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Guide to Protocol Writing

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32 views28 pages

Guide to Protocol Writing

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lee1820623
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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THESIS/DISSERTATION

WRITING
Formatting and Style Guide

Marivic A. Villamor, MD, MHPEd, PhD


CEU School of Medicine
CEU IERB
BASIC RESEARCH STRUCTURE
Perneger and Hudelson (2004). Writing a research article: advice to beginners. International Journal for Quality in Health Care, Volume 16, Issue
3,, Pages 191–192, https://doi.org/10.1093/intqhc/mzh053

The basic structure of a typical research paper is the sequence of


Introduction
Methods
Results
Discussion
Title of the Thesis/ Dissertation
Lang TA (2017). Writing a better research article. J Public Health Emerg;1:88. doi: 10.21037/jphe.2017.11.06

C onsider including any or all of the following elements when writing a title:
the setting and location
the subjects
the intervention
the study design
the time period (if applicable)
Introduction/Background of the
Study
Introduction/Background of the Study
• http://www.people.vcu.edu/~jldavis/resources/apa/APAproposal.pdf
• Perneger and Hudelson (2004). Writing a research article: advice to beginners. International Journal for Quality in Health Care, Volume 16, Issue 3,, Pages 191–192, https://doi.org/10.1093/intqhc/mzh053

The introduction serves to convince readers that your thesis/dissertation


topic is interesting and important (Significant).
Present broad background information about the topic in the first paragraph
State why the problem you address is important (Pernerger, 2004)
State what is lacking in the current knowledge (Pernerger, 2004)
State the objectives of your study or the research question (Pernerger, 2004)
Introduction/Background of the Study
Lang T (2010). How to Write, Publish, and Present in the Health Sciences: A Guide for Clinicians and Laboratory Scientists. Philadelphia: American
College of Physicians.

P urpose of the Study

The purpose of the study must be clear.


The purpose is never “to study”, “to evaluate”, “to compare” or “to investigate”, which are
actions, not purposes.
Instead, the purpose is “to determine”, “to verify”, “to describe” or “to select”, which refer
specifically to what you sought to accomplish with the research.
Study goals and objectives
https://www.who.int/groups/research-ethics-review-committee/recommended-format-for-a-research-protocol/

G oals

Broad statements of what the proposal hopes to accomplish.


They create a setting for the proposal.

S
pecific objectives are statements of the research question(s).
Objectives should be specific, measurable (Quantitative research), achievable, realistic, time-bound.
Conceptual Framework
McGaghie, Bordage and Shea (2001). Problem Statement, Conceptual Framework, and Research Question, Academic Medicine: Volume 76 - Issue
9 - p 923-924.

F unctions to
identify research variables
clarify relationships among the variables.

L inked to the problem statement, the conceptual framework ‘‘sets the stage’’ for presentation of the
specific research question that drives the study.
Review of Related Literature
Maggio, L. A., Sewell, J. L., & Artino, A. R., Jr (2016). The Literature Review: A Foundation for High-Quality Medical Education Research. Journal of
graduate medical education, 8(3), 297–303. https://doi.org/10.4300/JGME-D-16-00175.1

Literature review is a synthetic review and summary of


what is known and unknown regarding the topic of a
scholarly body of work, including the current work’s place
within the existing knowledge.
Review of Related Literature
Maggio, L. A., Sewell, J. L., & Artino, A. R., Jr (2016). The Literature Review: A Foundation for High-Quality Medical Education Research. Journal of
graduate medical education, 8(3), 297–303. https://doi.org/10.4300/JGME-D-16-00175.1

A literature review forms the basis for high-quality research and helps maximize relevance, originality,
generalizability, and impact.

A literature review provides context, informs methodology, maximizes innovation, avoids duplicative research, and
ensures that professional standards are met.

L iterature reviews take time, are iterative, and should continue throughout the research process.

R esearchers should maximize the use of human resources (librarians, colleagues), search tools (databases/search
engines), and existing literature (related articles).

K eeping organized is critical.


Review of Related Literature
http://www.people.vcu.edu/~jldavis/resources/apa/APAproposal.pdf

C ONTENT
Provide a literature review of prior research and theory that relates to the study.
The information should be from diverse sources.
Make sure it is clear to the reader how information is related to the study.
Relate information from various sources to each other and to your proposed research.
Review of Related Literature
http://www.people.vcu.edu/~jldavis/resources/apa/APAproposal.pdf

C ONTENT
Provide a literature review of prior research and theory that relates to the study.
The information should be from diverse sources.
Make sure it is clear to the reader how information is related to the study.
Relate information from various sources to each other and to your proposed research.
Review of Related Literature
http://www.people.vcu.edu/~jldavis/resources/apa/APAproposal.pdf

C itation of sources
Cite sources in APA style.
When citing a journal article
Never include the title of the paper
Do not mention the first names or initials of the authors
METHODS
Perneger and Hudelson (2004). Writing a research article: advice to beginners. International Journal for Quality in Health Care, Volume 16, Issue 3

Describe the context and setting of the study


Specify the study design
Describe the ‘population’
Describe the sampling strategy
Describe the intervention (if applicable)
Identify the main study variables (Quantitative Research) or Construct (Qualitative
Research)
Describe data collection instruments and procedures
Outline analysis methods
METHODS
McGaghie, Bordage and Shea (2001). Problem Statement, Conceptual Framework, and Research Question, Academic Medicine: Volume 76 - Issue
9 - p 923-924.

R esearch Design
helps the investigator focus on the research question(s) and
plan an orderly approach to the collection, analysis, and
interpretation of data that address the question.
METHODS
McGaghie, Bordage and Shea (2001). Problem Statement, Conceptual Framework, and Research Question, Academic Medicine: Volume 76 - Issue

R
9 - p 923-924.

esearch Design
defined and clearly described, and is sufficiently detailed to
permit the study to be replicated.
appropriate for the research question.
design and conduct of the study are plausible
METHODS
https://atsliteacher4. les.wordpress.com/2013/01/typesofresearch.png

fi
METHODS
Elmore Joann G. MD MPH,Wild Dorothea M.G. MD MPH,Nelson Heidi D. MD MPH MACP FRCP,Katz David L. MD MPH, 5 - Common research designs and issues in epidemiology, Jekel's Epidemiology, Biostatistics, Preventive Medicine,
and Public Health (Fifth Edition), edited by Elmore Joann G. MD MPH,Wild Dorothea M.G. MD MPH,Nelson Heidi D. MD MPH MACP FRCP,Katz David L. MD MPH, 2020, Pages 67-82.e1, ISBN 978-0-323-64201-9, http://dx.doi.org/
10.1016/B978-0-323-64201-9.00014-8.(https://www.clinicalkey.com/#!/content/3-s2.0-B9780323642019000148)
METHODS
McGaghie, Bordage and Shea (2001). Problem Statement, Conceptual Framework, and Research Question, Academic Medicine: Volume 76 - Issue
9 - p 923-924.

I nstrumentation
refers to the selection or development and the later use of
tools to make observations about variables in a research study.
METHODS
McGaghie, Bordage and Shea (2001). Problem Statement, Conceptual Framework, and Research Question, Academic Medicine: Volume 76 - Issue
9 - p 923-924.

I nstrumentation in Social and Behavioral Sciences Research


instruments are usually ‘‘paper- and-pencil’’ tools

I nstrumentation in Health, Biological and Physical Sciences Research


rely on tools such as microscopes, CAT scans, and many other laboratory technologies.
METHODS
McGaghie, Bordage and Shea (2001). Problem Statement, Conceptual Framework, and Research Question, Academic Medicine: Volume 76 - Issue

P
9 - p 923-924.

opulation and Sample


The population is defined clearly, for both subjects (participants) and
intervention
The population is sufficiently described to permit the study to be replicated.
The sampling procedures are sufficiently described.
Subject selection is appropriate to the research question.
Ethical aspects to consider in the Methods section
https://bestpractice.bmj.com/info/wp-content/uploads/2018/12/How-to-write-and-publish-a-paper-2018.pdf

Describe the consent procedure


Provide information summarizing measures done in the
study to protect subjects or respondents.
Describe the risks or benefits
METHODS
McGaghie, Bordage and Shea (2001). Problem Statement, Conceptual Framework, and Research Question, Academic Medicine: Volume 76 - Issue
9 - p 923-924.

D ata Analysis and Statistics (Quantitative Research)


Data-analysis procedures are sufficiently described
Data-analysis procedures conform to the research design
Statistical tests are appropriate
METHODS
McGaghie, Bordage and Shea (2001). Problem Statement, Conceptual Framework, and Research Question, Academic Medicine: Volume 76 - Issue
9 - p 923-924.

D ata Analysis (Qualitative Research)


relies on words instead of numbers
Describe procedures to establish reliability, validity,
trustworthiness
Reference/Citation
https://apastyle.apa.org/instructional-aids/reference-guide.pdf
Reference/Citation
https://apastyle.apa.org/instructional-aids/reference-guide.pdf
Appendices
https://bestpractice.bmj.com/info/wp-content/uploads/2018/12/How-to-write-and-publish-a-paper-2018.pdf

A ppend individually the following:

Curriculum Vitae of principal investigator/s


Informed consent form (including translated version if applicable)
Instruments or tools (eg. Questionnaire/Survey forms/Google forms)
Letter of approval from original authors (If applicable)
References

Lang TA (2017). Writing a better research article. J Public Health Emerg;1:88. doi: 10.21037/jphe.2017.11.06
Maggio, L. A., Sewell, J. L., & Artino, A. R., Jr (2016). The Literature Review: A Foundation for High-Quality
Medical Education Research. Journal of graduate medical education, 8(3), 297–303. https://doi.org/10.4300/
JGME-D-16-00175.1
McGaghie, Bordage and Shea (2001). Problem Statement, Conceptual Framework, and Research Question,
Academic Medicine: Volume 76 - Issue 9 - p 923-924.
Perneger and Hudelson (2004). Writing a research article: advice to beginners. International Journal for
Quality in Health Care, Volume 16, Issue 3,, Pages 191–192, https://doi.org/10.1093/intqhc/mzh053.
https://bestpractice.bmj.com/info/wp-content/uploads/2018/12/How-to-write-and-publish-a-paper-2018.pdf

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