The first step towards acquiring a post graduate thesis is the writing of a Thesis protocol and the presentation of the same to the research/thesis committee for a critical appraisal. The protocol needs to be corrected according to the suggestions given by the committee. Finally, it needs to be approved by the University. The thesis protocol is then considered an official document and the thesis work needs to conform to the same.
Components of thesis protocol
A. Title Page
Title of thesis
Title should be informative and relevant. It should preferably one sentence/phrase typed in sentence case. Abbreviations should not be used
What are the types of titles?
1. Indicative
2. Informative
3. Question type
4. Main or subtitle type
Title page of Thesis protocol contains the following:
Firstly, Name of the University
Secondly, Degree (with discipline) for which the thesis is being submitted
Thirdly, Years of the batch under the name of candidate
Also, Name and Signature of Candidate
Finally Name and Signature(s) of Supervisor and Co-supervisor(s)
Acknowledgements
One should put a page of thanks to those who have helped them in scientific matters and also indirectly by providing such essentials as food, education, genes, money, help, advice, friendship, etc.
Moreover, If any of your work is collaborative, you should make it quite clear who did which sections.
The thesis protocol should be arranged as:
1. Introduction
2. Review of literature
3. Aims and Objectives
4. Material & Methods
5. Statistical Analysis
6. Ethical Consideration
7. Consent
8. Information to patients
9. References
10. Annexures
11. Proforma
Introduction/Background
(1-2 pages)
Describe the problem under the consideration (disease or condition) briefly.
Discuss about What is known? & what are gaps?
Summaries briefly the review of literature
Write about research question and its significance
How would answering the research question amend the current knowledge of state?
Conclude introduction section by stating how proposal plans to answer the questions that should be focused, achievable, relevant, and measurable, clear and precise and also justify need for the study (no studies to date have reported outcomes, we examined or evaluation of the results of program was necessary to develop future programs).
The Introduction should answer the questions:
· What am I studying?
· Why is it an important question?
· What do I know about it before I do this study?
· How will this study help us advance the knowledge?
The structure of introduction section may be thought of as triangle which is inverted (up-side down) –
the broadest part which is on the top representing most general information & focusing down to specific problem one will study. Moreover, Organize the information so as to present more general aspects of the title early in introduction, then the narrow toward more specific current information that provides the context,
finally arriving at the statement of rationale and purpose.Also, Be sure to state clearly the purpose and/or hypothesis that one will investigate.
Finally, It is most customary to place the purpose of statement or hypothesis near the end of introduction, often as topic sentence of final paragraph.
Research Question
1. Most preferably in question format and not the statement
2. Focused, precise, and clear
3. S.M.A.R.T.- Specific, Measurable, Achievable, Relevant, Time format
Review of Literature (ROL)
(3-5 pages)
What is the present knowledge about subject of the study? How the difficulty has been approached by the others and what are the observations? Does the reported studies conflicting? What are the unfilled spaces in the existing knowledge?
1. Summarize the information about the level of problem under the consideration (disease or condition)
2. Discuss the related pathology or pathophysiology (do not include the textbook material–very understandable facts)
3. Review the available studies on the subject or intervention related to the research question. It is nice to provide the summary table of relevant studies where ever necessary
4. Write the summary of review- What is already known about the subject?
5. Identify relevant gaps in knowledge
6. This should ease writing a paragraph on “basis for the study” that should be concluding section of review of literature.
Aims and Objectives:
Aims refer to what is to be achieved by present study or how the present study would address bigger question or issue
Objectives refer to what would you actually do in the present study.
· Primary objective refers to the main research question (the primary outcome) and is the base for sample size.
· Secondary objective refers to the additional questions that are typically for ‘generation of the hypotheses’.
Material and Methods section
When (….. to …..) and where the study would be carried out.
Type of study- Prospective/Retrospective
Descriptive or analytical; If analytical, whether observational (cohort, case-control or cross-sectional) or interventional (RCT, cross-over)
Targeted population (Define the subjects of the study)
How would be the subjects chosen; age group, sex– Why being specific?
Any control group (If yes then define)
Sample size: basis of the number of cases
Place where the subjects would be recruited from
The inclusion criteria-Define ages, the criteria for defining the disease condition or normalcyThe exclusion criteria-Subjects who other-wise were eligible for inclusion but are excluded because of the possibility of introducing biasness
Method of Randomization- How the Randomization is done? How the allocation cover up or/and blinding is performed?
Procedure or Intervention
· Detail if using the new method or quote the standard reference if anyone else has described the method already that you are going to use in your study.
· Be certain to describe any alterations made of the standard or the published method.
· Quantitative aspects: masses, incubation times, volumes, concentrations, the machine specifications (include the manufacturer’s name & address)
· Duration and frequency of intervention
· Procedures and the schedules of examination or investigations or treatment, and the observation of the outcome measures
Dosage, schedules, formulations, duration of the drug treatments, if any
Outcome measures (like the union of fracture, birth weight, hemoglobin, etc.)
Follow up of the study participant, if applicable.
If there are multiple measurements, it is great to provide the table with the measurements. Aldo, add the time and tools used for the assessment and procedure for recording or controlling the confounding variable, if any should be mentioned. Standardization of the method and the reference to methodology must be given wherever required.
Statistical analysis:
One should mention the procedure for data entry, statistical methods or software for the statistical analysis, methods for handing the missing data etc.
Level of significance or the level of confidence should also be defined. “A p-value less than 0.05 were considered statistically significant”, since the choice of this cutoff point is arbitrary.
Ethical consideration and the informed consent:
When reporting the experiments on the human subjects, it should be shown whether procedures followed were in agreement with ethical standards on the human experimentation (as per guidelines decided by Central Ethical Committee of the ICMR).
Reference:
Use Vancouver styling and include the reference that the candidate has accessed and read. Number of references should be limited to 15-20.
Annexures: questionnaires/measurement tools etc.
Patient information sheet & consent form: Both in local and English languages
CERTIFICATE
I certify that facilities for working on the thesis entitled “xxxxxx” do exist in the department, hospital, laboratory under my/our charge and these shall be provided to candidate for his/her research work in pursuance of his/her plan of thesis. I/We shall guide the candidate in his/her work and shall ensure that the data being included in the thesis are genuine and that the work is being done by the candidate himself.
(Signature of Supervisor) (Signature of Co-supervisor)
Name and Designation Name and Designation
(Signature of Co-supervisor) Name and Designation