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Table 1 BIOCROSS evaluation tool. Depicted is the BIOCROSS evaluation tool aimed at evaluating the quality of reporting of biomarker cross sectional studies

From: Development and reliability assessment of a new quality appraisal tool for cross-sectional studies using biomarker data (BIOCROSS)

Item

Issues to consider (IC)

Study quality feature

 

1st Domain: Study rational

 

1.

1.1 Was the biomarker under study described?

1.2 Was the rationale for the study (research question) clearly presented?

1.3 Were the study objectives/ hypothesis clearly stated?

Hypothesis/Objective

 

2nd Domain: Design/Methods

 

2.

2.1 Were the characteristics of the study participants presented?

2.2 Were the disease stages or comorbidities of the included participants described?

2.3 Were the inclusion and exclusion criteria for study participation defined?

Study population selection

3.

3.1 Was the sampling frame reported (study population source)

3.2 Was the participation rate reported (i.e. eligible persons at least 50%)?

3.3 Was sample size justification or power description provided?

Study population representativeness

 

3rd Domain: Data analysis

 

4.

4.1 Were the study population characteristics (i.e. demographic, clinical and social) presented?

4.2 Were the exposures and potential confounders described?

4.3 Were any missing values and strategies to deal with missing data reported?

Study population characteristics

5.

5.1 Did the authors clearly report statistical methods used to calculate estimates (e.g. Spearman/Pearson/Linear regression, etc.)?

5.2 Were key potential confounding variables measured and adjusted statistically in reported analyses?

5.3 Was the raw effect size estimate (correlation coefficient, beta coefficient) or measure of study precision provided (e.g. confidence intervals, precise (!) p-value*)?

Statistical analysis

 

4th Domain: Data interpretation

 

6.

6.1 Was the data discussed in the context of study objectives/hypotheses?

6.2 Was the interpretation of the results considering findings from similar studies?

6.3 Was the biological context described?

Interpretation and evaluation of results

7.

7.1 Was the cross-sectional nature of the analysis discussed?

7.2 Did the authors acknowledge restricted interpretation due to measurements at one point in time and no statement about causality possible using cross-sectional studies?

7.3 Did the authors acknowledge need for consistency with other research?

Study limitations

 

5th Domain: Biomarker measurement

 

8.

8.1 Were the measurement methods described? (assay methods, preservation and storage, detailed protocol, including specific reagents or kits used)

8.2 Were the reproducibility assessments performed for evaluating biomarker stability?

8.3 Were the quantitation methods well described?

Specimen characteristics and assay methods

9.

9.1 Was the laboratory/place of measurement mentioned?

9.2 Were any quality control procedures and results reported (e.g. reported coefficient of variation?

9.3 Were the analyses blinded for laboratory staff?

Laboratory measurement

10.

10.1 Was the distribution of biomarker data reported (if non-normal how it was standardized)?

10.2 Did the authors report on methods or outlier detection and handling?

10.3 Were any possible errors resulting from measurement inaccuracies discussed?

Biomarker data modeling

  1. *Reporting not significant (ns) or p > 0.05 is not precise and does not allow a judgment on precision