EPC Partner's Guide

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This guide details information on the Evidence-based Practice Center (EPC) program for current and potential partner organizations. It presents background on the program and the roles and responsibilities of key participants, including the Agency for Healthcare Research and Quality (AHRQ), the partners, the EPCs, and the EPC Coordinating Center.

Also covered are the topic nomination process and specification of evidence questions, topic selection criteria, report dissemination, and resources on evidence-based health care.

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Contents

Introduction
Chapter 1: The Program
   AHRQ
   The Evidence-based Practice Centers Program
   What is a Systematic Review and How Are Reviews from the EPC Program Used?
Chapter 2: Report Topics
   Nominating a Topic
   Framing Evidence Questions for AHRQ Topic Nominations
   Selection Factors for Nominated Topics
Chapter 3: Roles and Responsibilities
   Partners
   AHRQ
   EPCs
   EPC Coordinating Center
Chapter 4: Timeline for Topic Nomination, Evidence Review, Report Completion
   Considering Past Performance for Partner Organizations
   Translation, Dissemination and Impact Measurement
   Resources on Effective Translation and Dissemination
Appendix A: Graphic Overview of the EPC Process
Appendix B: Resource Publications and Web Sites
References
Acknowledgments

Introduction

The pace of innovation in health care has never been greater, and this innovation is constantly adding to a broad and complex array of health care interventions and systems. Accompanying this growth in the capacity of health care is an expanding body of evidence regarding safety, effectiveness, appropriate indications, cost-effectiveness, and other attributes of these interventions and existing systems.

However, achieving these opportunities to improve health care depends on the ability of clinicians, patients, and policymakers to interpret and apply this body of evidence. As documented in a 2003 study of health care quality by RAND, Americans receive, on average, only about half of recommended health care.¹

Failure to understand which services work best, under what circumstances, and for which types of patients contributes to the increasing cost of care, threats to patient safety, and avoidable loss of life. Landmark reports of the Institute of Medicine, including To Err is Human² and Crossing the Quality Chasm,³ have drawn national attention to shortcomings in quality and patient safety. A substantial hurdle to improving quality of care remains the effective translation of research findings into sustainable improvements in patient outcomes.

The Agency for Healthcare Research and Quality (AHRQ) works to bridge this gap, not only by contributing to the health care knowledge base itself, but also by identifying priority areas for assembling, interpreting and translating to users findings from this knowledge base.

In the United States and around the world, AHRQ is recognized as a source of well-founded, reliable assessments of scientific evidence in health care. Through its Evidence-based Practice Centers (EPC) program, AHRQ works to improve the quality and effectiveness of health care by facilitating the translation of evidence-based research findings into clinical practice and policy. This program of user-driven research is designed to put information in the hands of the decisionmakers.

The 13 EPCs under contract to AHRQ produce science syntheses—evidence reports and technology assessments—that provide public and private organizations the foundation for developing and implementing their own practice guidelines, performance measures, educational programs, and other strategies to improve the quality of health care and decisionmaking. The evidence reports and technology assessments also may be used to inform coverage and reimbursement policies.

By conducting systematic reviews of the available evidence on a topic, the EPCs serve as a resource for partner organizations that will use the report. The growing number of partners to the EPC program includes private sector organizations and government agencies. Non-governmental partners include health professional organizations, voluntary health (e.g., disease-oriented) organizations, health payers, and others.

Evidence reports prepared by EPCs have been used in the development of clinical practice guidelines by organizations such as the American Psychiatric Association, the American Academy of Pediatrics (AAP), and the American Heart Association. The AAP, for example, developed a practice guideline based on an EPC report on diagnosis of attention-deficit/hyperactivity disorder.

Partners in government to date include the Centers for Medicare & Medicaid Services (CMS), the Social Security Administration, and the Food and Drug Administration (FDA). Within the National Institutes of Health (NIH), the Office of Medical Applications of Research uses EPC reports to support their consensus development program, the Office of Dietary Supplements uses evidence reports to assist their research agenda setting, and reports have also been requested by others including the National Cancer Institute, National Center for Complementary and Alternative Medicine, and the Office of Research on Women's Health. CMS uses technology assessments prepared by the EPCs to inform decisions about Medicare coverage of new and existing health technologies.

The EPC program can assist the increasing number of health care organizations who are promoting evidence-based medicine with systematic reviews on high priority topics. The EPC program welcomes the opportunity to expand relationships with partners to support their efforts to develop clinical practice guidelines, technology assessments and other evidence-based products.

This guide provides detailed information on the EPC program for current and potential partner organizations. It presents background on the program and the roles and responsibilities of its key participants, including AHRQ, the partners, the EPCs and the EPC Coordinating Center. Also covered are the topic nomination process and specification of evidence questions, topic selection criteria, strategies and expectations for report dissemination and resources on evidence-based health care.

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Chapter 1: The Program

AHRQ

AHRQ is the health services research arm of the U.S. Department of Health and Human Services (HHS). AHRQ's mission is to improve the quality, safety, efficiency, and effectiveness of health care for all Americans. AHRQ sponsors and conducts research that provides evidence-based information on health care outcomes, quality, cost, and access for use by health care decisionmakers, including patients, clinicians, health system leaders, policymakers and others.

AHRQ's activities are driven by the needs of health care decisionmakers. Through the EPC program, AHRQ applies the analytical capabilities of the EPCs to high-priority topics nominated by its partner organizations. Partners benefit from receiving high-quality systematic reviews from a recognized and credible source. They use EPC report findings to inform or develop evidence-based products and services, including clinical practice guidelines, performance/quality measures, educational materials and knowledge transfer strategies. This relationship allows AHRQ and partner organizations, through focused use of complementary resources, to pursue measurable improvements in health care.

AHRQ expects that partners whose topics are selected for EPC reports will translate the report findings into evidence-based products for their members or other target audiences. Further, they are expected to track the use, outcomes, or other impacts of these products. This information supports the accountability of AHRQ and partner efforts and provides feedback for ongoing program improvement.

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The Evidence-based Practice Centers Program

AHRQ launched the EPC program in 1997 as an initiative to promote evidence-based practice in everyday care. The EPC program is a user-driven research partnership with private and public sector organizations to facilitate the translation and dissemination of research findings to the memberships and other target audiences of the partner organizations. These include Federal and State agencies, private sector professional societies, health delivery systems, providers, payers, and others committed to evidence-based health care. Topics of interest identified by these partners may address clinical, social science/behavioral, economic, and other health care organization and delivery issues. They generally are common, expensive, and otherwise significant topics for Medicare, Medicaid, or other special populations.

Since the start of the program in 1997, the EPCs have conducted more than 100 systematic reviews and analyses of the literature on a wide spectrum of topics. The major products of the program are evidence reports, including comprehensive and more focused systematic reviews and technology assessments. These are based on rigorous syntheses and analyses of scientific literature and may include meta-analyses or cost analyses. The reports emphasize explicit and detailed documentation of methods, rationale, and assumptions. EPCs draw upon the expertise and experience of other diverse and representative health care and research organizations to gain the insight needed for well-founded, credible, and practical evidence products. The evidence reports and technology assessments do not make clinical recommendations or those related to coverage and reimbursement policies.

In June 2002, AHRQ announced the award of a second round of five-year contracts to the following 13 EPCs:

• Blue Cross and Blue Shield Association Technical Evaluation Center (TEC); Chicago, IL.
• Duke University; Durham, NC.
• ECRI; Plymouth Meeting, PA.
• Johns Hopkins University; Baltimore, MD.
• McMaster University; Hamilton, Ontario, Canada.
• Oregon Health & Science University; Portland, OR.
• RTI International-University of North Carolina; Chapel Hill, NC.
• Southern California Evidence-based Practice Center—RAND; Santa Monica, CA.
• Stanford University, Stanford, and University of California; San Francisco, CA.
• Tufts-New England Medical Center; Boston, MA.
• University of Alberta; Edmonton, Alberta, Canada.
• University of Minnesota; Minneapolis, MN.
• University of Ottawa; Ottawa, Canada.

In addition, AHRQ established an EPC Coordinating Center to serve as a resource and support center for AHRQ, the EPCs, partners, researchers, providers and other stakeholders committed to evidence-based health care. The Coordinating Center is operated by The Lewin Group, a health care policy and human services firm based in Falls Church, Virginia. Partners are welcomed to contact the Coordinating Center directly for assistance in all phases of the pre- and post-topic nomination process at partnerTA@lewin.com. The main telephone number of The Lewin Group is (703) 269-5500.

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What is a Systematic Review and How are Reviews from the EPC Program Used?

Systematic reviews are conducted to determine whether an intervention for a specific disease or health problem works. The topics of systematic reviews typically are framed by a set of evidence questions. Reviewers must locate, synthesize, and evaluate evidence from available scientific studies that meet predetermined inclusion criteria. Systematic reviews differ from traditional review papers because they adhere to established, transparent, methodologies designed to minimize bias, account for variations in study design, allow consideration of data from multiple studies, and maintain objective analysis and interpretation of available evidence. In answering well-refined evidence questions in a rigorous scientific manner, systematic reviews can be valuable sources of information for diverse groups of healthcare stakeholders.

Systematic reviews are useful in multiple scenarios, including, but not limited to, instances in which:

1. Conflicting evidence exists.
2. Data from only a few studies are available.
3. Comparisons of different interventions is necessary.
4. Assessment of the net balance of benefits and harms is warranted.
5. Review of the existing evidence base is essential to informing a research agenda or health policy or coverage decision.

EPC evidence reports can help answer questions regarding clinical and behavioral health interventions or organizational, financial and economic mechanisms that are poised to significantly influence the quality, effectiveness, and/or cost of health care. EPC reports typically are not conducted where evidence on particular interventions is clearly established in practice.

Systematic reviews are only as complete and useful as the evidence that exists on a particular topic or the scope and nature of the evidence questions that guide the review. To the extent that the body of evidence relevant to a particular topic is limited, the topic may not be appropriate for an EPC systematic review. Even so, a systematic review that identifies only limited relevant evidence pertaining to a topic can be useful in setting research agendas to extend or fill gaps in the relevant body of evidence.

Users of evidence reports and technology assessments include clinicians, health professional associations, health system managers, researchers, consumer organizations, policymakers, and other health stakeholders. Public and private sector organizations use EPC reports as a basis for developing a broad range of products, services and tools, including clinical guidelines, performance measures, quality or operational improvement tools and strategies and educational or knowledge transfer vehicles. These reports and assessments often are used in formulating coverage policies of managed care organizations, insurers, and other payers.

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Chapter 2: Report Topics

The topics addressed by the EPCs reflect areas of significant demand for information by partner organizations and their stakeholders. Topics may include the prevention, diagnosis, and/or treatment of particular clinical and behavioral conditions; use of alternative or complementary therapies; and appropriate use of commonly provided services, procedures, or technologies. Topics also may include issues related to the organization and financing of care, such as risk adjustment methodologies, market performance measures, provider payment mechanisms, and insurance purchasing tools as well as measurement or evaluation of provider integration of new scientific findings regarding health care and delivery innovations. The diversity of EPC topics is reflected in the following titles of evidence reports released in 2004:

• Regionalization of Bioterrorism Preparedness and Response.
• Measuring the Quality of Breast Cancer Care in Women.
• Celiac Disease.
• Community-Based Participatory Research.
• Pharmacological Treatment of Dementia.
• Islet Transplantation in Type 1 Diabetes Mellitus.
• Economic Incentives for Preventive Care.
• Literacy and Health Outcomes.
• Training of Hospital Staff to Respond to a Mass Casualty Incident.
• Meta-regression Approaches: What, Why, When, and How?
• Strategies for Improving Minority Healthcare Quality.
• Criteria to Determine Disability Related to Multiple Sclerosis.
• Pharmacological and Surgical Treatment of Obesity.
• Effects of Omega-3 Fatty Acids on Arrhythmogenic Mechanisms in Animal and Isolated Organ/Cell Culture Studies.
• Health Effects of Omega-3 Fatty Acids on Asthma.
• Effects of Omega-3 Fatty Acids on Cardiovascular Disease.
• Effects of Omega-3 Fatty Acids on Cardiovascular Risk Factors and Intermediate Markers of Cardiovascular Disease.
• Health Effects of Omega-3 Fatty Acids on Lipids and Glycemic Control in Type II Diabetes and the Metabolic Syndrome and on Inflammatory Bowel Disease, Rheumatoid Arthritis, Renal Disease, Systemic Lupus Erythematosus and Osteoporosis.
• Effectiveness of Adjuncts to Scaling and Root Planing Therapy for Periodontitis.
• Effectiveness of Behavioral Interventions to Modify Physical Activity Behaviors in General Populations and Cancer Patients and Survivors.
• Closing the Quality Gap: A Critical Analysis of Quality Improvement Strategies, Vol. 1: Series Overview and Methodology.
• Preventing Violence and Related Health-Risking Social Behaviors in Adolescents.

Topics of evidence reports published to date are listed at http://www.ahrq.gov/clinic/epcix.htm

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Nominating a Topic

Professional societies, health systems, employers, insurers, providers, and consumer groups are encouraged to nominate topics. AHRQ is very interested in receiving topic nominations from professional societies and organizations representing members of minority populations as well as topic nominations that have significant impact on AHRQ priority populations. These priority populations include the following:

• Low-income groups.
• Minority groups.
• Women.
• Children.
• The elderly.
• Individuals with special health care needs, such as those with disabilities or who need chronic care or end-of-life health care or live in inner-city and rural areas.

Nominations of topics from non-federal partners are solicited annually through a notice in the Federal Register. This notice specifies a due date, approximately 50 to 60 days following the publication date of the notice, for submittal of topics for consideration in the current fiscal year. Topic nominations also are accepted on an ongoing basis. All nominations received in the previous year, as well as topics that were previously submitted but not selected, are considered for the upcoming year. Federal partners that are interested in evidence reports to support their activities are encouraged to contact the EPC Program Director at AHRQ. AHRQ does not reply to individual nominations, but considers all nominations during the selection process.

Nominations of topics for AHRQ evidence reports and technology assessments should focus on specific aspects of prevention, diagnosis, treatment and/or management of a particular condition; an individual procedure, treatment or technology; or a specific health care organizational or financial strategy. Special consideration is given to topics having a significant impact on the health status of priority populations.

Required Nominating Information

For each topic, the nominating organization must provide the following information:

1. Rationale and supporting evidence on the relevance and importance of the topic.
2. Three to five focused questions on the topic to be addressed.
3. Plans for rapid translation of the evidence reports and technology assessments into clinical guidelines, performance measures, educational programs or other strategies for strengthening the quality of health care services, or plans to inform development of reimbursement or coverage policies.
4. Plans for use and/or dissemination of these derivative products, e.g., to organization memberships, if appropriate.
5. Process by which the nominating organization will measure the use of these products and impact of such use.

Where to Submit Topic Nominations

Topic nominations should be submitted to:

Beth Collins Sharp, Ph.D., R.N.
Acting Director, EPC Program
Center for Outcomes and Evidence
Agency for Healthcare Research and Quality
540 Gaither Road, Suite 6000
Rockville, MD 20850
Phone: (301) 427-1503
Fax: (301) 427-1520

Electronic submissions to epc@ahrq.gov are preferred.

Select for the current Federal Register notice for submission of topics for EPCs.

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Guidance on Framing Evidence Questions for AHRQ Topic Nominations

Topic nominations should include approximately three to five specific, well-defined questions that are appropriate for evidence reports. An appropriate question is one that can be addressed by a review of the available evidence by an EPC. As described below, questions that ask about clinical judgment or appropriate care for certain patients are not suitable for EPC review. Of course, an EPC evidence report may present an evidence base from which another group, such as the nominating partner organization, can derive a practice guideline or policy that would address such questions.

Questions that are vague or otherwise inappropriate for evidence reports can lead to unrealistic expectations among AHRQ, the EPCs, and the nominating partners as well as unnecessary delays. AHRQ encourages prospective and current partners to seek assistance from the EPC Coordinating Center in formulating evidence questions for EPC topics. Requests for such assistance can be made via the AHRQ EPC staff or the EPC Coordinating Center. This section presents common problems with topic questions and provides examples of evidence questions that are appropriate for EPC evidence reports.

Questions on Clinical Topics

Question #1: What are the appropriate indications for [procedure X]?

This type of question is not appropriate for an evidence review because its answer would be:

• "The appropriate indications for [procedure X] are a, b and c."

Such an answer calls for moving beyond reviewing evidence to stating a judgment regarding the clinical circumstances under which the procedure should be performed. Doing so would require developing a clinical practice guideline. Although a partner organization may intend to develop a practice guideline based on the EPC evidence report, it is not the role of EPCs to develop such guidelines. The following examples show how a question of this nature could be transformed into a question that is suitable for an EPC evidence review.

• Inappropriate: What are the appropriate indications for arthroscopic surgery?
• Appropriate: Does arthroscopic surgery improve [certain outcomes] for [certain types of] patients?
• Appropriate: For what types of patients is there strong evidence that arthroscopic surgery improves [certain outcomes]?

• Inappropriate: Should [procedure X] be routine in childbirth? If not, what are the indications for the procedure?
• Appropriate: What is the strength of the evidence for routine versus restricted use of [procedure X] in childbirth? What is the evidence that [procedure X] improves [certain outcomes] for [particular clinical circumstances of] childbirth?

Question #2: Can [procedure X] be used to treat [general disease Y]?

Questions that ask, "Can/should this be used?" are too vague for discerning the evidence question of interest to a potential partner. It is unclear whether the potential partner is asking if it is possible for the procedure to be used, if it is appropriate for it to be used or about the nature of the evidence that such use is effective.

• Inappropriate: Can the [laboratory test Y] be used as a screening test for hypertension?
• Appropriate: How effective is the [laboratory test Y] as a screening test for hypertension?

Question 3: What is the role of [procedure Z] in the treatment of pressure ulcers?

This type of question is too vague to be addressed through an evidence review. It does not suggest whether any particular indications, populations, care settings or outcomes are of interest to the partner. It does not specify whether evidence of effectiveness, safety, cost-effectiveness or other outcome or impact is of interest. This type of question could be transformed into an evidence question as follows:

• Inappropriate: What is the role of [procedure Z] as a stand-alone therapy and as an adjunct to conventional therapy for pressure ulcers?
• Appropriate: In which patient populations does [procedure Z] as stand-alone therapy improve healing of pressure ulcers? In which patient populations does [procedure Z] as an adjunct to conventional therapy improve healing of pressure ulcers?

The following is an example of a topic with accompanying questions that are well-defined and can be answered by an evidence review:

• Topic: Uterine Artery Embolization (UAE) for Treatment of Fibroids
• Questions:
  1. What are the health risks and benefits of UAE in relation to other surgeries (e.g., hysterectomy, myomectomy)?
  2. What are the effects of UAE on future fertility and pregnancy-related outcomes?
  3. What are the complications associated with UAE?

A "causal pathway" or "analytical framework" is a useful means of specifying evidence questions for many topics. These depict direct and indirect linkages between interventions and outcomes. They can be particularly useful for topics involving a chain of events or decisions, each of which could be the subject of an evidence question. Examples are screening or diagnostic interventions, which may affect health outcomes indirectly, i.e., via the use of treatments indicated by the results of a screening or diagnostic test. Although typically used to present clinical problems, they can be used as well for organizational, financing and other types of interventions or programs in health care. Graphing a topic of interest can help a prospective partner formulate evidence questions of interest. A sample causal pathway is shown in Figure 1.

Figure 1. Generic Analytic Framework for Screening Topics

Numbers refer to key questions as follows:

1. Is there direct evidence that screening reduces morbidity and/or mortality?
2. What is the prevalence of disease in the target group? Can a high-risk group be reliably identified?
3. Can the screening test accurately detect the target condition? (a) What are the sensitivity and specificity of the test? (b) Is there significant variation between examiners in how the test is performed? (c) In actual screening programs, how much earlier are patients identified and treated?
4. Does treatment reduce the incidence of the intermediate outcome? (a) Does treatment work under ideal, clinical trial conditions? (b) How do the efficacy and effectiveness of treatments compare in community settings?
5. Does treatment improve health outcomes for people diagnosed clinically? (a) How similar are people diagnosed clinically to those diagnosed by screening? (b) Are there reasons to expect people diagnosed by screening to have even better health outcomes than those diagnosed clinically?
6. Is the intermediate outcome reliably associated with reduced morbidity and/or mortality?
7. Does screening result in adverse effects? (a) Is the test acceptable to patients? (b) What are the potential harms, and how often do they occur?
8. Does treatment result in adverse effects?

The literature on evidence-based health care provides other guidance that may be useful in formulating questions for the EPC program. For example, specific, well-defined clinical questions can be formed using the approach shown in Figure 2.

Figure 2: Formulating an Evidence Question

Issue	Tips for Building Question	Example
Patient Population or Problem	"How would I describe this group of patients?" Balance precision with brevity.	"In patients with heart failure from dilated cardiomyopathy who are in sinus rhythm..."
Intervention (a cause, prognostic factor, treatment, etc.)	"Which main intervention is of interest?" Be specific	"...would adding anticoagulation with warfarin to standard heart failure therapy..."
Comparison Intervention (if necessary)	"What is the main alternative to compare with the intervention?" Be specific	"...when compared with standard therapy alone..."
Outcomes	"What do I hope the intervention will accomplish?" "What could this exposure really affect?" Be specific	"...lead to lower mortality or morbidity from thromboembolism? Is this enough to be worth the increased risk of bleeding?"

Adapted from: Focusing Clinical Questions. Centre for Evidence-Based Medicine, Institute of Health Sciences, University of Oxford. URL: http://www.cebm.net/focus_quest.asp. Used with permission.

Additional resources with guidance on formulating clinical questions that can be addressed by evidence reviews follow:

• Sackett DL, et al. Evidence-based medicine: how to practice and teach EBM. London: Churchill Livingstone; 2000:2.
• Richardson WS, Wilson MC, Nishikawa J, Hayward RSA. The well-built clinical question: a key to evidence-based decisions. ACP J Club 1995;123:A12-3.
• U.K. Centre for Evidence-Based Medicine: http://www.cebm.net/focus_quest.asp

Questions on Organization, Financing and Delivery Topics

Question #1: What are the effects on health care of [financing mechanism X]?

This question is vaguely worded. It is unclear what aspect of health care is of interest to the potential partner.

• Inappropriate: What are the effects on health care of defined contribution models?
• Appropriate:How does utilization of previously covered health care services change when employers offer defined contribution models to their employees?

Problem Question #2: Should [patient type X] be treated in [practice setting Y]?

Answering this question calls for moving beyond reviewing evidence to stating a judgment regarding the practice setting in which the patient should be treated.

• Inappropriate: Should patients with severe mental illness be placed in community-based care or treated in inpatient settings?
• Appropriate: What is the evidence that placing patients with severe mental illness in community-based care yields same or better access, effectiveness [on certain outcomes], and costs compared to placement in inpatient treatment settings?

Question #3: Is [provider type P] superior to [provider type Q] in providing [a certain type of care]?

This question does not provide a basis for determining relative performance. Further, what constitutes "superior" may be subject to judgments of value, not just evidence.

• Inappropriate: Do high-volume hospitals provide superior cardiac care?
• Appropriate: Are physicians practicing at academic medical centers or hospitals designated as "centers of excellence" for cardiac care more likely than other acute care hospitals to provide beta-blockers to patients who have had heart attacks?

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Selection Factors for Nominated Topics

In selecting topics for assignment to EPCs, AHRQ will consider the extent to which a nominated topic addresses the following factors:

1. Burden of disease, including severity, incidence and/or prevalence or relevance of organizational/financial topic to the general population and/or AHRQ's priority populations, which include:
   • Low-income groups, minority groups, women, children, the elderly and individuals with special health care needs, such as those with disabilities or who need chronic care or end-of-life health care or live in inner-city and rural areas.
2. Controversy or uncertainty about the topic and availability of scientific data to support the systematic review and analysis of the topic.
3. Total costs associated with a condition, procedure, treatment, technology, or organizational/financial topic, whether due to the number of people needing care, the unit cost of care or indirect costs.
4. Potential impact for reducing clinically significant variations in the prevention, diagnosis, treatment or management of a disease or condition, or in the use of a procedure or technology.
5. Potential for informing and for improving patient and/or provider decisionmaking; improving health outcomes; and/or reducing costs.
6. Relevance to the needs of the Medicare, Medicaid, or other Federal healthcare programs.
7. The organization's plan to disseminate derivative products and measure use and impact of these products on outcomes or otherwise incorporate the report into its managerial or policy decisionmaking.

For topic nominations from previous partners, AHRQ also will consider partner efforts in translation and dissemination of products derived from EPC evidence reports, as well as successes in use and impact of these products.

For many nominated topics, AHRQ will request that the EPC Coordinating Center conduct preliminary reviews (not evidence reports) of the quality and relevance of the available literature and related information pertaining to the topic. AHRQ uses these preliminary reviews to help inform its determination of the suitability of the topic.

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