evidence-based-practice-centers-epcs/epc-center-editorial-review-process/).

EPC Program Partners

EPCs work with many partners and stakeholders to review a variety of health care delivery and clinical areas of focus. Clinical areas may focus on traditional therapeutics as well as complementary, alternative, nutritional, and other emerging areas such as genomics and may span from preventative services to implementation of medical devices

AHRQ Effective Health Care Program

The EPC Program is the cornerstone of the Effective Health Care (EHC) Program. Section 1013 of the Medicare Prescription Drug, Improvement, and Modernization Act (MMA) of 2003 authorized AHRQ to conduct and support research with a focus on outcomes, comparative clinical effectiveness, and appropriateness of pharmaceuticals, devices, and health care services. Research is informed by the needs of the Medicare, Medicaid, and State Children’s Health Insurance Programs (SCHIP) and may include strategies for how these items and services are organized, managed, and delivered. The organizing framework of the Effective Health Care Program is applied to consider the needs of other government and private programs to support evidence-based practice and informed decision-making for additional users.

Under the EHC program, EPCs synthesize evidence, usually through systematic reviews (including comparative effectiveness reviews) and technical briefs to promote evidence-based decision making for various guideline groups, policy-makers, and others. EPC work is focused on helping health care decision-makers – patients and clinicians, health system leaders, purchasers and payers of healthcare, and policy-makers – make more informed decisions and improve the quality of health care. Informed healthcare decisions are best made within a context of scientific evidence. A stakeholder guide identifies ways in which decision makers can be involved in the EHC program, available at:

http://www.ahrq.gov/clinic/epcpartner/stakeholderguide/

Table 1: Sample List of Partners for EPC reports under the EHC Program

1. American Academy of Child and Adolescent Psychiatry

2. American Academy of Family Physicians

3. American Academy of Orthopedic Surgeons

4. American Academy of Otolaryngology—Head and Neck Surgery Foundation

5. American Academy of Pediatrics

6. American Academy of Neurology

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7. American Association for Clinical Chemistry

8. American Association of Colleges of Pharmacy

9. American College of Obstetrics and Gynecology

10. American College of Chest Physicians

11. American College of Family Physicians

12. American College of Physicians

13. American College of Radiology

14. American College of Rheumatology

15. American Gastroenterological Association

16. American Psychiatric Association

17. American Psychological Association

18. American Society of Clinical Oncology

19. American Urological Association

20. Association of American Medical Colleges

21. Autism Speaks

22. Infections Disease Society of America

23. Medicaid Medical Directors Learning Network

Under this program EPCs, work with other parts of the EHC program to promote evidence-based decision making.

John M. Eisenberg Clinical Decisions and Communications Science Center

The John M. Eisenberg Clinical Decisions and Communications Science Center, also referred to as the Eisenberg Center, takes a systematic approach to translate scientific knowledge about effective health care into understandable, actionable language for all decision-makers. As scientific evidence about effectiveness is synthesized by the EPC program, the Eisenberg Center then translates the scientific knowledge into targeted products for all stakeholders – including patients, providers, and policy-makers.

Stakeholders can use this knowledge to maximize benefits from their health care, minimize harm, and optimize the use of health care resources. An important function of the Eisenberg Center is to present the often complex scientific information in a format that stakeholders and the public can easily understand.

Healthcare Horizon Scanning System

The Healthcare Horizon Scanning System (HHSS) was developed in 2010 to identify, monitor, and track new and emerging health care technologies and interventions that could signal important changes to patient care, health outcomes, and the United States health care system. The HHSS will be a resource for the Effective Health Care Program as it makes decisions about allocating resources for patient-centered outcomes research. It will also be a tool for the public to identify and find information on new health care technologies and interventions. Any investigator or funder of research will be able to use the HHSS to select potential topics for research.

Scientific Resource Center

The function and role of the Scientific Resource Center (SRC) will be to work closely with AHRQ and EPCs to coordinate many of the scientific governance functions of the EHC and in particular EPC program, including:

• Topic triage o The SRC will assemble, schedule, set agendas for, and lead topic triage calls o The SRC will gather and track topic nominations

Evidence-based Practice Centers (EPC) V Page 9 of 97 o The SRC will provide lists of topics to AHRQ and help determine which are most appropriate for development by EPC.

o The SRC will develop topics for presentation to topic triage and provide guidance documents and templates to the EPCs to ensure consistency of processes in topic development o The SRC will track Systematic Reviews that are eligible for updating and provide resources to the EPCs to ensure consistency of processes in assessing the need to update reports

• Peer review o The SRC will coordinate and track EPC reports for peer review.

o The SRC will coordinate editorial process for review of draft and final reports. The SRC will provide guidance documents and feedback for associate editors to ensure consistency of processes in reviewing reports. The SRC will schedule, set agendas for, and lead regular associate editor calls and meetings for coordination purposes.

o The SRC will invite peer reviewers and collate comments for EPC reports.

• Coordination and logistic support o The SRC will work with EPCs to maintain and develop consistent guidance for the systematic review methods used by the EPC program.

o The SRC will work with AHRQ and the EPCs to develop a robust methods research, methods guidance, and methods implementation agenda.

Additional information on the EHC program in general, resources it provides, and descriptions of processes can be found at: http://www.effectivehealthcare.ahrq.gov/index.cfm/what-is-the-effective-health-care-program1/.

Information on each of the component parts of the EHC Program can be found at:

http://www.effectivehealthcare.ahrq.gov/index.cfm/who-is-involved-in-the-effective-health-care-program1/

Examples of products produced by each of the component parts of the Effective Health Care Program may be found at: http://effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and-reports/.

Specific examples of EPC reports for the EHC program can be found at:

http://www.effectivehealthcare.ahrq.gov/search-for-guides-reviews-and-reports/?category=&search=&trackID=1&methodCategory=&agencyType=2&language=1&searchButton= Search

US Preventive Services Task Force

The U.S. Preventive Services Task Force (USPSTF or Task Force) is an independent, volunteer panel of national experts in prevention and evidence-based medicine. Since its inception in 1984, the USPSTF has worked to improve the health of all Americans by making evidence-based recommendations about clinical preventive services and health promotion. These recommendations for adults and children address screening tests, counseling about healthful behaviors, and preventive medications.

Since 1998, the Agency for Healthcare Research and Quality (AHRQ) has been authorized by Congress to convene the USPSTF and to provide ongoing scientific, administrative, and dissemination support.

USPSTF recommendations focus on interventions to prevent disease, and they apply only to people without signs or symptoms of the disease or condition under consideration. USPSTF recommendations

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The USPSTF makes recommendations to help primary care clinicians and patients decide together whether a preventive service is right for an individual’s needs.

The work of the USPSTF is supported by Evidence-based Practice Centers (EPCs), which conduct rigorous, impartial assessments of the scientific evidence on specific topics in clinical prevention that serve as the scientific basis for USPSTF recommendations. USPSTF members use the evidence report as the basis for their assessment of the effectiveness of the preventive service under consideration.

They balance both the potential benefits and harms in making their recommendations. Potential benefits of clinical preventive services include reduction of risk factors to prevent disease, early identification of disease leading to earlier treatment, and, ultimately, improved health outcomes such as quality of life and length of life. Harms of preventive services can include adverse effects of the service itself as well as the harms of inaccurate test results that may lead to a cascade of additional followup tests (some of which are invasive and could cause harm) and unnecessary treatments. Potential harms also include side effects or complications of treatments. When appropriate and when evidence exists, the USPSTF evaluates the benefits and harms based on age, sex, and risk factors for the disease.

The USPSTF makes its recommendations based on its assessment of the effectiveness of each clinical preventive service. The USPSTF does not explicitly consider costs in its appraisal of the effectiveness of a service. The USPSTF recognizes that insurance coverage decisions involve additional considerations beyond a scientific assessment of the clinical benefit and harms.

The recommendation statement and a manuscript based on the full evidence review prepared by EPCs are often published in a peer-reviewed medical journal. To ensure that stakeholders and the public are informed about the recommendations and understand them, the USPSTF also develops plain language fact sheets on each draft and final recommendation statement and works with partner organizations on dissemination and implementation activities. The EPCs provide consultation to the USPSTF on developing its recommendations and translating them for multiple target audiences. Details of USPSTF methods and processes and the role of EPCs can be found at:

http://www.uspreventiveservicestaskforce.org/methods.htm#methods.

Examples of EPC reports for the USPSTF can be found at:

http://www.uspreventiveservicestaskforce.org/uspstopics.htm

Technology Assessment Program

Through the Technology Assessment (TA) Program, EPCs conduct focused systematic reviews of the literature, along with appropriate qualitative and quantitative methods of synthesizing data from multiple studies or sources. Systematic reviews conducted under the TA program are termed Technology Assessments, and are used by the Centers for Medicare and Medicaid Services (CMS) to inform its national coverage decisions for the Medicare Program as well as provide information to Medicare carriers.Information on the TA Program can be found at http://www.ahrq.gov/research/findings/ta/index.html.

Examples of completed EPC reports under the TA program can be found at http://www.ahrq.gov/research/findings/ta/index.html#tacomplete

EPC reports for other Federal or public agencies

EPCs synthesize evidence, primarily through conduct of systematic reviews and technical briefs on behalf of other Federal agencies or public partners. EPCs have conducted systematic reviews and technical briefs for individual centers within the National Institutes of Health (NIH), the Centers for Disease Control (CDC), the Department of Health and Human Services (DHHS), or other Federal branches of government. EPCs have also developed topics for organizations such as the Patient

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Centered Outcomes Research Institute.

B. Objectives

EPCs will work with various partners and stakeholders to synthesize evidence on a variety of health care delivery and clinical areas. EPCs must be able to address both healthcare delivery as well as clinical topics across the range of clinical specialty care areas that address partner needs. EPCs may be asked to focus on traditional therapeutics as well as complementary, alternative, nutritional, and other emerging areas such as genomics and may span from preventative services to implementation of medical devices. Through the EHC program, EPCs synthesize evidence for a variety of private and public partners. The EPCs also synthesize evidence for a variety of established Federal programs including the US Preventive Services Task Force (USPSTF), the Technology Assessment (TA) Program. EPCs work on a variety of clinical, and healthcare delivery or program topics on behalf of other Federal agencies, such as individual centers within the National Institutes of Health (NIH), the Centers for Disease Control (CDC), the Department of Health and Human Services (DHHS), the Center for Medicare and Medicaid Services (CMS), other Federal branches of government, or other publicly funded organizations, such as the Patient Centered Outcomes Research Institute (PCORI).

Specifically, EPCs will perform task orders to implement a collective mission to meet the following objectives:

• Promote the synthesis and translation of evidence.

o Engage private and federal partners and stakeholders to develop and refine questions in which systematic review will help disseminate and translate research findings for the stakeholder audience.

o Conduct systematic reviews or other forms of evidence synthesis for use by partners and other stakeholders.

o Collaborate with partners, including other EPCs and AHRQ programs, to promote relevant, consistent, transparent and valuable implementation of the systematic review process, dissemination of findings from evidence syntheses and the EPC Program as a whole.

• Improve validity and utility of systematic reviews for decision-making o Advance methods of systematic review through empiric methods research o Ensure quality of EPC reviews through associate editor and peer review.

• Improve consistency and cohesiveness of program o Develop methods guidance and translation of methods guidance to aid implementation efforts o Development of tools to improve EPC program efficiency

C. Personnel

Successful execution of the requirements of this contract will require an effective and efficient team of multidisciplinary individuals with a high level of consistent functioning at both the individual and collective levels.

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Senior Leadership Core

The EPC Director, Associate Director and Program Manager shall function as a core team for senior leadership within the EPC for any assigned tasks. They shall work collaboratively to direct and encourage the EPC’s collegial work on the various tasks outlined and to implement the underlying concepts in a consistent, integrated manner.

Work across the various tasks will include complex projects with varying timeframes, and multiple deliverables and pressing timelines. Senior leadership should have experience in managing such projects, with a combination of flexibility while providing strong direction to manage dynamic and high-visibility projects.

Building and maintaining capacity will be an on-going challenge. EPC leadership shall have experience and contingency plans for hiring, training, oversight and supervision of new staff and scientists and maintaining staff capacity and skills with a long-term view.

EPC Director

The EPC Director’s main responsibility continues to be to provide strong and consistent programmatic leadership at the EPC levels and across various tasks. It is the responsibility of the EPC Director to evaluate and assert performance expectations of all staff to produce top-quality contributions of such individuals. The magnitude of this work will require a primary effort, direct commitment and active engagement by the EPC Director for a dedicated portion of his/her time. Collaborative leadership with an Associate Director is appropriate, but final responsibility must reside with the EPC Director. The EPC Director must be willing to attest to the integrity and quality of each deliverable prior to submission to

AHRQ.

The EPC Director shall have documented training and extensive direct experience in evidence-based practice methods. The Director shall also have demonstrated methodological expertise in systematic review, and the assessment of a broad range of scientific data supportive of outcomes research, such as data from randomized controlled trials, computerized pharmacy records, diagnostic studies, technology assessments, epidemiologic and social sciences research (including but not limited to economics, sociology, and behavioral research).

This individual shall also direct and encourage the EPC’s collegial work on EPC program-wide initiatives, such as EPC meetings, interactions with other EHC partners, trans-EPC collaborative reviews or methodology projects. The EPC Director shall mentor new staff as they participate in EPC projects.

Leadership by example suggests that the EPC Director shall function as a project lead on a semi-regular basis, but at a minimum, s/he must attest to the integrity and quality of each deliverable prior to submission to AHRQ. For each task and review topic, EPCs are expected to include either EPC Director or Associate Director as part of the research team serving in the supervisory capacity and leadership function to ensure successful and efficient integration of the research team and the quality of the research products.

EPC Associate Director

The Associate Director shall assist the Director with promoting successful and consistent EPC work and provide continuity of leadership in the Director’s absence. The Associate Director often has a dual function as Lead Investigator on EPC projects. In collaboration with the EPC Director, the EPC Associate Director shall supervise and evaluate the work of Lead Investigators and other scientific functions. For each task and review topic, EPCs are expected to include either EPC Director or Associate Director as part of the research team serving in the supervisory capacity and leadership function to ensure successful and efficient integration of the research team and the quality of the research products.

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EPC Program Manager

The EPC Program Manager shall assist the Director by promoting successful and consistent EPC work.

For each task and review topic, EPCs are expected to include as part of the research team individual serving the function and capacity of a program manager. The EPC Program Manager may directly supervise and evaluate the work of research assistants and like roles. The EPC Program Manager will be responsible for preparation and submission of on-going status reports. The EPC Program Manager is expected to be familiar with Publishing Guidelines and format requirements for deliverables, including 508 compliance.

On a day-to-day basis, the EPC Program Manager shall supervise all activities across the EPC to maintain efficient and effective functioning across multiple concurrent tasks and projects. The Program Manager is responsible for identifying problems or challenges and initiating solutions quickly. Likewise, the Program Manager is expected to be responsive to problems or issues identified by the AHRQ Program Officer.

EPC Lead Investigators

EPC Lead Investigators shall apply their scientific and content expertise throughout the various steps of evidence synthesis and translation – including topic identification, refinement, systematic review, and identification of research needs. It is expected that at least one topic-specific clinical or cross-cutting domain content expert will be included as key personnel if that expertise is not held by the Lead Investigator. Examples of scientific expertise include meta-analysis or systematic review methods with non-randomized study literature or research on devices. Examples of clinical expertise include primary care, women’s health, heart disease or diabetology. These are examples only and should not be interpreted by Offerors as preferred areas of expertise. It is understood that lead investigators may be assisted by less experienced researchers. It is the responsibility of the EPC Director and/or Associate EPC Director to evaluate and assert performance expectations to produce top-quality contributions of such individuals. Similarly, if there are novice staff on a particular project, it the responsibility of the Lead Investigator and EPC Director to evaluate and assert performance expectations to produce top-quality contributions of such individuals.

Librarian

The librarian is a key member of the EPC project team to ensure a comprehensive and unbiased review of the literature. The EPC shall ensure that the search methods are consistent with EPC methods guidance, and reviewed internally for quality control purposes. For each review topic, EPCs are expected to include as part of the research team individual serving the function and capacity of a librarian. As described previously, the EPC Director, Associate Director and Program Manager hold important supervisory and leadership roles to ensure successful and efficient integration of these members of the team.

Statistician/Data analyst

Statistical analysis is a cornerstone of systematic reviews and appropriate statistical expertise ensures the quality of the report and protects against bias. For each review topic, EPCs are expected to include as part of the research team individual serving the function and capacity of a statistician/data analyst. As described previously, the EPC Director, Associate Director and Program Manager hold important supervisory and leadership roles to ensure successful and efficient integration of these members of the team.

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Medical Editor and/or Medical writers

Clarity and consistency of the EPC reports is essential for them to be useful. Because of the size and complexity of the EPC reviews, EPCs should ensure that the reports are edited for clarity and consistency. For each review topic, EPCs are expected to include as part of the research team individual serving the function and capacity of a medical editor/medical writer. As described previously, the EPC Director, Associate Director and Program Manager hold important supervisory and leadership roles to ensure successful and efficient integration of these members of the team.

Stakeholder Engagement

To ensure that EPC products are relevant and useful to stakeholders, EPCs will engage with program stakeholders, in collaboration with other aspects of the EHC Program, such as the Scientific Resource Center and Eisenberg Center. EPCs will engage the topic nominator and local clinical experts during topic development, a variety of key informants during refinement, clinical, and technical experts during the systematic review or technical brief. The patient perspective, especially as related to outcomes, is particularly important to include through all aspects of systematic reviews and technical briefs.

Engaging stakeholders throughout the process will help ensure relevance of the EPC product for their use. However, ensuring dissemination and use of EPC products will require additional considerations and efforts. EPCs must consider how to present clear, key findings so that stakeholders can readily understand and use the report. The EPC must have clear messages that can easily be translated into derivative products. The EPC must be available during any Task Order to provide technical input into the development of any translational products derived from the product. EPCs will collaborate with the Eisenberg Center, AHRQ and other EHC program partners for these activities.

This work of engaging stakeholders and partners for topic development, prioritizing research and disseminating findings, as described below in D.3.2 is expected to be at least 20% of the work of promoting evidence synthesis (i.e. tasks described in D.1) and the EPC should anticipate appropriate personnel for these efforts.

D. Tasks

D.1. Promote the synthesis and translation of evidence

The primary work of the EPC program is to synthesize existing evidence on a given topic area to promote evidence-based decision making. The primary established methodology for this is through systematic review.

Systematic review is a research product that has established methodology and procedures established by various groups (including the Methods Guide, by the EHC program, and the IOM Standards). In addition to the established methods for conducting the systematic review, various programs within the EPC Program may have some variation in the particular procedures to ensure smooth coordination with the various partners and collaborators.

There are three key sequential steps in the process of conducting comprehensive systematic reviews, each one building on the previous work. The EHC program has established methods and procedures for the conduct of each of these sequential steps as outlined in the EPC Methods guide and the Procedures guide, both of which are living documents (For current version of the Procedures guide, see Attachment J.3). Tasks should be conducted in accordance to these documents unless otherwise noted. The three steps are delineated in sections D.1.1 through D.1.3. below. Related procedures for updating reports are included in these sections as well.

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Other research methodologies are available to synthesize evidence. D.1.4. describes the Technical Brief, which employs systematic review methodology to topic areas where there is less published research.

The procedures for conducting a Technical Brief under the EHC program are described in the Procedures guide (see Attachment J.3), with specific instructions for drafting a Technical Brief in Attachment J.4.

Other evidence synthesis approaches, such as Decision modelling, clinical economic studies, and individual patient data meta-analysis have systematic review methods as the backbone, but employ other quantitative statistical methods as well. Methods and procedures for these product have not been as well standardized and described as those for systematic reviews, but are described generally in D.1.5 and D.1.6

D.1.1. Topic Development

After a topic is nominated, the EPC shall evaluate the topic against established criteria. The EPC shall prepare a topic brief describing the nomination and how it fits in the current clinical and research context along with how it fits with established criteria. In order to prepare the brief, the EPC shall

To prepare the brief, the EPC shall:

• Target discussions with specific stakeholders or topic experts to clarify the context of the decisional issue driving the topic nomination.

o These discussions are intended to be limited and efficient, focused solely on providing initial direction in developing the topic to be responsive to the decisional needs of stakeholders. Typically, the discussion(s) would be with the nominator or local clinicians, patients or other experts who are readily available to the EPCs.

• Conduct a limited literature scan o The purpose of the literature scan is to briefly describe the topic’s background and significance and to outline the research evidence available for the topic. The available evidence is assessed through a narrow search of defined resources such as ClinicalTrials.gov, the Cochrane database, and the National Guidelines Clearinghouse.

• Propose a beginning PICO(TS).

• Assess the topic’s fit with established criteria.

• Outline key considerations and discussion points for the further prioritization discussion.

Templates and criteria vary depending on partner and would be provided upon award. For example, topic briefs conducted for the EHC program should be evaluated against established EHC criteria, defined in Whitlock et al, 2009. Further information on the Topic nomination and selection process for the EHC program may be found at: http://effectivehealthcare.ahrq.gov/index.cfm/submit-a-suggestion-for-research/how-are-research-topics -chosen/.

D.1.1.2 Topic Development with Input from a Prioritization group

The EPC may develop topic nominations on behalf of various partners. On behalf of these partners, the EPC will prepare a Topic Brief (or background document) generally following the steps described in D.1.1. In addition to development of the Topic Brief (or background document), the EPC shall:

1. Present the findings from the brief (or background document) to a prioritization group

2. Provide technical expertise on the topic to assist the prioritization group in determining the final disposition of the topic.

3. Incorporate feedback into a final version of the Topic brief (or background document) that

Evidence-based Practice Centers (EPC) V Page 16 of 97 http://effectivehealthcare.ahrq.gov/index.cfm/submit-a-suggestion-for-research/how-are-research-topics%20-chosen/ http://effectivehealthcare.ahrq.gov/index.cfm/submit-a-suggestion-for-research/how-are-research-topics%20-chosen/ includes a description of the comments and revisions.

The USPSTF considers both new topic nominations as well as the topics for update through an established prioritization process. These procedures for developing the background document (or Topic Brief) are described in Attachment J.7 (or can also be found in the USPSTF Procedure Manual: Section 2: Topic Selection, Prioritization, and Updating.).

D.1.2. Topic Refinement

In the topic refinement process, the EPC shall develop key questions amenable to a systematic review based on the topic nomination and development process. The key questions should describe the specific Population, Intervention, Comparator, Outcome, Timing, and Setting (PICOTS) that will be covered in the scope of work. An analytic framework shall be developed that describes how the key questions fit into the clinical context. In order to define the PICOTS and the analytic framework, the EPC shall work with Key Informants to identify the decisional dilemma and to provide insight into the clinical and decisional context. The process for conducting a topic refinement for the EHC program can be found in the Procedures Guide (Attachment J.3).The topic refinement brief shall describe:

• Summary of Nomination

• Background and Clinical Context:

• Citations and Important References

• Preliminary Key Questions

• Analytic Framework

• Key Considerations for Key Informants

• Summary of Key Informant Discussions

• Contacts for Scientific Information Packets

Excerpted information will be posted for public comment:

• Key Questions

• Background

• Population(s)

• Interventions

• Outcomes

• Timing

• Setting

• Definition of Terms

• References

D.1.2.1. Topic Refinement for USPSTF

The U.S. Preventive Services Task Force follows similar processes to the EPC program. Specific procedures are outlined in the USPSTF Procedures for Evidence-based Practice Centers (Attachment J.7) and the USPSTF Manual (http://www.uspreventiveservicestaskforce.org/uspstf08/methods/procmanual.htm).

EPCs working with the USPSTF will be asked to develop a work…