MSTAT LABORATORY E.g.

blood pressure

STATISTICS- science and art of dealing with variation of APPLICATIONS OF BIOSTATISTICS

data to obtain reliable results and conclusions (JHSPH)
▪Problem identification
-science of analyzing data and drawing conclusions
▪Resource allocation of limited resources
thereby in the face of variability and uncertainty
▪Evaluation programs
-degree of variability is substantial even when
observational or interventional conditions are held as ▪Needs assessment
uniform and constant as possible
▪Tool in decision-making process
-challenge for the biomedical researcher is to UNEARTH
THE PATTERNS 2 BRANCHES

-statistics is the science of generalization- study of a. DESCRIPTIVE

sample population • summarizes and presents data in a form for
easy analysis and interpretation
3 DOMAINS • tabulation, graphical presentation,
computation of averages as well as measures of
▪ DESCRIPTION OF PATTERNS data sets through various
variability
descriptive measures (descriptive statistics)
• Categorical and numerical data - percentage,
▪ DRAWING CONCLUSIONS populations through various proportions, SD, & central tendencies
statistical tests applied to sample data (inferential b. INFERENTIAL
statistics) • methods involved to make generalization and
conclusions of a target population, based on a
▪ APPLICATION OF MODELING TECHNIQUES understand
sample
relationship between variables (statistical modeling)
• hypothesis testing
BIOSTATISTICS
HISTORY OF BIOSTATISTICS
BIO - life
➢started 150 years ago
STATISTICS -refers to the science dealing with the ➢FLORENCE NIGHTINGALE
collection, organization, analysis, and interpretation ➢icon of nursing
➢worked during the Crimean war of the 1850s
- Application of statistics to problems in the biological to improve the methods of constructing
sciences, medicine and public health mortality tables
E.g. ❑ statistical measures of the risk of developing ➢conclusions from her tables helped to change
acute kidney problem using herbal supplements the practices in Army hospitals around the
world
❑ quantifying the relationship of PTB patients’
compliance to developing multiple-drug resistance to ▪ JOHN SNOW
treatment ▪ applied simple statistical methods to support his
NEED OF BIOSTAT IN SCIENCE theory on contaminated water from a single hand pump
was the source of the London cholera epidemic in 1854
▪ Due to the phenomenon of variation
at present, statistics is an integral part of:
▪ Measurable characteristics have the tendency to
change (individual/ time) • conducting biomedical research

▪ Systematic way of describing and analyzing the •reading and understanding most biomedical literature
variability of different phenomenon for very few is
constant in life
oBiomedical researchers carry out studies in various 2.DEPENDENT VARIABLE ➢ changes based on the other
settings given factor/dependent of another variable

▪laboratory ➢ effect

▪clinic TYPES OF VARIABLE

▪field 1.Quantitative variable

▪simply with data already archived in databases ❑ measured on a suitable scale using an appropriate
measuring device
DATA - raw material for statistical work
❑ categories can be measured and ordered according
- records of measurement or observations or simply
to quantity or amount
counted
❑ values are in numeric or numbers
- data are the values of a variable
❑ values have numerical meaning
❑POPULATION - refers to a large collection of people,
objects or places 2. QUALITATIVE VARIABLE

❑ PARAMETER-any numerical value describing ❑defined by some characteristic, or quality

population
❑categories are used as labels to distinguish one group
❑SAMPLE- a portion/representative of a population in a from another
research study
E.g. economic status (poor, middle class, rich, filthy rich)
❑ STATISTIC- any numerical value describing a sample location, disease status (mild, moderate, severe)

POPULATION DATA (“PARAMETERS”) ➢have been i. best summarized by grouping the observations into
denoted by Greek letters (μ for mean, σ for SD, etc.) categories

➢description serves to identify patterns or distributions ii. counting the numbers in each, referred to as
in data sets from which important conclusions may be categorical variables.
drawn.

VARIABLES

▪phenomenon whose values or categories cannot be

predicted with certainty;

▪particular character on which a set of data are

recorded

▪influence the manner in which

▪ observations are undertaken

▪ the way in which they are summarized

▪ the choice of statistical tests that will be used

▪important to distinguish between two types of data or
variables

TYPES OF VARIABLE

1.INDEPENDENT VARIABLE ➢ variable being controlled

or effect change to other variables CATEGORY

➢ cause ➢ CONTINUOUS VARIABLE

- take on any value within a given range, including ▪ age of gestation
fractional values (fraction and decimal)
▪ drinking habit
- assume infinite values within a specified interval----
▪ attitude towards an issues (clean energy)
measurement
▪ educational attainment
➢ DISCRETE VARIABLE
▪ wellness
- can take on only certain discrete values within a given
range – often these values are integers (whole number) SAMPLE SIZE
- assume exact values only---counting • recommended minimum number of subjects is:
SCALE OF MEASUREMENT • 100-descriptive
▪identify scale of measurement to correctly determine • 50 – correlational
the type of statistical technique to be applied to the
data • 30 –experimental and causal-comparative
studies
▪helps in determining correct data presentation like
graph

• NOMINAL - no numerical value (e.g. dark, darker,

darkest)

• ORDINAL - ordered or ranked (e.g 1 st, 2nd, 3rd)

• RATIO - exact distance is measured with zero-point is

fixed (e.g. road distance 8km); scale; true zero “0”

• INTERVAL - whole or exact number or distance

between 2 categories but zero point is arbitrary (e.g. 25
degrees Celsius)

Example
QUIZ
Identify the applications of biostatistics
A branch of biostatistics that summarizes (4 points).
and presents data in a form for easy
analysis and interpretation. Response: Problem identification

Response: descriptive Response: Evaluate Needs

Identify 5 applications of biostatistics. Response: Resource allocation

Response: Evaluation programs Response: Tools for decision making

Response: Tool in decision-making TRUE OR FALSE. Nominal data show

process exact distance is measured with fixed
zero-point.
Response: Problem identification
Response: False
Response: Resource allocation of limited
resources _____ Identify the icon of nursing who
was believed to be one of the pioneers of
Response: Needs assessment biostatistics with her data recording and
_____ This refers to a large collection of analysis during the Crimean War.
people, objects or places (COMPLETE NAME IN ALL CAPS for 1
point1)
Response: Population
Response: FLORENCE NIGHTINGALE
Why there is a need to use Biostatistics
in Medical Field? The following are domains of statistics
except for one:.
Response: to systematically analyze
variables from a phenomenon Response: Biostatistics

This a study wherein statistics is applied _____ This is the raw material for
to biological sciences to better statistical work
understand the events. Response: Data
Response: Biostatistics This is the science of analyzing data and
drawing conclusions thereby in the face
of variability and uncertainty.
Response: Statistics
This allows the researcher to formulate
generalization or conclusion coming from
randomized samples.
Response: Inferential
This is the science of analyzing data and Quantitative research is a means for testing objective
drawing conclusions thereby in the face theories by examining the relationship among
of variability and uncertainty. variables. These variables can be measured typically on
Response: Statistics instruments, so the numbered data can be analyzed
using statistical procedures. The final written report has
a set of structure consisting of introduction, literature
LESSON 2 and theory, methods, results, and discussion (Creswell,
2014).
RESEARCH IN THE MEDICAL FIELD
QUANTITATIVE
ACCORDING TO KERLINGER (1973):
➢ empirico-analytical research
• “A SYSTEMATIC, CONTROLLED, EMPIRICAL AND
CRITICAL INVESTIGATION OF HYPOTHETICAL ➢ rigorous and consistent
PROPOSITIONS ABOUT THE PRESUMED RELATIONS
➢ objective
AMONG NATURAL PHENOMENA”
➢ observation and analysis by scientific method
ACCORDING TO O. M. MENDOZA (2010):
❑ induction
“A PROBLEM-SOLVING ACTIVITY THAT BEGINS WITH A
QUESTION AND ENDS UPON ARRIVING AT ANSWERS TO ❑ deduction
ONES QUERY
BEFORE STARTING
Research is a systematic process of collecting, analyzing
✓ WHAT TOPIC YOU’RE STUDYING?
and interpreting information in order to increase our
understanding of a phenomenon about which we are ✓ WHAT INFORMATION DO YOU WANT TO COLLECT?
interested or concerned (Leedy & Ormrod, 2013).
✓ FEASIBILITY OF THE STUDY
“research is a scientific, problem solving activity which
starts with a question in mind and ends when the ✓ HOW RELIABLE SHOULD THE INFORMATION BE?
person arrives at answers to ones query. This involves ✓ IS IT ETHICAL TO CONDUCT THE STUDY?
systematic search for pertinent information on a specific
topic with a careful, organized, and wellplanned ✓ HOW MUCH WILL IT COST TO CONDUCT THE STUDY
investigation” (Mendoza, O. et. al , 2010 PROCESS OF RESEARCH
SALIENT FEATURES OF RESEARCH: 1. IDENTIFY THE RESEARCH PROBLEM
➢ Systematic 2. REVIEW THE LITERATURE
➢ Objective 3. SPECIFY A RESEARCH PURPOSE
➢ reproducible 4. COLLECT DATA

5. ANALYZE AND INTERPRET DATA

6. REPORT AND EVALUATE RESEARCH

IDENTIFY & DEFINE RESEARCH PROBLEM

2 SUB STEPS topic with the highest score is the preferred topic to
study based on the elimination process using FINER
• SELECTION OF RESEARCH TOPIC
FORMULATE THE RESEARCH OBJECTIVES
• FORMULATION OF RESEARCH OBJECTIVES
-Reflect the questions that will answer the study’s
purpose
F EASIBILITY
-Declarative or interrogative
I NTEREST
•Provides general direction
N OVELTY
•Research design
E THICAL
•Data collected
R ELEVANCE
•Interpretation of results
FEASIBILITY
EXAMPLE-DECLARATIVE
1 = Study not feasible, considering available resources
•To determine the relationship between obesity,
2 = Study feasible, considering available resources hypertension and the age of a person.

3 = Study very feasible, considering available resources

INTERESTING

1 = Not interesting

2 = Interesting

3 = Very interesting

NOVEL 2 CATEGORIES

1 = Sufficient information already available -GENERAL

2 = Some information available but major issues not -SPECIFIC

covered
GENERAL OBJECTIVES
3 = No sound information available on which to base
•Generic statement which describes in broad terms
problemsolving
what the study needs to accomplish
ETHICAL ACCEPTABILITY
e.g. This study aims to determine the effectiveness of
1 = Major ethical problems the treatment program for PTB patients in Bacolod City
from2010-2020.
2 = Minor ethical problems
SPECIFIC OBJECTIVES
3 = No ethical problems
•Identify in detail and in measurable terms the aims of
RELEVANCE the research project
1 = Not relevant SPECIFIC OBJECTIVES
2 = Relevant •Provides more definite indicators
3 = Very relevant 1. To determine the demographic data of the PTB
SCORING patients.
2. To identify which treatment program is effective in ❑Decision must be based on examination and
terms of: comparison of the costs and benefits that may rise from
an action.
i. Age
❑Usually used in the academic
ii. Education attainment
ELEMENTS OF RESEARCH ETHICS
iii. Socio-economic status
1. SOCIAL VALUE
iv. Duration
2. INFORMED CONSENT
DESIRED CHARACTERISTICS OF RESEARCH
3. VULNERABILITY OR RESEARCH PARTICIPANTS
OBJECTIVES
4. RISKS, BENEFITS AND SAFETY
➢clear and specific
5. PRIVACY AND CONFIDENTIALLITY OF INFORMATION
e.g. To understand the cholera outbreak in
6. JUSTICE
Bacolod City.
7. TRANSPARENCY
To determine the demographic data of the PTB patients.
SOCIAL VALUE
➢measurable and operational terms
-Study is considered important in society at a given time
e.g. To determine the role of infant feeding in diarrhea.
- Societal concerns
To determine the percentage of children affected by
malnutrition in 2020 in Bacolod City - Dissemination plan must be included

➢measurable and operational terms INFORMED CONSENT

e.g. To compare the prevalence of diarrhea between - Decision by a competent potential participant to join
the process with full understanding
bottle, breast and mixed-fed infants in 2020.
- No decision, undue influence, or intimidation
RESEARCH ETHICS LESSON 2
-Human dignity and autonomy are highly respected
ETHICS
Informed Consent basic things to
Field of philosophy that deals with values and morals
include
3 MAJOR APPROACHES
 Purpose of research
DEONTOLOGICAL APPROACH
 Description of any possible risk/s or discomforts
❑ Identify and use UNIVERSAL CODE  Benefits to the participants
 Alternative treatment beneficial to them
❑ Action is either ethical or not  Confidentiality statement
ETHICAL SKEPTICISM  Contact person for any inquiries
 Voluntary participation
❑ Concrete and inviolate ethical or moral standards  Schedule of renumeration (if applicable)
cannot be formulated  Understandable

❑ Ethicis are not universal but are relative to ones IC WITH MINORS

particular culture, time, and even individual - Obtained from parent/guardians

UTILITARIANISM -Assent from the minor who are old enough to

volunteer oneself
❑Practical viewpoint
- Assent form the minor who are old enough to -Proper care to participants
volunteer oneself
- Compensation must be provided when harm is done or
losses incurred

TRANSPARENCY

-DISCLOSURE

-Primary ethical concern is fraudulent activity

-Fabrication or alteration of results Issue on

cheating or lying

-Partial publication

VULNERABILITY OR RESEARCH PARTICIPANTS

-Physical or mental disabilities LESSON 3

-Aysmmetric power relations DESCRIPTIVE EPIDEMIOLOGY

-Marginalization ❑ classifies the occurrence of disease according to the

variables of PERSON, PLACE, and TIME DESCRIPTIVE
EPIDEMIOLOGY

❑characterizes the amount and distribution of health

and disease within a population

USES OF DESCRIPTIVE EPIDEMIOLOGIC STUDIES

-Evaluating observed trends in health and disease

▪ monitoring known diseases and identify

emerging problems
RISKS, BENEFITS AND SAFETY
-Planning, provision, and evaluation of health services
-Researcher ensures that research participants are not
▪ for efficient allocation of resources
harmed by any means
-Identify problems to be studies by analytic methods
RISK : BENEFIT RATIO
and suggest areas that may be fruitful for investigation
PRIVACY AND CONFIDENTIALLITY OF INFORMATION
▪ may lead to a more complex analytic study
-ADHERE TO THE PRINCIPLES OF TRANSPARENCY,
TYPES OF DESCRIPTIVE EPIDEMIOLOGIC STUDY
LEGITIMATE PURPOSE AND PROPORTIONALITY IN THE
COLLECTION, RETENTION AND PROCESSING OF CASE REPORTS
PERSONAL INFORMATION ACCORDING TO THE DATA
o accounts of a single occurrence of a noteworthy
PRIVACY ACT OF 2012 (NATIONAL ETHICS GUIDELINES,
health-related incident or small collection of such
2017)
events
-RIGHT TO PRIVACY
-e.g. cosmetic surgery and related procedures
JUSTICE done to healthy individuals

- Fair selection of sample/participants -3 case reports of women who developed

adverse reactions to injection of cosmetic soft-tissue
fillers by unlicensed practitioner (study by CDC) in North ➢ sex differences in a wide scope of health phenomena
Carolina (morbidity and mortality)

➢ males generally have higher all-cause age-specific

mortality rates than females from birth to age 85 and
older
CASE SERIES
RACE/ETHNICITY
O a larger collection of cases of disease, often grouped
➢ origin or nativity (place of origin of the person and
consecutively and listing common features such as the
family)
characteristics of affected patients
E.g. ASTHMA- lower frequency reported cases among
-E.g. CDC study collecting cases of primary
non-Hispanic whites or blacks
amebic meningoencephalitis from 1937-2007 with 121
cases in 70 year-period. 2007 recorded the largest with -Hispanics have higher reported cases of Dm, heart
6 cases in a year. conditions and HPN compared to non-Hispanics

• Result: 93% affected were male (median age-12 years) SOCIO-ECONOMIC STATUS

• Primary exposure was fresh water in lakes and rivers ➢ person’s position in society

CROSS-SECTIONAL STUDIES ➢ interrelated to person’s income level, educational

“examines the relationship between diseases (or other level, and type of occupation
health-related characteristics) and other variables of
HEALTH DISPARITIES
interest as they exist in a defined population at one
particular time. The presence or absence of disease and differences in the occurrence of diseases and adverse
the presence or absence of the other variables… are health conditions in the population
determined in each member of the study population or
in a representative sample at one particular time” (Friis, PLACE VARIABLES
2010) ➢INTERNATIONAL
O focus is on the disease and a snapshot or 1-time o WHO major source of information about international
assessment of the prevalence of disease in a study variations in rates of disease
group that are mostly randomly sampled
o at present: infectious, communicable diseases,
O can be used to develop hypothesis for analytic studies malnutrition, IMR, suicide and others
e.g. The Behavioral Risk Factor Surveillance System o differences from each country may be attributed to:
(BRFSS) conducts an ongoing survey of civilian US
residents aged 18 years and older ▪ climate

VARIABLES TO CHARACTERIZE A HEALTHRELATED ▪ cultural factors

EVENT ▪ national dietary health habits
PERSON VARIABLES ▪ access to health care
AGE I. Highest Life Expectancy in 2008
➢ most important factor to consider in describing •Andorra (83.5 yo)
disease occurrence esp. age-specific disease rates show •Macau (83.3 yo)
greater variation •Japan (82.1 yo)
II. Lowest Life Expectancy in 2008
➢ as age increases, incidence also increases •Zambia (38.6 y.o.)
SEX •Angola (37.9 y.o.)
•Swaziland (32 y.o.)
➢NATIONAL CLUSTERING

o within the country due to: •“closely grouped series of events or cases of a disease
or other healthrelated event with well-defined
▪ regional differences
distribution patterns in relation to time or place or
▪ climate both” (Friis, 2010)

▪ environmental pollution •aggregation of relatively uncommon events or disease

o URBAN-RURAL DIFFERENCE •may suggest common exposure of the population to a

contaminant
onature of disease differs based on
2 TYPES OF CLUSTERING
exposures
1. Spatial clustering
▪ city: lead and city life health o indicates cases of disease due to specific
problem geographic location

▪ rural: farming injuries 2. Temporal clustering

➢LOCAL o related to time such that postpartum
depression few week post-partum or post
o specific environmental conditions that may vaccination causing syncope/fainting
exist in a specific area

• e.g. dengue fever TYPES OF MEDICAL RESEARCH

TIME VARIABLES CASE CONTROL
SECULAR TRENDS  A study in which the subjects are defined on the basis
of the presence or absence of an outcome of interest
o gradual changes in frequency of diseases over long
(Friis, 2010)
time periods
 Retrospective study
e.g. suicide rates of females decreased overtime using
firearms and increased by substance use CONTROLS- absence of the outcome
CYCLIC/SEASONAL TRENDS CASES- individuals who have an outcome or disease
• increases and decreases in the frequency of a disease MATCHED CASE-CONTROL STUDY
or other phenomenon over period of several years or
within a year Cases and controls have been matched according to
some factors like age, sex, education, etc.
E.g. February – mortality from pneumonia and influenza
peaks March & April - decreases during summer ECOLOGIC

POINT EPIDEMICS STUDY IN WHICH THE UNITS OF ANALYSIS ARE

POPULATIONS OR GROUPS
• indicates the response of a group of people affected
by a disease or exposed to a common factor in the same GROUP IS THE UNIT OF ANALYSIS
place and time Both exposure and outcomes
e.g. food poisoning due to consumption of E.G. NATIONS, STATES, REGIONS
contaminated spaghetti in a party
 R = random allocation to group

COHORT STUDIES O = observation or measurement

Defined group of people studied over a period of time E = experimental group

Occurs naturally over repeated points of time or C = control group

something unusual; concurrent
X = exposure of the group to the experimental
Exposure- used as criterion in choosing subjects for
Variable
cohort study
QUASI-EXPERIMENTAL
E.g.
 “quasi”= almost
Birth or age cohort
 No random allocations to control and experimental
Work cohort
groups
School/educational cohort
 E.g. control group---use of conventional treatment
PROSPECTIVE-new cases or longitudinal design experimental group ---new treatment

RETROSPECTIVE-historical data to determine exposure study by Smith (2002) therapeutic massage to

level hospitalized cancer patients

Measures: - 20 therapeutic massage - 21 received control therapy

Relative Risk - ratio of the incidence rate or a disease in

an exposed group to the incidence rate of the disease
LESSON 4: ANALYTICAL EPIDEMIOLOGICAL STUDY
Attributable Risk- difference between the incidence
■ examines causal (etiologic) hypotheses regarding the
rate of a disease in the exposed group and the IR in the
association between exposures and health conditions
nonexposed
■ proposes and evaluates causal models for etiologic
ADVANTAGES
associations and studies them empirically
 DIRECT OBSERVATION OF RISK
IMPORTANCE OF ANA EPI
 EXPOSURE FACTOR IS WELL DEFINED
o Prevention of disease
 STUDY UNCOMMON EXPOSURE
o Understand and Modification of risk factors
DISADVANTAGES
o Creation of quantitative evaluations of intervention
 EXPENSIVE programs

 TIME CONSUMING o Aids in determining safety and effectiveness of new

drugs, immunizations and medical procedures
 COMPLICATED AND DIFFICULT TO CARRY OUT
7 FACTORS THAT CHARACTERIZE STUDY DESIGNS
 MISCALCULATION OF EXPOSURE
1. Who manipulates the exposure factor?
EXPERIMENTAL
-Observational- randomly assigned to control
 A study wherein one group of subjects are exposed to
confounding
a treatment, while another group is exposed to
-Experimental-can control or manipulate
something inert (Taylor et al, 2012)
exposed and non-exposed group
 Controlled group -Quasi-experimental- controls the exposure of
individuals or units to the factor but is unable to
assign participants randomly
2. How many observations are made? ▪ ECOLOGIC COMPARISON STUDY- assessment of the
association between exposure rates and disease rates
-Done 1s - cross-sectional, ecologic and case-
during the same period
control
2.CASECONTROL
-2 or more examinations- cohort, experimental
▪ Defined with the presence or absence of a disease or
3. What is the directionality of exposure?
outcome of interest
RETROSPECTIVE: obtaining data from the past
▪ CASES - those with the outcome/disease
e.g. Case-control start with a person with disease and
e.g. may be taken from hospitals, clinics or communities
the past exposure
▪ CONTROL - do not have or absence of outcomes
SINGLE POINT IN TIME: survey; similar to taking a
snapshot of a population e.g. may be taken from same area but with different
disease, or from family/friends of the cases
e.g. Cross-sectional
▪ MATCHED CASE-CONTROL STUDY- case and controls
PROSPECTIVE- information about the study is collected
have been matched according to one of more criteria
in the future Experimental and cohort
like sex, age, race, etc.
e.g. Cohort
▪ RETROSPECTIVE APPROACH
st
1 --followed in the future for possible development of
• collecting data about exposure factor which occurred
disease
in the past
4. What are the methods of data collection?
• advantage: examine many potential exposures
Use of existing or requires collection of new
e.g of data collection is INTERVIEW OF CASES and
data Ecologic uses existing data
CONTROLS
5. What is the timing of data collection?
▪ ODDS-RATIO- use to measure association between
-data obtained about past exposures frequency of exposure and frequency of outcome used

among case and ctrls o𝑂𝑅 = 𝐴𝐷/BC

in case-control studies o Risk of outcome to exposure
■ retrospective

■ prospective ADVANTAGES
6. What is the unit of observation? ▪ can be used to study low prevalence conditions
■ individual ▪ relatively quick and easy to complete
■ entire group (e.g ecologic) ▪ usually inexpensive
7. How available are the study subjects? ▪ involve smaller numbers of subjects
■ depends on the subjects and ethical concerns DISADVANTAGES
TYPES OF ANALYTIC EPI ▪ Measurement of exposure may be inaccurate
1.ECOLOGIC STUDIES ▪ Representatives of cases and controls may be
▪ “ a study in which the units of analysis are populations unknown
or groups of people ▪ Provide indirect estimates of risk
e.g. residents of certain geographic areas: nations, ▪ Temporal relationship between exposure factor and
states, countries, regions outcome cannot always be ascertained

3.COHORT
▪ population group or subset (distinguished by a O epidemiological study in which subjects in a
common characteristics) followed over a long period of population are randomly allocated into groups, usually
time called study and control groups, to receive or not to
receive an experimental preventive or therapeutic
E.g. birth or age cohorts (baby boom generation) o
procedure, maneuver, or intervention
Work cohort o School/educational cohort (graduates of
certain year) USES OF RCT

TYPES of COHORT ▪ PROPHYLACTIC- to test the efficacy of new

medications and vaccines
PROSPECTIVE COHORT STUDY DESIGN/LONGITUDINAL
DESIGN ▪ evaluate medical treatment regimens and health
education programs
▪ Classified according to exposure to a factor of interest
and then observed over time to document the ▪ THERAPEUTIC - evaluate new treatment methods
occurrence of new case (incidence) of a disease or other
▪ CLINICAL TRIAL - “research activity that involves the
health events
administration of a test regimen to humans to evaluate
▪ At the inception of the study, participants are certified its efficacy and safety” (Friis, 2010)
as being FREE from DISEASE
COMPONENTS OF RCT
▪ May observe many outcomes but limited exposures
▪ SELECTION OF A STUDY SAMPLE
RETROSPECTIVE COHORT STUDY DESIGN
• voluntary
▪ Uses historical data to determine exposure level at
• patients who have a particular disease
some baseline in the past
• with rigorous inclusion & exclusion criteria
▪ Past is the baseline and studies until present
▪ ASSIGNMENT OF PARTICIPANTS TO STUDY
o Measures of Association in Cohort
CONDITIONS
▪ Relative Risk (RR) Ratio of incidence rate of a disease
• random assignment is used
or health outcome in an exposed group to the incidence
rate of the disease or condition in a nonexposed group • treatment group receives the new treatment,
procedures, or drug
4.EXPERIMENTAL
• control group receives alternative, commonly
▪interventional studies applied
used treatment/placebo (inactive medication or
▪investigation involving intentional change in some pill/sugar pill)
aspect of the status of the subject
▪ BLINDING OR MASKING
TYPES of EXPERIMENTAL
▪ prevent biases when the participants or
Experimental- factors to consider in doing experimental investigators know the conditions of the study to which
research: the participants will be assigned

✓Manipulation ▪ SINGLE-BLIND STUDY-subjects are unaware

✓Exposure • DOUBLE-BLIND STUDY-both investigators and

participants are unaware
✓Random selection

✓Measurement of effects
▪ MEASUREMENT OF OUTCOMES
RANDOMIZED CONTROLLED TRIAL (RCT)
▪ outcomes in both are measured same way
CLINICAL ENDPOINT- outcome of clinical trial DEVELOPING A PAPER & RRL

QUASIEXPERIMENTAL Steps in conducting research

o type of research in which investigator manipulates I. Identify and define research problem
the study factor but does not assign individual subjects ▪ Select a research topic
randomly to the exposed/nonexposed ▪ Formulate Research Objectives
II. Review of Related Literature
▪ may not use control group
III. Define Research Problem
▪ may use fewer study subjects IV. Formulate Hypothesis
V. Construct Research Design
o often used in community intervention or community VI. Design the Tools for Data Collection
trial to evaluate program intervention VII. Design the Plan for Data Analysis
e.g. efficacy of fluoridation of drinking water in VIII. Collect Data
preventing tooth decay during 1940 and 1950s in New IX. Process the Data
York (Newburgh and Kingston) X. Analyze the data
XI. Write the Research Report
CHALLENGES TO THE VALIDITY OF STUDY DESIGNS XII. Disseminate the Results
O External validity XIII. Utilize the Results

-ability to generalize from the results of the Review of Related Literature

study to an external population; may be due to 3 PRINCIPLES (according to Murray, R.)
sampling method like convenience and random
generally eliminates this except for sampling error -learning comes through writing
committed -quality comes through revision
O Internal validity -regular writing develops fluency
-degree to which the study has use Gay (1976) says that the review of related literature
methodologically sound procedures involves the systematic identification, location, and
Biases analysis of documents containing information related to
the research problem.
▪ Hawthorne effect- participants behavior changes as a
result of their knowledge of being in a study PURPOSES (Gay, 1976)

▪ Recall bias- cases may remember an exposure more -Source of conceptual/ theoretical framework
than the controls -Review and analyze sources
▪ Selection bias- distortion that result from procedures • Prevents unintentional duplication Review and
used to select subjects and from factors that influence analyze sources
participation of study
-Provides all needed constructs
▪ Confounding- effect of an exposure has been distorted
because an extraneous factor has entered into the Provides conclusions of past investigations
exposure-disease association
Gives you information about the ff:
o Associated with disease risk and produce
research methods
different distribution of outcomes in the exposure
groups population and sampling

o Age or smoking as confounders LITERATURE APPROACH

•LITERARY
 ❖conceptual and research STEPS:

•COUNTRY Identify

❖local or foreign -Identify relevant literature/sources

•THEME/TOPIC Organize

❖which bring together and classifies - organize search and recordkeeping

reviewed literature according to similarity of Identify

findings , theme or topic. - identify key terms

•CHRONOLOGIC Set

❖time they were written, -Set boundaries to the search

❖The recent ones should be presented Define Research Problem

SOURCES OF LITERATURE ❑Statement of the Problem ✓Expresses issues needing

to be addressed
▪Books
FORMULATE HYPOTHESIS & BASIC CONCEPTS
▪Conference proceedings
HYPOTHESIS
▪Reports
• originates from the problems
▪Theses
• an assertion or proposition about the relationship
▪Journals
between 2 or more variables
▪Articles
• observable and measurable
▪Indexes
• Formal statement of the expected relationship/s
CATEGORY OF REFERENCES between 2 or more variables in a specified population

PRIMARY Provides guide by:

written by the person who conducted the research • limiting area of investigation

SECONDARY • sensitizing the researcher to pertinent data and

relationships
written by somebody else other than the original
researcher • providing a unifying concept

NOT SCHOLARLY FRAMEWORKS

• news, magazines, opinions ❑Theoretical Framework

SCHOLARLY ✓group of interrelated theories that provide rationale

• valuable source of ideas ❑Conceptual Framework

• Theoretical works, research reports, review papers, ✓Less formal attempt at organizing a phenomena
books and refereed journal articles
RESEARCH DESIGN
SELECTING LITERATURE LIFESTYLE
•represent the strategy or the “plan of attack” of the
-Effects of lifestyle change to the management researcher in finding answers of the research objectives
of diabetes mellitus
Things to consider in choosing research design:
a. methods of subject selection

b. sample size

c. strategies for the control and manipulation of

relevant variables

d. establishment of criteria to evaluate outcomes

e. instrumentation

FINAL REMINDER FOR RD

-research objectives

-feasibility DESIGNING PLAN FOR DATA ANALYSIS

-ethical considerations • done before data collection
-economy and efficiency • construct dummy tables- skeleton tables drawn how
-internal and external validity data is going to be organized and presented

DATA COLLECTION Consider:

-Questionnaire • Methods

-Interview schedule • Sample size

-zOther forms • Instrumentation

• Standardized • Feasibility

• Self-made questionnaire • Research objective

• Ethical considerations

• Economy and efficiency

Design the Tools for Data Collection

-Survey

-Questionnaire

-Interview schedule

-FGD

-Observation

DESIGN THE PLAN FOR DATA ANALYSIS

• Measurable variables or not

• Dummy tables

Structuring and designing the survey questionnaire

design depends on

type of survey ,target audience, short questionnaire

Type of questions LESSON 5: DATA GATHERING AND DEMOGRAPHY

• multiple choice QUANTITATIVE DATA

• rating questions-easy but harder to analyze -value of data in the form of counts or numbers where
each data-set has an unique numerical value associated
• questions asking for opinions must be open-ended
with it
and allow the subject to give their own response
-data is any quantifiable information that can be used
Ordering questions
for mathematical calculations and statistical analysis
-Most relevant questions are
-used to answer questions such as
asked first
“How many?” “How often?” “How much?”
-Questions must be simple and
TYPES OF DATA
straightforward
i.Primary
-Use of simple language
• Obtained first-hand by the investigator
-Group questions about
ii.Secondary
similar topics
▪ existing ad have been obtained by other people for
-Try out a test survey purposes not necessarily those of the investigators

Process the Data QUALITIES OF STATISTICAL DATA

•editing ❑Timeliness

•tallying ❑Completeness

Analyze the data ❑Accuracy

• use of statistical tools (if applicable) ❑Precision

• Inferential ❑Relevance

• Descriptive ❑Adequacy

Write the Research Report SOURCES OF QUANTITATIVE DATA

-formal recording of the data gathered, analyzed and REGISTRIES OF VITAL EVENTS
interpreted in relation to the set research objectives to
• vital events-those related to births, changes in civil
answer the problems
status, deaths
-useful for dissemination of information
• required by law to be recorded
Disseminate the Results
• De facto basis-----events are registered where it
-sharing and spreading of gathered data and result happened
study to the society for awareness and learning
• major source of fertility and mortality
-Public knowledge of the research result and findings
• UNDER REGISTRATION AS A PROBLEM
Utilize the Results
• Ignorance of law
• Improving an industry or area using the research data
• Non-caring attitude
to conduct further study or to take action on the
identified problem based on the recommendations • Non-realization of its importance
REPORTS OF OCCURRENCES OF NOTIFIABLE DISEASES CENSUS-COMPLETE ENUMERATION OF A POPULATION

- diseases required to be reported by doh weekly for ▪ best source of data on population size and distribution
surveillance and monitoring ---- communicable diseases according to age, sex, geographical location and other
-e.g. diptheria, measles, typhoid, aids/hiv demographic variables

OTHER SOURCES OF DATA: ▪ may be used to estimate and project population size

✓ Laboratories ▪ regularly done by countries due to important

demographic data provided
✓ Pharmacies
▪ Philippines, set every 5 years and latest done last 2017
✓ Blood-bank
Survey questions can be divided into two broad types:
✓ Private clinics
➢Structured
Publications:
➢multiple-choice questions
Problem is the recency of data for it is published 2-3
years after the reference period ➢rating scale questions)

-Philippines ➢Unstructured

❑DOH-Weekly Disease Bulletin SURVEY DISTRIBUTION AND SURVEY DATA

COLLECTION
❑Philippines Health Statistics
➢ Email- most commonly used and most effective
-International
methods of survey distribution.
❑WHO-Weekly Epidemiologic Report
➢ Embed survey in a website- increases a high number
Annual Demographic Report of responses

REGISTERS OF DISEASE INTERVIEWS

-CAN RECORD DEFAULTERS, TREATED AND DEATHS ❖Interview schedule

O TB ❖quantitative data collection method which allows

opportunity to gather extensive data from the
O Cancer participants
O Leprosy ❖Quantitative interviews are immensely structured and
O Endemic: malaria and schistosomiasis play a key role in collecting information

SURVEYS FACE-TO-FACE INTERVIEWS:

➢ include answer options which they think are the most  an interviewer can prepare a list of important
appropriate for a particular question integral in interview questions
collecting feedback  provide exhaustive details about the topic under
➢ audience is larger than the conventional size discussion

➢ critical factor about surveys is that the responses  collect more details about the topic due
collected should be such that they can be generalized to ONLINE/TELEPHONIC INTERVIEWS:
the entire population without significant discrepancies.
▪ telephone-based interviews

▪ Google meet, Skype or Zoom

▪ distance between the interviewer and the interviewee ▪studies sample population only
and their corresponding time zones, communication
▪studies specific segments or subsets of the population
becomes one-click away with online interviews.
▪fairly accurate data collected
TYPES OF QUESTIONS:
▪may need to conduct observations
DICHOTOMOUS QUESTION
▪PE
o Yes/No, True/False or Agree/Disagree response
▪blood or any other bodily sample
QUESTIONS BASED ON LEVEL OF MEASUREMENT
▪behavior observation
o measure occupation using a nominal question
INTERVIEW VS. QUESTIONNAIRE
o e.g. Type of occupation
-Better interview to collect data
RANKING
-Questionnaire -less expensive and time consuming
o Respondents ask to rank order their preferences for
presidential candidates using an ordinal question: INSTRUMENTS
MEASURE OF INTERVAL LEVEL O Questionnaire
o Likert scale of measurement O standardized
o traditional 1-to-5 rating O self-made questionnaire
FILTER OR CONTINGENCY QUESTIONS O interview schedule
❑ Respondent answers one question in order to O available data
determine if they are qualified or experienced enough
to answer a subsequent one DATA COLLECTION DEPENDS ON:

❑ Try to avoid having more than three levels (two ❑quality and quantity of data
jumps) for any question. Too many jumps will confuse ❑time, money and manpower available
the respondent and may discourage them from
continuing with the survey

❑ If only two levels, use graphic to jump (e.g., arrow

and box). The example above shows how you can make
effective use of an arrow and box to help direct the
respondent to the correct subsequent question.

DOCUMENTED SOURCES

➢Advantages: saves time, money and energy

➢Challenge: missed out questions

➢routinely done

➢missed out questions

➢timeliness issue

➢confidentiality

SAMPLE SURVEY