Scientific Writing

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Scientific writing State Institute of Health & Family Welfare, Jaipur SIHFW: an ISO 9001:2008 certified Institution 1

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Good writing is difficult to define. It is easier to say what it is not than what it is. 2 SIHFW: an ISO 9001:2008 certified Institution

Writers fail to see their mistakes, for::

Writers fail to see their mistakes, for: Complacent attitude Writing courses are considered to be for kids 3 SIHFW: an ISO 9001:2008 certified Institution

Doctors are called upon to communicate in different situations:

Doctors are called upon to communicate in different situations Reports Article Proposals Web page Lecture Meetings Conferences Specific Audiences Non-technical Audiences General Audiences 4 SIHFW: an ISO 9001:2008 certified Institution

Basic Elements of Effective Writing:

Basic Elements of Effective Writing Know your purpose Know your audience Choose and organize content around your purpose and audience Write precisely and clearly Design your pages well Think visually Write ethically 5 SIHFW: an ISO 9001:2008 certified Institution

The Three Phases of the Writing Process:

The Three Phases of the Writing Process The Writing Process Problem Solving Planning Composing Revising Orientation Organization Execution Verification 6 SIHFW: an ISO 9001:2008 certified Institution

Writing Stages:

Writing Stages Getting in the Mood Writing the First Draft Revising, Revising, Revising Finishing 7 SIHFW: an ISO 9001:2008 certified Institution

Why write /publish research papers?:

Why write /publish research papers? Ideally – To share research findings / discoveries with the hope of improving healthcare. Practically – To get promoted To get funding To get a job To keep your job! 8 SIHFW: an ISO 9001:2008 certified Institution

Things to consider before writing:

Things to consider before writing Time to write the paper? Has a significant advancement been made? Is the hypothesis straightforward? Did the experiments test the Hypothesis? Are the controls appropriate & sufficient? Can describe the study in 1- 2 minutes? Can the key message be written in 1- 2 sentences? 9 SIHFW: an ISO 9001:2008 certified Institution

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Tables and figures Must be clear and concise Should be self-explanatory Read references Will help in choosing journal Better insight into possible reviewers 10 SIHFW: an ISO 9001:2008 certified Institution

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Choose journal Study “instructions to authors” Think about possible reviewers Quality of journal “impact factor” Tentative title and summary Choose authors (Participation simply in data collection?) 11 SIHFW: an ISO 9001:2008 certified Institution

Start by Analyze Your Constraints:

Start by Analyze Your Constraints Audience Who they are What they know Why they will read How they will read Occa sion Format Formality Politics and ethics Process and deadline Purpose To inform To persuade But first know your constraints 12 SIHFW: an ISO 9001:2008 certified Institution

Why am I writing: Know Your Purpose :

Why am I writing: Know Your Purpose Proposals? Interim reports for further funding? Reporting results for final signoff? Justification to management? 13 SIHFW: an ISO 9001:2008 certified Institution

Organize the content around the Purpose and the Audience:

Organize the content around the Purpose and the Audience General overviews to specific details Specific details to general concepts Describing events chronologically 14 SIHFW: an ISO 9001:2008 certified Institution

Write Precisely and Clearly:

Write Precisely and Clearly Use short paragraphs with a single idea Short direct sentences Active voice and action verbs that are clear on what is said and what is being done. Opinions and viewpoints should be clearly identified Don’t use Doublespeak. Say precisely what you mean. 15 SIHFW: an ISO 9001:2008 certified Institution

I see no reason to write ‘metropolis’ when they pay me the same to write ‘city’.(Mark Twain):

I see no reason to write ‘metropolis’ when they pay me the same to write ‘city’.(Mark Twain) The primary aim of scientific writing is to inform - not to impress or entertain Be concise Use simple short sentences Use simple short words/ one word instead of two or three spelling, punctuation and grammar abbreviation or acronym 16 SIHFW: an ISO 9001:2008 certified Institution

Design your pages well:

Design your pages well Use Judicious headings to organize the structure Break long sections into subsections to keep the readers interest Use appropriate fonts Use white space to guide the reader to the important areas 17 SIHFW: an ISO 9001:2008 certified Institution

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Font – Arial / Times New Roman Size of font – 11/12 Spacing – 1.5 lines – 2 lines (double spaced) 25-30 lines/page 400-450 words/page Use good quality paper Margins – Left 1.5” ; Right 1”Top 1”,Bottom 1” Continuous pagination Single digit number to be spelled, rest as numeric 18 SIHFW: an ISO 9001:2008 certified Institution

Think Visually:

Think Visually Pictures Sketches and drawings Tables Simple flow graphs Use color where appropriate Keep visuals simple, don’t make them cluttered 19 SIHFW: an ISO 9001:2008 certified Institution

Write Ethically:

Write Ethically Present facts accurately Report unfavorable results along with the favorable Present the limitations of the design Give full credit to others (references) Engineering is not marketing… 20 SIHFW: an ISO 9001:2008 certified Institution

Remember:

Remember Writing process has three phases Writing has different purposes and goals Writing has different formats Writing has different audiences Writing should be done often 21 SIHFW: an ISO 9001:2008 certified Institution

Three aspects of writing that affect assessment by readers :

Three aspects of writing that affect assessment by readers Content Style - the way you communicate Structure Illustration Language Form Format Typography Layout Mechanics Grammar Punctuation Spelling 21 SIHFW: an ISO 9001:2008 certified Institution

Content:

Content Be A ccurate Be B rief Be C lear 22 SIHFW: an ISO 9001:2008 certified Institution

Style:

Style A very complicated way of saying very simple things…Or a very simple way of saying very complicated things First person Active voice 24 SIHFW: an ISO 9001:2008 certified Institution

Formatting:

Formatting Formats vary considerably to serve different situations Formal Reports Journal Articles Not all rules of format are constant Typography, layout, font, sequencing 25 SIHFW: an ISO 9001:2008 certified Institution

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When you divide a section into subsections, all the pieces should be of the same pie Causes of Maternal mortality Sepsis Hemorrhage Obstructed labor 26 SIHFW: an ISO 9001:2008 certified Institution

Avoid large blocks of capital letters:

Avoid large blocks of capital letters WORDS SET IN ALL CAPS USE MORE SPACE THAN TEXT SET IN LOWERCASE. Words set in all caps use more space than words set in lowercase. TYPE IS TO READ Type is to read 27 SIHFW: an ISO 9001:2008 certified Institution

While writing, attend to::

While writing, attend to: Punctuation Hyphenation ( role-playing technique, two-way analysis , high-anxiety group, clear-cut case) Italics and Bold- italics for emphasis and bold for strong emphasis. Avoid italic bold , Fonts and Symbol Abbreviations and Acronyms( define it in parentheses the first time you use Headings-Paragraph Styles, and Lists Numbers and Statistics 28 SIHFW: an ISO 9001:2008 certified Institution

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Tables Figures Use of Words Grammar Flow of Ideas Style for Cited Publications References & source 29 SIHFW: an ISO 9001:2008 certified Institution

Beginnings prepare readers for understanding the work:

Beginnings prepare readers for understanding the work Title Orients reader to document to your area of work Separates your work from everyone else's work Summary tells readers what happens in document Introduction prepares readers for the middle 30 SIHFW: an ISO 9001:2008 certified Institution

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Organize the paper/clarify your ideas Maintain fidelity to the original argument matrix Maintain fidelity to the single, Overriding Communication Objective (SOCO) Maintain the flow of the story A B C… Cover all the essential points Leave out the nonessential points That is a great idea for a second paper!” Develop an outline 31 SIHFW: an ISO 9001:2008 certified Institution

Getting published: know the answers to:

Getting published: know the answers to Why ( I did the study-Introduction ) When (Methods) Where (Methods) Who (Methods) What (I found-results) How (use/outcome?) And that people often put as……. IMRaD 32 SIHFW: an ISO 9001:2008 certified Institution

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Title page Abstract Introduction Methods/ Ethical clearance Results Tables/Figures Discussion References Acknowledgements IMRaD Outline 33 SIHFW: an ISO 9001:2008 certified Institution

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I ntroduction Why did you start? M ethods What did you do? R esults What did you find? D iscussion What does it all mean? Bradford Hill’s questions for the IMRD structure 34 SIHFW: an ISO 9001:2008 certified Institution

Parts of a manuscript & order of writing:

Parts of a manuscript & order of writing Title Abstract Introduction Methods Results Discussion Acknowledgements References 35 SIHFW: an ISO 9001:2008 certified Institution

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Methods References Ghost Tables/Figures (analytic plan) Tables/Figures Results Introduction (brief literature review) Discussion Abstract Title page Acknowledgements Writing Order 36 SIHFW: an ISO 9001:2008 certified Institution

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Introduction What we know What we don’t know. What we did to find out Methods Participant selection Variables & procedures for each objective Analytic methods Results Subject recruitment & characteristics Evidence for first objective Evidence for specific objectives Discussion Main finding Implications/how does it change scenario Limitations Summary/conclusion Sections of a Paper/Report 37 SIHFW: an ISO 9001:2008 certified Institution

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Product of the analysis Five tables and figures Key points and recommendations Abstract Outline of the argument Slide set Poster The manuscript will wrap this around few ideas (2 or 3) that will be developed Starting points for a manuscript 38 SIHFW: an ISO 9001:2008 certified Institution

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Issues relating to the structure Misplaced elements Results in the “discussion” Interpretations in the “results” Issues relating to ideas Non-sequential ideas Missing links in the development of an idea Common road blocks in manuscript preparation 39 SIHFW: an ISO 9001:2008 certified Institution

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The title is not a section, but it is necessary and important. The title should be short and unambiguous, yet be an adequate description of the work. Use descriptive words that you would associate strongly with the content of your paper: the molecule studied, the organism used or studied, the treatment, the location of a field site, the response measured, etc. Title 40 SIHFW: an ISO 9001:2008 certified Institution

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A general rule-of-thumb is that the title should contain the key words describing the work presented. Title is the basis for most on-line computer searches - if your title is insufficient, few people will find or read your paper/report. Title is NOT underlined or italicized . 41 SIHFW: an ISO 9001:2008 certified Institution

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Draw the attention of a prospective reader to the paper Induce the reader to read the entire paper or at least the abstract Purposes of the title 42 SIHFW: an ISO 9001:2008 certified Institution

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Write simple, concise, but informative Aim at being interesting and eye-catching Be accurate and specific about content State subject in full Specify study design, animal species Ensure grammatical correctness State results? Title: Things to do 43 SIHFW: an ISO 9001:2008 certified Institution

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Use abbreviations (unless well accepted) Use literary titles Use interrogative/exclamatory titles Use all capitals Title: Things to avoid 44 SIHFW: an ISO 9001:2008 certified Institution

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Pediatric intussusception : A report of 55 cases Studies on cobalt estimation in liver disease Comparative study of two new hypoglycemic drugs Examples of titles: What do you think? 45 SIHFW: an ISO 9001:2008 certified Institution

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Provide a framework that: Respects the structure of the various sections Develops few ideas (2 or 3) logically & sequentially Use that framework to prepare the outline of the manuscript “Argument matrix” 46 SIHFW: an ISO 9001:2008 certified Institution

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Identifying data needs Spelling out the research question Formulating the study objectives Planning the analysis Preparing data collection instruments Analysing data Drawing conclusions Formulating recommendations Involving the programme Collecting data Intro (P1, P2) Intro (P3) Methods Results Discussion The sections of the paper summarize the life cycle of the investig ation 47 SIHFW: an ISO 9001:2008 certified Institution

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Introduction :What was known before, the local context Methods :The methods used to generate the finding Results: The facts and figures Discussion :Integration of all elements making the case Conclusion :The point made Recommendation :What the point calls in terms of action Linear construction to follow one idea throughout the manuscript 48 SIHFW: an ISO 9001:2008 certified Institution

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Introduction Boosters are important for long term diphtheria protection Methods Case control study to estimate booster efficacy Coverage survey methods Example of linear construction to follow one of the ideas throughout the manuscript 49 SIHFW: an ISO 9001:2008 certified Institution

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Results Booster protective efficacy Booster coverage data Discussion Attribution of high rates to low booster coverage Conclusion Boosters are key for protection yet are underused Recommendation Supplemental activities to increase booster coverage 50 SIHFW: an ISO 9001:2008 certified Institution

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Ideas Intro Methods Results Discussion Limitations Conclus Recs Idea #1 Idea #2 Idea #3 1. Direction used to construct the ideas developed (Follow this in the preparation to remain logical) Argument matrix template 51 SIHFW: an ISO 9001:2008 certified Institution

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Ideas Intro Methods Results Discussion Limitations Conc Recs Idea #1 Idea #2 Idea #3 2. Direction that the paper will follow (That is what the reader will see) Argument matrix template 52 SIHFW: an ISO 9001:2008 certified Institution

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Primary preparation Before a manuscript is started Secondary preparation To re-organize a draft Uses of an argument matrix 53 SIHFW: an ISO 9001:2008 certified Institution

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Primary preparation Organize ideas before drafting the manuscript Identify ideas Lay out the points according to the sections of the manuscript Uses of an argument matrix 54 SIHFW: an ISO 9001:2008 certified Institution

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Secondary preparation Re-organize the ideas Identify the main ideas Prepare a blank matrix Read the manuscript with a highlighter to identify the elements that belong to the main ideas Within each idea, identify the elements that belong to the various sections Distribute the elements in the blank matrix Identify the holes in the matrix 55 SIHFW: an ISO 9001:2008 certified Institution

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What? A succinct, accurate summary of the paper Why? Request to present at a conference Summarize information of a paper Is the only part of the paper that many people read Helps readers browse & decide whether to read the rest of the paper Abstracts 56 SIHFW: an ISO 9001:2008 certified Institution

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Objective Gain acceptance to present at a conference Circumstances Written before the completion of final report May be based upon preliminary analysis Remains in the proceedings May be quoted The abstract prepared for a conference 57 SIHFW: an ISO 9001:2008 certified Institution

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Objective Summarize the key elements of a manuscript Circumstances Finalize after the completion of the manuscript Based upon final analysis Included in several abstracting services (including PubMed) May be the only thing that will be read of your work The abstract prepared for a manuscript 58 SIHFW: an ISO 9001:2008 certified Institution

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Constitutes a summary of the source report Follows the same order of source report Does not refer to source report Includes only information from source report Fully understood on its own Basic rules of an abstract 59 SIHFW: an ISO 9001:2008 certified Institution

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Chose topic Review data / report Review rules of conference or journal Extract ideas and data from report Organize extracted material within outline Write and revise Steps in preparing an abstract 60 SIHFW: an ISO 9001:2008 certified Institution

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Investigation completed Analysis completed Data tables ready Key graphs drawn Main conclusion & recommendations clear Results discussed with team: Locally (Administrative clearance) Supervisors (Academic clearance) Checklist to choose a topic for an abstract to be submitted to a conference 61 SIHFW: an ISO 9001:2008 certified Institution

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Investigation already presented Investigation already published Incomplete analysis Uncertainty on key interpretation No agreement to make the results public Things to avoid when choosing a topic to present at a conference 62 SIHFW: an ISO 9001:2008 certified Institution

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If written report is available: Review report If written report not complete: Review protocol Analyze data Arrange in text, tables, graphs & charts Identify key pieces of evidence Draw main conclusion Propose essential recommendations Reviewing data and report 63 SIHFW: an ISO 9001:2008 certified Institution

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Structure Imposed (Introduction, methods, results & conclusion) None (unstructured) Common word limits 250-275 structured 100 unstructured Write structured abstract and edit Review rules of conference or journal 64 SIHFW: an ISO 9001:2008 certified Institution

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Background Little information is available on the knowledge about scientific writing among medical teachers Methods We administered a 10-point questionnaire to test knowledge about scientific writing among medical teachers participants attending a writing workshop. Structured abstract 65 SIHFW: an ISO 9001:2008 certified Institution

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Results 32 medical teachers participated. Of these, only 20 (63%) achieved a score of 50% or above. The younger participants (aged less than 30 years) scored worse than the older participants (aged > 30 years), the average scores in the two groups being 6.5 + 1.5 and 4.5 + 1.7, respectively (t-test; p<0.05). Conclusion Indian medical teachers lack skills in medical writing and steps to improve this are needed 66 SIHFW: an ISO 9001:2008 certified Institution

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Little information is available on the knowledge about scientific writing among medical teachers. We administered a 10-point questionnaire to test knowledge about scientific writing among medical teachers participants attending a writing workshop. 32 medical teachers participated. Of these, only 20 (63%) achieved a score of 50% or above. The younger participants (aged less than 30 years) scored worse than the older participants (aged > 30 years), the average scores in the two groups being 6.5 + 1.5 and 4.5 + 1.7, respectively (t-test; p<0.05). Indian medical teachers lack skills in medical writing and steps to improve this are needed. Unstructured abstract 67 SIHFW: an ISO 9001:2008 certified Institution

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Objective: To evaluate the efficacy of a single large oral dose of vitamin A in treating acute shigellosis in children in Bangladesh. Design: Randomized, double-blind, controlled clinical trial. Setting: Dhaka Hospital, International Centre for Diarrhoeal Disease Research, Bangladesh. Structured abstract: Drug trial 68 SIHFW: an ISO 9001:2008 certified Institution

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Subjects: 83 children aged 1­7 years with bacteriologically proved shigellosis but no clinical signs of vitamin A deficiency; 42 were randomized to treatment with vitamin A and 41 formed a control group. Intervention: Children were given a single oral dose of 200,000 IU of vitamin A plus 25 IU vitamin E or a control preparation of 25 IU vitamin E. 69 SIHFW: an ISO 9001:2008 certified Institution

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Main outcome measures: Clinical cure on study day 5 and bacteriological cure. Results: Baseline characteristics of the subjects in the two treatment groups were similar. Significantly more children in the vitamin A group than in the control group achieved clinical cure [19/42 (45%) v 8/14 (20%);  2 = 5.14, 1 df, P = 0.02; risk ratio = 0.68 (95% Unstructured abstract: Drug trial 70 SIHFW: an ISO 9001:2008 certified Institution

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confidence interval: 0.50 to 0.93)]. When cure was determined bacteriologically , the groups had similar rates [16/42 (38%) v 16/41 (39%);  2 = 0.02, 1 df , P = 0.89; risk ratio = 0.98 (0.70 to 1.39)]. Conclusion: Vitamin A reduces the severity of acute shigellosis in children living in areas where vitamin A deficiency is a major public health problem. 71 SIHFW: an ISO 9001:2008 certified Institution

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Read report Review data Identify key data elements Key table Key graph Build a logical argument around key data elements Extract Key Information 72 SIHFW: an ISO 9001:2008 certified Institution

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Background / Introduction Methods Results Findings Conclusion May include a short discussion element Outline abstract 73 SIHFW: an ISO 9001:2008 certified Institution

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Start from the data What are the KEY data elements Summarize for the results paragraph Draw key general conclusion Strictly based upon the data presented Formulate key recommendation Direct deduction of the conclusion Strictly based upon the data presented Building an autonomous abstract 74 SIHFW: an ISO 9001:2008 certified Institution

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Summarize the methods Spell out what is strictly necessary to document to believe the results presented Shape the introduction Explain why the study was done Make sure your conclusion matches the objective that you state 75 SIHFW: an ISO 9001:2008 certified Institution

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Most important information: Reasons that led to conduct the study Objective of the study Research question If necessary and possible: Documentation of the importance of the topic Key essential background information Background / introduction of an abstract 76 SIHFW: an ISO 9001:2008 certified Institution

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Importance Order Topic Example +++ 3rd Objective of the study We investigated the outbreak to identify its source ++ 2nd Reasons that led to conduct the study On XX May 200X, a cluster of gastro-enteritis was reported among guests of a wedding + 1st Importance of the topic / key background Festivals are common causes of food-borne outbreaks in India Example of background / introduction for an abstract 77 SIHFW: an ISO 9001:2008 certified Institution

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Study design Definitions Participants Any interventions, treatments Data collection Analysis Additional investigations: Laboratory methods Environmental assessment Methods paragraph of an abstract 78 SIHFW: an ISO 9001:2008 certified Institution

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We defined gastroenteristis as an acute onset of vomiting or diarrhea in the 24 hours following the banquet . [Definitions] We compared the attack rate of illness [Analysis] among the wedding guests [Participants] according to their consumption of the various food items [Design] on the basis of information collected using a standardized questionnaire . [Data collection] We collected leftover food items and stool samples for laboratory investigations [Laboratory methods] and probed food handlers for preparation methods . [Additional investigations] Example of a methods section 79 SIHFW: an ISO 9001:2008 certified Institution

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Major summary data Response Characteristics of participants Indicators Statistics Additional investigations Directly relating to the objectives Directly supporting conclusions & recommendations Results paragraph of an abstract 80 SIHFW: an ISO 9001:2008 certified Institution

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Among the XXX of the XXX guests interviewed (XX%) [Response], the median age was XX years, XX (XX%) were female, [Characteristics of subjects] and XXX were sick (XX%). [Indicators] The attack rate was higher among those who ate the fried fish compared to those who did not (relative risk: XX, 95% confidence interval: XX-XX, attributable fraction: XX%). [Statistics] Staphylococcus toxin was identified in the food leftovers. [Additional investigations] The fish egg-based batter has been left at room temperature 5 hours before cooking by a food handler with chronic staphylococcus infection . [Additional investigations] Example of results section 81 SIHFW: an ISO 9001:2008 certified Institution

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Key conclusion Integrate multiple lines of supporting evidence (if necessary) Key recommendation or action Mention actual or potential effect of the action (If possible) Limit to issues directly supported by data Remain general and robust if details needs further discussions Conclusion paragraph of an abstract 82 SIHFW: an ISO 9001:2008 certified Institution

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This staphylococcus food-borne outbreak was caused by an infected food handler with poor food hygiene practices. [Key conclusion] Public health authorities should work with food handlers to improve food safety during festivals and large gatherings . [Key recommendation] Example of conclusion section 83 SIHFW: an ISO 9001:2008 certified Institution

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Make key linkages between ideas Add words or phrases to extracted material Review / rearrange order of ideas & data Proceed in two steps: Start by writing all what needs to be stated Identify & remove unnecessary elements Rewrite Revise Writing the abstract 84 SIHFW: an ISO 9001:2008 certified Institution

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Do not begin without data Maximize space devoted to data Minimize space for words that do not provide data or information: “Additional data will be shown” “These results will be discussed” “Have not yet been established” Rule #1: The primacy of data 85 SIHFW: an ISO 9001:2008 certified Institution

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Avoid vague, unclear or obvious statements Strong verbs make strong sentences: “A descriptive study was done” Specify methods of measurement Give rates whenever possible Present data instead of names “A point source was noted” “Case counts rose from July 7, peaked on July 10 and decreased to baseline levels by July 14” Being specific 86 SIHFW: an ISO 9001:2008 certified Institution

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Quantify Avoid repetition or redundancy Do not add material not found in report Let the data explain Avoid explanations Avoid distorting the elementary messages More tactics 87 SIHFW: an ISO 9001:2008 certified Institution

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Allow plenty of time Write Re-write Share with co-authors Share with supervisors Revise, revise, revise Conduct final radical wordectomy Check with editor Seek clearance Revising 88 SIHFW: an ISO 9001:2008 certified Institution

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Identifies gap in knowledge Justify why was research carried out Reflects the objective of study What Introduction does… 89 SIHFW: an ISO 9001:2008 certified Institution

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Zoom in from the general to the specific Critically review what is known and unknown Flag the gaps in knowledge Make it natural that the study had to be done End with objectives Document facts with references Introduction: The “dos” 90 SIHFW: an ISO 9001:2008 certified Institution

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Never start by saying: Disease X is a major public health problem Prefer: Disease X is the Xth leading cause of mortality in the world etc. The classical trap 91 SIHFW: an ISO 9001:2008 certified Institution

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Write endlessly to fill pages General undocumented statements Focus exclusively on burden of disease Review the literature in details Plagiarize, cut and paste Provide excessive irrelevant historical details Introduction: The “don’ts” 92 SIHFW: an ISO 9001:2008 certified Institution

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What is known and unknown globally The elements that make this issue important The regional perspective on the issue The local presentation of the issue Objectives of the study to address the issue locally The effective introduction: A zoom in, paragraph by paragraph 93 SIHFW: an ISO 9001:2008 certified Institution

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“ We wish to suggest a structure for the salt of deoxyribose nucleic acid (D.N.A.). This structure has novel features which are of considerable biological importance” Watson JD, Crick FHC. A structure for deoxyribose nucleic acid. Nature 1953; 171: 737-8 The ultimate, Nobel prize winning introduction 94 SIHFW: an ISO 9001:2008 certified Institution

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Describe how the study was done with enough detail so that it could be replicated The reader can understand the representativeness of the sample Weaknesses and strengths of the study can be determined Methods—Goals 95 SIHFW: an ISO 9001:2008 certified Institution

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Overall study design Setting Study subjects and sampling Data collection/measurements Intervention (if any) Laboratory methods (environmental investigation) Data analysis Ethical considerations Sub-headings of Methods Section 96 SIHFW: an ISO 9001:2008 certified Institution

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Example: “We performed a 2-year longitudinal cohort study (study design) of all patients initiated on ARV from the Zagreb infectious disease hospital, to evaluate factors associated with the development of lipodystrophy .” 1. Overall study design Big picture of methods 97 SIHFW: an ISO 9001:2008 certified Institution

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Basic study designs: Cross-sectional survey Case-control study Cohort study Trial – Randomized, controlled Before-after study Combinations (describe both) 98 SIHFW: an ISO 9001:2008 certified Institution

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Setting can be a separate section, or merged with Study Design or Subjects sections. Geography District, urban, rural Facility Hospital, clinic, VCT sites—private, public, large etc. 2. Setting 99 SIHFW: an ISO 9001:2008 certified Institution

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Geography: “The setting of our study isJaipur,Rasthan, the State capital and largest city...” Facility: “Zanana Hospital are tertiary care facilities located in Central part of City of Jaipur near the areas inhabitated by mixed SE class of people Examples of settings 100 SIHFW: an ISO 9001:2008 certified Institution

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Goal: Need to understand what population the sample represents General description of the subjects/ case definitions Enrollment procedures and criteria and timeframe Sampling strategy, sample size Who is included in the final analysis - numbers 3. Study subjects and sampling 101 SIHFW: an ISO 9001:2008 certified Institution

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Description Enrolment criteria Inclusion, Exclusion criteria Time frame Example – We enrolled all mothers attending ANC clinics in rural Jaipur, Rajasthan (general description), from November 2003 through March 2004 (time). Women were included if they were >18 years of age, this was their first pregnancy, and they did not require immediate medical attention (criteria). 3a. Study subjects-example 102 SIHFW: an ISO 9001:2008 certified Institution

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Random sample- how selected Consecutive, convenience, systematic Multi-stage cluster sampling Random digit dialing Sub-sample of larger study (criteria for choosing?) Special sampling procedures Venue-Day-Time Respondent-Driven Sampling 3b.Subjects – What was the sampling strategy 103 SIHFW: an ISO 9001:2008 certified Institution

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Some understanding of the Population from which the sample is drawn This is often neglected– but is very important Example We randomly selected 4 schools out of 12 public schools in the district. There are also 5 private elementary schools. It is estimated that 80% of school aged children <12 years of age in the district attend school. Tells you: what proportion of schools were sampled (4 of 19 total); only public schools—(different SES?); some out of school children might be missed. 3c. Whom does the sample represent? 104 SIHFW: an ISO 9001:2008 certified Institution

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Depending on study and journal– this description could be Methods, or Results. Indicate the number: Who were screened (recruited) Excluded because failed to meet criteria Refused participation For whom data is not available and therefore not included in analyses. The total number evaluated in the study 3d. Subjects –who was finally included in the analysis? 105 SIHFW: an ISO 9001:2008 certified Institution

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Study units (Individuals/groups) Eligible to participate Not eligible Participants Non-participants Treatment Control Selection criteria Invitation to participate Randomization Subjects: use of algorithms to summarize information 106 SIHFW: an ISO 9001:2008 certified Institution

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Describes how data were collected If a qualitative study, describe: Type of interview (in-depth interviews, open-ended, semi-structured) Focus group discussions: recorded, transcribed how many per group How long it took, who performed them, and where Confidentiality, names, etc. 4 . Data collection/Measurements 107 SIHFW: an ISO 9001:2008 certified Institution

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If a quantitative study with questionnaire was used, describe the interview & questionnaire: Interviewer-administered, self-administered How long did it take; where done How developed – piloted, revised, translated, back translated? 4a. Data collection/Measurements 108 SIHFW: an ISO 9001:2008 certified Institution

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Were any items standardized? Was a follow-up questionnaire done – if so, differ? Describe general questionnaire domains, e.g.: demographics, symtpom h/o, HIV/AIDS knowledge and attitudies, risk behaviors 109 SIHFW: an ISO 9001:2008 certified Institution

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Clinical evaluation Physical exam- by whom, of what, including any particular measurements? Treatment provided? Follow-up exam? Include only those measurements that are ultimately presented in Results 4B. Data collection/Measurements 110 SIHFW: an ISO 9001:2008 certified Institution

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Details of intervention arm(s) Components of the intervention arm(s) “Dose”, -frequency with which delivered Control, comparison or placebo arm(s) Intervention and Control Activities may be separate sub-headings 5. Intervention 111 SIHFW: an ISO 9001:2008 certified Institution

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Describe tests used for screening and/or confirmation. Include: Manufacturer of tests: Product name (Company name, City, State or Country) References for new, experimental tests Indicate where performed –which lab May need to indicate parameters for a positive test (OD cut-off) 6. Laboratory 112 SIHFW: an ISO 9001:2008 certified Institution

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Describe testing algorithm used, & what determines a positive result (e.g.. Second rapid test, if discordant, third test) Test kits used –indicate “3 rapid test kits approved by the National AIDS Organization” When test results given to client (same day, 1 week?), or if not provided (surveillance) Pre and post test counseling What happens to HIV positives – treated, referred? 6a. HIV testing 113 SIHFW: an ISO 9001:2008 certified Institution

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Discuss where and into what program data was entered; where cleaned; where analyzed “Data were entered on site into Access (where) , transferred to SAS, and evaluated for range and logic checks (cleaned). The data were then transferred to the server at the TUC data management center for further cleaning & analysis using SAS version 9.1 (SAS Institute, Cary, NC).” 7. Data analysis, statistical methods 114 SIHFW: an ISO 9001:2008 certified Institution

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Appropriate statistical tests in order of use & presentation How data were analysed Univariate- Distributions of variables were evaluated using means, SD, median, range,and proportions Bivariate- Differences in proportions were evaluated using chi-square tests, difference in means using t-test. 7a. Data analysis:Statistical methods 115 SIHFW: an ISO 9001:2008 certified Institution

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Odds ratios were calcuated with 95% confidence intervals using logistic regression Multivariate Which variables were included and criteria – associated in bivariate analysis, and p<.10 Stratification Male vs. female, young vs. old Sub-group analyses Analysis of potential biases Participants vs. non-participants Lost to follow-up vs. retained in longitudinal studies 116 SIHFW: an ISO 9001:2008 certified Institution

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This section is usually at the beginning to end of the methods section Approval by IRBs Special considerations: Vulnerable populations (prisoners, minors) 8. Ethical considerations 117 SIHFW: an ISO 9001:2008 certified Institution

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“Subjects aged 15 to 18 years were considered emancipated minors and able to consent to the study. The protocol for this study was reviewed, approved, and monitored by the ethical committees of the Mahidol University and the University of California, San Francisco.” 8a. Examples of ethical considerations: special population 118 SIHFW: an ISO 9001:2008 certified Institution

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Use active voice Edit protocol (Turn future tense into past tense) Structure the section into appropriate subheadings Follow format from the journal to which you intend to submit Ensure methods are presented for all results Quote only the key references that describe the method used Methods: The “dos” 119 SIHFW: an ISO 9001:2008 certified Institution

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Do not use passive voice Do not provide results Do not provide excessive details on information collected Do not list every question on the instrument (list only the broad categories of information collected) Methods: The “don’ts” 120 SIHFW: an ISO 9001:2008 certified Institution

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Organized, organized, organized Specific, specific, specific Clear, clear, clear Recipe of a good methods section 121 SIHFW: an ISO 9001:2008 certified Institution

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The major existential question for the results section Which of the results should I extract from the table to mention in the text??? 122 SIHFW: an ISO 9001:2008 certified Institution

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Data have been analyzed and interpreted Tables / figures Highlight the key results. Summarize tables and figures ( not describe) Have a logical sequence: In parallel with methods Background data –descriptive – bivariate -multivariate. Pre-requisite to writing the results section 123 SIHFW: an ISO 9001:2008 certified Institution

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Use tables to highlight individual values Use figures to highlight trends or relationships In other words 124 SIHFW: an ISO 9001:2008 certified Institution

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From the simple to the complex From the general to the specific From the beginning to the end Choose your sequential logic 125 SIHFW: an ISO 9001:2008 certified Institution

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Description of the study population Descriptive epidemiology in context of agent, host and environment(Time place and person) Analytical epidemiology ---case control-, cohort- studies Experimental studies Potential sub-headings for a results section 126 SIHFW: an ISO 9001:2008 certified Institution

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Flow of participants Protocol deviations Dates of recruitment and follow up Baseline demographics Number of participants Summary of results Report other analyses Pre-defined/exploratory Adverse events Example of reporting guidelines : CONSORT for randomized controlled trials 127 SIHFW: an ISO 9001:2008 certified Institution

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Recycle the “methods” outline (If needed) Walk the reader through salient findings Provide numerators and denominators Of the XX subjects, XX (XX%) reported Caption the information in tables/ figures Cases and controls did not differ with respect to baseline characteristics (Table 1). Describe the information in simple terms Back up statements with data in the sentence, tables or say: “data not shown” Results: The “dos” 128 SIHFW: an ISO 9001:2008 certified Institution

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When you report the results belong to the past The paper will be read in the future. Hence, “present” will have no meaning Use the past tense to report results 129 SIHFW: an ISO 9001:2008 certified Institution

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In the simple regression analysis education and pregnancy status give highly significant relationship while language and counseled by give significant relationship. Clinic and complaints show no significance on screening Women who were educated, who spoke Hindi and who benefited of a counseling from a physician were more likely to consent to the screening test. Do not report results in statistical language 130 SIHFW: an ISO 9001:2008 certified Institution

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Test a hypothesis Use p-value You test the probability of being wrong Measuring a quantity Use confidence intervals You want to measure the confidence in the estimate P-value or confidence interval? Think of your initial objective! 131 SIHFW: an ISO 9001:2008 certified Institution

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Significant Not caused by chance Correlation Strength of linear relation between two quantitative variables Random Each element has equal chance of occurring Sample Part of a population Proper use of statistical terms in the results 132 SIHFW: an ISO 9001:2008 certified Institution

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Do not use general sentences Do not re-explain methods (e.g., criteria used, case definition) Do not discuss/ interpret results Do not quote references Do not spell out every result in the table Do not use adjectives and qualifiers Do not use “etcetera” Results: The “don’ts” 133 SIHFW: an ISO 9001:2008 certified Institution

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Less is often better Check all numbers against tables & graphs Leave “What you did” for the methods Results - Remember 134 SIHFW: an ISO 9001:2008 certified Institution

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CONSORT— CONsolidated Standards for Reporting Trials COPE—Committee on publication ethics STROBE – ST rengthening the R eporting of OB servational studies in E pidemiology Standard Abbreviations 135 SIHFW: an ISO 9001:2008 certified Institution

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Discussion Place of the discussion in the IMRD model Describing and interpreting Interpreting epidemiological data Interpreting in light of initial hypotheses Constructing an argument in a discussion 136 SIHFW: an ISO 9001:2008 certified Institution

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Interpretation Place of the discussion in the IMRD model Describing and interpreting Before you interpret, describe Imagine you are talking on the phone The person you talk to has not seen the evidence Interpreting epidemiological data Interpreting in light of initial hypotheses Constructing an argument in a discussion 137 SIHFW: an ISO 9001:2008 certified Institution

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Description and interpretation: The bottom line Follow the sequence Description (“Results” section) ‏ Interpretation (“Discussion” section) ‏ Keep the two stages separate Interpretation requires quality data How to interpret epidemiological data? 138 SIHFW: an ISO 9001:2008 certified Institution

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Descriptive epidemiology Incidence, prevalence Time, place and person data 139 SIHFW: an ISO 9001:2008 certified Institution

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Interpretation of descriptive epidemiological data to generate hypotheses Narrow epidemic curve Cluster of cases @ public tap Case patients used the tap Time Place Person Hypothesis: The public tap was contaminated for a brief duration and caused the outbreak 140 SIHFW: an ISO 9001:2008 certified Institution

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Analytical epidemiology Count, divide and compare Measures of association Relative risks Odds ratios Prevalence ratios 141 SIHFW: an ISO 9001:2008 certified Institution

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Interpretation of analytical epidemiological data & additional investigations to test an hypothesis Strong association water drinking / illness High attributable fraction Water positive for S. Typhi OR AFP Water analysis Epidemiological evidence supported the hypothesis of the tap as the source of the outbreak X-contamination sewage / water supply S anitary assessment Sewage contaminated the tap with S. Typhi and caused the outbreak 142 SIHFW: an ISO 9001:2008 certified Institution

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Interpreting epidemiological data: The bottom line Descriptive epidemiological data generates hypotheses Analytical epidemiological data tests hypotheses Can you guess why two different fishermen ? 143 SIHFW: an ISO 9001:2008 certified Institution

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Results Facts Figures Discussion Interpretation Build up of a number of points Recommen- dations Recommen- dations pro- posed on the basis of the conclusions Conclusions Points made on the basis of the evidence Bridge The discussion bridges the evidence with the next steps in terms of action 144 SIHFW: an ISO 9001:2008 certified Institution

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Example of a life cycle for an epidemiological investigation Hepatitis E endemic in South Asia Does hepatitis E vaccine works? What is the efficacy of the vaccine? Vaccine trial Surveillance Vaccine cards Relative risk Vaccine efficacy: 95% Consider use of the vaccine How do we use this vaccine? Data on vaccination and disease New cycle can start 145 SIHFW: an ISO 9001:2008 certified Institution

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Down and up the investigation life cycle, all processes are thought in parallel Identifying data needs Spelling out the research question Formulating the study objectives Planning the analysis Preparing data collection instruments Analyzing data Drawing conclusions Formulating recommendations Involving the programme Collecting data These two processes (arrows) parallel each other 146 SIHFW: an ISO 9001:2008 certified Institution

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A- The protocol preparation phase The formulation of the study objective leads to a hypothesis The analysis plan envisages what analysis will test the hypothesis 1. Formulating the study objectives 2. Planning the analysis 147 SIHFW: an ISO 9001:2008 certified Institution

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B- The data interpretation stage The analysis transforms data into information Interpretation of the information tests the hypothesis 1. Analyzing data 2. Drawing conclusions 148 SIHFW: an ISO 9001:2008 certified Institution

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A- Preparing the protocol for the hepatitis E vaccine trial Estimate vaccine efficacy through a comparison of incidence among vaccinated / unvaccinated Cohort study, calculation of relative risk and vaccine efficacy 1. Formulating the study objectives 2. Planning the analysis 149 SIHFW: an ISO 9001:2008 certified Institution

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B- Interpreting the data of the hepatitis E vaccine trial Relative risk: 0.05, efficacy: 95% The vaccine is highly effective 1. Analyzing data 2. Drawing conclusions 150 SIHFW: an ISO 9001:2008 certified Institution

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A malaria drug efficacy study, Ivory Coast, 1995 Unclear hypotheses: Difficult interpretation Treatment policy: Chloroquine Problem statement: None “We want resistance data” No hypothesis: No data on clinical outcomes Study: Resistance = 10% Interpretation: ??? Recommendation Obtain surveillance data (e.g., CFR)‏ 151 SIHFW: an ISO 9001:2008 certified Institution

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A malaria drug efficacy study, North Bengal, India, 2005 Treatment policy: Chloroquine / primaquine Problem statement: Increased incidence, anecdotal report of treatment failures, emergence of Falciparum 152 SIHFW: an ISO 9001:2008 certified Institution

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Hypothesis: Is chloroquine resistance > 15% threshold (WHO)? Study: Resistance = 52% Interpretation: Resistance common Recommendation: Change first line drug Clear hypotheses: Easy interpretation 153 SIHFW: an ISO 9001:2008 certified Institution

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Interpretation in light of initial hypotheses: The bottom line The protocol envisages hypotheses and determines how they will be tested The analysis looks at the information to test hypotheses It is difficult to interpret data unless initial hypotheses were formulated Data are always interpreted in light of the initial hypotheses / questions How do we report the interpretation in the discussion? 154 SIHFW: an ISO 9001:2008 certified Institution

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Summary of finding without quantified detailed results Making points First point Second point (Potentially a third point) Limitations Last paragraph of conclusions and recommendations What can be said What cannot be said What you make of it What was found Outline of a discussion 155 SIHFW: an ISO 9001:2008 certified Institution

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Statement of principal findings Strengths and weaknesses of the study Strengths and weaknesses in relation to other studies, discussing particularly any differences in results Meaning of the study: possible mechanisms and implications for clinicians or policymakers Unanswered questions and future research Suggested structure for discussion of scientific papers 156 SIHFW: an ISO 9001:2008 certified Institution

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“Discussion” is a misnomer The discussion is NOT a polite conversation around the data “Oh! You found this, this is interesting because I found that!” The discussion is the section of the paper dedicated to the interpretation of the data 157 SIHFW: an ISO 9001:2008 certified Institution

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Do Summarize the results in big picture terms Announce the points that will be discussed Avoid Interpreting Repeating results in great details Initiating the discussion of the results First paragraph of the discussion: One end of the bridge 158 SIHFW: an ISO 9001:2008 certified Institution

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Do Summarize conclusion points Propose recommendations on the basis of the conclusions Add action points Future studies Methods to monitor and evaluate intervention proposed Last paragraph of the discussion: The other end of the bridge 159 SIHFW: an ISO 9001:2008 certified Institution

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Avoid Proposing recommendations disconnected from conclusions Repeating results without adding a layer of interpretation 160 SIHFW: an ISO 9001:2008 certified Institution

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Do Start from results themselves Bridge results with conclusions through interpretation Review causality Review causes / consequences of findings; Interpret findings in light of information available Discussion points: The bridge itself 161 SIHFW: an ISO 9001:2008 certified Institution

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Avoid Systematically comparing with other studies Commenting results Listing possible explanations without hypothesis testing 162 SIHFW: an ISO 9001:2008 certified Institution

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Elements to consider before interpreting association as causation Chance Bias Confounding factor Causation Strength of the association Dose response Consistency Biological plausibility Exposure/ outcome sequence 163 SIHFW: an ISO 9001:2008 certified Institution

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Interpretation of data in a discussion section of a paper + = 164 SIHFW: an ISO 9001:2008 certified Institution

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Example of integration of various pieces of evidence into an interpretation Outbreak of cutaneous anthrax following a beef slaughter in West Bengal, India Cohort study to identify risk factors for infection Contact with meat is a clear risk factor Null hypothesis: Eating meat doesn’t cause cutaneous anthrax 165 SIHFW: an ISO 9001:2008 certified Institution

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Always consider the other hypothesis Avoid: We found that… This could be due to... [this real phenomenon] Prefer: The results are … Two possibilities This could be due to this real phenomenon This could be an artefact of the study Examine both options See what the data support and conclude 166 SIHFW: an ISO 9001:2008 certified Institution

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Dealing with an un-expected finding One unexpected risk factor turns out to be associated with outcome Absence of context No other studies No biological rationale 167 SIHFW: an ISO 9001:2008 certified Institution

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Treat as a hypothesis generation: The association between disease X and this risk factor should be examined in other studies Do not force an explanation/ rationalization “This may be due to…” 168 SIHFW: an ISO 9001:2008 certified Institution

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Language used for data Description and data interpretation Data description: RESULTS Cases started to occur at 5AM, peaked at 7AM and decreased with a last case at 10AM Cases clustered around the sweet shop Data interpretation: DISCUSSION The shape of the epidemic curve suggested a point source outbreak We generated the hypothesis that the sweet shop was the source of infection 169 SIHFW: an ISO 9001:2008 certified Institution

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Data description: Results Incidence of malaria was high among all age groups Cases were more likely than controls to be living under the poverty line Data interpretation: Discussion Incidence pattern suggested lack of immunity among adults Low socio economic status may be a risk factor for illness 170 SIHFW: an ISO 9001:2008 certified Institution

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Constructing an argument in a discussion: The bottom line The discussion brings all the pieces of the puzzle together What was known before What we learned This interpretation through inter-relation bridges the data with the conclusion 171 SIHFW: an ISO 9001:2008 certified Institution

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For each problem have a specific recommendation. The suggestions can be technical or managerial They can pertain to any of the management areas— Human resource Materials/ logistics& supply Financial HMIS Time Recommendations--specific 172 SIHFW: an ISO 9001:2008 certified Institution

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Feasible ----handled locally, or district or state or GOI Try to handle within means at the local level. Remember that NRHM has provision for improving the situation at district and below Practical recommendations 173 SIHFW: an ISO 9001:2008 certified Institution

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Based on the conclusions Practical Specific Well organized with the most important first Recommendations-Tips 174 SIHFW: an ISO 9001:2008 certified Institution

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ICJME Harvard Standard Text Citation Formats 175 SIHFW: an ISO 9001:2008 certified Institution

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No scientific knowledge starts in thin air Most ideas take pre-existing observations and hypothesis and expand upon them Connect scientific work to the existing body of thought Often a starting point Why emphasis on referencing? 176 SIHFW: an ISO 9001:2008 certified Institution

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Purpose- to quote work done by other authors on the subject area relevant to study Referencing helps in identifying the source of information that has been quoted Reference citation 177 SIHFW: an ISO 9001:2008 certified Institution

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Cite relevant information Provide reference to the information quoted depending upon the citation format e.g (Clarke 2001) Cite references in the flow of the text Take the information and put it into your own words; avoid paraphrasing since this can potentially lead to plagiarism Citing information from another source 178 SIHFW: an ISO 9001:2008 certified Institution

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Introduction Support background information Lacunae, gap in knowledge Methods Previously described technique Statistical methods Use standard statistical software Results: Usually no references are cited Discussion: Comparing, interpreting, justifying analyzing Use of references, section by section 179 SIHFW: an ISO 9001:2008 certified Institution

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Health care spending is considered catastrophic when it exceeds a threshold, defined in relation either to the household’s pre-payment income or the household’s capacity to pay (van Doorslaer et al. 2007) All estimates were weighted. STATAtm version 10.0 was used to carry out the analysis ( StataCorp LP, College Station, TX, USA). References in methods 180 SIHFW: an ISO 9001:2008 certified Institution

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PubMed (Index Medicus ) EMBASE ( Excerpta Medica ) Current contents BIOSIS: Biological abstracts Cochrane reviews References: Bibliographic databases 181 SIHFW: an ISO 9001:2008 certified Institution

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Do not reference the obvious (e.g., the population of India is rising…) But if it is important to mention that the population has risen x% in y years, then a reference is needed. Do not forget to reference The only study… shows a trend… References 182 SIHFW: an ISO 9001:2008 certified Institution

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Need to be accurate Journal offices tend to check citations In the list of references and in the text Avoid abstracts Papers accepted for publication: In press Papers submitted for publication Place in text as unpublished observations /data Personal communications Should have written consent References 183 SIHFW: an ISO 9001:2008 certified Institution

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www.icmje.org ; www.nih.nlm.gov Number consecutively in the order of first appearance in the text References in the tables and figures should be numbered sequentially with the text Identify references in text, tables and legends by Arabic numerals in superscript /parenthesis Abbreviate the journals as listed in the Index Medicus 184 SIHFW: an ISO 9001:2008 certified Institution

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Maternal Mortality Ratio is an integral part of assessment of a country’s progress towards overall development as envisaged under MDG’s (Millennium Development Goals), where a target of ¾ th reduction in maternal mortality levels from 1990 level by 2015 has been set. The tenth Plan targets reduction in MMR to 200/100,000 live births by 2007 and to 100/100,000 live births by 2012. Referencing in text 185 SIHFW: an ISO 9001:2008 certified Institution

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References: ICMJE (Journal) Style 186 SIHFW: an ISO 9001:2008 certified Institution

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Sackett DL, Rosenberg WM, Gray JA, Haynes RB, Richardson WS. Evidence based medicine: What it is and what it isn't. BMJ 1996;312:71-2. McAlister FA, Clark HD, van Walraven C, Straus SE, Lawson FM, Moher D, et al.The medical review article revisited: Has the science improved? Ann Intern Med 1999; 131: 947-51. References: ICMJE (Journal) Style 187 SIHFW: an ISO 9001:2008 certified Institution

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References: ICMJE (Book) style 188 SIHFW: an ISO 9001:2008 certified Institution

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Guyatt GH, Rennie D ( eds ). Users' guides to the medical literature. A manual for evidence-based clinical practice. Chicago: American Medical Association Press; 2002. Rowley AH, Shulman ST. Kawasaki disease. In: Behrman RE, Kliegman RM, Jensen HD ( eds ). Nelson’s textbook of pediatrics. 17th ed. Philadelphia: W. B. Saunders; 2004: 823-6. References: ICMJE (Book) style 189 SIHFW: an ISO 9001:2008 certified Institution

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Pai M, McCulloch M, Enanoria W, Colford JM. Systematic reviews of diagnostic test evaluations: What's behind the scenes? Evid Based Med & ACP Journal Club 2004 (in press). Population Reference Bureau. http://www.prb.org/ (accessed on 4 January 2006). Tynan T. Medical improvements lower homicide rate: Study sees drop in assault rate. The Washington Post. 2002 Aug 12;Sect. A:2 (col. 4). References: ICMJE Style 190 SIHFW: an ISO 9001:2008 certified Institution

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Dworkin SF. Somatization , distress and chronic pain. Qual Life Res 1994;3 ( Suppl 1): S77-S83. National Sample Survey Organization (NSSO). Morbidity and treatment of ailments. NSS (NSS 52nd round). July 1995-June 1996, Report No 441. New Delhi: Government of India, Department of Statistics; 1998. EpiInfo2000. Atlanta: Centers for Disease Control and Prevention; 2000. References: ICMJE Style 191 SIHFW: an ISO 9001:2008 certified Institution

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Journal: Two authors Timm , T. and B. Bugjuice . 1989. The role of whisker length in mouse nose-twitch courtship behavior . J Physiol 61(3):113-118. Timm and Bugjuice (1989) Journal: Multiple authors Bugjuice , B., Timm , T. and R. Cratchet . 1990. The role of estrogen in mouse courtship behavior changes as mice age. J Physiol 2(6):1130-1142. Bugjuice et al. (1990) 192 SIHFW: an ISO 9001:2008 certified Institution

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Only the last name of the author(s) and the year of publication are given,e.g.,Bugjuice 1970. Your Literature Cited section will contain the complete reference, and the reader can look it up there. For two author papers, give both authors' last names (e.g., Click and Clack 1974). Harvard 193 SIHFW: an ISO 9001:2008 certified Institution

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Articles with more than two authors are cited by the first authors last name followed "and others" or "et al.", and then the year. A string of citations should be separated by semicolons, e.g., ( Gumwad 1952:209; Bugjuice 1970; Bruhahauser et al 1973). 194 SIHFW: an ISO 9001:2008 certified Institution

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If the same author(s) are cited for two or more papers published within the same year, place a small case letter after the year to denote the sequence in which you referred to them. Example:Bugjuice , B. 1970a. Physiological effects of estrogen on mouse courtship behavior . J Physiol 40(2):140-145. Bugjuice , B. 1970b. Physiological effects of estrogen analogs : Insincere courtship xxxxbehavior in female mice. J Physiol 40(8):1240-1247. 195 SIHFW: an ISO 9001:2008 certified Institution

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Referencing in text In India, impoverishment due to health payments is substantial; various studies have estimated that between 32–39 million people are pushed into poverty every year due to health payments (van Doorslaer et al . 2006; Bonu et al . 2007; Garg and Karan 2009; Berman et al . 2010). References: Harvard style 196 SIHFW: an ISO 9001:2008 certified Institution

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Berman P, Ahuja R, Bhandari L. 2010. The impoverishing effect of healthcare payments in India: new methodology and findings. Economic & Political Weekly 45 : 65–71. Deaton A, Dreze J. 2008. Nutrition in India: facts and interpretations. Working paper, Princeton University, NJ, USA. Online at: http://weblamp.princeton.edu/chw/papers/deaton_dreze_india_nutrition.pdf, accessed 29 October 2009. 197 SIHFW: an ISO 9001:2008 certified Institution

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Honesty Accurate reports / protocols Identified conflicts of interest No falsification / misrepresentation of data Objectivity Not limited to experimental design Consciously look for bias Principles of Ethical Research 198 198 SIHFW: an ISO 9001:2008 certified Institution

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Integrity Carefulness Timely & orderly records of research and correspondence Openness Share information, tools & protocols Accept criticism and new ideas 199 SIHFW: an ISO 9001:2008 certified Institution

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Respect Intellectual Property Do not use unpublished data Give credit where credit is due Promote social good & minimize social harm Use resources efficiently 200 SIHFW: an ISO 9001:2008 certified Institution

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Educate / mentor junior colleagues Maintain competence & skills Avoid discrimination for reasons other than quality Obey relevant laws Exploit neither humans nor animals in studies 201 SIHFW: an ISO 9001:2008 certified Institution

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Errors of judgment - improper study design, bias Changing objectives of study under pressure from funding source Intentionally excluding a part of data from analysis Hiding details of methodology / results Unethical Research Practices 202 SIHFW: an ISO 9001:2008 certified Institution

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Fabrication, falsification & plagiarism (FFP) in planning, implementation, or reviewing research or in reporting results Fabrication: recording or presentation of false data Falsification: manipulation of data to produce a desired result Plagiarism is an unethical practice, lacks originality but is not illegal 203 SIHFW: an ISO 9001:2008 certified Institution

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Plagiarism (Latin word plagiarius – kidnapper, thief): using someone else’s words, ideas, or results without giving credit Self-plagiarism: re-using own published material (text recycling) & data partitioning 204 SIHFW: an ISO 9001:2008 certified Institution

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The currency of modern science Reasons for Research Publication Promotion Academic degree Financial Gain Improve knowledge Fame Generate Knowledge Publication 205 205 SIHFW: an ISO 9001:2008 certified Institution

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The Committee on Publication Ethics (COPE) published Guidelines on Good Publication Practice in 1994 ( http://www.publication ethics.org.uk ) Broadly, Publication ethics involve Research misconduct Protection of research participant’s identities Publication Ethics 206 206 SIHFW: an ISO 9001:2008 certified Institution

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Key Issues in Research & Publication Ethics Authorship Conflicts of interest Peer review Plagiarism Data ownership / retention Copyright Media/Press coverage 207 SIHFW: an ISO 9001:2008 certified Institution

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Failing to present data contradictory to previous research Ignoring or bypassing guidelines / rules protecting human participants/ animals Non-disclosure of conflict of interest Fabrication, falsification, or plagiarism (FFP) 208 SIHFW: an ISO 9001:2008 certified Institution

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Guidelines by International Committee of Medical Journal Editors (ICMJE) Include names of all scientific & technical personnel significantly contributing to the intellectual content Study design Implementation of study Authorship 209 SIHFW: an ISO 9001:2008 certified Institution

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Analysis and interpretation of data Writing of paper Revision and final approval of paper Author order often implies significance of contributions, but must be mutually agreeable to all involved Acknowledgment if a contribution, but not large enough to be an author 210 210 SIHFW: an ISO 9001:2008 certified Institution

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Gift Authors A personal or professional favour; sometimes reciprocal Honorary Authors Sign of respect or gratitude Sometimes an institutional requirement Bad Authorships 211 SIHFW: an ISO 9001:2008 certified Institution

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Prestige Authors Someone well known to give paper more visibility or impact Ghost Authors May help with writing, but no participation in planning, execution or analysis Worst form has even the researchers as the ghosts 212 SIHFW: an ISO 9001:2008 certified Institution

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COI arises when behind the conclusions of study - there is most probably more than a scientific reason Competing interests can involve all participants in the publication process: authors, reviewers, editors and publishers/journal owners Some journals may require declaration of COI for publications The existence of conflict of interest is not a crime as long as they are disclosed Conflict of Interest 213 SIHFW: an ISO 9001:2008 certified Institution

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Improve quality of paper Authors not aware of the identity of the reviewers but reviewers aware of the identity of authors – unfair approach Blind peer review Interaction between the Author, reviewer & editor should be confidential Reviewer / editor should not use the information in the paper for own benefit Peer Review 214 SIHFW: an ISO 9001:2008 certified Institution

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Guidelines for using other’s work Understand idea & express it in own words If you can not modify: express it within quotations Obtain written permission from author for using figures & diagrams In the discussion of results section, it is necessary to provide supportive & contradictory evidences, if any How To Avoid Plagiarism? 215 SIHFW: an ISO 9001:2008 certified Institution

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Almost always owned by the institution not the individual Investigators are stewards Data storage is responsibility of the P.I. Must be maintained for 3 years; 7 is recommended, but longer is not an uncommon practice If published, original data may be subject to scrutiny Data Ownership and Retention 216 SIHFW: an ISO 9001:2008 certified Institution

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Copyright gives the owner the exclusive right to reproduce, distribute, perform, display or license his work What can be used without worrying about copyright? Anything in the public domain Anything that falls under fair use Copyright 217 SIHFW: an ISO 9001:2008 certified Institution

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Government documents Someone has granted particular free licenses Decide who may make copies, distribute, sell or rent Lasts for lifetime of author(s) + 70 years Usually owned equally by all authors, not their institutions 218 218 SIHFW: an ISO 9001:2008 certified Institution

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Major medical breakthroughs attract major media attention Quite common major discoveries appear in newspapers before scientific journals Authors should see that they are simultaneously published Should give both strengths and weaknesses of the study, however in practice not balanced Media Coverage 219 SIHFW: an ISO 9001:2008 certified Institution

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How to Prevent Research and Publication (R & P) Misconduct? The widespread R & P misconduct indicates ineffective control measures Making “policing” of research more effective is not the solution 220 SIHFW: an ISO 9001:2008 certified Institution

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1. Education – key step Research training – clear guidance on ethics Make available Institutional Guidelines on Research ethics/ICMR Guidelines Publication ethics – quality rather than quantity 2. The Research Protocol driven Investigators & Collaborators Define roles Agreement on protocol Agreement on presentation of results The following may be useful to address the issue: 221 SIHFW: an ISO 9001:2008 certified Institution

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Define methodology for data analysis Statistical advice Ethical approval Supervision Training and good communication of staff Ensure good clinical practice Meticulous record keeping 3 . The Publication Disclose conflict of interest Approval by all contributors Submit to one journal at a time Assume research data audit 222 SIHFW: an ISO 9001:2008 certified Institution

Who the author(s) would be:

Who the author(s) would be First Author-who does the writing & coordinates the team of co-authors. The last author is the senior member of the team & is often the person who conceived the initial idea for the study and/or obtained funding. I declare that I participated in the (here list contributions made to the study such as design, execution or analysis of the paper) by … and colleagues entitled … and that I have seen and approved the final version. “I also declare that I have no conflict of interest in connection with this paper other than any noted in the covering letter to the editor” 223 SIHFW: an ISO 9001:2008 certified Institution

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Title : Map out your keywords to write a title References References place the work in the context of the known and the unknown Read instructions carefully Look at recent issue of journal Read ICMJE URM Key messages 224 SIHFW: an ISO 9001:2008 certified Institution

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Introduction: The introduction explains why you started It requires 4 sentences Background Gap in knowledge Question Study design 225 SIHFW: an ISO 9001:2008 certified Institution

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Methods : Write the story Display the evidence with crude simplicity and objectivity Discussion: It is harder to be short than to be long Systematic preparation and iterative rewriting are key to success 226 SIHFW: an ISO 9001:2008 certified Institution

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Results : Interpret, do not discuss Describe, then interpret Interpret descriptive epidemiological data to generate hypotheses and analytical epidemiological data to test hypotheses Interpret in light of initial hypotheses Bring all the pieces of the puzzle in the discussion section of the paper 227 SIHFW: an ISO 9001:2008 certified Institution

Scientific Writing: Communicating with Editors:

228 Scientific Writing: Communicating with Editors State Institute of Health & Family Welfare, Jaipur SIHFW: an ISO 9001:2008 certified Institution

PowerPoint Presentation:

“There is no way to get experience except through experience.” 229 SIHFW: an ISO 9001:2008 certified Institution

Getting published: know the answers to:

Getting published: know the answers to Why ( I did the study-Introduction ) When (Methods) Where (Methods) Who (Methods) What (I found-results) How (use/outcome?) And that people often put as……. IMR a D 230 SIHFW: an ISO 9001:2008 certified Institution

Getting a paper published:

231 Getting a paper published Competition for space in journals is intense Cost of publication is high, Rejection rates vary AJP = 50% Science, Nature = 90% SIHFW: an ISO 9001:2008 certified Institution

The players:

The players Paper Authors Editors Reviewers 232 SIHFW: an ISO 9001:2008 certified Institution

Where should I publish: choice of Journal:

Where should I publish: choice of Journal Peer reviewed journal Others- Papers, magazines, news letters, book chapters 233 SIHFW: an ISO 9001:2008 certified Institution

What constitutes a good journal?:

234 What constitutes a good journal? Impact factor – average number of times published papers are cited up to two years after publication. Immediacy Index – average number of times published papers are cited during year of publication. SIHFW: an ISO 9001:2008 certified Institution

Deciding where to submit:

Deciding where to submit Match your paper with the personality and scope of the journal Match your subject with the journal’s target audience Consider the impact factor and citation index Weigh up the journal prestige, the likelihood of acceptance and the likely time until publication Have realistic expectations Scan the journals for one that matches your content and study design Be strong and, if rejected, select another journal 235 SIHFW: an ISO 9001:2008 certified Institution

PowerPoint Presentation:

Process of Research publication Completion of research Preparation of manuscript Submission of manuscript Assignment and review Decision Revision Resubmission Re-review Acceptance Publication Rejection Rejection 236 SIHFW: an ISO 9001:2008 certified Institution

What makes a good research paper?:

237 What makes a good research paper? Good science Good writing- “having something to say and saying it as clearly as you can.” Publication in good journals Science Citation Index Impact factor Immediacy factor SIHFW: an ISO 9001:2008 certified Institution

How to get published-Tips:

238 How to get published- Tips Know the journal, its editors, and why you submitted the paper there; Pay close attention to spelling, grammar, and punctuation; Make sure references are comprehensive and accurate; Avoid careless mistakes; and Read and conform to “Instructions for Authors” SIHFW: an ISO 9001:2008 certified Institution

Follow Uniform Requirements:

Follow Uniform Requirements First developed in 1978 by Vancouver group Adopted by International Council of Medical Journal Editors (ICMJE) JAMA publishes its instructions to authors in January and July each year Consolidated Standards of Reporting Trials (CONSORT) guidelines Meta-analysis of Observational Studies in Epidemiology (MOOSE) 239 SIHFW: an ISO 9001:2008 certified Institution

Common problems with manuscripts:

Common problems with manuscripts Too long Not clear Subject not appropriate for journal Poorly structured Too much of assumption 240 SIHFW: an ISO 9001:2008 certified Institution

PowerPoint Presentation:

“Those who have the most to say usually say it with the fewest words” 241 SIHFW: an ISO 9001:2008 certified Institution

Parts of a manuscript & order of writing:

Parts of a manuscript & order of writing Title Abstract Introduction Methods Results Discussion Acknowledgements References 242 SIHFW: an ISO 9001:2008 certified Institution

Title:

243 Title Will determine whether paper gets read Be short, accurate, and unambiguous Give your paper a distinct personality Begin with the subject of the study Avoid long title (see journal rules) Avoid abbreviations Title format: “The effects of heat on ice” “Heat melts ice” “The role of heat in melting ice” SIHFW: an ISO 9001:2008 certified Institution

Effective titles: :

Effective titles: Identify the main issue of your paper Begin with the subject of your paper Are accurate, unambiguous, specific, and complete Do not contain abbreviations Attract readers 244 SIHFW: an ISO 9001:2008 certified Institution

Abstract:

245 Abstract Critical part of paper State main objective Summarize most important results State major conclusions and significance Avoid acronyms Write and rewrite until flawless SIHFW: an ISO 9001:2008 certified Institution

Introduction:

246 Introduction Build case for why study is important/necessary Provide brief background State hypothesis / central question Give a one sentence summary of finding s SIHFW: an ISO 9001:2008 certified Institution

Methods and materials:

247 Methods and materials Best to begin with experiments/ study still in progress. Detailed enough so results can be repeated Reference published methods where appropriate. Include ethics committee approval Use descriptive subheadings Surgical procedures Histochemistry SIHFW: an ISO 9001:2008 certified Institution

Results:

248 Results Briefly repeating protocols can be effective Tables and figures must be straight forward and concise Present main findings referring to tables/figures. Do not speculate or over discuss results. SIHFW: an ISO 9001:2008 certified Institution

Discussion:

249 Discussion First answer question posed in introduction Relate your conclusion to existing knowledge Discuss weaknesses and discrepancies Explain what is new without exaggerating Do not repeat results Conclusion/summary, perspectives,implications SIHFW: an ISO 9001:2008 certified Institution

References:

250 References Relevant and recent Be highly selective Read the references Do not misquote Use correct style for journal Vancouver Harvard SIHFW: an ISO 9001:2008 certified Institution

Once you have finished, Organize your paper for-:

Once you have finished, Organize your paper for- Visual appeal Use ample white space, Number your pages Put identification information in a header or footer Start each new section on new page Write short paragraphs Left-justify and double-space the text Avoid hyphenating words between lines Use subheadings to divide sections Use new paragraphs for new topics 251 SIHFW: an ISO 9001:2008 certified Institution

Words and expressions to avoid:

252 Words and expressions to avoid Jargon Preferred use a considerable amount of much on account of because a number of several Referred to as called In a number of cases some Has the capacity to can It is clear that clearly It is apparent that apparently Employ use Fabricate make SIHFW: an ISO 9001:2008 certified Institution

Revise, revise and revise:

253 Revise, revise and revise All authors should participate Review order of data presentation Polish the writing style Double check references Look for typos Double check spelling SIHFW: an ISO 9001:2008 certified Institution

Develop a good writing style:

254 Develop a good writing style Read well written articles Try to get good writers to review Learn from editing changes SIHFW: an ISO 9001:2008 certified Institution

Submission:

255 Submission Read instructions carefully Fill out all necessary forms Copyright transfer Conflict of interest Write cover letter (suggest reviewers) Confirm receipt after 6 weeks SIHFW: an ISO 9001:2008 certified Institution

Covering letter:

Covering letter An important piece Brief, highlight importance of paper Do not brag, be modest Be clear and specific. In 4-5 sentences explain What is already known? what the state of scientific knowledge was in this area before you did your study and why this study needed to be done. What this study adds? You might use the last sentence to summarize any implications for practice, research, policy, or public health. Follow instructions of the journal 256 SIHFW: an ISO 9001:2008 certified Institution

Covering letter/checklist:

Covering letter/checklist Signatures of all authors/ corresponding author Read and approved the contents Information on: Prior publication of part/abstract Presentation at conference Financial or other conflicts of interest Contact details of all authors/corresponding author (affiliation to the institute, email) Type of article the manuscript represents Any details that journal wants included 257 SIHFW: an ISO 9001:2008 certified Institution

Enclosures:

Enclosures Transfer of copyright, other forms Permission To reproduce previously published material From patients for clinical photographs Keep copies of everything you submit 258 SIHFW: an ISO 9001:2008 certified Institution

PowerPoint Presentation:

Dear Editor Please find enclosed a paper entitled ‘………’ ,for consideration for publication in your journal. The data included in this manuscript have not been published previously and are not under consideration by any other journal. A form with consent to publication signed by the authors is enclosed. All authors have read this final manuscript and have given their approval for the manuscript to be submitted in its present form. I enclose: Three paper copies of the manuscript Three copies of the tables and figures A labeled disk containing the electronic version. As the corresponding author, my contact details are shown on the cover page of the manuscript. Yours sincerely 259 SIHFW: an ISO 9001:2008 certified Institution

Selection of reviewers:

Selection of reviewers How? Database Known individuals Authors suggestions References How many? Usually 2-3 May go to a statistical or methodological expert 260 SIHFW: an ISO 9001:2008 certified Institution

Editor’s expectations of the reviewers’ role:

Editor’s expectations of the reviewers’ role Fair, honest, detailed comments Identification of the strengths and weaknesses of the paper Constructive criticism Assistance to improve the paper Timeliness Within a reasonable period: 3-4 weeks 261 SIHFW: an ISO 9001:2008 certified Institution

Reviewers are asked to comment on the following areas::

Reviewers are asked to comment on the following areas: Scientific rigor Experimental or study design Adequacy of data Importance and originality of the results Validity of conclusions reached Completeness of the literature cited Clarity of writing Interest to the journal readership 262 SIHFW: an ISO 9001:2008 certified Institution

An editorial committee may decide that a paper: :

An editorial committee may decide that a paper: Is acceptable for publication Is acceptable for publication following minor revisions Is acceptable for publication following major revision May be reconsidered for publication following major revisions May be considered for publication as a letter or a short report Is unacceptable for publication 263 SIHFW: an ISO 9001:2008 certified Institution

Three scenarios:

Three scenarios Acceptance Rejection Comments from reviewers 264 SIHFW: an ISO 9001:2008 certified Institution

Three scenarios:

Three scenarios Acceptance Clarifications on minor points Better photographs Convert table/figure, change text Provide key messages Clarify points Read proofs Local editors Language clarity Rejection Comments from reviewers 265 SIHFW: an ISO 9001:2008 certified Institution

Three scenarios:

Three scenarios Acceptance Rejection The paper is not acceptable in its present form because of pro forma policy : choose to resubmit Comments provided can help improve the article Useful to follow the same initial steps Comments from reviewers 266 SIHFW: an ISO 9001:2008 certified Institution

Major reasons for rejection:

267 Major reasons for rejection Poor experimental design Poor controls Hypothesis not adequately tested Inappropriate for journal Poorly written SIHFW: an ISO 9001:2008 certified Institution

Publish and perish:

Publish and perish Data manipulation, falsification Duplicate manuscripts Redundant publication Plagiarism Author conflicts of interest Animal use concerns Humans use concerns “The Seven Deadly Sins” 268 SIHFW: an ISO 9001:2008 certified Institution

How do I take a Rejection letter:

How do I take a Rejection letter Wait for 24 hrs. Calm when trying to understand the nature of the rejection Why was it rejected (see comments after deconstructing each message) The paper is not acceptable in its present form( format) The paper did not get a high enough priority (alternative ) The study is interesting but too preliminary (ensure results are put in total) The study is interesting but is technically flawed(methods ?) The work is more appropriate for a specialized journal ( alternative) The study is descriptive The manuscript lacks controls The data is not convincing 269 SIHFW: an ISO 9001:2008 certified Institution

PowerPoint Presentation:

Most studies have some imperfections. The question is the nature and severity of those flaws. If you disagree with the reviewer, the burden is on you to convince them, not to dismiss them. If the reviewers misread your manuscript or missed a point, chances are that your writing style confused them. If your conclusions go against conventional wisdom, then you need to explain and convince why your view is the valid one. 270 SIHFW: an ISO 9001:2008 certified Institution

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271 SIHFW: an ISO 9001:2008 certified Institution

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272 SIHFW: an ISO 9001:2008 certified Institution

A typical Rejection letter:

A typical Rejection letter Thank you for sending us your revised manuscript. We have now considered this very carefully at an editorial level and I am afraid that we have decided not to accept the paper for publication. I know that you addressed the comments made by the reviewers by making some modifications to the paper. However, our decision not to publish was on the basis that we did not feel that the information was new or would be of great interest to our readership. I apologize for disappointing you. 273 SIHFW: an ISO 9001:2008 certified Institution

Rejection:

Rejection Consider should you accept rejection or fight Do you have defense Disagree to comments-try convincing Submit elsewhere Appeal Rarely Only if you have a strong case Biased reviewer, wrong major points 274 SIHFW: an ISO 9001:2008 certified Institution

Responding to reviewers:

275 Responding to reviewers Carefully prepare your responses Address each comment Each change should be stated Be enthusiastic Reviewer may be wrong Be tactful – thank the reviewers Do not respond to reviewers while upset Never call the editor Get help from other authors SIHFW: an ISO 9001:2008 certified Institution

Prepare your response:

Prepare your response Simple and to the point Polite Provide enough supporting evidence Get approval from co-authors Revise paper, try and make the majority of the changes requested 276 SIHFW: an ISO 9001:2008 certified Institution

Submission:

Submission Covering letter Point-wise reply to the reviewer’s comments Original manuscript Revised manuscript Send well within deadline 277 SIHFW: an ISO 9001:2008 certified Institution

Addressing the points raised by the reviewer (s):

Addressing the points raised by the reviewer (s) When you will change the manuscript (Preferred) Just say: “We modified the manuscript according to the suggestion on line … paragraph…” When you will not change the manuscript Explanation / clarification to say you agree but that the manuscript does not need to be changed Explanation / clarification to say you respectfully disagree, with documentation of your point 278 SIHFW: an ISO 9001:2008 certified Institution

Mistakes to look for in the proofs:

Mistakes to look for in the proofs Names, initials and affiliations Formatting errors Symbols Reference numbering Reference format 279 SIHFW: an ISO 9001:2008 certified Institution

Mistakes to look for in the proofs :

Mistakes to look for in the p roofs Tables Alignment Totals Calculations Digit loss Figures Re-drawn OK No format loss 280 SIHFW: an ISO 9001:2008 certified Institution

Returning the proofs:

Returning the proofs Comments in separate document Final OK from technical editor Ready for the publication 281 SIHFW: an ISO 9001:2008 certified Institution

Communicating when a paper is published :

Communicating when a paper is published Notify co-authors Disseminate abstract List servers Make press release On the initiative of the journal On personal initiative 282 SIHFW: an ISO 9001:2008 certified Institution

PowerPoint Presentation:

Happy writing Hope, next time you get published, not rejected Thanks 283 SIHFW: an ISO 9001:2008 certified Institution

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