Draft Research Plan
Draft Research Plan for High Blood Pressure in Adults: Screening
This opportunity for public comment expires on July 5, 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.
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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.
Draft: Proposed Key Questions to Be Systematically Reviewed
- Does screening for high blood pressure in adults improve health outcomes?
- What is the accuracy of office-based blood pressure measurement during a single encounter as initial screening for high blood pressure compared with the reference standard (ambulatory blood pressure measurement [ABPM])?
- What screening protocol characteristics define the best diagnostic accuracy?
- What is the accuracy of confirmatory blood pressure measurement in adults who initially screen positive for high blood pressure compared with the reference standard (ABPM)?
- What confirmation protocol characteristics define the best diagnostic accuracy?
- What are the harms of screening for high blood pressure in adults?
Draft: Proposed Contextual Questions
Contextual questions are not systematically reviewed and are not shown in the Analytic Framework.
- What is the clinically appropriate rescreening interval for patients who have previously been screened and found to have normal blood pressure?
- What is the prevalence and prognosis of masked hypertension? Have practical methods for identifying masked hypertension been evaluated in primary care or community settings?
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).
|Aim||KQs 1, 2, 4: Screening for high blood pressure in a primary care setting
KQ 3: Measuring blood pressure to confirm diagnosis of hypertension
|Studies measuring blood pressure for reasons other than screening or confirmation of a hypertension diagnosis; mathematical transformation of blood pressure results (e.g., pulse pressure, variability) or diurnal variations (e.g., morning surge, dipping) for use as additional diagnostic criteria, predicting risk, or both|
|Population||KQs 1, 2, 4: Adults age ≥18 years or older
KQ 3: Adults age ≥18 years or older with at least one elevated blood pressure measurement (as defined by study) identified by clinic-based screening
|Intervention||KQs 1, 2, 4: Clinic-based, noninvasive brachial blood pressure measurement (manual or automated) using any common device or screening protocol during a single encounter
KQ 3: Any clinic-based or out-of-office noninvasive blood pressure measurement used to confirm an initial elevated blood pressure result (i.e., manual OBPM, AOBP, HBPM, or kiosk)
KQ 3a: ABPM screening protocol that differs from the comparator ABPM protocol (e.g., 12- vs. 24-hour ABPM, daytime vs. nighttime ABPM)
|Blood pressure measurement with wrist and finger monitors, forearm cuffs, or ankle and toe measures; any method not commonly used in routine blood pressure screening (e.g., invasive methods, noninvasive method of central blood pressure measurement); Osler’s maneuver|
|Comparator||KQs 1, 4: No blood pressure measurement
KQs 2, 3: ABPM (any protocol)
|KQs 2, 3: Within-class comparative effectiveness of devices (e.g., automated vs. automated; random zero vs. standard sphygmomanometer) with identical screening protocols; validation and accuracy studies of devices compared with standards or using specific protocols (e.g., British Hypertension Society, Association for the Advancement of Medical Instrumentation)|
KQs 2, 3: Sensitivity, specificity, and positive and negative predictive values
KQ 4: Harms of screening (e.g., labeling, absenteeism, quality of life measures, tolerability of ABPM devices)
|KQs 1, 3: Cardiovascular symptoms (e.g., palpitations), angina pectoris (chest pain), revascularization, carotid intima-media thickness, left ventricular hypertrophy, or patient satisfaction
KQs 2, 3: Studies that do not provide enough data to create 2×2 tables or to calculate sensitivity and specificity; studies designed to assess devices vs. blood pressure measurement standards
|Timing of outcome assessment||No restrictions||No restrictions|
|Setting||KQs 1, 2, 4: Eligible primary care settings must have personnel trained in blood pressure measurement, established blood pressure measurement protocols, and ongoing documentation procedures
KQ 3: Primary care settings (see above for definition) and out-of-office settings (e.g., home, pharmacy, kiosks in other settings)
|All KQs: Inpatient/residential facilities
KQs 1, 2, 4: Settings not generalizable to primary care
|Study design||KQ 1: RCTs or CCTs
KQs 2, 3: Diagnostic accuracy studies, RCTs, and CCTs
KQ 4: RCTs, CCTs, and cohort studies
|All KQs: Before-after studies, time series, case series, case reports, case-control studies, and simulation studies
KQ 3: Studies with a sample size <100KQ 4: Cross-sectional studies
|Country||Studies conducted in countries categorized as “very high” on the 2015 Human Development Index (as defined by the United Nations Development Programme)||Studies conducted in countries not categorized as “very high” on the 2015 Human Development Index|
|Language||English||Other languages than English|
|Study quality||Fair or good||Poor, according to design-specific USPSTF criteria|
Abbreviations: ABPM = ambulatory blood pressure measurement; AOBP = automated office blood pressure; CCT = controlled clinical trial; OBPM = office blood pressure measurement; RCT = randomized, controlled trial.
Internet Citation: Draft Research Plan: High Blood Pressure in Adults: Screening. U.S. Preventive Services Task Force. June 2018.