Draft Research Plan

Helicobacter Pylori Infection: Screening

November 17, 2022

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.

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The analytic framework depicts the five Key Questions (KQs) described in the Research Plan. Specifically, it illustrates the following questions: whether screening for H. pylori infection in asymptomatic children or adults improves patient health outcomes (e.g., health-related quality of life; morbidity and mortality from gastric adenocarcinoma or other upper gastrointestinal cancers; all-cause mortality; peptic ulcer disease; gastritis) (KQ1); the diagnostic accuracy of screening tests for H. pylori infection in asymptomatic children or adults (KQ2); whether H. pylori eradication treatment in asymptomatic children or adults improves patient health outcomes (e.g., health-related quality of life; morbidity and mortality from gastric adenocarcinoma or other upper gastrointestinal cancers; all-cause mortality; peptic ulcer disease; gastritis) (KQ3); the harms of screening for H. pylori infection in asymptomatic children or adults (KQ4); and the harms of eradication treatment of H. pylori infection in asymptomatic children or adults (KQ5).

*Asymptomatic includes unselected populations and persons with unrecognized or unreported symptoms.

  1. Does screening for Helicobacter pylori infection in asymptomatic children or adults improve patient health outcomes (e.g., health-related quality of life, morbidity and mortality from gastric adenocarcinoma or other upper gastrointestinal cancers, all-cause mortality, peptic ulcer disease, or gastritis)?
  2.  What is the diagnostic accuracy of screening tests for H. pylori infection in asymptomatic children or adults? 
  3. Does H. pylori eradication treatment in asymptomatic children or adults improve patient health outcomes (e.g., health-related quality of life, morbidity and mortality from gastric adenocarcinoma or other upper gastrointestinal cancers, all-cause mortality, peptic ulcer disease, or gastritis)?
  4. What are the harms of screening for H. pylori infection in asymptomatic children or adults?
  5. What are the harms of eradication treatment of H. pylori infection in asymptomatic children or adults?

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

  1. What are best practices for identifying persons at high risk for H. pylori infection, gastric cancer, or both, including availability and performance of risk assessment tools?
  2. What is the adherence to H. pylori eradication therapy and posttreatment test of cure in asymptomatic children or adults? What are barriers and facilitators to adherence to H. pylori eradication therapy and posttreatment test of cure?
  3. What is the prevalence of H. pylori recurrence after eradication therapy and of posttreatment test of cure in asymptomatic children or adults?
  4. What are the downstream harms for individuals and populations related to antimicrobial resistance?
  5. What are the considerations around age of screening initiation?
  6. What is the state of the evidence related to screening for early detection of gastric cancer (e.g., screening endoscopy or radiography) in the United States?

The review will outline differences in the incidence, burden, natural history, and outcomes of H. pylori infection and gastric cancer across specific population groups. We will also describe the population characteristics and screening program components in the included studies to the extent possible. Data on screening program components will help us explore if any components of screening programs may be differentially effective in different population groups or settings.

Data on population characteristics will help us explore the degree to which the findings are representative of persons at risk for H. pylori infection and gastric cancer as well as investigate, report, and highlight differences in benefit and harms of H. pylori screening by different population groups. These groups include, but are not limited to, categorizations by age; racial, ethnic, and cultural identity; country of origin; socioeconomic and insurance status; groups who have historically experienced systemic racism, discrimination, or other structural barriers to receiving healthcare; and groups with disproportionately high gastric cancer burden; exposure to regions or households with a high prevalence of H. pylori; family history of gastric cancer; and presence of social needs or social risk factors.

Additionally, the proposed Contextual Questions are designed to allow focused discussion of health equity considerations and structural barriers relevant to equitable implementation of screening should the U.S. Preventive Services Task Force recommend it. These include consideration of equitable risk assessment; barriers and facilitators to delivery of screening, treatment, and eradication testing; population-level harms related to antimicrobial resistance; and age at screening.

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.

Criteria Include Exclude
Populations Asymptomatic children or adults, with or without known risk factors (e.g., exposure to areas with high H. pylori prevalence, family history of gastric cancer)

Unselected populations and persons with unrecognized or unreported symptoms		 Populations with personal history of gastric cancer

Populations with previous confirmed H. pylori infection

Populations with previous treatment of H. pylori infection
Screening interventions Screening tests for detecting H. pylori infection (e.g., urea breath; stool antigen; stool PCR; blood antibody; urine antibody; endoscopic biopsy)  
Treatment interventions Combination therapy with antibiotics, with or without educational intervention  
Comparators KQ 1: No H. pylori screening; usual care; opportunistic case finding

KQ 2: Any reference standard; endoscopic biopsy where available

KQ 3: No treatment; placebo treatment

KQs 4, 5: Any or no comparator

 KQ 3: Alternate combination therapy
Outcomes KQs 1, 3:
  • Gastric adenocarcinoma morbidity, mortality.
  • Other upper gastrointestinal cancers (e.g., MALT lymphoma; esophageal cancer) morbidity, mortality.
  • All-cause mortality.
  • Health-related quality of life.
  • Gastritis; peptic ulcer disease.

KQ 2: Sensitivity, specificity, false-positive rate, false-negative rate, predictive value

KQs 4, 5: Any serious harm (e.g., as reported by study investigators; requiring unexpected medical attention; or persistent beyond 3 months)

  
Setting Studies conducted in countries categorized as “Very High” or “High” on the most recent Human Development Index (as defined by the United Nations Development Programme)  
Study design KQ 1: Randomized trials, controlled trials, nonrandomized studies of screening programs with contemporaneous controls

KQ 2: Diagnostic test accuracy studies; systematic reviews of diagnostic test accuracy

KQ 3: Randomized trials, controlled trials

KQs 4, 5: Randomized trials, controlled trials, large screening registry or database nonrandomized studies, cohort studies, systematically selected case series

 KQ 3: Comparative effectiveness studies; cost effectiveness studies
Publication language English  
Timing 1982 (year of discovery of H. pylori) to present  

Abbreviations: KQ=key question; MALT=mucosa associated lymphoid tissue; PCR=polymerase chain reaction.