Confidence Intervals and Power Calculations for Within-Person Biological Variation: Effect of Analytical Imprecision, Number of Replicates, Number of Samples, and Number of Individuals

Røraas, Thomas; Petersen, Per Hyltoft; Sandberg, Sverre

doi:10.1373/clinchem.2012.187781

Cited by 115 publications

(87 citation statements)

References 13 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…The power of the study to identify indices of biological variation should be calculated and presented b [26]. Outlier analysis 4.1 (C) Outliers should be excluded from the final analysis of the data.…”

Section: Discussionmentioning

confidence: 99%

“…It should apply equally to laboratory based measurements and quantitative physiological measurements (e.g., blood pressure). Compliance with the checklist will enable authors, reviewers and journal editors to assure that studies are fit for purpose, appropriately powered [26], share common terminology [13] and deliver estimates of BV accompanied by key metadata required to enable valid application of the BVD described [20][21][22]. Use of BV estimates accompanied by an MDS outlined in Table 2, delivers key metadata to enable transportability of data and further enable compilation of a database of BVD for use in setting of quality standards and other applications.…”

Section: Discussionmentioning

confidence: 99%

“…Power of the study and confidence limits around estimates of biological variation should be presented [26]. The results section should clearly identify the results of outlier analysis undertaken and confirm homogeneity of the data sets.…”

Section: (D)mentioning

confidence: 97%

“…Sampling 3.5 (C) Sampling protocols (e.g., subject preparation, sampling conditions) that minimise pre-analytical variation should be adequately described to enable transportability of the data [25]. Numbers of samples taken should be sufficient to deliver the required power to the study [25,26]. Samples 3.6 (C) Recorded details should include the beginning and end date of the study and timings of sampling.…”

Section: Section and Topic Item # (Mds Domain Mapping: A-f) A Evidencedmentioning

confidence: 99%

See 3 more Smart Citations

A checklist for critical appraisal of studies of biological variation

Bartlett

Braga

Carobene

et al. 2015

Clinical Chemistry and Laboratory Medicine (CCLM)

Self Cite

124

View full text Add to dashboard Cite

Data on biological variation are used for many purposes in laboratory medicine but concern exists over the validity of the data reported in some studies. A critical appraisal checklist has been produced by a working group established by the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) to enable standardised assessment of existing and future publications of biological variation data. The checklist identifies key elements to be reported in studies to enable safe accurate and effective transport of biological variation data sets across healthcare systems. The checklist is mapped to the domains of a minimum data set required to enable this process.

show abstract

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: (D)mentioning

confidence: 97%

Section: Section and Topic Item # (Mds Domain Mapping: A-f) A Evidencedmentioning

confidence: 99%

See 2 more Smart Citations

A checklist for critical appraisal of studies of biological variation

Bartlett

Braga

Carobene

et al. 2015

Clinical Chemistry and Laboratory Medicine (CCLM)

Self Cite

124

View full text Add to dashboard Cite

show abstract

“…That study was carried out with 10 subjects, five samples taken per subject, and the samples were measured in only one replicate. The absence of a duplicate measurement meant that it was not possible to calculate 95% confidence interval (CI) around the CV I by application of the method published by Roraas et al [21]. The lack of CI on BV data means that it was not possible to meaningfully compare these values with new values from another new study that is as yet not included in the BV-DB [22].…”

Section: Glycated Albuminmentioning

confidence: 99%

Reliability of biological variation data available in an online database: need for improvement

Carobene¹

2015

Clinical Chemistry and Laboratory Medicine (CCLM)

View full text Add to dashboard Cite

Background: Biological variation (BV) data enable assessment of the significance of changes in serial measurements observed within a subject and are used to set analytical quality specifications. This data is available in a database held in Westgard website (http://www.westgard.com/biodatabase1.htm). Some limitations of this data, however, have been identified in recent published reviews. The aim of this paper is to show the reliability of the published BV data and to identify ongoing works to address some of its limitations. Methods: The BV data currently hosted on the Westgard website was examined. Distribution of measurands stratified by the number of cited references upon which the database entry is based and the distribution of papers stratified by publication year, are shown. Moreover, BV data available in literature for glycated hemoglobin, C-reactive protein, glycated albumin, alanine aminotransferase, aspartate aminotransferase and γ-glutamyl transferase are evaluated. Results:The results obtained show that most BV data come just from a few papers or only one paper and that a lot of publications are dated, therefore this data is too obsolete to be used. Furthermore critical review of the BV database highlights a number of factors that might impact on the reliability of the BV data entries and translation into current practice. Conclusions: A number of issues clearly undermine the value of the current database. These issues are being considered by the European Federation of Clinical Chemistry and Laboratory Medicine, biological variation working

show abstract