HAND BOOK OF BASIC QUANTITATIVE RESEARCH METHODS IN HEALTH CARE

ABSTRACT

This Action plan lists out the broad goals and aims of
SAMRAKSHAN, an initiative developed and launched
by IRIA & ICRI to address perinatal mortality in India

Rijo Mathew Choorakuttil

SAMRAKSHAN

An IRIA & ICRI Initiative to address perinatal
mortality in India

SAMRAKSHAN

Contents

Rationale........................................................................................................................................... 2
Relevant Statistics that support the initiation of SAMRAKSHAN ..................................................... 2

Goals................................................................................................................................................. 3
Phase I............................................................................................................................................... 4

Training ......................................................................................................................................... 4
Selecting Locations ........................................................................................................................ 5
Information, Education and Communication Strategies ................................................................. 5
Goals First Year.................................................................................................................................. 6
Outcomes from First Year.................................................................................................................. 6
Integration with Academics ........................................................................................................... 7

1

SAMRAKSHAN

Rationale

Fetal Radiologists are uniquely equipped to identify maternal and fetal conditions that may

contribute to feto-maternal morbidity and mortality. Fetal Radiologists perform imaging studies

using different modalities like Ultrasound, Doppler studies, CT and MRI, Echocardiographic studies,

Neurosonograms, and Genetic sonograms, amongst others that help for early identification of

maternal and fetal morbidity or abnormalities. Multi-modality imaging studies offer the potential for

a systematic sequential assessment that minimizes risk of missed or misplaced findings and

interpretations.

India has a high perinatal rate and is a major contributor to the maternal mortality, neonatal and

infant mortality and stillborn rates worldwide. Despite significant and substantial progress in health

care in India, pregnancy induced hypertension, fetal growth and prematurity remain significant

factors that drive feto-maternal morbidity and mortality in India. These major factors can be

identified early through a systematic imaging study approach and can help with initiation of early

therapeutic strategies and consequently lead to a significant reduction in feto-maternal morbidity

and mortality.

Relevant Statistics that support the initiation of SAMRAKSHAN

 Estimated 27 million live births in India in 2017
 Estimated 75,658 live births average per day in India in 2018
 78.9% Institutional Deliveries in India
 Hypertensive disorders of pregnancy major cause of maternal mortality
 10.08% incidence of Pregnancy Induced Hypertension; Preeclampsia 8-10%,

Eclampsia 1-5%
 Estimated 3.5 million premature births in India in 2017
 Congenital Malformations prevalence 1.9% to 2.72%
 Estimated 621,000 babies born annually in India with congenital anomalies
 Congenital anomaly prenatal diagnosis was 10.98 per 10,000 births
 Prevalence of SGA 36.5%
 Prevalence of IUGR reported at 54%
 Prevalence of low birth weight babies 26%
 Attributable neonatal deaths (1000s) was 202.3 for all SGA

2

SAMRAKSHAN

Goals

 To enhance and promote the role of Radiologists in India in the National Mission to reduce
perinatal mortality incorporating experience and expertise with imaging studies and
multimodality approaches in perinatal care

 To develop a technical package that includes methods to assess and score at risk
pregnancies and fetuses for preeclampsia, prematurity, preterm, placental abnormalities,
fetal growth and fetal abnormalities

 To develop a training, documentation and reporting package that can be used as a
Continuous Learning Improvement Program (CLIP) to continuously train radiologists in India
on modalities in Fetal Radiology

 To develop Information, Education and Communication (IEC) packages that can be used to
increase awareness on the strengths and potential for fetal radiology in the early
identification of feto-maternal morbidity focused on all stakeholders, including but not
limited to, the community, other health care service providers involved in feto-maternal
health, other community based groups and organizations involved directly or indirectly with
feto-maternal wellbeing, and social and political and business communities.

3

SAMRAKSHAN

Phase I

Focuses on setting a strong foundation in place for enhanced quality of institutional based care.

Training

 Training Personnel
o Focused on currently practising Radiologists
o PG Residents in Radiology
o Training of Trainers
o Developing State and Regional Pools of Trainer of Trainers

 Training Centers/Institutes
o Centers that can become state wide and regional training centers
 Focus on
 Government Medical Colleges
 Private and Non-Government Sector Teaching Hospitals
 Large Diagnostic Centers in Private Sector
 Pre-requisites
 Outcomes
 Assessments, Audit and Evaluation
o Scale Training Centers into Centers of Excellence in Fetal Radiology

 Training Package
o Content of Training
 Modules
 Duration
 Outcomes
 Outcome Indicators Focused on Early Identification of
o Pre-Eclamspia

4

SAMRAKSHAN

o Fetal Growth
o Fetal Structure
o Fetal Environment
 Documentation
 Enrolment Forms
o Trainees
o Trainers
o Training Centers
 Individual Case Documentation Forms- Trimester Specific forms &
Outcomes forms
 Monthly Reporting Forms
 Annual Performance Form
 Reporting
 Audit and Evaluation
 Random Audit of Personnel
 Random Audit of Participating Centers

Selecting Locations

o States that are included in first or pilot phase of project
o Districts within states that are covered in pilot phase of project
o Plan for Scale up at State and National Level
o Coordinate with State IRIA

Information, Education and Communication Strategies

 Locally Relevant but Nationally Linked Information, Education and Communication Strategies
 Central and State Pool of Materials in local language and English
 Electronic, Digital and Paper Content

5

SAMRAKSHAN

 Audiovisual Content
o Paper and Electronic Posters
o Audio
o Video
o Podcasts
o Link to Community Radio as applicable

 State and National Brand Ambassadors

Goals First Year

 Inauguration and Launch of Samrakshan at SonoSummit, Chennai 2019
 Creation of National Steering Committee
 Creation of State Steering Committees
 Publicity of the Program

o Publicity Material
o Dedicated App
 Launch of State Programs in coordination with State Associations
o Enrol and Initiate Training Programs
 Develop Consolidated Technical Training package
 Explore possibility of Government Grants for Government Medical Colleges and PPP
processes
 Radiologists and IRIA at State and National Level to leverage political, social and business will
to support the program

Outcomes from First Year

 Develop a consolidated technical package for the implementation of the program
o Training Modules

6

SAMRAKSHAN
o IEC material
o Dedicated Portal

 Trainers, Experts, Faculty Pool Developed
 Data collection through reports collected
 Audit and Evaluation of training and participating centers to fine tune processes
 Publicity and Awareness generation on perinatal mortality and the important role of

radiologists to address perinatal mortality in each district focused on dissemination to all
stakeholders

Integration with Academics

1. Case Discussion Forums through Dedicated Website, WhatsApp or Telegram (or similar
approach) Group

2. Mentoring to publish case reports, case series and articles
3. Online Journal Club disseminating innovative and updated approaches in Fetal Radiology
4. Dedicated online interaction rooms to conduct regular academic case discussions at regular

intervals

7





























Review of literature

 Personally, I prefer starting with a review of th
prefer revisiting it at this stage)
 This is a personal preference and maybe I will s
The review of literature sets out what is already
provides information on what may be useful to s

he literature (If it has been done already, I still

share some of the reasons to start here
y known, the gaps in current knowledge and
study (as a value addition to existing knowledge)

What Should You Rev

Sounds simple, we should review the literature
This is a good place to state what we are NOT re
review to a) The journal or medium in which the
institution d) the funders or grant agency or e) t
This is an important point that we will revisit late

view?

!
eviewing. We are NOT reviewing or limiting the
e study is published b) the authors c) the
the number of citations a paper has
er

Where do I find the li

The easiest is to search in available databases a
However, our aim is to review literature that is p
help expand our understanding of our area of in
It helps to NOT LIMIT the search to only indexed

literature?

and repositories
pertinent to our research question and that can
nterest
d databases

What do we review?

There will be many papers and material to revie
available material is a bit too much. It is thus eas
What should the review focus on?
To recap, the review should focus ON the CONTE

?

ew and to hope that one can review all the
sier to start with indexed material.

ENT of the material or papers

What do we review?-

 The stated hypothesis and research question-
Does it add value to our hypothesis/question
The design of the study- was an appropriate de
The variables they have studied-how do they re
other

?-1

How similar is that to our hypothesis/question?

esign used?
elate to the question, how do they relate to each

What do we review?-

 The methods used- ascertaining measures, sta
appropriate for the research question?

 The results of the study- Do the results flow lo
pertinent to the research question?

The interpretation and discussion- Are limitatio
discussed? Do YOU agree with the interpretation

 The references that give a good clue to review

?-2

atistical tests, outcomes- Are the mthods

ogically from the methods mentioned and

ons discussed? Are areas for further study
n?
the literature

The Abstract?

 Well, what about the abstract?
 Ideally, use the abstract only as a snapshot to d
your research ideas
DO NOT use the abstract to form any judgment
DO NOT just accept the abstract as TRUE- Revie

determine if the broad areas are in sync with

ts on the validity of the research
ew the contents of the paper to form an opinion

A good review

A good review helps to
 Determine if our research question is worth stu
 To identify/confirm variables and outcome me
 To design an appropriate study with an approp
 To confirm methods of ascertainment
 To understand the limitations including potent

udying
easures to study
priate sample size

tial bias, confounders and address those

A good review

A good review comes from
 Practice
 Practice
 Practice
 Practice



A good review

REMEMBER-
 Do not get diverted by extraneous factors- the
agency, the number of citations etc
 Focus on the content
 A Review is to understand your topic better an
 A good review, used appropriately, adds great
research

e journal, the authors, the institute, the funding

nd not to just accept the authors conclusions
value to the conceptual strength of your

Title: Variables are not “worryables”

Choosing the variables to study

Module Summary:
In this module, we will look at variables that are needed to answer research questions. We
will explore briefly the different types of variables, determining the variables to study,
measuring variables and the importance of variables within the context of a research study.
At the end of this module:
You should be able to create a list of variables, indicate the type of each variable in the list,
measurement units and measurement procedure for each variable, indicate who will
measure, and justify choice of the variable.

You have defined your research question. You have a hypothesis in hand and are now ready
to start research that will either prove or disprove your hypothesis. You have searched the
literature, found evidence that indicates that it is worth the while to pursue your question.
You can now choose the variables for your study based on the literature review
Let us do a quick recap here.

A research question is a SMART question.
A hypothesis is a comment or a statement that we aim to prove or disprove through
our research.
Reliable answers to a research question are obtained only if you collect
relevant information through a study that is designed appropriately

Journal of Fetal Radiology by AMMA ERF & KREST Kochi

How do you prove or disprove your hypothesis?
You have to collect information.

You have to collect pertinent information
You have to collect pertinent information as appropriate measures
You have to collect pertinent information as appropriate measures and by
appropriate procedures
You have to collect pertinent information as appropriate measures, by appropriate
procedures and by appropriate persons/methods
You cannot claim The Right to Information Act here (maybe you can).

You may have to collect several pieces of information to reach from your question to
addressing your hypothesis. Several pieces of the puzzle exist and have to be sorted out.
What is a variable?
The pieces of information that you collect are called variables.
Why are they called variables?
They are called variables because the information collected may vary between persons or
within persons over a period of time.
Examples:

Age may vary between persons; Age may vary for the same person if measured over
time
Blood Pressure may vary between persons; BP may vary for the same person if
measured over time
Age is a variable- It can vary.
Blood Pressure is a variable- It can vary.
Variables can vary- there are different types of variables

Journal of Fetal Radiology by AMMA ERF & KREST Kochi

Variables can be
Dichotomous or nominal
Discrete, Categorical or Ordinal
Continuous, interval or ratio

Dichotomous Variables
These are variables with two levels- either/or. An example is a yes/no response. Gender –
Male/Female is dichotomous.
Discrete Variables
These are variables that have more than two levels. For example, strongly disagree,
disagree, agree, and strongly agree. The levels can be ranked in discrete variables;
however, placing a value on the levels is often not possible.
Continuous variables
These are variables that exist in a continuum. Age is an example for a continuous variable.
Height, weight are other examples of continuous variables.
In research, we often use the terms dependent variable and independent variable.
The dependent variable is a variable that may be influenced or is dependent on the
independent variable.

Example:
Blood Pressure- dependent variable
Independent Variable- Age, Sex
The dependent variable blood pressure may be dependent on or influenced by the
independent variables, age or sex. Thus, older people may have higher blood
pressure. Blood Pressure may be higher in males than females.
The reverse does not hold true, a dependent variable cannot influence the
independent variable. For example, a high BP cannot make you older or younger, or
cannot change your gender…..

Journal of Fetal Radiology by AMMA ERF & KREST Kochi

Choosing the variables to study

Can use a trawler approach- thrown the net to collect as many variables as possible-
some may be useful, some may not be useful to answer your question

Can use a scientific focused approach-

o Will collect variables that are pertinent to the question of interest.
o Will not collect additional variables unless they add value to the question

asked.

o Will consider that each variable to be measured needs cooperation of the
research subject and your time. If you will not use the information or the
information is not needed, you are disrespecting the time of the study subject
- bad ethics.

The trawler approach

We are going to the subject so let us collect all information possible. Will help us
avoid repeated visits for repeated information collection.

o Problem: cannot be sure if information collected now will be relevant for a
later time period

o Problem: Study subject has to give more time, may put off the subject
leading to refusals

o Problem: Use of information for other studies does not often happen as
different questions may need different levels of measurement

o Problem: Need sustained training for data collection personnel
o Problem: Need a larger data entry form
o Problem: Need more data entry and a larger database
o Problem: If will not use all that information after all that effort, why collect

it-everyone is overworked as is!
Example: We are going to those villages- let us collect all possible information
from each household- I don’t want to come back again for another study

Journal of Fetal Radiology by AMMA ERF & KREST Kochi

How do you choose which variables to study?
Personal experience
Literature review
Knowledge from Peers
Knowledge from Experts
Everyone collects it or ABC collected it, so I will also collect it- NOT GOOD. An
example may be socioeconomic status, education, occupation, reported monthly
income. Do not collect it unless it has a relationship with the question you are
asking.

Measuring Variables
Use standard, validated methods of measurement
Identify standard methods through a literature review
Example- How will you measure Hemoglobin? How will you measure diabetes? How
will you measure blood pressure? What standard procedure and what standard units
of measurement?

Who does the measurement?
Anyone can measure anything- WRONG
Some people can measure something- Clinical measurements by clinicians
People can be trained to make measurements- consider training, duration, content,
outcomes, certification as successfully trained
Example: Who can read a biopsy as a variable?
Document all training for study personnel- who got trained, who trained, what
duration, content of training, outcomes of training, outcomes assessment, and
certification.

Journal of Fetal Radiology by AMMA ERF & KREST Kochi

Why are variables important?
The choice of wrong variables can introduce a lot of “noise” in the analysis and results.
Wrongly characterized or measured variables can lead to loss of information.
For example:

Collecting age as a discrete variable, 0-10, 11-20, 21-30, 31-40, 40 and above will
not help us to present the mean, median or range of values.
Collecting duration of illness in years or months for acute conjunctivitis- the condition
often subsides in days so the unit of measurement has to be days.

You can save a lot of heartache if you plan your variables properly and well in
advance of data collection

KEY QUESTIONS

What value does this variable add to my study?
Is this necessary?
Do I have proof of its utility?
Is it feasible to collect this information?
Who will collect and how will it be measured?
What will I lose if I don’t study this variable?
Is this variable linked to other variables in the study?
Do they interact with other variables in any way? How does, if it does, this variable
influence or impact other variables in the study?
MOST IMPORTANT-HOW WILL I USE THIS INFORMATION AND DOES THE METHOD
OF ASCERTAINMENT ALLOW ME TO USE THIS INFORMATION APPROPRIATELY?

Journal of Fetal Radiology by AMMA ERF & KREST Kochi

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