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 Systematic review and meta-analysis of within-subject and between-subject biological variation estimates of 20 haematological parameters

2019 ◽  
Vol 58 (1) ◽  
pp. 25-32 ◽  
Author(s):  
Abdurrahman Coskun ◽  
Federica Braga ◽  
Anna Carobene ◽  
Xavier Tejedor Ganduxe ◽  
Aasne K. Aarsand ◽  
...  
Keyword(s):  
Systematic Review ◽  
Critical Appraisal ◽  
Complete Blood Count ◽  
Clinical Chemistry ◽  
Meta Analysis ◽  
Biological Variation ◽  
European Federation ◽  
Global Estimates ◽  
Using Data

Abstract Background Interpretation of the complete blood count (CBC) parameters requires reliable biological variation (BV) data. The aims of this study were to appraise the quality of publications reporting BV data for CBC parameters by applying the BV Data Critical Appraisal Checklist (BIVAC) and to deliver global BV estimates based on BIVAC compliant studies. Methods Relevant publications were identified by a systematic literature search and evaluated for their compliance with the 14 BIVAC criteria, scored as A, B, C or D, indicating decreasing compliance. Global CVI and CVG estimates with 95% CI were delivered by a meta-analysis approach using data from BIVAC compliant papers (grades A–C). Results In total, 32 studies were identified; four received a BIVAC grade A, 2 B, 20 C and 6 D. Meta-analysis derived CVI and CVG estimates were generally lower or in line with those published in a historical BV database available online. Except for reticulocytes, CVI estimates of erythrocyte related parameters were below 3%, whereas platelet (except MPV and PDW) and leukocyte related parameters ranged from 5% to 15%. Conclusions A systematic review of CBC parameters has provided updated, global estimates of CVI and CVG that will be included in the newly published European Federation of Clinical Chemistry and Laboratory Medicine BV Database.

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 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.

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 The EuBIVAS Project: Within- and Between-Subject Biological Variation Data for Serum Creatinine Using Enzymatic and Alkaline Picrate Methods and Implications for Monitoring

2017 ◽  
Vol 63 (9) ◽  
pp. 1527-1536 ◽  
Author(s):  
Anna Carobene ◽  
Irene Marino ◽  
Abdurrahman Coşkun ◽  
Mustafa Serteser ◽  
Ibrahim Unsal ◽  
...  
Keyword(s):  
Serum Creatinine ◽  
Clinical Chemistry ◽  
Biological Variation ◽  
European Federation ◽  
Healthy Individuals ◽  
Homogeneity Analysis ◽  
Variation Data ◽  
Performance Specifications ◽  
Age Range ◽  
Analytical Variation

Abstract BACKGROUND The European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) European Biological Variation Study (EuBIVAS) has been established to deliver rigorously determined biological variation (BV) indices. EuBIVAS determined BV for serum creatinine using the enzymatic and alkaline picrate measurement methods. METHOD In total, 91 healthy individuals (38 males, 53 females; age range, 21–69 years) were bled for 10 consecutive weeks at 6 European laboratories. An equivalent protocol was followed at each center. Sera were stored at −80 °C before analysis. Analyses for each patient were performed in duplicate within a single run on an ADVIA 2400 system (San Raffaele Hospital, Milan). The data were subjected to outlier and homogeneity analysis before performing CV-ANOVA to determine BV and analytical variation (CVA) estimates with confidence intervals (CI). RESULTS The within-subject BV estimates [CVI (95% CI)] were similar for enzymatic [4.4% (4.2–4.7)] and alkaline picrate [4.7% (4.4–4.9)] methods and lower than the estimate presently available online (CVI = 5.9%). No significant male/female BV differences were found. Significant differences were observed in mean creatinine values between men and women and between Turkish individuals and those of other nationalities. Between-subject BV (CVG) estimates, stratified accordingly, produced CVG values similar to historical BV data. CVA was 1.1% for the enzymatic and 4.4% for alkaline picrate methods, indicating that alkaline picrate methods fail to fulfill analytical performance specifications for imprecision (CVAPS). CONCLUSIONS The serum creatinine CVI obtained by EuBIVAS specifies a more stringent CVAPS than previously identified. The alkaline picrate method failed to meet this CVAPS, raising questions regarding its future use.

Sample collections from healthy volunteers for biological variation estimates’ update: a new project undertaken by the Working Group on Biological Variation established by the European Federation of Clinical Chemistry and Laboratory Medicine

2016 ◽  
Vol 54 (10) ◽  
Author(s):  
Anna Carobene ◽  
Marta Strollo ◽  
Niels Jonker ◽  
Gerhard Barla ◽  
William A. Bartlett ◽  
...  
Keyword(s):  
Working Group ◽  
Clinical Chemistry ◽  
Laboratory Medicine ◽  
Biological Variation ◽  
European Federation ◽  
Laboratory Measurements ◽  
Controlled Conditions ◽  
Edta Plasma ◽  
Blood Specimens

AbstractBackground:Biological variation (BV) data have many fundamental applications in laboratory medicine. At the 1st Strategic Conference of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) the reliability and limitations of current BV data were discussed. The EFLM Working Group on Biological Variation is working to increase the quality of BV data by developing a European project to establish a biobank of samples from healthy subjects to be used to produce high quality BV data.Methods:The project involved six European laboratories (Milan, Italy; Bergen, Norway; Madrid, Spain; Padua, Italy; Istanbul, Turkey; Assen, The Netherlands). Blood samples were collected from 97 volunteers (44 men, aged 20–60 years; 43 women, aged 20–50 years; 10 women, aged 55–69 years). Initial subject inclusion required that participants completed an enrolment questionnaire to verify their health status. The volunteers provided blood specimens once per week for 10 weeks. A short questionnaire was completed and some laboratory tests were performed at each sampling consisting of blood collected under controlled conditions to provide serum, KResults:Samples from six out of the 97 enroled subjects were discarded as a consequence of abnormal laboratory measurements. A biobank of 18,000 aliquots was established consisting of 120 aliquots of serum, 40 of EDTA-plasma, and 40 of citrated-plasma from each subject. The samples were stored at –80 °C.Conclusions:A biobank of well-characterised samples collected under controlled conditions has been established delivering a European resource to enable production of contemporary BV data.

scholarly journals The EuBIVAS: Within- and Between-Subject Biological Variation Data for Electrolytes, Lipids, Urea, Uric Acid, Total Protein, Total Bilirubin, Direct Bilirubin, and Glucose

2018 ◽  
Vol 64 (9) ◽  
pp. 1380-1393 ◽  
Author(s):  
Aasne K Aarsand ◽  
Jorge Díaz-Garzón ◽  
Pilar Fernandez-Calle ◽  
Elena Guerra ◽  
Massimo Locatelli ◽  
...  
Keyword(s):  
Uric Acid ◽  
Total Protein ◽  
Total Bilirubin ◽  
Service Providers ◽  
Clinical Chemistry ◽  
Hdl Cholesterol ◽  
Biological Variation ◽  
Direct Bilirubin ◽  
European Federation ◽  
Variation Data

Abstract BACKGROUND The European Federation of Clinical Chemistry and Laboratory Medicine European Biological Variation Study (EuBIVAS) has been established to deliver rigorously determined data describing biological variation (BV) of clinically important measurands. Here, EuBIVAS-based BV estimates of serum electrolytes, lipids, urea, uric acid, total protein, total bilirubin, direct bilirubin, and glucose, as well as their associated analytical performance specifications (APSs), are presented. METHOD Samples were drawn from 91 healthy individuals (38 male, 53 female; age range, 21–69 years) for 10 consecutive weeks at 6 European laboratories. Samples were stored at −80 °C before duplicate analysis of all samples on an ADVIA 2400 (Siemens Healthineers). Outlier and homogeneity analyses were performed, followed by CV-ANOVA on trend-corrected data, when relevant, to determine BV estimates with CIs. RESULTS The within-subject BV (CVI) estimates of all measurands, except for urea and LDL cholesterol, were lower than estimates available in an online BV database, with differences being most pronounced for HDL cholesterol, glucose, and direct bilirubin. Significant differences in CVI for men and women/women <50 years of age were evident for uric acid, triglycerides, and urea. The CVA obtained for sodium and magnesium exceeded the EuBIVAS-based APS for imprecision. CONCLUSIONS The EuBIVAS, which is fully compliant with the recently published Biological Variation Data Critical Appraisal Checklist, has produced well-characterized, high-quality BV estimates utilizing a stringent experimental protocol. These new reference data deliver revised and more exacting APS and reference change values for commonly used clinically important measurands, thus having direct relevance to diagnostics manufacturers, service providers, clinical users, and ultimately patients.

scholarly journals An overview of EFLM harmonization activities in Europe

2018 ◽  
Vol 56 (10) ◽  
pp. 1591-1597 ◽  
Author(s):  
Eric S. Kilpatrick ◽  
Sverre Sandberg
Keyword(s):  
Best Practice ◽  
Clinical Chemistry ◽  
Laboratory Medicine ◽  
Biological Variation ◽  
European Federation ◽  
Eu Countries ◽  
European Guidelines ◽  
Common Basis ◽  
Evaluation Procedures ◽  
E Learning

Abstract The European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) has initiated many harmonization activities in all phases of the examination process. The EFLM is dealing with both the scientific and the educational aspects of harmonization, with the intention of disseminating best practice in laboratory medicine throughout Europe. Priorities have been given (1) to establish a standard for conducting and assessing biological variation studies and to construct an evidence based EFLM webpage on biological variation data, (2) to harmonize preanalytical procedures by producing European guidelines, (3) to improve test ordering and interpretation, (4) to produce other common European guidelines for laboratory medicine and play an active part in development of clinical guidelines, (5) to establish a common basis for communicating laboratory results to patients, (6) to harmonize units of measurement throughout Europe, (7) to harmonize preanalytical procedures in molecular diagnostics and (8) to harmonize and optimize test evaluation procedures. The EFLM is also now launching the 5th version of the European Syllabus to help the education of European Specialists in Laboratory Medicine (EuSpLM), which is being supported by the development of e-learning courses. A register of EuSpLM is already established for members of National Societies in EU countries, and a similar register will be established for specialists in non-EU countries.

Research in anaesthesia

2017 ◽  
Author(s):  
Gary Minto ◽  
J. Robert Sneyd
Keyword(s):  
Clinical Practice ◽  
Clinical Research ◽  
Basic Science ◽  
Critical Appraisal ◽  
Perioperative Medicine ◽  
Limited Information ◽  
Priority Areas ◽  
Number Of Patients ◽  
Critical Appraisal Skills

Clinicians need critical appraisal skills to weigh up the quality of the literature and to decide whether it has implications for their practice. Every belief in medicine is a construct created from the limited information available and carries a degree of uncertainty. A centralized approach to research identifies the highest priority areas of uncertainty so as to bring about the most improvement for the largest number of patients. This patient-centred model classifies studies into basic science, translational, and clinical research. Adequately powered mega-trials are required to bridge the translational gap between efficacy (does a treatment work?) and effectiveness (does a treatment work when applied in ordinary clinical practice?). There is a paucity of these in perioperative medicine.

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