The Biological Variation Data Critical Appraisal Checklist: A Standard for Evaluating Studies on Biological Variation
| Autor: | Thomas Røraas, Pilar Fernandez-Calle, Zoraida Corte, Aasne K. Aarsand, Anna Carobene, Joana Minchinela, Pilar Fernández-Fernández, Federica Braga, Margarita Simón, William A. Bartlett, Abdurrahman Coskun, Carmen Ricós, Niels Jonker, Berna Aslan, Carmen Perich, Virtudes Alvarez, Sverre Sandberg, Jorge Díaz-Garzón, Beatriz Boned, Elisabet González-Lao |
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| Přispěvatelé: | Acibadem University Dspace |
| Rok vydání: | 2017 |
| Předmět: |
030213 general clinical medicine
business.industry Biochemistry (medical) Clinical Biochemistry MEDLINE Medical laboratory Alanine Transaminase Variance (accounting) 030204 cardiovascular system & hematology Checklist 03 medical and health sciences Critical appraisal 0302 clinical medicine Reference Values Biological variation Meta-analysis Chemistry Clinical Statistics Outlier Humans business |
| Zdroj: | Clinical chemistry. 64(3) |
| ISSN: | 1530-8561 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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