A checklist for critical appraisal of studies of biological variation

Abstract Data 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.

[1]  C Ricós,et al.  Current databases on biological variation: pros, cons and progress. , 1999, Scandinavian journal of clinical and laboratory investigation.

[2]  C. Petitclerc,et al.  Approved recommendation (1987) on the theory of reference values. Part 2. Selection of individuals for the production of reference values , 1987 .

[3]  S. Sandberg,et al.  A systematic review of data on biological variation for alanine aminotransferase, aspartate aminotransferase and γ-glutamyl transferase , 2013, Clinical chemistry and laboratory medicine.

[4]  M. Panteghini,et al.  Biological variability of glycated hemoglobin. , 2010, Clinica chimica acta; international journal of clinical chemistry.

[5]  N. Rifai,et al.  An appeal to medical journal editors: the need for a full description of laboratory methods and specimen handling in clinical study reports. , 2012, Clinical chemistry.

[6]  C G Fraser,et al.  Introduction: strategies to set global quality specifications in laboratory medicine. , 1999, Scandinavian journal of clinical and laboratory investigation.

[7]  P. H. Petersen,et al.  Terms and symbols used in studies on biological variation: the need for harmonization. , 2015, Clinical chemistry.

[8]  C G Fraser,et al.  Generation and application of data on biological variation in clinical chemistry. , 1989, Critical reviews in clinical laboratory sciences.

[9]  David Moher,et al.  Towards complete and accurate reporting of studies of diagnostic accuracy: The STARD Initiative. , 2003, Radiology.

[10]  H E Solberg,et al.  Approved recommendation (1988) on the theory of reference values. Part 3. Preparation of individuals and collection of specimens for the production of reference values. , 1988, Clinica chimica acta; international journal of clinical chemistry.

[11]  Sverre Sandberg,et al.  Confidence intervals and power calculations for within-person biological variation: effect of analytical imprecision, number of replicates, number of samples, and number of individuals. , 2012, Clinical chemistry.

[12]  Anders Kallner,et al.  STRATEGIES TO SET GLOBAL ANALYTICAL QUALITY SPECIFICATION, IN LABORATORY MEDICINE , 1999 .

[13]  Virtudes Alvarez,et al.  Within-subject biological variation in disease: collated data and clinical consequences , 2007, Annals of clinical biochemistry.

[14]  Callum G. Fraser,et al.  Biological Variation: From Principles to Practice , 2001 .

[15]  D. Bruns,et al.  [Current issues in measurement and reporting of urinary albumin excretion]. , 2010, Annales de biologie clinique.

[16]  Virtudes Alvarez,et al.  Biological variation database: structure and criteria used for generation and update , 2015, Clinical chemistry and laboratory medicine.

[17]  N. Rifai,et al.  An appeal to medical journal editors: the need for a full description of laboratory methods and specimen handling in clinical study reports. Statement by the Consortium of Laboratory Medicine Journal Editors , 2012, Annals of clinical biochemistry.

[18]  D Stamm,et al.  International Federation of Clinical Chemistry, Scientific Division: approved recommendation on the theory of reference values. Part 4. Control of analytical variation in the production, transfer and application of reference values. , 1991, European journal of clinical chemistry and clinical biochemistry : journal of the Forum of European Clinical Chemistry Societies.

[19]  David Moher,et al.  Towards complete and accurate reporting of studies of diagnostic accuracy: the STARD initiative. Standards for Reporting of Diagnostic Accuracy. , 2003, Clinical chemistry.

[20]  H. E. Solberg Approved recommendation (1987) on the theory of reference values. Part 5. Statistical treatment of collected reference values. Determination of reference limits , 1987 .

[21]  H. E. Solberg,et al.  Approved recommendation (1986) on the theory of reference values. Part 1. The concept of reference values. , 1987 .

[22]  H. E. Solberg,et al.  Approved recommendation (1987) on the theory of reference values. Part 6. Presentation of observed values related to reference values , 1987 .