Background_and_Statement_of_Work.docx

SECTION C- DESCRIPTION/SPECIFICATION/WORK STATEMENT

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

A. Background Information

The Agency for Healthcare Research and Quality The Agency for Healthcare Research and Quality (AHRQ) was established in 1989 as the Agency for Health Care Policy and Research. Its reauthorizing legislation (42 U.S.C. 299 et seq; “Healthcare Research and Quality Act of 1999”) renamed the Agency the Agency for Healthcare Research and Quality (AHRQ) and established it as the lead Federal agency for enhancing the quality, appropriateness, and effectiveness of health services and access to such services.

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

Evidence-based Practice Centers Program The EPCs were created in 1997 to synthesize existing scientific literature about important health care topics and promote evidence-based practice and decision-making.

The 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. EPCs produce various types of evidence reports, all based on the methodology of systematic review. A key feature of systematic reviews is that they systematically and critically appraise existing research and synthesize knowledge on a particular topic. Systematic review methods have been defined by EPCs in Methods Guide (www.effectivehealthcare.ahrq.gov/methodsguide.cfm) and other organizations, such as the IOM (IOM Standards, 2011). Technical briefs employ similar systematic review methods when applied to areas where there is less established evidence.

Users of EPC reports include clinicians, patients, policy-makers, and purchasers and payers of healthcare, and may be individuals or their related organizations. EPC work has been the 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 research agendas.

To advance the translation and synthesis of EPC reports, EPCs engage directly with stakeholders to determine the questions that patients, providers, and policy-makers ask though topic development and topic refinement phases prior to the actual systematic review process. EPCs continue to be involved in development of dissemination materials 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.

To improve the scientific rigor, transparency, and consistency of reviews conducted under the Effective Health Care Program (described below), 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: www.effectivehealthcare.ahrq.gov/methodsguide.cfm and http://www.effectivehealthcare.ahrq.gov/medtestsguide.cfm. Training modules are also provided which help new EPC investigators implement the methods guide and can be found as downloadable slides or CME at: http://www.effectivehealthcare.ahrq.gov/trainingmodules.cfm. 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/).

EPC Program Partners EPCs work with many 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 AHRQ Effective Health Care Program The EPC Program is the cornerstone of the Effective Health Care (EHC) Program. Section 1013 of the Medicare Prescription Drug, Improvement, and Modernization Act (MMA) of 2003 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) and 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.

Under the EHC program, EPCs synthesize evidence, usually through systematic reviews (including comparative effectiveness reviews) and technical briefs to promote evidence-based decision making for various guideline groups, policy-makers, and others. EPC work is focused on helping 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. A stakeholder guide identifies ways in which decision makers can be involved in the EHC program, available at: http://www.ahrq.gov/clinic/epcpartner/stakeholderguide/ Table 1: Sample List of Partners for EPC reports under the EHC Program

1. American Academy of Child and Adolescent Psychiatry

2. American Academy of Family Physicians

3. American Academy of Orthopedic Surgeons

4. American Academy of Otolaryngology—Head and Neck Surgery Foundation

5. American Academy of Pediatrics

6. American Academy of Neurology

7. American Association for Clinical Chemistry

8. American Association of Colleges of Pharmacy

9. American College of Obstetrics and Gynecology

10. American College of Chest Physicians

11. American College of Family Physicians

12. American College of Physicians

13. American College of Radiology

14. American College of Rheumatology

15. American Gastroenterological Association

16. American Psychiatric Association

17. American Psychological Association

18. American Society of Clinical Oncology

19. American Urological Association

20. Association of American Medical Colleges

21. Autism Speaks

22. Infections Disease Society of America

23. Medicaid Medical Directors Learning Network

Under this program EPCs, work with other parts of the EHC program to promote evidence-based decision making.

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, 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.

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.

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

· Topic triage

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

· The SRC will gather and track topic nominations

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

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

· The SRC will track Systematic Reviews that are eligible for updating and provide resources to the EPCs to ensure consistency of processes in assessing the need to update reports

· Peer review

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

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

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

· Coordination and logistic support

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

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

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/.

Specific examples of EPC reports for the EHC program can be found at: http://www.effectivehealthcare.ahrq.gov/search-for-guides-reviews-and-reports/?category=&search=&trackID=1&methodCategory=&agencyType=2&language=1&searchButton=Search

US Preventive Services Task Force The U.S. Preventive Services Task Force (USPSTF or Task Force) is an independent, volunteer panel of national experts in prevention and evidence-based medicine. Since its inception in 1984, the USPSTF has worked to improve the health of all Americans by making evidence-based recommendations about clinical preventive services and health promotion. These recommendations for adults and children address screening tests, counseling about healthful behaviors, and preventive medications.

Since 1998, the Agency for Healthcare Research and Quality (AHRQ) has been authorized by Congress to convene the USPSTF and to provide ongoing scientific, administrative, and dissemination support.

USPSTF recommendations focus on interventions to prevent disease, and they apply only to people without signs or symptoms of the disease or condition under consideration. USPSTF recommendations address services offered in the primary care setting or services referred by primary care professionals. The USPSTF makes recommendations to help primary care clinicians and patients decide together whether a preventive service is right for an individual’s needs.

The work of the USPSTF is supported by Evidence-based Practice Centers (EPCs), which conduct rigorous, impartial assessments of the scientific evidence on specific topics in clinical prevention that serve as the scientific basis for USPSTF recommendations. USPSTF members use the evidence report as the basis for their assessment of the effectiveness of the preventive service under consideration.

They balance both the potential benefits and harms in making their recommendations. Potential benefits of clinical preventive services include reduction of risk factors to prevent disease, early identification of disease leading to earlier treatment, and, ultimately, improved health outcomes such as quality of life and length of life. Harms of preventive services can include adverse effects of the service itself as well as the harms of inaccurate test results that may lead to a cascade of additional followup tests (some of which are invasive and could cause harm) and unnecessary treatments. Potential harms also include side effects or complications of treatments. When appropriate and when evidence exists, the USPSTF evaluates the benefits and harms based on age, sex, and risk factors for the disease.

The USPSTF makes its recommendations based on its assessment of the effectiveness of each clinical preventive service. The USPSTF does not explicitly consider costs in its appraisal of the effectiveness of a service. The USPSTF recognizes that insurance coverage decisions involve additional considerations beyond a scientific assessment of the clinical benefit and harms.

The recommendation statement and a manuscript based on the full evidence review prepared by EPCs are often published in a peer-reviewed medical journal. To ensure that stakeholders and the public are informed about the recommendations and understand them, the USPSTF also develops plain language fact sheets on each draft and final recommendation statement and works with partner organizations on dissemination and implementation activities. The EPCs provide consultation to the USPSTF on developing its recommendations and translating them for multiple target audiences. Details of USPSTF methods and processes and the role of EPCs can be found at: http://www.uspreventiveservicestaskforce.org/methods.htm#methods.

Examples of EPC reports for the USPSTF can be found at: http://www.uspreventiveservicestaskforce.org/uspstopics.htm

Technology Assessment Program Through the Technology Assessment (TA) Program, EPCs conduct focused systematic reviews of the literature, along with appropriate qualitative and quantitative methods of synthesizing data from multiple studies or sources. Systematic reviews conducted under the TA program are termed Technology Assessments, and are used by the Centers for Medicare and Medicaid Services (CMS) to inform its national coverage decisions for the Medicare Program as well as provide information to Medicare carriers.Information on the TA Program can be found at http://www.ahrq.gov/research/findings/ta/index.html.

Examples of completed EPC reports under the TA program can be found at http://www.ahrq.gov/research/findings/ta/index.html#tacomplete

EPC reports for other Federal or public agencies EPCs synthesize evidence, primarily through conduct of systematic reviews and technical briefs on behalf of other Federal agencies or public partners. EPCs have conducted systematic reviews and technical briefs for individual centers within the National Institutes of Health (NIH), the Centers for Disease Control (CDC), the Department of Health and Human Services (DHHS), or other Federal branches of government. EPCs have also developed topics for organizations such as the Patient Centered Outcomes Research Institute.

B. Objectives EPCs will work with various partners and stakeholders to synthesize evidence on a variety of health care delivery and clinical areas. EPCs must be able to address both healthcare delivery as well as clinical topics across the range of clinical specialty care areas that address partner needs. EPCs may be asked to 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. Through the EHC program, EPCs synthesize evidence for a variety of private and public partners. The EPCs also synthesize evidence for a variety of established Federal programs including the US Preventive Services Task Force (USPSTF), the Technology Assessment (TA) Program. EPCs work on a variety of clinical, and healthcare delivery or program topics on behalf of other Federal agencies, such as individual centers within the National Institutes of Health (NIH), the Centers for Disease Control (CDC), the Department of Health and Human Services (DHHS), the Center for Medicare and Medicaid Services (CMS), other Federal branches of government, or other publicly funded organizations, such as the Patient Centered Outcomes Research Institute (PCORI).

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

· Promote the synthesis and translation of evidence.

· Engage private and federal partners and stakeholders to develop and refine questions in which systematic review will help disseminate and translate research findings for the stakeholder audience.

· Conduct systematic reviews or other forms of evidence synthesis for use by partners and other stakeholders.

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

· Improve validity and utility of systematic reviews for decision-making

· Advance methods of systematic review through empiric methods research

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

· Improve consistency and cohesiveness of program

· Develop methods guidance and translation of methods guidance to aid implementation efforts

· Development of tools to improve EPC program efficiency

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Stakeholder Engagement To ensure that EPC products are relevant and useful to stakeholders, EPCs will engage with program stakeholders, in collaboration with other aspects of the EHC Program, such as the Scientific Resource Center and Eisenberg Center. EPCs will engage the topic nominator and local clinical experts during topic development, a variety of key informants during refinement, clinical, and technical experts during the systematic review or technical brief. The patient perspective, especially as related to outcomes, is particularly important to include through all aspects of systematic reviews and technical briefs.

Engaging stakeholders throughout the process will help ensure relevance of the EPC product for their use. However, ensuring dissemination and use of EPC products will require additional considerations and efforts. EPCs must consider how to present clear, key findings so that stakeholders can readily understand and use the report. The EPC must have clear messages that can easily be translated into derivative products. The EPC must be available during any Task Order to provide technical input into the development of any translational products derived from the product. EPCs will collaborate with the Eisenberg Center, AHRQ and other EHC program partners for these activities.

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

D. Tasks

D.1. Promote the synthesis and translation of evidence The primary work of the EPC program is to synthesize existing evidence on a given topic area to promote evidence-based decision making. The primary established methodology for this is through systematic review.

Systematic review is a research product that has established methodology and procedures established by various groups (including the Methods Guide, by the EHC program, and the IOM Standards). In addition to the established methods for conducting the systematic review, various programs within the EPC Program may have some variation in the particular procedures to ensure smooth coordination with the various partners and collaborators.

There are three key sequential steps in the process of conducting comprehensive systematic reviews, each one building on the previous work. The EHC program has established methods and procedures for the conduct of each of these sequential steps as outlined in the EPC Methods guide and the Procedures guide, both of which are living documents (For current version of the Procedures guide, see Attachment J.1). Tasks should be conducted in accordance to these documents unless otherwise noted. The three steps are delineated in sections D.1.1 through D.1.3. below. Related procedures for updating reports are included in these sections as well.

Other research methodologies are available to synthesize evidence. D.1.4. describes the Technical Brief, which employs systematic review methodology to topic areas where there is less published research. The procedures for conducting a Technical Brief under the EHC program are described in the Procedures guide (see Attachment J.1), with specific instructions for drafting a Technical Brief in Attachment J.2. Other evidence synthesis approaches, such as Decision modelling, clinical economic studies, and individual patient data meta-analysis have systematic review methods as the backbone, but employ other quantitative statistical methods as well. Methods and procedures for these product have not been as well standardized and described as those for systematic reviews, but are described generally in D.1.5 and D.1.6

D.1.1. Topic Development After a topic is nominated, the EPC shall evaluate the topic against established criteria. The EPC shall prepare a topic brief describing the nomination and how it fits in the current clinical and research context along with how it fits with established criteria. In order to prepare the brief, the EPC shall To prepare the brief, the EPC shall:

· Target discussions with specific stakeholders or topic experts to clarify the context of the decisional issue driving the topic nomination.

· These discussions are intended to be limited and efficient, focused solely on providing initial direction in developing the topic to be responsive to the decisional needs of stakeholders. Typically, the discussion(s) would be with the nominator or local clinicians, patients or other experts who are readily available to the EPCs.

· Conduct a limited literature scan

· The purpose of the literature scan is to briefly describe the topic’s background and significance and to outline the research evidence available for the topic. The available evidence is assessed through a narrow search of defined resources such as ClinicalTrials.gov, the Cochrane database, and the National Guidelines Clearinghouse.

· Propose a beginning PICO(TS).

· Assess the topic’s fit with established criteria.

· Outline key considerations and discussion points for the further prioritization discussion.

Templates and criteria vary depending on partner and would be provided upon award. For example, topic briefs conducted for the EHC program should be evaluated against established EHC criteria, defined in Whitlock et al, 2009. Further information on the Topic nomination and selection process for the EHC program may be found at: http://effectivehealthcare.ahrq.gov/index.cfm/submit-a-suggestion-for-research/how-are-research-topics -chosen/.

D.1.1.2 Topic Development with Input from a Prioritization group The EPC may develop topic nominations on behalf of various partners. On behalf of these partners, the EPC will prepare a Topic Brief (or background document) generally following the steps described in D.1.1. In addition to development of the Topic Brief (or background document), the EPC shall:

1. Present the findings from the brief (or background document) to a prioritization group

2. Provide technical expertise on the topic to assist the prioritization group in determining the final disposition of the topic.

3. Incorporate feedback into a final version of the Topic brief (or background document) that includes a description of the comments and revisions.

The USPSTF considers both new topic nominations as well as the topics for update through an established prioritization process. These procedures for developing the background document (or Topic Brief) are described in Attachment J.5 (or can also be found in the USPSTF Procedure Manual: Section 2: Topic Selection, Prioritization, and Updating.).

D.1.2. Topic Refinement In the topic refinement process, the EPC shall develop key questions amenable to a systematic review based on the topic nomination and development process. The key questions should describe the specific Population, Intervention, Comparator, Outcome, Timing, and Setting (PICOTS) that will be covered in the scope of work. An analytic framework shall be developed that describes how the key questions fit into the clinical context. In order to define the PICOTS and the analytic framework, the EPC shall work with Key Informants to identify the decisional dilemma and to provide insight into the clinical and decisional context. The process for conducting a topic refinement for the EHC program can be found in the Procedures Guide (Attachment J.1).The topic refinement brief shall describe:

· Summary of Nomination

· Background and Clinical Context:

· Citations and Important References

· Preliminary Key Questions

· Analytic Framework

· Key Considerations for Key Informants

· Summary of Key Informant Discussions

· Contacts for Scientific Information Packets Excerpted information will be posted for public comment:

· Key Questions

· Background

· Population(s)

· Interventions

· Outcomes

· Timing

· Setting

· Definition of Terms

· References D.1.2.1. Topic Refinement for USPSTF The U.S. Preventive Services Task Force follows similar processes to the EPC program. . Specific procedures are outlined in the USPSTF Procedures for Evidence-based Practice Centers (Attachment J.5) and the USPSTF Manual (http://www.uspreventiveservicestaskforce.org/uspstf08/methods/procmanual.htm).

EPCs working with the USPSTF will be asked to develop a work plan based on a template as found in the USPSTF Procedure Manual (see http://www.uspreventiveservicestaskforce.org/uspstf08/methods/procmanualap6.htm). Excerpted information from the work plan is used to create a draft Research Plan which is posted for public comment. Elements of the Research Plan include: the analytic framework, key and contextual questions and the inclusion/exclusion criteria following PICOTS. For the specific steps in developing a Work Plan and Research Plan for the USPSTF, please refer to Attachment J.5.

Please note that this task for the USPSTF includes revising and finalizing the research plan based on public comments and in conjunction with the USPSTF, which is not included in the general task described in D.1.2.

D.1.2.2. Systematic Review Surveillance AHRQ may designate several topics as priority areas where the EPC program will continuously monitor the field. Under this effort, the EPC will specify the questions from an existing systematic review to be updated using the process established for assessing the currency of a systematic review. This process of identifying the questions from a previous review for updating is conceptually similar to the topic refinement task, which engages stakeholders to identify the questions for systematic review. This process will include:

1. Kick Off Call The EPC shall convene and lead a conference call with the TOO and other optional participants, as determined by the TOO. During the call, the EPC shall:

· Review specific elements of work to be performed

· Describe plan for surveillance

· Describe plan for documentation and communication of work

· Establish lines of communication between the EPC, TOO, stakeholders, other AHRQ staff, and partners, including professional organizations and the United States Preventive Services Task Force (USPSTF) or other federal partners.

2. Develop workplan for maintaining currency of report for posting The EPC shall develop a workplan for assessing the currency of the report and specific methods to survey. The workplan shall reflect and build on established processes outlined in the Surveillance Procedures Guide (Attachment J.3)

3. Surveillance report on currency of systematic review The EPC shall assess the currency status of the systematic review and deliver a summary report to AHRQ describing the currency status of the key questions and conclusions of the original systematic review, along with evidence and methods used to arrive at that conclusion.

For surveillance reports conducted for the EHC program, the report should be in accordance with the EPC Procedures Guide (See attachment J.1).

Surveillance for USPSTF topics should follow a similar process called LitWatch which is a systematic way to review a select number of journals each month for articles on clinical preventive services (see Attachment J.4).

4. Development of draft protocol to update report.

The EPC shall develop a draft protocol for update the report, which shall include a summary of the surveillance report findings as rationale for the scope of the update. Further specifics are outlined in the EPC Procedures Guide (See attachment J.1)

5. Monthly Conference Calls and Status Reports The EPC shall participate in a monthly conference call with the TOO to summarize progress. The EPC will notify the TOO of any outdated key questions or conclusions as soon as identified in the surveillance process, without waiting for delivery of the full report.

Calls may be scheduled more or less frequently, as requested by the TOO. Within one week after the call, the EPC shall submit an electronic summary of the call to the TOO and place a copy on the secure site, which will serve as a status report to describe progress, any problems encountered and their resolution, and any foreseeable problems.

D.1.3. Systematic Reviews EPC systematic reviews are based on rigorous, comprehensive methods, emphasizing explicitly detailed documentation of methods rationale and assumptions. The EPC Methods Guide for Comparative Effectiveness Reviews (CERs) defines methodological standards to which EPC systematic reviews are expected to meet.

Specific procedures may vary depending on behalf of which partner or program the review is being conducted in order to ensure smooth coordination for use and dissemination. In general, the EPC review shall be defined by the methods defined in the protocol (which explicate standard and specific methods). The process shall include both scientific peer review and public review of draft evidence reports. EPC teams shall avoid or minimize and balance any financial or non-financial conflicts of interest (Viswanathan et al.). Specific Disclosure of Interests Policy and form for the EHC program is found in Attachment J.4. The general systematic review process shall include:

The systematic review process shall include:

1. Development of a Comprehensive Protocol

2. Literature Review

3. Technical Expert Panel (TEP) Calls and Consultation A TEP is constituted to inform the scientific processes of the subsequent research review. Technical Expert Panels provide input to the EPCs on clinical context or research availability during the systematic review process, particularly during the protocol development and searching of the literature. Typically composed of 5 to 8 members, the Technical Expert Panel usually include one or more clinical providers, methodology expert, and relevant professional society and health care purchaser representatives, and other content experts. The size and composition of the technical expert panel are intended to create a balance between content and methodology expertise and the user’s perspective.

During the course of developing evidence reports, Technical Expert Panels may assist the EPCs by providing input to:

· focus the literature search by helping to identify search strategies and relevant grey literature.

· identify inclusion/exclusion criteria to evaluate the quality of studies and rate the strength of the overall body of evidence, etc.

4. Draft Evidence Report The EPC shall prepare the draft evidence report and appendices in AHRQ’s required format (Publishing Guidelines available at: http://www.ahrq.gov/research/publications/pubcomguide/index.html; EPC specific templates and instructions will be made available upon award). The draft evidence report shall include an executive summary with specific content. Draft evidence reports shall be subject to concurrent peer review and public Web site posting for comments.

5. Peer Review The draft evidence report shall undergo peer review by at least three independent reviewers without conflicts of interest.].The EPC shall submit suggestions for peer reviewers 3 months prior to draft report submission.

6. Public Posting For Comments The draft evidence report will be posted for a period of time defined by the specific program (and described in the EPC Procedures Guide where relevant) to the public Web site for solicitation of public comments. The EPC shall respond to all public comments as well as peer review comments.

7. Disposition of Peer Reviewer and Public Comments The EPC shall review and analyze peer reviewers’ and public comments and revise the draft evidence report, as appropriate. EPCs shall document the process for reviewing and analyzing peer review comments, including a detailed description of the disposition of all comments, which shall be posted within 3 months of final report publication.

8. Final Evidence Report The EPC shall submit the final evidence report and appendices in AHRQ’s required format. The evidence report shall include an executive summary with specific content. The appendices of the report shall, as appropriate, include the entire study bibliography of included studies, detailed search strategy, inclusion and exclusion criteria, and all excluded studies with reason(s) for exclusions.

9. Upload Database into SRDR Data used in the completion of the final report shall be uploaded and made freely available to the public for download through the SRDR at www.srdr.ahrq.gov upon publication of the report. This applies whether the SRDR was used as a tool for data extraction or not. The EPC shall send an email to notify the TOO when the database has been uploaded and published within the SRDR.

10. Monthly Conference Calls and Status Reports After the first TEP call, the EPC shall participate in a monthly conference call with the TOO. Within one week after the call, the EPC shall submit an electronic summary of the call, which will serve as a status report to describe progress, any problems encountered and their resolution, any foreseeable problems, and any expected change to the delivery schedule.

11. Dissemination The utility and purpose of EPC evidence reports are to summarize information to disseminate into practice. As such, development of dissemination materials is an essential part of promoting evidence synthesis and translation for use. The EHC program has a number of partners who develop dissemination products, including clinician, patient, and policymaker guides, CME modules, webinars, and other materials by various media and venues. The EPC shall be available to review translational products for consistency with the original review. The purpose is to ensure that the key messages communicated in the derivative products are consistent with the key messages in the original review. The EPC shall also be available to make one webinar presentation of the methods and findings of the review to the stakeholder, partners or others as requested by AHRQ.

12. Feedback form With the final report, the EPC shall complete a feedback form. The emphasis will be on using these evaluations for reflection and collection of anecdotes for future learning and methods projects. The EPC shall report any unusual circumstances, or issues that required methodological adaptation or any particular insights gained from this report

The scope of the individual topics is expected to vary according to the topic and questions.

D.1.3.1. Systematic Reviews for the EHC program (including Comparative Effectiveness Reviews and updates) Under the EHC Program, the EPC shall conduct systematic reviews (including Comparative Effectiveness Reviews). The procedures for reviews conducted for the EHC program, including specification of deliverables, shall be guided by the Procedures guide (see Attachment J.1).

D.1.3.2. Systematic Review Updates It may be determined that an EPC report needs to be updated. This may happen during the course of surveillance of completed reviews. or during topic prioritization for the USPSTF.

Either the full report or only parts of the report will require an update. Although the general process of updating the report shall be similar to that of conducting a systematic review, the size of the update will vary according to the scope of questions identified for updating.

In the case where there is an addition of new questions or comparisons, the EPC will follow the methods and procedures defined for systematic reviews in the EPC Procedures Guide (see Attachment J.1) or for the USPSTF (see Attachment J.5). When no new questions or comparisons are identified and only a limited number of studies are to be included in the report, the EPC shall conduct an update of the specified section(s). Steps for the update should mirror the steps for a systematic review outlined in the EPC Procedures guide with minor changes below.

· A TEP shall be convened only if determined necessary by agreement between the EPC and TOO; if so, the primary role of the TEP shall focus on confirmation of any change in key questions and inclusion/exclusion criteria.

· Rather than developing a full protocol, the EPC will document any changes as an addendum to the related report protocol. The EPC will also prepare a protocol amendment outlining the approach to updating the specific portion of the systematic review.

· The EPC shall incorporate changes directly into the original systematic review document, highlighting the areas changed. The EPC shall also provide a document history for posting at the front of the systematic review which details the dates of changes made, provides a description of the changes made, and lists pages where changes were made.

D.1.3.3. Technology Assessments Technology Assessments are focused systematic reviews on specific technologies conducted on behalf of CMS, which otherwise follow the same processes and procedures as Systematic reviews defined in the EPC Procedures guide (see Attachment J.1) with minor changes.

1) The CMS partners provide, among other functions, the role of the TEP; therefore, no external TEP is needed for these systematic reviews.

2) The EPC shall present the findings of the report to CMS at either a MEDCAC meeting or forum and an Evidence Forum as described in the following paragraphs.

a. Evidence Forum Presentation:

In lieu of TEP involvement, the EPC shall present their Technology Assessment report via Web conference to the Center for Medicare and Medicaid Services (CMS) Coverage and Analysis Group staff. The presentation shall be approximately 50-55 minutes in length, with 5-10 minutes afterward for questions. The presentation shall be given by 1 or 2 team members. The audience for this presentation will be the entire Coverage and Analysis Group staff, some of whom will not be familiar with the topic at hand. Therefore, the presentation shall begin with a solid background and introduction to the topic. Slides for the Evidence Forum presentation shall be due 1 week prior to the presentation.

b. MedCAC /Forum Presentation:

In lieu of TEP involvement, the…