PHAR3504 -Practitioner and Patient

Preparing to Undertake Research as a Scientist

Tutor: Dr W Schlindwein E-mail: wss@dmu.ac.uk
Module Leader:

Mr J Waterfield

Why learn about research?

Your research project next year! Evidence-based practice much in vogue Lifelong learning Rate of change in Pharmaceutics & Practice Critical Skills Self/Career Development

What is Research?
The dictionary definition: Research Systematic investigation into and study of materials, sources, etc., in order to establish facts and reach new conclusions.

WHAT Methods/Approaches to Research in Pharmacy

Experiment (trials) Survey - a description/ quantitation Observation (Case-study) (Focus groups)
Similar to methods & approaches used in other human-centred research (e.g. psychology)

Philosophy: What is the scientific method?

Method implies a systematic procedure:
How knowledge is acquired How knowledge is recorded and transmitted How the truth or falsity of the knowledge is evaluated.

The Basic Elements of a Research Investigation

1
2 3
Setting your aims: ASKING THE QUESTION Background research and literature survey: WHAT HAS ALREADY BEEN DONE? Planning your research: HOW WILL YOU ANSWER THE QUESTION? Carrying out the research: GETTING RESULTS

4 5
6 7

Analysing and evaluating the results.

Conclusions. Recommending any further work.

Literature Search
Why is a Literature Search so Important? Write down why you think carrying out a literature search might be fundamental to a research project.

Questions you should be asking:

What have other people done in a similar subject area? What techniques have other people used? Were the methods used by other people appropriate/ successful? How have other people tested whether their aims have been achieved?

Evaluating Other Peoples Work

What factors do you think affect the reliability of information in for example, an academic article?

The questions you should be asking include:

Is the purpose of the research clearly defined? (This should be stated early on in the report/ article.)

What are the links with previous studies, if any? (The author(s) of the report/ article should have done their own literature review!)
Why was the specific method of study chosen? (Have the authors explained their reasons clearly?) Do the conclusions of the report relate back to the stated initial aim/ problem?

Citation
The importance of citation, or referencing, material cannot be over emphasised. Publication details: Author(s) Year of publication Title of article Journal/book title Publisher Volume and part number Page numbers

Citation
People sometimes get confused about the difference between a bibliography and a reference list. The bibliography will list more general literature sources (such as textbooks), which have been used for background reading. The reference list will contain details of specific articles and reports. Both will use either the Harvard or the Numeric citation system.

The Function of a Literature Review

1

The results of your literature review have to justify your project aim.

The literature review should include your revaluation and critical assessment of other peoples work.

Later on in your dissertation, you will need to relate your results back to existing knowledge.

Structuring a Literature Search

To get you thinking about different sources of information, study the following list of possible sources and write down the type of information you think each would provide: Books. Student dissertations. First hand experience. Questionnaire surveys. Academic journals. Popular journals (e.g. the New Scientist). Laboratory experiments. Patents. Newspapers. The World Wide Web.

Source Books.

Student Dissertations. First Hand Experience. Questionnaire Opinions and experiences of other Surveys. people. Academic Journals. Other peoples research methods and results. Popular Journals - Edited versions of other peoples (e.g. New Scientist). work. Laboratory Scientific and technical data. Experiments. Patents. Technical developments. Newspapers. Evolving topics. The World Wide Vast amount of information on Web virtually all subjects.

Type of Information General background, not necessarily up to date. Other peoples research methods and results. Personal knowledge.

Primary Sources of Information

Examples of primary sources of information are academic journal articles and student dissertations. Authors of primary sources are the researchers who have been directly involved, through observation and experience, in the work described. They are personally responsible for the reliability and authenticity of the information.

Secondary Sources of Information

Examples of secondary sources are books, databases, directories, and abstracts. The information contained in secondary sources has been edited and structured by someone other than the author. The information may be true, but is not necessarily the whole truth.

Project Preparation
Identifying the Research Problem
Formulation of question or hypothesis

Development of experimental design

Carry out experiment

Data collection

Analysis of results

Interpretation of results

Asking Questions
Based on your past experience, what factors do you think must be considered when planning your research project?

Factors to consider when planning a research project: Has the research been carried out before by other workers?
How much time is available for the work?

Is the aim of the research achievable in the time available? What is the most efficient way of achieving the project aims?

 Factors to consider when planning a research project: What resources will be needed for the work?

What are the potential sources of error and how can these be identified and minimised? How will the results of the work be evaluated?

Articulating the Problem

Formally, once we have established the research problem, it is necessary to write down a clear statement of our aims and objectives

Validity of Information
It is important that you learn to distinguish between different ways of acquiring knowledge.
Tenacity Intuition Authority

Tenacity
A willingness to accept ideas as valid due to the fact that these ideas have been accepted for so long that they have acquired an aura of unquestioned truth e.g. advertisers use this technique by constantly repeating a message in the hope that consumers will eventually accept it as truth.

Intuition
A method of acquiring information that requires no intellectual effort or use of our five senses e.g. extra sensory perception. We may intuitively feel that an idea is correct but with no way of substantiating our gut feeling.

Authority
The acceptance of an idea as valid because the source of that information is a respected one e.g. religious writings, government reports.

???
All of these methods of acquiring knowledge involve an uncritical acceptance of information.
Clearly, such approaches are non-scientific,

Scepticism
Any proposition or statement irrespective of source or authority is open to:

doubt - onus of proof

question/analysis - explanation, qualification, how? why? when? how much? to what extent? how often?

Scientific, Rigorous Methods of Acquiring Information

Rationalism Empiricism

Rationalism
Knowledge is developed through reasoning processes. Information is clearly stated and then an acceptable conclusion is reached by following a series of logical rules.

Rationalism
Example:
All tyres are black (major premise). This is a tyre (minor premise). Therefore this tyre is black (conclusion).
Using the major and minor premises we have logically derived the conclusion. However, if we apply the same logic in the following way we would have to reject the conclusion:

All tyres are black This is black Therefore this is a tyre.

Rationalism
So, we can see, that although a rationalistic approach is essential to the process of scientific enquiry, it clearly has limitations. In order to arrive at the correct conclusions, the premises must have been determined to be true by other supporting evidence.

Empiricism
Knowledge is acquired through the observation of real events. Scientific enquiry involves a continuous and systematic interchange of rational thought and empirical observation
Our experimental observations are not sufficient in themselves, we need to apply a rational process of abstract thought in order

to understand, explain and construct general principles

Empiricism
Enquiry is to be:
conducted by observation (s) verified through experience (s) an iterative process several (7??) stages

The seven stages of scientific investigation (not necessarily in this exact order)
1- Observation; description; measurement 2- Generalization and induction 3- Generation of hypotheses 4- Formulation of theories 5- Deduction 6- Controlled observation (experiment trial) 7- Support/verification or falsification

Establishing the Methodology

Before beginning to design an experiment, and thereby establishing the methods we need to use, we must make decisions regarding the following:
First and foremost, is the investigation significant? What information is required? What is the best way to obtain this information? How have other people approached the problem? Is the chosen analytical method suitable?

Generic Factors
Accuracy of measurement Precision of measurement Detection levels Repeatability of measurements Equipment considerations Samples

Accuracy & Precision

Accuracy:
The closeness of the agreement between the result of a measurement and the true value of the quantity being measured.

Precision:
The closeness of a series of replicate measurements to each other

Designing an Experiment
Independent variable Dependent variable Experimental procedure Experimental group Control group

 Experiment
The manipulation of one or more variables, and the measurement of the effects on other variables.

Independent Variable
The variable that is being manipulated.

Dependent Variable
The variable that is being impacted by manipulation of the independent variable.

Confounding variables
Those uncontrolled/unrecognized variables which might give/contribute towards giving a similar (or expected/hoped for) result

 Experimental Procedure
The manipulation of independent variables.

Experimental Group
The group exposed to experimental manipulation.

Control Group
The group not exposed to experimental manipulation but used as a basis against which to measure experimental effects.

Confounding variables
Levine MI, Sackett, MF (1946) Results of a Trial of BCG Vaccine Ann. Rev. Tuberculosis 53: 517
Table 1 Self selected parents

No. Number of deaths Children from tuberculosis Number % Vaccinated 445 3 0,67
Controls 545 18 3,30

Confounding variables
Table 2 Alternate allocation by parent

No. Number of deaths Children from tuberculosis Number % Vaccinated 556 8 1,44 Controls 528 8 1,52

The Importance of Methodological Rigour

Experimental procedures must be relevant, appropriate and justified.
You will need to ask yourself the following questions:
Is the method systematic? Is the method valid and verifiable? Are the observations empirical? Will the method withstand critical evaluation?

Calibration
The validity of your results is dependent on whether or not they are obtained within the calibration range of equipment
Calibration improves the comparability of measurements and may be carried out periodically (every few days or weeks) to check the performance of an instrument, or may be necessary before each sample run.

Experimental Methods
Observation
is the empirical process of using our senses to recognise and record factual events.
Scientific observation tends to be quantitative, although you should be aware that qualitative statements also make a significant contribution to an investigation

Experimental Methods
Description
Observation leads to description
In science, precise definitions have been formulated in order to ensure universality of meaning. This means that when writing the description, or record, of our experiment, we can communicate with other scientists by using universally accepted definitions of terms.

Cause and Effect

One event is the cause of the other only if suppression of it also suppressed the effect.
if we want to establish that two variables are causally related we will need to ask the following questions:
Is there a relationship between the two variables in your sample? If the variables are related in the sample, are the variables related in the total population? If the variables are related, did the independent variable cause the changes?

Correlation
A correlation describes the relationship between variables and is represented by an index known as the correlation coefficient.
The correlation coefficient can vary from 1.00 to +1.00.

The sign of the correlation coefficient indicates the type of relationship that exists between 2 variables.
Positive correlations Negative correlations

Analysis and Synthesis

When we observe an event, we need to break down and study separately those factors that have an influence on that event.

In other words, we must analyse the problem. We can ask the following questions: What are the influencing factors? Are the factors independent of each other? Are the factors mutually interacting?
e.g. human body

Hypothesis and Deduction

Theory
An integrated set of principles that explain observations and can be used to deduce hypotheses.

Hypothesis
A specific prediction that can be tested.

Law
A thoroughly documented relationship between 2 or more variables.

Recognise that a theory is not a fact or law.

Laboratory experiments -I
Much simpler than in communities Reasons why:

Laboratory experiments - II
But lab experiments are not as easy as you might think.
What kind(s) of response do you observe when you vary the concentration of an active molecule in a biological system? List the practicals in your MPharm course in which you have done this.

Summary
Undertaking research as a Scientist
Undertaking research as a Practitioner