MEDICAL PUBLISHING SERIES Jyoti Shah, Pippa Smart Series Editors E: [email protected], [email protected] doi: 10.1308/003588415X14181254788926

What to publish ‘The writer is an explorer. Every step is an advance into new land.’ Ralph Waldo Emerson Technological developments have transformed communications in the modern era. Innovations like Wikipedia have replaced shelves of encyclopaedias and e-books are replacing textbooks. Nevertheless, the scientific journal article has remained stagnated to a presentation that is as old as the academic journal itself: introduction, methods, results and discussion. The only difference is that they are much longer! The average scientific article in 1975 was 7.4 pages long and this has risen to 12.4 pages within a few decades.1 Despite this, readers are spending less time reading.2 Are they busier or has their attention span become shorter? If audiences are mainly reading the abstract, the conclusions, and looking at the illustrations, with only some maybe reading the whole article, perhaps articles need to reflect this change? Most journals want original, focused, well written articles, and manuscripts that advance the knowledge and understanding in a certain field. Communication can, however, be more than the original scientific article: case reports, reviews or summaries and letters or other short forms of communication. In this article Professor Alderson, editor-in-chief of the British Journal of Surgery, discusses what types of medical publications exist and at what stage of your career to consider writing them. What is clear is that readers are not interested in reports with no scientific interest, out-of-date work, duplications of previously published work and incorrect or unacceptable conclusions. JYOTI SHAH Commissioning Editor References 1. 2.

Tenopir C, King DW. Communication Patterns of Engineers. New York: Wiley; 2004. Maynard S. A Survey on the Use of Different Forms of Scholarly Output. Loughborough: Loughborough University; 2007.

D Alderson Barling Professor of Surgery, University of Birmingham, UK

CORRESPONDENCE TO Derek Alderson, E: [email protected]

There is no shortage of work that might be publishable. It may seem daunting to a clinician or researcher to know where and how to publish their research and findings, and what types of articles are most suitable. The key to being published is to have something interesting to write about and to ensure that you present it in a suitable format to the most appropriate journal. You may have the most fascinating research to present to the world but you must consider the most suitable presentation style – what type of article is most suitable? Does your research warrant a short case study or a long systematic review?

For most aspiring authors, the first opportunity comes as a result of a clinical experience that suggests a case report might be worthwhile. Writing a case report is a useful exercise in learning to overcome writer’s block (getting the words out of your head and on to the page) and reviewing existing literature on your chosen topic (when you will probably learn something new). Case reports may be considered ephemeral (or may even be discouraged in some journals) but they can be useful to clinicians and there are some specialist journals that serve to publish case reports exclusively. It is important to remember,

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Table 1 Types of articles and at what point in your career you should consider them Novice

Intermediate

Advanced

Case reports

Randomised controlled trials

Leading articles

Clinical audits

Observational studies

Invited reviews

Study protocols

Systematic reviews Experimental studies

however, that the case report must be novel and have a learning point. A high quality image nearly always helps and you will probably need permission to reproduce clinical images. Setting the case report aside, Table 1 lists the other main types of articles that you can publish and gives you some idea of when to tackle them. Most relate to clinical surgery but educational material is topical and may also be of interest. Space here limits a detailed description of publishing laboratory-based work but Box 1 lists the main types of articles that are published. Until you have genuinely become an expert, do not offer to write leading articles although you do not have to be a consultant to be an expert.1 Irrespective of article type, planning the research project that will lead to a potential publication is the key to success. In this planning phase, ensure that: > > > >

you have a clear research question there is a train of thought that is scientifically credible the originality of the work is clear you can explain its applicability to clinical disease

At the end of the study planning phase, there is an opportunity to publish the protocol as a citable source. This sets out what you intend to do and how you will go about it. It allows you to get feedback through peer review and inhibits post-hoc analyses based on study results. Posthoc tests are often used in situations where you can decide which comparisons you want to make after the experiment has concluded and after looking at the data. You do not need to plan ahead for this and the more you look at the data, the more likely it is that something will be found. In practice, post-hoc analyses are usually concerned with finding patterns that may have otherwise been undetected and undiscovered. Publishing the protocol as a citable source also allows funders, other researchers and patients to find out about the study. Some elements are common to most scientific articles. For nearly all studies, it is necessary to formulate a hypothesis that can be tested. The introduction should explain this clearly, leading to specific aims (the study endpoints). The methods then indicate the measures you have taken to minimise confounding and bias through your chosen study design. Statistical methods are the ways in which you express the precision of your results. Applicability of the results, their biologic relevance and their importance to

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human disease nearly always need to be covered in the discussion. All studies have limitations and these need to be acknowledged. Failure to follow these simple steps usually means rejection. One other important consideration is authorship. This is covered elsewhere in this series but it is worth noting here that you should try to agree authorship early in your research planning to avoid problems later about who should be named on your articles. Of the various different article types, some words are necessary in relation to each in order to avoid the common failings that lead to rejection.

Systematic reviews Systematic reviews and the accompanying statistical methods for combining individual study outcomes (meta-analysis) should be undertaken according to PRISMA (preferred reporting items for systematic reviews and meta-analyses) guidelines. Submission of a modified thesis introduction seems a popular pastime but is unlikely to conform to these guidelines. Systematic reviews are popular on the basis that they are thought to represent the highest levels of evidence. This is only true of those reviews based on randomised controlled trials (RCTs). Many surgical RCTs are underpowered and individual studies have differences in design that create heterogeneity, diminishing the value of the article.2 Performing a systematic review can be a useful way of carefully formulating a research question but you need to be trained about how to undertake this type of review correctly. Unless you have received this type of training, this is not the easiest place to start a writing career.

Randomised controlled trials RCTs represent the next best level of evidence. They are the best approach to testing efficacy and effectiveness. Efficacy or explanatory trials usually ask whether a new procedure B is better than a standard procedure A, often under ideal or restricted circumstances. Pragmatic or effectiveness trials then ask whether B is better than A or other accepted standard procedures when applied to a wider patient group or undertaken by a wider group of surgeons. Pragmatic trials are becoming more popular, as are adaptive trial designs.3 RCTs benefit from stratification where known prognostic confounders can be allocated equally to each group. Nevertheless, they are not immune to bias (consider the difficulties of blinding in surgical studies) and generalisability is always a problem when considering operations that apply to only a subset of patients. They are not much use if the exposure and outcome are many years apart (radiotherapy to the mediastinum and myocardial ischaemia) or where the outcome is very rare (recurrent nerve injury after thyroid surgery). Despite these deficiencies, RCTs do influence clinical practice, and they can be devised and executed by surgical trainees.4 They lend themselves to multicentre collaboration that improves

WHAT TO PUBLISH

Box 1 A to Z of publication types Abstract: A short abbreviated summary of a research article, thesis, review, conference proceeding or any other larger piece of work Bibliography: A list of books, articles, documents, publications and websites that are usually linked to a single subject or related subjects Book review: An article that critically analyses a book Case-controlled study: A study in which patients with a disease (cases) are compared with a group without the disease (controls) to see whether exposure to any factor has occurred more or less frequently in each group Case report: A clinical presentation of a difficult or unusual case that is usually followed by a literature search of the diagnosis Clinical trial: A clinical study of the safety, efficacy or optimum dose schedule of one or more diagnostic, therapeutic or prophylactic drugs, devices or techniques. This is usually a pre-planned study involving human subjects who are observed for a length of time. Clinical trial, phase I: A clinical trial carried out in a small number of healthy people to understand what effects an investigational product or procedure has. Allows scientists to determine what happens to the product in the body from when it has been administered to when it is excreted. Clinical trial, phase II: A trial designed to evaluate the safety and efficacy of an investigational product in patients with a specific illness or condition. Most subjects are at the same stage of the disease, and various doses are administered and monitored to establish the safest dosing regimen. Clinical trial, phase III: A trial carried out in a large number of patients where an investigational product may be compared with other available treatments or tested in combination with other therapies. The safety and efficacy of this new product is compared with that of currently acceptable standard treatment. Clinical trial, phase IV: A trial carried out after the investigational product has been approved for sale. The trial is designed to give wider experience of its safety and effectiveness in a larger number of patients, and to compare or combine it with other treatments. Phase IV studies largely focus on the long-term effects of the product. Clinical trial protocol: A document that describes the objectives, design, methodology, statistical considerations and organisation of a clinical trial Cohort study: A report of a group of patients followed over a period of time to assess the incidence of a disease or to describe the effect of an exposure to one or more factors of interest on the incidence of the outcome. Can be prospective or historical. Comment: A critical or explanatory note that is written to discuss, support or dispute an article that has already been published. Can be published as an article, letter, editorial, commentary, viewpoint or editorial comment. Editorial: An article that presents an opinion, a belief or policy of the editor or publisher of a journal, usually on a topic that is of current scientific or medical interest. Sometimes editorials are invited from external experts (guest editorial). Erratum (also called corrigendum): Note to correct an error in a published article Evaluation study: Work done to determine the effectiveness or use of a process, person or equipment Experimental study: A report of an intervention in the care of a patient undertaken in a pre-planned manner (eg randomised controlled trials or laboratory studies) Guideline: An article that contains statements, directions or principles to help decide on appropriate care for a specific clinical condition or circumstance. They are designed to reduce unacceptable or undesirable variation in practice and usually come from authorised bodies or working groups. Letter: Usually a commentary about a published article or a response from the authors of an article to a previously published comment or letter. Also sometimes a general comment about the medical discipline or another matter of interest to readers. Meta-analysis: A study combining the results of independent and usually published articles, producing a summary and conclusion using a quantitative method. It is often an overview of clinical trials and not to be confused with a review of the literature. Multicentre trial: A controlled study that is carried out by several cooperating institutions Observational study: A clinical study in which subjects may receive an intervention but this is not assigned by the investigator, who observes and records what happens (eg cohort studies and case-controlled studies) Original article: A generic term used to cover any article reporting original research Protocol: Rigid statements that set out a precise and logical sequence of listed activities that should be adhered to with little variation or flexibility Randomised controlled trial: A trial in which a similar number of people are randomly assigned to two (or more) groups to test a specific treatment. The experimental group receives the treatment being tested and the comparison or control group receives an alternative dummy (placebo) treatment or no treatment at all. All groups are followed up to see how effective the experimental treatment was. Retraction: Note to explain why an article should be removed from the scholarly record. Only articles that have severe ethical, technical or methodological errors are retracted. Review: An article that summarises and critically evaluates the current state of understanding on a topic that has been published previously by others. Can be systematic (determine an objective list of criteria and find all previous articles published that meet the criteria) or literature (usually a summary of what the authors believe are the best/relevant previous publications). study that sets out to establish the reliability. Validation study: A study that sets out to establish the reliability and relevance of a procedure

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recruitment and lessens the bias of a single centre study. There are enormous opportunities to transform surgery through pragmatic multicentre and multinational trials. There are straightforward guidelines to help construct and report RCTs: CONSORT (consolidated standards of reporting trials).

Observational studies (non-experimental studies about benefit, harm or causation) Every other type of clinical article falls into this category. They are often derided as being poor evidence as the investigator does not control allocation of the exposure (treatment) to the participants. Nevertheless, studies about prognosis are best done with a longitudinal cohort design and trying to evaluate the accuracy of a diagnostic test is best done with a cross-sectional study. The use of case controls and propensity score matching can strengthen the observations made from a case series. In general, simple case series are difficult to publish nowadays owing to lack of originality and missing data if there is no prospective database. Many specialist centres have clinical databases devoted to their practice and database mining is another popular pastime often encouraged on the basis that a prospectively developed database is complete. It is always preferable to ask the research question first and then see if it can be answered by information in the database rather than trawling the database for results and then trying to formulate a question that fits the answer. Fishing trips like this usually result in rejection. The STROBE (strengthening the reporting of observational studies in epidemiology) guidelines are useful in the preparation of manuscripts in this category.

Clinical audits These are not research articles but are publishable material. They are rejected frequently because the audit cycle has not been completed. They are often difficult to publish outside the country of origin as the results generally reflect the healthcare system. Again, like a systematic review, a well conducted audit can be used to develop a worthwhile research question.

Key questions > > >

Are the essentials present (clear hypothesis, originality, applicability to human disease)? Have you designed the study to minimise bias and confounding? Do you understand its limitations?

Reference 1. 2.

3. 4.

Lewis TL, Vohra RS. Smartphones make smarter surgeons. Br J Surg 2014; 101: 296–297. Sjoquist KM, Burmeister BH, Smithers BM et al. Survival after neoadjuvant chemotherapy or chemoradiotherapy for resectable oesophageal carcinoma: an updated meta-analysis. Lancet Oncol 2011; 12: 681–692. Chow SC, Chang M. Adaptive Design Methods in Clinical Trials. 2nd edn. Boca Raton, FL: CRC Press; 2012. Pinkney TD, Calvert M, Bartlett DC et al. Impact of wound edge protection devices on surgical site infection after laparotomy: multicentre randomised controlled trial (ROSSINI Trial). BMJ 2013; 347: f4305.

Coming up next time In the third article in this series, Elisabeth Heseltine informs readers ‘How to write’. Elisabeth became a scientific editor through science rather than language. She has worked as a researcher on the BBC science programmeHorizo n, as a proof-reader and then as copy-writer. She is head of publications at the World Health Organization International Agency for Research on Cancer, in Lyon, France. She has edited many documents for other United Nations agencies and for research institutes around the world. She also runs workshops in scientific communication in over 30 countries.

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What to publish.

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