### Sample Space vs Possible Outcomes

- What is the problem?
- What are the general aims and the precise questions to be answered?
- What will the study contribute to knowledge?
- What is already known about the problem?
- What study design will be used?
- What are the advantages and disadvantages of this design?
- Will an intervention be required?
- What population will be studied?
- Will a sample be necessary?
- How will it be chosen?
- What are the criteria for entry into the study?
- How many participants are required?
- What data are to be collected?
- What are the variables of most interest?
- What are the potential confounding variables?
- How are the data to be collected?
- Are the proposed methods reliable and valid?
- Are appropriate quality assurance methods available?>
- Who will collect the data?
- How will the data be recorded?
- What training will the observers need?
- How will the data be processed and analyzed?
- Is computerization necessary?
- How will the data be entered?
- What analyses are planned?
- Who will analyze the data?
- What tables and figures will be required?
- Is the study ethical?
- Which ethical committee will consider the protocol?
- What information is required for the participants?
- How will informed consent be obtained?
- Will any of the participants need a referral?
- How will this be arranged?
- What follow-up will be required?
- What is the timetable for the study?
- Who is responsible for each of the steps?
- Is a pilot study required?
- If so, how many participants are required?
- How long should the pilot study last?
- Will the participants in the pilot study enter the main study?
- How much will the study cost?
- Where will the money come from?
- What resources, apart from money, are required?
- How will the results of the study be publicized?
- How can the results and their public health implications best be communicated to the scientific community, decision-makers, and the general community?
- Will a report and papers be written?
- How will the participants obtain feedback?
- How will the result be applied?

**Observed Association**

- Could it be due to selection or measurement bias?
- Could it be due to confounding?
- Could it be a result change?
- Could it be casual?
- Apply guidelines and make a judgment

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