scholarly journals Evaluación crítica y meta-análisis de estudios de variación biológica para albúmina glicosilada, glucosa y HbA1c

2020 ◽  
Vol 1 (3) ◽  
Author(s):  
Carmen Ricós ◽  
Pilar Fernández-Calle ◽  
Elisabet Gonzalez-Lao ◽  
Margarida Simón ◽  
Jorge Díaz-Garzón ◽  
...  
Keyword(s):  
Critical Appraisal ◽  
Biological Variation ◽  
Revisión Sistemática ◽  
Variation Data

ResumenObjetivosA lo largo de los años se han publicado numerosos artículos sobre variación biológica (VB) de diferente calidad. Los objetivos de este trabajo fueron realizar una revisión sistemática y una evaluación crítica de los estudios de VB para albúmina glicosilada y proporcionar datos actualizados de VB para glucosa y HbA1c, incluyendo prestigiosos estudios recientemente publicados como el Estudio de Variación Biológica Europea (EuBIVAS).MétodosSe hizo una búsqueda bibliográfica sistemática para identificar estudios sobre VB, encontrándose 9 estudios no incluidos en la primera revisión: 4 para albúmina glicosilada, 3 para glucosa y 3 para HbA1c. Se realizó una evaluación crítica de los estudios relevantes, utilizando la herramienta Biological Variation Data Critical Appraisal Checklist (BIVAC). Se obtuvieron los estimados globales de VB mediante meta-análisis de los estudios que cumplían los requisitos BIVAC, realizados en individuos sanos con estudios de diseño similar.ResultadosUn estudio recibió el grado A, dos el B y 6 el C. en la mayoría de los casos el grado C se asoció a deficiencias en el análisis estadístico de los datos. Los estimados de VB para albúmina glicosilada fueron: CVI = 1,4%(1,2–2,1) y CVG = 5,7%(4,7–10,6); para HbA1c, CVI = 1,2%(0,3–2,5), CVG = 5,4%(3,3–7,3) y para glucosa, CVI = 5,0%(4,1–12,0), CVG = 8,1%(2,7–10,8) no difirieron de los estimados globales previamente descritos.ConclusionesLa evaluación crítica y clasificación de los estudios de VB a tenor de su calidad metodológica, seguido de un meta-análisis, genera estimados de VB robustos y fiables. Este estudio proporciona datos de VB para albúmina glicolisada, glucosa y HbA1c actualizados y basados en la evidencia científica.

scholarly journals Critical appraisal and meta-analysis of biological variation studies on glycosylated albumin, glucose and HbA1c

2020 ◽  
Vol 1 (3) ◽  
Author(s):  
Carmen Ricós ◽  
Pilar Fernández-Calle ◽  
Elisabet Gonzalez-Lao ◽  
Margarida Simón ◽  
Jorge Díaz-Garzón ◽  
...  
Keyword(s):  
Healthy Subjects ◽  
Critical Appraisal ◽  
Meta Analysis ◽  
Biological Variation ◽  
Evidence Based ◽  
Literature Searches ◽  
Variation Data ◽  
Global Estimates ◽  
Systematic Literature Searches

AbstractObjectivesNumerous biological variation (BV) studies have been performed over the years, but the quality of these studies vary. The objectives of this study were to perform a systematic review and critical appraisal of BV studies on glycosylated albumin and to deliver updated BV estimates for glucose and HbA1c, including recently published high-quality studies such as the European Biological Variation study (EuBIVAS).MethodsSystematic literature searches were performed to identify BV studies. Nine publications not included in a previous review were identified; four for glycosylated albumin, three for glucose, and three for HbA1c. Relevant studies were appraised by the Biological Variation Data Critical Appraisal Checklist (BIVAC). Global BV estimates were derived by meta-analysis of BIVAC-compliant studies in healthy subjects with similar study design.ResultsOne study received BIVAC grade A, 2B, and 6C. In most cases, the C-grade was associated with deficiencies in statistical analysis. BV estimates for glycosylated albumin were: CVI=1.4% (1.2–2.1) and CVG=5.7% (4.7–10.6), whereas estimates for HbA1c, CVI=1.2% (0.3–2.5), CVG=5.4% (3.3–7.3), and glucose, CVI=5.0% (4.1–12.0), CVG=8.1% (2.7–10.8) did not differ from previously published global estimates.ConclusionsThe critical appraisal and rating of BV studies according to their methodological quality, followed by a meta-analysis, generate robust, and reliable BV estimates. This study delivers updated and evidence-based BV estimates for glycosylated albumin, glucose and HbA1c.

scholarly journals The Biological Variation Data Critical Appraisal Checklist: A Standard for Evaluating Studies on Biological Variation

2018 ◽  
Vol 64 (3) ◽  
pp. 501-514 ◽  
Author(s):  
Aasne K Aarsand ◽  
Thomas Røraas ◽  
Pilar Fernandez-Calle ◽  
Carmen Ricos ◽  
Jorge Díaz-Garzón ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Critical Appraisal ◽  
Clinical Chemistry ◽  
Essential Elements ◽  
Biological Variation ◽  
European Federation ◽  
Variation Data ◽  
Global Estimates ◽  
Variance Homogeneity

Abstract BACKGROUND Concern has been raised about the quality of available biological variation (BV) estimates and the effect of their application in clinical practice. A European Federation of Clinical Chemistry and Laboratory Medicine Task and Finish Group has addressed this issue. The aim of this report is to (a) describe the Biological Variation Data Critical Appraisal Checklist (BIVAC), which verifies whether publications have included all essential elements that may impact the veracity of associated BV estimates, (b) use the BIVAC to critically appraise existing BV publications on enzymes, lipids, kidney, and diabetes-related measurands, and (c) apply metaanalysis to deliver a global within-subject BV (CVI) estimate for alanine aminotransferase (ALT). METHODS In the BIVAC, publications were rated as A, B, C, or D, indicating descending compliance for 14 BIVAC quality items, focusing on study design, methodology, and statistical handling. A D grade indicated that associated BV estimates should not be applied in clinical practice. Systematic searches were applied to identify BV studies for 28 different measurands. RESULTS In total, 128 publications were identified, providing 935 different BV estimates. Nine percent achieved D scores. Outlier analysis and variance homogeneity testing were scored as C in >60% of 847 cases. Metaanalysis delivered a CVI estimate for ALT of 15.4%. CONCLUSIONS Application of BIVAC to BV publications identified deficiencies in required study detail and delivery, especially for statistical analysis. Those deficiencies impact the veracity of BV estimates. BV data from BIVAC-compliant studies can be combined to deliver robust global estimates for safe clinical application.

scholarly journals A checklist for critical appraisal of studies of biological variation

2015 ◽  
Vol 53 (6) ◽  
Author(s):  
William A. Bartlett ◽  
Federica Braga ◽  
Anna Carobene ◽  
Abdurrahman Coşkun ◽  
Richard Prusa ◽  
...  
Keyword(s):  
Critical Appraisal ◽  
Clinical Chemistry ◽  
Laboratory Medicine ◽  
Biological Variation ◽  
European Federation ◽  
Data Sets ◽  
Data Set ◽  
Minimum Data ◽  
Effective Transport ◽  
Variation Data

AbstractData 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.

Study of total error specifications of lymphocyte subsets enumeration using China National EQAS data and Biological Variation Data Critical Appraisal Checklist (BIVAC)-compliant publications

2021 ◽  
Vol 59 (1) ◽  
pp. 179-186
Author(s):  
Chenbin Li ◽  
Yu Wang ◽  
Hong Lu ◽  
Zhongli Du ◽  
Chengshan Xu ◽  
...  
Keyword(s):  
Quality Control ◽  
Critical Appraisal ◽  
Total Error ◽  
Reference Intervals ◽  
Biological Variation ◽  
Lymphocyte Subset ◽  
High Concentration ◽  
Variation Data ◽  
Quality Specifications ◽  
Minimum Criteria

AbstractObjectivesIt is important to select proper quality specifications for laboratories and external quality assessment (EQA) providers for their quality control and assessment. The aim of this study is to produce new total error (TE) specifications for lymphocyte subset enumeration by analyzing the allowable TE using EQAS data and comparing them with that based on reliable biological variation (BV).MethodsA total of 54,400 results from 1,716 laboratories were collected from China National EQAS for lymphocyte subset enumeration during the period 2017–2019. The EQA data were grouped according to lower limits of reference intervals for establishing concentration-dependent specifications. The TE value that 80% of laboratories can achieve were considered as TE specifications based on state of the art. The BV studies compliant with Biological Variation Data Critical Appraisal Checklist (BIVAC) were used to calculate the three levels of TE specifications. Then these TE specifications were compared for determining the recommended TE specifications.ResultsFour parameters whose quality specifications could achieve the optimum criteria were as follows: the percentages of CD3+, CD3+CD4+ (high concentration) and CD3–CD16/56+ cells, and the absolute count of CD3–CD16/56+ cells. Only the TE specifications of CD3–CD19+ cells could achieve the minimum criteria. The TE specifications of remaining parameters should reach the desirable criteria.ConclusionsNew TE specifications were established by combining the EQA data and reliable BV data, which could help laboratories to apply proper criteria for continuous improvement of quality control, and EQA providers to use robust acceptance limits for better evaluation of EQAS results.

scholarly journals Harmonization initiatives in the generation, reporting and application of biological variation data

2018 ◽  
Vol 56 (10) ◽  
pp. 1629-1636 ◽  
Author(s):  
Aasne K. Aarsand ◽  
Thomas Røraas ◽  
William A. Bartlett ◽  
Abdurrahman Coşkun ◽  
Anna Carobene ◽  
...  
Keyword(s):  
Critical Appraisal ◽  
Clinical Chemistry ◽  
Meta Analysis ◽  
Laboratory Medicine ◽  
Biological Variation ◽  
Quality Data ◽  
European Federation ◽  
High Quality ◽  
Wide Range ◽  
Variation Data

Abstract Biological variation (BV) data have many applications in laboratory medicine. However, concern has been raised that some BV estimates in use today may be irrelevant or of unacceptable quality. A number of initiatives have been launched by the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) and other parties to deliver a more harmonized practice in the generation, reporting and application of BV data. Resulting from a necessary focus upon the veracity of historical BV studies, critical appraisal and meta-analysis of published BV studies is possible through application of the Biological Variation Data Critical Appraisal Checklist (BIVAC), published in 2017. The BIVAC compliant large-scale European Biological Variation Study delivers updated high-quality BV data for a wide range of measurands. Other significant developments include the publication of a Medical Subject Heading term for BV and recommendations for common terminology for reporting of BV data. In the near future, global BV estimates derived from meta-analysis of BIVAC appraised publications will be accessible in a Biological Variation Database at the EFLM website. The availability of these high-quality data, which have many applications that impact on the quality and interpretation of clinical laboratory results, will afford improved patient care.

scholarly journals Performance Criteria for Testosterone Measurements Based on Biological Variation in Adult Males: Recommendations from the Partnership for the Accurate Testing of Hormones

2012 ◽  
Vol 58 (12) ◽  
pp. 1703-1710 ◽  
Author(s):  
Yeo-Min Yun ◽  
Julianne Cook Botelho ◽  
Donald W Chandler ◽  
Alex Katayev ◽  
William L Roberts ◽  
...  
Keyword(s):  
Total Error ◽  
Full Range ◽  
Biological Variation ◽  
Analytical Performance ◽  
Performance Criteria ◽  
Performance Goals ◽  
Adult Males ◽  
Large Variability ◽  
Wide Range ◽  
Variation Data

BACKGROUND Testosterone measurements that are accurate, reliable, and comparable across methodologies are crucial to improving public health. Current US Food and Drug Administration–cleared testosterone assays have important limitations. We sought to develop assay performance requirements on the basis of biological variation that allow physiologic changes to be distinguished from assay analytical errors. METHODS From literature review, the technical advisory subcommittee of the Partnership for the Accurate Testing of Hormones compiled a database of articles regarding analytical and biological variability of testosterone. These data, mostly from direct immunoassay-based methodologies, were used to specify analytical performance goals derived from within- and between-person variability of testosterone. RESULTS The allowable limits of desirable imprecision and bias on the basis of currently available biological variation data were 5.3% and 6.4%, respectively. The total error goal was 16.7%. From recent College of American Pathologists proficiency survey data, most currently available testosterone assays missed these analytical performance goals by wide margins. Data from the recently established CDC Hormone Standardization program showed that although the overall mean bias of selected certified assays was within 6.4%, individual sample measurements could show large variability in terms of precision, bias, and total error. CONCLUSIONS Because accurate measurement of testosterone across a wide range of concentrations [approximately 2–2000 ng/dL (0.069–69.4 nmol/L)] is important, we recommend using available data on biological variation to calculate performance criteria across the full range of expected values. Additional studies should be conducted to obtain biological variation data on testosterone from women and children, and revisions should be made to the analytical goals for these patient populations.

scholarly journals Within-day biological variation and hour-to-hour reference change values for hematological parameters

2017 ◽  
Vol 55 (7) ◽  
Author(s):  
Judith M. Hilderink ◽  
Lieke J.J. Klinkenberg ◽  
Kristin M. Aakre ◽  
Norbert C.J. de Wit ◽  
Yvonne M.C. Henskens ◽  
...  
Keyword(s):  
Hematological Parameters ◽  
Biological Variation ◽  
Natural Fluctuation ◽  
Sample Collection ◽  
Blood Samples ◽  
Variation Data ◽  
Random Fluctuations ◽  
Analytical Variation ◽  
Variability Data

AbstractBackground:Middle- and long-term biological variation data for hematological parameters have been reported in the literature. Within-day 24-h variability profiles for hematological parameters are currently lacking. However, comprehensive hour-to-hour variability data are critical to detect diurnal cyclical rhythms, and to take into account the ‘time of sample collection’ as a possible determinant of natural fluctuation. In this study, we assessed 24-h variation profiles for 20 hematological parameters.Methods:Blood samples were collected under standardized conditions from 24 subjects every hour for 24 h. At each measurement, 20 hematological parameters were determined in duplicate. Analytical variation (CVResults:All parameters showed higher CVConclusions:We present complete 24-h variability profiles for 20 hematological parameters. Hour-to-hour reference changes values may help to better discriminate between random fluctuations and true changes in parameters with rhythmic diurnal oscillations.

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