A study seeks to answer a question; the answer is not chosen before observation. Until executed, use the label proposed protocol and keep all results as not measured.
Before executing
Question: which uncertainty needs to be reduced?
Relevance and hypothesis, where applicable
Method: which observation can answer the question?
Comparison: is there an alternative or reference situation?
Sample: who or what will be observed, how it was selected, inclusions and exclusions
Measures: what will be counted, assessed or described
Analysis: how the records will be interpreted; what would be a sufficient result for the decision
Ethics and safety: which review or authorisation is needed; who funds and who has an interest in the result
Dissemination: what may be published and under what conditions
Quando parar e pedir ajuda
In contexts with risk or regulation, the necessary approval precedes any data collection. Do not collect data from owners or professionals without a legal basis and authorisation.
After executing
Period, number of valid observations, exclusions, method deviations and losses
Results (separated from interpretation)
Interpretation and external factors (experience, seasonality, simultaneous changes, observation effect, dropouts)
Standardised conclusion
Under the conditions [description], [result] was observed. The method allows stating [scope]. It does not allow concluding [limits]. The uncertainties [items] remain. The next recommended decision is [proportional action].