EPC IV Solicitation 2_14_12.pdf

Request for Proposal AHRQ-12-10009

Evidence-based Practice Centers (EPCs) IV Page 1 of 94

PART I - THE SCHEDULE Request for Proposal

SECTION A - SOLICITATION FORM AHRQ-12-10009

Date Issued: ______February 17, 2012____ Date Questions Due: __March 8, _2012__ 12:00 Noon EST Date Notice of Intent Due: _March15, 2012____ Date Proposals Due: __March 30, 2012__ 12:00 Noon EST

You are invited to submit a proposal to the Agency for Healthcare Research and Quality (AHRQ) for Request for Proposal (RFP) No. AHRQ-12-10009, entitled ―Evidence-based Practice Centers (EPCs) IV.‖ Your proposal must be developed and submitted in accordance with the requirements and instructions of this RFP.

Solicitation Information: Please review the table of contents and refer to the appropriate section of this RFP for requirements, proposal instructions and evaluation information. The

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

Conflict of Interest: The contractors selected for this requirement will prepare reports for the

Effective Health Care Program as EPCs. Therefore, an organization that receives/coordinates

EHC/EPC deliverables, including the EPC Scientific Resource Center (SRC) has been identified as having a significant Organizational Conflict of Interest that is considered unable to be mitigated. (Reference FAR subpart 9.5, Section L.7, and SOW paragraph #D3.3). Awards under this RFP and RFP AHRQ-12-10010 will not be made to the same entity, Proposal Intent: If you intend to submit a proposal in response to this solicitation, please inform the Contracting Officer of your intent by completing the Proposal Intent Response Form (See section L.13 and Attachment 1) and send it to the Contracting Officer no later than the date shown above. You may mail it to the address below, fax it to 301-427-1740, Attention: Gayle

Sunde, Contract Specialist/Contracting Officer or email it to Gayle. Sunde@ahrq.hhs.gov.

Questions: All Questions regarding this solicitation shall be received in this office no later than the date shown above. All questions shall be submitted electronically by e-mail to Gayle Sunde, Contract Specialist/Contracting Officer, at the following email address: Gayle.

Sunde@ahrq.hhs.gov. Subject line shall read: Proposal Questions RFP No. AHRQ-12-10009.

Answers to questions and all solicitation amendments will be posted to the Federal Business

Opportunities web page: www.fedbizopps.gov. It is your responsibility to monitor the web site.

mailto:Erin.Lange@ahrq.hhs.gov http://www.fedbizopps.gov/

Evidence-based Practice Centers (EPCs) IV Page 2 of 96

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 ten (10) contracts from this solicitation on or about August 2012.

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

The NAICS code for this requirement is 541990 with a size standard of $7M.

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

Agency for Healthcare Research and Quality

Division of Contracts Management

540 Gaither Road

Rockville, Maryland 20850

Attn: Gayle Sunde, (301) 427-1573

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

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

Central Contractor Registration: In accordance with Federal Acquisition Regulation, all contractors must be registered in the central contractor registration (CCR) database in order to conduct business with the government [See Section I - FAR clause 52.204-7 Central Contractor

Registration

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 Gayle Sunde, (301) 427-1573 or e-mail:

Gayle. Sunde@ahrq.hhs.gov. Please note e-mail requests should state subject as RFP AHRQ-12-

10009.

Evidence-based Practice Centers (EPCs) IV Page 3 of 96

TABLE OF CONTENTS

PART I Pages

Section A Solicitation 1-3

Section B Supplies or Services & Prices/Costs 4

Section C Description/Specification/Work Statement 7

Section D Packaging and Marking 29

Section E Inspection and Acceptance 29

Section F Deliveries or Performance 30

Section G Contract Administration Data 32

Section H Special Contract Requirements 37

PART II

Section I Contract Clauses 53

PART III

Section J List of Attachments 61

PART IV

Section K Representations and Certifications 62

Section L Instructions, Conditions & Notices to Offerors 70

Section M Evaluation Factors for Award 93

Attachments

1. Proposal Intent Response Form

2. Past Performance Questionnaire and Contractor Performance

3. SF LLL-A, Disclosure of Lobbying Activities

4. Sample format for Cost Proposal

5. Certificate of Current Cost or Pricing Data

6. Task Order No. 1, ―Methods and Dissemination: Collaboration to

Improve validity, consistency, and utility of systematic reviews‖, dated January 30, 2012

7. EPC Procedures Guide, dated October 18, 2011

8. Policy on Disclosure of Financial, Business, and Professional Interests

Related to EPC Evidence Reports and Other Products, dated January 1, 2008

9. Topic Nomination Development Packet

Evidence-based Practice Centers (EPCs) IV Page 4 of 96

SECTION B-SUPPLIES OR SERVICES AND PRICES/COSTS

B.1 BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

―Agency for Healthcare Research and Quality (AHRQ) Evidence-based Practice Centers (EPCs) IV Program.‖ See Section C for a complete description.

B.2 TASK ORDERS

This is a Multiple Award, Indefinite Delivery/Indefinite Quantity IDIQ contract. All services will be acquired on an as-needed basis through issuance of Task Orders. Under this IDIQ contract, the minimum is $70,000, while the total maximum amount of all task orders competed and awarded under the program shall not exceed $50,000,000 over the five (5) year period of this contract.

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. Section C. - Tasks

Technical Area Prices

Task D.1.1.2 Task D.2.

Topic Development Dissemination and Implementation

FFP

Task D.1.1.1.

Task D.1.1.3.

Task D.1.1.5.

Task D.1.1.6.

Topic Identification Topic Refinement Future Research Needs Decision Analysis and Modeling

Task D.1.1.4. Technology Brief Small Systematic Review Small Comparative Effectiveness Review Small Technical Assessment (without topic refinement)

Task D.1.1.4. Medium Systematic Review Medium Comparative Effectiveness Review Medium Technology Assessment (without topic refinement)

Task D.1.1.4. Large Scientific Review Large Comparative Effectiveness Review Large Technology Assessment (without topic refinement)

6 Task D.3 EHC – other related studies To Be Negotiated

Evidence-based Practice Centers (EPCs) IV Page 5 of 96

Items 3, 4 and 5 listed in the above chart are based on the following requirements for a small, medium or large task order request:

Small Scientific Review (SR) or Comparative Effectiveness Review (CER) – would have an estimated less than 50 articles

Medium SR or CER – would have an estimated 50-180 articles included; or estimated less than 50 included articles, but with a broad search that yields over 10,000 articles

Large SR or CER -- would have an estimated over 180 articles included; or estimated 50-180 included articles, but with a broad search that yields over 10,000 articles

Mechanisms for Pricing Task Order(s)

All Requests for Task Order (RFTO) will identify the item numbers(s) and quantity being procured from the above listed table.

Items 1 through 5 will be based on the firm-fixed price set forth for that item. Therefore, the contractor shall only be required to submit a technical proposal for that RFTO.

When the RFTO is for Item 6 above, ―EHC – other related studies‖, the contractor will be required to submit a technical and cost/price proposal that will be negotiated prior to award for that task(s) order.

All Tasks are separate. For example; under item 1. Task D.1.1.2., ―Topic Development‖ is a separate requirement from D.2.‖Dissemination and Implementation‖. Both tasks have the same price.

All TOs awarded will be in accordance with Article H.6 Task Order Selection Criteria and Procedures., B.3 PROVISIONS APPLICABLE TO DIRECT COSTS

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

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

(2) Rearrangement or alteration of facilities;

(3) Purchase or lease of any item of general purpose-office furniture or office equipment regardless of dollar value.

(General purpose equipment is defined as any items of personal property which are usable for purposes other than research, such as office equipment and furnishings, pocket calculators, etc.);

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(4) Accountable Government property (defined as both real and personal property with an acquisition cost of $1,000 or more, with a life expectancy of more than two years) and "sensitive items" (defined and listed in the HHS Contracting Guide for Contract of Government Property), regardless of acquisition value;

(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

(12) Food and Beverages.

b. 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."

Evidence-based Practice Centers (EPCs) IV Page 7 of 96

SECTION C- DESCRIPTION/SPECIFICATION/WORK STATEMENT

Statement of Work

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, not otherwise provided by the Government as needed to perform the Evidence based Practice Center (EPC) IV 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 the Agency for Healthcare Research and Quality (AHRQ) and established it as the lead Federal agency for enhancing the quality, appropriateness, and effectiveness of health services and access to such services.

To achieve these goals, the Agency conducts and supports a broad base of scientific research and promotion of improvements in clinical and health systems practices, including the prevention of diseases and other health conditions. AHRQ sponsors and conducts research that develops and presents evidence-based information on healthcare outcomes, quality, patient safety, cost, use and access. Included in AHRQ‘s mandate is support of synthesis and dissemination of available scientific evidence, including dissemination research and analytic methods or systems for rating the strength of scientific evidence. AHRQ sponsors and conducts research on existing as well as innovating technologies, and conducts research on methods for measuring quality and strategies for improving quality. AHRQ also recognizes that a number of populations experience persistent disparities in health status, access to care, quality of care, and poor health outcomes. To address these disparities, AHRQ encourages research projects to include special populations such as low-income groups, racial and ethnic minority groups, women, children, the elderly, and individuals with disabilities and chronic health conditions.

AHRQ Effective Health Care Program

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

AHRQ-supported research helps health care decision-makers – patients and clinicians, health system leaders, purchasers and payers of healthcare, and policy-makers – make more informed decisions and improve the quality of health care. Informed healthcare decisions are best made within a context of scientific evidence. AHRQ‘s Effective Health Care Program provides an organizing framework for this context through a comprehensive approach with three primary components. The three approaches are a.) Synthesize scientific evidence (including

Evidence-based Practice Centers (EPCs) IV Page 8 of 96 through the Evidence-based Practice Center Program); b.) Generate new scientific evidence and analytic tools (including through the Centers for Education and Research on Therapeutics and the Developing Evidence to Inform Decisions about Effectiveness Research Network) and c.) Translate the scientific findings for different audiences (through grants, Knowledge Transfer contract work, and the John M Eisenberg Clinical Decisions and Communications Science Center).

In addition, three new research areas under the EHC program include a) Identification of New and Emerging Issues in Comparative Effectiveness Research (through Horizon Scanning),

b) a greater focused effort in Evidence Gap Identification (through the Evidence-based Practice Center Program), and c) development of a Community Forum. The collective goal of this work is to identify new, high priority areas for research and to advance methods for improving the utility of research, reflecting the core principles of the EHC Program – to be relevant and timely, to be objective, and scientifically rigorous, and to increase public participation and transparency (Slutsky et al, 2008)

Developing Evidence to Inform Decisions about Effectiveness (DEcIDE) Research Network

The other scientific component of the Effective Health Care Program seeks to generate new scientific evidence and analytic tools. The DEcIDE Research Network was created in 2005 to focus on the program component that generates new knowledge. The main purpose of the DEcIDE Research Network is to expeditiously develop valid scientific evidence and methodologies about the outcomes, comparative clinical effectiveness, safety, and appropriateness of health care items and services. The DEcIDE Network is comprised of academic, clinic, and practice-based organizations with access (or partners providing access) to electronic health information databases and the capacity to conduct timely research. Examples of electronic health databases relevant to the DEcIDE Research Network include electronic medical record data, pharmacy records, public or private health insurance data, long-term care data, and special databases such as disease, medical procedure, or medical device registries.

Initial research focused on individual research projects on the outcomes of prescription drug use and other interventions for which randomized controlled trials would not be feasible or timely, or would raise ethical concerns that are difficult to address. Other DEcIDE Research Network projects may focus on electronic registries, methods for analyzing health databases, and prospective observational or interventional studies.

John M. Eisenberg Clinical Decisions and Communications Science Center

The John M. Eisenberg Clinical Decisions and Communications Science Center, also referred to as the Eisenberg Center, takes a systematic approach to translate scientific knowledge about effective health care into understandable, actionable language for all decision-makers. As scientific evidence about effectiveness is synthesized by the EPC program and generated by the DEcIDE Research Network, the Eisenberg Center then translates the scientific knowledge into targeted products for all stakeholders – including patients, providers, and policy-makers. Stakeholders can use this knowledge to maximize benefits from their health care, minimize harm, and optimize the use of health care resources. An important function of the Eisenberg Center is to present the often complex scientific information in a format that stakeholders and the public can easily understand.

Other Programs Associated with the Effective Health Care Program

Other programs at AHRQ share goals with the Effective Health Care Program. These

Evidence-based Practice Centers (EPCs) IV Page 9 of 96 programs generally include other mechanisms for scientific support within their structures. At the time of this Solicitation, the Centers for Education and Research on Therapeutics (CERTs) have collaborated with the Effective Health Care Program on some relevant projects. CERTs is a national initiative to conduct research and provide education that advances the optimal use of therapeutics (i.e., drugs, medical devices, and biological products). The cooperative agreement program consists of 11 research centers and a Coordinating Center.

Healthcare Horizon Scanning System

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

Community Forum

The Community Forum was convened in 2010 to improve and expand public and stakeholder engagement in the Patient-Centered Outcomes Research (PCOR), or Comparative Effectiveness Research (CER). The Community Forum will identify useful and effective ways to engage stakeholders and the general public in AHRQ Programs at all stages of the report, from topic nomination and identification, to conduct of research, to dissemination of research findings.

Additional information on the EHC program in general, resources it provides, and descriptions of processes can be found at:

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

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

http://www.effectivehealthcare.ahrq.gov/index.cfm/who-is-involved-in-the-effective-health-care-program1/ Examples of products produced by each of the component parts of the Effective Health Care Program may be found at: http://effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and-reports/.

Scientific Resource Center

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

Topic triage o The SRC will assemble, schedule, set agendas for, and lead topic triage calls o The SRC will gather and track topic nominations o The SRC will provide lists of topics to AHRQ and help determine which are most appropriate for development by EPC.

http://www.effectivehealthcare.ahrq.gov/index.cfm/what-is-the-effective-health-care-program1/ http://www.effectivehealthcare.ahrq.gov/index.cfm/who-is-involved-in-the-effective-health-care-program1/ http://www.effectivehealthcare.ahrq.gov/index.cfm/who-is-involved-in-the-effective-health-care-program1/ http://effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and-reports/ http://effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and-reports/

Evidence-based Practice Centers (EPCs) IV Page 10 of 96 o The SRC will develop topics for presentation to topic triage and provide resources to the EPCs to ensure consistency of processes in topic development o The SRC will track Systematic Reviews that are eligible for updating and provide resources to the EPCs to ensure consistency of processes in assessing the need to update reports

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

o The SRC will coordinate editorial process for review of draft and final reports.

The SRC will provide resources for associate editors to ensure consistency of processes in reviewing reports. The SRC will schedule, set agendas for, and lead regular associate editor calls and meetings for coordination purposes.

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

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

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

Evidence-based Practice Centers (EPC) Program

The Evidence-based Practice Centers Program is the cornerstone of the Effective Health Care 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. These reviews use the research methodology of systematic review to systematically and critically appraise existing research and synthesize knowledge on a particular topic. These are systematic reviews based on rigorous, comprehensive methods, emphasizing explicitly detailed documentation of methods rationale and assumptions.

Since 1997, the EPCs have developed evidence reports and technology assessments on a wide spectrum of topics, both clinical and policy-oriented. The expertise of the EPCs is used for comparative and effectiveness reviews (CERs) on medications, devices, and other relevant interventions, funded under MMA Section 1013. Published EPC evidence reports are available at one of two sites listed below.

The ultimate goal of EPC work is to present the ―state of the science‖ on a given topic in a manner that can be directly applied to decisions made by users of health care information.

These users include clinicians, patients, policy-makers, and purchasers and payers of healthcare, and may be individuals or their related organizations. Specifically, evidence reports and technology assessments have been used as a scientific foundation for development and implementation of clinical practice guidelines, clinical pathways, review criteria, performance measures, and other clinical quality improvements tools, individual treatment decisions, coverage or reimbursement policies, and to develop research agendas.

EPCs work with various partners and stakeholders to review a variety of health care delivery and clinical areas of focus. Clinical areas may focus on traditional therapeutics as well

Evidence-based Practice Centers (EPCs) IV Page 11 of 96 as complementary, alternative, nutritional, and other emerging areas such as genomics and may span from preventative services to implementation of medical devices. Of particular note, the EHC program works with a variety of partners and conducts reviews through the EPC for a variety of other Federal programs including the US Preventive Services Task Force (USPSTF), the Technology Assessment (TA) Program, and 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), or other Federal branches of government.

Through the Technology Assessment (TA) Program, EPCs conduct abbreviated, focused technical briefs based on a systematic review of the literature, along with appropriate qualitative and quantitative methods of synthesizing data from multiple studies or sources. These Technology Assessment Reports are used by the Centers for Medicare and Medicaid Services (CMS) through the Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) to inform its national coverage decisions for the Medicare program as well as provide information to Medicare carriers. Examples of Technology Assessment Reports can be found at: http://www.ahrq.gov/clinic/techix.htm.

The U.S. Preventive Services Task Force (USPSTF), first convened by the U.S. Public Health Service in 1984, and since 1998 sponsored by AHRQ, is the leading independent panel of private-sector experts in prevention and primary care. The USPSTF reviews the scientific evidence for the effectiveness of a broad range of clinical preventive services, including screening tests, counseling services, and preventive medications to determine the balance of benefits and harms for specific groups of people based on age, gender, and other risk factors for disease. Based on that evidence review, the USPSTF makes recommendations to primary care providers about which clinical preventive health care services to offer their patients and how often.

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. The EPCs also provide consultation to the Task Force on developing its recommendations and translating them for multiple target audiences. Details of USPSTF methods and processes and the role of EPCs can be found at: http://www.uspreventiveservicestaskforce.org/methods.htm#methods.

Recently, work of the EPCs has expanded under the EHC Program to advance the translation and synthesis of knowledge with a broader array of stakeholders than those previously established partner organizations. Within specific areas of concentration, the EPCs engaged directly with stakeholders to determine the questions that patients, providers, and policy-makers ask though topic generation, topic development, and topic refinement phases prior to the actual systematic review process. EPCs continue to be involved in development of dissemination materials such as those produced by the Eisenberg Center to ensure that key messages are accurately portrayed. In addition to various stakeholders, EPCs also continue to engage technical experts to provide input while developing the protocol in order to ensure that the review will be comprehensive and relevant. The EHC program has recently expanded the work that EPCs did in identifying research gaps from a review to identify the highest priority future research needs from within a systematic review through engaging stakeholders.

In addition to advancing clinical practice through the identification, conduct, and http://www.ahrq.gov/clinic/techix.htm http://www.uspreventiveservicestaskforce.org/methods.htm#methods

Evidence-based Practice Centers (EPCs) IV Page 12 of 96 dissemination of systematic reviews, EPCs have contributed to the scientific methods of systematic reviews. AHRQ has invested in EPC work to conduct empiric methods research and to move the systematic review discipline forward in providing comprehensive, relevant, timely, and unbiased evidence for decision-makers. To improve the scientific rigor, transparency, and consistency of reviews, the EPC program has collaborated to improve the methods used by developing guidance to the program as well as instituting processes to uphold the quality of the methods of reports. The Methods Guide for Effectiveness and Comparative Effectiveness Reviews is an ongoing, collaborative process by the EPCs to provide guidance on how to handle the most difficult methodologic issues in conducting systematic reviews. The current guidance papers can be found at the website listed below. Training modules are also provided which help new EPC investigators implement the methods guide and can be found as downloadable slides or CME at the website listed below. In addition to reference and teaching materials, the EPC program has a rigorous editorial and peer review process to ensure the production of quality, unbiased reports. A panel of associate editors and peer reviewers are selected to provide unbiased expert feedback to authors (http://www.effectivehealthcare.ahrq.gov/index.cfm/who-is-involved-in-the-effective-health-care-program1/about-evidence-based-practice-centers-epcs/epc-center-editorial-review-process/).

Examples of EPC products may be found at the links listed below.

EPC References:

Examples of EPC Products

– CERs and systematic reviews o http://www.effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and-reports/?category=&search=&trackID=1&methodCategory=&agencyType=2&stat usType=3&language=1&searchButton=Search o http://www.ahrq.gov/clinic/epc/epcseries.htm

– Future research needs o http://effectivehealthcare.ahrq.gov/futureresearch.cfm

– Advanced Systematic Reviews for USPSTF o http://www.uspreventiveservicestaskforce.org/serfiles.htm

– Abbreviated, Focused Reviews (Technical Briefs) for TA Program:

o http://www.ahrq.gov/clinic/techix.htm#completed

– Empiric Methods work o http://www.effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and-reports/?category=&search=&methodCategory=9&agencyType=2&language=1& searchButton=Search

Methods Guide - EPC investigators developed a methods guide that addresses particular issues in the conduct of comparative effectiveness reviews and systematic reviews of http://www.effectivehealthcare.ahrq.gov/index.cfm/who-is-involved-in-the-effective-health-care-program1/about-evidence-based-practice-centers-epcs/epc-center-editorial-review-process/ http://www.effectivehealthcare.ahrq.gov/index.cfm/who-is-involved-in-the-effective-health-care-program1/about-evidence-based-practice-centers-epcs/epc-center-editorial-review-process/ http://www.effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and-reports/?category=&search=&trackID=1&methodCategory=&agencyType=2&statusType=3&language=1&searchButton=Search http://www.effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and-reports/?category=&search=&trackID=1&methodCategory=&agencyType=2&statusType=3&language=1&searchButton=Search http://www.effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and-reports/?category=&search=&trackID=1&methodCategory=&agencyType=2&statusType=3&language=1&searchButton=Search http://www.effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and-reports/?category=&search=&trackID=1&methodCategory=&agencyType=2&statusType=3&language=1&searchButton=Search http://www.ahrq.gov/clinic/epc/epcseries.htm http://effectivehealthcare.ahrq.gov/futureresearch.cfm http://www.uspreventiveservicestaskforce.org/serfiles.htm http://www.ahrq.gov/clinic/techix.htm#completed http://www.effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and-reports/?category=&search=&methodCategory=9&agencyType=2&language=1&searchButton=Search http://www.effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and-reports/?category=&search=&methodCategory=9&agencyType=2&language=1&searchButton=Search http://www.effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and-reports/?category=&search=&methodCategory=9&agencyType=2&language=1&searchButton=Search http://www.effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and-reports/?category=&search=&methodCategory=9&agencyType=2&language=1&searchButton=Search

Evidence-based Practice Centers (EPCs) IV Page 13 of 96 medical tests. EPCs are expected to adhere to the established guidance and to contribute to development, updating, or revision of further methods guidance, as directed under task order, as described in section D.2 of the statement of work below.

– Methods Guide for Effectiveness and Comparative Effectiveness Reviews. AHRQ Publication No. 10(11)-EHC063-EF. Rockville, MD: Agency for Healthcare Research and Quality. March 2011. Chapters available at:

http://www.effectivehealthcare.ahrq.gov/methodsguide.cfm

– Methods guide for Medical Test Reviews draft available at:

http://www.effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productid=558

– Methods research on identifying and prioritizing future research needs available at:

http://effectivehealthcare.ahrq.gov/futureresearchmethods.cfm

– Training modules – EPC investigators developed training modules to help new investigators operationalize the material developed in the Methods Guide. These materials can be found at: http://www.effectivehealthcare.ahrq.gov/trainingmodules.cfm

The Effective Health Care Program Stakeholder Guide provides information for current and potential stakeholder organizations about the Effective Health Care Program and the roles and responsibilities of key participants including AHRQ stakeholders (which include EPC partners), the EPCs, and the Scientific Resource Center. The guide also outlines the research process, products, and ways in which stakeholders can be involved. Available at:

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

B. Objectives

As the EPC program continue to pursue its mission through the EHC program in the coming years, EPCs will continue to work with a variety of partners such as guideline development groups, patients, providers, policy-makers and other consumers of evidence reports, including researchers and funders of research to identify, develop, refine questions for systematic review, synthesize evidence, and identify future research needs. It is anticipated that within the EHC Program, the EPCs will continue to work with stakeholders to synthesize evidence relating to their questions across the priority conditions and cross-cut areas listed below.

http://www.effectivehealthcare.ahrq.gov/methodsguide.cfm http://www.effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productid=558 http://www.effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productid=558 http://effectivehealthcare.ahrq.gov/futureresearchmethods.cfm http://www.effectivehealthcare.ahrq.gov/trainingmodules.cfm http://www.ahrq.gov/clinic/epcpartner/stakeholderguide/

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Table 1: EHC Program priority conditions and cross-cut areas

1. Arthritis and nontraumatic joint disorders

2. Attention-deficit hyperactivity disorder

3. Cancer

4. Cardiovascular disease, including stroke and hypertension

5. Dementia, including Alzheimer's Disease

6. Depression, other mental health disorders

7. Developmental delays, autism

8. Diabetes mellitus

9. Functional limitations and disability

10. Infectious diseases including HIV/AIDS

11. Obesity

12. Peptic ulcer disease and dyspepsia

13. Pregnancy, including preterm birth

14. Pulmonary disease/asthma

15. Substance abuse

16. Cross-cut theme 1

a. Care delivery, management, and coordination

b. Prevention

17. Cross-cut theme 2

a. Medical testing

b. Imaging technologies

c. Medical and assistive devices

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

Promote the synthesis and translation of evidence.

Engage stakeholders to identify and refine questions in which systematic review will help disseminate and translate research findings for the stakeholder audience.

Conduct comparative effectiveness reviews, technical briefs, and updates of reviews with systematic and transparent methods.

Engage stakeholders to identify and characterize Future research needs to inform real-world healthcare decisions.

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

c. Improve validity and utility of systematic reviews for decision-making

a. Advance methods of systematic review through empiric methods research

b. Ensure quality of EPC reviews through associate editor and peer review.

d. Improve consistency and cohesiveness of program

a. Develop methods guidance and translation of methods guidance to aid implementation efforts

i. CERs and systematic reviews

ii. Reviews of medical tests

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iii. Identification of Future research needs

iv. Topic identification

b. Development of tools to improve EPC program efficiency

C. Personnel

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

Senior Leadership Core

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

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

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

EPC Director

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

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

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

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

EPC Associate Director

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

EPC Project Manager

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

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

EPC Lead Investigators

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

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Librarian

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

Statistician/Data analyst

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

Medical Editor and/or Medical writers

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

Stakeholder Engagement

EPCs will engage with program stakeholders, in collaboration with other aspects of the EHC Program, such as the Scientific Resource Center and Eisenberg Center. The patient perspective, especially as related to outcomes, is particularly important to include through all aspects of comprehensive comparative effectiveness reviews. Other stakeholders are anticipated to be involved include the topic nominator and local clinical experts during topic development, a variety of key informants during refinement, clinical, and technical experts during the CER, primary researchers and funders of research for identification of future research needs, and others needing to make a healthcare decision directly related to the topic.

In particular, the EPC will be available during any Task Order to provide technical input into the development of any translational products derived from the product. EPCs will collaborate with the Eisenberg Center, AHRQ and other EHC program partners for these activities.

This work of engaging stakeholders and partners for topic development, prioritizing research and disseminating findings, as described below in D.3.2 is expected to be at least 20% of the work of promoting evidence synthesis within a given clinical area and the EPC should anticipate appropriate personnel for these efforts.

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D. Tasks

D.1. Promote the synthesis and translation of evidence through conduct of tasks within 5 distinct but sequentially related work activities.

There are five sequential steps in the process of conducting comprehensive Comparative Effectiveness Reviews, each one building on the previous work. All tasks shall be conducted in accordance with the EPC methods guide. The five steps are delineated in sections D.1.1.1 through D.1.1.5, below.

D.1.1.1. Topic identification

In topic identification, the EPC will identify clinical questions from stakeholders that are eligible for systematic review. The EPC will pre-define the process to identify stakeholders, to elicit their questions, to describe background and other materials to be provided to stakeholders and to prioritize the questions. The EPC will be able to describe how the final prioritized list of questions reflects high priority stakeholder needs that a systematic review may help to answer.

The EPC may consider other sources of information in addition to directly asking decision makers to identify topics that maintain an end-user focus.