Decide what the paper contributes
Before a research paper is drafted, its authors settle why it should be published and how its story will be told. Those decisions rest on why research is published at all, on what readers want from a research paper, on whether the work is research that has something to report, on the significance the target journal weighs, and on the qualities editors and readers look for in the manuscript.
Why research is published
Publishing papers in medical and scientific journals is an important way of communicating research results, in an academic or a commercial setting alike, and by one account the most important. Whether a researcher writes the paper or a medical writer writes it on a researcher's behalf, three questions come first: why publish, which journal, and how to unveil the scientific story. In the commercial setting the reason for publishing is usually connected with marketing strategies, while academic publishing primarily aims to advance scientific and medical knowledge.
Reporting clinical research findings in peer-reviewed journals, from single-patient case reports to large multicentre clinical trials, is an important way to disseminate new medical knowledge and improve clinical practice, both regionally and internationally. Reasoning is ideally based on observed facts, that is, on data, and the report of a clinical study is medical science's best format today for presenting and analysing them. The advancement of science depends on sharing knowledge in print.
Whether the researcher is a patient care physician or a research-track academic, and whether the work was a bench project in the laboratory or a randomized clinical trial, the research is not completed until its results are reported in print. In academic medicine there is no substitute for publication. However brilliant the idea, groundbreaking the research or proficient the writing, the effort is largely wasted if the paper is not published, so that it can be cited, criticised or praised.
A critical aspect of a career in medicine involves sharing clinical experiences and research findings with the broader medical community. Reporting findings in a peer-reviewed journal is one measure of career success for clinical researchers. For a clinical investigator in academic medicine, getting results published can be the difference between professional success and failure, and can determine whether the investigator gets a big grant or receives tenure. Entire academic careers have been built on a single groundbreaking research study, carefully reported in a prestigious journal.
What readers want from a research paper
One editor sees a conflict of interest between writer and reader. Researchers have much they would like to share about their project and what they have learned from the literature, while most readers of science papers want to get to the main point, what is new, as quickly as possible. For example, a researcher who recommended that colleagues publish in British journals because they allow more words than American ones said she preferred to read the American ones, because they are shorter.
Research reports are intended to be recorded in the scientific literature and subsequently cited by others, not to be read in the usual sense: they are repositories of scientific data rather than literary gems, and they just happen to be written in prose. In one scientist's view, the communication of research results is a more prosaic procedure than literature. Even so, authors of research papers should construct paragraphs thoughtfully, avoid long and convoluted sentences, select words carefully, avoid jargon and express their ideas as clearly as possible.
In a report of clinical research, the art of writing must take a back seat to research design. Such a report is chiefly about medical science, where art cannot trump science, and skilful prose should not mask questionable methods or unjustified conclusions.
What counts as reportable research
In most cases, the decision to write a paper comes when there are meaningful research results to report. Preparing the report of original research is arguably the most challenging undertaking in medical writing, less because the writing is complicated, since the model is prescribed, than because it needs a completed study with its data available.
A research report describes research, whether it involves humans, rats or a meta-analysis of previously published studies, and in general the researcher generates a research question and then collects data to answer it. Studies such as one asking whether aircraft noise is associated with death from myocardial infarction, or a well-designed study of probiotics in colicky babies, have research questions that, in one experienced author's view, provoke interest, and reports like these have implications for daily practice and public health. The definition of research can be stretched too far. A surgeon's findings from the last 200 cases of an operation, or an internist's account of 100 consecutive patients treated for congestive heart failure, do not set out to answer a clinical question and generally have nothing important to say; they may qualify as quality improvement efforts but are not likely to result in a publishable research paper.
Data mining, sifting through tons of data to find anything that has statistical significance, is not good research, and an informed reviewer will deem a paper describing it inferior. Parachute trials take their name from the fanciful research question whether parachutes are effective in preventing major trauma related to gravitational challenge. A study showing that antibiotic therapy of meningitis is more effective than watchful waiting would be one, and would hardly need reporting; a published genetic study showing basically that overweight mothers had overweight babies is another, and perhaps even a report that released prisoners taking their psychotropic medication behaved less violently. Data mining and parachute trial reports are published, but the best hypothesis-based studies have the best chance of acceptance in the leading journals.
The significance a journal weighs
Competition for publication space in leading refereed journals is intense, and research papers are typically rewritten several times before final acceptance. A clinical research paper is ultimately judged by its impact on its specialty and on the greater body of medical knowledge, as evidenced by its citation in other research articles, review papers and textbooks.
A journal editor's goal is to increase the status of the journal in its field, so editors are interested in high-quality research that is novel and has high clinical relevance, and in manuscripts that will interest their readers and be highly cited. Editors also want manuscripts written in clear and concise English, which means not simply good spelling and grammar but communicating the authors' ideas and findings clearly and effectively.
Significance indicates the importance of an article's findings, and it can be divided into three components: novelty, relevance and appeal.
Journals differ in how much weight they put on significance. Some will accept an article on well-executed research alone; others, especially those with a higher impact factor, place greater emphasis on the significance of the findings, so authors should evaluate that significance honestly and objectively when choosing a journal. Writing a clinical manuscript that has impact and relevance to its intended audience is crucial for publication success.
Novelty, relevance and appeal are clearly interrelated, but each should be considered independently and emphasised in the manuscript, so that the significance of the article is clearly communicated.
Novelty should be communicated clearly, particularly where the findings represent a conceptual advance in the field. Authors often overestimate the novelty of their results, so a medical writer needs to know the general state of the field and to have a keen eye for results that might have wide-reaching implications. Identifying the novel aspects of the findings, such as a new mechanism of disease or improved safety of a new medicine, helps the writer focus the manuscript on the most important results and interpretations. Where the findings represent only a small or incremental advance, the manuscript might focus instead on how the results will help improve current practice or suggest next steps in research.
Relevance turns on whether the results have implications only for a restricted geographical location or ethnic group, or for broader areas and populations. Authors may want to emphasise regional findings locally to maximise their immediate practical use, but the broader the relevance, the greater the significance and impact worldwide. A medical writer needs to consider the authors' goals and target audience and to tailor the discussion of relevance to them.
Appeal bears on citation: journal editors want research that will be widely read and highly cited, and research with a high level of popular appeal is likely to be cited more simply because more people become aware of it. So a medical writer should work with the authors to identify the important research questions their work raises and to emphasise its potential clinical applications in the manuscript.
Qualities editors and readers look for
Editors and readers look for a set of qualities in a medical oncology paper, and regardless of the research topic or target journal, medical writers working on clinical manuscripts should aim to include all of them somewhere in the manuscript and emphasise to authors the importance of including them:
- Accurate, objective reporting of methodology and results: enough method detail to replicate, a clear rationale, a calculation of statistical power and limited interpretation in the results section.
- Concise illustrations and descriptions: figures showing key outcomes such as progression-free survival, overall survival and response rates, and a table listing adverse events.
- Insightful and objective discussion: findings placed in the context of what is known, with limited speculation and statements supported by evidence.
- Full disclosure and registered trial: the registry and registration number given.
- Full ethical compliance: the details of institutional review board approval and informed consent given.
- Multiple, complementary, well-controlled experiments: a combination of imaging, pathology and clinical work-up to tell a more convincing story.
- Mechanistic findings to complement clinical findings: cellular or biochemical findings to support descriptions of clinical effects.
- Clear description of clinical implications and how the findings might influence clinical practice: what the results mean for patients and how clinical decisions might be improved on the basis of the findings.
Combining these elements produces a high-quality clinical manuscript containing information that influences clinical practice, based on the most appropriate methods for the research question.