Diagnostic and Predictive Accuracy of Blood Pressure Screening Methods With Consideration of Rescreening Intervals: A Systematic Review for the U.S. Preventive Services Task Force
Nearly 1 in 3 U.S. adults has high blood pressure (BP) including two thirds of those aged 60 years or older (1) Elevated BP is the largest contributing risk factor to all cause and cardiovascular mortality (2) Despite the clear importance of accurate diagnosis of high BP, recommendations for BP measurement protocols and rescreening intervals are not based on systematic reviews of the literature (3, 4) and recommended protocols, such as repeated measurements, are rarely followed in routine health care settings (59) To help address these issues, newer measurement methods have been developed to reduce error, simplify performance of repeated measurements, evaluate BP throughout the 24 hour cycle, and allow use in nonmedical settings. Evidence based measurement methods and rescreening intervals could improve the benefits and efficiency of BP screening. In 2007, the U.S. Preventive Services Task Force (USPSTF) reaffirmed its 2003 A recommendation to screen for high BP in adults aged 18 years or older (10) In 2003, a synthesis of indirect evidence for BP screening found good quality evidence that treatment of high BP in adults substantially decreases the incidence of cardiovascular events (11) Both reviews found that screening and treatment for high BP cause few major harms (11, 12) Given the strong evidence base for the previous recommendations and recently updated guidelines for BP control (4, 13) the USPSTF did not believe that updating the indirect evidence path was necessary. However, the previous systematic reviews did not identify a BP measurement reference standard, address diagnostic accuracy of BP measurement methods and protocols, or determine the most appropriate rescreening interval. Our evidence review was designed to address these important aspects of screening for high BP and update the direct evidence of benefits and harms of screening. Methods To conduct this review, we developed an analytic framework with 5 key questions (Appendix Figure 1) that examined direct evidence for the benefits and harms of screening for high BP (key questions 1 and 5, respectively) diagnostic accuracy of office BP measurement (OBPM) (key question 2) prediction of cardiovascular events by BP method and diagnostic accuracy of nonoffice measurement (key question 3) and rescreening interval (key question 4) Detailed methods are available in our full evidence report (14) The analytic framework, review questions, and methods for locating and qualifying evidence were posted on the USPSTF Web site for public comment before we started the review, and the final versions reflect public input. Appendix Figure 1. Analytic framework. ABPM ambulatory blood pressure monitoring; BP blood pressure; CHD coronary heart disease; CVD cardiovascular disease; ESKD end stage kidney disease; HBPM home blood pressure monitoring; HF heart failure. Defined as the threshold for pharmacologic treatment. Data Sources and Searches We searched MEDLINE, PubMed, the Cochrane Central Register of Controlled Trials, and CINAHL from 2003 through 8 August 2014 to update benefits and harms of screening for high BP. We searched the same databases (excluding CINAHL) through 24 February 2014 as follows: starting in 1992 (to allow for implementation of the first guidelines for validation of BP monitoring devices [15] for prediction of cardiovascular events by BP method and diagnostic accuracy of nonoffice measurement, and starting in 1966 (the beginning of MEDLINE) for rescreening interval. On the basis of the findings from these updated searches, we did not further update them because any studies we found would probably not have changed the overall conclusions. We also searched bibliographies of relevant reviews, included studies, and publication lists of highly referenced studies. Study Selection Two investigators independently reviewed abstracts and full text articles against prespecified inclusion and exclusion criteria (14) We required all studies to have enrolled untreated adults and to have been conducted in countries rated as very high on the 2013 Human Development Index (16) For prediction of cardiovascular events, we allowed studies that included treated patients because a proportion of persons followed over time would inevitably begin treatment. Ambulatory BP monitoring (ABPM) and home BP monitoring (HBPM) devices were eligible for use in confirming an initially elevated OBPM result. For screening benefits and harms, cardiovascular events we analyzed included fatal or nonfatal myocardial infarction; sudden cardiac death; stroke; heart failure; atrial fibrillation; transient ischemic attack; end stage kidney disease; or a composite of any of the aforementioned events, excluding cardiovascular symptoms, angina, revascularization, carotid intimamedia thickness, and left ventricular hypertrophy. For diagnostic accuracy of OBPM, we included studies that compared different office based devices or measurement protocols and reported sensitivity, specificity, predictive values, or concordance (for example, For diagnostic accuracy of confirmatory BP measurement methods, eligible study populations had an initial elevated office BP at screening, which allowed for reporting or calculation of the positive predictive value (PPV) For prediction of cardiovascular events, eligible studies followed a cohort of patients over time and reported the associations (hazard or risk ratios) of BP as a continuous variable, measured by at least 2 methods at baseline, with data on overall mortality or cardiovascular events collected during follow up. For rescreening interval, we included studies that followed cohorts of initially nonhypertensive adults over time and reported hypertension incidence at rescreening intervals of up to 6 years. Data Extraction and Quality Assessment One investigator abstracted data from all included studies, and a second checked for accuracy. Two investigators independently assessed the quality of included studies by using predefined, design specific criteria (1719) We rated study quality as good, fair, or poor and excluded all poor quality studies (17) We resolved disagreements about quality through discussion with a third investigator. Where reported, studies with various threats to internal validity were downgraded to fair quality according to USPSTF standards (17) Data Synthesis and Analysis We qualitatively described the results on the benefits and harms of screening. Per our protocol, we first calculated the diagnostic accuracy of OBPM by using the recommendations of the American Heart Association as the reference standard because there is no gold standard for BP measurement (3) With the subsequent identification of ABPM as the best predictor of cardiovascular events, we calculated the diagnostic accuracy of OBPM and confirmatory BP measurement methods by using ABPM as the reference standard where possible. We qualitatively described all diagnostic accuracy results because data were insufficient for quantitative synthesis. For prediction of cardiovascular events, we combined fatal and nonfatal events within outcome categories (cardiovascular, stroke, and cardiac) Risk was most commonly reported as the hazard ratio associated with each 10mm Hg increase in systolic BP and each 5mm Hg increase in diastolic BP. We converted hazard ratios to these common increments if they were reported differently (14) We depicted the hazard ratios in forest plots for qualitative evaluation; because of the small numbers of studies for each outcome and heterogeneity across studies, we did not calculate summary meta analytic estimates of risk to determine the best BP measurement method for prediction. We conducted exploratory meta analyses to compare ABPM protocols (24 hour, daytime, and nighttime) by generating estimates of cardiovascular events or mortality risk for each protocol by using the DerSimonianLaird random effects method (20) In sensitivity analyses, these results were compared to estimates generated by using profile likelihood (21) and KnappHartung methods (22) For rescreening, we pooled reported incidence rates across all studies to generate a weighted mean incidence at yearly intervals (reported within0.5 year) We qualitatively examined within study comparisons among a priori subgroups of age, BP, sex, body mass index (BMI) smoking status, and race/ethnicity (14) When constructing the overall summary of evidence (Appendix Table 1) we evaluated included studies within the context of each review question for consistency of results for important outcomes and relevance to primary care. Appendix Table 1. Overall Summary of Evidence, by Key Question Role of the Funding Source Staff from the Agency for Healthcare Research and Quality (AHRQ) provided oversight for the project and assisted in external review of the companion draft evidence synthesis. Liaisons for the USPSTF helped to resolve issues about the scope of the review but were not involved in the conduct of the review. Results We reviewed 19309 abstracts and 1171 articles for possible inclusion (Appendix Figure 2) Appendix Figure 2. Summary of evidence search and selection. KQ key question. Surveillance search results through August 2014 for trials reporting direct benefits of screening were not included; no additional trials were identified. Benefits of Screening for High BP For direct evidence of screening benefit, we included only randomized, controlled trials (RCTs) that reported changes in health outcomes as a result of screening for hypertension compared with no screening. We identified 1 good quality cluster RCT of a community pharmacybased BP screening program targeting adults aged 65 years or older (23) Trained volunteer health educators also provided participants with educational materials and resources to support self management. This trial found fewer annual composite cardiovascular related hospitalizations in the intervention group than in t
Annals of Internal Medicine