SRC II Solicitation 2_14_12.pdf

Request for Proposal AHRQ-12-10010

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PART I - THE SCHEDULE Request for Proposal

SECTION A - SOLICITATION FORM No. AHRQ-12-10010

Date Issued: February 17, 2012

Date Questions Due: March 8, 2012 noon EST

Date Notice of Intent Due: March 15, 2012 noon EST

Date Proposals Due: March 30, 2012 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-12-10010 entitled ―Scientific Resource

Center II‖. 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 contractor selected for this requirement will be instrumental in working with the Evidence-based Practice Centers ( EPCs). Therefore, the EPC IV contracts have been identified as having a significant Organizational Conflict of Interest that is considered unable to be mitigated. (Reference FAR subpart 9.5 and Section L.7 herein). 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-

10010. 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/

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Additional Information:

A cost type contract is contemplated for a period of one year, with four one-year options.

The Government anticipates awarding one (1) contract 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-

12-10010.

mailto:%20Erin.Lange@ahrq.hhs.gov mailto:%20Erin.Lange@ahrq.hhs.gov

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TABLE OF CONTENTS

PART I Pages

Section A Solicitation 1-2

Table of Contents 3

Section B Supplies or Services & Prices/Costs 4

Section C Description/Specification/Work Statement 6

Section D Packaging and Marking 19

Section E Inspection and Acceptance 20

Section F Deliveries or Performance 20

Section G Contract Administration Data 24

Section H Special Contract Requirements 28

PART II

Section I Contract Clauses 42

PART III

Section J List of Attachments 48

PART IV

Section K Representations and Certifications 49

Section L Instructions, Conditions & Notices to Offerors 57

Section M Evaluation Factors for Award 78

Attachments

1. Proposal Intent Response Form

2. Past Performance Questionnaire and Contract Performance Form

3. SF LLL-A, Disclosure of Lobbying Activities

4. Sample Format for Cost Proposal

5. Certificate of Current Cost or Pricing Data

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SECTION B-SUPPLIES OR SERVICES AND PRICES/COSTS

B.1 BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

―Scientific Resource Center II‖. See Section C for a complete description.

B.2 ESTIMATED COST

a. The Estimated Cost for performance of the work under this contract, including direct and indirect costs is $ To Be Negotiated (TBN).

B.3 OPTION PERIODS

If the Government exercises its option(s) pursuant to the option article in Section H of this contract, the Government‘s total contract amount represented by the sum of the estimated cost plus fixed fee will be revised as follows:

Period of Performance

Estimated Cost Total Estimated Cost

Base Year

Option Year 1 $ $

Option Year 2 $ $

Option Year 3 $ $

Option Year 4

The base period and each option are separate and distinct from one another for accumulation of costs and billing purposes.

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;

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(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 (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 Contractor's Guide for Control of Government Property, 1990, 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. Travel Costs

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

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

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

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B.5 CONTRACTING OFFICER AUTHORIZATION

Other provisions of this contract notwithstanding, approval of the following items within the limits set forth is hereby granted without further authorization from the Contracting Officer.

To Be Negotiated

SECTION C - DESCRIPTION/SPECIFICATION/WORK STATEMENT

Independently and not as an agent of the Government, the Contractor shall be required to furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government, as needed to perform the Statement of Work as follows:

Statement of Work

Unless otherwise noted under a specific task, this Statement of Work applies to the base period and all options (if exercised).

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.

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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 through the Evidence-based Practice Center Program); b.)

Generate new scientific evidence and analytic tools (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).

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 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). .

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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/.

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 payers, 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.

With funding from a variety of sources, each with a different program goal, 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 as complementary, alternative, nutritional, and other emerging areas such as genomics and may span from preventative services to implementation of medical devices.

The EPCs have expanded the work 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, encompassing the 14 priority conditions of the EHC http://www.effectivehealthcare.ahrq.gov/index.cfm/what-is-the-effective-health-care-program1/ 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/

Scientific Resource Center II Page 9 of 82 program (found at http://www.effectivehealthcare.ahrq.gov/index.cfm/submit-a-suggestion-for-research/how-are-research-topics-chosen/), 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, , 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.

Through the EHC program, the 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 within given areas of concentration 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.

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

In addition to working with a variety of partners through the EHC program, EPCs will conduct reviews 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 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 will continue to 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 Technical briefs are used by the Centers for

Medicare and Medicaid Services (CMS) through the Medicare Evidence Development and Coverage Advisory http://www.effectivehealthcare.ahrq.gov/index.cfm/submit-a-suggestion-for-research/how-are-research-topics-chosen/ http://www.effectivehealthcare.ahrq.gov/index.cfm/submit-a-suggestion-for-research/how-are-research-topics-chosen/

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Committee (MEDCAC) to inform its national coverage decisions for the Medicare program as well as provide information to Medicare carriers. Examples of Technical briefs can be found at the link below.

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.

For a detailed explanation of the USPSTF's methods, go to the USPSTF Procedure Manual at http://www.uspreventiveservicestaskforce.org/uspstf08/methods/procmanual.htm. To access a current list of released topics and a list of topics in progress visit www.uspreventiveservicestaskforce.org.

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/).

In addition to advancing clinical practice through the identification, conduct, and 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.

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&statusType =3&language=1&searchButton=Search o http://www.ahrq.gov/clinic/epc/epcseries.htm

– Future research needs o http://effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productid=521

– Advanced Systematic Reviews for USPSTF http://www.uspreventiveservicestaskforce.org/uspstf08/methods/procmanual.htm http://www.uspreventiveservicestaskforce.org/ 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.ahrq.gov/clinic/epc/epcseries.htm http://effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productid=521 http://effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productid=521

Scientific Resource Center II Page 11 of 82 o http://www.uspreventiveservicestaskforce.org/serfiles.htm

– Abbreviated, Focused Reviews 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&searchB utton=Search

Methods Guide - EPC investigators developed a methods guide that addresses particular issues in the conduct of comparative effectiveness reviews and systematic reviews of medical tests. EPCs are expected to adhere to the established guidance and to contribute to development, updating, or revision of further methods guidance, 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

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/

- Procedures guide – available as attachment

B. Objectives

The SRC will will work closely with AHRQ and EPCs to support and coordinate many of the cross-cutting functions of the EHC program, including:

1. Coordinate and maintain updates of the EPC Methods Guide for Effectiveness and Comparative Effectiveness Reviews.

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

b. The SRC will convene regular meetings and webinars to discuss coordination, consistency of EPC products and methodologic approaches.

2. Provide scientific and technical support to protect scientific credibility and independence of EHC Program Products

a. The SRC will work with EPCs to conduct searches of grey literature, including FDA site and solicitation of scientific information packets, for use in systematic reviews or for use in evaluating need to conduct or update a comparative effectiveness review.

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

c. 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 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/methodsguide.cfm http://www.effectivehealthcare.ahrq.gov/trainingmodules.cfm http://www.ahrq.gov/clinic/epcpartner/stakeholderguide/

Scientific Resource Center II Page 12 of 82 in reviewing reports. The SRC will schedule, set agendas for, and lead regular associate editor calls and meetings for coordination purposes.

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

3. Provide technical support, transparency, scientific support and conduct of topic development processes, including evaluations for the need to update reviews conducted under the EHC Program.

a. The SRC will assemble, schedule, set agendas for, and lead topic triage calls

b. The SRC will gather and track topic nominations

c. The SRC will provide lists of topics to AHRQ and help determine which are most appropriate for development by EPCs.

d. The SRC will develop topics for presentation to topic triage and provide resources to the EPCs to ensure consistency of processes in topic development

e. 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.

4. Develop and maintain EHC program resources, including methods library, procedure documents and guidance tools, and mechanisms for collaboration and mutual learning.

a. The SRC will work with AHRQ to maintain and update tools and documents for greater consistency among EPC products, for smooth functioning among the different parts of the EHC program, and for improved adherence to EHC policies and procedures.

C. Personnel

The SRC will work closely with AHRQ staff and EPCs:

Senior Leadership Core

The SRC Director, Associate Director and Project Manager shall function as a core team for senior leadership. They shall work collaboratively to direct and encourage the SRC‘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. SRC leadership shall have experience and contingency plans for hiring and training new staff, mentoring young scientists and maintaining staff capacity and skills with a long-term view.

SRC Director

The SRC Director‘s main responsibility continues to be to provide strong and consistent programmatic leadership at the SRC levels and across various tasks. It is the responsibility of the SRC 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 SRC Director for a dedicated portion of his/her time. Collaborative leadership with an Associate Director is appropriate, but final responsibility must reside with the SRC Director. The SRC Director must be willing to attest to the integrity and quality of each deliverable prior to submission to

AHRQ.

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The SRC 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 SRC‘s collegial work on EPC program-wide initiatives, such as EPC meetings, interactions with other EPCs through methods guide, learning network, topic development, associate editor and peer review work or other trans-EPC collaborative reviews or methodology projects. The SRC Director shall mentor new staff.

Leadership by example suggests that the SRC 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.

Senior leadership is a key feature of the administrative structure within the SRC. It is expected that senior leadership will be available at a minimum and consistent availability of 70% fulltime equivalent. At a practical level, this senior leadership may be shared with the SRC Associate Director, but the SRC Director shall consistently contribute a minimum of 20% FTE and explicit, strategic sharing of the leadership role must be obvious. Regardless of percent FTE, the SRC Director holds the ultimate responsibility for functioning of the SRC under her/his directorship.

SRC Associate Director

The Associate Director shall assist the Director with promoting successful and consistent SRC work and provide continuity of leadership in the Director‘s absence. The Associate Director often has a dual function as Lead Investigator on SRC projects. In collaboration with the SRC Director, the SRC Associate Director shall supervise and evaluate the work of Lead Investigators and other scientific functions.

It is expected that the SRC Director and Associate Director will be available at a minimum and consistent availability of 70% fulltime equivalent. At a practical level, this senior leadership may be shared with the SRC Associate Director, but the SRC Director shall consistently contribute a minimum of 20% FTE and explicit, strategic sharing of the leadership role must be obvious. Regardless of percent FTE, the SRC Director holds the ultimate responsibility for functioning of the SRC under her/his directorship.

SRC Project Manager

The SRC Project Manager shall assist the Director by promoting successful and consistent SRC work. It is expected that this shall be 100% full-time position. The SRC Project Manager may directly supervise and evaluate the work of research assistants and like roles. The SRC Project Manager will be responsible for preparation and submission of on-going status reports. The SRC Project Manager is expected to be familiar with content, location, and status of EPC Program templates, guidance, and resources (for all processes and scientific methods of the EPC program). The SRC shall maintain these documents and update them on a regular basis. The Project manager will maintain or oversee maintenance of tracking of EPC program comparative effectiveness reviews for topic development (both new topic nominations as well as those eligible for update) and peer review. The Project Manager will coordinate or oversee coordination of learning network webinars.

On a day-to-day basis, the SRC Project Manager shall supervise all activities across the SRC 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.

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SRC Lead Investigators

SRC Lead Investigators shall apply their scientific methods expertise in various aspects of the SRC work – including developing individual clinical topics for presentation to topic triage (for both new topic nominations as well as reviews eligible for update), serving as associate editors for comparative effectiveness reviews or DEcIDE reports, co-leading update of methods guidance, or development of training or resource materials for the EHC program on scientific processes. Lead investigators who co-lead update of methods guidance must also demonstrate the ability to facilitate groups of diverse research opinions through series of webinars or other means to identify areas of consensus and guidance. It is understood that lead investigators may be assisted by less experienced researchers. It is the responsibility of the SRC Director and/or Associate SRC 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 is the responsibility of the Lead Investigator and SRC Director to evaluate and assert performance expectations to produce top-quality contributions of such individuals.

Librarian

The librarian is a key member of the SRC project team who will maintain the methods library, monitor the FDA site, coordinate and request Scientific Information Packets, develop and lead guidance in systematic review search methods, and assist in literature or other website searches to assess the need to conduct or update a comparative effectiveness review. As described previously, the SRC 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. To ensure the scientific credibility of EHC products, statistician expertise is necessary in both the scientific review of EHC products as well as the development and update of methods guidance. As described previously, the SRC Director, Associate Director and Project Director hold important supervisory and leadership roles to ensure successful and efficient integration of these members of the team.

D. Tasks

D.1. Coordinate and maintain updates of the EPC Methods Guide for Effectiveness and Comparative Effectiveness Reviews.

D.1.1. The SRC shall designate one lead investigator to organize one of four workgroup areas, outlined below. The SRC lead investigator will be responsible for organizing calls with EPC workgroup members, setting agendas, keeping notes, tracking resources, clarifying roles and responsibilities, and ensuring timely completion of tasks for each workgroup. Each workgroup will consider current EPC resources and needs, prioritize workgroup efforts to improve quality and consistency of EPC products, develop papers or tools, implement guidance and promote mutual learning (via webinars or in-person meetings), and serve as and/or provide resources to other EPCs within the focus area.

D.1.2. As described in the EPC4 RFTO 1: Each workgroup area will:

Prioritize the needs within the EPC program within the given methodologic focus area.

Submit prioritized list of suggested work to the TOO. As approved by the TOO, develop a workplan for and conduct work on the highest priority need or needs.

o Updating methods guidance (EPC Methods Guide) o Improve implementation of methods guidance o Conduct empiric research

Organize and host about 2 webinar sessions per year and about 2 sessions at in-person EPC meetings.

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Identify and consolidate a library of materials (e.g. slide presentations, guidance documents, or other implementation tools) that can help EPCs in conducting reviews that use rigorous and consistent methods.

D.1.3. Workgroup areas of Methodologic focus

Area 1 – Defining research and Systematic Review Needs

Engaging stakeholders for topic identification, development, and refinement

Prioritization of systematic review topics and future research needs

Updating systematic reviews

Area 2 – Developing and Implementing SR protocols for unbiased reviews

Literature searching

Determining inclusion and exclusion criteria

Literature screening and data abstraction

Peer review and the editorial process

Area 3 – Analyzing and reporting SR findings

Statistical methods for data synthesis

Assessing the risk of bias of individual studies and grading the overall strength of evidence

Presentation of systematic review findings

Area 4 – Frontiers in SRs

Medical test reviews

Health system, health program reviews

Rapid reviews and technical briefs

D.1.4 The SRC shall convene at least one in-person meeting yearly to discuss coordination and consistency of EPC products and methodologic approaches. The SRC shall assist in setting the meeting agenda, inviting speakers, and collating materials for distribution. These meetings will be held at AHRQ.

D.2. Provide scientific and technical support to protect scientific credibility and independence of EHC Program Products

D.2.1. Participate in providing independent scientific review of EHC products. The SRC shall manage the assembly, coordination, training of associate editors (AE) for EPC products including comparative effectiveness reviews, effectiveness reviews or other EPC reports, methods projects, technical briefs, and DEcIDE reports. The SRC will convene regular calls with associate editors to improve consistency and efficiency in AE review as well as identify areas for quality improvement within the program, such as areas where methods guidance may improve quality or consistency or templates, guidance, workshops, or other venues may improve presentation of evidence. The SRC shall also manage the assignment of reports to AEs.

D.2.2. Manage Peer review. Using the ScholarOne software or other appropriate software, the SRC shall manage a peer review process for AHRQ products including comparative effectiveness reviews, effectiveness reviews or other EPC reports, methods projects, technical briefs, and DEcIDE reports. The SRC shall continue to maintain and refine ScholarOne processes to enhance efficient associate editor, AHRQ Task Order Officer, and peer review of EHC products. The SRC shall convene regular biweekly calls with AHRQ to identify needs of the program, to design and develop appropriate processes, to test and implement those processes and monitor processing of reports in a timely manner. These peer review comments shall be available to AHRQ and EPC authors at the end of comment period. The SRC shall coordinate with the Eisenberg center staff to ensure that public review comments are provided to the EPC along with peer review comments.

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D.2.3. Request Scientific information packets and monitor FDA site. The SRC shall institute a system to request Scientific information packets from industry for each EPC review (comparative effectiveness reviews or other EPC reports, or technical briefs). The SRC shall also monitor the FDA site for information relevant to specific EPC reviews as well as for identifying the need to update an existing comparative effectiveness review. The SRC will provide topic specific information to the EPC for consideration in their review of topic development as appropriate.

D.2.4. Provide statistical review for EPC reviews. The SRC statistician shall be available to review EPC reports with meta-analysis for compliance with the Methods Guide or to identify the need for external statistician review.

D.2.5. Provide methodological support. The SRC shall be available to EPC authors for assistance in methodologic issues or processes such as searches of the FDA site, clinicaltrials.gov site, or relevant registries or other data sources.

D.3. Provide technical support, transparency, scientific support and conduct of topic development processes, including evaluations for the need to update reviews conducted under the EHC Program.

D.3.1. Provide Technical Support for Topic Selection Processes.

The SRC will work with the Eisenberg Center staff to download topics nominated via the website, and will collate them on a regular basis to put these into the Topic Triage process.

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