PILOT STUDY

SIMI. J. L SRM CON

PILOT STUDY
Also called Feasibility study. A trial run. A small scale version. A preliminary investigation.

Conducting a pilot study does not guarantee success in the main study, but it does increase the likelihood.

DEFINITION:
The term 'pilot studies' refers to mini versions of a full-scale study, as well as the specific pre-testing of a particular research instrument such as a questionnaire or interview schedule.

http://www.cirem.org.uk/definitions.html

DEFINITION CONTD

The study carried out at the end of planning phase of research, in order to explore and test the research elements.

Basavanthappa (2000)

OBJECTIVES:

TWO FOLD : To make improvements in research project.

To

detect problems that must be eradicated.

OBJECTIVES:

To acquaint the researcher with problems that can be corrected in preparation for the large research projects. To provide the researcher with an opportunity to try out the procedures for collecting data. To test as many elements of the research proposal as possible.

OBJECTIVES: CONTD

Eg: To pretest the instrument.

Test

whether the variables defined by the operational definition are actually observable and measurable.

NEED FOR PILOT STUDIES:

Developing and testing adequacy of research instruments . Assessing the feasibility of a (fullscale) study/survey. Designing a research protocol . Assessing whether the research protocol is realistic and workable. Establishing whether the sampling frame and technique are effective .

NEED FOR PILOT STUDIES: CONTD

Assessing the likely success of proposed recruitment approaches. Identifying logistical problems which might occur using proposed methods. Estimating variability in outcomes to help determining sample size . Collecting preliminary data. Determining what resources (finance, staff) are needed for a planned study.

NEED FOR PILOT STUDIES: CONTD

Assessing the proposed data analysis techniques to uncover potential problems . Developing a research question and research plan. Training a researcher in as many elements of the research process as possible. Convincing funding bodies that the research team is competent and

NEED FOR PILOT STUDIES: CONTD

Convincing funding bodies that the main study is feasible and worth funding. Convincing other stakeholders that the main study is worth supporting.

MISCONCEPTIONS REG. PILOT

STUDIES.

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.

A pilot investigation is a small study that is similar in size to someone elses published study.

MISCONCEPTIONS REG. PILOT

STUDIES.

A pilot study is a small study done by a student or an intern - which can be completed quickly and does not require funding.

PILOT STUDY- ELEMENTS

Process: This assesses the feasibility of the steps that need to take place as part of the main study. Resources: This deals with assessing time and budget problems that can occur during the main study..

PILOT STUDY- ELEMENTS

Management: This covers potential human and data optimization problems such as personnel and data management issues at participating centres. Scientific: This deals with the assessment of treatment safety, determination of dose levels and response, and estimation of treatment effect and its variance.

Calculating sample size:

This calculation based on a common formula for obtaining a 95% CI for a single proportion: p 1.96 P(1-P)/n where p is the prior estimate of the proportion of interest and n is the sample size.

Calculating sample size:

For example, suppose we had a pilot trial designed primarily to determine adherence rates to the standardized risk assessment form to enhance venous thromoprophylaxis in hospitalized patients. Suppose it was also decided a priori that the criterion for success would be: the main trial would be feasible if the risk assessment form is completed for

Calculating sample size:

Using a 95% CI for the proportion of eligible patients who complete the assessment form, a margin of error (ME) of 0.05, a lower bound of this CI of 0.70, and an expected completion rate of 75% based on an educated guess, the required sample for the pilot study would be at least 75 patients. This calculation is based on a common formula for obtaining a 95% CI for a single proportion:

Outcome of a pilot study

(i) Stop - main study not feasible. (ii) Continue, but modify protocol feasible with modifications. (iii) Continue without modifications, but monitor closely- feasible with close monitoring.

GUIDELINES:
Sample for the pilot study should be as representative of the entire research sample as possible. Should be large enough. Should be a comparable structure to that of main study. Ideally selected as random from the research sample.

GUIDELINES: CONTD
Should succeed in disclosing the significant difficulties to be guarded against. Informations discussed during pilot study should be kept confidential.

improve the internal validity of a questionnaire:

Administer the questionnaire to pilot subjects in exactly the same way as it will be administered in the main study. Ask the subjects for feedback to identify ambiguities and difficult questions . Record the time taken to complete the questionnaire and decide whether it is reasonable .

Pilot study procedures to improve the internal validity of a questionnaire:

Discard all unnecessary, difficult or ambiguous questions . Assess whether each question gives an adequate range of responses. Establish that replies can be interpreted in terms of the information that is required. Check that all questions are answered . Re-word or re-scale any questions that are not answered as expected . Shorten, revise and, if possible, pilot again.

ADVANTAGES:

It permits preliminary testing of the hypotheses that leads to testing more precise hypotheses in the main study.
It

may lead to changing some hypotheses, dropping some, or developing new hypotheses.

It provides the researcher with ideas, approaches, and clues that may not have foreseen before conducting the pilot study.

Such ideas and clues increase the chances of getting clearer findings in the main study.

ADVANTAGES: contd.

It permits a thorough check of the planned statistical and analytical procedures, giving a chance to evaluate their usefulness for the data.
You

may then be able to make needed alterations in the data collecting methods, and therefore, analyze data in the main study more efficiently.

It can greatly reduce the number of unanticipated problems because of an

ADVANTAGES: contd.

It may save a lot of time and money. (Unfortunately, many research ideas that seem to show great promise are unproductive when actually carried out). The pilot study almost always provides enough data for the researcher to decide whether to go ahead with the main study. In the pilot study, the researcher may try out a number of alternative measures and then select those that produce the clearest results for the main study.

LIMITATIONS:
The possibility of making inaccurate predictions or assumptions on the basis of pilot data. Problems arising from contamination. Problems related to funding.

CONTAMINATION:

This may arise in two ways: where data from the pilot study are included in the main results; where pilot participants are included in the main study, but new data are collected from these people.

FAILED OR BAD PILOT STUDY?

- No study is a complete failure; it can

always be used as bad example! However, a pilot study that shows the main study is not likely to be feasible is not a failed (pilot) study. In fact, it is a success - because you avoided wasting scarce resources on a study destined for failure!