developed in conjunction with:

Colgate Palmolive Clinical Research Training Program

Module 5 Scientific Writing

Content Creator and Trainer: Bruce Pihlstrom, D.D.S., M.S.Professor Emeritus, University of MinnesotaAssociate Editor for Research, Journal of the American Dental Association (JADA)Independent Oral Health Research ConsultantFormer Director of Extramural Clinical Research, National Institute of Dental and Craniofacial Research (NIDCR), National Institutes of Health (NIH)

Disclosure (May 1, 2016): Dr. Pihlstrom currently receives financial compensation as a research consultant to AAL and severaluniversities. He currently receives financial compensation as the Associate Editor for Research of JADA and as an author of the bimonthly JSCAN article that is published by JADA. He has received financial compensation as a consultant to the Colgate Palmolive Company in the past. He has received support from several corporations for research conducted while he was an active faculty member at the University of Minnesota (1974-2002) and as an independent research consultant. He currently receives no financial compensation from any company that markets professional or consumer dental products.

This educational material was created by Dr. Pihlstrom and should not be construed as reflecting policies or practices of the University of Minnesota, the Journal of the American Dental Association, the NIDCR, or any other organization or body.

Module 5 Goal

Provide an overview of technical and scientific writing for publication and for proposals for research funding

Overall References for this module:

Bader J. Publication of research findings. In: Giannobile WV, Burt BA, Genco RJ. Clinical Research in Oral Health. (2010) Hoboken NJ: Wiley Blackwell, pp. 321-339.

Pihlstrom BL, Barnett ML. Clinical and translational research grantsmanship: funding opportunities and obtaining research support. In: Giannobile WV, Burt BA, Genco RJ. Clinical Research in Oral Health. (2010) Hoboken NJ: Wiley Blackwell, pp. 79-101.

Karp BI, Nussenblatt RB. Writing a Protocol. In: Gallin JI, Ognibene FP. (2012). Principles and Practice of Clinical Research, 3rd ed., London: Academic Press, pp. 482-489.

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Learning Objectives

Learn how to write basic components ofscientific articles for publication

Learn how to write the basic components ofproposals for research funding

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Writing Scientific Articles for Publication

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Defining the Purpose and Target Readers of Scientific Articles for Publication

Why the article is being written? Publish results of specific study? Satisfy sponsor expectations?Inform clinicians and influence clinical practice? Update readers about a specific topic? Meet promotion and tenure requirements?

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Defining the Purpose and Target Readers for Scientific Articles for Publication

Who will read the article? Practitioners? Researchers? Patients / consumers / public Policy makers? Research sponsors?

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Basic Components of Scientific Articles for Publication

Title Abstract Introduction Methods and Materials Results and Data Presentation Discussion Conclusions

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Preparation of Scientific Articles for Publication

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READ, RE-READ AND…

FOLLOW AUTHOR INSTRUCTIONS FOR SUBMISSION OF MANUSCRIPTS!

Preparation of Scientific Articles for Publication

Follow guidelines:

For reporting clinical trials: CONSORT Statementhttp://www.consort-statement.org/checklists/view/32-consort/66-title

For observational studies: STROBE Statementhttp://www.strobe-statement.org/

For systematic reviews and meta-analysis:PRISMA Statement:http://prisma-statement.org

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Title of Scientific Article

Concise – length is limited by journalrequirements

Clearly & succinctly describes article content Often includes main research conclusion Determines whether reader will be interested in

article Use of key words is important for purposes of

database indexing - i.e., PubMed

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Title of Scientific Article - Examples

Poor Title“A study of Preterm Birth”

Better – but still poor:“A Clinical Trial of Preterm Birth”

Good Title“Effect of Periodontal therapy on Preterm Birth: ARandomized Clinical Trial”

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Abstract

Background A few sentences describing background and

justification for study

Purpose One sentence that clearly and simply states the

specific purpose or objective of the study

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Abstract

Methods Type of study and design (cross-sectional, case-

control, prospective cohort, parallel non-inferiority clinical trial, etc.)

Brief description of number and demographiccharacteristics of study subjects

Intervention (for clinical trials) Primary and secondary outcome variables

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Abstract

Methods (cont.) How subjects were selected for observational

study or randomized to treatment groups forclinical trials

Masking of subjects, care-givers, evaluatorsand/or data analysts

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Abstract

Results State the results in terms of the primary and

secondary outcomes in a few sentences Results should state whether the outcomes

were statistically significant and the level ofstatistical significance (p-value)

95% confidence limits are preferred foroutcomes by many journals

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Abstract

Conclusion One or two sentences that describes the overall

conclusions of the study. Think of it as the “take-home” message or the

“bottom line” of the study Make sure that the conclusion addresses the

primary purpose of the study as stated earlier inthe abstract

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Main Paper - Introduction

Background and pertinent literature review thatjustifies conducting the study

No more than a few paragraphs

Does not include an extensive literature review

Last sentence should state the purpose of thestudy

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Main Paper - Methods

Study design and main features e.g., case-control, prospective cohort,

randomized clinical trial, control group etc.

Participants Numbers

Inclusion and exclusion criteria

Recruitment methods

Intervention (if any)

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Main Paper - Methods Data Collection Describe what and how data on variables were

collected Number of examiners and examiner training and

calibration methods

Sample size determination and statisticalpower

Describe any masking (blinding) of studypersonnel and participants

Statistical analysisPrimary and secondary analysis methods

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Main Paper – Results and Data Presentation Results Include: Demographics, numbers of subjects completing

study Reasons for subjects discontinuing study Participant compliance with study protocol Statistical analysis of primary and secondary

outcomes Number and severity of adverse events (for

trials) Appropriate tables and figures for results

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Main Paper - Discussion

Discussion Includes:

Brief restatement of main results in generalterms – do not repeat detailed results of study

An interpretation of the results and significanceof study to the target readers

Discussion of similarities and differences infindings to results of previous studies

Realistic assessment of advantages andlimitations of the study

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Main Paper - Conclusions

Brief, clearly stated summary of findings thatanswer the main question of the study

Answers the main question posed by the study A one sentence answer to the one-sentence

question posed by the study

Do not conclude anything that is not supportedby the study results!

The wording of the conclusion must be exactlythe same in this section as in the abstract.

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Writing Proposals for Research Funding

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Defining the Purpose and Target Readers for Proposals and Applications for Funding Research

Format for application depends on: The question being asked Type of study proposed Funding sources

Public funding (government health agencies) Corporate funding Foundation funding

READ, RE-READ AND FOLLOWINSTRUCTIONS !!

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Components of Proposals for Research Funding

Title Abstract Investigators Budget Introduction Research hypothesis Significance

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Specific aims Preliminary data Research strategy Bibliography and

references Consultants and letters

of support Human subjects

protections

Components of Proposals for Research Funding

Title The first thing reviewers will read Keep it simple – short & descriptive

Abstract The second thing reviewers will read Critical that it clearly state the background,

purpose, method and significance of theproposed research

Investigators - follow format required by fundingsource

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Components of Proposals for Research Funding

Budget After the title and the abstract, the requested

funding amount is usually the third part of anapplication that reviewers will read

Be honest and realistic – do not overestimateor underestimate the cost of the proposedresearch

Follow the instructions and format required bythe funding source

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Components of Proposals for Research Funding Introduction to research proposal Provides a brief, pertinent, review of literature

and the reasons or uncertainty that forms thebasis or question for the proposed study

Provides the rationale for the researchhypothesis

Ends by stating the overall goal of theproposed research

Research hypothesis Follows the logic of the introduction Must be clearly and simply stated

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Components of Proposals for Research Funding

Significance Extremely important component of any

proposalMust make a strong argument for supporting

the research by the funding agency Answer the question – Why is this study

important to the mission of the funding agency?Must be clearly and simply stated

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Components of Proposals for Research Funding

Specific aims A “bulleted” or number list of the 2-4 specific

things that will be accomplished in order tomeet the overall goal of answering the researchquestion

Keep the specific aims, simple, clear andunderstandable

Do not be overly optimistic – be realistic in thespecific aims that are proposed

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Components of Proposals for Research Funding Preliminary data Present data from previous studies that

support the proposal for funding – either therationale for doing the study or the methodsthat are proposed in the application

Laboratory or animal data Previous data from human studies

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Components of Proposals for Research Funding Research strategy Study methods are presented in this section Shows how each specific aim will be achieved Following must be included in any clinical

research proposal Study design details Number and type of research subjects Subject inclusion and exclusion criteria

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Components of Proposals for Research Funding Research Strategy (cont.): Subject recruitment methods Sample size calculations including statistical

power Data collection, management, and plans for

statistical analysis

Bibliography and references Consultants and letters of support

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Components of Proposals for Research Funding Protection of human subjects How will human subjects will be protected

under international rules and guidelines? How will informed consent be obtained? How will welfare and safety of human subjects

be assured? How will confidentiality be assured? How will study be reviewed and approved by

ethics committee or Institutional Review Board(IRB)?

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Module 5 Key Points

In order to write a scientific article for publication, itis essential that it be determined why the article isbeing written and who is expected to read it

Clinical investigators need to understand thepurpose and contents of the various sections of ascientific paper including the: title, abstract,introduction, methods, results, discussion, andconclusions

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Module 5 Key Points

In order to write a successful application forscientific funding, it is essential to define thepurpose of the application and determine who willread and evaluate the application

To obtain funding for research, clinical investigatorsneed to understand the purpose and contents of thevarious sections of funding applications and followthe specific instructions of the proposed fundingagency

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End of Module 5

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