Cochrane Workshop Picos

Francisco J Grajales III
Francisco J Grajales IIIDigital Shaman at Canadian Forces
Defining a Researchable
Question: the PICOS Approach
     Cochrane Reviewers’ Training
               Workshop
          January 22-23, 2009
    Session Presenter: Marcus Vaska

   Slides adapted from “Defining a Researchable Question..” by
   Miranda Cumpston, with additions and deletions by Dr. Roger
   Thomas; “Review Protocol and Designing Your Research Question,”
   by the Cochrane Collaboration
Session Goals


   Learn about strategies/tips used to help
    design a research question



   Learn about the PICOS approach, and be
    able to apply this method when defining your
    own researchable question
Strategies/Tips for Designing a
          Research Question
   Main Objective: summarize the question in order to
    help the reader understand the evidence and/or make
    a practical decision about a health care decision

   Remember:
         Remain neutral, not biased (do not impose own values and/or
     
         preferences when defining your research question)
         Although you may be an expert in your particular subject area,
     
         don’t assume your readership is. Therefore, the Cochrane
         review needs to be easy to understand and follow by a person
         who may have only marginal knowledge about the topic.
A Brief Note on
         Cochrane Review Titles
   All Cochrane titles and reviews of diagnostic
    tests utilize one of the following standard
    formats:
        <intervention> for <health problem>
    
             i.e. <antibiotics> for <tuberculosis>
         

        <intervention A> vs. <intervention B. for <health
    
        problem>
             i.e. <modern medicine> vs. <traditional, homeopathic
         
             remedies> for <malaria>
        <intervention> for <health problem> in
    
        <participant group/location>
             i.e. <education programs> for <AIDS> in
         
             <pastoralist/nomadic societies>
Sample Topic for
     Demonstration Purposes


In lieu of traditional homeopathic remedies,
  can the administration of modern
  medicine help alleviate the malaria
  epidemic among children in Africa?
The PICOS Approach:
What is it and Why is it Important?
   PICOS = a framework designed to make the process
    of defining and designing a research question easier

   Why is it Important?
        To create a clear question
    
        To identify the information needed to answer that question
    
        To translate the question into searchable terms
    
        To develop and refine the search approach
    



    “It looks easy. It can be tricky. It is absolutely
       invaluable.”
    [Evidence-Based Answers to Clinical Questions for Busy Clinicians. (2006). The
       Centre for Clinical Effectiveness, Monash Institute of Health Services
       Research, Melbourne, Australia, p. 2]
The PICOS Approach
   P
            Population, Patient
        

   I
            Intervention
        

   C
            Comparison
        

   O
            Outcome
        

   S
            Study Design
        
P = Population/Patient

    When defining this question component,

    consider the following patient
    characteristics:
      Disease/condition, including the duration,
    
      localization, and type of symptoms
     Age
     Gender
     Setting
     Standard Diagnostic Criteria
Sample: Modern Medicine for
       Treating Malaria
                 Who are the         Children in Africa
P (Population,
                 patients? Who is    (excluding
Patient)
                 affected? Any       adults) suffering
                 exclusions?         from malaria
                 Describe the
                 specific patient
                 population
                 characteristics
                 and/or context of
                 the disease
P (Population/Patient)
    Considerations to Remember



    Restrictions on populations/settings

    should be based on a sound rationale –
    important for Cochrane reviews to be
    globally relevant
I = Intervention

    When deciding on the intervention(s) that

    will be present in a systematic review,
    the following should be explicitly
    described:
      Type of intervention
    

     Intensity of intervention

     Frequency of intervention

     Duration of intervention
Sample: Modern Medicine for
       Treating Malaria
I (Intervention) What is being   Modern medicine
                 done? What      (antibiotics)
                 interventions
                 should be
                 evaluated?
                 Define the
                 intervention!
I (Intervention)
    Considerations to Remember
  Interventions can consist of: treatment,

  diagnostic/screening test, exposure, or
  prognostic factor
 Should all variations be included?
 How will co-interventions, or trials that
  only include part of an intervention be
  handled?
C = Comparison

  Main alternative being considered

 Intervention should be explicitly defined
      Placebo
    

     Standard therapy

     No treatment

     Another treatment

     Usual care (“the gold standard”)
Sample: Modern Medicine for
      Treating Malaria
               What is the          Traditional
C
               alternative to the   medicine
(Comparison)
               intervention? How    (homeopathic
               effective are        remedies)
               different
               interventions?
C (Comparison)
    Considerations to Remember



    Control groups



      Inactive Control
    

     Active Control
O = Outcome

   When determining the desired/expected
    outcomes of a systematic review, it is key to
    consider the following:
        Explicit outcome measures and tools
    

        Standardized, validated, established outcome
    
        measures appropriate for the disease condition
        Focus on outcomes that are important to patients
    

        Side effects (if known) should be included
    

        Timing of outcome measures should be described
    
Sample: Modern Medicine for
      Treating Malaria
              What are the      Malaria
O (Outcome)
              relevant          prevention, death
              outcomes? What reduction
              do you want to
              accomplish,
              measure,
              improve? Define
              specific outcomes
O (Outcome)
    Considerations to Remember
  Include all important outcomes (primary

  and secondary)
 Include adverse effects
 Consider Economic Data
 Do Not Include an outcome that is trivial
  or meaningless to decision makers!
S = Study Design


    The type of study design utilized is

    dependent on the type of question
    defined. The presence of bias with
    different designs should be considered
    before deciding which one is most suited
    to the question being pondered
Types of Study Designs
   (Interrupted) Time Series
        A research design that collects observations at multiple time
    
        points before and after an intervention (interruption). The
        design attempts to detect whether the intervention has had an
        effect significantly greater than the underlying trend.

   Case-Control Study
        A study that compares people with a specific disease or
    
        outcome of interest (cases) to people from the same
        population without that disease or outcome (controls), and
        which seeks to find associations between the outcome and
        prior exposure to particular risk factors. This design is
        particularly useful where the outcome is rare and past
        exposure can be reliably measured. Case-Control studies are
        usually retrospective, but not always

                          Source: Glossary of Terms in the
                        Cochrane Collaboration Version 4.2.5
                                     May 2005
Types of Study Designs
               (continued)
   Cohort Study
        An observational study in which a defined group of people
    
        (the cohort) is followed over time. The outcomes of people in
        subsets of this cohort are compared, to examine people who
        were exposed or not exposed (or exposed at different levels)
        to a particular intervention or other factor of interest

   Randomized Controlled Trial (RCT)
        An experiment in which two or more interventions, possibly
    
        including a control intervention or no intervention, are
        compared by being randomly allocated to participants. In
        most trials one intervention is assigned to each individual but
        sometimes assignment is to defined groups of individuals (for
        example, in a household) or interventions are assigned within
        individuals (for example, in different orders or to different parts
        of the body)
                           Source: Glossary of Terms in the
                         Cochrane Collaboration Version 4.2.5
                                      May 2005
Sample: Modern Medicine for
       Treating Malaria
           What is the best   Therapy =
S (Study
           study design to    prospective RCT;
Design)
           answer the         Prevention =
                              RCTCohort
           question ?
                              StudyCase
                              Control
S (Study Design)
    Considerations to Remember
    Most reviews use RCT’s as a threshold

    (RCTs are considered the least biased
    form of evidence)

    Cochrane and Campbell collaborations

    may also take evidence from interrupted
    time series
Class Exercise



Topic: Interventions to increase influenza
 vaccination rates of the elderly in the
 community and in institutions
Exercise: Interventions to Increase
   Influenza Vaccination Rates
                 Who are the
P (Population,                        Age=adults, elderly,
                                     seniors, NOT
                 patients? Who is
Patient)                             children, NOT
                 affected? Any
                                     adults <60)
                 exclusions?
                                     Gender= male &
                 Describe the        female
                 specific patient    Setting=institution
                 population          (hospital, care centre)
                 characteristics     vs. community
                                     (home, public place)
                 and/or context of
                                     Disease/Condition =
                 the disease
                                     influenza
Exercise: Interventions to Increase
   Influenza Vaccination Rates
I (Intervention) What is being    Patient
                 done? What      interventions;
                 interventions   Administrative
                 should be       interventions;
                 evaluated?      Health care
                 Define the      workers (HCW)
                 intervention    interventions;
                                 Societal
                                 interventions
Exercise: Interventions to Increase
   Influenza Vaccination Rates
                                    No alternative
               What is the
C
                                    intervention, other
               alternative to the
(Comparison)                        than to observe the
               intervention? How    effectiveness of
               effective are        different interventions
               different
               interventions?       Comparison of
                                    influenza rates,
                                    illness, mortality
Exercise: Interventions to Increase
   Influenza Vaccination Rates
              What are the         Effects of
O (Outcome)
              relevant            interventions on
              outcomes? What      both immediate
              do you want to      and long-term
              accomplish,         changes in
              measure,            influenza
              improve? Define     vaccination rates,
              specific outcomes   and on outcomes
                                  of interest
Exercise: Interventions to Increase
   Influenza Vaccination Rates
             What is the best   RCTs
S (Study
             study design to
Design)
             answer the
             question ?
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Cochrane Workshop Picos

  • 1. Defining a Researchable Question: the PICOS Approach Cochrane Reviewers’ Training Workshop January 22-23, 2009 Session Presenter: Marcus Vaska Slides adapted from “Defining a Researchable Question..” by Miranda Cumpston, with additions and deletions by Dr. Roger Thomas; “Review Protocol and Designing Your Research Question,” by the Cochrane Collaboration
  • 2. Session Goals  Learn about strategies/tips used to help design a research question  Learn about the PICOS approach, and be able to apply this method when defining your own researchable question
  • 3. Strategies/Tips for Designing a Research Question  Main Objective: summarize the question in order to help the reader understand the evidence and/or make a practical decision about a health care decision  Remember: Remain neutral, not biased (do not impose own values and/or  preferences when defining your research question) Although you may be an expert in your particular subject area,  don’t assume your readership is. Therefore, the Cochrane review needs to be easy to understand and follow by a person who may have only marginal knowledge about the topic.
  • 4. A Brief Note on Cochrane Review Titles  All Cochrane titles and reviews of diagnostic tests utilize one of the following standard formats: <intervention> for <health problem>  i.e. <antibiotics> for <tuberculosis>  <intervention A> vs. <intervention B. for <health  problem> i.e. <modern medicine> vs. <traditional, homeopathic  remedies> for <malaria> <intervention> for <health problem> in  <participant group/location> i.e. <education programs> for <AIDS> in  <pastoralist/nomadic societies>
  • 5. Sample Topic for Demonstration Purposes In lieu of traditional homeopathic remedies, can the administration of modern medicine help alleviate the malaria epidemic among children in Africa?
  • 6. The PICOS Approach: What is it and Why is it Important?  PICOS = a framework designed to make the process of defining and designing a research question easier  Why is it Important? To create a clear question  To identify the information needed to answer that question  To translate the question into searchable terms  To develop and refine the search approach  “It looks easy. It can be tricky. It is absolutely invaluable.” [Evidence-Based Answers to Clinical Questions for Busy Clinicians. (2006). The Centre for Clinical Effectiveness, Monash Institute of Health Services Research, Melbourne, Australia, p. 2]
  • 7. The PICOS Approach  P Population, Patient   I Intervention   C Comparison   O Outcome   S Study Design 
  • 8. P = Population/Patient When defining this question component,  consider the following patient characteristics: Disease/condition, including the duration,  localization, and type of symptoms  Age  Gender  Setting  Standard Diagnostic Criteria
  • 9. Sample: Modern Medicine for Treating Malaria Who are the Children in Africa P (Population, patients? Who is (excluding Patient) affected? Any adults) suffering exclusions? from malaria Describe the specific patient population characteristics and/or context of the disease
  • 10. P (Population/Patient) Considerations to Remember Restrictions on populations/settings  should be based on a sound rationale – important for Cochrane reviews to be globally relevant
  • 11. I = Intervention When deciding on the intervention(s) that  will be present in a systematic review, the following should be explicitly described: Type of intervention   Intensity of intervention  Frequency of intervention  Duration of intervention
  • 12. Sample: Modern Medicine for Treating Malaria I (Intervention) What is being Modern medicine done? What (antibiotics) interventions should be evaluated? Define the intervention!
  • 13. I (Intervention) Considerations to Remember Interventions can consist of: treatment,  diagnostic/screening test, exposure, or prognostic factor  Should all variations be included?  How will co-interventions, or trials that only include part of an intervention be handled?
  • 14. C = Comparison Main alternative being considered   Intervention should be explicitly defined Placebo   Standard therapy  No treatment  Another treatment  Usual care (“the gold standard”)
  • 15. Sample: Modern Medicine for Treating Malaria What is the Traditional C alternative to the medicine (Comparison) intervention? How (homeopathic effective are remedies) different interventions?
  • 16. C (Comparison) Considerations to Remember Control groups  Inactive Control   Active Control
  • 17. O = Outcome  When determining the desired/expected outcomes of a systematic review, it is key to consider the following: Explicit outcome measures and tools  Standardized, validated, established outcome  measures appropriate for the disease condition Focus on outcomes that are important to patients  Side effects (if known) should be included  Timing of outcome measures should be described 
  • 18. Sample: Modern Medicine for Treating Malaria What are the Malaria O (Outcome) relevant prevention, death outcomes? What reduction do you want to accomplish, measure, improve? Define specific outcomes
  • 19. O (Outcome) Considerations to Remember Include all important outcomes (primary  and secondary)  Include adverse effects  Consider Economic Data  Do Not Include an outcome that is trivial or meaningless to decision makers!
  • 20. S = Study Design The type of study design utilized is  dependent on the type of question defined. The presence of bias with different designs should be considered before deciding which one is most suited to the question being pondered
  • 21. Types of Study Designs  (Interrupted) Time Series A research design that collects observations at multiple time  points before and after an intervention (interruption). The design attempts to detect whether the intervention has had an effect significantly greater than the underlying trend.  Case-Control Study A study that compares people with a specific disease or  outcome of interest (cases) to people from the same population without that disease or outcome (controls), and which seeks to find associations between the outcome and prior exposure to particular risk factors. This design is particularly useful where the outcome is rare and past exposure can be reliably measured. Case-Control studies are usually retrospective, but not always Source: Glossary of Terms in the Cochrane Collaboration Version 4.2.5 May 2005
  • 22. Types of Study Designs (continued)  Cohort Study An observational study in which a defined group of people  (the cohort) is followed over time. The outcomes of people in subsets of this cohort are compared, to examine people who were exposed or not exposed (or exposed at different levels) to a particular intervention or other factor of interest  Randomized Controlled Trial (RCT) An experiment in which two or more interventions, possibly  including a control intervention or no intervention, are compared by being randomly allocated to participants. In most trials one intervention is assigned to each individual but sometimes assignment is to defined groups of individuals (for example, in a household) or interventions are assigned within individuals (for example, in different orders or to different parts of the body) Source: Glossary of Terms in the Cochrane Collaboration Version 4.2.5 May 2005
  • 23. Sample: Modern Medicine for Treating Malaria What is the best Therapy = S (Study study design to prospective RCT; Design) answer the Prevention = RCTCohort question ? StudyCase Control
  • 24. S (Study Design) Considerations to Remember Most reviews use RCT’s as a threshold  (RCTs are considered the least biased form of evidence) Cochrane and Campbell collaborations  may also take evidence from interrupted time series
  • 25. Class Exercise Topic: Interventions to increase influenza vaccination rates of the elderly in the community and in institutions
  • 26. Exercise: Interventions to Increase Influenza Vaccination Rates Who are the P (Population, Age=adults, elderly, seniors, NOT patients? Who is Patient) children, NOT affected? Any adults <60) exclusions? Gender= male & Describe the female specific patient Setting=institution population (hospital, care centre) characteristics vs. community (home, public place) and/or context of Disease/Condition = the disease influenza
  • 27. Exercise: Interventions to Increase Influenza Vaccination Rates I (Intervention) What is being Patient done? What interventions; interventions Administrative should be interventions; evaluated? Health care Define the workers (HCW) intervention interventions; Societal interventions
  • 28. Exercise: Interventions to Increase Influenza Vaccination Rates No alternative What is the C intervention, other alternative to the (Comparison) than to observe the intervention? How effectiveness of effective are different interventions different interventions? Comparison of influenza rates, illness, mortality
  • 29. Exercise: Interventions to Increase Influenza Vaccination Rates What are the Effects of O (Outcome) relevant interventions on outcomes? What both immediate do you want to and long-term accomplish, changes in measure, influenza improve? Define vaccination rates, specific outcomes and on outcomes of interest
  • 30. Exercise: Interventions to Increase Influenza Vaccination Rates What is the best RCTs S (Study study design to Design) answer the question ?