Table A1.
Domain | IC | Recommendation | Included/Excluded | Changes/Justification |
---|---|---|---|---|
Study Rational | ||||
Hypothesis/Objective | 1 | 1.1 Was the biomarker under study described? | Included | Was the outcome measure of mitochondrial dysfunction described? |
1.2 Was the rational for the study (research questions) clearly stated? | Included | |||
1.3 Were the study objectives/hypothesis clearly stated? | Included | |||
Design/Methods | ||||
Study population selection | 2 | 2.1 Were the characteristics of the study population presented? | Included | |
2.2 Were the disease stages or comorbidities of the included participants described? | Included | Were diabetes and DKD status of the included participants described? | ||
2.3 Were the inclusion and exclusion criteria for study participation defined? | Included | |||
Study population representativeness | 3 | 3.1 Was the sampling frame reported (study population source)? | Included | Was the sampling frame reported for samples used to assess mitochondrial dysfunction? |
3.2 Was the participation rate reported (i.e., eligible persons at least 50%)? | Excluded | Not applicable as the only outcome of interest was group differences between NDC, DC, and DKD. | ||
3.3 Was sample size justification or power description provided? | Excluded | Not applicable for analysis. | ||
Data analysis | ||||
Study population characteristics | 4 | 4.1 Were the study population characteristics (i.e., demographic, clinical, and social) presented? | Excluded | Considered to repeat 2.1. |
4.2 Were the exposures and potential confounders described? | Included | |||
4.3 Were any missing values and strategies to deal with missing data reported? | Excluded | Not applicable for analysis. | ||
Statistical analysis | 5 | 5.1 Did the authors clearly report statistical methods used to calculate estimates (e.g., Spearman/Pearson/Linear Regression, etc.)? | Included | Were statistical methods used to identify group differences clearly reported? |
5.2 Were key potential confounding variables measured and adjusted statistically in reported analysis? | Excluded | Not applicable for analysis. | ||
5.3 Was the raw effect size estimate (correlation coefficient, beta coefficient) or measure of study precision provided (e.g., confidence intervals, precise (1) p-value)? | Included | Was the p-value reported to distinguish group differences? | ||
Data interpretation | ||||
Interpretation and evaluation of results | 6 | 6.1 Was the data discussed in the context of study objectives/hypothesis? | Included | |
6.2 Was the interpretation of the results considering findings from similar studies? | Included | |||
6.3 Was the biological context described? | Included | |||
Study limitations | 7 | 7.1 Was the cross-sectional nature of the analysis discussed | Excluded | Not applicable as the only outcome of interest was group differences between NDC, DC, and DKD. |
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? | Excluded | Not applicable as the only outcome of interest was group differences between NDC, DC, and DKD, not possible causality. | ||
7.3 Did the authors acknowledge need for consistency with other research? | Included | |||
Biomarker measurement | ||||
Specimen characteristics and assay methods | 8 | 8.1 Were the measurement methods described? (assay methods, preservation and storage, detailed protocol, including specific reagents or kits used) | Included | Were the method(s) used to assess mitochondrial dysfunction adequately described? |
8.2 Were the reproducibility assessments performed for evaluating biomarker stability? | Excluded | Not applicable as the only outcome of interest was group differences between NDC, DC, and DKD. | ||
8.3 Were the quantitation methods well described? | Excluded | Not applicable for analysis. | ||
Laboratory measurement | 9 | 9.1 Was the laboratory/place of measurement mentioned? | Included | |
9.2 Were any quality control procedures and results reported (e.g., reported coefficient of variation? | Excluded | Not applicable as the only outcome of interest was group differences between NDC, DC, and DKD. | ||
9.3 Were the analysis blinded for laboratory staff? | Included | |||
Biomarker data modelling | 10 | 10.1 Was the distribution of biomarker data reported (if non-normal how was it standardised)? | Excluded | Not applicable as the only outcome of interest was group differences between NDC, DC, and DKD. |
10.2 Did the authors report on methods or outlier detection and handling? | Included | |||
10.3 Were any possible errors resulting from measurement inaccuracies discussed? | Included |
DC, diabetic control without DKD; DKD, diabetic kidney disease; IC, Issues to consider; NDC non-diabetic control.