Dataset Information

Comparison of automated clinical and research blood pressure measurements: Implications for clinical practice and trial design.

ABSTRACT: Discrepancies between clinic and research blood pressure (BP) measurements lead to uncertainties in translating hypertension management guidelines into practice. We assessed the concordance between standardized automated clinic BP, from a primary care clinic, and research BP, from a randomized trial conducted at the same site. Mean single-visit clinic BP was higher by 4.4/3.8 mm Hg (P = 0.007/<0.001). Concordance in systolic BP (SBP) improved with closer proximity of measurements (difference = 2.5 mm Hg, P = 0.21 for visits within 7 days), but not averaging across multiple visits (difference =5.1(9.2) mm Hg; P < 0.001). This discrepancy was greater among female participants. Clinic-based difference in SBP between two visits was more variable than research-based change (SD = 19.6 vs 14.0; P = 0.002); a 2-arm trial using clinic measurements would need 95% more participants to achieve comparable power. Implementation of a bundled standardization intervention decreased discrepancies between clinic and research BP, compared to prior reports. However, clinic measurements remained higher and more variable, suggesting treatment to research-based targets may lead to overtreatment and using clinic BP approximately halves power in trials.

SUBMITTER: Tang O

PROVIDER: S-EPMC6289771 | biostudies-literature | 2018 Dec

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Comparison of automated clinical and research blood pressure measurements: Implications for clinical practice and trial design.

Tang Olive O Juraschek Stephen P SP Appel Lawrence J LJ Cooper Lisa A LA Charleston Jeanne J Boonyasai Romsai T RT Carson Kathryn A KA Yeh Hsin-Chieh HC Miller Edgar R ER

Journal of clinical hypertension (Greenwich, Conn.) 20181107 12

Discrepancies between clinic and research blood pressure (BP) measurements lead to uncertainties in translating hypertension management guidelines into practice. We assessed the concordance between standardized automated clinic BP, from a primary care clinic, and research BP, from a randomized trial conducted at the same site. Mean single-visit clinic BP was higher by 4.4/3.8 mm Hg (P = 0.007/<0.001). Concordance in systolic BP (SBP) improved with closer proximity of measurements (difference = 2 ...[more]

PMID: 30403006

Similar Datasets

Project description:BackgroundAccurate measurement of blood pressure is the foundation of appropriate diagnosis, treatment and ongoing management of hypertension. The use of automated blood pressure devices in community settings such as pharmacies provide opportunities for additional blood pressure measurement; however, it is important to ensure that these measurements are comparable to those taken in physicians' offices using the same devices. We conducted a randomized controlled trial to assess whether blood pressure readings assessed by use of an automated device differed according to the setting, specifically in community pharmacies and family physicians' offices.MethodsWe included adults aged 65 years and older who did not live in long-term care facilities or in hospital. The trial was administered by volunteer peer health educators, family physicians and pharmacists in 2 midsized communities in Ontario from April to September 2010. The 5 participating family physicians mailed invitations to their eligible patients. Those who gave informed consent were randomly allocated to 1 of 2 assessment sequences: group A had their blood pressure measured at their physician's office, then at a pharmacy, then again at their physician's office; those in group B had their blood pressure measured at a pharmacy, then at their physician's office, then again at a pharmacy. An automated blood pressure device (BpTRU) was used in both settings. We calculated the differences in mean systolic and diastolic blood pressure, and we compared the readings at both settings and by sequence of assessment.ResultsIn total, 275 adults completed the trial (mean age 75.9 yr, 49.5% male, 46.9% with a self-reported diagnosis of hypertension). There were no statistically significant differences in systolic or diastolic blood pressure measurements associated with the sequence of assessment or the setting. There was a significant difference in the overall mean systolic blood pressure between the 2 assessment sequences (group A 122.0 v. group B 127.8 mm Hg, p < 0.001).InterpretationAutomated devices used in pharmacies to measure blood pressure provide accurate and valid information that can be used in the diagnosis and management of hypertension among older adults in the community.Trial registrationwww.controlled-trials.com, no. ISRCTN91799042.

Project description:Purpose To compare the classification of breast density with two automated methods, Volpara (version 1.5.0; Matakina Technology, Wellington, New Zealand) and Quantra (version 2.0; Hologic, Bedford, Mass), with clinical Breast Imaging Reporting and Data System (BI-RADS) density classifications and to examine associations of these measures with breast cancer risk. Materials and Methods In this study, 1911 patients with breast cancer and 4170 control subjects matched for age, race, examination date, and mammography machine were evaluated. Participants underwent mammography at Mayo Clinic or one of four sites within the San Francisco Mammography Registry between 2006 and 2012 and provided informed consent or a waiver for research, in compliance with HIPAA regulations and institutional review board approval. Digital mammograms were retrieved a mean of 2.1 years (range, 6 months to 6 years) before cancer diagnosis, with the corresponding clinical BI-RADS density classifications, and Volpara and Quantra density estimates were generated. Agreement was assessed with weighted ? statistics among control subjects. Breast cancer associations were evaluated with conditional logistic regression, adjusted for age and body mass index. Odds ratios, C statistics, and 95% confidence intervals (CIs) were estimated. Results Agreement between clinical BI-RADS density classifications and Volpara and Quantra BI-RADS estimates was moderate, with ? values of 0.57 (95% CI: 0.55, 0.59) and 0.46 (95% CI: 0.44, 0.47), respectively. Differences of up to 14% in dense tissue classification were found, with Volpara classifying 51% of women as having dense breasts, Quantra classifying 37%, and clinical BI-RADS assessment used to classify 43%. Clinical and automated measures showed similar breast cancer associations; odds ratios for extremely dense breasts versus scattered fibroglandular densities were 1.8 (95% CI: 1.5, 2.2), 1.9 (95% CI: 1.5, 2.5), and 2.3 (95% CI: 1.9, 2.8) for Volpara, Quantra, and BI-RADS classifications, respectively. Clinical BI-RADS assessment showed better discrimination of case status (C = 0.60; 95% CI: 0.58, 0.61) than did Volpara (C = 0.58; 95% CI: 0.56, 0.59) and Quantra (C = 0.56; 95% CI: 0.54, 0.58) BI-RADS classifications. Conclusion Automated and clinical assessments of breast density are similarly associated with breast cancer risk but differ up to 14% in the classification of women with dense breasts. This could have substantial effects on clinical practice patterns. (©) RSNA, 2015 Online supplemental material is available for this article.

Project description:ImportanceThere are concerns with translating results from the Systolic Blood Pressure Intervention Trial (SPRINT) into clinical practice because the standardized protocol used to measure blood pressure (BP) may not be consistently applied in routine clinical practice.ObjectivesTo evaluate the concordance between BPs obtained in routine clinical practice and those obtained using the SPRINT protocol and whether concordance varied by target trial BP.Design, setting, and participantsThis observational prognostic study linking outpatient vital sign information from electronic health records (EHRs) with data from 49 of the 102 SPRINT sites was conducted from November 8, 2010, to August 20, 2015, among 3074 adults 50 years or older with hypertension without diabetes or a history of stroke. Statistical analysis was performed from May 21, 2019, to March 20, 2020.Main outcomes and measuresBlood pressures measured in routine clinical practice and SPRINT.ResultsParticipant-level EHR data was obtained for 3074 participants (2482 men [80.7%]; mean [SD] age, 68.5 [9.1] years) with 3 or more outpatient and trial BP measurements. In the period from the 6-month study visit to the end of the study intervention, the mean systolic BP (SBP) in the intensive treatment group from outpatient BP recorded in the EHR was 7.3 mm Hg higher (95% CI, 7.0-7.6 mm Hg) than BP measured at trial visits; the mean difference between BP recorded in the outpatient EHR and trial SBP was smaller for participants in the standard treatment group (4.6 mm Hg [95% CI, 4.4-4.9 mm Hg]). Bland-Altman analyses demonstrated low agreement between outpatient BP recorded in the EHR and trial BP, with wide agreement intervals ranging from approximately -30 mm Hg to 45 mm Hg in both treatment groups. In addition, the difference between BP recorded in the EHR and trial BP varied widely by site.Conclusions and relevanceOutpatient BPs measured in routine clinical practice were generally higher than BP measurements taken in SPRINT, with greater mean SBP differences apparent in the intensive treatment group. There was a consistent high degree of heterogeneity between the BPs recorded in the EHR and trial BPs, with significant variability over time, between and within the participants, and across clinic sites. These results highlight the importance of proper BP measurement technique and an inability to apply 1 common correction factor (ie, approximately 10 mm Hg) to approximate research-quality BP estimates when BP is not measured appropriately in routine clinical practice.Trial registrationSPRINT ClinicalTrials.gov Identifier: NCT01206062.

Dataset Information

Comparison of automated clinical and research blood pressure measurements: Implications for clinical practice and trial design.

Publications

Comparison of automated clinical and research blood pressure measurements: Implications for clinical practice and trial design.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets