How to Write a Clinical Paper

8/12/2019 How to Write a Clinical Paper

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How to write a clinical paperfor publicationJonothan J Earnshaw

AbstractResearch is an essential part of surgical training, so a surgical trainee

must publish to prosper. The most important piece of advice is to seek

expert help before commencing the process of research and subsequent

publication. Having a piece of research worthy of communication to peers

is an essential prerequisite, but there are many different types of publica-

tion, and many different avenues for publication. Starting with a simple

case report is often a good beginning; publication in high-profile, high-

impact-factor journals requires high-quality research such as randomized

trials or systematic reviews. The more high profile the research, the more

likely there are to be formal rules about its conduct and its publication

(CONSORT, PRISMA etc). Writing in scientific English requires economy

of style and linguistic restraint; many readers will not have English asa first language. By convention, scientific articles are written in IMRAD

style e introduction, methods, results and discussion. This author has

evolved a method to make writing a scientific manuscript as painless

as possible. It may be tempting to relax once the writing is complete,

but managing the paper through submission can also be challenging.

Most journals will not accept a paper immediately, but will require correc-

tions suggested by independent referees after formal peer review. All

dealings with journal editors should be professional and courteous.

Keywords CONSORT; electronic publication; impact factor; peer review;

PRISMA; statistics; surgical publication; surgical training

Introduction: why publish?

The truth is that the main reason most doctors write a paper is to

enhance their career. It is expected of all surgical trainees that

they undertake some scientific research, and it is very hard to

find a senior surgeon who does not think this is generally a good

idea. There is a moral imperative to communicate the results of

research, since there is no point in doing a project and not

writing it up, even if the study is negative. Also, surgeons owe it

to participants involved in the study, and indeed to themselves to

publish.

There are other positive benefits of publishing research.

Writing a manuscript teaches how scientific surgical papers are

structured and it will mean that, when reading research pub-

lished by others, it will be easier to follow and the messages will

be simpler to identify. It also helps create a critical eye that

enables a clinician to judge whether published material is sound

or flawed. There are also altruistic reasons for research and

publishing. First, conducting a research project is a way of

improving your personal knowledge about a subject, and second,

communicating that knowledge improves the understanding

among the rest of the scientific community (as long as you can

get your papers published).

Getting scientific research published is not easy, particularly

when an author is just starting. The most important advice I can

give is that you get as much help as possible in the early stages

from an experienced and sympathetic senior colleague who haspublished widely before.

Before you take up a pen

Before you start to create any sort of manuscript, you will need

material with which to work. Most people will have done

a research project or have research results available. A good

research project always starts with a hypothesis and then the

collection of data to confirm (or refute) the hypothesis. This

article is going to assume that that material is already available,

and that a research project has come triumphantly to its fruition.

An important part of any research project is to do a thorough

literature review, since this will provide the background infor-

mation on which to base the research and also help to inform and

populate the discussion section of the manuscript afterwards.

Many young surgeons these days use electronic support, such as

a Reference Manager, that automatically places research

references in the correct order of the reference section at the end

of the manuscript. The alternative is to create the reference

section manually at the end, but this can lead to confusion if

a manuscript goes through several versions or major structural

change.

For surgeons early in their publishing career, the advice of

a senior colleague who is experienced in writing and publishing

manuscripts will be invaluable. Seeking support should have

predated the start of the study, since an experienced researcher

will be able to give advice about whether or not a research

project is novel and worthwhile, and will later help to point out

exactly how and where a paper could be published.

Finally, before you start to think about writing, you need to

clear time and space so that there are no other competing pres-

sures. But do not wait too long; it gets increasingly difficult to

write a manuscript the longer you leave it after the last result is

in.

Types of article

There are many different types of article for publication, just as

there are many different journals. One key to publication is

picking the right paper for the right journal. There is anascending value, or currency, for all research, which is largely

based on how useful it is in modifying clinical practice ( Figure 1).

The best journals have the highest impact factor (IF), which is

a metric designed to value each research paper (and each jour-

nal). Simplistically, the IF of a paper is the number of times that

article is cited in a paper published by another author in the 2

years after the index paper is published. The IF of a journal is

thus the average IF of all its papers. Journals with a very high IF

(20e30) tend to be the major weeklies (British Medical Journal,

Lancet, New England Journal of Medicine, Journal of the Amer-

ican Medical Association). Most surgical journals are published

monthly, and have an IF between 2 and 5; the British Journal of

Jonothan J Earnshaw DMFRCSis a Consultant Surgeon at Gloucestershire

Hospitals NHS Foundation Trust and Joint Chief Editor, British Journal of

Surgery, UK. Conflicts of interest: none declared.

DEVELOPING LEADERSHIP IN SURGICAL TRAINING

SURGERY 30:9 437 2012 Elsevier Ltd. All rights reserved.
http://dx.doi.org/10.1016/j.mpsur.2012.06.010http://dx.doi.org/10.1016/j.mpsur.2012.06.010


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Surgery (BJS) had an IF of 4.44 in 2010, the second highest

general surgical journal in the world.

Case report

The first paper almost everyone publishes is a short case report.

This is because it is the easiest thing to start on. Usually it

consists of a description of a rare or interesting patient or

procedure, with a summary of the available literature. My first

case report took a total of 18 months to write and get published1;

I reference it here so it will have been cited at least once!

Publication came with 50 free offprints, none of which was ever

requested. I still have 49, and my Mum has the other. It is easiest

to get case reports published if they contain an unusual illus-tration or image. Many journals have sections now for publishing

good pictures, particularly if they are good quality and in colour.

Alternatively there are a number of online resources that accept

case reports for electronic publication only. Remember that if

you take clinical photographs, you must request permission from

the affected patient, and this must be sent to a journal with any

submission. Very few clinical cases are so rare that they have not

been written about before, as will be found by a thorough liter-

ature search; however, a clear and well written case report will

usually be published somewhere, though often in a lower

ranking journal.

Case series

These sound better if they are called Cohort Studies, but they are

in reality just reviews of a series of patients with the same

condition, often treated in a potentially novel way. My aim as

a young trainee was to find out the single procedure or technique

that my consultant trainer did that was different from everyone

else; almost all consultants have favourite conditions or opera-

tions. I would volunteer to review the patients and write them

up, thus improving my CV, but also ingratiating myself to the

trainer. Simple, but effective, and a good way to build up a series

of publications: one per trainer! The clinical material may be

collected prospectively, as many clinicians keep electronic

databases, but they are usually analysed retrospectively. Alter-

natively, a series of case notes may be retrieved and summarized

retrospectively, to try and learn how a condition may be

managed optimally. Once again it is important the literature is

reviewed thoroughly and that the paper is aimed at an appro-

priate journal for publication. Recently, even this type of paper

has come under scrutiny with published recommendations about

structure and content (www.strobe-statement.org).

Case control study

This is a particular type of study where two cohorts of patients

are matched in every respect except the condition of interest;

thus factors contributing to a condition can be identified by

comparing individuals with it (cases) to those without (controls).

This requires careful planning and is often quite difficult to do

since it is easy to introduce confounding factors if the two

cohorts are not well matched.

Controlled study

These are important studies, described as the bedrock of scien-tific literature, since they provide the best evidence that under-

pins changes in practice. A controlled study involves a formal

comparison of two groups treated in different ways, selected at

random: one group may be controls with no active treatment,

though more commonly they receive optimal existing treatment,

and the second group receives the new medication or treatment

according to random chance. These randomized controlled trials

(RCTs) require formal construction and reporting using a partic-

ular structure called the CONSORT Style, which not only helps

design the trial but assists in reporting it in the journals.2 There

are many poor RCTs and much of this is due to the fact that they

are inappropriately small to answer the question posed by the

hypothesis. Making sure there is a plan to recruit an adequatenumber of participants to an RCT is an essential prerequisite

before starting, and requires a formal power calculation. RCTs

are often large and very expensive to run; they usually require

application to formal funding bodies, and may need to be con-

ducted in multiple centres. It is important to remember to register

an RCT before it is undertaken (e.g. www.clinicaltrials.gov,

www.controlled-trials.com).

Systematic review and meta-analysis

These are formal research tools, where high quality RCTs are

aggregated and analysed together using formal statistical meth-

odology. Together they often provide the best evidence on whichto base changes in practice. There are a number of organizations

such as the Cochrane Collaboration (http://www.cochrane.org)

who will arrange and coordinate these sorts of publications,

which are high profile and highly cited. There is modern

tendency to attempt meta-analysis on small heterogeneous RCTs

and then to conclude that there are not enough data from which

make positive recommendations. This should be discouraged as

it devalues this currency of research. There is a formal way to

conduct and analyze systematic reviews and meta-analysis using

PRISMA guidelines.3 These show the importance of a systematic

search of the literature, but also an assessment of the quality of

the studies included in the report.

Systematic reviewsand meta-analysis

Randomizedcontrolled double

blind studies

Cohort studiesCase control studies

Case series

Case reports

Ideas, editorials, opinions

Animal research

In vitro (test tube) research

The ascending value or currency of research

Figure 1


http://www.strobe-statement.org/http://www.clinicaltrials.gov/http://www.controlled-trials.com/http://www.cochrane.org/http://dx.doi.org/10.1016/j.mpsur.2012.06.010http://dx.doi.org/10.1016/j.mpsur.2012.06.010http://www.cochrane.org/http://www.controlled-trials.com/http://www.clinicaltrials.gov/http://www.strobe-statement.org/


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Laboratory-based research

This type of research is usually only carried out in hospitals with

appropriate research facilities or animal laboratories. The

research is often part of an ongoing programme, rather than

starting afresh. Randomization is often not appropriate here

since there is no consent involved. Anyone writing about animal

experiments should avoid using the word animal, or the species

in the title of the paper since this can inflame animal rightsactivists. The correct description is to use the word experi-

mental in the title.

Leaders or Editorials

This sort of publication is usually the province of the experienced

researcher or surgeon since it is often based on opinion rather

than fact. They are not the best place to start your publishing

career. They are usually invited by journal Editors; if you feel

moved to write this type of manuscript, it is well worthwhile

contacting the journal beforehand, to avoid wasting effort.

Writing styleWriting in scientific English is not like writing a novel. It should

be precise, direct and as compact as possible. Sentences should

be short and simple, punctuation and grammar should be accu-

rate, and the manuscript should be an adjective-free zone. Short

words should be used, where possible, and dense scientific

jargon avoided at all costs. It should not be forgotten that English

is the language of science worldwide, and so many readers of

scientific papers will not have English as a first language.

There is a standard way of constructing a scientific manu-

script: IMRAD e introduction, methods, results and discussion

(see below). This has stood the test of time, and all original

scientific articles should be written this way.

How I do it

When I am writing up a piece of research, the first thing I usually

to do to get started is to create a title page. This focuses my ideas

about what I am trying to say, and it helps me think about the

potential impact of the paper. It means I sort out who are going to

be the authors of the paper since the rules of authorship are clear

and explicit,4 but perhaps most importantly, it means I can print

something off to leave in my briefcase that reminds me that the

job needs to be finished.

I enjoy writing titles. I like them to be brief and succinct but

many journals have their own styles and it is worth exploring

this before you write the title. Randomized trials require a formal

inclusion of these words in the title, as do systematic reviews andmeta-analyses, so they are easy to find in repositories such as

PubMed. I try to avoid questions in the title, although I will admit

to trying to jazz up negative research by putting the question I

was researching in the title. I seldom write the results of the

study in the title. I also usually try to avoid punctuation and

abbreviations within a title.

The next easiest section to write is the methods, because it is

simply a question of recording what you actually did. This part of

a paper can often be written up long before the trial is completed.

Where possible, refer to previously published methods sections,

particularly for experimental research. There is no need to

publish complicated research methodology or experimental

techniques in great detail more than once, since few people ever

read that bit of a manuscript. However, there should be sufficient

detail for someone else to repeat the experiment. It is important

to include details of the method of analysis to be used, and

whether statistics are required and which will be used. I am not

a big fan of statistics, and they are often superfluous, when

results speak for themselves. When statistics are used, they must

be accurate and used appropriately. Unless you are an expert, theadvice of a statistician will be essential, and I would strongly

advise contacting them before the study is conducted, as they are

usually more amenable when a project is discussed at its

inception, rather than being asked as a tag-on once the study has

been done. There needs to be a justification of the number of

people who are included in a study, which may require a formal

power calculation. The method section should never include the

number of people in the study since this was not known before

the research was commenced. All the details in the method

section should have been known before the research was started.

Next I write the results. I will usually start with the most

important piece of information from the trial, but I also try and

report in a logical sequence. When reporting the results of anoperation, describe the preoperative state first, then the operative

findings, then the postoperative outcome, starting with early and

then late. If that sounds all too obvious, you will be amazed how

many people report 5-year outcomes in their manuscript before

they report the complications of a procedure. Results should be

a mixture of tables, figures and text. None of these areas should

overlap or duplicate. Where possible, it is much better to present

results in a table or figure, all of which should have their own

individual legend that explains fully the presented information.

Once the methods and results are done, the most difficult bit

of the paper is completed, and the most important information is

now recorded. The introduction and the discussion simply place

the research in context and enable you to say where you thinkthe research is strong, but to admit its limitations. The intro-

duction to a paper should be short and punchy, never more than

one side of A4. It places the research into context and goes into

some detail about why the study was done. It should finish with

the hypothesis or the aim of the study, which will almost

certainly then lead to the first line of the results section (and the

discussion).

For most people, the discussion is the fun bit, the opportunity

to wax lyrical on a chosen topic, and to indulge in wide-ranging,

often fanciful discourse. Often a discussion section has very little

to do with the research that was undertaken, particularly if the

results were negative or expected. The following is a suggested

format for a discussion: Start by recording the principal results of the study in the

first paragraph of the discussion.

The second paragraph should contain a summary of the

literature on the subject so far.

The third paragraph should describe what the current

research adds to what is known, and where it takes the

subject.

The penultimate paragraph should describe the strengths

and weaknesses of the study. It is always worth pointing

out the limitations of your study because it makes you

seem like an honest citizen, and if you do not, you can be

sure that the referees who look at your manuscript will.


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Some journals like to have a concluding paragraph,

which summarizes the results again. Others, such as BJS

prefer no conclusion, since it is simply reiterating what

has already been said. Once again it is worth looking

at the journal you are submitting to, and adopt their

style.

The reference section should be easy if you have been using an

electronic referencing tool. If not, at this stage you will need toreference the manuscript. A standard research paper should have

20e30 references. More are only required for systematic reviews

or meta-analyses. It is important that all the premium papers on

a subject are included in the discussion, but the list does not need

to be exhaustive and should not include low quality, small series.

The reference section should be updated just before the manu-

script is submitted, in order to make sure that the latest research

is included. There is a huge temptation on all authors to include

as many as possible of their own manuscripts to enhance

personal citations. Whilst this is acceptable if they refer directly

to the subject in question, many editors will red pen through

gratuitous citations.

I usually write the abstract for the paper as the final act.Sometimes the stimulus will have been the deadline for

submission of the research to a scientific meeting for presenta-

tion. I will often write a more jazzy title for an abstract that is

submitted for presentation at a surgical meeting. Writing

abstracts is an art. Each journal has their own rules about

abstract submission and it is important that these are adhered to.

There is very often a journal style and a word limit. The intro-

duction and discussion sections should be short; the meat is in

the results section and this should entice a reader to look at the

whole paper. It is important that the abstract for a paper stands

alone as a formal record of the research, since it will be listed on

Medline in perpetuity.

Manuscript submission

Once the first draft of the paper is completed, it should be shared

around all the other co-authors for their comments. These should

be taken into account and the paper amended appropriately. I

find it helpful to put a paper aside once you have finished it for 2

or 3 weeks and then to read it again thoroughly and make

corrections, as a little distance often gives clearer sight. This is

also a good time to choose which journal to submit your

manuscript to. You may well need advice from a senior author

and it is important to have looked the style of the journal before

you submit. All authors want to have their work published in

high impact factor journals and it may be worth submitting

a manuscript to a higher impact factor journal than you are

expecting to start with, though expecting the chance of rejection.

If you want to have papers published you will have to get used to

the idea of rejection since it is a common phenomenon with all

manuscripts.

Before actually submitting the manuscript, it is really impor-

tant to check it thoroughly. You should make sure all the refer-

ences are correctly numbered and refer to the correct point in the

manuscript. There are often changes in the numbering for figures

and tables, which you need to check. Always run your manu-

script through a spellchecker, as there is nothing so irritating for

journal editors as simple spelling mistakes. Before actually

submitting the manuscript you must check the main instructions

to authors for the particular journal in some detail; often there

will be a checklist for you to tick as you go through. Any

randomized trials or meta-analyses must be submitted using the

appropriate CONSORT and PRISMA guidelines. There are also

guidelines for submission of cohort studies (STROBE), but not all

journals insist on them.

Most journals now have electronic submission so you willneed to register with a journal and then send in your manuscript.

If often takes quite a while to work out exactly how to do this and

you may benefit from the assistance of someone who is familiar

with the process. Once familiar, it is really quite quick. Finally,

after the manuscript is submitted you can breathe a sigh of relief

and go and do something else until the response comes in some

weeks later.

Many authors choose their journal for submission depend-

ing on the speed of response. Some of the weekly journals

respond within a few days, but the quickest surgical journals,

such asBJS take approximately 3 to 4 weeks. The slowest ones

can take much longer! Most responses lead to an initial

depression. Very few manuscripts are accepted immediately.Most journals will seek the views of a number of experienced

referees who will then send their own comments in about your

manuscript and how it could be improved and made suitable

for publication. It is important to read the responses carefully;

you are more likely to get your paper published if you revise

your paper taking into account the views of the referees. It is

very irritating to journal editors if the authors response to

referees is to argue and question their authority or expertise.

Some authors misinterpret this initial letter as formal rejection

of their manuscript, whereas in fact the most journals expect

resubmission unless a paper is not salvageable. Most journals

will make this very clear. If you have a definite rejection letter

there is no point in resubmitting your manuscript to the samejournal and you may need to take advice about what to do and

where to resubmit.

Revision of a manuscript is a very important process, since in

many cases the paper is likely to be published if you are able to

answer the referees comments in a sensible and timely fashion.

Papers that have been rejected outright may still be submitted

elsewhere, particularly if a lower impact factor journal or one

that is more specialist is chosen. It is always worth considering

the responses of the referees after rejection, because you may

well be able to improve the manuscript even though you are

resubmitting it elsewhere.

Writing an article for publication is hard work, but it is very

satisfying once you finally see your manuscript in print. Theeffort required is one reason why a good publication record is

a much valued achievement on the training ladder. And who

knows, like me, you may enjoy the process and decide an

academic career is for you. A

REFERENCES

1 Earnshaw JJ. Gastric teratoma in infancy. J R Coll Surg Edinb 1985; 6:

95e7.

2 CONSORT 2010 statement. http://dx.doi.org/10.1186/1745-6215-11-

32. Published, www.consort-statement.org; 24 March 2010.


http://www.consort-statement.org/http://dx.doi.org/10.1016/j.mpsur.2012.06.010http://dx.doi.org/10.1016/j.mpsur.2012.06.010http://www.consort-statement.org/


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3 Moher D, Liberati A, Tetzlaff J, Altman DG. The PRISMA

group. Preferred reporting items for systematic reviews and

meta-analyses: the PRISMA statement. Open Med 2009; 3:

123e30.

4 BJS authorship.Br J Surg 2009; 96: 1498e9.

FURTHER READING

British Journal of Surgery runs courses on how to write a paper once or

twice a year: see BJS or BJS website for details (www.bjs.co.uk).

Schein M, Farndon JR, Fingerhut A, eds. A surgeons guide to writing and

publishing. Shropshire: TFM publishing, 2001.


http://www.bjs.co.uk/http://dx.doi.org/10.1016/j.mpsur.2012.06.010http://dx.doi.org/10.1016/j.mpsur.2012.06.010http://www.bjs.co.uk/

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