early stages of research programmes: pilot and feasibility studies from scoping to activity...
TRANSCRIPT
Early stages of research programmes: pilot and feasibility studies
From Scoping to Activity Rehabilitation Conference
A Byrne
Realising potential……
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
What are we trying to achieve?• Patient orientated vs. disease
orientated
• Pragmatic vs. explanatory
• Multiprofessional/disciplinary vs. elite
• Policy/public vs. opinion leading
Why….?
• Best practice…..best care
• Influence policy and strategy
• Efficacy and efficiency
The challenge of evidence
• Patient orientated…
• Disease orientated….
• Change = confidence in quality
Scientific method
• Produce evidence that is verifiable by repeated observation
• Language of reliability and consistency
• Hierarchies of evidence
Evaluation of complex interventions:
Campbell et al BMJ 2000;321:694-6
Trial by Design…
Why failures…..?
• Lack of clarity
• Poor methodology
• Poor infrastructure
Supportive and Palliative Care• Organisation
• Workforce
• Infrastructure
• Small, fragmented groups
• Lack of training, funds
• Minimal access to resource
“Difficult to research” crux
? Do nothing………or
Anything goes?
Best patient care
From knowledge to practice
Ignorance
Pattern Recognition
Organized Observation
Collateral knowledge
Trials
Certainty
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
Tackling Complexity…
Best patient care
Ignorance
Pattern Recognition
Organized Observation
Collateral knowledge
Trials
Certainty
Systematic Phase I
Descriptive Phase II
Qualitative/quantitative Phase III
What feasibility provides..
• Information on the population
• Information on the intervention
• Information on the methodology
• Information on the trial conduct
What feasibility demonstrates..• Clarity and focus
• Organized:-thinking
-multidisc engagement -project management
• Track record:- of funding- of working
together
What feasibility promises…
• Opportunity for phase III funding
• Potential to develop programme grants
• Enticement to broad vision…..
Portfolio
Policy andstrategy Practice and
care
Access andrecruitment
Key next steps
• Commonality of theme• Methodological expertise and
innovation• Multidisciplinary approach• Resource base: CTUs• Opportunism….