2. 2
INTRODUCTION
Pilot studies are “pre studies”
Designed and carried out in preparation for a
more expensive full study, they are a separate
and external dress rehearsal
Pilot studies are intended to provide
researches with an opportunity to test (trial run
or try out) one or more aspects of the
anticipated full study’s proposed protocol. Also
called as ‘Feasibility Studies’
3. 1. Definition
• A small scale version or trial run done in
preparation for a major study.
• It is a trial study carried out before a
research design is finalized to assist in
defining the research question or to test
the feasibility, reliability and validity of the
proposed design
3
4. 1.1 Meaning and concepts
A pilot study is a small study designed to gather
information prior to a large study, in order to
improve the quality of final study
It can reveal deficiencies in the design of a
proposed research proposal
A good research strategy requires careful planning
4
5. 1.2 Value of the pilot study
According to Welman and Kruger (1999:146)
many novice researchers are disillusioned
when they find out that the guidelines for
research are only valid in an ideal
environment, and not in the practical
research environment where they conduct
their research study.
This might be the main reason why a pilot study
is needed.
5
6. 1.3 Three values of a pilot study
• It is needed to detect possible flaws in
measurement procedures (including
instructions, time limits, etcetera) and in the
operationalisation of independent variables.
• A pilot study is also valuable to identify
unclear or ambiguous items in a
questionnaire.
• The non-verbal behaviour of participants in
the pilot study may give important information
about any embarrassment or discomfort
experienced concerning the content or wording
of items in a questionnaire.
6
7. 1.4 Reasons for Conducting Pilot Studies
In general, the rationale for a pilot study can be
grouped under several broad classifications
- process, resources, management and
scientific.
Process:
This assesses the feasibility of the steps that
need to take place as part of the main study.
Examples include determining sample
recruitment rates, retention rates, etc.
7
8. Resources: This deals with assessing time and
budget problems that can occur during the main
study. The idea is to collect some pilot data on
such things as the length of time to mail or fill out
all the survey forms.
Management: This covers potential human and data
optimization problems such as personnel and data
management issues at participating centers.
Scientific: This deals with the assessment of
treatment safety, determination of dose levels and
response, and estimation of treatment effect and
its variance.
8
9. 9
1.5 Purposes of pilot study
1.5.1.To test and assess proposed study
processes and procedures
• Identifying and recruiting sufficient number and
diversity of eligible study participants
• Assess the degree to which participants receive
the intervention
• To gain familiarity in working and applying the
procedure
• Obtaining, using, maintaining and storing any
instrument and equipment needed
10. 10
• Testing data collection instruments ( reliability
and validity)
• Testing randomization, blinding and concealed
allocation procedures for the study
• Assessing feasibility, accuracy, completeness
of data collection and entry
• Identifying, recruiting, obtaining consent from
retaining study participants (sampling frame)
• Analyzing data
11. 11
•If applicable, identifying, recruiting monitoring
additional study scales
• Obtaining, using maintaining and storing any
instruments and equipment needed
• Choosing between 2 or more possible data
collection methods
12. 12
1.5.2.To evaluate the safety of the
proposed main study
• Is it safe to use the study drug/ intervention?
• What is the safe dose level?
• Do patients respond to the drug?
• What is the estimate of the treatment effect?
13. 13
1.5.3.To evaluate the acceptability of the
main study
Acceptability by person:
• Stakeholders
• Participants
• Parents
• Research collaborators
• Health care providers
• Institutional managers
• Community leaders
14. 14
Acceptable in terms of
Kind and amount of data collected
Frequency and length of study visit
Intrusiveness of outcome
15. 15
1.5.4.To test and assess the potential and
proposed outcome measures
Identifying, testing and assessing proposed and
potential outcome measures by
“Objectives can be achieved or not”
16. 16
1.5.5.To estimate the resources
Staff: co-investigators and assistants
Supplies( equipments): available
Budget : to conduct the study
Time: to fill the study form and process time
17. 17
1.5.6.To provide evidence of feasibility
and worth of full study
• Finding of study provide the end of worthiness
• Provides evidence of feasibility
18. 18
1.5.7.To provide the data to assist in
planning the proposed study
• What challenges do study personnel have?
• Are there any problems in entering data in the
computer?
• Whether any important data values forgotten
about?
19. 1.6 Advantages
• It permits preliminary testing of hypothesis that
leads to testing more precise hypothesis in the
main study.
• It often provides the researcher with ideas,
approaches and clues the researcher may not
have foreseen before conducting the pilot study
• It permits a thorough check of the planned
statistical and analytical procedures, giving a
researcher a chance to evaluate their usefulness
to the data
19
20. 20
• It can greatly reduce the number of unanticipated
problems because the researcher have all
opportunity to design parts of his/her study to
overcome difficulties that the pilot study reveals.
• It may save lot of time & money
• In the pilot study, the researcher may try out a
number of alternative measures & then select those
that produce the clearest results for the clearest
result for the main study.
21. 21
• It can give advance warning about where the
main research project can fail
• It indicates where research protocols might not
be followed
• The pilot study can also identify practical
problems of the research procedure
• It indicates whether proposed methods or
instruments are inappropriate or too complicated
22. 1.7 Challenges of and Common
Misconceptions about Pilot Studies
Quite often the emphasis is wrongly placed on
statistical significance, not on feasibility - which
is the main focus of the pilot study.
Most of the pilot projects are not well designed: i.e.
there are no clear feasibility objectives; no clear
analytic plans; and certainly no clear criteria for
success of feasibility
In many cases, pilot studies are conducted to
generate data for sample size calculations.
22
23. 23
• This seems especially sensible in situations where there
are no data from previous studies to inform this process.
• However, it can be dangerous to use pilot studies to
estimate treatment effects, as such estimates may be
unrealistic/biased because of the limited sample size
• The first common misconception is that a pilot study is a
small single-centre study. For example, researchers often
state lack of resources for a large multi-centre study as a
reason for doing a pilot.
• The second common reason is that a pilot investigation is
a small study that is similar in size to someone else
published study
24. 24
1.8 Sample size for pilot studies
•It is important that the sample for a pilot be
representative of the target study population.
•It should also be based on the same
inclusion/exclusion criteria as the main study.
•As a rule of thumb, a pilot study should be large
enough to provide useful information about the
aspects that are being assessed for feasibility.
•10% of the main study sample.
25. 25
1.9 Ethical aspects
REB- Research Ethics Board approval is
necessary
Clear outline of proposal to be submitted
Suggestions from REB should be incorporated in
pilot study
26. 26
1.10 Reporting the pilot study
Title and abstract: should indicate that the study is
a “pilot” or “feasibility”
Background: Scientific and specific one
Objectives: Same as main study
Methodology: Setting, participants details,
interventions, sample size, outcomes must be
same as main study
Discussion and interpretation: Focus on feasibility
of the main study
27. 27
Can pilot study participants and their data be
included in main study?
NO
28. 1.11 How to Interpret the Results of a Pilot
Study: Criteria for Success
The criteria should be based on the primary
feasibility objectives. These provide the basis
for interpreting the results of the pilot study and
determining whether it is feasible to proceed to
the main study.
28
29. In general, the outcome of a pilot study can
be one of the following:
continue, but modify protocol - feasible with
modifications;
Stop - main study not feasible;
Continue without modifications, but monitor
closely - feasible with close monitoring and
Continue without modifications - feasible as
it is
29
30. Summary
• Pilot studies are intended to provide researches
with an opportunity to test (trial run or try out)
one or more aspects of the anticipated full
study’s proposed protocol. It is also called as
‘Feasibility Studies’. It is a trial study carried out
before a research design is finalized to assist in
defining the research question or to test the
feasibility, reliability and validity of the proposed
design
30
31. References
• Burns, N., & Grove, K. S. (2005). The practice of
nursing research: Conduct, critique and utilization
(5th ed.). Missouri: Elsevier Publication.
• Munshall, P. L. (2001). Nursing Research: A
qualitative perspective. Sudbury, MA: Jones &
Bartlett
• Polit, F. D., & Beck, T. C. (2011). Nursing
research generating and assessing evidence fir
nursing practice (8th ed.). New Delhi: Wolters
Kluwer (India) Pvt. Ltd.
• Taylor, T. (2011). The literature review: A few tips
on conducting it. Retrieved June 6, 2011 from
http://wwwwriting utoronto ca/advice/specific –
types-of-listing/literature-review.
