Your Easy Guide to Clinical Studies

The research question must be clear and answerable. A good way to build a research question is to use the PICO model.

 

PICO stands for:

• P – Population: describes the study population and its characteristics (e.g. age, gender, geographic location, health problem, diagnosis)
• I – Intervention: describes the treatment or exposure being studied. In the health care system, this could include the:
  • Administration of a drug treatment
  • Conduct of a diagnostic test (e.g. testing a new tool to measure blood pressure)
  • Any other type of procedure (e.g. recommendation regarding life style changes)
• C – Comparison: describes a potential alternative or reference point to the intervention (e.g. a control or comparison group such as a placebo group)
• O – Outcome: describes the parameter(s) that will be measured to address the objective of the study (e.g. to assess the success of an intervention)

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As a SP-INV, describe your research question based on the PICO model.

 

Consult a statistician to ensure the research question is statistically:

• Answerable: the study outcome includes parameters that are measurable and that can be analysed statistically (e.g. blood parameters, various health scores such as pain scores or quality of life scores)
• Clear: complying with the PICO model will ensure that the research question becomes clear, as it contains all the required information for the set-up and planning of the study.

 

In some studies the aim is not to quantify the effect of an intervention (I) on an outcome (O). The aim is rather to describe a given population (e.g. frequency of patients with a cardiac event in the cancer department of a hospital). Thus, there is no actual intervention and no comparison is made to a control group. In these types of studies, I and C questions of the PICO model are not applicable. The research question is only built using the P and O questions (e.g. P: patients of the cancer department, O: occurrence of cardiac event during hospital stay).

Swiss Law

ClinO – see in particular article

• Art. 2b Definition of intervention

ClinO-MD – see in particular article

• Art. 2a Definition of clinical intervention
• Art. 2a Definition of performance study

HRO – see in particular article

• Art. 3a Definition of research
• Art. 3f Definition of health-related personal data