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Contents
I. Introduction 3
II. Objectives 3
III. Main Content Areas 4
IV. Methodology 5
V. Category & Number of participants 5
VI. Evaluation of Workshop 5
VII. Tentative workshop schedule 6
VIII. Group work-I, Issues related to protocol writing and research in
DNB accredited hospitals/institutions. Need for research and
listing of skills desired for protocol writing and
conducting research 7
IX. Group work-II, identification of research problem and writing
research objectives and study variables 12
X. Group work-III, , identification of research design to fulfil the
research objectives identified, and to identify the study area
and study population for the study 21
XI. Group work-IV, identification of sampling technique and
sample size for the study 26
XII. Group work-V, identification of data collection techniques
and data collection tools 31
XIII. Group work-VI, identification of statistical data analysis
methods and data presentation methods 39
XIV. Group work-VII, identification and application of statistical
tests of significance on the data 55
XV. Group work-VIII, Writing a thesis protocol 57
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Introduction
The National Board of Examination was established in 1975 with the primary
objective of improving the quality of the Medical Education by elevating the level
and establishing standards of post graduate examinations in modern medicine,
on an all India basis. There are more than 450 accredited hospitals/institutions,
imparting DNB courses in 43 medical specialties. In order to improve the
competencies of DNB candidates in medical research (as envisaged in the
requirement of thesis submission by them) it has been suggested to conduct
short term workshops on regional basis.
General Objective
To enhance the knowledge and skills of the participants so that they are
able to write thesis protocol and conduct medical research for DNB training
programme.
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Specific Objectives
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Duration
3 days
Methodology
The DNB candidates who are in first year and are preparing for their
thesis protocol along with DNB trainers from NBE accredited hospitals/
institutions.
The number of the participants per workshop will be 35-40.
Evaluation of Workshop
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TENTATIVE WORKSHOP SCHEDULE
Day-1
9.30-10.30AM Registration, Inauguration & workshop brief
10.30-1.00PM Group work-I, Issues related to protocol writing and
research in DNB accredited hospitals/institutions.
Need for research and listing of skills desired for
protocol writing and conducting research.
Day-3
9.30-10.30AM Review of the previous day’s activities
10.30-1.00PM Group work-VII, identification and application of
statistical tests of significance on the data
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GUIDELINES FOR GROUP WORK-I
Group Work –I, Issues related to protocol writing and research in DNB
accredited hospitals/institutions. Need for research and listing of skills desired
for protocol writing and conducting research.
Group Task
The participants would be divided into groups and each group would complete
the task of identifying Issues related to protocol writing and research in DNB
accredited hospitals/institutions and listing of skills desired for protocol writing
and conducting research.
ii. Discuss in group and list the problems/ difficulties faced in protocol
writing and research in DNB accredited hospitals/institutions
iv. Discuss and list skills desired for protocol writing and conducting
research.
v. Prepare the group work report and discuss it with the facilitator.
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Exercise-I, Group work-I, Issues related to protocol writing and research in
DNB accredited hospitals/institutions
1. Please consider your own hospital/ institutions and the DNB training
programme and list five difficulties related to protocol writing.
2. Please consider your own hospital/ institutions and the DNB training
programme and list five difficulties related to the conduction of research
for your thesis work.
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3. Please write your suggestions for overcoming the difficulties related to
protocol preparation.
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5. Refer to the thesis and list out the deficiencies in the thesis.
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6. Discuss with your issues within the group and list common issues faced
by all the members of the group and discuss the same with your
facilitator.
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Exercise-II, Group work-I, Need for research and listing of skills desired for
protocol writing and conducting research.
1. Refer to the handouts and discuss the need for research during DNB
training programme in your group.
2. List the three positive aspects of having thesis during the DNB training
programme.
3. List the three negative aspects of having thesis during the DNB training
programme.
4. Discuss in the group and write the majority opinion of group members
and discuss with your facilitator.
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5. Discuss in the group and list various skills which are required for writing a
good thesis protocol and for conducting the research for thesis work.
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GUIDELINES FOR GROUP WORK-II
Group Task
The participants would be divided into groups and each group would complete
the task of identifying research problem and study variables and writing
research objectives
ii. Discuss in group and list the research topics which can be done
in DNB accredited hospitals/institutions and allot one topic to each
member of the group.
iii. Each member in the group will write study objectives for the topic
allocated to him/her and later on discuss with the facilitator .
iv. Each member in the group will write study variables for the study
and later on discuss with the facilitator .
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Exercise-I, Group work-II, identification of research problem/issue.
1. Consider your own specialty and list three problems/topics on which you
would like to work for your thesis work.
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2. Please complete the following information about the research
problems/issues listed by you:
Any other
List the most common research issue/ problem you can cover during your thesis
research work. Discuss in the group and with your facilitator the reason for
selecting the topic for your research work.
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Exercise-2, Group work-II, Writing objectives for the research study.
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2. Discuss your objectives with the group members and the facilitator and
write the final modified objectives for the study.
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Exercise-3, Group work-II, Identification of study variables
1. Dependent variable
2. Independent variables
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3. Background variables
4. Confounding variables
5. Discuss in the group and with your facilitator the variables listed by you.
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GUIDELINES FOR GROUP WORK-III
Group Task
The participants would be divided into groups and each group would complete
the task of identifying research design to fulfil the research objectives , identify
the study area and study population for the study.
iii. The group members will then list the research deign most feasible
for their individual studies and discuss the same with the facilitator.
iv. Each member in the group will write the study area and study
population for the study and discuss the same with the facilitator .
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Exercise-1, Group work-III, Identification of research design for the
proposed study.
Consider your study objectives and resources available to you for your study
and
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2. Write reasons for selecting the design for your study.
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Exercise-2, Group work-III, Identification of study area and study
population for the study.
1. Consider the study design and the objectives for your study and write the
name of the hospital/ institution/ community where you would like to
carry out the study and also mention the reasons for such decision.
2. Describe the characteristics of the study area you have chosen for your
study.
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3. List the categories of the subjects and their characteristics whom you
would include in your study (for example children below 5 years having
operated for a particular disease in the hospital; adult females in the
reproductive age group admitted for delivery; relatives of the cases who
are accompanying the patient; treating doctors; nursing staff providing
care to patients etc.)
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GUIDELINES FOR GROUP WORK-IV
Group Work –IV, identification of sampling technique and sample size for the
study
Group Task
The participants would be divided into groups and each group would complete
the task of identifying sampling technique and sample size for the study
iii. The group members will then list the sampling technique most
feasible for their individual studies and discuss the same with the
facilitator.
v. Each member in the group will calculate the sample size most
appropriate for their study and discuss the same with the
facilitator .
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Exercise-1, Group Work-IV, Identification of the sampling technique.
1. List the sampling techniques which will suit your study the most and give
reasons for selecting the same.
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2. List possible reasons for bias which are likely to be there in your study,
and how will you try to minimize the same.
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Exercise-2, Group Work-IV, Calculation of sample size
1. Consider the study objectives and study design you have identified, and
list what type of data will be collected. Will it be quantitative or qualitative?
(If you will collect data which will be measured in terms prevalence rate
for a disease, or cure rate for a drug regimen, or number of cases which
developed complications or died, or a characteristic which is present or
absent in the person or in biological fluids, etc. such type of data is called
qualitative data.
If you will collect data which will be measured in terms weight /height gain
after a therapy, changes in blood pressure, change in bio-chemical
parameters such as blood hemoglobin, sugar, urea, etc. this type of data
will be quantitative data.)
4. If you are going to collect the quantitative data then what is the expected
value of the Mean and standard deviation.
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5. Determine the sample size if Standard deviation of the population is 6, the
mean blood urea level is = 25, and the sample mean is= 23 and the
desired level of precision is 99%. Value of Z at 99% = 2.576.
Given
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6. Determine the sample size if five years survival rate is 20% after
diagnosis of carcinoma lung. You are willing to accept in your study a
variations of +/_ = 5%, the desired level of precision is 99%. Value of Z at
99% = 2.576.
Given
Survival rate, p = 20
Q= 100-p= 100-20= 80
Difference of proportion which is acceptable = 5
Z = 2.576
N= pXqX2.576/ 5X5
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GUIDELINES FOR GROUP WORK-V
Group Work –V, identification of data collection techniques and data collection
tools
Group Task
The participants would be divided into groups and each group would complete
the task of identifying data collection techniques and data collection tools
for the study
iv. The group members will then list the data collection techniques
most feasible for their individual studies and discuss the same with
the facilitator.
v. Discuss in group basic components of a data collection tool.
vi. Each member in the group will develop one data collection tool
for their study and discuss the same with the facilitator .
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Exercise-1, Group work-V, selection of data collection techniques
2. Consider your study design, study objectives and the resources available
to you for your thesis work and list our the data collection techniques you
would like to use for your study.
3. Discuss with your facilitators the reasons for selecting various data
collection techniques selected by you.
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Exercise-2, Group work-V, Development of data collection tools
1. Title of tool
First part of the data collection tool is the title and it should also contain
the name of the institute/hospital, and the category of subject from whom
the information is to be collected.
Write the title of your study, name and address of the hospital.
Write the category of the subject (s) from whom you would collect the
information using the tool.
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2. Identification data
The second part of the tool is the identification data and background
variable about the subject from whom you are going to collect the
information.
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3. Body of the tool
It contains the questions which you are going to ask from the subjects of your
study.
There are two types of questions -Open ending ( e.g. what are your main
complaints? In such a question the subject will use his/her own words to give
his/her response and you write the same. The advantage is that you may have
additional information from the subjects. But these questions are difficult to
analyze); Close ending questions( Are you vegetarian or non-vegetarian. Here
you have limited the response from the subject to two choices of being
vegetarian or non vegetarian. Do you some? Here the response is limited to
Yes/No. The advantages of close ending questions is that you get focused
information which is easy to analyze.) You should have both the open and close
ending questions in your tool.
Consider your study objectives and the study variables and write the questions
for getting responses from your subjects.
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4. Remarks
The last part of the tool is the remarks from the investigator who is collecting
information from the subject.
He may like to add certain additional details not included in the tool, or some
observations about the behavior of the subject like the subject being not co-
operative, etc. or some instructions to the person who will analyze the data
collected by the investigator.
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GUIDELINES FOR GROUP WORK-VI
Group Work –VI, identification of statistical data analysis methods and data
presentation methods
Group Task
The participants would be divided into groups and each group would complete
the task of identifying statistical data analysis methods and data presentation
methods.
for the study
iv. The group members will then list the data analysis method most
feasible for their individual studies and discuss the same with the
facilitator.
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Exercise-1, Group Work-VI, Tabulation of data
Consider the above data and draw a table for the same. You should refer to the
handout for the exercise-1, Group work-VI.
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2. Show the table you have prepared to your facilitator.
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Exercise-2, Group Work-VI, Presentation of data
A 20.0
B 15.0
C 25.0
D 30.0
E 10.0
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2.2 Consider the following data
A 5 10 5 10
B 10 5 5 5
C 10 5 10 5
D 5 20 5 10
E 5 5 10 5
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2.3 Consider the following data
A 5 10 15
B 10 5 10
C 10 5 15
D 5 20 15
E 5 5 15
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2.4 Consider the following data
A 5 10 5 10
B 10 5 5 5
C 10 5 10 5
D 5 20 5 10
E 5 5 10 5
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2.5 Consider the following data
A 180 160 - 20
B 200 150 - 50
C 220 180 - 40
D 200 210 + 10
E 195 200 +5
F 210 190 - 20
G 220 190 - 30
H 220 225 +5
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2.6 Consider the following data
A 15 40 15 30
B 20 55 35 45
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2.7 Consider the following data
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Exercise-3, Group Work-VI, calculation of mean, Mode, Median and
Standard deviation
1.1. Mean systolic Blood pressure in male subjects ( Add systolic blood
pressure for all male subjects and divide the sum with 20)
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2. Draw the frequency and cumulative frequency table for the following
Write the range of systolic blood pressure in males ( e.g. minimum is 100 and
maximum is 210) = 210- 100 = 110
Write the number of classes you would like to have for the data ( e.g. 5 or 10 )
Write the class interval ( Divide the range with number of classes) 110/5= 22; or
110/10 = 11, in case you select to have 5 classes the class interval will be 22
and for 10 classes the class interval will be 11.
Write the frequency ( number of male subjects with systolic blood pressure in
the class interval) in the following table.
Write the cumulative frequency ( Add the frequency of the row to the frequency
of immediately above row ) for various class intervals in the table
Class interval Frequency Cumulative frequency
100- 122
122-144
144-166
166-188
188-210
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3. Calculate the mean value using the above tables.
Mean = Sum of all ( Mid class interval x frequency in the class)/ number of
subjects.
( Mode is the most common number of the series, the modal class will be the
one which has been represented maximum number of times)
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5. Calculate the median value using the above tables.
( Median is that value in distribution which divide the distribution in two equal
halves. The formula for median is as follows:
ii. Look into the cumulative frequency(C.F) column and look in for the C.F
value which is equal or just greater than the value you have calculated in
i.
iii. This is median class.
Median =
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6. Calculate the Standard deviation
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GUIDELINES FOR GROUP WORK-VII
Group Task
The participants would be divided into groups and each group would complete
the task of identification and application of statistical tests of significance on the
given data
iii. The group members will then apply one test on the data given to
them and discuss the same with the facilitator.
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Exercise-1, Group work-VII, Identification and application of statistical
tests of significance on the data
1. Consider your data, type of distribution, sampling technique and sample size
etc. and decide which type of test would be the most suitable. The parametric
tests are those tests which make assumption about the data, its distribution,
randomness of sampling and adequate sample size etc. Some times when we
are not able to fulfill these conditions then we go for the non-parametric tests.
2. When you decide to go for the parametric tests then you decide, which type
of data you are dealing with( qualitative or quantitative).
2.1. In case you are dealing with qualitative data, then you have to see whether you
wish to compare the single attribute or proportion with the population value
or two attributes or proportions.
2.1.1. For the comparison of single proportion or attribute with population value,
the test used will be Standard normal deviate test for single proportion.
2.1.2. For the comparison of two proportions or attributes the test used will be
Standard normal deviate test for two proportions.
2.2 For the quantitative data, you need to consider the sample size, if sample is
more than 30 and you wish to compare two means, then you can use the
Standard normal deviate test.
2.3. For the quantitative data with sample size of less than 30 and comparison of two
sample means the test used will be Student’s –t test.
2.4. For the quantitative data with sample size less than 30 and tow observations on
the same subjects the test used will be Students-’t paired test.
2.5. For comparison of more than two sample means you need to use the
Analysis of variance or F-test.
3.0 When you decide to go for the parametric tests, you can use the X2 Chi-
square test, Sign test, Run test etc.
4.0 Write the names of the tests you have selected and discuss the reasons
with your facilitator.
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Exercise – I, Student’s – t test ( when sample size is less than 20)
Whether these two sample means differ or not. Test by student ‘t’ test
(Student ‘t’ Table Value at 17d.f,0.05 = 2.11).
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Exercise – I, Student’s - t test (when sample size is less than 20)
Whether these two sample means differ or not. Test by student ‘t’ test
(Student ‘t’ Table Value at 17d.f, 0.05 = 2.11).
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Exercise II– for Student’s- ‘t’ paired- test
The Blood Urea profile for six patients before & after administration of a
drug was as follow:
Blood Urea
Subject After drug Adm.
Before drug Adm.
A 58 53
B 29 28
C 30 31
D 55 48
E 56 50
F 45 42
Can we say that the drug was effective in reducing Blood Urea levels.
Test at 5% level of significance (Table value student’s-t, test at 0.05 = 2.57).
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Exercise II– for Student’s- ‘t’ paired- test
The Blood Urea profile for six patients before & after administration of a
drug was as follow:
Blood Urea
Subject After drug Adm.
Before drug Adm.
A 58 53
B 29 28
C 30 31
D 55 48
E 56 50
F 45 42
Can we say that the drug was effective in reducing Blood Urea levels.
Test at 5% level of significance (Table value student’s-t, test at 0.05 = 2.57).
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Exercise – III, for Z-test( For two sample means when size of sample is
>20)
The intelligence test was done on Boys & Girls the results were as follow:
Measure S.D N
X1 78
Girls SD1 12 n1 80
X2 75
Boys SD2 17 n2 120
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Exercise – III, for Z-test( For two sample means when size of sample is
>20)
The intelligence test was done on Boys & Girls the results were as follow:
Measure S.D N
X1 78
Girls SD1 12 n1 80
X2 75
Boys SD2 17 n2 120
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Exercise –IV, For Chi-square test
Test the hypothesis that the drug ‘A’ is no better than the placebo.
(Using Chi-square test; Chi-square at 2 d.f , 0.05= 5.99)
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GUIDELINES FOR GROUP WORK-VIII
Group Task
The participants would be divided into groups and each group would complete
the task of writing a thesis protocol.
ii. Discuss in group the steps and heading under which a protocol
should be written.
iii. The group members will then write individual protocol taking in to
consideration previous group work reports and discuss the same
with the facilitator.
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Exercise-1, Group work-VIII, Writing of a thesis protocol
Please refer to the handout on exercise-1, group work-VIII, and complete the
following information:
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2. Introduction (Giving introduction to the subject, rationale for the study
and justification etc.)
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3. Objectives for the study
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4. Review of literature
Please mention the main heads and subheads under which you would like to
review the relevant literature.
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5. Materials and methods
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5.3. Study variables
5.3.1. Please list the independent study variables for your study.
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5.3.2. Please list the dependent study variables
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5.3.3. Please list the background variables for your study.
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5.4. Sampling techniques and sample size
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5.4. Data collection techniques
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5.4.3. Develop tool (s) for your study
5.4.3.1 Title
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5.4.3.3. Body of the tool
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5.4.3.4. Remarks
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5.5. Data analysis plan
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5.5.2. Statistical analysis plan
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5.5.3. Statistical tests of significance
5.6. References
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