| 1 |
Study rationale |
| a |
State the biomarker under study (including nature of the specimen) |
| b |
Describe the biological hypothesis(/es) tested* |
| 2 |
Ascertainment of delirium |
| a |
Describe the training and/or credentials of personnel who ascertained delirium cases |
| b |
Specify the delirium tool and/or diagnostic process that was used to ascertain cases |
| c |
Describe frequency, timing and duration of delirium assessment |
| 3 |
Outcome measures |
| a |
Define and justify all clinical endpoint(s) and their measures (including relationship to delirium where relevant) |
| 4 |
Assay procedure |
| a |
Specify the assay method used with a detailed protocol that includes reagents/kits |
| b |
Describe the methods of preservation, storage and processing of the biological sample |
| c |
Describe the assay validation method for repeatability and robustness including the sensitivity limits of the assay |
| d |
Specify the inter- and intra- assay coefficients of variation |
| e |
Specify the method of blinding biomarker results |
| 5 |
Timing of collection of the biological sample |
| a |
Precisely describe the time of collection of the biological sample in relation to delirium (onset, presence, resolution) |
| b |
Provide a rationale for the timing of the sample collection based on the clinical scenario, the hypothesis being tested, and/or the study design |
| 6 |
Confounding variables |
| a |
State the confounding variables assessed and whether or not they were specified a priori |
| b |
Clearly define and provide justification for the confounding variables (including the relationship to delirium where relevant) |
| 7 |
Sample size |
| a |
Describe how sample size was determined and provide a rationale |
| 8 |
Statistical analysis |
| a |
Account for clinical and biomarker missing data in the analysis plan based on the design of the study |
| b |
State how confounding variables were accounted for in the analysis |
| 9 |
Univariate and multivariable analysis |
| a |
Report the estimated effect size or the p values with their Confidence Intervals (CI) |
| b |
Specify whether the biomarker was dichotomised using a cut-point and/or threshold |
| c |
Specify the number of included participants and reasons for attrition or missing data |
| d |
Describe how model assumptions were verified (multivariable) |