The Biological Variation Data Critical Appraisal Checklist: A Standard for Evaluating Studies on Biological Variation
Por:
Aarsand, AK, Roraas, T, Fernandez-Calle, P, Ricos, C, Diaz-Garzon, J, Jonker, N, Perich, C, Gonzalez-Lao, E, Carobene, A, Minchinela, J, Coskun, A, Simon, M, Alvarez, V, Bartlett, WA, Fernandez-Fernandez, P, Boned, B, Braga, F, Corte, Z, Aslan, B and Sandberg, S
Publicada:
1 mar 2018
Resumen:
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. (c) 2017 American Association for Clinical Chemistry
Filiaciones:
Aarsand, AK:
Haukeland Hosp, Lab Clin Biochem, Norwegian Porphyria Ctr, NO-5021 Bergen, Norway
Haraldsplass Deaconess Hosp, Norwegian Qual Improvement Lab Examinat NOKLUS, Bergen, Norway
Roraas, T:
Haraldsplass Deaconess Hosp, Norwegian Qual Improvement Lab Examinat NOKLUS, Bergen, Norway
Fernandez-Calle, P:
La Paz Univ Hosp, Madrid, Spain
Analyt Qual Commiss, Spanish Soc Lab Med SEQC ML, Barcelona, Spain
Ricos, C:
Analyt Qual Commiss, Spanish Soc Lab Med SEQC ML, Barcelona, Spain
Diaz-Garzon, J:
La Paz Univ Hosp, Madrid, Spain
Analyt Qual Commiss, Spanish Soc Lab Med SEQC ML, Barcelona, Spain
Jonker, N:
Wilhelmina Ziekenhuis Assen, Certe, Assen, Netherlands
Perich, C:
Analyt Qual Commiss, Spanish Soc Lab Med SEQC ML, Barcelona, Spain
Hosp Valle De Hebron, Clin Lab, Barcelona, Spain
Gonzalez-Lao, E:
Analyt Qual Commiss, Spanish Soc Lab Med SEQC ML, Barcelona, Spain
Mutua Terrassa Univ Hosp, Clin Lab, Catlab, Barcelona, Spain
Carobene, A:
Osped San Raffaele, Serv Med Lab, Milan, Italy
:
Analyt Qual Commiss, Spanish Soc Lab Med SEQC ML, Barcelona, Spain
Germans Trias & Pujol Univ Hosp, Metropolitana Nord Unified Lab LUMN, Badalona, Spain
Coskun, A:
Acibadem Univ, Sch Med, Istanbul, Turkey
Simon, M:
Analyt Qual Commiss, Spanish Soc Lab Med SEQC ML, Barcelona, Spain
Lab Alt Penedes Anoia & Garraf, Barcelona, Spain
Alvarez, V:
Analyt Qual Commiss, Spanish Soc Lab Med SEQC ML, Barcelona, Spain
Bartlett, WA:
Ninewells Hosp & Med Sch, Blood Sci, Dundee, Scotland
Fernandez-Fernandez, P:
Analyt Qual Commiss, Spanish Soc Lab Med SEQC ML, Barcelona, Spain
Boned, B:
Analyt Qual Commiss, Spanish Soc Lab Med SEQC ML, Barcelona, Spain
Royo Villanova Hosp, Zaragoza, Spain
Braga, F:
Univ Milan, Res Ctr Metrol Traceabil Lab Med CIRME, Milan, Italy
Corte, Z:
Analyt Qual Commiss, Spanish Soc Lab Med SEQC ML, Barcelona, Spain
San Agustin Univ Hosp, Aviles, Asturias, Spain
Aslan, B:
Ctr Proficiency Testing, IQMH, Toronto, ON, Canada
Sandberg, S:
Haukeland Hosp, Lab Clin Biochem, Norwegian Porphyria Ctr, NO-5021 Bergen, Norway
Haraldsplass Deaconess Hosp, Norwegian Qual Improvement Lab Examinat NOKLUS, Bergen, Norway
Univ Bergen, Fac Med & Dent, Dept Global Hlth & Primary Care, Bergen, Norway
Green Published, Bronze
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