STUDY DESIGNS

Definition
• A study design is a specific plan or
protocol for conducting the study, which
allows the investigator to translate the
conceptual hypothesis into an operational
one.
 Definition of Terms
• Case studies-An in depth examination of
groups of people.

• Phenomenological studies-Examine human

experiences through the descriptions that
are provided by the people involved.
 Cont…
• Action research-seeks attention to improve
practice and studies the effects of the action
that was taken.

• Historical studies-concerned with the

identification, location and synthesis of
data from the past.
 Choice of Study Design
Depends on:
– Research Questions
– Research Goals
– Researcher Beliefs and Values
– Researcher Skills
– Time and Funds
 Cont…
It is also related to:
• Status of existent knowledge
• Occurrence of disease
• Duration of latent period
• Nature and availability of information
• Available resources
 Types of Study Designs
• Qualitative
• Quantitative
– Observational
• Basic
• Hybrid
• Incomplete
 Observational Designs
(Classification II)
• Preliminary (case-reports, case-series)
• Basic (cross-sectional, case-control, cohort
[prospective, retrospective] )
• Hybrid (two or more of the above, nested
case-control within cohort, etc)
 Quantitative study design cont…
• Quasi experiment – used to estimate the causal impact of an
intervention using treatment and control groups
• Correlational – study of relationship or connection between two
variables
• Descriptive – study to depict participants in their natural
occurrence or accurately
• Survey – research that gets information from a specific group of
people and can be done on phone, face to face or email
• Experimental - controlled factor or variable is subjected to a
certain treatment or intervention to compare with a factor kept constant
• Comparative - compares two groups of participants in an attempt
to draw a conclusion on the subject of study
• Evaluative – determines the impact of an intervention or program
mostly in a social context
 RCT
– The “gold standard” of research designs.
They thus provide the most convincing
evidence of relationship between exposure
and effect.
– Example:
 Trials of hormone replacement therapy in
menopausal women found no protection
for heart disease, contradicting findings
of prior observational studies
 Qualitative study designs
• The grounded theory tradition, with roots
in sociology, seeks to describe and
understand the key social psychological
processes that occur in a social setting

It was developed in the 1960s Glaser and

Strauss (1967).
• Phenomenology, rooted in a
philosophical tradition developed by
Husserl and Heidegger, is concerned with
the lived experiences of humans.

• Its an approach to thinking about what life

experiences of people are like and what they
mean
• Ethnography is the primary research tradition
within anthropology, and provides a framework
for studying the lifeways and experiences of a
defined cultural group.

• Ethnographers typically engage in

extensive fieldwork, often participating in the life
of the culture under study.
 Historical Research
• “History is an estimate of the past from the
standpoint of the present.”
• Historical research examines the events of the
past.
• Historical research increases the nurse’s
understanding of their profession.
 Philosophical Inquiry
• Philosophical researcher considers an idea or issue from
all perspectives through an extensive exploration of the
literature, examining conceptual meaning, raising
questions, proposing answers, and suggesting the
implications of the answers.
• The purpose of philosophical inquiry is to perform
research using intellectual analyses to clarify meanings,
make values manifest, identify ethics and study the
nature of knowledge.
• It consists of 3 types: Foundational inquiry, Philosophical
analysis and Ethical inquiry.
 Critical Social Theory
• Critical social theory involves analysis of
systems of thought that lead to patterns of
domination and prevent personal growth of
individuals within a society.
 Qualitative Research Techniques
• Participant observation
– Gains insight into understanding cultural patterns to
determine what’s necessary and needed in tool
development (complementary to interviews)

• Interviews/Focus groups with

stakeholders
– Explores how tools are used and could be used in a
novice programming course
– Gains insight into the meaning of tools for students for
learning to program
 Cont…
• Data analysis
– Themes arising from data would provide insight into
current “learning to program” issues and see what is
important to students / tutors / administrators
• Survey
– Useful for verifying results on a larger scale
• User Testing
– Useful for triangulating results
Rigor in Qualitative Research

• Dependability
• Credibility
• Transferability
• Confirmability
 Dependability
• Refers to the stability & trackability of the
changes in data over time & conditions
• Reflects the reality that people’s situations
change & reality differs for people
• Want to determine the extent to which
another researcher with similar training &
rapport with participants would make the
same observations
• This is determined by an audit trail
 Credibility
• Refers to the accuracy of the description
• Enhanced by prolonged time in the field
• Repeatedly observing & interacting with
participants
• Triangulation (that facilitates validation of data
through cross verification from two or more
sources of data, methods, data type,
investigators, & theories
• Member checks-participants involved with data
analysis
 Transferability
• Concerned with generalizability or
fittingness of findings to other settings,
populations, & contexts

• Lack of transferability is often viewed as a

weakness of qualitative methods
 Confirmability
• Neutrality is the focus
• Do conclusions depend upon the subjects &
conditions of inquiry rather than on the
researcher
• Would 2 independent researchers agree about the
meanings emerging from the data
• An audit trail is used
• Researcher must explicate how personal biases
may have come into play and consider alternative
explanations
 Advantages of Qualitative
• Helps explain relationships • Less dependent on
in detail; individualistic instrument
• Can help validate • Can bring change in
quantitative findings by institutions and society
further investigation – In-depth
• Can help close gap between – Personalized
research and practice – Examines specific issues
– Needs of individuals in
institutions
– Study problems more
relevant to policy makers
 Disadvantages of Qualitative
• Strong dependency on • Convenience sampling
sample population
• Lack of training or
– Access
– Honest and valid
knowledge about
information methodology
• Time and resources • Lack of ability to
needed for collection and produce and
analysis is intensive comprehend research
• Lack of objectivity and
bias by researcher
– Inferences made
– Incorrect conclusions
 Study populations
• Cross-sectional: where only ONE set of
observations is collected for every unit in the study,
at a certain point in time, disregarding the length of
time of the study as a whole.

• Longitudinal: where TWO or MORE sets of

observations are collected for every unit in the study,
i.e. follow-up is involved in order to allow
monitoring of a certain population (cohort) over a
specified period of time. Such populations are AT
RISK (disease-free) at the start of the study.
 Case-series:
Clinical case series
• Clinical case-series: usually a coherent and
consecutive set of cases of a disease (or similar
problem) which derive from either the practice of
one or more health care professionals or a defined
health care setting, e.g. a hospital or family practice.
• A case-series is, effectively, a register of cases.
• Analyse cases together to learn about the disease.
• Clinical case-series are of value for:
– Studying symptoms and signs
– Creating case definitions
– Clinical education, audit and research
 Case series:
Population based

• When a clinical case-series is complete for a

defined geographical area for which the
population is known, it is, effectively, a
population based case-series consisting of a
population register of cases.
• The most important case-series are registers
of serious diseases or deaths, and of health
service utilisation, e.g. hospital admissions.
• Usually compiled for administrative and legal
reasons.
 Cross-sectional Studies
(Community health studies, surveys)
• Characteristics: detects point prevalence;
relative conditions; allows for stratification
• Merits: feasible; quick; economic; allows study of
several diseases / exposures; useful for estimation
of the population burden, health planning and
priority setting of health problems
• Limitations: temporal ambiguity (cannot
determine whether the exposure preceded
outcome); possible measurement error; not
suitable for rare conditions; liable to survivor bias
• Effect measure: Odds Ratio
 Cohort Studies
• Characteristics: follow-up period
(prospective; retrospective)
• Merits: no temporal ambiguity; several
outcomes could be studied at the same time;
suitable for incidence estimation
• Limitations (of prospective type):
expensive; time-consuming; inefficient for
rare diseases; may not be feasible
• Effect measure: Risk Ratio (Relative Risk)
 Advantages of Quantitative
• Observations are used • Predicts correlation
throughout studies between objects
• Formulating • Systematic data
collection and analysis
hypotheses allows for
• Generalizable to other
speculation about
institutions for further
outcomes; applicable research
instrument • Recognized criteria for
• Safeguards used to assessment and validity
minimize or eliminate • More research conducted
bias by this method
 Disadvantages of Quantitative
• Should only be used if data
can be measured by
numbers, results quantified
• Instrument or method
chosen is subjective and
research is dependent upon
tool chosen
• Lack of independent
thought by researcher when
dependent on instrument
or mathematics used to
extract or evaluate data
• Individuals’ decisions not
evaluated based on their
culture or social interactions
• Decisions made without regard
to individual human thought
or choice to predict behavior
• All individuals are measured
same way
– Experiences
– Backgrounds
– Intelligence
– Ability to change decisions at
any given point in time
– Independent though
 Comparison
Qualitative Quantitative

• Understanding
• Interview/observation
• Discovering frameworks
• Textual (words)
• Theory generating
• Quality of informant more
important than sample size
• Subjective
• Embedded knowledge
• Models of analysis: fidelity to
text or words of interviewees
• Prediction
• Survey/questionnaires
• Existing frameworks
• Numerical
• Theory testing (experimental)
• Sample size core issue in
reliability of data
• Objective
• Public
• Model of analysis: parametric,
non-parametric