How to write an article: An introduction to basic scientific medical writing.

An original scientific article published in a peer-reviewed professional journal of repute provides great personal satisfaction, adds stature and endows professional respectability to contributing authors. Various types of surgical publications that exist nowadays are case report, cohort study, case-control study, randomised controlled trial narrative review, systematic review, Cochrane review, meta-analysis, editorials and leading articles. A study/research protocol is a standardised document, common to all research projects that typically comprise study objectives, study design, selection of participants, study intervention, study evaluations, safety assessments, statistics and participant rights committees. Once the study protocol is completed and reviewed, it is submitted to the local Institutional Review Board/Institutional Ethics Committee for approval. An outline of the levels of evidence and grades of recommendation is available from the Centre for evidence-based medicine at the University of Oxford. A standardised, structured template exists for scientific presentations in the field of medicine which is also followed in medical writing and publications Introduction Methods Results And Discussion (IMRAD). Instructions to authors would normally include reference to International Committee of Medical Journal Editors and Committee on Publication Ethics guidelines for good and ethical publication practice. It is strongly advised to follow the recommended guidelines appropriate for the published study.

INTRODUCTION

The impact of the published article in a scientific journal of repute is powerful and protracted for as Kenneth Rothman states, ‘The written word reaches the widest audience and constitutes the archival message’. Authorship in a scientific journal implies that the authors have critically analysed and presented a scientific work of merit. ‘Reading maketh a full man, conference a ready man and writing an exact man’, (Francis Bacon). With scientific publishing, surgeons make their contributions to the profession for wide dissemination within their community and in the process create intellectual property that will be preserved down the ages. ‘The universal object of men of letters is reputation’, said John Adams.

A majority of practicing surgeons would not write and would remain engaged in busy surgical practices, bread winning and increasing administrative responsibilities. However, an increasing segment of surgeons in training and academic surgeons now feel the need to write and publish. The reasons for writing and publishing are both egoistic and altruistic.[1] Egoistic motives are the desire to progress academically and professionally, improve status and develop professional contacts. Altruistic motives are dissemination of knowledge and a moral obligation to publish a significant novel observation in the larger interest of better patient care. In several institutions, for academic appointments and promotions, the pressures to publish are sometimes inordinate. In many teaching institutions, to progress academically to whatever academic title one aspires, one's published output must constantly grow in number and quality. However, good-quality writing and publishing are not just in the domain of academic institutions. Several astute clinicians with clarity of vision from non-academic institutions have made significant contributions to surgical literature. It is imperative that contributions to surgical literature are derived from surgeons (academic and non-academic) at various locations (different continents, regions and nationalities) and workplaces (urban, semi-urban and rural). Such literature would be more relevant to the real world as opposed to surgical practice in highly sophisticated ivory towers. In the final analysis, an original scientific article published in a peer-reviewed professional journal of repute provides great personal satisfaction adds stature and endows professional respectability to contributing authors.

MANUSCRIPT TYPES

‘You don’t write because you want to say something; you write because you have something to say’, (Scot Fitzgerald). The essence of fine surgical writing is to write what you as a surgeon would want to read. Enumerated below is a list of various types of surgical publications that exist nowadays arranged in the order of increasing complexity.

Letter/communication to the Editor

Case report

Cohort study (non-randomised, observational study)

Case–control study (non-randomised, observational study)

Randomised controlled trial (RCT)

Narrative review

Systematic review and Cochrane review

Meta-analysis

Editorials and leading articles.

Letter/communication to the editor

This would be with reference to an article that has previously been published. The letter should be polite, constructive and should provide comments that offer a novel perspective of the published article. The comments should add, detract or critically review the contents of the published article in a fair and reasonable manner. The objective is to closely focus on and examine critical issues that may not have been appropriately addressed.

Case report

Many esteemed surgical writers, even journal editors, began a literary career with a time-honoured case report.[2] The humble case report would probably be the first step that an aspiring surgeon takes in surgical writing. Unfortunately, pressure of space and editorial policies directed at enhancing the impact factor of individual journals have reduced the opportunities for publication of case reports.[3]

The cohort study, case–control study and RCT constitute ‘original articles’ in surgical publications. The narrative review, systematic review and meta-analysis are ‘review articles’.

Cohort study (non-randomised, observational study)

A cohort study is when patients are followed forward and assessed from time of exposure until time of consequences of exposure (target outcome). An example is ‘initial experience with single incision laparoscopic cholecystectomy.’

Case–control study (non-randomised, observational study)

A case–control study is when patients are selected once they have the target outcome or not and researchers look backward to try to determine the factors of exposure. An example is ‘bile duct injury with single incision laparoscopic cholecystectomy.’

Randomised controlled trial

An RCT is performed when investigators want to assess treatment effects, usually considered to be beneficial. An example is ‘an RCT comparing recurrence rates between laparoscopic hernioplasty and Shouldice repair for groin hernias’.

A cohort study is feasible when randomisation of exposure is not possible. A case–control study overcomes temporal delays and may only require small sample size. However, both these studies are susceptible to bias and therefore have limited validity. The advantage of an RCT is that it provides the highest level of evidence. It is therefore useful to disprove efficacy which is important in the present era of technology-driven surgery. There is immense pressure from the manufacturers to use devices and procedures, many of which may not measure up to the scientific scrutiny of a well-conducted RCT. The design and execution of an RCT in surgery, however, is fraught with several difficulties and challenges. The nature of treatment by surgical intervention may lead to ethical issues that make design of the study difficult. Moreover, surgical skills and competence may vary from one hospital and surgeon to another making comparison odious. In most surgical studies, blinding of procedure from assessor is very difficult, and therefore, bias is inevitable.

Narrative review

A narrative review is usually written by invitation to an expert. The expert objectively reviews the subject in a concise and impartial manner. He/she addresses new developments and summarises recent literature. A narrative review leaves an imprint of the approach and thought process of the expert on the subject.

Systematic review and Cochrane review

A systematic review involves more rigorous compilation of evidence. A systematic review is designed to present complete and unbiased evidence on the subject that presently exists in the literature. Strict adherence to follow and complete all components of a clearly defined protocol is mandatory.

Meta-analysis

A meta-analysis is a type of systematic review that uses statistical methods to combine and summarise the results of clinical trials. A meta-analysis must always include a formal examination of heterogeneity as an indicator of similar or divergent results.

Editorials and leading articles

These are usually written by invitation on a specific research area. The opinion and judgement of the editor do not only be based on review of literature but also carry the imprimatur of his/her personal beliefs and experience.

EVIDENCE-BASED MEDICINE

We live in an era of evidence-based medicine where increasingly an evidence-based approach to surgical practice would dictate the refining of systems and processes of patient care. Evidence-based practice is the, explicit and judicious use of the current best evidence in making decisions about the care of individual patients’.[4] An outline of the levels of evidence and grades of recommendation is available from the Centre for evidence-based medicine at the University of Oxford[56] Table 1 describes the levels of evidence for therapeutic studies.[7]

Table 1

Levels of evidence for therapeutic studies

Level	Type of evidence
1A	Systematic reviews (with homogeneity) of randomised controlled trials
1B	Individual randomised controlled trials (with narrow confidence intervals)
1C	All or none randomised controlled trials
2A	Systematic review (with homogeneity) of cohort studies
2B	Individual cohort study or low-quality randomised controlled trials (e.g. <80% follow-up)
2C	‘Outcomes’ research; ecological studies
3A	Systematic review (with homogeneity) of case-control studies
3B	Individual case-control study
4	Case series (and poor-quality cohort and case–control study)
5	Expert opinion without explicit critical appraisal, or based on physiology, bench research or ‘first principles’

CONSTRUCTING THE MANUSCRIPT

‘If you can’t explain it simply, you don’t understand it well enough’, (Albert Einstein).

At the outset, formulation of the study/research protocol is required. The study/research protocol is a standardised document, common to all research projects that should be available in teaching institutions. The protocol template typically comprises the following.

Study objectives

Study design

Selection of participants

Study intervention

Study evaluations

Safety assessments

Statistics

Participant rights

Committees.

Once the study protocol is completed and reviewed, it is submitted to the local Institutional Review Board (IRB)/Institutional Ethics Committee (IEC) for approval. Written consent is obtained and the study is registered at the Clinical Trial Registry of India at www.ctri.in.

‘If you don’t know where you are going, you will end up someplace else’, (Yogi Berra).

A standardised, structured template exists for scientific presentations in the field of medicine, and this is also followed in Medical writing and publications Introduction Methods Results And Discussion (IMRAD).

Introduction: Why did we start?

Methods: What did we do?

Results: What did we find?

Discussion: Hence, what does it mean?

Enumerated below are the constituent segments and contents therein in an original article of a scientific medical manuscript.

Introduction (two paragraphs)

The Introduction commences with a brief lesson on the subject as described in literature. Current knowledge, insights and recent developments on the subject are briefly stated. A lacuna or gap in knowledge or incomplete information on some aspect of the subject forms the basis and reason to perform the present research/study. The last line in the Introduction section normally reads ‘The aim of this study was…’, ‘We report… or ‘We reviewed…’.

Methods (seven paragraphs)

The Methods section narrates the story of what the authors did. The narration is arranged in a logical framework of time. A logical sequence for presentation is ethical approval, patient selection, surgical intervention, outcome assessments and statistical methods employed.

Results (six paragraphs)

The Results Section is an overall description of the major findings of the study. The Results section presents measurements and data on all stated end-points (primary and secondary) of the study. Data presentation should be clear and concise.

Discussion (seven paragraphs)

The Discussion section summarises the article and presents a perspective of the message in the article. The first paragraph provides a summary of the main aim, methods and results of the study. The last paragraph provides a tentative answer to the research question posed in the study and also a suggestion for future research in a related area of the study. The limitations of the present study are discussed (e.g. nature of study, numbers of patients and limited follow-up). The strengths of the present study, if any, may be enumerated. Similar studies in the literature are discussed and how the present study fits in is analysed. The implications of the present study are discussed in terms of future research, change in patient management policies and suggested amendments to clinical practice.

Title

The title should be descriptive yet concise while conveying the essential features of the contents of the article. The title should contain words that will make the article accessible to workers in the field. Clarity, brevity and above all human interest are the hallmarks of a good title.

Abstracts

Titles and abstracts are freely available to browse across a wide array of databases on the Internet. An attractive title and a concise abstract serve to attract the attention of readers. The abstract serves as a stand-alone summary that describes the major contents and message of the article. The abstract is structured (IMRAD) with a strict word limit. It serves as a quick reference and shortcut for busy researchers.

Keywords

Keywords are short phrases that capture the main topics of the article. These follow the abstract in the article. Keywords assist in cross-indexing and literature search.

Authorship

Most journal editors subscribe to guidance from the International Committee of Medical Journal Editors (ICMJE)[8] also known as the Vancouver group. Contributors who meet all four of the below-mentioned criteria qualify for authorship.

Substantial contributions to the conception or design of the work or the acquisition, analysis or interpretation of data for the work

Drafting the work or revising it critically for important intellectual content

Final approval of the version to be published

Agreement to be accountable for all aspects of the work.

Acknowledgements

Those whose contributions do not justify authorship may be acknowledged and their contributions should be specified (e.g., ‘served as scientific advisors’, ‘critically reviewed the study proposal’, ‘collected data’, ‘provided and cared for study patients’ and ‘participated in writing or technical editing of the manuscript’).[8]

Conflict of interest

The ICMJE states that ‘a conflict of interest exists when professional judgement concerning a primary interest (such as patient's welfare or the validity of research) may be influenced by a secondary interest (such as financial gain)’. Public trust in the scientific process and the credibility of published articles depend in part on how transparently conflicts of interest are handled during the planning, implementation, writing, peer review, editing and publication of scientific work. Financial relationships (such as employment, consultancies, stock ownership or options, honoraria, patents and paid expert testimony) are the most easily identifiable conflicts of interest and the most likely to undermine the credibility of the journal, the authors, and science itself.[8]

References

A reference to articles serves to guide readers to a connected body of literature. Conference abstracts should not be used as references. They can be cited in the text, in parentheses, but not as page footnotes. References to papers accepted but not yet published should be designated as ‘in press’ or ‘forthcoming’. Information from manuscripts submitted but not accepted should be cited in the text as ‘unpublished observations’ with written permission from the source. Avoid citing a ‘personal communication’ unless it provides essential information not available from a public source, in which case the name of the person and date of communication should be cited in parentheses in the text.[8]

INSTRUCTIONS TO AUTHORS

It is mandatory to read and follow ‘Instructions to Authors’ provided by the journal where the manuscript is being sent for evaluation. Journals require electronic submission of manuscripts through specially designed editorial software (e.g. edition manager, manuscript central). The instructions provide detailed submission guidelines to Authors for submission of manuscripts. Instructions would normally include reference to ICMJE what an editor expects…pg 1124[9] and Committee on Publication Ethics (COPE) Guidelines[10] for good and ethical publication practice.

REPORTING GUIDELINES

It is strongly advised to follow recommended guidelines appropriate for the published study. These guidelines set international standards for reporting different types of research studies. A good checklist is provided for preparing the publication. The guidelines standardise trial design, facilitate accurate reporting and correct interpretation of results [Table 2].[11]

Table 2

Reporting guidelines for main study types

Study Types	Guidelines
Randomised trials	CONSORT
Observational studies	STROBE
Systematic reviews	PRISMA
Case reports	CARE
Qualitative research	SRQR
Diagnostic/prognostic studies	STARD
Quality improvement studies	SQUIRE
Economic evaluations	CHEERS
Animal pre-clinical studies	ARRIVE
Study protocols	SPIRIT

ROLE OF BIOSTATISTICIAN

The biostatistician provides invaluable input, advice and suggestions in construction of the manuscript. He/she should be consulted right from the concept and planning stage. He/she assists in protocol development with study design and study evaluations. He/she plans data management by confirming assessment of data on primary and secondary end-points of the study. He/she supervises data collection, archival and analysis. He/she implements and monitors the study on a periodic basis to its conclusion. Finally, the biostatistician assists with reporting results during writing of the manuscript.

DATA MANAGEMENT

Data management is the strategy used for collecting, organising and analysing data. The ultimate aim of conducting a study is to generate data to provide answers to the research question. The quality of data generated plays an important role in the outcome of the study. It follows that if primary data collection and entry are not considerate and meticulous, subsequent data analysis for outcome measures would not be satisfactory. Data need to be ultimately stored in electronic data capturing systems for ease of data management and analysis.

Several data analysis software systems are available that provide statistical results when data are fed into then in a predetermined format (Analyse-it, SPSS, WINKS SDA, Stata, Vitalnet).

WRITING STYLE

An effective writing style is easy to read and simple to understand. The connoisseur writer filters out unnecessary details and distills the essence of his/her communication in the manuscript. A short manuscript presented clear and lucidly is the most effective. Simple sentences in straightforward language convey the most information. A short sentence is easier to read and comprehend than a long rambling one, short, simple and familiar words are more reader-friendly than longer complicated phrases (replace ‘illustrate’ with ‘show’, ‘fundamental’ with ‘basic’ and ‘remainder’ with ‘rest’). A spell check and grammar check are mandatory after completing the manuscript.

New information is provided in a new paragraph. The main point appears at the start and should be clear, succinct and easy to find. The author consciously needs to avoid elitism/triumphalism in the article (the first report, the only study, the largest cohort). Exclamation and quotation marks are avoided in a formal medical manuscript. Proper punctuation marks such as full stops and commas are mandatory.

Text verbatim (copy and paste) from a previously published article or book must be marked as reference source. The author needs to follow the reference style required for submission to the journal. The Vancouver system[12] is the most commonly used. Abbreviations (INR – international normalised ratio, PT – prothrombin time) and acronyms (IMV – inferior mesenteric vein) should always be defined the first time they are used in the text. Abbreviations are useful to avoid unnecessary and frequent use of long phrases in the text. However, their use should be restricted in the text and never used in the title and abstract. In figures, abbreviations need to be explained in the legend and for tables in the footnote.

Tables and figures must be sufficiently clear, well labelled and interpretable without having to refer to the text. These should be placed in the text as near as possible to the place where they are referred to. Tables should not be used when data can be summarised in text (e.g. population sizes, sex ratios) or where data are better represented in graphs and figures. The legend carries descriptive information on the tables and figures to make them understandable as stand-alone segments. Table legends are placed above the body of the table, and figure legends are placed below the figures. Footnotes in a table explain abbreviations and P values.

PUBLICATION ETHICS

The COPE was founded in 1997 as a voluntary body to attempt to define best practice in the ethics of scientific publishing. The COPE guidelines on good publication practice are useful for authors, editors, editorial board members, readers, owners of journals and publishers. They address study design and ethical approval, data analysis, authorship, conflicts of interest, peer-review process, redundant publication, plagiarism, duties of editors, media relations, advertising and how to deal with misconduct.

Study design and ethical approval: Good research should be well justified, well planned appropriately designed and ethically approved. To conduct research to a lower standard may constitute misconduct

Data analysis: Data should be appropriately analysed, but inappropriate analysis does not necessarily amount to misconduct. Fabrication and falsification of data do constitute misconduct

Authorship: There is no universally agreed definition of authorship although attempts have been made. As a minimum, authors should take responsibility for a particular section of the study

Conflicts of interest: Conflicts of interest comprise those which may not be fully apparent and which may influence the judgement of author, reviewers and editors. They have been described as those which, when revealed later, would make a reasonable reader feel misled or deceived

They may be personal, commercial, political, academic or financial. ‘Financial’ interests may include employment, research funding, stock or share ownership, payment for lectures or travel, consultancies and company support for staff

Peer review: Peer reviewers are external experts chosen by editors to provide written opinions, with the aim of improving the study. Working methods vary from journal to journal, but some use open procedure in which the name of the reviewer is disclosed, together with the full or ‘edited’ report

Redundant publication: Redundant publication occurs when two or more papers, without full cross-references, share the same hypothesis, data, discussion points, or conclusions

Plagiarism: Plagiarism ranges from the unreferenced use of others published and unpublished ideas, including research grant applications to submission under ‘new’ authorship of a complete paper, something in a different language. It may occur at any stage of planning, research writing or publication: It applies to print and electronic versions

Duties of editors: Editors are stewards of journals. They usually take over their journal from the previous editor(s) and always want to hand over the journal in good shape. Most editors provide direction for the journal and build a strong management team. They must consider and balance the interests of many constituents, including readers, authors, staff, owners, editorial board members, advertisers and the media

Media relations: Medical research findings are of increasing interest to the print and broadcast media. Journalists may attend scientific meetings at which preliminary research findings are presented, leading to their premature publication in the mass media

Advertising: Many scientific journals and meetings derive significant income from advertising. Reprints may also be lucrative.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.