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Early stages of research programmes: pilot and feasibility studies
From Scoping to Activity Rehabilitation Conference
A Byrne
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Realising potential……
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Paths to wisdom….
• What are we trying to achieve?
• How will success be measured?
• What hasn’t worked?
• How feasibility studies support transition to success
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What are we trying to achieve?• Patient orientated vs. disease
orientated
• Pragmatic vs. explanatory
• Multiprofessional/disciplinary vs. elite
• Policy/public vs. opinion leading
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Why….?
• Best practice…..best care
• Influence policy and strategy
• Efficacy and efficiency
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The challenge of evidence
• Patient orientated…
• Disease orientated….
• Change = confidence in quality
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Scientific method
• Produce evidence that is verifiable by repeated observation
• Language of reliability and consistency
• Hierarchies of evidence
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Evaluation of complex interventions:
Campbell et al BMJ 2000;321:694-6
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Trial by Design…
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Why failures…..?
• Lack of clarity
• Poor methodology
• Poor infrastructure
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Supportive and Palliative Care• Organisation
• Workforce
• Infrastructure
• Small, fragmented groups
• Lack of training, funds
• Minimal access to resource
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“Difficult to research” crux
? Do nothing………or
Anything goes?
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Best patient care
From knowledge to practice
Ignorance
Pattern Recognition
Organized Observation
Collateral knowledge
Trials
Certainty
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Research Question
Large scale study
Education Training
Systematic Review
Clinical Trials Unit Academicqualification
Patient InvolvementRecruitment
MethodologyOutcome measurement
DisseminationChange in practice
Driver
Opportunity
Infrastructure
Skilled workforce
PublicationFacilitated learning
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Tackling Complexity…
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Best patient care
Ignorance
Pattern Recognition
Organized Observation
Collateral knowledge
Trials
Certainty
Systematic Phase I
Descriptive Phase II
Qualitative/quantitative Phase III
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What feasibility provides..
• Information on the population
• Information on the intervention
• Information on the methodology
• Information on the trial conduct
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What feasibility demonstrates..• Clarity and focus
• Organized:-thinking
-multidisc engagement -project management
• Track record:- of funding- of working
together
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What feasibility promises…
• Opportunity for phase III funding
• Potential to develop programme grants
• Enticement to broad vision…..
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Portfolio
Policy andstrategy Practice and
care
Access andrecruitment
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Key next steps
• Commonality of theme• Methodological expertise and
innovation• Multidisciplinary approach• Resource base: CTUs• Opportunism….