Section 1: Overview of U.S. Preventive Services Task Force Structure and Processes

1.1 Purpose

The purpose of this procedure manual is to document the methods used by the U.S. Preventive Services Task Force (USPSTF or Task Force), staff of the Agency for Healthcare Research and Quality (AHRQ), and the AHRQ-designated Evidence-based Practice Centers (EPCs) in developing reviews and recommendations for clinical preventive services.

The USPSTF is charged with making evidence-based recommendations on a wide range of preventive services. AHRQ staff is charged with providing methodologic, scientific and administrative support to the USPSTF. The EPCs are charged with assisting the work of the Task Force by developing an extensive series of technical reports, evidence summaries, and other documents that update topics and that assess entirely new topics. The USPSTF, AHRQ, and the EPCs are dedicated to ensuring high-quality, consistent, and unbiased procedures for reviewing the evidence and making recommendations.

The methods outlined in this procedure manual are intended to ensure that the products created in this process are methodologically sound, scientifically defensible, reproducible, and well documented. This manual may be amended by vote of the Methods Work Group. It is expected that any issues that require broader discussion will be brought to the entire Task Force, and that any necessary changes to the manual made as a result of such discussions will be inserted after each USPSTF meeting. In addition, a sub-group of the Methods Work Group will review the entire Procedure Manual at least annually. The Procedure Manual will be posted on the USPSTF Web site (http://www.preventiveservices.ahrq.gov).

Additional information about the Task Force and its processes can be found in a series of published articles (References 1, 2, 3, 4, and 5).

1.2 Intended Audience

The Procedure Manual is intended to serve as a user's manual for everyone on the USPSTF team—including AHRQ and EPC staff as well as Task Force members. It is designed primarily for internal use as a guide to developing USPSTF recommendations, but may also be of interest to researchers or methodologists. It reflects the current procedures of the USPSTF team.

1.3 History of the U.S. Preventive Services Task Force; Scope of Work

The U.S. Preventive Services Task Force (USPSTF), first convened by the U.S. Public Health Service in 1984, is a leading independent panel of nationally recognized non-federal experts in prevention and evidence-based medicine. Programmatic responsibility for the Task Force was transferred to AHRQ in 1995. (Go to Appendix I, Congressional Mandate Establishing the USPSTF.)

The first Task Force concluded its work in 1989 with the publication of the Guide to Clinical Preventive Services. A second Task Force, appointed in 1990, concluded its work with the release of the second edition of the Guide to Clinical Preventive Services in December 1995. In 1998, members of the third Task Force were appointed for five-year terms. The third Task Force released its recommendations incrementally. The current Task Force features a rolling panel of members appointed for 4 years, with the possibility of a 1- or 2-year extension.

Since its inception more than 20 years ago, the USPSTF has worked to fulfill its mission of:

1. Assessing the benefits and harms of preventive services in people asymptomatic for the target condition, based on age, gender, and risk factors for disease.
2. Making recommendations about which preventive services should be incorporated routinely into primary care practice.

Task Force recommendations are intended to improve clinical practice and promote the public health. The Task Force's scope is specific: its recommendations address primary or secondary preventive services targeting conditions that represent a substantial burden in the United States and that are provided in primary care settings or available through primary care referral.

Primary preventive measures in a clinical setting are those provided to individuals to prevent the onset of a targeted condition (for example, the routine immunization of healthy children), whereas secondary preventive measures identify and treat asymptomatic persons who have already developed risk factors or preclinical disease but in whom the condition has not become clinically apparent (for example, screening for diabetes or colon cancer). Accordingly, most counseling topics and chemoprevention would today be categorized as primary prevention. Preventive measures that are part of the treatment and management of persons with clinical disease are usually considered tertiary prevention and are outside the scope of the USPSTF.

While the main audience for Task Force recommendations is the primary care clinician, the recommendations also have relevance for and are widely used by policymakers, managed care organizations, public and private payers, quality improvement organizations, research institutions, and patients.

In 1997, AHRQ launched its initiative to promote evidence-based practice in everyday care through establishment of 12 EPCs. The EPCs develop evidence reports and technology assessments on topics relevant to clinical, social and behavioral, economic, and health care organization and delivery issues—specifically, issues related to those health services that are common, expensive, and/or significant for the Medicare and Medicaid populations. Since 1997, AHRQ has contracted primarily with the Oregon EPC to conduct systematic evidence reviews which serve as the foundation for USPSTF recommendations. AHRQ also contracts with other EPCs that have expertise related to individual topics of interest to the USPSTF.

1.4 USPSTF Members

There are currently 16 members on the Task Force. They represent an array of health-related disciplines including internal medicine, family medicine, behavioral medicine, pediatrics, obstetrics/gynecology and nursing.

1.4.1 Selection of USPSTF Members

Each year, a notice is placed in the Federal Register soliciting nominations for new USPSTF members. This notice is circulated to all USPSTF Partner organizations and distributed via AHRQ's prevention listserv. (See section 1.8 for a definition of a USPSTF partner organization.) Individuals nominated but not appointed in previous years, as well as those newly nominated, are considered in the annual selection process.

Nominated individuals are selected for the Task Force on the basis of the qualifications outlined below and the current needs of the Task Force for particular areas of expertise. Strongest consideration is given to individuals who are recognized nationally or internationally for scientific leadership within their fields of expertise. Applicants must have no substantial conflicts of interest that would impair the scientific integrity of the work of the Task Force, including financial, intellectual, or other conflicts. The AHRQ Director appoints new members.

In order to qualify for nomination to the Task Force, an applicant must demonstrate the following:

1. Knowledge and experience in the critical evaluation of research published in peer reviewed literature and in the methods of evidence review.
2. Understanding and experience in the application of synthesized evidence to clinical decision-making and/or policy.
3. Expertise in disease prevention and health promotion.
4. Ability to work collaboratively with peers.
5. Clinical expertise in the primary health care of children and/or adults, and/or expertise in counseling and behavioral interventions for primary care patients. Some Task Force members without primary health care clinical experience may be selected based on other expertise such as medical decision-making, clinical epidemiology, behavioral medicine, and health economics.

1.4.2 Terms of Members

In 2001 the USPSTF underwent a transition to a standing Task Force. Currently, members are invited to serve for a 4-year term, with a possible 1-2 year extension. New members are selected each year to replace those who have completed their appointments. As a result, approximately one fourth of the Task Force is replaced each year.

1.5 USPSTF Meetings

The Task Force meets 3 times a year, in March, July, and November. Meetings are by invitation only. Representatives from USPSTF partner agencies and organizations have standing invitations. Special guests are invited to attend meetings for specific purposes.

1.5.1 Quorum and Voting

A quorum for official votes is 10 members, including the chair. Voting procedures include the following:

1. Formal votes are taken for major procedural and methodological decisions, for final recommendations, and for statements about clinical practice. Votes may be taken for other decisions at the discretion of the chair.
2. Votes are taken by voice or hand, without secret ballots.
3. Votes are recorded as yes, no, abstain, or absent. Members recused by reason of potential conflict of interest are recorded as recused and do not vote.
4. Reconsideration of a previously voted statement requires approval of two thirds of those present or 8 members, whichever is larger.
5. Members who are unable to be present at the time a vote is taken may leave proxy votes with the chair.
6. An electronic vote may be taken if a quorum is not available, or at the discretion of the chair. Members will have one week to respond to an electronic poll. The requirements for a quorum, for recording votes, and for determining a majority are the same as stated above.
7. In votes that are less than unanimous, there are no minority reports.

1.5.2 Conflict of Interest

The public must have confidence in the integrity of the process by which the Task Force makes its recommendations. The reputations of the Task Force members as highly regarded researchers, clinicians, and academicians contribute to this objective and must be protected if the Task Force recommendations are to be accepted and implemented. It is also essential that Task Force deliberations benefit from members' vigorous exchange of perspectives that are derived from and shaped by the member's research and/or practice experiences.

Prior to each meeting, Task Force members are asked to disclose any information that may interfere with their abilities to discuss and/or vote on a specific topic. Conflicts may arise, for example, if a member has a financial, business/professional, and/or intellectual interest in areas related to a particular topic. All members are expected to provide full disclosure of their interests related to all topics that will be discussed at each meeting. A committee comprised of AHRQ staff and the USPSTF Chair and Vice Chair review each member's disclosures and issue a recommendation on the member's eligibility to participate on a specific topic(s). Each member is notified by AHRQ staff of the recommendation prior to each meeting. Members are free to recuse themselves voluntarily from participation in the processes for specific topics; however, a voluntary recusal does not free a member from the obligation to disclose a conflict.

Completed Disclosure Forms and recommendations are kept on file at AHRQ. (Go to Appendix II.)

1.5.2.1 USPSTF Conflict of Interest Procedures for Task Force Members

To achieve the objectives of the Task Force, AHRQ requires the following procedures:

1. Completion of Disclosure Form of potentially conflicting interests; and,
2. Review of completed Disclosure Forms and determination of appropriate actions

1.5.2.2 Process for Disclosure

The USPSTF Disclosure Form will be completed by Task Force members prior to each meeting to provide information to AHRQ on financial, business/professional, and intellectual potential conflicts of interest related to the topics addressed. Task Force members are expected to provide full disclosure for new topics, and an updated disclosure, reflecting changes in their situation since the form was last completed, for continuing topics. The USPSTF Disclosure Form will also be completed by new Task Force members prior to their participation. Completed Disclosure Forms will be kept on file by AHRQ.

EPC members will file separate disclosure forms which will also be kept on file with AHRQ.

Although AHRQ's intention is to keep personal information confidential, it is possible that information may be shared with the public if requested under the Freedom of Information Act.

1.5.2.3 Process for Determining Appropriate Actions

AHRQ staff will review the Disclosure Forms and consult as appropriate with the Task Force chair and/or vice-chair in recommending one of the following:

1. No action.
   No disclosure or recusal necessary.
2. Information disclosure to Task Force only.
   Member may participate as topic lead, and may discuss and vote on the topic.
3. Recusal from participation as lead of topic workgroup; information disclosure to Task Force.
   Member may discuss and vote on the topic.
4. Recusal from all participation; information disclosure to Task Force.
   Member may not participate as topic lead, and may not discuss or vote on the topic. Member will leave the meeting room for all discussion and voting Publicly released recommendations will denote the member's recusal from participation and voting on this topic.

Prior to the meeting or to new member participation, AHRQ staff will notify the Task Force member of the recommended action, and AHRQ's recommendation will be kept on file. If a Task Force member feels that a more conservative action is appropriate than that recommended, he or she can withdraw from any part of the process for that topic.

Task Force member contributions are invaluable and essential to the process of the Task Force. To that end, AHRQ staff, in consultation with the Task Force chair/vice-chair, will make recommendations always keeping in mind the overall goal of protecting the transparency, integrity, and acceptability of Task Force recommendations and products.

1.6 Members' Public Activities

Task Force members are encouraged to discuss, disseminate, and defend Task Force recommendations in various forums. To this end, Task Force members may provide expert testimony or case review on prevention-related health issues relevant to topics discussed by the USPSTF, with the following limitations/considerations:

1. If a Task Force member has provided expert testimony or expert review in a medical malpractice case on a given Task Force-related topic in the past five years, that Task Force member should disclose this information in the current USPSTF Disclosure Forms and the current disclosure protocol will be followed:
   1. The USPSTF Disclosure Form will be completed with updated information by Task Force members prior to each meeting.
   2. AHRQ staff will review the Disclosure Forms and consult as appropriate with the Task Force chair and/or vice-chair and make a recommendation for action.
   3. Prior to each meeting or to new member participation, AHRQ staff will notify the Task Force member of the recommended action.
   4. AHRQ's recommendation will be kept on file.
2. In order to avoid any real or apparent financial conflict of interest, Task Force members should not derive greater than $10,000 per year from medical expert testimony or expert review for medical malpractice cases. Annually, Task Force members will be asked to disclose any testimony or expert review in medical malpractice cases and attest to income over $10,000 derived from such activity over the past year. Task Force members should provide this disclosure in the USPSTF Disclosure Forms and current disclosure protocol will be followed. If the above financial limit has been exceeded, AHRQ staff, Task Force chair and/or vice chair, and the member will discuss the appropriate recommendation for action related to the member's continuation on the Task Force.

1.7 Procedures for Writing Papers /Documents

Each individual designated as an author of a paper to be submitted to a journal, or other public document created on behalf of the Task Force, should have participated sufficiently in the work to take public responsibility for the content. Authorship credit should be based on (1) substantial contributions to the conception, design, analysis, or interpretation of data or literature; (2) participation in the drafting of the document or its revision for important intellectual content; and (3) giving of final approval of the version to be published. All three conditions must be met. Members who participate in the work but do not meet these criteria should be listed, with their permission, in the acknowledgments.

The Task Force does not recognize "courtesy" authorship given to Task Force or EPC members based on nominal role or position within a working group. General supervision of the working group, and participation in conference calls or group discussions, are not sufficient for authorship.

The USPSTF works under severe time constraints in producing its products. Accordingly, Task Force and EPC members who wish to be authors should expect to provide component drafts, supporting materials, comment, and feedback on a timely basis to the lead author. (A 1-week turnaround is a typical benchmark.) Individuals who are not able to meet reasonable timelines for a given product should not expect to be listed as authors.

The order of authorship should be a joint decision of the coauthors. Because the order is assigned in different ways, its meaning cannot be inferred accurately unless it is stated by the authors. Authors may wish to explain the order of authorship in a footnote.

This policy is derived from the Uniform Requirements for Manuscripts Submitted to Biomedical Journals, from the International Committee of Medical Journal Editors. This document is available at http://www.icmje.org/

1.8 Partner Organizations

Partner organizations provide ongoing liaison to the USPSTF. They include the major primary care societies and Federal agencies that are stakeholders in the process and products of the Task Force. Partner organization representatives contribute their expertise to the evaluation process and help disseminate the work of the USPSTF to their members and constituents. They are invited to attend and observe the USPSTF meetings and are permitted to comment on the proceedings during the meetings. Partners are sent drafts of the evidence report and recommendation statement and may arrange for these documents to be reviewed in detail by content experts within their organizations. This opportunity for comment by partners is in addition to the peer review that is obtained from experts who are not involved in the Task Force process, and the peer review provided by journals, as described in the next section.

Federal partners currently include the Centers for Disease Control and Prevention (CDC), Centers for Medicare and Medicaid Services (CMS), Department of Defense (DOD) Military Health System, Department of Veterans Affairs (VA) Center for Health Promotion and Disease Prevention, Health Resources and Services Administration (HRSA), Indian Health Service (IHS), National Institutes of Health (NIH), and U.S. Food and Drug Administration (FDA).

Primary care partners currently include the American Academy of Family Physicians (AAFP), American Academy of Nurse Practitioners (AANP), American Academy of Pediatrics (AAP), American Academy of Physician Assistants (AAPA), American College of Obstetricians and Gynecologists (ACOG), American College of Physicians (ACP), American College of Preventive Medicine (ACPM), American Medical Association (AMA), American Osteopathic Association (AOA), America's Health Insurance Plans (AHIP), National Committee for Quality Assurance (NCQA), and National Organization of Nurse Practitioner Faculties (NONPF).

1.9 Review and Comment for USPSTF Reports and Recommendations

As is summarized in the step-by-step description of the process in the next section, review of documents by individuals outside the Task Force occurs at several different points during the development of evidence reports and recommendation statements. This section specifies the different steps that involve external review.

Evidence Reports: The USPSTF incorporates expert review and partner comment of background documents in order to confirm that all relevant outcomes are being considered, that relevant literature has been considered, and that the evidence presented for USPSTF consideration is accurate. For all topics that are new to the USPSTF, and for some updates, the evidence-based practice center selects content area experts to provide peer review at the work plan stage of an evidence review. These comments are shared with the Task Force, and appropriate adjustments made to the work plan.

Once an evidence review is in draft form, and prior to its presentation to the Task Force, it is sent to content area experts and to the USPSTF's federal partner organizations. Their comments are shared with the Task Force at the time of the topic's presentation at a Task Force meeting.

Recommendation Statements: Once the evidence for a topic has been presented at a Task Force meeting, the Task Force will typically vote on a recommendation at that same meeting. The language for the draft recommendation statement then takes shape over the weeks that follow the meeting. The draft recommendation, developed by AHRQ staff and Task Force topic leads, is sent to all federal and primary care partners of the USPSTF, as well as to appropriate clinical specialty societies. The USPSTF requests comments on the clarity, clinical usefulness, and scientific accuracy of the recommendation statement. The Task Force views its role as a decision maker engaged in a deliberative process. Throughout this process, the Task Force maintains its independence by making these decisions without outside influence by professional societies or governmental entities.

Ultimately, the end-users of the recommendations have opportunities to respond to the recommendation statements and their accompanying evidence reviews through editorials in peer-reviewed publications and through formal letters to the editor of peer-reviewed journals. These letters are an important source of feedback to the Task Force.

1.10 Overview of the Process from Topic Selection to Recommendation Dissemination

As the diagram illustrates (Figure 1), there are three organizations involved in the process that results in formulating Task Force recommendations: the Task Force itself, the Agency for Healthcare Research and Quality (AHRQ), and Evidence-based Practice Centers (EPCs). Each plays a unique role in the process:

Task Force:   The Task Force selects and prioritizes topics for review; defines the questions and outcomes of interest in an analytic framework; interacts with AHRQ and the EPC about evidence issues; synthesizes, judges and grades the level of the available evidence; determines the balance of benefits and harms; and makes the recommendation.

AHRQ:   In addition to convening the Task Force, AHRQ provides ongoing administrative, research, and technical support for its operations, including coordination and support of the dissemination of the recommendations. Each topic is under the supervision of an AHRQ Medical Officer, who is responsible for all necessary technical input and coordination for that topic. In addition, AHRQ staff prepares evidence reviews in-house for some updated topics, including all reaffirmation topics.

EPC:   Under contract to AHRQ, the EPC conducts systematic reviews of specified questions concerning the evidence on prioritized topics in clinical prevention. These EPC evidence reports serve as the scientific basis for USPSTF recommendations. The EPC's review process includes operationalizing the questions and outcomes of interest specified by the USPSTF for systematic review, locating and retrieving the relevant evidence, evaluating the quality of individual studies, qualitatively or quantitatively summarizing review findings for each question for use by the USPSTF in its evaluation of the evidence, and producing the reports.

USPSTF federal partners (CDC, CMS, FDA, IHS, NIH, and the VA) are invited to review and comment on draft work plans, evidence reports, and recommendation statements. In addition, USPSTF partners representing primary care professional organizations, including AAFP, AANP, AAP, AAPA, ACOG, ACP, ACPM, AMA, AOA, AHIP, NCQA, and NONPF are invited to comment on all draft recommendation statements prior to their release. (Go to Section 1.8.)

The procedures for developing a recommendation statement are presented in Figure 2 below. A brief summary follows. However, each step will be described in more detail in later sections of the Procedure Manual.

1.10.1 Topic Selection

Topic selection begins with the identification of topics to be considered. Topics can be nominated by organizations, individuals, EPCs, and Task Force members. Suggestions for new topics will be solicited every 2 years, through a notice in the Federal Register and notices to partner organizations. Periodically throughout the year, the Task Force Topic Prioritization Work Group drafts a prioritized list of topics including new topics and updates to be worked on during that year. This list is made according to criteria for prioritization: public health importance (burden of suffering and potential of preventive service to reduce the burden); potential change to a prior recommendation if there was one (for example, because new evidence has become available); and, potential for Task Force impact (controversy, practice not reflective of evidence, timeliness). The ultimate goal is to balance the annual portfolio by populations, types of services (screening, counseling, and preventive medications), disease types (cancer, endocrine system diseases, etc.) and size of projects (updates versus new topics). The Task Force also aims to update topics every 5 years in order to keep the recommendations in the Task Force library current. As part of their support of the work of the Topic Prioritization Work Group, AHRQ staff prepare a standardized summary of current literature in clinical prevention. This literature surveillance process is described in Appendix III.

1.10.2 Work Plan Development

For every prioritized topic, a "topic team" is appointed. This team consists of 3-4 "leads" from the USPSTF, members of the AHRQ staff (including a Medical Officer), and evidence review team members, including a lead investigator. The responsibilities of the USPSTF topic team members are described in Appendix IV. AHRQ solicits Task Force members to volunteer to be leads, and issues a work assignment for the topics it assigns to the EPC. The EPC, working with AHRQ staff and Task Force leads, (or, in the case of an in-house evidence review, the AHRQ medical officer working with the Task Force leads) develops a preliminary work plan from the work assignment that contains the literature search strategy, analytic framework, key questions, and a timeline. AHRQ organizes a conference call of the entire topic team to discuss and refine the project scope and finalize the work plan. For new topics, work plans are sent for expert review. Work plans for topic updates are usually not reviewed by experts. If further communication regarding the work plan is needed, this communication is coordinated through AHRQ staff.

1.10.3 External Work Plan Peer Review

Work plans for new topics are sent to a limited number of outside experts in appropriate areas for their review and comments. Work plans for topic updates are not routinely sent to experts for review.

1.10.4 Approval of Work Plan

Work plans for new topics are presented by the EPC to the entire Task Force for the first time at a regular meeting. The EPC's presentation is followed by comments from Task Force leads. The Task Force then discusses the plan, focusing on any issue of importance, but especially the Key Questions. The work plan is revised by the EPC as requested by the Task Force, and finalized. Work plans for topic updates are approved by the Task Force leads but are not routinely presented to the entire Task Force for discussion.

1.10.5 Draft Evidence Report

Based on the final work plan, the EPC conducts a systematic evidence review to address the questions posed by the Task Force and presents the resulting information to AHRQ in a draft evidence report, with evidence tables.

1.10.6 Review of Draft Evidence Report by Task Force Leads, Experts and Partners

All draft evidence reports are sent to a limited number of experts in the field and six federal USPSTF partners (CDC, CMS, FDA, IHS, NIH, and the VA) for review. In addition, Task Force leads are asked to comment on the draft evidence report.

1.10.7 Development of Draft Recommendation Statement

While the draft evidence report is under review and revision, AHRQ staff schedules one or more conference calls with the Task Force leads to discuss specific recommendations and the content of the clinical considerations section of the recommendation. The Task Force leads draft the recommendation statement with the AHRQ Medical Officer, and together they edit the draft recommendation statement, which is presented to the entire Task Force at its next meeting.

1.10.8 USPSTF Vote on Draft Recommendation Statement

At the Task Force meeting, a representative from the EPC presents the peer-reviewed evidence report findings, and the Task Force leads discuss the evidence and present the draft recommendation statement. The entire Task Force discusses the evidence and recommendation statement. Any proposed changes to the specific language of the recommendation are discussed. The Task Force votes on various formulations of the recommendation statement until one version gains the support needed. It usually takes from 9 to 15 months from the date the work plan is approved to the date the peer-reviewed evidence synthesis and draft recommendation statement are presented to the Task Force for a vote.

1.10.9 Final Evidence Report

Upon receiving all comments from experts, partners, the USPSTF (in particular, the topic leads), and the AHRQ Medical Officer, the EPC edits the evidence report. Often this finalization precedes the review process for the recommendation statement, and does not reflect any comments on the report from the partner comment process undertaken for the recommendation statement. The EPC sends a summary of all comments received and the revised evidence report, indicating how the comments were addressed to the AHRQ Medical Officer. After the AHRQ Medical Officer has reviewed and approved the revised document, the report is considered final. At this point, the EPC may undertake preparation of a manuscript for submission for publication in a peer-reviewed journal. An effort is made to synchronize the publication in the journal with the publication and/or release of the USPSTF recommendation statement.

1.10.10 Review of Draft Recommendation Statement by Partners

One of the Task Force leads or the AHRQ Medical Officer revises the recommendation statement based on discussion at the meeting. This revised recommendation statement is sent to all Task Force leads for approval. It is then sent to appropriate partners for comment.

1.10.11 Approval of Final Recommendation Statement

Task Force leads and the AHRQ Medical Officer discuss the partners' comments on the recommendation statement; Task Force leads decide on any changes. Depending on the magnitude of the proposed changes, the controversial nature of the topic, and the timing of next Task Force meeting, the revised (and hopefully final) recommendation statement may, in some unusual cases, be distributed electronically to Task Force members between meetings.

1.10.12 Release of Recommendation Statement and Evidence Report

An arrangement is often made with Annals of Internal Medicine, American Journal of Preventive Medicine, Pediatrics, Annals of Family Medicine, and other appropriate journals to simultaneously publish the recommendation statement (which is published by the journal without substantive editing) and the manuscript derived from the EPC report. The desired timeline from USPSTF vote to recommendation release is 9 months. All recommendation statements and supporting evidence reports are made available on AHRQ's Web site (http://www.preventiveservices.ahrq.gov).

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