From Topic Nomination to Clinical Practice: Making a Task Force Recommendation

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Slide 1. From Topic Nomination to Clinical Practice: Making a Task Force Recommendation. An Overview of Task Force Processes and Methods. June 2021

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Slide 2. How to Read This Presentation. This presentation gives an overview of the processes and methods used by the United States Preventive Services Task Force (USPSTF, Task Force). It follows a fictional topic, “Preventive Service for Topic X,” (Topic X), on its journey from topic nomination through the development of a recommendation and grade and on to dissemination and implementation. For more in-depth information, please refer to the USPSTF Procedure Manual. Look for this symbol [ ] throughout for links to relevant sections of the manual.

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Slide 3. Table of Contents

 

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Slide 4. Recommendations Development Process. Graphic showing the steps from Review Topic Nominations to Review Public Comments & Finalize Recommendation

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Slide 5. Review Topic Nominations. Anyone can nominate a new topic for review at any time. USPSTF reviews nominated topics for relevant to and impact on prevention, primary care, and public health. USPSTF selects and prioritizes topics for review.

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Slide 6. Nominating a New Topic for Review. Preventive Service for Topic X is nominated as a new topic through the Task Force website. The Task Force considers Topic X along with other nominated topics and previously reviewed topics that need update. The Task Force determines that Topic X is within the scope of the Task Force’s work. The target population has no known signs or symptoms of Condition X. The topic is a screening test, preventive medicine, or counseling about healthful behaviors. The service helps to prevent development of the condition or identify the condition early. The preventive service can be provided by or referred by a primary care clinician.

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Slide 7. Selecting the Topic. Once the Task Force determines Preventive Service for Topic X is within scope, additional criteria are used to determine if Topic X will become part of the Task Force’s portfolio, including: The topic's relevance to prevention and primary care Its importance for public health The potential impact of the recommendation Whether there is new evidence that may change a current recommendation If Topic X is deemed a high priority, then it is added to the schedule of topics to be reviewed.

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Slide 8. Develop Draft Research Plan. Once a topic is prioritized for review, USPSTF and an Evidence-based Practice Center (EPC) develop a research plan and seek expert input. USPSTF posts the draft research plan to website for public comment.

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Slide 9. Developing the Draft Research Plan. The Task Force, with support from Agency for Healthcare Research and Quality (AHRQ) staff and the Evidence-based Practice Center (EPC), determines the key questions that will drive the review of evidence for Preventive Service for Topic X and develops a Draft Research Plan. The Draft Research Plan consists of the key questions, the analytic framework, and the inclusion and exclusion criteria that will be used to guide the evidence review. Topic experts are engaged by the EPC as part of developing the research plan. The EPC invites expert reviewers to provide feedback that informs the Topic X Draft Research Plan. Blue box: Task Force Process Notes The EPCs are specialized academic or research organizations that are engaged to support the Task Force in developing the research plan and conduct the evidence review.

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Slide 10. Developing the Analytic Framework. From the research questions on Preventive Service for Topic X, an analytic framework is developed for the Draft Research Plan. Image of sample analytic framework is shown on slide.

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Slide 11. Inclusion and Exclusion Criteria. The Draft Research Plan includes criteria for the types of evidence that will be reviewed for each key question on Preventive Service for Topic X. The criteria for Topic X include rules for study designs, sample sizes, and populations studied. Criteria describing studies that are out of scope for the review and that will be excluded from the review are also listed. Blue box: Task Force Process Notes Inclusion and exclusion criteria are determined on a topic and key question basis. The goal is to identify the highest-quality evidence to make an accurate determination of benefits and harms of a preventive service.

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Slide 12. Posting the Draft Research Plan for Public Comment. The Draft Research Plan on Preventive Service for Topic X is posted for public comment on the Task Force website for 4 weeks. The Draft Research Plan is shared broadly with various audiences to solicit public comment. (See Dissemination and Outreach section, starting on Slide 29.) Blue box: Task Force Process Notes. Anyone can comment on a Draft Research Plan.

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Slide 13. Review Public Comments & Finalize Research Plan. USPSTF and EPC review all comments carefully and revise the research plan. USPSTF posts the final research plan to website.

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Slide 14. Reviewing and Incorporating Public Comments. The Preventive Service for Topic X Draft Research Plan receives comments from stakeholders, partners, clinicians, researchers, and members of the public during the public comment period. The Task Force carefully reviews and considers all submitted comments. Updates are made to the Topic X research plan based on public comments that help to clarify the research plan. For Topic X, the Task Force adds additional language on the type of evidence it will include and exclude in the evidence review.

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Slide 15. Finalizing the Research Plan. To support transparency, the Final Research Plan for Preventive Service for Topic X includes a section called “Response to Public Comment” that summarizes public comments received and changes made as a result. The Final Research Plan for Topic X is posted to the Task Force website. The posting of the Final Research Plan and the beginning of the evidence review process are shared broadly to various audiences. (See Dissemination and Outreach section, starting on Slide 29.) Blue box: Task Force Process Notes It takes about 6 to 7 months for a research plan to be developed, posted for public comment, and finalized.

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Slide 16. Review Evidence and Develop Draft Recommendation. EPC analyzes peer-reviewed evidence; develops a draft evidence review. USPSTF assesses EPC-gathered evidence, weighting effectiveness and benefits/harms, and develops a draft recommendation statement. USPSTF posts the draft recommendation statement and EPC evidence review to its website for public comment.

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Slide 17. Conducting the Evidence Review. The EPC gathers and summarizes the body of applicable evidence from relevant studies on Preventive Service for Topic X and prepares a systematic evidence review. Each study is judged against the Final Research Plan’s inclusion and exclusion criteria to determine if it qualifies to be included in the literature review. The EPC solicits expert peer review of the Draft Evidence Review. The EPC develops a Draft Evidence Review for presentation to the Task Force.

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Slide 18. Assessing the Evidence. Using the EPC’s Draft Evidence Review, the Task Force follows its methods for assessing the evidence on Preventive Service for Topic X. The Task Force: Assesses the adequacy of the evidence across the analytic framework, assesses separately for benefits and harms Determines the magnitude of benefits and, separately, the magnitude of harms Assesses the certainty of the overall evidence on the benefits and harms Determines the magnitude of net benefit (i.e., What is the balance of benefits and harms?) if there is enough evidence. Do the benefits outweigh the harms? Do the harms cancel out or outweigh the benefits? Is the evidence unclear and the Task Force cannot determine whether benefits or harms are greater? Blue Box: Task Force Process Notes The USPSTF only uses evidence to make its assessments and determinations; it does not use opinion as part of its process.

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Slide 19. Determining the Recommendation. After assessing the certainty and magnitude of net benefit, the Task Force determines the appropriate grade for Topic X. The Task Force concludes with moderate certainty that Preventive Service for Topic X has moderate net benefit. Therefore, the benefits outweigh the harms, and the Task Force votes to recommend that clinicians offer Preventive Service for Topic X. This is a B Grade recommendation.

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Slide 20. Determining Grades. Table showing how grades are determined by the USPSTF. The Task Force rates magnitude of net benefit as substantial, moderate, small, or zero/negative. "Substantial" net benefit indicates that the benefits substantially outweigh the harms, whereas "zero/negative" net benefit indicates that the harms equal or outweigh the benefits.

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Slide 21. Task Force Grade Table. Grade A: The USPSTF recommends the service. There is high certainty the net benefit is substantial. Grade B: The USPSTF recommends the service. There is a high certainty the net benefit is moderate or there is moderate certainty that the net benefit is moderate to substantial. Grade C: The USPSTF recommends selectively offering or providing this service to individual patients based on professional judgement and patient preferences. There is at least a moderate certainty that the net benefit is small. Grade D: The USPSTF recommends against the service. There is moderate or high certainty that the service has no net benefit or that the harms outweigh the benefits. I Statement: The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of the service. Evidence is lacking, or poor quality, or conflicting, and the balance of benefits and harms cannot be determined.

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Slide 22. Writing the Draft Recommendation Statement. The Task Force writes a Draft Recommendation Statement on Preventive Service for Topic X with the following sections: Summary/Top Line: Summary statement of recommendation and assigned grade or grades: “The USPSTF recommends Preventive Service for Topic X in all adults. (Grade B)” Importance: Description of Topic X, prevalence, burden of disease – why prevention of the condition matters. USPSTF Assessment of Magnitude of Net Benefit: Summary of the Task Force’s assessment of the evidence and magnitude of net benefit – a table provides more detail on the rationale for grade determination. Practice Considerations: Information to assist clinicians in implementing the recommendation in the clinical setting. Blue Box: Task Force Process Notes It takes about 18 months for the EPC and Task Force to complete gathering, analyzing, and assessing the evidence and for the Task Force to determine a grade and develop a Draft Recommendation Statement.

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Slide 23. Writing the Draft Recommendation Statement (cont.). Supporting Evidence: Description of the evidence the Task Force considered in developing the recommendation on Preventive Service for Topic X and grade. Covers scope of review and benefits and harms of the preventive service. Research Needs and Gaps: Discussion of gaps in the evidence on Preventive Service for Topic X and what further research is still needed. Recommendations of Others: Summary of recommendations on Preventive Service for Topic X from other guideline-making bodies.

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Slide 24. Posting the Draft Recommendation Statement for Public Comment. Supporting Evidence: Description of the evidence the Task Force considered in developing the recommendation on Preventive Service for Topic X and grade. Covers scope of review and benefits and harms of the preventive service. Research Needs and Gaps: Discussion of gaps in the evidence on Preventive Service for Topic X and what further research is still needed. Recommendations of Others: Summary of recommendations on Preventive Service for Topic X from other guideline-making bodies. Blue Box: Task Force Process Notes Anyone can comment on a Draft Recommendation Statement and Draft Evidence Review. 

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Slide 25. Review Public Comments & Finalize Recommendation. EPC and USPSTF consider all comments on the draft evidence review, then EPC finalizes. USPSTF considers all comments on the draft recommendation statement, then finalizes. USPSTF posts the final recommendation and evidence summary to website and publishes in a peer-reviewed journal.

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Slide 16. Reviewing and Incorporating Public Comments. The Preventive Service for Topic X Draft Recommendation Statement is posted for public comment and receives various comments from stakeholders, partners, clinicians, researchers, and members of the public. All comments are considered when finalizing the recommendation statement.  Updates are made to the Preventive Service for Topic X recommendation statement based on public comments. Blue Box: Task Force Process Notes All Final Recommendation Statements include a section called “Response to Public Comment” that outlines public comments received and changes made as a result.

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Slide 27. Finalizing the Recommendation Statement. The Final Recommendation Statement is reviewed and ratified by the full Task Force. The EPC finalizes the Evidence Review and prepares an Evidence Summary. The Preventive Service for Topic X Final Recommendation Statement and Evidence Summary are posted on the Task Force website. A Clinician Summary chart is posted that summarizes the Topic X recommendation and provides key information for clinicians to implement the recommendation in practice. The Final Recommendation Statement is disseminated broadly to raise awareness and encourage use in clinical practice. (See Dissemination and Outreach section, starting on Slide 29.)

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Slide 28. Publishing in a Peer-Reviewed Journal. In addition to posting on the Task Force website, the Preventive Service for Topic X Final Recommendation Statement and Evidence Summary are published in a peer-reviewed journal of record. Currently, that journal is the Journal of the American Medical Association (JAMA). JAMA develops additional materials such as editorials, a podcast recorded with one of the Task Force members, and a page for consumers on its website.

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Slide 29. Dissemination and Outreach

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Slide 30. Audiences and Purpose. The Task Force conducts dissemination and outreach at every stage of the Preventive Service for Topic X recommendation development process. It is essential that various audiences are aware of and understand the Topic X recommendation so it can be put into practice. Primary audiences include healthcare providers, clinicians, and staff who implement Task Force recommendations. Other audiences include Task Force partners, healthcare experts, topic-specific stakeholders, patients, and the general public. Blue Box: Task Force Process Notes Communication and outreach efforts: Increase awareness and understanding of the Task Force. Demonstrate transparency into the Task Force’s methods, processes, and findings. Invite participation into the Task Force’s work through the public comment process. Establish and strengthen relationships with key groups and individuals.

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Slide 31. USPSTF Listserv Message. The Task Force sends an email to USPSTF Listserv subscribers to alert them of the posting of the Draft Research Plan, Final Research Plan, Draft Recommendation Statement, and Final Recommendation Statement for Preventive Service for Topic X. The more than 60,000 Listserv subscribers include clinical stakeholders, researchers, patient advocacy groups, members of the public, and more. Blue Box: Task Force Process Notes Anyone can subscribe to the USPSTF Listserv. Table underneath text showing Listserv is sent with each topic posting.

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Slide 32. Partner and Stakeholder Outreach. The Task Force engages with partners throughout development of the Preventive Service for Topic X recommendation to enhance accuracy and relevance of the recommendation, disseminate findings, and help ensure implementation. At the beginning of the recommendation development process, the Task Force contacts stakeholder organizations to alert them about the topic and to encourage them to sign up for the USPSTF Listserv to stay abreast of future activity on Topic X and other preventive service topics. Blue Box: Task Force Process Notes Partners include key dissemination and implementation partners and related Federal agencies. Task Force partners can be viewed here.  Stakeholders are topic-specific clinical health groups representing primary care and specialists, consumer/patient advocacy groups, and as appropriate, relevant industries or trade associations.

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Slide 33. Media Outreach. The Task Force sends a news bulletin to national trade and consumer media outlets when the Draft and Final Recommendation Statements for Preventive Service for Topic X are posted to the Task Force website. Task Force spokespeople conduct several interviews with wire services and trade and consumer press.  Preventive Service for Topic X receives broadcast coverage and stories in top national outlets. Blue Box: Task Force Process Notes Anyone can access Task Force news bulletins on the website.

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Slide 34. Implementation Tools. The final recommendation for Preventive Service for Topic X is included in Prevention TaskForce, a digital app for primary care clinicians. This tool allows clinicians to access Task Force recommendations easily in the clinical setting. The final recommendation is also added to the Healthfinder.gov consumer website. Blue Box: Task Force Process Notes The Prevention TaskForce app includes all final Task Force recommendation statements and is designed to help primary care clinicians identify the right clinical preventive services for each individual patient. Healthfinder.gov is a consumer tool to help people determine which preventive services they may need.

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Slide 35. Becoming Part of Clinical Care. Clinicians learn about the Task Force’s new Final Recommendation Statement on Preventive Service for Topic X from reading JAMA, from the Task Force website, from their professional societies, through the news media, and via updates to the Prevention TaskForce digital app. Clinicians begin to discuss Preventive Service for Topic X with their patients and implement the Task Force’s recommendation when appropriate. To the right of the text is a photo of a physician talking to a patient.

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Slide 36. Thank you for your interest. www.uspreventiveservicestaskforce.org

 

Current as of June 2021