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Evidence-based proposal for the number of ambulatory readings required for assessing blood pressure level in research settings: an analysis of the IDACO database

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posted on 2019-04-10, 12:55 authored by Wen-Yi Yang, Lutgarde Thijs, Zhen-Yu Zhang, Kei Asayama, José Boggia, Tine W. Hansen, Takayoshi Ohkubo, Jørgen Jeppesen, Katarzyna Stolarz-Skrzypek, Sofia Malyutina, Edoardo Casiglia, Yuri Nikitin, Yan Li, Ji-Guang Wang, Yutaka Imai, Kalina Kawecka-Jaszcz, Eoin O’Brien, Jan A. Staessen

Background: Guidelines on the required number of ambulatory blood pressure (ABP) readings focus on individual patients. Clinical researchers often face the dilemma of applying recommendations and discarding potentially valuable information or accepting fewer readings.

Methods: Starting from ABP recordings with ≥30/≥10 awake/asleep readings in 4277 participants enrolled in eight population studies in the International Database on Ambulatory Blood Pressure in Relation to Cardiovascular Outcomes (IDACO), we randomly selected a certain number of readings (from 30 to 1 awake and 10 to 1 asleep readings) at a time over 1000 bootstraps at each step. We evaluated: (i) concordance of the ABP level; (ii) consistency of the cross-classification based on office blood pressure and ABP; and (iii) accuracy in predicting cardiovascular complications. For each criterion, we fitted a regression line joining data points relating outcome to the number of readings covering the ranges of 30-20/10-7 for awake/asleep readings.

Results: Reducing readings widened the SD of the systolic/diastolic differences between full (reference) and selected recordings from 1.7/1.2 (30 readings) to 14.3/10.3 mm Hg (single reading) during wakefulness, and from 1.9/1.4 to 10.3/7.7 mm Hg during sleep; lowered the κ statistic from 0.94 to 0.63, and decreased the hazard ratio associated with 10/5 mm Hg increments in systolic/diastolic ABP from 1.21/1.14 to 1.06/1.04 during wakefulness and from 1.26/1.17 to 1.14/1.08 during sleep. The first data points falling off these regression lines during wakefulness/sleep corresponded to 8/3 and 8/4 readings for criteria (i) and (iii) and to 5 awake readings for criterion (ii).

Conclusions: 24-h ambulatory recordings with ≥8/≥4 awake/asleep readings yielded ABP levels similar to recordings including the guideline-recommended ≥20/≥7 readings. These criteria save valuable data in a research setting, but are not applicable to clinical practice.

Funding

The European Union (HEALTH-F7-305507 HOMAGE), the European Research Council (Advanced Researcher Grant 2011-294713-EPLORE and Proof-of-Concept Grant 713601-uPROPHET), the European Research Area Net for Cardiovascular Diseases (JTC2017-046-PROACT), and the Fonds voor Wetenschappelijk Onderzoek Vlaanderen, Ministry of the Flemish Community, Brussels, Belgium (G.0881.13) currently support the Studies Coordinating Centre in Leuven. The European Union (grants LSHM-CT-2006–037093 and HEALTH-F4-2007–201550) also supported the research groups in Shanghai, Kraków, Padova, and Novosibirsk. The Ohasama study received support via a Grant-in-Aid for Scientific Research (23249036, 23390171, 24390084, 24591060, 24790654, 25253059, 25461083, 25461205, 25860156, 26282200, 26860093, 16H05243, 16K09472, 16K11850, and 16K15359) from the Ministry of Education, Culture, Sports, Science, and Technology, Japan; a Grant-in-Aid from the Japan Society for the Promotion of Science (JSPS) fellows (25*7756, 25*9328, 26*857, and 27*656); the Japan Arteriosclerosis Prevention Fund; an Intramural Research Fund (22-4-5) for Cardiovascular Diseases of National Cerebral and Cardiovascular Center; and a Health Labor Sciences Research Grant (H26-Junkankitou [Seisaku]-Ippan-001) from the Ministry of Health, Labor, and Welfare, Japan. The Asociación Española Primera en Salud supported the research group in Montevideo. The Danish Heart Foundation (grant 01-2-9-9A-22914) and the Lundbeck Fonden (grant R32-A2740) supported the studies in Copenhagen. The National Natural Science Foundation of China (grants 81170245, 81270373, 81470533, and 91639203), the Ministry of Science and Technology (2013CB530700 and a grant for China-European Union collaborations [1012]), Beijing, China, and the Shanghai Commissions of Science and Technology (grants 14ZR1436200 and 15XD1503200) and Education (Gaofeng Clinical Medicine Grant Support 20152503) supported the JingNing study in China. The funding source had no role i

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