What do we currently know about the research topic?

What type of study are you conducting (descriptive, analytical, comparative, interventional, observational, etc.)?

What variables will you use, and which subjects will be exposed to which variables?

How often and when will the data be collected?

How can you control all the factors that might affect prediction models and outcomes?

Do you have to adjust design because of some feasibility issues? If so, what factors?

Ethical considerations (all animal or human studies must discuss factors like ethics committee approval of research protocol, informed consent of human subjects, etc.

Study setting (time, place, etc.), where applicable.

For living subjects (humans and animals): demographic and clinical conditions, gender, weight, species, age, special characteristics, living conditions, etc.

Any preparations of subjects made before starting experiments.

Sampling method, including target population, sampling frame, instruments used, and any stratification, clustering or weighting.

Recruitment method and its effectiveness, including profiles of any subjects that refused (where applicable).

For comparative studies: group allocation and randomization procedures.

Follow-up procedures for longitudinal studies.

Variables measured (identify only the key predictors and all outcomes of those variables).

Methods and instruments used to collect data (include information such as an instrument’s manufacturer and model, calibration procedures, and other information necessary to allow others to reproduce your experimental results).

Bias controls (e.g., blinding procedures).

Descriptive statistics (e.g., means, medians, standard deviations, etc.).

Inferential methods (include confidence intervals, hypothetical testing methods, and regression models or other modeling procedures used).

Methods used to address confounding observational studies.

Interim analysis methods.

Adjustments made to sampling methods and weighting procedures.

Missing data.

Sample size.

Power determination.

Software used.

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