Appendix V. Work Plan/Research Plan Template
For each topic, a preliminary draft of the work plan following this template is circulated prior to the first topic conference call with the Task Force leads, EPC review team, and AHRQ Medical Officer. This document is then revised based on the initial topic call, and the research plan (section IV of this template) is posted for public comment. After public comment, the entire work plan is finalized by the EPC review team and approved by the Task Force leads as the "final work plan." The final research plan is then posted on the Task Force Web site.
Instructions: This template is to be used for the final work plan, which includes the research plan for public posting. The text 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.
AHRQ Medical Officer:
EPC Project Lead Investigator:
EPC Project Staff:
Task Force Leads:
Section I. Purpose and Background
This report will be used by the USPSTF to:
What is the history of this Task Force recommendation (i.e., new, update from 1996, update from another update or initial recommendation made after 2000)?
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 subpopulations? (If case distribution varies significantly by subpopulation, consider whether background questions about high-prevalence groups need to be addressed here, and also whether [and how] issues related to prevalence in subpopulations will be handled in this review as part of the "scope" section below.)
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 below.)
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 below.)
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 below.)
Intervention/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 below.)
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? (A table showing the recommendations of other groups should be included here, detailing any recommendations for specific subpopulations.) (If current practice issues seem important, consider whether background questions about current clinical practice need to be addressed here.)
Potential background questions (these may or may not apply to a particular topic).
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 subpopulations:
Do a disproportionate number of clinical cases come from one or a few subpopulations?
Is there "pseudo-disease" present among the apparently diseased population?
How long does it take for latent disease to become symptomatic?
How is the disease understood to come about, from a physiological perspective? What organs or systems are involved and what normal functions or mechanisms are aberrant when the disease is present?
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? (This is the "discriminatory" value of a risk calculation. Even though a set of risk factors may double or triple risk, these risk factors may still be poor at discriminating those persons who will have the clinical condition from those who will not if the initial risk is small. If risk factors do not discriminate, they may have little clinical use.)
If there are multiple ways of detecting the disease/condition, is one (or more) most valid?
If there are multiple ways of detecting the disease/condition, 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?
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 synthesizing the literature?
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 synthesizing the literature?
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 that are presumed to be in effect for the treatment to be effective?
Section II. Previous Review and USPSTF Recommendations
(This section is applicable to update topics only.)
Previous Task Force Recommendation(s)
"In (year of recommendation), the Task Force concluded (statement of the evidence) to recommend (recommendation statement). (Recommendation grade)"
Include any subpopulation-specific recommendations. Also list all the recommendation language in any 1996 or earlier Task Force topics, even if not a graded recommendation statement.
Previous Task Force Conclusions
List all conclusions made by the Task Force in the prior recommendation and rationale statement, including any evidence gaps identified by the Task Force.
Previous Analytic Framework and Key Questions
Insert analytic framework and key questions from the previous evidence review.
Previous Review Findings
Insert summary of evidence table with overall quality assessment for each key question.
Previous Review Conclusions
List all conclusions made by the authors of the prior evidence review. 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
Identify limitations cited in the prior evidence review and/or recommendation statement. Identify and list scope or method limitations identified 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," and other specific topics (such as "Potential Preventable Burden," "Current Practice").
Section III. Scan of Evidence Since Previous Recommendation
Existing Synthesized Evidence
Organize, summarize, and cite new evidence 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. Clearly delineate how systematic reviews have handled subpopulation considerations.
Previously Identified Pending Studies
Provide followup data on previously identified pending studies.
Newly 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 evidence review. Which key questions in the analytic framework will be addressed? Which key questions will not be updated, as their evidence is viewed as "established"? Are there areas that will be updated nonsystematically (i.e., contextual questions)?
The analytic framework, key questions, contextual questions, and inclusion/exclusion criteria will be copied from this section into the research plan template for public comment posting, so it should be written with that purpose in mind.
Analytic Framework and Key Questions
Analytic framework. Insert the analytic framework.
Key questions. Insert key questions.
Contextual questions. Insert contextual questions (if applicable).
Scope of Review
Using the inclusion/exclusion criteria table template (Appendix Table 1), specify who and what will be addressed in terms of populations, screening and treatment interventions, comparisons, outcomes, setting, study design, and quality. Other categories for which inclusion/exclusion criteria may be defined include study aim, disease/condition, timing of outcome assessment, intervention duration, publication date, and language. The descriptions below may help guide completion of the table. An introductory paragraph describing the general inclusion/exclusion criteria may be included.
Populations. Define the sex, age, and other sociodemographic or medical characteristics of the study participants addressed in this review and identify any important subpopulations.
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 the 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 the 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? What role does quality assessment play in study eligibility?
Settings. What settings (timeframes, countries, populations) are minimally acceptable for evaluating each key question?
Study quality. Specify that fair-and good-quality studies based on USPSTF criteria will be included and poor-quality studies will be excluded.
Be clear about decisions to exclude populations, interventions, comparisons, outcomes, or settings and their rationale.
Include databases and time periods for each key question, as well as search terms for existing systematic evidence reviews and meta-analyses.
Briefly describe how, in addition to qualitative synthesis, quantitative synthesis will generally be conducted.
The timeline is negotiated with AHRQ after work plan conference calls and is submitted with the final work plan as part of the deliverable. The timeline includes major milestones, including expected date for presentation at a future Task Force meeting. Since the length of the research plan review process may affect the timeline, the timeline should not be included until the final work plan is submitted.
Use of Outside Experts
Provide information on peer review of the work plan, if planned in addition to public comment, as appropriate. If known, describe the use or nonuse of previous review team members to provide continuity.
Section V. Research Plan
Use the following template for the research plan. The analytic framework, key questions, contextual questions, and inclusion/exclusion criteria should be copied from the appropriate section above. The "Response to Public Comment" section is only included in the final research plan.
USPSTF Draft Research Plan
Insert title of project.
Proposed Analytic Framework
Insert analytic framework.
Proposed Key Questions to Be Systematically Reviewed
Insert key questions.
Proposed Contextual Questions
"Contextual questions will not be systematically reviewed and are not shown in the Analytic Framework."
Insert contextual questions.
Proposed Research Approach
"The Proposed Research Approach identifies the study characteristics and criteria that the Evidence-based Practice Center will use to search for publications and to determine whether identified studies should be included or excluded from the Evidence Review. Criteria are overarching as well as specific to each of the key questions."
Insert inclusion/exclusion table from work plan.
Response to Public Comment
"The draft Research Plan was posted for public comment on the USPSTF Web site from [date] to [date]."
Insert a summary of the comments received by the USPSTF, how they were addressed in revisions to the research plan, and/or how they will be addressed during preparation of the systematic review.
Internet Citation: Appendix V. Work Plan/Research Plan Template. U.S. Preventive Services Task Force. July 2017.