| 1(e) |
The study objective should include: the method of biomarker collection |
11 (91) |
1 (9) |
N/A |
4 (36)a |
7 (65)a |
| 1(f) |
The study objective should include: A description of which delirium pathophysiological theory the study will address |
10 (86) |
2 (14) |
N/A |
1 (9) |
11 (91) |
| 3(a) |
Delirium biomarker studies should support the person with delirium and their proxy decision maker by: Providing clear procedures to assist staff in interacting and supporting the patient during biomarker collection and other data collection |
3 (20) |
9 (80) |
Not specific to delirium biomarker studies. |
N/A |
N/A |
| 3(b) |
Delirium biomarker studies should support the person with delirium and their proxy decision maker by: Explaining the value of the research in lay terms and how it can contribute to the understanding of delirium |
0 (0) |
12 (100) |
Not specific to delirium biomarker studies. |
N/A |
N/A |
| 3(c) |
Delirium biomarker studies should support the person with delirium and their proxy decision maker by: Clear processes for informed consent |
0 (0) |
12 (100) |
Not specific to delirium biomarker studies. |
N/A |
N/A |
| 4(a) |
When selecting control(s) group: As delirium is a complex clinical condition with many influencing clinical variables, several control groups will strengthen the ability to interpret the findings |
5 (40) |
7 (60) |
Having multiple control groups is not always appropriate and will reduce the power of the study. Recruitment in delirium studies is difficult, therefore this item should be removed. |
N/A |
N/A |
| 4(b) |
The following control groups would be important to consider: Participants with delirium superimposed onto dementia |
4 (30) |
8 (70) |
Do not need a list of examples for control groups in the guideline. |
3 (25)a |
8 (75)a |
| 4(c) |
In studies which follow participants longitudinally, the following are appropriate additional comparator groups: Participants with delirium of a shorter duration |
0 (0) |
12 (100) |
Do not need a list of examples for control groups in the guideline. |
N/A |
N/A |
| 5(b) |
The biomarker in a delirium study should be: Supported by a biologically plausible rationale |
0 (0) |
12 (100) |
To be merged with item 1. |
N/A |
N/A |
| 7(b) |
Description of the assay procedure should include the following as a minimum: An assay validation for assay repeatability and robustness |
12 (100) |
0 (0) |
N/A |
12 (100) |
0 (0) |
| 7(c) |
Description of the assay procedure should include the following as a minimum: The inter- and intra- assay coefficients of variation |
12 (100) |
0 (0) |
N/A |
12 (100) |
0 (0) |
| 8(b) |
In biomarker studies, confounding variables need to take into account the population being studied/the clinical condition |
12 (100) |
0 (0) |
N/A |
9 (82)a |
2 (18)a |
| 9 |
The minimum clinical covariates that should be taken into account are: Age, gender, concurrent medication, comorbidities, prior cognitive impairment, illness severity, sepsis, prior neurological conditions, frailty, inflammation, delirium risk and delirium precipitants |
4 (30) |
8 (70) |
Too many items to list as the minimum clinical covariates. These are not always feasible and every study needs to be judged on its own experimental environment. |
N/A |
N/A |
| 12(b) |
The analysis plan should plan for clinical and biomarker missing data due to: Practical challenges of biomarker collection in people with delirium |
8 (70) |
4 (30) |
N/A |
4 (38) |
7 (63) |
| 13(c) |
Univariate analyses of biomarker and clinical endpoints of interest should report the following: How missing data were handled |
0 (0) |
12 (100) |
To be merged with item 12 |
N/A |
N/A |
| 14(d) |
Multivariate analyses of biomarker and clinical endpoints of interest should report the following: How missing data were handled |
0 (0) |
12 (100) |
To be merged with item 12 |
N/A |
N/A |