AHRQ-25-10002.pdf

IDIQ Request for Proposal v. May 2024; FAC 2024-04 AHRQ-25-10002

Evidence-Based Practice Centers (EPC) VII Page 1 of 95

Request for Proposal

No. AHRQ-25-10002

PART I - THE SCHEDULE

SECTION A - SOLICITATION FORM

Date Issued: August 19, 2024

Date Questions Due: August 22, 2024

Please Note: All questions and inquires will be processed on a non-attribution basis.

Date Notice of Intent Due: September 4, 2024

Date and Time Proposals Due: September 26, 2024 11:00 AM, EST

You are invited to submit a proposal to the Agency for Healthcare Research and Quality (AHRQ) for Request for Proposal (RFP) No. AHRQ-25-10002 entitled “Evidence-Based Practice Centers

(EPC) VII”. Your proposal must be developed and submitted in accordance with the requirements and instructions of this RFP.

Please note: Conflict of Interest: A significant organizational conflict of interest has been identif ied for this solicitation. See section L herein for additional information.

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 sending an email to Scott Henderson, Contract

Specialist/Contracting Officer at scott.henderson@ahrq.hhs.gov no later than September 4, 2024.

Subject line shall read: Proposal Intent RFP No. AHRQ-25-10002.

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/Contracting Officer, at the following email address:

scott.henderson@ahrq.hhs.gov. Subject line shall read: Proposal Questions RFP No. AHRQ-25-

10002. Answers to questions and all solicitation amendments will be posted to the Contract

Opportunities web page: https://sam.gov/content/home. It is your responsibility to monitor the web site. Questions should be submitted in a Word table in the following format:

mailto:scott.henderson@ahrq.hhs.gov https://sam.gov/content/home

Evidence-Based Practice Centers (EPC) VII Page 2 of 95

RFP (or Attachment) Page Number

Relevant Section Number or Title

Question

Additional Information:

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

• The Government anticipates awarding up to 11 contracts from this solicitation on or about

January 24, 2025.

• 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 541715 with a size standard of 1000 employees.

Proposal Submission:

To submit a proposal, offerors are required to use the AHRQ Proposal Module. Mailed proposal and E-mailed proposals will not be accepted.

In order to access the AHRQ Proposal Module offerors must be registered in the system before the proposal due date. To ensure your organization is registered in the system, please send the following information to scott.henderson@ahrq.hhs.gov no later than 11:00 AM, EST September

19, 2024:

Official Company name

Unique Entity Identif ier

Point of Contact name, email, phone number

Failure to respond timely and provide the requested information could result in an inability to submit a proposal.

Before the proposal due date, instructions on how to upload proposals to the AHRQ Proposal

Module will be emailed to your organization’s point of contact.

NOTE: For the Business Proposal submission, the offeror must submit two versions. This includes a Word or PDF version AND an Excel document version.

The proposal shall be signed by an authorized official to bind your organization. Signatures can be electronic if necessary.

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 https://sam.gov/content/home/.

https://www.sam.gov/SAM/

Evidence-Based Practice Centers (EPC) VII Page 3 of 95

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-25-10002.

Evidence-Based Practice Centers (EPC) VII Page 4 of 95

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

Evidence-Based Practice Centers (EPC) VII Page 5 of 95

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

B.1 BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

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

B.2 IDIQ CONTRACT

This is a Multiple Award, Indefinite Delivery/Indefinite Quantity (IDIQ) contract. Refer to the following Sections for more information:

• Section C for Statement of Work requirements,

• Section F for Period of Performance information,

• Section G for invoicing requirements, and

• Section H for ordering procedures for task orders.

B.3 TASK ORDERS AND PRICES

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 $100,000 while the total maximum amount of all task orders awarded to any IDIQ contractor shall not exceed $40,000,000. 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 Price

1 D.2.3.5 Webinar

2 D.2.3.6

Remotely Delivered Presentation with All-Day

Virtual Meeting Attendance (1 Person/1 Day)

3 D.2.3.7

Virtual Meeting Attendance (2 Persons/1 Day)

4 D.2.3.8

Virtual Meeting Attendance (1 Person/2 Days)

5 D.2.3.9

Virtual Meeting Attendance (2 Persons/2 Days)

6 D.2.3.1 In-Person Presentation (1 Person/1 Day)

7 D.2.3.2 In-Person Presentation (2 Persons/1 Day)

8 D.2.3.3 In-Person Presentation (1 Person/2 Days)

9 D.2.3.4 In-Person Presentation (2 Persons/2 Days)

D.1.1 Topic Development Brief

D.2.1 Manuscript Preparation

Evidence-Based Practice Centers (EPC) VII Page 6 of 95

Item

11 D.1.6.1 Rapid Response

12 D.1.7.1 Living Review Surveillance

13 D.1.7.2 Focused Update for Living Review

14 D.1.6.2 Rapid Review

15 D.1.2 Small Topic Refinement

16 D.1.2 Medium Topic Refinement

17 D.1.2 Large Topic Refinement

D.1.5 Technical Brief

D.1.4 Small SR Update

D.1.3 Small Systematic Review

D.1.4 Medium SR Update

D.1.3 Medium Systematic Review

D.1.4 Large SR Update

21 D.1.3 Large Systematic Review

22 D.4 Other Related EPC Activities To be negotiated

Item

23 D.1.8.2

Small Topic Bundle for USPSTF (Small TR, Small SR, Manuscript)

24 D.1.8.3

Medium Topic Bundle for USPSTF (Medium TR, Medium SR, Manuscript)

25 D.1.8.4

Large Topic Bundle for USPSTF (Large TR, Large SR, Manuscript)

26 D.1.8.1

Reaffirmation Bundle for USPSTF (Small TR, Reaffirmation Review, Research Letter)

27 D.1.9 Decision modeling* To be negotiated

* To be purchased only in addition to a topic bundle (Item 22, 23, or 24).

B.4 PROVISIONS APPLICABLE TO DIRECT COSTS

a. Items Unallowable Unless Otherwise Provided

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

Evidence-Based Practice Centers (EPC) VII Page 7 of 95 office equipment regardless of dollar value;

(4) Travel to attend general scientif ic meetings;

(5) Foreign Travel;

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

(7) Rental of meeting rooms;

(8) Any subcontract agreement (including consultants) not otherwise expressly provided for in the contract;

(9) Information Technology hardware or software; and

(10) Food and Beverages.

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."

No funding or expenditures will be authorized under this contract 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.

Evidence-Based Practice Centers (EPC) VII Page 8 of 95

SECTION C - DESCRIPTION/SPECIFICATION/WORK STATEMENT

Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualif ied personnel, material, equipment, and facilities, to perfor m the Statement of Work:

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 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 sponsors and conducts research that develops and presents evidence-based information on healthcare outcomes, quality, patient safety, cost, use and access. AHRQ also sponsors and conducts research on existing as well as innovative technologies and conducts research on methods for measuring quality and strategies for improving quality.

AHRQ work in Patient Centered Outcomes Research

Under Section 937 of the Affordable Care Act (ACA) passed in 2011 (42 USC 299b-37), AHRQ is mandated to disseminate research findings published by Patient Centered Outcomes Research Institute (PCORI) and other government-funded research relevant to comparative clinical effectiveness resea rch to physicians, healthcare providers, patient, payers and policy makers supported by the Patient-Centered Outcomes Research Trust Fund (PCORTF). In support of this mandate AHRQ invests in disseminating and implementing high-value patient-centered outcome research findings to promote evidence-based practice and improve health outcomes. Significant investments include EvidenceNOW and Clinical Decision Support. In December 2019, Congress reauthorized the

PCORTF through September 30, 2029.

The AHRQ Evidence-based Practice Centers (EPCs) synthesize scientific evidence, which is the first step in dissemination and implementation of evidence into practice. In support of the AHRQ PCORTF Framework, the

EPC Program will continue to support primary care and understanding and addressing healthcare disparities.

Evidence-based Practice Center Program

The Evidence-based Practice Centers (EPCs) were created in 1997 to synthesize scientific literature about important health care topics and promote evidence-based practice and decision-making. The EPC program has evolved over 25 years by using new methods and processes to adapt to changing needs of EPC report end-users and partners. Its processes are consistent with the IOM Standards for Systematic Review. The EPC program will continue to adapt to a rapidly changing healthcare environment as well as public health emergencies such as the COVID-19 pandemic. For example, in response to the pandemic the EPC program was able to leverage past methods investments and experience in surveillance, rapid reviews, and review updates to commission a series of rapid updates and living reviews to address urgent COVID-related questions.

EPCs synthesize evidence for a range of partners to inform practice and policy and improve patient care and outcomes. Users of EPC reports include Federal agencies, guideline developers, clinicians, patients, policymakers, research funders, knowledge translators, and purchasers and payers of healthcare. EPC work has been the scientific foundation for development and implementation of clinical practice guidelines, review criteria, performance measures, other clinical quality improvements efforts, individual https://www.ahrq.gov/pcor/strategic-framework/index.html https://www.ahrq.gov/evidencenow/index.html https://cds.ahrq.gov/ https://www.ahrq.gov/sites/default/files/wysiwyg/pcor/strategic-framework.pdf https://effectivehealthcare.ahrq.gov/about/epc https://www.ncbi.nlm.nih.gov/books/NBK209518/ https://www.ncbi.nlm.nih.gov/books/NBK209518/ https://effectivehealthcare.ahrq.gov/products/collections/covid-resources

Evidence-Based Practice Centers (EPC) VII Page 9 of 95 treatment decisions, coverage and other policies, and research agendas that lead to research funding opportunities.

EPCs produce various types of evidence reports including systematic reviews, technical briefs/scoping reviews/evidence maps, living reviews, rapid reviews, and rapid responses. The reviews focus on a range of topics, including patient experience and perspectives, treatment effectiveness and harms, prevention, healthcare delivery, models of care, health equity, and implementation concerns. They cover a wide range of medical specialties that include primary care, oncology, endocrinology, cardiology, infectious disease, rehabilitation medicine, urology, behavioral health, nutrition, as well as maternal and child health.

Regardless of their planned use and content, EPCs strive to produce reports that are responsive to the needs of their eventual end-users.

In this increasingly connected and digital world, EPCs will need to further innovate to allow for seamless integration and interoperability of EPC findings; and use technology, such as AI, machine-learning, and other resources or approaches to optimize rigor and efficiency of systematic reviews, living reviews, rapid reviews, or other evidence synthesis reports.

EPC Program Vision

The vision of the EPC Program is that all healthcare decisions are based on the best available evidence, resulting in the best possible health outcomes. The mission of the EPC Program is to be a recognized source for scientif ically rigorous and unbiased analysis of evidence that transforms healthcare by increasing the quality and use of evidence. The EPC Program seeks to achieve this mission and vision by:

1) Synthesizing evidence for healthcare decisions

2) Increasing the uptake and utilization of evidence

3) Developing methods and tools for evidence synthesis

4) Improving future evidence for healthcare decisions

Key Principles

Key principles of the EPC Program are: Relevance, Scientific Rigor, and Independent and Unbiased. The EPC Program is also committed to producing timely products that are relevant and useful to partners and other end-users. AHRQ upholds these principles supported through a contract with the Scientific Resource Center (SRC). The SRC manages the editorial and peer review process for EPC reports;

organizes collaborative EPC methods work; conducts pilot projects and quality improvement efforts;

supports collaborative learning through program-wide meetings; convenes a stakeholder panel; and manages of the EPC program’s topic nomination, assessment, and selection process for new evidence review topics.

Relevance

Engagement with relevant perspectives augments the ability of the EPC to deliver reports that are not only methodologically rigorous, but also relevant to decision-making. EPCs engage with stakeholders to understand their concerns and to develop questions for the evidence review. These perspectives may include patients, caregivers, clinicians, guidance groups, Federal agencies, healthcare funders, advocacy groups, health systems, research funders, and policymakers. End-users and partners of EPC reports ask a broad range of questions, not only about effectiveness of treatment and prevention, but also around implementation and other concerns, such as preferences, and strategies for implementation; equity concerns; healthcare delivery processes; and contextual factors that may inf luence benef its or harms.

EPC reports must address questions that are relevant to the clinical, policy, implementation decisional contexts and also ensure that the results are presented in a way that is helpful to making decisions within these contexts. EPCs engage key informants, technical experts, partners, and peer and public reviewers at various stages throughout the process to provide input on the protocol, and draft report to ensure that they will be comprehensive, relevant, and useful.

The EPC Program has also convened stakeholder panels to provide (1) feedback on EPC reports, (2) ideas for tools to facilitate adoption and use of evidence, and (3) topic nominations for new evidence reviews. As a result of input from a panel of health system leaders, the EPC program developed methods

Evidence-Based Practice Centers (EPC) VII Page 10 of 95 papers around improving the usefulness of evidence reviews when evidence was scant; and co -developed a report snapshot and interactive visual dashboard to help leaders understand and use EPC report f indings. The latest iteration of the EPC stakeholder panel includes a broad range of perspectives, including patients, clinicians, journal editors, health system leaders, and others. This panel has provided input on important groups to interface with around understanding the patient perspective, p atient groups that could partner with the EPC program on reviews, and how to increase the impact of the EPC Program on healthcare and healthcare delivery.

During the COVID pandemic, collaborations were established with a number of national and international groups. Continued engagement and coordination efforts provide an opportunity to extend and amplify the work of the program.

Scientifically Rigorous

The EPC Program has established systematic review methods guidance to promote the scientific rigor, transparency, and consistency of reviews by EPCs and continues to invest in methods development. Recent methods investments include work on updating guidance on inclusion of nonrandomized studies of interventions (NRSIs) in systematic reviews, which are particularly relevant to address health topics for which there are few randomized controlled trials. This work has led to other activities including collaboration with other international institutions for further development of a web-based platform to house tools to assess risk of bias of NRSIs. Other methods work has included pilots around the use of real-world evidence alongside systematic reviews, and methods to synthesize complex interventions.

In addition to upholding the rigor of EPC reports, ensuring that EPC reports are understood and used requires work in defining questions to better identify the main decisional dilemmas, efforts to improve the clarity of EPC reports and their findings, and novel ways to help partners make evidence-informed decisions when the evidence is not robust.

Independent and Unbiased

The EPC Program has an editorial and peer review process to ensure the production of quality, unbiased reports. A panel of EPC methodologic reviewers and peer reviewers are selected to provide unbiased expert feedback to authors.

A hallmark of EPC program products is the strict conflict of interest policy that AHRQ upholds. EPC authors and all persons involved in the production, writing, or review of an EPC report are assessed for financial and non-financial conflicts of interest. Any conflicts or perceived conflicts may exclude participation or must be managed appropriately.

Innovative, Timely and Efficient

Without sacrificing scientific rigor or the need for transparency, the EPC program will continue to explore methods and tools to advance efficiency and usefulness of EPC reports. Previous investments include upgrading of machine learning algorithms in Abstrackr, an AHRQ-funded abstract screening tool, its incorporation in the Systematic Review Data Repository Plus platform, and development of rapid evidence synthesis methods.

EPC Program Partners

EPCs work with many partners and groups to review a variety of health care delivery and clinical topics.

EPCs may work with a range of public or private partners through different funding mechanisms.

Different partners may have varied levels of engagement throughout the process and EPCs may expect to participate in multiple and ongoing discussions to ensure that the work is in line with expectations.

To ensure useful reports the EPC Program continues to explore how best to address and respond to a broad range of partner needs, including those of Federal agencies, to inform policy, research funding, program planning, and coverage decisions. This may involve examining complex system level interventions, developing conceptual frameworks for nascent research fields, and syntheses focusing on healthcare delivery and implementation. Diverse new methods may be needed to answer end-user questions beyond understanding effectiveness and to combine and synthesize diverse information effectively.

https://effectivehealthcare.ahrq.gov/products/collections/cer-methods-guide https://effectivehealthcare.ahrq.gov/sites/default/files/epc-disclosure-policy-form.pdf http://abstrackr.cebm.brown.edu/ https://srdrplus.ahrq.gov/

Evidence-Based Practice Centers (EPC) VII Page 11 of 95

The EPC Program has a number of long-standing partnerships with other Federal agencies and groups.

In some cases, processes have been established to enhance the usefulness of EPC reviews and ensure that the evidence synthesis development process meets their needs. We discuss these groups below.

Public Nominators

EPC Program partners include clinical groups who use EPC reports to inform clinical guidance; insurers to inform coverage decisions; research funders to inform future research priorities; health systems to inform guidance and implementation activities; and patients to inform healthcare decisions. Through a nomination process through a publicly-accessible website, the EPC Program accepts suggestions for evidence review topics on a continuous basis. Groups that have submitted topics include patients, clinicians, health systems, guideline groups, Federal agencies, healthcare funders, and advocacy groups.

US Congress

The United States Congress commissions EPC evidence reports to inform future legislation on healthcare delivery for specific diseases and conditions of interest or interventions aimed at addressing these.

Federal Agencies and Government-funded Organizations

The EPCs also synthesize evidence for a variety of other Federal agencies, such as individual centers and offices 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), and other branches of the Federal government such as the Department of Transportation. These reviews have informed clinical guidance, policies, and future research. Current topics of interest for HHS include health equity, maternal health, environmental health impact, and substance use disorder.

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 people nationwide by making evidence-based recommendations about clinical preventive services and health promotion. These recommendations for adults and children include screening tests, counseling about healthful behaviors, and preventive medications.

Since 1998, AHRQ has been authorized by Congress to convene the USPSTF and to provide ongoing administrative, scientific, technical, 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 address services offered in the primary care setting or services referred by primary care professionals.

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.

The USPSTF balances 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 follow-up 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 consider financial costs of providing a service in its assessment of the balance of benefits and harms. The USPSTF does not make insurance coverage decisions and recognizes that those decisions involve additional considerations beyond a scientific https://effectivehealthcare.ahrq.gov/get-involved/suggest-topic https://uspreventiveservicestaskforce.org/uspstf/ https://www.uspreventiveservicestaskforce.org/Page/Name/methods-and-processes

Evidence-Based Practice Centers (EPC) VII Page 12 of 95 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 recommendation statement and works with partner organizations on dissemination and implementation activities. The EPCs work closely with the USPSTF throughout the recommendation process to help them understand the evidence so that the USPSTF can develop its recommendation.

NIH Pathways to Prevention Program

EPCs produce evidence reports that support the NIH Pathways to Prevention (P2P) Program (https://prevention.nih.gov/research-priorities/research-needs-and-gaps/pathways-prevention) of the NIH Office of Disease Prevention (ODP). Through P2P Workshops and EPC evidence reports, an expert panel develops a research agenda pertinent to disease prevention topics and develops action plans to move the field forward. EPCs present the findings of their authored evidence reports during the P2P workshop and at a pre-workshop webinar. With the research agenda, NIH and other Federal agencies fund research to close the identified research gaps.

Patient-Centered Outcomes Research Institute

EPCs produce evidence reports that support Patient-Centered Outcomes Research Institute (PCORI), the leading funder of patient-centered comparative clinical effectiveness research in the United States.

PCORI has provided funding for EPC reports to identify areas for investments in comparative effectiveness research, to support guidelines for clinical groups, and to support dissemination and implementation efforts.

B. Objectives

EPCs shall perform task orders to:

• Promote the translation and dissemination of evidence through evidence synthesis.

o Engage with public and federal partners, and stakeholders to develop and ref ine evidence synthesis questions to inform specif ic healthcare decisions.

o Clearly and concisely synthesize evidence through systematic reviews or other methods for use by public and federal partners and other stakeholders. Engage with such groups to make the reports clear, relevant, and accessible to diverse users.

o Collaborate with partners, including other EPCs and AHRQ programs, to promote relevant, consistent, and transparent products and implementation of evidence-based f indings f rom evidence syntheses and other EPC Program products.

• Improve validity and utility of evidence synthesis for decision-making and practice o Collaborate with other EPCs, the SRC, and AHRQ to improve quality, ef f iciency, and consistency across the EPC program.

o Advance utility, rigor, and ef f iciency of evidence synthesis for decision-making and practice through development and update of guidance, methods, and tools.

o Ensure quality and utility of EPC products through quality assurance processes, such as methodologic review and shared learning.

C. Relevant Documents

Table 1: Supporting Documents https://prevention.nih.gov/research-priorities/research-needs-and-gaps/pathways-prevention https://www.pcori.org/impact/evidence-synthesis-reports-and-interactive-visualizations/pcori-ahrq-systematic-reviews

Evidence-Based Practice Centers (EPC) VII Page 13 of 95

Supporting Document Name

Supporting Document Description Supporting Document Location

EPC Program Procedures Guide for EPC VII Request for Proposals

This Procedure Guide describes the process for developing evidence reviews and other products for the Evidence-based Practice Center (EPC) Program in order to promote consistency and high quality for AHRQ reports and to foster a common understanding of the steps needed to complete an EPC evidence review. This guide applies to the EPC VII Request for Proposal.

RFP Attachment 1A

EPC Methods Guide for Ef fectiveness and Comparative Effectiveness Reviews

AHRQ, the Scientif ic Resource Center, and the Evidence-based Practice Centers (EPCs) have developed a Methods Guide for systematic reviews. This Guide presents issues key to the development of systematic reviews and describes recommended approaches for addressing difficult, frequently encountered methodological issues.

Methods Guide for Effectiveness and Comparative Effectiveness Reviews |

Effective Health Care (EHC) Program (ahrq.gov)

USPSTF Procedure Manual This Procedure Manual describes the methods used by the Task Force to ensure that its recommendations are scientif ically sound, reproducible, and well documented. It is intended as a guide for anyone who is interested in the Task Force, Task Force members, and those who support the Task Force's work, including staff of AHRQ and its designated EPCs.

Procedure Manual | United States Preventive Services Taskforce (uspreventiveservicestaskforce.org)

USPSTF Procedures Guide for EPCs

This guide documents steps and approaches for the development of systematic reviews for the USPSTF.

RFP Attachment 1B

EPC Policy on Financial and Nonf inancial Interests and Disclosure form for Conf licts of Interest

This form is an agreement signed by each EPC team member that documents f inancial and nonf inancial disclosures.

epc-disclosure-policy-form.pdf

(ahrq.gov)

Conf identiality Forms for EPC Staf f

This form is an agreement signed by each EPC team member that outlines the parameters of conf identiality for each EPC project.

epc-rev-team-confidentiality-form.pdf

(ahrq.gov)

Conf identiality Forms for KI and TEP

This form is an agreement signed by the Key Informants and Technical Expert Panel members that outlines the parameters of conf identiality for each EPC project.

epc-ki-tep-confidentiality-form.pdf (ahrq.gov)

AHRQ Publishing and Communications Guidelines

These publishing guidelines outline the standards for AHRQ products developed in-house and by contractors.

Publishing and Communications Guidelines | Agency for Healthcare Research and Quality (ahrq.gov)

Table 2: Tasks and supporting documents for the EPC Program (all orders other than the USPSTF) https://effectivehealthcare.ahrq.gov/products/collections/cer-methods-guide https://effectivehealthcare.ahrq.gov/products/collections/cer-methods-guide https://effectivehealthcare.ahrq.gov/products/collections/cer-methods-guide https://effectivehealthcare.ahrq.gov/products/collections/cer-methods-guide https://www.uspreventiveservicestaskforce.org/uspstf/about-uspstf/methods-and-processes/procedure-manual https://www.uspreventiveservicestaskforce.org/uspstf/about-uspstf/methods-and-processes/procedure-manual https://www.uspreventiveservicestaskforce.org/uspstf/about-uspstf/methods-and-processes/procedure-manual https://effectivehealthcare.ahrq.gov/sites/default/files/epc-disclosure-policy-form.pdf https://effectivehealthcare.ahrq.gov/sites/default/files/epc-disclosure-policy-form.pdf https://effectivehealthcare.ahrq.gov/sites/default/files/wysiwyg/pdf/epc-rev-team-confidentiality-form.pdf https://effectivehealthcare.ahrq.gov/sites/default/files/wysiwyg/pdf/epc-rev-team-confidentiality-form.pdf https://effectivehealthcare.ahrq.gov/sites/default/files/wysiwyg/pdf/epc-ki-tep-confidentiality-form.pdf https://effectivehealthcare.ahrq.gov/sites/default/files/wysiwyg/pdf/epc-ki-tep-confidentiality-form.pdf https://www.ahrq.gov/research/publications/pubcomguide/index.html https://www.ahrq.gov/research/publications/pubcomguide/index.html

Evidence-Based Practice Centers (EPC) VII Page 14 of 95

Task Number Product Name Documents needed for Task Completion

D.1.1

D.1.6.1

D.1.6.2

Topic Development Brief

Rapid Response

Rapid Review

EPC Program VII Acquisition Procedures Guide

EPC Methods Guide for Effectiveness and Comparative Effectiveness Reviews

EPC Policy on Financial and Nonfinancial Interests and Disclosure form for Conflicts of Interest

Confidentiality Forms for EPC Staff

AHRQ Publishing and Communications Guidelines | Agency for Healthcare Research and Quality

D.1.2

D.1.3

Topic Refinement

Systematic Review

EPC Methods Guide for Effectiveness and Comparative Effectiveness Reviews

EPC Policy on Financial and Nonfinancial Interests and Disclosure form for Conflicts of Interest

Confidentiality Forms for EPC Staff

Confidentiality Forms for KI and TEP

AHRQ Publishing and Communications Guidelines | Agency for Healthcare Research and Quality

D.1.4

D.1.5

D.1.7.1

D.1.7.2

Systematic Review Update

Technical briefs

Living Review Surveillance

Focused Update of a Living Review

EPC Program VII Acquisition Procedures Guide

EPC Methods Guide for Effectiveness and Comparative Effectiveness Reviews

EPC Policy on Financial and Nonfinancial Interests and Disclosure form for Conflicts of Interest

Confidentiality Forms for EPC Staff

Confidentiality Forms for KI and TEP

AHRQ Publishing and Communications Guidelines | Agency for Healthcare Research and Quality

D.2.1

D.2.3

D.3.4

Manuscript Preparation

Presentations

Participate in methodologic review of EPC products

D.3 Development, pilot, and update of guidance and tools to advance utility, rigor, and efficiency of systematic reviews for decision-making and practice

EPC Program VII Acquisition Procedures Guide

EPC Methods Guide for Effectiveness and Comparative Effectiveness Reviews

AHRQ Publishing and Communications Guidelines | Agency for Healthcare Research and Quality https://effectivehealthcare.ahrq.gov/products/collections/cer-methods-guide https://effectivehealthcare.ahrq.gov/products/collections/cer-methods-guide https://effectivehealthcare.ahrq.gov/sites/default/files/epc-disclosure-policy-form.pdf https://effectivehealthcare.ahrq.gov/sites/default/files/epc-disclosure-policy-form.pdf https://effectivehealthcare.ahrq.gov/sites/default/files/wysiwyg/pdf/epc-rev-team-confidentiality-form.pdf https://www.ahrq.gov/research/publications/pubcomguide/index.html https://www.ahrq.gov/research/publications/pubcomguide/index.html https://effectivehealthcare.ahrq.gov/products/collections/cer-methods-guide https://effectivehealthcare.ahrq.gov/products/collections/cer-methods-guide https://effectivehealthcare.ahrq.gov/sites/default/files/epc-disclosure-policy-form.pdf https://effectivehealthcare.ahrq.gov/sites/default/files/epc-disclosure-policy-form.pdf https://effectivehealthcare.ahrq.gov/sites/default/files/wysiwyg/pdf/epc-rev-team-confidentiality-form.pdf https://effectivehealthcare.ahrq.gov/sites/default/files/wysiwyg/pdf/epc-ki-tep-confidentiality-form.pdf https://www.ahrq.gov/research/publications/pubcomguide/index.html https://www.ahrq.gov/research/publications/pubcomguide/index.html https://effectivehealthcare.ahrq.gov/products/collections/cer-methods-guide https://effectivehealthcare.ahrq.gov/products/collections/cer-methods-guide https://effectivehealthcare.ahrq.gov/sites/default/files/epc-disclosure-policy-form.pdf https://effectivehealthcare.ahrq.gov/sites/default/files/epc-disclosure-policy-form.pdf https://effectivehealthcare.ahrq.gov/sites/default/files/wysiwyg/pdf/epc-rev-team-confidentiality-form.pdf https://effectivehealthcare.ahrq.gov/sites/default/files/wysiwyg/pdf/epc-ki-tep-confidentiality-form.pdf https://www.ahrq.gov/research/publications/pubcomguide/index.html https://www.ahrq.gov/research/publications/pubcomguide/index.html https://effectivehealthcare.ahrq.gov/products/collections/cer-methods-guide https://effectivehealthcare.ahrq.gov/products/collections/cer-methods-guide

Evidence-Based Practice Centers (EPC) VII Page 15 of 95

The following tasks are only applicable to the USPSTF.

Table 3: Tasks and supporting documents for the USPSTF

Task Number Product Name Documents needed for Task Completion

D.1.8.1

D.1.8.2

D.1.8.3

D.1.8.4

Reaffirmation bundle (small topic refinement D.1.2, reaffirmation review D.1.6.3, and research letter D.2.2)

Small topic bundle (small topic refinement D.1.2, small systematic review D.1.3, and manuscript D.2.1)

Medium topic bundle (medium topic refinement D.1.2, medium systematic review D.1.3, and manuscript D.2.1)

Large topic bundle (large topic refinement D.1.2, large systematic review D.1.3, and manuscript D.2.1)

USPSTF Procedure Manual

USPSTF Procedures Guide for EPCs

D.1.9 Decision modeling* USPSTF Procedures Guide for EPCs

*to be purchased with a topic bundle

D. Tasks

Tasks completed under the EPC program are often complex with varying and pressing timeframes with multiple deliverables, requiring consistency within and among EPC deliverables. All tasks require a high level of management and quality control to ensure consistent, high-quality deliverables. EPCs shall have adequate leadership, capacity, mentorship, management, clinical expertise, editorial expertise, and quality control/oversight plans to ensure that EPC reports are clinically relevant, adhere to rigorous evidence synthesis standards, are cohesive, well written with clear synthesis that are relevant and useful to end-users, and consistent with AHRQ and EPC Program policies and processes.

D.1. Promote the translation and dissemination of evidence

The EPC program has established different types of evidence synthesis products for different end-user purposes, questions, or bodies of literature. Systematic Reviews are defined in Section D.1.3. Updates of systematic reviews are described in Section D.1.4. Other types of evidence synthesis products are described in D.1.5 to D.1.9.

The EPC program has defined specific products to inform prioritization and selection decisions (sections D.1.1) and refinement of questions for a systematic review (section D.2). Tasks should be conducted in accordance with documents described in Section C and may be further defined in each individual task order.

https://www.uspreventiveservicestaskforce.org/Page/Name/procedure-manual

Evidence-Based Practice Centers (EPC) VII Page 16 of 95

D.1.1. Topic Development Brief

The EPC shall evaluate the topic against established criteria, such as EPC topic selection criteria (https://effectivehealthcare.ahrq.gov/about/epc/nomination). The EPC shall prepare a topic development brief describing the topic area, the clinical decisional dilemma, how it fits in the current clinical and research context, and an assessment of how it fits with selection criteria. In summary the process shall include:

1. Targeted discussions with topic experts or other stakeholders to clarify the decisional dilemma and context of the decisional issue driving the topic nomination.

a. 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 an end-user. Typically, the discussion(s) would be with the nominator or local clinicians, patients or other experts who are readily available to the EPCs.

2. Conducting a limited literature scan

a. 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 EPC shall conduct a narrow search to identify existing systematic reviews, guidelines, and primary studies and to identify relevant contextual issues.

3. Development of a topic development brief. This includes include description of findings from literature scan, an assessment of the topic’s fit with established criteria, and key considerations and discussion points for the further discussion by the partner.

D.1.2. Topic Refinement

The purpose of topic refinement is to identify the decisional dilemma and area of greatest uncertainty to focus and refine the systematic review questions. In the topic refinement process, the EPC shall develop focused key questions that address the decisional dilemma(s) which are amenable to a systematic review. The key questions should describe the scope using a PICOTS (Population, Intervention, Comparator, Outcome, Timing, and Setting (PICOTS) framework or other relevant framework. Contextual questions could be included which require valid but not necessarily systematic summary of current research to provide context to aid in decision-making of the end-users of the report. An analytic framework or logic model can be developed that describes how the key questions fit into the clinical context. To define the review scope, the EPC shall work with partners and Key Informants to identify the decisional dilemma and to provide insight into the clinical and decisional context, and to prioritize the most relevant populations, interventions, and outcomes. Key informants include a range of perspectives, including patients, family members and caregivers; practicing clinicians; health systems; professional and consumer organizations; researchers; and other who make healthcare decisions pertinent to the review topic. The EPC Program has specific processes to obtain effective input from different key informant perspectives, particularly those of patients. The EPC shall conduct preliminary literature searches to inform and augment key informant discussions. In summary, the process shall include:

1. Discussion with partner about important decisional issues and context for the review.

2. Brief literature scan

3. Discussion with key informants to focus the scope of the review in light of the decisional issues on the topic. They may provide input that will focus the scope on populations, interventions, comparators and outcomes of most relevance and importance to decision-making. The number of key informants and level of engagement may vary depending on the complexity of the review and how well-defined the scope of the review is.

4. Public input on the review scope to gain a broader perspective about the decisional issues and PICOTS of most relevance and importance.

5. Draft protocol with revision of scope in response to input

Topic Ref inement size will be determined by a combination of factors: 1) level of def inition of

Evidence-Based Practice Centers (EPC) VII Page 17 of 95

PICOTS and 2) number of partners and/or Key Informants to engage. For example:

• A small TR might be expected to have a PICOTS that are specif ic and def ined and include engagement with only 1-2 individuals (partners and key informants). These topics are expected to require fewer resources (i.e., fewer calls, and a clearly defined topic that does not require much input to ref ine).

• A medium TR might be expected to engage 3-6 individuals (partners and key informants) for ref inement of a moderately def ined PICOTS.

• A large TR might be expected to have a poorly defined PICOTS and include engagement with 7-9 individuals (partners and key informants). These topics are expected to require more resources (i.e., increased number of calls, and other ef forts to ref ine the topic for systematic review).

Topic refinement for the USPSTF shall include a work plan based on a template as found in the USPSTF Procedure Manual. Excerpted information from the work plan is used to create a draft Research Plan, which is posted for public comment. Elements of the Research Plan include: the analytic framework, key and contextual questions and the inclusion/exclusion criteria following PICOTS. The research plan is revised and finalized with the USPSTF. Topic refinements for the USPSTF are an element of a Bundle and shall be procured as part of a Bundle (D.1.8.1, D.1.8.2, D.1.8.3, or D.1.8.4).

D.1.3. Systematic Reviews

EPC systematic reviews explicitly identify and address the decisional dilemma. Rigorous, comprehensive methods are defined to address the type of question and decisional dilemma (e.g., harms, complex intervention), volume and type of literature available and to maximize efficiency and rigor.

The procedures for systematic reviews, including specification of deliverables, shall be guided by the EPC Procedures guide. The methods used for individual systematic reviews are generally established by the EPC Methods Guide and more specifically by the individual protocol. Systematic reviews include qualitative and/or quantitative analysis, such as with meta-analysis or meta-regression. Other qualitative or quantitative approaches may also be appropriate, such as network meta-analysis, qualitative evidence synthesis, or qualitative comparative analysis.

Systematic review size will be determined by a combination of factors. The main factor for determining size is the anticipated number of studies included for analysis.

• A Small SR might have up to 35 studies included for analysis.

• Medium SR/updates might have 36-90 studies included for analysis.

• Large SR/update might have >90 studies.

Other factors to determine sizing may be considered including: 1) complexity or specificity of search, and

2) complexity or specif icity of questions (number of interventions, comparisons, outcomes)

Factors that may decrease the size of a systematic review or review update:

• Inclusion of only RCTs

• Focused search (e.g., search yields <3,000 studies, development of only a single search strategy)

• Well focused questions. Signals of well-focused questions may include:

o Number of interventions limited to 8 or less o Number of comparators limited to 3 or less o Number of outcomes limited to 8 or less

Factors that may increase the size of a systematic review/update:

• Poor specif icity of search (e.g., search yields >10,000 studies, multiple disease conditions, populations, settings, or types of questions requiring searches for dif ferent bodies of literature)

• Broad questions. Signals of broad…