UCLA Types of Medical Writing Discussion

Description

In this discussion you will post and respond to classmates regarding the different types of medical writing. You will demonstrate your understanding of the course readings on types of medical writing and address the importance of being familiar with different medical writing genres.
Instructions
Initial Post
Create a discussion post that responds to all three of the following prompts:
Drawing from and directly citing at least 2 different course readings on types of medical writing, describe the different types/genres of medical writing. In your answer, consider how the purpose and audience might be impactful for these different types of medical writing. (Your answer should be at least 150 words).
Drawing from Taylor’s Chapter 11: “How to Write a Report of a Research Study,” explain the parts of the IMRAD format. What is the purpose of each section? Also, how might understanding the function of the IMRAD format help you as a reader better understand research study reports? (Your Answer should be at least 150 words)
Based on what you learned about different types of medical writing from the course materials, explain why it is important to understand the many types of medical writing in order to be an effective reader and writer of medical writing. (Your answer should be 100 words or more).

Replies
After posting your response to the three prompts, read what your classmates have written in their posts. Respond thoroughly to at least 2 classmates. When you respond consider:
What has your classmate addressed that you did not?

How has your classmate helped you understand/consider the different types of medical writing from the class readings?
What did your classmate not address from the readings that you think is important to remember about the different types of medical writing?8/31/2021
Mercury Reader
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What Types of Medical Writing Are
There?
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Medical writing is an interesting
and often lucrative career, and the
demand for medical writers is
high. Those new to the field may
wonder exactly what kind of work
medical writers do, whether it is
writing for medical journals or
newspapers, helping with research
efforts, or supporting medical
education. The answer is that there are many types of medical writing, medical
writers are called on in many different capacities, and their paths may take them
to a variety of employers and projects.
Assessing the Types of Medical Writing
The following are the most common professional areas of medical writing.
1. Regulatory writing: Medical writers in this professional area help write and
edit documents required by regulatory agencies, including the US Food and
Drug Administration, in the approval process for drugs, biologic agents, and
medical devices. Regulatory writers work at pharmaceutical, biotech, and
medical device companies as well as contract research organizations
(CROs).
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2. Scientific publications: In this area, medical communicators work with
physicians and other researchers to write and edit manuscripts for peerreviewed journals as well as posters, abstracts, and oral presentations for
medical conferences. Other medical communicators create summaries of
conference sessions and news and feature articles for professional
audiences. Medical communicators in the scientific publications area may
work at academic or health care institutions or at pharmaceutical, biotech,
or medical device companies.
3. Health communication: Medical writers in health communication write and
edit an array of materials for lay audiences, including patient education,
decision aids, public health communication, website content, medical/health
news, news releases, and public relations/communications. There are a
variety of settings for working in the health communication area, including
health care institutions, public health offices, government agencies,
publishers, and media outlets.
4. Education for professionals: In this area, medical communicators create the
various documents needed to develop educational activities for physicians
and other health care professionals. These documents include needs
assessments, slide sets, and outcomes analyses. Other medical
communicators write training materials for staff in pharmaceutical and
biotech settings. Medical communicators who develop these documents may
work at medical education companies, at academic institutions or health
care centers, or at pharma and biotech companies.
5. Promotional writing: Medical communicators in this setting create a variety
of materials to promote a drug, intervention, or medical device. These
materials can include marketing and advertising pieces that promote
diagnostic or therapeutic products. Medical communicators creating these
materials work at pharma, biotech, and medical device companies or at
medical communications companies. Other medical communicators write
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press releases and strategic communications in health care institutions and
organizations and in corporate settings.
6. Grantsmanship: Medical communicators write and edit grant proposals for
funding of scientific research. The settings range from academic and health
care institutions to private foundations, patient advocacy groups, and
professional associations.
Where Medical Writers May Work
As seen in the descriptions of the many types of medical writing, professional
medical communicators work in a variety of settings. Perhaps the best-known
work setting is the pharmaceutical industry, also known as pharma, which
represents not only drug companies but also medical device manufacturers and
biotechnology companies.
CROs represent another work setting and include companies that provide
support to the pharmaceutical, medical device, and biotechnology industries in
the form of research services outsourced on a contract basis.
Medical communication agencies provide consultancy services to the
pharmaceutical industry to help raise awareness of medicines through
promotional and marketing campaigns. Medical education companies are
designed to provide medical education for health care professionals.
Some medical communicators work in a health care setting, such as an academic
medical center, hospital, or managed care organization.
Associations of health care professionals, such as the American Heart Association
or the American Academy of Physician Assistants, are another setting in which
medical communicators create documents for both professional and lay
audiences. Patient advocacy groups, such as the Pancreatic Cancer Action
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Network and the Diabetes Patient Advocacy Coalition, employ medical
communicators to work on documents and website content for lay audiences.
A large proportion of medical communicators are independent contractors (or
freelancers), and they either work from a home office or accept short-term
contracts to work onsite at a company. Some freelance medical communicators
specialize in one type of medical writing or editing, whereas others work on a
variety of types.
Those seeking to learn more about the types of writing, settings, and projects
available to medical communicators may want to take AMWA’s online learning
session A Career in Medical Communication: Steps to Success. Also, the Ultimate
Guide to Becoming a Medical Writer further describes opportunities for both
full-time and freelance writers to excel in the field and find fulfillment, as well as
to advance the medical communication profession.
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Categories:
Career development, Getting
Started
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4/4
Chapter 11
How to Write a Report
of a Research Study
In questions of science, the authority of a thousand is not worth the
humble reasoning of a single individual.
Italian physicist and philosopher Galileo Galilei (1564–1642).
Galileo, a leader in the Scientific Revolution that followed
the hyper-religiosity and doctrinaire thinking of the Middle
Ages, was a champion of reasoning. Ideally, of course, reasoning is based on observed facts—data—and medicine science’s
best format for data presentation and analysis today is the
report of a clinical study.
In the Journal of the American Medical Association
(JAMA) is a report of a study intended “to investigate the
associations between major classes of psychotropic medications and violent reoffending.” The researchers followed
22,275 released prisoners over a mean follow-up period of
4.6 years. They found that the rates of violent reoffending
were lower when subjects were receiving psychotropic drugs
compared with periods when they were not dispensed these
medications (Chang Z et al. JAMA. 2016;316:1798).
A study reported by Lauch et al. described the use of cabbage leaf wraps as therapy for treatment of symptomatic
osteoarthritis (OA) of the knee in 81 patients, finding “cabbage leaf wraps are more effective for knee OA than usual
© Springer International Publishing AG 2018
R.B. Taylor, Medical Writing,
https://doi.org/10.1007/978-3-319-70126-4_11
289
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11.
How to Write a Report of a Research Study
care, but not compared with diclofenac gel” (Lauche R et al.
Clin J Pain. 2016;32:961).
In Epidemiology is the report of a study that examined the
risk of fatal myocardial infarction in persons exposed to aircraft noise (Huss A et al. Epidemiology. 2010;21:829).
Following analysis of 4.6 million individuals over 5 years, the
authors concluded that there is, indeed, a dose-related association between aircraft noise and death from myocardial
infarction, independent of possible confounding factors such
as particulate matter air pollution and socioeconomic status
of the municipality.
According to a report published in Pediatrics, the use of
probiotics, specifically Lactobacillus reuteri, can reduce daily
crying episodes in colicky babies, a conclusion based on a
randomized, double-blind, placebo-controlled trial involving
50 infants (Savino F et al. Pediatrics. 2011;126;e526).
A research report in the New England Journal of Medicine
(NEJM) titled “Effect of Short-Term vs. Long-Term Blood
Storage on Mortality after Transfusion” found “no significant
difference in the rate of death among those who underwent
transfusion with the freshest available blood and those who
underwent transfusion according to the standard practice of
transfusing the oldest available blood” (Heddle NM. NEJM.
2016;375:1937).
Preparing the report of original research is arguably the
most challenging undertaking in medical writing. It is not
necessarily that writing the report is so complicated, because
the model is prescribed. In a sense, you need only to fill in the
blanks. The challenging part is that one needs to have completed a research study and have the resulting data available.
What follows assumes that you have completed that task and
are composing your research report for publication.
Because there is a prescribed model, writing the report of
original research has one advantage over other types of
medical writing. You will not need to dream up a concept and
structure for the article. In previous chapters I discussed
diverse ways to approach the review article, editorial, book
chapter, and other models of medical publication. For the
Thinking About the Research Report
291
report of original research, there is only one model, called
IMRAD. This acronym stands for the major parts of a
research report: introduction, methods, results, and discussion. The IMRAD format is what editors are accustomed to
reviewing. It is what clinicians and scientists are used to reading. Deviating from this format risks summary rejection. I
describe the IMRAD format below.
The rigid format for the report of original research highlights the fact that research reports are intended to be
recorded in the scientific literature and subsequently cited by
others; they are not really written to be read, as most of us
think of reading. They are intended to be repositories of scientific data rather than literary gems. They just happen to be
written in prose. Day has summarized this viewpoint very
well: “Some of my old-fashioned colleagues think that scientific papers should be literature, that the style and flair of an
author should be clearly evident, and that variations in style
encourage the interest of the reader. I disagree. I think scientists should indeed be interested in reading literature, and
perhaps even in writing literature, but the communication of
research results is a more prosaic procedure” [1].
With that said, I still plead with authors, even those composing research papers, to construct paragraphs thoughtfully,
avoid long and convoluted sentences, select words carefully,
avoid the use of jargon, and express their ideas as clearly as
possible.
Thinking About the Research Report
For the clinical investigator, getting research results published can be the difference between professional success and
failure in the academic medicine arena. It can determine
whether or not one gets the big grant or receives tenure.
Entire academic careers have been built on a single groundbreaking research study, carefully reported in a prestigious
journal. Whether you are a patient care physician or a
research-track academic faculty member, whether you have
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11. How to Write a Report of a Research Study
done a bench project in the laboratory or a randomized clinical trial, remember that your research is not completed until
the results are reported in print.
The five papers I cited above all had research questions
that provoked my interest and perhaps yours. The paper
describing less violent reoffending in released prisoners when
taking psychotropic drugs seems to provide some data supporting an assumption we have long held. I had never heard
of cabbage leaf wraps for treatment of knee OA, but this safe
and inexpensive remedy may appeal to some patients who
favor alternative medicine. Although I had never thought
much about the issue before I read the title, I wanted to know
if aircraft noise might be associated with death from myocardial infarction. I was intrigued by the well-designed study of
the use of probiotics in colicky babies. The finding that “old”
bank blood is just as good as the freshest blood helps to support standard blood bank practice. Because these and other
research reports have implications for daily practice and
public health, I briefly summarized the study outcomes, even
though this is a book about writing and not clinical science.
I mention the above—about my interest in the research
questions that prompted the studies—because you may be
tempted to stretch the definition of research too far. As a
surgeon, you may consider reporting the findings of your last
200 cases of lumbar laminectomy or laparoscopic cholecystectomy. If you are an internist, you may believe that your
colleagues are keenly interested in how you treated 100 consecutive patients with congestive heart failure. Such studies
do not set out to answer a clinical question and generally do
not have anything important to say. They may qualify as quality improvement efforts, but are not likely to result in a publishable research paper.
A research report describes your research, whether it
involves humans, rats, or a meta-analysis of previously published studies. In general, you generate a research question
and then collect data to answer the question. “Data mining,”
sifting through tons of data to find something, anything that
has statistical significance, is not good research, and a paper
Thinking About the Research Report
293
describing such a method will be deemed inferior by an
informed reviewer.
Then there are “parachute trials.” These studies get their
name from asking the fanciful research question: Are parachutes effective in preventing major trauma related to gravitational challenge? (Smith GCS et al. BMJ. 2003;327:1459). For
example, would we really need to report a study showing that
antibiotic therapy of meningitis is more effective than watchful
waiting? Consider the study of “Genetic Evidence for Causal
Relationships Between Maternal Obesity-Related Traits and
Birth Weight,” showing basically that overweight mothers had
overweight babies (Tyrrel J et al. JAMA. 2016;315:1129). Or
perhaps even the previously cited report that released prisoners
taking their psychotropic medication exhibited less violent
behavior. Yes, data mining and parachute trial reports are published, but the best hypothesis-based studies have the best
chance of acceptance in the leading journals.
When planning a research report, be aware that competition for publication space in leading refereed journals is
intense, and research papers are typically rewritten several
times before final acceptance. Ultimately, your clinical
research paper will be judged by its impact on your specialty
and on the greater body of medical knowledge, as evidenced
by its citation in other research articles, review papers, and
textbooks.
Just before launching into a discussion of how to write a
report of hypothesis-based research based on the quantitative scientific model, I want to acknowledge another branch
of research that also is reported in the literature—qualitative
research. This type of research, which medical science has
borrowed from our colleagues in sociology and anthropology,
does not generate piles of data. Instead, we find terms such as
focus groups, studying stories, and mixed methods research
[2]. The IMRAD model, describe below, does not readily lend
itself to reports of qualitative research, which tend to use
more innovative styles, prompted by the nature of the results
being reported. Here, we will examine how to report the
results of traditional quantitative research.
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11. How to Write a Report of a Research Study
The Expanded IMRAD Model
The IMRAD model of research reports has evolved over
generations of scientific publications. It has at its core four
elements:
 Introduction: Why is the topic important, what prior
research has been done, and what question did you set out
to answer?
 Methods: Who were your subjects and what did you do to
them? How did you analyze the data?
 Results: What did you find out?
 Discussion: What do your findings mean? What are the
cautions regarding interpretation?
These four items are the foundation of IMRAD. Research
papers, however, have more than just the four main components, and I am going to present an expanded IMRAD
model. Keep in mind the four key elements as we explore the
IMRAD model and more, beginning with selection of the
title for the report.
Those reporting on scientific research should also consult
the EQUATOR (Enhancing the QUAlity and Transparency
Of health Research) network, an international collaboration
that aims to promote accurate and reliable reporting of
health research studies. The web site provides reporting
guidelines for the various types of health research studies:
randomized trials, observational studies, systematic reviews,
and so forth. The EQUATOR network site is available at
http://www.equator-network.org.
Title
The title is the “label” for the paper. The title must tell, more
or less, what was studied. An early question the writer must
answer is this: Should I reveal my conclusion in the title?
One of the studies cited at the beginning of the chapter is
titled “Association Between Prescription of Major
The Expanded IMRAD Model
295
Psychotropic Medications and Violent Reoffending After
Prison Release.” If I read only the title and have no other
background knowledge, I might misunderstand the authors’
meaning and presume that prescription psychotropic medications lead to violent reoffending after prison release. In fact,
the study showed just the opposite. Therefore, I believe that
a better title would be “Prescription of Major Psychotropic
Medications Reduces Violent Reoffending After Prison
Release.” Might the title of the cited article called “Aircraft
Noise, Air Pollution, And Mortality From Myocardial
Infarction” be improved by stating that, yes, there does seem
to be an association between aircraft noise and myocardial
infarction?
A title telling your conclusion is called a declarative title.
For example, the “fat mothers/fat babies” study cited above
might have been titled “Genetic Evidence Found for Causal
Relationships Between Maternal Obesity-Related Traits and
Birth Weight.” Note the insertion of a verb in the title.
Whimster writes: “I believe that readers need a verb in the
title, such as a newspaper headline usually has, and that to be
meaningful it should convey the message, as in: ‘Rickettsial
Endocarditis Is Not A Rare Complication Of Congenital
Heart Disease In Dental Practice: A Report Of Five Cases’”
[3]. Some journals encourage such titles, while others discourage or even prohibit them. A study by Wager et al. found “no
evidence that the use of a declarative title affected readers’
perceptions about study conclusions” [4].
Sometimes we authors dream up witty titles. Consider the
following title: “It’s B-A-A-A-A-A-A-Ck Again, Or How To
Live With The New APA Manual: Reprise For Edition 6”
(Baggs JG et al. Res Nurs Health. 2009;32:477). Generally,
editors counsel against using clever phrases in titles and
rightfully so.
Note how often colons show up in article titles. They allow
progression from the general to the specific, all in an integrated title phrase. An example is the title “A July Spike in
Fatal Medication Errors: A Possible Effect of New Medical
Residents.” The authors discuss the general problem and then
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11. How to Write a Report of a Research Study
the approach used in the research. The reader has a better
idea of the article’s contents than if only the first phrase was
listed.
Today it is fashionable to title a research study with an
acronymic name and to carry this over into the title of the
research report. An example is “Effect of LaparoscopicAssisted Resection vs Open Resection on Pathological
Outcomes in Rectal Cancer: The ALaCaRT Trial” (Stevenson
ARL et al. JAMA 2015;314:1356). The ALaCaRT acronym is
derived from the Australian Laparoscopic Cancer of the
Rectum Trial. Consider also “Anticholinergic vs. Long-Acting
Beta-agonist in Combination With Inhaled Steroids in Black
Adults with Asthma: the BELT Randomized Clinical Trial”
(Wechsler ME et al. JAMA 2015;314:1720). The BELT acronym comes from “The Blacks and Exacerbations on LABA vs
Tritropium (BELT) Study,” which I submit seems to be a
bacronym, a word (BELT) turned into an acronym by creating
a phrase to match the letters.
An article’s title can influence the citation rates. Jacques
et al. studied citation rates of articles published in three prestigious journals. They found: “The number of citations was
positively correlated with the length of the title, the presence
of a colon in the title and the presence of an acronym. Factors
that predicted poor citation included reference to a specific
country in the title” [5].
On a technical basis, the instructions for authors may prescribe a word or character limit for the title. Also, I believe that
titles should not contain acronyms or abbreviations, no matter
how widespread the author and editor consider their use.
Authors
The chief issues in an authorship of a research report are
generally twofold: (1) Who is an author? (2) How shall the
authors be listed?
As discussed in Chap. 5, everyone who contributed substantially to a research project and preparation of the report
should be listed as author. Furthermore, each author should
The Expanded IMRAD Model
297
have participated sufficiently in the work to take public
responsibility for appropriate portions of the content [6, 7].
What about adding author names of those who have contributed very little? Strasburger describes the problem:“Fiction
is written by one individual; medical articles may be written by
committee. There is no such thing as ‘author inflation’ in fiction, simply because there is no need for it. Medical writers
must publish or perish, academically. Fiction writers must publish or perish, existentially” [8]. Despite the need to avoid
perishing, it is inappropriate to have your name listed if you
have not met the criteria listed in the previous paragraph. You
must not become an perpetrator of author inflation.
No department chair or research director should insist on
being named as an author unless he or she has made a significant contribution to the study and to writing the paper.
Authorship listing by administrative fiat is academic malpractice. Adding the name of a prestigious senior faculty member
as the final entry on a long author list might help get the
paper a better review, but including the well-known name
implies that person’s active participation in the project.
Gratuitous addition of an author name—honorary authorship—is ethically inappropriate.
The order in which authors are listed on a research report
should be decided very early in the process, generally during
one of the first meetings of the research group planning the
study. Changes in the rank order can be made later if
contributions of individuals to the project do not turn out to
be what was originally planned.
The first author should logically be the one who has done
most of the work on the study being reported. Generally this
is the person who led the research team and who has created
the early drafts of the paper. From then on, authors should be
listed according to how much they contributed to the study
and the report. As one whose last name begins with a letter
toward the end of the alphabet, I have never considered
alphabetical listings of names to be fair to the Taylors,
Washingtons, and Zells of the world. And Alpert, citing his
mentor, reminds us, “The fastest way to make an enemy is to
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11. How to Write a Report of a Research Study
fail listing someone as an author who thought they should
have been included” (Alpert JS. Am J Med. 2015;128:551).
A quirk of citation listing holds that when the paper is used
as a reference in other studies, if your paper has seven or more
authors, only the first three are named and the rest will join
the et al. army of obscurity. Johnson has given us a humorous
poem titled “Buried in the Et Al” (Johnson DH. The Pharos,
Summer 2016:35) that include the memorable lines:
I made a contribution,
But got no attribution.
… buried in the “et al.”
Abstract
The Abstract is an author-generated synopsis of the paper.
Many advise that the final version of the abstract should be
the last item written, since only then will you know exactly
what is in the paper that you are summarizing. When writing
an abstract, select each word as if your paper’s being read
depended on it and jettison verbal clutter ruthlessly.
In general I have always taught that the abstract should mirror the IMRAD structure of the paper. That is, the paper’s
introduction, methods, results, and discussion (conclusions)
should each be presented in a sentence or two, and many good
abstracts have exactly four short paragraphs. According to the
International Committee of Medical Journal Editors (ICMJE)
recommendations, “The abstract should provide the context or
background for the study and should state the study’s purpose,
basic procedures (selection of study participants, settings,
measurements, analytical methods), main findings (giving specific effect sizes and their statistical and clinical significance, if
possible), and principal conclusions” [6].
Many abstracts set the stage by starting with an unassailable
general statement. Here is an example:The abstract for a report
titled “A Prospective Study of Sudden Cardiac Death among
Children and Young Adults” begins with the sentence, “Sudden
cardiac death among children and young adults is a devastating
event” (Bagnall RD et al. NEJM. 2016;374:2441).
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299
The current trend is for journals to require structured
abstracts [9]. This means that information in the abstract is
presented according to specific headings that differ a little
with each journal. All structured abstracts will include the
four key components of the IMRAD model, although synonyms for these headings may be used, including some variations such as “Context” and “Main Outcome Measures.”
Some journals prefer abstracts with full sentences; others
encourage the use of phrases. Here, from the Archives of
Surgery, is what we find in a well-written structured abstract
for a paper titled “Risk Factors for Lymphedema in a
Prospective Breast Cancer Survivorship Study” (Kwan ML
et al. Arch Surg. 2010;145:1055):
Objective: To determine the incidence of breast cancerrelated lymphedema (BCRL) during the early survivorship
period as well as demographic, lifestyle, and clinical factors
associated with BCRL development.
Design: The Pathways Study, a prospective cohort study of
breast cancer survivors with a mean follow-up time of
20.9 months.
Setting: Kaiser Permanente Northern California medical
care program.
Participants: We studied 997 women diagnosed from
January 9, 2006 through October 15, 2007, with primary invasive breast cancer and who were at least 21 years of age at
diagnosis, had no history of any cancer, and spoke English,
Spanish, Cantonese, or Mandarin.
Main outcome measure: Clinical indication for BCRL as
determined from outpatient or hospitalization diagnostic
codes, outpatient procedural codes, and durable medical
equipment orders.
Note that so far, only one section—Participants—contains
a complete sentence. Later in the abstract, under Results and
Conclusions, paragraphs become longer and the style changes
from phrases to complete sentences.
The instructions for authors for the Journal of the American
Medical Association state, “Reports of original data should
include an abstract of no more than 350 words using the
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11. How to Write a Report of a Research Study
headings listed.” These headings are: Importance, Objective,
Design, Setting, Participants, Intervention(s) or Exposure(s),
Main Outcome(s) and Measure(s), Results, Conclusions and
Relevance, and Trial Registration. The JAMA Instructions
for Authors goes on to tell what should be presented in each
section of the abstract [10].
The tight word limitation and the many topics to be covered serve to get the important data into tightly written
abstracts but at the expense of some very complicated, number-laden, and almost incomprehensible sentences in the
Results section. For brevity, most journals allow incomplete
sentences in the abstract.
On a technical basis, descriptions of work that has been
done (Methods and Results) should be written in the past tense.
An explanation of what you think (Discussion) is written in
present tense, often with a phrase such as “We conclude.…” In
the spirit of intellectual honesty, the abstract must never contain a conclusion that is not supported by what is in the body
of the paper.
Be sure to end the Conclusions and Relevance section of
the abstract by telling the results of your research. Curiously,
some authors seem to want to keep their conclusions a secret.
Consider the following from a trial of fecal microbiota transplantation (FMT) to treat relapsing C. difficile infection:
“This preliminary study among patients with relapsing C. difficile infection provides data on adverse events and rates of
resolution of diarrhea following administration of FMT using
frozen encapsulated inoculum from unrelated donors”
(Youngster I et al. JAMA. 2014;312:1772). Wonderful. But
what were your conclusions?
Clinical Trial Registration
For all clinical trials, the name of the trial registry, registration number, and URL of the registry must be included. A
list of acceptable trial registries can be found at http://www.
icmje.org.
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301
Keywords
In some instances you will be asked to identify Keywords.
Keywords can be what keep your report from being lost in
the information jungle. They are part of the retrievability
process that can contribute to the number of times your
paper will be cited. In the instructions for authors, many journals request that you submit a short list of keywords or
phrases. These will be used to cross-index the article; they
may or may not published with the abstract. Terms from the
Medical Subject Headings (MeSH) list from the US Library
of Medicine should be used if possible. For more information
on MeSH, see https://www.nlm.nih.gov/mesh/ and Chap. 1 of
this book.
Introduction
Finally we arrive at the “I” in IMRAD. The introduction
should identify the problem you set out to solve. In a sense, it
describes the context of the study. In general terms, the introduction should cover three areas:
 Problem statement: What is the general nature of the problem that merits valuable journal space and the reader’s
attention?
 Background and work to date: What are the most pertinent, timely published studies that relate to the problem?
 The research question: What is the specific, focused
question(s) that you set out to answer? If you have a formally stated hypothesis, here is where it should be
presented.
The Problem
The Introduction classically opens with a broad statement
that puts the problem in context. The introduction to a paper
on aspirin and colorectal cancer begins, “Colorectal cancer is
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the second most common cancer in developed countries…”
(Rothwell PM et al. The Lancet. 2010;376(9754):1741).
Good introductions are often written as a three-level
“inverted pyramid.” The broadest statement comes first.
Here is an example: Primary care clinicians encounter many
patients with headaches. Next comes a more narrow statement: The clinician treating a headache patient is always
aware that, in a few individuals, the cephalgia might be the
tip-off to a life-threatening disease. This might be followed by
an even more specific statement setting out the purpose of
the study: This study examines patient records to identify
symptoms and signs that might identify persons most at risk
for life-threatening causes of head pain who should be
referred for diagnostic imaging.
Background
Describe the key work that has been done on the topic to
date. Do not present an exhaustive literature review dating
back to the Renaissance. Be very selective and include only
articles that have a direct bearing on your research question.
Research Question
State clearly the question you are trying to answer. One
focused question is usually better than many. The question
may be stated as a query or perhaps as a hypothesis but often
is phrased as a statement of intent: In the study of aircraft
noise and fatal heart attacks, the research question is stated:
“We examined residential exposure to aircraft noise and
mortality from myocardial infarction, taking air pollution
into account.”
To inform the reader as to what your study is all about, it
is vital that you articulate the research question clearly in the
introduction. I wish that writers of research reports would all
do so and would frame their research questions as direct queries or even as hypotheses. For example, the authors of the
paper on blood storage and mortality, cited earlier in the
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chapter, state clearly, “Our goal was to determine whether the
in-hospital rate of death among patients requiring transfusion
was lower among those who received blood after short-term
storage than among those who received blood after longterm storage” (Heddle NM et al. NEJM. 2016;375:1937).
However, many authors are less explicit, and I have
learned to be content with somewhat vaguely stated research
questions such as: “The purpose of this study was to investigate both early and late dumping syndromes after gastrectomy for gastric cancer in 2 high-volume centers in Japan”
(Mine S et al. J Am Coll Surg. 2010;211:628). At this point in
the paper, I am still not aware what question the authors set
out to answer.
Technical Issues in Writing the Introduction
When writing your introduction, use the present tense to
describe the general nature of the problem and the background work. Then the research question, if presented as a
statement, is usually in past tense, as in the examples above.
The ICMJE recommendations advise, “Do not include data
or conclusions from the work being reported” [6]. Not everyone agrees with this stance. Both Day [1] and Whimster [3]
advocate stating the conclusions early in the article, and not
keeping the reader in suspense, as you would with a whodunit
mystery novel. The best spot for the important implication for
translation of your findings to clinical practice may be in the
introduction. In this area where controversy exists, use your
best judgment, based on the data you are presenting.
Methods
The Methods section, sometimes called Participants and
Methods or perhaps Methods and Materials, should describe
a logical experimental approach. Because this section presents
a number of topics, subheadings are often used. The Methods
section of the article mentioned above about aircraft noise
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and fatal MI has five headings: Study Population, Outcomes,
Exposure to Aircraft Noise, Exposure to Air Pollution, and
Statistical Analysis. In the article about blood storage and
mortality after transfusion, the Methods section has six subheadings: Study Design, Patient Population, Randomization
and Intervention, Outcomes, Data Collection, and Statistical
Analysis.
Fundamentally, this section needs to describe the subjects,
what you did to them, and what statistical methods you used.
After writing the first draft of the Methods section, ask yourself whether what you are presenting allows reproducibility.
That is, could a trained investigator in your field replicate
your study, given the information you have provided?
Methods should not include numerical data, which should
be presented in the Results section.
Subjects
Describe the subjects studied, including age, gender, and other
important characteristics that may be pertinent to the study.
The ICMJE Recommendations state that when authors use
such variables as race or ethnicity, they “should define how
they measured these variables and justify their relevance” [6].
Tell also whether any potential subjects were excluded and
why they were excluded, if there is a meaningful reason. For
example, in a study of the use of probiotics to reduce infant
colic, subjects with chronic illness or gastrointestinal disorders were excluded (Savino F et al. Pediatrics. 2011;126:e526).
Methods
Here you describe what was actually done to the subjects.
Also, if appropriate, describe any data collection tools, such
as survey instruments. If apparatus was used, identify the
item and manufacturer. Be sure to identify all drugs by
generic name; adding the trade name is optional but is useful
for the practicing clinician. Be sure to include medication
doses and routes of administration.
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Statistics
Describe the statistical methods used, “with enough detail to
enable a knowledgeable reader with access to the original
data to verify the reported results” [6]. This generally means
identifying specific tests used. In the study of aircraft noise
and fatal MI, the description of the statistics used begins, “We
analyzed the association between aircraft noise and cardiovascular mortality using Cox proportional hazard models,
with age as the underlying timescale.”
In an effort to make this book more useful for those
involved in research studies, I have added a lexicon explaining commonly encountered methodological and statistical
terms. (See Appendix D.) In the meantime, here are some
thoughts, several taken directly from the ICMJE recommendations [6], about the use of statistics in presenting reports of
clinical research studies:
 Avoid relying solely on statistical hypotheses testing such
as P values, which fail to convey important information
about effect size [6].
 When data allow, present quantifiable findings with appropriate indicators of measurement error or uncertainty
(such as confidence intervals) [6].
 When describing the statistics you employed in analyzing
data, specify the statistical software package(s) and versions used [6].
 Don’t hesitate to seek help with statistics. It is easy to get
lost in the unfamiliar forest of statistical analysis. A study
by Strasak et al. found, “Five of 31 papers for the New
England Journal of Medicine (NEJM) (16.1%) contained
usage of wrong or suboptimal statistical tests, either
because of incompatibility of test with examined data,
inappropriate use of parametric methods, or use of an
inappropriate statistical test for the scientific hypothesis
under investigation” [11].
 Finally, you should never allow a pharmaceutical company
or other research sponsor to do the statistical analysis of
your data [12].
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How to Write a Report of a Research Study
Table 11.1 Sources of statistical information for medical writers
Bland M. An introduction to medical statistics. 4th ed.
New York: Oxford University Press; 2015
Everitt BS. Medical statistics from A to Z: a guide for clinicians
and medical students. 2nd ed. London: Cambridge University
Press; 2007
Good PI, Hardin JW. Common errors in statistics (and how to
avoid them). 4th ed. Hoboken, NJ: Wiley; 2012
Hastie T, Tibshirani R, Friedman J. The elements of statistical
learning: data mining, inference, and prediction. 2nd ed.
New York: Springer; 2013
Kirkwood B, Sterne J. Essential medical statistics. 3rd ed.
Hoboken, NJ: Wiley-Blackwell; (for release in 2020)
Lang TA, Secic M. How to report statistics in medicine:
Annotated guidelines for authors, editors, and reviewers
(medical writing and communication). 2nd ed. Philadelphia:
American College of Physicians; 2006
Peacock JL, Peacock PJ. Oxford handbook of medical statistics.
New York: Oxford University Press, 2011
Scott I, Mazhindu D. Statistics for healthcare professionals: an
introduction. 2nd ed. Thousand Oaks, CA: Sage; 2014
Table 11.1 lists some publications that may be helpful for
the statistically challenged.
Results
What did you discover at the end of your research trial?
Describe your findings in a logical sequence and do so fully,
yet succinctly. To support my plea for readability in research
reports, I like the image created by Alexandrov: “Make data
presentation so clear and simple that a tired person riding
late on an airplane can take your manuscript and get the message at first reading” [13]. (As a physician, I find this a slight
challenge, given that with the imperfect pressurization of
aircraft cabins, there is a measureable decrement in blood
oxygen saturation and hence in cerebral oxygenation, at
35,000-feet elevation.)
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I have sometimes said, only partly in jest, that the ideal
Results section has a single sentence, “The results are presented in Table 1,” followed by a single, carefully constructed
table. In reality, presenting research results is never this simple, but the use of tables and figures can help organize numbers in ways that cannot be accomplished in words. Also, the
Results section should begin with some explanatory prose
before sending the reader to the first table. Keep in mind that
figures are expensive to produce and tables are a leading
source of error. On balance, however, most Results sections
benefit from one or more tables or figures. The article on
blood storage and mortality after transfusion, described earlier, has three figures and two tables.
Tables and figures for all types of publication models are
discussed in detail in Chap. 4. Here I will only emphasize the
importance of creating a legend for each that explains the table
so that it can be reasonably understood without referring to the
accompanying text. That is, a lecturer can readily incorporate
your table with its legend into a PowerPoint presentation (with
credit to you, of course) with minimal explanatory prose.
Tables and figures should not duplicate data presented in
the text. Select only one location to present the numbers.
Discussion
In Chap. 1, I stated that each article must face the “So what?”
question. The Discussion section should answer that question
by stating the relationships among facts discovered, relating
them to prior studies (the ones you mentioned earlier in the
introduction), and postulating what it may all mean—the
conclusions. Discuss the results, but do not restate what has
already been said under Results. A good way to begin this
section is with the phrase: “Our study showed…” [13].
The Discussion section is where you might describe your
opinion of the novelty of your findings or how they may
affirm or contradict previous research or experience in the
field. For example, in the study of psychotropic medication
and violence after release from prison described above, the
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11. How to Write a Report of a Research Study
authors write: “There has been uncertainty about whether
treatment for released prisoners with mental disorders
should focus on crimogenic rather than mental health-related
factors. The current observational study supports the potential role of treating psychiatric disorders, including by psychotropic medication” (Chang Z. JAMA. 2016;316:1798).
The Holy Grail in all of this is generalizability: Can what
you discovered in your study be extended to the population
at large? Or does what you have found apply only to your
group of subjects, a weakness of the small sample or the
single-institution study? In an ideal world, your findings have
implications for similar patients elsewhere, the obvious
advantage of the large trial involving thousands of subjects in
various sites, such as the aircraft noise vs. fatal myocardial
infarction study mentioned at the beginning of the chapter.
State any weaknesses of the study design, or these will
surely be described enthusiastically by reviewers or in letters
to the editor. The Discussion section is also where you should
tell about any factors that may have biased collection of the
data, such as unexpected events, attrition of subjects, or midstudy changes in methods, such as terminating one of the
study groups. The aircraft noise study, for instance, describes
the possibility of bias in the coding of deaths. Here is also
where you describe any disagreement among coauthors
regarding the interpretation of results.
In the last paragraph (where the grazing reader may go
right after reading the abstract), present a summary of your
conclusions and what your team thinks they mean. State the
implications for others in your field and perhaps how the
findings of your study might translate to patient care in the
office or hospital. Write this paragraph very carefully. It represents the outcome of months of effort.
References
Your references are where you have obtained background
information; the list indicates your awareness of prior work in
the area of your research. A focused list of citations is more
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valuable to your reader—and to you, as author—than a very
large collection of papers including some that are only
slightly related to the topic of your article.
References serve other purposes. Readers often use them
as part of their own research on topics. For these individuals,
your list is already a little out of date by the time it is published, but it can be a useful starting point at times. Your reference list also represents a sort of “merit badge” for the
authors, indicating that you valued their papers enough to
cite them as credible sources.
When using a reference citation to support a statement, be
sure that you are conveying the actual meaning of the author.
I have seen too many references used to support statements
when the paper cited says something entirely different. Today,
the ready availability of PubMed and other sites makes it
easy to match author assertions and the actual words of
authors.
The technical considerations of presenting references are
similar for all publication models and are presented in Chap.
4, along with the most familiar models (Table 4.2). Here I will
list just a few additional suggestions and comments:
 The ideal reference citation is the original research source.
 Avoid citing the “gray literature,” such as working papers,
white papers, and conference abstracts.
 If in doubt in listing the name of a journal, write it out,
because, for example, “Psych” could mean psychiatry or
psychology. PubMed provides a guide to standard abbreviation of journal titles.
 By custom, a journal with a single word title, such as
Nature or Science, is written in full and is not abbreviated.
 A paper accepted for publication, but not yet published,
can be cited as “in press” or “forthcoming.” If the paper is
published before your article goes to press, the citation can
be updated in page proofs to provide the details of
publication.
 Try to avoid using web sites as references in a scientific
report; these sites contain a lot of specious data and outright fiction.
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11. How to Write a Report of a Research Study
 If you must cite a web site: Because the site of electronic
citations can change or disappear altogether, the author
citing a web site should print out a copy of the online
material, in case it is requested later.
 Never cite a source you have not read and copied for your
electronic or paper files.
Acknowledgments
Some papers have a final section listing those who assisted
with the work. This includes everyone who helped with
research project or manuscript preparation, but did not meet
the criteria for authorship, such as a person who provided
purely technical support or assistance with the report or a
department chair who provided encouragement (and perhaps
some research time), but was not part of the research team. For
example, at the end of his article “How to Write a Research
Paper,” Alexandrov states: “The author is not a native English
speaker. I am indebted to John Norris, MD, FRCP, for—among
many things during fellowship training—his patience with my
‘a’s’ and ‘the’s’ and the first lessons in study design, analysis,
and presentation” [13]. If financial or material support has not
been disclosed elsewhere, it should be included here.
There is one important caveat: Be sure that all the people you
thank are pleased to be acknowledged and that they actually
agree with the substance of the paper. Being mentioned allows
readers to infer that those acknowledged support the data and
conclusions, whether this is true or not. For this reason, you must
have written permission from all persons listed in the acknowledgments. Some journals have specific online forms for this
purpose; others will accept a signed note on a letterhead.
Avoiding Common Problems in Reports
of Clinical Studies
What are the common mistakes seen in reports of clinical
studies? Despite the many hours of labor that go into scientific manuscripts, there are a few errors that occur even with
Avoiding Common Problems in Reports of Clinical Studies
311
the most experienced medical researchers and writers. Maybe
some creep in as unhappy compromises during group wordsmithing. Others may be the result of midnight editing, when
not all the mental light bulbs are on. Whatever the reason, we
make mistakes in following the recipe for writing research
reports. To help you avoid these missteps, I offer the following to act as a checklist to use when you think your manuscript is done.
 Be sure to prepare a Title Page listing the article title, the
names and affiliations of all authors, sources of support
such as grants, the number of tables and figures, a word
count, and anything else requested in your target journal’s
instructions for authors.
 Remember that the title page should specify the “corresponding author”—the author who will represent the
research team in conversations with the editor—along
with this individual’s full contact information.
 Check once again to assure that your title accurately
describes your study and that it just might prompt the
casual reader to learn more.
 Ask yourself: Have I stated the problem clearly?
 Perform a last-minute review of the literature to assure
that you have not overlooked a recent key report.
 Review the Results section of your research report to be
sure that it does not contain background information
(which should be in the Introduction).
 Ask yourself: Have I tried to put too much in my tables
and figures?
 Also check to be sure that you have not repeated the same
data in tables, figures, and text.
 Verify that interpretation of what you found is in the
Discussion section and not in Results.
 Remember that the Discussion section is not the place to
introduce new information.
 Eliminate overused words, overly clever phrases, and clichés. The word “impact” comes to mind here.
 Be sure your conclusions are consistent with the data, even
if you are disappointed with the outcome.
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11. How to Write a Report of a Research Study
 Consider ruthless removal of anything that causes you to
think, “I just want to get this fact in print.”
 Reconsider acknowledgments: Remember that leaving
someone out can lead to hard feelings.
 Assure that you have clearly identified any potential conflict of interest.
 Have a last meeting of the research/writing team to assure
that everyone knows exactly what is being submitted and
that all agree, once again, on the initial target journal.
Thoughts About Research and Research
Reports
Quality Writing and Research Design
Medical composition is a laudable skill, one that we should all
work to improve. Wager, in an article telling “What Medical
Writing Means to Me,” observes that medical writing “inhabits a strange boundary zone between science and art” [14].
When it comes to writing a report of a clinical research study,
however, the art of medical writing skill must take a back seat
to research design. Have you ever read a research report and
wondered whether the skillful prose—perhaps composed
chiefly by an editorial assistant—masks questionable methods or unjustified conclusions? As Dirckx has written,
employing no less than four metaphors, that one should
guard “against the temptation to cover his lack of information with a rhetorical snow job, to palm off muddy thinking
under a veneer of smooth writing” [15]. Medical writing,
especially in the case of research reports, is chiefly about
medical science, and here art cannot trump science.
Stating What You Really Think
Reports of research studies are often written by committee;
the members seek consensus on what will appear in print.
Perhaps this is why the final version of the paper does not
Thoughts About Research and Research Reports
313
always include the heartfelt opinions of some researchers on
the team and often does not reflect the diversity of author
opinions. Richard Horton, editor of The Lancet, surveyed
contributors to ten research articles published in The Lancet.
Thirty-six of 54 contributors to the ten articles responded to
questions in a qualitative analysis. The research question in
the study was: “To determine whether the views expressed in
a research paper are accurate representations of contributors’ opinions about the research being reported” [16]. The
study found unreported concerns about study weaknesses
and disagreements among authors about findings and their
significance. The study concludes that one remedy for the
problem of suppressed opinions may be structured Discussion
sections in research papers, as we now see in Abstracts.
Research Mentors
Research is best undertaken in teams, and members of the
team bring different skills, one of which may just be mentoring.
Research mentors can be especially important team members,
who provide nurturing and guidance to the less experienced.
They help keep young researchers on track, which can yield
surprisingly good outcomes. Hoff writes: “When I finished
medical school, I did not intend to do research as part of my
life in surgery. That all changed when I met a mentor who
inspired me during my training days. I had some protected
time, assembled space and equipment, developed a hypothesis,
and went to it. I’ll never forget my first experiment and publication. Frankly, it was my best” [17].
Getting Your Research Report in Print
General Douglas MacArthur once said, “There is no substitute
for victory.” In academic medicine, there is no substitute for
publication. You can have a brilliant idea, perform groundbreaking research, and write the results with great proficiency,
but if the paper is not published—so that it can be cited, criticized, or praised—then the effort has been largely wasted. The
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advancement of science depends on sharing knowledge in
print. Chapter 12 discusses how to achieve publication, for
your research report or other publication models.
References
1. Day RA. How to write and publish a scientific paper. Westport,
CT: Oryx; 1998. p. 34.
2. Cohen DJ, Crabtree BF. Evaluative criteria for qualitative
research in health care: controversies and recommendations.
Ann Fam Med. 2008;6(4):331–9.
3. Whimster WF. Biomedical research: how to plan, publish, and
present it. New York: Springer; 1997. p. 101, 105.
4. Wager E, Altman DG, Simera I, Toma TP. Do declarative titles
affect readers’ perceptions of research findings? Research integrity. Peer Rev. 2016;1:11.
5. Jacques TS, Sebire NJ. The impact of article titles on citation
hits: an analysis of general and specialist medical journals. JRSM
Short Rep. 2010;1:2.
6. International Committee of Medical Journal Editors.
Recommendations for the conduct, reporting, editing, and publication of scholarly work in medical journals. http://www.icmje.
org/recommendations/.
7. Meyer H, Varpio L, Gruppen L, Gurjit S. The ethics and etiquette of research collaboration. Acad Med. 2016;91(12):e13.
8. Strasburger VC. Righting medical writing. JAMA.
1985;254(13):1789–90.
9. Nakayama T, Hirai N, Yamazaki S, Naito M. Adoption of structured abstracts by general medical journals and format for a
structured abstract. J Med Libr Assoc. 2005;93(2):237–42.
10. Journal of the American Medical Association. Instructions
for authors. http://jamanetwork.com/journals/jama/pages/
instructions-for-authors#SecAbstractsforReportsofOriginalData.
11. Strasak AM, Zaman Q, Marinel G, Pfeiffer KP, Ulmer H. The
use of statistics in medical research: a comparison of The New
England Journal of Medicine and Nature Medicine. Am Stat.
2007;61(1):47–55.
12. Gotta AW. Review of Taylor RB. The clinician’s guide to
medical writing. Ed. 1. New York: Springer-Verlag, 2005. JAMA.
2005;293(9):1142.
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13. Alexandrov AV. How to write a research paper. Cerebrovasc
Dis. 2004;18(2):135–8.
14. Wager E. What medical writing means to me. Mens Sana
Monogr. 2007;5(1):169–78.
15. Dirckx J. Dx+Rx: a physician’s guide to medical writing. Boston:
G.K. Hall; 1977. p. 99.
16. Horton R. The hidden research paper. JAMA. 2002;287:2775–8.
17. Hoff JT. Research by academic surgeons. Am J Surg.
2003;85(1):13–5.

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