Attachment_7_-_USPSTF_Procedures_for_EPCs.pdf

U.S. Preventive Services Task Force Procedures for Evidence-based Practice Centers

1. Topic Nomination & Prioritization

Background Information

Anyone can nominate a new topic for Task Force consideration or request an update of an existing topic at any time online at http://www.uspreventiveservicestaskforce.org/tftopicnom.htm.

Topic nominations are first considered by the Task Force's Topic Prioritization Workgroup, which then recommends selection and prioritization of new topics to the entire Task Force.

The Topic Prioritization Workgroup first considers whether newly nominated topics are within the scope of the Task Force using the following criteria:

• The focus population should be asymptomatic for the condition of interest

• The nominated topic should represent a clinical preventive service (e.g., screening test, preventive medication, counseling about healthy behaviors)

• The preventive service should meet the definition of primary prevention (i.e., avoid the development of disease) or secondary prevention (i.e., identify and treat an existing disease before it results in significant symptoms)

• The preventive service should be provided in or referable from primary care

To further specify the situation that is the object of its concern, the Task Force has adopted the Institute of Medicine's definition of primary care:

Primary care is the provision of integrated, accessible health care services by clinicians who are accountable for addressing a large majority of personal health care needs, developing a sustained partnership with patients, and practicing in the context of family and community. This definition acknowledges the importance of the patient clinician relationship as facilitated and augmented by teams and integrated delivery systems.

The Task Force considers interventions that are delivered in primary care settings or are judged to be feasible for delivery in or referable from primary care. To be feasible in primary care, the intervention could target patients seeking care in primary care settings, and the skills to deliver the intervention are or could be present in clinicians and/or related staff in the primary care setting, or the intervention could generally be ordered/initiated by a primary care clinician.

Topics that are within the scope of the Task Force are then assessed for relevance using the following criteria:

• Public health importance (i.e., burden of suffering and expected effectiveness of the preventive service to reduce that burden);

• Potential for a Task Force recommendation to affect clinical practice (based on existing controversy or the belief that a gap exists between evidence and practice);

• Balance of Task Force portfolio (i.e., does the nomination overlap with current or in-process Task Force recommendations; does the nomination balance the overall Task Force portfolio of recommendations by populations, types of services, disease types, and/or size of project).

Based on the above criteria, the Topic Prioritization Workgroup assigns each nomination to one of the following categories for consideration by the entire Task Force:

a. Out of scope

b. In scope, of less relevance

c. In scope, already addressed

d. In scope, potential new topic.

The entire Task Force ultimately votes on the selection of potential new topic nominations for inclusion in the Task Force portfolio. As new topics are selected, the Topic Prioritization Workgroup and full Task Force prioritize the potential new topics in comparison to the existing new topic nominations. The Task Force maintains a list of 1-3 new topic nominations for possible review over the next 2 years. All potential new topics enter the yearly prioritization process.

Additional information on topic nominations for the USPSTF can be found at:

http://www.uspreventiveservicestaskforce.org/uspstf08/methods/procmanual.htm.

Specific EPC Procedures

Following the current procedures of the USPSTF, topic nomination and prioritization development shall include the following activities

1. Based on the templates included as Attachments, the EPC should develop a background document on new topics nominated via the USPSTF Web site or on topics that need to be updated and prioritized.

2. The EPC will present the background document to the USPSTF Topic Prioritization Workgroup during one of its monthly calls. The EPC will respond to questions and provide technical expertise on the topic to assist the USPSTF in determining the final disposition for the topic. For new topics this could include: out of scope; In scope, of less relevance; In scope, already addressed, etc.. For topics updates, this could include the decision to inactive the topic or refer to others. .

3. Based on feedback from the USPSTF, the EPC will finalize the Background Document and update the disposition table.

2. Topic Refinement

Once a topic is prioritized by the Task Force for a new or updated recommendation, the scope of the topic and approach to the review must be defined to guide the researchers undertaking the systematic review process.

A topic team is appointed for each prioritized topic before topic scoping begins and consists of Task Force leads (including one of the Task Force chairs), at least one AHRQ Medical Officer, and the review team from an Evidence-based Practice Center (EPC). Based on expertise and interest, several Task Force members volunteer to serve as leads for each topic. An AHRQ Medical Officer is assigned to oversee the topic, and may be joined by the Task Force Scientific Director and/or Associate Scientific Director in overseeing that topic. A lead investigator is assigned by the EPC to lead the evidence review team.

Two integrated products are produced during topic refinement: a work plan and a research plan.

Both of these documents are revised and finalized through discussions with the Task Force leads and the AHRQ Medical Officer in an ongoing process that includes public comment.

Based on the template described below, a work plan that captures the history, previous Task Force recommendations, and proposed approach to the topic is drafted by the EPC review team. The purpose of the work plan is to establish the review perspective for the upcoming review.

During work plan development, the EPC review team considers the scope of the evidence needed for the Task Force to make its recommendation. For reviews undertaken to update existing Task Force recommendations, this process is based on:

1. Examination of the previous Task Force recommendation(s), including populations and clinical preventive services addressed, to determine their fit with current questions about the clinical preventive service.

2. Examination of the previous Task Force evidence review process for the topic and the review findings in order to identify established evidence, important review limitations, and evidence gaps.

3. Determination of current contextual information (e.g., changes in understanding of the nature of the disease process, or changes in diagnosis, therapeutics, or practice;

controversy over any of these elements).

In order to facilitate the consistent development of the review approach across topics, the Task Force has developed a template to guide the development of the final work plan (see http://www.uspreventiveservicestaskforce.org/uspstf08/methods/procmanualap6.htm).

This template can be considered generally analogous to a protocol, such as those developed for an AHRQ Effective Health Care Program review or a Cochrane Review. It is also an articulation of the rationale for the scope decisions made in framing the topic.

The systematic review work plan development process includes identification of important sources of potential heterogeneity of screening or treatment effect and related subpopulations for each topic. The EPC review team summarizes the following information about subpopulations from literature searches that are routinely conducted during work plan development:

• How other guideline groups have recently handled subpopulation considerations for the topic

• How any recent, well-conducted systematic reviews have handled subpopulation considerations for the topic

• Data on incidence/prevalence, complications/morbidity, and mortality for the condition of interest by age, sex, race/ethnicity, and important topic-specific clinical characteristics

The above information is used to develop questions for key informant interviews. The EPC review team will consult 2-4 key informants who are clinical and content experts to help determine what is known about sources of heterogeneity of screening or treatment effect and potential subpopulation differences for the topic. Information obtained from literature searches and key informant interviews will guide decisions of whether and how the EPC review team will incorporate relevant subpopulations into the analytic framework, key questions, and inclusion/exclusion criteria.

To further specify the situation that is the object of its concern, the Task Force has adopted the Institute of Medicine's definition of primary care:

Primary care is the provision of integrated, accessible health care services by clinicians who are accountable for addressing a large majority of personal health care needs, developing a sustained partnership with patients, and practicing in the context of family and community. This definition acknowledges the importance of the patient clinician relationship as facilitated and augmented by teams and integrated delivery systems.

The Task Force considers interventions that are delivered in primary care settings or are judged to be feasible for delivery in or referable from primary care. To be feasible in primary care, the intervention could target patients seeking care in primary care settings, and the skills to deliver the intervention are or could be present in clinicians and/or related staff in the primary care setting, or the intervention could generally be ordered/initiated by a primary care clinician.

Task Force recommendations address primary or secondary preventive services. Primary preventive measures in a clinical setting are those provided to individuals to prevent the onset of a targeted condition (for example, aspirin for prevention of colorectal cancer), 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). 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 Task Force.

Based on the full draft work plan, a draft research plan that contains the analytic framework, key questions, and inclusion/exclusion criteria is created for public comment. After approval by the Task Force leads, this document is posted on the Task Force website for four weeks to allow public comment. All results from the comment period are provided verbatim to the topic team, and the EPC review team summarizes major themes and makes suggested revisions based on these comments.

The topic team discusses any major suggestions for revisions, the EPC review team incorporates final revisions into the research plan and work plan, and the Task Force leads approve these final products. For new topics, the work plan may be peer-reviewed and presented to the entire Task Force at one of its regular meetings. Development of a work plan generally takes from 6-9 months, including public comment.

Additional information on topic refinement for the USPSTF and a template for the workplan can be found at: http://www.uspreventiveservicestaskforce.org/uspstf08/methods/procmanual.htm

Specific EPC Procedures

Following the current procedures of the USPSTF, a complete topic refinement shall include the following activities

a. Submit Disclosure Forms

USPSTF Disclosure forms shall be completed for each person contributing to the content of the report including EPC staff, consultants, subcontractors, and others.

The disclosure forms shall be completed and forwarded to the USPSTF Senior Coordinator, Medical Officer (MO) and Task Order Office (TOO) for review and approval prior to the initial Kick-off call. In the case of team members joining after the kick off, it is expected that their forms will precede them being introduced to AHRQ or the topic team of Task Force members. Disclosure forms shall be revised and resubmitted to MO/TOO when any major changes occur in activities of the team members.

b. Develop Topic Work Plan

The EPC shall begin its own review of salient literature in order to refine the draft key questions and analytic framework, as well as clarifying and adding to sections on inclusion criteria and exclusion criteria. The developing document built in this process will be referred to as a ‘topic work plan’ and the format shall follow the template developed as part of EPC-II (see http://www.uspreventiveservicestaskforce.org/uspstf08/methods/procmanualap6.htm). Final approval of the work plan will come from the AHRQ MO/TOO following agreement arrived at with the Task Force topic team, Scientific Directors, and the EPC staff. The main work of the evidence review performed by the EPC team will be directed by the detailed information in this topic work plan.

1) Request Kick-Off Calls

The EPC shall request a first call with the AHRQ Medical Officer (MO)/Task Order Officer (TOO) assigned to the topic to review the draft topic work plan.

The EPC shall request a second “kick off” call with the MO/TOO and the USPSTF members assigned to the topic (“leads”). MO/TOO The EPC shall provide a draft of the topic work plan and other relevant materials for participants to review no later than 2 days prior to the call with the MO/TOO and no later than 5 days prior to the call with the Task Force leads. The EPC shall lead these discussions.

2) Summarize the Kick-Off Call and Revise Draft Topic Work Plan

The EPC shall summarize the initial kick off call and distribute minutes. In every case, the EPC shall summarize the second kick off call, distribute minutes from the call, and revise the work plan according to the MOMO/TOO.

3) The EPC may be asked to participate in additional calls with the MO and Task Force leads in order to finalize the draft topic work plan. The EPC should plan on at least one additional call.

c. Submit Draft Research Plan for Posting for Public Comment

1) For topic refinements for systematic evidence reviews, the EPC shall create a document based on the revised draft topic work plan referred to as a draft ‘Research Plan’ for posting for public comment. The elements in the draft Research Plan shall include: the analytic framework, key questions, contextual questions and a table of inclusion/exclusion criteria (referred to as Scientific Approach). The EPC will not be responsible for posting the draft Research Plan, developing instructions or questions for the Research Plan or for collecting or aggregating the public comments. The EPC shall provide alternate text for the analytic framework to meet 508 requirements according to HHS 508 regulations (http://www.hhs.gov/web/508).

d. Review Public/Peer Reviewer Comments on the Draft Research Plan, Revise and Finalize the Work Plan and Research Plan

1) For topic refinements for systematic evidence reviews, the EPC will be provided with a table of the comments received from the public on the draft Research Plan which will include all unedited comments. The EPC shall review the comments and will develop a disposition table with proposed revisions to the Research Plan. The EPC shall send a memo to the MO/TOO with suggestions on revisions to the Research Plan/Work Plan and a Research Plan with tracked changes representing the proposed changes. Depending on the nature and number of public comments received, the EPC may request a conference call with the MO/TOO (with or without the USPSTF leads) to discuss the general tenor of the comments and review the plan for disposition of the comments, including how disparate comments will be handled. MO/TOO The EPC shall provide the revised research plan and other relevant materials for participants to review no fewer than 2 days prior to each call. The EPC will lead these discussions.

The EPC shall draft a section for the final Research Plan that summarizes the changes that were made in response to the public comments received.

e. Submit Final Topic Work Plan and Final Research Plan http://www.hhs.gov/web/508

1) For topic refinements for systematic evidence reviews, the EPC shall submit the final work plan and final research plan that incorporates comments to the MO/TOO. The Final Research Plan shall include a section, Response to Public Comments. The Final Research Plan shall be 508 compliant and ready for posting on the USPSTF website.

3. Systematic Evidence Reviews

The Task Force has determined that using systematic reviews is the best method for organizing and evaluating the existing scientific evidence relevant to questions about a clinical preventive service. In order to answer the relevant questions about a clinical preventive service, the EPC review team usually undertakes a series of related systematic reviews to answer each of the questions in the analytic framework.

Additional information on conducting systematic evidence reviews for the USPSTF can be found at: http://www.uspreventiveservicestaskforce.org/uspstf08/methods/procmanual.htm.

Specific EPC Procedures

Following the current procedures of the USPSTF, a complete systematic evidence review for the USPSTF shall include the following activities:

a. Literature Search, Review, and Development of Data Collection Forms

In drafting evidence reviews, the EPC shall follow the standard methodological procedures of the USPSTF (see USPSTF Procedure Manual at www.uspreventiveservicestaskforce.org). The EPC shall systematically search, abstract, review, and analyze the scientific evidence for each question and the variance, if any, of the evidence according to age, gender, race/ethnicity and any other important subgroups. Specifically, following the final work plan, the EPC shall:

1) Provide important background information including the epidemiology of the risk factors, disease, and complications from the disease by important subgroups age, sex, and race/ethnicity (at a minimum) and information about current practice;

2) Develop appropriate data collection forms;

3) Systematically search Medline, Cochrane, NICE and other appropriate databases containing literature relevant to the questions to be addressed

4) Review abstracts against inclusion/exclusion criteria to determine potential eligibility for inclusion in evidence syntheses;

5) Retrieve and review full articles on potentially eligible studies;

6) Extract key data from each eligible study and enter abstracted data into electronic database;

7) Maintain file of excluded studies with reasons for exclusion; reasons for exclusion shall be recorded at the full-article screening stage;

http://www.uspreventiveservicestaskforce.org/

8) Review each eligible study to assess quality according to a three-point scale (good, fair, poor) developed by the USPSTF (see the USPSTF Procedure Manual at www.uspreventiveservicestaskforce.org); quality assessment of individual studies may use methods in addition to the USPSTF procedures, if newer methods for quality assessment are available or if study designs are not fully addressed by USPSTF methods. All assessments should result in quality ratings of good, fair, poor. All methods for quality assessment should be fully described in the work plan and approved by the TOO.

9) Use appropriate procedures and monitoring to reduce bias, enhance consistency and to check accuracy of study reviews (e.g., abstraction by at least two reviewers, etc.)

Participate in Call with Medical Officer/Task Order Officer to Discuss Progress of Literature Review

The EPC shall participate in a call with the MO/TOO and USPSTF leads to discuss interim results from the literature review. The MO/TOO will facilitate scheduling the call. The EPC shall lead this discussion and shall prepare summary materials for this call and submit them to the MO/TOO. The EPC should plan for at least one call with the USPSTF topic leads to present interim results.

b. Synthesize Literature and Conduct Analyses

Following the final work plan, the EPC shall:

1) Prepare evidence tables and summary of estimates of important patient health outcomes associated with each preventive service, including a summary of overall benefits and harms associated with each potential intervention;

2) Incorporate the results from the previous systematic evidence review if available and if studies from previous review meet current inclusion criteria;

3) Determine the need/availability of data for meta-analysis, decision analysis, and cost or cost-effectiveness analysis. Develop a brief plan for supplemental analysis and obtain MO/TOO approval of the plan.

4) Perform meta-analyses, if approved by the MO/TOO;

5) Rate the body of evidence for each key question according to predetermined criteria (see the USPSTF Procedure Manual at www.uspreventiveservicestaskforce.org) for EPC assessment at the key question level;

6) Identify priorities for future research.

c. Submit List of Suggested Expert Reviewers

At least three months prior to submission of the draft evidence report, the EPC shall identify 4-6 individuals to suggest as peer reviewers. The EPC shall submit the names and professional affiliations of the selected peer reviewers to the MO/TOO. The MO/TOO may also add names of individuals for peer reviewers, including other federal agencies before approving the final list. The EPC shall invite approved peer reviewers, assess conflict of interest, and determine, with the MO/TOO, an appropriately balanced peer review panel.

d. Produce Draft Evidence Review (Report)

The EPC shall prepare a draft evidence report with tables and appendices that follows the template and the requirements of AHRQ’s EPC Style Guidelines in preparing the final report and appendices. Questions about any part of the Style Guidelines should be directed to Chris Heidenrich (Christine.Heidenrich@ahrq.hhs.gov).

Draft evidence reports for peer review are expected to be complete and of the same quality as a final report so that the peer review process can function effectively. Peer Review Draft reports that are not complete and/or which do not follow AHRQ’s format will be returned as incomplete.

The evidence report is to be concise and written in sufficient detail and clarity to be the primary document. It shall include a synopsis of the scientific evidence on each key question and subsets, and reference to the linkages in the analytic framework, as well as a summary of the quality of the evidence for each key question. The discussion shall be a synthesis of the results and include future research and conclusions sections. The evidence report also shall incorporate results from the previous systematic evidence review, if available. The EPC shall submit the draft report to the MO/TOO; the MO/TOO will conduct a quick review prior to requesting the EPC to send it to peer reviewers.

Specifically, the draft report shall include:

Structured Abstract Chapter 1. Introduction and Background (with appropriate subheadings) Chapter 2. Methods Chapter 3. Results Key Question 1 Key Question 2 Key Question 3, etc.

Chapter 4. Discussion

Summary of Review Findings Contextual Issues Limitations Emerging Issues/Next Steps Relevance for priority populations, particularly racial/ethnic minorities and older adults Future Research Conclusions

Acknowledgments References Figures Figure 1. Analytic Framework and Key Questions

Summary Tables

Table 1. Recommendations of Other Groups Table 2. Summary of Evidence Table (using USPSTF template that will be provided upon award) Table 3. KQ1 Evidence table (included studies) mailto:Christine.Heidenrich@ahrq.hhs.gov

Table 4. KQ 2 Evidence table (included studies) Table 5. KQ 3 Evidence table (included studies) Table 6. KQ 4 Evidence table (included studies) Table 7. KQ 5 Evidence table (included studies) Table 8. KQ 6 Evidence table (included studies)

Appendix A. Detailed Methods

Appendix A1. Search Strategies Appendix A2. Inclusion and Exclusion Criteria Appendix A3. Literature Flow Diagram Appendix A4. List of Excluded Studies Appendix A5. U.S. Preventive Services Task Force Quality Rating Criteria Appendix A6. Expert Reviewers of the Draft Report

Appendix B. Evidence Tables and Quality Tables

Appendix B1. Data Abstraction of Studies Appendix B2. Quality Ratings of Studies

Appendix C. Supplemental Materials

Other Appendices As Needed

e. Submit Draft Evidence Review for AHRQ and Task Force Review

The EPC shall send the draft report to the MO/TOO for review. The MO/TOO will approve the draft for peer review and public comment.

f. Submit Draft Evidence Review for Peer Review

The EPC shall send the report directly to reviewers as a hard copy. To be considered for the peer review task, the individuals must commit to reviewing the draft report and providing written comments within a very circumscribed time frame. The EPC shall use a watermark (preferable) or header that identifies the report as a draft. The EPC shall develop a reviewer form to capture their comments.

AHRQ will send the draft report and modified reviewer form to eight federal partners of the USPSTF (CDC, CMS, FDA, HRSA, IHS, NIH, SAMHSA, VA). AHRQ will collect the comments from federal partners and send an aggregated document to the EPC.

g. Update Literature Search

During the peer review time period, the EPC shall perform an updated literature search, using the same search strategy as originally done, to ensure that the search is current (i.e., no more than one year old when the final report is anticipated to be published). The EPC shall discuss the findings of the updated search with the MO/TOO assigned to the topic, particularly findings that may change the results of the systematic review (may be done at the same time as comments are reviewed in the subsequent task). The EPC shall incorporate the findings into the final report.

h. Review Peer Reviewer Comments and Create Disposition Table

The EPC shall review and analyze the comments received from the peer reviewers, Task Force leads, and federal partners and revise the draft report as appropriate.

The EPC shall document the process for reviewing and analyzing all comments, including a detailed description of the disposition of substantive comments. The EPC shall submit one complete copy of each reviewer’s comments to the MO/TOO and a report/disposition table of comments to the MO/TOO and Contracting Officer, along with the revised evidence report.

i. Request Call with Medical Officer and Task Order Officer to Discuss Draft

Evidence Review

The EPC shall request a call with the MO/TOO to discuss the draft evidence report. This call should take place no earlier than one week after the distribution of the draft report.

The MO/TOO will designate an AHRQ Medical Officer for each topic as well as 3-4 Task Force members who will serve as leads on the topic. The MO/TOO will facilitate scheduling the call. The EPC shall lead this discussion. A draft slide presentation to facilitate the discussion of the evidence is required and shall be sent no later than 2 days before the call with the MO/TOO. Two calls are required in order to walk the Task Force leads through all the evidence and address all of their questions. The MO/TOO may invite and authorize any individuals necessary for the calls. The EPC may be asked to participate in additional calls based on the complexity of the evidence for presentation and the nature of the Task Force leads’ questions.

j. Participate in Call with Medical Officer /Task Order Officer and Task Force Leads to Discuss Draft Recommendation Statement

The EPC shall participate in up to 2 calls with the MO/TOO and Task Force leads to discuss the draft recommendation statement. The MO/TOO may invite and authorize any individuals necessary for the calls. The EPC PI shall serve as a consultant to the MO/TOO on the available evidence during these calls. The MO/TOO will facilitate scheduling the call. The EPC will not lead this discussion and is not responsible for sending a summary of the call to all participants. However, the EPC shall prepare materials for these calls, as requested by the MO/TOO. At times, the Task Force members may request additional summary tables of the evidence or additional calculations in order to help them estimate the net benefits. Any requested materials shall be submitted 3 days in advance of the call.

k. Submit Draft Systematic Evidence Review for USPSTF Meeting Briefing Book

The EPC shall revise the draft report based on any feedback received from the MO/TOO. A final draft evidence review shall be submitted a minimum of 3 weeks prior to the scheduled USPSTF in-person meeting.

l. Give Presentation on Evidence at In-person USPSTF Meeting

The EPC shall revise the slides used during the call with the MO/TOO and Task Force leads based on their feedback. These slides will be used for the presentation during the in-person Task Force meeting. Final slides and any other materials shall be submitted to AHRQ no later than 1 week prior to the in-person Task Force meeting. .

The Principle Investigator and one other member of the research team shall present a summary of the evidence to the full USPSTF at one of its in-person meetings. The USPSTF meets three times a year in March, July and November in Rockville, MD.

m. Submit Draft Evidence Review for Posting for Public Comment

Based on the discussion during the in-person Task Force meeting, the EPC and MO/TOO shall determine whether the draft evidence report submitted for the Briefing Book (Task k) needs to be revised before it is posted for public comment. The EPC will not be responsible for posting the draft Evidence Review, developing instructions or questions for the Evidence Review or for collecting or aggregating the public comments.

The report shall be submitted electronically. Separate files shall be submitted for each section of the report (i.e., body of paper, appendices, figures, tables), along with one combined pdf file. The draft evidence review shall be 508 compliant and ready to be posted on the USPSTF website.

n. Review Public Comments on the Draft Evidence Review

The EPC will be provided with a table of the comments received from the public on the draft Evidence Review. The EPC shall review the comments and shall develop a disposition table with proposed revisions to the Evidence Review. The EPC shall send a memo to the MO/TOO with suggestions on revisions to the Evidence Review. If necessary, depending on the nature and number of public comments received, the EPC shall request a conference call with the MO/TOO (with or without the USPSTF topic team) to discuss the general tenor of the comments and any specific critical comments and review the plan for disposition of the comments, including how conflicting comments will be handled. The MO/TOO will facilitate scheduling the call. The EPC shall provide the revised evidence review and other relevant materials such as new evidence for participants to review 1 week prior to any call. The EPC shall lead these discussions.

o. Finalize Systematic Evidence Review (Report)

To finalize the report, the EPC shall make any changes necessary to address concerns raised during the in-person Task Force meeting and/or the public comment/peer review period. This may include additional review and analysis of the evidence. The EPC shall draft a section in the report, Response to Public Comments that summarizes the changes made to the final report in response to the public comments received. The final report shall be edited by the EPC to remove grammatical, typographical, numerical, and citation errors.

p. Submit Final Systematic Evidence Review (Report)

The EPC shall submit the final evidence report to the Task Order Officer and the Contracting Officer at AHRQ. The reports shall be submitted electronically. Separate files shall be submitted for each section of the report (i.e., body of paper, appendices, figures, tables), but also as one combined pdf file. The final report shall be 508 compliant and ready to be posted on the USPSTF website.

Endnote or other reference manager software shall be used to compile reference lists and bibliography. Citations shall be “grabbed” electronically by the software from PubMed or another source to render them as accurate as possible. A final bibliography also shall be submitted electronically (if feasible given software versions) and on CD (only the MO/TOO needs to receive the bibliography on CD). Tables and charts must be delinked from underlying databases.

4. Manuscript

Manuscripts based on the evidence reports (articles summarizing evidence syntheses produced by the EPCs for each topic) are published in the same peer-reviewed journals as the corresponding recommendations of the USPSTF. The USPSTF currently has publishing agreements with Annals of Internal Medicine and Pediatrics.

Following the current procedures of the U.S. Preventive Services Task Force, preparation of a manuscript shall include the following activities:

a. Prepare Draft Manuscript for Submission to Peer-reviewed Journal

The EPC shall prepare a draft manuscript based on the findings of the evidence review for publication in a peer-reviewed journal. The USPSTF currently has an agreement with Annals of Internal Medicine that gives the publisher first right of refusal to publish manuscripts from the USPSTF Program that pertain to adults or adolescents in accordance with their manuscript requirements. It also has an agreement with Pediatrics for publishing child health topics. AHRQ will work directly with AIM and Pediatrics to coordinate publication of the report with the manuscript publication. The EPC is responsible for keeping the MO/TOO updated on the status of any and all journal publications.

The EPC shall submit the draft manuscript to the Task Order Officer for approval prior to submission. The manuscript shall be submitted electronically. The EPC shall aim to submit the approved manuscript to the publisher at the same time the draft evidence report is posted for public comment (approximately 3-6 months after the Task Force meeting).

b. Respond to Reviewer Comments

The EPC shall respond to reviewer comments made by the journal according to the timelines specified by the journal as well as any comments on the draft report or draft recommendation statement received from the public that may impact the manuscript.

The EPC shall consult with the MO/TOO to discuss extensive or “unrealistic” comments, request adjustments to the timeline, etc. The EPC shall submit the revised manuscript to the journal, and at the same time, send a copy to the MO/TOO.

c. Review Galley and Page Proofs

The EPC shall review all proofs of the manuscript necessary for publication. The EPC shall send any revisions to the journal and provide a copy to the MO/TOO.

5. Time-Limited Bridge Searches

There are times that the work of the Task Force prohibits the timely publication of manuscripts based on the systematic evidence review. The EPC shall be asked to perform an updated literature search, using the same search strategy as was used for the systematic evidence review. These will be time-limited searches, no more than 18 months from the last search date in the systematic evidence review.

The EPC shall discuss the findings of the updated search with the MO/TOO, particularly findings that may change the results of the systematic review or of the USPSTF recommendation. The EPC also may be asked to attend a call with the MO/TOO and Task Force leads to discuss significant findings from the bridge search.

The EPC shall revise the manuscript to incorporate the findings from the bridge search prior to publication. The EPC also shall create an amendment for the final systematic evidence review to indicate a bridge search was conducted and to summarize the findings. The amendment may be as brief as a box that will be placed on the front cover of the report or it may be a several page document.

6. Refinements to the Systematic Evidence Review

Despite all attempts to determine the scope of a topic and to provide the Task Force with the most thorough review of the evidence, there are times, after deliberating the evidence on a topic, that the Task Force has several questions that need to be addressed before they can finalize the draft recommendation. The EPC shall be asked to conduct a systematic evidence review on one additional key question; that is, a key question that was not included as part of the final research plan. The EPC also may be asked to conduct a review of no more than 2 additional contextual questions.

The EPC should follow the USPSTF standard procedures for searching the literature, abstracting data, quality rating studies and reporting the findings for these additional question(s). The EPC shall present the results for the additional question(s) on a call with the MO/TOO and Task Force leads. Depending on the timing of this request, the EPC shall incorporate the findings for the question(s) into the draft systematic evidence review or the final systematic evidence review and manuscript.

More information on the difference between key questions and contextual questions is available in the USPSTF Procedure Manual.

7. Administration

The EPC will be asked to participate in regular calls with the MO/TOO to review the status of a topic, and to submit monthly status reports. With the final report, the EPC shall complete a short self-evaluation. The emphasis will be on using these evaluations for quality improvement.

Where problems are identified, the EPC shall describe reasons for the problems and plans for future improvement.

Attachments

1. Topic Nomination & Prioritization Development

Template for Background Document for New Topics

USPSTF SRC

Background document

Template for Background Document for Update Topics

USPSTF SRC

Background document