Overview of Protocol and Thesis Writing

Why research?
Advancement of medical science Understanding of published research Requirement for post-graduation

Two essential ingredients of research

Curiosity

Training

Steps in conduct of research

Identify the area of research

Broad area depends on the specialty of postgraduation Specific research question based on
Interest of supervisor/ student Facilities/ funds available Patient profile (in case of clinical research) Duration of research

FINER criteria for good research question

F Feasible Adequate number of subjects Adequate technical expertise Affordable in time and money Manageable in scope

I N

Interesting To the investigator, peers and community Novel Confirms, refutes or extends previous findings

E
R

Ethical
Relevant

Should be ethically acceptable

To scientific knowledge To clinical and health policy To future research

Finding the current knowledge Literature review

Primary literature
Research papers
Original data Peer reviewed

Case studies
Normally peer reviewed

Conference proceedings
Sometimes reviewed, sometimes not Often preliminary data

Secondary literature
Review articles
Information about primary sources Compilation or synthesis of ideas and data Should be reasonably objective (although often arent) Usually peer reviewed

Tertiary literature
Textbooks Present science theory rather than contributing to it

Look for the missing links

How to write a literature review

Styles of writing review of literature
Chronological Conceptual Methodological
Introduce the topic Give important and relevant background information Review the methods used in earlier studies Review the results and conclusions of those studies

Example
Title: Cancer chemoprevention by Grape Seed and Cranberry extract
Basic principles of carcinogenesis Cancer epidemiology Migration studies Fruit consumption and cancer risk Chemoprevention Dietary components (fat, fiber, micronutrients) Mechanisms of chemoprevention Examples Methods for preparing/ standardizing extracts Rationale for testing in animal model

Review of literature is NOT annotated bibliography

Framing the research question, hypothesis, aim and objectives

PICO method
Framing the research question
Eg. 1
2 3

Problem/ patient In patients with bed sores

In patients after lumbar puncture In a rural hospital

Intervention Does hydrocolloid dressing

Does 6 hour bed rest Does ambulatory care unit

Comparator Compared to gauze dressing

Compared to 24 hour bed rest Compared to no unit

Outcome Give greater patient comfort?

Increase headache? Reduce the patient load?

Framing the hypothesis 1. Hydrocolloid dressing gives greater comfort to the patient when compared to gauze dressing 2. Six hour bed rest after lumbar puncture does not increase the risk of headache 3. ?

Aim and objectives

Term Aim Definition General research question Example To compare antibiotics X & Y for surgical wound prophylaxis

Primary objective

Specific statements 1. Compare in inguinal hernia repair Sample size calculated 2. Compare in inguinal versus neck on this objective surgery
1. Compare cost of treatment 2. Compare the adverse effects of X & Y

Secondary Additional information objective to be generated

Methods

 When (x date to y date) Where ( Department and Institution) Type of study

Prospective/ Retrospective Descriptive/ Analytical Observational/ Interventional

Population (subjects of the study)

Inclusion & exclusion criteria

Control/ comparison group Randomization, how? Details of intervention/ methods Outcome measures Analysis/ statistical methods

Introduction

Structure of Introduction
Most general information at the top
Specific information at the bottom Lacuna in the current status of knowledge How you will approach the problem

Complementary feeding is recommended to be started at 6 months along with continued breastfeeding

Malnutrition sets in usually at 6-12 months in many children. Poor intake from complementary foods is the usual reason for malnutrition

Breast milk and complementary foods given together interfere with each others intake. Energy density, frequency and consistency believed to be important determinants of this relation
Studies have established optimal energy density and frequency of complimentary feed. No recommendation about the consistency

Lead the reader from the known to the unknown

Deciding the title of the study

 Brief and informative (12-15 word) Important words towards the beginning May include research hypothesis, study population, research design Do not include place and period of study Use PICO + Study design format

Example
Design Patient Intervention Control Outcome healing of

A fissure in randomized ano double blind crossover trial

local placebo application of controlled nitroglycerine

Title: A randomized placebo controlled double blind crossover trial of local application of nitroglycerine in healing of fissure in ano

References

 Why are references necessary?

Gives credibility Avoids plagiarism

Vancouver style is preferred Ensure all citations in main text have a corresponding reference Reference only those articles which you have read Prefer current articles Include indigenous research papers Reference vs Bibliography Referencing software: Endnote, Refworks

Results

Aim of Results section

Presents
Main data collected
Analyses and interprets results

Guides the reader through the questions investigated Sets the stage for discussion in the next section

Analyzing and interpreting results

Determine the relevant data
Results relevant to the research questions

Important
Present all relevant data, whether they support the hypothesis or not Outcome of every item mentioned in the material and methods should be presented (and vice versa)

Analysis includes descriptive statistics and results of statistical tests Do not present raw data Do not discuss the data

Handling Tables and Figures

Decide the best way of presenting analyzed data Text, table, figure or graph Do not duplicate the same data, presenting it in a different way Each table or figure must be referenced in text, which must highlight key results contained in these

Writing The Results Section

Introduce the result section mentioning
The objective and rationale of the research Broad reference to the methodology

Sequence of tables and figures is usually

In the order of methodology

Should be written in past tense

When To Present Data In A Table?

Precise numerical data rather than proportion or trends Large numbers of related data Complex information that would be clearer in a table than in text form or graph

When To Present Data In Graphs

Show trends and patterns in data (not otherwise) Reveal relations between variables Make a visual impact Used for extensive or complicated data

Compare

Graph preferred over table

Economic activity rate Czech Republic, 2008 Age (years) 15-19 20-24 25-29 30-34 35-39 40-44 45-49 50-54 55-59 60-64 65-69 70+ Women 6.3 44.4 66.4 66.0 80.0 91.0 92.5 87.7 55.7 15.1 6.5 2.5 Men 8.4 60.8 90.9 96.8 97.6 96.5 94.6 91.7 84.8 40.7 13.3 5.9

Source: UNECE Statistical Database

A good and a bad chart

My busy chart
30 Series1

My clearer chart
30 25

25 20

20 15
15

10 10

10 10

0 A B C

0 A B C

Discussion

 Objectives of discussion
Explain your findings Compare with other similar research Discuss important differences Identify limitation of the study Direction for future studies

Follow the same sequence as results Each paragraph

Begins with result Ends with explanation/ recommendation Has comparison with other studies in the middle

Example
Result: Thirteen out of 60 (21%) premature babies developed retinopathy of prematurity (ROP) Discussion:
Beginning Middle End

At 21%, the incidence of ROP in this study was lower than that described in the literature.

Other studies from India Thus, every nursery could have reported incidences conduct audits, and as high as 37-41%.2,3,6,9 establish their own These studies, conducted screening criteria for in well established NICUs, early diagnosis of ROP. include babies that are smaller and younger than those seen in our nursery.

Conclusion

 Move from specific (your research) to general Summarize

What was learned based on the aim and objectives What remains to be learned Limitations of what was done Benefits, advantages, applications of the research, and recommendations

Example
Thesis title: Masters theses from a University Medical College: publication in indexed scientific journals
Specific Publication rates of theses related research conducted in a University medical college, and factors promoting publication, were studied. Only thirty percent of theses were published in indexed, peer reviewed journals. None of the factors that we studied had a significant role in encouraging publication. Less specific This study was performed in the local setting of one medical college in India. General Thus, the findings might be useful when considering interventions in PG training.

Though each institution is Perhaps institutional unique, the malaise is global. endorsement, and reward for published work may help.

Annexures

Consent form Patient information sheet Data entry sheet Master chart

Summary of the talk

Steps in conduct of research

Steps Identify the area of research Find the current knowledge in that area Identify the lacunae in the current knowledge Frame the research question/ Title Decide the methodology Write the introduction Write the references Compile the results Discuss the results Summarize the research How Self interest, guided, FINER method Review the literature Identify the missing links PICO method Feasibility General to specific Vancouver style Text, tables, figures Compare, discuss Specific to general

Annexures

Consent, Patient information sheet, data entry form, master chart

Thank You!
Questions are welcome