Table 4. Expectations toward rigor in study design.
All research | Research informing a formal knowledge claim (i.e. research requiring maximal rigor) |
|
---|---|---|
Study plan | Should be defined and documented before starting the experiments | Must be defined and documented before starting the experiments |
Study hypothesis | Advised to define | Must be pre-specified |
Blinding | Advised to implement | Should be implemented, exceptions must be justified and documented |
Randomization | Advised to implement | Should be implemented, exceptions must be justified and documented |
Sample size calculation | Advised to define and document before starting the experiments | Must be defined and documented before starting the experiments (e.g. included in the study plan) |
Data analysis | Advised to define and document before starting the experiments | Must be defined and documented before starting the experiments (e.g. as a formal statistical analysis plan and/or included in the study plan) |
Inclusion and exclusion criteria | Advised to define and document before starting the experiments | Must be defined and documented before starting the experiments (e.g. included in the study plan) |
Deviations from study plan | Advised to document | Must be documented |
Preregistration | - | Should be implemented |