Biomedical research

Research Capacity
Building Workshop
Presentation
Dr. Deepa Devhare
Assistant professor
Dept of Microbiology
Content:
• Research
• Types of research methodologies
• Research cycle
 Research question
 Study design
 Components of research
 Statistical analysis of results
• Ethics in research
Research
• process of steps used to collect and analyze information to
increase our understanding of a topic or issue".
Biomedical research
Research cycle
1. Research question
A question that a study or
research project aims to
answer.
1. Research question
Structure of the Research Question
PICOT
P: Patients, Population, Participants, Problem
I: Intervention, Independent Variable, Input variable,
Index Test
C: Camparator, Comparision,Control
O: Outcome(Health outcome), patient oriented
outcome
T: Timed Outcome
Biomedical research
Eg. Researcher wants to study effect of folic acid
supplementation on gingival overgrowth in pediatric patients
taking phenytoin as a treatment
Formulating a research question in PICOT structure
P: Children aged 6-15 yrs recently started on phenytoin
monotherapy
I: Folic acid supplementation0.5mg/day
C: Placebo
O: Incidence of any degree of gingival overgrowth
T: 6months
2. Research/Study Design
 refers to the overall strategy that you choose to integrate the
different components of the study in a coherent and logical
way, thereby, ensuring you will effectively address the
research problem
 it constitutes the blueprint for the collection, measurement
and analysis of data.
Study design
Descriptive
 describes the
phenomenon as
it exists.
 Used to identify
and obtain information
on the characteristics
of a particular issue
Analytic
 Aims to
understand
the phenomenon
Study design
Types of
study
designs
Cross sectional study
Case control study
Cohort study
Diagnostic study
Randomised control trials
1. Cross
sectional
study
Biomedical research
2. Case control studies
 Analytical observational study
 Always retrospective
Biomedical research
Biomedical research
3. Cohort study
 Cohort -derived from latin word meaning an
enclosure, company or crowd
 In research, the cohort is a group of people with
something in common usually an exposure or
involvement in a defined population group
COHORT
STUDY
Biomedical research
Biomedical research
Cohort study
Biomedical research
4. RANDOMISED CONTROL TRIALS
Biomedical research
Biomedical research
Hierarchy Based on Study Designs
Biomedical research
Components of research
Variables Sample Bias Outcome Data
Variable: refers to a person, place, thing, or phenomenon
that you are trying to measure in some way
Independent
variable
• Input variable
• can be changed
and tested
Dependent
variable
• Output variable
• Directly affected
by input
variable
not studying for a test Test score
Study population
• refers to a smaller,
manageable version of a
larger group.
• It is a subset containing the
characteristics of a larger
population.
Accessible
population
Biomedical research
Probability sampling
Non probability sampling
Independent variable
• can be changed and tested.
Random error-
Difference between
study finding and truth
due to chance
Systematic error
Difference between study
finding and truth due to
methodological issues
Researcher misreading the weight of
study participanats
uncalibrated weighing
machine giving wrong
readings
What can go wrong in
research?
TYPES OF BIAS
Selection bias
Allocation bias
Performance bias
Detection bias
Attrition bias
Interpersonal bias
Outcome
Types of outcome Example
Hard outcome Diabetes mellitus
Soft outcome Impact of DM on
quality of life
Surrogate outcome HBA1C
Patient centric
outcome
Diseases/not diseases
Cured /not cured
• final product or end result; consequence; issue.
• conclusion reached through a process of logical thinking.
Data and data handling
• Anything that can be grouped based on
comparable parameters IS DATA.
• Data Handling is the process of gathering,
recording, and presenting information that is
helpful to analyze, make predictions and choices.
Biomedical research
Introduction to Statistical tests
Before analysing data we need to know whether
data is normally distributed or not?
Normal distribution
Skewed distribution
Normal distribution (Gaussian curve)
• its mean , median and mode are all
equal to one another
• The distribution then falls
symmetrically around the mean,
the width of which is defined by
the standard deviation.
Skewed distribution
• Appearance of graph:Asymmetrical curve
• Skewness: If SD is >1/2 of mean
• Median far away from mean
Biomedical research
Statistical
analysis for
diagnostic study
designs
Sensitivity
Specificity
Positive predictive
value
Negative
predictive value
Biomedical research
• human research to be approved by an Institution
Ethics Committee
• Informed consent necessary from study
participants
• Responsibility of principal investigator
Ethical committee approval and
informed consent
Biomedical research
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Biomedical research

  • 1. Research Capacity Building Workshop Presentation Dr. Deepa Devhare Assistant professor Dept of Microbiology
  • 2. Content: • Research • Types of research methodologies • Research cycle  Research question  Study design  Components of research  Statistical analysis of results • Ethics in research
  • 3. Research • process of steps used to collect and analyze information to increase our understanding of a topic or issue".
  • 6. 1. Research question A question that a study or research project aims to answer.
  • 8. Structure of the Research Question PICOT P: Patients, Population, Participants, Problem I: Intervention, Independent Variable, Input variable, Index Test C: Camparator, Comparision,Control O: Outcome(Health outcome), patient oriented outcome T: Timed Outcome
  • 10. Eg. Researcher wants to study effect of folic acid supplementation on gingival overgrowth in pediatric patients taking phenytoin as a treatment Formulating a research question in PICOT structure P: Children aged 6-15 yrs recently started on phenytoin monotherapy I: Folic acid supplementation0.5mg/day C: Placebo O: Incidence of any degree of gingival overgrowth T: 6months
  • 11. 2. Research/Study Design  refers to the overall strategy that you choose to integrate the different components of the study in a coherent and logical way, thereby, ensuring you will effectively address the research problem  it constitutes the blueprint for the collection, measurement and analysis of data.
  • 12. Study design Descriptive  describes the phenomenon as it exists.  Used to identify and obtain information on the characteristics of a particular issue Analytic  Aims to understand the phenomenon
  • 14. Types of study designs Cross sectional study Case control study Cohort study Diagnostic study Randomised control trials
  • 17. 2. Case control studies  Analytical observational study  Always retrospective
  • 20. 3. Cohort study  Cohort -derived from latin word meaning an enclosure, company or crowd  In research, the cohort is a group of people with something in common usually an exposure or involvement in a defined population group
  • 29. Hierarchy Based on Study Designs
  • 31. Components of research Variables Sample Bias Outcome Data
  • 32. Variable: refers to a person, place, thing, or phenomenon that you are trying to measure in some way Independent variable • Input variable • can be changed and tested Dependent variable • Output variable • Directly affected by input variable not studying for a test Test score
  • 33. Study population • refers to a smaller, manageable version of a larger group. • It is a subset containing the characteristics of a larger population. Accessible population
  • 37. Independent variable • can be changed and tested. Random error- Difference between study finding and truth due to chance Systematic error Difference between study finding and truth due to methodological issues Researcher misreading the weight of study participanats uncalibrated weighing machine giving wrong readings What can go wrong in research?
  • 38. TYPES OF BIAS Selection bias Allocation bias Performance bias Detection bias Attrition bias Interpersonal bias
  • 39. Outcome Types of outcome Example Hard outcome Diabetes mellitus Soft outcome Impact of DM on quality of life Surrogate outcome HBA1C Patient centric outcome Diseases/not diseases Cured /not cured • final product or end result; consequence; issue. • conclusion reached through a process of logical thinking.
  • 40. Data and data handling • Anything that can be grouped based on comparable parameters IS DATA. • Data Handling is the process of gathering, recording, and presenting information that is helpful to analyze, make predictions and choices.
  • 42. Introduction to Statistical tests Before analysing data we need to know whether data is normally distributed or not? Normal distribution Skewed distribution
  • 43. Normal distribution (Gaussian curve) • its mean , median and mode are all equal to one another • The distribution then falls symmetrically around the mean, the width of which is defined by the standard deviation.
  • 44. Skewed distribution • Appearance of graph:Asymmetrical curve • Skewness: If SD is >1/2 of mean • Median far away from mean
  • 48. • human research to be approved by an Institution Ethics Committee • Informed consent necessary from study participants • Responsibility of principal investigator Ethical committee approval and informed consent