Critical Review of Current Approaches for Echocardiographic Reproducibility and Reliability Assessment in Clinical Research.

Crowley, Anna Lisa; Yow, Eric; Barnhart, Huiman X; Daubert, Melissa A; Bigelow, Robert; Sullivan, Daniel C; Pencina, Michael; Douglas, Pamela S

Critical Review of Current Approaches for Echocardiographic Reproducibility and Reliability Assessment in Clinical Research.

dc.contributor.author	Crowley, Anna Lisa
dc.contributor.author	Yow, Eric
dc.contributor.author	Barnhart, Huiman X
dc.contributor.author	Daubert, Melissa A
dc.contributor.author	Bigelow, Robert
dc.contributor.author	Sullivan, Daniel C
dc.contributor.author	Pencina, Michael
dc.contributor.author	Douglas, Pamela S
dc.date.accessioned	2021-04-01T22:06:17Z
dc.date.available	2021-04-01T22:06:17Z
dc.date.issued	2016-12
dc.date.updated	2021-04-01T22:06:16Z
dc.description.abstract	Background There is no broadly accepted standard method for assessing the quality of echocardiographic measurements in clinical research reports, despite the recognized importance of this information in assessing the quality of study results. Methods Twenty unique clinical studies were identified reporting echocardiographic data quality for determinations of left ventricular (LV) volumes (n = 13), ejection fraction (n = 12), mass (n = 9), outflow tract diameter (n = 3), and mitral Doppler peak early velocity (n = 4). To better understand the range of possible estimates of data quality and to compare their utility, reported reproducibility measures were tabulated, and de novo estimates were then calculated for missing measures, including intraclass correlation coefficient (ICC), 95% limits of agreement, coefficient of variation (CV), coverage probability, and total deviation index, for each variable for each study. Results The studies varied in approaches to reproducibility testing, sample size, and metrics assessed and values reported. Reported metrics included mean difference and its SD (n = 7 studies), ICC (n = 5), CV (n = 4), and Bland-Altman limits of agreement (n = 4). Once de novo estimates of all missing indices were determined, reasonable reproducibility targets for each were identified as those achieved by the majority of studies. These included, for LV end-diastolic volume, ICC > 0.95, CV < 7%, and coverage probability > 0.93 within 30 mL; for LV ejection fraction, ICC > 0.85, CV < 8%, and coverage probability > 0.85 within 10%; and for LV mass, ICC > 0.85, CV < 10%, and coverage probability > 0.60 within 20 g. Conclusions Assessment of data quality in echocardiographic clinical research is infrequent, and methods vary substantially. A first step to standardizing echocardiographic quality reporting is to standardize assessments and reporting metrics. Potential benefits include clearer communication of data quality and the identification of achievable targets to benchmark quality improvement initiatives.
dc.identifier	S0894-7317(16)30397-2
dc.identifier.issn	0894-7317
dc.identifier.issn	1097-6795
dc.identifier.uri	https://hdl.handle.net/10161/22519
dc.language	eng
dc.publisher	Elsevier BV
dc.relation.ispartof	Journal of the American Society of Echocardiography : official publication of the American Society of Echocardiography
dc.relation.isversionof	10.1016/j.echo.2016.08.006
dc.subject	Image Enhancement
dc.subject	Echocardiography
dc.subject	Sensitivity and Specificity
dc.subject	Reproducibility of Results
dc.subject	Evidence-Based Medicine
dc.subject	Biomedical Research
dc.subject	Quality Assurance, Health Care
dc.subject	Practice Guidelines as Topic
dc.subject	Data Accuracy
dc.title	Critical Review of Current Approaches for Echocardiographic Reproducibility and Reliability Assessment in Clinical Research.
dc.type	Journal article
duke.contributor.orcid	Barnhart, Huiman X\|0000-0003-0988-3439
duke.contributor.orcid	Daubert, Melissa A\|0000-0002-8485-565X
duke.contributor.orcid	Sullivan, Daniel C\|0000-0002-7556-5650
duke.contributor.orcid	Pencina, Michael\|0000-0001-5798-8855\|0000-0002-1968-2641
duke.contributor.orcid	Douglas, Pamela S\|0000-0001-9876-4049
pubs.begin-page	1144
pubs.end-page	1154.e7
pubs.issue	12
pubs.organisational-group	School of Medicine
pubs.organisational-group	Duke Clinical Research Institute
pubs.organisational-group	Radiology
pubs.organisational-group	Duke
pubs.organisational-group	Institutes and Centers
pubs.organisational-group	Clinical Science Departments
pubs.organisational-group	Biostatistics & Bioinformatics
pubs.organisational-group	Basic Science Departments
pubs.organisational-group	Medicine, Cardiology
pubs.organisational-group	Medicine
pubs.publication-status	Published
pubs.volume	29