Developing A Research Question
Formulating a research question (using PICO)
PICO is an acronym which stands for:
- Patient or Problem
- Intervention
- Comparator
- Outcome
It is used to translate a clinical problem into a structured question which identifies specific key concepts
Example 1: Is progesterone a good thing for preventing preterm birth?
Patient or Problem |
Intervention |
Comparator |
Outcome |
| ? | ? | ? | ? |
Participants –Define disease/condition
- Severity, stages of condition
- Setting (hospital, community)
- Age range, Gestation
- Other illnesses
- Exclusions?
Intervention – Define intervention
- Dose, duration, frequency, route
- Drugs- any in a class?
- Define optional and essential elements of the intervention (who must, how must it be done)
Comparator – Specify the comparator
- Placebo
- Nothing
- Usual care
- Other intervention – best evidenced based alternative
Outcomes
- What outcomes are important, and to whom?
- Have scales or measurement tools been validated?
- Use of surrogate outcome - related to the “real outcome”
- Primary vs secondary
Patient or Problem |
Intervention |
Comparator |
Outcome |
| Women with a previous preterm birth birth <34 weeks, exclusions… |
Vaginal progesterone, 100mgs daily, 20 weeks -34 wks |
Placebo | Neonatal RDS, Safety, Maternal emotional well-being, Cost |
Question as a testable hypothesis:
In women with a previous preterm birth less than 34 weeks (P), does antenatal administration of vaginal progesterone, 100mgs daily, from 20 to 34 weeks gestation (I), compared with placebo (C) reduce neonatal respiratory distress by 30% from 15% to 10% (O).
Example 2: How do we really know when to take a the best time to transfer a newborn from an isolette to an open cot?
Patient or Problem |
Intervention |
Comparator |
Outcome |
| Preterm infants with a birthweight less than 1600gm | Transfer at 1600gm | Transfer at 1800gm | Weight gain, adverse events, length of stay |
Question as a testable hypothesis:
In preterm infants with a birthweight less than 1600gm (P) , does transfer at 1600gm (I) , compared with 1800gm (C) results in similar weight gain, no increase in adverse outcome and shorter length of stay (O’s).
How to write a problem statement
Basically think: “What is?” and “What should be?”
Example 1:
What is?
There is wide variation in practice in the care of women with preterm prelabour rupture of the membranes between 34 and 37 weeks gestation.
What should be?
We should know which care options are best for women with this problem.
Example 2:
What is?
Gum disease and periodontal disease may increase the risk of a women giving birth preterm. There has been minimal assessment of whether dental health preventative strategies during pregnancy may reduce the risk of preterm birth.
What should be?
These strategies require rigorous assessment.
These materials are based on content originally provided by the WOMBAT collaboration. The WOMBAT Collaboration was formed to promote and support high quality randomised clinical trials in the perinatal area in order to improve the health and wellbeing of women and their children (2005 – 2010).
Prepared by Vicki Flenady (Mater Research – University of Queensland) and Rebecca Tooher (WOMBAT)
Last revised: 26 October 2007.