AHRQ-20-10001_Amendment_1.pdf

IDIQ Request for Proposal v. Jan 19; FAC 100 AHRQ-20-10001 Amendment 1 Evidence-Based Practice Centers (EPC) VI Page 1 of 101

Request for Proposal No. AHRQ-20-10001 Amendment #1

PART I - THE SCHEDULE

SECTION A - SOLICITATION FORM

Date Issued: January 24, 2019 Date Questions Due: February 14, 2019 11:00 AM, EST Please Note: All questions and inquires will be processed on a non-attribution basis.

Date Notice of Intent Due: March 14, 2019 Date and Time Proposals Due: April 8, 2019 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-20-10001 entitled “Evidence-Based Practice Centers (EPC) VI”. 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 identified for this solicitation. See Section H.16 and 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 of your intent by sending an email to Megan Osele, Contracting Officer at megan.osele@ahrq.hhs.gov no later than March 14, 2019. Subject line shall read: Proposal Intent RFP No. AHRQ-20-10001.

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 Megan Osele, Contracting Officer, at the following email address: megan.osele@ahrq.hhs.gov. Subject line shall read: Proposal Questions RFP No. AHRQ-20-10001. 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. Questions should be submitted in a Word table in the following format:

mailto:megan.osele@ahrq.hhs.gov http://www.fbo.gov/

Evidence-Based Practice Centers (EPC) VI Page 2 of 101

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 7-9 contracts from this solicitation on or about December 1, 2019.

• Proposals submitted in response to this solicitation must state that they are valid for a period of at least 240 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: The proposal shall be signed by an authorized official to bind your organization and must be received by the due date specified above. The proposal must be submitted to the following address:

Agency for Healthcare Research and Quality (AHRQ)* Division of Contracts Management* 5600 Fishers Lane* Mail Stop 06N34B* Rockville, Maryland 20857* Attn: Megan Osele, (301) 427-1460*

*All boxes must be clearly labeled with this information.

Please read this section carefully. Some mail and package delivery procedures have changed due to security controls. All mail and packages are screened at a local offsite facility before being delivered to 5600 Fishers Lane.

The U.S. Postal Service’s “Express Mail” does not deliver to our Rockville, Maryland address.

Please do not use this means of delivery for proposal submission.

Proposals delivered by commercial package delivery company (example: Fedex, UPS, DHL, etc.):

Submit and label as instructed above. These companies are familiar with the delivery procedures at 5600 Fishers Lane.

Hand carried or hand carry courier service: The 5600 Fishers Lane building security does not allow packages to be delivered directly to the building. Hand carried or courier delivered proposals should be labeled as instructed above, however they must be delivered directly to the offsite screening facility at 12225 Wilkins Avenue Rockville MD 20852. The operating hours at

Evidence-Based Practice Centers (EPC) VI Page 3 of 101 the Wilkins Avenue facility are 7:00 AM to 3:30 PM Monday through Friday. Please note that anyone who arrives at the Fishers Lane location with a delivery will be directed to the screening facility, however this will cause delay. Packages will be accepted and date/time stamped at the screening facility. Please allow ample time as proposals cannot be date/time stamped until they have gone through security.

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://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 Megan Osele, (301) 427-1460 or e-mail:

megan.osele@ahrq.hhs.gov. Please note e-mail requests should state subject as RFP AHRQ- 20-10001.

https://www.sam.gov/

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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

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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) VI”. 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 $50,000, 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 Prices

1 Task D.2.3.5 Webinar Presentation $ FFP 2 Task D.2.3.1 In Person Presentation – one person, one day

$ FFP

3 Task D.2.3.2 In Person Presentation – two persons, one day

$ FFP

4 Task D.2.3.3 In Person Presentation – one person, two days

$ FFP

5 Task D.2.3.4 In Person Presentation – two persons, two days

$ FFP

6 Task D.2.2 Research Letter $ FFP 7 Task D.1.1

Task D.1.7.1 Task D.2.1

Topic Development Brief Rapid Response Manuscript Preparation

$ FFP

8 Task D.1.2 Small Topic Refinement $ FFP 9 Task D.1.2 Medium Topic Refinement $ FFP

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Task D.1.3 Systematic Review Surveillance

Task D.1.2 Task D.1.5 Task D.1.7.2

Large Topic Refinement Limited Systematic Review Update Rapid review

$ FFP

Task D.1.6 Task D.1.5 Task D.1.4 Task D.1.4.2

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

12 Task D.1.4 Task D.1.5 Task D.1.4.2

Small Systematic Review Medium Systematic Review Update Small Technology Assessment

13 Task D.1.4 Task D.1.5 Task D.1.4.2

Medium Systematic Review Large Systematic Review Update Medium Technology Assessment

Task D.1.4 Task D.1.4.2

Large Systematic Review Large Technology Assessment

15 Task D.1.8

Task D.1.9 Task D.1.10 Task D.2.4

Task D.3

Task D.4

Decision-Analysis, Modeling and Clinical Economic studies Individual Patient Data Meta-analysis Living Update Dissemination with Contextual Information Improve Validity and utility of evidence synthesis methods for decision-making and practice Other Related EPC Activities

To Be Negotiated

Task D.1.2.1 Task D.1.4.1 Task D.2.1

Small Topic Bundle for USPSTF

• Small Topic Refinement

• Small Systematic Review

• Manuscript Preparation

$ FFP

Task D.1.2.1 Task D.1.4.1 Task D.2.1

Medium Topic Bundle for USPSTF

• Medium Topic Refinement

• Medium Systematic Review

• Manuscript Preparation

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Task D.1.2.1 Task D.1.4.1 Task D.2.1

Large Topic Bundle for USPSTF

• Large Topic Refinement

• Large Systematic Review

• Manuscript Preparation

$ FFP

Topic Refinement size Topic Refinement size will be determined by a combination of factors: 1) level of definition of PICOTS 2) number of partners and/or Key Informants to engage

For example:

A small TR might be expected to have a PICOTS that are specific and defined and include engagement with only 1-2 partners or key informants. These topics may have an existing previous review. These topics are expected to require fewer resources (i.e fewer calls; focused search, clearly defined topic that does not require much input to refine).

A medium TR might be expected to engage 3-6 partners or key informants for refinement of a moderately defined PICOTS. These topics are expected to require moderate resources (i.e moderate number of calls, moderate efforts for input and refinement).

A large TR might be expected to have a poorly defined PICOTS and include engagement with 7-9 partners or key informants. These may have multiple related topics within the portfolio that will overlap and may need consideration when reviewing the topic. These topics are expected to require more resources (i.e increased number of calls, and other efforts to refine the topic for systematic review).

Systematic review/Technology Assessment size 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.

For example:

A Limited SR/update/technology assessment might have less than 16 studies included for analysis.

A Small SR/update/technology assessment might have 16-35 studies included for analysis.

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

Large SR/update/technology assessment might have >90 studies.

Greater than 150 studies for analysis may require an additional SR/update/technology assessment.

Other factors to determine sizing may be considered including: 1) complexity or specificity of search 2) complexity or specificity of questions (number of interventions, comparisons, outcomes) and 3) level of internal review required before peer review.

Factors that may decrease the size of a review/update/technology assessment:

• Inclusion of only RCTs

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

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• 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

• Use of rapid review methods

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

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

• Broad questions. Signals of broad questions may include:

o Number of interventions greater than 30 o Number of comparators greater than 8 o Number of outcomes greater than 20

• Multiple partner review prior to peer review

B. 4 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;

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

(10) Consultant fees;

(11) Information Technology hardware or software; and

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(12) 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.

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SECTION C - DESCRIPTION/SPECIFICATION/WORK STATEMENT

When authorized via task order, independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, needed to perform the Evidence based Practice Center (EPC) VI Statement of Work requirements, as specified below:

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 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 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 PCORI and other government-funded research relevant to comparative clinical effectiveness research to physicians, healthcare providers, patient, payers and policy makers. In support of this mandate AHRQ is investing in disseminating and implementing high-value patient-centered outcome research findings to promote evidence-based practice, and improve health outcomes (http://www.ahrq.gov/pcor/index.html). Significant investments include EvidenceNOW, Health IT Clinical Decision Support, and the PCOR Dissemination and Implementation Initiative.

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

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 EPC program has evolved in over 20 years of existence with development of new methods to adapt to changing needs of users. The EPC program will need to continue to adapt to a rapidly changing health care environment. EPC reviews must be scientifically rigorous. Tools and methods for information exchange are rapidly developing, including http://www.ahrq.gov/pcor/index.html).

Evidence-Based Practice Centers (EPC) VI Page 11 of 101 new technologies to enable more efficient reviews, better data visualization and presentation of findings, and to accelerate the uptake of current evidence into practice. EPCs are expected to optimize the efficiency of the review process as well as convey relevant information in the most useful format for users.

Technologies that AHRQ and the EPC program have previously funded include machine learning tools to accelerate the article screening and the Systematic Review Data Repository. The process, content, and format of EPC reports will need to continue to evolve to keep up with the needs of partners and stakeholders.

The core work of the EPC Program 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. These reviews are considered the first step in implementation of evidence-based practices.

EPCs synthesize evidence for partners to translate into practice and policy to improve patient care and outcomes. Traditional users of EPC reports include guideline developers, clinicians, patients, policy-makers, 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 treatment decisions, coverage or reimbursement policies, and research agendas. EPC program recognizes that direct engagement with health systems can accelerate the adoption of evidence-based practices, such as through clinical pathways or clinical quality improvement efforts. This has led to investigations into different types of questions, methods, and presentation formats to meet the needs of learning health systems.

Under this contract, the EPC program anticipates emphasis on specific areas. In this increasingly connected and digital world, EPCs will need to further innovate to allow for seamless integration and interoperability of EPC findings. Future innovations may enable EPC products to be available in the most useful format to diverse users. EPCs shall use technology and other resources or approaches to maximize efficiency and rigor of systematic reviews, review updates, or other rapid evidence products.

Improving clarity and usability of EPC reports will also require greater emphasis and work in refining topics to better identify the main decisional dilemmas and focus the review questions.

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 nationally recognized source for scientifically 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

To provide timely, unbiased, high quality, and actionable evidence to our stakeholders.

2) Increasing the uptake and utilization of evidence

To increase the uptake and utilization of evidence through

• involving patients, clinicians, policymakers, and other decision-makers in the development of reports

• developing tools and translation materials, and

• working with partners

3) Developing methods and tools for evidence synthesis To improve the explanatory power and efficiency of evidence synthesis by developing guidance, tools, and novel methods for synthesizing, summarizing, and contextualizing evidence for healthcare decisions

4) Improving future evidence for healthcare decisions To accelerate the elimination of evidence gaps through

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• analysis of the weaknesses in the current evidence

• identifying strategies to address those weaknesses, and

• promoting quality evidence.

Key Principles

Key principles of the EPC Program are: Stakeholder-driven, Scientific Rigor and Independent and Unbiased. The EPC program is also committed to producing timely products that are relevant and useful to partners and stakeholders. AHRQ upholds these principles with support from the Scientific Resource Center.

Scientific Resource Center

The Scientific Resource Center (SRC) was conceived in 2007 to promote efficiency, rigor, consistency, and quality across the Evidence-based Practice Centers (EPCs). The SRC supports the scientific rigor of the EPC Program through leadership, organization and handling of the editorial and peer review process for EPC reports; through organization, development, leadership and authorship of methodological papers, tools, and materials to promote consistency across EPCs and for the scientific field; through development and maintenance of tools and identification and development of opportunities to promote learning opportunities, coordination, collaboration, and sharing of information;

and through tracking and assessment of topics for evidence review by the EPCs. The SRC’s scientific expertise and experience is essential to effectively lead and convene innovative methods work by experts in research and systematic review; to ensure and maintain excellence and rigor in each of its centralized activities on behalf of the program; and to promote and improve the impact of the EPC program and its products.

Stakeholder-driven

To advance the relevance and use of EPC reports, EPCs engage directly with stakeholders to determine the questions that patients, providers, learning health systems, policy-makers, implementation and knowledge translators ask though topic nomination, development and topic refinement phases prior to the actual systematic review process. Engagement with relevant stakeholders augments the ability of the EPC to deliver reports that are not only methodologically rigorous, but also relevant to decision making.

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 technical experts, partners, and peer and public reviewers at various stages throughout the process to provide input while developing the protocol, and to get feedback on the report in order to ensure that the reports will be comprehensive and relevant.

There are a myriad of different ways that stakeholders can be involved in the EPC review process. See Section C for resources about how stakeholders can be involved.

Ensuring utility of EPC reports by stakeholders requires not only ensuring that the right questions are being asked and the right methods are being applied, but also ensuring that the information is clear and clinically and contextually relevant.

Scientifically Rigorous

A key feature of systematic reviews is that they systematically and critically appraise existing research and synthesize knowledge on a particular topic. The EPC Program has established systematic review methods that raise the scientific rigor, transparency, and consistency of reviews by EPCs in Methods Guide for Effectiveness and Comparative Effectiveness Reviews (see Section C of the SOW). Recent methods investments include work on complex interventions, which are particularly relevant to learning health systems. This work has led to other activities including collaboration with other organizations such as GRADE and WHO for further development of systematic review methods; and development of a reporting guideline for systematic reviews of complex interventions. The EPC Methods Guide was a

Evidence-Based Practice Centers (EPC) VI Page 13 of 101 cornerstone for the development of the IOM Standards for Systematic Review (see Section C of the SOW).The EPC program published a response to these standards in 2013 (see Section C of the SOW).

Independent and Unbiased

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 (see Section C of the SOW, Webpage: EPC Program Editorial and review process).

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. See Section C of the SOW for the EPC and USPSTF Disclosure of Interest policy and the form for the USPSTF.

Relevant and Useful

The EPC program engages partners and stakeholders throughout the process to identify the key decisional dilemma and to identify the context in which decisions are made and what information is needed in scientifically rigorous reviews. The EPC program has made some small investments in and will continue to examine the optimal content and format for providing information to be most relevant and useful to partners and stakeholders (see section C of the SOW, Webpage: AHRQ EPC Program Helps Health Systems Use Evidence).

Innovative, Timely and Efficient

Without sacrificing scientific rigor or the need for transparency and stakeholder engagement, the EPC program will continue to explore methods to advance efficiency of EPC reports. Technologies that the EPC program has previously invested in and will continue to explore include machine learning tools, re-use of data from the Systematic Review Data Repository (https://srdr.ahrq.gov), and other rapid review methods or text mining software tools. The EPC program is committed to continued innovation including developing, testing and implementing innovative approaches, methods, tools, training and guidance.

EPC Program Partners

EPCs work with many partners and stakeholders to review a variety of health care delivery and clinical areas of focus. 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, particularly with public partners to ensure that the work is in line with expectations. EPCs should plan appropriate levels of engagement and response to partner inquiries and requests.

AHRQ Effective Health Care Program Under the EHC program, EPCs synthesize evidence, usually through systematic reviews (including comparative effectiveness reviews) and other evidence synthesis reports. EPC work is focused on helping health care decision-makers – such as patients and clinicians, learning health systems, purchasers and payers of healthcare, policy-makers, implementation and knowledge translators (including Clinical Decision Support developers)– make and promote more informed decisions and improve the quality of health care. Informed healthcare decisions are best made within a context of scientific evidence.

EPCs, under the EHC program, may synthesize evidence for:

• healthcare delivery or implementation approaches;

• comparative effectiveness or harms of technologies, pharmaceuticals, nutrition or behavioral strategies, across a variety of clinical areas;

• Preventive (screening, counselling and preventive medications), or diagnostic, or prognostic https://effectivehealthcare.ahrq.gov/about/epc/review http://srdr.ahrq.gov/

Evidence-Based Practice Centers (EPC) VI Page 14 of 101 testing or management.

EPC reports consider the decisional, clinical, policy, and implementation context in summarizing and presenting findings to optimize usefulness of EPC reports. Analysis methods may vary based on the topic, decisional dilemma, and type of evidence available and may include meta-analysis, meta-regression, network meta-analysis, qualitative comparative analysis, or other qualitative or quantitative approaches. EPCs may conduct work for greater dissemination and implementation of evidence-based practices such as modelling studies or predictive analytics.

See section C for the link to a webpage with additional information on the EHC program in general, resources it provides, and descriptions of processes.

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 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.

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 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 recommendations. See Section C for a weblink for details of USPSTF methods and processes and the role of EPCs.

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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.

See section C for a link to information on the TA Program.

EPC reports for other Federal or public agencies

EPCs synthesize evidence, primarily through conduct of systematic reviews and other evidence synthesis products 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 such as the National Highway Traffic Safety Administration (NHTSA). EPCs also conduct systematic reviews for other organizations including the Patient 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. Reports must consider the relevant clinical, policy, and implementation decisional contexts. EPCs may be asked to focus on healthcare delivery or implementation; comparative effectiveness or harms of clinical interventions such as pharmaceuticals, devices, or behavioral or nutritional interventions; or preventative, diagnostic, or prognostic testing or management. Through the EHC program, EPCs synthesize evidence for a variety of private and public partners, including professional organizations, health systems, and policymakers. The EPCs also synthesize evidence for a variety of established programs including the US Preventive Services Task Force (USPSTF), the Technology Assessment (TA) Program, and for 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). 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, particularly with public partners to ensure that the work is in line with expectations. EPCs should plan appropriate levels of engagement and response to partner inquiries and requests. EPCs may also conduct other types of analyses to promote evidence-based practices, such as through modelling or predictive analytics.

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

• Promote the translation and dissemination of evidence.

o Engage private and federal partners and stakeholders to develop and refine questions in which evidence synthesis will inform specific healthcare decisions and will help disseminate and translate research findings for the stakeholder audience.

Evidence-Based Practice Centers (EPC) VI Page 16 of 101 o Clearly and concisely synthesize evidence through systematic reviews or other methods for use by public and private partners and other stakeholders. Include sufficient detail for the report to be a primary document. Engage with such partners and stakeholders to make the reports 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 findings from evidence syntheses and other EPC Program products.

• Improve validity and utility of evidence synthesis for decision-making and practice o Collaboration to improve efficiency, quality, and consistency across the EPC program o Advance utility, rigor, and efficiency of evidence synthesis for decision-making and practice through development and update of guidance and tools.

o Ensure quality and utility of EPC products including through the associate editor and peer review process.

C. Relevant Documents Table 1: Supporting Documents

Supporting Document Name

Supporting Document Description

Supporting Document Location

EPC Program Procedures Guide

This Procedure Guide describes the process for developing evidence reviews 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 evidence review by an EPC.

https://www.ahrq.gov/funding/contracts/epc-vi.html

EPC Methods Guide for Effectiveness and Comparative Effectiveness Reviews

AHRQ, the Scientific 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.

https://effectivehealthcare.ahrq.gov/topics/cer-methods-guide/overview/

USPSTF Procedures Guide This Procedure Manual describes the methods used by the Task Force to ensure https://www.uspreventiveservicestaskforce.org/Page /Name/procedure-manual https://effectivehealthcare.ahrq.gov/topics/cer-methods-guide/overview/ https://effectivehealthcare.ahrq.gov/topics/cer-methods-guide/overview/ https://www.uspreventiveservicestaskforce.org/Page/Name/procedure-manual https://www.uspreventiveservicestaskforce.org/Page/Name/procedure-manual

Evidence-Based Practice Centers (EPC) VI Page 17 of 101

Supporting Document Name

Supporting Document Description

Supporting Document Location that its recommendations are scientifically 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 the Agency for Healthcare Research and Quality (AHRQ) and its designated Evidence-based Practice Centers (EPCs).

USPSTF Procedures Guide for EPCs

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

Collaborative Modeling Evaluation Checklist

This is a checklist to help evaluate and appraise a decision analysis for the

USPSTF.

USPSTF EPC Disclosure Policy and Form

This form is an agreement signed by each EPC team member, Key Informant, Technical Expert Panel Member that documents financial and nonfinancial disclosures.

USPSTF Confidentiality Forms for EPC Staff

This form is an agreement by the EPC team member and outlines the parameters of confidentiality for each EPC project.

USPSTF Confidentiality Forms for KI and TEP

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

https://www.ahrq.gov/funding/contracts/epc-vi.html

Evidence-Based Practice Centers (EPC) VI Page 18 of 101

Supporting Document Description

Supporting Document Location

USPSTF Confidentiality Forms for Peer Reviewers

This form is an agreement by the peer reviewers and outlines the parameters of confidentiality for each EPC project.

USPSTF Behavioral Intervention Implementation Steps

This guide documents steps for extracting implementation information from interventions for behavioral counseling topics that previously received an “A” or “B” grade

USPSTF Behavioral Intervention Implementation Table

This is a checklist to help evaluate and appraise implementation information from interventions for behavioral counseling topics that previously received an “A” or “B” grade

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

This form is an agreement signed by each EPC team member that documents financial and nonfinancial disclosures.

https://effectivehealthcare.ahrq.gov/sites/default/file s/epc-disclosure-policy-form.pdf

Confidentiality Forms for EPC Staff

This form is an agreement by the EPC team member and outlines the parameters of confidentiality for each EPC project.

Confidentiality Forms for KI and TEP

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

Publishing Guidelines for Reports Developed by Evidence-based Practice Centers

These publishing guidelines provide standards and guidance for the EPCs to use in preparing reports.

These publishing guidelines are intended for use at all stages in the report’s development, beginning with the writing of the first draft.

EPC Report Template This document provides the parameters for EPC reports consistent with the AHRQ publishing style and the EPC Publishing guide.

Topic Development Brief Template

This document describes the content and format for topic development briefs.

https://www.ahrq.gov/funding/contracts/epc-vi.html 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://www.ahrq.gov/funding/contracts/epc-vi.html https://www.ahrq.gov/funding/contracts/epc-vi.html https://www.ahrq.gov/funding/contracts/epc-vi.html

Evidence-Based Practice Centers (EPC) VI Page 19 of 101

Supporting Document Description

Supporting Document Location

Topic Refinement Document Content Guidance

This document describes the content for the topic refinement document.

Protocol Content Guidance This document describes the content for the systematic review protocols.

Systematic Review Content Guidance

This document describes the content for systematic review reports.

Evidence Summary Content Guidance

This document describes the content for evidence summaries that accompany systematic reviews.

Key Messages Guidance This document describes the content and parameters for key messages within reports for systematic reviews, technical briefs, and rapid evidence products.

Technical Brief Protocol

This document describes the content for technical brief protocols.

Technical Brief Report

This document describes the content for reports of technical briefs.

Rapid Evidence Product Guidance

This document provides guidance for the processes in developing a rapid product.

Surveillance report template

This document describes the content for surveillance reports.

508 Compliance resources

These resources describe the technical requirements and criteria that are used to measure conformance with the Section 508 law.

• Section 508 https://www.hhs.gov/web/section- 508/index.html

• Contracting https://www.hhs.gov/web/section- 508/contracting/index.html

• Making Files Accessible https://www.hhs.gov/web/section-508/making-files-accessible/index.html

• Text of the Standards and Guidelines https://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-ict-refresh/final-rule/text-of-the-standards-and-guidelines#appendix-a

AHRQ Publishing and Communications Guidelines

This document outlines the publishing standards for AHRQ products developed in-house and by contractors.

https://www.ahrq.gov/research/publications/pubcom guide/index.html

IOM Standards-Finding What Works in Health Care:

Standards for Systematic Reviews

This is an IOM report that outlines the standards for systematic reviews.

http://www.nationalacademies.org/hmd/Reports/201 1/Finding-What-Works-in-Health-Care-Standards-for-Systematic-Reviews.aspx https://www.ahrq.gov/funding/contracts/epc-vi.html https://www.ahrq.gov/funding/contracts/epc-vi.html https://www.ahrq.gov/funding/contracts/epc-vi.html https://www.ahrq.gov/funding/contracts/epc-vi.html https://www.ahrq.gov/funding/contracts/epc-vi.html https://www.ahrq.gov/funding/contracts/epc-vi.html https://www.ahrq.gov/funding/contracts/epc-vi.html https://www.ahrq.gov/funding/contracts/epc-vi.html https://www.ahrq.gov/funding/contracts/epc-vi.html https://www.hhs.gov/web/section-508/index.html https://www.hhs.gov/web/section-508/index.html https://www.hhs.gov/web/section-508/contracting/index.html https://www.hhs.gov/web/section-508/contracting/index.html https://www.hhs.gov/web/section-508/making-files-accessible/index.html https://www.hhs.gov/web/section-508/making-files-accessible/index.html https://www.ahrq.gov/research/publications/pubcomguide/index.html https://www.ahrq.gov/research/publications/pubcomguide/index.html http://www.nationalacademies.org/hmd/Reports/2011/Finding-What-Works-in-Health-Care-Standards-for-Systematic-Reviews.aspx http://www.nationalacademies.org/hmd/Reports/2011/Finding-What-Works-in-Health-Care-Standards-for-Systematic-Reviews.aspx http://www.nationalacademies.org/hmd/Reports/2011/Finding-What-Works-in-Health-Care-Standards-for-Systematic-Reviews.aspx

Evidence-Based Practice Centers (EPC) VI Page 20 of 101

Supporting Document Description

Supporting Document Location

EPC Response to IOM Standards for Systematic Reviews

This is a paper that outlines the response of the EPC Program to the IOM standards for systematic review.

https://effectivehealthcare.ahrq.gov/sites/default/file s/pdf/iom-standards_white-paper.pdf

Brochures: Stakeholder resources

These brochures describe how stakeholders are involved in EPC reports.

https://effectivehealthcare.ahrq.gov/topics/get-involved/synthesizing-evidence-brochure;

https://effectivehealthcare.ahrq.gov/topics/get-involved/making-sure-brochure

Webpage: EPC Program Editorial and review process

This webpage provides background about the EPC program’s editorial and review process.

https://effectivehealthcare.ahrq.gov/about/epc/revie w

Webpage: AHRQ EPC Program Helps Health Systems Use Evidence

This webpage provides an overview of EPC Program efforts with work with health systems.

https://effectivehealthcare.ahrq.gov/topics/health-systems-use-evidence/overview

Webpage: About the Effective Health Care Program

This webpage provides general background information about the Effective Health Care Program.

https://effectivehealthcare.ahrq.gov/about

Webpage: AHRQ Technology Assessment Program

This webpage provides background and information about the AHRQ Technology Assessment Program.

http://www.ahrq.gov/research/findings/ta/index.html.

Webpage: U.S. Preventive Services Task Force, Methods and Processes

This webpage provides and overview to the methods and processes for the U.S.

Preventive Services Task Force, and the role of the EPCs.

https://www.uspreventiveservicestaskforce.org/Page /Name/methods-and-processes https://effectivehealthcare.ahrq.gov/sites/default/files/pdf/iom-standards_white-paper.pdf…