Appendix VI

Work Assignment/Plan Template USPSTF Topic Reviews

For each topic, a preliminary draft of this template document will be circulated prior to the first topic conference call with TF leads, EPC researchers, and the AHRQ medical officer. This document will then be revised based on the initial topic call and finalized by the EPC to represent the "final work plan."

Instructions: This template will be used to create a work assignment and for the final work plan. The text in italics provides questions that should be answered about this clinical preventive service as part of that particular section. The questions themselves can be omitted, but the other template items (headers, boilerplate text) should be incorporated into the final work plan for each topic for consistency. Level 1 and 2 Headings should be in Arial font. Level 3 Headings and all body text should be in Times New Roman font.

Project Title:

AHRQ Medical Officer:

Oregon EPC Project Lead Investigator:

Oregon EPC Project Staff:

USPSTF Leads:

Section I. Purpose and Background

Purpose

This report will be used by the United States Preventive Services Task Force (USPSTF) to... What is the history of this USPSTF recommendation (new, update from 1996, update from update or initial recommendation made after 2000)?

Condition Background

Condition definition. What defines the disease/condition of interest?

Prevalence and burden of disease/illness. What is the prevalence of the disease/condition overall and in various sub-populations? (If case distribution varies significantly by sub-population, consider whether background questions about high prevalence groups need to be addressed here, and also whether [and how] issues related to prevalence in subgroups will be handled in this review as part of the "scope" section.)

Who is primarily affected by this disease/condition? (If this condition affects a significant proportion of the population, consider whether there are primary as opposed to secondary causes of the condition, and how issues related to etiology will need to be specified in the review as part of the "scope" section.)

Etiology and natural history. What causes the disease/condition? (If there are multiple causes, consider whether background questions about etiology need to be addressed here and whether a section describing how they are addressed in this review needs to be included in the "scope" section.)

What are the consequences of this disease/condition if left untreated? Is there heterogeneity in its natural history? (If yes, consider whether background questions about natural history also apply to this condition.)

Risk factors. What are risk factors for the condition? Can the individuals primarily affected be practically distinguished as high risk? (If high-risk identification seems to be a potential approach as part of this clinical preventive service, consider whether additional background questions about prevalence and populations with risk factors need to be addressed here or need to be considered in determining the scope of this review.)

Rationale for screening/screening strategies. What is the rationale for screening or early intervention? How is the disease/condition detected? (If there are multiple ways of detecting this disease/condition, consider whether background questions about detection/screening need to be addressed here and whether a section addressing how this review will structure its inclusion/exclusion criteria in order to address this issue should be included in the "scope" section.)

Interventions/treatment. What preventive intervention(s) are of interest? How do they work? (If there are multiple ways of treating this disease/condition, consider whether background questions about intervention/treatment need to be addressed here and whether a section addressing how the review will handle this issue needs to be included in the "scope" section.)

Current clinical practice. What factors in current practice, or in the context of the culture, are important in understanding this clinical preventive service? Have major changes or controversies about this clinical preventive service emerged since the last recommendation was issued? If it is needed as context for the review, a table showing the Recommendations of Other Groups may be included here. (If current practice issues seem important, consider whether background questions about current clinical practice need to be addressed here.)

Go to Section V for more potential background questions that may apply to a particular topic.

Section II. Previous Review and USPSTF Recommendations

(This section is applicable to update topics only)

Previous USPSTF Recommendation(s)

Say: "In (year of recommendation), the USPSTF concluded (statement of the evidence) to recommend (recommendation statement). (Recommendation grade)"

Also list all of the recommendation language in any 1996 or earlier USPSTF topics, even if not a graded recommendation statement.

Previous USPSTF Conclusions

List all conclusions made by the USPSTF in the prior recommendation and rationale statement.

Previous Review Analytic Framework and Key Questions

Insert analytic framework and key questions from the previous topic review.

Previous Review Findings

Insert summary of evidence table with overall quality assessment for each key question. Insert additional main findings from the evidence review as needed in a bullet format. Conclusions should not be included in this section.

List any ongoing studies identified in the previous review.

Previous Review Conclusions

List all conclusions made by the authors of the prior systematic review in the prior Evidence Synthesis and/or article. Make clear which conclusions appear to be based on a stable evidence base and could be used as foundational evidence in this review.

Identified Limitations from Previous Review Process

Identify limitations cited in the prior systematic review, article, and/or recommendation and rationale statement. Identify and list scope limitations or review method limitations you identify from the previous review.

Evidence Gaps Remaining After the Last Review

Summarize the previous review findings, conclusions, and limitations into a series of evidence gaps remaining at the completion of the last review. Order the evidence gaps into the logical sequence of the analytic framework with section subtitles of Overarching (Direct) Evidence, Screening, Treatment/Intervention, Harms, Costs, and other specific topics (such as Potential Preventable Burden, Current Practice).

Priority Evidence for Updating (Optional section)

What studies (types of designs and comparisons) and settings (timeframes, countries, populations) are most applicable to this update? Consider defining the types of evidence necessary to change the USPSTF recommendation, as in the Table below, if that assists in focusing the review.

Table X: Types of evidence required to alter recommendations

2002 Recommendation

Level of evidence required to change the recommendation

I recommendation: Insufficient evidence to recommend for or against routine screening.

Good quality RCT or other controlled trials comparing screened and unscreened patients in primary care settings, showing improved outcomes among screened populations. Good quality RCT or other controlled trials comparing screened and unscreened patients in primary care settings, showing no improvement in outcomes among screened populations. Good evidence that the potential benefits of screening and treatment outweigh any potential harms. Good evidence that the potential harms of screening and treatment outweigh any benefits.

Section III. Scan of New Evidence Since Previous Recommendation (see Section V for search strategy)

Organize, summarize, and cite new evidence from the evidence scan and from the systematic review searches in the same order the evidence gaps were presented. Section subtitles should also be the same. Make sure you indicate where priority evidence may or may not be available, based on these initial literature scans.

Previously Identified Pending Studies

Provide follow-up data on previously identified pending studies. Identify new relevant ongoing studies and their expected completion dates and contacts.

Section IV. Update Review Approach

Outline the proposed overall approach to this topic (if an update), answering the following questions and any others necessary to capture a summary of the approach being proposed for this systematic review. Should this be a staged, focused, or complete systematic review? Which key questions in the analytic framework will be addressed? How should they be addressed in terms of sequence and priority? Which key questions will not be updated as their evidence is viewed as "established"? Are there areas that will be updated non-systematically (contextual questions)?

Analytic Framework and Key Questions

All Key Questions.

Update Key Questions.

Contextual Questions.

Review Scope

Specify who and what will be addressed in terms of populations, interventions, comparisons, outcomes, and settings.

Populations. Define the sex, age, and other sociodemographic or medical characteristics of the study participants addressed in this review.

Diseases. Define the spectrum of the disease/condition that the review will include and exclude, including the rationale. (See the background questions on disease/condition to be answered as needed to support your approach). If this condition affects a significant proportion of the population, address how this issue will affect the review. If there are multiple causes of the disease describe how they will be addressed in this review.

Screening interventions. Define the means of detection/screening that will be reviewed, including the rationale (see background questions on screening/detection to be answered as needed to support your approach). If there are multiple ways of detecting this disease discuss how this will be managed in the review. Define outcomes and gold standards as appropriate.

Treatment interventions. Define the methods of treatment/intervention that will be reviewed, including the rationale (see background questions on intervention/treatment to be answered as needed to support your approach). Define outcomes as appropriate.

Study designs. What study designs (types of designs and comparisons) are minimally acceptable for evaluating each key question?

Settings. What settings (timeframes, countries, populations) are minimally acceptable for evaluating each key question?

Costs. Define how cost/cost effectiveness will be addressed in this review. At a minimum, cost-effectiveness articles should be retrieved when encountered as part of the systematic review for key questions (see background questions for other potential cost considerations).

What is Excluded from This Review?

Be clear about decisions to exclude populations, interventions, comparisons, outcomes, or settings, and their rationale.

Search Criteria

Include databases and time periods for each key question, as well as search terms for existing systematic evidence reviews and meta-analyses.

Budget and Timeline

As negotiated with AHRQ after work plan conference calls with AHRQ and the TF leads. Submitted with final work plan as part of the deliverable. Details budget in two phases (work plan development/topic refinement and review phase). Timeline includes major milestones, including expected date for presentation at a future USPSTF meeting. Timeline should be inserted here, but budget should be submitted as a separate document.

Plan to Use Outside Experts and Their Contact Information

Provide information on peer review of workplan as appropriate. If known at the time the final workplan is submitted, justify use or nonuse of previous review team members to provide continuity.

References Cited in Work Plan

Section V. Supportive Materials for Work Assignment/Work Plan Development

Methods to Scan for New Primary Evidence Since the Last Review:

Purpose: To locate the main new evidence for a topic, particularly related to update key questions.

Method: AHRQ staff will perform literature searches in the PubMed and Cochrane databases on the benefits and harms of the preventive service. The literature search will use the MeSH terms from the previous evidence review (if available), will search for studies published since the last review (3 months prior to the end-date of the previous search), will be limited to the English language, will be limited to humans, and will be limited to the journals in the abridged Index Medicus (120 "core clinical journals" in PubMed®). For the literature search on benefits, the search will be limited to meta-analyses, systematic reviews, and RCTs; for harms, the search will include meta-analyses, systematic reviews, RCTs, cohorts, and case-control studies. AHRQ staff will prepare a brief (1-2 paragraph) summary of the results of their literature search as part of the work assignment.

Methods of Searching for New Synthesized Evidence Since the Last Review

Purpose: To identify sources of synthesized evidence and ongoing studies that could affect review planning.

Method: At the work plan development stage (after receiving the work assignment), the Oregon EPC librarian works with the topic team to develop a strategy for searching the literature to identify existing systematic reviews and other high quality synthesized literature (such as meta-analyses). The following databases and Web sites are searched: Cochrane Database of Systematic Reviews, Database of Abstracts of Reviews of Effects, Health Technology Assessment Database (UK), National Institute for Health and Clinical Excellence—NICE (UK), Institute of Medicine, MEDLINE via PubMed (using the systematic reviews search hedge developed by NLM), and when appropriate, subject-specific databases (e.g., PsycINFO). Searches are not limited in terms of timeframes, except in the case of databases such as MEDLINE and subject-specific databases, which are searched beginning a year prior to the most recent, relevant citation in the previous review.

The EPC librarian and/or topic team search ClinicalTrials.gov (and CRISP, when necessary) to identify current trials and/or studies relevant to this review. The topic team also checks to determine whether there is a finished, in process, or planned Community Task Force review for the clinical preventive service being reviewed. The timing of this search (work plan stage or later) is left to the discretion of the topic work team.

Other sources for articles: Expert reviewer suggestions during work plan development and/or work plan peer review.

Definitions of Terms

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. (Primary Care: America's Health in a New Era. Institue of Medicine (IOM): National Academy Press, 1996.)

Primary Care Interventions Addressed by the USPSTF: The USPSTF considers interventions that are delivered in primary care settings or are judged to be feasible for delivery in primary care. To be feasible in primary care, an intervention could be applicable for patients seeking care in primary care settings, and the skills to deliver the intervention are typically present in clinicians and/or related staff in the primary care setting, or the intervention can generally be ordered/initiated by a primary care clinician.

Types of Questions Answered by Evidence Reviews for USPSTF

Key Questions

Definition: Key questions, in association with the analytic framework, establish the clinical logic to support implementation of a clinical preventive service in primary care. Key questions articulate the details of relevant patients, interventions, outcomes, and comparisons, which are essential in focusing the review on a manageable and clinically relevant topic and which directly guide the systematic literature review process. Each question is clearly tied to a step in the analytic framework, although certain linkages that are already well established may not have a key question that is actively answered during the review for the USPSTF. In addition, there may be reason to focus on an overarching linkage (and the associated key question) in an analytic framework rather than the intermediate linkages (and their associated key questions). All key questions are reviewed and approved by the topic team in the process of assessing and refining the topic before the detailed literature review. Key questions addressed in a systematic review are listed in the methods section and used to organize the results section of the report.

Methods: Key questions are addressed using up-to-date systematic review methods and under the current guidance and methods of the USPSTF. Each key question is addressed through a distinct literature search and reported separately in the results section of the review report.

Update Key Questions

Definition: Update key questions are associated with an analytic framework for a clinical preventive service and are used by the USPSTF to direct the researchers conducting the review to focus on a limited, specific set of key questions from the analytic framework during the updated review process. Update key questions are used to focus the review for a topic update in two main ways: 1) on examining only critical gaps in the evidence that would be required by the USPSTF in order to make a recommendation, and 2) on evaluating new research addressing parts of the topic that might confirm or change the evidence basis for a previous recommendation. An update key question approach is taken to maximize efficiency in updating when, in the context of the previous review and recommendation, the USPSTF determines that a systematic review of only a limited part of the analytic framework is necessary to validly update its evidence-based recommendation.

Methods: Update key questions are addressed in the same manner as key questions and reported in the results section of the review report.

Contextual Questions

Definition: These questions are not key questions associated with the analytic framework, but represent issues in an updated review for which the USPSTF needs a valid but not necessarily systematic summary of current research in order to provide the context for its vote and recommendation statement. Contextual questions may represent a range of different types of information, including: 1) updated information for a key question that is not being systematically updated; 2) contextual information on natural history, current practice, prevalence and risk groups, or other aspects of the service for which it is strongly believed there will not be information, but which are part of the TF considerations (e.g., screening interval, stopping ages for screening, or newer technologies for screening and/or intervention); 3) cost effectiveness.

Methods: Contextual questions are not necessarily addressed systematically, although the approach taken may meet criteria for a systematic review. Comprehensive literature searches are not generally undertaken specifically to answer these questions. Information for contextual questions is gathered in a variety of ways: 1) through targeted literature searches, 2) from authoritative surveys or reviews, 3) from expert input, and 4) opportunistically while reviewing comprehensive literature searches for key questions. Contextual questions are not listed as separate questions in the methods section of the report and are not reported in the results section. The information resulting from their non-systematic review by the researcher conducting the review should be included as part of the introduction or in the discussion section, and related as appropriate to the results of the systematic review.

Potential Background Questions: (these may or may not apply to a particular topic)

Etiology:

What primarily causes the disease/condition?
Are there other causes of the disease condition?
    Are these causes common?
    How are these other causes to be treated in this review?
    Is disease/condition due to other causes detected in the same way?
    Does it have the same prognosis/disease impact?
    Does it affect the same population?

If included, how should the disease (due to different causes) be distinguished in this review?

Prevalence in key sub-populations:

Do a disproportionate number of clinical cases come from one or a few sub-populations (e.g., 90% of abdominal aortic aneurysm (AAA) ruptures are in older male ever-smokers)?

Natural history:

Is there "pseudo-disease" present among the apparently diseased population?

Risk factors and populations with risk factors:

What is the prevalence of cases in high-risk individuals?
Is there a significant absolute difference in risk between "high" and "low" risk individuals? (e.g., with the breast cancer Gail Model, "high" risk has an absolute 5-year risk of 1.66%—still a very low risk, although it is "high" compared with others who have a risk of <1%). This is the "discriminatory" value of a risk calculation. Even though a set of risk factors may double or triple the risk, the risk factors may still be poor at discriminating those who will "get" the clinical condition from those who will not if the risk they are doubling or tripling is small. If risk factors do not discriminate, they may have little clinical use.

Detection/Screening:

If there are multiple ways of detecting, is one (or more) most valid?
If there are multiple ways of detecting, is one (or more) most relevant to current practice?
Which means of detection are of interest for this review?
How will different means of detection be prioritized, combined, or compared in synthesizing the literature?

Intervention/Treatment:

If there are multiple ways of treating the disease/condition, is one (or more) most valid?
If there are multiple ways of treating the disease/condition, is one (or more) most relevant to current practice?
Which treatments are of interest for this review?
How will different treatments be prioritized, combined, or compared in a literature synthesis?

Outcome:

How do we know that treatment is successful (health outcomes of interest to physicians, patients, or their families; intermediate outcomes often measured with established or potential relationship to health outcomes)?
Over what time frame should treatment success be evaluated considering initial results and maintenance of treatment success?
If there are multiple measures of health outcome, is one (or more) most valid?
If there are multiple measures of health outcome, is one (or more) most relevant to practitioners and patients?
How will outcomes be prioritized, combined, or compared in a literature synthesis?

Current Clinical Practice:

What is the current level of use of the service (e.g., What percentage of eligible patients has had it? What percentage of actual practices is doing this regularly?)
How adequate is the provision of the diagnostic, treatment, or monitoring aspects of the preventive service (e.g., follow up of positive mammograms, treatment of hypertension) that are presumed to be in effect for the treatment to be effective?

Cost: (These do not replace the need to identify cost-effectiveness studies as part of key questions)

How much additional "effort", extra training or equipment does this require from a practice, particularly to get a new service implemented?
Does it require "tracking" people to be sure they get it done regularly and are appropriately followed up? (This would likely not be quantitative, but would be more descriptive.)
What is the cost of delivering the service (actual service costs and time costs for patient and practice) on a population basis?
What is the cost of follow up, especially with respect to false positives?

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