Misclassification and discordance of measured blood pressure from patient's true blood pressure in current clinical practice

A clinical trial simulation case study

Yuyan Jin, Robert Bies, Marc R. Gastonguay, Norman Stockbridge, Jogarao Gobburu, Rajanikanth Madabushi

Research output: Contribution to journalArticle

12 Citations (Scopus)

Abstract

Treatment decisions for hypertension using sphygmomanometer based measurements and the current clinical practice paradigm do not account for the timing of blood pressure (BP) measurement. This study aimed to evaluate the clinical implications of discordance between measured and true BP, to quantify BP misclassification rate at a typical clinical visit in current clinical practice, and to propose a BP calibration systemto decrease the impact of timing ofBP measurement. A clinical trial simulation case study was performed using an in silico Monte Carlo Simulation approach. The time-courses ofBPs with andwithout an antihypertensive treatment effect were simulated from a baseline BP model combined with an antihypertensive PK/PD model. Virtual subject characteristics were sampled from the FDA internal database.The baselineBPmodelwas qualified using observed 24 h ambulatory BP monitoring (ABPM) data from 225 subjects by a visual predictive check as well as a global sensitivity analysis. First of all, our results showed that the measured cuffBP in current typical clinical practice deviated from the true values. (1) Cuff BP deviated from the true values by more than 5 mmHg in 57 % (95 % CI: 54-61 %) of patients and more than 10 mmHg in 26 % (95 % CI: 22-32 %) of patients respectively. (2) These discordances were reduced to 28 % (deviation ≥5 mmHg, 95 % CI: 18-40 %) and 9 % (deviation ≥10 mmHg, 95 % CI: 4-18%) of patients assuming perfect sphygmomanometer measurement and thus represent the contribution of ignoring the daily circadian rhythm ofBP. Secondly, our results showed 23-32 %of patientswere misclassified to an incorrect BP category for a casual clinical visit based on JNC7 guideline. In addition, the accuracy of the measured cuff BP varied by time of clinic visit. Specifically, 11:00 AM to 3:00 PM was identified to be the better time frame,while times before 9:00 AMwere theworst time frame. Therefore, clinic visit time may need to be adjusted accordingly. Finally, we proposed an easy BP calibrationmethod for clinic use to adjust for time of day differences due to circadian variability in case that the desirable clinic visit time cannot be tailored for practical reasons.

Original languageEnglish
Pages (from-to)283-294
Number of pages12
JournalJournal of Pharmacokinetics and Pharmacodynamics
Volume39
Issue number3
DOIs
StatePublished - Jun 2012

Fingerprint

Clinical Trials
Blood Pressure
Ambulatory Care
Sphygmomanometers
Antihypertensive Agents
Ambulatory Blood Pressure Monitoring
Circadian Rhythm
Computer Simulation
Calibration
Databases
Guidelines
Hypertension
Therapeutics

Keywords

  • Blood pressure calibration
  • Blood pressure misclassification
  • Circadian rhythm
  • Hypertension
  • Modeling and simulation
  • Public health
  • Sphygmomanometer

ASJC Scopus subject areas

  • Pharmacology

Cite this

Misclassification and discordance of measured blood pressure from patient's true blood pressure in current clinical practice : A clinical trial simulation case study. / Jin, Yuyan; Bies, Robert; Gastonguay, Marc R.; Stockbridge, Norman; Gobburu, Jogarao; Madabushi, Rajanikanth.

In: Journal of Pharmacokinetics and Pharmacodynamics, Vol. 39, No. 3, 06.2012, p. 283-294.

Research output: Contribution to journalArticle

@article{362cb44824db479cad7c9cc73a910dc2,
title = "Misclassification and discordance of measured blood pressure from patient's true blood pressure in current clinical practice: A clinical trial simulation case study",
abstract = "Treatment decisions for hypertension using sphygmomanometer based measurements and the current clinical practice paradigm do not account for the timing of blood pressure (BP) measurement. This study aimed to evaluate the clinical implications of discordance between measured and true BP, to quantify BP misclassification rate at a typical clinical visit in current clinical practice, and to propose a BP calibration systemto decrease the impact of timing ofBP measurement. A clinical trial simulation case study was performed using an in silico Monte Carlo Simulation approach. The time-courses ofBPs with andwithout an antihypertensive treatment effect were simulated from a baseline BP model combined with an antihypertensive PK/PD model. Virtual subject characteristics were sampled from the FDA internal database.The baselineBPmodelwas qualified using observed 24 h ambulatory BP monitoring (ABPM) data from 225 subjects by a visual predictive check as well as a global sensitivity analysis. First of all, our results showed that the measured cuffBP in current typical clinical practice deviated from the true values. (1) Cuff BP deviated from the true values by more than 5 mmHg in 57 {\%} (95 {\%} CI: 54-61 {\%}) of patients and more than 10 mmHg in 26 {\%} (95 {\%} CI: 22-32 {\%}) of patients respectively. (2) These discordances were reduced to 28 {\%} (deviation ≥5 mmHg, 95 {\%} CI: 18-40 {\%}) and 9 {\%} (deviation ≥10 mmHg, 95 {\%} CI: 4-18{\%}) of patients assuming perfect sphygmomanometer measurement and thus represent the contribution of ignoring the daily circadian rhythm ofBP. Secondly, our results showed 23-32 {\%}of patientswere misclassified to an incorrect BP category for a casual clinical visit based on JNC7 guideline. In addition, the accuracy of the measured cuff BP varied by time of clinic visit. Specifically, 11:00 AM to 3:00 PM was identified to be the better time frame,while times before 9:00 AMwere theworst time frame. Therefore, clinic visit time may need to be adjusted accordingly. Finally, we proposed an easy BP calibrationmethod for clinic use to adjust for time of day differences due to circadian variability in case that the desirable clinic visit time cannot be tailored for practical reasons.",
keywords = "Blood pressure calibration, Blood pressure misclassification, Circadian rhythm, Hypertension, Modeling and simulation, Public health, Sphygmomanometer",
author = "Yuyan Jin and Robert Bies and Gastonguay, {Marc R.} and Norman Stockbridge and Jogarao Gobburu and Rajanikanth Madabushi",
year = "2012",
month = "6",
doi = "10.1007/s10928-012-9250-8",
language = "English",
volume = "39",
pages = "283--294",
journal = "Journal of Pharmacokinetics and Pharmacodynamics",
issn = "1567-567X",
publisher = "Springer New York",
number = "3",

}

TY - JOUR

T1 - Misclassification and discordance of measured blood pressure from patient's true blood pressure in current clinical practice

T2 - A clinical trial simulation case study

AU - Jin, Yuyan

AU - Bies, Robert

AU - Gastonguay, Marc R.

AU - Stockbridge, Norman

AU - Gobburu, Jogarao

AU - Madabushi, Rajanikanth

PY - 2012/6

Y1 - 2012/6

N2 - Treatment decisions for hypertension using sphygmomanometer based measurements and the current clinical practice paradigm do not account for the timing of blood pressure (BP) measurement. This study aimed to evaluate the clinical implications of discordance between measured and true BP, to quantify BP misclassification rate at a typical clinical visit in current clinical practice, and to propose a BP calibration systemto decrease the impact of timing ofBP measurement. A clinical trial simulation case study was performed using an in silico Monte Carlo Simulation approach. The time-courses ofBPs with andwithout an antihypertensive treatment effect were simulated from a baseline BP model combined with an antihypertensive PK/PD model. Virtual subject characteristics were sampled from the FDA internal database.The baselineBPmodelwas qualified using observed 24 h ambulatory BP monitoring (ABPM) data from 225 subjects by a visual predictive check as well as a global sensitivity analysis. First of all, our results showed that the measured cuffBP in current typical clinical practice deviated from the true values. (1) Cuff BP deviated from the true values by more than 5 mmHg in 57 % (95 % CI: 54-61 %) of patients and more than 10 mmHg in 26 % (95 % CI: 22-32 %) of patients respectively. (2) These discordances were reduced to 28 % (deviation ≥5 mmHg, 95 % CI: 18-40 %) and 9 % (deviation ≥10 mmHg, 95 % CI: 4-18%) of patients assuming perfect sphygmomanometer measurement and thus represent the contribution of ignoring the daily circadian rhythm ofBP. Secondly, our results showed 23-32 %of patientswere misclassified to an incorrect BP category for a casual clinical visit based on JNC7 guideline. In addition, the accuracy of the measured cuff BP varied by time of clinic visit. Specifically, 11:00 AM to 3:00 PM was identified to be the better time frame,while times before 9:00 AMwere theworst time frame. Therefore, clinic visit time may need to be adjusted accordingly. Finally, we proposed an easy BP calibrationmethod for clinic use to adjust for time of day differences due to circadian variability in case that the desirable clinic visit time cannot be tailored for practical reasons.

AB - Treatment decisions for hypertension using sphygmomanometer based measurements and the current clinical practice paradigm do not account for the timing of blood pressure (BP) measurement. This study aimed to evaluate the clinical implications of discordance between measured and true BP, to quantify BP misclassification rate at a typical clinical visit in current clinical practice, and to propose a BP calibration systemto decrease the impact of timing ofBP measurement. A clinical trial simulation case study was performed using an in silico Monte Carlo Simulation approach. The time-courses ofBPs with andwithout an antihypertensive treatment effect were simulated from a baseline BP model combined with an antihypertensive PK/PD model. Virtual subject characteristics were sampled from the FDA internal database.The baselineBPmodelwas qualified using observed 24 h ambulatory BP monitoring (ABPM) data from 225 subjects by a visual predictive check as well as a global sensitivity analysis. First of all, our results showed that the measured cuffBP in current typical clinical practice deviated from the true values. (1) Cuff BP deviated from the true values by more than 5 mmHg in 57 % (95 % CI: 54-61 %) of patients and more than 10 mmHg in 26 % (95 % CI: 22-32 %) of patients respectively. (2) These discordances were reduced to 28 % (deviation ≥5 mmHg, 95 % CI: 18-40 %) and 9 % (deviation ≥10 mmHg, 95 % CI: 4-18%) of patients assuming perfect sphygmomanometer measurement and thus represent the contribution of ignoring the daily circadian rhythm ofBP. Secondly, our results showed 23-32 %of patientswere misclassified to an incorrect BP category for a casual clinical visit based on JNC7 guideline. In addition, the accuracy of the measured cuff BP varied by time of clinic visit. Specifically, 11:00 AM to 3:00 PM was identified to be the better time frame,while times before 9:00 AMwere theworst time frame. Therefore, clinic visit time may need to be adjusted accordingly. Finally, we proposed an easy BP calibrationmethod for clinic use to adjust for time of day differences due to circadian variability in case that the desirable clinic visit time cannot be tailored for practical reasons.

KW - Blood pressure calibration

KW - Blood pressure misclassification

KW - Circadian rhythm

KW - Hypertension

KW - Modeling and simulation

KW - Public health

KW - Sphygmomanometer

UR - http://www.scopus.com/inward/record.url?scp=84865491867&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84865491867&partnerID=8YFLogxK

U2 - 10.1007/s10928-012-9250-8

DO - 10.1007/s10928-012-9250-8

M3 - Article

VL - 39

SP - 283

EP - 294

JO - Journal of Pharmacokinetics and Pharmacodynamics

JF - Journal of Pharmacokinetics and Pharmacodynamics

SN - 1567-567X

IS - 3

ER -