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How to write & publish a scientific paper DR. MOHAMMED MOSTAFA EMAM INAYA MEDICAL COLLEGE (IMC) NMT 472 - LECTURES
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Mar 17, 2018

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Page 1: NMT 472 - LECTURES - · PDF fileNMT 472 - LECTURES. 2 ... Contraire of (Alternative to) RESEARCH •Authority •Tradition •Common sense •Media myths •Personal experience DR.

How to write & publisha scientific paper

DR. MOHAMMED MOSTAFA EMAM

INAYA MEDICAL COLLEGE (IMC)NMT 472 - LECTURES

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2

Course Outlines

• What is Research?

• Research Types

• Qualities for Researcher

• Research models and samples

• Theory & Research

• Qualitative & Quantitative Methods

• Research Ethics

DR. MOHAMMED MOSTAFA EMAM

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• References & Bibliography

• Literature Review

• Research Process

• Research questions & Hypothesis

• Measurement & scaling

• Reliability & validity

• Sampling Procedures

DR. MOHAMMED MOSTAFA EMAM

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• Questionnaire Design

• Research Proposal Writing

• Content Analysis

• Surveys

• Focus Group

• Experimental Methods

• Longitudinal Research

DR. MOHAMMED MOSTAFA EMAM

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• Participant Observation

• Case Studies

• Using Secondary Data

• Analysis of Qualitative data

• Analysis of Quantitative data

• Research Report Writing

DR. MOHAMMED MOSTAFA EMAM

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RESERACH

• Re ---------------- Search

• Re means (once more, afresh, anew)OR (back; with return to a previousstate)

• Search means (look thorough or go overthoroughly to look something) OR(examine to find anything concealed)

DR. MOHAMMED MOSTAFA EMAM

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Chief executive officer CEO of a company wants to launch its

company in KSA?

DR. MOHAMMED MOSTAFA EMAM

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He is in a process of Decision Making

DR. MOHAMMED MOSTAFA EMAM

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Decision making Needs…

CONVICTION

There should be

no doubts

Knowledge to justify

your decisions

Goals achievement

DR. MOHAMMED MOSTAFA EMAM

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Research?

Research is an ORGANIZED and SYSTEMATIC way of FINDING

ANSWERS to QUESTIONS.

DR. MOHAMMED MOSTAFA EMAM

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• SYSTEMATIC ..

because there is a definite set of proceduresand steps which you will follow. There arecertain things in the research process whichare always done in order to get the mostaccurate results.

DR. MOHAMMED MOSTAFA EMAM

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• ORGANIZED..

in that there is a structure or method in goingabout doing research. It is a plannedprocedure, not a spontaneous one. It isfocused and limited to a specific scope.

DR. MOHAMMED MOSTAFA EMAM

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• FINDING ANSWERS..

is the end of all research. Whether it is theanswer to a hypothesis or even a simplequestion, research is successful when wefind answers. Sometimes the answer is no,but it is still an answer.

DR. MOHAMMED MOSTAFA EMAM

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• QUESTIONS..

are central to research. If there is noquestion, then the answer is of no use.Research is focused on relevant, useful, andimportant questions. Without a question,research has no focus, drive, or purpose.

DR. MOHAMMED MOSTAFA EMAM

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Research?

Research is an ORGANIZED and SYSTEMATIC way of FINDING

ANSWERS to QUESTIONS.

DR. MOHAMMED MOSTAFA EMAM

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Defining Research

Research must be systematic and followa series of steps and a rigid standardprotocol. These rules are broadly similarbut may vary slightly between thedifferent fields of science.

DR. MOHAMMED MOSTAFA EMAM

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Defining Research

Research must has a collection of methodsand methodologies that researchers applysystematically to produce scientifically basedknowledge about the social world.

DR. MOHAMMED MOSTAFA EMAM

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Research Methodology and Methods

DR. MOHAMMED MOSTAFA EMAM

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• Methodology & Methods:»Methodology & Methods, two terms are

often treated as synonyms.

DR. MOHAMMED MOSTAFA EMAM

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• Methodology :»Methodology is broader and envelops

methods. It is understanding the social-organizational context; philosophicalassumptions, ethical principals andpolitical issues of the enterprise ofresearchers who use methods.

DR. MOHAMMED MOSTAFA EMAM

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• Methods:»Methods are set of specific techniques

for selecting cases, measuring andobserving aspects of social life,gathering and refining data, analyzingdata and reporting on results.

DR. MOHAMMED MOSTAFA EMAM

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Research is used as

Basis of knowledge

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Contraire of (Alternative to)RESEARCH

• Authority

• Tradition

• Common sense

• Media myths

• Personal experience

DR. MOHAMMED MOSTAFA EMAM

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1). Authority

• When you accept something as true justbecause someone in a position of authoritysays it is true or it is an authoritativepublication, you are using authority as basisof knowledge.

• Parents, Teachers, Books.

DR. MOHAMMED MOSTAFA EMAM

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2). Tradition

• Tradition is a special case of authority-theauthority of the past.

• It means you accept something as being truebecause “it’s the way things have alwaysbeen”.

DR. MOHAMMED MOSTAFA EMAM

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3). Common Sense

• You rely on what everyone knows and what “just makes sense”.

• It is about ordinary reasoning.

• It can originate from tradition

DR. MOHAMMED MOSTAFA EMAM

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4). Media Myths

• Media tends to perpetuate the myths of a culture.

DR. MOHAMMED MOSTAFA EMAM

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5). Personal Experience

• If something happens to you, if youpersonally experience it or see it, you acceptit as true.

DR. MOHAMMED MOSTAFA EMAM

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Types of Research

1. Quantitative Research

2. Basic Research

3. Applied Research

4. Longitudinal Research

5. Cross sectional Research

6. Qualitative Research

7. Descriptive Research

8. Classification Research

DR. MOHAMMED MOSTAFA EMAM

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Types of Research

9. Comparative Research

10. Explorative Research

11. Explanatory Research

12. Causal Research

13. Theory-testing Research

14. Theory-Building Research

15. Action Research

DR. MOHAMMED MOSTAFA EMAM

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1). Quantitative Research

• It is based on methodological principals.

• It obeys standards of strict research design.

• Statistical analysis is used in it.

DR. MOHAMMED MOSTAFA EMAM

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2). Basic Research

• Purpose of gaining knowledge

• It advanced understanding about social world

• Help in supporting & rejecting existing hypothesis & theories

DR. MOHAMMED MOSTAFA EMAM

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3). Applied Research

• Aims at solving specific problems

• Aims at establishing policy programs that will help to improve social life

• Types of applied research are action research, social impact studies, cost-benefit analysis, evaluation research

DR. MOHAMMED MOSTAFA EMAM

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4). Longitudinal Research

• It involves study of sample at more than one point in time or occasion

• e.g. Trend studies, Panel studies

DR. MOHAMMED MOSTAFA EMAM

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5). Cross sectional Research

• It involves study of many cases at one point in time or occasion.

DR. MOHAMMED MOSTAFA EMAM

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5). Qualitative Research

• It is based on methodological principals of phenomenology, symbolic interactionism, interpretational.

• It aims at exploration of social world; following elements are there….exploration, relationship discovery, establishing construct, testing hypothesis.

DR. MOHAMMED MOSTAFA EMAM

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7). Descriptive Research

• Usually it forms preliminary study of a research project.

• It aims at describe social events, relations and events.

• It provides background information about an event in question.

DR. MOHAMMED MOSTAFA EMAM

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8). Classification research

• It aims at categorization of units into groups

• To demonstrate differences

• To explain relationships

DR. MOHAMMED MOSTAFA EMAM

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9). Comparative Research

• To identify similarities and differences between units at all levels.

DR. MOHAMMED MOSTAFA EMAM

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10). Exploratory Research

• It aims at gaining information about an issue in hand.

DR. MOHAMMED MOSTAFA EMAM

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11). Explanatory Research

• It aims at explaining social relations and events.

• To build, test or revise a theory.

DR. MOHAMMED MOSTAFA EMAM

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12). Causal Research

• It aims at establishing cause and effect relationship among variables.

DR. MOHAMMED MOSTAFA EMAM

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13). Theory testing Research

• It aims at testing validity of a theory

DR. MOHAMMED MOSTAFA EMAM

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14). Theory building Research

• To establish and formulate theory

DR. MOHAMMED MOSTAFA EMAM

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15). Action Research

• It is application of fact findings to practicalproblem solving in a social situation with aview to improve quality of action within it,involving collaboration and cooperation ofresearchers, practitioners and laymen.

• It can be situational (diagnose a problem andattempts to solve it), collaborative,participatory (researcher take part inimplementation of findings) and self-evaluation (it involves constant evaluationand adjustment of research and practice)

DR. MOHAMMED MOSTAFA EMAM

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How to Write a Critical Analysishttp://www.wikihow.com/Write-a-Critical-Analysis#Writing_an_Effective_Analysis_sub

https://youtu.be/ShKr_DfFSSg

• Critical Reading

• Writing an Effective Analysis

• Organizing the Review

DR. MOHAMMED MOSTAFA EMAM 46

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I. Before start writing

II.Writing the article

III.Making the article to be published

How to write & publish a scientific paper

DR. MOHAMMED MOSTAFA EMAM 47

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I. Before start writing

II.Writing the article

III.Making the article to be published

How to write & publish a scientific paper

DR. MOHAMMED MOSTAFA EMAM 48

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Why an article is published?

It says something new: Original

It is well plotted: IMRAD structure

It was timely sent to the appropriate publication: “MARKETED”

DR. MOHAMMED MOSTAFA EMAM 49

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Why an article is published?

It says something new: Original

It is well plotted: IMRAD structure

Introduction, Methods, Results, and Discussion

In scientific writing, IMRAD refers to a commonorganization structure. IMRAD is the mostprominent norm for the structure of a scientificjournal article of the original research type.

It was timely sent to the appropriate publication: “MARKETED”

DR. MOHAMMED MOSTAFA EMAM 50

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What we need to write an article?

a) Knowledge

b) Norms of publication

c) Hardware and software

d) Matter

DR. MOHAMMED MOSTAFA EMAM 51

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a) Knowledge

b) Norms of publication

c) Hardware and software

d) Matter

DR. MOHAMMED MOSTAFA EMAM 52

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How many articles are sent to a journal?

How many are rejected?

Why are they rejected?

How many are reoriented to another journal?

DR. MOHAMMED MOSTAFA EMAM 53

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How many articles are sent to a journal?

How many are rejected?

Why are they rejected?

How many are reoriented to another journal?

DR. MOHAMMED MOSTAFA EMAM 54

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How many articles are sent to a journal?

How many are rejected?

Why are they rejected?

How many are reoriented to another journal?

DR. MOHAMMED MOSTAFA EMAM 55

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How many articles are sent to a journal?

How many are rejected?

Why are they rejected?

How many are reoriented to another journal?

DR. MOHAMMED MOSTAFA EMAM 56

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Select a group of journals of interest and read them periodically:

-Updated

-”Get the tempo”

For General Internal Medicine:

NEJM

BMJ

Arch Int Med

Med Clin

DR. MOHAMMED MOSTAFA EMAM 57

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Select a group of journals of interest and read them periodically:

-Updated

-”Get the tempo”

For General Internal Medicine:

NEJM >> ASSIGNMENT >>

BMJ WHAT ARE THE

Arch Int Med MEANING OF

Med Clin THESE ACRONYMS ?

DR. MOHAMMED MOSTAFA EMAM 58

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To know how to perform an up-to-date

Are you really discovering anything new?

State of the Art

DR. MOHAMMED MOSTAFA EMAM 59

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• Give overview of a topic; print textbooks, electronic textbooks, narrative reviews in journals

1. Harrison’s Online 2. Scientific American Medicine Online 3. MD Consult 4. Medline articles

a. Ovid b. PubMed

DR. MOHAMMED MOSTAFA EMAM 60

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• Give overview of a topic; print textbooks, electronic textbooks, narrative reviews in journals

1. Harrison’s Online 2. Scientific American Medicine Online 3. MD Consult 4. Medline articles

a. Ovid b. PubMed>> ASSIGNMENT >>

>>WHAT ARE YOU LOOKING FOR IN THESES SITES?

DR. MOHAMMED MOSTAFA EMAM 61

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DR. MOHAMMED MOSTAFA EMAM 62

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Knowledge of medical writing:

- It is concise, usually uses the passive form.

- The asseverations are based on other articles published.

- The conclusions are based on the results of the study.

- Inductive thinking.

DR. MOHAMMED MOSTAFA EMAM 63

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Knowledge of medical writing:

- It is concise, usually uses the passive form.

- Complete:

- The asseverations are based on …

- The conclusions are based on …

DR. MOHAMMED MOSTAFA EMAM 64

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a) Knowledge

b) Norms of publication

c) Hardware and software

d) Matter

DR. MOHAMMED MOSTAFA EMAM 65

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Norms of publication

Make a folder with the norms of publication of your “target journals”

Make a list of “target journals”

DR. MOHAMMED MOSTAFA EMAM 66

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a) Knowledge

b) Norms of publication

c) Hardware and software

d) Matter

DR. MOHAMMED MOSTAFA EMAM 67

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PC.

Internet.

Word processor

DR. MOHAMMED MOSTAFA EMAM 68

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a) Knowledge

b) Norms of publication

c) Hardware and software

d) Matter

DR. MOHAMMED MOSTAFA EMAM 69

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Clinical case

Series of clinical cases

Observational study

Trial

Randomized

Non randomized

Review

Meta-analysis

Opinion

Matter

DR. MOHAMMED MOSTAFA EMAM 70

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Clinical case

Series of clinical cases

Observational study

Trial

Randomized

Non randomized

Review

Meta-analysis

Opinion

Matter .. Could be

DR. MOHAMMED MOSTAFA EMAM 71

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Clinical case

Series of clinical cases

Observational study

Trial

Randomized

Non randomized

Review

Meta-analysis

Opinion

Matter .. Could be

DR. MOHAMMED MOSTAFA EMAM 72

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Clinical case

Series of clinical cases

Observational study

Trial

Randomized

Non randomized

Review

Meta-analysis

Opinion

Matter .. Could be

DR. MOHAMMED MOSTAFA EMAM 73

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Clinical case

Series of clinical cases

Observational study

Trial

Randomized

Non randomized

Review

Meta-analysis

Opinion

Matter .. Could be

DR. MOHAMMED MOSTAFA EMAM 74

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Clinical case

Series of clinical cases

Observational study

Trial

Randomized

Non randomized

Review

Meta-analysis

Opinion

Matter .. Could be

DR. MOHAMMED MOSTAFA EMAM 75

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Clinical case

Series of clinical cases

Observational study

Trial

Randomized

Non randomized

Review

Meta-analysis

Opinion

Matter .. Could be

DR. MOHAMMED MOSTAFA EMAM 76

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Clinical case

Series of clinical cases

Observational study

Trial

Randomized

Non randomized

Review

Meta-analysis;

Opinion

Matter .. Could be

DR. MOHAMMED MOSTAFA EMAM 77

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Clinical case

Series of clinical cases

Observational study

Trial

Randomized

Non randomized

Review

What is Meta-analysis?

Opinion

Matter .. Could be

DR. MOHAMMED MOSTAFA EMAM 78

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Clinical case

Series of clinical cases

Observational study

Trial

Randomized

Non randomized

Review

Meta-analysis; Technique or procedure ofillustration the results of a research by combiningthe results of a number of independent studies.

Opinion

Matter .. Could be

DR. MOHAMMED MOSTAFA EMAM 79

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Clinical case

Series of clinical cases

Observational study

Trial

Randomized

Non randomized

Review

Meta-analysis

Opinion

Matter .. Could be

DR. MOHAMMED MOSTAFA EMAM 80

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We are ready to start writing

LET START WRITING!

DR. MOHAMMED MOSTAFA EMAM 81

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We are ready to start writing

We have an interesting subject

We know this finding had not been published before

We have a state of the art vision of the matter

We have a word processor and a web link

LET START WRITING!

DR. MOHAMMED MOSTAFA EMAM 82

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We are ready to start writing

We have an interesting subject

We know this finding had not been published before

We have a state of the art vision of the matter

We have a word processor and a web link

LET START WRITING!

DR. MOHAMMED MOSTAFA EMAM 83

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We are ready to start writing

We have an interesting subject

We know this finding had not been published before

We have a state of the art vision of the matter

We have a word processor and a web link

LET START WRITING!

DR. MOHAMMED MOSTAFA EMAM 84

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We are ready to start writing

We have an interesting subject

We know this finding had not been published before

We have a state of the art vision of the matter

We have a word processor and a web link

LET START WRITING!

DR. MOHAMMED MOSTAFA EMAM 85

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I. Before start writing

II.Writing the article

III.Making the article to be published

How to write & publish a scientific paper

DR. MOHAMMED MOSTAFA EMAM 86

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I. Before start writing

II.Writing the article

III.Making the article to be published

How to write & publish a scientific paper

DR. MOHAMMED MOSTAFA EMAM 87

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The title

Once of the most important items to publish an article. It has to have “catch up”

First impressions are strong impressions; a title oughttherefore to be well studied, and to give, so far as itslimits permit, a definite and concise indications of whatis to come

T Clifford Allbutt

DR. MOHAMMED MOSTAFA EMAM 88

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Do:

Write the results of the article:

“Absence of an Effect of Liposuction on Insulin Action and Risk Factors for Coronary Heart Disease”

Write the aim of the study:

“Cardiovascular Effects of Continuous Positive Airway Pressure in Patients with Heart Failure and Obstructive Sleep Apnea”

“Influenza Vaccination and Reduction in Hospitalizations for Cardiac Disease and Stroke among the Elderly”

Ask a question:

“Exposure to Lead in Children — How Low Is Low Enough?”

DR. MOHAMMED MOSTAFA EMAM 89

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Don´t

Use very long titles:

“On the addition to the method of microscopicresearch by a new way of producin colour-contrastbetween an object and its background or between partsof the object itself”

Use metaphoric sentences

DR. MOHAMMED MOSTAFA EMAM 90

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Structure IMRAD

o Introduction

o Material and Method

o Results

o And

o Discussion

DR. MOHAMMED MOSTAFA EMAM 91

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Introduction

It has the aim of giving a brief vision of the state-of-art of the matter and justifying the study.

“The situation about the matter is A.....There is a blank of the knowledge with respect to B......so...we did C”

All the asseverations will have to be supported by bibliographical references

DR. MOHAMMED MOSTAFA EMAM 92

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Rheumatoid arthritis is a systemic autoimmune disease that affects approximately 1 percent of the

adult population.1 It is characterized by chronic inflammation in the synovial membrane of affected

joints that ultimately leads to loss of daily function due to chronic pain and fatigue. The majority of

patients also have deterioration of cartilage and bone in the affected joints, which may eventually lead

to permanent disability. Rheumatoid arthritis is associated with increased morbidity and mortality.2

Although the precise pathogenesis of rheumatoid arthritis remains unclear, it has been postulated that

multiple exogenous or endogenous antigenic triggers, or both, act in the presence of a background

genetic predisposition to initiate a self-perpetuating series of autoimmune responses in the synovial

compartment.3,4 Many cell populations, including monocytes, macrophages, B cells, T cells, endothelial

cells, and fibroblasts, participate in the ongoing inflammatory process.3 The precise contribution of B

cells to the immunopathogenesis of rheumatoid arthritis is not fully understood, although a number of

mechanisms have been proposed.4,5,6 However, strong evidence for a critical role of B cells in

rheumatoid arthritis came from a small open-label study of rituximab in combination with

cyclophosphamide and corticosteroids.7

Rituximab is a genetically engineered chimeric anti-CD20 monoclonal antibody that is approved for the

treatment of relapsed or refractory, low-grade or follicular, CD20+ B-cell non-Hodgkin's lymphoma.

CD20 is a B-cell surface antigen that is expressed only on pre-B and mature B cells. It is not present on

stem cells and is lost before differentiation of B cells into plasma cells. Therefore, rituximab causes a

selective transient depletion of the CD20+ B-cell subpopulation.7 To confirm the role of B cells in

rheumatoid arthritis, we evaluated the effect of rituximab in patients with active rheumatoid arthritis

in a multicenter, randomized, double-blind, controlled study.

DR. MOHAMMED MOSTAFA EMAM 93

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Rheumatoid arthritis is a systemic autoimmune disease that affects

approximately 1 percent of the adult population.1 It is characterized by

chronic inflammation in the synovial membrane of affected joints that

ultimately leads to loss of daily function due to chronic pain and fatigue.

The majority of patients also have deterioration of cartilage and bone in

the affected joints, which may eventually lead to permanent disability.

Rheumatoid arthritis is associated with increased morbidity and

mortality.2

Says what is known about the disease

Highlights the importance of a fact

DR. MOHAMMED MOSTAFA EMAM 94

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Always backed by bibliographical references

DR. MOHAMMED MOSTAFA EMAM 95

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Although the precise pathogenesis of rheumatoid arthritis remains unclear,

it has been postulated that multiple exogenous or endogenous antigenic

triggers, or both, act in the presence of a background genetic predisposition

to initiate a self-perpetuating series of autoimmune responses in the synovial

compartment.3,4 Many cell populations, including monocytes, macrophages,

B cells, T cells, endothelial cells, and fibroblasts, participate in the ongoing

inflammatory process.3 The precise contribution of B cells to the

immunopathogenesis of rheumatoid arthritis is not fully understood,

although a number of mechanisms have been proposed.4,5,6 However, strong

evidence for a critical role of B cells in rheumatoid arthritis came from a

small open-label study of rituximab in combination with cyclophosphamide

and corticosteroids.7

Blank in the knowledge

Transition to the “so...”DR. MOHAMMED MOSTAFA EMAM 96

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Rituximab is a genetically engineered chimeric anti-CD20 monoclonal

antibody that is approved for the treatment of relapsed or refractory,

low-grade or follicular, CD20+ B-cell non-Hodgkin's lymphoma.

CD20 is a B-cell surface antigen that is expressed only on pre-B and

mature B cells. It is not present on stem cells and is lost before

differentiation of B cells into plasma cells. Therefore, rituximab causes

a selective transient depletion of the CD20+ B-cell subpopulation.7 To

confirm the role of B cells in rheumatoid arthritis, we evaluated the

effect of rituximab in patients with active rheumatoid arthritis in a

multicenter, randomized, double-blind, controlled study

So...What we did?

DR. MOHAMMED MOSTAFA EMAM 97

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Material and MethodHow we did it?

A short paragraph

Must include:

-What subjects we included,

-Definitions

-What parameters were assessed,

-What instrumentation was used to assess

-Was there a statistical study? What kind?

DR. MOHAMMED MOSTAFA EMAM 98

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“We studied the patients with the characteristicsA and excluded those with the item B. Wemeasured C, D and F. We defined F as C+D. Tomake the measurements we used the device ABC.To study if there were statistical differencebetween the patients, we did the test X...”

DR. MOHAMMED MOSTAFA EMAM 99

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Patients

Patients were recruited from 26 rheumatology centers in 11 countries (Australia,

Canada, Israel, and 8 European countries). Eligible patients were at least 21 years

of age, fulfilled the revised 1987 American Rheumatism Association criteria,1 and

had active disease despite treatment with at least 10 mg of methotrexate per week.

Active disease was defined by the presence of at least eight swollen and eight

tender joints and at least two of the following: a serum C-reactive protein level of

at least 15 mg per liter, an erythrocyte sedimentation rate of at least 28 mm per

hour, or morning stiffness lasting longer than 45 minutes. In addition, eligible

patients were seropositive for rheumatoid factor, as defined by a plasma

rheumatoid factor level of at least 20 IU per milliliter.

Patients were excluded if they had an autoimmune disease other than rheumatoid

arthritis (except concurrent Sjögren's syndrome), American Rheumatism

Association functional class IV disease,).

Inclusion criteriaDefinitions

Exclusion criteria

DR. MOHAMMED MOSTAFA EMAM 100

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Study Protocol

Therapy with Patients were randomly assigned to receive one of fourtreatments: oral methotrexate at a dose of 10 mg or more per weekplus placebos for rituximab and cyclophosphamide (control group),rituximab plus placebos for methotrexate and cyclophosphamide,rituximab plus cyclophosphamide in an intravenous infusion of 750 mg ondays 3 and 17 plus placebo for methotrexate, and rituximab plusmethotrexate at a dose of 10 mg or more a week plus placebo forcyclophosphamide. In all three groups that received rituximab(MabThera, Roche; Rituxan, Genentech and IDEC Pharmaceuticals),rituximab was administered as a 1000-mg intravenous infusion on days1 and 15. Investigators and patients remained blinded to the assignedstudy medications.

Clinical assessments were performed at baseline (day 1) and at weeks12, 16, 20, and 24 according to the American College of

What was done?

DR. MOHAMMED MOSTAFA EMAM 101

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Rheumatology (ACR) core set of disease-activity measures. These consisted of a count of swollen joints (66 joints evaluated),... andlaboratory evaluation of acute-phase reactants (serum C-reactiveprotein level and erythrocyte sedimentation rate).

Laboratory assessments (including complete blood counts and serum biochemical analyses) were performed at screening (three weeks before baseline), on days 1, 3, 15, and 17, and at weeks 4, 8, 12, 16, 20, and 24. ...

What instrument was used?

Definitions

DR. MOHAMMED MOSTAFA EMAM 102

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Clinical Outcome Measures

The primary end point of the study was the proportion of patients with an ACR 50 response at week 24. ...and the value for one acute-phase reactant (either serum C-reactive protein level or erythrocyte sedimentation rate).9

Secondary outcomes included ACR 20 and ACR 70 responses (20 percent and 70 percent improvement, respectively, according to the ACR criteria), ... 10 and the response according to the criteria of the European League againstRheumatism (EULAR response).11

What do we study-measure?

DR. MOHAMMED MOSTAFA EMAM 103

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Statistical Analysis

Sample-size calculations were based on the assumption..... On the basis of these assumptions and with the use of Fisher's exact test with a two-sidedsignificance level of 0.05, we calculated that a sample of 40 patients per treatment group would provide the study with 82 percent power to detect a difference between the two proportions.

What tools we use to detect differences?

How the assessed parameters were statistically treated

DR. MOHAMMED MOSTAFA EMAM 104

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Results

Short and concise paragraph

Answers the questions on the section Material and Method

We might write it in the same order than it was in the section Material and Method.

Never try to explain the results or take any conclusion

DR. MOHAMMED MOSTAFA EMAM 105

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“N patients were studed. A were included. B were excluded for having 1, demographical features being D, E and F. With respect to the parameter A the result was 1, with respect to B, the result was 2. With respect to C, the result was D....”

DR. MOHAMMED MOSTAFA EMAM 106

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Of the 4164 hospital admissions sampled from theparticipating hospitals, 3745 patient charts (89.9%) wereeligible for a full screening by the stage 1 reviewers (Fig. 1).Of these, 1527 (40.8%) were assessed as positive for 1 ormore screening criteria (Table 1)...

Included & excluded

DR. MOHAMMED MOSTAFA EMAM 107

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...the physician reviewers identified a total of 1133 injuries or complications in 858 charts. In 401 (46.7%) of these charts the injuries resulted in death, disability at the time of discharge or prolonged hospital stay. In 255 of the charts one or more of the AEs were rated 4 or higher on the 6-pointcausation scale (Box 1).

Enumerates results

DR. MOHAMMED MOSTAFA EMAM 108

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Statistical analysis (if necessary)

There was a trend for AEs to occur more frequently in the teaching hospitals than in the large community or small hospitals (Table 2). The trend was significant for AEs across the 3 hospital types (p < 0.001) but not for preventable AEs (p= 0.8)...

DR. MOHAMMED MOSTAFA EMAM 109

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Discusion

Highlights the importance of the subject. It may start with a short review.

Gives an explanation of the results

Compares the results with those of other studies

Result-comparation-explanation

Signs limitations of the study

A review of the state of the art can be done

DR. MOHAMMED MOSTAFA EMAM 110

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“Is an extended version of the introduction, followed by a summary of the results, comparison with those of other studies, and what our results mean.”

“Starts where the introduction ended”

“It is the place for new hypotesis”

DR. MOHAMMED MOSTAFA EMAM 111

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“ A is a very important parameter to determine B, as other studies have shown. Ours showed that A had the characteristics 1, 2 and 3, which is similar to

other studies carried out to this respect. Nevertheless, It had the characteristic 4, which was

different. We think that it may be due to...”

DR. MOHAMMED MOSTAFA EMAM 112

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Incident rates of endometrial cancer vary more than 10-fold worldwide.18

In addition to host susceptibility, dietary factors may play an important role...

In our study population, the average intake of isoflavones from soya food was about 25 times that reported in a Western population....11 Some of these previous studies were not specifically designed to investigate the role of soya food...The sample sizes of the previous studies were relatively small, which limited the statistical power ...This population based case-control study... indicates that usual consumption of soya foods by adults, ... is associated with a significantly reduced risk of endometrial cancer....

Although not all associations were statistically significant in subgroup analyses, the different measurements produced similar results.

...Studies with measured oestrogen concentrations are needed to better understand the joint effect of soya and endogenous oestrogen on endometrial cancer risk.

DR. MOHAMMED MOSTAFA EMAM 113

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Incident rates of endometrial cancer vary more than 10-fold worldwide.18 In addition to

host susceptibility, dietary factors may play an important role...

In our study population, the average intake of isoflavones from soya food was about 25

times that reported in a Western population....11 Some of these previous studies were not

specifically designed to investigate the role of soya food...The sample sizes of the

previous studies were relatively small, which limited the statistical power ...This

population based case-control study... indicates that usual consumption of soya foods by

adults, ... is associated with a significantly reduced risk of endometrial cancer....

Although not all associations were statistically significant in subgroup analyses, the

different measurements produced similar results.

...Studies with measured oestrogen concentrations are needed to better understand the

joint effect of soya and endogenous oestrogen on endometrial cancer risk.

ReviewResults of our study

Comparison with respect to other studies

Limitations of the study

Conclusion/Hypotesis

DR. MOHAMMED MOSTAFA EMAM 114

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Introduction

Clinical case

Conclusions

AND IF IT IS A CLINICAL CASE?

DR. MOHAMMED MOSTAFA EMAM 115

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Introduction: Usually based on rarity.

Clinical case:

“A N yr-old wo/man was admitted for a featureof....his/her clinical history was....in the physicalexamination…the laboratory findings showed…theradiological techniques were…To exclude a…the A testwas asked, with the result 1. With the suspect of a B,test B, was asked….Thus, we diagnosed the pathology P”

DR. MOHAMMED MOSTAFA EMAM 116

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A 28-year-old man was admitted to the hospital because of abdominal pain and fever.

The patient had been well until 10 days earlier, when mild epigastric pain developed.

Two days before admission...

On physical examination, the patient did not appear to be in severe pain, and there

was...

The urine was positive (+) for ketones; the sediment contained....

...Radiographs of the abdomen obtained both while the patient was supine and while he

was upright showed ..... A cystic mass, 1.5 cm in diameter, was contiguous with the

head and neck of the pancreas. The remainder of the pancreas was unremarkable

Oral intake was stopped. The patient was given fluid and electrolytes as well as

ranitidine, metronidazole, ampicillin, minidose heparin, and morphine, which was

administered...

DR. MOHAMMED MOSTAFA EMAM 117

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I. Before start writing

II.Writing the article

III.Making the article to be published

How to write & publish a scientific paper

DR. MOHAMMED MOSTAFA EMAM 118

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I. Before start writing

II.Writing the article

III.Making the article to be published

How to write & publish a scientific paper

DR. MOHAMMED MOSTAFA EMAM 119

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The article has been written

And now....?

Cover page

Be sure it has the conditions required by the journal (length, structure....)

Submit it to the editor

Undergo the review process

DR. MOHAMMED MOSTAFA EMAM 120

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Writing the first page

It is a cover with

the name of the article,

the names of the authors

and the institution,

in the lower left corner, coreespondence to...

DR. MOHAMMED MOSTAFA EMAM 121

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Be sure it has the conditions required by the journal (length, structure....)

Submit it to the editor

Undergo the review process

DR. MOHAMMED MOSTAFA EMAM 122

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Get the folder “target journals”

Be sure that:

This subject is at least occasionally treated in this publication.

Select the section were it fits better (Original papers, clinicalcase, letters to editor…).

Verify that the article has the structure required for thisformat.

Verify (once again) with the tool of “counting words” that thewhole do not exceed the maximum number of characters.

Verify that once again that the article “has to do” with his title.

DR. MOHAMMED MOSTAFA EMAM 123

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The document is ready

Let´s send it:

By conventional mail:

Use first class paper

First class mail

Presentation letter

Original and 3 copies

CD or DVD.

Copy of photographs

DR. MOHAMMED MOSTAFA EMAM 124

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By e-mail:

-Letter of presentation

-Attached file with text

-Attached file with photographs

DR. MOHAMMED MOSTAFA EMAM 125

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Presentation letter:

Dear Dr….(Journal’s Reviewer),

“Enclosed are two complete copies of a manuscript by….and…. Titled “…….” which is going to be submitted forpossible publication in the “…” section of the “(name of thejournal)”

This manuscript is new, is not being considered elsewhereand reports new findings that extends results we reportedearlier in “(name of the Journal)”. An abstract of thismanuscript was presented earlier ( write Congress)

Sincerely yours

Author A Author B Author C Author D

DR. MOHAMMED MOSTAFA EMAM 126

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Delays:

a) To the notification of receiving the article:

a) 1-7 days

b) To the rejection letter:

a) 2-3 weeks

c) To the acceptation letter:

a) 3-8 weeks

d) To the publication

a) Up to 2 years

DR. MOHAMMED MOSTAFA EMAM 127

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The reviewing process

DR. MOHAMMED MOSTAFA EMAM 128

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The reviewer CHECK POINTS Yes No

1. Does the paper fall within the scope of a general interest quality assurance

journal?

2. Is this a new and original contribution?3. Is the title suitable and well worded?

4. Is the abstract clearly written and free of abbreviations?5. Are the keywords concise and appropriate to the material?

6. Are the methods sound and adequately described?7. Are the concepts appropriately defined and used?

8. Is the statistical treatment adequate?

9. Are the points of interpretation clearly separated from the results?

10. Are the conclusions and interpretations sound and justified by the data?

11. Are the figures adequate?12. Are the tables adequate?

13. Is the article unnecessarily long?

14. Are all the references necessary?

15. Is the English acceptable?

16. Is the paper addressed to an international audience?

DR. MOHAMMED MOSTAFA EMAM 129

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In the event the manuscript is revised, would you like to serve as reviewer?

Yes

No

OVERALL RECOMMENDATION

1 Accept

2 Minor Revision - reassessment not required

3 Major Revision - reassessment required

4 Reject - Fair, but contributing little

5 Reject - Not acceptable

DR. MOHAMMED MOSTAFA EMAM 130

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REVIEWER GUARANTEE: - IMPORTANT: PLEASE COMPLETE THIS SECTION

I, guarantee that, to the best of my knowledge, I have no conflictof interest in reviewing this paper that might influence thecomments I have provided on these pages.

Yes

No

PRIORITY OF PUBLICATION

Merits rapid publication

No urgency

Low priorityDR. MOHAMMED MOSTAFA EMAM 131

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Are all acceptations equal?

DR. MOHAMMED MOSTAFA EMAM 132

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Kinds of acceptation: The “negotiation”

a) Unconditional acceptation:

“Dear Dr....We have read the article titled...and we have considered it acceptable for publication....In 4 weeks you will be sent the printing proofs for correction”

b) Conditioned acceptation.

“We have read the article and have found the following points that have to be set…”

1…..

2…..

3….

Consider it published.

Make the corrections suggested

DR. MOHAMMED MOSTAFA EMAM 133

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Conditioned acceptation (cont)

After the corrections, verify that the article has the allowed length and send a letter:

DR. MOHAMMED MOSTAFA EMAM 134

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Auther’s Reply:

“Dear editor. Thank you for your kind suggestions with respect to the article…with reference number….Following your instructions, the next points were restructured:

1. Write the point 1 of the letter 1 and write what you did:

“1. As it was suggested, the epidemiology of Salmonella was updated, the new result being…..”

2. Do the same with all the points.

Thank you again for these suggestions that have contributed to improve the quality of the article.Sincerely yours…”

DR. MOHAMMED MOSTAFA EMAM 135

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Modified acceptation:

The article is accepted but to be published in anothersection.

“We have read your article and we considered itacceptable for publication. Nevertheless, we considerit has an excessive length. We advice you torestructure it to fit in the section…(usually is ashorter section Original papers---Clinical Cases----Letters to Editor)”

DR. MOHAMMED MOSTAFA EMAM 136

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Rejection

a) Absolute rejection:

“We have read with interest your article…since we have to ponder many papers, yours has not been selected for publication…”

b) Relative rejection:

“We think your article is not appropriate to be published in our journal since it has the defects A, B and C…”

DR. MOHAMMED MOSTAFA EMAM 137

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What to do with a “relative rejection’’?

Option A. Make the corrections the editor pointed toreject the article and resend the article as if it were a“relative rejection”. 80% new rejections.

Option B. Don´t desperate. Get advantage of thecommentaries and send to another publication (thereviewers are sometimes the same and they will like tosee the corrections they suggested done)

DR. MOHAMMED MOSTAFA EMAM 138

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Resending the article

Most articles are not published for a lack of persistance

Think that once the article has been written making itto be published is only a question of time.

Look for another publication, make changes (ifneccesary) to fit the requirements and send it again

Before sending the article for the first time, it has tobe set that it will have to travel through a “spiral ofimpact factor” before being published

DR. MOHAMMED MOSTAFA EMAM 139

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After an average of 3-4 tries, your article will be accepted for a publication

DR. MOHAMMED MOSTAFA EMAM 140

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The printing proofs

Once the article has been accepted, a preliminar version is sent to the author

Don´t modify or add contents

Don´t make modifications on grammar

It is only done to correct ortography

Sent them back as soon as possible, since they are ussually sent just before being published

Preferable to be sent by Fax

DR. MOHAMMED MOSTAFA EMAM 141

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Letters about the article

In the fisrt two months after the publication of the article.

Possitive or negative commentaries on the study

The author of the study has the right to answer the questions of the letter, but the authors are rarely allowed to reply.

A letter of the editorial together with the letter commenting the article is sent two months before the publication

DR. MOHAMMED MOSTAFA EMAM 142

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How to write a study protocol

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Study protocolWhat is it?

• Describes every step of a study

• Answer relevant questions

- public health problem important?

- study question relevant to problem?

- objectives consistent with study question?

- study design achieves objectives?

- sufficient power?

- public health impact of the findings?

DR. MOHAMMED MOSTAFA EMAM 144

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• The research protocol is considered as an essential guide; May be called the “operation manual for the study”.

DR. MOHAMMED MOSTAFA EMAM 145

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A well-thought out and well-written protocol can be judged according to three main criteria:-

• Is it adequate to answer the researchquestion(s), and achieve the study objective?

• Is it feasible in the particular set-up for thestudy?

• Does it provide enough detail that can allowanother investigator to do the study and arriveat comparable conclusions?

DR. MOHAMMED MOSTAFA EMAM 146

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Study protocol:

Why do it?

• Check

- can objectives be achieved?

- is study feasible?

• Ensure collect crucial information

• Lay down rules for all partners (quality)

• Obtain approval of ethical committee(s)

• Apply for funds

DR. MOHAMMED MOSTAFA EMAM 147

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Study protocolHow to start ?

• Get

– good examples

– ideas from similar published studies

– ideas from colleagues

• Use a checklist of items to include

• Obtain requested format (grant application)

DR. MOHAMMED MOSTAFA EMAM 148

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Protocol outline

1. Presentation (cover page)

2. Background and justification

3. Objectives

4. Methods

5. Ethical considerations

6. Project management

7. Timetable

8. Resources

9. References

10. Appendices

DR. MOHAMMED MOSTAFA EMAM 149

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1. Presentation(cover page)

• Title

– short, accurate, concise

• Investigators

• Main centres

• Steering committee

• Summary of the protocol

DR. MOHAMMED MOSTAFA EMAM 150

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2. Background and justification

• Statement of problem, study justification

importance of subject area

• magnitude, frequency

gaps in existing knowledge

principal question(s) to be addressed

contribution of results to existing knowledge

public health use of results

• Review relevant literature

DR. MOHAMMED MOSTAFA EMAM 151

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3. Objectives

• Should answer the study question

• S.M.A.R.T.

Principal objective

• Must be achieved

• Dictates design and methods

Secondary objectives

• Of interest, but not essential

DR. MOHAMMED MOSTAFA EMAM 152

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How to write SMART objectives

• An objective is a clear statement of something that needs to be accomplished over a period of time. SMART objectives are:

DR. MOHAMMED MOSTAFA EMAM 153

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How to write SMART objectives

• An objective is a clear statement of something that needs to be accomplished over a period of time. SMART objectives are:

• Specific – states exactly what you need to achieve

• Measurable – includes a quality or quantity measure

• Agreed – between you and your Reviewer

• Realistic – can be challenging but must be achievable

• Timebound – with a clear end date or timescale

DR. MOHAMMED MOSTAFA EMAM 154

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Here are some tips for ensuring that your objectives are SMART:

• SPECIFIC

• Objectives should clearly state what you are expected to achieve, using action verbs to describe

• what has to be done. For example:

• Not specific: Encourage more people to join the Sports Centre

• Specific: Increase membership of the Sports Centre

• Not specific: Conduct research

• Specific: Formulate plans for research on topic X

DR. MOHAMMED MOSTAFA EMAM 155

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Here are some tips for ensuring that your objectives are SMART:

• MEASURABLE• Objectives should include a quality and/or quantity

reference so that you can measure whether or not you have achieved them.

• For example:• Not measurable: Increase membership of the Sports

Centre• Measurable: Increase membership of the Sports Centre

by 10%• Not measurable: Formulate plans for research on topic X• Measurable: Formulate plans for research on topic X and

submit grant application to X Research Council

DR. MOHAMMED MOSTAFA EMAM 156

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Here are some tips for ensuring that your objectives are SMART:

• AGREED

• Objectives should be agreed between you andyour Reviewer, relevant to your job and driven byUniversity strategy and chool/Institute/Sectionplans.

Your Reviewer will help ensure that your objectivesare relevant and appropriate.

DR. MOHAMMED MOSTAFA EMAM 157

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Here are some tips for ensuring that your objectives are SMART:

• REALISTIC

• Objectives should be challenging but achievable i.e.they should not be unrealistic. For example, it might berealistic to plan to lose 10 pounds in weight but itwould be unrealistic to plan to lose 10 pounds in oneweek.

• Objectives should also take account of the skills,knowledge and resources needed to achieve them.

You may need to consider whether you need any trainingor development (or other support) in order to achievethe objective.

DR. MOHAMMED MOSTAFA EMAM 158

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Here are some tips for ensuring that your objectives are SMART:

• TIMEBOUND

• Objectives should include a time reference, such as a specific deadline. For example:

• Not timebound: Increase membership of the Sports Centre by 10%

• Timebound: Increase membership of the Sports Centre by 10% over the next six months

• Not Timebound: Formulate plans for research on topic X and submit grant application to X Research Council

• Timebound: Formulate plans for research on topic X and submit grant application to X Research Council by 1 June 2009.

• The time reference for other objectives might be in terms of frequency or turnaround time.

• For example:

• Timebound: Once a month, update all library web pages and printed guides

• Timebound: Circulate minutes of Committee Y within five days of the meeting.

• If there is a particularly long timescale involved, you may need to break your objective down, identify the steps you need to take to achieve your overall objective and work out how long each step is likely to take so that you can agree a target date.

DR. MOHAMMED MOSTAFA EMAM 159

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3. Objectives

• Should answer the study question

• S.M.A.R.T.

Principal objective

• Must be achieved

• Dictates design and methods

Secondary objectives

• Of interest, but not essential

DR. MOHAMMED MOSTAFA EMAM 160

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Principal objective

• To determine if sharing a haemodialysis machine with an HCV infected patient is a risk factor for HCV infection.

Secondary objective:

• To identify failures in procedures designed to prevent cross-infection via haemodialysis machines

3. Objectivesexample 1

DR. MOHAMMED MOSTAFA EMAM 161

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Hypotheses

• Translation of the objectives in terms that allow statistical testing.

“The incidence of HCV infection in haemodialysispatients is higher in patients sharing machineswith HCV infected patients than in patients notsharing machines with HCV infected patients”

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3. Objectivesexample 2

• To estimate the current mortality, among theInternally Displaced Population present inthe settlements at the time of the survey,in each of the three states of Greater Darfurregion.

DR. MOHAMMED MOSTAFA EMAM 163

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Hypotheses

• Translation of the objectives in terms that allow statistical testing.

The current crude mortality rate in IDPs in Darfur is above 1 death per 10,000 per day

CMR > 1/10,000/day

DR. MOHAMMED MOSTAFA EMAM 164

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Protocol outline

1. Presentation

2. Background and justifications

3. Objectives

4. Methods

5. Ethical considerations

6. Project management

7. Timetable

8. Resources

9. References

10. AppendicesDR. MOHAMMED MOSTAFA EMAM 165

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4. Methods

• Procedures to achieve objectives

– what will be done?

– how?

• Information used to judge validity

DR. MOHAMMED MOSTAFA EMAM 166

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4. Methods

• Study design cohort, case-control, cross-sectional…

brief justification

• Study population

definition

criteria for inclusion and exclusion

mechanisms of recruitment

accessibility, follow up, representativeness

DR. MOHAMMED MOSTAFA EMAM 167

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4. Methods

• Sampling design frame: district, household, persons,…

method: random, cluster, stratified,…

randomisation procedures

replacement procedures (in case of refusal)

• Sample size

sample size, power calculations based on principal objective feasibility

DR. MOHAMMED MOSTAFA EMAM 168

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4. Methods

• Selection and definition

exposures:

risk factors, protective factors, confounding factors

outcomes:

definition of case and the control group

• Items to be measured– scales used

• e.g: smoking ? lung cancer

- smoking: definition, quantification, categories- lung cancer: case definition, control group definition

DR. MOHAMMED MOSTAFA EMAM 169

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MethodsData analysis plan

• Structured in terms of objectives

• Hypotheses tested, dummy tables

• Statistical tests used, adjustment, standardisation

DR. MOHAMMED MOSTAFA EMAM 170

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MethodsData analysis plan

• Define

– indicators you will need to reach objectives

– data you will need to collect

• Better estimates of sample size for analysis of sub groups

DR. MOHAMMED MOSTAFA EMAM 171

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MethodsData analysis

Dummy table: Food specific attack rates of Salmonella infection

in a day care centre, Paris, May 1999

ill

n

total

n

AR

%

RR 95%CI

ice-cream yes

ice-cream no

fruit cake yes

fruit cake no

pudding yes

pudding no

DR. MOHAMMED MOSTAFA EMAM 172

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MethodsData analysis

Case-control study, risk factors for brucellosis in France

Cases Controls OR

Exposed Unexp Exposed Unexp

Age group < 15 15 – 25 26 - 60 > 60

Sex M F

Occupation

Travel

Cheese

DR. MOHAMMED MOSTAFA EMAM 173

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4. MethodsData collection

• How interview, observation, record review

• By whom interviewers: selection, training

level of supervision

• Tools questionnaires, recording materials

questionnaires: self or interviewer administered, face to face or telephone interview

• Procedures for taking samples

DR. MOHAMMED MOSTAFA EMAM 174

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4. MethodsData handling

• Coding

during data collection, afterwards?

by whom?

• Processing

software, hardware

entry

• during the study, afterwards?

• single entry, double entry?

• Validation and data cleaning

DR. MOHAMMED MOSTAFA EMAM 175

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4. MethodsPilot studies, pre-testing

• No study without test

Feasibility of sampling

Data collection, measurement methods

Questionnaire

• Describe how to test

DR. MOHAMMED MOSTAFA EMAM 176

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4. MethodsLimitations

• Identification of potential sources of biases

selection bias

information bias

• How to deal with them

possibilities for correcting

how they will affect the results

DR. MOHAMMED MOSTAFA EMAM 177

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Protocol outline

1. Presentation

2. Background and justifications

3. Objectives

4. Methods

5. Ethical considerations

6. Project management

7. Timetable

8. Resources

9. References

10. Appendices

DR. MOHAMMED MOSTAFA EMAM 178

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5. Ethical considerations

• Informed consent

• Confidentiality, record anonymity

• Data storage and protection

• Ethical committee

DR. MOHAMMED MOSTAFA EMAM 179

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6. Project management

• Participating institutes and persons

• Responsibilities and tasks of each partner

• Data ownership

DR. MOHAMMED MOSTAFA EMAM 180

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7. Timetable

Planning/organisation of the study• questionnaire design, recruitment, purchases

• permission

• obtain funding

“Pilot study”

Final study• data collection• analysis• presentation of results and write up

DR. MOHAMMED MOSTAFA EMAM 181

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8. Resources

• Extent of this section depends on target audience

• Specify

available sources

requested sources

• Keep budget

reasonable

detailed

well justified

DR. MOHAMMED MOSTAFA EMAM 182

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9. References

• Limit number of references to key articles

• Follow recommended style

Many sites provide sources to ease the process of finding references;

University of Southampton Library

http://www.southampton.ac.uk/library/

DR. MOHAMMED MOSTAFA EMAM 183

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10. Appendices

• Methodological appendices

• List of definitions

• Questionnaires

• Introductory letters to study participants

• Forms for informed consent

…..

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Common problems

• Too ambitious: too many questions

• Insufficient attention to literature

• Poor justification

why is it important to answer this question?

what impact does it have on public health?

• Poorly formulated objectives

• Inappropriate analysis

• Inadequate description

• Absence of pilot

DR. MOHAMMED MOSTAFA EMAM 185

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Study protocoland now….

A PRACTICAL GUID FORHEALTH RESEARCHS

Open Discussion

DR. MOHAMMED MOSTAFA EMAM 186

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A PRACTICAL GUID FORHEALTH RESEARCHS

Open Discussion

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Health System Research: Designs and Methods

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Development of HSR

– In 1967, Division of Research inEpidemiology and Communication Science(RECS) was established for research works,under WHO.

– In 1972, RECS was restructured into Divisionof Strengthening Health Services (SHS) andHealth Services Research responsibilitiestransferred to SHS.

DR. MOHAMMED MOSTAFA EMAM 189

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Development cont…

– In 1978, Global Advisory Committee onMedical Research and Sub-committee onHealth Services Research were formed-

• to achieve “Health for All by the year2000” and

• Implement the “Primary Health Care”approach successfully.

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• In 1980, as per the recommendation ofHealth Services Research Sub-committee,WHO had recognized Health Service Researchas a priority area and established HealthSystem Research.

Development cont…

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• In 1980, Health System Research wasconsidered as an organization with followingmandates-

– Promotion, coordination and informationexchange in the practice of HSR,

– Strengthening of national capabilities for HSRtraining and development

– Support to substantive research in priority areas.

Development cont…

DR. MOHAMMED MOSTAFA EMAM 192

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• In 1990, Technical Discussions of Forty-ThirdWorld Health Assembly finalized thefollowing four major themes/issues in healthresearch-

–Health systems research,

–Nutrition research,

–Research capability strengthening, and

– Science, research and health care.

Development cont…

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• In 2000, Health Policy and Systems Research wasofficially launched with the following objectives :

– Stimulate the generation and synthesis ofknowledge, encompassing evidence, tools andmethods

– Facilitate the development of capacity for thegeneration, dissemination and use of knowledgeamong researchers, policy makers and otherstakeholders

– Promote the dissemination and use of knowledgeto improve the performance of health systems.

Development cont…

DR. MOHAMMED MOSTAFA EMAM 194

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• First time in 2002, under the umbrella ofHealth System Research there was initiated anew sub area Public Health System Researchby the public health system research interestgroup (PHSR-IG).

Development cont…

DR. MOHAMMED MOSTAFA EMAM 195

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Supply and demand barriers to utilization of health care

DR. MOHAMMED MOSTAFA EMAM 196

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Health System Research: Designs and Methods

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Outlines

• Introduction• Development • Objective • Areas• Designs, methods & techniques• Ethical issues• Limitations • Conflict of interest• Conclusion

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Data Collection Techniques

• Using available information,

• Observing,

• Interviewing,

• Administering written questionnaire,

• Focus group discussion,

• Projective technique,

• Mapping scaling, and

• others

DR. MOHAMMED MOSTAFA EMAM 199

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Using available information

• Routinely collected data,

• Secondary data: HMIS, NDHS, Census etc

• Unpublished record report,

• Publications

• Grey literature( rarely available published documents),

• Newspapers,

• Case histories, etcDR. MOHAMMED MOSTAFA EMAM 200

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Observing

• Observation of human behaviours,

• Observation of objects

• Types of observation-

– Participatory vs non-participatory

– Open vs conceal

• Observation tool: checklist

– Structural

– Semi-structural

DR. MOHAMMED MOSTAFA EMAM 201

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Interviewing

• High degree of flexibility: In-depth interview

• Semi-structural interview

• Low degree of flexibility: structural interview

• Exit interview, supplementary interview, etc

• Interview tools

– Guideline

– Structured schedule

DR. MOHAMMED MOSTAFA EMAM 202

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Administering

• Ways of administering-

– Sending by mail/email and receiving by same ways,

– Hand-to-hand delivering and later collection,

– Gathering respondent and requesting to response and return immediately.

DR. MOHAMMED MOSTAFA EMAM 203

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Projective technique (PT)

• Ask the participant to response the hypothetical or incomplete question.

• E.g.– Suppose your child suffered from ARI, what

would you do?

– If your wife was to propose that you use condoms, you would ...

• PT can be combined with other methods: FGD, questionnaire, interview etc

DR. MOHAMMED MOSTAFA EMAM 204

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Mapping and Scaling

• Mapping is a valuable technique for visually displaying relationships and resources.

– Process mapping

– Service mapping

• Scaling is a technique that allows researchers through their respondents to categorise certain Variables.

DR. MOHAMMED MOSTAFA EMAM 205

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Systematic/extensive review

• Online available literature review

• Published documents review

• Grey literature review

• Unpublished document/desk review

• Review focused on analytical question, etc

DR. MOHAMMED MOSTAFA EMAM 206

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Case studies

• Examine to a great extent in order to find out and correct possible errors.

• Common used case studies techniques

– Use systemic rapid assessment toolkit

– Use conceptual framework

– Use unstructured questionnaire

– Participatory observation, etc.

DR. MOHAMMED MOSTAFA EMAM 207

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System Review• systems review is a technique, used to elicit the situation

(Past and present) of an organization. • Common techniques of SR-

– Structural review– Narrative analysis of selective documents– Time and motion analysis– Cost analysis– Trend analysis– Demand and supply analysis– Gaps and surplus analysis– Disease burden analysis– Lot Quality Assurance Sampling(LQAS)

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Program Evaluation

• Common techniques –– Content analysis: textual analysis

• both qualitative and quantitative studies

• Analysis: objective, scopes, outputs/outcome

– Cost analysis1. Cost-utility 2. Cost-benefit

3. Cost- effectiveness 4. Cost –minimization

– Budget analysis• Sources of revenue

• Areas of expenditure

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Program Evaluation cont…

– Financing analysis• Government financing in health

• Corporate financing

• Private financing in health

• Per-capita health expenditure

• Catastrophic healthcare/expenditure

• Role of user fees, etc

Health expenditure= government financing + private expenditure

DR. MOHAMMED MOSTAFA EMAM 210

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Demand and supply analysis

Supply side intervention Demand side intervention

Institutional Innovation

Financial incentives

Skill development

Improved infrastructure

Providers

Health

ServicesConsumers

/users

Empowerment

Awareness

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Social Network Analysis (SNA)• It is defined as a distinctive set of methods used for

mapping, measuring and analysing the social relationships between people, groups and organizations.

• It consists of 3 stages:

– describing the set of actors and members of the network;

– characterizing the relationships between actors; and

– analysing the structure of the systems and generating information…

DR. MOHAMMED MOSTAFA EMAM 212

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Meta-Analysis

• A systematic method of evaluating statistical data based on results of several independent studies of the same problem.

• Produces a stronger conclusion than can be provided by any individual study.

• Useful for quantitative as well as qualitative studies

DR. MOHAMMED MOSTAFA EMAM 213

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Ethical issues in HSR

• Ethical approval and informed consent,

• Respect of participants,

• Autonomy of individual participants,

• Benefits and risks,

• Dissemination and publication of results,

• Unique human nature and implementation of protocol

• Conflict of interest, …

DR. MOHAMMED MOSTAFA EMAM 214

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Limitations of HSR• Difficult in randomization and equal participation of

subject, • High turnover: retirement, transfer, change, etc • Difficult to match with relevance policy and

community’s expectation, • Cost and benefits: control and distribution• Implementation of results with scare resources• Donor interest and influence• Access/permission , publication and dissemination

of results

DR. MOHAMMED MOSTAFA EMAM 215

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Conflict of Interest in HSR

• Among research team/s and members.

• Financial issues and quality of research.

• Disseminating and publishing of the results.

• Maintaining the distance and relationship with participants.

• Conflict with government’s regulations, policies, programs, interests…

DR. MOHAMMED MOSTAFA EMAM 216

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Conclusion• HSR is a new discipline of research/ health

research.

• Health services research, health policy and system research and public health system research are very close terms with health system research.

• Health system research is being influenced by global politics and investments rather than its own philosophy.

DR. MOHAMMED MOSTAFA EMAM 217

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At last…

• First Global Symposium on Health SystemsResearch (HSR), was organized inMontreux, Switzerland, 16–19 November2010

• Second Global Symposium was organizedfrom 31st Oct. to 3rd Nov. 2012, Beijing,People's Republic of China.

DR. MOHAMMED MOSTAFA EMAM 218

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CONCLUD

Orientation on Research

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Meaning of Research

• The word research was originated from ‘Research’

which means to travel through or survey.

• RE+SEARCH= Search after search and search

• Careful search or inquiry into any subject matter.

• To investigate thoroughly

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• Research is the process of finding solution to a

problem after a through study and analysis of the

situational factors.

• Research as a movement, a movement from

unknown to known.

– It is a systematic effort to gain of knowledge.

DR. MOHAMMED MOSTAFA EMAM 221

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Research is systematic collection, analysis and

interpretation of data to answer a certain question or

solve a problem.

Research need to conducted in a

systematic fashion,

Logical,

Orderly process.

DR. MOHAMMED MOSTAFA EMAM 222

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PURPOSES OF RESEARCH

• Generation new knowledge

• Improve understanding

• Application testing

• Comparing best practices

• Helping with decision making

Exploration

Description

Explanation

Generalization/prediction

Theory building

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CHARACTERISTICS OF

RESEARCH

• Demands a clear statement of the problem,

• Requires a scientific plan,

• Purposiveness,

• Relevance, testability, effectiveness,

• Ethnical,

• Collection and interpretation of data.

DR. MOHAMMED MOSTAFA EMAM 224

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OBJECTIVES OF RESEARCH

• To gain familiarity with a phenomenon or to gainnew insights into it.

• To describe the characteristics of a particular cause,situation or environment.

• To determine the relationship between two or morevariables.

• To test hypothesis.

• To solve the problems.

• It provides answers for questions like what, where,when, how and why.

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TYPES OF RESEARCHOn the basis of

Application of research study

• Basic research

• Applied research

Objectives in understanding the research

• Observational research

• Experimental research

Method of study

• Quantitative research

• Qualitative research

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RESEARCH PROCESS

Research is a team workDR. MOHAMMED MOSTAFA EMAM 227

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RESEARCH PROCESS

• Identification of the research problem

• Review of literature

• Formulation of the objectives of the study

• Protocol preparation

• Conducting the study

• Analysis of the data

• Preparation of report

DR. MOHAMMED MOSTAFA EMAM 228

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CRITERIA FOR SELECTING A RESEARCH

PROJECT

Interest

Relevance

Avoidance of duplication

Feasibility

Political acceptability

Applicability

Cost-effectiveness

Ethical considerations

DR. MOHAMMED MOSTAFA EMAM 229

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FORMULATING STUDY PROBLEM

Formulating a study problem is thefirst and most important steps in thestudy process.

A study problem identifiesresearcher’s destination and decidewhat he want to find out.

DR. MOHAMMED MOSTAFA EMAM 230

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CRITERIA FOR DEVELOPING A GOOD

RESEARCH QUESTION

Feasibility

Interesting

Novel

Ethical

Relevant

231

FINER

DR. MOHAMMED MOSTAFA EMAM

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ABSTRACT

The abstract should be written in about 200 words, it contentsbrief synopsis of activities to be carried out in the study. Ithelps to understand the frame of study activities for the reader.

DR. MOHAMMED MOSTAFA EMAM 232

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BACKGROUND

The background may provide general ideaabout formulating problem and linked betweenpresent situation and past experiences.

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OBJECTIVE

Objectives of Research should be

S=Specific

M=Measurable

A=Achievable

R=Reasonable

T=Timeliness

DR. MOHAMMED MOSTAFA EMAM 234

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Literature Review

A literature review is a written summary of articles,

books and other documents that describe the past

and current state ok knowledge about topic.

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FORMULATING THE

HYPOTHESES

Hypotheses is always developed in response to the

purpose statement or to answer the research

question.

DR. MOHAMMED MOSTAFA EMAM 236

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METHODOLOGY

• Study design,

• Study area and population,

• Sampling and Sample selection,

• Study variables,

• Data collection,

• Data analysis.

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SAMPLING AND SAMPLE

SELECTION

There are different process of sampling methods;

• Probability sampling

• Non-probability sampling

DR. MOHAMMED MOSTAFA EMAM 238

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STUDY VARIABLES

• Dependent variables

• Independent Variable

Variables may take numerical (quantitative) or non-

numerical (qualitative) values.

Quantitative Variables

Qualitative Variables

DR. MOHAMMED MOSTAFA EMAM 239

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INSTRUMENTS

• Questionnaires

• Checklist

• Guidelines

• Lab equipment

• Medicines

DR. MOHAMMED MOSTAFA EMAM 240

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DATA COLLECTION

Process contains four interdependent elements;

• Defining a research methods,

• Defining and constituting the sample,

• Choosing and preparing data collection tools,

• Evaluating the tools-pre test.

DR. MOHAMMED MOSTAFA EMAM 241

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DATA ANALYSIS

• Entered into a database

• Editing and coding

• Computer software used; dBase IV, SPSS, Epi,Epinfo, STATA, Excel,

• Frequencies and cross-tabulations

• Selection of analytical techniques

DR. MOHAMMED MOSTAFA EMAM 242

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INTERPRETATION OF FINDINGS AND

REPORT WRITING

CONTAINS OF REPORT

• Research title• Acknowledgement• Abbreviations• List of table• List of figures• Introduction (background, statement of problem and its justification or rationale)• Objectives• Methodology• Results• Discussion• Recommendations• References• Annexes

DR. MOHAMMED MOSTAFA EMAM 243