Taks 3 – Teaming up
Learning goals:
1) What is feasibility and a pilot study? (subtypes etc.)
Difference between pilot and feasibility study
A pilot trial replicates, in miniature, a planned larger study, whereas a feasibility study may help in
the development of the intervention and/or outcome measures. Consequently, in the definitive trial,
the intervention may be different and the outcomes may have changed.
FEASIBILITY STUDIES
Feasibility studies are relied on to produce a set of findings that help determine whether an
intervention should be recommended for efficacy testing. The term feasibility study is used more
broadly to encompass any sort of study that can help investigators prepare for full-scale research
leading to intervention.
Feasibility studies are used to determine whether an intervention is appropriate for further testing,
they enable the researchers to assess whether (or not) the ideas and findings can be shaped to be
relevant and sustainable. Such research may identify not only what in the research methods or
protocols needs modification but also how changes might occur.
Areas of focus
It is proposed that there are eight general areas of focus addressed by feasibility studies:
- Acceptability = looks at how the intended individuals recipients react to the intervention.
- Demand = demand for the intervention can be assessed by gathering data on estimated use
or by actually documenting the use of selected intervention in a defined intervention
population or setting.
- Implementation = concerns the extend, likelihood and manner in which an intervention can
be fully implemented as planned and proposed often in an uncontrolled design.
- Practicality = explores the extent to which an intervention can be delivered when resources,
time, commitment are constrained in some way.
- Adaptation = focuses on changing program contents or procedures to be appropriate in a
new situation.
- Integration = assesses the level of system change needed to integrate a new program or
process into an existing infrastructure or program. The documentation of change that occurs
within the organizational setting as a direct result of integrating the new program can help to
determine if the new venture is truly feasible.
- Expansion = examines the potential success of an already-successful intervention with a
different population or in a different setting.
- Limited-efficacy testing = many feasibility studies are designed to test an intervention in a
limited way. Such tests can be conducted in a convenience sample, with intermediate
outcomes, shorter follow-up period or with limited statistical power.
The choice of an optimal research design depends upon the selected area of focus. In the initial
phase of developing an intervention, Can it work? Is usually the main question. Given some evidence
that a treatment might work, the next question is Does it work?, and does it do so under ideal or
actual conditions compared to other practices. Given evidence that an intervention is efficacious and
effective, the question Will it work?, is applied to the myriad contexts, settings and cultures that
might translate the intervention into practice.
, Taks 3 – Teaming up
Design options for feasibility studies
- Can it work?
o Initial phase of developing an intervention
- Does it work?
Preliminary positive results can suggest that an intervention is ready to be tested in a full-scale trial.
At that juncture, a variety of new feasibility questions must be addressed:
o Can the outcome be measures reliably and validly?
o Can the intervention be clarified and conveyed in a disseminatable format that permits
replication of the treatment?
A major feasibility issue that precedes the mounting of a full evaluation trial is the need to derive and
effect-size estimate for the treatment. A small-scale randomized trial that mirrors the intended
efficacy study may be valuable here. Such feasibility studies are sometimes called Phase-I or Phase-II
clinical trials. Usually the design is an RCT and entails a smaller sample size than a full Phase-III trial.
Earlier phase trials are used to estimate effect size, power and sample size for a full Phase-III-
trial.
- Will it work?
New feasibility questions now arise, as interest shifts to disseminating and implementing broadly the
intervention in diverse practice system. It becomes critical to understand the perspectives of
Learning goals:
1) What is feasibility and a pilot study? (subtypes etc.)
Difference between pilot and feasibility study
A pilot trial replicates, in miniature, a planned larger study, whereas a feasibility study may help in
the development of the intervention and/or outcome measures. Consequently, in the definitive trial,
the intervention may be different and the outcomes may have changed.
FEASIBILITY STUDIES
Feasibility studies are relied on to produce a set of findings that help determine whether an
intervention should be recommended for efficacy testing. The term feasibility study is used more
broadly to encompass any sort of study that can help investigators prepare for full-scale research
leading to intervention.
Feasibility studies are used to determine whether an intervention is appropriate for further testing,
they enable the researchers to assess whether (or not) the ideas and findings can be shaped to be
relevant and sustainable. Such research may identify not only what in the research methods or
protocols needs modification but also how changes might occur.
Areas of focus
It is proposed that there are eight general areas of focus addressed by feasibility studies:
- Acceptability = looks at how the intended individuals recipients react to the intervention.
- Demand = demand for the intervention can be assessed by gathering data on estimated use
or by actually documenting the use of selected intervention in a defined intervention
population or setting.
- Implementation = concerns the extend, likelihood and manner in which an intervention can
be fully implemented as planned and proposed often in an uncontrolled design.
- Practicality = explores the extent to which an intervention can be delivered when resources,
time, commitment are constrained in some way.
- Adaptation = focuses on changing program contents or procedures to be appropriate in a
new situation.
- Integration = assesses the level of system change needed to integrate a new program or
process into an existing infrastructure or program. The documentation of change that occurs
within the organizational setting as a direct result of integrating the new program can help to
determine if the new venture is truly feasible.
- Expansion = examines the potential success of an already-successful intervention with a
different population or in a different setting.
- Limited-efficacy testing = many feasibility studies are designed to test an intervention in a
limited way. Such tests can be conducted in a convenience sample, with intermediate
outcomes, shorter follow-up period or with limited statistical power.
The choice of an optimal research design depends upon the selected area of focus. In the initial
phase of developing an intervention, Can it work? Is usually the main question. Given some evidence
that a treatment might work, the next question is Does it work?, and does it do so under ideal or
actual conditions compared to other practices. Given evidence that an intervention is efficacious and
effective, the question Will it work?, is applied to the myriad contexts, settings and cultures that
might translate the intervention into practice.
, Taks 3 – Teaming up
Design options for feasibility studies
- Can it work?
o Initial phase of developing an intervention
- Does it work?
Preliminary positive results can suggest that an intervention is ready to be tested in a full-scale trial.
At that juncture, a variety of new feasibility questions must be addressed:
o Can the outcome be measures reliably and validly?
o Can the intervention be clarified and conveyed in a disseminatable format that permits
replication of the treatment?
A major feasibility issue that precedes the mounting of a full evaluation trial is the need to derive and
effect-size estimate for the treatment. A small-scale randomized trial that mirrors the intended
efficacy study may be valuable here. Such feasibility studies are sometimes called Phase-I or Phase-II
clinical trials. Usually the design is an RCT and entails a smaller sample size than a full Phase-III trial.
Earlier phase trials are used to estimate effect size, power and sample size for a full Phase-III-
trial.
- Will it work?
New feasibility questions now arise, as interest shifts to disseminating and implementing broadly the
intervention in diverse practice system. It becomes critical to understand the perspectives of
