Biologically implausible carotid intima-media thickness measurement values: effects on rate of change over time

Sanne A E Peters; Hester M den Ruijter; Mike K Palmer; Diederick E Grobbee; John R Crouse; Daniel H. O'Leary; Gregory W Evans; Joel S Raichlen; Michiel L Bots

doi:10.1185/03007995.2012.689255

Biologically implausible carotid intima-media thickness measurement values: effects on rate of change over time

Sanne A E Peters, Hester M den Ruijter, Mike K Palmer, Diederick E Grobbee, John R Crouse, Daniel H. O'Leary, Gregory W Evans, Joel S Raichlen, Michiel L Bots,

Research output: Contribution to journal › Article › Academic › peer-review

Abstract

OBJECTIVE: Carotid intima-media thickness (CIMT) is a marker of atherosclerosis that is commonly used to assess the effect of therapeutic interventions. It is currently unclear to what extent biologically implausible values affect treatment effects. We evaluated the impact of biologically implausible CIMT values on the estimated rate of change in CIMT.

METHODS: Data were used from the METEOR (Measuring Effects on Intima-media Thickness: an Evaluation of Rosuvastatin) trial. METEOR was a randomized, placebo-controlled trial showing that rosuvastatin reduced the 2-year change in CIMT among low-risk individuals with subclinical atherosclerosis. In the main METEOR analysis, the data were analyzed without exclusion of biologically implausible data. In this post-hoc analysis, we constructed twelve definitions to define mildly or extremely biologically implausible values using distance from the interquartile range, median or mean. We evaluated the effect of removing implausible values on the estimated rate of change in CIMT.

RESULTS: The percentage of biologically implausible CIMT values ranged from 0.6% to 9.7%, depending on the definition used. Across all definitions, removal of biologically implausible CIMT values marginally reduced standard errors and did not change the primary outcome (i.e., a nonsignificant change in the rosuvastatin group, significant progression in the placebo group, and a statistically significant difference between treatment groups).

LIMITATION: This study was focussed on the impact of implausible values in the analytical part of a CIMT study. Ultrasound images were not re-examined to determine whether an implausible measurement was due to measurement error or temporal morphological thickening,

CONCLUSION: Removal of biologically implausible CIMT values marginally decreased the variability of the estimated rate of change in CIMT without having a large impact on the estimated rate of change.

Original language	English
Pages (from-to)	891-899
Number of pages	9
Journal	Current Medical Research and Opinion
Volume	28
Issue number	6
DOIs	https://doi.org/10.1185/03007995.2012.689255
Publication status	Published - 2012

Keywords

Anticholesteremic Agents
Atherosclerosis
Carotid Intima-Media Thickness
Disease Progression
Double-Blind Method
Female
Fluorobenzenes
Humans
Male
Middle Aged
Placebos
Predictive Value of Tests
Pyrimidines
Randomized Controlled Trials as Topic
Rosuvastatin Calcium
Sulfonamides
Time Factors
Tunica Intima
Journal Article
Research Support, Non-U.S. Gov't

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10.1185/03007995.2012.689255

http://www.ncbi.nlm.nih.gov/pubmed/22536884

Cite this

@article{91562d10d2674fb9961b2be3c88e6739,

title = "Biologically implausible carotid intima-media thickness measurement values: effects on rate of change over time",

abstract = "OBJECTIVE: Carotid intima-media thickness (CIMT) is a marker of atherosclerosis that is commonly used to assess the effect of therapeutic interventions. It is currently unclear to what extent biologically implausible values affect treatment effects. We evaluated the impact of biologically implausible CIMT values on the estimated rate of change in CIMT.METHODS: Data were used from the METEOR (Measuring Effects on Intima-media Thickness: an Evaluation of Rosuvastatin) trial. METEOR was a randomized, placebo-controlled trial showing that rosuvastatin reduced the 2-year change in CIMT among low-risk individuals with subclinical atherosclerosis. In the main METEOR analysis, the data were analyzed without exclusion of biologically implausible data. In this post-hoc analysis, we constructed twelve definitions to define mildly or extremely biologically implausible values using distance from the interquartile range, median or mean. We evaluated the effect of removing implausible values on the estimated rate of change in CIMT.RESULTS: The percentage of biologically implausible CIMT values ranged from 0.6% to 9.7%, depending on the definition used. Across all definitions, removal of biologically implausible CIMT values marginally reduced standard errors and did not change the primary outcome (i.e., a nonsignificant change in the rosuvastatin group, significant progression in the placebo group, and a statistically significant difference between treatment groups).LIMITATION: This study was focussed on the impact of implausible values in the analytical part of a CIMT study. Ultrasound images were not re-examined to determine whether an implausible measurement was due to measurement error or temporal morphological thickening,CONCLUSION: Removal of biologically implausible CIMT values marginally decreased the variability of the estimated rate of change in CIMT without having a large impact on the estimated rate of change.",

keywords = "Anticholesteremic Agents, Atherosclerosis, Carotid Intima-Media Thickness, Disease Progression, Double-Blind Method, Female, Fluorobenzenes, Humans, Male, Middle Aged, Placebos, Predictive Value of Tests, Pyrimidines, Randomized Controlled Trials as Topic, Rosuvastatin Calcium, Sulfonamides, Time Factors, Tunica Intima, Journal Article, Research Support, Non-U.S. Gov't",

author = "Peters, {Sanne A E} and {den Ruijter}, {Hester M} and Palmer, {Mike K} and Grobbee, {Diederick E} and Crouse, {John R} and O'Leary, {Daniel H.} and Evans, {Gregory W} and Raichlen, {Joel S} and Bots, {Michiel L}",

year = "2012",

doi = "10.1185/03007995.2012.689255",

language = "English",

volume = "28",

pages = "891--899",

journal = "Current Medical Research and Opinion",

issn = "0300-7995",

publisher = "Informa Healthcare",

number = "6",

}

TY - JOUR

T1 - Biologically implausible carotid intima-media thickness measurement values

T2 - effects on rate of change over time

AU - Peters, Sanne A E

AU - den Ruijter, Hester M

AU - Palmer, Mike K

AU - Grobbee, Diederick E

AU - Crouse, John R

AU - O'Leary, Daniel H.

AU - Evans, Gregory W

AU - Raichlen, Joel S

AU - Bots, Michiel L

PY - 2012

Y1 - 2012

N2 - OBJECTIVE: Carotid intima-media thickness (CIMT) is a marker of atherosclerosis that is commonly used to assess the effect of therapeutic interventions. It is currently unclear to what extent biologically implausible values affect treatment effects. We evaluated the impact of biologically implausible CIMT values on the estimated rate of change in CIMT.METHODS: Data were used from the METEOR (Measuring Effects on Intima-media Thickness: an Evaluation of Rosuvastatin) trial. METEOR was a randomized, placebo-controlled trial showing that rosuvastatin reduced the 2-year change in CIMT among low-risk individuals with subclinical atherosclerosis. In the main METEOR analysis, the data were analyzed without exclusion of biologically implausible data. In this post-hoc analysis, we constructed twelve definitions to define mildly or extremely biologically implausible values using distance from the interquartile range, median or mean. We evaluated the effect of removing implausible values on the estimated rate of change in CIMT.RESULTS: The percentage of biologically implausible CIMT values ranged from 0.6% to 9.7%, depending on the definition used. Across all definitions, removal of biologically implausible CIMT values marginally reduced standard errors and did not change the primary outcome (i.e., a nonsignificant change in the rosuvastatin group, significant progression in the placebo group, and a statistically significant difference between treatment groups).LIMITATION: This study was focussed on the impact of implausible values in the analytical part of a CIMT study. Ultrasound images were not re-examined to determine whether an implausible measurement was due to measurement error or temporal morphological thickening,CONCLUSION: Removal of biologically implausible CIMT values marginally decreased the variability of the estimated rate of change in CIMT without having a large impact on the estimated rate of change.

AB - OBJECTIVE: Carotid intima-media thickness (CIMT) is a marker of atherosclerosis that is commonly used to assess the effect of therapeutic interventions. It is currently unclear to what extent biologically implausible values affect treatment effects. We evaluated the impact of biologically implausible CIMT values on the estimated rate of change in CIMT.METHODS: Data were used from the METEOR (Measuring Effects on Intima-media Thickness: an Evaluation of Rosuvastatin) trial. METEOR was a randomized, placebo-controlled trial showing that rosuvastatin reduced the 2-year change in CIMT among low-risk individuals with subclinical atherosclerosis. In the main METEOR analysis, the data were analyzed without exclusion of biologically implausible data. In this post-hoc analysis, we constructed twelve definitions to define mildly or extremely biologically implausible values using distance from the interquartile range, median or mean. We evaluated the effect of removing implausible values on the estimated rate of change in CIMT.RESULTS: The percentage of biologically implausible CIMT values ranged from 0.6% to 9.7%, depending on the definition used. Across all definitions, removal of biologically implausible CIMT values marginally reduced standard errors and did not change the primary outcome (i.e., a nonsignificant change in the rosuvastatin group, significant progression in the placebo group, and a statistically significant difference between treatment groups).LIMITATION: This study was focussed on the impact of implausible values in the analytical part of a CIMT study. Ultrasound images were not re-examined to determine whether an implausible measurement was due to measurement error or temporal morphological thickening,CONCLUSION: Removal of biologically implausible CIMT values marginally decreased the variability of the estimated rate of change in CIMT without having a large impact on the estimated rate of change.

KW - Anticholesteremic Agents

KW - Atherosclerosis

KW - Carotid Intima-Media Thickness

KW - Disease Progression

KW - Double-Blind Method

KW - Female

KW - Fluorobenzenes

KW - Humans

KW - Male

KW - Middle Aged

KW - Placebos

KW - Predictive Value of Tests

KW - Pyrimidines

KW - Randomized Controlled Trials as Topic

KW - Rosuvastatin Calcium

KW - Sulfonamides

KW - Time Factors

KW - Tunica Intima

KW - Journal Article

KW - Research Support, Non-U.S. Gov't

U2 - 10.1185/03007995.2012.689255

DO - 10.1185/03007995.2012.689255

M3 - Article

C2 - 22536884

SN - 0300-7995

VL - 28

SP - 891

EP - 899

JO - Current Medical Research and Opinion

JF - Current Medical Research and Opinion

IS - 6

ER -

Biologically implausible carotid intima-media thickness measurement values: effects on rate of change over time

Abstract

Keywords

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