Skip to navigation bar Skip to breadcrumbs Skip to page content Skip to comments area
clear place holder
Envelope icon E-mail Updates Teal square Text size:  a A A
You are here: HomePublic Comments and NominationsOpportunity for Public CommentDraft Research Plan : Draft Research Plan

Draft Research Plan

Draft Research Plan for Abnormal Blood Glucose and Type 2 Diabetes Mellitus: Screening

This opportunity for public comment expires on August 1, 2018 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.

Send Us Your Comments

In an effort to maintain a high level of transparency in our methods, we open our draft Research Plans to a public comment period before we publish the final version.

Leave a Comment >>

Draft: Proposed Analytic Framework

Figure 1 depicts the key questions within the context of the eligible populations, screenings/interventions, comparisons, outcomes, and settings. On the left, the population of interest is nonpregnant adults without symptoms or a diagnosis of diabetes. Moving from left to right, the figure illustrates the overarching question: Is there direct evidence that screening for type 2 diabetes and prediabetes in asymptomatic adults improves health outcomes (KQ1)? Screening may result in harms (KQ2). After diagnosis of type 2 diabetes or prediabetes, the figure illustrates the questions: Do interventions provide an incremental benefit in health outcomes when delivered at the time of detection compared with initiating interventions later, after clinical diagnosis (KQ3), and do interventions improve health outcomes compared with no interventions, usual care, or different treatment targets (KQ4)? For recently diagnosed type 2 diabetes, the figure illustrates the question: Do interventions improve health outcomes compared with no interventions, usual care, or different treatment targets (KQ5)? Interventions may result in harms (KQ6). For prediabetes, the figure depicts the question: Do interventions delay or prevent progression to type 2 diabetes (KQ7), and after intervention, what is the magnitude of change in health outcomes that results from a specified change in type 2 diabetes incidence (KQ8)?

 

Draft: Proposed Key Questions to Be Systematically Reviewed

1. a. Is there direct evidence that screening for type 2 diabetes and prediabetes in asymptomatic adults improves health outcomes?
    b. Does the effectiveness of screening differ for subgroups defined by age, sex, race/ethnicity, or body mass index (BMI)?
2. a. What are the harms of screening for type 2 diabetes and prediabetes in asymptomatic adults?
    b. Do the harms of screening differ for subgroups defined by age, sex, race/ethnicity, or BMI?
3. a. Do interventions for screen-detected type 2 diabetes and prediabetes provide an incremental benefit in health outcomes when delivered at the time of detection compared with initiating interventions later, after clinical diagnosis?
    b. Does the effectiveness of these interventions differ for subgroups defined by age, sex, race/ethnicity, or BMI?
4. a. Do interventions for screen-detected type 2 diabetes and prediabetes improve health outcomes compared with no interventions, usual care, or different treatment targets?
    b. Does the effectiveness of these interventions differ for subgroups defined by age, sex, race/ethnicity, or BMI?
5. a. Do interventions for recently diagnosed type 2 diabetes improve health outcomes compared with no interventions, usual care, or different treatment targets?
    b. Does the effectiveness of these interventions differ for subgroups defined by age, sex, race/ethnicity, or BMI?
6. What are the harms of interventions for prediabetes, screen-detected type 2 diabetes, or recently diagnosed type 2 diabetes?
7. a. Do interventions for prediabetes delay or prevent progression to type 2 diabetes?
    b. Does the effectiveness of these interventions differ for subgroups defined by age, sex, race/ethnicity, or BMI?
8. After interventions for prediabetes are provided, what is the magnitude of change in health outcomes that results from a specified change in type 2 diabetes incidence?

Draft: Proposed Contextual Questions

Contextual questions will not be systematically reviewed and are not shown in the Analytic Framework.

  1. Are there risk assessment tools that are feasible for use in primary care settings, accurately predict the risk of prediabetes or type 2 diabetes, and have been externally validated in U.S. populations?
  2. What is the rate of agreement between screening tests* for prediabetes and diabetes?
  3. Which of these screening tests* best predicts future adverse health outcomes associated with type 2 diabetes?
  4. What is the yield (incidence) of rescreening at different intervals in adults with an initial normal screening test* result?     
  5. What is the utility of recently published modeling studies that assess screening for type 2 diabetes and prediabetes (vs. no screening) in examining health outcomes?

*Screening tests under consideration include hemoglobin A1c, fasting plasma glucose, and the oral glucose tolerance test.

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).

  Include Exclude
Populations KQs 1, 2: Asymptomatic, nonpregnant adults

KQs 3, 4: Asymptomatic, nonpregnant adults with screen-detected prediabetes or type 2 diabetes

KQ 5: Asymptomatic, nonpregnant adults with recently diagnosed type 2 diabetes

KQ 6: Asymptomatic, nonpregnant adults with screen-detected prediabetes or type 2 diabetes; nonpregnant adults with recently diagnosed type 2 diabetes

KQ 7, 8: Asymptomatic, nonpregnant adults with screen-detected prediabetes

KQs 1–8: Children, adolescents, and pregnant women; persons with symptomatic prediabetes or type 2 diabetes

KQ 5: Persons with diabetes for more than 1 year or with more advanced diabetes (e.g., persons already taking insulin or other medications; persons with proliferative retinopathy, nephropathy)

Screening KQs 1, 2: Screening (targeted or universal) for prediabetes* or diabetes; tests include hemoglobin A1c, fasting plasma glucose, and the oral glucose tolerance test  
Interventions KQs 3–6: Interventions for glycemic control, including pharmacotherapy, counseling, or lifestyle modifications; interventions for more intensive risk reduction of atherosclerotic cardiovascular disease, including more intensive blood pressure control, lipid control, or aspirin

KQs 7, 8: Interventions for glycemic control, including pharmacotherapy or lifestyle modifications

  • Counseling interventions aimed at falls prevention, depression, or cognitive functioning
  • Prenatal or postnatal dietary counseling
  • Counseling interventions that are primarily community-based, nonreferral (e.g., occupational/worksite or school-based)
  • Social marketing (e.g., media campaigns)
  • Policy (e.g., local or state public/health policy)
  • Stress management interventions (e.g., meditation, yoga, tai chi)
  • Use of incentives (e.g., paying persons to lose weight)
  • Supervised exercise with the goal of assessing effects of exercise
Comparisons KQs 1, 2: No screening or alternative screening strategies

KQ 3: Comparison based on timing; sooner vs. later intervention (i.e., starting intervention upon detection by screening vs. starting later based on clinical diagnosis); clinical diagnosis refers to any approach based on development of symptoms (e.g., polyuria, polydipsia, paresthesia) or monitoring of biomarkers (e.g., increase in hemoglobin A1c above a certain threshold)

KQs 4, 5: No intervention, usual care (can include minimal intervention), different treatment targets (e.g., glucose or blood pressure targets), or attention controls (for lifestyle interventions)

KQ 6: All comparisons eligible for KQs 3–5

KQs 7, 8: Sooner vs. later intervention, no intervention, usual care, or attention controls (for lifestyle interventions)

Comparative effectiveness (head-to-head) trials of medications without another eligible control group
Outcomes
KQs 1, 3–5, 8: Mortality, cardiovascular morbidity (including myocardial infarction, stroke, congestive heart failure), chronic kidney disease, amputations, skin ulcers, visual impairment (including blindness), periodontitis (including tooth loss), moderate to severe neuropathy, and quality of life

KQ 2: Labeling, anxiety, harms from false-positive results, and unnecessary testing and treatment

KQ 6: Serious side effects from treatment, including mortality, myocardial infarction, stroke, cancer, and hypoglycemic events requiring medical attention

KQ 7: Development of type 2 diabetes

 
Study Designs All KQs: Controlled clinical trials

KQs 2, 6: Controlled prospective cohort studies and case-control studies are also eligible

KQ 8: Controlled prospective cohort studies are also eligible
Modeling studies, systematic reviews,** case series, case reports, uncontrolled observational studies, retrospective cohort studies, editorials, and all other study designs
Settings All KQs: Studies conducted in or recruited from primary care settings or settings otherwise applicable to primary care Settings not generalizable to primary care (e.g., inpatient hospital units, emergency departments, nursing home and other institutional settings, school-based programs, occupational settings, other community-based settings)
Countries Studies conducted in countries categorized as “Medium” or higher on the 2016 Human Development Index (as defined by the United Nations Development Programme Studies conducted in countries that are not categorized as “Medium” or higher on the 2016 Human Development Index
Language English language Languages other than English
Study quality Good- or fair-quality Poor-quality (according to design-specific USPSTF criteria)

* Prediabetes includes persons who meet criteria for impaired fasting glucose or impaired glucose tolerance and persons with an A1c level of 5.7% to 6.4%.
** Systematic reviews will be excluded from the evidence review; however, separate searches will be conducted to identify relevant systematic reviews, and the citations of all studies included in those systematic reviews will be reviewed to ensure that the database searches have captured all relevant primary studies.

Current as of: July 2018

Internet Citation: Draft Research Plan: Abnormal Blood Glucose and Type 2 Diabetes Mellitus: Screening. U.S. Preventive Services Task Force. July 2018.
https://www.uspreventiveservicestaskforce.org/Page/Document/draft-research-plan/abnormal-blood-glucose-and-type-2-diabetes-mellitus-screening

USPSTF Program Office   5600 Fishers Lane, Mail Stop 06E53A, Rockville, MD 20857