Citizen'sRFP.doc

PART I - THE SCHEDULE

Request for Proposal

SECTION A - SOLICITATION FORM

No. AHRQ-10-10004 Date Issued: February 22, 2010 Date Due: April 7, 2010

Time Due: 12 noon local time.

You are invited to submit a proposal to the Agency for Healthcare Research and Quality (AHRQ) for Request for Proposal (RFP) No. AHRQ-10-10004, entitled “Citizen’s Forum”. Your proposal must be developed and submitted in accordance with the requirements and instructions of this RFP.

A Firm Fixed Price contract of three (3) years and two (2) option years is contemplated to be awarded from this RFP and this is also a full and open competition contract, open to all sources.

Please submit the following:

A. Technical Proposal (See Section L. 8) Original and 10 Copies B. Business Proposal (Section L.10) Original and 3 Copies C. Small Disadvantaged Business Subcontracting Proposal Original and 3 Copies

D. Past Performance Information (SEE Section L.9) Original and 3 copies

Your proposal must provide the full name of your company, the address, including county, Tax Identification Number (TIN), Dun and Bradstreet Number (DUNS No.) and if different, the address to which payment should be mailed.

YOUR ATTENTION IS ALSO DIRECTED TO THE TECHNICAL PROPOSAL INSTRUCTIONS IN SECTION L.8 OF THE SOLICITATION.

PLEASE ALSO NOTE: The prospective contract award from this RFP is to be funded using American Recovery and Reinvestment (ARRA) Funds. That will require adherence to ARRA reporting requirements.

Your technical proposal must be concisely written and should be limited to 100 typewritten pages (double-spaced, single sided), exclusive of personnel qualifications (ie: resume, etc., SEE Section l.10 for further details). Your appendices are limited to 50 pages (single sided) including resumes, bibliographies, exhibits and attachments. This limitation is for administrative purposes only and exceeding this limitation is not, in and of itself, to be considered a basis for rejection of your proposal.

Questions regarding this solicitation shall be received in this office no later than March 15, 2010. Your questions should be submitted to the attention of Robert Zuhlke, Contracting Officer, Agency for Healthcare Research and Quality, 540 Gaither Road, Rockville, MD 20850 and the envelope should be marked “Proposal Questions RFP No. AHRQ-10-10004 if being sent via US Mail. Questions may also be emailed to Robert.Zuhlke@ahrq.hhs.gov .

The proposal shall be signed by an authorized official to bind your organization and must be received in our Contracts Office no later than 12:00 Noon, local prevailing time, on April 7, 2010. Your proposal must be mailed to the following address:

Agency for Healthcare Research and Quality

OPART/ Contracts Management

540 Gaither Road

Rockville, MD 20850

Hand carried proposals may be dropped off at the above location. The Contracts Management offices are located on the 4th Floor. However, please allow ample time as proposals cannot be accepted until they have been processed 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."

The RFP does not commit the Government to pay any costs for the preparation and submission of a proposal. It is also brought to your attention that the Contracting Officer is the only individual who can legally commit the Government to the expenditure of public funds in connection with the proposed acquisition.

In accordance with Federal Acquisition Circular (FAC) 2001-16, all contractors must be registered in the central contractor registration (CCR) data base in order to conduct business with the government [See Section I – FAR clauses 52.204-7 Central Contractor Registration (OCT. 2003), Alternate I (OCT. 2003)]. As stated in paragraph (h) of this clause, additional information can be obtained at http://www.ccr.gov or by calling 1-888-227-2423, or 269-961-5757.

Request for any information concerning this RFP should be referred to Mr. Robert Zuhlke 301-427-1714. Robert.Zuhlke@ahrq.hhs.gov Sincerely, Robert A. Zuhlke

Contracting Officer

Agency for Healthcare Research and Quality

TABLE OF CONTENTS

PART I

PAGES

Section A

Solicitation

1a -2a

Table of Contents

Section B

Supplies or Services & Prices/Costs 2 – 3

Section C

Description/Specifications

4 – 42

Work Statement

Section D

Packaging and Marking

Section E

Inspection and Acceptance

Section F

Deliveries and Performance

44 – 49

Section G

Contract Administration Data

50 – 52

Section H

Special Contract Requirements

53 – 62

PART II

Section I

Contract Clauses

63 – 66

PART III

Section J

List of Attachments

PART IV

Section K

Representations and Instructions

68 – 74 Section L

Instructions, Conditions & Notices

75 – 91

To Offerors

Section M

Evaluation Factors

92 – 95 Attachments

1. Past Performance Questionnaire

2. Performance Requirements Summary

SECTION B – SUPPLIES OR SERVICES AND PRICES/COSTS

B.1

BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

“Citizen’s Forum”. SEE Section C for complete description

B.2

FIRM FIXED PRICE

a. The firm fixed price for this three (3) year contract is $ (TO BE NEGOTIATED).

B.3

OPTION PERIODS

In the event that the option period(s) is exercised, contract value will be increased by the following amounts:

Option 1 (7/15/13 – 7/14/14)

$ (TO BE NEGOTIATED)

Option 2 (7/15/14 – 7/15/15)

$ (TO BE NEGOTIATED)

B.4

PROVISIONS APPLICABLE TO DIRECT COSTS

a.

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

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

(2) Rearrangement or alteration of facilities;

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

(4) Accountable Government property (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 in excess of $800/day;

(11) Information Technology hardware or software; and

(12) Food or 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.

SECTION C/ STATEMENT OF WORK

DESCRIPTION/SPECIFICATION/WORK STATEMENT

I. OVERVIEW

The Agency for Healthcare Research and Quality (AHRQ) is soliciting proposals for a Citizens’ Forum. The Citizens’ Forum is an initiative funded by the American Recovery and Reinvestment Act (ARRA) to expand and systematize broad citizen and stakeholder engagement in AHRQ’s comparative effectiveness research initiative. Specifically, the goal of this effort is to develop and demonstrate mechanisms to engage representatives of the public – both citizens and stakeholders – in processes that utilize comparative effectiveness evidence for making decisions concerning healthcare policy and practice, and in decisions related to the conduct of comparative effectiveness research itself. For purposes of this RFP, we define citizens as members of the general public without intended medical or clinical background. AHRQ’s stakeholders are persons or groups who have a vested interest in the clinical decision and the evidence that supports that decision.

The Citizens’ Forum Contractor will work in cooperation with AHRQ and its contractors who are implementing Section 1013 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA), which instructs AHRQ to conduct and support Comparative Effectiveness Research (CER), comparing the outcomes, clinical effectiveness, and appropriateness of pharmaceuticals, devices, and health care services. The activities of the Citizens’ Forum will support the MMA mandate to ensure that there is broad and ongoing consultation with relevant stakeholders. This section of the mandate supports the basic premise that stakeholder involvement leads to more applicable and relevant research and results to support healthcare decision making. The Citizens’ Forum will develop and test methods to gather informed citizen and clinician opinion on value-based health care questions. The Citizens’ Forum will also work closely with AHRQ and EHC Program components, including its research networks, to expand stakeholder involvement in EHC research processes and activities.

The background information which follows describes and provides context within which the Citizens’ Forum will function. It provides greater detail on AHRQ and its CER initiative, the Effective Health Care Program, followed by a discussion of stakeholder and citizen participation.

II.

BACKGROUND

A.

The Agency for Healthcare Research and Quality

The mission of the AHRQ is to improve the quality, safety, efficiency, and effectiveness of health care for all Americans. To achieve these goals, the Agency conducts and supports a broad base of scientific research and promotion of improvements in clinical and health system 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 generation, synthesis and dissemination of scientific evidence, including effectiveness research and analytic methods. AHRQ also sponsors and conducts research on existing as well as innovative technologies, and conducts research on methods for measuring quality and strategies for improving quality.

AHRQ recognizes that a number of populations experience persistent disparities in access to care, quality of care, and 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-supported research helps health care decision makers—patients and clinicians, health system leaders, and policymakers—make more informed decisions and improve health care quality, accessibility, and outcomes of care.

B.

The American Recovery and Reinvestment Act and Comparative Effectiveness

The American Recovery and Reinvestment Act (ARRA) appropriated $1.1 billion for comparative effectiveness research (CER), of which $300 million was appropriated to AHRQ. CER has been an integral component of AHRQ’s health services research program for the past decade. The goal of CER is to improve health outcomes by providing evidence to inform and enhance medical decisions made by patients and their medical providers.

The Department of Health and Human Services uses the definition of CER set forth by the Federal Coordinating Council for Comparative Effectiveness Research:

Box 1

Comparative effectiveness research is the conduct and synthesis of research comparing the benefits and harms of different interventions and strategies to prevent, diagnose, treat, and monitor health conditions in “real world” settings. The purpose of this research is to improve health outcomes by developing and disseminating evidence-based information to patients, clinicians, and other decision-makers, responding to their expressed needs, about which interventions are most effective for which patients under specific circumstances.

Federal Coordinating Council for Comparative Effectiveness Research. (June 30, 2009).

Report to the President and the Congress on Comparative Effectiveness Research.

U.S. Department of Health and Human Services. http://www.hhs.gov/recovery/programs/cer/cerannualrpt.pdf, accessed July 1, 2009.

The purpose of CER is to provide information that helps clinicians and patients choose the preventive, diagnostic, treatment or other healthcare options which best fit an individual patient's needs and preferences. Clinicians and patients need to know not only that a treatment works on average but also which interventions work best for specific types of patients. Policy makers and public health professionals need comparative effectiveness information to inform system-level decisions. CER is essential for translating new discoveries into better health outcomes for Americans, accelerating the application of beneficial innovations, and delivering the right treatment to the right patient at the right time.

AHRQ is using ARRA funds to expand and broaden existing CER activities, located within its Effective Healthcare Program (EHC), and to support new CER initiatives. ARRA-funded programs will include activities in the broad areas of identifying emerging issues and existing gaps in CER; synthesizing comparative effectiveness evidence; generating new CER; improving the infrastructure for gathering data to support comparative effectiveness studies; training and career development; and enhancing public participation, as described in this RFP. The overall effort is designed to increase the national output of comparative effectiveness research; in addition, it will build research infrastructure and capacity, allowing future studies to address questions where data are currently not sufficient to provide guidance about competing alternatives and improving the efficiency with which the research infrastructure is able to respond to pressing health care questions. All research activities will be performed using rigorous scientific methods within an established process that emphasizes stakeholder involvement and transparency, that was designed to prioritize among pressing health issues, and whose products are designed for maximum usefulness for health care decision makers.

C.

AHRQ’s CER Initiative – The Effective Health Care Program

The Effective Health Care (EHC) Program is AHRQ’s Comparative Effectiveness Research (CER) initiative, launched in 2005 under the authorization of Section 1013 of the Medicare Prescription Drug, Improvement, and Modernization Act (MMA) of 2003. The EHC Program focuses on research comparing the relative benefits and risks of different therapeutic approaches for a clinical condition in different populations, on clear and accessible translation of research results, and on advancing CER methods. The EHC Program does not make treatment recommendations, but instead provides relevant, accessible, and current comparative effectiveness information to support health care decisions in both the clinical and policy domains.

C.1.

EHC Program Framework and Components

The EHC Program was built on three main components of CER: evidence synthesis, generation of new evidence, and translation and dissemination of research findings. ARRA funding will expand the scope and capacity of the EHC Program in each of these areas and will formalize additional program components.

The comparative effectiveness research process (Figure 1) starts with horizon scanning, the identification of current or emerging medical interventions available to diagnose, treat, or otherwise manage a particular condition. Horizon scanning activities are vital for understanding the relevant healthcare context and landscape as a basis for identifying and beginning to prioritize among research needs. AHRQ is using ARRA funding to establish an infrastructure to identify new and emerging issues for comparative effectiveness review investments.

Figure 1.

Once issues are identified, evidence synthesis focuses on the systematic review, critical appraisal, and synthesis of current medical research, to provide rigorous evaluation of what is known about the comparative effectiveness of alternative approaches to the given clinical problem. Evidence synthesis involves the distillation of a body of evidence generally comprised of multiple studies and often including a combination of trials and non-experimental studies.

AHRQ’s Evidence-based Practice Centers (EPCs) house the EHC Program’s activities in evidence synthesis. AHRQ created the EPCs in 1997 to conduct systematic literature reviews and to promote evidence-based practice and decision making; they became an essential component of the EHC Program at its inception in 2005. The EPCs are located at 14 public- and private-sector research institutions throughout the United States and Canada. The EPCs’ major products are evidence reports including systematic reviews, technology assessments, technical briefs, and research reviews covering non-clinical methods topics. For the EHC Program the EPCs conduct Comparative Effectiveness Reviews, a subset of their systematic reviews focusing on explicit comparisons among available treatments or other interventions for a given condition. With ARRA funding, AHRQ will significantly expand CER topic development, refinement, and evidence synthesis through the EPCs.

The process of identifying evidence needs and gaps locates areas where new research conducted within a comparative effectiveness framework would contribute to bridging the gap between existing medical research and clinical practice. AHRQ will use ARRA funds to advance systematic and rigorous methods to identify evidence needs, emphasizing consideration of the timing, value, and feasibility of research as well as systems for coordinating research efforts with other funders and researchers.

Another important component of CER is the generation of new evidence or scientific knowledge to fill evidence gaps. The EHC Program targets its efforts in evidence generation to areas where randomized controlled trials would not be feasible or timely, or would raise ethical concerns that are difficult to address. To supply this information, the EHC Program conducts practical studies using electronic health data to examine outcomes, comparative clinical effectiveness, safety, and appropriateness of health care items and services. These studies are undertaken through the DEcIDE (Developing Evidence to Inform Decisions about Effectiveness) Network. Created in 2005 as part of the EHC Program, the DEcIDE Network is comprised of 13 academic, clinical, and practice-based organizations with access (or partners providing access) to electronic health information databases and the capacity to conduct timely research. The DEcIDE Network also develops new analytic tools to inform patients, providers, and policy-makers involved in decisions about the effectiveness, comparative effectiveness, appropriateness, safety, efficiency, and outcomes of healthcare items and services. (See: http://effectivehealthcare.ahrq.gov.)

The EHC Program has also collaborated with the Centers for Education and Research on Therapeutics (CERTs) to generate new scientific evidence and provide education that advances the optimal use of therapeutics (i.e., drugs, medical devices, and biological products). Established in 1999, the CERTs is a cooperative agreement program administered by AHRQ in consultation with the U.S. Food and Drug Administration, and is comprised of 14 research centers. CERTs projects focus on therapeutic areas where there is a demonstrated need for improved clinical practice or implementation. CERTs projects for the Effective Health Care Program may be found at http://certs.hhs.gov/about/certsovr.htm.

ARRA funds will support the generation of new evidence in several ways. Funding will support additional comparative effectiveness research through the DeCIDE network. In addition, AHRQ has begun to invest significantly in investigator-initiated research through grant mechanisms. Grants funded under the AHRQ Clinical and Health Outcomes Initiative in Comparative Effectiveness (CHOICE) will be large comparative effectiveness projects in priority areas of clinical care having a high likelihood of creating major advancements in those areas. Grants funded as AHRQ Prospective Outcome Systems using Patient-specific Electronic data to Compare Tests and therapies (PROSPECT) studies will focus on developing infrastructure and improving the methodology for collecting prospective data from electronic clinical databases to generate new evidence on the comparative effectiveness of healthcare interventions. The Electronic Data Methods Forum will convene PROSPECT Studies investigators, relevant stakeholders, and other experts in health information technology and outcomes research to identify challenges to conducting comparative effectiveness research using electronic data and to propose realistic solutions to advance this field of research.

The final stage of the research development process is to translate complex research findings into understandable summary guides and disseminate them to decision-makers who can use them. The EHC Program oversees the John M. Eisenberg Clinical Decisions and Communications Science Center, located at Baylor College of Medicine in Houston, Texas, in taking a systematic approach to translating scientific evidence produced by EHC Program. Products include a range of short, plain-language materials and products, including summary guides and decision aids, designed for three audiences: consumers (patients, family members and others who are not medical professionals), clinicians, and policy makers. The Eisenberg Center works closely with AHRQ’s Office of Communication and Knowledge Transfer (OCKT) to disseminate the guides, and it maintains the Effective Health Care Web site, www.effectivehealthcare.ahrq.gov.

With ARRA funding, AHRQ will increase efforts in translation and dissemination through expanded Eisenberg Center activities and new investigator-initiated research, Grants under the iADAPT (Innovative Adaptation and Dissemination of AHRQ Comparative Effectiveness Research Products) Funding Opportunity Announcement will support development and implementation of innovative approaches for integrating comparative effectiveness research findings into clinical practice and health care decision making. These grants will fund local organizations such as medical societies, state institutions of higher learning, patients, and community advocacy organizations in projects that promote education, dissemination and application of comparative effectiveness research.

C.2. Public Involvement in the EHC Program: Stakeholder Participation

Public input regarding health care research has been a mainstay of AHRQ’s EHC Program since its inception. Stakeholder involvement at all stages in the research process helps ensure that the program responds to the issues that are most pressing for health care decision makers and in ways that are accessible and useful. Stakeholders – persons or groups who have a vested interest in the clinical decision and the evidence that supports that decision - contribute to the research process by nominating topics for comparative effectiveness research, developing specific research questions, refining research strategy and design, reviewing draft research reports, and facilitating product dissemination. A formal stakeholder panel, the EHC Stakeholder Group, has also provided guidance on broad elements of the program such as transparency of research processes and approaches to development, dissemination, and use of program research products.

Topic Identification and Nomination. The EHC Program has a formal process by which any person may nominate a topic for comparative effectiveness research using a web-based form (http://www.effectivehealthcare.ahrq.gov/getInvolved.cfm?involvetype=sr#suggestRes). The Program also seeks topic nominations actively from specific organizations and convenes meetings with an array of health care decision-makers and researchers to identify questions of interest.

Topic Refinement for Research Reviews. After a research review is assigned to an EPC, the investigative team must identify Key Questions to guide the systematic review. Stakeholders contribute to this process as Key Informants, helping to ensure that the topic and research questions are valid, relevant, and applicable to the real-world decision the research will address, and advising on the appropriate audience for eventual research products. Key informants typically include patients and caregivers, practicing clinicians, professional and consumer organizations, purchasers of health care, policy-makers, and others with direct experience in making health care decisions relevant to the topic. At the stage of topic refinement, the public also has an opportunity to comment on the Key Questions proposed for research or review.

Expert Consultation. The EHC Program draws on an external Technical Expert Panel (TEP) to inform the technical scientific processes of the research review or project. For a systematic review, input may address study aspects such as literature search strategies or inclusion criteria; TEP members may later serve as peer reviewers. Patient, caregiver, and consumer group representation in TEPs is encouraged to assist in maintaining a patient-centered focus to the research activities.

Review, Translation, and Dissemination. The EHC Program invites both scientific peer review and public review of all draft Research Reviews and Research Reports. To enhance transparency, all comments and responses are publicly posted. The process of research translation involves the public as members of focus groups to ensure that products are easy to understand and answer questions relevant to their audience. Dissemination efforts include partner organizations that can disseminate EHC research products to their constituencies and encourage their use.

Program Input. The EHC Stakeholder Group provides input to improve program quality and impact among users. This volunteer panel, which has included consumers, practicing clinicians, researchers, policymakers, industry representatives, private and public healthcare purchasers, and other healthcare leaders, brings unique experiences and perspectives to the table. The Stakeholder Group provides feedback on concerns such as program transparency, quality improvement of products and processes, types of products that will be most useful to healthcare decision-makers, dissemination and implementation issues for EHC Program findings, and report content.

Other stakeholder engagement. In addition to the engagement of stakeholders in development stages of the research process, the EHC Program also periodically convenes stakeholders and scientists to better identify and define the questions which raise important health care dilemmas. EPCs and DEcIDEs work with stakeholders (particularly policy-makers and guideline groups) to consider the potential for change resulting from evidence review or the generation of new evidence. The DEcIDE Consortia have met with their stakeholder committees to identify and prioritize topics for new research in cardiovascular disease, diabetes, and cancer. The EHC Program also plans to engage stakeholder through Issue Exploration Forums to explore and identify research needs in the areas of common gynecologic problems and common gastrointestinal disorders.

The Citizens’ Forum. As described in this RFP, ARRA funding will support the Citizens’ Forum Initiative to develop new mechanisms and refine existing approaches to eliciting public – both citizens’ and stakeholders’ – views as an input to health care decisions. This effort will expand our ability to draw on public views to inform health care policy, with particular application to obtaining input that will inform comparative effectiveness research in AHRQ’s Effective Healthcare Program.

D.

ENGAGING THE PUBLIC IN HEALTHCARE DECISION-MAKING

To date, the EHC Program has focused on seeking input from decision makers with a broad public health and clinical decision interest, such as professional societies and representatives of public and private payers. ARRA funding will allow the program to expand its efforts to obtain valuable guidance and insights from a broader public. This initiative will develop and demonstrate methods for obtaining input from “frontline” health care decision makers—patients and practicing clinicians—and more generally will advance the Program’s ability to obtain public input, particularly on questions that cannot be decided on the basis of technical or scientific expertise alone.

Interest in eliciting citizens’ values and preferences to inform healthcare decisions made by public officials or healthcare institutions has grown steadily in recent years. A number of reasons are given to involve the public in health care decision making (See Box 2). Research describing differences in the views of members of the public from those of researchers and professionals has added momentum to efforts to find ways to bring public perspectives into both research and policy decisions.

Box 2

· Increasing the transparency and legitimacy of the decision making process of healthcare institutions;

· Making the healthcare system more responsive to the needs and desires of the public;

· Becoming better informed about societal values, needs, concerns and preferences;

· Fostering discussion about the direction of future healthcare reforms);

· Including users’ perspectives in designing program changes;

· Gauging the public’s response to a decision or proposal;

· Educating the public about a particular issue;

· Building support or consensus for a final decision; or

· Addressing public or media criticisms of an issue From: A Framework for Involving the public in healthcare coverage and resource allocation decisions, 2007(accessed at www.dal.ca/shsa/Research/)

In addition to early efforts in the United States, government officials and public commissions in a number of countries have cited the need and priority for a greater public voice in health care policies and have moved to develop processes for obtaining public input. In the U.K., interest in opening the national health system to public input grew during the 1990s (Minton 2009). Citizens’ juries, consultation panels, and surveys have been used to assess health care needs and to consider research prioritization and technology-related issues. In Canada, calls for greater public involvement in health technology assessment and coverage policy have led to a variety of efforts to incorporate public values into existing processes, including deliberative and “dialogue” approaches.

In the United States, efforts to incorporate public views in healthcare decision making processes are prevalent, although not systematic. Citizen and stakeholder representatives have been included in processes to set research priorities and to consider coverage decisions in public settings. For example, the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC), which advises the Centers for Medicare and Medicaid Services on coverage policy and other issues, includes a consumer representative and patient advocate at every meeting. Medicare’s rule-making activities for payment decisions and its national coverage process are statutorily mandated to have citizen participation, accomplished through soliciting public comments at various points during each process. Consumer representatives are regularly included in policy settings, such as advising Institute of Medicine committees that generate policy recommendations regarding health care policies and practices. At AHRQ, stakeholders have participated in the CER program since its inception. The Obama Administration has highlighted a commitment to broadening citizen participation in government, including the health care arena:

“Much of the expertise we need can be found among the nation’s citizens. From economic recovery and health care reform to environmental protection and homeland security, we must ensure that government makes the best possible decisions informed by the best possible expertise and information.”

There are a variety of mechanisms beyond traditional opinion polls that are in development or in use for eliciting public views on healthcare topics. Most, although not all of these, involve a process of educating participants, eliciting views, providing feedback, and opportunities for revising opinion. Table 1 describes these methods.

Table 1.

Despite the interest in these approaches, methods for eliciting informed opinion are not well-developed nor have they been broadly tested. Little work has been done to develop the mechanisms or the ability to involve a broad cross section of the public in processes for obtaining public input. Although the Web and other online technologies offer tremendous potential for informing and involving the public, work to design or develop such tools for obtaining public input relevant to health care decisions is just beginning.

E. Web Technology

The Obama Administration and many federal departments, including HHS, have encouraged the use of Web 2.0 and Social Media technologies to engage citizens in the important decisions and actions of our nation. Web 2.0 and Social Media use many technologies and forms to integrate technology, social interaction, and content creation. These include blogs, wikis, video-sharing, podcasts, social networking, mashups, virtual worlds, micro-blogs, and widgets. Technology tools that specifically facilitate polling and deliberative processes, such as ideascale.com, have also been developed. Use of Web 2.0 and Social Media technologies is accelerating in the health care arena with applications in medical education, continuing education, communities of practice, and learning communities. The evidence-base supporting the use of these tools is just beginning to develop.

The White House has made public engagement and an open government a top priority; HHS is working to provide guidance to facilitate implementation of that priority. The U.S. General Services Administration has also been instrumental in government technology adoption by developing terms of service agreements with a number of social media sites that can then be used by each Federal Department and its own Agencies.

Utilizing Web 2.0 and Social Media has important potential to contribute to the development of formal, scalable methods to engage the public in health care decision making. Further development of these tools must address important challenges, such as the inclusion of population subgroups whose access to access to computers or cell phones is currently limited, representativeness of participants, management of ”information overload” and fragmented dialogue, and barriers related to consideration of legal, privacy and other issues.

To incorporate public views more systematically and effectively in U.S. healthcare policy and other decision processes, more formal, scalable techniques for eliciting public views are needed. It is the goal of the Citizens’ Forum RFP to develop and demonstrate mechanisms for obtaining input relevant to healthcare decisions, in particular those relevant to the processes of comparative effectiveness research and implementation.

III.

STATEMENT OF WORK

A.

GOALS

ARRA funding will support the Citizens’ Forum Initiative to develop new mechanisms and refine existing approaches to eliciting public views as an input to health care decisions. This effort will expand our ability to draw on public views to inform health care policy, with particular application to obtaining input that will inform comparative effectiveness research in AHRQ’s Effective Healthcare Program. The Citizens’ Forum initiative will expand AHRQ’s existing efforts to obtain professional and consumer input to inform its EHC Program activities, build methods and capacity for obtaining public input, and allowing the program to obtain guidance and insights from a broader public.

B.

Project Tasks

The work under this contract is divided into two (2) focus areas with separate tasks as indicated below.

Focus Area 1

Broadly engage members of the public in providing input on ethical and value-based questions that arise in health care decisions, particularly questions arising in the conduct and use of comparative effectiveness research.

Task 1: Review literature on use of deliberative methods

Task 2: Design, develop, demonstrate and evaluate mechanisms for eliciting informed public input on ethical and value-based questions.

Focus Area 2

Ensure consistent and comprehensive stakeholder involvement in all aspects of AHRQ’s expanded Effective Health Care (EHC) Program.

Task 3: Develop Innovative Methods to Meaningfully Engage Stakeholders in Comparative Effectiveness Research

Task 4: Support Stakeholder Engagement in EHC Program Research Processes

Task 5: Manage and Support the Effective Health Care Stakeholder Group

Cross-Cutting Task 6: Manage Contract

A detailed description of each Focus Area and Task follows.

FOCUS AREA 1: Broadly engage members of the public in providing input on ethical and value-based questions that arise in health care decisions, particularly questions arising in the conduct and use of comparative effectiveness research.

TASK 1 - Review literature on use of deliberative methods

The Contractor will conduct a Literature Review on the subject of Deliberative Methods, covering the background and development of these methods, how they have been used in the context of health care, and current efforts to advance the field. The review should also describe the use of Deliberative Methods in other (non-healthcare) settings where relevant to past applications or potential future applications in health care.

The Contractor shall submit the draft Literature Review to the AHRQ Project Officer within four (4) months EDOC. The AHRQ staff will review and comment on the draft within 1 month of draft submission. The Contractor shall submit the final Literature Review to the AHRQ Project Officer within six (6) months EDOC.

TASK 2 - Design, develop, demonstrate and evaluate mechanisms for eliciting informed public input on ethical and value-based questions that arise in the context of the design, evaluation, and implementation of comparative effectiveness research.

Subtask 2.1 – Design and develop methods for eliciting public input.

A preliminary description of the approach to be used for eliciting public input for this task will be proposed and justified in the Proposal developed in response to this RFP (see Technical Proposal Instructions - L.10.C.). Once the contract is awarded, the Contractor will be responsible for fully designing and developing the methods to be used and presenting them in the Deliberative Approach Conceptual Framework and Methods Document (see Subtask 2.6).

The methods used should reflect a deliberative approach that includes the education of respondents about the topic at hand, elicitation of initial views, feedback regarding the implications of these views, and revision of opinion based on such feedback. The approach should advance the state of the art in deliberative methods, either improving on methods that have been used within or outside of the healthcare sector or developing new approaches to eliciting public input.

Methods should be developed with consideration of their relevance to the task of broadening citizen input in health care decision making and the ultimate scalability of the methods.

Subtask 2.1.1 – Convene Technical Expert Panel

The Contractor shall convene a Technical Expert Panel (TEP) composed of 4-6 individuals expert in deliberative processes, at a location to be agreed upon by the Contractor and the TOO. The purpose of the TEP will be to assist the Contractor in designing and developing methods for eliciting public input and provide feedback to the Contractor as the project progresses. The Contractor will present literature review findings and preliminary ideas for the methods for eliciting public input which the Contractor intends to develop and pilot at a ½ - 1-day meeting. The Contractor will obtain further input and feedback from members of the TEP by conference call or email. Please note: In accordance with AHRQ policy, contract funds may not be used to purchase meals or refreshments for attendees at this or any other meeting described in this Statement of Work.

Subtask 2.2 – Technology tools to implement the deliberative process.

The Contractor is encouraged to consider the use of Web 2.0, Social Media, and/or other technology tools to enhance the quality of communications and improve the scalability and the feasibility of processes to elicit input on health related questions. The use of such tools should be described in the Proposal developed in response to this RFP (see Technical Proposal Instructions - L.10.C.).

The Contractor should describe the approach, the advantages offered by the proposed tools, and the work required to develop and implement the tools for use in eliciting citizen input. For any proposed Web 2.0, Social Media, or other technology solution the Contractor must provide:

· a description of solutions that will support and facilitate the deliberative approach;

· the costs of acquisition of these solutions and the number of licenses covered, if applicable;

· the purpose of the solutions and how they will be used in this contract;

· whether and to what extent programming will be needed to customize the solutions for the purposes of this contract;

· the solutions’ compliance with federal regulations and measures for remedying any compliance issues; and

· the terms of service agreements for the solutions (http://www.newmedia.hhs.gov/standards/).

The proposed technology solutions or tools must adhere to HHS and AHRQ guidance and requirements (see http://www.ahrq.gov/news/policyix.htm and http://www.newmedia.hhs.gov/standards/).

Once the contract is awarded, the Contractor will be responsible for fully articulating and describing these elements in the Deliberative Approach Conceptual Framework and Methods Document (see Subtask 2.6). In addition, the Contractor should provide electronic information in a format that is accessible to the public with disabilities, consistent with Section 508 of the Rehabilitation Act (see Subtask 6.10).

Subtask 2.3 – Educational Materials

The Citizens’ Forum initiative is concerned with eliciting informed public views; a critical component of the proposed process will be the task of developing educational materials to educate participants. Materials should utilize state-of-the-art, evidence-based approaches to communicating the information that will contribute to participants’ information base. The Contractor should describe in the Deliberative Approach Conceptual Framework and Methods Document (see Subtask 2.6) the topics education materials will address, the approach to preparing these materials, what will be included in the materials, and how they will be evaluated.

Educational materials may be electronic (web-based or using other electronic formats) or hard copy. They should be part of a considered deliberative approach, enhancing the usability and scalability of the process. Materials may include background information concerning health topic(s) to be addressed, information on ethical contexts, information on decision strategies, devices for practicing and obtaining feedback on decisions, or any other materials required to implement the project.

Materials should be pilot tested. Methods for developing materials, sources, and other information necessary to reproduce the service shall be documented. When Web-based tools and materials are proposed, the Contractor shall address compliance with 508 regulations (see Subtask 6.10), adding the appropriate time and budget to the plan, and adherence to the AHRQ Publishing and Communication Guidelines.

In addition to materials targeted to the citizens providing input on their views, educational materials should also include manuals or other training materials for those conducting group surveys or sessions, including all materials required to implement the proposed activities.

Any educational or training materials developed shall be submitted to the Project Offer for review and approval at least 1 month prior to use and implementation.

Subtask 2.4 – Evaluation Plan

The Contractor will submit an Evaluation Plan as part of the Deliberative Approach Conceptual Framework and Methods Document (see Subtask 2.6) outlining the evaluation criteria for all aspects of the project. This plan will form the basis for the evaluation of the project.

Subtask 2.5 – Demonstrate Mechanism

This subtask covers the Contractor’s work in demonstrating the deliberative methods that are developed in Subtask 2.1.

Subtask 2.5.1 – Determine and finalize target groups to be included in the demonstration of elicitation of public input for this project.

A preliminary definition of the target demographic groups from whom views will be elicited for this project will be proposed and justified in the Proposal developed in response to this RFP (see Technical Proposal Instructions - L.10.C.). Once the contract is awarded, the Contractor will be responsible for fully articulating the choice of target groups, the composition of subgroups of each target group to be included in the demonstration and the selection process. These aspects of the Contractor’s plan will be presented in the Deliberative Approach Conceptual Framework and Methods Document (See Subtask 2.6).

The Contractor should justify the choice of target groups for the demonstration on the basis of the importance of the input of the target group for decision makers responsible for decisions concerning the conduct of comparative effectiveness research or for decisions drawing on comparative effectiveness findings. A minimum of 4 target groups should be identified, with emphasis on priority populations. The Contractor should justify the number of persons in each target group to be included in the demonstration and the size of subgroups. (For example, the deliberative methods developed might suggest an optimal group size of 15 persons, in which case the Contractor might propose that Target Group 1 would include 60 members, who would be convened in groups of 4, meeting 3 times each.) The target groups should be described in terms of demographics, geographic location, and all other characteristics that serve as a basis for their selection.

The Contractor will be responsible for developing and implementing a plan for selecting a sample of members of the target group who will participate in the demonstration of the deliberative process.

Subtask 2.5.2 – Determine and finalize ethical and value-based questions on three (3) different comparative effectiveness research topics that will be used in the demonstration of the deliberative methods developed in this project.

In Subtask 2.1, the Contractor will develop methods for eliciting public views on ethical and value-based questions. Subtask 2.2, in which the Contractor will demonstrate these methods, requires ethical and value-based questions on specific comparative effectiveness research topics that will serve as the focus of public input. This part of Subtask 2.2 addresses the development of these questions.

Preliminary questions on specific comparative effectiveness research topics will be proposed and…