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Question formulation using PICO

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Question formulation using PICO Powered By Docstoc
					Question formulation
using PICO




   WOMen and Babies Health and Wellbeing: Action through Trials
   www.wombatcollaboration.net.au
It is important to recognise the
extent to which authoritarian
opinions expressed by influential
people guide both practice and
research

Sir Ian Chalmers. Birth 1991; 18 (3):137-141




           WOMen and Babies Health and Wellbeing: Action through Trials
           www.wombatcollaboration.net.au
What drives the research agenda?
 • What should OR what does drive the
   clinical research agenda?
   – commercial interests
   – professional development
   – clinical problems/curiosity
      • care providers, care receivers
   – encouraging preliminary findings
      • basic science, observational studies, RCTs
   – gaps identified after careful consideration of
     needs and review of existing evidence
      • Cochrane (and other systematic) reviews, CPGs
                WOMen and Babies Health and Wellbeing: Action through Trials
                www.wombatcollaboration.net.au
     CONSORT checklist
Criteria number 5: Objectives
• Specific objectives and hypotheses




            WOMen and Babies Health and Wellbeing: Action through Trials
            www.wombatcollaboration.net.au
Vague question…vague answers
  Was there a properly framed QUESTION
    (specific)?
  Were the METHODS appropriate to
    answer the question?
  To produce adequate RESULTS that you
    can trust
  to enable you to draw the correct
    CONCLUSIONS

             WOMen and Babies Health and Wellbeing: Action through Trials
             www.wombatcollaboration.net.au
Is progesterone a good thing for
     preventing preterm birth?




         WOMen and Babies Health and Wellbeing: Action through Trials
         www.wombatcollaboration.net.au
Is progesterone (?) a good thing (?)
    for preventing preterm birth (?)
      and compared with what?




           WOMen and Babies Health and Wellbeing: Action through Trials
           www.wombatcollaboration.net.au
 Formulate a question (PICO)
Translate clinical problem into a structured
question and identify the key concepts – be
specific
  Patient or   Intervention       Comparison            Outcome
   problem



      ?              ?                  ?                    ?




                 WOMen and Babies Health and Wellbeing: Action through Trials
                 www.wombatcollaboration.net.au
             Participants
•   Define disease/condition
•   Severity, stages of condition
•   Setting (hospital, community)
•   Age range, Gestation
•   Other illnesses
•   Exclusions?



              WOMen and Babies Health and Wellbeing: Action through Trials
              www.wombatcollaboration.net.au
             Interventions
Define intervention
• Dose, duration, frequency, route
• Drugs - any in a class?
• Define optional and essential elements of the
  intervention
  – who, how, when?
• Consider complex interventions/packages of
  interventions
  – how easy would these be to implement in clinical
    practice?

               WOMen and Babies Health and Wellbeing: Action through Trials
               www.wombatcollaboration.net.au
           Comparator
Specify the comparator
• Placebo
• Nothing
• Usual care
• Other intervention –best evidenced
  based alternative



            WOMen and Babies Health and Wellbeing: Action through Trials
            www.wombatcollaboration.net.au
              Outcome
• What outcomes are important, and to
  whom?
• Have scales or measurement tools
  been validated?
• Use of surrogate outcomes - related to
  the “real outcome”
• Primary vs secondary



            WOMen and Babies Health and Wellbeing: Action through Trials
            www.wombatcollaboration.net.au
 Formulate a question (PICO)
        Is progesterone a good thing for
            preventing preterm birth?
  Patient or       Intervention        Comparison            Outcome
   problem

 Women with a            Vaginal                           Neonatal RDS,
                     progesterone,
    previous                                              Safety, Maternal
                    100mg daily, 20
 preterm birth,                            Placebo           emotional
                   weeks – 37 weeks,
birth <37 weeks,   self administered                      wellbeing, Cost
  exclusions…          in evening


                   Consider PICOT – Time frame


                      WOMen and Babies Health and Wellbeing: Action through Trials
                      www.wombatcollaboration.net.au
The question as a testable hypothesis

  In women with a previous preterm
   birth less than 37 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)
            WOMen and Babies Health and Wellbeing: Action through Trials
            www.wombatcollaboration.net.au
  Formulate a question (PICO)
 Karen New at work in the Special Care nursery one day
asked: “How do we really know the best time to transfer a
        newborn from an isolette to an open cot?

   Patient or   Intervention       Comparison            Outcome
    problem


       ?              ?                   ?                   ?




                Consider PICOT – Time frame


                  WOMen and Babies Health and Wellbeing: Action through Trials
                  www.wombatcollaboration.net.au
The question as a testable hypothesis

 In preterm infants with a birthweight
  less than 1600gm (P), does transfer
      at 1600gm (I) , compared with
   1800gm (C) result in similar weight
 gain, no increase in adverse outcome
     and shorter length of stay (O’s)


            WOMen and Babies Health and Wellbeing: Action through Trials
            www.wombatcollaboration.net.au
Writing the protocol

Aims and hypotheses
Background/Justification


    WOMen and Babies Health and Wellbeing: Action through Trials
    www.wombatcollaboration.net.au
Is there adequate justification for this study?

   • Have other RCTs asked this or similar
     questions?
   • What impact could the results of RCT
     have on care for mothers, babies,
     families and communities?
   • Why is the topic a priority?




               WOMen and Babies Health and Wellbeing: Action through Trials
               www.wombatcollaboration.net.au
Have other RCTs asked this question?
 • How do you find this out?
   – Trial registries
   – Cochrane and other systematic reviews
   – Electronic databases
   – Cochrane review groups
   – Contacting experts



      Beware of publication bias

             WOMen and Babies Health and Wellbeing: Action through Trials
             www.wombatcollaboration.net.au
      Problem statement
• 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.



             WOMen and Babies Health and Wellbeing: Action through Trials
             www.wombatcollaboration.net.au
      Problem statement
• What is?
  – Gum disease and peridontal 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
             WOMen and Babies Health and Wellbeing: Action through Trials
             www.wombatcollaboration.net.au
       Problem description
•   Who?
•   What?
•   Why?
•   When?
•   Where?
•   Who cares?
•   So what?


            WOMen and Babies Health and Wellbeing: Action through Trials
            www.wombatcollaboration.net.au
    Background/Justification
•   Timeliness                   •   Implications
•   Magnitude                    •   Wide interest
•   Severity                     •   Previous research
•   Relevance                    •   Savings/spinoffs
                                 •   Feasibility




                 WOMen and Babies Health and Wellbeing: Action through Trials
                 www.wombatcollaboration.net.au
    Aims and hypotheses
• Clearly state aims of the study
• Describe purpose of study in terms of
  hypothesised effects on primary
  measures of interest
• Each objective should be identified
  when final results published




            WOMen and Babies Health and Wellbeing: Action through Trials
            www.wombatcollaboration.net.au

				
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Description: Question formulation using PICO