The origins and development of the scientific and technical press can be traced back to 1665 when the first “modern” scientific papers appeared and were characterized by non standardised form and style 1 . Subsequently, nearly 300 years ago 2 , in an attempt to ensure that articles met the journal’s standards of quality and scientific validity, the peer-reviewed process for scientific manuscripts was born in England and France. Since then, there has been an enormous proliferation of scientific journals and manuscripts so that, at present, the numbers of biomedical papers published annually by over 20,000 journals, at a rate of 5,500 new papers per day, far exceeds 2,000,000 1 , 2 .
Published scientific papers and professional meetings are really essential to disseminate relevant information and research findings. However, most of the abstracts of presentations given at scientific meetings are usually available only in conference proceedings although they have the potential to be subsequently published as articles in peer-reviewed journals.
A recently published Cochrane review showed that only 44.5% of almost 30,000 scientific meeting abstracts were published as articles 3 . No association between full publication and authors’ country of origin was detected. Factors associated with full publication included acceptance vs rejection of abstracts for oral or poster presentations, acceptance for oral presentations rather than poster sessions, “positive” results, using the report authors’ definition of “positive”, randomised trial study design and basic rather than clinical research.
Possible reasons for failed publication include lack of time, research still underway, problems with co-authors and negative results 4 . Undoubtedly, lack of the necessary skills and experience in the process of writing and publishing is another possible contributing factor also in the field of Transfusion Medicine although the specialists in this discipline are currently adopting the principles and research methodologies that support evidence-based medicine 5 , and high-level research is actually being carried out at the same rate as in all medical specialties.
There are three broad groups of manuscripts: original scientific articles, reviews and case reports. Although case reports are part of the evidence hierarchy in evidence-based practice, albeit at a lower level, and case series are incorporated in a significant proportion of health technology assessments 6 , this article will address the multiple steps required in writing original articles and reviews with the aim of providing the reader with the necessary tools to prepare, submit and successfully publish a manuscript.
The history of scientific journals dates from 1665, when the French “Journal des sçavans” and the English “Philosophical Transactions of the Royal Society” first began systematically publishing research results 7 . From then on, the initial structure of scientific papers evolved gradually from letters (usually by a single author, with a polite style and contemporarily addressing multiple subjects) and experimental reports (essentially descriptive and presenting experiences and effects in chronological order) to a better structured and more fluent form characterised by an embryonic description of methods and interpretation of results. This evolved way of reporting experiments gradually replaced the letter form.
It was not, however, until the second half of the 19 th century that the method description became fully developed and a comprehensive organisation of the manuscripts known as “theory-experiment-discussion” emerged 1 . At the beginning of the last century a gradual decrease of the use of the literary style coincided with a growing standardisation of the editorial rules that paved the way for the formal established Introduction, Methods, Results, and Discussion (IMRAD) structure of scientific papers, which was adopted in the 1980s.
At present, IMRAD is the format encouraged for the text of observational (i.e. retrospective/descriptive) and experimental (i.e. randomised controlled) studies by the “Uniform Requirements for Manuscripts Submitted to Biomedical Journals” which have become the most important and widely accepted (by over 500 biomedical journals) guide to writing, publishing, and editing in international biomedical publications 8 . The Uniform Requirements are released by the International Committee of Medical Journal Editors (ICMJE), an evolution of the initial group of Journal Editors who met for the first time in Vancouver in 1978 and subsequently issued a number of editorial policy statements and guidelines for manuscript submission.
According to the ICMJE, “this so-called IMRAD structure is not an arbitrary publication format but rather a direct reflection of the process of scientific discovery” 9 . In addition it facilitates modular reading and locating of specific information, which is normally found in pre-established sections of an article 7 .
“Long articles may need subheadings within some sections (especially Results and Discussion) to clarify their content. Other types of articles, such as case reports, reviews and editorials, probably need to be formatted differently” 9 .
This format does not comprise other important and integral parts of the article, such as the Title Page, Abstract, Acknowledgements, Figures and Tables (comprising their legends) and References 8 .
There are often slight variations from one journal’s format to another but every journal has instructions to authors available on their website and it is crucial that authors download and comply with them.
The latest edition of the Uniform Requirements was updated in April 2010; it is available at the ICMJE website and is an essential guideline for all authors writing a biomedical manuscript 9 .
Medical science depends entirely on the transparent reporting of clinical trials 10 .
Unfortunately, several reviews have documented deficiencies in reports of clinical trials 11 – 15 .
In 1996, a group of scientists and editors developed the CONsolidated Standards Of Reporting Trials (CONSORT) statement which is intended to improve the reporting of a randomised, controlled trial (RCT), enabling readers to understand the design of a trial, its conduct, analysis and interpretation and to assess the validity of its results 16 . It emphasises that this can only be achieved through complete transparency from authors.
The CONSORT statement was updated in 2001 and after the 2007 meeting the statement was further revised and published as CONSORT 2010 which is the most up-to-date version and can be freely viewed and downloaded through one of the several link to Journals available at the CONSORT website under the section “CONSORT Statement - Downloads” 17 . The statement facilitates critical appraisal and interpretation of RCT and many leading medical journals and major international editorial groups have endorsed it.
The statement consists of a checklist (25 items) and a flow diagram that authors can use for reporting a RCT. The checklist items pertain to the content of the Title, Abstract, Introduction, Methods, Results, Discussion and Other information. The flow diagram is intended to depict the passage of participants through a RCT (enrolment, intervention allocation, follow-up and analysis). It is strongly recommended that the CONSORT Statement be used in conjunction with the CONSORT Explanation and Elaboration Document which is available at the CONSORT website under the above mentioned section 17 .
Another major point to consider is the obligation to register clinical trials 9 .
In September 2004 the ICMJE changed their policy and decided they would consider trials for publication only if they had been registered before the enrolment of the first participant. The ICMJE accepts registration in the international registries listed in Table I .
International trial registries acceptable to the International Committee of Medical Journal Editors and relevant websites.
| Registry | Website |
|---|---|
| Australian New Zealand Clinical Trials Registry (ANZCTR) | www.anzctr.org.au |
| ClinicalTrials.gov | www.clinicaltrials.gov |
| International Standard Randomised Controlled Trial Number Register (ISRCTN) | www.ISRCTN.org |
| University Hospital Medical Information Network Clinical Trial Registry (UMIN-CTR) | www.umin.ac.jp/ctr/index/htm |
| Netherlands Trial Register | www.trialregister.nl/ |
| European Union Drug Regulating Authorities Clinical Trials (EudraCT) Database | https://eudract.ema.europa.eu/ |
| Any of the primary registries that participate in the WHO International Clinical Trials Registry Platform (ICTRP) | http://www.who.int/ictrp/network/primary/en/index.html |
The reporting of observational studies frequently lacks details and is not clear enough 18 , 19 . Consequently the quality is poor although many questions in medical research are investigated in observational studies and overwhelming evidence is also extrapolated from them 20 . In fact, observational studies are more suitable for the detection of rare or late adverse effects of treatments, and are more likely to provide an indication of what is achieved in daily medical practice 21 .
To improve the reporting of observational studies (cohort, case-control or cross-sectional studies) a group of methodologists, researchers and editors developed a useful checklist of 22 items: the StrengThening the Reporting of OBservational studies in Epidemiology (STROBE) Statement 21 . The checklist items pertain to the content of the Title, Abstract, Introduction, Methods, Results, Discussion and Other information sections of articles. The STROBE checklists can be freely viewed and downloaded at the STROBE website under the section “Available checklists” 22 . They also include a draft checklist for conference abstracts (items to be included when reporting observational studies in a conference abstract) pertaining to the content of the following sections: Title, Authors, Study design, Objective, Methods, Results and Conclusion.
The STROBE Statement provides guidance to authors on how to improve the reporting of observational studies, it facilitates critical appraisal and interpretation of studies and is widely supported by reviewers, a growing number of biomedical journal editors and readers.
The STROBE checklist is best used in conjunction with an explanation and elaboration article which discusses each of the 22 checklist items, gives methodological background, publishes examples of transparent reporting and is freely available at the STROBE Statement website under the above mentioned section through the link with the Journals in which the document has been published (PLoS Medicine, Annals of Internal Medicine and Epidemiology) 22 .
As review articles comprehensively cover a specific biomedical topic and justify future research directions, they require that the author extensively review and master the literature and then develop some general statements and conclusions with practical implications for patients’ care 23 , 24 . In addition, they should provide an updated reference for those readers interested in broadening their knowledge of critical issues. Review articles are, therefore, important not only for younger physicians early in their career but also for senior academic staff as they represent a tool for intellectual enrichment and enhancement of the standards of research. Writing a review requires knowledge and continuous improvement of qualifications in line with the accumulation of better and updated scientific literature evidence. For this reason, journals often invite experts on a specific topic to write a review article. However, authors can also ask Editors if they would be interested in publishing a review article on a particular, topical, relevant and debated issue.
As reviews are the most accessed among the various types of articles and contribute substantially to the impact factor of journals, obviously they are welcomed and encouraged by many journals and have become an inseparable part of the writing scientific culture.
The three basic types of literature reviews are narrative reviews (which include editorials, commentaries and narrative overviews or non-systematic narrative reviews), qualitative systematic reviews and quantitative systematic reviews (meta-analyses) ( Table II ) 25 .
Summary of the types of literature reviews.