The biological variation data critical appraisal checklist: A standard for evaluating studies on biological variation

AK Aarsand, T Røraas, P Fernandez-Calle, C Ricos, J Díaz-Garzón, N Jonker, C Perich, E González-Lao, A Carobene, J Minchinela, A Coşkun, M Simón, V Álvarez, WA Bartlett, P Fernández-Fernández, B Boned, F Braga, Z Corte, B Aslan, S Sandberg & 4 others on behalf of the European Federation of Clinical Chemistry, Laboratory Medicine Working Group on Biological Variation, Task Joint Task Force on the Management, Finish Group for the Biological Variation Database

Research output: Contribution to journalArticle

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 (CV I ) 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 CV I 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. © 2017 American Association for Clinical Chemistry.
Original languageEnglish
Pages (from-to)501-514
Number of pages14
JournalClinical Chemistry
Volume64
Issue number3
DOIs
Publication statusPublished - 2018

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Aarsand, AK., Røraas, T., Fernandez-Calle, P., Ricos, C., Díaz-Garzón, J., Jonker, N., ... Database, F. G. F. T. B. V. (2018). The biological variation data critical appraisal checklist: A standard for evaluating studies on biological variation. Clinical Chemistry, 64(3), 501-514. https://doi.org/10.1373/clinchem.2017.281808

The biological variation data critical appraisal checklist: A standard for evaluating studies on biological variation. / Aarsand, AK; Røraas, T; Fernandez-Calle, P; Ricos, C; Díaz-Garzón, J; Jonker, N; Perich, C; González-Lao, E; Carobene, A; Minchinela, J; Coşkun, A; Simón, M; Álvarez, V; Bartlett, WA; Fernández-Fernández, P; Boned, B; Braga, F; Corte, Z; Aslan, B; Sandberg, S; Chemistry, on behalf of the European Federation of Clinical; Variation, Laboratory Medicine Working Group on Biological; Joint Task Force on the Management, Task; Database, Finish Group for the Biological Variation.

In: Clinical Chemistry, Vol. 64, No. 3, 2018, p. 501-514.

Research output: Contribution to journalArticle

Aarsand, AK, Røraas, T, Fernandez-Calle, P, Ricos, C, Díaz-Garzón, J, Jonker, N, Perich, C, González-Lao, E, Carobene, A, Minchinela, J, Coşkun, A, Simón, M, Álvarez, V, Bartlett, WA, Fernández-Fernández, P, Boned, B, Braga, F, Corte, Z, Aslan, B, Sandberg, S, Chemistry, OBOTEFOC, Variation, LMWGOB, Joint Task Force on the Management, T & Database, FGFTBV 2018, 'The biological variation data critical appraisal checklist: A standard for evaluating studies on biological variation', Clinical Chemistry, vol. 64, no. 3, pp. 501-514. https://doi.org/10.1373/clinchem.2017.281808
Aarsand, AK ; Røraas, T ; Fernandez-Calle, P ; Ricos, C ; Díaz-Garzón, J ; Jonker, N ; Perich, C ; González-Lao, E ; Carobene, A ; Minchinela, J ; Coşkun, A ; Simón, M ; Álvarez, V ; Bartlett, WA ; Fernández-Fernández, P ; Boned, B ; Braga, F ; Corte, Z ; Aslan, B ; Sandberg, S ; Chemistry, on behalf of the European Federation of Clinical ; Variation, Laboratory Medicine Working Group on Biological ; Joint Task Force on the Management, Task ; Database, Finish Group for the Biological Variation. / The biological variation data critical appraisal checklist: A standard for evaluating studies on biological variation. In: Clinical Chemistry. 2018 ; Vol. 64, No. 3. pp. 501-514.
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T1 - The biological variation data critical appraisal checklist: A standard for evaluating studies on biological variation

AU - Aarsand, AK

AU - Røraas, T

AU - Fernandez-Calle, P

AU - Ricos, C

AU - Díaz-Garzón, J

AU - Jonker, N

AU - Perich, C

AU - González-Lao, E

AU - Carobene, A

AU - Minchinela, J

AU - Coşkun, A

AU - Simón, M

AU - Álvarez, V

AU - Bartlett, WA

AU - Fernández-Fernández, P

AU - Boned, B

AU - Braga, F

AU - Corte, Z

AU - Aslan, B

AU - Sandberg, S

AU - Chemistry, on behalf of the European Federation of Clinical

AU - Variation, Laboratory Medicine Working Group on Biological

AU - Joint Task Force on the Management, Task

AU - Database, Finish Group for the Biological Variation

PY - 2018

Y1 - 2018

N2 - 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 (CV I ) 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 CV I 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. © 2017 American Association for Clinical Chemistry.

AB - 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 (CV I ) 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 CV I 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. © 2017 American Association for Clinical Chemistry.

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DO - 10.1373/clinchem.2017.281808

M3 - Article

VL - 64

SP - 501

EP - 514

JO - Clinical Chemistry

JF - Clinical Chemistry

SN - 0009-9147

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