Guidance to Understand Research AMSRA – AINSHAMS MEDICAL STUDENTS RESEARCH ASSOCIATION

Today’s ILOs

Definition of Research

Scientific Validity Definition

Writing research Question Using PICOT Formula

FINER Criteria to choose your research question

Differentiate between Qualitative and Quantitative Research Design

Study Hypothesis Definition and types of Hypothesis

What Does Random Error Mean ( Type 1 and Type 2 Error) Mean?

What Does Variable Mean

What Does Effect Size Mean

What Does Outcome mean

An Introduction to Sample Size definition

Clinical Reseaech Vs Clinical PracticeClinical research

Systematic Approach designates activity designed to test hypothesis, permit conclusions, and thereby

develop or contribute to generalizable knowledge (expressed in theories, principles, and statements of

relationships)

Clinical practice

interventions designed solely to enhance well-being of individual patient or client and have reasonable

expectation of success, purpose to provide diagnosis, preventive treatment or therapy to particular individuals

Or

To Provide The Best Available Care for The patient ( Socially , Economically , Scientifically )

Thinking as A Researcher

Step 1 : An Idea of Making Research

Step 2 : Writing Research Question

Step 3 : Choosing a Research Design

Step 4 : Developing Hypothesis

Step 5 : Identifying my Variables

Step 6 : Identifying my outcomes

Step 7 : Writing a Protocol and Getting IRB approval

Step 8 : Statistical analysis Plan

Step 9 : Data collection and Management

Step 10 : Data entry and analysis

Step 11 : Writing Down a paper

Thinking as A Researcher Measurement Terminologies : Subject : living To be studied

Predictor Variable : data who changes during study and need to be recorded

Outcome Variable : the resultant of the study

Clinical Endpoint : the target outcomes of the trial or Cause of Withdrawal of Trial

Surrogate endpoint : a biomarker intended to substitute for a clinical endpoint

Effect Size : The size of association between The predictor and Outcome Variable

Precision VS accuracy

Types Of Subjects :

Animal Subjects

Human Subjects

- ordinary population : Have the capacity to consent

- Vulnerable Groups e.g : Children, Pregnants , Institutionalized .

Types Of Variables :

Categorical

Qualitative Data

Nominal : Mutual Exclusive

e.g : Sex – Blood Groups

Ordinal : ordered Mutual Exclusive

e.g Disease Severity – Pain Severity

Numerical Quantitative Data

Discrete: have Considerable

Value e.g Days Sick in last

Month

Continuous: Can Take Any Value e.g Weight – Height

Categorical Values can be Binary or Dichotomous : have Two values e.gdead/alive – Male/female

Event A Event B Event A Event B

Mutual Exclusive Not Mutual Exclusive

Define Type of Variable

Blood Pressure Measures

Size of Ulcer

Glagow Coma Scal

Hb Level

Hand Deformities in Rhuematoid Arthritis

Osteoarthritis Grading in Xray

Age groups

Pregnancy status

Outcomes

Event outcomes

MorbidityMortality

Surrogate/biomarker outcomes

Resvascularization (e.g., CABG, PTCA)

Patient-specific outcomes

Pain/symptoms

Quality of Life/PROs

Composite outcomes

Precision Vs Accuracy

Precision also Means : Reproducibility – Consistency – Reliability

Accuracy Nearly Equal to Validity

Confounding Factor Variables that Affect the Predictor and Outcome and didn’t

Measured

Confounding Factor

OutcomePredictor

Thinking as A Researcher

Hypothesis : a statement about what investigator believes to

be true about nature and relationships of two or more

variable to each other

Null Hypothesis H0 : No Difference between the predictor

and outcome

Alternative Hypothesis H1 : There’s A difference between the

predictor and the outcome

One Sided hypothesis : Takes one direction .Used When one Direction of

the effect is Clinically important

Two sided hypothesis : state that association exist but doesn’t Specify

Direction

The Random Errors مامسوك فى قضية حشيش و مخدرات ... سنة 20... محمد أحمد عبد السالم

محمد فى فرصة القضاء اتهم محمد برأ محمد القضاء

الحكم عليه

محمد مذنبشامخالقضاء!!هرب

محمد برئ!!ظلم القضاء شامخ

The Random Errors مامسوك فى قضية حشيش و مخدرات ... سنة 20... محمد أحمد عبد السالم

No Association

between Predictor and outcome

ASSOCIATION

BETWEEN

PREDICTOR AND OUTCOME

Type 1

FP

CorrectReject Null

H0

CorrectType 2

FN

Fail to

Reject H0

The Random Errors

Type 1 Error (FP) : Rejecting Null which is Actually

true in Nature

Type 2 Error ( FN ) : Accepting Null Which is Actually Not True in Population

Thinking as A Researcher Literature : every source of Info to be used in searching process

Errors in Research :

a) Systematic Error : errors due to Bias => Affect Accuracy and Validity

of Research

b) Random Error: errors due to Chance => Affect Precision

Bias : The Distortion of Results from its correct answer

Translational Research : Translating findings from

A) Basic Science to clinical Research ( T1) B) From Clinical Research to Population (T2)

Thinking as A Researcher

Sampling Terminologies : Population ( of interest ) : Set of people with specific Character with Certain

characteristics ( Target Population )

Sample : subset of population of interest that represent them in nature

Thinking as A Researcher

Source Population

Study Population

SampleSample Size Calculation

Statistical Inferences

Thinking as A Researcher Consider an epi study carried out in Cairo to assess whether obesity is associated with

hypertension in young adults. The investigators decided that it was not feasible to

consider taking a sample from among all young adults in the city. It was decided that

fitness centers would provide a large source of young Egyptian adults. A sample of

subjects is taken from several randomly selected fitness centers throughout the city and

their blood pressure is measured to determine hypertension status.

1. What is the source population for this study?

2. What is the study population in this study?

3. Does the sample represent the study population?

4. Does the study population represent the source population?

Types of Sample

Types of Sample

Non-probablitySampling

Convenient Sampling

Snowball Sample

Quota Sample

Judgmental Sample

Probability

Simple Random Sample

Systematic Sample

Stratified Sampling

Cluster Sampling

Types of Sample

Probability Sample :

a sampling technique in which the probability of getting any particular

sample may be calculated

Simple Random Sample : individual is chosen randomly and entirely by

chance, such that each individual has the same probability of being

chosen at any stage during the sampling

Systematic Sample : selection of subjects from an ordered sampling

frame.

Stratified Sample : dividing population into stratum then choosing simple random or systematic sample from each

Cluster Sample: used when "natural" but relatively homogeneous groupings

are evident. the total population is divided into these groups (or clusters)

and a simple random sample of the groups is selected.

Simple Random Sample

Cluster Sample

Systematic Sample

Stratified Sample

Types of Sample

Non - Probability Sample :

Convenience, Haphazard or Accidental sampling - members of the population are chosen based on their relative ease of access.

Snowball sampling - The first respondent refers a friend. The friend also

refers a friend, and so on. Used with population who fear of Social

Stigma

Judgmental sampling or Purposive sampling - The researcher chooses

the sample based on who they think would be appropriate for the study. This is used primarily when there is a limited number of people that have

expertise in the area being researched. Such samples are biased

because prominent experts may differ from other, equally expert, less prominent persons.

Thinking as A Researcher Longitudinal Studies : Studies that assess finding over Time ( Prospective

or Retrospective )

Prospective ( concurrent ) Study : assess Findings in advance

Retrospective( Non- Concurrent ) Study : assess Findings backwards

Cross- Sectional : assess Findings in point of Time

Longitudinal Study is Like A Film while Cross-sectional Study is Like A Photo

Step One: An Idea of Making Research

Origin of Good Research Question Mastering the Literature

Being Alert to New ideas and Technology - Conferences

- Published Work in this Area

Keep the imagination rooming

My Clinical practice:

“What do I have” (diagnosis)

“How bad is it” (prognosis)

“Can I give it to my family?” (natural history)

“How did I get this?” (etiology)

“Will this stuff help me?” (treatment or prevention)

Choosing Mentor - Person who has experience in that Field with published work in

Criteria for Good Research Idea : FINER

Feasible

Interesting

Achievable

Novel

Ethical

Relevant

Feasibility and Scientific Validity

Feasiblity Includes :

a) Number of Subjects

B) Techinical Expertise

C) Cost in time and Money

D) Scope

Scientific Validity : ability of study to correctly answer research question

posed

Feasible but Not Valid : Not ETHICAL

Study Results

Truth in the Study

Truth in population

Actual Subjects

IntendedSample

PopulationIn

fere

nc

e

Imp

lem

en

tatio

n

Internal Validity ( Control )

External Validity (Generalizability)D

esi

gn

ing

Study Results

Truth in the Study

Truth in population

Actual Subjects

IntendedSample

Population

Infe

ren

ce

Imp

lem

en

tatio

n

Subjects Enrollment

Inclusion Criteria

De

sig

nin

g

Step 2 : Designing a Good Research Question

Criteria of Good Research Question : PICOT

Population

Intervention

Comparison

Outcome

Time

Phases of Clinical Trials

Preclinical Phases : Testing of drug in non-human subjects, to gather

efficacy, toxicity and pharmacokinetic information

Phase 0 : First in Human Trial

Phase I : Testing of drug on healthy volunteers for dose-ranging using

Subtheraputic doses

Aim : To Know Dose –Limiting Toxcity (DLT )

Phase 2 : Testing of drug on patients to assess efficacy and safety

Phase 3 : Testing Drug on Patients in comparison to the standard

treatment

Phase 4 : Post Marketing Surveys

Phase 5 : looping – Translational Research

Step 3 : Study Designs

Study designs

Observational

Descriptive

Case Report

Case Series

Ecological Study

Analytical

Cross-sectional

Study

Case – control Study

Cohort Study

Experimental

Clinical Trial

Sequential Trial

Cross-over Trial

Historical Withdrawal Trial

Superiority Trial

Non- Inf. Trial

Factorial Trial

References

Principles and practice of Clinical Research , 3rd edition

Designing Clinical Research , 4th Edition

Medical Statistics at a glance , 3rd Edition

A Pocket Guide to Epidemiology , 2009

Kaplan Books , Epidemiology

Wikipedia , Probability and Non- Probability Sampling