Draft Research Plan
Draft Research Plan for Pancreatic Cancer: Screening
This opportunity for public comment expired on May 24, 2017 at 8:00 PM EST
Note: This is a Draft Research Plan. This draft is distributed solely for the purpose of receiving public input. It has not been disseminated otherwise by the USPSTF. The final Research Plan will be used to guide a systematic review of the evidence by researchers at an Evidence-based Practice Center. The resulting Evidence Review will form the basis of the USPSTF Recommendation Statement on this topic.
Recommendations made by the USPSTF are independent of the U.S. government. They should not be construed as an official position of the Agency for Healthcare Research and Quality or the U.S. Department of Health and Human Services.
Draft: Proposed Analytic Framework
The analytic framework depicts the five key questions (KQs) described in the draft research plan. Specifically, it illustrates the following questions: whether screening for pancreatic adenocarcinoma improves cancer morbidity or mortality or all-cause mortality (KQ1); whether screening effectiveness varies by clinically relevant subpopulations, such as older adults, persons with a family history of pancreatic cancer, or persons with diabetes (KQ1a); the diagnostic accuracy of screening tests for pancreatic adenocarcinoma (KQ2); the harms of screening for pancreatic adenocarcinoma (KQ3); whether treatment of screen-detected or asymptomatic pancreatic adenocarcinoma improves cancer mortality, all-cause mortality, or quality of life (KQ4); and the harms of treatment of screen-detected pancreatic adenocarcinoma (KQ5).
Draft: Proposed Key Questions to Be Systematically Reviewed
- Does screening for pancreatic adenocarcinoma improve cancer morbidity or mortality or all-cause mortality?
- Does screening effectiveness vary by clinically relevant subpopulations (e.g., older adults, persons with family history of pancreatic cancer, or persons with diabetes)?
- What is the diagnostic accuracy of screening tests for pancreatic adenocarcinoma?
- What are the harms of screening for pancreatic adenocarcinoma?
- Does treatment of screen-detected or asymptomatic pancreatic adenocarcinoma improve cancer mortality, all-cause mortality, or quality of life?
- What are the harms of treatment of screen-detected pancreatic adenocarcinoma?
Draft: Proposed Contextual Questions
Contextual questions will not be systematically reviewed and are not shown in the Analytic Framework.
- What tools are available for assessing risk of pancreatic adenocarcinoma in primary care?
- What is the natural history and prognosis of early- versus late-stage pancreatic adenocarcinoma?
- What is the role of biomarkers or multiple-biomarker panels in screening for pancreatic adenocarcinoma?
Draft: 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 (KQs).
|Population||KQs 1–3: Adults age ≥18 years, with or without risk factors for pancreatic adenocarcinoma (e.g., family history, diabetes, tobacco use)*
KQs 4, 5: Adults with screen-detected or asymptomatic pancreatic adenocarcinoma
|Setting||Studies conducted in countries categorized as "Very High" on the 2015 Human Development Index (as defined by the United Nations Development Programme)|
|Screening test||Any imaging-based screening protocol, including computerized tomography, endoscopic ultrasonography, magnetic resonance imaging, and abdominal ultrasonography||Serum, stool, or saliva-based testing for biomarkers, such as cancer antigen 19-9, carcinoembryonic antigen, cell-surface proteins, micro-RNA, hypermethylation of specific genes in circulating DNA, circulating tumor cells, or multiple-biomarker panels|
|Treatment||KQs 4, 5: Surgical resection, with or without chemotherapy or radiation therapy||Chemotherapy or palliative care alone|
|Comparisons||KQ 1: No screening
KQ 2: Reference standard (e.g., clinical followup)
KQ 4: No treatment or delayed treatment
|Comparative effectiveness screening or treatment studies|
|Outcomes||KQs 1, 4: Reduced pancreatic adenocarcinoma morbidity or mortality, reduced all-cause mortality, and improved quality of life
KQ 2: Sensitivity, specificity, positive predictive value, and lesion detection rate
KQs 3, 5: Any harm from screening or treatment, including false-positive or false-negative results, serious psychological harms, or treatment-related adverse events
|KQ 3: Incidentally identified lesions|
|Study design||All KQs: Fair- or good-quality studies (according to design-specific USPSTF criteria) published from 2002 to the present‡
KQ 1: Randomized, controlled trials; controlled clinical trials
KQ 2: Diagnostic accuracy studies with a reference standard; systematic evidence reviews
KQs 3, 5: Randomized, controlled trials; controlled clinical trials; cohort studies; case-control studies
KQ 4: Randomized, controlled trials; controlled clinical trials; cohort studies
|Poor-quality studies with a fatal flaw; studies occurring outside of the specified publication dates; case reports and case series; narrative reviews, commentaries, editorials, theses, qualitative studies, ecologic studies, comparative effectiveness studies, and decision analyses; studies not available in the English language|
* Results will be stratified by risk factors, such as age, sex, or clinical characteristics, where possible.
† Studies consisting entirely of populations with high-risk genetic syndromes will be excluded, but populations that also include individuals with other risk factors will not.
‡ Studies included in the previous USPSTF review (search dates through December 2001) that meet current inclusion criteria will be included.
Internet Citation: Draft Research Plan: Pancreatic Cancer: Screening. U.S. Preventive Services Task Force. April 2017.