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1 SRI BALAJI VIDYAPEETH UNIVERSTY PUDUCHERRY GUIDE LINES TO POST GRADUATE DEGREE STUDENTS FOR WRITING DISSERTATION

SRI BALAJI VIDYAPEETH UNIVERSTY …sbvu.ac.in/pdf/PG DISSERTATION-MGMC.pdfPONDICHERRY DISSERTATION PROTOCOL FOR MD/MS STUDENTS 1. Name of the candidate Phone Number E Mail 2. Course

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SRI BALAJI VIDYAPEETH UNIVERSTY

PUDUCHERRY

GUIDE LINES TO POST GRADUATE DEGREE STUDENTS

FOR WRITING DISSERTATION

2

DISSERTATION

Objectives

1. The student would be able to demonstrate capability in research by planning and

conducting systematic scientific inquiry & data analysis and deriving conclusion.

2. Communicate scientific information for health planning.

Guide for Dissertation

1. Chief guide will be from the parent department

2. Co-guide(s) will be from the parent department or from other disciplines related to

the thesis.

The concerned Guides/Co-guides are to supervise and to see that the dissertations

are done properly by utilizing the clinical materials/infrastructure of their own

department/institution. The students must learn the design and interpretation of research

studies, responsible use of informed consent and research methodology and interpretation

of data and statistical analysis. They should seek the help of qualified staff members in

the conduct of research. If necessary, they can utilize the facilities in other Institutions.

They must learn to use the library and computer based search. This training will help

them to develop skills in planning, designing and conduct of research studies.

Submission of Dissertation Protocol

It should be submitted at the end of six months after admission in the course.

1. Protocol in essence should consist of:

a. Introduction and objectives of the research project.

b. Brief review of literature.

c. Suggested materials and methods, and (scheme of work)

d. Statistician should be consulted at the time of selection of groups, number of cases

and method of study. He should also be consulted during the study.

e. References.

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3. The protocol must be presented in the parent department before being forwarded to

the Research Committee of the Institute. Protocol will be approved by the research

committee appointed by the Dean/Principal to scrutinize the thesis protocol in

references to its feasibility, statistical validity, ethical aspects, etc.

4. All candidates admitted to undergo Post-Graduate Degree courses shall be assigned a

topic for dissertation / Thesis by the head of the concerned Unit and the title of the

topics assigned to the candidates be intimated to the Controller of Examinations of this

University by the Head of the Department through the Head of the Institution before

the end of 1st year of the course.

Model Dissertation Protocol is given here: Page No 4-10

4

MAHATMA GANDHI MEDICAL COLLEGE AND RESEARCH INSTITUTE

PONDICHERRY

DISSERTATION PROTOCOL FOR MD/MS STUDENTS

1.

Name of the candidate

Phone Number

E Mail

2.

Course to which

admitted

3.

Month and year of

admission

4.

Month and year of

appearing in the final

Examination

5.

Month and year of

submission of

dissertation

5

6.

Name of the Guide:

Designation:

Phone Number:

E Mail:

7.

Name of the Co-Guide:

Designation:

Phone Number:

E Mail:

8.

Name of the Co-Guide:

Designation:

Phone Number:

E Mail:

9.

Name of the Co-Guide:

Designation:

Phone Number:

E Mail:

10.

Departments involved

6

11.

Place of Study

12.

Title of dissertation

13.

Introduction

14.

Aims and Objectives

15.

Relevant review of

literature

16.

Research Question or

hypothesis

17.

Methods (include a

diagrammatic

representation)

18.

Study parameters

(outcome measures)

being monitored

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19.

Whether procedure

involves

Animals/humans or

both

20.

Type of study

21.

Number of groups to be

studied

22.

Sample size in each

group (with

justification)

23.

Inclusion criteria (for

human studies)

24.

Exclusion criteria (for

human studies)

25.

Drugs used, if any

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26.

Procurement of

investigational drugs

and storage, if any

27.

Methods of statistical

analysis

28.

References

29.

Work already done

30.

Data Management

(Enclose proforma)

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ETHICAL CONSIDERATIONS

31.

Ethical issues involved in the

study

32.

Procedure involved for

obtaining informed consent

33.

Procedure involved for

recruiting volunteers, if any

34.

Officer designated by the

department for quality control

Designation:

Phone:

E Mail:

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35.

Procedure for subject

withdrawal/dropout

36.

Safety check for subjects, if

applicable

37.

Procedure for termination of

the study

38.

Data Accessibility

39.

Publication policy

40.

Sponsor‘s study monitor, if

any (with address, contact

number and E Mail)

41.

Outside funding, if any

42.

Mode of reporting results of

study

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Title of the dissertation:

INVESTIGATOR’S DECLARATION

We have read and agree to comply with the procedures detailed in this document.

All the relevant standard procedures will be adopted to conduct this study with the

highest ethical standards. We have read the Helsinki declaration (for clinical studies),

ICP-GCP guidelines / CPCSEA guidelines / ICMR ethical guidelines and other

applicable guidelines and undertake to follow them strictly in performance of this study.

The study will be performed as per approved protocol. Permission will be obtained from

the ethical committee for any deviations. The study will be terminated immediately in

case of any unforeseen adverse consequences and the ethical committee informed

immediately.

NAME

DESIGNATION

SIGNATURE

DATE

CANDIDATE

GUIDE

CO-GUIDE

CO-GUIDE

CO-GUIDE

HOD

DEAN

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HOW TO WRITE A DISSERTATION

What is Dissertation?

―A formal, often lengthy treatise or discourse, especially one written by a candidate for a

doctoral degree‖

―It is an exercise to train a PG student to plan, execute, evaluate, write and report a

scientific project‖.

―It is an in depth study of a particular topic which contributes new information and

knowledge in the field‖

Words ‗Thesis‘ and ‗Dissertation‘ are used interchangeably. Thesis is much shorter than

Dissertation. (1 year versus 3-4 years) Master‘s s Thesis and Doctoral Dissertation have

different objectives. Objective of Thesis is to teach and train a PG student in Research

Methodology and in Thesis process is more important than outcome. Whereas in

Doctoral Dissertation (PhD) there is bound to be a new outcome and it reflects the critical

thinking of the candidate on the research topic

.

Why to do a Dissertation? (AS FAR AS POST GRADUATE DEGREE COURSE IS

CONCERNED THE TERM ‘DISSERTATION’ IS USED INSTEAD OF ‘THESIS’)

As per the guidelines of MCI, many universities in India including SRI BALAJI

VIDYAPEETH have made Dissertation a mandatory part of PG degree curriculum,

because the Dissertation:

1. Teaches the fundamentals of Research Methodology & stimulates interest in research.

2. Helps to develop scientific attitude.

3. Teaches to probe in depth of a topic.

4. Teaches the critical appraisal of the medical literature.

5. Encourages to develop special technical skills.

6. Encourages the students to use library and electronic medical data bases.

7. Contributes new knowledge.

8. Teaches publishing of a scientific data.

9. Satisfies the academic /scientific instincts of PG students.

10. Brings about a behavioural change in a student.

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Role of Postgraduate Students

Wrong notion amongst the students & inability to relate the need of dissertation with

their clinical goal leads to malpractice like cooking the data, statistics, & copying from

other sources.

They must realize its importance, get truly involved in their projects, work sincerely

and honestly to make use of this best opportunity of learning.

Role of Guides

Supervision & guidance of the candidate at all stages of the dissertation.

Helping from all angles to conduct a proper study.

Role of University

To set a standard for dissertation

Interim (Midterm) assessment

To give a proper weightage for dissertation by making approval of dissertation as a pre-

requisite to appear for final examination

Where and How to Start?

Selection of the topic

1). Idea: Invariably comes from the guide, since the guide is an experienced person with

the knowledge of the research and the limitations of the facilities available in the

institution and moreover it is a maiden experience for the PG student.

Suppose an anesthesiologist (guide) who has a special interest in post operative

pain relief reads an article in a journal about the description of various receptors

present in the spinal cord and effective pain relief that can be achieved by blocking

them. This information is relatively new to the field to him and so he does a literature

search with cross references, books and electronic data bases and gets a better

understanding of this subject.

He wonders whether, Ketamine, a time tested, widely used, anaesthetic agent that

has powerful analgesic properties can be used epidurally in subanaesthetic doses to

provide effective post operative pain relief following upper abdominal surgeries. This

is only a broad idea and many issues need to be sorted out. He will give this idea to a

PG student and ask him to work on it.

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2) Formulation of Hypothesis: --

Hypothesis is nothing but an idea, which is yet to be proved. From the above

example a Research hypothesis can be formulated.

―Epidural Ketamine in subanaesthetic doses provides effective post operative pain

relief following upper abdominal surgeries”.

‘Null Hypothesis’: also known as statistical hypothesis states exactly opposite of the

research hypothesis.

eg: ― Epidural Ketamine in subanaestheic doses does not provide postoperative pain

relief following upper abdominal surgeries”. Null hypothesis is the one that will be

tested by the statistical significance tests and is either rejected or not rejected. This

hypothesis if not rejected concludes that the observed post operative pain relief with

Ketamine could be due to chance alone and not due to systematic course. On the other

hand its rejection signifies that the observed post operative pain relief is statistically

significant indeed.

Useful hints for the selection of a topic:

1) Avoid topics on which dissertation has already been carried out in the previous 5

years, in the same institution.

2) As far as possible select a topic, which requires minimal help from other

departments (equipments or personnel). If unavoidable official appointment of a

co-guide from the collaborating department will be useful.

Defining an objective

At this stage only vague objective can be formed. To define a clear objective

more information may be needed. Next thing is to search for available literature on the

topic. A thorough reading of Anaesthesia/Pharmacology textbooks on Ketamine will be

helpful. The cross reference from the original articles should be gathered. One should

also find out whether similar studies have been conducted or published elsewhere, to

avoid duplication.

Now the objective can be defined with precision. If the literature search reveals

that the idea has already been tested by many, one has to drop that idea and go for

another one. If it is found that the other studies have missed an important aspect, your

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study can be modified to explore that aspect. The objectives have to be simple, clear,

precise and should be only one or two. Please keep in mind the limitation of available

time. In our example the objective will be ―To study the analgesic efficacy of

subanaesthetic doses of epidural Ketamine for post operative pain relief in patients

undergoing upper abdominal surgeries.

Difference between Aims and Objectives.

There is no real difference between an Aim (Goal) and an Objective. Aims

point out the general purpose of the study, whereas Objectives spell out specifically what

one intends to do in the study.

eg: Aim is to study the analgesic efficacy of epidural Ketamine.

Objective is to compare the duration of pain relief, pain score (VAS) in

Ketamine group Vs. Saline (Placebo) group. In any study objectives must be justifiable

and the PG student must be able to defend them

Review of Literature (ROL)

Sources: Books: * Textbooks & Reference books

* Journals Index Medicus.

* Electronic Database: Medline.

Advantages:

ROL reveals

1. Those aspects of topics on which research has not been carried out

2. Strength and weaknesses of other studies which will serve as guide for the proposed

study.

3. Requirements and difficulties for the proposed study.

4. Information about dose of the drug, animal model, sample size, statistical methods

used, which is very much useful to design the study properly.

5. The knowhow or the technical details for the proposed study.

Requirements for a PG dissertation

1. Competent guide and a determined student

2. Adequate time

3. Instrument, Equipments, Consumable & Drugs with technical know-how to use them.

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PROTOCOL --- PROFORMA

A Proforma consisting of the details of the patient, details of the methodology,

technical details, observations (in the convenient format for recording), complications

and all the relevant details needed for the study have to be prepared by the students with,

of course the help of guide/co-guide for approval by Dissertation committee.

Approval by Ethical committee: -

Any scientific study epidemiological microbiological, pharmacological,

pathological, clinical, nonclinical which involves human subjects, requires clearance

from ethical committee. There is no clear line to demarcate what is ethical and what is

non-ethical. A self-test such as asking oneself ―Would I conduct this study on myself or

my child (or parent).‖ is one way of solving this dilemma. If the answer is ‗yes‘, go ahead

and plan the study.

Consent from all Patients enrolled in the study is very essential. The proformas

are to be xeroxed and kept ready in the place of work and one copy is to be utilized for

one patient. The details of the study, results procured, are to be entered in the proforma

then and there itself.

A separate logbook for all the cases of the dissertation has to be maintained by the

students. A logbook is the only document, which can bailout a student if the credibility

of his dissertation is challenged.

PILOT STUDY.

Registration of the Dissertation:

Once all the requirements for the study are satisfied, perform the pilot study

always in the physical presence of the guide. Some or many of the unanticipated

difficulties / problems/ complications may be encountered. At times, it may be necessary

to modify/ alter some of the material and methods to achieve the goals of the dissertation,

after the pilot study. Relevant changes may have to be made in the proforma. Once about

five (n/10) cases are conducted in each of the groups in the study a synopsis has to be

prepared as per the format provided by the university, containing every detail of the study

and the dissertation has to be registered with the university within 6 months of joining the

post graduate course.

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EXECUTION

Useful hints:

* Be meticulous in recording the data.

* Interact with the guide/co guide as frequently as possible (at least once a month)

* The dissertation team (candidate, guide and co-guide) should meet at least once in 3

months and quarterly report should be submitted to the Departmental Dissertation

Committee.

* Collection of data should be complete in one year.

* Consult a statistician for scientific analysis of the study including for calculation of

sample size at the beginning of the study itself.

* Six months would sufficient for writing the dissertation,

* Dissertation should be submitted six months prior to the examination as per University

stipulations.

Details to be worked out before execution.

1) Study design and methods of elimination of errors, in the study.

2) Sample size & number of groups.

3) Inclusion/Exclusion criteria.

4) Technical details.

5) Parameters to be measured.

6) Data collection, organization and analysis

7) Statistical methods.

Strategies to Eliminate Errors:

Errors may creep into a study at any time, even during interpretation of results. They can be:

* Random or Systematic

* Due to bias or oversight.

Error elimination can be done by:

* Controls

* Randomization

* Cross over designs

* Placebo

* Blinding

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STUDY DESIGNS

A study may be:

i) Prospective: - Data collected from the follow up of patients/ volunteers over a period of

time. Look forward after the exposure (drug /intervention) to

observe the outcome.

ii) Retrospective: Data collected from past records. Look back with the aim of finding a

cause.

A study may be:

i) Descriptive: - Describe the characteristics of a disease in relation to a person, place or

time. They are mainly epidemiological studies necessary for planning of preventive/

control /eradication programs

Three sub types viz. Correlational, Case studies, Cross sectional surveys.

ii) Analytical: - A hypothesis is tested

Two sub types –i) Observational (Case Control & Cohort)

ii) Interventional (Experimental) Clinical trials.

SAMPLE SIZE ( SS)

Denotes the number of subjects to be used in the study

A correct sample/size is the real strength of a study, the results of which can be applied

to a population.

Incorrect sample size will lead to: i) Wrong Conclusion ii) Poor quality research

iii) Wastage of resources and invite iv) Ethical problem.

Factors affecting sample size: 1) Prevalence rate of the factor. 2) Degree of difference

expected. 3) Degree of variation among subjects 4) Desired level of significances.

5) Power of the study 6) Drop out cases.7) Non compliance to treatment 8) Resources

available.

The correct method to calculate the sample size of a study is to use one of formulae

depending upon type of a study and study design.

One of the commonest formula often used. n= 4pq/ d² {n= Sample size, p= Prevalence of

a factor in the population, q= (1-p) / (100-p), d= error allowed}

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ANATOMY OF A DISSERTATION

* Title

* Introduction including aims and objectives.

* Review of the literature

* Material and methods.

* Results.

* Discussion

* Summary & conclusion

* References.

* Acknowledgement

* Certificate.

The Title

It should be concise, but informative, short, active, & brisk. No abbreviations are

to be used. The title must indicate in fewest possible words the i) objective of the study ii)

the type of study iii) the place where the study was conducted and the duration of the

study.

Introduction.

Avoid Long preambles in the introduction. Should answer why did you start? The

introduction should include (in 200-500 words) the purpose of the study, the hypothesis

being tested and the methods employed for the study. Need for the study has to funneled

down from- What is known of a topic through What‘s not known to identify the

unexplored aspect of a topic.

Review Of Literature

Strictly pertinent references are to be written. Critical approach to the reliability

of previous work has to be performed. A retrospective ramble is boring and so – use your

discrimination in including various studies. Evolve a consistent theme in the narration.

Avoid data / conclusion from the work being reported, in the review.

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Material & Methods

It should contain that much information (and no more) for a competent worker to

repeat your work. It should contain sample size, sampling procedure. selection criteria,

randomization, blinding if any, data collection procedure, instrument, and investigation.

Results

This is usually the shortest part of the dissertation and should precisely state your

findings, analysis plan, statistical measures employed, confidence interval, level of

significance etc. Present the data wherever possible in the form of a) Graphics—

histogram, bar diagram, pie chart, frequency polygon. b) Illustrations. c) Photographs.

Discussion

The discussion should contain (in the sequence given ) i) Present principles,

relationships and generalizations shown by the results. ii) Point out exceptions or lack of

correction. iii) Indicate agreement or contrast with previously published work. iv) State

the implications of your results v) Give reasons for your conclusions.

vi).Mention limitation of your work vii).Indicate the scope for further work.

The Summary & conclusion:

The summary should concisely describe, (within 150-200 words).i) the

problem. ii) the solution and iii) the principle conclusion. In the summary, avoid all

experimental details and references to previous work.

References: References should be written in the Vancouver style.

Vancouver Style:

References are numbered according to their appearance in the text. The first

author cited in the text is reference number 1 the second author cited is reference number

2 and so on. These numbers are written as Superscripts in the text at their relevant places

and enlisted at the end serially

The standard format for writing references is given by the International

Committee of Medical Journal Editors (Uniform requirements for manuscripts

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submitted to the biomedical journals). This article is a MUST for anyone attempting to

write a dissertation or scientific paper. (SEE ANNEXURE).

Certificate

Certificate from 1) Self (declaration) 2) Guide and Co-guide, 3) Head of the

department must be included in the dissertation. The head of the institution must

countersign the dissertation.

Acknowledgement

Acknowledge without fail 1) all persons who have helped directly or indirectly

2) source of funds if any.

Time management

Phase—I (0-6 Months)

•Problem identification

•Review of Literature

•Proforma

•Pilot study

•Synopsis

Phase II --- (7-18 Months)

Data Collection

Phase III – (19-24 Months)

Analysis

Discussion

Publication.

Books for Further Readings:

1) A practical approach to PG dissertation by R. Raveendran. Jay pee Publishers, 1997.

2) WHO Health Research Methodology ; A guide for training in Research Methods.

Oxford University press 1993.

3) ―International committee of Medical Journal Editors. Uniform requirements for

manuscripts submitted to biomedical journals. N.Eng. J Med; 324: 424-8‖

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3) An Epidemiologic Approach to Reproductive Health. CDC Atlanta, Georgia,

USA World Health Organization Geneva, Switawrland. Editor Phyllis. A Wingo

& others. 1994.

Submission of thesis

1. The thesis shall relate to the candidate own work on a specific research problem

or a series of clinical case studies in accordance with the approved plan.

2. The thesis shall be written in English, printed on white bond paper A4 size with

a margin of 3.5 cm. bearing the matter on one side of paper only and bound with

cloth/rexine, with the title, author‘s name and the name of the College printed on

the front cover. Plates, Pictures, Tables, Charts, Graphs, Certification,

Acknowledgements and Table of Contents must be printed on glossy art

paper and not in photo print paper, to avoid total bulk of the dissertation book.

3. The thesis shall contain: Introduction, review of literature, materials and methods,

observations, discussions, conclusion and summary and references as per

Vancouver format. All these must be serially page numbered with the pictures,

photos, tables, graphs and charts inserted then and there relevantly, so that it will

be convenient for thesis evaluator to go through all sequentially.

4. The dissertation / thesis shall be a bound volume of a minimum of 50 pages and

not exceeding 75 pages of typed matter (1.5 line spacing and on one side only)

excluding Certification, Acknowledgements, references, Plates, Pictures, Tables,

Charts, Graphs Table of Contents, Annexures, etc.

5. Each candidate shall submit to the Dean four copies of thesis, through their

respective Heads of the Departments, not later than six months prior to the date of

commencement of theory examination in the subject.

23

6. Two copies are to be submitted as an electronic version in PDF format of the

entire dissertation in a standard C.D. format by mentioning the details and

technicalities used in the C.D. format.

Evaluation of thesis

1. The thesis shall be referred by the University evaluation to the Examiners

appointed by the University. The examiners will report independently to the

Controller of Examinations and recommend whether the Dissertation is:

a) approved

b) returned for improvements as suggested or

c) rejected ( reasons for rejection should be detailed)

2. The thesis shall be deemed to have been accepted when it has been approved by a

minimum of three examiners; one internal and two external examiners, who shall

not be the examiners for theory and clinical examinations.

3. The thesis shall be deemed to have been accepted when it has been approved by at

least two examiners.

4. Where improvements have been suggested by two or more of the examiners, the

candidate shall be required to re-submit the thesis, after making the requisite

improvements for evaluation.

5. When a thesis is rejected by the examiners, it shall be returned to the candidate

who shall have to write it again. The second thesis, as and when submitted shall

be treated as a fresh thesis and processed.

6. Acceptance of thesis submitted by the candidate shall be a pre-condition for

his/her admission to the written, oral and practical/clinical part of the

examination.

24

7. There shall be no separate marks allotted to the thesis. Provided that under special

circumstances if the report from one or more examiners is not received by the

time, the Post-graduate examination is due, the candidate may be permitted

provisionally to sit for the examination but the result be kept with held till the

receipt of the report subject to the condition that if the thesis is rejected then the

candidate in addition to writing a fresh thesis, shall have to appear in the entire

examination again.

8. A candidate whose thesis stands approved by the examiners but fails in the

examination, shall not be required to submit a fresh one if he/she appears in the

examination in the same branch on a subsequent occasion.

ENCLOSED HEREWITH:

1. International Committee of Medical Journal Editors

2. Model Dissertation Book