Fundamentals of Research

Sami Siraj PhD.

Medical Research Perspectives

• What is Medical Research?

• Fundamental Concepts & Definitions

• Areas of Medical Research

• Impediments to Research

• Some Important Considerations

What is Research? I• A scientific study to seek hidden knowledge• A scientific study to answer a question• A scientific study of causes and effects• A scientific attempt towards new discoveries• A systematic method of inquiry• A logical attempt to find answers to problems• A systematic approach to a (medical) problem• A scientific attempt to discover the truth

What is Research? II

• Research is the systematic collection, analysis and interpretation of data to answer a certain question or solve a problem.

• Health Research, likewise, is a research effort to address health related problems and come up with better solutions to mitigate the prevailing problem.

Basic & Applied Research

• Basic ~ Extends Knowledge• Basic research in health ~ Generate new

knowledge and technologies• Applied ~ Addresses Problems• Applied research in health ~ Prioritizes to

achieve greater benefits under the resources.

Why Do Research?

• Provides answers to unknown important questions

• Stimulates learning and acquisition of new knowledge

• Research-based knowledge is usually authentic and verifiable

• Develops a higher level of professional competence in the relevant field

• Directly affects patient care and health policy

Areas of Medical Research

• Parameters of Health• Parameters of Disease• Risk of Disease• Outcome of Disease• Outcome of Treatment• Evaluating Treatments and Procedures• Vital Statistics and Trends

Outcome of Research

• Is it just “academic / ancillary” activity?• Basic versus Applied Research• An agent for change in society?• Morally, Ethically & Financially justified?• Is research the basis of all (medical) knowledge?• Awareness / Publications / Promotions, etc.• Need for Regulations – Peer, Societal, Legal• Use / Abuse of Medical Research Data

Levels of Research

• Inquisition • Difficulty • Ability

Research Mindedness

• The desire to acquire only that knowledge which can be objectively established as fact.

• The ability to see problems in existence followed by the will, the resolve & the means to solve them.

• To be able to honestly conduct research and accept the results for whatever they are.

Research Ability

• Good powers of observation• Accurate recording of details• "Science is nothing, but trained and organized

common sense." - Thomas Huxley • Single-minded concentration, if needed• Lumpers versus Splitters• Persistence / Perseverance• No pain-----

Impediments to Research

• Lack of Research Environment• Lack of Funds for Research• Lack of priority for research as opposed to

clinical activities• Lack of teaching research methodology in

undergraduate and postgraduate curricula• Lack of implementation of research

recommendations / outcomes

Some Important Considerations

• Do Research only when really needed• Be crystal clear on what you want to do• Avoid Duplication of Research Studies• Be Ethical and Humane• Avoid Biases of all types• Accept the results for whatever they are• Be very careful in Inferential Studies• Maintain Quality Control at all levels• Try and Be Economical

RESEARCH LANGUAGE ANDTERMINOLOGIES

The research Language

• Like all specialized fields of study, research has its own

terminology, which makes sense to researchers and often

confuses non-researchers.

• Though quite diverse, some terms and their definitions are

common to essentially all types of research.

• A researcher must be thoroughly familiar with the standard

terms and their definitions, so as not to develop false

perceptions.

Bias

• Any internal or external influence(s) that may affect the accuracy of

the study. Bias favors one outcome over another; a good study does

not tilt to any outcome.

• If biases are not removed, systematic errors can occur in all steps of

the research project.

• It is thus essential to identify all sources of bias before the study is

undertaken as well as during the study.

• Common biases arise due to sample size, sampling methods and

data collection techniques.

Blinding

• A procedure for making data collection less biased in drug trials.

• Single Blinding:

– The patient does not know if he/she is receiving a test drug or not.

• Double Blinding:

– The patient and the doctor/researcher do not know which patient is

being the test drug.

• Triple Blinding:

– The patient, the researcher and the data analyst do not know which

patient is being given the test drug.

Census

• If data are collected from the entire population, it is called a

CENSUS.

• Usually data are collected from a representative SAMPLE of the

population.

• A census normally is too extensive and expensive to be carried out

by an individual or a group; governments or large organizations

carry out national censuses.

• However data collected is valid for short time periods as the

population keeps on changing.

Citation & Bibliography

• Mentioning a reference in an article, thesis or dissertation (usually

in introduction and discussion).

• Citations are of two types:

– Harvard style (for thesis)

– Vancouver style (for journal articles)

• Usually in the form of:

– Name of author(s) and year of publication (Harvard )

– a serial number that is superscripted at the place of reference

(Vancouver).

Confounder

• From “CONFOUND = TO CONFUSE”

• Any influence that causes a confusion in the analysis or

interpretation of results of a study.

• In Cause-Effect analytic studies, a confounder can

influence either or both the cause(s) and the effect(s).

• Possible confounders have to be identified and

removed before and during the study.

Credibility

• The trustworthiness (credentials, education,

experience, etc.) of a researcher or data presented in a

research study.

• The internal validity of qualitative research.

• Credibility may influence acceptance, approval and

funding of research projects.

• A more credible study will find greater applicability.

Deduction/Deductive Reasoning

• Reasoning in which the conclusion is necessitated by, or

reached from, previously known facts.

• For example, the picture is above the desk. Since the desk

is above the floor, therefore the picture is above the floor.

• An example of an invalid deductive reasoning attempt is:

– Every criminal opposes the government. Everyone in the

opposition party opposes the government. Therefore everyone

in the opposition party is a criminal.

Demographics

• Description of the vital statistics or objective and

quantifiable characteristics of an audience or population.

• Demographic designators include age, marital status,

income, family size, occupation, and personal or household

characteristics such as age, sex, income, or educational

level.

• It also includes measurable values such as a person’s

height, weight, etc.

Direction of study

• Actually refers to data collection:

– Prospective: when data are collected by

researcher first hand during the study.

– Retrospective: when data have already been

collected by other people and researcher merely

compiles and analyses them as a study.

Epidemiology

• From Greek: Epi (above/ among); demos (people).

• The study of populations in order to determine the

frequency and distribution of disease and measure risks

(Community based research).

• In the clinical setting, epidemiology is focused specifically

upon patients (Hospital based research).

• A good epidemiological study provides a lot of useful

information for many years in future.

Hypothesis

• A statement or logical assumption for which there is no evidence of

support or negation.

• Hence this statement has to tested by doing a research study.

• A research question can lead to research hypotheses:

– The Null Hypothesis: statement of no difference

– The Alternate Hypothesis: statement of difference

• It is not the job of a researcher to support or deny any hypothesis,

merely to test it by research and then state which hypothesis is true

and which is false.

Induction/Inductive Reasoning

• The process of reasoning in which the premises of an argument

support the conclusion but do not ensure it.

• Also called ‘Educated Guess’ or ‘Hypothesis Construction’.

• Induction is employed, for example, in the following argument:

– Every life form we know of depends on liquid water to exist. All life

depends on liquid water to exist.

• Inductive reasoning allows for the possibility that the conclusion is

false, even where all of the premises are true. For example:

– All of the swans we have seen are white. All swans are white.

Intervention

• Any attempt by researcher to modify/ alter the natural course of

events for the purpose of research.

• Common examples:

– Giving a drug to see its effect on a disease or condition.

– Providing mass vaccination to prevent an epidemic.

– Performing surgery/ manipulations to alleviate a disease/ condition.

• Basically, an intervention is an experiment conducted under

controlled conditions.

Performa/ Questionnaire

• A tool for data collection containing:

– A set of questions through data is collected from subjects.

– A set of values or measurements (e.g., lab values, clinical values,

demographics etc.) which are part of the data to be collected.

• Performa is essential to every research project as it is the main data

collection instrument.

• Designing a Performa takes time, skill and expertise.

• It is usually pretested (pilot study) on a small sample before the

actual large project.

Pilot study

• A small, initial study, on a limited sample, just to ‘get the

feel of things’.

• Usually done before a large research project, so that the

research proposal, especially the methodology can be

further refined.

• Identifies any ‘bugs’ in the planned methodology, so these

can be gotten rid of in the main study.

• A sample of 20-30 subjects usually suffices.

Plagiarism

• Taking credit for some one else’s work.

• Often done in article writing, thesis and dissertations:

– Copying other researchers’ original work and publishing as one’s own.

– Not giving proper references / citations while showing the work of

other researchers.

– Copy-pasting from Internet sources.

• One must read the work of others (literature search) but then write

it in one’s own words, or give proper credit through citations.

Population & Sample

• Population in research is not the same as the population of some city or

country.

• Population is the larger group of people/ subjects/ objects from whom a

Sample has been taken.

• A study population is the defined population from whom a sample was

taken for the research study.

• A target population is the group of people on whom the findings / results

can be applied in future.

• A sample is the group of people/ subjects/ objects from whom the data

have been collected by researcher.

Random

• A process of sample selection where every subject has an

equal chance (hence independent) of being selected in the

sample.

• It is considered the most representative sampling method.

• It is used to eliminate bias in the study.

• The results of a random sample are also truly applicable.

Rationale

• An argument or reasoning given to support a point of view

or some defined purpose.

• In research, it is the supportive data and the importance of

the study that will be undertaken.

• It is an essential part of a research proposal, written at the

end of Introduction.

• A strong rationale increase the chance of acceptance/

funding/ publishing of the research study.

Representative sample

• An assessment of how truly a sample depicts the real

events of the population.

• Representativeness is increased by:

– Large sample size

– Random sampling method

– Dividing the population into clusters/ strata before sampling

• Only a representative sample allows for inferences to be

drawn and applied to the target population.

Risk

• A risk (of disease) is defined as the chances of a person

acquiring that disease under a given set of conditions/

circumstances.

• It implies exposure to ‘risk factors’ that cause disease.

• It can be measured or calculated based on a research study.

• Risks are widely used in epidemiology and in international

travel plans of people.

NEEDS ASSESSMENT

• A formal needs assessment has to be done before a

research project can be started. This is essential to:

– Provide a complete knowledge of what is required to

complete the project

– Start the process of acquiring the resources that would be

needed

– Get an idea about the logistics and budget involved

– Provide needed information about feasibility of the

project.

Needs Assessment

• Needs assessment usually involves three areas

(3 Ms):

MATERIALS

MANPOWER

MONEY

Needs defined

• Includes a comprehensive and extensive list of ALL

materials that would be needed for the research study

– Equipment: Lab-based; field-based

– Laboratory space and requirements

– Reagents/Chemicals

– Stationery items

– Computers and related peripherals

– Books, Journals, etc.

Materials

• Basically it means the persons required to carry out the study

– May include patients and controls (subjects of study)

– Principal Investigator

– Co-Investigator(s)

– Research team members

– Data collectors

– Laboratory personnel

– Statistician / Computer operator

– Any other people who would be hired or used in the study

Manpower

• Funding / Budget is an absolute requirement for

carrying out the research project

– A formal Budget should be made for all items such as

materials, salaries, trips, literature search, etc.

– Each budget item has to be justified

– Costs should be kept to the minimum and be realistic, but

should be upscalable so that there is no deficiency during

the project

Money

• A complete needs assessment forms an essential

part of a research project proposal.

• It has to be written in the Methodology

(Materials and Methods) section of a project

proposal.

• Chances of approval/ funding of the project

increase if this section is well-written.

Relevance to research project

• Currently, the best sources for needs assessment are:

– Research articles

– Supervisors / Senior researchers

– Internet

• Other sources may include:

– Textbooks

– Libraries

– Field workers

– Senior laboratory technicians

Sources for needs assessment