early stages of research programmes: pilot and feasibility studies from scoping to activity...

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….