CLINICAL RESEARCH

RESEARCH
We do research because we are curious and interested in solving
problems

Research is systematic investigation which aims to discover new

knowledge or to validate and refine existing knowledge
Nurse and midwives are in a good position to generating new
knowledge that informs their practice and to validating best practice
for health care delivery

CLINICAL RESEARCH
Clinical research is a systematic method for evaluating the
effectiveness of treatment and for establishing a basis for
inductive generalizations about intervention

The ultimate goal is to further intellectual progress by contributing

to the scientific base of practice through the development of
theory

THEORY
A set of interrelated constructs
(variables), definitions and propositions
that present a systematic view of
phenomena by specifying relations
among variables, with the purpose of
explaining natural phenomena

CHARACTERISTICS OF THEORY
ECONOMICAL

Using only those concepts that are truly relevant and necessary to
the explanation offered by theory

Theories become the mirror of professions values and identity

IMPORTANT

ACCEPTANCES

Theories must be consistent with observed facts and the already

established body of knowledge and must adapt to changes in that
knowledge as technology and scientific evidence improve

BASIC PRINCIPLES IN
CLINICAL RESEARCH
AUTONOMY

BENEFICENCE

THE
PROTECTION
OF HUMAN
RIGHTS

JUSTICE
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MIND FRAME OF
INFORMED CONSENT
Subject must be fully
informed

Subject should known what will be done to them, how long it take, what the will feel,
what side effects can be expected and what types of questions they may be asked

Subject information
should be confidential
and anonymous

Research subject should be told what steps are being taken to ensure confidentiality of all
information, whenever possible, a subject anonymity should be protected

The informed consent

form must be written
in lay language

The language must be clear and basic so that the average reasonable individual can follow
it and Professional jargon is unacceptable
Language should be written for the lowest educational level

The researcher must

offer to answer
questions at any time

The researcher is responsible for ensuring that the subject understands all relevant
information
Subject should feel free to question the procedures at any time during the course of the
study
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CONSENT ELEMENTS
Consent must be voluntary
Subject should participate in a research project of their own free
will, they must be informed that there is no penalty to them if
they refuse

Special consideration for vulnerable subjects

If subject is not competent, consent must be provided by a legal
guardian or advocate

Subjects must be free to withdraw consent any time

The researcher would discontinue the experiment at any time if
necessary for the subjects safety or comfort
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DETAIL ELEMENT OF
INFORMED CONSENT
Purpose of the research project
A clear explanation of the reason for doing the study and why it is
important
Reason for selecting this particular individual

Procedure
A clear detailed explanation of what will be done to or by the
individual

Risks and discomforts

Truthful and inclusive statements of risks that may result and
discomforts that can be expected
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DETAIL ELEMENT OF
INFORMED CONSENT
Benefits
A description of potential benefits of the individual
participant, to the general knowledge, or to the
future administration of health care

Alternatives to participant
A description of reasonable alternative procedures
that might be used in the treatment of this individual
when a treatment intervention is being studied
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DETAIL ELEMENT OF
INFORMED CONSENT
Confidentiality
Statements of the procedures used to ensure the anonymity of
the individual in collecting, storing, and reporting information
and who (person or agencies) will have access to the information
Specific authorization
What information may be used?
Who may use the information?
For what purpose? (may be referred to the description of the
study)
Is there any expiration date?
This authorization must be signed as part of the informed
consent document or as a separate document
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DETAIL ELEMENT OF
INFORMED CONSENT
Request for more information
A statement that the individual may ask questions about or
discuss participant in the study at an time, naming an individual
to contact

Refusal or withdrawal
A statement that the individual may refuse to participate or
discontinue participation at any time without prejudice

Injury statement
A description of measures to be taken if injury occurs as a direct
result of the research
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DETAIL ELEMENT OF
INFORMED CONSENT
Consent statement
A confirmation that the individual consents to
participate in the research project

Signature
Participant
Parent or guardian (for the care of minors)
Assent of minor over age 7 (17 in Indonesia)
Witness
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QUANTIFICATION AND MEASUREMENT

(SCALE)
RATIO;
Distance, age,
time, decibels,
weight

Number represent units with equal

interval, measured from true zero

INTERVAL;
calendar years,
C or F

Numbers have equal intervals, but

no true zero

ORDINAL;
manual muscle
test, function,
pain

Numbers indicate rank order

NOMINAL;
gender, blood
type, diagnosis

Numeral are category labels

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RESEARCH PROBLEM
SELECT TOPIC OF INTEREST

CLINICAL
EXPERIENCE

CLINICAL THERORY

PROFESSIONAL
LITERATURE

STATE THE RESEARCH

PROBLEM
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DEFINE RESEARCH QUESTION

EVALUATE THE RESEARCH
PROBLEM

IDENTIFY TARGET
POPULATION

STATE RESEARCH
RATIONALE
Background

IDENTIFY VARIABLES
Operational Definition

CLARIFY RESEARCH OBJECTIVES

State Specific Purpose or Hypotheses
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IMPORTANCE AND FEASIBILITY OF

THE RESEARCH QUESTION
THE QUESTION
SHOULD BE
IMPORTANT: THE SO
WHAT? TEST
THE QUESTION
SHOULD BE
ANSWERABLE

THE STUDY SHOULD

BE FEASIBLE

The results should be meaningful dan

useful

The research problem should also

incorporate variables that can be
defined and measured
The researcher must have the necessary
skill, background and resources to be
able to complete the project properly
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RESEARCH DESIGN

RESEARCH
DESIGN

QUANTITATIVE

QUALITATIVE

DESCRIPTIVE

SURVEY

ANALITICAL

EKSPERIMENTAL

QUASI

CASE STUDY

ORAL HISTORY

PARTICIPANT
OBSERVATION

FOCUS GROUP /
GROUP
INTERVIEWS

TRUE

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VARIABLES

VARIABLES

RESEARCH

The building blocks of the research question

A property that can differentiate members of a group or set
Represents a concept or factor, that can have more than one value
Characeteristics that can vary

Examine the relationship among variables or describe how variables exist in

nature
In descriptive and correlational studies, variables represent the phenomena
being examined
In explanatory and experimental studies, the investigator examines relationships
among two or more variables to predict outcomes or to establish one variable
influences another

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INDEPENDENT AND DEPENDENT

VARIABLES
INDEPENDENT VARIABLE
A predictor variable
A condition, intervention or characteristic that will
predict or cause a given outcome

DEPENDENT VARIABLE
The outcome variable
A response or effect that is presumed to vary
depending on the independent variable
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INDEPENDENT AND DEPENDENT

VARIABLES IN THE STUDIES
EXPLORATORY STUDIES
Independent and dependent variables are usually measured together, to determine
if they have a predictive relationship
These types of studies often involve several independent variables, as the
researcher tries to establish how different factors interrelate to explain the outcome
variable

EXPERIMENTAL STUDIES
Comparison of different conditions to investigate causal realtionships, where the
independent variable is controlled and the dependent variable is measured
A change in the dependent variables is presumed to be caused by the value of the
independent variable

COMPARATIVE STUDIES
Can be designed with more than one independent or dependent variable
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HYPOTHESES
Hypothesis

The researcher propose an educated guess about the

outcome of the study
A declarative statement that predicts the relationship
between the independent and dependent variables,
specifying the population that will be studied

Research
hypothesis

Following identification of the problem, a review of

relevant literature and final conceptualization of the
research variables

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TARGET POPULATION
TARGET
POPULATION

The group of
individuals to which
the results of the study
will apply

Target population
should be sufficiently
clear and complete
that it will be obvious
who will not be
considered a member
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POPULATIONS AND SAMPLES

POPULATION

SAMPLE

The larger group to which research results

are generalized
Aggregate of persons, objects or events that
meet a specified set o criteria

A researcher choose a subgroup of the

population
Th reference group for estimating
characteristic of or drawing conclusions
about the population
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LEVELS OF SAMPLING PROCESS

TARGET
POPULATION

Group of a people to
which the researcher
intends to generalize
findings

ACCESSIBLE
POPULATION

Some portion of the

target population that
has a chance to be
selected

SAMPLE

A researcher choose a
subgroup of the
population

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INCLUSION AND EXCLUSION

CRITERIA

The primary traits of the

target and accessible
populations that will qualify
someone as a subject
Variety of characteristics present in
the population in terms of clinical
findings
Demographic and geographic factors
Whether these factors are important
to the question being studied

Factors that would preclude

someone from being a subject
Theses factors will generally be
considered potentially confounding
to the results
Likely to interfere with interpretation
of the findings

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SAMPLING TECHNIQUES
PROBABILITY
SAMPLING

Simple Random Sampling

Systematic Sampling
Stratified Random
Sampling
Disproportional Sampling
Cluster Sampling

NONPROBABILITY
SAMPLING

Convenience Sampling
Quota Sampling
Purposive Sampling
Snowball Sampling
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EXPERIMENTAL RESEARCH DESIGN

(PRE AND POST-TEST ONE GROUP DESIGN)

STUDY
SAMPLE

PRE TEST

EXPERIMENTAL
INTERVENTION

POST
TEST

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EXPERIMENTAL RESEARCH DESIGN

(PRE AND POST-TEST CONTROL GROUP DESIGN)

EXPERIMENTAL
GROUP

PRE TEST

EXPERIMENTAL
INTERVENTION

POST
TEST

CONTROL
GROUP

PRE TEST

NO INTERVENTION
OR PLACEBO

POST
TEST

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EXPERIMENTAL RESEARCH DESIGN

(TWO GROUP PRE AND POST-TEST DESIGN)

EXPERIMENTAL
GROUP 1

EXPERIMENTAL
GROUP 2

PRE TEST

EXPERIMENTAL
INTERVENTION 1

POST
TEST

PRE TEST

EXPERIMENTAL
INTERVENTION 2 OR
STANDARD CARE

POST
TEST

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ANALYSIS STATISTIC
TYPE OF HYPOTHESIS
TYPE OF
MEASUREMENT
SCALE

COMPARATIVE
UN-PAIRED

PAIRED

CORELATIVE

2 GROUPS

>2 GROUPS

2 GROUPS

>2 GROUPS

NUMERICAL

Independent
T-test

One way
ANOVA

Dependent
T-test

Repeated
ANOVA

Pearson

CATEGORICAL
(ORDINAL)

Mann
Whitney

Kruskal Wallis

Friedman

Spearman
Somersd
Gamma

CATEGORICAL
(NOMINAL /
ORDINAL)

Chi-Square
Fisher
Kolmogorov Smirnov
(Tabel B x K)

Wilcoxon

McNemar, Cochran,
Marginal Homogeneity
Wilcoxon, Friedman

Coeficient
Contigency
Lambda
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